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Sample records for 6-month open-label extension

  1. A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension.

    PubMed

    Remington, Ruth; Lortie, Jevin J; Hoffmann, Heather; Page, Robert; Morrell, Christopher; Shea, Thomas B

    2015-01-01

    Thirty-four individuals with mild cognitive impairment were randomized for 6 months to a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or indistinguishable placebo, followed by a 6-month open-label extension in which all individuals received NF. The NF cohort improved in the Dementia Rating Scale (DRS; effect size >0.7) and maintained baseline performance in CLOX-1. The placebo cohort did not improve in DRS and declined in CLOX-1, but during the open-label extension improved in DRS and ceased declining in CLOX-1. These findings extend prior studies of NF efficacy for individuals without cognitive impairment and with Alzheimer's disease.

  2. 14-day prulifloxacin treatment of acute uncomplicated cystitis in women with recurrent urinary tract infections: a prospective, open-label, pilot trial with 6-month follow-up.

    PubMed

    Cai, T; Mazzoli, S; Nesi, G; Boddi, V; Mondaini, N; Bartoletti, R

    2009-11-01

    Recurrent urinary tract infections (UTI) are very common in otherwise healthy young women, and can have a very negative social and economic impact. In order to evaluate the tolerability and efficacy of a 14-day course of prulifloxacin orally administered once daily, 51 young female patients, attending the same STD center between may and June 2007 for symptoms of cystitis, with a history of recurrent UTI and urine culture positive for uropathogens, were enrolled in this prospective study. Microbiological and clinical efficacy was tested over three follow-up visits at 1, 3 and 6 months. Quality of life (QoL) was measured and the impact of prulifloxacin in modifying the Lactobacillus vaginal flora was also evaluated. At baseline, the pathogens most commonly isolated were Enterococcus faecalis (43.2%) and Escherichia coli (27.5%). 41 of the 51 women, (80.3%) had Lactobacillus spp. in vaginal samples at baseline. microbiological results at follow-up examinations were as follows: after 1 month, 47 patients were recurrence-free and 4 had recurrence; after 3 months, 41 were recurrence-free, while 6 reported recurrence; finally, after 6 months, 36 were recurrence-free and 5 had recurrence. A statistically significant difference was reported between the QoL questionnaire mean scores at baseline (0.63), 1 (0.77), 3 (0.77) and 6 months (0.78) after treatment (all p<0.001). the vaginal swab cultures demonstrated that Lactobacillus spp. flora was maintained in 38 out of the 41 (92.6%) patients who had positive vaginal swab sample at baseline. in conclusion, a 14-day administration of prulifloxacin 600 mg is a safe, well tolerated and effective treatment for the management of UTI in young women. PMID:19933045

  3. Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension

    PubMed Central

    Koh, Jung-Min; Chung, Dong Jin; Chung, Yoon-Sok; Kang, Moo-Il; Kim, In-Ju; Min, Yong-Ki; Oh, Han-Jin; Park, Il Hyung; Lee, Yil-Seob; Waterhouse, Brian; Nino, Antonio; Fitzpatrick, Lorraine A.

    2016-01-01

    Purpose The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study. Materials and Methods Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg. Results Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals. Conclusion Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women. PMID:27189284

  4. Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials

    PubMed Central

    Goodman, Andrew D; Bethoux, Francois; Brown, Theodore R; Schapiro, Randall T; Cohen, Ron; Marinucci, Lawrence N; Henney, Herbert R

    2015-01-01

    Background: In Phase 3 double-blind trials (MS-F203 and MS-F204), dalfampridine extended release tablets 10 mg twice daily (dalfampridine-ER; prolonged-release fampridine in Europe; fampridine modified or sustained release elsewhere) improved walking speed relative to placebo in patients with multiple sclerosis (MS). Objectives: Evaluation of long-term safety and efficacy of dalfampridine-ER in open-label extensions (MS-F203EXT, MS-F204EXT). Methods: Patients received dalfampridine-ER 10 mg twice daily; and had Timed 25-Foot Walk (T25FW) assessments at 2, 14 and 26 weeks, and then every 6 months. Subjects were categorized as dalfampridine-ER responders or non-responders, based on their treatment response in the double-blind parent trials that assessed T25FW. Results: We had 269 patients enter MS-F203EXT and 154 patients complete it; for a maximum exposure of 5 years. We had 214 patients enter MS-F204EXT and 146 complete it; for a maximum exposure of 3.3 years. No new safety signals emerged and dalfampridine-ER tolerability was consistent with the double-blind phase. Improvements in walking speed were lost after dalfampridine-ER was discontinued in the parent trial, but returned by the 2-week assessment after re-initiation of the drug. Throughout the extensions, mean improvement in walking speed declined, but remained improved, among the double-blind responders as compared with non-responders. Conclusions: The dalfamipridine-ER safety profile was consistent with the parent trials. Although walking speed decreased over time, dalfampridine-ER responders continued to show improved walking speed, which was sustained compared with non-responders. PMID:25583832

  5. Rotigotine transdermal system for long-term treatment of patients with advanced Parkinson's disease: results of two open-label extension studies, CLEOPATRA-PD and PREFER.

    PubMed

    LeWitt, Peter A; Boroojerdi, Babak; Surmann, Erwin; Poewe, Werner

    2013-07-01

    Open-label extensions [studies SP516 (NCT00501969) and SP715 (NCT00594386)] of the CLEOPATRA-PD and PREFER studies were conducted to evaluate the safety, tolerability and efficacy of the dopaminergic agonist, rotigotine, over several years of follow-up in patients with advanced Parkinson's disease (PD). Eligible subjects completing the double-blind trials received open-label adjunctive rotigotine (≤16 mg/24 h) for up to 4 and 6 years in Studies SP516 and SP715, respectively. Safety and tolerability were assessed using adverse events, vital signs and laboratory parameters, and efficacy assessed using the unified Parkinson's disease rating scale (UPDRS). Of the 395 and 258 patients enrolled in the SP516 and SP715 studies, 48 and 45 % completed, respectively. Adverse events were typically dopaminergic effects [e.g., somnolence (18-25 %/patient-year), insomnia (5-7 %/patient-year), dyskinesias (4-8 %/patient-year) and hallucinations (4-8 %/patient-year)], or related to the transdermal application of a patch (application site reactions: 14-15 %/patient-year). There were no clinically relevant changes in vital signs or laboratory parameters in either study. Mean UPDRS part II (activities of daily living) and part III (motor function) total scores improved from double-blind baseline during dose titration, then gradually declined over the maintenance period. In study SP516, mean UPDRS part II and III total scores were 0.8 points above and 2.8 points below double-blind baseline, respectively, at end of treatment. In study SP715, mean UPDRS part II and III total scores were 4.1 points above and 0.2 points below baseline, respectively, at end of treatment. In these open-label studies, adjunctive rotigotine was efficacious with an acceptable safety and tolerability profile in patients with advanced PD for up to 6 years.

  6. A multicenter, open-label extension study of velaglucerase alfa in Japanese patients with Gaucher disease: Results after a cumulative treatment period of 24months.

    PubMed

    Ida, Hiroyuki; Tanaka, Akemi; Matsubayashi, Tomoko; Murayama, Kei; Hongo, Teruaki; Lee, Hak-Myung; Mellgard, Björn

    2016-07-01

    Enzyme replacement therapy (ERT) with exogenous glucocerebrosidase is indicated to treat symptomatic Gaucher disease (GD), a rare, inherited metabolic disorder. ERT with velaglucerase alfa, which is produced in a human cell line using gene activation technology, was studied in a 12-month phase III trial in Japanese patients with type 1 or 3 GD who were switched from imiglucerase ERT (n=6); the current, open-label, 12-month extension study was designed to assess longer-term safety and efficacy. Two adult and three pediatric patients (aged <18years) were enrolled into the extension study. Every-other-week intravenous infusions were administered for 63-78weeks at average doses between 51.5 and 60.7units/kg. Three non-serious adverse events were considered related to velaglucerase alfa treatment, but no patient discontinued from the study. Six serious but non-drug-related adverse events were reported. No patient tested positive for anti-velaglucerase alfa antibodies. Hemoglobin concentrations, platelet counts, and liver and spleen volumes (normalized to body weight) in these patients were generally stable over a cumulative 24-month period from the baseline of the parent trial. The data suggest that velaglucerase alfa was well tolerated and maintained clinical stability in Japanese GD patients over 2years after switching from imiglucerase. ClinicalTrials.gov identifier NCT01842841. PMID:27241455

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  9. Effect of Micronutrients on Behavior and Mood in Adults with ADHD: Evidence from an 8-Week Open Label Trial with Natural Extension

    ERIC Educational Resources Information Center

    Rucklidge, Julia; Taylor, Mairin; Whitehead, Kathryn

    2011-01-01

    Objective: To investigate the effect of a 36-ingredient micronutrient formula consisting mainly of minerals and vitamins in the treatment of adults with both ADHD and severe mood dysregulation (SMD). Method: 14 medication-free adults (9 men, 5 women; 18-55 years) with ADHD and SMD completed an 8-week open-label trial. Results: A minority reported…

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

    PubMed Central

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

    2016-01-01

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

  11. The safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies.

    PubMed

    Baldwin, David S; Chrones, Lambros; Florea, Ioana; Nielsen, Rebecca; Nomikos, George G; Palo, William; Reines, Elin

    2016-03-01

    The safety and tolerability of vortioxetine in adults with major depressive disorder was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomized, double-blind placebo-controlled short-term studies in major depressive disorder: six with an active reference. Symptoms following discontinuation were assessed through the Discontinuation-Emergent Signs and Symptoms checklist in three studies. Long-term (⩽52 weeks) tolerability was evaluated in five open-label extension studies. Patients (n =5701) were acutely treated with either placebo (n=1817), vortioxetine (5-20mg/day; n=3018), venlafaxine XR (225mg/day; n=113) or duloxetine (60mg/day; n=753). The withdrawal rate due to TEAEs during treatment with vortioxetine (5-20mg/day) was 4.5-7.8%, compared with placebo (3.6%), venlafaxine XR (14.2%) or duloxetine (8.8%). Common TEAEs (incidence ⩾5% and >2 × placebo) with vortioxetine (5-20mg/day) were nausea (20.9-31.2%) and vomiting (2.9-6.5%). For vortioxetine (5-20mg/day), the incidence of TEAEs associated with insomnia was 2.0-5.1% versus 4.0% for placebo, and with sexual dysfunction 1.6-1.8% versus 1.0% for placebo. Discontinuation symptoms as assessed by the mean Discontinuation-Emergent Signs and Symptoms total score after abrupt discontinuation were comparable to placebo in the first and second week. Vortioxetine had no effect relative to placebo on clinical laboratory parameters, body weight, heart rate or blood pressure. Vortioxetine showed no clinically relevant effect on ECG parameters, including the QTcF interval. In long-term treatment, no new types of TEAEs were seen; the mean weight gain was 0.7-0.8kg. Thus, vortioxetine (5-20mg/day) appears safe and generally well tolerated in the treatment of major depressive disorder.

  12. The safety and tolerability of vortioxetine: Analysis of data from randomized placebo-controlled trials and open-label extension studies

    PubMed Central

    Baldwin, David S; Chrones, Lambros; Florea, Ioana; Nielsen, Rebecca; Nomikos, George G; Palo, William; Reines, Elin

    2016-01-01

    The safety and tolerability of vortioxetine in adults with major depressive disorder was assessed. Tolerability was based on the nature, incidence and severity of treatment-emergent adverse events (TEAEs) during acute (6/8) week treatment in 11 randomized, double-blind placebo-controlled short-term studies in major depressive disorder: six with an active reference. Symptoms following discontinuation were assessed through the Discontinuation-Emergent Signs and Symptoms checklist in three studies. Long-term (⩽52 weeks) tolerability was evaluated in five open-label extension studies. Patients (n =5701) were acutely treated with either placebo (n=1817), vortioxetine (5–20mg/day; n=3018), venlafaxine XR (225mg/day; n=113) or duloxetine (60mg/day; n=753). The withdrawal rate due to TEAEs during treatment with vortioxetine (5–20mg/day) was 4.5–7.8%, compared with placebo (3.6%), venlafaxine XR (14.2%) or duloxetine (8.8%). Common TEAEs (incidence ⩾5% and >2 × placebo) with vortioxetine (5–20mg/day) were nausea (20.9–31.2%) and vomiting (2.9–6.5%). For vortioxetine (5–20mg/day), the incidence of TEAEs associated with insomnia was 2.0–5.1% versus 4.0% for placebo, and with sexual dysfunction 1.6–1.8% versus 1.0% for placebo. Discontinuation symptoms as assessed by the mean Discontinuation-Emergent Signs and Symptoms total score after abrupt discontinuation were comparable to placebo in the first and second week. Vortioxetine had no effect relative to placebo on clinical laboratory parameters, body weight, heart rate or blood pressure. Vortioxetine showed no clinically relevant effect on ECG parameters, including the QTcF interval. In long-term treatment, no new types of TEAEs were seen; the mean weight gain was 0.7–0.8kg. Thus, vortioxetine (5–20mg/day) appears safe and generally well tolerated in the treatment of major depressive disorder. PMID:26864543

  13. Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy

    PubMed Central

    2013-01-01

    Introduction Two replicate randomized, placebo-controlled six-month trials (RCTs) and an open-label treatment extension (OLE) comprised the pegloticase development program in patients with gout refractory to conventional therapy. In the RCTs, approximately 40% of patients treated with the approved dose saw complete response (CR) of at least one tophus. Here we describe the temporal course of tophus resolution, total tophus burden in patients with multiple tophi, tophus size at baseline, and the relationship between tophus response and urate-lowering efficacy. Methods Baseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase (8 mg biweekly or monthly) or placebo in the RCTs, and pegloticase in the OLE. Tophus response, a secondary endpoint in the trials, was evaluated two ways. Overall tophus CR was the proportion of patients achieving a best response of CR (without any new/enlarging tophi) and target tophus complete response (TT-CR) was the proportion of all tophi with CR. Results Among 212 patients randomized in the RCTs, 155 (73%) had ≥1 tophus and 547 visible tophi were recorded at baseline. Overall tophus CR was recorded in 45% of patients in the biweekly group (P = 0.002 versus placebo), 26% in the monthly group, and 8% in the placebo group after six months of RCT therapy. TT-CR rates at six months were 28%, 19%, and 2% of tophi, respectively. Patients meeting the primary endpoint of sustained urate-lowering response to therapy (responders) were more likely than nonresponders to have an overall tophus CR at six months (54% vs 20%, respectively and 8% with placebo). Both overall tophus CR and TT-CRs increased with treatment duration in the OLE, reaching 70% (39/56) of patients and 55% (132/238) of target tophi after one year of treatment in patients receiving pegloticase during both the RCTs and OLE. At that time point, more tophi had resolved in responders (102/145 or 70% of tophi) than

  14. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia

    PubMed Central

    Landbloom, Ronald P.; Mackle, Mary; Pallozzi, Wendi; Braat, Sabine; Hundt, Carla; Wamboldt, Marianne Z.; Mathews, Maju

    2015-01-01

    Abstract Objective: The purpose of this study was to evaluate the safety and efficacy of asenapine in adolescents with schizophrenia. Methods: In an 8 week, randomized, double-blind placebo-controlled trial, subjects (12–17 years of age) meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for schizophrenia were randomized 1:1:1 to placebo, asenapine 2.5 mg b.i.d., or asenapine 5 mg b.i.d. Subjects who completed the 8 week acute study could participate in a 26 week flexible-dose asenapine-only open-label extension (OLE). Results: A similar percentage of subjects completed treatment on day 56 (2.5 mg b.i.d. (n=98): 83%; 5 mg b.i.d. [n=106]: 79%; placebo [n=102]: 79%). In the mixed model for repeated measures analysis of the primary end-point (with Hochberg correction for multiplicity), least squares (LS) mean differences between asenapine and placebo on the Positive and Negative Syndrome Scale (PANSS) total score at day 56 were not significant (−4.8 for 2.5 mg b.i.d., p=0.070; −5.6 for 5 mg b.i.d., p=0.064). Significant improvement in the Clinical Global Impressions-Severity score was observed in the 5 mg b.i.d. group versus placebo on day 56 (LS mean −0.3, p=0.024). In the acute phase, ≥7% weight gain and the composite event of somnolence, sedation, and hypersomnia were more common in both asenapine groups than in the placebo group. Akathisia, fasting glucose elevation, and extrapyramidal syndrome were more common in the 5 mg b.i.d. group than in the placebo group. There were no unexpected adverse events in the OLE, and PANSS total scores decreased by −16.1 points in the group previously treated with placebo (n=62) and by −11.2 points in the continuous asenapine group (n=131) from OLE baseline to week 26. Conclusions: Although improvements in PANSS total score at day 56 of the acute phase were numerically greater for both asenapine 2.5 and 5 mg b.i.d. than for placebo and were

  15. Developmental milestones record - 6 months

    MedlinePlus

    Normal childhood growth milestones - 6 months; Childhood growth milestones - 6 months; Growth milestones for children - 6 months ... the weight on hands (often occurs by 4 months) Able to pick up a dropped object Able ...

  16. Monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, and curcumin: a randomized, double-blind placebo-controlled cross-over 4g study and an open-label 8g extension study.

    PubMed

    Golombick, Terry; Diamond, Terrence H; Manoharan, Arumugam; Ramakrishna, Rajeev

    2012-05-01

    Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) represent useful models for studying multiple myeloma precursor disease, and for developing early intervention strategies. Administering a 4g dose of curcumin, we performed a randomised, double-blind placebo-controlled cross-over study, followed by an open-label extension study using an 8g dose to assess the effect of curcumin on FLC response and bone turnover in patients with MGUS and SMM. 36 patients (19 MGUS and 17 SMM) were randomised into two groups: one received 4g curcumin and the other 4g placebo, crossing over at 3 months. At completion of the 4g arm, all patients were given the option of entering an open-label, 8g dose extension study. Blood and urine samples were collected at specified intervals for specific marker analyses. Group values are expressed as mean ± 1 SD. Data from different time intervals within groups were compared using Student's paired t-test. 25 patients completed the 4g cross-over study and 18 the 8g extension study. Curcumin therapy decreased the free light-chain ratio (rFLC), reduced the difference between clonal and nonclonal light-chain (dFLC) and involved free light-chain (iFLC). uDPYD, a marker of bone resorption, decreased in the curcumin arm and increased on the placebo arm. Serum creatinine levels tended to diminish on curcumin therapy. These findings suggest that curcumin might have the potential to slow the disease process in patients with MGUS and SMM. PMID:22473809

  17. Strong Correlation Between Concentrations of Tenofovir (TFV) Emtricitabine (FTC) in Hair and TFV Diphosphate and FTC Triphosphate in Dried Blood Spots in the iPrEx Open Label Extension: Implications for Pre-exposure Prophylaxis Adherence Monitoring

    PubMed Central

    Gandhi, Monica; Glidden, David V.; Liu, Albert; Anderson, Peter L.; Horng, Howard; Defechereux, Patricia; Guanira, Juan V.; Grinsztejn, Beatriz; Chariyalertsak, Suwat; Bekker, Linda-Gail; Grant, Robert M.

    2015-01-01

    Self-reported adherence to pre-exposure prophylaxis (PrEP) has limitations, raising interest in pharmacologic monitoring. Drug concentrations in hair and dried blood spots (DBS) are used to assess long-term-exposure; hair shipment/storage occurs at room temperature. The iPrEx Open Label Extension collected DBS routinely, with opt-in hair collection; concentrations were measured with liquid chromatography/tandem mass spectrometry. In 806 hair-DBS pairs, tenofovir (TFV) hair levels and TFV diphosphate (DP) in DBS were strongly correlated (Spearman coefficient r = 0.734; P < .001), as were hair TFV/DBS emtricitabine (FTC) triphosphate (TP) (r = 0.781; P < .001); hair FTC/DBS TFV-DP (r = 0.74; P < .001); hair FTC/DBS FTC-TP (r = 0.587; P < .001). Drug detectability was generally concordant by matrix. Hair TFV/FTC concentrations correlate strongly with DBS levels, which are predictive of PrEP outcomes. PMID:25895984

  18. Strong Correlation Between Concentrations of Tenofovir (TFV) Emtricitabine (FTC) in Hair and TFV Diphosphate and FTC Triphosphate in Dried Blood Spots in the iPrEx Open Label Extension: Implications for Pre-exposure Prophylaxis Adherence Monitoring.

    PubMed

    Gandhi, Monica; Glidden, David V; Liu, Albert; Anderson, Peter L; Horng, Howard; Defechereux, Patricia; Guanira, Juan V; Grinsztejn, Beatriz; Chariyalertsak, Suwat; Bekker, Linda-Gail; Grant, Robert M

    2015-11-01

    Self-reported adherence to pre-exposure prophylaxis (PrEP) has limitations, raising interest in pharmacologic monitoring. Drug concentrations in hair and dried blood spots (DBS) are used to assess long-term-exposure; hair shipment/storage occurs at room temperature. The iPrEx Open Label Extension collected DBS routinely, with opt-in hair collection; concentrations were measured with liquid chromatography/tandem mass spectrometry. In 806 hair-DBS pairs, tenofovir (TFV) hair levels and TFV diphosphate (DP) in DBS were strongly correlated (Spearman coefficient r = 0.734; P < .001), as were hair TFV/DBS emtricitabine (FTC) triphosphate (TP) (r = 0.781; P < .001); hair FTC/DBS TFV-DP (r = 0.74; P < .001); hair FTC/DBS FTC-TP (r = 0.587; P < .001). Drug detectability was generally concordant by matrix. Hair TFV/FTC concentrations correlate strongly with DBS levels, which are predictive of PrEP outcomes.

