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1

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

PubMed

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

2013-08-05

2

Long term safety and efficacy of unilateral deep brain stimulation of the thalamus for parkinsonian tremor  

Microsoft Academic Search

The objective was to investigate the long term safety and efficacy of unilateral deep brain stimulation (DBS) of the VIM nucleus of the thalamus in Parkinson's disease.Twelve patients with Parkinson's disease underwent unilateral DBS of the thalamus for medication resistant tremor between 1994 and 1997. Patients were evaluated with the motor section of the unified Parkinson's disease rating scale (UPDRS)

K E Lyons; W C Koller; Steven B. Wilkinson; R Pahwa

2001-01-01

3

Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis  

Microsoft Academic Search

Objectives. Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor a (TNF-a) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration. Methods. In this 54-week open

J. Brandt; J. Listing; H. Haibel; H. Sorensen; A. Schwebig; M. Rudwaleit; J. Sieper; J. Braun

2005-01-01

4

Long-term treatment of cervical dystonia with botulinum toxin A: efficacy, safety, and antibody frequency  

Microsoft Academic Search

Data from 616 patients suffering from idiopathic cervical dystonia were analyzed to determine the efficacy and safety of\\u000a treatment with botulinum neurotoxin type A (BoNT\\/A). Since the specific purpose of this study was to determine the long-term\\u000a effects of this treatment, the analysis focused specifically on the patients (n = 303) having received six or more injections. Statistical analysis of

Kirn R. Kessler; Michael Skutta; R. Benecke

1999-01-01

5

Efficacy and safety of risperidone in the long-term treatment of patients with schizophrenia  

Microsoft Academic Search

The long-term efficacy and safety of risperidone were evaluated in patients with chronic schizophrenia in an open-label study. Thirty-two patients received risperidone for 1 year and 19 of the 32 received risperidone for 2 years. The mean dose of risperidone was 9.4 mg\\/d in the 1-year follow-up and 8 mg\\/d in the 2-year follow-up. At the end of 1 and

Eva Lindström; Bo Eriksson; Anders Hellgren; Lars von Knorring; Göran Eberhard

1995-01-01

6

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.

Ramirez-Castaneda, Juan; Jankovic, Joseph

2013-01-01

7

Long-term efficacy and safety of gabapentin enacarbil in Japanese restless legs syndrome patients.  

PubMed

Several short- and long-term studies conducted in Europe/North America have demonstrated good efficacy and tolerability of 600-1800 mg gabapentin enacarbil (GEn). However, no studies have evaluated the efficacy of long-term treatment with GEn in Asian patients. Therefore, the objective of this study was to evaluate the efficacy and safety of long-term treatment with GEn in Japanese patients with restless legs syndrome (RLS) in a multicenter open-label study. RLS patients aged 20-80 years were allocated to receive oral GEn 1200 mg/day for a treatment period of 52 weeks. International Restless Legs Syndrome Scale (IRLS) score, investigator- and patient-rated Clinical Global Impression (CGI) scores, Pittsburgh Sleep Quality Index (PSQI) total scores and subscores, and short form (SF)-36 subscores were assessed, and adverse events (AEs) were monitored. In 181 patients (mean age, 54.9±12.2 years; BMI, 23.0±2.6 kg/m²) IRLS score decreased from 24.4±0.4 at baseline to 6.3±0.6 at week 52, with a reduction of -18.0±0.6. The IRLS responder rate was 80.3% at week 52. ICGI and PCGI responder rates were 87.1% and 87.1%, respectively. PSQI and SF-36 also showed significant improvements. AEs were reported in 96.2% of patients but remained mild-to-moderate in nearly all the cases. Serious AEs occurred in 1.6%. Dizziness and somnolence were noted in 46.2% and 41.2% of patients, respectively, and mostly occurred during the first 4 weeks. No episodes of augmentation were reported. In conclusion, long-term treatment with GEn improved RLS symptoms as well as investigator- and patient-reported outcomes in Japanese patients with moderate-to-severe RLS, with an acceptable safety profile. Randomized, double-blind, placebo/active-controlled trials are desirable to confirm these preliminary results. PMID:22036917

Inoue, Yuichi; Uchimura, Naohisa; Kuroda, Kenji; Hirata, Koichi; Hattori, Nobutaka

2011-10-19

8

Long-term safety and efficacy of endovascular abdominal aortic aneurysm repair  

PubMed Central

Endovascular abdominal aortic aneurysm repair (EVAR) is a safe and efficacious treatment for both unruptured and ruptured abdominal aortic aneurysms. While perioperative mortality is lower with EVAR, long-term outcomes are similar between EVAR and open repair, including quality of life and cost-effectiveness. We review the long-term outcomes from the EUROSTAR registry, and DREAM, EVAR 1, and OVER trials.

Propper, Brandon W; Abularrage, Christopher J

2013-01-01

9

Long-term efficacy and safety of eculizumab in Japanese patients with PNH: AEGIS trial.  

PubMed

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, progressive hematopoietic stem cell disorder characterized by chronic complement-mediated hemolysis leading to life-threatening complications and early mortality. Eculizumab, a humanized anti-C5 monoclonal antibody, inhibits terminal complement activation, reduces hemolysis, decreases the risk of thrombosis, and improves renal function and quality of life in PNH patients. The long-term efficacy and safety of eculizumab in Japanese patients were assessed in a 2-year extension to a 12-week, open-label study (AEGIS). Eculizumab treatment led to an immediate and sustained reduction in intravascular hemolysis (P < 0.001) and red blood cell transfusions (P = 0.0016) compared with baseline levels. There were no reports of thromboembolism during eculizumab treatment. The majority of patients had stable (56 %) or improved (41 %) renal function and an improved quality of life (P = 0.015), with sustained reductions in fatigue and dyspnea. Eculizumab was well tolerated; no deaths or serious hemolytic events were reported, and the rate of infections declined over time. There were no significant differences in the response to eculizumab in patients with or without bone marrow dysfunction. These results demonstrate that eculizumab is an effective, well-tolerated long-term treatment for Japanese PNH patients and leads to continued amelioration of some hemolytic complications. PMID:23934275

Kanakura, Yuzuru; Ohyashiki, Kazuma; Shichishima, Tsutomu; Okamoto, Shinichiro; Ando, Kiyoshi; Ninomiya, Haruhiko; Kawaguchi, Tatsuya; Nakao, Shinji; Nakakuma, Hideki; Nishimura, Jun-Ichi; Kinoshita, Taroh; Bedrosian, Camille L; Ozawa, Keiya; Omine, Mitsuhiro

2013-08-11

10

Deferasirox: appraisal of safety and efficacy in long-term therapy  

PubMed Central

Deferasirox is a once-daily, oral iron chelator that is widely used in the management of patients with transfusional hemosiderosis. Several Phase II trials along with their respective extension studies as well as a Phase III trial have established the efficacy and safety of this novel agent in transfusion-dependent patients with ?-thalassemia, sickle-cell disease and bone marrow-failure syndromes, including myelodysplastic syndrome and aplastic anemia. Data from various clinical trials show that a deferasirox dose of 20 mg/kg/day stabilizes serum ferritin levels and liver iron concentration, while a dose of 30–40 mg/kg/day reduces these parameters and achieves negative iron balance in red cell transfusion-dependent patients with iron overload. Across various pivotal clinical trials, deferasirox was well tolerated, with the most common adverse events being gastrointestinal disturbances, skin rash, nonprogressive increases in serum creatinine, and elevations in liver enzyme levels. Longer-term extension studies have also confirmed the efficacy and safety of deferasirox. However, it is essential that patients on deferasirox therapy are monitored regularly to ensure timely management for any adverse events that may occur with long-term therapy.

Chaudhary, Preeti; Pullarkat, Vinod

2013-01-01

11

Long-term safety and efficacy of endovascular abdominal aortic aneurysm repair.  

PubMed

Endovascular abdominal aortic aneurysm repair (EVAR) is a safe and efficacious treatment for both unruptured and ruptured abdominal aortic aneurysms. While perioperative mortality is lower with EVAR, long-term outcomes are similar between EVAR and open repair, including quality of life and cost-effectiveness. We review the long-term outcomes from the EUROSTAR registry, and DREAM, EVAR 1, and OVER trials. PMID:23579199

Propper, Brandon W; Abularrage, Christopher J

2013-04-03

12

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

13

Long-term, Multicenter Study of the Safety and Efficacy of Topical Alprostadil Cream in Male Patients with Erectile Dysfunction  

Microsoft Academic Search

Introduction. Alprostadil is approved for treatment of male erectile dysfunction (ED) by injection or urethral insertion. Topical delivery of alprostadil offers an improved alternative. Aim. To evaluate the long-term safety and efficacy of topical alprostadil cream. Methods. This was a multicenter, open-label, long-term study in 1,161 patients (998 double-blind rollover; 163 naïve) with ED. For the first 4 weeks, patients

Michael Rooney; William Pfister; Mary Mahoney; Melissa Nelson; James Yeager; Christopher Steidle

2009-01-01

14

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

PubMed

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

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

2013-04-25

15

Long-term Efficacy and Safety of Piracetam in the Treatment of Progressive Myoclonus Epilepsy  

Microsoft Academic Search

Background: Piracetam has been proven to be effec- tive and well tolerated in the treatment of myoclonus in short-term studies. Objective: To assess its long-term clinical efficacy, 11 patients with disabling myoclonus due to progressive my- oclonus epilepsy were treated with piracetam in an open- label study. Methods: Neurologic outcome (at the 1st, 6th, 12th, and 18th month of treatment)

Marco Fedi; David Reutens; Francois Dubeau; Eva Andermann; Daniela D'Agostino; Frederick Andermann

2001-01-01

16

Staphylococcus aureus Bacteremia and Buttonhole Cannulation: Long-Term Safety and Efficacy of Mupirocin Prophylaxis  

PubMed Central

Background and objectives: Buttonhole (constant-site) cannulation (BHC) continues to gain popularity with home and in-center dialysis programs worldwide. However, long-term safety data are lacking. This paper reports the authors' single-center experience with Staphylococcus aureus bacteremia (SAB) and the efficacy of topical mupirocin prophylaxis (MP). Design, setting, participants, & measurements: This study was a retrospective prepost comparison of SAB rates after establishing MP. Fifty-six consecutive patients on home nocturnal hemodialysis via arteriovenous fistulae, mean age 51.5 ± 10.6 years, 38% women, and vintage 44.5 ± 34.5 months were observed for a total of 93.4 (pre-MP) and 193.5 (post-MP) patient-years. Results: Ten episodes of SAB were observed, with metastatic complications in four cases, including pneumonia (n = 2), septic arthritis, and a fatal C3 epidural abscess. When analyzed by observation period, the odds ratio (OR) for SAB before versus after the introduction of MP was 6.4 [95% confidence interval (CI) = 1.3 to 32.3; P = 0.02]. Two SAB episodes occurred after the MP started. Both patients had discontinued the MP for 3 weeks (nonadherent) preceding infection; hence, no SAB episodes were observed on treatment. In an as-treated analysis, the OR for SAB in the absence of MP was 35.3 (95% CI = 2.0 to 626.7; P = 0.01). Conclusions: BHC is associated with a significant risk of SAB with metastatic complications. In this prepost comparison of SAB rates, no infections were observed with MP. While awaiting more definitive studies, this simple intervention should be considered for patients using BHC.

Cuerden, Meaghan; Wong, Joseph H.S.; Pierratos, Andreas

2010-01-01

17

Long-term efficacy and safety outcomes with OROS-MPH in adults with ADHD  

PubMed Central

Methylphenidate (MPH) is widely prescribed for adults with attention deficit hyperactivity disorder (ADHD), but data on long-term treatment and maintenance of effect are lacking. Osmotic release oral system-methylphenidate (OROS–MPH) was evaluated in a 52-wk open-label study in subjects who had previously completed a short-term placebo-controlled trial and short-term open-label extension. Efficacy was assessed using the investigator- and subject-rated Conners’ Adult ADHD Rating Scales (CAARS:O-SV and CAARS:S-S), and the Clinical Global Impression – Severity (CGI-S), Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects completing ?52 wk of treatment were eligible for a 4-wk randomized, placebo-controlled withdrawal phase in which loss of treatment effect was assessed using CAARS:O-SV and CGI-S. In the open-label phase (n=156), mean CAARS:O-SV score decreased from baseline by 1.9±7.8 (p<0.01), and small, statistically significant improvements from baseline were observed for CAARS:S-S, CGI-S and SDS. In the double-blind phase (OROS-MPH, n=23; placebo, n=22), CAARS:O-SV increased from double-blind baseline in the OROS-MPH and placebo arms (4.0±7.6 vs. 6.5±7.8, not statistically significant). Long-term OROS-MPH treatment was well tolerated, and there was no evidence of withdrawal or rebound after discontinuation. In conclusion, the short-term benefits of OROS-MPH continue during long-term open-label treatment. Maintenance of efficacy in a placebo-controlled withdrawal design remains to be confirmed in larger patient populations.

Buitelaar, Jan K.; Trott, Gotz-Erik; Hofecker, Maria; Waechter, Sandra; Berwaerts, Joris; Dejonkheere, Joachim; Schauble, Barbara

2012-01-01

18

Safety and Efficacy of Long-Term Use of Rimantadine for Prophylaxis of Type A Influenza in Nursing Homes  

Microsoft Academic Search

The safety and efficacy of rimantadine for long-term prophylaxis of influenza A (H3N2) infection were evaluated among elderly residents in 10 nursing homes. Within each nursing home, participating residents wererandomlyassignedtoreceiveplaceboorrimantadineat100or200mg\\/day.Residentswereevaluateddaily for symptoms and significant health events as possible side effects, as well as for influenza-like illness. The study medications were administered to 328 residents for up to 8 weeks, with

ARNOLD S. MONTO; SUZANNE E. OHMIT; KENNETH HORNBUCKLE

1995-01-01

19

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

Microsoft Academic Search

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

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

2000-01-01

20

Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia  

PubMed Central

Introduction Previously, controlled trials have demonstrated the efficacy and tolerability of fixed doses of incobotulinumtoxinA (Xeomin, NT 201, botulinum toxin type A free from complexing proteins) to treat cervical dystonia (CD). To explore the clinical relevance of these findings, this study evaluated long-term use of flexible dosing regimens of incobotulinumtoxinA in a setting close to real-life clinical practice. Methods Patients with CD received five injection sessions of incobotulinumtoxinA using flexible intervals (10–24?weeks) and dosing (?300 Units) based on patients’ needs. Outcome measures included Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), the Dystonia Discomfort Scale (DDS), Investigator Global Assessment of Efficacy (IGAE) and Patient Evaluation of Global Response (PEGR). Results Of 76 patients enrolled (men: 34%; naïve to botulinum toxin: 25%), 64 completed the study, receiving treatment over a duration of 49.3–114.1?weeks (total maximum duration: 121?weeks). Mean TWSTRS-Total and DDS scores significantly improved from study baseline to 4?weeks after each injection session (ranges of improvement: TWSTRS-Total: ?11.7 to ?14.3; DDS: ?20.2 to ?23.0). Up to 81.6% of investigators rated the efficacy as ‘good’ or ‘very good’ (IGAE) and up to 78.9% of patients rated the treatment response as ‘improved’ (PEGR). The most common adverse events were dysphagia, nasopharyngitis and headache. Conclusions In this long-term study, incobotulinumtoxinA was administered using more flexible dosing regimens than those permitted in previous controlled trials. Repeated injections of highly purified incobotulinumtoxinA are effective and well tolerated for the treatment of CD in a setting close to real-life clinical practice.

Dressler, Dirk; Paus, Sebastian; Seitzinger, Andrea; Gebhardt, Bernd; Kupsch, Andreas

2013-01-01

21

Short and long-term efficacy and safety of risperidone in adults with disruptive behavior disorders  

Microsoft Academic Search

Rationale: Function in society can be severely affected by disruptive behaviors in adults. Objectives: To examine the efficacy and safety of risperidone in the treatment of disruptive behavior disorders in intellectually disabled adults. Methods: Intellectually disabled patients with disruptive behavior disorder were randomly assigned to receive risperidone (n=39) in a flexible dosage ranging from 1 to 4 mg\\/day (mean dosage,

Carllo Gagiano; Stephen Read; Lilian Thorpe; Mariëlle Eerdekens; Ilse Van Hove

2005-01-01

22

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

PubMed

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

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

2013-02-22

23

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.

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

2013-01-01

24

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

PubMed

Exemestane, a steroidal aromatase inhibitor, is licensed for postmenopausal patients with estrogen receptor (ER)-positive breast cancer as second-line therapy in metastatic disease following antiestrogen failure and as part of sequential adjuvant therapy following initial tamoxifen. This study is a systematic literature review, evaluating exemestane in different clinical settings. The Ovid Medline (1948-2012), Embase (1980-2012), and Web of Science (1899-2012) databases were searched. Forty-two relevant articles covering randomized controlled trials were reviewed for efficacy and safety, and three for adherence. With regard to efficacy in metastatic disease, exemestane is superior to megestrol acetate after progression on tamoxifen. There is evidence for noninferiority to fulvestrant (following a prior aromatase inhibitor) and to nonsteroidal aromatase inhibitors in the first-line setting. Combined use with everolimus is shown to be more efficacious than exemestane alone following previous aromatase inhibitor use. In the adjuvant setting, a switch to exemestane after 2-3 years of tamoxifen is superior to 5 years of tamoxifen. Exemestane is noninferior to 5 years of tamoxifen as upfront therapy, and may have a role as an extended adjuvant therapy. Used as neoadjuvant therapy, increased breast conservation is achievable. As chemoprevention, exemestane significantly reduces the incidence of breast cancer in "at-risk" postmenopausal women. Exemestane is associated with myalgias and arthralgias, as well as reduced bone mineral density and increased risk of fracture, which do not appear to persist at follow-up, with subsequent return to pretreatment values. Compared with tamoxifen, there is a reduced incidence of endometrial changes, thromboembolic events, and hot flashes. Limited evidence shows nonadherence in 23%-32% of patients. Evidence is growing in support of exemestane in all clinical settings. It is generally more efficacious and has a better safety profile than tamoxifen. How it compares with the nonsteroidal aromatase inhibitors remains to be established. Further studies are required on adherence to ensure that maximum benefit is obtained. PMID:23569364

Walker, Ga; Xenophontos, M; Chen, Lc; Cheung, Kl

2013-03-27

25

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

PubMed

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

Billecke, Scott S; Marcovitz, Pamela A

2013-03-16

26

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

PubMed Central

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

Billecke, Scott S; Marcovitz, Pamela A

2013-01-01

27

Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study  

PubMed Central

Objective To evaluate the efficacy and safety of adalimumab plus methotrexate (MTX) given for up to 4 years in patients with active, longstanding rheumatoid arthritis. Methods Patients responding inadequately to MTX were entered into a 24?week, controlled study (ARMADA) with adalimumab plus MTX or placebo plus MTX, and some were enrolled in a subsequent open label extension. The efficacy and safety of treatment were evaluated. Additional analyses were made for those patients whose corticosteroid and/or MTX dosages were adjusted during the extension. Results Of 271 patients in the original ARMADA trial, 262 received at least one dose of adalimumab and were evaluated. At the time of analysis, 162/262 (62%) patients had remained in the study and received treatment for a mean of 3.4?years. Withdrawals were for lack of efficacy (8%), adverse events (12%), and other reasons (18%). In 147 patients who completed 4?years' treatment, efficacy achieved at 6?months was maintained. At 4?years, 78%, 57%, and 31% had achieved ACR20/50/70; 43% achieved clinical remission (DAS28 <2.6); and 22% had no physical function abnormalities (HAQ?=?0). Results were similar for 196 patients who received treatment for 2–4?years. Efficacy was maintained in many patients when dosages were decreased (corticosteroids (51/81 (63%) patients), MTX (92/217 (42%)), or both (25/217 (12%))). Serious adverse events were comparable during open label treatment and the controlled phase. Serious infections occurring during open label treatment and the blinded period were similar (2.03 v 2.30 events per 100 patient?years, respectively). Conclusions Adalimumab plus MTX sustained clinical response and remission in patients with RA during 4?years. The safety profile during the first 6?months was similar to that after 4?years' follow up. Reduction of corticosteroid and/or MTX dosages did not adversely affect long term efficacy.

Weinblatt, M E; Keystone, E C; Furst, D E; Kavanaugh, A F; Chartash, E K; Segurado, O G

2006-01-01

28

Long-term efficacy and safety of human umbilical cord mesenchymal stromal cells in rotenone-induced hemiparkinsonian rats.  

PubMed

Several studies have shown functional improvements, neuroprotective, and neuroregenerative effects after mesenchymal stem cells transplantation to parkinsonian animal models. However, questions remain about the safety, feasibility, and long-term efficacy of this approach. In this study, we investigated migration, therapeutic, tumorigenesis, and epileptogenic effects of human umbilical cord mesenchymal stromal cells (HUMSCs) 1 year after transplantation into rotenone-induced hemiparkinsonian rats. Our data indicated that DiI-labeled HUMSCs migrated in the lesioned hemisphere, from corpus striatum (CPu) to substantia nigra. By integrating with host cells and differentiating into NSE, GFAP, Nestin, and tyrosine hydroxylase-positive cells, HUMSCs prevented 48.4% dopamine neurons from degeneration and 56.9% dopamine terminals from loss, both correlating with improvement of apomorphine-induced rotations. The CD50 and CD97 value of pentylenetetrazol and semiquantitative immunohistochemical analysis of proliferating cell nuclear antigen (PCNA), ?-catenin, C-myc, and NF-?B expression showed no significant difference between HUMSCs transplanted and untransplanted groups, whereas the expressions of Bcl-2 and P53 in the grafted CPu were upregulated by 281% and 200% compared to ungrafted CPu. The results of this long-term study suggest that HUMSCs transplantation, 1 of the most potential treatments for Parkinson's disease, is an effective and safe approach. PMID:20542126

Xiong, Nian; Cao, Xuebing; Zhang, Zhentao; Huang, Jinsha; Chen, Chunnuan; Zhang, Zhaowen; Jia, Min; Xiong, Jing; Liang, Zhihou; Sun, Shenggang; Lin, Zhicheng; Wang, Tao

2010-06-10

29

Efficacy and safety of ramipril in combination with hydrochlorothiazide: results of a long-term study.  

PubMed

Hypertensive patients from a double-blind study comparing 5 mg of ramipril, 10 mg of ramipril, and 5 mg of ramipril + 25 mg of hydrochlorothiazide (HCTZ) were enrolled in an open 1-year extension study with ramipril and concomitant HCTZ. The starting dose of ramipril was 5 mg/day. Patients were given 25 mg of HCTZ in addition only if their diastolic blood pressure (DBP) was higher than 90 mm Hg. During treatment, the investigator was permitted to adjust the dosage of ramipril and HCTZ according to BP response and tolerance. A total of 159 patients were included in the 1-year study (86 men, 73 women, mean age of 54 years). One hundred twenty-one of the 159 patients received the combination of ramipril + HCTZ at some point in the study, 83 of them for more than 50 weeks. Thirty-eight patients were treated with ramipril alone over the entire study. In patients treated with ramipril monotherapy throughout the study, the largest drop in blood pressure occurred before visit 1. In patients treated with ramipril + HCTZ for greater than or equal to 50 weeks, the mean blood pressure continued to fall up to around week 10, while the therapy was being adjusted. Subsequently, the mean blood pressures remained low and fairly stable in both treatment groups. Similar results were seen in patients treated with the combination for less than 50 weeks. Adverse events were reported in 11 of the 38 patients in the ramipril group, in 22 of 83 patients treated with the combination for more than 50 weeks, and in 9 of 38 patients treated with the combination for 50 weeks or less. The analysis of the laboratory values revealed no general deterioration. It can be concluded that ramipril alone and in combination with HCTZ is an effective and safe drug for the long-term treatment of essential hypertension. PMID:1725034

Heidbreder, D; Froer, K L; Bauer, B; Cairns, V; Breitstadt, A

1991-01-01

30

A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy  

Microsoft Academic Search

Objective: To assess the continued efficacy of modafinil in the treatment of excessive daytime somnolence (EDS) of narcolepsy.Background: Modafinil has been shown to be a safe and effective treatment for the EDS presented by patients with narcolepsy. However, the duration of treatment has been relatively brief, particularly considering the chronic nature of the disease.Methods: Sixty-nine patients with narcolepsy, who completed

H Moldofsky; R. J Broughton; J. D Hill

2000-01-01

31

Long-term safety, efficacy and palatability of oral meloxicam at 0.01–0.03 mg\\/kg for treatment of osteoarthritic pain in cats  

Microsoft Academic Search

Osteoarthritis is a chronic, painful condition that is now recognised as affecting a large proportion of cats. Non-steroidal anti-inflammatory drugs (NSAIDs) have proven efficacy in dogs and humans but there are limited published data on the use of NSAIDs in the long-term management of this condition in cats. This prospective study aimed to assess the long-term safety and palatability of

Marcus N. Gunew; Victor H. Menrath; Rhett D. Marshall

2008-01-01

32

Efficacy and Safety of 4Aminopyridine in Patients with Long-Term Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled Trial  

Microsoft Academic Search

Objectives: To study the efficacy and safety of 4-aminopyridine (4-AP), and to document sensorimotor changes after discontinuation of the drug in patients with long- term spinal cord injury. Design: Randomized, double-blind, placebo-controlled trial. Setting: Clinical research unit. Patients: Twenty-seven patients with long-term spinal cord injury. Intervention: Patients were randomized to receive either oral 4-AP 5 mg\\/day, which was increased by

Israel Grijalva; Gabriel Guízar-Sahagún; Gilberto Castañeda-Hernández; Dolores Mino; Héctor Maldonado-Julián; Guadalupe Vidal-Cantú; Antonio Ibarra; Omar Serra; Hermelinda Salgado-Ceballos; Rita Arenas-Hernández

2003-01-01

33

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

PubMed

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

2012-06-19

34

Safety and efficacy of long-term treatment with inhaled beclomethasone dipropionate in steroid-dependent asthma.  

PubMed Central

An open long-term trial of inhaled beclomethasone dipropionate was carried out in 32 asthmatic patients chronically dependent on systemic corticosteroids. Our objectives were to study the efficacy and safety of beclomethasone and to determine the proportion of patients in whom systemic steroids could be replaced by the new drug. All subjects had a clear history and physical findings of asthma as well as significant improvement in respiratory function after inhalation of salbutamol. Patients were followed for 4 to 8 years. Compared with a baseline period, patients receiving beclomethasone had reduced symptoms and needed less bronchodilator therapy, but their pulmonary function was unchanged. Bronchial biopsy specimens from seven patients who had been taking beclomethasone for as long as 8 years did not differ histologically from specimens from five asthmatic patients who had never taken the drug. Nine patients were able to stop taking systemic corticosteroids within 9 months, eight required them occasionally, and in eight the requirement was substantially reduced; the requirement did not change appreciably in the remaining seven. Inhaled beclomethasone is a safe and effective drug for chronic administration to asthmatic patients, and in 78% of our subjects the need for systemic steroids was substantially reduced or eliminated.

Broder, I; Tarlo, S M; Davies, G M; Thomas, P; Leznoff, A; Sturgess, J; Baumal, R; Mintz, S; Corey, P N

1987-01-01

35

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

PubMed Central

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

Messalli, Enrico M; Scaffa, Cono

2010-01-01

36

An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia  

PubMed Central

Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE) monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7%) subjects completed this study: 209 of the 279 subjects (75%) in the 6-month group and 55 of the 111 subjects (50%) in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (?10% of subjects) were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs) were reported by 36 (9%) subjects. The AE profile in this study was qualitatively similar to those of other studies in adult subjects with schizophrenia and in other psychiatric studies of risperidone in pediatric populations. Conclusions Risperidone maintenance treatment in adolescents over 6 to 12 months was well tolerated, consistent with related studies in this clinical population, and associated with continued efficacy. Clinical trials ClinicalTrials.gov registration number: NCT00246285 http://clinicaltrials.gov/ct2/show/NCT00246285?term=NCT00246285&rank=1

2012-01-01

37

Long-term efficacy and safety of endotherapy for management of biliary anastamotic strictures following liver transplantation  

Microsoft Academic Search

IntroductionBiliary anastomotic strictures are among the commonest biliary complications following liver transplantation. Endoscopic therapy including balloon dilatation of stricture and maximal stent placement, is widely used as the preferred means of managing these patients.12 However, endoscopic therapy is not standardized and there is very limited prospective data to support the long-term efficacy of this approach. The aim of our study

S Putta; V Sagar; B Gunson; G Haydon; D Freshwater; A Holt; S Pathmakanthan; J Ferguson

2011-01-01

38

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

39

Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study  

Microsoft Academic Search

The long-term efficacy and safety of donepezil (up to 10 mg\\/day) was evaluated in a multicentre, non-randomised, open-label extension study of 133 patients with mild to moderate Alzheimer's disease (AD) who had completed a previous 14-week double-blind, placebo-controlled trial of donepezil. Assessments were conducted at three-weekly intervals for 12 weeks, then 12-weekly for up to 192 weeks. Efficacy, assessed by

S. L Rogers; L. T Friedhoff

1998-01-01

40

Efficacy and safety of long-term continuous growth hormone treatment in children with Prader-Willi syndrome  

Microsoft Academic Search

Background: Children with Prader-Willi syndrome (PWS) have abnormal body composition and impaired growth. Short-term GH treatment has beneficial effects. Objectives: The aim of the study was to investigate effects of long-term continuous GH treatment on body composition, growth, bone maturation, and safety parameters. Setting: We conducted a multicenter prospective trial. Design: Fifty-five children with a mean ± SD age of

Lind van Wijngaarden de R. F. A; E. P. C. Siemensma; D. A. M. Festen; B. J. Otten; Mil van E. G. A. H; J. J. Rotteveel; R. J. H. Odink; G. C. B. Bindels-de Heus; M. van Leeuwen; D. A. J. P. Haring; G. Bocca; E. C. A. Mieke Houdijk; J. J. G. Hoorweg-Nijman; R. C. F. M. Vreuls; P. E. Jira; Trotsenburg van A. S. P; B. Bakker; E. J. Schroor; J. W. Pilon; J. M. Wit; S. L. S. Drop; A. C. S. Hokken-Koelega

2009-01-01

41

Long-Term Antihypertensive Efficacy and Safety of the Oral Direct Renin Inhibitor Aliskiren A 12Month Randomized, Double-Blind Comparator Trial With Hydrochlorothiazide  

Microsoft Academic Search

Background—Diuretics are recommended as first-line agents for the treatment of hypertension. This randomized, double-blind, multicenter study assessed the long-term efficacy and safety of the direct renin inhibitor aliskiren in comparison with the diuretic hydrochlorothiazide in patients with essential hypertension. Methods and Results—After a 2- to 4-week placebo run-in, 1124 patients (mean sitting diastolic blood pressure (BP) 95 to 109 mm

Roland E. Schmieder; Thomas Philipp; Javier Guerediaga; Manuel Gorostidi; Beverly Smith; Nicole Weissbach; Mojdeh Maboudian; Jaco Botha; Hein van Ingen

42

Efficacy and Safety of Long-Term Treatment with the Dual 5?-Reductase Inhibitor Dutasteride in Men with Symptomatic Benign Prostatic Hyperplasia  

Microsoft Academic Search

Objectives:Dutasteride, a dual inhibitor of Type 1 and Type 2 5?-reductase, has been shown to improve disease measures in patients with symptomatic benign prostatic hyperplasia (BPH) in three randomised, placebo-controlled, large-scale, 2-year Phase III clinical studies. This paper reports the pooled results of a 2-year open-label extension of the three randomised studies assessing the long-term efficacy and safety of dutasteride.

Frans Debruyne; Jack Barkin; Peter van Erps; Mario Reis; Teuvo L. J. Tammela; Claus Roehrborn

2004-01-01

43

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.

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

2008-01-01

44

Long-term safety and efficacy of deferasirox (Exjade(R)) for up to 5 years in transfusional iron-overloaded patients with sickle cell disease  

PubMed Central

To date, there is a lack of long-term safety and efficacy data for iron chelation therapy in transfusion-dependent patients with sickle cell disease (SCD). To evaluate the long-term safety and efficacy of deferasirox (a once-daily oral iron chelator), patients with SCD completing a 1-year, Phase II, randomized, deferoxamine (DFO)-controlled study entered a 4-year extension, continuing to receive deferasirox, or switching from DFO to deferasirox. Average actual deferasirox dose was 19·4 ± 6·3 mg/kg per d. Of 185 patients who received at least one deferasirox dose, 33·5% completed the 5-year study. The most common reasons for discontinuation were withdrawal of consent (23·8%), lost to follow-up (9·2%) and adverse events (AEs) (7·6%). Investigator-assessed drug-related AEs were predominantly gastrointestinal [including nausea (14·6%), diarrhoea (10·8%)], mild-to-moderate and transient in nature. Creatinine clearance remained within the normal range throughout the study. Despite conservative initial dosing, serum ferritin levels in patients with ?4 years deferasirox exposure significantly decreased by ?591 ?g/l (95% confidence intervals, ?1411, ?280 ?g/l; P=0·027; n=67). Long-term deferasirox treatment for up to 5 years had a clinically acceptable safety profile, including maintenance of normal renal function, in patients with SCD. Iron burden was substantially reduced with appropriate dosing in patients treated for at least 4 years.

Vichinsky, Elliott; Bernaudin, Francoise; Forni, Gian Luca; Gardner, Renee; Hassell, Kathryn; Heeney, Matthew M; Inusa, Baba; Kutlar, Abdullah; Lane, Peter; Mathias, Liesl; Porter, John; Tebbi, Cameron; Wilson, Felicia; Griffel, Louis; Deng, Wei; Giannone, Vanessa; Coates, Thomas

2011-01-01

45

Long-term efficacy and safety of treatment with stimulants and atomoxetine in adult ADHD: a review of controlled and naturalistic studies.  

PubMed

Attention-deficit/hyperactivity disorder (ADHD) is a common disorder of childhood that often persists into adulthood. Although stimulant medications are recommended as the first-line treatment for ADHD because of their documented short-term effects in children and adults, less is known about their effects on long-term outcome in adults. Here we review the long-term efficacy and safety of the stimulant drugs methylphenidate and amphetamine, as well as the related compound atomoxetine. We performed a systematic review to identify direct and indirect effects of stimulant therapy on long-term outcome in adults. Five randomized controlled trials (RCTs), and 10 open-label extension studies of initial short-term RCTs, with total follow-up of at least 24weeks, were identified. All these RCTs found that medication was significantly more efficacious than placebo in treating ADHD in adults, and the extension studies showed that this favorable effect of medication was maintained during the open-label follow-up period. However, since the maximum duration of these pharmacological trials was 4years, we also reviewed 18 defined naturalistic longitudinal and cross-sectional studies, to provide more information about longer term functional outcomes, side effects and complications. These observational studies also showed positive correlations between early recognition of the disorder, stimulant treatment during childhood and favorable long-term outcome in adult ADHD patients. In conclusion, stimulant therapy of ADHD has long-term beneficial effects and is well tolerated. However, more longitudinal studies of long duration should be performed. In addition, the ethical issues involved in performing double blind RCTs of many years duration should be further explored. PMID:22917983

Fredriksen, Mats; Halmøy, Anne; Faraone, Stephen V; Haavik, Jan

2012-08-20

46

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

PubMed Central

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

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

2008-01-01

47

Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs  

PubMed Central

Background Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan. Methods This was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20?mg once daily) in Japanese patients (aged ?20?years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive. Results A total of 130 patients (73.1% women, mean age 62.1?years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased ?-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1?year. Conclusion Long-term treatment with esomeprazole (20?mg once daily) is well tolerated and efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer. Trial registration ClinicalTrials.gov identifier NCT00595517.

2013-01-01

48

Long-term efficacy and safety of self-intracavernous injection of prostaglandin E1 for treatment of erectile dysfunction in China.  

PubMed

The study evaluated the long-term efficacy and safety profiles of self-intracavernous injection of prostaglandin E1 (PGE1) for erectile dysfunction (ED). Four hundred and sixteen ED patients were treated with self-intracavernous injection of PGE1 from January 1998 to December 2007 in our outpatient service. Follow-up was made to investigate the efficacy and side effects of this treatment. It was found that 261 patients (62.7%) felt satisfied and kept using this treatment due to its advantages of satisfactory efficacy and reasonable expense. Twenty-seven of them (6.5%) got rid of PGE1 treatment after five times injections and did not need any other drugs to maintain satisfactory sexual lives. Two hundred and fourteen (51.4%) patients kept using this treatment for over 1 year, 26 (6.2%) over 5 years, 12 (2.9%) over 8 years and 7 (1.7%) over 10 years. The major complications of self-intracavernous injection of PGE1 include fibrosis of corpus cavernosum (three cases), ecchymosis associated with vascular injury due to injection (23 cases) and pain associated with injection (295 cases). There were no patients displaying priapism. It is concluded that self-intracavernous injection of PGE1 is a safe and effective treatment for ED with various aetiologies and a broad range of severity, and no serious complications were observed after long-term application. PMID:21486416

He, L; Wen, J; Jiang, X; Chen, H; Tang, Y

2011-03-25

49

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

Microsoft Academic Search

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

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

2009-01-01

50

Assessing efficacy/effectiveness and safety/tolerability profiles of adjunctive pramipexole in bipolar depression: acute versus long-term data.  

PubMed

Bipolar depression represents the most difficult-to-treat phase of bipolar disorder, mood-stabilizing compounds and second-generation antipsychotics being only partially effective, whereas the use of antidepressants is highly controversial because of risks of inefficacy, switching, rapid cycling, and increased suicidality. Among various augmentative pharmacological treatments, compounds with dopamine-enhancing activity have been shown to be variably beneficial in the treatment of bipolar depression with drug-resistance features. In particular, pramipexole - a dopamine D2/D3 receptor agonist - showed antidepressant properties in bipolar depressed patients in both randomized-controlled trials and open acute and follow-up reports. The present review aims to provide an updated perspective on the use of adjunctive pramipexole in bipolar depression, taking into account randomized-controlled trials, as well as open naturalistic studies, with a specific focus on the evaluation of acute versus long-term data in terms of effectiveness and tolerability. Despite methodological differences, short-term studies support the acute efficacy and tolerability/safety of adjunctive pramipexole, whereas open extended observations seem to confirm the effectiveness of the compound, with some additional concern in terms of safety and tolerability issues. Adjunctive pramipexole may be a valid option in both the acute and the long-term treatment of drug-resistant bipolar depression, with possible superior tolerability in the short term. PMID:24081199

Dell'osso, Bernardo; Ketter, Terence A

2013-11-01

51

Efficacy of ibandronate: a long term confirmation  

PubMed Central

Data deriving from randomized clinical trials, observational studies and meta-analyses, including treatment regimens unlicensed for use in clinical practice, clearly support that 150 mg once-monthly oral and 3 mg quarterly i.v. doses of ibandronate are associated with efficacy, safety and tolerability; notably both these marketed regimens, which largely correspond to ACE ?10.8 mg, may in addition provide a significant efficacy on non-vertebral and clinical fracture (Fx) efficacy. The MOBILE and the DIVA LTE studies confirmed a sustained efficacy of monthly oral and quarterly i.v. regimens respectively, over 5 years. Furthermore, improved adherence rates with monthly ibandronate, deriving from studies evaluating large prescription databases, promise to enhance fracture protection and decrease the social and economic burden of postmenopausal osteoporosis.

Di Munno, Ombretta; Delle Sedie, Andrea

2010-01-01

52

Sustained efficacy and safety of pimecrolimus cream 1% when used long-term (up to 26 weeks) to treat children with atopic dermatitis.  

PubMed

Atopic dermatitis is a chronic, inflammatory condition affecting up to 20% of children. Here, we report the long-term extension study of previously published pivotal phase III studies with pimecrolimus cream 1%. Two identical, 26-week studies (6-week, double-blind, followed by 20-week, open-label phases) were conducted in children aged 2 to 17 years with atopic dermatitis. Pooled efficacy and safety analyses were performed. At day 43, 34.8% pimecrolimus-treated patients versus 18.4% in the vehicle group (p < 0.001) were clear/almost clear (Investigators' Global Assessment 0/1) of disease, with significant differences (p < 0.05) between treatment groups for all double-blind visits in all parameters. Pimecrolimus was significantly more effective (based on the Eczema Area and Severity Index) in treating the face and neck versus the rest of the body (p < 0.0001) and versus vehicle (p < 0.0001) in the double-blind phase. Disease control was sustained in the pimecrolimus group throughout the whole study. Patients treated with vehicle during the double-blind phase experienced rapid, marked improvement when switched to pimecrolimus in the open-label phase. The incidence of adverse events was low and comparable between treatment groups. In conclusion, pimecrolimus cream 1% is effective and well tolerated in the long-term control of children with mild to moderately severe atopic dermatitis. PMID:18577032

Langley, Richard G B; Eichenfield, Lawrence F; Lucky, Anne W; Boguniewicz, Mark; Barbier, Nathalie; Cherill, Robert

53

Safety and Efficacy of the Long-term Adjuvant Treatment of Primary Intermediate to High-Risk Malignant Melanoma (UICC\\/AJCC Stage II and III) with a Standardized Fermented European Mistletoe (Viscum album L.)  

Microsoft Academic Search

Summary Background: Mistletoe therapy is the most frequently used complementary treatment in cancer patients in Germany and Switzerland. However, its safety and efficacy were controversially discussed, also in case of malignant melanoma (MM). Objectives: The present study should evaluate the therapeutic safety and effi- cacy of a long-term therapy with a stand- ardized fermented European mistletoe (Viscum album L.) extract

Matthias Augustina; Paul R. Bockb; Marita Karasmann; Berthold Schneider

54

Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device  

PubMed Central

The intrauterine device (IUD), primarily in the form of the copper IUD, is used by more than 150 million women around the world, making it the most widely used reversible method of contraception. With a remarkably low failure rate of less than 1 per 100 women in the first year of use, the Copper T-380A is in the top tier of contraceptives in terms of efficacy. Risks of utilization include perforation and an increased risk of infection in the first 20 days following insertion. Overall, the number of adverse events is low, making the Copper T-380A a very safe contraceptive method. The most common reasons for the discontinuation of this method are menstrual bleeding and dysmenorrhea. However, cumulative discontinuation rates of Copper T-380A are lower than that have been reported for other methods, indicating that the Copper T-380A is highly acceptable to women. After 5 years, approximately 50% of all women, who have a Copper T-380A inserted, will continue to use this highly effective contraceptive method.

Kaneshiro, Bliss; Aeby, Tod

2010-01-01

55

Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension  

PubMed Central

Objective To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA). Methods Patients eligible for the open-label extension (OLE, weeks 52–204) received infliximab 3–6 mg/kg every 8 weeks plus methotrexate. Results Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively. Conclusions In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate. Clinical trials registration number NCT00036374.

Ruperto, Nicolino; Lovell, Daniel J; Cuttica, Ruben; Woo, Patricia; Meiorin, Silvia; Wouters, Carine; Silverman, Earl D; Balogh, Zsolt; Henrickson, Michael; Davidson, Joyce; Foeldvari, Ivan; Imundo, Lisa; Simonini, Gabriele; Oppermann, Joachim; Xu, Stephen; Shen, Yaung-Kaung; Visvanathan, Sudha; Fasanmade, Adedigbo; Mendelsohn, Alan; Martini, Alberto; Giannini, Edward H

2010-01-01

56

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.

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

2012-01-01

57

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

2012-12-06

58

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.

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

59

Long term efficacy, safety, and tolerabilitity of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF100) in the treatment of functional chronic constipation  

Microsoft Academic Search

AIMSTo assess the long term therapeutic effectiveness, safety, and tolerability of low daily doses of isosmotic PEG electrolyte solutions (PMF-100) administered for a six month period for the treatment of functional constipation, in a double blind, placebo controlled, parallel group study.METHODSAfter an initial four week run in period with PMF-100 (250 ml twice daily; PEG 14.6 g twice daily), 70

E Corazziari; D Badiali; G Bazzocchi; G Bassotti; P Roselli; G Mastropaolo; M G Lucà; R Galeazzi; E Peruzzi

2000-01-01

60

Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response  

Microsoft Academic Search

BackgroundEfficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.

Yago González-Lama; Antonio López-San Román; Ignacio Marín-Jiménez; Begoña Casis; Isabel Vera; Fernando Bermejo; José Lázaro Pérez-Calle; Carlos Taxonera; Francisca Martínez-Silva; Luis Menchén; Pilar Martínez-Montiel; Marta Calvo; José Antonio Carneros; Pilar López; Juan Luis Mendoza; José María Milicua; Alaín Huerta; Fernando Sánchez; Luis Abreu; Natalia López-Palacios; José Maté; Javier P. Gisberta

2008-01-01

61

Efficacy and Safety of a Traditional Herbal Medicine, Hochu-ekki-to in the Long-Term Management of Kikyo (Delicate Constitution) Patients with Atopic Dermatitis: A 6Month, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study  

Microsoft Academic Search

Hochu-ekki-to is a traditional herbal (Kampo) medicine that has been shown to be effective for patients with Kikyo (delicate, easily fatigable, or hypersensitive) constitution. Previous case reports have suggested that this herbal drug was effective for a certain subgroup of patients with atopic dermatitis (AD). We aimed to evaluate the efficacy and safety of Hochu-ekki-to in the long-term management of

Hiromi Kobayashi; Masamitsu Ishii; Satoshi Takeuchi; Yoichi Tanaka; Takahiro Shintani; Atsushi Yamatodani; Tadashi Kusunoki; Masutaka Furue

2010-01-01

62

Long-Term Safety and Efficacy of Donepezil in Patients with Severe Alzheimer’s Disease: Results from a 52Week, Open-Label, Multicenter, Extension Study in Japan  

Microsoft Academic Search

Background\\/Aims: A 6-month, randomized, double-blind, placebo-controlled study was extended to evaluate long-term safety and efficacy of donepezil in community-dwelling Japanese patients with severe Alzheimer’s disease (AD). Methods: 189 patients were enrolled from the double-blind study into a 52-week, open-label extension study. After a 2- to 8-week washout, donepezil was escalated within 6 weeks to 10 mg\\/day. Main outcomes were Severe

Akira Homma; Yukimichi Imai; Hisao Tago; Takashi Asada; Masahiro Shigeta; Toshihiko Iwamoto; Masashi Takita; Itaru Arimoto; Hiroshi Koma; Takao Takase; Toshio Ohbayashi

2009-01-01

63

Combination of ramipril and hydrochlorothiazide in the treatment of mild to moderate hypertension--Part 2: An open long-term study of efficacy and safety.  

PubMed

In an open, multicenter extension of a short-term study, 159 patients with mild to moderate hypertension were treated with either ramipril monotherapy or a combination of ramipril and hydrochlorothiazide for up to 1 year. Patients started with either 5 mg ramipril once daily (responders in the short-term study) or a combination of ramipril 5 mg plus hydrochlorothiazide 25 mg once daily. The dose could be adjusted and nonresponders to ramipril monotherapy could have hydrochlorothiazide added. In the 38 patients treated with ramipril monotherapy, the largest drop in mean blood pressure (BP) had already occurred in the previous short-term study; from Week 2 in the long-term study, the BP remained stable with means below 150/90 mmHg. In the 83 patients treated with the combination for 50 weeks or more, mean BP continued to decrease until around Week 10 in the long-term study while therapy was being adjusted. Thereafter, it also remained stable with means below 150/85 mmHg. Both treatment groups showed good mean reductions at end point, as did the group of 38 patients treated with the combination for less than 50 weeks. High response rates (84-95%) were seen in all groups at end point. The combination was well tolerated and the efficacy of ramipril in combination with hydrochlorothiazide was maintained over the 1-year period of investigation. PMID:8416760

Heidbreder, D; Froer, K L; Bauer, B; Cairns, V; Breitstadt, A; Bender, N

1993-01-01

64

Long-Term Efficacy of Dynamic Graciloplasty for Fecal Incontinence  

Microsoft Academic Search

PURPOSE: Patients with end-stage fecal incontinence in whom all standard medical and surgical treatment has failed or is not expected to be effective can be treated by dynamic graciloplasty. The aim of this study was to review the long-term efficacy data. METHODS: Success was defined as a greater than 50 percent decrease in the frequency of incontinent episodes. Measured physiologic

Steven D. Wexner; Cor Baeten; Randolph Bailey; Arne Bakka; Bruce Belin; Paul Belliveau; Eugen Berg; W. Donald Buie; Marcus Burnstein; John Christiansen; John Coller; Susan Galandiuk; J. Lange; Robert Madoff; Klaus E. Matzel; Lars Påhlman; Rolland Parc; John Reilly; Massimo Seccia; Alan G. Thorson; Anthony M. Vernava III

2002-01-01

65

Long-term safety, efficacy and side-effects of continuous subcutaneous insulin infusion treatment for Type 1 (insulin-dependent) diabetes mellitus: a one centre experience  

Microsoft Academic Search

Summary  A follow-up study of 116 Type 1 (insulin-dependent) diabetic patients on long-term continuous subcutaneous insulin infusion was conducted after 4.5±0.2 years. The average HbA1c-value of these patients decreased by 1% to 6.7±0.1% during this observation period. Typical side effects of continuous subcutaneous insulin infusion such as skin inflammation at the catheter insertion site occurred with similar frequency as has been

E. Chantelau; M. Spraul; I. Miahlhauser; R. Gause; M. Berger

1989-01-01

66

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  

Microsoft Academic Search

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

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

2011-01-01

67

[Efficacy and safety of administration of low-dose unfractionated heparin (LDUH) for the prevention of pulmonary thromboembolism after surgery for lung cancer; the long term outcome].  

PubMed

We evaluated the efficacy and safety of the administration of low-dose unfractionated heparin(LDUH)for the prevention of pulmonary thromboembolism after lung cancer surgery. We operated on 206 patients with primary lung cancer for 8 years;128 males and 78 females, mean age:69.9±8.8 years. All patients were administrated LDUH 5,000 units every 12 hours from the operation day until the day when the patient could walk around the floor. No patients suffered from clinical pulmonary thromboembolism in this period. The duration of treatment was 4.6±2.6 days and the chest tube duration was 5.4±3.0 days. We experienced post-operative intra-thoracic bleeding in 2 patients during the previous 4 years. Based on this experience, we introduced new eligibility criteria;we discontinued LDUH administration on the operation day if diffuse adhesion in the thoracic cavity was observed at operation or intraoperative blood loss was over 500 ml. The dose of LDUH was decreased to 2,500 unit every 12 hours if the postoperative bleeding was over 400 ml on the operation day or the patient's body weight was less than 40 kg. After introduction of the new criteria, no severe bleeding complications occurred during the latter 4 years. PMID:23381353

Muraoka, Masashi; Mochinaga, Kouji; Sengyoku, Hideyori; Ryu, Chusei; Ikuta, Yasushi; Tabuchi, Satoshi; Satou, Ayako; Inamasu, Eiko; Tobinaga, Shuichi; Komatsu, Hideaki; Yamaguchi, Hiroyuki; Kimino, Kouji

2013-02-01

68

A long-term, open-label trial of the safety and efficacy of etanercept (Enbrel) in patients with rheumatoid arthritis not treated with other disease-modifying antirheumatic drugs  

PubMed Central

Objective To evaluate the long?term safety and efficacy of etanercept in patients with rheumatoid arthritis. Methods 549 patients entered this 5?year, open?label extension study and received etanercept 25?mg twice weekly. All patients showed inadequate responses to disease?modifying antirheumatic drugs before entry into the double?blind studies. Safety assessments were carried out at regular intervals. Primary efficacy end points were the numbers of painful and swollen joints; secondary variables included American College of Rheumatology (ACR) response rate, Disease Activity Score and acute?phase reactants. Efficacy was analysed using the last?observation?carried?forward approach. Results Of the 549 patients enrolled in the open?label trial, 467 (85%), 414 (75%) and 371 (68%) completed 1, 2 and 3?years, respectively; 363 (66%) remained in the study at the time of this analysis. A total exposure of 1498 patient?years, including the double?blind study, was accrued. In the open?label trial, withdrawals for efficacy?related and safety?related reasons were 11% and 13%, respectively. Frequent adverse events included upper respiratory infections, flu syndrome, rash and injection?site reactions. Rates of serious infections and malignancies remained unchanged over the course of the study; there were no reports of patients with central demyelinating disease or serious blood dyscrasias. After 3?years, ACR20, ACR50 and ACR70 response rates were 78%, 51% and 27%, respectively. The Disease Activity Score score was reduced to 3.0 at 3?months and 2.6 at 3?years from 5.1. A sustained improvement was found in Health Assessment Questionnaire scores throughout the 3?year time period. Conclusion After 3?years of treatment, etanercept showed sustained efficacy and a favourable safety profile.

Klareskog, L; Gaubitz, M; Rodriguez-Valverde, V; Malaise, M; Dougados, M; Wajdula, J

2006-01-01

69

Does cyclosporine achieve a real advantage for treatment of idiopathic nephrotic syndrome in children? A long-term efficacy and safety study  

Microsoft Academic Search

Background  Cyclosporine (CsA) was found to be efficient in decreasing proteinuria in both steroid-dependent and steroid-resistant nephrotic\\u000a patients. We aimed to explore the potential long-term benefits and hazards of CsA and their predictors among a large group\\u000a of nephrotic patients.\\u000a \\u000a \\u000a \\u000a Methods  In this retrospective analysis, we included 197 pediatric patients with idiopathic nephrotic syndrome (INS) of whom 103 were\\u000a steroid dependent and

Hussein Sheashaa; Ihab Mahmoud; Fathy El-Basuony; Amr El-Husseini; Nabil Hassan; Mahmoud El-Baz; Nagy Sayed Ahmed; Mohamed Sobh

2007-01-01

70

Long-term efficacy, safety, and tolerability of rilpivirine (RPV, TMC278) in HIV type 1-infected antiretroviral-naive patients: week 192 results from a phase IIb randomized trial.  

PubMed

TMC278-C204 (NCT00110305), a 96-week trial of the nonnucleoside reverse transcription inhibitor (NNRTI) rilpivirine (RPV, TMC278) in 368 HIV-1-infected, treatment-naive patients, was extended to investigate long-term safety and efficacy. Week 192 analysis results are presented. This was a long-term follow-up of a Phase IIb, randomized trial. No significant RPV dose-response relationships with respect to the primary endpoint (composite ITT-TLOVR algorithm) were observed at week 48 or 96. All RPV-treated patients were switched to open-label 75?mg qd at week 96 and then to 25?mg qd, the Phase III dose, at approximately week 144 as it gave the best benefit-risk balance. All control patients continued receiving open-label efavirenz (EFV) 600?mg qd. At week 192, 59% of RPV- and 61% of EFV-treated patients maintained confirmed viral load <50 copies/ml (ITT-TLOVR algorithm). The mean changes from baseline in CD4 cell count were similar in both groups (RPV: 210 cells/mm(3) vs. EFV: 225 cells/mm(3)). No new safety concerns were noted between week 48 and 192. In the week 192 analysis, RPV compared with EFV was associated with a lower overall incidence of grade 2-4 adverse events (AEs) at least possibly related to treatment, including rash (p<0.001) and neurologic AEs (p<0.05 Fisher's exact test, post hoc analyses) Incidences of serious AEs, grade 3 or 4 AEs, and discontinuations due to AEs were similar across groups. Increases in total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides were significantly lower with RPV than with EFV. RPV continued to show sustained efficacy similar to EFV at week 192 with a generally more favorable safety profile. PMID:21902621

Wilkin, Aimee; Pozniak, Anton L; Morales-Ramirez, Javier; Lupo, Sergio H; Santoscoy, Mario; Grinsztejn, Beatriz; Ruxrungtham, Kiat; Rimsky, Laurence T; Vanveggel, Simon; Boven, Katia

2011-10-17

71

Long-term safety and efficacy follow-up of prophylactic higher fluence collagen cross-linking in high myopic laser-assisted in situ keratomileusis  

PubMed Central

Background The purpose of this study was to evaluate the safety and efficacy of ultraviolet A irradiation cross-linking on completion for cases of high myopic laser-assisted in situ keratomileusis (LASIK). Methods Forty-three consecutive LASIK cases treated with femtosecond laser flap and the WaveLight excimer platform were evaluated perioperatively for uncorrected visual acuity, best corrected spectacle visual acuity, refraction, keratometry, topography, total and flap pachymetry, corneal optical coherence tomography, and endothelial cell count. All eyes at the completion of LASIK had cross-linking through the repositioned flap, with higher fluence (10 mW/cm2) ultraviolet light of an average 370 ?m wavelength and 10 mW/cm2 fluence applied for 3 minutes following an earlier single instillation of 0.1% riboflavin within the flap interface. Mean follow-up duration was 3.5 (range 1.0–4.5) years. Results Mean uncorrected visual acuity changed from 0.2 to 1.2, best corrected spectacle visual acuity from 1.1 to 1.2, spherical equivalent from ?7.5 diopters (D) to ?0.2 D, keratometry from 44.5 D to 38 D, flap pachymetry from 105 ?m to, total pachymetry from 525 to 405, and endothelial cell count from 2750 to 2800. None of the cases developed signs of ectasia or significant regression during follow-up. Conclusion Prophylactic collagen cross-linking for high-risk LASIK cases appears to be a safe and effective adjunctive treatment for refractive regression and potential ectasia. This application may be viewed as prophylactic customization of the biomechanical behavior of corneal collagen.

Kanellopoulos, Anastasios John

2012-01-01

72

Safety of long-term large doses of aspartame.  

PubMed

Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a randomized, double-blind, placebo-controlled, parallel-group design in 108 male and female volunteers aged 18 to 62 years. Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks. No persistent changes over time were noted in either group in vital signs; body weight; results of standard laboratory tests; fasting blood levels of aspartame's constituent amino acids (aspartic acid and phenylalanine), other amino acids, and methanol; or blood formate levels and 24-hour urinary excretion of formate. There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject. These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day. PMID:2802896

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

1989-10-01

73

Efficacy and safety of moricizine in patients with ventricular tachycardia: results of a placebo-controlled prospective long-term clinical trial.  

PubMed

This was a prospective, placebo-controlled, single-blind trial of moricizine (ethmozine) in a dose averaging 10 mg/kg/day in 50 patients, the single entrance criterion being the presence of 10 or more runs of nonsustained ventricular tachycardia (VT) on a screening 24 hr ambulatory electrocardiographic (ECG) recording. Electrophysiologic study was not included as part of this trial design. The placebo frequency of VT (average 3 days of recording) was 1036 +/- 479 runs of VT per day. Most patients (31/50) had coronary artery disease. The study population had a mean left ventricular ejection fraction (LVEF) of 36 +/- 16%; 20 patients also had a history of sustained VT. Protocol failure was defined as failure to achieve a 75% or greater reduction in runs of VT (as judged by ambulatory ECG recording) and/or recurrence of sustained VT while on moricizine. Among the 48 patients treated with moricizine, the drug was initially efficacious in 35 (73%), with two-thirds having total abolition of nonsustained VT. Although it was effective in reducing runs of nonsustained VT, moricizine was ineffective in preventing the recurrence of sustained VT (63% failure rate). Side effects were uncommon and the drug was well tolerated in most patients with LVEFs of 30% or less. PMID:3512124

Pratt, C M; Wierman, A; Seals, A A; English, L; Leon, C; Young, J B; Quinones, M A; Roberts, R

1986-04-01

74

Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial  

PubMed Central

Objective To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX). Methods Patients randomised to abatacept or placebo (+MTX) during the 1-year double-blind period of the Abatacept in Inadequate responders to Methotrexate (AIM) trial received open-label abatacept (+MTX) in the long-term extension (LTE). Safety was assessed for patients who received ?1 dose of abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to abatacept who entered the LTE. Results 433 and 219 patients were randomised and treated with abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score). Conclusion In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.

Kremer, Joel M; Russell, Anthony S; Emery, Paul; Abud-Mendoza, Carlos; Szechinski, Jacek; Westhovens, Rene; Li, Tracy; Zhou, Xianhuang; Becker, Jean-Claude; Aranda, Richard; Peterfy, Charles; Genant, Harry K

2011-01-01

75

Safety of long-term consumption of plant sterol esters-enriched spread  

Microsoft Academic Search

Objective: To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters.Design: Randomized double-blind placebo-controlled parallel trial.Subjects: Hundred and eighty-five healthy volunteers (35–64 y).Interventions: Volunteers daily consumed 20 g spread enriched with 1.6 g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle.

H F J Hendriks; E J Brink; G W Meijer; H M G Princen; F Y Ntanios

2003-01-01

76

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.

Cianferotti, Luisella; D'Asta, Federica

2013-01-01

77

Efficacy and Safety of Long-term Complementary Treatment with Standardised European Mistletoe Extract (Viscum album L.) in Addition to the Conventional Adjuvant Oncological Therapy in Patients with Primary Non-metastatic Breast Cancer Results of a multicentre, comparative, epidemiological cohort study in Germany and Switzerland  

Microsoft Academic Search

Summary Objectives: The purpose of the study was to evaluate the therapeutic efficacy and safety of long-term complementary the- rapy in primary, non-metastatic breast cancer patients in UICC stage I?III with a standardized European mistletoe ex- tract (Viscum album L., Iscador ? , \\

Paul R. Bock; Walter E. Friedel; Jürgen Hanisch; Marita Karasmann; Berthold Schneider

78

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

PubMed

Benidipine (CAS 91599-74-5) has been reported as an effective antihypertensive treatment and its cardioprotective effects have been shown in several basic and clinical studies. However, the long-term efficacy and safety of benidipine remain unknown in elderly Chinese patient with hypertension. In this prospective, multicenter, open-label clinical trial, 152 eligible patients aged 60 to 75 years with mild to moderate essential hypertension (sitting systolic blood pressure (BP) > or = 140 mmHg and/or sitting diastolic BP > or = 90 mmHg) entered a 52-week study. All patients initially received benidipine 2-4 mg once a day, followed by titration to benidipine 8 mg/day to achieve the target BP (< 140/90 mmHg in non-diabetics and <130/80 mmHg in diabetics). Add-on hydrochlorothiazide (CAS 58-93-5) and/or metoprolol tartaric acid (CAS 3750-58-6) were permitted during the study. Overall, 132 patients completed the 52-week treatment with benidipine as monotherapy or combination therapy. It showed that the regimen based on benidipine provided an obvious mean trough BP reduction of 13.8 +/- 12.4/8.3 +/- 9.2 mmHg (p < 0.001), and 62.5% of patients reached the target BP. In patients with left ventricular hypertrophy, the left ventricular mass index significantly decreased from 147.1 +/- 27.6 g/m2 at baseline to 136.0 +/- 17.5 g/m2 at 52 weeks (p = 0.036). Clinical adverse events (AEs) were found in 15.1% of all patients, and six patients discontinued the treatment due to drug-related AEs during the entire trial. Patients' compliance was an average of 98.7%. Benidipine, with a favorable tolerability profile, provides a long-term antihypertensive effect and potential benefit for the heart in elderly patients with mild to moderate hypertensive, suggesting that it is suitable for elderly patients with hypertension. PMID:21528640

Qi, Weilin; Fan, Weihu

2011-01-01

79

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

80

Efficacy and Safety of a Traditional Herbal Medicine, Hochu-ekki-to in the Long-term Management of Kikyo (Delicate Constitution) Patients with Atopic Dermatitis: A 6-month, Multicenter, Double-blind, Randomized, Placebo-controlled Study.  

PubMed

Hochu-ekki-to is a traditional herbal (Kampo) medicine that has been shown to be effective for patients with Kikyo (delicate, easily fatigable, or hypersensitive) constitution. Previous case reports have suggested that this herbal drug was effective for a certain subgroup of patients with atopic dermatitis (AD). We aimed to evaluate the efficacy and safety of Hochu-ekki-to in the long-term management of Kikyo patients with AD. In this multicenter, double blind, randomized, placebo-controlled study, 91 Kikyo patients with AD were enrolled. Kikyo condition was evaluated by a questionnaire scoring system. All patients continued their ordinary treatments (topical steroids, topical tacrolimus, emollients or oral antihistamines) before and after their protocol entry. Hochu-ekki-to or placebo was orally administered twice daily for 24 weeks. The skin severity scores, total equivalent amount (TEA) of topical agents used for AD treatment, prominent efficacy (cases with skin severity score = 0 at the end of the study) rate and aggravated rate (more than 50% increase of TEA of topical agents from the beginning of the study) were monitored and evaluated. Seventy-seven out of 91 enrolled patients completed the 24-week treatment course (Hochu-ekki-to: n = 37, placebo: n = 40). The TEA of topical agents (steroids and/or tacrolimus) was significantly (P < 0.05) lower in the Hochu-ekki-to group than in the placebo group, although the overall skin severity scores were not statistically different. The prominent efficacy rate was 19% (7 of 37) in the Hochu-ekki-to group and 5% (2 of 40) in the placebo group (P = 0.06). The aggravated rate was significantly (P < 0.05) lower in the Hochu-ekki-to group (3%; 1 of 37) than in the placebo group (18%; 7 of 39). Only mild adverse events such as nausea and diarrhea were noted in both groups without statistical difference. This placebo-controlled study demonstrates that Hochu-ekki-to is a useful adjunct to conventional treatments for AD patients with Kikyo constitution. Use of Hochu-ekki-to significantly reduces the dose of topical steroids and/or tacrolimus used for AD treatment without aggravating AD. PMID:18955318

Kobayashi, Hiromi; Ishii, Masamitsu; Takeuchi, Satoshi; Tanaka, Yoichi; Shintani, Takahiro; Yamatodani, Atsushi; Kusunoki, Tadashi; Furue, Masutaka

2008-01-31

81

Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial  

Microsoft Academic Search

In an open-label extension of a randomized, double-blind clinical trial, the long-term efficacy and tolerability of a fixed\\u000a combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule (PRO 160\\/120) were investigated\\u000a in elderly men with moderate or severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Two\\u000a hundred and fifty-seven patients were

Nikolai Lopatkin; Andrey Sivkov; Sandra Schläfke; Petra Funk; Alexander Medvedev; Udo Engelmann

2007-01-01

82

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

PubMed

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

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

2009-01-01

83

Long-term efficacy of radiofrequency ablation in treatment of common and palmo-plantar warts.  

PubMed

Current treatments for warts induce significant local tissue damage and do not prevent recurrence. We evaluated the efficacy of localised radiofrequency heat (RFH) therapy in inducing the long-term resolution of common and palmo-plantar warts in a placebo-controlled randomised single blind trial. Our data show that RFH therapy is a safe, cosmetically acceptable and long-term effective treatment for warts. PMID:23127158

Khandelwal, Kanika; Bumb, Ram A; Mehta, Rajesh D; Ghiya, Bhikam C; Satoskar, Abhay R

2012-11-06

84

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

PubMed Central

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

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

2013-01-01

85

Long-term safety of aromatase inhibitors in the treatment of breast cancer  

PubMed Central

Following promising data for metastatic breast cancer in terms of efficacy and safety profile, third-generation aromatase inhibitors (AI), anastrozole, letrozole, and exemestane, underwent a full development in early setting. If recent results consistently show the superiority of these agents over tamoxifen, the therapeutic strategies of AIs in adjuvant setting are still debated. Beyond the choice of clinical strategy, the long duration of exposure to AI in adjuvant setting required a full determination of the long-term toxicity profile of these agents. While all three AIs have either favorable (decreased incidence of hot flashes, gynecologic and thromboembolic side-effects) or unfavorable (skeletal complications, arthralgia, musculoskeletal pain, sexual dysfunction) class adverse events, some variability between AIs has been reported in side-effects as well as gastrointestinal, urogenital, neurologic, and visual disturbances, confirming the lack of interchangeability between the three AIs. The overall therapeutic index of AIs appears today superior to that of tamoxifen with proven improved efficacy and better toxicity profile. This review will explore the results from the available adjuvant AIs trials with a particular emphasis on safety profiles, quality of life, and therapeutic index, helping to define the present role of AIs in the adjuvant management of postmenopausal patients with breast cancer.

Nabholtz, Jean-Marc A

2008-01-01

86

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

87

Long-term efficacy of miglustat in paediatric patients with Niemann-Pick disease type C.  

PubMed

Niemann-Pick disease type C (NP-C) is a rare inherited neurovisceral disease characterized by progressive neurological manifestations. Oral miglustat was first approved for the treatment of children and adults with NP-C in Europe in 2009. There are still relatively few published data on the long-term efficacy and safety of miglustat in patients with NP-C in clinical practice. We report the effects of up to 6 years of treatment with miglustat 100 mg t.i.d. in five children. Overall, 3/5 patients displayed progressive dysphagia before starting miglustat, and 4/5 showed marked cognitive and/or motor impairment. The mean age at treatment start was 11.6 years, and the median (range) duration of therapy so far is 4 (4.1 to 6.1) years. No treatment dose alterations were required, but therapy was interrupted for 1-3 months at least once in all patients due to supply issues. Swallowing function was stabilised during miglustat therapy, with no significant increase in Han dysphagia scale or aspiration-penetration index scores among four evaluable patients (p > 0.05). Scores on the mini-mental state examination indicated an improvement in cognitive function during the first 3-6 months of miglustat therapy, followed by stabilisation up to 5 years. Ambulatory function remained stable for at least the first 2 years of treatment in most patients, but there was a trend towards deterioration thereafter, possibly related to treatment interruptions. The safety/tolerability profile of miglustat was similar to previous clinical studies, although reports of gastrointestinal disturbances were rare. Overall, miglustat appeared to stabilise key parameters of neurological disease progression. PMID:22476655

Chien, Y H; Peng, S F; Yang, C C; Lee, N C; Tsai, L K; Huang, A C; Su, S C; Tseng, C C; Hwu, W L

2012-04-05

88

Efficacy and Safety of Up to 8 Years of Long-term Growth Hormone Treatment in Short Children Born Small for Gestational Age in Japan: Analysis of the Subpopulation According to the Japanese Guideline  

PubMed Central

The efficacy and safety of 8 yr of GH treatment was assessed in 44 Japanese children with small for gestational age (SGA) short stature who met the criteria for GH treatment initiation (height SD score (SDS) <–2.5 SD) of the Japanese guidelines. Height SDS in subjects improved throughout the study period, and average height SDS improved from –3.5 to –1.6 and from –3.4 to –1.9 in the 0.033/0.067 mg and 0.067/0.067 mg groups, respectively, after 8 yr of GH treatment. Delta height SD was approximately +2 after 4 yr of treatment, and ? IGF-1 showed a significant positive correlation with ? height SD after both 1 and 2 yr (r = 0.415 and 0.488, respectively) of treatment. There was no correlation between the age at the start of treatment and age at onset of puberty, and the median age at the onset of puberty in the subjects was almost the same as that in healthy children. In conclusion, clinically significant improvements in the height SDS was confirmed in short children born SGA after 8 yr of GH treatment without any safety problems.