  19. Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study

    PubMed Central

    Jacobsen, Paula L.; Harper, Linda; Chrones, Lambros; Chan, Serena

    2015-01-01

    Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in patients who completed one of three randomized, double-blind, placebo-controlled, 8-week vortioxetine trials. All patients were switched to 10 mg/day vortioxetine for week 1, then adjusted between 15 and 20 mg for the remainder of the study, but not downtitrated below 15 mg. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), vital signs, laboratory values, physical examination, and the Columbia-Suicide Severity Rating Scale. Efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Hamilton Anxiety Scale, the Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability Scale. Of the 1075 patients enrolled, 1073 received at least one dose of vortioxetine and 538 (50.0%) completed the study. A total of 537 patients withdrew early, with 115 (10.7% of the original study population) withdrawing because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the most common TEAEs (≥10%) were nausea and headache. Laboratory values, vital signs, and physical examinations revealed no trends of clinical concern. The mean Montgomery–Åsberg Depression Rating Scale total score was 19.9 at the start of the extension study and 9.0 after 52 weeks of treatment (observed cases). Similar improvements were observed with the Hamilton Anxiety Scale (Δ−4.2), the Clinical Global Impression Scale-Severity of Illness (Δ−1.2), and the Sheehan Disability Scale (Δ−4.7) total scores after 52 weeks of treatment (observed case). In this 52-week, flexible-dose OLE study, 15 and 20

  20. Long-term efficacy and safety of oxycodone–naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study

    PubMed Central

    Guerriero, Fabio; Roberto, Anna; Greco, Maria Teresa; Sgarlata, Carmelo; Rollone, Marco; Corli, Oscar

    2016-01-01

    Background Two-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone–naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years. Methods In this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52). Results Fifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0–10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated. Conclusion This study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs. PMID:27143857

  1. Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

    PubMed

    Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

    2016-07-01

    Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on

  2. Open-Label Memantine in Fragile X Syndrome

    ERIC Educational Resources Information Center

    Erickson, Craig A.; Mullett, Jennifer E.; McDougle, Christopher J.

    2009-01-01

    Glutamatergic dysfunction is implicated in the pathophysiology of fragile X syndrome (FXS). The purpose of this pilot study was to examine the effectiveness and tolerability of memantine for a number of target symptoms associated with FXS. Medical records describing open-label treatment with memantine in 6 patients with FXS and a comorbid…

  3. Mediated Imitation in 6-Month-Olds: Remembering by Association.

    ERIC Educational Resources Information Center

    Barr, Rachel; Vieira, Aurora; Rovee-Collier, Carolyn

    2001-01-01

    Two experiments examined whether associating an imitation task with an operant task affected 6-month-olds' memory for either task. Results indicated that infants successfully imitated a puppet's action for up to 2 weeks only if the associated operant task (pressing a lever to activate a miniature train) was retrieved first. Follow-up study…

  4. Retrieval Protracts Deferred Imitation by 6-Month-Olds

    ERIC Educational Resources Information Center

    Barr, Rachel; Rovee-Collier, Carolyn; Campanella, Jennifer

    2005-01-01

    Past research using a deferred imitation task has shown that 6-month-olds remember a 3-part action sequence for only 1 day. The concept of a time window suggests that there is a limited period within which additional information can be integrated with a prior memory. Its width tracks the forgetting function of the memory. This study asked if…

  5. Maternal Regulation of Infant Reactivity From 2 to 6 Months.

    ERIC Educational Resources Information Center

    Jahromi, Laudan B.; Putnam, Samuel P.; Stifter, Cynthia A.

    2004-01-01

    Previous research has investigated the effect of maternal soothing behaviors on reducing infant reactivity but not the differential effects of specific maternal behaviors on infant stress responses. The present study investigated maternal regulation of 2- and 6-month-olds' responses to an inoculation and found a significant decline with age in…

  6. Congenital Panfollicular Nevus in a 6-Month-Old Girl.

    PubMed

    Duan, Linna; Antaya, Richard J; Ko, Christine J; Narayan, Deepak

    2016-01-01

    A 6-month-old girl presented with an irregular nodule on the right lateral neck. The lesion, which superficially resembled a lymphangioma or mastocytoma, had been present since birth but had recently been growing. The patient was referred for surgical resection. Microscopic findings were compatible with a recently described rare hamartoma termed "panfollicular nevus," which is a well-circumscribed lesion containing aberrantly differentiated, clustered hair follicles in high density. PMID:26822169

  7. Safety and efficacy of oral slow release morphine for maintenance treatment in heroin addicts: a 6-month open noncomparative study.

    PubMed

    Vasilev, Georgi N; Alexieva, Daniela Z; Pavlova, Rositsa Z

    2006-01-01

    This open-label, noncomparative, single-center trial evaluated the safety and efficacy of once-daily treatment with slow release oral morphine (SROM) capsules for the maintenance treatment of 20 outpatients with heroin dependency over 6 months at the National Institute for Addictions in Sofia, Bulgaria. Doses were individually titrated up to a mean daily maintenance dose of 760 mg (range 440-1,200 mg). SROM was effective in significantly reducing the signs and symptoms of opioid withdrawal and craving for heroin, with stabilization generally evident within two weeks. Nineteen patients completed 6 months of treatment and illicit opioid use was virtually eliminated. One patient withdrew voluntarily at 22 weeks. Validated questionnaires and tests indicated improvements in patients' well-being from baseline assessments. These included significant improvements with regard to suicidal depression (85%), anxiety and dysphoria (66%), general illness (58%), social dysfunction (54%), sense of hopelessness (34%), attention (25%), and self-reported typical depressive (27%) and disease-related (11%) symptoms. No deaths, serious adverse events, or withdrawals due to adverse events occurred. Five episodes of constipation and one episode of sweating (all nonserious and of mild or moderate severity) were reported. Vital signs were unaffected by SROM and no weight change was evident over the study period. The observations made in this study indicate a promising role for once-daily treatment with SROM in the clinical management of heroin dependency.

  8. Vitamin E treatment in patients with nonalcoholic steatohepatitis: A six-month, open-label study of sixteen patients

    PubMed Central

    Yakaryilmaz, Fahri; Guliter, Sefa; Ozenirler, Seren; Erdem, Ozlem; Akyol, Gulen

    2004-01-01

    Background Free radicals have a pivotal role in the pathogenesis of nonalcoholic steatohepatitis (NASH). Decreasing oxidative stress might have beneficial effects on the biochemical and histologic progression of this disease. Objective We aimed to determine the therapeutic effect of vitamin E, a potent antioxidant, on liver enzymes and histology in NASH. Methods This 6-month, open-label study was conducted at the Departments of Gastroenterology and Pathology, Gazi University School of Medicine (Ankara, Turkey). Patients aged 18 to 70 years with biopsy-proven NASH were included in the study. All patients received vitamin E 800 U/d in 2 divided doses, orally (capsules) for 6 months. Patients were not advised to change their exercise or dietary habits. Body mass index (BMI) was calculated at months 0 (baseline) and 6. Histologic scoring of steatosis, necroinflammatory grade, and fibrosis stage was performed at 0 and 6 months. Liver enzyme activities (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], and gamma-glutamyltransferase [GGT]) were monitored monthly. Control biopsy specimens were obtained at the end of the treatment. All of the liver biopsies were read by a single pathologist (G.A.) who was blinded to the clinical, laboratory, and histopathologic data, as well as the sequence of liver biopsies. Assessments of compliance and tolerability of treatment were performed using a pill count and patient interview, respectively, at the end of each month. Results Sixteen patients (12 men, 4 women; mean [SD] age, 45.5 [6.9] years [range, 37–60 years]) were enrolled. All patients completed 6 months of treatment. Mean BMI did not change significantly from baseline. Significant improvements in mean (SD) serum liver enzyme activities were observed at 6 months compared with baseline (ALT: 38.6 [16.3] U/L vs 84.8 [22.1] U/L, respectively, P = 0.001; AST: 29.8 [15.4] U/L vs 46.0 [16.0] U/L, respectively, P = 0.001; ALP: 154.6 [64

  9. Gesture Performance in Schizophrenia Predicts Functional Outcome After 6 Months

    PubMed Central

    Walther, Sebastian; Eisenhardt, Sarah; Bohlhalter, Stephan; Vanbellingen, Tim; Müri, René; Strik, Werner; Stegmayer, Katharina

    2016-01-01

    The functional outcome of schizophrenia is heterogeneous and markers of the course are missing. Functional outcome is associated with social cognition and negative symptoms. Gesture performance and nonverbal social perception are critically impaired in schizophrenia. Here, we tested whether gesture performance or nonverbal social perception could predict functional outcome and the ability to adequately perform relevant skills of everyday function (functional capacity) after 6 months. In a naturalistic longitudinal study, 28 patients with schizophrenia completed tests of nonverbal communication at baseline and follow-up. In addition, functional outcome, social and occupational functioning, as well as functional capacity at follow-up were assessed. Gesture performance and nonverbal social perception at baseline predicted negative symptoms, functional outcome, and functional capacity at 6-month follow-up. Gesture performance predicted functional outcome beyond the baseline measure of functioning. Patients with gesture deficits at baseline had stable negative symptoms and experienced a decline in social functioning. While in patients without gesture deficits, negative symptom severity decreased and social functioning remained stable. Thus, a simple test of hand gesture performance at baseline may indicate favorable outcomes in short-term follow-up. The results further support the importance of nonverbal communication skills in subjects with schizophrenia. PMID:27566843

  10. Malignant hyperthermia in a 6-month-old infant.

    PubMed

    Mathur, P R; Rundla, M; Jain, N; Mathur, V

    2016-01-01

    Malignant hyperthermia (MH) is a rare hypermetabolic disorder of skeletal muscles that manifests as a life-threatening crisis in susceptible individuals, after exposure to triggering agents, most commonly halothane and succinylcholine. MH presents with multiple nonspecific signs and laboratory findings such as tachycardia, hyperthermia, hypercarbia, acidosis, and muscle rigidity. Caffeine halothane contracture test is not available at most centers in India. Larach et al. have described a clinical grading scale for determining the MH raw score based on clinical findings and biochemical tests. The high degree of suspicion, early recognition and aggressive treatment should commence immediately. It is imperative to avoid triggering agents, such as volatile anesthetics and succinylcholine, and promote the use of total intravenous anesthesia in MH susceptible patients. We report a case of 6-month-old child undergoing laparotomy under general anesthesia, who presented with signs and symptoms of MH, had MH rank 5 and raw score 36. PMID:27375398

  11. Malignant hyperthermia in a 6-month-old infant

    PubMed Central

    Mathur, PR; Rundla, M; Jain, N; Mathur, V

    2016-01-01

    Malignant hyperthermia (MH) is a rare hypermetabolic disorder of skeletal muscles that manifests as a life-threatening crisis in susceptible individuals, after exposure to triggering agents, most commonly halothane and succinylcholine. MH presents with multiple nonspecific signs and laboratory findings such as tachycardia, hyperthermia, hypercarbia, acidosis, and muscle rigidity. Caffeine halothane contracture test is not available at most centers in India. Larach et al. have described a clinical grading scale for determining the MH raw score based on clinical findings and biochemical tests. The high degree of suspicion, early recognition and aggressive treatment should commence immediately. It is imperative to avoid triggering agents, such as volatile anesthetics and succinylcholine, and promote the use of total intravenous anesthesia in MH susceptible patients. We report a case of 6-month-old child undergoing laparotomy under general anesthesia, who presented with signs and symptoms of MH, had MH rank 5 and raw score 36. PMID:27375398

  12. Ethosuximide for Essential Tremor: An Open-Label Trial

    PubMed Central

    Gironell, Alexandre; Marin-Lahoz, Juan

    2016-01-01

    Background T-type calcium channel activation has been postulated to underlie rhythmicity in the olivo-cerebellar system that is implicated in ET. Ethosuximide reduces T-type calcium currents and can suppress tremor in two animal models of ET. We explored the effects of ethosuximide in subjects with ET in an open-label trial using both clinical scales and accelerometric recordings measures. We initially planned to conduct the trial with 15 patients, but due to lack of efficacy and a high incidence of adverse effects, the trial was stopped after seven patients had participated. Methods Seven patients diagnosed with ET were included in the study. The ethosuximide dose was 500 mg daily (BID). The main outcome measures were: 1) tremor clinical rating scale (TCRS) score, 2) accelerometric recordings, and 3) self-reported disability scale score. Results Five patients completed the study, and two dropped out due to adverse effects. There were no significant changes in clinical scores in motor task performance (TCRS 1+2), daily living activities (TCRS 3), or in the patients’ subjective assessment (TCRS 4) and global appraisal. There were no differences observed for accelerometry data or disability scale scores. Anxiety, nervousness, headache, and dizziness were reported by two patients while on ethosuximide, causing them to stop the trial. No patient preferred to continue ethosuximide treatment. Discussion The results of our exploratory study suggest that ethosuximide is not an effective treatment for ET. PMID:27625899

  13. Treatment of snoring and obstructive sleep apnea with a mandibular protruding device: an open-label study.

    PubMed

    Fransson, A M; Isacsson, G; Leissner, L C; Näsman, A B; Alton, M K

    2001-01-01

    The study objectives were to describe the changes in signs and symptoms of obstructive sleep apnea (OSA) and snoring using a mandibular protruding device (MPD) and to define the group of responders. The design of the study was a nonrandomized, open-labeled, prospective clinical study with a duration of 6 months. The setting was a hospital sleep laboratory and an ear, nose, and throat and dental outpatient clinic. Patients included 35 individuals treated: 22 with a diagnosis of OSA and 13 who snored without apnea. The intervention before MPD prescription entailed a medical examination, a one-night somnographic registration, a questionnaire, and a clinical jaw function examination. All procedures were iterated at the 6-month follow-up. When the patients used the MPD, the subjective symptoms decreased significantly (p < 0.001). Twenty-four of the 35 patients were classified as responders, i.e., reduced their symptoms > or = 50%. In the groups of OSA patients, the mean peak intensity of the snoring sound decreased from 71.6 dB to 62.0 dB (p < 0.001) and in the group of snorers, from 63.5 dB to 57.5 dB (p < 0.05). Eighteen of the 22 OSA patients decreased their ODI values by > or = 50% (responders). The mean ODI decreased from 15.4 to 3.5 (p < 0.001) and the blood oxygen saturation, SaO(2) nadir, increased from mean 81.9 to 85.7 (n.s.). Most patients with tongue base hyperplasia were classified as responders to the MPD treatment. In conclusion, a 6-month perspective shows that the MPD could be an effective treatment in reducing signs and symptoms of OSA and/or snoring, the compliance was acceptable and only minor adverse events occurred.

  14. Audiovisual temporal fusion in 6-month-old infants.

    PubMed

    Kopp, Franziska

    2014-07-01

    The aim of this study was to investigate neural dynamics of audiovisual temporal fusion processes in 6-month-old infants using event-related brain potentials (ERPs). In a habituation-test paradigm, infants did not show any behavioral signs of discrimination of an audiovisual asynchrony of 200 ms, indicating perceptual fusion. In a subsequent EEG experiment, audiovisual synchronous stimuli and stimuli with a visual delay of 200 ms were presented in random order. In contrast to the behavioral data, brain activity differed significantly between the two conditions. Critically, N1 and P2 latency delays were not observed between synchronous and fused items, contrary to previously observed N1 and P2 latency delays between synchrony and perceived asynchrony. Hence, temporal interaction processes in the infant brain between the two sensory modalities varied as a function of perceptual fusion versus asynchrony perception. The visual recognition components Pb and Nc were modulated prior to sound onset, emphasizing the importance of anticipatory visual events for the prediction of auditory signals. Results suggest mechanisms by which young infants predictively adjust their ongoing neural activity to the temporal synchrony relations to be expected between vision and audition.

  15. Compliance and acceptability of maintaining a 6-month pedometer diary in a rural, African American community-based walking intervention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Limited research has been done on the compliance and acceptability of maintaining the pedometer diaries for an extensive time frame in community-based interventions targeting minority populations. Community "coaches" led participants in a 6-month community-based walking intervention that included we...

  16. Perceived stress among a workforce 6 months following hurricane Katrina.

    PubMed

    Leon, Kyla A; Hyre, Amanda D; Ompad, Danielle; Desalvo, Karen B; Muntner, Paul

    2007-12-01

    To determine stress levels among a workforce 6 months after hurricane Katrina made landfall, a web-based survey that included the four-item Perceived Stress Scale was administered to employees of the largest employer in New Orleans. An overall Perceived Stress Scale score was obtained by pooling responses for the four items. Among 1,542 adult respondents, 24.1% stated they felt that they were "fairly often" or "very often" unable to control the important things in their life and 21.4% considered that their difficulties were "fairly often" or "very often" piling up so high that they could not overcome them. Also, 6.1% reported that they "almost never" or "never" felt confident about their ability to handle their personal problems and 15.2% indicated that things were "almost never" or "never" going their way. The overall mean Perceived Stress Scale score was 6.3 (standard deviation = 3.1; range = 0-16). Higher stress scale scores, indicating more stress, were present for women, and for participants with lower income, displaced longer than 3 months, who were more afraid of losing their life during hurricane Katrina and its immediate aftermath, and who knew someone that died during the storm. Additionally, participants who were living in a relative of friend's house or in a temporary trailer at the time of the survey had higher stress scores compared to their counterparts who had returned to live in their pre-hurricane residence. There was a direct association between higher stress scores and symptoms of post-traumatic stress disorder. Employers and health care providers should be apprised of the need for monitoring stress and offering counseling opportunities for returning workforces following future large-scale disasters. PMID:17932611

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  20. Adjunctive agomelatine therapy in the treatment of acute bipolar II depression: a preliminary open label study

    PubMed Central

    Fornaro, Michele; McCarthy, Michael J; De Berardis, Domenico; De Pasquale, Concetta; Tabaton, Massimo; Martino, Matteo; Colicchio, Salvatore; Cattaneo, Carlo Ignazio; D’Angelo, Emanuela; Fornaro, Pantaleo

    2013-01-01

    Purpose The circadian rhythm hypothesis of bipolar disorder (BD) suggests a role for melatonin in regulating mood, thus extending the interest toward the melatonergic antidepressant agomelatine as well as type I (acute) or II cases of bipolar depression. Patients and methods Twenty-eight depressed BD-II patients received open label agomelatine (25 mg/bedtime) for 6 consecutive weeks as an adjunct to treatment with lithium or valproate, followed by an optional treatment extension of 30 weeks. Measures included the Hamilton depression scale, Pittsburgh Sleep Quality Index, the Clinical Global Impression Scale–Bipolar Version, Young Mania Rating Scale, and body mass index. Results Intent to treat analysis results demonstrated that 18 of the 28 subjects (64%) showed medication response after 6 weeks (primary study endpoint), while 24 of the 28 subjects (86%) responded by 36 weeks. When examining primary mood stabilizer treatment, 12 of the 17 (70.6%) valproate and six of the 11 (54.5%) lithium patients responded by the first endpoint. At 36 weeks, 14 valproate treated (82.4%) and 10 lithium treated (90.9%) subjects responded. At 36 weeks, there was a slight yet statistically significant (P = 0.001) reduction in body mass index and Pittsburgh Sleep Quality Index scores compared to respective baseline values, regardless of mood stabilizer/outcome. Treatment related drop-out cases included four patients (14.28%) at week 6 two valproate-treated subjects with pseudo-vertigo and drug-induced hypomania, respectively, and two lithium-treated subjects with insomnia and mania, respectively. Week 36 drop outs were two hypomanic cases, one per group. Conclusion Agomelatine 25 mg/day was an effective and well-tolerated adjunct to valproate/lithium for acute depression in BD-II, suggesting the need for confirmation by future double blind, controlled clinical trials. PMID:23430979

  1. Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia

    ClinicalTrials.gov

    2016-08-01

    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

  2. Differential efficacy of treatment with acetylcholinesterase inhibitors in patients with mild and moderate Alzheimer's disease over a 6-month period.

    PubMed

    López-Pousa, S; Turon-Estrada, A; Garre-Olmo, J; Pericot-Nierga, I; Lozano-Gallego, M; Vilalta-Franch, M; Hernández-Ferràndiz, M; Morante-Muñoz, V; Isern-Vila, A; Gelada-Batlle, E; Majó-Llopart, J

    2005-01-01

    There are various anticholinesterase inhibitors (AChEIs) for the symptomatic treatment of mild to moderate Alzheimer's disease (AD). All AChEIs have shown greater efficacy than placebo in randomized, double-blind, parallel-group clinical trials. No differential studies have yet been made of the efficacy between all AChEIs. The study aims to determine the differential efficacy of the AChEIs with respect to a historical sample of patients with AD that were not treated with AChEIs. An open-label, prospective, observational study with a retrospective control group was undertaken to examine the evolution of the cognitive function over a 6-month period. The patients were assessed with the Mini-Mental State Examination (MMSE) at study entry and at 6 months. A general linear model was applied for repeated measurements with the MMSE score as the dependent variable, treatment type as an independent variable and the severity of the deterioration, age and the MMSE baseline score as covariables. Of the sample of 147 patients, 40 initiated treatment with donepezil, 32 with galantamine, 30 with rivastigmine and 45 were part of a historical sample of the memory clinic patients between 1991 and 1996 that had not been treated with AChEIs. The average age was 73.7 years (SD = 6.9; range = 52-86), 67.3% were women, 78.2% of the cases were mild and the MMSE baseline score was 18.1 points (range = 11-27). No significant intergroup differences were observed in these variables. The average doses of donepezil, galantamine and rivastigmine were 5.87 mg/day (SD = 1.92), 14.81 mg/day (SD = 6.25) and 6.41 mg/day (SD = 1.82), respectively. At 6 months, the difference in the MMSE score with respect to the untreated group was 1.6 points for donepezil (95% CI 0.79-2.37; p < 0.001), 0.99 points for galantamine (95% CI 0.14-1.85; p = 0.01) and 0.90 points for rivastigmine (95% CI 0.05-1.74; p = 0.03). No significant differences were observed in the efficacy among the groups treated with AChEIs (p

  3. Open-Label Trial of Atomoxetine Hydrochloride in Adults with ADHD

    ERIC Educational Resources Information Center

    Johnson, Mats; Cederlund, Mats; Rastam, Maria; Areskoug, Bjorn; Gillberg, Christopher

    2010-01-01

    Background: While atomoxetine is an established treatment for attention-deficit/hyperactivity disorder in children, few studies have examined its efficacy for adults. Methods: Open-label trial of atomoxetine in 20 individuals with ADHD, aged 19-47 years, for 10 weeks, and a total of one year for responders. Results: Ten patients met primary…

  4. Open-Label, Prospective Trial of Olanzapine in Adolescents with Subaverage Intelligence and Disruptive Behavioral Disorders

    ERIC Educational Resources Information Center

    Handen, Benjamin L.; Hardan, Antonio Y.