Tanaka, Toshiaki; Yokoya, Susumu; Fujieda, Kenji; Seino, Yoshiki; Tada, Hiroshi; Mishina, Jun; Saito, Susumu; Takata, Ami; Ohki, Nobuhiko

2012-01-01

89

The efficacy of tonsillectomy on long-term renal survival in patients with IgA nephropathy  

Microsoft Academic Search

The efficacy of tonsillectomy on long-term renal survival in patients with IgA nephropathy.BackgroundLittle information has been available until now about the clinical efficacy of tonsillectomy on long-term renal survival of patients with idiopathic immunoglobulin A nephropathy (IgAN).MethodsTo investigate the effect of tonsillectomy on long-term renal survival, we reviewed the clinical course of 118 patients with idiopathic biopsy-diagnosed IgAN from 1973

Yuansheng Xie; Shinichi Nishi; Mitsuhiro Ueno; Naofumi Imai; Minoru Sakatsume; Ichiei Narita; Yasushi Suzuki; Kouhei Akazawa; Hisaki Shimada; Masaaki Arakawa; Fumitake Gejyo

2003-01-01

90

Long-Term Efficacy of Biofeedback Therapy for Dyssynergic Defecation: Randomized Controlled Trial  

Microsoft Academic Search

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 1-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 (VASs), colonic transit, anorectal manometry, and balloon

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

2010-01-01

91

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

Microsoft Academic Search

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

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

2001-01-01

92

Long-term efficacy of Botulinum toxin in classical achalasia: a prospective study  

Microsoft Academic Search

OBJECTIVE:We sought to examine the long-term efficacy of intrasphincteric Botulinum toxin A injection in a prospective cohort study of 30 patients with achalasia.METHODS:Thirty patients with classical achalasia were treated with intrasphincteric Botulinum toxin A injection. Follow-up consisted of clinical assessment, symptom scoring, and postinjection manometry.RESULTS:Symptomatic improvement for >3 months was seen in 23 of 30 patients (77%). Of the 23

Jeff Kolbasnik; William E. Waterfall; Beth Fachnie; Ying Chen; Gervais Tougas

1999-01-01

93

Technology Professional Development: Long-Term Effects on Teacher Self-Efficacy  

Microsoft Academic Search

The West Virginia K-12 RuralNet Project was an NSF funded program to train inservice teachers on integrating the Internet into science and mathematics curriculum. The program involved training inservice teachers through an intensive summer workshop and supplemental online courses. This study examines the effects of the project on the long-term self-efficacy of inservice teachers and their use of the Internet

George Watson

2006-01-01

94

Efficacy of long-term ezetimibe therapy in patients with nonalcoholic fatty liver disease  

Microsoft Academic Search

Background  Hyperlipidemia, insulin resistance, and oxidative stress can heavily contribute to the initiation and progression of nonalcoholic\\u000a fatty liver disease (NAFLD). Currently, there is no established treatment for this disease. Recently, several studies have\\u000a shown that ezetimibe (EZ), a lipid-lowering drug, attenuates liver steatosis in an experimental NAFLD model. This study was\\u000a designed to assess the efficacy of long-term EZ monotherapy

Toshihide Shima; Kanji Yamaguchi; Hironori Mitsuyoshi; Masahito Minami; Kohichiroh Yasui; Yoshito Itoh; Toshikazu Yoshikawa; Michiaki Fukui; Goji Hasegawa; Naoto Nakamura; Mitsuhiro Ohta; Hiroshi Obayashi; Takeshi Okanoue

2011-01-01

95

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

2013-01-01

96

Research on long term safety of nuclear waste disposal at the research center Karlsruhe, Germany  

Microsoft Academic Search

In Germany the safe disposal of radioactive waste is in the responsibility of the federal government. The R and D performed in the Institute for Nuclear Waste Disposal (INE) at the Research Center Karlsruhe contributes to the German provident research in the field of long-term safety for final disposal of high level heat producing nuclear wastes. INE's research is focused

Klaus Gompper; Dirk Bosbach; Melissa A. Denecke; Horst Geckeis; Bernhard Kienzler; Reinhardt Klenze

2007-01-01

97

Long-term efficacy of hepatitis B vaccine, booster policy, and impact of hepatitis B virus mutants  

Microsoft Academic Search

The long-term efficacy of hepatitis B vaccine, long-term effectiveness of hepatitis B immunisation programmes, immune memory induced by hepatitis B vaccine, current booster policies, and impact of hepatitis B virus mutants on immunisation programmes were reviewed at the Viral Hepatitis Prevention Board (VHPB) meeting in Sevilla, Spain, March 2004. The main focus was on universal vaccination programmes with data being

David FitzSimons; Guido François; Andrew Hall; Brian McMahon; André Meheus; Alessandro Zanetti; Bernard Duval; Wolfgang Jilg; Wulf Otto Böcher; Sheng-Nan Lu; Ulus Akarca; Daniel Lavanchy; Susan Goldstein; Jangu Banatvala; Pierre Van Damme

2005-01-01

98

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

PubMed

The objective of this study was to assess cognition and behavior in children (4-16 years; n = 103) with partial-onset seizures using the Leiter-R International Performance Scale and Achenbach Child Behavior Checklist. The study was a multicenter, open-label, noncomparative 48-week extension study (NCT00152516) of adjunctive levetiracetam (20-100 mg/kg/d, mean 50.2 mg/kg/d). Improvement from baseline in Leiter-R Memory Screen composite score at weeks 24 and 48 (mean [SD] change, +4.8 [12.6] and +4.5 [15.3]) was similar to changes observed with levetiracetam and placebo in a prior study. Child Behavior Checklist Syndrome scores improved from baseline at weeks 24 and 48 (total problems mean [SD] change, -9.3 [22.2] and -10.4 [23.4]). Adjunctive levetiracetam was well tolerated (most frequently reported central nervous system-related treatment-emergent adverse events: headache [24.3%], aggression [7.8%], irritability [7.8%]). Of the patients, 4.9% discontinued because of treatment-emergent adverse events. Levetiracetam provided good and sustained seizure control (median percentage reduction from baseline in partial-onset seizure frequency/wk during maintenance: 86.4%); 24.7% of patients had continuous seizure freedom from all seizure types for ?40 weeks. In children, adjunctive levetiracetam was associated with long-term stability in cognitive functioning and improvement in emotional/behavioral functioning over time. PMID:21876066

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

2011-08-29

99

Long-term efficacy of infliximab maintenance therapy for perianal Crohn's disease  

PubMed Central

AIM: To assess the long-term efficacy of seton drainage with infliximab maintenance therapy in treatment of stricture for perianal Crohn’s disease (CD). METHODS: Sixty-two patients with perianal CD who required surgical treatment with or without infliximab between September 2000 and April 2010 were identified from our clinic’s database. The activities of the perianal lesions were evaluated using the modified perianal CD activity index (mPDAI) score. The primary endpoint was a clinical response at 12-15 wk after surgery as a short-term efficacy. Secondary endpoints were recurrence as reflected in the mPDAI score, defined as increased points in every major element. The clinical responses were classified as completely healed (mPDAI = 0), partially improved (mPDAI score decreased more than 4 points), and failure or recurrence (mPDAI score increased or decreased less than 3 points). RESULTS: There were 43 males and 19 females, of whom 26 were consecutively treated with infliximab after surgery as maintenance therapy. Complete healing was not seen. Failure was seen in 10/36 (27.8%) patients without infliximab and 4/26 (15.4%) patients with infliximab (P = 0.25). Partial improvement was seen in 26/36 (72.2%) patients without infliximab and 22/26 (88.5%) patients with infliximab (P = 0.25). Short-term improvement was achieved in 48/62 (77.4%) patients. Although the mPDAI score improved significantly with surgery regardless of infliximab, it decreased more from baseline in patients with infliximab (50.0%) than in those without infliximab (28.6%), (P = 0.003). In the long-term, recurrence rates were low regardless of infliximab in patients without anorectal stricture. In patients with anorectal stricture, cumulative recurrence incidences increased gradually and exceeded 40% at 5 years regardless of infliximab. No efficacy of infliximab treatment was found (P = 0.97). Although the cumulative rate of ostomy creation was also low in patients without stricture and high in patients with stricture, no protective efficacy was found with infliximab treatment (P = 0.6 without stricture, P = 0.22 with stricture). CONCLUSION: Infliximab treatment was demonstrated to have short-term efficacy for perianal lesions. Long-term benefit with infliximab was not proven, at least in patients with anorectal stricture.

Uchino, Motoi; Ikeuchi, Hiroki; Bando, Toshihiro; Matsuoka, Hiroki; Takesue, Yoshio; Takahashi, Yoshiko; Matsumoto, Takayuki; Tomita, Naohiro

2011-01-01

100

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD  

ERIC Educational Resources Information Center

|Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

101

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD  

ERIC Educational Resources Information Center

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

102

Long-Term Safety of Oral Transmucosal Fentanyl Citrate for Breakthrough Cancer Pain  

Microsoft Academic Search

This open-label study evaluated the long-term safety and tolerability of oral transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-based practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrough pain, and had achieved relief of their breakthrough

Richard Payne; Paul Coluzzi; Lowell Hart; Mary Simmonds; Alan Lyss; Richard Rauck; Robert Berris; Michael A Busch; Earl Nordbrook; Diane B Loseth; Russell K Portenoy

2001-01-01

103

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

PubMed

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

Anderson, Paul A; Hashimoto, Robin

2012-02-01

104

LISA (Long Term Isolation Safety Assessment): A Code for Safety Assessment in Nuclear Waste Disposals Program Description and User Guide.  

National Technical Information Service (NTIS)

The code LISA (Long Term Isolation Safety Assessment), developed at the Joint Research Center, Ispra is a useful tool in the analysis of the hazard due to the disposal of nuclear waste in geological formations. The risk linked to preestablished release sc...

A. Saltelli G. Bertozzi D. A. Stanners

1984-01-01

105

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

106

Short- and long-term efficacy of endoscopic balloon dilation in Crohn's disease strictures  

PubMed Central

AIM: To evaluate short- and long-term efficacy of endoscopic balloon dilation in a cohort of consecutive patients with symptomatic Crohn’s disease (CD)-related strictures. METHODS: Twenty-six CD patients (11 men; median age 36.8 year, range 11-65 years) with 27 symptomatic strictures underwent endoscopic balloon dilation (EBD). Both naive and post-operative strictures, of any length and diameter, with or without associated fistula were included. After a clinical and radiological assessment, EBD was performed with a Microvasive Rigiflex through the scope balloon system. The procedure was considered successful if no symptom reoccurred in the following 6 mo. The long-term clinical outcome was to avoid surgery. RESULTS: The mean follow-up time was 40.7 ± 5.7 mo (range 10-94 mo). In this period, forty-six EBD were performed with a technical success of 100%. No procedure-related complication was reported. Surgery was avoided in 92.6% of the patients during the entire follow-up. Two patients, both presenting ileocecal strictures associated with fistula, failed to respond to the treatment and underwent surgical strictures resection. Of the 24 patients who did not undergo surgery, 11 patients received 1 EBD, and 13 required further dilations over time for the treatment of relapsing strictures (7 patients underwent 2 dilations, 5 patients 3 dilations, and 1 patient 4 dilations). Overall, the EBD success rate after the first dilation was 81.5%. No difference was observed between the EBD success rate for naive (n = 12) and post-operative (n = 15) CD related strictures (P > 0.05). CONCLUSION: EBD appears to be a safe and effective procedure in the therapeutic management of CD-related strictures of any origin and dimension in order to prevent surgery.

de'Angelis, Nicola; Carra, Maria Clotilde; Borrelli, Osvaldo; Bizzarri, Barbara; Vincenzi, Francesca; Fornaroli, Fabiola; De Caro, Giuseppina; de'Angelis, Gian Luigi

2013-01-01

107

Estimation of underground cavities stability for long-term safety of nuclear waste repository  

NASA Astrophysics Data System (ADS)

There is the increased interest to a problem of storages of radioactive waste creation in geological structures in present. Such projects are developed and the construction of these objects is conducted in many countries. This is caused by real, safety and economically acceptable character of radioactive waste underground isolation from human environment. Exploitation term of this objects is tens, hundreds and more years. The rock massif is the long acting natural barrier on a way of radionuclides distribution so the problem of ecological safety is long-term stability of storages and surrounding rock. Therefore one of the main problems is the development of evaluation and forecasting methods of underground structures supporting constructions long stability. The regularities of roof of cameras and pillars deformation and failure in time, depending on its geometric sizes, physical-mechanical properties of rocks, stress state and massif structure are obtained as result of mine research. On basis of kinetic theory of rock failure, creep theory and statistical analysis of experimental datas, which was obtained in mine conditions, the model of supporting constructions long-term strength is developed. This model allows to make an estimation and forecasting of underground structures current state evolution in time.

Rogojnikov, O.; Mansurov, V.

2003-04-01

108

Research on long term safety of nuclear waste disposal at the research center Karlsruhe, Germany  

SciTech Connect

In Germany the safe disposal of radioactive waste is in the responsibility of the federal government. The R and D performed in the Institute for Nuclear Waste Disposal (INE) at the Research Center Karlsruhe contributes to the German provident research in the field of long-term safety for final disposal of high level heat producing nuclear wastes. INE's research is focused on the actinide elements and long lived fission products since these dominate the radiotoxicity over a long time. The research strategy synergistically combines fundamental science of aquatic radionuclide chemistry with applied investigations of real systems (waste form, host rock, aquifer), studied on laboratory scale and in underground laboratories. Because Germany has not yet selected a site for a high-level waste repository, all host rock formations under discussion in the international community (salt, hard rock, clay/tone) are investigated. Emphasis in long-term safety R and D at INE is on the development of actinide speciation methods and techniques in the trace concentration range. (authors)

Gompper, Klaus; Bosbach, Dirk; Denecke, Melissa A.; Geckeis, Horst; Kienzler, Bernhard; Klenze, Reinhardt [Forschungszentrum Karlsruhe, Institut fuer Nukleare Entsorgung, P.O. Box 3640, 76021 Karlsruhe (Germany)

2007-07-01

109

Long-term therapeutic efficacy of photo-selective vaporization of prostate  

NASA Astrophysics Data System (ADS)

OBJECTIVES: We evaluated the long term therapeutic efficacy of 80 watt photo-selective vaporization of the prostate (PVP) in patients suffering from lower urinary tract symptoms (LUTS) secondary to prostatic obstruction. MATERIAL & METHODS: 150 unselected patients at the average age 73 (range 51-92) and a mean American Society of Anesthesiologists score of 2.4 (median 2.0), of whom 33% were medicated with acetylsalicylic acid and 5% were anticoagulated with warfarin. Inclusion/exclusion criteria were the same as for TUR-P at our institution. First patient was operated March 2004 and yearly follow-up of all patients has been attempted for 5 years. Follow-up variables have included yearly creatinine, PSA, IPSS, ØOL, post-void residual urin and maximum/average urine flow rate. RESULTS: At 12 and 24 months postoperatively, the following parameters were significantly (p<0.001) improved: trans-rectal ultrasound, international prostate symptom score, quality of life score, post-void residual urine volume, flow max/average, opening pressure, pressure @ flow-max, and micturition resistance. At 48 and 60 months creatinine, PSA, IPSS, ØOL, post-void residual urin and maximum/average urine flow rates were still significantly (p<0.001) improved compared to pre-operative values. CONCLUSION: Up to 5 year follow-up reveals that 80 watt PVP provides significant and stable symptom relief as well as objective improvement in residual urine and flowmetric outcomes.

Arum, Carl-Jørgen; Muller, Camilla; Romundstad, Pal; Stokkan, Inger; Mjønes, Jan

2010-02-01

110

Efficacy and Long-Term Outcome of Endoscopic Treatment of Sporadic Nonampullary Duodenal Adenoma  

PubMed Central

Background/Aims Endoscopic resection has proven to be a safe and effective alternative to surgery for duodenal adenomas. However, few data are available on the adequacy of resection and long-term outcomes. This study evaluated the efficacy and longterm endoscopic findings in a cohort of Korean patients who underwent endoscopic mucosal resection (EMR) of sporadic duodenal adenomas. Methods Seventeen patients with nonampullary duodenal adenomas without familial polyposis syndrome and who were treated by EMR between January 2001 and December 2007 were evaluated retrospectively. Their management, follow-up, and outcomes were reviewed. Results In total, seventeen lesions were removed from EMR in 17 patients (mean age, 59.3 years; 6 women, 11 men). The mean size of the tumors was 15.1 mm (median, 13 mm, range, 8-27 mm). Of these 17 adenomas, 16 adenomas were tubulous and 1 was tubulovillous. The EMR was performed successfully in all 17 patients in a single session. After a median follow-up period of 29 months (range, 13-72 months), all patients remained in remission. One patient had bleeding at the site of the EMR. There were no perforations after the EMR. Conclusions EMR for sporadic duodenal adenomas seemed to be a safe and effective treatment modality.

Kim, Hyung-Keun; Chung, Woo Chul; Lee, Bo-In

2010-01-01

111

The safety and effectiveness of long-term warfarin therapy in an anticoagulation clinic.  

PubMed

Whenever long-term anticoagulation is prescribed, the risks of such therapy must be evaluated accurately. Whether these risks are influenced by the duration of therapy, the indication for therapy, patient demographics and social habits, or the use of an anticoagulation clinic is controversial. This study examined the occurrence rates of major hemorrhage, minor hemorrhage, and thromboembolic events among an inception cohort of 82 patients receiving long term-warfarin therapy in an anticoagulation clinic. During 199.34 patient-years of observation, there were 4 major hemorrhages (0.0201/patient-year), 31 minor hemorrhages (0.1555/patient-year), and 7 thromboembolic events (0.0351/patient-year). Although each type of event tended to occur during the first 6 months of therapy, this trend was not statistically significant. Failure to demonstrate statistically significant influence of any of the evaluated variables may have been due to the unusually low rate of complications, a finding that may reflect the safety of anticoagulant therapy when managed by a specialized clinic. PMID:2788876

Bussey, H I; Rospond, R M; Quandt, C M; Clark, G M

1989-01-01

112

Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study  

PubMed Central

Study Objectives: To evaluate long-term efficacy and safety of zolpidem extended-release 3 to 7 nights/week for chronic primary insomnia. Design: Multicenter, 25-week, phase IIIb, randomized, double-blind, placebo-controlled, parallel-group. Setting: Outpatient; visits every 4 weeks. Patients: Aged 18 to 64 years; DSM-IV criteria for chronic primary insomnia; ?3 months of difficulty initiating or maintaining sleep or experiencing nonrestorative sleep. Interventions: Single-dose zolpidem extended-release 12.5 mg (n = 669) or placebo (n = 349), self-administered from a minimum of 3 nights/week to a maximum of 7 nights/week. Measurements and Results: Patient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to week 24. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures—sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)—and next-day functioning. At week 12, PGI, Item 1 (aid to sleep), the primary endpoint, was scored as favorable (i.e., “helped me sleep”) by 89.8% of zolpidem patients vs. 51.4% of placebo patients (P < 0.0001, based on rank score) and at week 24 by 92.3% of zolpidem extended-release patients vs. 59.7% of placebo patients. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1–4) and CGI-I (P < 0.0001, rank score), TST, WASO, QOS (P < 0.0001), and SOL (P ? 0.0014); NAW (Months 2–6; P < 0.0001). Sustained improvement (P < 0.0001, all time points) was observed in morning sleepiness and ability to concentrate (P = 0.0014, month 6) with zolpidem extended-release compared with placebo. Most frequent adverse events for zolpidem extended-release were headache, anxiety and somnolence. No rebound effect was observed during the first 3 nights of discontinuation. Conclusions: These findings establish the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness. Citation: Krystal AD; Erman M; Zammit GK; Soubrane C; Roth T. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study. SLEEP 2008;31(1):79-90.

Krystal, Andrew D.; Erman, Milton; Zammit, Gary K.; Soubrane, C.; Roth, Thomas

2008-01-01

113

Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip.  

PubMed

Safety data on the inactivated split influenza vaccine, Vaxigrip, were compiled and analysed from 28 clinical trials (total: 4599 subjects aged 6 months to 99 years) to provide a robust estimate of the reactogenicity profile. The most frequent solicited reactions were non-severe injection site pain and erythema in children, adults, and elderly. Mild or moderate fever was the most frequent reaction in 6-36 months olds; few systemic reactions were reported in older groups. Reactogenicity was comparable in healthy and high-risk children. The long-term experience with the world's most widely used influenza vaccine, Vaxigrip, confirms its excellent tolerability, and supports its continued use in clinical practice worldwide. PMID:16271424

Delore, Valentine; Salamand, Camille; Marsh, Grenville; Arnoux, Sabine; Pepin, Stephanie; Saliou, Pierre

2005-10-18

114

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

SciTech Connect

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

DeHart, M.D.

1999-08-01

115

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

2013-03-19

116

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

PubMed

This large-scale postmarketing surveillance of raloxifene (60 mg/day) was conducted to assess the safety and effectiveness of raloxifene for long-term use in postmenopausal Japanese women with osteoporosis. The baseline examination included 6,967 women (mean age, 70.4 years). Participants completed observation after 6, 12, 24, and 36 months of therapy. Adverse drug reactions (ADR) were reported in 776 participants (11.14 %), with a total of 87 serious ADR cases occurring in 76 participants (1.09 %). The most frequently reported ADRs were edema peripheral (45/6,967, 0.65 %) and venous thromboembolism (11/6,967, 0.16 %). Of the 6,967 participants, 2,784 were included in the effectiveness analysis. Lumbar spine bone mineral density (BMD) increased significantly (p < 0.001, paired t test) compared with baseline at 6, 12, 24, and 36 months (2.51 %, 2.85 %, 4.76 %, and 3.51 %, respectively). Significant decreases in serum and urinary cross-linked amino-terminal telopeptide of type I collagen (NTX) and urinary deoxypyridinoline levels from baseline were observed at 3 months, followed by a significant decrease of serum bone alkaline phosphatase at 6 months [p < 0.001 for all comparisons except serum NTX (p = 0.011), Wilcoxon signed-rank test]. Early reductions in the biochemical markers of bone turnover (BTM) observed at 3 months with raloxifene treatment correlated negatively with subsequent increases in lumbar spine BMD at 1 year (r = -0.347, p = 0.008). The incidence of any new clinical fractures within 3 years was 1.18 % (82/6,967 participants). In summary, no new signals in safety were observed in the daily use of raloxifene. Moreover, the effectiveness profile of raloxifene was confirmed in practical use by this large-scale, long-term, postmarketing surveillance. PMID:22752125

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

2012-07-03

117

Perineural morphine in patients with chronic ischemic lower extremity pain: efficacy and long-term results  

Microsoft Academic Search

Purpose  To compare the efficacy, safety, and impact on daily activity of peripherally administered morphine plus a local anesthetic\\u000a with that of a local anesthetic alone in patients with chronic ischemic lower extremity pain.\\u000a \\u000a \\u000a \\u000a Methods  Fifty patients with lower extremity ischemic pain due to peripheral vascular disease who had undergone surgical sympathectomy\\u000a and who were not responding to systemic analgesics were included.

Kader Keskinbora; Isik Aydinli

2009-01-01

118

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.

119

Risperidone Treatment in Children and Adolescents With Autism: Short and Long-Term Safety and Effectiveness  

Microsoft Academic Search

ObjectiveAtypical neuroleptics, including risperidone, are used to treat children with autism, despite limited efficacy and safety data. Many clinicians believe that risperidone will not induce dyskinesias in children. The authors investigated open risperidone treatment in children with autism and included findings on dyskinesias.

RICHARD P. MALONE; GREG MAISLIN; MUNIYA S. CHOUDHURY; CYNTHIA GIFFORD; MARY ANNE DELANEY

2002-01-01

120

Technology Professional Development: Long-Term Effects on Teacher Self-Efficacy  

ERIC Educational Resources Information Center

The West Virginia K-12 RuralNet Project was an NSF funded program to train inservice teachers on integrating the Internet into science and mathematics curriculum. The program involved training inservice teachers through an intensive summer workshop and supplemental online courses. This study examines the effects of the project on the long-term

Watson, George

2006-01-01

121

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

122

The efficacy of pulmonary thromboendarterectomy on long-term gas exchange  

Microsoft Academic Search

It has not been delineated in detail how pulmonary thromboen- darterectomy (PTE) affects gas exchange through long-term follow-up. In Japan, this surgery has been undertaken in a limited number of institutions, and the results of PTE have not been well publicized. A total of 25 patients were operated on during the period from 1985 to 1996 at our institution, and

N. Tanabe; O. Okada; Y. Nakagawa; M. Masuda; K. Kato; N. Nakajima; T. Kuriyama

1997-01-01

123

Long-term residual efficacy of commerical formulations of 16 pesticides to Typhlodromus pyri Scheuten (Acari: Phytoseiidae) inhabiting commerical vineyards  

Microsoft Academic Search

The long-term residual efficacy of 16 pesticides to the predatory phytoseiid mite,Typhlodromus pyri Scheuten, inhabiting commercial sprayed vineyards in South Moravia, Czchoslovakia, was evaluated in laboratory bioassays. Omethoate, chlorpyrifos-methyl and esfenvalerate were assessed as harmful and should not be sprayed. Mancozeb-efosite-Al mixture, diazinon, dicofol, bromopropylate, azinphos-ethyl and phosmet were assessed as moderately harmful. Fenitrothion, phosalone and mancozeb were assessed as

Miloslav Zacharda; Milan Hluchý

1991-01-01

124

Chapter 28: Studies to assess the long-term efficacy and effectiveness of HPV vaccination in developed and developing countries  

Microsoft Academic Search

We review studies of the implementation of human papillomavirus (HPV) vaccination programmes in developed and developing countries. The review spans the period from establishment of long-term vaccine efficacy follow-up studies, operational research on issues of vaccine preparedness, and relevant predictive modelling studies during the pre-licensure phase to plans of phase IV effectiveness trials, forms of epidemiological surveillance, and further operational

Matti Lehtinen; Rolando Herrero; Philippe Mayaud; Ruanne Barnabas; Joakim Dillner; Jorma Paavonen; Peter G. Smith

2006-01-01

125

Long-term Efficacy of Polyethylene Glycol 3350 for the Treatment of Chroni Constipation in Children with and without Encopresis  

Microsoft Academic Search

Seventy-four children (43 with chronic constipation, 31 with constipation and encopresis) treated with polyethylene glycol 3350 (PEG) for longer than 3 months were studied to assess long-term efficacy. The mean duration of PEG therapy was 8.4 months (range, 3-30). Weekly stool frequency, stool consistency, and symptoms associated with constipation improved significantly with PEG therapy in all 74 patients. In 31

Dinesh S. Pashankar; Warren P. Bishop; Vera Loening-Baucke

2003-01-01

126

Long-term efficacy of group-based treatment for childhood obesity compared with routinely given individual counselling  

Microsoft Academic Search

Objective:We investigated the long-term efficacy of two childhood obesity treatment programs, routine counselling (two appointments for children) and group treatment (15 sessions separately for children and parents) in a randomised controlled trial. As published earlier, group treatment was more effective than routine counselling in the treatment of 7–9 year-old obese children in the short term.Design:The children's heights and weights were

M Kalavainen; M Korppi; O Nuutinen

2011-01-01

127

Long-term safety study of iguratimod in patients with rheumatoid arthritis.  

PubMed

We conducted a 52-week clinical study of iguratimod in 394 Japanese patients with rheumatoid arthritis to evaluate the long-term safety of the drug. Iguratimod was administered orally at a daily dose of 25 mg for the first 4 weeks and 50 mg for the subsequent 48 weeks. Some of the patients continued the treatment for 100 weeks for their benefit. The cumulative incidence of adverse events for 100 weeks was 97.6%. The cumulative incidence of adverse reactions was 65.3%; unfavorable symptoms and signs (excluding abnormal laboratory data changes) accounted for 33.2% of the reactions, and abnormal laboratory data changes accounted for 50.4%. The continued treatment rate was 66.8% at week 28 and 53.6% at week 52. For reference, the American College of Rheumatology (ACR) 20 response rate was calculated for the patients who had assessable disease activity, who did not violate the study protocol, and who continued the study treatment at weeks 28 and 52. The rate was 46.9% at week 28 and 41.0% at week 52. To use iguratimod safely for a long time, patients should be observed closely for adverse reactions such as increased hepatic enzymes. PMID:17278016

Hara, Masako; Abe, Tohru; Sugawara, Sachiko; Mizushima, Yutaka; Hoshi, Keiko; Irimajiri, Shoichiro; Hashimoto, Hiroshi; Yoshino, Shinichi; Matsui, Nobuo; Nobunaga, Masashi

2007-02-20

128

Long-term efficacy of combined relaxation: biofeedback treatments for chronic headache.  

PubMed

Thirty-four patients having chronic idiopathic headaches participated in a long-term study comparing autogenic relaxation training alone (REL) with combinations of relaxation and electromyographic biofeedback (REL + EMG) or relaxation and temperature biofeedback (REL + TEMP). Assignment to treatment conditions was balanced on demographics and clinical characteristics, as well as headache classification according to muscle contraction or vascular headache symptomatology. The results indicate that REL + TEMP produced no additional improvements over REL following the 8-week treatment program, or at 6-month, or 12-month follow-up. However, REL + EMG produced significantly greater reductions in headache activity measures than the REL and REL + TEMP conditions at all post-treatment time points. Headache activity continued to improve over the follow-up period independent of treatment condition. These data indicate that EMG biofeedback augments long-term clinical improvements in headache patients who undergo autogenic relaxation training. PMID:1454404

Cott, A; Parkinson, W; Fabich, M; Bédard, M; Marlin, R

1992-10-01

129

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

130

Olfactory associative discrimination: a model for studying modifications of synaptic efficacy in neuronal networks supporting long-term memory.  

PubMed

This review summarizes research that correlates behavioral performance and cellular physiology leading to modifications in the neuronal networks supporting long-term memory in the mammalian brain. Rats were trained in an olfactory associative discrimination task in which natural odors were replaced by mimetic olfactory stimulations. Olfactory learning induced synaptic modifications that affected behavioral performance along the central olfactory pathways. Starting with an early increase in monosynaptic efficacy in the dentate gyrus on the first session, a polysynaptic modification appeared later on in this hippocampal network, when rats began to make associations between cues and rewards. Therefore, only when rats made consistent associations did a long-term potentiation in the synapses of the piriform cortex pyramidal neurons appear. These modifications may correspond to the long-term storage of the meaning of the cue-reward association in a specific cortical area. Based on these cumulative results, a hypothesis is proposed to account for how, when, and where synaptic modifications in neural networks are required to constitute long-term memory. PMID:15046196

Roman, François S; Truchet, Bruno; Chaillan, Franck A; Marchetti, Evelyne; Soumireu-Mourat, Bernard

2004-01-01

131

Channel Gating Kinetics and Synaptic Efficacy: A Hypothesis for Expression of Long-Term Potentiation  

Microsoft Academic Search

A kinetic model of the glutamate DL-alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor\\/channel complex was used to test whether changes in the rate constants describing channel behavior could account for various features of long-term potentiation (LTP). Starting values for the kinetic parameters were set to satisfy experimental data (e.g., affinity, mean open time, mean burst length, etc.) and physical constraints (i.e., microreversibility). The

Jose Ambros-Ingerson; Gary Lynch

1993-01-01

132

Efficacy of Cordyceps sinensis in long term treatment of renal transplant patients.  

PubMed

High doses of cyclosporin A (CsA) can not be used in the long term treatment of kidney allograft recipients primarily due to severe side effects. In the present study, we investigated the potential application of Cordyceps sinensis (CS) in the long term treatment of renal transplant patients. The renal function and survival rates of grafts and patients did not show significantly different between the control group and the treatment group. However, the incidences of complications were significantly lower in the treatment group compared with that in control group with the exception of those showing acute rejection. Furthermore, the dosage and the whole blood trough concentrations of CsA were significantly lower than control group. However, there was no significant difference in the serum level of IL-2 in the two groups. Interestingly, the serum level of IL-10 in the treatment group was significantly higher than that in control group. These data demonstrat that CS may be used in combination with a low dose of CsA in the long term treatment of kideny transplant patients. PMID:21196310

Ding, Chenguang; Tian, Pu-xun; Xue, Wujun; Ding, Xiaoming; Yan, Hang; Pan, Xiaoming; Feng, Xinshun; Xiang, Heli; Hou, Jun; Tian, Xiaohui

2011-01-01

133

The Transplantation of Human Fetal Neuroretinal Cells in Advanced Retinitis Pigmentosa Patients: Results of a Long-Term Safety Study  

Microsoft Academic Search

The purpose of this study was to determine the long-term safety of transplanting human fetal neuroretinal cells (14 to 18 week gestational age) into a series of patients with advanced retinitis pigmentosa (RP). After obtaining informed consent, both hosts and mothers of donors were screened for transmissible diseases. Pre- and postoperative clinical exams, visual acuity, electroretinograms, and fluorescein angiograms were

Taraprasad Das; Manuel del Cerro; Subhadra Jalali; Vallam S. Rao; Vamsi K. Gullapalli; Caroline Little; David A. D. Loreto; Savitri Sharma; A. Sreedharan; Constancia del Cerro; Gullapalli N. Rao

1999-01-01

134

Long-term outcome and safety of transanal colonic irrigation for neurogenic bowel dysfunction  

Microsoft Academic Search

Study design:Long-term follow-up study.Objectives:Short-term results find transanal colonic irrigation (TAI) favourable in the treatment of neurogenic bowel dysfunction (NBD). Therefore, long-term results need to be described.Setting:Department of Surgery P, Aarhus University Hospital, Denmark.Methods:Between 1994 and 2007, 211 (115 female) patients with NBD (age: 7–81 years (median 49)) were introduced to TAI. One hundred and seventy-three patients had spinal cord injury

P M Faaborg; P Christensen; B Kvitsau; S Buntzen; S Laurberg; K Krogh

2009-01-01

135

Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain  

Microsoft Academic Search

Purpose  Previous studies show that fentanyl pectin nasal spray (FPNS) rapidly provides clinically meaningful pain relief in the treatment\\u000a of breakthrough cancer pain (BTCP). This study assessed the long-term tolerability, acceptability and consistency of effect\\u000a of FPNS in patients with BTCP.\\u000a \\u000a \\u000a \\u000a \\u000a Methods  Patients (new and rolled over from earlier controlled studies) with cancer experiencing one to four episodes per day of BTCP

Lukas Radbruch; Luis M. Torres; John E. Ellershaw; Antonio Gatti; Guillermo Luis Lerzo; Julia Revnic; Donald Taylor

136

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

Microsoft Academic Search

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

William D. Barrick; Michael D. Kinney

2008-01-01

137

Long-term safety and outcome of a temporary self-expanding metallic stent for achalasia: a prospective study with a 13-year single-center experience  

Microsoft Academic Search

To prospectively evaluate the long-term clinical safety and efficacy of a newly designed self-expanding metallic stent (SEMS)\\u000a in the treatment of patients with achalasia. Seventy-five patients with achalasia were treated with a temporary SEMS with\\u000a a 30-mm diameter. The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4–5 days after stent placement.\\u000a Follow-up data focused on dysphagia score, technique

Jun-Gong Zhao; Yong-Dong Li; Ying-Sheng Cheng; Ming-Hua Li; Ni-Wei Chen; Wei-Xiong Chen; Ke-Zhong Shang

2009-01-01

138

Safety of the long-term use of proton pump inhibitors  

PubMed Central

The proton pump inhibitors (PPIs) as a class are remarkably safe and effective for persons with peptic ulcer disorders. Serious adverse events are extremely rare for PPIs, with case reports of interstitial nephritis with omeprazole, hepatitis with omeprazole and lansoprazole, and disputed visual disturbances with pantoprazole and omeprazole. PPI use is associated with the development of fundic gland polyps (FGP); stopping PPIs is associated with regression of FGP. In the absence of Helicobacter pylori infection, the long-term use of PPIs has not been convincingly proven to cause or be associated with the progression of pre-existing chronic gastritis or gastric atrophy or intestinal metaplasia. Mild/modest hypergastrinemia is a physiological response to the reduction in gastric acid secretion due to any cause. The long-term use of PPIs has not been convincingly proven to cause enterochromaffin-like cell hyperplasia or carcinoid tumors. PPIs increase the risk of community acquired pneumonia, but not of hospital acquired (nosocomial) pneumonia. There is no data to support particular care in prescribing PPI therapy due to concerns about risk of hip fracture with the long-term use of PPIs. Long-term use of PPIs does not lead to vitamin B12 deficiencies, except possibly in the elderly, or in persons with Zollinger-Ellison Syndrome who are on high doses of PPI for prolonged periods of time. There is no convincingly proven data that PPIs increase the risk of Clostridium difficile-associated diarrhea in persons in the community. The discontinuation of PPIs may result in rebound symptoms requiring further and even continuous PPI use for suppression of symptoms. As with all medications, the key is to use PPIs only when clearly indicated, and to reassess continued use so that long-term therapy is used judiciously. Thus, in summary, the PPIs are a safe class of medications to use long-term in persons in whom there is a clear need for the maintenance of extensive acid inhibition.

Thomson, Alan BR; Sauve, Michel D; Kassam, Narmin; Kamitakahara, Holly

2010-01-01

139

Long-Term Efficacy and Rotational Stability of AcrySof Toric Intraocular Lens Implantation in Cataract Surgery  

PubMed Central

Purpose To evaluate the long-term efficacy and rotational stability of the AcrySof toric intraocular lens (IOL) in correcting preoperative astigmatism in cataract patients. Methods This prospective observational study included 30 eyes from 24 consecutive patients who underwent implantation of an AcrySof toric IOL with micro-coaxial cataract surgery between May 2008 and September 2008. Outcomes of visual acuity, refractive and keratometric astigmatism, and IOL rotation after 1 day, 1 month, 3 months, and long-term (mean, 13.3±5.0 months) follow-up were evaluated. Results At final follow-up, 73.3% of eyes showed an uncorrected visual acuity of 20/25 or better. The postoperative keratometric value was not different from the preoperative value; mean refractive astigmatism was reduced to -0.28±0.38 diopter (D) from -1.28±0.48 D. The mean rotation of the toric IOL was 3.45±3.39 degrees at final follow-up. One eye (3.3%) exhibited IOL rotation of 10.3 degrees, the remaining eyes (96.7%) had IOL rotation of less than 10 degrees. Conclusions Early postoperative and long-term follow-up showed that implantation of the AcrySof toric IOL is an effective, safe, and predictable method for managing corneal astigmatism in cataract patients.

Kim, Myung Hun; Chung, Tae-Young

2010-01-01

140

Liposomal glucocorticosteroids in treatment of chronic autoimmune demyelination: long-term protective effects and enhanced efficacy of methylprednisolone formulations.  

PubMed

Liposomal encapsulation leads to enhanced efficacy of glucocorticosteroids (GS) in treatment of autoimmune diseases. Here we compare liposomal prednisolone (PL) to liposomal methylprednisolone (MPL) in chronic-relapsing myelin oligodendrocyte glycoprotein-induced experimental autoimmune encephalomyelitis (EAE), a model closely reflecting aspects of multiple sclerosis (MS). At the maximum of the first relapse, a single dose of PL or MPL was applied at 10 mg/kg or at 4 mg/kg and compared to classical methylprednisolone (MP) pulse therapy. PL at 10 mg/kg was superior to free MP with long-term efficacy and a sustained protection even during the second and third relapse. At the same time, in vivo magnetic resonance imaging of rat brains revealed a significant reduction of T2-lesions after PL application. Comparison of PL and MPL at 10 mg/kg disclosed superior effects for MPL with an enhanced reduction of inflammatory infiltration as well as preservation of myelin and axons. Dose titration experiments underscored a dose-dependent efficacy of liposomal GS with a sustained efficacy especially of the higher dosage. In histological analyses, PL10 was superior in reducing macrophage and T cell infiltration as well as demyelination and axonal loss while the lower dosages were still at least as effective as free MP. FACS analyses revealed an effect of liposome formulations on T cell numbers, the CD4/CD8 ratio, frequencies of regulatory T cells and adhesion molecule expression. In summary, liposomal GS and especially methylprednisolone formulations display an enhanced efficacy not only in acute inflammatory, but also in chronic demyelinating models of MS and confer long-term protection from relapses. These findings lay the groundwork for applying liposomal GS in clinical MS trials in the near future. PMID:18394606

Linker, Ralf A; Weller, Charlotte; Lühder, Fred; Mohr, Alexander; Schmidt, Jens; Knauth, Michael; Metselaar, Josbert M; Gold, Ralf

2008-02-29

141

Long-term efficacy of leptin replacement in patients with Dunnigan-type familial partial lipodystrophy  

PubMed Central

The Dunnigan-type familial partial lipodystrophy (FPLD) is characterized by a variable loss of fat from the extremities and trunk and excess subcutaneous fat in the chin and supraclavicular area. Associated metabolic abnormalities include hypoleptinemia, insulin resistance, and dyslipidemia. Our goal was to observe changes in metabolic parameters for patients with FPLD on long-term leptin replacement and to compare the metabolic characteristics seen in FPLD with those seen in generalized lipodystrophy (GL) from our previous studies. This was an open-label study of 6 patients with FPLD receiving maximal doses of oral antidiabetic and lipid-lowering medications at baseline. Recombinant leptin was given through twice-daily subcutaneous injections at a maximal dose of 0.08 mg/kg per day over 12 months to simulate normal to high normal physiologic levels. Triglycerides were reduced by 65% at 4 months (749 ± 331 to 260 ± 58 mg/dL) and significantly reduced at 12 months for 5 patients (433 ± 125 to 247 ± 69 mg/dL; P = .03). Total cholesterol also decreased (280 ± 49 to 231 ± 41 mg/dL; P = .01). Insulin sensitivity and fasting glucose levels (190 ± 26 to 151 ± 15 mg/dL; P < .01) improved. Glucose tolerance and glycosylated hemoglobin levels (8.4% ± 0.6% to 8.0% ± 0.4%; P = .07) did not change. As shown in patients with GL, patients with FPLD have improvement in triglycerides, fasting glucose, and insulin sensitivity with leptin replacement. In contrast to the patients with GL, the patients with FPLD are older, have higher leptin levels, and notably lower insulin secretion for a similar degree of hyperglycemia. Low-dose recombinant methionyl human leptin for patients with FPLD has an important role in improving triglycerides, beyond that of available lipid-lowering agents. In improving glycemic control, normalization of glucose tolerance in hypoinsulinemic patients with FPLD requires insulin and leptin therapy. This is the first study to examine the effects of long-term leptin replacement in patients with FPLD.