    2006-01-01

    Objective: Olanzapine, an atypical antipsychotic, has been shown to be efficacious for treatment of psychotic and mood disorders in adults. This prospective, open-label study was conducted to examine the safety and usefulness of olanzapine in treating disruptive behavior disorders in adolescents with subaverage intelligence. Method: Sixteen…

  5. An Open-Label Trial of Escitalopram in Pervasive Developmental Disorders.

    ERIC Educational Resources Information Center

    Owley, Thomas; Walton, Laura; Salt, Jeff; Guter, Stephen J., Jr.; Winnega, Marrea; Leventhal, Bennett L.; Cook, Edwin H., Jr.

    2005-01-01

    Objective: To assess the effect of escitalopram in the treatment of pervasive developmental disorders (PDDs). Method: This 10-week study had a forced titration, open-label design. Twenty-eight subjects (mean age 125.1 [+ or -] 33.5 months) with a PDD received escitalopram at a dose that increased weekly to a maximum dose of 20 mg as tolerated. The…

  6. STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study

    ERIC Educational Resources Information Center

    Erickson, Craig A.; Veenstra-Vanderweele, Jeremy M.; Melmed, Raun D.; McCracken, James T.; Ginsberg, Lawrence D.; Sikich, Linmarie; Scahill, Lawrence; Cherubini, Maryann; Zarevics, Peter; Walton-Bowen, Karen; Carpenter, Randall L.; Bear, Mark F.; Wang, Paul P.; King, Bryan H.

    2014-01-01

    STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32…

  7. Methylphenidate Transdermal System in Adults with Past Stimulant Misuse: An Open-Label Trial

    ERIC Educational Resources Information Center

    McRae-Clark, Aimee L.; Brady, Kathleen T.; Hartwell, Karen J.; White, Kathleen; Carter, Rickey E.

    2011-01-01

    Objective: This 8-week, open-label trial assessed the efficacy of methylphenidate transdermal system (MTS) in 14 adult individuals diagnosed with ADHD and with a history of stimulant misuse, abuse, or dependence. Method: The primary efficacy endpoint was the Wender-Reimherr Adult ADHD Scale (WRAADS), and secondary efficacy endpoints included the…

  8. Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial

    PubMed Central

    Malbrán, A; Riedl, M; Ritchie, B; Smith, W B; Yang, W; Banerji, A; Hébert, J; Gleich, G J; Hurewitz, D; Jacobson, K W; Bernstein, J A; Khan, D A; Kirkpatrick, C H; Resnick, D; Li, H; Fernández Romero, D S; Lumry, W

    2014-01-01

    Hereditary angioedema (HAE) is characterized by potentially life-threatening recurrent episodes of oedema. The open-label extension (OLE) phase of the For Angioedema Subcutaneous Treatment (FAST)-1 trial (NCT00097695) evaluated the efficacy and safety of repeated icatibant exposure in adults with multiple HAE attacks. Following completion of the randomized, controlled phase, patients could receive open-label icatibant (30 mg subcutaneously) for subsequent attacks. The primary end-point was time to onset of primary symptom relief, as assessed by visual analogue scale (VAS). Descriptive statistics were reported for cutaneous/abdominal attacks 1–10 treated in the OLE phase and individual laryngeal attacks. Post-hoc analyses were conducted in patients with ≥ 5 attacks across the controlled and OLE phases. Safety was evaluated throughout. During the OLE phase, 72 patients received icatibant for 340 attacks. For cutaneous/abdominal attacks 1–10, the median time to onset of primary symptom relief was 1·0–2·0 h. For laryngeal attacks 1–12, patient-assessed median time to initial symptom improvement was 0·3–1·2 h. Post-hoc analyses showed the time to onset of symptom relief based on composite VAS was consistent across repeated treatments with icatibant. One injection of icatibant was sufficient to treat 88·2% of attacks; rescue medication was required in 5·3% of attacks. No icatibant-related serious adverse events were reported. Icatibant provided consistent efficacy and was well tolerated for repeated treatment of HAE attacks. PMID:24749847

  9. Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial

    PubMed Central

    Rossi, Roberta; Bonanni, Alice; Quinn, Robert R.; Sica, Felice; Bodria, Monica; Pasini, Andrea; Montini, Giovanni; Edefonti, Alberto; Belingheri, Mirco; De Giovanni, Donatella; Barbano, Giancarlo; Degl’Innocenti, Ludovica; Scolari, Francesco; Murer, Luisa; Reiser, Jochen; Fornoni, Alessia; Ghiggeri, Gian Marco

    2015-01-01

    Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1–16 years who had developed SDNS in the previous 6–12 months and were maintained in remission with high prednisone doses (≥0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m2; intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m2 per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for ≥1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6–13.5 years]) were enrolled and followed for ≤60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS. PMID:25592855

  10. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

    PubMed Central

    Dalgleish, Angus G; Stebbing, Justin; Adamson, Douglas JA; Arif, Seema Safia; Bidoli, Paolo; Chang, David; Cheeseman, Sue; Diaz-Beveridge, Robert; Fernandez-Martos, Carlos; Glynne-Jones, Rob; Granetto, Cristina; Massuti, Bartomeu; McAdam, Karen; McDermott, Raymond; Martín, Andrés J Muñoz; Papamichael, Demetris; Pazo-Cid, Roberto; Vieitez, Jose M; Zaniboni, Alberto; Carroll, Kevin J; Wagle, Shama; Gaya, Andrew; Mudan, Satvinder S

    2016-01-01

    Background: Immune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. Methods: Patients were randomised (2 : 1) to IMM-101 (10 mg ml−l intradermally)+GEM (1000 mg m−2 intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) were collected. Results: IMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44–1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33–0.87, P=0.01). Conclusions: IMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study. PMID:27599039

  11. Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial

    PubMed Central

    Zhou, Zun-Qiang; Guan, Jiao; Tong, Da-Nian; Zhou, Guang-Wen

    2016-01-01

    Although the combination of cisplatin and gemcitabine (GEM) is considered the standard first-line chemotherapy against unresectable hilar cholangiocarcinoma (HC), its efficacy is discouraging. The present randomized open-label clinical trial aimed to evaluate the efficacy and safety of the GEM plus S-1 (GEM-S-1) combination against unresectable HC. Twenty-five patients per group were randomly assigned to receive GEM, S-1 or GEM-S-1. Neutropenia (56%) and leukopenia (40%) were the most common chemotherapy-related toxicities in the GEM-S-1 group. Median overall survival (OS) in the GEM-S-1, GEM and S-1 groups was 11, 10 and 6 months, respectively. GEM plus S-1 significantly improved OS compared to S-1 monotherapy (OR=0.68; 95%CI, 0.50–0.90; P=0.008). Median progression-free survival (PFS) times in the GEM-S-1, GEM and S-1 groups were 4.90, 3.70 and 1.60 months, respectively. GEM plus S-1 significantly improved PFS compared to S-1 monotherapy (OR=0.50; 95%CI, 0.27–0.91; P=0.024). Response rates were 36%, 24% and 8% in the GEM-S-1, GEM and S-1 groups, respectively. A statistically significant difference was found in response rates between the gemcitabine-S-1 and S-1 groups (36% vs 8%, P=0.017). Patients with CA19-9<466 U/ml were more responsive to chemotherapeutic agents than those with CA19-9≥571 U/ml (88.9% vs 0%, P<0.001). We conclude that the combination of GEM plus S-1 provides a better OS, PFS and response rate than S-1 monotherapy, but it did not significantly differ from GEM monotherapy. (ChiCTR-TRC-14004733). PMID:27058753

  12. Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial.

    PubMed

    Li, Hao; Zhang, Zheng-Yun; Zhou, Zun-Qiang; Guan, Jiao; Tong, Da-Nian; Zhou, Guang-Wen

    2016-05-01

    Although the combination of cisplatin and gemcitabine (GEM) is considered the standard first-line chemotherapy against unresectable hilar cholangiocarcinoma (HC), its efficacy is discouraging. The present randomized open-label clinical trial aimed to evaluate the efficacy and safety of the GEM plus S-1 (GEM-S-1) combination against unresectable HC. Twenty-five patients per group were randomly assigned to receive GEM, S-1 or GEM-S-1. Neutropenia (56%) and leukopenia (40%) were the most common chemotherapy-related toxicities in the GEM-S-1 group. Median overall survival (OS) in the GEM-S-1, GEM and S-1 groups was 11, 10 and 6 months, respectively. GEM plus S-1 significantly improved OS compared to S-1 monotherapy (OR=0.68; 95%CI, 0.50-0.90; P=0.008). Median progression-free survival (PFS) times in the GEM-S-1, GEM and S-1 groups were 4.90, 3.70 and 1.60 months, respectively. GEM plus S-1 significantly improved PFS compared to S-1 monotherapy (OR=0.50; 95%CI, 0.27-0.91; P=0.024). Response rates were 36%, 24% and 8% in the GEM-S-1, GEM and S-1 groups, respectively. A statistically significant difference was found in response rates between the gemcitabine-S-1 and S-1 groups (36% vs 8%, P=0.017). Patients with CA19-9<466 U/ml were more responsive to chemotherapeutic agents than those with CA19-9≥571 U/ml (88.9% vs 0%, P<0.001). We conclude that the combination of GEM plus S-1 provides a better OS, PFS and response rate than S-1 monotherapy, but it did not significantly differ from GEM monotherapy. (ChiCTR-TRC-14004733).

  13. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    PubMed Central

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  14. Imatinib mesylate (Gleevec) in the treatment of diffuse cutaneous systemic sclerosis: results of a 1-year, phase IIa, single-arm, open-label clinical trial

    PubMed Central

    Spiera, Robert F; Gordon, Jessica K; Mersten, Jamie N; Magro, Cynthia M; Mehta, Mansi; Wildman, Horatio F; Kloiber, Stacey; Kirou, Kyriakos A; Lyman, Stephen; Crow, Mary K

    2011-01-01

    Objective To assess the safety and effectiveness of imatinib mesylate in the treatment of diffuse cutaneous systemic sclerosis (dcSSc). Methods In this phase IIa, open-label, single-arm clinical trial, 30 patients with dcSSc were treated with imatinib 400 mg daily. Patients were monitored monthly for safety assessments. Modified Rodnan skin scores (MRSS) were assessed every 3 months. Pulmonary function testing, chest radiography, echocardiography and skin biopsies were performed at baseline and after 12 months of treatment. Results Twenty-four patients completed 12 months of therapy. 171 adverse events (AE) with possible relation to imatinib were identified; 97.6% were grade 1 or 2. Twenty-four serious AE were identified, two of which were attributed to study medication. MRSS decreased by 6.6 points or 22.4% at 12 months (p=0.001). This change was evident starting at the 6-month time point (Δ=−4.5; p<0.001) and was seen in patients with both early and late-stage disease. Forced vital capacity (FVC) improved by 6.4% predicted (p=0.008), and the diffusion capacity remained stable. The improvement in FVC was significantly greater in patients without interstitial lung disease. Health-related quality of life measures improved or remained stable. Blinded dermatopathological analysis confirmed a significant decrease in skin thickness and improvement in skin morphology. Conclusions Treatment with imatinib was tolerated by most patients in this cohort. Although AE were common, most were mild to moderate. In this open-label experience, improvements in skin thickening and FVC were observed. Further investigation of tyrosine kinase inhibition for dcSSc in a double-blind randomised placebo controlled trial is warranted. ClinicalTrials.gov, NCT00555581 PMID:21398330

  15. A cohort study of developmental polychlorinated biphenyl (PCB) exposure in relation to post-vaccination antibody response at 6-months of age

    SciTech Connect

    Jusko, Todd A.; De Roos, Anneclaire J.; Schwartz, Stephen M.; Paige Lawrence, B.; Palkovicova, Lubica; Nemessanyi, Tomas; Drobna, Beata; Fabisikova, Anna; Kocan, Anton; Sonneborn, Dean; Jahnova, Eva; Kavanagh, Terrance J.; Trnovec, Tomas; Hertz-Picciotto, Irva

    2010-05-15

    Background: Extensive experimental data in animals indicate that exposure to polychlorinated biphenyls (PCBs) during pregnancy leads to changes in offspring immune function during the postnatal period. Whether developmental PCB exposure influences immunologic development in humans has received little study. Methods: The study population was 384 mother-infant pairs recruited from two districts of eastern Slovakia for whom prospectively collected maternal, cord, and 6-month infant blood specimens were available. Several PCB congeners were measured in maternal, cord, and 6-month infant sera by high-resolution gas chromatography with electron capture detection. Concentrations of IgG-specific anti-haemophilus influenzae type b, tetanus toxoid, and diphtheria toxoid were assayed in 6-month infant sera using ELISA methods. Multiple linear regression was used to estimate the relation between maternal, cord, and 6-month infant PCB concentrations and the antibody concentrations evaluated at 6-months of age. Results: Overall, there was little evidence of an association between infant antibody concentrations and PCB measures during the pre- and early postnatal period. In addition, our results did not show specificity in terms of associations limited to a particular developmental period (e.g. pre- vs. postnatal), a particular antibody, or a particular PCB congener. Conclusions: At the PCB concentrations measured in this cohort, which are high relative to most human populations today, we did not detect an association between maternal or early postnatal PCB exposure and specific antibody responses at 6-months of age.

  16. A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea.

    PubMed

    Lee, Nam Young; Kim, Se Hyun; Cho, Seong Jin; Chung, Young-Cho; Jung, In Kwa; Kim, Chang Yoon; Kim, Duk Ho; Lee, Dong Geun; Lee, Yo Han; Lim, Weon Jeong; Na, Young Suk; Shin, Sang Eun; Woo, Jong-Min; Yoon, Jin Sang; Yoon, Bo-Hyun; Ahn, Yong Min; Kim, Yong Sik

    2014-09-01

    This study was designed to investigate long-term clinical outcomes of risperidone long-acting injectable (RLAI) in patients with schizophrenia or schizoaffective disorder. An open-label, 48-week, prospective study of RLAI treatment was carried out at 63 centers in South Korea. Initial and maintenance dosage of RLAI were adjusted according to clinical judgment. Efficacy was measured by the remission rate, continuation rate, and changes in the clinical measurements such as eight items of the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression - Severity, and the Schizophrenia Quality of Life Scale. In terms of the safety, Simpson-Angus rating Scale, adverse events (AEs), and BMI were investigated. Of the 522 patients who were enrolled, 472 patients who had been assessed on the eight items of PANSS at baseline and at least once during RLAI treatment were included in the intention-to-treat (ITT) population. The per-protocol (PP) population included 184 patients (39.0%), who completed all assessments during 48 weeks of the follow-up period. Total scores of eight items of PANSS, Clinical Global Impression - Severity, and Schizophrenia Quality of Life Scale were reduced significantly from baseline to endpoint in both ITT and PP populations. The mean dose (SD) of RLAI was 33.2 (7.6) mg. In the PP population, the number of patients who scored 1-3 on eight items of PANSS were 47 (25.5%) at baseline and 144 (78.3%) at 48 weeks. According to the remission defining as scores 1-3 on eight items of PANSS sustaining of at least 6 months' duration by Andreasen, the numbers of patients who achieved remission were 45 (24.5%) at 24 weeks and 120 (65.2%) at 48 weeks. A significant decrease in the mean score of Simpson-Angus rating Scale and a significant increase in BMI over time in last observation carried forward were observed, and patients who fulfilled the remission criteria during the study showed more weight gain than those who did not. During the study

  17. Self-reported Recent PrEP Dosing and Drug Detection in an Open Label PrEP Study.

    PubMed

    Amico, K Rivet; Mehrotra, Megha; Avelino-Silva, Vivian I; McMahan, Vanessa; Veloso, Valdilea G; Anderson, Peter; Guanira, Juan; Grant, Robert

    2016-07-01

    Monitoring adherence to pre-exposure prophylaxis (PrEP) is part of the recommended package for PrEP prescribing, yet ongoing concerns about how to do so confidently are exacerbated by gross discrepancies in reported and actual use in clinical trials. We evaluated concordance between reports of recent PrEP dosing collected via neutral interviewing and drug quantitation in the iPrEx open-label extension, where participants (n = 1172) had the choice to receive or not receive PrEP. Self-report of recent dosing (at least one PrEP dose in the past 3-day) was the most common report (84 % of participants), and among these 83 % did have quantifiable levels of drug. The vast majority of those reporting no doses in the past 3-day (16 % of the sample) did not have quantifiable levels of drug (82 %). Predictors of over-report of dosing included younger age and lower educational attainment. Monitoring recent PrEP use through neutral interviewing may be a productive approach for clinicians to consider in implementation of real-world PrEP. Strategies to capture longer term or prevention-effective PrEP use, particularly for younger cohorts, are needed.

  18. Influence of growth during infancy on endothelium-dependent vasodilatation at the age of 6 months.

    PubMed

    Touwslager, Robbert N H; Gerver, Willem-Jan M; Tan, Frans E S; Gielen, Marij; Zeegers, Maurice P; Zimmermann, Luc J; Houben, Alfons J H M; Blanco, Carlos E; Stehouwer, Coen D A; Mulder, Antonius L M

    2012-11-01

    Low birth weight and accelerated infant growth are associated with cardiovascular disease in adulthood. Endothelial dysfunction is regarded as a precursor of atherosclerosis and is also related to infant growth. We aimed to examine whether an association between infant growth and endothelial function is already present during discrete periods of growth during the first 6 months of life in healthy term infants. A cohort of 104 newborns was studied in the first week after birth and reexamined at the age of 6 months. Maximum vasodilatation in response to acetylcholine (endothelium dependent) and nitroprusside (endothelium independent) was measured in the vasculature of the forearm skin, using laser Doppler flowmetry and iontophoresis. Growth was calculated as difference in Z scores for weight, length, weight-for-length, and head circumference. Multivariable multilevel linear regression was used for the analysis. Growth from 0 to 1 month (calculated as difference in weight) was the only window in the first 6 months of life that was significantly and inversely associated with endothelium-dependent vasodilatation at 6 months (b=-11.72 perfusion units per Z score, P=0.01 in multivariable analysis). Birth size was not important when considered simultaneously with infant growth. Maximum endothelium-independent vasodilatation was not associated with birth size or growth parameters. We conclude that growth in the first month of life is inversely associated with endothelium-dependent vasodilatation at the age of 6 months in healthy term infants, regardless of birth size.

  19. Infant sleep development from 3 to 6 months postpartum: links with maternal sleep and paternal involvement.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Volkovich, Ella; Manber, Rachel; Meiri, Gal; Shahar, Golan

    2015-03-01

    The aims of this longitudinal study were to examine (a) development of infant sleep and maternal sleep from 3 to 6 months postpartum; (b) concomitant and prospective links between maternal sleep and infant sleep; and (c) triadic links between paternal involvement in infant caregiving and maternal and infant sleep. The study included 57 families that were recruited during pregnancy. Maternal and infant sleep was assessed using actigraphy and sleep diaries for 5 nights. Both fathers and mothers completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. The results demonstrated moderate improvement in infant and maternal sleep percent between 3 and 6 months. Maternal sleep percent at 3 months significantly predicted infant sleep percent at 6 months. Greater paternal involvement in infant daytime and nighttime caregiving at 3 months significantly predicted more consolidated maternal and infant sleep at 6 months. These findings suggest that maternal sleep is an important predictor of infant sleep and that increased involvement of fathers in infant caregiving responsibilities may contribute to improvements in both maternal and infant sleep during the first 6 months postpartum.

  20. A model to examine the validity of the 6-month abstinence criterion for liver transplantation.

    PubMed

    Yates, W R; Martin, M; LaBrecque, D; Hillebrand, D; Voigt, M; Pfab, D

    1998-04-01

    Six months of abstinence from alcohol is a commonly used criterion for liver transplantation eligibility for patients with alcoholic cirrhosis. There is limited evidence to document the validity of this criterion with regard to risk of alcoholism relapse. Ninety-one patients with alcoholic cirrhosis were interviewed for relapse risk using the High Risk Alcoholism Relapse (HRAR) Scale. The HRAR model can be used to predict relapse risk independent of duration of sobriety and therefore can be used to examine the validity of the 6 months of abstinence criteria in this clinical population. The two methods demonstrated poor to fair agreement. Agreement was highest with a cutoff allowing a 5% 6-month relapse risk when 79% agreement (c = 0.56) was demonstrated between the two methods. Using the 6-month abstinence criterion alone disallows a significant number of candidates who have a low relapse risk based on their HRAR score. The validity of the 6-month abstinence criterion is supported somewhat by comparison with the HRAR model. However, use of the 6-month abstinence criterion alone forces a significant number of patients with a low relapse risk by HRAR to wait for transplant listing. A relapse risk model based on an estimate of alcoholism severity in addition to duration of sobriety may more accurately select patients who are most likely to benefit from liver transplantation. PMID:9581661

  1. Infant sleep development from 3 to 6 months postpartum: links with maternal sleep and paternal involvement.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Volkovich, Ella; Manber, Rachel; Meiri, Gal; Shahar, Golan

    2015-03-01

    The aims of this longitudinal study were to examine (a) development of infant sleep and maternal sleep from 3 to 6 months postpartum; (b) concomitant and prospective links between maternal sleep and infant sleep; and (c) triadic links between paternal involvement in infant caregiving and maternal and infant sleep. The study included 57 families that were recruited during pregnancy. Maternal and infant sleep was assessed using actigraphy and sleep diaries for 5 nights. Both fathers and mothers completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. The results demonstrated moderate improvement in infant and maternal sleep percent between 3 and 6 months. Maternal sleep percent at 3 months significantly predicted infant sleep percent at 6 months. Greater paternal involvement in infant daytime and nighttime caregiving at 3 months significantly predicted more consolidated maternal and infant sleep at 6 months. These findings suggest that maternal sleep is an important predictor of infant sleep and that increased involvement of fathers in infant caregiving responsibilities may contribute to improvements in both maternal and infant sleep during the first 6 months postpartum. PMID:25704738

  2. Perception of neon color spreading in 3-6-month-old infants.

    PubMed

    Yang, Jiale; Kanazawa, So; Yamaguchi, Masami K

    2009-12-01

    Although lots of studies about neon color spreading have been reported, few of these studies have focused on the perceptual development of it in human infants. Therefore, this study explores the perceptual development of neon color spreading in infants. In experiment 1, we examined 3-6-month-olds' perception of neon color spreading in static conditions. In experiment 2, we examined 3-6-month-olds' perception of neon color spreading in moving conditions. Our results suggest that while only 5-6-month-old infants show a preference for neon color spreading in the static condition, 3-4-month-old infants also prefer neon color spreading if motion information is available.

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

    PubMed

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

    2016-02-01

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

  4. Local Heat Application for the Treatment of Buruli Ulcer: Results of a Phase II Open Label Single Center Non Comparative Clinical Trial

    PubMed Central

    Vogel, Moritz; Bayi, Pierre F.; Ruf, Marie-Thérèse; Bratschi, Martin W.; Bolz, Miriam; Um Boock, Alphonse; Zwahlen, Marcel; Pluschke, Gerd; Junghanss, Thomas

    2016-01-01

    Background. Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material. Methods. In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints ‘absence of clinical BU specific features’ or ‘wound closure’ within 6 months (“primary cure”), and ‘absence of clinical recurrence within 24 month’ (“definite cure”). Results. Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm2. Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions. Conclusions. Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available. Clinical Trials Registration. ISRCT 72102977. PMID:26486698

  5. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    PubMed Central

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-01-01

    Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

  6. Surgical Retrieval of Tooth Fragment from Lower Lip and Reattachment after 6 Months of Trauma

    PubMed Central

    Bansal, Kalpana; Srivastava, Ankit; Maheshwari, Neha

    2015-01-01

    ABSTRACT Dental traumas are one of the most frequent facial traumas especially in children. Maxillary incisors are the most frequently involved teeth. Here we present, a report of a child who sustained a crown fracture with lost portion of tooth embedded in her lower lip for 6 months. The fragment was surgically retrieved and successfully reattached to the fractured 21 using acid-etch resin technique. How to cite this article: Marwaha M, Bansal K, Srivastava A, Maheshwari N. Surgical Retrieval of Tooth Fragment from Lower Lip and Reattachment after 6 Months of Trauma. Int J Clin Pediatr Dent 2015;8(2):145-148. PMID:26379385

  7. Peyronie's disease and low intensity shock wave therapy: Clinical outcomes and patient satisfaction rate in an open-label single arm prospective study in Australian men

    PubMed Central

    2015-01-01

    Purpose To evaluate the efficacy, safety and patient satisfaction outcomes following low intensity extracorporeal shock wave therapy (LiESWT) in men with Peyronie's disease (PD) using a standardised protocol. Materials and Methods In this open-label single arm prospective study, patients with PD were enrolled following informed consent. Patient demographics, change in penile curvature and plaque hardness, International Index of Erectile Function (IIEF)-5 score, and overall satisfaction score (on a 5-point scale) were recorded. Treatment template consists of 3000 shock waves to the Peyronie's plaque over 20 minutes, twice weekly for 6 weeks. Results The majority of patients have PD history longer than 6 months (mean, 12.8 months; range, 6-28 months). Two thirds of patients have received and failed oral medical therapy. There were improvements in penile curvature (more than 15 degrees in 33% of men), plaque hardness (60% of men) and penile pain (4 out of 6 men) following LiESWT. There was a moderate improvement in IIEF-5 score (>5 points reported in 20% of men). No complication was reported and the majority of patients were satisfied (rated 4 out of 5; 70% of men) and would recommend this therapy to others. Conclusions In a carefully selected group of men with PD, LiESWT appears to be safe, has moderate efficacy and is associated with high patient satisfaction rate in the short term. PMID:26568796

  8. Transient hypogammaglobulinemia and severe atopic dermatitis: Open-label treatment with immunoglobulin in a case series

    PubMed Central

    Lin, Joanna H.; Roberts, Robert; Lim, Kellie J.; Stiehm, E. Richard

    2016-01-01

    Background: We reported on six infants between 5 and 11 months old, with transient hypogammaglobulinemia of infancy and severe refractory atopic dermatitis, who were treated with open-label immunoglobulin (Ig) after conventional therapy failed. All six infants had an IgG level of <225 mg/dL, elevated eosinophil and IgE levels, and no urine or stool protein losses, but they did exhibit hypoalbuminemia. Objective: To evaluate the utility of open-label immunoglobulin in infants with severe atopic dermatitis for whom conventional therapy failed. We reviewed the clinical utility of intravenous immunoglobulin in the treatment of severe atopic dermatitis, the most recent research in the field, and suggested mechanisms for its benefit. Methods: The six infants were identified from a retrospective chart review at the University of California Los Angeles Allergy and Immunology outpatient pediatric clinic. Results: All six patients were treated with 400 mg/kg/month of intravenous immunoglobulin and had normalization of their IgG and albumin levels, and all but one had clinically improved atopic dermatitis. Conclusion: Infants with severe atopic dermatitis who did not respond to conventional therapy avoidance may benefit from intravenous immunoglobulin therapy. PMID:27470901

  9. Mississippi Communities for Healthy Living: Results of a 6-month nutrition education comparative effectiveness trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The United States Lower Mississippi Delta (LMD) region suffers from high prevalence of chronic health conditions with nutritional etiologies, including obesity, high cholesterol, hypertension, and diabetes. Responding to the need for effective nutrition interventions in the LMD, a 2-arm, 6-month, n...

  10. Conditioning 1-6 Month Old Infants by Means of Myoelectrically Controlled Reinforcement.

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

    In order to evaluate possibilities of fitting myoelectrically controlled prosthetic arms on infants, this study examined whether 32 infants (1-6 months) could learn to control environmental contingencies by means of contracting the forearm flexor muscle group. Results indicated that older subjects (age greater than 104 days) demonstrated learning,…

  11. Relationship between Visual and Tactual Exploration by 6-Month-Olds.

    ERIC Educational Resources Information Center

    Bushnell, Emily W.; And Others

    1985-01-01

    Investigating relationship between infants' visual and tactual exploration, looking and touching responses of 6-month-olds to objects only visually or tactually novel were observed. Results indicated infants were capable of tactual recognition memory, that temperature was salient object property, and that visual and tactual exploration are not…

  12. Infant and Maternal Behaviors Regulate Infant Reactivity to Novelty at 6 Months

    ERIC Educational Resources Information Center

    Crockenberg, Susan C.; Leerkes, Esther M.

    2004-01-01

    Three issues were investigated: (a) the regulatory effects of presumed infant and maternal regulation behaviors on infant distress to novelty at 6 months, (b) stability of infant regulatory effects across contexts that vary in maternal involvement, and (c) associations and temporal dynamics between infant and maternal regulation behaviors.…

  13. Determining the Impact of Prenatal Tobacco Exposure on Self-Regulation at 6 Months

    ERIC Educational Resources Information Center

    Wiebe, Sandra A.; Fang, Hua; Johnson, Craig; James, Karen E.; Espy, Kimberly Andrews

    2014-01-01

    Our goal in the present study was to examine the effects of maternal smoking during pregnancy on infant self-regulation, exploring birth weight as a mediator and sex as a moderator of risk. A prospective sample of 218 infants was assessed at 6 months of age. Infants completed a battery of tasks assessing working memory/inhibition, attention, and…

  14. Night Waking in 6-Month-Old Infants and Maternal Depressive Symptoms

    ERIC Educational Resources Information Center

    Karraker, Katherine Hildebrandt; Young, Marion

    2007-01-01

    Relations between night waking in infants and depressive symptoms in their mothers at 6 months postpartum were examined using the data from the National Institute for Child Health and Human Development Study of Early Child Care. Although more depressive symptoms were only weakly correlated with a higher frequency of infant waking, longer wake…

  15. Child-Parent Psychotherapy: 6-Month Follow-up of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lieberman, Alicia F.; Ippen, Chandra Ghosh; Van Horn, Patricia

    2006-01-01

    Objective: To examine the durability of improvement in child and maternal symptoms 6 months after termination of child-parent psychotherapy (CPP). Method: Seventy-five multiethnic preschool-age child-mother dyads from diverse socioeconomic backgrounds were randomly assigned to (1) CPP or (2) case management plus community referral for individual…

  16. The Impact of SNAP-ED and EFNEP on Program Graduates 6 Months after Graduation

    ERIC Educational Resources Information Center

    Koszewski, Wanda; Sehi, Natalie; Behrends, Donnia; Tuttle, Elizabeth

    2011-01-01

    Research was conducted to determine if graduates from either the Supplemental Nutrition Assistance Program-Education or Expanded Food and Nutrition Education Program maintained behavioral changes 6 months after completing the program. Staff asked graduates to complete a 10- or 15-question behavior checklist that was identical to the entry and exit…

  17. Perception of Speech Modulation Cues by 6-Month-Old Infants

    ERIC Educational Resources Information Center

    Cabrera, Laurianne; Bertoncini, Josiane; Lorenzi, Christian

    2013-01-01

    Purpose: The capacity of 6-month-old infants to discriminate a voicing contrast (/aba/--/apa/) on the basis of "amplitude modulation (AM) cues" and "frequency modulation (FM) cues" was evaluated. Method: Several vocoded speech conditions were designed to either degrade FM cues in 4 or 32 bands or degrade AM in 32 bands. Infants…

  18. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe.

    PubMed

    Pérez-Romero, P; Bulnes-Ramos, A; Torre-Cisneros, J; Gavaldá, J; Aydillo, T A; Moreno, A; Montejo, M; Fariñas, M C; Carratalá, J; Muñoz, P; Blanes, M; Fortún, J; Suárez-Benjumea, A; López-Medrano, F; Barranco, J L; Peghin, M; Roca, C; Lara, R; Cordero, E

    2015-11-01

    Preventing influenza infection early after transplantation is essential, given the disease's high mortality. A multicentre prospective cohort study in adult solid organ transplant recipients (SOTR) receiving the influenza vaccine during four consecutive influenza seasons (2009-2013) was performed to assess the immunogenicity and safety of influenza vaccination in SOTR before and 6 months after transplantation. A total of 798 SOTR, 130 of them vaccinated within 6 months of transplantation and 668 of them vaccinated more than 6 months since transplantation. Seroprotection was similar in both groups: 73.1% vs. 76.5% for A/(H1N1)pdm (p 0.49), 67.5% vs. 74.1% for A/H3N2 (p 0.17) and 84.2% vs. 85.2% for influenza B (p 0.80), respectively. Geometric mean titres after vaccination did not differ among groups: 117.32 (95% confidence interval (CI) 81.52, 168.83) vs. 87.43 (95% CI 72.87, 104.91) for A/(H1N1)pdm, 120.45 (95% CI 82.17, 176.57) vs. 97.86 (95% CI 81.34, 117.44) for A/H3N2 and 143.32 (95% CI 103.46, 198.53) vs. 145.54 (95% CI 122.35, 174.24) for influenza B, respectively. After adjusting for confounding factors, time since transplantation was not associated with response to vaccination. No cases of rejection or severe adverse events were detected in patients vaccinated within the first 6 months after transplantation. In conclusion, influenza vaccination within the first 6 months after transplantation is as safe and immunogenic as vaccination thereafter. Thus, administration of the influenza vaccine can be recommended as soon as 1 month after transplantation.

  19. A 6-month supervised employer-based minimal exercise program for police officers improves fitness.

    PubMed

    Rossomanno, Colleen I; Herrick, Jeffery E; Kirk, Stacie M; Kirk, Erik P

    2012-09-01

    The purpose of the study was to determine the effects of a 6-month supervised, job-specific moderate exercise program in police officers on body composition, cardiovascular and muscular fitness. Body weight (BW), body mass index (BMI), and cardiovascular and muscular fitness were assessed at baseline, after a 6-month supervised fitness program and at 12-month follow-up (18 months). One hundred sixty-five (n = 131 men and n = 34 women) young (mean ± SEM, 26.4 ± 1.9 years), overweight (BMI = 26.2 ± 1.2 kg·m) police officers participated. Aerobic exercise progressed from 3 d·wk, 20 minutes per session at 60% of the heart rate reserve (HRR) to 5 d·wk, 30 minutes per session at 75% of HRR at 3 months, and this level was maintained until 6 months. Muscular strength training progressed using 8 different calisthenics exercises from 3 d·wk, 2 sets of 5 repetitions using the participant's own BW to 5 d·wk, 3 sets of 15 repetitions of the participant's own BW at 3 months, and this level was maintained until 6 months. Cardiovascular and muscular fitness was measured using a 0.25-mile obstacle course incorporating various job-specific exercises and expressed as the physical abilities test (PAT) time. There was a significant reduction in BMI (-0.6 ± 0.2 kg·m, p < 0.001) and BW (-2.8 ± 2.3 kg) and reduction in PAT time (-11.9 ± 2.1%, p < 0.01) from baseline to 6 months. However, BMI (1.4 ± 1.1 kg·m, p < 0.001), BW (5.1 ± 3.0 kg, p < 0.01), and PAT time significantly increased (12.8 ± 2.2%, p < 0.01) from 6 to 18 months. There were no sex by time differences. The practical applications of this study indicate that a supervised, job-specific exercise program for police officers improves fitness and body composition after 6 months in both men and women, but continued supervision of exercise program may be necessary for maintenance of health benefits.

  20. Crown lengthening in the maxillary anterior region: a 6-month prospective clinical study.

    PubMed

    Deas, David E; Mackey, Scott A; Sagun, Ruben S; Hancock, Raymond H; Gruwell, Scott F; Campbell, Casey M

    2014-01-01

    The purpose of this study was to assess osseous parameters and stability of maxillary anterior teeth following crown lengthening surgery. Thirty-six patients requiring facial crown lengthening of 277 maxillary anterior and first premolar teeth were included. Presurgical and intraoperative clinical measurements were recorded at baseline and 1, 3, and 6 months postsurgery at midfacial, mesiofacial, and distofacial line angles. The data presented here suggest that when crown lengthening anterior maxillary teeth, the distance between the desired gingival margin and alveolar crest is usually insufficient to allow for biologic width. In addition, there is significant tissue rebound that may stabilize by 6 months. Tissue rebound appears related to flap position relative to the alveolar crest at suturing. These findings suggest that clinicians should establish proper anterior crown length with osseous resection.

  1. Predicting sights from sounds: 6-month old infants’ intermodal numerical abilities

    PubMed Central

    Feigenson, Lisa

    2011-01-01

    Although the psychophysics of infants’ non-symbolic number representations has been well studied, less is known about other characteristics of the Approximate Number System (ANS) in young children. Here, 3 experiments explored the extent to which the ANS yields abstract representations by testing infants’ ability to transfer approximate number representations across sensory modalities. These experiments showed that 6-month old infants matched the approximate number of sounds they heard to the approximate number of sights they saw, looking longer at visual arrays that numerically mis-matched a previously heard auditory sequence. This looking preference was observed when sights and sounds mismatched by 1:3 and 1:2 ratios, but not by a 2:3 ratio. These findings suggest that infants can compare numerical information obtained in different modalities using representations stored in memory. Furthermore, the acuity of 6-month old infants’ comparisons of intermodal numerical sequences appears to parallel that of their comparisons of unimodal sequences. PMID:21616502

  2. An unusual form of localized papulonodular cutaneous histiocytosis in a 6-month-old boy.

    PubMed

    van Haselen, C W; Toonstra, J; den Hengst, C W; van Vloten, W A

    1995-09-01

    We report a 6-month-old boy with an unusual form of cutaneous histiocytosis. The lesions were noticed shortly after birth, and there was no evidence of systemic disease. This histiocytic disorder could not be classified according to the Histiocyte Society classification, and was therefore designated an 'unclassified' group II histiocytic disorder. The clinical picture was characterized by dark-red papulonodules with a tendency to coalesce into plaques. Histologically, the infiltrate was characterized by non-epidermotropic histiocytes showing varying degrees of differentiation, eosinophils and lymphocytes, and by the absence of foamy cells and Touton giant cells. As a most conspicuous feature, electron microscopic examination revealed laminated dense bodies, whereas Birbeck granules and comma-shaped bodies were absent. This further distinguished this uncommon variant from the well-known class II histiocytoses. During a 6-month follow-up period all the lesions showed marked regression.

  3. Prevention of Traumatic Stress in Mothers of Preterms: 6-Month Outcomes

    PubMed Central

    St John, Nick; Lilo, Emily; Jo, Booil; Benitz, William; Stevenson, David K.; Horwitz, Sarah M.

    2014-01-01

    OBJECTIVE: Symptoms of posttraumatic stress disorder are a well-recognized phenomenon in mothers of preterm infants, with implications for maternal health and infant outcomes. This randomized controlled trial evaluated 6-month outcomes from a skills-based intervention developed to reduce symptoms of posttraumatic stress disorder, anxiety, and depression. METHODS: One hundred five mothers of preterm infants were randomly assigned to (1) a 6- or 9-session intervention based on principles of trauma-focused cognitive behavior therapy with infant redefinition or (2) a 1-session active comparison intervention based on education about the NICU and parenting of the premature infant. Outcome measures included the Davidson Trauma Scale, the Beck Depression Inventory II, and the Beck Anxiety Inventory. Participants were assessed at baseline, 4 to 5 weeks after birth, and 6 months after the birth of the infant. RESULTS: At the 6-month assessment, the differences between the intervention and comparison condition were all significant and sizable and became more pronounced when compared with the 4- to 5-week outcomes: Davidson Trauma Scale (Cohen's d = −0.74, P < .001), Beck Anxiety Inventory (Cohen's d = −0.627, P = .001), Beck Depression Inventory II (Cohen's d = −0.638, P = .002). However, there were no differences in the effect sizes between the 6- and 9-session interventions. CONCLUSIONS: A brief 6-session intervention based on principles of trauma-focused cognitive behavior therapy was effective at reducing symptoms of trauma, anxiety, and depression in mothers of preterm infants. Mothers showed increased benefits at the 6-month follow-up, suggesting that they continue to make use of techniques acquired during the intervention phase. PMID:25049338

  4. An open-label naturalistic pilot study of acamprosate in youth with autistic disorder.

    PubMed

    Erickson, Craig A; Early, Maureen; Stigler, Kimberly A; Wink, Logan K; Mullett, Jennifer E; McDougle, Christopher J

    2011-12-01

    To date, placebo-controlled drug trials targeting the core social impairment of autistic disorder (autism) have had uniformly negative results. Given this, the search for new potentially novel agents targeting the core social impairment of autism continues. Acamprosate is U.S. Food and Drug Administration-approved drug to treat alcohol dependence. The drug likely impacts both gamma-aminobutyric acid and glutamate neurotransmission. This study describes our initial open-label experience with acamprosate targeting social impairment in youth with autism. In this naturalistic report, five of six youth (mean age, 9.5 years) were judged treatment responders to acamprosate (mean dose 1,110 mg/day) over 10 to 30 weeks (mean duration, 20 weeks) of treatment. Acamprosate was well tolerated with only mild gastrointestinal adverse effects noted in three (50%) subjects.

  5. Internalized stigma of mental illness and depressive and psychotic symptoms in homeless veterans over 6 months.

    PubMed

    Boyd, Jennifer E; Hayward, H'Sien; Bassett, Elena D; Hoff, Rani

    2016-06-30

    We investigated the relationship between internalized stigma of mental illness at baseline and depressive and psychotic symptoms 3 and 6 months later, controlling for baseline symptoms. Data on homeless veterans with severe mental illness (SMI) were provided by the Northeast Program Evaluation Center (NEPEC) Special Needs-Chronic Mental Illness (SN-CMI) study (Kasprow and Rosenheck, 2008). The study used the Internalized Stigma of Mental Illness (ISMI) scale to measure internalized stigma at baseline and the Symptom Checklist-90-R (SCL-90-R) to measure depressive and psychotic symptoms at baseline and 3 and 6 month follow-ups. Higher levels of internalized stigma were associated with greater levels of depressive and psychotic symptoms 3 and 6 months later, even controlling for symptoms at baseline. Alienation and Discrimination Experience were the subscales most strongly associated with symptoms. Exploratory analyses of individual items yielded further insight into characteristics of potentially successful interventions that could be studied. Overall, our findings show that homeless veterans with SMI experiencing higher levels of internalized stigma are likely to experience more depression and psychosis over time. This quasi-experimental study replicates and extends findings of other studies and has implications for future controlled research into the potential long-term effects of anti-stigma interventions on mental health recovery.

  6. Neck strain in car occupants: injury status after 6 months and crash-related factors.

    PubMed

    Ryan, G A; Taylor, G W; Moore, V M; Dolinis, J

    1994-10-01

    In this study, 29 individuals who sustained a neck strain as a result of a car crash were drawn from a group of physiotherapy and general practices and were followed up after 6 months. The aim was to examine relationships between the state of the neck injury at the time of follow up and crash-related factors, notably crash severity and occupant awareness. Crash severity was assessed by measurement of damage to the involved vehicles, while 6-month injury status was established through physical examinations and interviews. No statistically significant associations between crash severity and 6-month injury status were found, but subjects who were unaware of the impending collision had a greatly increased likelihood of experiencing persisting symptoms of and/or signs of neck strain, compared with those who were aware (odds ratio = 15.0; 95 per cent confidence limits: 1.8, 178). While the role of crash severity in the production and duration of neck strains remains unclear, awareness appears to have a strong protective influence and may prove to be a useful prognostic indicator in clinical settings.