Park, Jean Y.; Javor, Edward D.; Cochran, Elaine K.; DePaoli, Alex M.; Gorden, Phillip

2008-01-01

142

Long-term efficacy of leptin replacement in patients with Dunnigan-type familial partial lipodystrophy.  

PubMed

The Dunnigan-type familial partial lipodystrophy (FPLD) is characterized by a variable loss of fat from the extremities and trunk and excess subcutaneous fat in the chin and supraclavicular area. Associated metabolic abnormalities include hypoleptinemia, insulin resistance, and dyslipidemia. Our goal was to observe changes in metabolic parameters for patients with FPLD on long-term leptin replacement and to compare the metabolic characteristics seen in FPLD with those seen in generalized lipodystrophy (GL) from our previous studies. This was an open-label study of 6 patients with FPLD receiving maximal doses of oral antidiabetic and lipid-lowering medications at baseline. Recombinant leptin was given through twice-daily subcutaneous injections at a maximal dose of 0.08 mg/kg per day over 12 months to simulate normal to high normal physiologic levels. Triglycerides were reduced by 65% at 4 months (749+/-331 to 260+/-58 mg/dL) and significantly reduced at 12 months for 5 patients (433+/-125 to 247+/-69 mg/dL; P=.03). Total cholesterol also decreased (280+/-49 to 231+/-41 mg/dL; P=.01). Insulin sensitivity and fasting glucose levels (190+/-26 to 151+/-15 mg/dL; P<.01) improved. Glucose tolerance and glycosylated hemoglobin levels (8.4%+/-0.6% to 8.0%+/-0.4%; P=.07) did not change. As shown in patients with GL, patients with FPLD have improvement in triglycerides, fasting glucose, and insulin sensitivity with leptin replacement. In contrast to the patients with GL, the patients with FPLD are older, have higher leptin levels, and notably lower insulin secretion for a similar degree of hyperglycemia. Low-dose recombinant methionyl human leptin for patients with FPLD has an important role in improving triglycerides, beyond that of available lipid-lowering agents. In improving glycemic control, normalization of glucose tolerance in hypoinsulinemic patients with FPLD requires insulin and leptin therapy. This is the first study to examine the effects of long-term leptin replacement in patients with FPLD. PMID:17379009

Park, Jean Y; Javor, Edward D; Cochran, Elaine K; DePaoli, Alex M; Gorden, Phillip

2007-04-01

143

Tolerability and safety of alosetron during long-term administration in female and male irritable bowel syndrome patients  

Microsoft Academic Search

OBJECTIVES:Alosetron (Lotronex) is a new therapeutic agent for irritable bowel syndrome (IBS) in women with diarrhea-predominant IBS. This multicenter randomized, double-blind, placebo-controlled study assessed the safety and tolerability of alosetron during long-term (?12 months) treatment.METHODS:A total of 859 subjects (637 female and 222 male) with IBS were enrolled from 130 sites in the United States and were randomized 3:1 to

Steven G. Wolfe; William Y. Chey; Mary Kay Washington; Jacqueline Harding; Amy T. Heath; David J. McSorley; George E. Dukes; Christine M. Hunt

2001-01-01

144

Long-Term Immunogenicity and Efficacy of Hepatitis B Vaccine in Hemodialysis Patients  

Microsoft Academic Search

Although the efficacy of hepatitis B vaccines in patients under chronic hemodialysis treatment has been well documented, the persistence of immunity in this population remains largely unknown. In this study we have followed 60 hemodiaysis patients up to 3 years after primary hepatitis B vaccination (four doses of recombinant hepatitis B vaccine; Engerix B, 20 mg\\/dose) to evaluate the persistence

Maria Buti; Luis Viladomiu; Rosendo Jardi; Antonio Olmos; Juan Antonio Rodriguez; Jorge Bartolome; Rafael Esteban; Jaime Guardia

1992-01-01

145

Long-term efficacy of continuing hepatitis B vaccination in infancy in two Gambian villages  

Microsoft Academic Search

In 1984, all non-immune children under the age of 5 years in the Gambian villages of Keneba and Manduar were vaccinated against hepatitis B virus (HBV). All children born in these villages since 1984 have been vaccinated in infancy. Despite a rapid fall in antibody concentrations, vaccine efficacy against HBV infection and chronic carriage of HBsAg has increased with time.

H. C. Whittle; J. Pilkington; N. Maine; M. Mendy; M. Fortuin; A. Hall; J. Bunn; L. Allison; C. Howard

1995-01-01

146

Probabilistic system assessment of the long-term safety of the Waste Isolation Pilot Plant  

Microsoft Academic Search

Before disposing of transuranic radioactive waste at the Waste Isolation Pilot Plant (WIPP), the U.S. Department of Energy (DOE) must evaluate compliance with long-term regulations of the U.S. Environmental Protection Agency, specifically, the [open quotes]Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes[close quotes] (40CFR191) and the [open quotes]Hazardous and Solid Waste Amendments

Marietta

1993-01-01

147

Long-Term Efficacy and Patterns of Failure After Accelerated Partial Breast Irradiation: A Molecular Assay-Based Clonality Evaluation  

SciTech Connect

Purpose: To determine the long-term efficacy and cosmetic results of accelerated partial breast irradiation (APBI) by reviewing our institution's experience. Methods and Materials: A total of 199 patients with early-stage breast cancer were treated prospectively with adjuvant APBI after lumpectomy using interstitial brachytherapy. All patients had negative margins, 82% had Stage I disease, median tumor size was 1.1 cm, and 12% had positive lymph nodes. The median follow-up for surviving patients was 8.6 years. Fifty-three patients (27%) have been followed for {>=}10 years. Results: Six ipsilateral breast tumor recurrences (IBTRs) were observed, for a 5-year and 10-year actuarial rate of 1.6% and 3.8%, respectively. A total of three regional nodal failures were observed, for a 10-year actuarial rate of 1.6%. Five contralateral breast cancers developed, for a 5- and 10-year actuarial rate of 2.2% and 5.2%, respectively. The type of IBTR (clonally related vs. clonally distinct) was analyzed using a polymerase chain reaction-based loss of heterozygosity assay. Eighty-three percent of IBTRs (n = 5) were classified as clonally related. Multiple clinical, pathologic, and treatment-related factors were analyzed for an association with the development of an IBTR, regional nodal failure, or contralateral breast cancer. On multivariate analysis, no variable was associated with any of these events. Cosmetic results were rated as excellent/good in 99% of patients. Conclusions: Long-term results with APBI using interstitial brachytherapy continue to demonstrate excellent long-term local and regional control rates and cosmetic results. According to a polymerase chain reaction-based loss of heterozygosity assay, 83% of recurrences were classified as clonally related.

Vicini, Frank A. [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States)]. E-mail: fvicini@beaumont.edu; Antonucci, J. Vito [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Wallace, Michelle R.N. [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Gilbert, Samuel [University of Michigan, Ann Arbor, MI (United States); Goldstein, Neal S. [Department of Anatomic Pathology, William Beaumont Hospital, Royal Oak, MI (United States); Kestin, Larry [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Chen, Peter [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Kunzman, Jonathan [Western Michigan University, Kalamazoo, MI (United States); Boike, Thomas [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States); Benitez, Pamela [Department of Surgery, William Beaumont Hospital, Royal Oak, MI (United States); Martinez, Alvaro [Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States)

2007-06-01

148

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

PubMed

Dengue is a rapidly growing public health threat with approximately 2.5 billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use. PMID:23570986

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

2013-04-06

149

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

150

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…

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

2005-01-01

151

The short- and long-term efficacy of empirical esophageal dilation in patients with nonobstructive dysphagia: a prospective, randomized study  

Microsoft Academic Search

OBJECTIVE:The efficacy of empirical esophageal dilation for nonobstructive dysphagia (NOD) is unknown. Our aim was to assess the efficacy and safety of empirical dilation with a large bougie in patients with NOD.METHODS:Patients with NOD (normal barium swallow, free passage of a 13-mm barium pill, and normal esophagogastroduodenoscopy) were randomized to dilation with either a 50-Fr (Group A) or 26-Fr (Group

Victor J. Colon; Michele A. Young; Francisco C. Ramirez

2000-01-01

152

Assessing long-term treatment efficacy in chronic hepatitis B and C: between evidence and common sense.  

PubMed

Chronic infection with the hepatitis B and C virus represents a major health problem worldwide, as it is estimated that roughly 400 and 200 million people respectively, are infected by each virus. By definition, any antiviral therapy that claims to be effective should have as its ultimate efficacy end point an improvement in patients' survival, or at least a reduction in the development rates of liver-related complications. However, this is extremely complicated to prove as the natural course of both viral diseases is extremely slow, requiring decades to evolve in cirrhosis and even more years to lead to liver complications. For this reason, clinicians and health authorities have relied on so called surrogate end points to assess the efficacy of any therapeutic intervention for viral hepatitis. Obviously, this allows for standardization in study designs that ultimately translates into an accelerated time frame for therapeutic drugs as well as healthcare innovations to enter the viral hepatitis clinical practice. However, it also calls for demonstration that surrogate end points in the treatment of patients with chronic hepatitis B or C are good and reliable markers of long-term efficacy. PMID:22750749

Aghemo, Alessio; Lampertico, Pietro; Colombo, Massimo

2012-06-28

153

Intraoperative defibrillation threshold testing and postoperative long-term efficacy of cardioverter-defibrillator implantation  

PubMed Central

The aim of this study was to determine the defibrillation threshold (DFT) of implantable cardioverter-defibrillators (ICDs) and outcomes of treatment. Sixty-four patients received cardioverter-defibrillator implantation. During implantation, the DFT was determined by the defibrillation safety margin (DSM). All patients were followed up for 12–48 months after the implantation. The overall DFT was 14.27±2.56 J and the DSM was 18.40±1.89 J. Malignant ventricular arrhythmias occurred in 42 patients following cardioverter-defibrillator implantation including 500 episodes of non-sustained ventricular tachycardia (VT) and 289 episodes of persistent VT. VT was treated using antitachycardia pacing (ATP); 265 episodes were treated successfully by a single ATP treatment (91.69%) and 12 episodes were treated successfully by two ATP treatments (4.15%). Twelve episodes were converted by low-energy electrical cardioversion (4.15%). A total of 175 ventricular fibrillation (VF) episodes were identified, of which 18 episodes automatically terminated prior to treatment. In total, 146 episodes were converted by a single cardioversion with a defibrillation energy of 13.21±2.58 J and 11 episodes were converted by two cardioversions with a defibrillation energy of 16.19±2.48 J. It is safe and feasible to determine the DFT by DSM measurement during cardioverterdefibrillator implantation.

GAN, TIANYI; CAO, XIAOZHI; YU, ZHANG; TANG, BAOPENG; LI, JINXIN; XU, GUOJUN; ZHOU, XIANHUI; ZHANG, YANYI; LI, YAODONG; ZHANG, JIANGHUA

2013-01-01

154

A study of the long-term efficacy and tolerability of oral nicardipine in hypertensive patients.  

PubMed

This study was designed to evaluate the efficacy of oral nicardipine in 91 patients with uncomplicated essential hypertension over a period of 12 months. All patients started on a fixed nicardipine dose of 30 mg three times daily which was adjusted in the range 10-40 mg three times daily, where necessary to achieve a target diastolic blood pressure less than 95 mm Hg. At 6 weeks, blood pressure (mean +/- s.e. mean) was reduced from an average of 190 +/- 22/112 +/- 8 to 167 +/- 23/96 +/- 11 mm Hg supine and from 180 +/- 21/113 +/- 7 to 154 +/- 17/95 +/- 11 mm Hg standing and remained controlled in all patients throughout the study. A total of 96 unwanted experiences were reported by 49 patients (54%); 17 (19%) reported a single symptom once and two (2%) reported a single symptom more than once. The most frequently reported adverse experiences were peripheral oedema in 27 (28%) and headaches in 15 patients (16%). The majority of the adverse experiences occurred in the first 3 months of treatment. Ten patients (11%) withdrew from the study during this time and eight (9%) in the subsequent 9 months because of drug-related side effects; five others (5%) withdrew for unrelated reasons. The incidence of adverse experiences was dose-related. Three patients reported unwanted effects on 10 mg three times daily, eight on 20 mg three times daily, 36 on 30 mg three times daily, and 12 on 40 mg three times daily oral nicardipine.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:3940158

Taylor, S H; Frais, M A; Lee, P; Verma, S P; Jackson, N; Reynolds, G; Silke, B

1985-01-01

155

Long-Term Effects of Nucleus Accumbens Deep Brain Stimulation in Treatment-Resistant Depression: Evidence for Sustained Efficacy  

PubMed Central

Deep brain stimulation (DBS) to the nucleus accumbens (NAcc-DBS) was associated with antidepressant, anxiolytic, and procognitive effects in a small sample of patients suffering from treatment-resistant depression (TRD), followed over 1 year. Results of long-term follow-up of up to 4 years of NAcc-DBS are described in a group of 11 patients. Clinical effects, quality of life (QoL), cognition, and safety are reported. Eleven patients were stimulated with DBS bilateral to the NAcc. Main outcome measures were clinical effect (Hamilton Depression Rating Scale, Montgomery-Asperg Rating Scale of Depression, and Hamilton Anxiety Scale) QoL (SF-36), cognition and safety at baseline, 12 months (n=11), 24 months (n=10), and last follow-up (maximum 4 years, n=5). Analyses were performed in an intent-to-treat method with last observation carried forward, thus 11 patients contributed to each point in time. In all, 5 of 11 patients (45%) were classified as responders after 12 months and remained sustained responders without worsening of symptoms until last follow-up after 4 years. Both ratings of depression and anxiety were significantly reduced in the sample as a whole from first month of NAcc-DBS on. All patients improved in QoL measures. One non-responder committed suicide. No severe adverse events related to parameter change were reported. First-time, preliminary long-term data on NAcc-DBS have demonstrated a stable antidepressant and anxiolytic effect and an amelioration of QoL in this small sample of patients suffering from TRD. None of the responders of first year relapsed during the observational period (up to 4 years).

Bewernick, Bettina H; Kayser, Sarah; Sturm, Volker; Schlaepfer, Thomas E

2012-01-01

156

Long-term in vivo modulation of synaptic efficacy at the neuromuscular junction of Rana pipiens frogs  

PubMed Central

Prolonged changes in motor neurone activity can result in long-term changes in synaptic transmission. We investigated whether mechanisms commonly thought to be involved in determining synaptic efficacy of vertebrate motor neurones are involved in these long-term changes. The nerve supplying the cutaneus pectoris muscle was chronically stimulated via skin surface electrodes in freely moving frogs for 5–7 days. Chronic stimulation induced a 50% reduction in evoked endplate potential (EPP) amplitude at stimulated neuromuscular junctions (NMJs). These changes appear to be presynaptic since miniature EPP (mEPP) amplitude was unchanged while mEPP frequency was decreased by 46% and paired-pulse facilitation was increased by 26%. High frequency facilitation (40 Hz, 2 s) was also increased by 89%. Moreover, stimulated NMJs presented a 92% decrease in synaptic depression (40 Hz, 2 s). An increase in mitochondrial metabolism was observed as indicated by a more pronounced labelling of active mitochondria (Mitotracker) in stimulated nerve terminals, which could account for their greater resistance to synaptic depression. NMJ length visualized by ?-bungarotoxin staining of nAChRs was not affected. Presynaptic calcium signals measured with Calcium Green-1 were larger in stimulated NMJs at low frequency (0.2 Hz) and not different from control NMJs at higher frequency (40 Hz, 2 s and 30 s). These results suggest that some mechanisms downstream of calcium entry are responsible for the determination of synaptic output, such as a down-regulation of some calcium-binding proteins, which could explain the observed results. The possibility of a change in frequenin expression, a calcium-binding protein that is more prominently expressed in phasic synapses, was, however, refuted by our results.

Belair, Eve-Lyne; Vallee, Joanne; Robitaille, Richard

2005-01-01

157

Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder  

PubMed Central

Background: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting. Patients and methods: Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks. Results: Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ?7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill). Conclusion: Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.

Berman, Robert M; Thase, Michael E; Trivedi, Madhukar H; Hazel, James A; Marler, Sabrina Vogel; McQuade, Robert D; Carson, William; Baker, Ross A; Marcus, Ronald N

2011-01-01

158

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

PubMed Central

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

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

2008-01-01

159

Mathematical models as tools for probing long-term safety of CO2 storage  

Microsoft Academic Search

Subsurface reservoirs being considered for storing CO include saline aquifers, oil and gas reservoirs, and unmineable coal seams (Baines and Worden, 2004; IPCC, 2005). By far the greatest storage capacity is in saline aquifers (Dooley et al., 2004), and our discussion will focus primarily on CO storage in saline formations. Most issues for safety and security of CO storage arise

Karsten Pruess; Jens Birkholzer; Quanlin Zhou

2009-01-01

160

Long-term efficacy of single-dose combinations of albendazole, ivermectin and diethylcarbamazine for the treatment of bancroftian filariasis  

Microsoft Academic Search

In a ‘blinded’ trial (in Sri Lanka, 1996–1998) of 47 male asymptomatic microfilaraemic subjects with Wuchereria bancrofti infection, the safety, tolerability and filaricidal efficacy of 3 single-dose combination regimens were compared: albendazole 400 mg with ivermectin 200 ?g\\/kg, albendazole 400 mg with diethylcarbamazine citrate (DEC) 6 mg\\/kg or albendazole 600 mg with ivermectin 400 ?g\\/kg. Treated subjects were followed-up for

M. M. Ismail; R. L. Jayakody; G. J. Weil; Deepika Fernando; M. S. G. De Silva; G. A. C. De Silva; W. K. Balasooriya

2001-01-01

161

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

ScienceCinema

Regulations require that the repository be evaluated for its health and safety effects for 10,000 years for the Site Recommendation process. Regulations also require potential impacts to be evaluated for up to a million years in an Environmental Impact Statement. The Yucca Mountain Project is in the midst of the Site Recommendation process. The Total System Performance Assessment (TSPA) that supports the Site Recommendation evaluated safety for these required periods of time. Results showed it likely that a repository at this site could meet the licensing requirements promulgated by the Nuclear Regulatory Commission. The TSPA is the tool that integrates the results of many years of scientific investigations with design information to allow evaluations of potential far-future impacts of building a Yucca Mountain repository. Knowledge created in several branches of physics is part of the scientific basis of the TSPA that supports the Site Recommendation process.

162

Catheter sepsis during parenteral nutrition: the safety of long-term OpSite dressings.  

PubMed

A prospective controlled study of the safety of various catheter dressing protocols was carried out in 168 patients receiving parenteral nutrition via an infraclavicular central venous catheter. Four protocols were compared: 36 patients received gauze dressings changed three times per week; 31 received OpSite dressings changed every 7th day (OpS-7), 32 received OpSite changed every 10th day (OpS-10), and 69 received OpSite changed twice weekly (OpS-ICU). Mean duration of parenteral nutrition was approximately 2 weeks and all groups were well matched except that OpS-ICU patients suffered more frequently from an acute illness. Catheter-related sepsis was identified by clinical signs of systemic sepsis, positive peripheral venous blood and catheter-tip cultures and/or defervescence of fever after catheter removal. Catheter-related sepsis rates were low in all groups: 1/36 for Gauze, 0/31 for OpS-7, 1/32 for OpS-10, and 2/69 for OpS-ICU. Septicemia attributable to causes apart from catheter sepsis occurred in two, two, three, and four patients, respectively. Bacterial colonization of skin beneath OpSite was no more common in the OpS-10 than in the other groups. Signs of inflammation at catheter insertion sites were common in all groups but did not relate closely to skin colonization. OpSite can be safely applied to central venous catheters inserted under strict aseptic conditions, even in patients with open septic drainage. Dressings can be left in place for 7 days with a margin of safety lasting to 10 days, thus saving on cost of materials and nursing time. PMID:3138446

Young, G P; Alexeyeff, M; Russell, D M; Thomas, R J

163

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

PubMed

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

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

2010-07-21

164

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

PubMed Central

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

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

2010-01-01

165

Long-Term Safety, Tolerability, and Weight Loss Associated With Metformin in the Diabetes Prevention Program Outcomes Study  

PubMed Central

OBJECTIVE Metformin produced weight loss and delayed or prevented diabetes in the Diabetes Prevention Program (DPP). We examined its long-term safety and tolerability along with weight loss, and change in waist circumference during the DPP and its long-term follow-up. RESEARCH DESIGN AND METHODS The randomized double-blind clinical trial of metformin or placebo followed by a 7–8-year open-label extension and analysis of adverse events, tolerability, and the effect of adherence on change in weight and waist circumference. RESULTS No significant safety issues were identified. Gastrointestinal symptoms were more common in metformin than placebo participants and declined over time. During the DPP, average hemoglobin and hematocrit levels were slightly lower in the metformin group than in the placebo group. Decreases in hemoglobin and hematocrit in the metformin group occurred during the first year following randomization, with no further changes observed over time. During the DPP, metformin participants had reduced body weight and waist circumference compared with placebo (weight by 2.06 ± 5.65% vs. 0.02 ± 5.52%, P < 0.001, and waist circumference by 2.13 ± 7.06 cm vs. 0.79 ± 6.54 cm, P < 0.001 in metformin vs. placebo, respectively). The magnitude of weight loss during the 2-year double-blind period was directly related to adherence (P < 0.001). Throughout the unblinded follow-up, weight loss remained significantly greater in the metformin group than in the placebo group (2.0 vs. 0.2%, P < 0.001), and this was related to the degree of continuing metformin adherence (P < 0.001). CONCLUSIONS Metformin used for diabetes prevention is safe and well tolerated. Weight loss is related to adherence to metformin and is durable for at least 10 years of treatment.

2012-01-01

166

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 Central

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.

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

2012-01-01

167

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

PubMed

Development is defined sustainable when it meets the needs of the present without compromising the ability of future generations to meet their own needs. Pivoting on social, environmental and economic aspects of food chain sustainability, this paper presents the concept of sustainable food safety based on the prevention of risks and burden of poor health for generations to come. Under this respect, the assessment of long-term, transgenerational risks is still hampered by serious scientific uncertainties. Critical issues to the development of a sustainable food safety framework may include: endocrine disrupters as emerging contaminants that specifically target developing organisms; toxicological risks assessment in Countries at the turning point of development; translating knowledge into toxicity indexes to support risk management approaches, such as hazard analysis and critical control points (HACCP); the interplay between chemical hazards and social determinants. Efforts towards the comprehensive knowledge and management of key factors of sustainable food safety appear critical to the effectiveness of the overall sustainability policies. PMID:19567981

Frazzoli, Chiara; Petrini, Carlo; Mantovani, Alberto

2009-01-01

168

Mathematical models as tools for probing long-term safety of CO2 storage  

SciTech Connect

Subsurface reservoirs being considered for storing CO{sub 2} include saline aquifers, oil and gas reservoirs, and unmineable coal seams (Baines and Worden, 2004; IPCC, 2005). By far the greatest storage capacity is in saline aquifers (Dooley et al., 2004), and our discussion will focus primarily on CO{sub 2} storage in saline formations. Most issues for safety and security of CO{sub 2} storage arise from the fact that, at typical temperature and pressure conditions encountered in terrestrial crust, CO{sub 2} is less dense than aqueous fluids. Accordingly, CO{sub 2} will experience an upward buoyancy force in most subsurface environments, and will tend to migrate upwards whenever (sub-)vertical permeable pathways are available, such as fracture zones, faults, or improperly abandoned wells (Bachu, 2008; Pruess, 2008a, b; Tsang et al., 2008). CO{sub 2} injection will increase fluid pressures in the target formation, thereby altering effective stress distributions, and potentially triggering movement along fractures and faults that could increase their permeability and reduce the effectiveness of a caprock in containing CO{sub 2} (Rutqvist et al., 2008; Chiaramonte et al., 2008). Induced seismicity as a consequence of fluid injection is also a concern (Healy et al., 1968; Raleigh et al., 1976; Majer et al., 2007). Dissolution of CO{sub 2} in the aqueous phase generates carbonic acid, which may induce chemical corrosion (dissolution) of minerals with associated increase in formation porosity and permeability, and may also mediate sequestration of CO{sub 2} as solid carbonate (Gaus et al., 2008). Chemical dissolution of caprock minerals could promote leakage of CO{sub 2} from a storage reservoir (Gherardi et al., 2007). Chemical dissolution and geomechanical effects could reinforce one another in compromising CO{sub 2} containment. Additional issues arise from the potential of CO{sub 2} to mobilize hazardous chemical species (Kharaka et al., 2006), and from migration of the large amounts of brine that would be mobilized by industrial-scale CO{sub 2} injection (Nicot et al., 2008; Birkholzer et al., 2008a, b).

Pruess, Karsten; Birkholzer, Jens; Zhou, Quanlin

2009-02-01

169

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

PubMed

Treatment-emergent adverse events (AEs) were monitored during an 8-week, double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 children and adolescents with a lifetime diagnosis of autistic disorder. In addition, 37 placebo nonresponders received open-label risperidone for another 8 weeks. Of all the risperidone responders (n=65), 63 entered an open extension of another 16 weeks (6 months total risperidone exposure), and 32 of them were rerandomized to either continued risperidone therapy (n=16) or gradual replacement with placebo (n=16) over 8 weeks. We collected the following measures of safety and tolerability: (1) laboratory blood assessments (CBC with differential, electrolytes, and liver function tests) and urinalyses, (2) vital signs, (3) Side Effects Review of AEs thought to be associated with risperidone, (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No clinically significant changes were found on the lab tests. During the 8-week acute trial, the most common AEs on the Side Effects Review, scored as moderate or higher, were as follows (placebo and risperidone, respectively): Somnolence (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). "Difficulty falling asleep" and anxiety actually favored the risperidone condition at statistically significant levels. The same AEs tended to recur through 6 months of treatment, although often at reduced levels. Using Centers for Disease Control (CDC) standardized scores, both weight and body mass index (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and into open-label extension (0.19 and 0.16 SDs, respectively), although the amount of gain decelerated with time. Extrapyramidal symptoms, as assessed by the SARS, were no more common for drug than placebo, although drooling was reported more often in the risperidone group. There were no differences between groups on the AIMS. Two subjects had seizures (one taking placebo), but these were considered unrelated to active drug. Most AEs were mild to moderate and failed to interfere with therapeutic changes; there were no unanticipated AEs. The side effects of most concern were somnolence and weight gain. PMID:16379507

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

2005-12-01

170

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

171

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.

2012-01-01

172

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

173

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

174

Transitioning Opioid-Dependent Patients from Detoxification to Long-term Treatment: Efficacy of Intensive Role Induction  

PubMed Central

Despite findings that opioid detoxification serves little more than a palliative function, few patients who enter detoxification subsequently transition to long-term treatment. The current study evaluated intensive role induction (IRI), a strategy adapted from a single-session intervention previously shown to facilitate engagement of substance-dependent patients in drug-free treatment. IRI was delivered either alone or combined with case management (IRI+CM) to determine the capacity of each condition to enhance transition and engagement in long-term treatment of detoxification patients. Study participants were 240 individuals admitted to a 30-day buprenorphine detoxification delivered at a publicly-funded outpatient drug treatment clinic. Following clinic intake, participants were randomly assigned to IRI, IRI+CM, or standard clinic treatment (ST). Outcomes were assessed in terms of adherence and satisfaction with the detoxification program, detoxification completion, and transition and retention in treatment following detoxification. Participants who received IRI and IRI+CM attended more counseling sessions during detoxification than those who received ST (both p’s < .001). IRI, but not IRI+CM participants, were more likely to complete detoxification (p = .017), rated their counselors more favorably (p = .01), and were retained in long-term treatment for more days following detoxification (p = .005), than ST participants. The current study demonstrates that an easily administered psychosocial intervention can be effective for enhancing patient involvement in detoxification and for enabling their engagement in long-term treatment following detoxification.

Katz, Elizabeth C.; Brown, Barry S.; Schwartz, Robert P.; O'Grady, Kevin E.; King, Stuart D.; Gandhi, Devang

2011-01-01

175

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

ERIC Educational Resources Information Center

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

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

2011-01-01

176

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

ERIC Educational Resources Information Center

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

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

2011-01-01

177

Short and Long-Term Efficacy of Hexadecylphosphocholine against Established Leishmania infantum Infection in BALB\\/c Mice  

Microsoft Academic Search

In the immunocompetent host, visceral leishmaniasis (VL) is a fatal disease if untreated. In immunosup- pressed patients, VL is an opportunistic infection for which there is no effective treatment for relapses. Here we report on the long-term activity of orally administered hexadecylphosphocholine (HDPC) against estab- lished Leishmania infantum infection in BALB\\/c mice. HDPC is a synthetic phospholipid with antiproliferative properties

YVES LE FICHOUX; DEBORAH ROUSSEAU; BERNARD FERRUA; SANDRINE RUETTE; ALAIN LELIEVRE; DOMINIQUE GROUSSON; JOANNA KUBAR

1998-01-01

178

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

PubMed

Predicting the risks of permanent gene therapy approaches involving the use of integrative gene-targeting vectors has become a critical issue after the unfortunate episode of a clinical trial in children with X-linked severe combined immunodeficiency (X-SCID). Safety pre-assessment of single isolated gene-targeted stem cells or their derivative clones able to regenerate their tissue of origin would be a major asset in addressing untoward gene therapy effects in advance. Human epidermal stem cells, which have extensive proliferative potential in vitro, theoretically offer such a possibility as a method of assessment. By means of optimized organotypic culture and grafting methods, we demonstrate the long-term in vivo regenerative capacity of single gene-targeted human epidermal stem cell clones (holoclones). Both histopathological analysis of holoclone-derived grafts in immunodeficient mice and retroviral insertion site mapping performed in the holoclone in vitro and after grafting provide proof of the feasibility of pre-assessing genotoxicity risks in isolated stem cells before transplantation into patients. Our results provide an experimental basis for previously untested assumptions about the in vivo behavior of epidermal stem cells prospectively isolated in vitro and pave the way for a safer approach to cutaneous gene therapy. PMID:17579576

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

2007-06-19

179

Long-term efficacy of AMS 800 artificial urinary sphincter in male patients with urodynamic stress incontinence due to spinal cord lesion  

Microsoft Academic Search

Study design:Retrospective analysis.Objectives:To evaluate long-term efficacy and complications of AMS 800 (American Medical Systems®) artificial urinary sphincter (AUS) in treatment of urodynamic stress incontinence (USI) in male patients with spinal cord lesion (SCL).Setting:London Spinal Injuries Unit, Stanmore, UK and Institute of Urology and Nephrology, London, UK.Patients and methods:A retrospective analysis identified nine males with SCL (five thoracic, three lumbar, one

P Patki; R Hamid; P J R Shah; M Craggs

2006-01-01

180

Evaluation of long-term efficacy of interferon alpha-2b and ribavirin in combination in naive patients with chronic hepatitis C: an Italian multicenter experience  

Microsoft Academic Search

Background\\/Aims: A combination of interferon alpha and ribavirin has been suggested to reach a higher rate of sustained virological response in patients with chronic hepatitis C than monotherapy. In this study we assessed the long-term efficacy of this combination therapy in the treatment of selected Italian naive chronic hepatitis C patients compared to interferon alpha monotherapy.Methods: We enrolled 428 naive

Giuseppe Barbaro; Gabriella Di Lorenzo; Maurizio Soldini; Giuseppe Giancaspro; Adriano Pellicelli; Benvenuto Grisorio; Giorgio Barbarini

2000-01-01

181

The effectiveness of a long-term professional development program on teachers' self-efficacy, attitudes, skills, and knowledge using a thematic learning approach  

Microsoft Academic Search

The purpose of this research study was to determine the effectiveness of a long-term professional development program on self-efficacy beliefs, science attitudes, skills, and knowledge of elementary teachers. The target school was located in the Lower Rio Grande Valley of Texas. Major elements of the study included the use of thematic science strands, use of the 5E constructivist-oriented instructional model,

Richard Kinna Tinnin

2000-01-01

182

Efficacy of Three Different Dosages of Esomeprazole in the Long-Term Management of Reflux Disease: A Prospective, Randomized Study, Using the Wireless Bravo pH System  

Microsoft Academic Search

OBJECTIVES:Gastroesophageal reflux disease (GERD) is a chronic condition that usually requires long-term maintenance therapy with proton-pump inhibitors (PPIs). In clinical practice, patients receive PPIs at the lowest dose to control symptoms. However, it is not known whether this approach adequately controls acidic esophageal reflux. We sought to investigate the efficacy of three different dosages of esomeprazole in patients receiving maintenance

Konstantinos V Vasiliadis; Nikos Viazis; Jiannis Vlachogiannakos; Spiros N Sgouros; Gerasimos Stefanidis; Athanasios Archimandritis; Dimitrios G Karamanolis

2010-01-01

183

Pneumococcal polysaccharide 23-valent vaccine: long-term persistence of circulating antibody and immunogenicity and safety after revaccination in adults.  

PubMed

Since publication of a 1997 review of the immunogenicity and safety data for pneumococcal polysaccharide vaccines (PPSVs), dozens of additional studies have been published, involving larger cohorts, longer observation periods, and more specific assays. Additionally, a 13-valent pneumococcal conjugate vaccine (PCV) has been licensed for adults. This paper reviews adult studies assessing antibody persistence for ? 3 years after pneumococcal vaccination, and adult studies of immunogenicity and safety after revaccination. This review emphasizes the currently registered PPSV23 formulations containing 25-?g polysaccharide per serotype, for which far more long-term data are available. Broadly, IgG and functional antibody levels after PPSV23 in adults persist above concentrations in unvaccinated adults for at least 5-10 years in most studies. The few exceptions involve populations of non-ambulatory adults or those with confounding host-factor issues. Revaccination with PPSV23 5-10 years after a previous dose consistently and substantially increases both IgG and functional antibody levels. There is an inverse association between circulating antibody level just before primary or revaccination and subsequent antibody increase. Although injection-site reactions (e.g., pain, swelling, redness) were reported more commonly after PPSV23 revaccination than after primary vaccination in most studies, these reactions typically resolved within 5 days. We interpret the contemporary literature as supporting pneumococcal revaccination as a means to sustain anti-pneumococcal antibodies at levels greater than among unvaccinated adults. PPSV23 is a broad-spectrum public-health tool to help prevent serious pneumococcal diseases across the adult lifespan. PMID:22542818

Grabenstein, John D; Manoff, Susan B

2012-04-26

184

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

185

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

186

Benefits and Safety of Long-Term Fenofibrate Therapy in People With Type 2 Diabetes and Renal Impairment  

PubMed Central

OBJECTIVE Diabetic patients with moderate renal impairment (estimated glomerular filtration rate [eGFR] 30–59 mL/min/1.73 m2) are at particular cardiovascular risk. Fenofibrate’s safety in these patients is an issue because it may elevate plasma creatinine. Furthermore, guidelines regarding fenofibrate dosing in renal impairment vary internationally. We investigated fenofibrate’s effects on cardiovascular and end-stage renal disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. RESEARCH DESIGN AND METHODS Type 2 diabetic patients (aged 50–75 years) with eGFR ?30 mL/min/1.73 m2 were randomly allocated to a fixed dose of fenofibrate (200 mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal function (Modification of Diet in Renal Disease equation) was grouped by eGFR (30–59, 60–89, and ?90 mL/min/1.73 m2). The prespecified outcome was total cardiovascular events (composite of cardiovascular death, myocardial infarction, stroke, and coronary/carotid revascularization). Serious adverse events and instances of ESRD (plasma creatinine >400 ?mol/L, dialysis, renal transplant, or renal death) were recorded. Analysis was by intention to treat. RESULTS Overall, fenofibrate reduced total cardiovascular events, compared with placebo (hazard ratio 0.89 [95% CI 0.80–0.99]; P = 0.035). This benefit was not statistically different across eGFR groupings (P = 0.2 for interaction) (eGFR 30–59 mL/min/1.73 m2: 0.68 [0.47–0.97], P = 0.035; eGFR ?90 mL/min/1.73 m2: 0.85 [0.70–1.02], P = 0.08). ESRD rates were similar between treatment arms, without adverse safety signals of fenofibrate use in renal impairment. CONCLUSIONS Patients with type 2 diabetes and moderate renal impairment benefit from long-term fenofibrate, without excess drug-related safety concerns compared with those with no or mild renal impairment. Fenofibrate treatment should not be contraindicated in moderate renal impairment, suggesting that current guidelines may be too restrictive.