  7. Curcumin effects on blood lipid profile in a 6-month human study.

    PubMed

    Baum, Larry; Cheung, Stanley K K; Mok, Vincent C T; Lam, Linda C W; Leung, Vivian P Y; Hui, Elsie; Ng, Chelsia C Y; Chow, Moses; Ho, Ping C; Lam, Sherry; Woo, Jean; Chiu, Helen F K; Goggins, William; Zee, Benny; Wong, Adrian; Mok, Hazel; Cheng, William K F; Fong, Carmen; Lee, Jenny S W; Chan, Ming-Houng; Szeto, Samuel S L; Lui, Victor W C; Tsoh, Joshua; Kwok, Timothy C Y; Chan, Iris H S; Lam, Christopher W K

    2007-12-01

    Studies in animals and a short-term human study have suggested that curcumin, a polyphenolic compound concentrated in the curry spice turmeric, decreases serum cholesterol concentration. However, no controlled human trials have examined the effect of curcumin on cholesterol. This study investigated the effects of consuming curcumin on the serum lipid profile in men and women. Elderly subjects (n=36) consumed 4 g/d curcumin, 1g/d curcumin, or placebo in a 6-month, randomized, double-blind trial. Plasma curcumin and its metabolites were measured at 1 month, and the serum lipid profile was measured at baseline, 1 month, and 6 months. The plasma curcumin concentration reached a mean of 490 nmol/L. The curcumin concentration was greater after capsule than powder administration. Consumption of either dose of curcumin did not significantly affect triacylglycerols, or total, LDL, and HDL cholesterol over 1 month or 6 months. However, the concentrations of plasma curcumin and serum cholesterol were positively and significantly correlated. Curcumin consumption does not appear to have a significant effect on the serum lipid profile, unless the absorbed concentration of curcumin is considered, in which case curcumin may modestly increase cholesterol.

  8. Repairing the Brain by SCF+G-CSF Treatment at 6 Months Postexperimental Stroke

    PubMed Central

    Cui, Lili; Wang, Dandan; McGillis, Sandra; Kyle, Michele

    2016-01-01

    Stroke, a leading cause of adult disability in the world, is a severe medical condition with limited treatment. Physical therapy, the only treatment available for stroke rehabilitation, appears to be effective within 6 months post-stroke. Here, we have mechanistically determined the efficacy of combined two hematopoietic growth factors, stem cell factor (SCF) and granulocyte-colony stimulating factor (G-CSF; SCF + G-CSF), in brain repair 6 months after cortical infarct induction in the transgenic mice carrying yellow fluorescent protein in Layer V pyramidal neurons (Thy1-YFP-H). Using a combination of live brain imaging, whole brain imaging, molecular manipulation, synaptic and vascular assessments, and motor function examination, we found that SCF + G-CSF promoted mushroom spine formation, enlarged postsynaptic membrane size, and increased postsynaptic density-95 accumulation and blood vessel density in the peri-infarct cavity cortex; and that SCF + G-CSF treatment improved motor functional recovery. The SCF + G-CSF-enhanced motor functional recovery was dependent on the synaptic and vascular regeneration in the peri-infarct cavity cortex. These data suggest that a stroke-damaged brain is repairable by SCF + G-CSF even 6 months after the lesion occurs. This study provides novel insights into the development of new restorative strategies for stroke recovery. PMID:27511907

  9. ARE OPEN-LABEL PLACEBOS ETHICAL? INFORMED CONSENT AND ETHICAL EQUIVOCATIONS

    PubMed Central

    Blease, Charlotte; Colloca, Luana; Kaptchuk, Ted J

    2016-01-01

    The doctor-patient relationship is built on an implicit covenant of trust yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebearers physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified.. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect AND SUCH EFFECTS NECESSARILY INVOLVE A BINARY DISTIINCTION BETWEEN AUTONOMY AND BENEFICIENCE. In this paper we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. PMID:26840547

  10. Neuromuscular Evaluation With Single-Leg Squat Test at 6 Months After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Hall, Michael P.; Paik, Ronald S.; Ware, Anthony J.; Mohr, Karen J.; Limpisvasti, Orr

    2015-01-01

    Background: Criteria for return to unrestricted activity after anterior cruciate ligament (ACL) reconstruction varies, with some using time after surgery as the sole criterion—most often at 6 months. Patients may have residual neuromuscular deficits, which may increase the risk of ACL injury. A single-leg squat test (SLST) can dynamically assess for many of these deficits prior to return to unrestricted activity. Hypothesis: A significant number of patients will continue to exhibit neuromuscular deficits with SLST at 6 months after ACL reconstruction. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Patients using a standardized accelerated rehabilitation protocol at their 6-month follow-up after primary ACL reconstruction were enrolled. Evaluation included bilateral SLST, single-leg hop distance, hip abduction strength, and the subjective International Knee Documentation Committee (IKDC) score. Results: Thirty-three patients were enrolled. Poor performance of the operative leg SLST was found in 15 of 33 patients (45%). Of those 15 patients, 7 (45%) had concomitant poor performance of the nonoperative leg compared with 2 of 18 patients (11%) in those who demonstrated good performance in the operative leg. The poor performers were significantly older (33.6 years) than the good performers (24.2 years) (P = .007). Those with poor performance demonstrated decreased hip abduction strength (17.6 kg operative leg vs 20.5 kg nonoperative leg) (P = .024), decreased single-leg hop distance (83.3 cm operative leg vs 112.3 cm nonoperative leg) (P = .036), and lower IKDC scores (67.9 vs 82.3) (P = .001). Conclusion: Nearly half of patients demonstrated persistent neuromuscular deficits on SLST at 6 months, which is when many patients return to unrestricted activity. Those with poor performance were of a significantly older age, decreased hip abduction strength, decreased single-leg hop distance, and lower IKDC subjective scores. Clinical Relevance: The SLST

  11. 78 FR 54218 - Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... that are not only important for airport safety, agricultural use, and restoration activities, but also... Mazama Pocket Gopher as Threatened On December 11, 2012, we published a proposed rule (77 FR 73770) to... comment period for an additional 30 days to accept additional public comments (78 FR 20074; April 3,...

  12. 78 FR 57835 - Endangered and Threatened Wildlife and Plants; Notice of 6-Month Extension of the Final...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... Federal Register (77 FR 73219) in response to a petition from the Center of Biological Diversity to list... Coral as Threatened or Endangered Under the Endangered Species Act and Reclassify Acropora cervicornis... corals (59 in the Pacific and seven in the Caribbean) and to re- classify two species already...

  13. 76 FR 75858 - Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... published a proposed rule (75 FR 77801) to list the dunes sagebrush lizard, a lizard known from southeastern... the dunes sagebrush lizard that was published in the Federal Register on December 14, 2010 (75 FR... public meetings in April 2011 and reopened the comment period to accept additional public comments (76...

  14. 78 FR 41022 - Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... in the Federal Register a proposed rule (77 FR 73828) to list the lesser prairie-chicken (Tympanuchus... Oklahoma, and the Texas Panhandle, as a threatened species under the Endangered Species Act of 1973, as..., 2013; in Garden City, Kansas, on February 7, 2013; in Lubbock, Texas, on February 11, 2013; and...

  15. 78 FR 51129 - Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... salamanders. (2) Data on water quality and quantity as it relates to the status of these two species. (3... disagreement regarding the sufficiency or accuracy of the available data relevant to our determination... 77 FR 50768, is reopened. We will consider all comments received or postmarked on or before...

  16. 78 FR 43123 - Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determinations on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-19

    ... the amount of future growth in human populations and development that is expected to occur within the...; (4) Projections for future residential development and human population growth within Gunnison sage... (78 FR 2486) and a proposed designation of critical habitat for the Gunnison sage-grouse (78 FR...

  17. Risperidone in Children with Disruptive Behavior Disorders and Subaverage Intelligence: A 1-Year, Open-Label Study of 504 Patients

    ERIC Educational Resources Information Center

    Croonenberghs, Jan; Fegert, Joerg M.; Findling, Robert L.; de Smedt, Goedele; van Dongen, Stefan

    2005-01-01

    Objective: To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children. Method: A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted. Results: Seventy-three percent of the 504 patients enrolled completed the study.…

  18. ADHD Treatment with Once-Daily OROS Methylphenidate: Final Results from a Long-term Open-Label Study

    ERIC Educational Resources Information Center

    Wilens, Timothy; McBurnett, Keith; Stein, Mark; Lerner, Marc; Spencer, Thomas; Wolraich, Mark

    2005-01-01

    Objective: Few studies have assessed effectiveness and tolerability of stimulants when used for prolonged periods in children with attention-deficit/hyperactivity disorder (ADHD). This article presents final results from an open-label, multisite study of a once-daily formulation of methylphenidate (MPH), OROS[R] MPH. Method: Subjects received OROS…

  19. Six-Week Open-Label Reboxetine Treatment in Children and Adolescents with Attention-Deficit/hyperactivity Disorder.

    ERIC Educational Resources Information Center

    Ratner, Sharon; Laor, Nathaniel; Bronstein, Yifat; Weizman, Abraham; Toren, Paz

    2005-01-01

    Objective: This open-label study assessed the effectiveness of reboxetine, a selective norepinephrine reuptake inhibitor, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) resistant to a previous methylphenidate trial. Method: Thirty-one child and adolescent outpatients, aged 8 to 18 (mean age, 11.7; SD = 2.87)…

  20. Top-down modulation in the infant brain: Learning-induced expectations rapidly affect the sensory cortex at 6 months

    PubMed Central

    Emberson, Lauren L.; Richards, John E.; Aslin, Richard N.

    2015-01-01

    Recent theoretical work emphasizes the role of expectation in neural processing, shifting the focus from feed-forward cortical hierarchies to models that include extensive feedback (e.g., predictive coding). Empirical support for expectation-related feedback is compelling but restricted to adult humans and nonhuman animals. Given the considerable differences in neural organization, connectivity, and efficiency between infant and adult brains, it is a crucial yet open question whether expectation-related feedback is an inherent property of the cortex (i.e., operational early in development) or whether expectation-related feedback develops with extensive experience and neural maturation. To determine whether infants’ expectations about future sensory input modulate their sensory cortices without the confounds of stimulus novelty or repetition suppression, we used a cross-modal (audiovisual) omission paradigm and used functional near-infrared spectroscopy (fNIRS) to record hemodynamic responses in the infant cortex. We show that the occipital cortex of 6-month-old infants exhibits the signature of expectation-based feedback. Crucially, we found that this region does not respond to auditory stimuli if they are not predictive of a visual event. Overall, these findings suggest that the young infant’s brain is already capable of some rudimentary form of expectation-based feedback. PMID:26195772

  1. Infants, mothers, and dyadic contributions to stability and prediction of social stress response at 6 months.

    PubMed

    Provenzi, Livio; Olson, Karen L; Montirosso, Rosario; Tronick, Ed

    2016-01-01

    The study of infants' interactive style and social stress response to repeated stress exposures is of great interest for developmental and clinical psychologists. Stable maternal and dyadic behavior is critical to sustain infants' development of an adaptive social stress response, but the association between infants' interactive style and social stress response has received scant attention in previous literature. In the present article, overtime stability of infant, maternal, and dyadic behaviors was measured across 2 social stress (i.e., Face-to-Face Still-Face, FFSF) exposures, separated by 15 days. Moreover, infant, maternal, and dyadic behaviors were simultaneously assessed as predictors of infants' social stress to both FFSF exposures. Eighty-one mother-infant dyads underwent the FFSF twice, at 6 months (Exposure 1: the first social stress) and at 6 months and 15 days (Exposure 2: repeated social stress). Infant and mother behavior and dyadic synchrony were microanalytically coded. Overall, individual behavioral stability emerged between FFSF exposures. Infants' response to the first stress was predicted by infant behavior during Exposure 1 Play. Infants' response to the repeated social stress was predicted by infants' response to the first exposure to the Still-Face and by infants' behavior and dyadic synchrony during Exposure 2 Play. Findings reveal stability for individual, but not for dyadic, behavior between 2 social stress exposures at 6 months. Infants' response to repeated social stress was predicted by infants' earlier stress response, infants' own behavior in play, and dyadic synchrony. No predictive effects of maternal behavior were found. Insights for research and clinical work are discussed.

  2. Local cytokine changes in complex regional pain syndrome type I (CRPS I) resolve after 6 months.

    PubMed

    Lenz, Melanie; Uçeyler, Nurcan; Frettlöh, Jule; Höffken, Oliver; Krumova, Elena K; Lissek, Silke; Reinersmann, Annika; Sommer, Claudia; Stude, Philipp; Waaga-Gasser, Ana M; Tegenthoff, Martin; Maier, Christoph

    2013-10-01

    There is evidence that inflammatory processes are involved in at least the early phase of complex regional pain syndrome (CRPS). We compared a panel of pro- and antiinflammatory cytokines in skin blister fluids and serum from patients with CRPS and patients with upper-limb pain of other origin (non-CRPS) in the early stage (< 1 year) and after 6 months of pain treatment. Blister fluid was collected from the affected and contralateral nonaffected side. We used a multiplex-10 bead array cytokine assay and Luminex technology to measure protein concentrations of the cytokines interleukin-1 receptor antagonist (IL-1RA), IL-2, IL-6, IL-8, IL-10, IL-12p40, and tumor necrosis factor-alpha (TNF-α) and the chemokines eotaxin, monocyte chemotactic protein-1 (MCP-1), and macrophage inflammatory protein-1β (MIP-1β). We found bilaterally increased proinflammatory TNF-α and MIP-1β and decreased antiinflammatory IL-1RA protein levels in CRPS patients compared to non-CRPS patients. Neither group showed side differences. After 6 months under analgesic treatment, protein levels of all measured cytokines in CRPS patients, except for IL-6, significantly changed bilaterally to the level of non-CRPS patients. These changes were not related to treatment outcome. In serum, only IL-8, TNF-α, eotaxin, MCP-1, and MIP-1β were detectable without intergroup differences. Blister fluid of CRPS patients showed a bilateral proinflammatory cytokine profile. This profile seems to be relevant only at the early stage of CRPS. Almost all measured cytokine levels were comparable to those of non-CRPS patients after 6 months of analgesic treatment and were not related to treatment outcome.

  3. Prenatal maternal depression alters amygdala functional connectivity in 6-month-old infants

    PubMed Central

    Qiu, A; Anh, T T; Li, Y; Chen, H; Rifkin-Graboi, A; Broekman, B F P; Kwek, K; Saw, S-M; Chong, Y-S; Gluckman, P D; Fortier, M V; Meaney, M J

    2015-01-01

    Prenatal maternal depression is associated with alterations in the neonatal amygdala microstructure, shedding light on the timing for the influence of prenatal maternal depression on the brain structure of the offspring. This study aimed to examine the association between prenatal maternal depressive symptomatology and infant amygdala functional connectivity and to thus establish the neural functional basis for the transgenerational transmission of vulnerability for affective disorders during prenatal development. Twenty-four infants were included in this study with both structural magnetic resonance imaging (MRI) and resting-state functional MRI (fMRI) at 6 months of age. Maternal depression was assessed at 26 weeks of gestation and 3 months after delivery using the Edinburgh Postnatal Depression Scale. Linear regression was used to identify the amygdala functional networks and to examine the associations between prenatal maternal depressive symptoms and amygdala functional connectivity. Our results showed that at 6 months of age, the amygdala is functionally connected to widespread brain regions, forming the emotional regulation, sensory and perceptual, and emotional memory networks. After controlling for postnatal maternal depressive symptoms, infants born to mothers with higher prenatal maternal depressive symptoms showed greater functional connectivity of the amygdala with the left temporal cortex and insula, as well as the bilateral anterior cingulate, medial orbitofrontal and ventromedial prefrontal cortices, which are largely consistent with patterns of connectivity observed in adolescents and adults with major depressive disorder. Our study provides novel evidence that prenatal maternal depressive symptomatology alters the amygdala's functional connectivity in early postnatal life, which reveals that the neuroimaging correlates of the familial transmission of phenotypes associated with maternal mood are apparent in infants at 6 months of age. PMID:25689569

  4. Infants, mothers, and dyadic contributions to stability and prediction of social stress response at 6 months.

    PubMed

    Provenzi, Livio; Olson, Karen L; Montirosso, Rosario; Tronick, Ed

    2016-01-01

    The study of infants' interactive style and social stress response to repeated stress exposures is of great interest for developmental and clinical psychologists. Stable maternal and dyadic behavior is critical to sustain infants' development of an adaptive social stress response, but the association between infants' interactive style and social stress response has received scant attention in previous literature. In the present article, overtime stability of infant, maternal, and dyadic behaviors was measured across 2 social stress (i.e., Face-to-Face Still-Face, FFSF) exposures, separated by 15 days. Moreover, infant, maternal, and dyadic behaviors were simultaneously assessed as predictors of infants' social stress to both FFSF exposures. Eighty-one mother-infant dyads underwent the FFSF twice, at 6 months (Exposure 1: the first social stress) and at 6 months and 15 days (Exposure 2: repeated social stress). Infant and mother behavior and dyadic synchrony were microanalytically coded. Overall, individual behavioral stability emerged between FFSF exposures. Infants' response to the first stress was predicted by infant behavior during Exposure 1 Play. Infants' response to the repeated social stress was predicted by infants' response to the first exposure to the Still-Face and by infants' behavior and dyadic synchrony during Exposure 2 Play. Findings reveal stability for individual, but not for dyadic, behavior between 2 social stress exposures at 6 months. Infants' response to repeated social stress was predicted by infants' earlier stress response, infants' own behavior in play, and dyadic synchrony. No predictive effects of maternal behavior were found. Insights for research and clinical work are discussed. PMID:26569560

  5. Data analysis of 87 tic patients for 6 months' treatment in a Korean medicine clinic.

    PubMed

    Chun, Young-Ho; Kim, Won-Ill; Kim, Bo-Kyung

    2013-10-01

    This study was carried out to investigate the relationship between the therapeutic effects of treatment for tic disorder and Korean medicine clinical tests, including body mass index (BMI) and heart variability rate (HRV). This study was not a clinical trial, but a data analysis of 87 tic patients who were treated for 6 months during the time period from Nov. 2010 to Jan. 2012. The clinical evaluation of the symptoms was recorded using the Korean version of the Yale Global Tic Severity Scale (YGTSS). The BMI and the HRV were measured according to a schedule, and various kinds of statistical methods were used. Among the 87 patients, the number of males was 3.34 times the number of females, and 58 patients (66.7%) had been suffering for more than 12 months. The onset age of the males was significantly lower than that of the females, and males had the symptoms longer than females had. Also, males with a family history of tics were 2.5 times as many as females, and their onset ages were substantially lower. At the first medical examinations, the average score on the YGTSS was 34.08, and it decreased linearly as the treatment progressed. After 4 and 6 months of treatment, it had decreased significantly. The YGTSS score and the period of suffering correlated positively. At the first visit, each HRV datum was in the normal range. After the 6 months' treatment, Ln (TP), Ln (LF), and Ln (HF) had dropped substantially in the normal range while Ln (VLF) and the LF/HF ratio had not changed in a meaningful way. During the treatment period, the BMI stayed relatively constant without any meaningful changes.

  6. Quadriceps neural alterations in anterior cruciate ligament reconstructed patients: A 6-month longitudinal investigation.

    PubMed

    Lepley, A S; Gribble, P A; Thomas, A C; Tevald, M A; Sohn, D H; Pietrosimone, B G

    2015-12-01

    The purpose of this investigation was to evaluate differences in quadriceps corticospinal excitability, spinal-reflexive excitability, strength, and voluntary activation before, 2 weeks post and 6 months post-anterior cruciate ligament reconstruction (ACLr). This longitudinal, case-control investigation examined 20 patients scheduled for ACLr (11 females, 9 males; age: 20.9 ± 4.4 years; height:172.4 ± 7.5 cm; weight:76.2 ± 11.8 kg) and 20 healthy controls (11 females, 9 males; age:21.7 ± 3.7 years; height: 173.7 ± 9.9 cm; weight: 76.1 ± 19.7 kg). Maximal voluntary isometric contractions (MVIC), central activation ratio (CAR), normalized Hoffmann spinal reflexes, active motor threshold (AMT), and normalized motor-evoked potential (MEP) amplitudes at 120% of AMT were measured in the quadriceps muscle at the specific time points. ACLr patients demonstrated bilateral reductions in spinal-reflexive excitability compared with controls before surgery (P = 0.02) and 2 weeks post-surgery (P ≤ 0.001). ACLr patients demonstrated higher AMT at 6 months post-surgery (P ≤ 0.001) in both limbs. No MEP differences were detected. Quadriceps MVIC and CAR were lower in both limbs of the ACLr group before surgery and 6 months post-surgery (P ≤ 0.05) compared with controls. Diminished excitability of spinal-reflexive and corticospinal pathways are present at different times following ACLr and occur in combination with clinical deficits in quadriceps strength and activation. Early rehabilitation strategies targeting spinal-reflexive excitability may help improve postoperative outcomes, while later-stage rehabilitation may benefit from therapeutic techniques aimed at improving corticospinal excitability.

  7. A Prospective Controlled Study of Kidney Donors: Baseline and 6-Month Follow-up

    PubMed Central

    Kasiske, Bertram L.; Anderson-Haag, Teresa; Ibrahim, Hassan N.; Pesavento, Todd E.; Weir, Matthew R.; Nogueira, Joseph M.; Cosio, Fernando G.; Kraus, Edward S.; Rabb, Hamid H.; Kalil, Roberto S.; Posselt, Andrew A.; Kimmel, Paul L.; Steffes, Michael W.