Ting, Ru-Dee; Keech, Anthony C.; Drury, Paul L.; Donoghoe, Mark W.; Hedley, John; Jenkins, Alicia J.; Davis, Timothy M.E.; Lehto, Seppo; Celermajer, David; Simes, R. John; Rajamani, Kushwin; Stanton, Kim

2012-01-01

187

US Department of Energy Approach to Probabilistic Evaluation of Long-Term Safety for a Potential Yucca Mountain Repository  

SciTech Connect

Regulatory requirements being addressed in the US geological repository program for spent nuclear fuel and high-level waste disposal specify probabilistically defined mean-value dose limits. These dose limits reflect acceptable levels of risk. The probabilistic approach mandated by regulation calculates a ''risk of a dose,'' a risk of a potential given dose value at a specific time in the future to a hypothetical person. The mean value of the time-dependent performance measure needs to remain below an acceptable level defined by regulation. Because there are uncertain parameters that are important to system performance, the regulation mandates an analysis focused on the mean value of the performance measure, but that also explores the ''full range of defensible and reasonable parameter distributions''...System performance evaluations should not be unduly influenced by...''extreme physical situations and parameter values''. Challenges in this approach lie in defending the scientific basis for the models selected, and the data and distributions sampled. A significant challenge lies in showing that uncertainties are properly identified and evaluated. A single-value parameter has no uncertainty, and where used such values need to be supported by scientific information showing the selected value is appropriate. Uncertainties are inherent in data, but are also introduced by creating parameter distributions from data sets, selecting models from among alternative models, abstracting models for use in probabilistic analysis, and in selecting the range of initiating event probabilities for unlikely events. The goal of the assessment currently in progress is to evaluate the level of risk inherent in moving ahead to the next phase of repository development: construction. During the construction phase, more will be learned to inform a new long-term risk evaluation to support moving to the next phase: accepting waste. Therefore, though there was sufficient confidence of safety at the end of the site-characterization phase to warrant moving ahead to construction, the expectation is that still more confidence may be had in the next evaluation of risk for a repository at Yucca Mountain. More confidence does not always mean lower risk, just as less uncertainty does not necessarily mean lower risk. What needs to be shown is that there is a basis for confidence in the outcome of such evaluations, meaning that the potential repository promises to provide acceptable public safety, as defined by the regulation, at every phase in its long life.

Dr. R. Dyer; Dr. R. Andrews; Dr. A. Van Luik

2005-04-15

188

Long-term efficacy of trilostane for Cushing's syndrome due to adrenocorticotropin-independent bilateral macronodular adrenocortical hyperplasia.  

PubMed

A 66-year-old man with Cushing's syndrome due to adrenocorticotropin-independent bilateral macronodular adrenocortical hyperplasia (AIMAH) was treated for 7 years with trilostane, a 3?-hydroxysteroid dehydrogenase inhibitor. Administration of trilostane reduced the serum cortisol level to around the upper limit of normal for 7 years, and symptoms of excessive glucocorticoid production (such as moon face and obesity) were gradually improved. On the other hand, the size of both adrenal glands gradually increased despite treatment with trilostane. Though trilostane therapy could not prevent adrenal growth, it did suppress cortisol secretion over the long term, so it might be a reasonable option for AIMAH in addition to adrenalectomy. PMID:22041369

Obata, Yoshinari; Yamada, Yuya; Baden, Megu Yamaguchi; Hosokawa, Yoshiya; Saisho, Kenji; Tamba, Sachiko; Yamamoto, Koji; Matsuzawa, Yuji

2011-11-01

189

Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia  

Microsoft Academic Search

ObjectivesTo assess the long-term safety and efficacy of dutasteride, a dual type 1 and type 2 5-?-reductase inhibitor, in the treatment of symptomatic benign prostatic hyperplasia and associated lower urinary tract symptoms.

Claus G Roehrborn; Leonard S Marks; Tom Fenter; Sheldon Freedman; John Tuttle; Marc Gittleman; Betsy Morrill; Eric T Wolford

2004-01-01

190

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.

Case, Ryan C.; Schweinfurth, John

2009-01-01

191

Neuroprotective properties of catalpol in transient global cerebral ischemia in gerbils: dose-response, therapeutic time-window and long-term efficacy.  

PubMed

The present study evaluated for the first time the dose-effectiveness, therapeutic time-window and long-term efficacy of the neuroprotection of catalpol by behavioral and histological measures in gerbils subjected to transient global cerebral ischemia. Catalpol (1 mg/kg ip) used immediately after reperfusion and repeatedly at 12, 24, 48 and 72 h significantly rescued neurons in the hippocampal CA1 subfield and reduced cognitive impairment. The neuroprotective efficacy of catalpol became more evident at the doses of 5 and 10 mg/kg. Of great importance were the findings that the neuroprotective efficacy of catalpol still could be seen even when the treatment was delayed 3 h and when the observational period was lasted out 35 days after ischemia. It was reasonable to draw the conclusion that catalpol was truly neuroprotective rather than simply delayed the onset of neuronal damage. These results suggested that catalpol might be of therapeutic value for global cerebral ischemia. PMID:15542072

Li, Dan-Qing; Bao, Yong-Ming; Zhao, Jun-Jun; Liu, Chui-Ping; Liu, Ying; An, Li-Jia

2004-12-17

192

Long-term therapy with agalsidase alfa for Fabry disease: safety and effects on renal function in a home infusion setting  

Microsoft Academic Search

Background. Fabry disease is an X-linked disorder of glycosphingolipid catabolism that is the result of an intracellular deficiency in the lysosomal enzyme a-galactosidase A (a-Gal A). This enzymatic defect results in the accumulation of globotriaosylceramide (Gb3) within cells and causes progressive neurological, cardiovascular and renal dysfunction. Our objective is to describe the safety and renal effects of long-term enzyme replacement

Raphael Schiffmann; Markus Ries; Margaret Timmons; John T. Flaherty; Roscoe O. Brady

2006-01-01

193

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

194

The long-term efficacy of a behavioral parent training intervention for families with 2-year-olds.  

PubMed

The effectiveness of a behavioral parent training (BPT) intervention for improving maternal self-efficacy, maternal stress, and the quality of mother-toddler interactions has been demonstrated (Gross, Fogg, & Tucker, 1995). The 1-year follow-up of the 46 parents of toddlers (assigned to an intervention or comparison group) who participated in that study is reported. It was hypothesized that (a) BPT would lead to enduring positive changes in parenting self-efficacy, parenting stress, and parent-toddler interactions; and (b) the amount of parent participation in the intervention would be correlated with greater gains in parent-child outcomes at 1 year. All the families were retained and significant gains in maternal self-efficacy, maternal stress, and mother-child interactions were maintained. Minimal BPT effects were found for fathers. BPT dosage was related to reductions in mother critical statements and negative physical behaviors at 1-year postintervention. The findings are consistent with self-efficacy theory and support parenting self-efficacy as a target for BPT in families of young children. PMID:9609505

Tucker, S; Gross, D; Fogg, L; Delaney, K; Lapporte, R

1998-06-01

195

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

PubMed

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

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

2013-05-16

196

Choice of long-term strategy for the management of patients with severe esophagitis: A cost-utility analysis  

Microsoft Academic Search

BACKGROUND & AIMS: Omeprazole has shown remarkable efficacy and safety in the treatment of patients with gastroesophageal reflux disease (GERD); similarly, laparoscopic techniques have allowed less morbidity in patients undergoing fundoplication procedures. Concerns about the long-term cost and safety of both strategies have prompted a debate of their role in long-term management of patients with severe erosive esophagitis. METHODS: A

GR Heudebert; R Marks; CM Wilcox; RM Centor

1997-01-01

197

Long-Term Efficacy and Side Effects of Tap Water Iontophoresis of Palmoplantar Hyperhidrosis – the Usefulness of Home Therapy  

Microsoft Academic Search

Treatment of palmoplantar hyperhidrosis was carried out with a conventional galvanic generator in 40 patients and with a newly developed iontophoresis apparatus, which is suited for home treatment, in 31 patients. The new apparatus is operated by a rechargeable energy source or by batteries and is disconnected from the electrical net during treatment. It conforms to most recent safety regulations

E. Hölzle; N. Alberti

1987-01-01

198

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

Microsoft Academic Search

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

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

2003-01-01

199

Liposomal glucocorticosteroids in treatment of chronic autoimmune demyelination: Long-term protective effects and enhanced efficacy of methylprednisolone formulations  

Microsoft Academic Search

Liposomal encapsulation leads to enhanced efficacy of glucocorticosteroids (GS) in treatment of autoimmune diseases. Here we compare liposomal prednisolone (PL) to liposomal methylprednisolone (MPL) in chronic-relapsing myelin oligodendrocyte glycoprotein-induced experimental autoimmune encephalomyelitis (EAE), a model closely reflecting aspects of multiple sclerosis (MS). At the maximum of the first relapse, a single dose of PL or MPL was applied at 10 mg\\/kg

Ralf A. Linker; Charlotte Weller; Fred Lühder; Alexander Mohr; Jens Schmidt; Michael Knauth; Josbert M. Metselaar; Ralf Gold

2008-01-01

200

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

Microsoft Academic Search

INTRODUCTION: While the role of mycophenolate mofetil (MMF) in the management of lupus nephritis has been increasingly recognized, limited information is available regarding its efficacy and safety as a long-term maintenance treatment. The aim of the present study was to evaluate the efficacy and safety profile of MMF as maintenance therapy for proliferative lupus nephritis. METHODS: Thirty-three consecutive patients with

Katerina Laskari; Clio P Mavragani; Athanasios G Tzioufas; Haralampos M Moutsopoulos

2010-01-01

201

Low-dose methotrexate treatment of rheumatoid arthritis; long-term observation of efficacy and safety.  

PubMed

Forty-one patients with rheumatoid arthritis (RA) were treated with a weekly low-dose of methotrexate for a mean period of 32 months (range, 5-81 months) and were given a mean total dose of 954 mg (range, 145-2000 mg). Eighty-three percent of the patients improved. Of these 39% (16 patients) had a complete clinical remission and 17% (7 patients) showed marked improvement, 27% (11 patients) showed moderate improvement and 17% (7 patients) were unchanged. Patients responding to methotrexate therapy maintained the improvement as long as the therapy continued, unless severe infections occurred. Seven patients withdrew during the study including two, who died of myocardial infarction. Methotrexate was withdrawn because of adverse drug reactions in two patients, fear of toxicity in two and for administrative reasons in one patient. Adverse reactions developed in 25 patients (61%). In all but two cases these reactions were mild and reversible. Pancytopenia, a major side effect, was present in two patients: in one patient in association with pneumonia and in the other patient associated with an acute infectious enteritis (after three years treatment in the first and six years in the second patient); both recovered when methotrexate was discontinued. Age, sex, duration of treatment did not remarkably influence the outcome of therapy or the occurrence of adverse reactions. PMID:2805607

Szanto, E

1989-09-01

202

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

2011-06-03

203

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

204

The effectiveness of a long-term professional development program on teachers' self-efficacy, attitudes, skills, and knowledge using a thematic learning approach  

NASA Astrophysics Data System (ADS)

The purpose of this research study was to determine the effectiveness of a long-term professional development program on self-efficacy beliefs, science attitudes, skills, and knowledge of elementary teachers. The target school was located in the Lower Rio Grande Valley of Texas. Major elements of the study included the use of thematic science strands, use of the 5E constructivist-oriented instructional model, a focus on the interdisciplinary nature of the science process skills, and guided, inquiry-based learning experiences. These elements mirror the principles identified as being essential components of effective professional development for mathematics, and science education (Fullan, 1985; Sparks & Loucks-Horsley, 1990; Loucks-Horsley, 1997). The research team was actively involved with the participants for a total of 30 days at their school over the 24 months of the study. During each training, the research team modeled the 5E constructivist-oriented instructional strategy, and the interdisciplinary nature of the science process skills, set up a wide variety of activity centers, and provided the teachers with opportunities to improve their attitudes, skills, and knowledge of the science content, and teaching strategies. The 15 participants completed pre-, post-, and post-post-Leadership Team Surreys. Quantitative data analyses of gain scores measuring level of confidence to teach Marine and Earth Science, content knowledge, and teaching strategies were significant, p < .001. The participants' efficacy-beliefs and outcome expectancy were assessed with a pre- and posttest Science Teacher Self-Efficacy Beliefs Instrument that measures both elements. Self-efficacy beliefs were significant at p < .001. Outcome expectancies were not significant, p > .05. Qualitative analysis of reflective journal comments, classroom observations, and the participants understanding, and use of science process skills across the curriculum supported the quantitative data results. The data demonstrate significant improvement in the self-efficacy beliefs, attitudes, skills, and knowledge toward teaching science of the Pre-Kindergarten--2nd -grade teachers who participated in this long-term professional development study.

Tinnin, Richard Kinna

205

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.

Camilleri, Michael

2011-01-01

206

New treatment options for chronic constipation: mechanisms, efficacy and safety.  

PubMed

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

2011-10-01

207

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

Microsoft Academic Search

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

2002-01-01

208

Atrial fibrillation in long term care.  

PubMed

Increasing age is a potent risk factor for the development of atrial fibrillation (AF), as well as for incident stroke in patients with AF. The prevalence of AF in long term care facilities ranges from 7.5% to 17%, and such patients often present management challenges due to heightened risk for both stroke and bleeding complications related to thromboprophylaxis. This article reviews the diagnosis and management of AF in long term care. In general, patients with minimal symptoms can be managed with rate-control medications and anticoagulation. Patients with persistent symptoms and impaired quality of life despite adequate rate-control should be considered for cardioversion and antiarrhythmic drug therapy aimed at maintaining sinus rhythm. A small percentage of patients who do not respond to rate-control or rhythm-control interventions may be candidates for a catheter-based or surgical ablative procedure. In most older adults, the benefits of systemic anticoagulation in reducing the risk of stroke outweigh the risk of serious bleeding; therefore, anticoagulation is indicated in the majority of older AF patients, including nursing home residents. Although warfarin remains the preferred agent for stroke prophylaxis in the long term care setting, primarily due to very limited experience with the newer agents dabigatran, rivaroxaban, and apixaban, it is likely that the use of these newer drugs will increase as additional data accumulate documenting their safety and efficacy in AF patients of advanced age. PMID:22889728

Rich, Michael W

2012-08-11

209

Efficacy and safety of repeated intrathecal triamcinolone acetonide application in progressive multiple sclerosis patients  

Microsoft Academic Search

Available immunomodulatory and conventional steroid treatment options for patients with progressive multiple sclerosis (MS) only provide limited symptomatic benefit. We performed an open trial on the short-term and long-term efficacy and safety of repeated intrathecal application of the sustained release steroid triamcinolone acetonide (TCA) in 36 progressive MS patients. Six TCA administrations, performed every third day, reduced the EDSS score

Volker Hoffmann; Sebastian Schimrigk; Saida Islamova; Kerstin Hellwig; Carsten Lukas; Nils Brune; Dieter Pöhlau; Horst Przuntek; Thomas Müller

2003-01-01

210

Long-term Efficacy of an Internet-based Intervention for Infant and Toddler Sleep Disturbances: One Year Follow-Up  

PubMed Central

Objective: To examine at one-year follow-up the efficacy of an internet-based intervention for infant and toddler sleep disturbances, as well as to assess any indirect benefits to maternal sleep and confidence. Methods: Participants included 171 (64.8%) of 264 mothers of an infant or toddler (ages 18-48 months) who had previously participated in a 3-week study. Families had been randomly assigned to one of 2 intervention groups (algorithmic internet-based intervention alone or in combination with a prescribed bedtime routine) or a control group. After a one-week baseline, the intervention groups followed personalized sleep recommendations. The initial internet-intervention was found to be efficacious at 2 weeks post-intervention. The current study investigates a one-year follow-up, with mothers completing a short survey that included 8 questions from the Brief Infant Sleep Questionnaire and 1 question from the Pittsburgh Sleep Quality Index. Results: Improvements in difficulty falling asleep, number/duration of night wakings, and longest continuous sleep period were maintained at one year follow-up in the 2 intervention groups compared to baseline and end of the initial study, p < 0.001. Children in the control group, in which limited changes were seen in the initial study, showed improvements in the duration of night wakings and longest continuous sleep period compared to the end of the initial study. Mothers in all groups were less likely to describe their child's sleep as a problem. Conclusions: These results suggest that a brief internet-intervention for early childhood sleep problems is effective in improving child and maternal sleep, with improvements maintained one year later. Citation: Mindell JA; Du Mond CE; Sadeh A; Telofski LS; Kulkarni N; Gunn E. Long-term efficacy of an internet-based intervention for infant and toddler sleep disturbances: one year follow-up. J Clin Sleep Med 2011;7(5):507-511.

Mindell, Jodi A.; Du Mond, Courtney E.; Sadeh, Avi; Telofski, Lorena S.; Kulkarni, Neema; Gunn, Euen

2011-01-01

211

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.

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

212

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

Microsoft Academic Search

ContextEstablishing the long-term benefit of therapy in chronic diseases has been challenging. Long-term studies require non-randomized designs and, thus, are often confounded by biases. For example, although disease-modifying therapy in MS has a convincing benefit on several short-term outcome-measures in randomized trials, its impact on long-term function remains uncertain.ObjectiveData from the 16-year Long-Term Follow-up study of interferon-beta-1b is used to

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

2011-01-01

213

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

214

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

215

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

PubMed Central

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

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

2011-01-01

216

Pathogen safety of long-term treatments for bleeding disorders: (un)predictable risks and evolving threats.  

PubMed

Substantial improvements in the safety of blood and plasma products for the management of bleeding disorders have been achieved in recent decades. This has led some clinicians to believe that the infectious threat is over and that inhibitor formation is the foremost complication of hemophilia therapy. On the contrary, elimination of all microbes from blood is difficult, potentially impossible, and there are always threats from emerging pathogens. The risk of infection transmission is also increasing due to greater exposure to products, increasing prophylaxis and high-dose regimens for immune tolerance, and longevity of hemophilia patients. Current products can be considered "reasonably safe," but pathogen testing is not all-inclusive, and manufacturing and purification techniques are often not standardized. Although safer nonplasma-derived products are widely used, they are not available for all bleeding disorders, and so there is an ongoing need for plasma-derived products. This review will discuss the evolving risk from emerging pathogens in the context of the issues described. Reducing the risk from emerging infections requires global collaboration to devise ways to monitor and continue to improve blood safety. PMID:24030344

Di Minno, Giovanni; Canaro, Mariana; Ironside, James W; Navarro, David; Perno, Carlo F; Tiede, Andreas; Guertler, Lutz

2013-09-12

217

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.

218

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

Microsoft Academic Search

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

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

2004-01-01

219

Clinical and Electrophysiologic Characteristics and Long-Term Efficacy of Slow-Pathway Catheter Ablation in Patients With Spontaneous Supraventricular Tachycardia and Dual Atrioventricular Node Pathways Without Inducible Tachycardia  

Microsoft Academic Search

Objectives. We sought to investigate the long-term efficacy of slow-pathway catheter ablation in patients with spontaneous, documented paroxysmal supraventricular tachycardia (PSVT) and dual atrioventricular (AV) node pathways but without induc- ible tachycardia. Background. The lack of reproduction of clinical PSVT by programmed electrical stimulation, which is not uncommon in AV node reentrant tachycardia (AVNRT), is a dilemma in making the

JIUNN-LEE LIN; SHOEI K. STEPHEN HUANG; LING-PING LAI; WEN-CHIN KO; YUNG-ZU TSENG; WEN-PIN LIEN

220

Bioeffect and safety of long-term feeding of common salt fortified with iron and iodine (double fortified salt) in rat  

Microsoft Academic Search

A doubly fortified salt formulation developed at NIN as a public health measure for combating iron deficiency anemia and iodine deficiency disorders was evaluated for its efficacy and safety in experimental rats. The hemoglobin regenerating ability of diet with double fortified salt (DFS) containing 1000 ppm iron, 30 ppm iodine and 1% of sodium hexametaphosphate (SHMP), as the stabilizer, was

K. Madhavan Nair; B. Sesikeran; S. Ranganathan; B. Sivakumar

1998-01-01

221

Long-Term Results of Endoscopic Resection in Early Gastric Cancer: The Western Experience  

Microsoft Academic Search

OBJECTIVES:In the West, neither acute nor long-term results of endoscopic resection (ER) for early gastric cancer (EGC) have been reported in large studies. The aim of this study was to prospectively evaluate the efficacy and safety of ER in patients with EGC in a long-term follow-up (FU).METHODS:From May 1995 to October 2004, 179 patients were referred to our department for

Hendrik Manner; Thomas Rabenstein; Andrea May; Oliver Pech; Liebwin Gossner; Daniel Werk; Nicola Manner; Erwin Günter; Jürgen Pohl; Michael Vieth; Manfred Stolte; Christian Ell

2009-01-01

222

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

PubMed Central

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

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

2013-01-01

223

Long Term Quadrotor Stabilization.  

National Technical Information Service (NTIS)

The work of this thesis focuses on the IMU and getting the best performance possible out of the IMU to achieve better long term stability and a better navigation solution. This is done in two ways. First, the IMU accelerometer output is examined to determ...

N. Hamilton

2011-01-01

224

Long-term benefit of hepatitis C therapy in a safety net hospital system: a cross-sectional study with median 5-year follow-up  

PubMed Central

Objectives To demonstrate the survival benefit from sustained virological response (SVR) in a safety net hospital population with limited resources for hepatitis C virus (HCV) therapy. Design and setting We conducted a retrospective study at an urban safety net hospital in the USA. Participants and intervention 242 patients receiving standard HCV therapy between 2001 and 2006. Primary and secondary outcome measures Response rates, including SVR, were recorded for each patient. Univariate and multivariate analyses were performed to identify predictors of SVR and 5-year survival. Results A total of 242 eligible patients were treated. Treatment was completed in 197 (81%) patients, with 43 patients discontinuing therapy early—32 due to adverse events and 11 due to non-compliance. Complications on treatment were frequent, including three deaths. SVR was achieved in 83 patients (34%). On multivariate analysis, independent predictors of a decreased likelihood of achieving SVR included African–American race (OR 0.20, 95% CI 0.07 to 0.54), genotype 1 HCV infection (OR 0.25, 95% CI 0.13 to 0.50) and the presence of cirrhosis (OR 0.26, 95% CI 0.12 to 0.58). Survival was 98% in those achieving SVR (median follow-up 72?months) and 71% in non-responders and those discontinuing therapy (n=91, median known follow-up 65 and 36?months, respectively). On multivariate analysis, the only independent predictor of improved survival was SVR (HR 0.12, 95% CI 0.03 to 0.52). Both cirrhosis and hypoalbuminaemia were independent predictors of increased mortality. Conclusions Treatment before histological cirrhosis develops, in combination with careful selection, may improve long-term outcomes without compromising other healthcare endeavours in safety net hospitals and areas with financial limitations.

Singal, Amit G; Dharia, Tushar D; Malet, Peter F; Alqahtani, Saleh; Zhang, Song; Cuthbert, Jennifer A

2013-01-01

225

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

PubMed

This clinical study was conducted to investigate the safety and effect of D-psicose on postprandial blood glucose levels in adult men and women, including borderline diabetes patients. A randomized double-blind placebo-controlled crossover experiment of single ingestion was conducted on 26 subjects who consumed zero or 5 g of D-psicose in tea with a standard meal. The blood glucose levels at fasting and 30, 60, 90, and 120 min after the meal were compared. The blood glucose level was significantly lower 30 and 60 min after the meal with D-psicose (p<0.01, p<0.05), and a significant decrease was also shown in the area under the curve (p<0.01). The results suggest that D-psicose had an effect to suppress the postprandial blood glucose elevation mainly in borderline diabetes cases. A randomized double-blind placebo-controlled parallel-group experiment of long-term ingestion was conducted on 17 normal subjects who took 5 g of D-psicose or D-glucose with meals three times a day for 12 continuous weeks. Neither any abnormal effects nor clinical problems caused by the continuous ingestion of D-psicose were found. PMID:20208358

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

2010-03-07

226

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

ERIC Educational Resources Information Center

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

Sigel, Benjamin A.

2010-01-01

227

Natural family planning with and without barrier method use in the fertile phase: efficacy in relation to sexual behavior: a German prospective long-term study  

Microsoft Academic Search

A large prospective long-term study with users of natural family planning (NFP) methods has been conducted to analyze the relation between unintended pregnancy rates and sexual behavior with special reference to barrier method use in the fertile phase. Seven hundred and fifty eight NFP beginners, 19-45 years of age, 14 870 cycles, 28 unintended pregnancies were studied.

P. Frank-Herrmann; G. Freundl; Ch. Gnoth; E. Godehardt; J. Kunert; S. Baur; U. Sottong

1997-01-01

228

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

229

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

Microsoft Academic Search

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

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

2003-01-01

230

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.

2013-01-01

231

Guidance for Industry: Safety, Efficacy, and Pharmacokinetic ...  

Center for Biologics Evaluation and Research (CBER)

... they may jeopardize the patient or subject and ... either previously untreated or previously treated patients). ... conducted to establish efficacy and safety. ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances

232

Safety and Efficacy of Alprostadil Sterile Powder (S. Po., CAVERJECT®) in Diabetic Patients with Erectile Dysfunction  

Microsoft Academic Search

Objectives: To evaluate the long–term efficacy and safety of intracavernosal alprostadil (CAVERJECT®) in diabetic patients with erectile dysfunction (ED).Patients and Methods: This study included 31 diabetic men (aged 44–75 years) with ED of ?4 months duration. All patients were initially instructed in the self–injection technique at the investigator’s clinic. The optimal dose was determined for each patient and set at

2000-01-01

233

[Comparative efficacy of different regimens of locomotor training in long-term space flights by the data of biomechanical and electromyographic parametrs of walking].  

PubMed

Biomechanical and electromyographic characteristics of locomotion were investigated before and after space flight on the 3rd, 7th and 10th day after landing in 18 cosmonauts--crewmembers of long-term ISS space flights. It was shown that microgravity causes the development of significant changes in biomechanical and electromyographic characteristics of walking. Decrease of the angular displacement amplitude in leg joints, reduction of the length of the double step, increase of the electromyographic cost of locomotion were recorded after flight. It was also shown that interval locomotor physical training in long-term space flights in the regimen of alternation running and walking prevents physiological cost of locomotor movements increase after space flight and provides more effective maintenance of the neuromuscular system functions after flight. After flight smaller changes of biomechanical and electromyographic characteristics of walking were observed in cosmonauts who used locomotor training in interval regimen. PMID:23789385

Shpakov, A V; Voronov, A V; Fomina, E V; Lysova, N Iu; Chernova, M V; Kozlovskaia, I B

234

Factors Predictive of the Short and Long-Term Efficacy of Growth Hormone Treatment in Prepubertal Children with Chronic Renal Failure  

Microsoft Academic Search

To evaluate the growth-stimulating effects of short- and long-term treatment with recombinant human growth hor- mone (rhGH) in growth-retarded children with chronic renal failure (CRF), 103 prepubertal children with CRF on conser- vative treatment (n = 74) or dialysis (ti = 29) were treated with rhGH for up to 5 yr. rhGH treatment persistently increased standardized height (+ 1.6 SD

DIETER HAFFNER; ELKE WUHL; FRANZ SCHAEFER; RICHARD NISSEL; BURKHARD TONSHOFF; OTTO MEHLS

235

Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes  

Microsoft Academic Search

Aims\\/hypothesis  The aim of this analysis was to examine the long-term effects of pioglitazone or gliclazide addition to failing metformin monotherapy and pioglitazone or metformin addition to failing sulphonylurea monotherapy in patients with type 2 diabetes.Methods  Two 2-year, randomised, multicentre trials were performed in patients with inadequately controlled type 2 diabetes (HbA1c 7.5–11% inclusive), who were receiving either metformin or a sulphonylurea

B. Charbonnel; G. Schernthaner; P. Brunetti; D. R. Matthews; R. Urquhart; M. H. Tan; M. Hanefeld

2005-01-01

236

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

237

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

PubMed Central

Background We compared the time to discontinuation due to lack of tolerability over 24 weeks in patients suffering from schizophrenia treated with pomaglumetad methionil (LY2140023 monohydrate, the prodrug of metabotropic glutamate 2/3 receptor agonist, LY404039) or standard of care (SOC: olanzapine, risperidone, or aripiprazole). Methods Study HBBR was a multicenter, randomized, open-label study comparing the long-term safety and tolerability of LY2140023 with SOC for schizophrenia. Patients had moderate symptomatology with prominent negative symptoms and evidence of functional impairment. Those who met entry criteria were randomized to open-label treatment with either LY2140023 (target dose: 40 mg twice daily [BID]; n?=?130) or SOC (n?=?131). Results There was no statistically significant difference between LY2140023 and SOC for time to discontinuation due to lack of tolerability (primary objective; P?=?.184). The Kaplan-Meier estimates revealed comparable time to event profiles. Only 27% of LY2140023 and 45% of SOC patients completed the 24-week open-label, active treatment phase. Twenty-seven patients (20.8%) in the LY2140023 group and 15 patients (11.5%) in the SOC group discontinued due to lack of efficacy (P?=?.044). Twenty-three patients (17.7%) in the LY2140023 group and 19 patients (14.5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P?=?.505). The incidence of serious adverse events was comparable between groups. LY2140023-treated patients reported significantly more treatment-emergent adverse events of vomiting, agitation, and dyspepsia, while SOC-treated patients reported significantly more akathisia and weight gain. The incidence of treatment-emergent parkinsonism (P?=?.011) and akathisia (P?=?.029) was significantly greater in SOC group. Improvement in PANSS total score over the initial 6 to 8 weeks of treatment was similar between groups, but improvement was significantly greater in the SOC group at 24-week endpoint (P?=?.004). LY2140023 and SOC groups had comparable negative symptom improvement at 24-week endpoint (P?=?.444). Conclusion These data provide further evidence that the potential antipsychotic LY2140023 monohydrate, with a glutamatergic mechanism of action, may have a unique tolerability profile characterized by a low association with some adverse events such as extrapyramidal symptoms and weight gain that may characterize currently available dopaminergic antipsychotics. Trials registration A Long-term, Phase 2, Multicenter, Randomized, Open-label, Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients with DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier: NCT00845026.

2013-01-01

238

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

SciTech Connect

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

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

1985-05-17

239

An evaluation of the initial and long-term antihypertensive efficacy of zofenopril compared with enalapril in mild to moderate hypertension.  

PubMed

Angiotensin-converting enzyme inhibitors (ACEIs) are used in the management of a range of cardiovascular disorders and are well established in primary as well as secondary cardiovascular prevention programmes. Over the years, several second- and third-generation ACEIs have been introduced into the clinic. In a comparative study in patients with mild to moderate hypertension, the efficacy and safety of zofenopril 30 mg od (with an up-titration to 60 mg od after 4 weeks in non-responder patients) was compared with enalapril 20 mg od (with an up-titration to 40 mg od after 4 weeks in nonresponders) during 12 weeks of treatment. Both treatments significantly reduced systolic (SBP) and diastolic blood pressure (DBP). BP reduction was significantly greater with zofenopril (30 mg/day) during the initial 4 weeks of treatment compared with enalapril (20 mg/day). A larger proportion of patients needed dose up-titration with enalapril compared with zofenopril to reach preset BP goals. After 12 weeks of treatment and after appropriate dose up-titration, SBP and DBPs were lowered to similar extent in the two treatment groups, resulting in no differences between the groups in terms of response and control rates. A similar number of patients reported adverse events in the two study groups. However, the severity of adverse events were significantly milder with zofenopril compared with enalapril. In mild to moderate hypertensive patients, zofenopril treatment results in a more pronounced lowering of BP compared with enalapril at recommended dose levels. Additionally, at clinical and comparative antihypertensive doses, zofenopril presents a more beneficial adverse event profile compared with enalapril. PMID:18046974

Mallion, Jean-Michel

2007-10-01

240

Efficacy and long-term follow-up of IL-1R inhibitor anakinra in adults with Still's disease: a case-series study  

PubMed Central

Introduction To assess the efficacy and safety of the interleukin-1 receptor (IL-1R) inhibitor anakinra in adult patients with refractory Still's disease. Methods Twenty-five patients (13 males and 12 females, median age 32 years, median disease duration seven months) with Still's disease were treated with subcutaneous injections of anakinra (100 mg/day). Treatment was given as adjunct therapy in 16 patients and as standalone in 9 patients for a median time of 15 months (range 1.5-71). The clinical and laboratory parameters during follow-up were recorded. Results In 84% of patients the clinical activity resolved completely within a few days (median time 0.2 months), and response was maintained until the last visit in all but one patient. A complete response of all disease-related symptoms (clinical and laboratory) occurred subsequently within a median time of three months in 80% of patients. A partial clinical and laboratory improvement was shown in 12% and 16% of patients, respectively. The Visualized Analogue Scale and Health Assessment Questionnaire scores significantly decreased during treatment. The proportion of patients achieving the American College of Rheumatology 20 (ACR20) score (20% improvement) was 82% at one month and improved to 100% at one year. The mean oral corticosteroid dose was significantly reduced at each visit. Anakinra was discontinued due to unresponsiveness in one patient and due to relapsing disease in another. Treatment was also withdrawn in three patients with severe skin reactions (urticaria). Seven patients experienced an infection during follow-up. Conclusions The rapid and sustained response in the majority of our patients encourages the use of anakinra in adults with Still's disease.

2011-01-01

241

Long-Term Memory Improvement?  

ERIC Educational Resources Information Center

Tests Piaget's interpretation of long-term memory improvement among 82 five- and six-year-old children. Concludes that there is little evidence for long-term memory improvement or for Piaget's theory of memory. (Author/RH)

Maurer, Daphne; And Others

1979-01-01

242

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.

243

Excimer Laser-Assisted High-Flow Extracranial\\/Intracranial Bypass in Patients With Symptomatic Carotid Artery Occlusion at High Risk of Recurrent Cerebral Ischemia Safety and Long-Term Outcome  

Microsoft Academic Search

Background and Purpose—The goal of this study was to determine safety and long-term outcome of the excimer laser-assisted high-flow extracranial\\/intracranial (EC\\/IC) bypass in patients with symptomatic carotid artery occlusion (CAO) at high risk of recurrent stroke. Methods—In a prospectively collected cohort of 103 patients with symptomatic CAO, 15 patients were selected for excimer laser-assisted EC\\/IC bypass surgery on the basis

Catharina J. M. Klijn; L. Jaap Kappelle; Albert van der Zwan; Jan van Gijn; Cornelis A. F. Tulleken

244

Long-term outcome of patients with drug-refractory atrial flutter and fibrillation after single- and dual-site right atrial pacing for arrhythmia prevention  

Microsoft Academic Search

Objectives. An initial crossover study comparing dual- and single-site right atrial pacing was performed followed by a long-term efficacy and safety evaluation of dual-site right atrial pacing in patients with drug-refractory atrial fibrillation (AF). Also examined was the efficacy of two single-site right atrial pacing modes (high right atrium and coronary sinus ostium) and the long-term need for cardioversion, antithrombotic

Philippe Delfaut; Sanjeev Saksena; Atul Prakash; Ryszard B. Krol

1998-01-01

245

Efficacy and Safety of Long-term Prophylaxis in Severe Hemophilia A Dogs Following Liver Gene Therapy Using AAV Vectors  

Microsoft Academic Search

Developing adeno-associated viral (AAV)–mediated gene therapy for hemophilia A (HA) has been challenging due to the large size of the factor VIII (FVIII) complementary DNA and the concern for the development of inhibitory antibodies to FVIII in HA patients. Here, we perform a systematic study in HA dogs by delivering a canine FVIII (cFVIII) transgene either as a single chain

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

2011-01-01

246

Current medical treatment of diabetes type 2 and long term morbidity: how to balance efficacy and safety?  

PubMed

Current medical treatment of type 2 diabetes mellitus (T2DM) requires special attention to different comorbidities that often are associated with hyperglycemia, such as overweight or obesity, dyslipidemia, hypertension, microvascular or macrovascular complications, etc. .. The control of these factors risk to health is as important as the glucose control in diabetes type 2, it is essential for the antidiabetes drugs consider these risk factors. The consensus statement published by the ADA/EASD and AACE emphasizes that the potential effects of antidiabetes medications on CV risk factors besides hyperglycemia (ie, overweight/obesity, hypertension, and dyslipidemia) should be considered in pharmacotherapy selection. Since T2DM is a progressive disease with worsening HbA1C values over time, monotherapy, even with different agents, will eventually fail to maintain the glycemic target. Because insulin resistance occurs in a variety of organs and tissues, many patients may achieve fasting glycemic control but develop postprandial hyperglycemia. Other issues include the risk for hypoglycaemia or weight gain with traditional glucose-lowering medications. The AACE/ACE algorithm for glycemic control is structured according to categories of HbA1C and suggests an HbA1C goal of =6.5%, although that may not be appropriate for all patients.42 The algorithm recommends monotherapy, dual therapy, or triple therapy based on initial HbA1C level of 6.5% to 7.5%, 7.6% to 9%, and >9% and reserves initiation of insulin therapy until treatment with oral or other injectable agents has failed. GLP-1 receptor agonists and DPP-4 inhibitors are novel options to improve glycemic control and reduce the incidence of weight gain. Combination therapy with newer and traditional agents improves glycemic control with a low incidence of hypoglycemia. PMID:23834040

Carrera Boada, C A; Martínez-Moreno, J M

2013-03-01

247

Long-term consequences of foodborne infections.  

PubMed

Foodborne infections with Campylobacter, E. coli O157:H7, Listeria monocytogenes, Salmonella, Shigella, Toxoplasma gondii, and other pathogens can result in long-term sequelae to numerous organ systems. These include irritable bowel syndrome, inflammatory bowel disease, reactive arthritis, hemolytic uremic syndrome, chronic kidney disease, Guillain-Barré Syndrome, neurological disorders from acquired and congenital listeriosis and toxoplasmosis, and cognitive and developmental deficits due to diarrheal malnutrition or severe acute illness. A full understanding of the long-term sequelae of foodborne infection is important both for individual patient management by clinicians, as well as to inform food safety and public health decision making. PMID:24011832

Batz, Michael B; Henke, Evan; Kowalcyk, Barbara

2013-07-25

248

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

PubMed

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

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

2013-08-01

249

Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up  

Microsoft Academic Search

Objective. To quantify the efficacy of a series of baths containing natural radon and carbon dioxide (1.3 kBq\\/l, 1.6 g carbon dioxide\\/l on average) versus artificial carbon dioxide baths alone in patients with rheumatoid arthritis. Subjects. Sixty patients participating in an in-patient rehabilitation programme including a series of 15 baths were randomly assigned to two groups. Design. Pain intensity (100

A. Franke; L. Reiner; H. G. Pratzel; T. Franke; K. L. Resch

2000-01-01

250

Separating therapeutic efficacy from glucocorticoid side-effects in rodent arthritis using novel, liposomal delivery of dexamethasone phosphate: long-term suppression of arthritis facilitates interval treatment  

Microsoft Academic Search

INTRODUCTION: Glucocorticoids have extensively been used in the treatment of rheumatoid arthritis and other inflammatory diseases. However, their side-effects remain the major limitation in clinical use and an improved therapeutic index is needed. METHODS: Therapeutic efficacy and persistence of free and liposomal dexamethasone phosphate (DXM-P) were determined in mouse collagen-induced arthritis. For regimens with equal therapeutic benefit, the side-effect profiles

Una Rauchhaus; Franz Werner Schwaiger; Steffen Panzner

2009-01-01

251

Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial  

Microsoft Academic Search

Background\\/Aims: To evaluate the therapeutic efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B.Methods: One hundred and fifty-one patients were randomly assigned to receive either recombinant interferon alpha-2b (nine million units three times per week) and lamivudine (100mg\\/daily per os) for 24 weeks or lamivudine alone (100mg\\/daily per os) for 52

Giorgio Barbarini

2001-01-01

252

Safety, long-term results, and predictors of recurrence after complete endocardial ventricular tachycardia substrate ablation in patients with previous myocardial infarction.  

PubMed

Conduction channels and electrograms with isolated component/late potentials are sensitive markers of the substrate of post-myocardial infarction sustained monomorphic ventricular tachycardia (VT). Ablation of all conduction channels and isolated component/late potentials (complete endocardial VT substrate ablation [CEVTSA]) during sinus rhythm could simplify and facilitate the ablation procedure, mainly in patients without references for clinical VT substrate identification. The aim of this study was to assess the safety, efficacy, and predictors of VT recurrence after CEVTSA. Electroanatomic mapping and CEVTSA were performed in 59 post-myocardial infarction patients (mean age 67 ± 9 years, mean left ventricular ejection fraction 30 ± 11%), 24 of whom did not have clinical VT substrate references. The mean areas of scar (?1.5 mV) and dense scar (?0.5 mV) were 76 ± 42 and 34 ± 24 cm(2), respectively; isolated component/late potentials and conduction channels were identified and ablated in 97% and 83% of patients (mean ablation area 14 ± 10 cm(2)). No life-threatening complications occurred during the procedure. After 1 year and at the end of follow-up (mean 39 ± 21 months), 81% and 58% of patients were free of VT. No differences were observed between patients with and without specific clinical VT substrate identification. Univariate analysis identified the left ventricular ejection fraction, VT cycle length (VTCL), infarct location (inferior vs anterior), and dense scar area as predictors of VT recurrence, and Cox analysis identified VTCL (hazard ratio 0.42, p <0.001) and dense scar area (hazard ratio 2.65, p <0.0006) as independent predictors. No patients with dense scar area ?25 cm(2) and VTCL >350 ms had recurrences. In conclusion, CEVTSA is safe and effective, even in patients without clinical VT substrate identification. Scar area and VTCL are valuable predictors of VT recurrence. PMID:23228925

Arenal, Ángel; Hernández, Jesús; Calvo, David; Ceballos, Cecilia; Atéa, Leonardo; Datino, Tomás; Atienza, Felipe; González-Torrecilla, Esteban; Eídelman, Gabriél; Miracle, Ángel; Avila, Pablo; Bermejo, Javier; Fernández-Avilés, Francisco

2012-12-08

253

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.

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

1995-01-01

254

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

255

Presynaptic long-term plasticity  

PubMed Central

Long-term synaptic plasticity is a major cellular substrate for learning, memory, and behavioral adaptation. Although early examples of long-term synaptic plasticity described a mechanism by which postsynaptic signal transduction was potentiated, it is now apparent that there is a vast array of mechanisms for long-term synaptic plasticity that involve modifications to either or both the presynaptic terminal and postsynaptic site. In this article, we discuss current and evolving approaches to identify presynaptic mechanisms as well as discuss their limitations. We next provide examples of the diverse circuits in which presynaptic forms of long-term synaptic plasticity have been described and discuss the potential contribution this form of plasticity might add to circuit function. Finally, we examine the present evidence for the molecular pathways and cellular events underlying presynaptic long-term synaptic plasticity.

Yang, Ying; Calakos, Nicole

2013-01-01

256

State of the Art Review: Long-term Pharmacotherapy for Overweight and Obesity: A Review of Sibutramine, Orlistat, and Rimonabant  

Microsoft Academic Search

The objective of this review is to evaluate the safety and efficacy of pharmacotherapy for long-term maintenance of weight loss in overweight and obese patients. Literature was obtained through a MEDLINE (1966 to July 2006) search and a bibliographic review of published articles. Key terms used included overweight, obesity, sibutramine, orlistat, and rimonabant. The search was further limited to clinical

Kaelen C. Dunican; Alicia R. Desilets; Ronald J. DeBellis

2007-01-01

257

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

258

Efficacy and safety of oral naltrexone treatment for pruritus of cholestasis, a crossover, double blind, placebo-controlled study  

Microsoft Academic Search

Background\\/Aims: To assess the efficacy and safety of naltrexone for the short and long term treatment of pruritus of cholestasis.Methods: Twenty patients with pruritus and cholestasis were included. A baseline pruritus score was obtained over 1 week. Patients were then randomized to receive 50 mg\\/day of naltrexone or placebo for 2 weeks. Subsequently, a 1-week washout period ensued and patients

Rubén Terg; Emma Coronel; Juan Sordá; Alberto E Muñoz; Jorge Findor

2002-01-01

259

Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature  

Microsoft Academic Search

Objectives  Transcatheter aortic valve implantation (TAVI) promises effective treatment for high-risk elderly patients with symptomatic\\u000a severe aortic stenosis (AS). However, the adoption of TAVI must be justified and guarantee long-term performance. Systematic\\u000a reviews are a core methodology in evidence-based health economics for judging medical effectiveness. In this work, the methodology\\u000a was applied to provide objective evidence on the efficacy and safety

L. Figulla; A. Neumann; H. R. Figulla; P. Kahlert; R. Erbel; T. Neumann

2011-01-01

260

Persistent clinical efficacy and safety of anti-tumour necrosis factor   therapy with infliximab in patients with ankylosing spondylitis over 5 years: evidence for different types of response  

Microsoft Academic Search

Background: There is insufficient evidence for the long- term efficacy and safety of anti-tumour necrosis factor therapy in patients with ankylosing spondylitis (AS). This is the first report on the treatment with infliximab over 5 years. Methods: As part of a multicentre randomised trial, 69 patients with active AS at baseline (BL) have been continuously treated with infliximab (5 mg\\/kg

J Braun; X Baraliakos; J Listing; C Fritz; R Alten; G Burmester; A Krause; S Schewe; M Schneider; H Sorensen; H Zeidler; J Sieper

2007-01-01

261

Topical Bromfenac Sodium for Long-Term Management of Vernal Keratoconjunctivitis  

Microsoft Academic Search

Background\\/Aims: We evaluated the efficacy and safety of long-term management of patients with vernal keratoconjunctivitis (VKC) with bromfenac sodium eye drops in combination with corticosteroids and anti-allergic eye drops. Methods: Twenty-two patients with VKC were randomly assigned to receive two test eye drops, either bromfenac sodium 0.1% (group A) or placebo eye drops (normal saline; group B) for a mean

Eiichi Uchio; Yuki Itoh; Kazuaki Kadonosono

2007-01-01

262

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

263

Long-term intravenous treatment of Pompe disease with recombinant human alpha-glucosidase from milk  

Microsoft Academic Search

OBJECTIVE: Recent reports warn that the worldwide cell culture capacity is\\u000a insufficient to fulfill the increasing demand for human protein drugs.\\u000a Production in milk of transgenic animals is an attractive alternative.\\u000a Kilogram quantities of product per year can be obtained at relatively low\\u000a costs, even in small animals such as rabbits. We tested the long-term\\u000a safety and efficacy of recombinant

Hout van den J. M. P; Joep H. J. Kamphoven; J. P. Brakenhoff; A. H. Cromme-Dijkhuis; N. Weisglas-Kuperus; A. J. J. Reuser; A. G. Vulto; W. C. J. Hop; Corven van E. J; O. P. van Diggelen; Ploeg van der A. T; P. A. van Doorn; E. I. van der Voort; Doorn van P. A; E. J. van Corven; J. L. van Hove; J. A. M. Smeitink; G. de Jong; L. P. F. Winkel; A. T. van der Ploeg

2004-01-01

264

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

Microsoft Academic Search

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

Hania Szajewska; Maria Makrides

2011-01-01

265

Topical 5% Imiquimod Long-Term Treatment of Cutaneous Warts Resistant to Standard Therapy Modalities  

Microsoft Academic Search

Background: Long-lasting cutaneous warts may represent an unbearable stigma to patients and therefore pose a singular challenge for the physician. Generally, these warts are induced by human papillomavirus (HPV) 2, HPV-27 or HPV-57. Objectives: The present study was conducted to evaluate the efficacy and safety of long-term treatment with imiquimod 5% cream applied to long-lasting (mean duration 6.3 years) common

E.-I. Grussendorf-Conen; S. Jacobs; A. Rübben; U. Dethlefsen

2002-01-01

266

Long-term, open-label, phase III multicenter study of tamsulosin in benign prostatic hyperplasia  

Microsoft Academic Search

Objectives. To investigate the long-term efficacy and safety of tamsulosin in patients with benign prostatic hyperplasia and to monitor the increases and decreases in therapeutic response over time. Tamsulosin, a uroselective alpha-adrenergic receptor antagonist for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia, targets alpha1A-adrenergic receptors of prostatic smooth muscle with greater affinity than the vascular

Perinchery Narayan; Herbert Lepor

2001-01-01

267

Long-term evaluation of a behavior-based method for improving safety performance: a meta-analysis of 73 interrupted time-series replications  

Microsoft Academic Search

Research and applications of behavioral principles have established behavior-based safety initiatives as potentially effective solutions to certain occupational health and safety challenges. The present study adds to the existing literature a longitudinal evaluation of an employee-driven behavior-based accident prevention initiative implemented in industrial settings. Up to 5 years of injury data from 73 companies, drawn from a target population of

T. R Krause; K. J Seymour; K. C. M Sloat

1999-01-01

268

Safety and Efficacy of Vaccines Against Intracellular ...  

Center for Biologics Evaluation and Research (CBER)

... Infection with M. tuberculosis causes a chronic (long-term) disease in both mice and humans that is often not resolved during the life of the host. ... More results from www.fda.gov/biologicsbloodvaccines/scienceresearch/biologicsresearchareas

269

Lithium: still a cornerstone in the long-term treatment in bipolar disorder?  

PubMed

Background: Scientific literature considers lithium a key treatment for the acute and long-term management of bipolar disorder (BD). Despite its worldwide clinical use, the effectiveness of lithium has been questioned. The aim of this work is to critically review the available data on randomized controlled trials (RCTs) concerning long-term lithium treatment. Methods: A systematic search for long-term treatment RCTs with at least 6 months of follow-up was performed. Six RCTs enrolling 1,561 bipolar I and II patients of adult and pediatric age, randomizing 534 to lithium, were identified. All studies are controlled trials sponsored by industry, investigating new treatments for BD, with lithium as an active comparator, and therefore not specifically designed to study lithium efficacy or safety. Results: Results from earliest studies suggest a high effectiveness of lithium against both mania and depression, while more recent studies highlight lithium as more effective than placebo in mania and hypomania, without significant evidence in depression. Lithium does not achieve significant differences in efficacy when compared with divalproex; it seems less effective than lamotrigine in preventing depression and less effective than olanzapine in manic and mixed episodes. Conclusions: Despite a number of methodological issues (enriched designs, unbalanced samples, potential inclusion of lithium nonresponders in some studies), lithium appears to have a clear antimanic prophylactic activity and some efficacy in the prevention of depression. Lithium should still have a major role in the long-term treatment of BD. PMID:20453532

Nivoli, Alessandra M A; Murru, Andrea; Vieta, Eduard

2010-05-07

270

Evaluation of efficacy and safety of finasteride 1 mg in 3177 Japanese men with androgenetic alopecia.  

PubMed

Before now, there has been no study of finasteride use exceeding 1 year in Japanese men with androgenetic alopecia (AGA) except the study subsequently conducted from the development phase. Since the launch of finasteride, no study in a larger population had been reported. Ethnic variation of the onset age, progressive nature and degree of hair loss of androgenetic alopecia are known. The therapeutic effect of oral finasteride (Propecia) was examined on androgenetic alopecia of Japanese men. The efficacy and safety of finasteride (1 mg tablet) was evaluated in Japanese men with AGA in the long term. The study enrolled 3177 men given finasteride 1 mg/day from January 2006 to June 2009 at our clinic. Efficacy was evaluated in 2561 men by the modified global photographic assessment; the photographs were assessed using the standardized 7-point rating scale. Safety data were assessed by interviews and laboratory tests in all men enrolled in the study. The overall effect of hair growth was seen in 2230 of 2561 men (87.1%), in whom hair greatly (11.1%), moderately (36.5%) and slightly (39.5%) increased. The response rate improved with increasing duration of treatment. Adverse reactions occurred in 0.7% (23/3177) of men; seven men discontinued treatment based on risk-benefit considerations. No specific safety problems associated with long-term use were observed. This study represents data collected at a single institution. Many patients did not receive follow-up examination. In Japanese men with AGA, oral finasteride used in the long-term study maintained progressive hair regrowth without recognized side-effect. PMID:21980923

Sato, Akio; Takeda, Akira

2011-10-10

271

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

272

? Carinae long-term variability  

NASA Astrophysics Data System (ADS)

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

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

2011-07-01

273

Acute and long-term treatment of mania  

PubMed Central

The treatment of mania starts with a correct diagnosis and elementary measures to prevent risks for the patient, relatives, and others. Sometimes, compulsory admission and treatment may be required for a few days. Patients with psychotic or mixed mania may be more difficult to treat. At the present time, there is solid evidence supporting the use of lithium, the anticonvulsants valproate and carbamazepine, and the antipsychotics chlorpromazine, haloperidol, risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and asenapine in acute mania, and some evidence supporting the use of clozapine or electroconvulsive therapy in treatment-refractory cases. However, in clinical practice, combination therapy is the rule rather than the exception. The treatment of acute mania deserves a long-term view, and the evidence base for some treatments may be stronger than for others. When taking decisions about treatment, tolerabiliiy should also be a major concern, as differences in safety and tolerability may exceed differences in efficacy for most compounds, Psychoeducation of patients and caregivers is a povi/erful tool that should be used in combination with medication for optimal long-term outcome. Functional recovery should be the ultimate goal.

Vieta, Eduard; Sanchez-Moreno, Jose

2008-01-01

274

Current Antiviral Therapy of Chronic Hepatitis B: Efficacy and Safety  

Microsoft Academic Search

The treatment of chronic hepatitis B is in constant evolution. Interferon, the first agent licensed for chronic hepatitis\\u000a B treatment, has been superseded by the growing popularity of nucleoside\\/nucleotide analogues (NA). However, resistance to\\u000a these agents is a major challenge. Newer NAs, such as entecavir and tenofovir dipivoxil fumarate, have very low resistance\\u000a rates and favorable safety profiles. Long-term use

Yuk-Fai Lam; Man-Fung Yuen; Wai-Kay Seto; Ching-Lung Lai

275

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

276

Safety and efficacy of drugs in pregnancy.  

PubMed

Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women. PMID:22113261

Knoppert, David

2011-11-14

277

Retinectomy for treatment of intractable glaucoma: long term results  

PubMed Central

Aim: To report long term efficacy and complications of retinectomy as an intraocular pressure lowering procedure for intractable glaucoma. Methods: This was a consecutive interventional case series. In 44 consecutive eyes (39 patients, 22 men and 17 women) retinectomy was performed to lower the intraocular pressure (IOP) in patients with uncontrolled IOP (>35 mm Hg for more than 4 months) despite conventional filtering surgery and drug treatment. Pars plana vitrectomy was performed and the peripheral retina was surgically excised to various degrees. The procedure was concluded by an intraocular gas tamponade of 20% C3F8. Included were patients with neovascular glaucoma (12 eyes), infantile and juvenile glaucoma (three eyes), secondary glaucoma due to aphakia (13 eyes), severe ocular trauma (seven eyes), uveitis (seven eyes), and glaucoma in Ehlers-Danlos syndrome (two). Results: All patients underwent successful surgical retinectomy. All patients were followed for 5 years. Mean postoperative IOP after 4 years was 15.7 (SD 9.4) mm Hg, representing a decrease of IOP by 61% compared to the preoperative level (41.2 (9.4) mm Hg). In 52.3% of eyes long term regulation of IOP could be achieved without complications. Retinectomy was least effective in neovascular glaucoma because of central retinal vein occlusion (CRVO). Eyes with glaucoma secondary to uveitis showed a tendency towards low IOP levels with subsequent phthisis bulbi. The initial visual acuity of all patients was lower than 20/50 (mean 1.8 (0.8) logMAR) in the treated eye. Final visual acuity was 2.3 (0.6) logMAR. 21 out of 44 cases developed retinal complications (retinal detachment or proliferative vitreoretinopathy (PVR)) after surgery, requiring silicone tamponade in 11 eyes (52%) either for persistent low IOP or for PVR. Nine eyes developed phthisis, seven of which were enucleated during the follow up. Conclusions: Long term results after retinectomy demonstrate its efficacy in otherwise intractable glaucoma. Efficacy and safety of retinectomy are dependent on the underlying disease.

Joussen, A M; Walter, P; Jonescu-Cuypers, C P; Koizumi, K; Poulaki, V; Bartz-Schmidt, K U; Krieglstein, G K; Kirchhof, B

2003-01-01

278

Safety and Efficacy of Sacrospinous Vault Suspension  

Microsoft Academic Search

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

D. Lovatsis; H. P. Drutz

2002-01-01

279

Prucalopride: safety, efficacy and potential applications.  

PubMed

Chronic constipation is a very common functional gastrointestinal disorder which can be associated with significant impairments in quality of life for some people with the condition. Its management has, traditionally, been based on dietary and lifestyle changes and the use of a variety of laxative agents. The evidence base for the efficacy of the latter is, in many cases, slim. Not surprisingly, many patients remain dissatisfied with laxatives thus leading to the development of more pharmacological approaches. Among these approaches is the use of prokinetic agents; while prior molecules have been troubled by lack of selectivity and cardiac side effects, the new agent, prucalopride, appears to be highly selective for the serotonin 5-HT4 receptor and is, therefore, a potent stimulator of gut motility. In three large pivotal randomized controlled trials, prucalopride has been effective in relieving the cardinal symptoms of chronic constipation; these effects have been sustained in open-label follow up for as long as 18 months. The safety profile has been encouraging and, especially so, the absence of arrhythmogenic potential. Studies in men, in constipation-predominant irritable bowel syndrome and in other motor disorders are eagerly awaited. PMID:22282705

Quigley, Eamonn M M

2012-01-01

280

Prucalopride: safety, efficacy and potential applications  

PubMed Central

Chronic constipation is a very common functional gastrointestinal disorder which can be associated with significant impairments in quality of life for some people with the condition. Its management has, traditionally, been based on dietary and lifestyle changes and the use of a variety of laxative agents. The evidence base for the efficacy of the latter is, in many cases, slim. Not surprisingly, many patients remain dissatisfied with laxatives thus leading to the development of more pharmacological approaches. Among these approaches is the use of prokinetic agents; while prior molecules have been troubled by lack of selectivity and cardiac side effects, the new agent, prucalopride, appears to be highly selective for the serotonin 5-HT4 receptor and is, therefore, a potent stimulator of gut motility. In three large pivotal randomized controlled trials, prucalopride has been effective in relieving the cardinal symptoms of chronic constipation; these effects have been sustained in open-label follow up for as long as 18 months. The safety profile has been encouraging and, especially so, the absence of arrhythmogenic potential. Studies in men, in constipation-predominant irritable bowel syndrome and in other motor disorders are eagerly awaited.

2012-01-01

281

Cervarix Long-term Safety Surveillance  

ClinicalTrials.gov

Myositis; Guillain-Barre Syndrome; Autoimmune Thyroiditis; Multiple Sclerosis; Cutaneous Lupus; Lupus Erythematosus; Inflammatory Arthritis; Type 1 Diabetes; Central Demyelination; Dermatomyositis; Idiopathic Thrombocytopenic Purpura; Graves Disease

2013-02-07

282

Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients  

PubMed Central

Objectives Evaluation of long-term safety of rituximab in rheumatoid arthritis (RA). Methods Pooled observed case analysis of data from patients with moderate-to-severe, active RA treated with rituximab in a global clinical trial programme. Results As of September 2010, 3194 patients had received up to 17 rituximab courses over 9.5?years (11?962 patient-years). Of these, 627 had >5 years’ follow-up (4418 patient-years). A pooled placebo population (n=818) (placebo+methotrexate (MTX)) was also analysed. Serious adverse event and infection rates generally remained stable over time and multiple courses. The overall serious infection event (SIE) rate was 3.94/100 patient-years (3.26/100 patient-years in patients observed for >5?years) and was comparable with placebo+MTX (3.79/100 patient-years). Serious opportunistic infections were rare. Overall, 22.4% (n=717) of rituximab-treated patients developed low immunoglobulin (Ig)M and 3.5% (n=112) low IgG levels for ?4?months after ?1 course. SIE rates were similar before and during/after development of low Ig levels; however, in patients with low IgG, rates were higher than in patients who never developed low IgG. Rates of myocardial infarction and stroke were consistent with rates in the general RA population. No increased risk of malignancy over time was observed. Conclusions This analysis demonstrates that rituximab remains generally well tolerated over time and multiple courses, with a safety profile consistent with published data and clinical trial experience. Overall, the findings indicate that there was no evidence of an increased safety risk or increased reporting rates of any types of adverse events with prolonged exposure to rituximab during the 9.5?years of observation.

van Vollenhoven, Ronald F; Emery, Paul; Bingham, Clifton O; Keystone, Edward C; Fleischmann, Roy M; Furst, Daniel E; Tyson, Nicola; Collinson, Neil; Lehane, Patricia B

2013-01-01

283

Clozapine: balancing safety with superior antipsychotic efficacy.  

PubMed

Clozapine is often referred to as the gold standard for the treatment of schizophrenia and yet has also been described as the most underutilized treatment for schizophrenia supported by solid evidence-based medicine. In 2008, it was used to treat only 4.4% of patients with schizophrenia in the U.S., which is ~10-20% of those with approved indications for clozapine for which there is no alternative of equal efficacy. Its use is much higher in Scandinavian countries and China. The primary indications for clozapine are: 1) treatment-resistant schizophrenia or schizoaffective disorder, defined as persistent moderate to severe delusions or hallucinations despite two or more clinical trials with other antipsychotic drugs; and, 2) patients with schizophrenia or schizoaffective disorder who are at high risk for suicide. Concerns over a number of safety considerations are responsible for much of the underutilization of clozapine: 1) agranulocytosis; 2) metabolic side effects; and, 3) myocarditis. These side effects can be detected, prevented, minimized and treated, but there will be a very small number of fatalities. Nevertheless, clozapine has been found in two large epidemiologic studies to have the lowest mortality of any antipsychotic drug, mainly due to its very large effect to reduce the risk for suicide. Other reasons for limited use of clozapine include the extra effort entailed in monitoring white blood cell counts to detect granulocytopenia or agranulocytosis and, possibly, minimal efforts to market it now that it is largely generic. Awareness of the benefits and risks of clozapine is essential for increasing the use of this lifesaving agent. PMID:23006238

Meltzer, Herbert Y

2012-10-01

284

Long-term follow-up of patients with cutaneous T-cell lymphoma treated with extracorporeal photochemotherapy  

Microsoft Academic Search

Background: Few studies have assessed the long-term outcome of patients with cutaneous T-cell lymphoma (CTCL) treated with extracorporeal photochemotherapy (ECP).Objective: Our objective was to assess the efficacy, safety, and survival of a cohort of patients with refractory T-cell lymphoma in various stages of cutaneous involvement who were treated with ECP.Methods: Twenty patients who had received at least 6 months of

John A Zic; George P Stricklin; John P Greer; Marsha C Kinney; Yu Shyr; David C Wilson; Lloyd E King

1996-01-01

285

Double-blind, randomized comparison of olanzapine versus fluphenazine in the long-term treatment of schizophrenia  

Microsoft Academic Search

This study was undertaken to evaluate the efficacy and safety of olanzapine compared with fluphenazine in the treatment of patients who met the Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnostic criteria for schizophrenia or schizoaffective disorder. This was a long-term (22-week), randomized, double-blind, parallel clinical trial. Sixty patients (mean age, 35.4 years) were randomly assigned to either olanzapine (n=30)

Martin R. K Dossenbach; Vera Folnegovic-Smalc; Ljubomir Hotujac; Borben Uglesic; Gary D Tollefson; Starr L Grundy; Philip Friedel; Miroslav Miro Jakovljevic

2004-01-01

286

Technology for long-term care.  

PubMed

Severe staff shortages in long-term care (LTC) make it difficult to meet the demands of the growing aging population. Further, technology-savvy Baby Boomers are expected to reshape the current institutional environments toward gaining more freedom and control in their care and lives. Voices from business, academia, research, advocacy organizations, and government bodies suggest that innovative technological approaches are the linchpin that may prepare society to cope with these projected demands. In this article, we review the current state of aging-related technology, identify potential areas for efficacy testing on improving the quality of life of LTC residents in future research, and discuss barriers to implementation of LTC technology. Finally, we present a vision of future technology use that could transform current care practices. PMID:20128544

Tak, Sunghee H; Benefield, Lazelle E; Mahoney, Diane Feeney

2010-01-27

287

Safety and Efficacy of Tocilizumab for the Treatment of Rheumatoid Arthritis  

PubMed Central

Because of the pathological role of IL-6 in rheumatoid arthritis (RA), tocilizumab (TCZ), a humanized anti-IL-6 receptor monoclonal antibody, was expected to improve inflammation and joint destruction of RA. Indeed, randomized clinical trials demonstrated the clinical efficacy of TCZ as monotherapy or combined with methotrexate (MTX) for RA patients with inadequate responses to disease-modifying antirheumatic drugs, MTX or tumor necrosis factor (TNF) inhibitors. Although long-term tolerability for TCZ is superior to that for TNF inhibitors, information regarding the potency of drug free remission of TCZ is limited at present. In terms of its safety profile, the general risk of infection when using TCZ is comparable to that of TNF inhibitors. TCZ has some advantage in RA patients who can not use MTX and are non-responders to TNF inhibitors. In conclusion, TCZ is one of the most prospective next generation biologics for the treatment of RA.

Ogata, Atsushi; Hirano, Toru; Hishitani, Yoshihiro; Tanaka, Toshio

2012-01-01

288

Long Term Care: Early Planning Pays Off  

MedlinePLUS

... reprinted for personal, noncommercial use only. Long term care: Early planning pays off By Mayo Clinic staff ... your e-mail address Sign up Long term care: Early planning pays off It's best to talk ...

289

Long-Term Care Ombudsman Program  

MedlinePLUS

... shortly. Unable to Share This Page Long-Term Care Ombudsman Program (OAA, Title VII, Chapter 2, Sections ... Services Provided to Persons Living in Long-Term Care Facilities Program data for FY 2011 indicate that ...

290

Botulinum toxin and anal fissure: Efficacy and safety systematic review  

Microsoft Academic Search

Purpose  The main purpose of this study was to investigate the efficacy and safety of botulinum toxin in the treatment of anal fissure.\\u000a An answer was attempted to the following research questions: (i) what is the efficacy of botulinum toxin in healing of anal\\u000a fissure compared to placebo, (ii) what is the efficacy of botulinum toxin in healing of anal fissure

Eugenia Yiannakopoulou

291

Short and long-term exposure of CNS cell lines to BPA-f a radiosensitizer for boron neutron capture therapy: safety dose evaluation by a battery of cytotoxicity tests.  

PubMed

Despite the current clinical use of boronophenylalanine-fructose (BPA-f), as radiosensitizer, in BNCT application for brain tumors, still remains to be determined the safety dose of this agent. We evaluated the potential risk of primary BPA-f toxicity before neutronic irradiation at different concentrations (0-100?gBeq/ml) after short- and long-term exposure (4-48h and 7-10 days), using a battery of tests (i.e. MTT assay, calcein-AM/Propidium Iodide staining, clonogenic test) in CNS cell models (D384 and SH-SY5Y), and non-neuronal primary human fibroblasts (F26). MTT data showed: (i) no cytotoxic effects after short-term exposure (4h) to any of BPA-f concentrations tested in all cell models; (ii) dose- and time-dependent mitochondrial activity impairment in D384 and SH-SY5Y cells only (with 60% and 40% cell death in D384 and SH-SY5Y, respectively, after 48h exposure to BPA-f 100?gBeq/ml). By Calcein-AM/PI staining, BPA-f treatment was specific toward SH-SY5Y cells only: a dose-dependent cell density reduction was observed, with a more pronounced effect after 48h exposure (15-40% at doses ranging 20-100?gBeq/ml). Clonogenic data revealed dose-dependent decrease of cell proliferative capacity in all cell lines, still the SH-SY5Y cells were the most sensitive ones: the lowest dose (20?gBeq/ml) produced 90% cell decrease. These results indicate dose- and time-dependent cytotoxic effects of BPA-f, with CNS cells showing a lower tolerance compared to fibroblasts. Long-term exposure to BPA-f compromised the proliferative capacity regardless of cell model type (cell sensitivity being SH-SY5Y>D384>F26). In short-time exposure, BPA-f exhibits a safe dosage up to 40?gBeq/ml for the viability of CNS cell lines. PMID:23261588

De Simone, U; Manzo, L; Ferrari, C; Bakeine, J; Locatelli, C; Coccini, T

2012-12-21

292

Long-term compliance with a novel vitamin and mineral supplement in older people with PKU  

Microsoft Academic Search

Summary\\u000a Background:  The long-term efficacy of vitamin and mineral preparations in dietary-treated adult patients with phenylketonuria (PKU) is\\u000a unreported. Aim: In an open, intervention trial, the acceptability, safety and impact on biochemical and haematological micronutrient status\\u000a of a new vitamin and mineral tablet (Phlexy Vits, SHS International) was investigated.\\u000a \\u000a \\u000a \\u000a Methods:  Fifteen subjects with PKU (median age 21 years, range 8–33 years) on low-phenylalanine diet

A. MacDonald; P. Lee; P. Davies; A. Daly; M. Lilburn; H. Gokmen Ozel; M. A. Preece; C. Hendriksz; A. Chakrapani

2008-01-01

293

One year efficacy and safety of oral sildenafil treatment in severe pulmonary hypertension.  

PubMed

Severe pulmonary hypertension is a progressive disease which leads to limitations of functional status and poor survival. We evaluated efficacy and safety of a short (3 months) and a long term (12 months) sildenafil treatment in patients with severe pulmonary hypertension. We treated 12 patients with pulmonary hypertension with oral sildenafil. Patients were followed at three time points, at baseline, and after 3 and 12 months of treatment. Primary end point was improvement in functional exercise capacity assesed by 6-minute walk test, and secondary end points were changes in right ventricle hemodynamics. We found significant improvement in 6-minute walk test distance from 357 +/- 193 m at baseline to 431 +/- 179 m after three months and further improvement to 501 +/- 159 m after 12 months (p < 0.01); decrease in right ventricule pressure from 107 +/- 42 mmHg at baseline to 87 +/- 32 mmHg after 12 months (p < 0.01); and, decrease in right ventricule diameter from 3.2 +/- 1.1 cm to 2.76 +/- 0.86 cm after twelve months (p < 0.01). Drug-related adverse events were mild and transient in our group of patients. Long-term (12 months) sildenafil treatment is effective and safe in our patients with idiopathic and chronic thrombo-embolic pulmonary hypertension. PMID:19860106

Samarzija, Miroslav; Zuljevi?, Ervin; Jakopovi?, Marko; Sever, Branko; Knezevi?, Aleksandar; Dumija, Zeljko; Vidjak, Vinko; Samija, Mirko

2009-09-01

294

Long-Term Effects of Peace Workshops in Protracted Conflicts  

ERIC Educational Resources Information Center

|The current study evaluates the efficacy of an intensive four-day contact intervention (a peace workshop) organized in Sri Lanka and represents an initial step toward understanding the long-term impact of such interventions on attitudes and behaviors in the context of protracted ethnic conflict. Compared with two control groups, the participant…

Malhotra, Deepak; Liyanage, Sumanasiri

2005-01-01

295

High pressure rotating reverse osmosis for long term space missions  

Microsoft Academic Search

Rotating reverse osmosis, which uses reverse osmosis to purify water and rotating filtration to improve the efficacy of filtration, has great potential for wastewater recycling on a long term space mission. Previous investigations of a proof-of-concept device indicated that the most efficient method to improve rotating reverse osmosis performance is to increase the operational pressure. Thus, a second generation device

Cynthia Lynn Christensen Pederson

2005-01-01

296

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

297

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

SciTech Connect

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

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

2011-11-15

298

Long-term plutonium storage: Design concepts  

SciTech Connect

An important part of the Department of Energy (DOE) Weapons Complex Reconfiguration (WCR) Program is the development of facilities for long-term storage of plutonium. The WCR design goals are to provide storage for metals, oxides, pits, and fuel-grade plutonium, including material being held as part of the Strategic Reserve and excess material. Major activities associated with plutonium storage are sorting the plutonium inventory, material handling and storage support, shipping and receiving, and surveillance of material in storage for both safety evaluations and safeguards and security. A variety of methods for plutonium storage have been used, both within the DOE weapons complex and by external organizations. This paper discusses the advantages and disadvantages of proposed storage concepts based upon functional criteria. The concepts discussed include floor wells, vertical and horizontal sleeves, warehouse storage on vertical racks, and modular storage units. Issues/factors considered in determining a preferred design include operational efficiency, maintenance and repair, environmental impact, radiation and criticality safety, safeguards and security, heat removal, waste minimization, international inspection requirements, and construction and operational costs.

Wilkey, D.D.; Wood, W.T. [Los Alamos National Lab., NM (United States); Guenther, C.D. [Fluor Daniel, Inc., Irvine, CA (United States)

1994-08-01

299

Transuranic waste: long-term planning  

SciTech Connect

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

Young, K.C.

1985-07-01

300

Long-term control with etanercept (Enbrel) of a severe acrodermatitis continua of Hallopeau refractory to infliximab (Remicade).  

PubMed

Hallopeau's acrodermatitis is characterized by the presence of aseptic pustules on an inflammatory basis of the periungual or subungual region. The cyclic recurrences induce important physical and psychological morbidity. By analogy to the efficacy of TNF-alpha antagonists in the treatment of generalized pustular psoriasis, our patient illustrates the long-term efficacy and safety of etanercept (Enbrel) in the treatment of Hallopeau's acrodermatitis refractory to infliximab (Remicade). This treatment alternative should in consequence be considered in patients with a recalcitrant form of a potentially debilitating disease. PMID:18503258

Thielen, A-M; Barde, C; Marazza, G; Saurat, J-H

2008-05-26

301

A probabilistic quantitative risk assessment model for the long-term work zone crashes  

Microsoft Academic Search

Work zones especially long-term work zones increase traffic conflicts and cause safety problems. Proper casualty risk assessment for a work zone is of importance for both traffic safety engineers and travelers. This paper develops a novel probabilistic quantitative risk assessment (QRA) model to evaluate the casualty risk combining frequency and consequence of all accident scenarios triggered by long-term work zone

Qiang Meng; Jinxian Weng; Xiaobo Qu

2010-01-01

302

Omics Screening for Pharmaceutical Efficacy and Safety in Clinical Practice  

PubMed Central

As molecular techniques have improved, investigators have attempted to improve pharmaceutical efficacy and safety by making trait associations with genomic, epigenomic, transcriptomic, proteomic, and metabolomic polymorphisms. The ‘omics era has seen screening assays for pharmaceutical efficacy and safety translated into clinical practice. This manuscript will discuss each ‘omic field and the screening assays available to the clinician. While success has been demonstrated in each ‘omic field, many challenges remain. Assays need wider availability, predictive values remain low, and costs remain high. In order for clinicians to realize improved efficacy and safety due ‘omic screens, development of improved techniques, combining of ‘omic assays, and increased clinical utilization is necessary. This is an exciting time for investigators and clinicians that desire improved pharmaceutical therapy.