    2013-01-01

    Background Most previous studies of living kidney donors have been retrospective and have lacked suitable healthy controls. Needed are prospective controlled studies to better understand the effects of a mild reduction in kidney function from kidney donation in otherwise normal individuals. Study Design Prospective, controlled, observational cohort study. Setting & Participants Consecutive patients approved for donation at 8 transplant centers in the US were asked to participate. For every donor enrolled, an equally healthy control with 2 kidneys who theoretically would have been suitable to donate a kidney was also enrolled. Predictor Kidney donation. Measurements At baseline pre-donation and at 6 months after donation, a medical history, vital signs, measured (iohexol) glomerular filtration rate and other measurements were collected. There were 201 donors and 198 controls that completed both baseline and 6 month visits and form the basis of this report. Results Compared to controls, donors had 28% lower glomerular filtration rate at 6 months (94.6±15.1 [SD] v. 67.6±10.1 mL/min/1.73m2; P<0.001), associated with a 23% greater parathyroid hormone (42.8±15.6 v. 52.7±20.9 pg/mL; P<0.001), 5.4% lower serum phosphate (3.5±0.5 v. 3.3±0.5 mg/dL; P<0.001), 3.7% lower hemoglobin (13.6±1.4 v. 13.1±1.2 g/dL; P<0.001), 8.2% greater uric acid (4.9±1.2 v. 5.3±1.1 mg/dL; P<0.001), 24% greater homocysteine (1.20±0.34 v. 1.49±0.43 mg/L; P<0.001), and 1.5% lower high density lipoprotein cholesterol (54.9±16.4 v. 54.1±13.9 mg/dL; P=0.03) level. There were no differences in albumin-creatinine ratios (5.0 [IQR, 4.0-6.6] v. 5.0 [IQR, 3.3-5.4] mg/g; P=0.5), office blood pressure, or glucose homeostasis. Limitations Short duration of follow-up and possible bias resulting from an inability to screen controls with kidney and vascular imaging performed in donors. Conclusions Kidney donors have some, but not all, abnormalities typically associated with mild chronic kidney

  8. A near fatality in a 6-month-old boy from an aspirated toy.

    PubMed

    Dorfman, Annette; Pauze, Denis; Tilney, Pete

    2011-01-01

    At 6:27 p.m., a local flight team was activated for an interfacility transfer of a 6-month-old boy with a foreign body aspiration. The child was reportedly playing with an older sibling at home. According to the patient's mother, she stepped out of the room briefly and returned to find the child coughing and mildly cyanotic. The older sibling reported that the baby had ingested an object that was likely a plastic toy. Ground 911 EMS was called, and the child was transported to a local community hospital without any change in his respiratory status. PMID:21382562

  9. Pertussis in infants less than 6 months of age and household contacts, Italy, April 2014.

    PubMed

    Sali, Michela; Buttinelli, Gabriele; Fazio, Cecilia; Vacca, Paola; La Sorda, Marilena; Carannante, Anna; Spanu, Teresa; Valentini, Piero; Stefanelli, Paola

    2015-01-01

    We report pertussis cases in 4 infants less than 6 months admitted with symptoms compatible with pertussis to the intensive care unit of the Università Cattolica del Sacro Cuore in Rome, April 2014. Realtime PCR confirmed pertussis diagnosis for the 4 infants, 2 of them were cousins, and for the household contacts of 1 of them. Analysis of pertussis toxin, its promoter and pertactin was also performed. First of all, this report emphasizes the need to investigate household contact of infants with pertussis; secondly, to evaluate the selective vaccination of household members of newborns as an effective program to reduce pertussis in infants.

  10. Efficacy of Two versus Three-Day Regimens of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Military Personnel in Northern Cambodia: An Open-Label Randomized Trial

    PubMed Central

    Vanachayangkul, Pattaraporn; So, Mary; Sea, Darapiseth; Se, Youry; Gosi, Panita; Lanteri, Charlotte; Chaorattanakawee, Suwanna; Sriwichai, Sabaithip; Chann, Soklyda; Kuntawunginn, Worachet; Buathong, Nillawan; Nou, Samon; Walsh, Douglas S.; Tyner, Stuart D.; Juliano, Jonathan J.; Lin, Jessica; Spring, Michele; Bethell, Delia; Kaewkungwal, Jaranit; Tang, Douglas; Chuor, Char Meng; Satharath, Prom; Saunders, David

    2014-01-01

    Introduction Emerging antimalarial drug resistance in mobile populations remains a significant public health concern. We compared two regimens of dihydroartemisinin-piperaquine in military and civilians on the Thai-Cambodian border to evaluate national treatment policy. Methods Efficacy and safety of two and three-day regimens of dihydroartemisinin-piperaquine were compared as a nested open-label evaluation within a malaria cohort study in 222 otherwise healthy volunteers (18% malaria-infected at baseline). The first 80 volunteers with slide-confirmed Plasmodium falciparum or vivax malaria were randomized 1:1 to receive either regimen (total dose 360mg dihydroartemisinin and 2880mg piperaquine) and followed weekly for up to 6 months. The primary endpoint was malaria recurrence by day 42. Volunteers with vivax infection received primaquine at study discharge with six months follow-up. Results Eighty patients (60 vivax, 15 falciparum, and 5 mixed) were randomized to dihydroartemisinin-piperaquine. Intention-to-treat all-species efficacy at Day 42 was 85% for the two-day regimen (95% CI 69–94) and 90% for the three-day regimen (95% CI 75–97). PCR-adjusted falciparum efficacy was 75% in both groups with nearly half (45%) still parasitemic at Day 3. Plasma piperaquine levels were comparable to prior published reports, but on the day of recrudescence were below measurable in vitro piperaquine IC50 levels in all falciparum treatment failures. Conclusions In the brief period since introduction of dihydroartemisinin-piperaquine, there is early evidence suggesting declining efficacy relative to previous reports. Parasite IC50 levels in excess of plasma piperaquine levels seen only in treatment failures raises concern for clinically significant piperaquine resistance in Cambodia. These findings warrant improved monitoring of clinical outcomes and follow-up, given few available alternative drugs. Trial Registration ClinicalTrials.gov NCT01280162 PMID:24667662

  11. Exenatide Treatment for 6 Months Improves Insulin Sensitivity in Adults With Type 1 Diabetes

    PubMed Central

    Sarkar, Gayatri; Alattar, May; Brown, Rebecca J.; Quon, Michael J.; Harlan, David M.; Rother, Kristina I.

    2014-01-01

    OBJECTIVE Exenatide treatment improves glycemia in adults with type 2 diabetes and has been shown to reduce postprandial hyperglycemia in adolescents with type 1 diabetes. We studied the effects of exenatide on glucose homeostasis in adults with long-standing type 1 diabetes. RESEARCH DESIGN AND METHODS Fourteen patients with type 1 diabetes participated in a crossover study of 6 months' duration on exenatide (10 μg four times a day) and 6 months off exenatide. We assessed changes in fasting and postprandial blood glucose and changes in insulin sensitivity before and after each study period. RESULTS High-dose exenatide therapy reduced postprandial blood glucose but was associated with higher fasting glucose concentrations without net changes in hemoglobin A1c. Exenatide increased insulin sensitivity beyond the effects expected as a result of weight reduction. CONCLUSIONS Exenatide is a promising adjunctive agent to insulin therapy because of its beneficial effects on postprandial blood glucose and insulin sensitivity in patients with type 1 diabetes. PMID:24194508

  12. Infant Humor Perception from 3- to 6-months and Attachment at One Year

    PubMed Central

    Mireault, Gina; Sparrow, John; Poutre, Merlin; Perdue, Brittany; Macke, Laura

    2012-01-01

    Infancy is a critical time for the development of secure attachment, which is facilitated by emotionally synchronous interactions with parents. Humor development, which includes shared laughter and joint attention to an event, emerges concurrently with attachment, but little is known regarding the relationship, if any, between humor development and attachment in the first year. Thirty 3-month-old infants were videoed at home each month until they were 6-months old while their parents attempted to amuse them. Frequency of infants’ smiles and laughs served as a measure of “state humor”, and the smiling/laughing subscale of the Infant Behavior Questionnaire-Revised served as a measure of “trait humor”. State and trait humor were not correlated. Lower trait humor as 6 months predicted higher attachment security on the Attachment Q-sort at 12-months (r=. 46), suggesting that less good-humored infants elicit greater parental engagement, which works to the benefit of attachment, or vice versa. Future studies should examine the importance of smiling and laughter as they relate to other developmental phenomena in the first year. PMID:22982281

  13. [Inconsolable crying revealing primary erythermalgia in a 6-month-old infant].

    PubMed

    Ahogo, K-C; Menet, V; Modiano, P; Lasek, A

    2014-03-01

    Erythermalgia is a peripheral vascular disease triggered by exposure to heat. The primary infantile form is rare. No cases have been described in infants. We report a case in a 6-month-old child revealed by crying bouts associated with erythema of the lower limbs. A 6-month-old child was brought in for consultation for daily crying bouts, occurring six times a day, associated with erythema of the lower limbs. Blood count, abdominal ultrasound and endoscopy were normal, excluding gastroesophageal reflux and intussusception. Attacks disappeared during winter but recurred at high temperatures. The diagnosis was primary infant erythemalgia. Treatment with analgesics and ice packs was established. Erythermalgia is a rare peripheral vascular disease characterized by paroxysmal pain triggered by heat and relieved by cold. The primary form occurs in childhood but has never been reported in infants. The pathophysiology is based on an alteration of sodium channels inducing neuropathy in small-caliber fibers. Genetic mutations have been found in the SNC9 gene on chromosome 2q, with autosomal dominant transmission. Support of this condition is difficult due to resistance to conventional analgesics. The prognosis is sometimes poor with a significant death rate in the pediatric population. PMID:24468061

  14. A cornea substitute derived from fish scale: 6-month followup on rabbit model.

    PubMed

    Yuan, Fei; Wang, Liyan; Lin, Chien-Chen; Chou, Cheng-Hung; Li, Lei

    2014-01-01

    A fish scale-derived cornea substitute (Biocornea) is proposed as an alternative for human donor corneal tissue. We adopt a regenerative medicine approach to design a primary alternative to the use of fish scale for restoring sight by corneal replacement. Biocornea with corneal multilayer arrangement collagen was implanted to rabbits by pocket implantation. Our study demonstrated the safety and detailed morphologic and physiologic results from the 6 months of followup of rabbit model. In the peripheral Biocornea, the collagen fibrils were arranged in reticular fashion. Slit lamp examination showed that haze and an ulcer were not observed in all groups at 3 months postoperatively while all corneas with Biocornea were clear at both 3 months and 6 months postoperatively. The interface of Biocornea and stromal tissue were filled successfully and without observable immune cells at postoperative day 180. Moreover, the Biocornea was not dissolved and degenerated but remained transparent and showed no apparent fragmentation. Our study demonstrated that the Biocornea derived from fish scale as a good substitute had high biocompatibility and support function after a long-term evaluation. This revealed that the new approach of using Biocornea may yield an ideal artificial cornea substitute for long-term inlay placement. PMID:25089206

  15. A Cornea Substitute Derived from Fish Scale: 6-Month Followup on Rabbit Model

    PubMed Central

    Yuan, Fei; Wang, Liyan; Lin, Chien-Chen; Chou, Cheng-Hung; Li, Lei

    2014-01-01

    A fish scale-derived cornea substitute (Biocornea) is proposed as an alternative for human donor corneal tissue. We adopt a regenerative medicine approach to design a primary alternative to the use of fish scale for restoring sight by corneal replacement. Biocornea with corneal multilayer arrangement collagen was implanted to rabbits by pocket implantation. Our study demonstrated the safety and detailed morphologic and physiologic results from the 6 months of followup of rabbit model. In the peripheral Biocornea, the collagen fibrils were arranged in reticular fashion. Slit lamp examination showed that haze and an ulcer were not observed in all groups at 3 months postoperatively while all corneas with Biocornea were clear at both 3 months and 6 months postoperatively. The interface of Biocornea and stromal tissue were filled successfully and without observable immune cells at postoperative day 180. Moreover, the Biocornea was not dissolved and degenerated but remained transparent and showed no apparent fragmentation. Our study demonstrated that the Biocornea derived from fish scale as a good substitute had high biocompatibility and support function after a long-term evaluation. This revealed that the new approach of using Biocornea may yield an ideal artificial cornea substitute for long-term inlay placement. PMID:25089206

  16. Implications of newborn amygdala connectivity for fear and cognitive development at 6-months-of-age.

    PubMed

    Graham, Alice M; Buss, Claudia; Rasmussen, Jerod M; Rudolph, Marc D; Demeter, Damion V; Gilmore, John H; Styner, Martin; Entringer, Sonja; Wadhwa, Pathik D; Fair, Damien A

    2016-04-01

    The first year of life is an important period for emergence of fear in humans. While animal models have revealed developmental changes in amygdala circuitry accompanying emerging fear, human neural systems involved in early fear development remain poorly understood. To increase understanding of the neural foundations of human fear, it is important to consider parallel cognitive development, which may modulate associations between typical development of early fear and subsequent risk for fear-related psychopathology. We, therefore, examined amygdala functional connectivity with rs-fcMRI in 48 neonates (M=3.65 weeks, SD=1.72), and measured fear and cognitive development at 6-months-of-age. Stronger, positive neonatal amygdala connectivity to several regions, including bilateral anterior insula and ventral striatum, was prospectively associated with higher fear at 6-months. Stronger amygdala connectivity to ventral anterior cingulate/anterior medial prefrontal cortex predicted a specific phenotype of higher fear combined with more advanced cognitive development. Overall, findings demonstrate unique profiles of neonatal amygdala functional connectivity related to emerging fear and cognitive development, which may have implications for normative and pathological fear in later years. Consideration of infant fear in the context of cognitive development will likely contribute to a more nuanced understanding of fear, its neural bases, and its implications for future mental health.

  17. Effect of testosterone supplementation on sexual functioning in aging men: a 6-month randomized controlled trial.

    PubMed

    Emmelot-Vonk, M H; Verhaar, H J J; Nakhai-Pour, H R; Grobbee, D E; van der Schouw, Y T

    2009-01-01

    Serum testosterone levels decline significantly with aging and this has been associated with reduced sexual function. We have conducted a double-blind, randomized, placebo-controlled trial to investigate the effect of testosterone supplementation on sexual function in 237 elderly men with a testosterone level <13.7 nmol l(-1). Participants were randomly assigned to receive oral testosterone undecanoate or a placebo for 6 months. A total of 207 men completed the study. After treatment, there were no differences in scores on sexual function between the groups. Subanalysis showed that although a baseline testosterone level in the lowest tertile was associated with significantly lower scores for sexual fantasies, desire of sexual contact and frequency of sexual contact, supplementation of testosterone did not result in improvement on any of these items in this group. In conclusion, the findings do not support the view that testosterone undecanoate supplementation for 6 months to elderly men with low-normal testosterone concentrations favorably affects sexual function. PMID:19225466

  18. Prognostic utility of routine chimerism testing at 2 to 6 months after allogeneic hematopoietic cell transplantation.

    PubMed

    Mossallam, Ghada I; Kamel, Azza M; Storer, Barry; Martin, Paul J

    2009-03-01

    The utility of routine chimerism analysis as a prognostic indicator of subsequent outcomes after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens remains controversial. To address this controversy, routine chimerism test results at 2 to 6 months after HCT with myeloablative conditioning regimens were evaluated for association with subsequent risk of chronic graft-versus-host disease (GVHD), nonrelapse mortality (NRM), relapse, and overall mortality. Only 70 of 1304 patients (5%) had < 95% donor-derived cells in the marrow. Low donor chimerism in the marrow occurred more often in patients with low-risk diseases compared with those with higher-risk diseases and was significantly associated with a reduced risk of chronic GVHD. Among 673 patients evaluated, 164 (24%) had < 85% donor-derived T cells in the blood. Low donor T cell chimerism was more frequent in patients with low-risk diseases compared with those with higher-risk diseases, in those who received conditioning with busulfan compared with those who received conditioning with total body irradiation, and in those with lower-grade acute GVHD. Low donor T cell chimerism in the blood was significantly associated with a reduced risk of chronic GVHD but not with a reduced risk of relapse, NRM, or overall mortality. Routine testing of chimerism in the marrow and blood at 2 to 6 months after HCT with myeloablative conditioning regimens may be helpful in documenting engraftment in clinical trials, but provides only limited prognostic information in clinical practice.

  19. Optimizing parent-infant sleep from birth to 6 months: a new paradigm.

    PubMed

    Whittingham, Koa; Douglas, Pamela

    2014-01-01

    Currently, the dominant paradigm for infant sleep from birth to 6 months is behavioral sleep interventions that aim to entrain the infant's biological patterns of sleep using techniques such as delayed response to cues, feed-play-sleep routines, sleep algorithms, and education of parents about "tired cues" and "overstimulation." A recent systematic literature review has identified that while behavioral sleep interventions may modestly increase the length of time an infant sleeps at night without signaling, they are not associated with improved infant or maternal outcomes and may have unintended negative consequences (Douglas & Hill, 2013). This article reviews the empirical literature on behavioral infant sleep interventions, sleep regulation, and sleep disturbance. Based on the available scientific literature, a new paradigm for infant sleep intervention, from birth to 6 months of age, is proposed. This new approach, the Possums Sleep Intervention, integrates interdisciplinary knowledge from developmental psychology, medical science, lactation science, evolutionary science, and neuroscience with third-wave contextual behaviorism, acceptance and commitment therapy, to create a unique, new intervention that supports parental flexibility, cued care, and the establishment of healthy biopsychosocial rhythms. PMID:25798510

  20. Replicating ¡Cuídate!: 6-Month Impact Findings of a Randomized Controlled Trial

    PubMed Central

    Layzer, Carolyn; Layzer, Jean; Price, Cristofer; Juras, Randall; Blocklin, Michelle; Mendez, Jacqueline

    2016-01-01

    Objectives. To test whether ¡Cuídate!, a program culturally adapted for Hispanic youths, affects sexual risk behavior. Methods. We evaluated 3 replications of ¡Cuídate! in California, Arizona, and Massachusetts in a randomized controlled trial (registry no. NCT02540304) in which 2169 primarily Hispanic participants were randomly assigned to an intervention (n = 1326) or a control (n = 870) group. Youths were surveyed at baseline (September 2012–April 2014) and 6 months postbaseline (March 2013–October 2014). We estimated pooled and subgroup impacts using a regression framework with baseline covariates to increase statistical precision (1216 youths analyzed in the treatment group, 806 analyzed in the control group). Results. We found no impacts on the study’s primary outcomes of recent sexual activity or recent unprotected sexual activity. However, ¡Cuídate! improved knowledge (10%–20% increase; P < .001), attitudes (effect size = .24; P < .001), and skills (effect size = .14; P = .002). Exploratory subgroup analyses suggest potentially problematic effects for some groups. Conclusions. Findings suggest that ¡Cuídate! was effective in improving youths’ knowledge and attitudes. However, after 6 months, these changes did not translate to improvements in reported sexual risk behaviors. PMID:27689498

  1. Origins of a stereotype: categorization of facial attractiveness by 6-month-old infants.

    PubMed

    Ramsey, Jennifer L; Langlois, Judith H; Hoss, Rebecca A; Rubenstein, Adam J; Griffin, Angela M

    2004-04-01

    Like adults, young infants prefer attractive to unattractive faces (e.g. Langlois, Roggman, Casey, Ritter, Rieser-Danner & Jenkins, 1987; Slater, von der Schulenburg, Brown, Badenoch, Butterworth, Parsons & Samuels, 1998). Older children and adults stereotype based on facial attractiveness (Eagly, Ashmore, Makhijani & Longo, 1991; Langlois, Kalakanis, Rubenstein, Larson, Hallam & Smooth, 2000). How do preferences for attractive faces develop into stereotypes? Several theories of stereotyping posit that categorization of groups is necessary before positive and negative traits can become linked to the groups (e.g. Taifel, Billig, Bundy & Flament, 1971; Zebrowitz-McArthur, 1982). We investigated whether or not 6-month-old infants can categorize faces as attractive or unattractive. In Experiment 1, we familiarized infants to unattractive female faces; in Experiment 2, we familiarized infants to attractive female faces and tested both groups of infants on novel faces from the familiar or novel attractiveness category. Results showed that 6-month-olds categorized attractive and unattractive female faces into two different groups of faces. Experiments 3 and 4 confirmed that infants could discriminate among the faces used in Experiments 1 and 2, and therefore categorized the faces based on their similarities in attractiveness rather than because they could not differentiate among the faces. These findings suggest that categorization of facial attractiveness may underlie the development of the 'beauty is good' stereotype. PMID:15320380

  2. Origins of a stereotype: categorization of facial attractiveness by 6-month-old infants.

    PubMed

    Ramsey, Jennifer L; Langlois, Judith H; Hoss, Rebecca A; Rubenstein, Adam J; Griffin, Angela M

    2004-04-01

    Like adults, young infants prefer attractive to unattractive faces (e.g. Langlois, Roggman, Casey, Ritter, Rieser-Danner & Jenkins, 1987; Slater, von der Schulenburg, Brown, Badenoch, Butterworth, Parsons & Samuels, 1998). Older children and adults stereotype based on facial attractiveness (Eagly, Ashmore, Makhijani & Longo, 1991; Langlois, Kalakanis, Rubenstein, Larson, Hallam & Smooth, 2000). How do preferences for attractive faces develop into stereotypes? Several theories of stereotyping posit that categorization of groups is necessary before positive and negative traits can become linked to the groups (e.g. Taifel, Billig, Bundy & Flament, 1971; Zebrowitz-McArthur, 1982). We investigated whether or not 6-month-old infants can categorize faces as attractive or unattractive. In Experiment 1, we familiarized infants to unattractive female faces; in Experiment 2, we familiarized infants to attractive female faces and tested both groups of infants on novel faces from the familiar or novel attractiveness category. Results showed that 6-month-olds categorized attractive and unattractive female faces into two different groups of faces. Experiments 3 and 4 confirmed that infants could discriminate among the faces used in Experiments 1 and 2, and therefore categorized the faces based on their similarities in attractiveness rather than because they could not differentiate among the faces. These findings suggest that categorization of facial attractiveness may underlie the development of the 'beauty is good' stereotype.

  3. Maternal Music Exposure during Pregnancy Influences Neonatal Behaviour: An Open-Label Randomized Controlled Trial

    PubMed Central

    Arya, Ravindra; Chansoria, Maya; Konanki, Ramesh; Tiwari, Dileep K.

    2012-01-01

    Objective. This study evaluated the effect of antenatal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods. This was a single-centre, randomized, open-label controlled trial. Primigravida mothers aged 19–29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less, were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard antenatal care (intervention arm) or standard care only (control arm). Perinatal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol. The trial is registered with ClinicalTrials.gov (NCT01278329). Results. One hundred and twenty-six newborns in the music group and 134 in the control group were subjected to BNBAS assessment. The infants of mothers exposed to music during pregnancy performed significantly better on 5 of the 7 BNBAS clusters. The maximal beneficial effect was seen with respect to orientation (ES 1.13, 95% CI 0.82–1.44, P < 0.0001) and habituation (ES 1.05, 95% CI 0.53–1.57, P = 0.0001). Conclusion. Prenatal music exposure to mother significantly and favourably influences neonatal behaviour. PMID:22518187

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

    PubMed

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

    2009-03-01

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

  5. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

    PubMed Central

    Khindri, Sanjeev; Vahdati-Bolouri, Mitra; Church, Alison; Fahy, William A.