Monte, Andrew A.; Vasiliou, Vasilis; Heard, Kennon J.

2012-01-01

303

Multistage Optimization for Long-term Investors  

Microsoft Academic Search

Multi-stage simulation and optimization models are effective for solving long-term financial planning problems. Prominent examples include: asset-liability management for pension plans, integrated risk management for insurance companies, and long-term planning for individuals. Several applications will be briefly mentioned. A multi-stage framework provides advantages over single-period myopic approaches. First, the investor gains an understanding of the risks that a long-term goal

John M. Mulvey

304

LONG-TERM PLASTIC PIPE STIFFNESS  

Microsoft Academic Search

The parallel-plate loading mechanism (ASTM D2412 standard test method) was used for investigating the long-term pipe stiffness values of HDPE, PVC and ABS pipes. Both conventional and accelerated test procedures were used. The nominal inside diameters of the test pipes were 300 and 400mm. S-type long-term deflection curves were observed for the test plastic pipes on a semi-log scale. Long-term

Chiwan Wayne Hsieh; Chien-Chih Huang; Jau-Bih Wang

305

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

306

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

PubMed Central

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

Chue, Pierre

2007-01-01

307

Safety and efficacy of GABAergic medications for treating alcoholism.  

PubMed

This article highlights the proceedings of a symposium presented at the 27th Annual Scientific Meeting of the Research Society on Alcoholism in Vancouver, British Columbia, Canada, June 29, 2004. The organizers and co-chairs were Bankole A. Johnson, MD, PhD, and Robert M. Swift, MD, PhD. The presentations included (1) Introduction, by Bankole A. Johnson; (2) Safety, Tolerability, and Efficacy of gamma-Hydroxybutyric Acid and Baclofen in the Treatment of Alcohol Addiction, by Giovanni Addolorato; (3) Safety of Gabapentin in Treating Alcoholism, by Hugh Myrick; (4) New Data on the Safety and Effectiveness of Topiramate in the Treatment of Alcohol Dependence, by Bankole A. Johnson; (5) Evaluating the Risk of Benzodiazepine Prescription to Alcohol-Dependent Individuals, by Domenic A. Ciraulo; and (6) Safety and Efficacy of GABAergic Agents in Treating Alcoholics: Discussion, by Robert M. Swift. PMID:15714047

Johnson, Bankole A; Swift, Robert M; Addolorato, Giovanni; Ciraulo, Domenic A; Myrick, Hugh

2005-02-01

308

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

309

Financing long-term care in Canada.  

PubMed

Financial policies relating to long-term care in Canada are changing rapidly in response to demands for health care reform. This chapter focuses on the financial structure of institutional care, primarily nursing homes, in the western provinces of Alberta and British Columbia. Community-based long-term care is discussed briefly. PMID:10169492

Jacobs, P; Mills, C; Hollander, M

1997-06-01

310

Long-Term Results After Pancreas Transplantation  

Microsoft Academic Search

With the advances in technique and immunosupression, not only the short- but the long-term outcomes of pancreas transplantation have improved significantly. This retrospective study describes the long-term outcomes of simultaneous pancreas and kidney (SPK) transplants, pancreas after kidney (PAK), and pancreas transplants alone (PTA). An overall analysis was performed for all deceased donor (DD) primary pancreas transplants performed in the

D. E. R. Sutherland; A. C. Gruessner

2007-01-01

311

Long-term marriages: A critical review  

Microsoft Academic Search

Research guidelines are proposed for the study of long-term marriages based on a critical review of existing studies. Current problems in the collection and analysis of the data include the lack of agreement about the minimum length of a “long-term” relationship, the failure to make couple comparisons, or to follow samples longitudinally. In addition, the response rate is uniformly low

Michael J. Sporakowski; Leland V. Axelson

1984-01-01

312

Paying for Long-term Care  

Microsoft Academic Search

This Policy Brief aims to present information on the current picture of (public and private) expenditure on long-term care (LTC) for older people and discuss the challenges of financing care. It also reviews the rationale for public funding of long-term care needs, since the funding is currently relatively low in most European countries when compared to other social protection areas.

Ricardo Rodrigues; Andrea Schmidt

2010-01-01

313

Veterans Affairs Benefits (Long-Term Care)  

MedlinePLUS

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

314

Real World Pricing of Long Term Contracts  

Microsoft Academic Search

Long dated contingent claims are relevant in insurance, pension fund management and derivative pricing. This paper proposes a paradigm shift in the valuation of long term contracts, away from classical no-arbitrage pricing towards pricing under the real world probability measure. In contrast to risk neutral pricing, the long term excess return of the equity market, known as the equity premium,

Eckhard Platen

2009-01-01

315

Virtual Models of Long-Term Care  

ERIC Educational Resources Information Center

|Nursing homes, assisted living facilities and home-care organizations, use web sites to describe their services to potential consumers. This virtual ethnographic study developed models representing how potential consumers may understand this information using data from web sites of 69 long-term-care providers. The content of long-term-care web…

Phenice, Lillian A.; Griffore, Robert J.

2012-01-01

316

LONG-TERM MONITORING SENSOR NETWORK  

Microsoft Academic Search

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

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

2003-01-01

317

Reporting of long-term extension studies: lack of consistency calls for consensus.  

PubMed

Double-blind, randomised controlled studies represent the gold-standard approach to determine the safety and efficacy of therapeutic interventions. In chronic conditions such as rheumatoid arthritis (RA), long-term data are vital to confirm maintenance of effect and identify potential safety signals. The recent introduction of numerous biological therapies for RA has been followed by various long-term extension (LTE) studies. Although useful, the design and method of analysis in such studies vary significantly, partly due to their complexity. This viewpoint highlights general considerations needed when undertaking a LTE study and illustrates the lack of consistency in studies of RA to date. It addresses issues of selection bias, patient discontinuation and missing data. Although used for safety reporting, the lack of adequate powering makes LTE studies of limited benefit. Ethical considerations and challenges are highlighted, including potential conflicts of interest. Finally, the authors suggest the need for consensus to ensure more reliable interpretation and application of data for clinical practice. Following the development of guidelines on reporting of clinical trials in RA and more recently, registry data, a similar approach for LTE studies would be a useful endeavour. PMID:21378403

Buch, Maya H; Aletaha, Daniel; Emery, Paul; Smolen, Josef S

2011-03-06

318

Paying for long-term care.  

PubMed Central

Everyone agrees that insurance for long-term care is inadequate in the United States. Disagreement exists, however, on whether such insurance should be provided through the private or public sector. Private insurance generally uses the experience-rating principle that persons with higher risk of illness are charged higher premiums. For private insurance for long-term care, this principle creates a dilemma. Most policies will be purchased by the elderly; yet, because the elderly have a high risk of needing long-term care, only about 20% of them can afford the cost of premiums. A public-private partnership by which the government partially subsidizes private long-term-care insurance is unlikely to resolve this dilemma. Only a social insurance program for long-term care can provide universal, affordable, and equitable coverage.

Estes, C L; Bodenheimer, T

1994-01-01

319

The clinical efficacy and safety of a fluoroquinolone-containing regimen for pulmonary MAC disease.  

PubMed

Despite recent advances in chemotherapy, the treatment of pulmonary Mycobacterium avium complex (MAC) disease remains unsatisfactory. Judging from its MIC, fluoroquinolones including gatifloxacin (GFLX) are expected to demonstrate efficacy against MAC disease. However, there have been few clinical studies using fluoroquinolones. Therefore, a prospective study to evaluate the clinical efficacy and safety of a fluoroquinolone-containing regimen for the treatment of pulmonary MAC disease was conducted. In this trial, patients with pulmonary MAC disease received protocol-guided combined chemotherapy with rifampin (RFP) and ethambutol (EB) plus either GFLX or clarithromycin (CAM). Adult patients who fulfilled the criteria of the ATS definition of pulmonary MAC disease were enrolled in this study. The patients provided their informed consent, and treatments were administered for 1 year. Of 27 patients enrolled from three facilities, 14 patients were treated with the CAM-containing regimen and 13 patients were treated with the GFLX-containing regime. Four patients did not complete the 1-year treatment because of adverse events. Nine patients (64.3%) in the CAM group and 11 patients (84.6%) in the GFLX group achieved eradication of pathogens. Adverse events were observed more frequently in the GFLX group than in the CAM group. However, there were no severe adverse events in either group. The long-term results showed a similar relapse rate between the CAM and GFLX groups. The fluoroquinolone-containing regimen demonstrated both high efficacy and relative safety for pulmonary MAC disease that was similar to that of the CAM-containing regimen, which is considered to be the standard regimen. PMID:21927844

Fujita, Masaki; Kajiki, Akira; Tao, Yoshiaki; Miyazaki, Masayuki; Ouchi, Hiroshi; Harada, Eiji; Ikegame, Satoshi; Matsumoto, Takemasa; Uchino, Junji; Watanabe, Kentaro; Nakanishi, Yoichi

2011-09-17

320

Sildenafil: Efficacy and Safety in Daily Clinical Experience  

Microsoft Academic Search

Objectives: Sildenafil citrate (Viagra™) is a potent selective inhibitor of phosphodiesterase type 5 proposed for the oral treatment of erectile dysfunction (ED). The aim of this study was to evaluate its efficacy and safety when used in daily practice in patients with ED of various aetiology.Patients and Methods: From September 1998 to April 1999, 380 patients chose sildenafil as treatment

Fabrizio Palumbo; Carlo Bettocchi; Francesco P. Selvaggi; John P. Pryor; David J. Ralph

2001-01-01

321

Safety and efficacy of prehospital diltiazem.  

PubMed

Introduction: Very few studies exist on the use of diltiazem in the prehospital setting. Some practitioners believe this medication is prone to causing hypotension in this setting. Our goals were to determine whether the prehospital administration of diltiazem induced hypotension and to evaluate the efficacy of the drug. Methods: Our two-tiered system is located in a suburban region of New Jersey with advanced life support (ALS) care provided by fly-car units. The ALS units do not transport patients, and all of them are hospital based. The ALS providers are employed by the hospital system. In New Jersey, all ALS care requires online medical control, including the administration of diltiazem. We retrospectively reviewed patient care records for those who were believed to be in rapid atrial fibrillation and were given diltiazem in a suburban emergeny medical services system over a 22-month period. We examined the differences between heart rate (HR) and blood pressure (BP) on the initial evaluation and on arrival to the emergency department (ED). A hypotensive response was defined as a final systolic BP (SBP) less than 90 mmHg and a drop in SBP of at least 10 mmHg. Diltiazem was considered effective if the ED HR was <100 beats per minute (bpm) or if it decreased ?20%. Results: During the study period, 26,979 patients were transported. Of these patients, 2,488 had a documented rhythm of atrial fibrillation or atrial flutter. Of the 320 patients who received diltiazem, 42 patient encounters were excluded for incomplete data, yielding 278 patients for analysis. The average initial SBP was 139 mmHg and the average diastolic BP was 84 mmHg. The average diltiazem dosage was 16.7 mg. Two patients became hypotensive. The average initial HR was 154 bpm. On arrival to the ED, 33% of the patients had an HR < 100 bpm and 69% had a drop in HR ? 20%. The overall efficacy of prehospital diltiazem was 73%. Conclusion: In the prehospital setting, diltiazem is associated with a very low rate of hypotension and appears to be effective in decreasing HR adequately. Prospective studies are needed to confirm these findings. PMID:23687551

Luk, Jeffrey H; Walsh, Brian; Yasbin, Paul

2013-05-01

322

Safety and Efficacy of Prehospital Diltiazem  

PubMed Central

Introduction: Very few studies exist on the use of diltiazem in the prehospital setting. Some practitioners believe this medication is prone to causing hypotension in this setting. Our goals were to determine whether the prehospital administration of diltiazem induced hypotension and to evaluate the efficacy of the drug. Methods: Our two-tiered system is located in a suburban region of New Jersey with advanced life support (ALS) care provided by fly-car units. The ALS units do not transport patients, and all of them are hospital based. The ALS providers are employed by the hospital system. In New Jersey, all ALS care requires online medical control, including the administration of diltiazem. We retrospectively reviewed patient care records for those who were believed to be in rapid atrial fibrillation and were given diltiazem in a suburban emergeny medical services system over a 22-month period. We examined the differences between heart rate (HR) and blood pressure (BP) on the initial evaluation and on arrival to the emergency department (ED). A hypotensive response was defined as a final systolic BP (SBP) less than 90 mmHg and a drop in SBP of at least 10 mmHg. Diltiazem was considered effective if the ED HR was <100 beats per minute (bpm) or if it decreased ?20%. Results: During the study period, 26,979 patients were transported. Of these patients, 2,488 had a documented rhythm of atrial fibrillation or atrial flutter. Of the 320 patients who received diltiazem, 42 patient encounters were excluded for incomplete data, yielding 278 patients for analysis. The average initial SBP was 139 mmHg and the average diastolic BP was 84 mmHg. The average diltiazem dosage was 16.7 mg. Two patients became hypotensive. The average initial HR was 154 bpm. On arrival to the ED, 33% of the patients had an HR < 100 bpm and 69% had a drop in HR ? 20%. The overall efficacy of prehospital diltiazem was 73%. Conclusion: In the prehospital setting, diltiazem is associated with a very low rate of hypotension and appears to be effective in decreasing HR adequately. Prospective studies are needed to confirm these findings.

Luk, Jeffrey H.; Walsh, Brian; Yasbin, Paul

2013-01-01

323

Safety and efficacy of high-purity concentrates in haemophiliac patients undergoing surgery by continuous infusion.  

PubMed

In this study we explore the feasibility of high-purity double-inactivated concentrates by continuous infusion for the treatment of haemophiliacs in a group of patients undergoing different surgical procedures. The patients were enrolled in the study on the basis of their transfusion history, which was well known due to their long-term follow up at our Haemophilia Center. We did not perform a pre-operative pharmacokinetic study because one of the aims of this study was to demonstrate that continuous infusion can become a first choice standard treatment in patients with haemophilia. Fourteen haemophilia A and one haemophilia B patients who needed at least 5 days of replacement therapy were monitored for haemostatic efficacy, post-operative factor VIII and factor IX levels and evaluated for safety and flexibility of the products. The infusion rate of 3 IU kg-1 h-1 was demonstrated to be sufficient to ensure haemostasis and patients did not need additional bolus infusion during the post-operative period. Our study demonstrates the safety and feasibility of high-purity concentrates in patients undergoing surgery by continuous infusion, also in the absence of a previous pharmacokinetic study. PMID:10583530

Tagariello, G; Davoli, P G; Gajo, G B; De Biasi, E; Risato, R; Baggio, R; Traldi, A

1999-11-01

324

Postsynaptic contribution to long-term potentiation revealed by the analysis of miniature synaptic currents  

Microsoft Academic Search

Miniature excitatory synaptic currents were recorded from CA1 pyramidal cells in hippocampal slices to study the site of the persistent change in synaptic efficacy during long-term potentiation. Induction of long-term potentiation produced a large increase in the amplitude of these currents. Such a change in amplitude suggests an increase in postsynaptic transmitter sensitivity.

Toshiya Manabe; Pius Renner; Roger A. Nicoll

1992-01-01

325

Antipsychotic agents: efficacy and safety in schizophrenia  

PubMed Central

Antipsychotics have provided a great improvement in the management of people with schizophrenia. The first generation antipsychotics could establish the possibility of managing many psychotic subjects in an outpatient setting. With the advent of the second (SGA) and third generation antipsychotics (TGA), other psychiatric disorders such as bipolar depression, bipolar mania, autism, and major depressive disorder have now been approved for the use of these drugs for their treatment. Also, the administration of more specific assessment tools has allowed for better delineation of the repercussions of these drugs on symptoms and the quality of life of patients who use antipsychotic agents. In general, the SGA share similar mechanisms of action to achieve these results: dopamine-2 receptor antagonism plus serotonin-2A receptor antagonism. The TGA (eg, aripiprazole) have partial agonist activity at the dopamine-2 receptor site, and are also called dopaminergic stabilizers. The pharmacological profile of SGA and TGA may provide better efficacy against negative symptoms, and are less likely to produce extrapyramidal symptoms; however, the SGA and TGA are associated with many other adverse events. The clinician has to balance the risks and benefits of these medications when choosing an antipsychotic for an individual patient.

de Araujo, Arao Nogueira; de Sena, Eduardo Ponde; de Oliveira, Irismar Reis; Juruena, Mario F

2012-01-01

326

Angiotensin receptor blockers: pharmacology, efficacy, and safety.  

PubMed

KEY POINTS AND PRACTICAL RECOMMENDATIONS: •? The angiotensin receptor blockers are highly effective antihypertensive agents that are also particularly well tolerated. •? There are no major differences in efficacy or other clinical characteristics among older drugs in this class, although some of the newer agents may more effectively reduce blood pressure than older agents. •? Major randomized clinical trials have demonstrated that angiotensin receptor blockers provide significant outcomes benefits in conditions such as diabetic nephropathy, chronic heart failure or heart failure following myocardial infarction, hypertension with left ventricular hypertrophy and in patients whose histories of previous events or complicated diabetes puts them at high cardiovascular risk. •? In treating hypertension, angiotensin receptor blockers can be used as first-line therapy or added at later stages of treatment titration. •? These drugs are very effective in combination with thiazide diuretics or calcium channel blockers and there are several single-pill, fixed-dose combinations of angiotensin receptor blockers with hydrochlorothiazide, amlodipine, or aliskiren. These combinations can be given as initial therapy (where appropriate) or later in the course of treatment. Three-drug combinations (angiotensin receptor blocker plus amlodipine plus hydrochlorothiazide and angiotensin receptor blocker plus aliskiren plus hydrochlorothiazide) are also available. PMID:21896150

Taylor, Addison A; Siragy, Helmy; Nesbitt, Shawna

2011-07-27

327

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.

Martin, Jennifer L.; Ancoli-Israel, Sonia

2008-01-01

328

Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study.  

PubMed

In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ?2.0 mg/kg/day (?80 mg/day). Of 306 eligible patients from OV-1002 or OV-1012, 267 entered the open-label extension. As of the interim date, July 1, 2010, 213 patients (79.8%) had remained in the trial, and 189 had received clobazam for ?12 months, 128 for ?18 months, and 94 for ?24 months. Median percentage decreases in average weekly rates of drop seizures were 71.1% and 91.6% at Months 3 and 24. Mean modal and mean maximum daily dosages were 0.94 mg/kg and 1.22 mg/kg for those who had received clobazam for ?1 year. The 4 most common adverse events were upper respiratory tract infection (18.4%), fall (14.2%), pneumonia (13.9%), and somnolence (12.7%). Clobazam's adverse event profile was consistent with its profile in controlled trials. PMID:23141144

Ng, Yu-Tze; Conry, Joan; Paolicchi, Juliann; Kernitsky, Lydia; Mitchell, Wendy; Drummond, Rebecca; Isojarvi, Jouko; Lee, Deborah; Owen, Randall

2012-11-07

329

Long-term efficacy and safety of efavirenz dose reduction to 200 mg once daily in a Caucasian patient with HIV.  

PubMed

A 48-year-old Caucasian male patient presented with severe adverse drug events (ADEs) while being treated with a standard dose (600 mg/day) of efavirenz. The patient's clinical course was favourable; however, he also described intense nightmares, cramps in his legs and anxiety disturbances that made him highly irritable. Measurement of the patient's efavirenz plasma concentrations revealed a mean minimum steady-state concentration during a dosage interval (C(min,ss)) of 12.7 mg/L, which was much higher than that recommended for this drug (therapeutic range 1-4 mg/L). Consequently, the dose of efavirenz was reduced to 400 mg/day, which resulted in a decrease in the frequency of ADEs. Subsequent genotype testing showed that the patient was homozygous for both the CYP2B6-G516T (T/T) and CYP2B6-A785G (G/G) alleles; these polymorphisms are associated with reduced enzymatic activity and elevated efavirenz plasma concentrations. Because of this and the fact that the patient's mean efavirenz C(min,ss) was still high (4.6 mg/L), a second dosage reduction was undertaken, to 200 mg/day. This also resulted in a reduction in ADEs. At present, the patient's CD4+ levels remain stable, his viral load continues to be undetectable and the mean efavirenz C(min,ss) is within the therapeutic range (2.7 mg/L). PMID:20441246

Cabrera Figueroa, Salvador; Iglesias Gómez, Alicia; Sánchez Martín, Almudena; de la Paz Valverde Merino, María; Domínguez-Gil Hurlé, Alfonso; Cordero Sánchez, Miguel

2010-01-01

330

Efficacy and safety of right and left atrial ablations on the beating heart with irrigated bipolar radiofrequency energy: A long-term animal study  

Microsoft Academic Search

Objective: The Cox maze procedure is the most effective surgical treatment for atrial fibrillation; however, its complexity has limited its clinical utility. The purpose of this study was to simplify the procedure by using an irrigated bipolar radiofrequency ablation device on the beating heart without cardiopulmonary bypass. Methods: Six domestic pigs underwent median sternotomy. The pulmonary veins were circumferentially ablated.

Spencer J. Melby; Sydney L. Gaynor; Jordon G. Lubahn; Anson M. Lee; Paymon Rahgozar; Shelton D. Caruthers; Todd A. Williams; Richard B. Schuessler; Ralph J. Damiano Jr

2006-01-01

331

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

ERIC Educational Resources Information Center

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

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

2008-01-01

332

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

2013-08-16

333

The Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Completed the Phase I Clinical Trial of Neurostem®-AD  

ClinicalTrials.gov

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Delirium, Dementia, Amnestic, Cognitive Disorders; Mental Disorders

2012-09-27

334

Safety and Efficacy of Shilajit (Mumie, Moomiyo).  

PubMed

Shilajit (mumie; moomiyo, mummiyo) has been used for a wide variety of illnesses and conditions for many years. However, relatively few well-controlled human studies have been conducted on the effects of shiliajit, although a growing number of studies have been published in recent years involving animal and in vitro systems. The safety of shilajit is well documented based on animal and human studies. Various research studies indicate that shilajit exhibits antioxidant, anti-inflammatory, adaptogenic, immunomodulatory, and anti-dyslipidemic properties. Animal and human studies indicate that shilajit enhances spermatogenesis. Furthermore, animal and human data support its use as a 'revitalizer', enhancing physical performance and relieving fatigue with enhanced production of ATP. Key constituents in shilajit responsible for these effects appear to be dibenzo-?-pyrones and fulvic acid and their derivatives. Various mechanistic studies provide support for the above observed effects. Additional well-controlled human and animal studies involving the use of standardized products are needed. Copyright © 2013 John Wiley & Sons, Ltd. PMID:23733436

Stohs, Sidney J

2013-06-01

335

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.

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

336

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

PubMed

This long-term extension of an 8-week randomized, naturalistic study in patients with panic disorder with or without agoraphobia compared the efficacy and safety of clonazepam (n = 47) and paroxetine (n = 37) over a 3-year total treatment duration. Target doses for all patients were 2 mg/d clonazepam and 40 mg/d paroxetine (both taken at bedtime). This study reports data from the long-term period (34 months), following the initial 8-week treatment phase. Thus, total treatment duration was 36 months. Patients with a good primary outcome during acute treatment continued monotherapy with clonazepam or paroxetine, but patients with partial primary treatment success were switched to the combination therapy. At initiation of the long-term study, the mean doses of clonazepam and paroxetine were 1.9 (SD, 0.30) and 38.4 (SD, 3.74) mg/d, respectively. These doses were maintained until month 36 (clonazepam 1.9 [SD, 0.29] mg/d and paroxetine 38.2 [SD, 3.87] mg/d). Long-term treatment with clonazepam led to a small but significantly better Clinical Global Impression (CGI)-Improvement rating than treatment with paroxetine (mean difference: CGI-Severity scale -3.48 vs -3.24, respectively, P = 0.02; CGI-Improvement scale 1.06 vs 1.11, respectively, P = 0.04). Both treatments similarly reduced the number of panic attacks and severity of anxiety. Patients treated with clonazepam had significantly fewer adverse events than those treated with paroxetine (28.9% vs 70.6%, P < 0.001). The efficacy of clonazepam and paroxetine for the treatment of panic disorder was maintained over the long-term course. There was a significant advantage with clonazepam over paroxetine with respect to the frequency and nature of adverse events. PMID:22198456

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

2012-02-01

337

Long Term Dissolution Testing of Mine Waste.  

National Technical Information Service (NTIS)

This document reports the results of long term laboratory studies to examine the dissolution of abandoned mine wastes and the consequent drainage quality. The objectives of the study were to provide a description of longer term dissolution of mine wastes,...

K. Lapakko J. Wessels D. Antonson

1995-01-01

338

The Long Term Care Questionnaire and Report.  

National Technical Information Service (NTIS)

The purpose of this report is to describe an experimental data gathering activity designed to provide information on the utilization of long-term care facilities in western South Dakota. The report describes Western Health Systems, the organization doing ...

D. O. Mueller

1974-01-01

339

Long-Term Corrosion Testing Plan.  

National Technical Information Service (NTIS)

This document describes the testing and facility requirements to support the Yucca Mountain Project long-term corrosion testing program. The purpose of this document is to describe a corrosion testing program that will (a) reduce model uncertainty and var...

F. D. Wall N. R. Brown

2009-01-01

340

Modeling long-term collider performance.  

National Technical Information Service (NTIS)

A model for the SSC arcs is described with multipole lattice field errors agglomerated into 32 lattice points, and with first order lattice errors and modulation provided by discrete transfer elements. Numerical solutions for long term dynamic aperture st...

D. Ritson

1991-01-01

341

Long Term Effects of Food Poisoning  

MedlinePLUS

... develop chronic arthritis. Brain and nerve damage A Listeria infection can lead to meningitis, an inflammation of ... brain. If a newborn infant is infected with Listeria , long-term consequences may include mental retardation, seizures, ...

342

Efficacy, safety, and patient acceptability of the Essure™ procedure.  

PubMed

The Essure™ system for permanent contraception was developed as a less invasive method of female sterilization. Placement of the Essure™ coil involves a hysteroscopic transcervical technique. This procedure can be done in a variety of settings and with a range of anesthetic options. More than eight years have passed since the US Food and Drug Administration approval of Essure™. Much research has been done to evaluate placement success, adverse outcomes, satisfaction, pain, and the contraceptive efficacy of the Essure™. The purpose of this review is to summarize the available literature regarding the efficacy, safety, and patient satisfaction with this new sterilization technique. PMID:21573052

Lessard, Collette R; Hopkins, Matthew R

2011-04-28

343

Clinical efficacy and safety of statins in managing cardiovascular risk  

PubMed Central

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

Kapur, Navin K; Musunuru, Kiran

2008-01-01

344

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.

2011-01-01

345

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

346

Long-term results of endonasal dacryocystorhinostomy  

Microsoft Academic Search

The aim of this study is to review the long-term results of endonasal endoscopic dacryocystorhinostomy (DCR) according to\\u000a our experience as well as to evaluate potential prognostic factors for long-term outcomes. The files of 165 patients who underwent\\u000a endonasal DCR at a tertiary referral centre between 1991 and 2001 were retrospectively assessed. Furthermore, these cases\\u000a were clinically evaluated at least

Johannes Zenk; Alexander D. Karatzanis; George Psychogios; Katrin Franzke; Michael Koch; Joachim Hornung; George A. Velegrakis; Heinrich Iro

2009-01-01

347

Long-term preservation of anammox bacteria  

Microsoft Academic Search

Deposit of useful microorganisms in culture collections requires long-term preservation and successful reactivation techniques.\\u000a The goal of this study was to develop a simple preservation protocol for the long-term storage and reactivation of the anammox\\u000a biomass. To achieve this, anammox biomass was frozen or lyophilized at two different freezing temperatures (?60°C and in liquid\\u000a nitrogen (?200°C)) in skim milk media

Michael J. Rothrock Jr; Matias B. Vanotti; Ariel A. Szögi; Maria Cruz Garcia Gonzalez; Takao Fujii

348

Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study  

Microsoft Academic Search

BACKGROUND: Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ? 65 years; n = 101) who participated in a large, multinational, open-label study. METHODS: Patients meeting DSM-IV criteria for MDD received

Madelaine M Wohlreich; Craig H Mallinckrodt; John G Watkin; Donald P Hay

2004-01-01

349

Intracavernous Alprostadil Alfadex—an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study  

Microsoft Academic Search

Long-term efficacy and safety of Alprostadil-Alfadex (EDEXR\\/VIRIDALR) in intracavernous self-injection therapy for chronical erectile failure was investigated in a four year running multicenter European trial. Of the 16 886 protocolled injections 93% (15 713) resulted in rigid erections followed by successful sexual intercourse. Reported side effects by patients were prolonged erections >6 h only occurring during the first year in

H Porst; J Buvat; E Meuleman; V Michal; G Wagner

1998-01-01

350

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

Microsoft Academic Search

ObjectiveThe 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.

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

2005-01-01

351

Evaluation of Adverse Reactions in Hemophiliacs from Long-Term Exposure to Blood and Blood Products.  

National Technical Information Service (NTIS)

This study assesses current therapeutic efficacy and adverse reactions in hemophiliacs. Approximately 50 percent of hemophiliacs showed long term (greater than 6 months) abnormalities of liver function. A significant increase in diastolic blood pressure w...

S. S. Shapiro

1976-01-01

352

Retrolective, Comparative, Epidemiological Cohort Study with Parallel Groups Design for Evaluation of Efficacyand Safety of Drugs with ‘Well-Established Use’ Experience with the Long-Term Treatment Using the European Mistletoe Extract (Viscum album L.) in Addition to Conventional Oncological Therapy in Primary, Non-Metastatic Breast Carcinoma  

Microsoft Academic Search

SummaryThe randomized controlled clinical trial (RCT) is accepted as the ‘golden standard’ for the evaluation of efficacy and safety of new drugs. In contrast, to demonstrate efficacy and safety of drugs with ‘well-established use’ that have been on the European Community market for long time, observational comparative epidemiological studies can be used according to the European drug regulation directive. However,

P. R. Bock; W. E. Friedel; J. Hanisch; M. Karasmann; B. Schneider

2004-01-01

353

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

354

Long-term surveillance plan for the Mexican Hat disposal site Mexican Hat, 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 Mexican Hat, Utah, disposal site. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Mexican Hat 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

1997-06-01

355

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

356

Behavioural stress facilitates the induction of long-term depression in the hippocampus  

Microsoft Academic Search

The induction of activity-dependent persistent increases in synap-tic efficacy, such as long-term potentiation (LTP), is inhibited by behavioural stress1,2. The question arises whether stress also affects the ability to induce persistent decreases in synaptic efficacy, such as long-term depression (LTD)3-5. We now report that the induction of stable homosynaptic LTD in the CA1 area of the hippocampus of awake adult

Lin Xu; Roger Anwyl; Michael J. Rowan

1997-01-01

357

The Efficacy and Safety of Irbesartan in Treating Essential Hypertension  

Microsoft Academic Search

Background:Irbersatan, an orally active antihypertensive agent, effectively reduce blood pressure by di- rectly blocking angiotensin ? receptors without any significant adverse effects. The purpose of this study is to evaluate the efficacy and safety of irbesartan in patients with mild to moderate hypertension. Methods: This study enrolled 83 patients who had diastolic pressure above 95 mmHg and below 110 mmHg

Cheol Eom; Joon-Han Shin; Han-Soo Kim; Seung-Jae Tahk; Jong-Hoon Koh; Byung-il William Choi; Eui-Soo Hong; Jeong-Kee Seo; Jun Kwan; Keum-Soo Park; Woo-Hyung Lee

358

Efficacy and safety of Cerebrolysin in patients with hemorrhagic stroke  

PubMed Central

The purpose of the study was to investigate the efficacy and safety of Cerebrolysin in patients with hemorrhagic stroke. The primary objective of this trial was to assess the clinical efficacy and safety of a 10–days course of therapy with a daily administration of Cerebrolysin (50 mL ? per day). The trial had to demonstrate that Cerebrolysin treatment is safe in hemorrhagic stroke. Methods: The study was performed as a prospective, randomized, double blind, placebo–controlled, parallel group study with 2 treatment groups. Efficacy measures were the Unified Neurological Stroke Scale, Barthel Index, and Syndrome Short Test. The duration of the trial was of 21 days for each patient. Out of 100 randomized patients, a total of 96 (96%) completed the study. Results: Overall, no statistically significant group effects were observed based on single average comparisons at the individual visits. It could be shown that the treatment of hemorrhagic stroke with Cerebrolysin is safe and well tolerated. Conclusion: In the changes of UNSS, BI and SST from baseline to day 21, the group differences are not statistically significant; however, the use of Cerebrolysin in hemorrhagic stroke is safe and well tolerated and studies with a larger sample size may provide statistical evidence of Cerebrolysin's efficacy in patients with hemorrhagic stroke.

Tiu, C; Moessler, H; Antochi, F; Muresanu, D; Popescu, BO; Novak, P

2010-01-01

359

Ibogaine: complex pharmacokinetics, concerns for safety, and preliminary efficacy measures.  

PubMed

Ibogaine is an indole alkaloid found in the roots of Tabernanthe Iboga (Apocynaceae family), a rain forest shrub that is native to western Africa. Ibogaine is used by indigenous peoples in low doses to combat fatigue, hunger and thirst, and in higher doses as a sacrament in religious rituals. Members of American and European addict self-help groups have claimed that ibogaine promotes long-term drug abstinence from addictive substances, including psychostimulants and opiates. Anecdotal reports attest that a single dose of ibogaine eliminates opiate withdrawal symptoms and reduces drug craving for extended periods of time. The purported efficacy of ibogaine for the treatment of drug dependence may be due in part to an active metabolite. The majority of ibogaine biotransformation proceeds via CYP2D6, including the O-demethylation of ibogaine to 12-hydroxyibogamine (noribogaine). Blood concentration-time effect profiles of ibogaine and noribogaine obtained for individual subjects after single oral dose administrations demonstrate complex pharmacokinetic profiles. Ibogaine has shown preliminary efficacy for opiate detoxification and for short-term stabilization of drug-dependent persons as they prepare to enter substance abuse treatment. We report here that ibogaine significantly decreased craving for cocaine and heroin during inpatient detoxification. Self-reports of depressive symptoms were also significantly lower after ibogaine treatment and at 30 days after program discharge. Because ibogaine is cleared rapidly from the blood, the beneficial aftereffects of the drug on craving and depressed mood may be related to the effects of noribogaine on the central nervous system. PMID:11085338

Mash, D C; Kovera, C A; Pablo, J; Tyndale, R F; Ervin, F D; Williams, I C; Singleton, E G; Mayor, M

2000-09-01

360

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

361

Long-term outcomes of robotic-assisted laparoscopic sacrocolpopexy with a minimum of three years follow-up  

Microsoft Academic Search

We describe efficacy and safety of robotic-assisted laparoscopic vaginal vault prolapse repair with long-term follow-up. We\\u000a reviewed the records of 40 consecutive patients with posthysterectomy vaginal vault prolapse who underwent a robotic-assisted\\u000a laparoscopic sacrocolpopexy at our institution between September 2002 and September 2006. Patient analysis focused on complications,\\u000a patient satisfaction, and morbidity, with a minimum of 36 months’ follow-up. Median follow-up

Mark S. Shimko; Eric C. Umbreit; George K. Chow; Daniel S. Elliott

362

Balancing the Efficacy and Safety of Vaccines in the Elderly.  

PubMed

With advances in global health care, ageing populations are expected to grow worldwide throughout the 21(st) century. Increased lifespan is a testament to modern medical and social practices, but also presents a growing challenge to a system with limited resources. Elderly populations present specific concerns related to preventative health practices, especially vaccination. Although the power of vaccination is unquestionable in controlling infectious disease, immunosenescence can lead to reduced immune responses following immunization in the elderly, and increased morbidity and mortality. Further complicating this issue, some vaccines themselves may pose a substantial safety risk in the elderly when compared to younger counterparts. Though any health care intervention must balance risk and reward, safety and immunogenicity are often poorly characterized in older populations. This review explores several domestic and travel vaccines, examining what is known concerning efficacy and safety in the elderly, and considers future alternatives. PMID:23565132

Amanna, Ian J

2012-06-29

363

Relationship between short- and long-term memory and short- and long-term extinction  

Microsoft Academic Search

Both the acquisition and the extinction of memories leave short- and long-term mnemonic traces. Here, we show that in male Wistar rats, the short-term memory for a step-down inhibitory avoidance task (IA) is resistant to extinction, and that its expression does not influence retrieval or extinction of long-term memory. It has been known for some time that short- and long-term

Martín Cammarota; Lia R. M. Bevilaqua; Janine I. Rossato; Maria Ramirez; Jorge H. Medina; Iván Izquierdo

2005-01-01

364

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

365

Efficacy and safety of tiotropium Respimat® SMI in COPD in two 1-year randomized studies  

PubMed Central

Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 ?g versus placebo, inhaled via the Respimat® Soft Mist™ Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV1 response, Mahler Transition Dyspnea Index [TDI] and St George’s Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV1: 1.09 L). The mean trough FEV1 response of tiotropium 5 or 10 ?g relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 ?g (RR = 0.78; P = 0.002) and tiotropium 10 ?g (RR = 0.73; P = 0.0008); the health-related quality of life and Mahler TDI co-primary endpoints were significantly improved with both doses (both P < 0.0001). Adverse events were generally balanced except anticholinergic class effects, which were more frequent with active treatment. Fatal events occurred in 2.4% (5 ?g), 2.7% (10 ?g), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat® SMI 5 ?g demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 ?g dose but with a lower frequency of anticholinergic adverse events.