    2016-01-01

    This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%). Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments. PMID:27730198

  6. An Open-Label Trial of Memantine for Cognitive Impairment in Patients with Posttraumatic Stress Disorder

    PubMed Central

    Ramaswamy, Sriram; Madabushi, Jayakrishna; Hunziker, John; Bhatia, Subhash C.; Petty, Frederick

    2015-01-01

    Background. Studies using standard neuropsychological instruments have demonstrated memory deficits in patients with PTSD. We evaluated the efficacy and safety of the N-methyl-D-aspartate antagonist memantine in veterans with PTSD and cognitive impairment. Methods. Twenty-six veterans with PTSD and cognitive impairment received 16 weeks of memantine in an open-label fashion. Cognition was assessed using the Spatial Span, Logical Memory I, and Letter-Number Sequencing subtests of the Wechsler Memory Scale III and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS measures attention, language, visuospatial skills, and immediate and delayed memories. The Clinician Administered PTSD Scale (CAPS), Hamilton Depression Scale (HAM-D), Hamilton Anxiety Scale (HAM-A), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and Sheehan Disability Scale (SDS) were secondary outcome measures. Results. There was a significant improvement in RBANS, both total and subscale scores (P < 0.05), over time. There was a reduction in total CAPS scores, avoidance/numbing symptoms (CAPS-C) and hyperarousal symptoms (CAPS-D), HAM-D, Q-LES-Q, and SDS scores. However, there was no reduction in reexperiencing (CAPS-B) and HAM-A scores. Memantine was well tolerated. Conclusions. Memantine improved cognitive symptoms, PTSD symptoms, and mood in veterans with PTSD. Randomized double-blind studies are needed to validate these preliminary observations. PMID:26064685

  7. Neural correlates of change in major depressive disorder anhedonia following open-label ketamine.

    PubMed

    Lally, Níall; Nugent, Allison C; Luckenbaugh, David A; Niciu, Mark J; Roiser, Jonathan P; Zarate, Carlos A

    2015-05-01

    Anhedonia is a cardinal symptom of major depression and is often refractory to standard treatment, yet no approved medication for this specific symptom exists. In this exploratory re-analysis, we assessed whether administration of rapid-acting antidepressant ketamine was associated specifically with reduced anhedonia in medication-free treatment-refractory patients with major depressive disorder in an open-label investigation. Additionally, participants received either oral riluzole or placebo daily beginning 4 hours post-infusion. A subgroup of patients underwent fluorodeoxyglucose positron emission tomography scans at baseline (1-3 days pre-infusion) and 2 hours post-ketamine infusion. Anhedonia rapidly decreased following a single ketamine infusion; this was sustained for up to three days, but was not altered by riluzole. Reduced anhedonia correlated with increased glucose metabolism in the hippocampus and dorsal anterior cingulate cortex (dACC) and decreased metabolism in the inferior frontal gyrus and orbitofrontal cortex (OFC). The tentative relationship between change in anhedonia and glucose metabolism remained significant in dACC and OFC, and at trend level in the hippocampus, a result not anticipated, when controlling for change in total depression score. Results, however, remain tenuous due to the lack of a placebo control for ketamine. In addition to alleviating overall depressive symptoms, ketamine could possess anti-anhedonic potential in major depressive disorder, which speculatively, may be mediated by alterations in metabolic activity in the hippocampus, dACC and OFC.

  8. Rotigotine Objectively Improves Sleep in Parkinson's Disease: An Open-Label Pilot Study with Actigraphic Recording.

    PubMed

    Calandra-Buonaura, Giovanna; Guaraldi, Pietro; Doria, Andrea; Zanigni, Stefano; Nassetti, Stefania; Favoni, Valentina; Cevoli, Sabina; Provini, Federica; Cortelli, Pietro

    2016-01-01

    Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson's disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4-8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021.

  9. Rotigotine Objectively Improves Sleep in Parkinson's Disease: An Open-Label Pilot Study with Actigraphic Recording

    PubMed Central

    Calandra-Buonaura, Giovanna; Guaraldi, Pietro; Doria, Andrea; Zanigni, Stefano; Nassetti, Stefania; Favoni, Valentina; Cevoli, Sabina; Provini, Federica; Cortelli, Pietro

    2016-01-01

    Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson's disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4–8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021. PMID:26981312

  10. Efficacy and tolerability of quetiapine in cluster B personality disorder: an open-label study.

    PubMed

    Le Bloc'h, Yves; Baumann, Pierre; Stigler, Michael; Eap, Chin B; Zullino, Daniele F; Le Bloc'h, Yves; Baumann, Pierre; Stigler, Michael; Eap, Chin B; Zullino, Daniele F

    2007-01-01

    Objective. The aim of this open-label 8-week study was to assess the effectiveness of quetiapine on aggressive behaviour and social dysfunctions in patients suffering from a cluster B personality disorder (DSM-IV). Methods. The visits were performed at baseline and at days 14, 28 and 56. After a standard titration schedule, the patients received a dose augmented or reduced dose, within a range from 50 to 400 mg/day during the visits, depending on efficacy and tolerance. Assessment of efficacy was based on the French version of the Social Disability and Aggression Scale SDAS (SDAS-21). Response was defined as a decrease of ≥50% reduction of the total scores compared to baseline. Tolerability was assessed with the CGI, UKU, EPS-scales. Results and conclusion. Eight of the 12 patients included received 200 mg/day quetiapine after titration (all patients: 50-400 mg/day). At week 8, five out of 12 patients were responders based on the SDAS-21 scores for the average expression of the symptoms, and six out of 12 on the basis of SDAS-21 scores for the peak expression. There was a significant correlation between weight change and total SDAS variation (Kendall's τb= -0.644; p=0.02). These findings should be reexamined in further studies.

  11. Autologous Bone Marrow Mononuclear Cell Therapy for Autism: An Open Label Proof of Concept Study

    PubMed Central

    Sharma, Alok; Gokulchandran, Nandini; Sane, Hemangi; Nagrajan, Anjana; Kulkarni, Pooja; Shetty, Akshata; Mishra, Priti; Kali, Mrudula; Biju, Hema; Badhe, Prerna

    2013-01-01

    Cellular therapy is an emerging therapeutic modality with a great potential for the treatment of autism. Recent findings show that the major underlying pathogenetic mechanisms of autism are hypoperfusion and immune alterations in the brain. So conceptually, cellular therapy which facilitates counteractive processes of improving perfusion by angiogenesis and balancing inflammation by immune regulation would exhibit beneficial clinical effects in patients with autism. This is an open label proof of concept study of autologous bone marrow mononuclear cells (BMMNCs) intrathecal transplantation in 32 patients with autism followed by multidisciplinary therapies. All patients were followed up for 26 months (mean 12.7). Outcome measures used were ISAA, CGI, and FIM/Wee-FIM scales. Positron Emission Tomography-Computed Tomography (PET-CT) scan recorded objective changes. Out of 32 patients, a total of 29 (91%) patients improved on total ISAA scores and 20 patients (62%) showed decreased severity on CGI-I. The difference between pre- and postscores was statistically significant (P < 0.001) on Wilcoxon matched-pairs signed rank test. On CGI-II 96% of patients showed global improvement. The efficacy was measured on CGI-III efficacy index. Few adverse events including seizures in three patients were controlled with medications. The encouraging results of this leading clinical study provide future directions for application of cellular therapy in autism. PMID:24062774

  12. Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

    PubMed Central

    Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

    2016-01-01

    Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%; P = 0.012). Conclusions Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

  13. Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial

    PubMed Central

    Tranche, Salvador; Brotons, Carlos; Pascual de la Pisa, Beatriz; Macías, Ramón; Hevia, Eduardo; Marzo-Castillejo, Mercè

    2016-01-01

    Abstract Objectives: The objective of this study is to evaluate the effects of a soy drink with a high concentration of isoflavones (ViveSoy®) on climacteric symptoms. Methods: An open-label, controlled, crossover clinical trial was conducted in 147 peri- and postmenopausal women. Eligible women were recruited from 13 Spanish health centers and randomly assigned to one of the two sequence groups (control or ViveSoy®, 500 mL per day, 15 g of protein and 50 mg of isoflavones). Each intervention phase lasted for 12 weeks with a 6-week washout period. Changes on the Menopause Rating Scale and quality of life questionnaires, as well as lipid profile, cardiovascular risk and carbohydrate and bone metabolism were assessed. Statistical analysis was performed using a mixed-effects model. Results: A sample of 147 female volunteers was recruited of which 90 were evaluable. In both sequence groups, adherence to the intervention was high. Regular consumption of ViveSoy® reduced climacteric symptoms by 20.4% (p = 0.001) and symptoms in the urogenital domain by 21.3% (p < 0.05). It also improved health-related quality life by 18.1%, as per the MRS questionnaire (p <0.05). Conclusion: Regular consumption of ViveSoy® improves both the somatic and urogenital domain symptoms of menopause, as well as health-related quality of life in peri- and postmenopausal women. PMID:26806546

  14. An open-label study of naftifine hydrochloride 1% gel in the treatment of tinea versicolor.

    PubMed

    Gold, Michael H; Bridges, Tancy; Avakian, Edward; Plaum, Stefan; Pappert, Eric J; Fleischer, Alan B; Hardas, Bhushan

    2011-01-01

    Tinea versicolor (TV) is a superficial cutaneous fungal infection characterized by cutaneous pigment changes, pruritus, scaling, and erythema. This open-label, single-center pilot study evaluated the efficacy and safety of naftifine 1% gel applied twice daily for 2 weeks in 10 men and women (median age 38 years) with TV. Baseline mycology status was determined by potassium hydroxide (KOH) and microscopy and clinical symptom severity (CSS) scored by the investigator using a 0 to 9 scale (0=absent, 9=worst). Patients applied naftifine HCI 1% gel to the affected area twice daily for 14 days. They returned for follow-up efficacy and safety assessments at the end of treatment (week 2), 2 weeks after treatment (week 4), and 6 weeks after treatment (week 8). All patients had a positive mycology at baseline; one was KOH negative at week 2, two were negative at week 4, and five (50%) were negative at week 8. Mean investigator total CSS score decreased from a baseline value of 4.7 to 3.2 at week 2 (32% improvement), 2.6 at week 4 (45% improvement), and 2.7 at week 8 (43% improvement). The patients rated their symptoms to be improved at all follow-up visits. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel is a safe and efficacious topical treatment for TV. PMID:22165042

  15. Immunogenicity, Safety, and Tolerability of 13-Valent Pneumococcal Conjugate Vaccine Followed by 23-Valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged ≥2 Years: An Open-Label Study

    PubMed Central

    Cordonnier, Catherine; Ljungman, Per; Juergens, Christine; Maertens, Johan; Selleslag, Dominik; Sundaraiyer, Vani; Giardina, Peter C.; Clarke, Keri; Gruber, William C.; Scott, Daniel A.; Schmoele-Thoma, Beate

    2015-01-01

    Background. Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention. Methods. In an open-label study, patients (n = 251) 3–6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and vaccine safety were assessed. Results. In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99–23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00–6.97), and little change after PPSV23 (GMFR range, 0.86–1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barré syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study vaccines. Conclusions. A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. Clinical Trials Registration. NCT00980655. PMID:25870329

  16. [TESTING STABILITY OF TABLETED ACETAMINOPHEN AND FUROSEMIDE AFTER 6-MONTH STORAGE IN SPACE FLIGHT].

    PubMed

    Bogomolov, V V; Kondratenko, S N; Kovachevich, I V

    2015-01-01

    It was shown that multiple spaceflight factors (i.e., acceleration, overvibration, microgravity etc.) do not impact stability of acetaminophen and furosemide tablets stored onboard the International space station over 6 months. Acetaminophen dose in a tablet was 496.44 ± 6.88 mg (99.29 ± 1.38%) before spaceflight (SF) and 481.77 ± 1 2.40 mg (96.35 ± 0.48%) after 6 mos. of storage; furosemide dose in a tablet was 40.19 ± 0.28 mg (100.47 ± 0.71%) before and 39.24 ± 0.72 mg (98.105 ± 1.80%) after SF remaining within the established limits.

  17. [Severe megaloblastic anemia in 6-month-old girl breast-fed by a vegetarian mother].

    PubMed

    Cheron, G; Girot, R; Zittoun, J; Mouy, R; Schmitz, J; Rey, J

    1989-03-01

    The case of a young girl, born to a woman who was a vegetarian for 18 years, is presented. She had been exclusively breast-fed until the age of 6 months when a severe anemia was discovered with an extremely low hemoglobin level (1.9 g/100 ml). Her physical growth and psychomotor development had been normal until 3 months of age. Bone marrow showed megaloblastosis and the serum B12 level was low (45 ng/l). B12 levels were also decreased in both parents (110 and 105 ng/l) and in the mother's milk (12 ng/l). Treatment with parenteral B12 was successful. The importance of a careful dietetic inquiry in the case of an infant with megaloblastic anemia is stressed and likewise, as a preventive measure during all normal pregnancies.

  18. [Acute enteritis and dietetic errors in the first 6 months of life].

    PubMed

    Cataldo, F; Violante, M; Bellia, L; Traverso, M G; Ruggeri, G; Romano, G

    1989-01-01

    The dietary habits of 174 infants under 6 months old and suffering from enteritis were analysed revealing a high incidence of feeding errors (almost always feeding with artificial formulas, wrong concentration of milk powder, failure to sterilise the bottle and the water used to dilute the milk, too early administration of undiluted, unboiled bottled cow's milk, too early and incorrect weaning). Such mistakes appeared to be linked to the poor economic and sociocultural conditions of the families concerned. It is claimed that dietary errors conditioned by the poor economic and sociocultural conditions encountered may have favoured the onset of enteritis and that the adequate prophylaxis of acute infantile enteritis will depend on improving people's dietary habits and living conditions.

  19. A 6-month dermal toxicity test with dithranol and butantrone in miniature swine.

    PubMed

    Männistö, P T; Hanhijärvi, H; Kosma, V M; Collan, Y

    1986-07-01

    Continuous topical administration of dithranol and butantrone for 6 months caused different irritation profiles in miniature swine. In paraffin wax sticks in white petrolatum, butantrone gave rise to much less initial irritation than dithranol, but after 2-3 weeks the situation had equalized. In gel formulations, butantrone was initially more irritant than dithranol. The vehicles themselves induced significant irritation. Signs of skin hyperplasia (parakeratosis and acanthosis) and inflammation were frequent histopathological findings at the end of the study, but no malignant changes were found. Dithranol and butantrone did not produce any chemical, hematological or serious histological abnormalities during the treatment, suggesting a lack of systemic toxicity. No evidence of systemic absorption was found. This long-term study did not predict delayed irritation of butantrone observed in about 1/3 of the psoriatic patients after treatment for 1-2 months.

  20. [TESTING STABILITY OF TABLETED ACETAMINOPHEN AND FUROSEMIDE AFTER 6-MONTH STORAGE IN SPACE FLIGHT].

    PubMed

    Bogomolov, V V; Kondratenko, S N; Kovachevich, I V

    2015-01-01

    It was shown that multiple spaceflight factors (i.e., acceleration, overvibration, microgravity etc.) do not impact stability of acetaminophen and furosemide tablets stored onboard the International space station over 6 months. Acetaminophen dose in a tablet was 496.44 ± 6.88 mg (99.29 ± 1.38%) before spaceflight (SF) and 481.77 ± 1 2.40 mg (96.35 ± 0.48%) after 6 mos. of storage; furosemide dose in a tablet was 40.19 ± 0.28 mg (100.47 ± 0.71%) before and 39.24 ± 0.72 mg (98.105 ± 1.80%) after SF remaining within the established limits. PMID:26087581

  1. Comparison of methods to diagnose lymphoedema among breast cancer survivors: 6-month follow-up.

    PubMed

    Hayes, Sandi; Cornish, Bruce; Newman, Beth

    2005-02-01

    One of the more problematic and dreaded complications of breast cancer is lymphoedema. Our objective was to determine the prevalence of lymphoedema 6-months following breast cancer treatment and to examine potential risk factors among a population-based sample of women residing in South-East Queensland (n = 176). Women were defined as having lymphoedema if the difference between the sum of arm circumferences (SOAC) of the treated and untreated sides was >5 cm (prevalence = 11.9%) or >10% (prevalence = 0.6%), their multi- frequency bioelectrical impedance (MFBIA) score was > or =3 standard deviations above the reference impedance score (prevalence = 11.4%), or they reported 'yes' when asked if arm swelling had been present in the previous 6 months (prevalence = 27.8%). Of those with lymphoedema defined by MFBIA, only 35% were detected using the SOAC method (difference > 5 cm), while 65% were identified via the self-report method (i.e., respective sensitivities). Specificities for SOAC (difference > 5 cm) and self-report were 88.5% and 76.9%, respectively. When examining associations between presence of lymphoedema and a range of characteristics, findings also varied depending on the method used to assess lymphoedema. Nevertheless, one of the more novel and significant findings was that being treated on the non-dominant, compared to dominant, side was associated with an 80% increased risk of having lymphoedema (MFBIA). Our work raises questions about the use of circumferences as the choice of measurement for lymphoedema in both research and clinical settings, and assesses MFBIA as a potential alternative. PMID:15754119

  2. Investigating fatigue of less than 6 months' duration. Guidelines for family physicians.

    PubMed Central

    Godwin, M.; Delva, D.; Miller, K.; Molson, J.; Hobbs, N.; MacDonald, S.; MacLeod, C.

    1999-01-01

    OBJECTIVE: To develop an evidence-based systematic approach to assessment of adult patients who present to family physicians complaining of fatigue of less than 6 months' duration. The guidelines present investigative options, making explicit what should be considered in all cases and what should be considered only in specific situations. They aim to provide physicians with an approach that, to the extent possible, is based on evidence so that time and cost are minimized and detection and management of the cause of the fatigue are optimized. QUALITY OF EVIDENCE: MEDLINE was searched from 1966 to 1997 using the key words "family practice" and "fatigue." Articles about chronic fatigue syndrome were excluded. Articles with level 3 evidence were found, but no randomized trials, cohort studies, or case-control studies were found. Articles looking specifically at the epidemiology, demographics, investigations, and diagnoses of patients with fatigue were chosen. Articles based on studies at referral and specialty centres were given less weight than those based on studies in family physicians' offices. MAIN MESSAGE: Adherence to these guidelines will decrease the cost of investigating the symptom of fatigue and optimize diagnosis and management. This needs to be proved in practice, however, and with research that produces level 1 and 2 evidence. CONCLUSIONS: Adults presenting with fatigue of less than 6 months' duration should be assessed for psychosocial causes and should have a focused history and physical examination to determine whether further investigations should be done. The guidelines outline investigations to be considered. The elderly require special consideration. These guidelines have group validation, but they need to be tested by more physicians in various locations and types of practices. PMID:10065311

  3. Integrating Vitamin A Supplementation at 6 months into the Expanded Program of Immunization in Sierra Leone.

    PubMed

    Hodges, Mary H; Sesay, Fatmata F; Kamara, Habib I; Nyorkor, Emmanuel D; Bah, Mariama; Koroma, Aminata S; Kandeh, Joseph N; Ouédraogo, Rasmata; Wolfe, Adam C; Katcher, Heather I; Blankenship, Jessica L; Baker, Shawn K

    2015-09-01

    Since 2004, twice-yearly mass vitamin A supplementation (VAS) has equitably reached over 85% of children 6-59 months old in Sierra Leone. However infants who turn 6 months after the event may wait until they are 11 months old to receive their first dose. The effectiveness of integrating VAS at 6 months into the Expanded Program of Immunization (EPI) in a revised child health card was studied. Health facilities matched according to staff cadre and work load were assigned to provide either a 'mini package' of VAS and infant and young child feeding (IYCF), a 'full package' of VAS, IYCF and family planning (FP), or 'child health card' only. 400 neonates were enrolled into each group, caregivers given the new child health card and followed until they were 12 months old. More infants in the full: 74.5% and mini: 71.7% group received VAS between 6 and 7 months of age compared with the new CH card only group: 60.2% (p = 0.002, p < 0.001 respectively). FP commodities were provided to 44.5% of caregivers in the full compared with <2.5% in the mini and new child health card only groups (p < 0.0001). Integration of VAS within the EPI schedule achieved >60% coverage for infants between 6 and 7 months of age. Provision of FP and/or IYCF further improved coverage. Funding was provided by the Canadian Department of Foreign Affairs, Trade and Development who had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

  4. A Prognostic Model for 6-Month Mortality in Elderly Survivors of Critical Illness

    PubMed Central

    Narain, Wazim R.; Wunsch, Hannah; Schluger, Neil W.; Cooke, Joseph T.; Maurer, Mathew S.; Rowe, John W.; Lederer, David J.; Bach, Peter B.