Bateman, Eric; Singh, Dave; Smith, David; Disse, Bernd; Towse, Lesley; Massey, Dan; Blatchford, Jon; Pavia, Demetri; Hodder, Rick

2010-01-01

366

Efficacy, safety, acceptability and affordability of cryotherapy: a review of current literature.  

PubMed

As a result of widespread screening and treatment programs, the incidence of cervical cancer has decreased by as much as 75% in the developed world. Commonly used treatment modalities for precancerous lesions include cone biopsy, the Loop Electrosurgical Excision Procedure (LEEP), laser ablation and cryotherapy. In recent years LEEP has replaced cryotherapy as a commonly provided outpatient procedure in many places; however increased awareness of the burden of cervical cancer in the developing world and increased awareness of long term consequences of LEEP ? such as cervical insufficiency ? have renewed interest in cryotherapy. We reviewed current literature addressing the technique, efficacy, safety and acceptability of cryotherapy, as well as special topics such as cost effectiveness, HIV, and low resource settings. Among studies we reviewed, cure rates ranged from 56.8-96.6% among prospective controlled trials and from 70-95.5% among observational studies. Cryotherapy has very low complication rates and serious complications requiring medical intervention or affecting future reproductive outcomes are extremely rare. Side effects including vaginal discharge and cramping are temporary, generally self-limited, and well tolerated after anticipatory patient counseling. When surveyed, women find cryotherapy highly acceptable. Compared to other treatment modalities, cryotherapy is very affordable and feasible to integrate into cervical cancer screening and treatment programs. PMID:22481625

McClung, E C; Blumenthal, P D

2012-04-01

367

Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia.  

PubMed

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are highly prevalent in older men. Medical therapy is the first-line treatment for LUTS associated with BPH. Mainstays in the treatment of male LUTS and clinical BPH are the ?(1)-adrenergic receptor antagonists. Silodosin is a new ?(1)-adrenergic receptor antagonist that is selective for the ?(1A)-adrenergic receptor. By antagonizing ?(1A)-adrenergic receptors in the prostate and urethra, silodosin causes smooth muscle relaxation in the lower urinary tract. Since silodosin has greater affinity for the ?(1A)-adrenergic receptor than for the ?(1B)-adrenergic receptor, it minimizes the propensity for blood pressure-related adverse effects caused by ?(1B)-adrenergic receptor blockade. In the clinical studies, patients receiving silodosin at a total daily dose of 8 mg exhibited significant improvements in the International Prostate Symptom Score and maximum urinary flow rate compared with those receiving placebo. Silodosin showed early onset of efficacy for both voiding and storage symptoms. Furthermore, long-term safety of silodosin was also demonstrated. Retrograde or abnormal ejaculation was the most commonly reported adverse effect. The incidence of orthostatic hypotension was low. In conclusion, silodosin, a novel selective ?(1A)-adrenergic receptor antagonist, was effective in general and without obtrusive side effects. This review provides clear evidence in support of the clinical usefulness of silodosin in the treatment of LUTS associated with BPH. PMID:21753871

Yoshida, Masaki; Kudoh, Junzo; Homma, Yukio; Kawabe, Kazuki

2011-06-22

368

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.

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

2009-01-01

369

MP29-02 for the treatment of seasonal allergic rhinitis: a review of clinical pharmacology, efficacy and safety.  

PubMed

This review presents the pharmacology, clinical efficacy and safety of MP29-02 (Dymista®), a unique product for the treatment of allergic rhinitis. Allergic rhinitis is often thought of more as a nuisance than a meaningful medical condition, and the health impact of allergic rhinitis can easily be underestimated. As a result, allergic rhinitis can be undertreated, expectations for relief may not be met, and patients may be left dissatisfied and non-compliant with their medications. MP29-02 is the only currently available allergic rhinitis medication to provide potent early-phase histamine-receptor blocking and long-term anti-inflammatory effects in a single intranasal formulation and delivery system that represents an advance in the therapy of allergic rhinitis, in particular for patients with moderate-to-severe disease. PMID:24070043

Berger, William E

2013-09-01

370

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

2011-10-18

371

Long-term measurement of tremor.  

PubMed

To account for the fluctuating and context-dependent nature of tremor, the method of ambulatory long-term electromyography (EMG) was developed for quantification of this symptom. It is based on successive evaluation of 15-s intervals by using a fast Fourier transformation (FFT). The standard results obtained are (a) tremor occurrence, a measure of how many intervals contain tremor; (b) mean tremor intensity; and (v) mean tremor frequency. This new method fulfills the so-called "test criteria" such as reliability, validity, sensitivity, and specificity for tremor quantification in essential tremor (ET) and Parkinson's disease (PD). In addition, we developed a method of determining the antagonist activation pattern by using cross-correlation analysis, also based on the long-term approach. This allows differentiation between ET and PD with a high sensitivity and a high interrater reliability. We conclude that long-term EMG is useful for both quantification and differentiation of tremor. PMID:9827600

Spieker, S; Boose, A; Breit, S; Dichgans, J

1998-01-01

372

[Efficacy and safety of levofloxacin to non-gonorrheal urethritis].  

PubMed

We investigated the efficacy and safety of levofloxacin (LVFX) 500mg once a day in patients with non-gonorrheal urethritis. Men, aged 20 years or older, with urethritis symptoms, and detection of Chlamydia trachomatis (C. trachomatis) or Mycoplasma genitalium (M. genitalium) by a microbiological examination were eligible for this study. Patients were administered LVFX 500mg, orally, once a day and the dosage period was seven days. We assumed 22 patients for a safety and efficacy analysis. In 22 patients, 17 patients had urethritis with C. trachomatis, 4 patients urethritis with M. genitalium, and one patient mixed infection of C. trachomatis and M. genitalium. In the clinial study, the primary endpoint was set as the bacteriological eradication rate at two to four weeks after completion of treatment. The bacterial eradication rate in the urethritis was 86.4% (19/22). The bacterial eradication rate in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 94.1% (16/17), 50.0% (2/4), 100% (1/1), respectively. A significant difference was not recognized among the three groups. The clinical efficacy at two to four weeks after completion of treatment was 90.9% (20/22). The clinical efficacy rates in the urethritis with C. trachomatis, M. genitalium, and mixed infection of C. trachomatis and M. genitalium were 100% (17/17), 50.0% (2/4), 100% (1/1), respectively. The efficacy rate of urethritis with M. genitalium was significantly low. No adverse drug reactions were observed. These results suggest that once-a-day levofloxacin (500mg) is effective and safe treatment for non-gonorrheal urethritis. PMID:23593735

Onodera, Shoichi; Onoe, Yasuhiko; Hosobe, Takahide; Kato, Tetsuro; Yoshida, Masaki

2012-12-01

373

Health of long term benzodiazepine users  

PubMed Central

The physical and psychological health of long term (over one year) users of benzodiazepines in one general practice was assessed by patients' self reporting of illness and by general practitioners' records. Of 3741 patients registered with the practice, 82 had been prescribed a benzodiazepine, and 64 of these agreed to enter the study. All but five of these patients were over 40 years of age, nearly a third (19) were given a diagnosis related to depression by interviewers, and between a third and a half reported a current physical illness. Long term treatment with benzodiazepines is not necessarily optimum management but may reflect the realities of general practice.

Rodrigo, E K; King, M B; Williams, P

1988-01-01

374

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

375

Transitions in long-term care.  

PubMed

This article examines transitions between the community and nursing homes among the private pay and the Medicaid eligible older (65+) persons. Discrete-time hazard functions were estimated to determine factors associated with the probability of these transitions. The analysis shows that recent hospitalizations for stroke, dementia, or hip fractures, while strongly predictive of nursing home admissions among the Medicaid elderly, were not significant (except for dementia) predictors for the private pay population. The results are of particular relevance in designing long-term care insurance, and more broadly, long-term care policy. PMID:7750776

Temkin-Greener, H; Meiners, M R

1995-04-01

376

Valuing a long-term care facility.  

PubMed

The business valuation industry generally uses at least one of three basic approaches to value a long-term care facility: the cost approach, sales comparison approach, or income approach. The approach that is chosen and the resulting weight that is applied to it depend largely on the circumstances involved. Because a long-term care facility is a business enterprise, more weight usually is given to the income approach which factors into the estimate of value both the tangible and intangible assets of the facility. PMID:10145686

Mellen, C M

1992-10-01

377

Long-term nuclear waste management: Present status and alternatives  

NASA Astrophysics Data System (ADS)

Long-term nuclear waste management deals with the final and irreversible stage of waste disposal, on surface and in deep geological formations (according to the waste type), when institutional surveillance is over. There are presently two main options available to deal with the wastes generated by spent nuclear fuel unloaded from reactors and containing most of the radiotoxicity produced all along the nuclear fuel cycle. Since the end of Word War II, spent-fuel reprocessing technology has gone through three different stages, ending up with considerable technical achievements and large investments (construction of large facilities, UP3 in France and THORP in the UK). However, having to face spent-fuel risings and lack of reprocessing capacities, since the mid-seventies some countries are considering the possibility of direct spent-fuel disposal without reprocessing. These two options are discussed in terms of long-term waste management. Because of the types of waste conditioning and packaging adopted with present reprocessing technology, in that case long-term safety, after a few centuries, relies completely on the geological barriers. On the other hand, long-term safety with the second option is based essentially on the retention properties of uranium oxide with respect to actinides. Finally, alternatives such as chemical partitioning of minor actinides followed by their transmutation, either in reactors or using high-energy particle accelerators, are under discussion. Apart from the standard reprocessing (after a cooling period of 3-5 years), all the other options called for a long period (50 years) of interim storage, preventing the adoption of irreversible, costly and not well proved waste management solutions, and leaving time to develop and assess these alternative methods.

Schapira, J. P.

1989-08-01

378

Safety and Efficacy of Periprocedural Anticoagulation With Enoxaparin in Patients Undergoing Peripheral Endovascular Revascularization.  

PubMed

Background: Periprocedural anticoagulation is primarily used in endovascular procedures to prevent acute reocclusion of the target vessel, but periprocedural anticoagulation might also have an impact on long-term outcome. Consecutive bleeding events are feared complications. Despite changes in peripheral endovascular revascularizations (EVRs), the periprocedural management has remained unchanged for years. Unfractionated heparin is still the treatment of choice during and immediately after EVR. Materials and Methods: We performed a prospective, single-center, open-label phase III study comparing 2 different regimes of enoxaparin peri-interventional to peripheral EVR stratified into low- and high-risk groups according to the acute and long-term reocclusion risk due to their vessel morphology. In both groups, 0.5 mg/kg of enoxaparin as a bolus was administered intravenously 10 to 15 minutes before the start of the procedure. In the low-risk group, 40 mg of enoxaparin were administered once daily for 7 days; whereas in the high-risk group, 1 mg/kg of enoxaparin was administered subcutaneously (sc) 2 times a day for 48 hours after the procedure and afterward 40 mg of enoxaparin was administered sc once daily for 5 days. Results: For the analysis of the per protocol population, 44 patients remained in the low-risk group and 140 in the high-risk group. Concerning the primary safety end point, a total of 25 (13.59%) bleeding events occurred until day 30; 5 (11.36%) of them in the low-risk group and 20 (14.29%) in the high-risk group (P = .809 for low vs high risk). None of the bleeding events observed were major according to Thrombolysis In Myocardial Infarction criteria. Concerning our primary efficacy end point, none of the patients showed an acute reocclusion classified as a significant decrease in ankle-brachial index (ABI) or elevated peak systolic velocity ratio confirmed by duplex sonography until day 30. Concerning the second end point of prevention of chronic reobstruction, at day 180 ABI has decreased in the low-risk group from mean 0.94 at day 30 to mean 0.89 and from 1.28 at day 30 to 0.85 after 6 months in the high-risk group. No significant reobstruction was found in the low-risk group, whereas 5 significant reobstruction events were objectified in the high-risk group, all of them in the femoropopliteal arterial segment at day 180. Conclusion: We conclude that low-molecular-weight heparin either in a low-dose or high-dose regime during a peripheral EVR is safe concerning bleeding complications and acute reobstructions. The long-term follow-up showed no significant difference between our high- and low-risk groups concerning reobstruction. The periprocedural anticoagulation seems to have no influence on the long-term patency rate after peripheral EVR. PMID:23785050

Brodmann, Marianne; Dorr, A; Hafner, F; Gary, T; Froehlich, H; Kvas, E; Deutschmann, H; Pilger, E

2013-06-18

379

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

Microsoft Academic Search

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

J. Brownlee

2010-01-01

380

Assessing the efficacy of famotidine and rebamipide in the treatment of gastric mucosal lesions in patients receiving long-term NSAID therapy (FORCE—famotidine or rebamipide in comparison by endoscopy)  

Microsoft Academic Search

Background  Nonsteroidal anti-inflammatory drugs (NSAIDs) and Helicobacter pylori infection are major causes of gastric mucosal lesions.\\u000a In Japan, histamine-2 receptor antagonists are frequently prescribed, but the literature regarding their efficacy is limited.\\u000a In this study, we compare the effects of famotidine and rebamipide on NSAID-associated gastric mucosal lesions using upper\\u000a gastrointestinal endoscopy.\\u000a \\u000a \\u000a \\u000a Methods  This study examined 112 patients taking NSAIDs for either

Jun-ichi Yamao; Eiryo Kikuchi; Masami Matsumoto; Masaki Nakayama; Tatsuichi Ann; Hideyuki Kojima; Akira Mitoro; Motoyuki Yoshida; Masaaki Yoshikawa; Hiroshi Yajima; Yoshizumi Miyauchi; Hiroshi Ono; Koichi Akiyama; Goro Sakurai; Yoshikazu Kinoshita; Ken Haruma; Yoshinori Takakura; Hiroshi Fukui

2006-01-01

381

LONG-TERM RELIABILITY OF CRT MONITORS  

Microsoft Academic Search

In this study, an attempt is made to establish design procedures for the CRT (Cathode Ray Tube) monitor based on the statistical evaluation of long-term reliability considering the delayed fracture of the glass that has the scatters and size effect in the strength. The four-point flexure tests are carried out by use of the glass specimens for the examination of

Y. Omoto; S. Tani; S. Ohsugi; T. Karita

382

Long Term Care Aide. Course Outline.  

ERIC Educational Resources Information Center

This course outline is intended to assist the instructor in the development of a curriculum for a long-term care aide program by specifying one component of the curriculum--the objectives. These objectives, or competencies expected as outcomes for student performance on completion of the program, describe the capabilities an individual must…

Wilbee, Judy

383

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...

384

Long Term Strength of Structural Adhesive Joints  

Microsoft Academic Search

The long term static strength of adhesive joints is analyzed in terms of a modified Prot method and sustained load tests. Data from the failure times under different loading rates are used to predict the static stress that an adhesive joint will withstand for an infinite time, i.e., the endurance limit. Despite theoretical shortcomings, the method is found to give

Armand F. Lewis; Raymond A. Kinmonth; Robert P. Kreahling

1972-01-01

385

Oral health in long-term care  

Microsoft Academic Search

When an investigation designed to compare extant models of delivering oral health and dental services to the institutionalized elderly revealed that structural variables explained very little of the difference between effective and ineffective programs, secondary analytic techniques were employed to consider alternative explanations. The original study was a program evaluation based on a comparative case study of 12 long-term care

Sally E. Thorne; Arminee Kazanjian; Michael I. MacEntee

2001-01-01

386

Long-Term Memory and Learning  

ERIC Educational Resources Information Center

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

Crossland, John

2011-01-01

387

Long-term solar-terrestrial observations.  

National Technical Information Service (NTIS)

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-ter...

1988-01-01

388

Long-term fixed income market structure  

NASA Astrophysics Data System (ADS)

Long-term fixed income market securities present a strong positive correlation in daily returns. By using a metrical approach and considering ``modified'' time series, I show how it is possible to show a more complex structure which depends strictly on the maturity date.

Grilli, Luca

2004-02-01

389

Adding Long-Term Care to Medicare  

Microsoft Academic Search

The rancor accompanying the repeal of most of the 1988 Medicare Catastrophic Act reflects both the national need to improve health and long-term care benefits for the elderly and the political obstacles to finding new sources of financing for such benefits. Neither the need nor the obstacles will go away, but policymakers are now likely to look for lower-cost, efficient,

Walter N. Leutz; Merwyn Greenlick; Sam Ervin; Eli Feldman; Joelyn Malone

1992-01-01

390

Long-term outcome after coronary stenting  

Microsoft Academic Search

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

Adnan Kastrati; Donald Hall; Albert Schömig

2000-01-01

391

Predictors of Long-term Weight Maintenance  

Microsoft Academic Search

Objective: The purpose of this study was to evaluate available variables of a long-term weight maintenance study to investigate possible factors predisposing to weight regain after a period of weight loss.Research Methods and Procedures: The Maastricht Weight Maintenance Study is an ongoing longitudinal study of healthy men and women (29 men and 62 women; 18 to 65 years of age;

Neeltje Vogels; Kristel Diepvens; Margriet S. Westerterp-Plantenga

2005-01-01

392

Are retrotransposons long-term hitchhikers?  

Microsoft Academic Search

Transposable elements represent a large fraction of the genomes of eukaryotes, and yet we know little of their origins or stability. Striking examples of cross-species transfer have been discovered among mariner elements (transposable elements that are widespread in insects and other animals), confirming the impression that horizontal transfers are essential to the long-term success of transposable elements. We show that

William D. Burke; Harmit S. Malik; Warren C. Lathe; Thomas H. Eickbush

1998-01-01

393

Ethics Environment in Long-Term Care  

Microsoft Academic Search

This study assesses three hypotheses regarding a long-term care facility’s ethics environment and the relationships between ethics environment, employees’ work features, and residents’ outcomes. Validated questionnaires measure ethics environment, work satisfaction, managing disagreement, goal attainment, care and work opinion including retention, and mental health status among full-time employees (N = 110; 53%) and residents (N = 139; 57%) who volunteered

Charlotte McDaniel; James K. Roche; Emir Veledar

2011-01-01

394

Long-term use of potassium perchlorate  

Microsoft Academic Search

A case of Graves' disease with potassium perchorate for 22 years without ill effect is described. Thyrotoxicosis recurred 4 weeks after the medication was withdrawn, suggesting that euthyroidism had been maintained by chronic use of the drug. As toxicity of perchlorate is probably dose related, it is suggested that long-term use of low dose perchlorate may be no more hazardous

J. M. Connell

1981-01-01

395

Long-term opioid therapy reconsidered.  

PubMed

In the past 20 years, primary care physicians have greatly increased prescribing of long-term opioid therapy. However, the rise in opioid prescribing has outpaced the evidence regarding this practice. Increased opioid availability has been accompanied by an epidemic of opioid abuse and overdose. The rate of opioid addiction among patients receiving long-term opioid therapy remains unclear, but research suggests that opioid misuse is not rare. Recent studies report increased risks for serious adverse events, including fractures, cardiovascular events, and bowel obstruction, although further research on medical risks is needed. New data indicate that opioid-related risks may increase with dose. From a societal perspective, higher-dose regimens account for the majority of opioids dispensed, so cautious dosing may reduce both diversion potential and patient risks for adverse effects. Limiting long-term opioid therapy to patients for whom it provides decisive benefits could also reduce risks. Given the warning signs and knowledge gaps, greater caution and selectivity are needed in prescribing long-term opioid therapy. Until stronger evidence becomes available, clinicians should err on the side of caution when considering this treatment. PMID:21893626

Von Korff, Michael; Kolodny, Andrew; Deyo, Richard A; Chou, Roger

2011-09-01

396

Long-Term Breastfeeding: Nourishment or Nurturance?  

Microsoft Academic Search

Mothers frequently describe the primary benefit of breastfeeding beyond a year as providing comfort rather than nourishment. Little is known about the effect of extended breastfeeding on the growth or nutritional status of children in the United States. Data collected on 38 long-term breastfeeding children (12 to 43 months old) included growth measurements, breastfeeding patterns, and dietary intake obtained through

Kathleen M. Buckley

2001-01-01

397

Long-term course of anorexia nervosa  

Microsoft Academic Search

There is no predictable or normative long-term course associated with anorexia nervosa. Some Individuals achieve complete recovery; others are ravaged by a chronic disorder; and some die from it. Predicting course and outcome of anorexia nervosa is complicated by the intrinsic complexity of the disorder; a lack of shared terminology in studying the disorder; and a paucity of controlled clinical

Kathleen M. Pike

1998-01-01

398

Evaluating Long-Term Disability Insurance Plans.  

ERIC Educational Resources Information Center

This report analyzes the factors involved in reviewing benefits and services of employer-sponsored group long-term disability plans for higher education institutions. Opening sections describe the evolution of disability insurance and its shape today. Further sections looks at the complex nature of "value" within a plan, relationship between plan…

Powell, Jan

1992-01-01

399

Long-Term Monitoring of Polars  

NASA Astrophysics Data System (ADS)

We present long-term observations of magnetic cataclysmic variables AM Her, AN UMa, AR UMa, DP Leo, and V1309 Ori obtained with the ROTSEIIId telescope. All data have been analysed and preliminary results indicate periods of 170 days, 217 days, and 180 days for AM Her, AN UMa, and AR UMa, respectively.

Kalomeni, B.

2012-04-01

400

Long-Term Care -- Actuarial Cost Estimates.  

National Technical Information Service (NTIS)

The areas covered by this paper, which is designed to help Congress in its deliberations on changes in existing programs, include: (1) the demand for long-term health and social services; (2) the existing supply of the services; and (3) the cost of certai...

1977-01-01

401

Long Term Consequences Of Early Childhood Malnutrition  

Microsoft Academic Search

This paper examines the impact of preschool 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 preschool nutritional status across siblings. Improvements in height-for-age in preschoolers are associated with increased

Harold Alderman; John Hoddinott; Bill Kinsey

2004-01-01

402

Pulmonary complications after long term amiodarone treatment  

Microsoft Academic Search

BACKGROUND: Amiodarone hydrochloride is an antiarrhythmic agent useful in arrhythmias refractory to standard therapy. Although interstitial pneumonitis is known to be its most serious side effect, several aspects of amiodarone lung toxicity are still controversial. METHODS: Pulmonary side effects were examined in a sample of 61 symptomless patients (mean (SD) age 55 (7) years) who had had long term treatment

J Roca; M Heras; R Rodriguez-Roisin; J Magriñà; A Xaubet; G Sanz

1992-01-01

403

NATIONAL LONG TERM CARE SURVEY (NLTCS)  

EPA Science Inventory

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

404

Review of the efficacy and safety of radiofrequency ablation for the treatment of small renal masses  

PubMed Central

Background Small renal masses are increasingly being discovered incidentally on imaging performed for another reason. The standard of care for these masses involves excision by open or laparoscopic techniques. Recently, ablative techniques such as radiofrequency ablation (RFA) and cryoablation have taken a more prominent role in the treatment algorithm for these masses. We sought to evaluate the efficacy and safety of radiofrequency ablation in the treatment of renal tumours. Methods We conducted a review of the literature. There was no language restriction. We obtained studies from the following sources: the Cochrane Library, PubMed, EMBASE, LILACS and Current Controlled Trials. Results We identified no clinical trials in the literature. Thus we described the results from case series and retrospective studies with a reasonable sample size (number of reported patients in each study > 65). Most patients undergoing RFA had T1a disease with a mean tumour size of about 3 cm. Radiofrequency ablation was usually performed percutaneously with image guidance. Reported follow-up was short and ranged from 1 to 30 months. Most series used radiographic response as a surrogate for cancer control. The rates of local recurrence of the tumour were as high as 13.0% (average 8.5%) and were slightly higher than those associated with cryoablation and partial nephrectomy. Complications included hemorrhage, ureteral strictures and loss of a renal unit. Conclusion Our review demonstrates that RFA is a suitable and promising therapy in patients with small renal tumours who are considered to be poor candidates for more involved surgery. However, clinical trials with long-term data are needed to establish the oncological efficacy.

Dib, Regina El; Touma, Naji J.; Kapoor, Anil

2009-01-01

405

[Efficacy and safety of sitafloxacin for lower respiratory tract infections].  

PubMed

We investigated the efficacy and safety of sitafloxacin (STFX) in patients with mild to moderate community-acquired pneumonia or secondary infections of chronic respiratory tract diseases. The results showed that the efficacy rate was 96.5% (111/115) in patients analyzed for efficacy. The efficacy rate by STFX administration method was 93.9% (46/49) at 50mg b.i.d., 100% (37/37) at 100 mg q.d. and 96.6% (28/29) at 100mg b.i.d. In chest X-rays, the image improvement rate in 102 patients with shadows before treatment was 94.1% (96/102). The image improvement rate by STFX administration method was 90.5% (38/42) at 50 mg b.i.d., 97.1% (33/34) at 100mg q.d. and 96.2% (25/26) at 100mg b.i.d. Side effects occurred in five out of 115 patients (4.3%). Abnormalities in hepatic function test values appeared in two patients and abnormalities in renal function test values appeared in three patients. In four cases, the abnormalities were very mild and STFX administration was continued without any treatment. In the other patient, the abnormal value rapidly returned to normal after STFX administration was discontinued. These findings indicated that STFX can be used safety in routine practice by adjusting the administration within the approved dose based on patient characteristics. Good therapeutic effects can be expected in patients with respiratory tract infections. PMID:22428212

Mukae, Hiroshi; Yatera, Kazuhiro; Nagata, Shuya; Yamasaki, Kei; Nishida, Chinatsu; Kawanami, Toshinori; Ishimoto, Hiroshi; Yoshii, Chiharu; Inoue, Naomasa; Noguchi, Shingo; Awaya, Yukikazu; Kawajiri, Tatsunori; Imanaga, Tomotoshi; Kido, Takashi; Choujin, Yasuo; Obata, Hideto; Matsushima, Atsushi; Suzuki, Yu

2011-10-01

406

Costs and How to Pay (Long-Term Care)  

MedlinePLUS

... Expand Long-term Care Insurance Costs Expand Using Life Insurance to Pay for Long-term Care Expand Paying ... long-term care insurance , personal income and savings, life insurance, annuities and reverse mortgages to ensure they can ...

407

Efficacy and safety of pregabalin in alcohol dependence  

Microsoft Academic Search

Introduction  Pregabalin is a new anxiolytic that selectively binds to the alpha2-delta subunit of voltage-gated calcium channels, inhibiting\\u000a release of excessive levels of excitatory neurotransmitters. In this open-label trial we aimed to investigate the efficacy\\u000a of pregabalin on alcoholism indices in detoxified alcohol-dependent subjects. Reduction of cravings, psychiatric symptom improvements,\\u000a and the evaluation of safety parameters were the secondary endpoints.\\u000a \\u000a \\u000a \\u000a Methods  Thirty-one

Giovanni Martinotti; Marco Di Nicola; Daniela Tedeschi; Marianna Mazza; Luigi Janiri; Pietro Bria

2008-01-01

408

Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities  

PubMed Central

Background Adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat knee and hand osteoarthritis may be more frequent in certain patient populations. Topical NSAIDs, such as diclofenac sodium 1% gel (DSG), have equivalent efficacy and fewer adverse events compared with oral NSAIDs. This post hoc analysis assessed the long-term tolerability of DSG in elderly patients and patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events. Methods Patients ? 35 years of age with knee osteoarthritis applied DSG (4 g) to one or both knees for 12 weeks during either of two primary studies and for 9 months during a long-term extension study. Other patients entered the long-term extension study directly and applied DSG for 12 months. Safety was assessed by reported adverse events. Subpopulations were defined based on age, or the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease. Results The safety population consisted of 947 patients who received at least one dose of DSG during the primary or extension study. Patients aged < 65 years (68.2%) and ?65 years (67.2%) experienced any adverse event at similar rates. The percentage of patients who experienced any adverse event was similar between patients with and without hypertension (65.5% versus 69.7%, respectively), type 2 diabetes mellitus (64.0% versus 68.2%), or cerebrovascular or cardiovascular disease (61.9% versus 68.5%). Among the 15 patients with all three comorbidities, the percentage of patients with any adverse event (53.3%) was less than that of patients who did not have all three comorbidities (68.0%). Conclusion These results suggest that long-term DSG treatment is safe in patient subpopulations with an elevated risk of NSAID-related adverse events, such as the elderly and those with the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.

Peniston, John H; Gold, Morris S; Wieman, Matthew S; Alwine, Lawrence K

2012-01-01

409

The Risks and Benefits of Long-term Use of Hydroxyurea in Sickle Cell Anemia: A 17.5 Year Follow-Up  

PubMed Central

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 ? = 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.

Steinberg, MH; McCarthy, WF; Castro, O; Ballas, SK; Armstrong, FD; Smith, W; Ataga, K; Swerdlow, P; Kutlar, A; DeCastro, L; Waclawiw, MA

2010-01-01

410

Efficacy and safety of rituximab therapy for systemic lupus erythematosus: a systematic review and meta-analysis  

PubMed Central

Objective: To review the efficacy and safety of rituximab therapy for systemic lupus erythematosus (SLE).Methods: We searched for randomized controlled trails and observational studies that evaluated the effect of rituximab based on the systemic lupus erythematosus disease activity index (SLEDAI), British Isles lupus assessment group index (BILAG), urine protein levels, and the prednisolone dose, and had adequate data to calculate the mean, standard deviation (SD), and 95% confidence intervals, and to systematically review and meta-analyze observational studies with fixed effects model or random effects model. Results: We included 2 randomized controlled studies and 19 observational clinical studies. We summarized the data from the 19 observational studies, analyzed the heterogeneity of the literature, and then used fixed effect model or random effect model for statistical analysis. The SLEDAI, BILAG, and urine protein levels and the prednisolone dosage were decreased after rituximab treatment, and the decreases in the BILAG, urine protein levels, and the prednisolone dose were found to be significant (P<0.05), when compared with baseline level. Rituximab’s adverse effects generally could be controlled with an effective dosing regimen. Conclusions: Although there are still controversies about rituximab’s treatment on SLE, but our study had showed that rituximab had favorable effects on refractory lupus. The long-term efficacy and safety of rituximab require further study.

Lan, Lan; Han, Fei; Chen, Jiang-hua

2012-01-01

411

Efficacy and safety of deferasirox in myelodysplastic syndromes.  

PubMed

Transfusion dependence in myelodysplastic syndrome (MDS) patients may lead to organ damage due to accumulation of non-transferrin-bound iron with consequent increased oxidative stress. Iron chelation has been reported in retrospective studies to improve overall survival in low-risk MDS patients, but this information needs to be validated in prospective trials. The oral iron chelator, deferasirox, has been shown to reduce serum ferritin levels in chelation naïve and pre-treated patients and to reduce labile plasma iron, independently from the efficacy on iron overload. Deferasirox is a potent NF-kB inhibitor, tested in vivo and on acute myeloid leukemia and MDS cell lines, and this effect may explain in part the phenomenon of hematological improvements reported in case reports and in different clinical trials. The drug has an acceptable safety profile, with the most common side effects reported being non-progressive change in serum creatinine level, gastrointestinal disturbances, and skin rash. In this review, we report the results of different studies testing safety and efficacy of deferasirox in MDS patients, side effects associated with the drug, and suggested management of iron overload. PMID:23417759

Breccia, Massimo; Alimena, Giuliana

2013-02-17

412

Postmenopausal osteoporosis treatment with antiresorptives: effects of discontinuation or long-term continuation on bone turnover and fracture risk--a perspective.  

PubMed

Osteoporosis may be a lifelong condition. Robust data regarding the efficacy and safety of both long-term osteoporosis therapy and therapy discontinuation are therefore important. A paucity of clinical trial data regarding the long-term antifracture efficacy of osteoporosis therapies necessitates the use of surrogate endpoints in discussions surrounding long-term use and/or discontinuation. Long-term treatment (beyond 3-4 years) may produce further increases in bone mineral density (BMD) or BMD stability, depending on the specific treatment and the skeletal site. Bisphosphonates, when discontinued, are associated with a prolonged reduction in bone turnover markers (BTMs), with a very gradual increase to pretreatment levels within 3 to 60 months of treatment cessation, depending on the bisphosphonate used and the prior duration of therapy. In contrast, with nonbisphosphonate antiresorptive agents, such as estrogen and denosumab, BTMs rebound to above pretreatment values within months of discontinuation. The pattern of BTM change is generally mirrored by a more or less rapid decrease in BMD. Although the prolonged effect of some bisphosphonates on BTMs and BMD may contribute to residual benefit on bone strength, it may also raise safety concerns. Adequately powered postdiscontinuation fracture studies and conclusive evidence on maintenance or loss of fracture benefit is lacking for bisphosphonates. Similarly, the effects of rapid reversal of bone turnover upon discontinuation of denosumab on fracture risk remain unknown. Ideally, studies evaluating the effects of long-term treatment and treatment discontinuation should be designed to provide head-to-head "offset" data between bisphosphonates and nonbisphosphonate antiresorptive agents. In the absence of this, a clinical recommendation for physicians may be to periodically assess the benefits/risks of continuation versus discontinuation versus alternative management strategies. PMID:22467094

Boonen, Steven; Ferrari, Serge; Miller, Paul D; Eriksen, Erik F; Sambrook, Philip N; Compston, Juliet; Reid, Ian R; Vanderschueren, Dirk; Cosman, Felicia

2012-03-29

413

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

PubMed Central

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

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

2013-01-01

414

Randomized controlled trial on the long-term efficacy of a multifaceted, interdisciplinary lifestyle intervention in reducing cardiovascular risk and improving lifestyle in patients at risk of cardiovascular disease.  

PubMed

The objective of the study was to evaluate the efficacy of an interdisciplinary intervention known as Educoeur in reducing cardiovascular risk and improving health behaviors in people without evidence of cardiovascular disease and to compare the Educoeur program to interventions in a specialized clinic and in usual care family practice. In a parallel, randomized, controlled trial of 185 adults with at least two modifiable cardiovascular risk factors, patients were randomly assigned to either Educoeur, specialized clinic or usual care. Cardiovascular risk, biological and lifestyle measures were assessed at baseline and at 2 years. In Educoeur, measurements were also taken before and after the lifestyle group treatment program. In 12 weeks, patients in Educoeur significantly lowered their cardiovascular risk, weight, body mass index, waist circumference, systolic blood pressure, kilocalories intake and improved their VO2 Max and mental health. Changes remained significant at 2 years. Between group comparisons at 2 years demonstrated that Educoeur was significantly better in reducing cardiovascular risk than interventions in usual care. Together, these results highlight the importance of providing interdisciplinary programs that optimize cardiovascular risk reduction and promote active lifestyles in patients at risk of cardiovascular disease. PMID:22402823

Goyer, Lysanne; Dufour, Robert; Janelle, Caroline; Blais, Chantal; L'Abbé, Christine; Raymond, Emilie; de Champlain, Jacques; Larochelle, Pierre

2012-03-09

415

Long term survival in primary pulmonary hypertension.  

PubMed

The mean survival of patients with severe primary pulmonary hypertension (PPH) is < 3 years without appropriate treatment. There are no long term reports on the spontaneous course of mild PPH over a longer period. Stable long term follow up is described of a 39 year old patient with PPH without treatment over a 30 year period. PPH had been diagnosed 30 years previously after right heart catheterisation (mean pulmonary artery pressure 35 mm Hg) and 30 years later, repeated measurements showed nearly unchanged haemodynamic parameters. Further examinations confirmed the diagnosis of PPH. It is suggested that PPH with modestly limited physical activity (New York Heart Association functional class II) does not always seem to coincide with progression of the disease and, therefore, it may be feasible to withhold treatment while closely monitoring these patients. PMID:15201266

Halank, M; Marx, C; Hoeffken, G

2004-07-01

416

[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

417

Case presentation: long-term treatment.  

PubMed

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

Glucksman, Myron L

2013-01-01

418

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

Microsoft Academic Search

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

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

1998-01-01

419

Peer Mentoring in Long-Term Care  

Microsoft Academic Search

This article describes two successful peer-mentoring programs designed to improve the quality of care in nursing homes and retention rates among direct care staff. The first program, “Growing Strong Roots,” examined CNA retention rates and the second program, “Peer Mentoring for Long Term Charge Nurses,” examined RN and LPN retention rates. These programs include a training component, an on-the-job mentoring

Carol Hegeman; Debi Hoskinson; Heather Munro; Patricia Maiden; Karl Pillemer

2007-01-01

420

Long-term study measures radon  

NASA Astrophysics Data System (ADS)

Preliminary results from a long-term study of indoor radon levels will be presented on Tuesday, May 19, at the AGU Spring Meeting in Baltimore, Md. The study, which is still in progress, has already pointed to some possible links between levels of radon gas in homes and local geology and home construction, according to Douglas Mose and George Mushrush of George Mason University (Fairfax, Va.).

Katzoff, Judith A.

421

Quantal analysis and long-term potentiation.  

PubMed

Quantal analysis is useful for assessing the pre- and/or post-synaptic locus of the expression of long-term tetanic potentiation with the condition, however, that the studied synaptic potentials have been evoked by single cell stimulations, as is the case with paired recordings of identified neurons. The application of this methodology, primarily with indirect criteria, has produced conclusions which dance back and forth across the synaptic cleft. PMID:9759330

Korn, H; Faber, D S

422

Rotator cuff repair. Long-term results  

Microsoft Academic Search

Objectives. – To evaluate the results of rotator cuff repair and to look for preoperative and\\/or intraoperative predictors of long-term outcomes.Patients and methods. – All patients who underwent open rotator cuff repair surgery for a full-thickness tear between 1990 and 1996 an