    2013-01-01

    Background: Although 1.4 million elderly Americans survive hospitalization involving intensive care annually, many are at risk for early mortality following discharge. No models that predict the likelihood of death after discharge exist explicitly for this population. Therefore, we derived and externally validated a 6-month postdischarge mortality prediction model for elderly ICU survivors. Methods: We derived the model from medical record and claims data for 1,526 consecutive patients aged ≥ 65 years who had their first medical ICU admission in 2006 to 2009 at a tertiary-care hospital and survived to discharge (excluding those patients discharged to hospice). We then validated the model in 1,010 patients from a different tertiary-care hospital. Results: Six-month mortality was 27.3% and 30.2% in the derivation and validation cohorts, respectively. Independent predictors of mortality (in descending order of contribution to the model’s predictive power) were a do-not-resuscitate order, older age, burden of comorbidity, admission from or discharge to a skilled-care facility, hospital length of stay, principal diagnoses of sepsis and hematologic malignancy, and male sex. For the derivation and external validation cohorts, the area under the receiver operating characteristic curve was 0.80 (SE, 0.01) and 0.71 (SE, 0.02), respectively, with good calibration for both (P = 0.31 and 0.43). Conclusions: Clinical variables available at hospital discharge can help predict 6-month mortality for elderly ICU survivors. Variables that capture elements of frailty, disability, the burden of comorbidity, and patient preferences regarding resuscitation during the hospitalization contribute most to this model’s predictive power. The model could aid providers in counseling elderly ICU survivors at high risk of death and their families. PMID:23632902

  5. Integrating Vitamin A Supplementation at 6 months into the Expanded Program of Immunization in Sierra Leone.

    PubMed

    Hodges, Mary H; Sesay, Fatmata F; Kamara, Habib I; Nyorkor, Emmanuel D; Bah, Mariama; Koroma, Aminata S; Kandeh, Joseph N; Ouédraogo, Rasmata; Wolfe, Adam C; Katcher, Heather I; Blankenship, Jessica L; Baker, Shawn K

    2015-09-01

    Since 2004, twice-yearly mass vitamin A supplementation (VAS) has equitably reached over 85% of children 6-59 months old in Sierra Leone. However infants who turn 6 months after the event may wait until they are 11 months old to receive their first dose. The effectiveness of integrating VAS at 6 months into the Expanded Program of Immunization (EPI) in a revised child health card was studied. Health facilities matched according to staff cadre and work load were assigned to provide either a 'mini package' of VAS and infant and young child feeding (IYCF), a 'full package' of VAS, IYCF and family planning (FP), or 'child health card' only. 400 neonates were enrolled into each group, caregivers given the new child health card and followed until they were 12 months old. More infants in the full: 74.5% and mini: 71.7% group received VAS between 6 and 7 months of age compared with the new CH card only group: 60.2% (p = 0.002, p < 0.001 respectively). FP commodities were provided to 44.5% of caregivers in the full compared with <2.5% in the mini and new child health card only groups (p < 0.0001). Integration of VAS within the EPI schedule achieved >60% coverage for infants between 6 and 7 months of age. Provision of FP and/or IYCF further improved coverage. Funding was provided by the Canadian Department of Foreign Affairs, Trade and Development who had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. PMID:25665894

  6. Activation of 5-HT3 receptors leads to altered responses 6 months after MDMA treatment.

    PubMed

    Gyongyosi, Norbert; Balogh, Brigitta; Katai, Zita; Molnar, Eszter; Laufer, Rudolf; Tekes, Kornelia; Bagdy, Gyorgy

    2010-03-01

    The recreational drug "Ecstasy" [3,4-methylenedioxymethamphetamine (MDMA)] has a well-characterised neurotoxic effect on the 5-hydroxytryptamine (5-HT) neurons in animals. Despite intensive studies, the long-term functional consequencies of the 5-HT neurodegeneration remains elusive. The aim of this study was to investigate whether any alteration of 5-hydroxytryptamine-3 (5-HT(3)) receptor functions on the sleep-wake cycle, motor activity, and quantitative EEG could be detected 6 months after a single dose of 15 mg/kg of MDMA. The selective 5-HT(3) receptor agonist m-chlorophenylbiguanide (mCPBG; 1 mg/kg, i.p.) or vehicle was administered to freely moving rats pre-treated with MDMA (15 mg/kg, i.p.) or vehicle 6 months earlier. Polysomnographic and motor activity recordings were performed. Active wake (AW), passive wake (PW), light slow wave sleep (SWS-1), deep slow wave sleep (SWS-2), and paradoxical sleep were classified. In addition, EEG power spectra were calculated for the second hour after mCPBG treatment for each stage. AW increased and SWS-1 decreased in the second hour after mCPBG treatment in control animals. mCPBG caused significant changes in the EEG power in states with cortical activation (AW, PW, paradoxical sleep). In addition, mCPBG had a biphasic effect on hippocampal theta power in AW with a decrease in 7 Hz and a stage-selective increase in the upper range (8-9 Hz). Effects of mCPBG on the time spent in AW and SWS-1 were eliminated or reduced in MDMA-treated animals. In addition, mCPBG did not increase the upper theta power of AW in rats pre-treated with MDMA. These data suggest long-term changes in 5-HT(3) receptor function after MDMA. PMID:20052506

  7. Virtual Reality Job Interview Training and 6-Month Employment Outcomes for Individuals with Schizophrenia Seeking Employment

    PubMed Central

    Smith, Matthew J.; Fleming, Michael F.; Wright, Michael A.; Roberts, Andrea G.; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D.

    2015-01-01

    BACKGROUND Individuals with schizophrenia have low employment rates and the job interview presents a critical barrier for them to obtain employment. Virtual reality training has demonstrated efficacy at improving interview skills and employment outcomes among multiple clinical populations. However, the effects of this training on individuals with schizophrenia are unknown. This study evaluated the efficacy of virtual reality job interview training (VR-JIT) at improving job interview skills and employment outcomes among individuals with schizophrenia in a small randomized controlled trial (n=21 VR-JIT trainees, n=11 waitlist controls). METHODS Trainees completed up to 10 hours of virtual interviews using VR-JIT, while controls received services as usual. Primary outcome measures included two pre-test and two post-test video-recorded role-play interviews scored by blinded human resource experts and self-reported interviewing self-confidence. Six-month follow-up data on employment outcomes were collected. RESULTS Trainees reported the intervention was easy-to-use, helpful, and prepared them for future interviews. Trainees demonstrated increased role-play scores between pre-test and post-test while controls did not (p=0.001). After accounting for neurocognition and months since prior employment, trainees had greater odds of receiving a job offer by 6 month follow-up compared to controls (OR: 8.73, p=0.04) and more training was associated with fewer weeks until receiving a job offer (r=−0.63, p<0.001). CONCLUSIONS Results suggest VR-JIT is acceptable to trainees and may be efficacious for improving job interview skills in individuals with schizophrenia. Moreover, trainees had greater odds of receiving a job offer by 6-month follow-up. Future studies could evaluate the effectiveness of VR-JIT within community-based services. PMID:26032567

  8. Brief Report: An Open-Label Study of the Neurosteroid Pregnenolone in Adults with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Fung, Lawrence K.; Libove, Robin A.; Phillips, Jennifer; Haddad, Francois; Hardan, Antonio Y.

    2014-01-01

    The objective of this study was to assess the tolerability and efficacy of pregnenolone in reducing irritability in adults with autism spectrum disorder (ASD). This was a pilot, open-label, 12-week trial that included twelve subjects with a mean age of 22.5 ± 5.8 years. Two participants dropped out of the study due to reasons unrelated to adverse…

  9. An open label, prospective, clinical study on a polyherbal formulation in osteoarthritis of knee

    PubMed Central

    Nipanikar, Sanjay U.; Saluja, Manjit; Kuber, Vinod V.; Kadbhane, Kalyan P.; Chopra, Arvind; Khade, Namdev R.

    2013-01-01

    Background: Currently, though pharmacological, mechanical, and surgical interventions are used, there is no known cure for osteoarthritis (OA). Objectives: The main aim of the study was to assess the efficacy and safety of “TLPL/AY/03/2008”, a polyherbal formulation on knee joint pain assessed on visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Materials and Methods: It was an open label, single center, prospective, clinical study conducted in 36 patients of OA Knee. Two capsules of ‘TLPL/AY/03/2008’ were given to all patients twice daily orally after meals for 180 days. Results: Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. The mean joint pain (as assessed on VAS) reduced significantly (59.85%; P < 0.05) and the mean WOMAC combined score, WOMAC pain sub-score, WOMAC stiffness sub-score, and WOMAC difficulty sub-score also reduced significantly at the end of the study. The mean time taken by the patients to walk 50 feet too, was reduced significantly (25.26%) at the end of the study. At the end of 4 months of the treatment, no patient needed paracetamol as rescue medicine to control pain. Most of the patients had shown good overall improvement assessed by the physician and by the patients. Majority of the patients showed excellent tolerability to the study drug. No significant change in most of the safety laboratory parameters was observed at the end of the study. Conclusion: The study provides good evidence in support of the efficacy and safety of the ‘TLPL/AY/03/2008’ in OA of knee. PMID:23741160

  10. A 24-month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease

    PubMed Central

    Sibley, Cailin H; Chioato, Andrea; Felix, Sandra; Colin, Laurence; Chakraborty, Abhijit; Plass, Nikki; Rodriguez-Smith, Jackeline; Brewer, Carmen; King, Kelly; Zalewski, Christopher; Kim, H Jeffrey; Bishop, Rachel; Abrams, Ken; Stone, Deborah; Chapelle, Dawn; Kost, Bahar; Snyder, Christopher; Butman, John A; Wesley, Robert; Goldbach-Mansky, Raphaela

    2014-01-01

    Objective To study efficacy and safety of escalating doses of canakinumab, a fully human anti-IL-1β monoclonal antibody in the severe cryopyrin-associated periodic syndrome, neonatal-onset multisystem inflammatory disease (NOMID). Methods 6 patients were enrolled in this 24-month, open-label phase I/II study. All underwent anakinra withdrawal. The initial subcutaneous canakinumab dose was 150 mg (or 2 mg/kg in patients ≤40 kg) or 300 mg (or 4 mg/kg) with escalation up to 600 mg (or 8 mg/kg) every 4 weeks. Full remission was remission of patientreported clinical components and measures of systemic inflammation and CNS inflammation. Hearing, vision and safety were assessed. Primary endpoint was full remission at month 6. Results All patients flared after anakinra withdrawal, and symptoms and serum inflammatory markers improved with canakinumab. All patients required dose escalation to the maximum dose. At month 6, none had full remission, although 4/6 achieved inflammatory remission, based on disease activity diary scores and normal C-reactive proteins. None had CNS remission; 5/6 due to persistent CNS leucocytosis. At the last study visit, 5/6 patients achieved inflammatory remission and 4/6 had continued CNS leucocytosis. Visual acuity and field were stable in all patients, progressive hearing loss occurred in 1/10 ears. Adverse events (AEs) were rare. One serious AE (abscess due to a methicillin-resistant Staphylococcus aureus infection) occurred. Conclusions Canakinumab at the studied doses improves symptoms and serum inflammatory features of NOMID, although low-grade CNS leukocytosis in four patients and headaches in one additional patient persisted. Whether further dose intensifications are beneficial in these cases remains to be assessed. ClinicalTrials.gov identifier NCT00770601. PMID:24906637

  11. A pilot open label, single dose trial of fenobam in adults with fragile X syndrome

    PubMed Central

    Berry-Kravis, E; Hessl, D; Coffey, S; Hervey, C; Schneider, A; Yuhas, J; Hutchison, J; Snape, M; Tranfaglia, M; Nguyen, D V; Hagerman, R

    2009-01-01

    Objective: A pilot open label, single dose trial of fenobam, an mGluR5 antagonist, was conducted to provide an initial evaluation of safety and pharmacokinetics in adult males and females with fragile X syndrome (FXS). Methods: Twelve subjects, recruited from two fragile X clinics, received a single oral dose of 50–150 mg of fenobam. Blood for pharmacokinetic testing, vital signs and side effect screening was obtained at baseline and numerous time points for 6 h after dosing. Outcome measures included prepulse inhibition (PPI) and a continuous performance test (CPT) obtained before and after dosing to explore the effects of fenobam on core phenotypic measures of sensory gating, attention and inhibition. Results: There were no significant adverse reactions to fenobam administration. Pharmacokinetic analysis showed that fenobam concentrations were dose dependent but variable, with mean (SEM) peak values of 39.7 (18.4) ng/ml at 180 min after the 150 mg dose. PPI met a response criterion of an improvement of at least 20% over baseline in 6 of 12 individuals (4/6 males and 2/6 females). The CPT did not display improvement with treatment due to ceiling effects. Conclusions: Clinically significant adverse effects were not identified in this study of single dose fenobam across the range of dosages utilised. The positive effects seen in animal models of FXS treated with fenobam or other mGluR5 antagonists, the apparent lack of clinically significant adverse effects, and the potential beneficial clinical effects seen in this pilot trial support further study of the compound in adults with FXS. PMID:19126569

  12. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study

    PubMed Central

    van de Logt, Anne-Els; Beerenhout, Charles H.; Brink, Hans S.; van de Kerkhof, Jos J.; Wetzels, Jack F.; Hofstra, Julia M.

    2015-01-01

    New therapeutic agents are warranted in idiopathic membranous nephropathy. Synthetic ACTH may be advantageous with reported remission rates up to 85% and few side effects. We conducted a prospective open label cohort study from 2008 till 2010 (NCT00694863). We prospectively selected patients with idiopathic membranous nephropathy and high risk for progression (defined as βeta-2-microglobulin (β2m) excretion of >500 ng/min). For comparison, we selected matched historical controls treated with cyclophosphamide. The prospectively selected patients received intramuscular injections of synthetic ACTH during 9 months (maximal dose 1 mg twice a week). The primary endpoints concerned the feasibility and incidence of remissions as a primary event. Secondary endpoints included side effects of treatment and the incidence of remissions and relapses at long-term follow-up. Twenty patients (15 men) were included (age 54±14 years, serum creatinine 104 μmol/l [IQR 90–113], urine protein:creatinine ratio 8.7 g/10 mmol creatinine [IQR 4.3–11.1]). Seventeen patients (85%) completed treatment. 97% of injections were administered correctly. Cumulative remission rate was 55% (complete remission in 4 patients, partial remission 7 patients). In a group of historical controls treated with cyclophosphamide and steroids, 19 of 20 patients (95%) developed a remission (complete remission in 13 patients, partial remission in 6 patients) (p<0.01). The main limitation of our study is its small size and the use of a historical control group. We show that treatment with intramuscular injections of synthetic ACTH is feasible. Our data suggest that synthetic ACTH is less effective than cyclophosphamide in inducing a remission in high risk patients with idiopathic membranous nephropathy. The use of synthetic ACTH was also associated with many adverse events. Therefore, we advise against synthetic ACTH as standard treatment in membranous nephropathy. Trial Registration ClinicalTrials.gov NCT

  13. A 10-month, open-label evaluation of desvenlafaxine in Japanese outpatients with major depressive disorder.

    PubMed

    Tourian, Karen; Wang, Ying; Ii, Yoichi

    2013-07-01

    The objective of this study was to evaluate the long-term safety of desvenlafaxine for continuation treatment of major depressive disorder (MDD) in Japanese patients. This was a phase 3, multicenter, 10-month, open-label study with flexible dosing of desvenlafaxine (25, 50, 100 mg/day). Japanese patients with MDD who had completed an 8-week, double-blind, placebo-controlled study in which patients received 25 or 50 mg/day desvenlafaxine or placebo were enrolled. In this study, patients received desvenlafaxine 25 mg/day from days 1 to 14, with subsequent upward titration, to a maximum of 100 mg/day, determined by clinical response. Of 304 patients, 75 (24.7%) discontinued during the on-therapy period; patient request was the most common reason (11.5%). Treatment-emergent adverse events were reported by 240 patients (78.9%) during the on-therapy period; the most common adverse events were nasopharyngitis (37.2%), somnolence (11.5%), headache (10.5%), and nausea (10.2%). For the ITT-LOCF population, the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D₁₇) total score was -4.76 (95% confidence interval: -5.47 to -4.05); continued numerical improvements in the HAM-D₁₇ total scores and other depression outcome measures were observed irrespective of treatment in the previous study. Long-term use of desvenlafaxine was safe and well tolerated, with a clinical benefit/risk profile similar to that in other populations.

  14. An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder

    PubMed Central

    Pilkinton, Patricia; Berry, Carlos; Norrholm, Seth; Bartolucci, Al; Birur, Badari; Davis, Lori L.

    2016-01-01

    Objective Selective serotonin reuptake inhibitors (SSRIs) remain the first-line treatment for posttraumatic stress disorder (PTSD). However, adjunctive atypical antipsychotics are often used to target residual or refractory symptoms. Asenapine is a novel atypical antipsychotic that possesses a high serotonin (5-HT2A) to dopamine (D2) affinity ratio and alpha-adrenergic antagonism, which may be advantageous in treating PTSD. This pilot study aimed to identify the therapeutic potential of asenapine as an adjunctive treatment for PTSD. Method Eighteen subjects initiated treatment in this single-site prospective, open-label, 12-week trial of flexibly-dosed asenapine in Veterans with PTSD who had not responded to an adequate course of treatment with an SSRI, venlafaxine, or mirtazapine. Subjects remained on their antidepressant medication and were started on adjunctive asenapine 5 mg sublingual at bedtime, which was gradually titrated to a maximum of 10 mg twice per day, as tolerated. The primary outcome measure was the Clinician Administered PTSD Scale (CAPS) for DSM-IV. Results Fifteen subjects finished at least 4 weeks and eleven completed the 12 week study. There was a significant and clinically meaningful decrease in CAPS from baseline (77.56 ± 14.48) to week 4 (48.7 ± 30.6), and to week 12 (35.3 ± 19.7). Six participants experienced adverse events possibly related to asenapine; however, only three participants discontinued early due to related adverse events. Conclusion This pilot study demonstrated that adjunctive treatment with asenapine may provide additional benefit to some patients experiencing residual PTSD symptoms in spite of optimal antidepressant therapy. A larger efficacy study may be warranted. PMID:27738377

  15. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam.

    PubMed

    Yates, Stephen L; Fakhoury, Toufic; Liang, Wei; Eckhardt, Klaus; Borghs, Simon; D'Souza, Joseph

    2015-11-01

    We evaluated nonpsychotic behavioral adverse events (BAEs) in patients receiving levetiracetam (LEV) who switched to brivaracetam (BRV). Patients ≥16 years of age, receiving 2-3 antiepileptic drugs (AEDs), including LEV 1-3g/day, and experiencing BAEs within 16 weeks of LEV treatment initiation, enrolled in an open-label Phase 3b study (NCT01653262) comprising a ≤1-week screening period, an immediate switch from LEV to BRV 200mg/day (without titration), and a 12-week treatment period. The percentages of patients with investigator-assessed clinically meaningful reduction in BAEs, shift in maximum BAE intensity, and change in health-related quality of life (HRQoL) (Patient-Weighted Quality of Life in Epilepsy Inventory-Form 31 [QOLIE-31-P]) were assessed. Of 29 patients enrolled, 26 (89.7%) completed the study. At the end of the treatment period, 27/29 (93.1%) patients switched to BRV had clinically meaningful reductions in BAEs. Physicians reported a reduction in the maximum intensity of primary BAEs in 27/29 (93.1%) patients. Mean change from baseline to Week 12 in QOLIE-31-P total score was 12.1, indicating improved HRQoL. During the treatment period, 23/29 (79.3%) patients reported treatment-emergent adverse events (TEAEs). One patient reported a serious TEAE (suicidal ideation and suicide attempt). Two patients discontinued BRV because of TEAEs. Findings from this small study suggest that patients experiencing BAEs associated with LEV may benefit from switching to BRV.

  16. An open-label study of memantine treatment in 3 subtypes of frontotemporal lobar degeneration.

    PubMed

    Boxer, Adam L; Lipton, Anne M; Womack, Kyle; Merrilees, Jennifer; Neuhaus, John; Pavlic, Danijela; Gandhi, Anisha; Red, Dana; Martin-Cook, Kristen; Svetlik, Doris; Miller, Bruce L

    2009-01-01

    There are currently no Food and Drug Administration-approved treatments for frontotemporal lobar degeneration (FTLD). The objectives of this study were to explore the tolerability of memantine treatment in FTLD and to monitor for possible effects on behavior, cognition, and function. Forty-three individuals who met clinical criteria for FTLD [21 with frontotemporal dementia (FTD), 13 with semantic dementia (SD), and 9 with progressive nonfluent aphasia (PA)] received 26 weeks of open-label treatment with memantine at a target dose of 20 mg daily. Concurrent treatment with acetylcholinesterase inhibitors was prohibited. Cognitive and functional outcome measures included the Mini Mental State Examination, Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog), clinical dementia rating-sum of boxes, Neuropsychiatric Inventory (NPI), Frontal Behavior Inventory, Executive Interview (EXIT25), Texas Functional Living Scale (TFLS), Geriatric Depression Scale, and Unified Parkinson's Disease Rating Scale-motor scale. Most subjects were able to tolerate the target dose of memantine. A transient improvement was observed on the total NPI score primarily in the FTD group. Variable declines were observed on the ADAS-cog, EXIT25, Frontal Behavior Inventory, NPI, TFLS, and UPDRS scores. The FTD and SD groups declined on most of the cognitive and behavioral outcome measures, but remained stable on the UPDRS, whereas the progressive nonfluent aphasia group remained relatively stable on the ADAS-cog, NPI, and TFLS, but declined on the UPDRS. Memantine was well-tolerated in these subjects. Future placebo-controlled trials of memantine in FTLD are warranted and may have greater power to detect behavioral and cognitive effects if focused on the FTD and SD clinical syndromes. PMID:19812461

  17. The Efficacy of Neurofeedback in Patients with Major Depressive Disorder: An Open Labeled Prospective Study.

    PubMed

    Cheon, Eun-Jin; Koo, Bon-Hoon; Choi, Joong-Hyun

    2016-03-01

    The purpose of this study was to evaluate the effect of neurofeedback on depressive symptoms and electrophysiological disturbances in patients with major depressive disorder. We recruited participants suffering from depression to evaluate efficacy of left prefrontal beta with alpha/theta training. An 8-week, prospective, open-label study was undertaken. Twenty participants were recruited. The treatment protocol was twice or three times a week training of beta at F3 with alpha/theta at Pz for 8 weeks. When every visit, patients were received beta training for 30 min, and then alpha/theta training for 30 min. Baseline, 4 and 8 week scores of; the Hamilton rating scale for Depression (HAM-D), the Hamilton rating scale for Anxiety (HAM-A), the Beck Depression Inventory (BDI)-II, the Beck Anxiety Inventory (BAI), Clinical global impression-severity (CGI-S), and pre- and post-treatment resting state EEGs were compared. Interhemispheric alpha power asymmetry (A score) was computed for homologous sites F3-F4. Pre- and post-training clinical assessments revealed significant improvements in HAM-D, HAM-A, BDI, and CGI-S scores. Cumulative response rates by HAM-D were 35.0 and 75.0 % at 4 and 8 weeks, respectively, corresponding cumulative remission rates by HAM-D were 15.0 and 55.0 %, respectively. No significant differences were found between pre- and post-treatment A score. Neurofeedback treatment could improve depressive symptoms significantly. In addition, anxiety symptoms and clinical illness severity decreased significantly after neurofeedback treatment. Despite its several limitations, such as, small sample size and lack of a control group, this study suggested neurofeedback has significant effects in patients with major depressive disorder. PMID:26392114

  18. Nutritional and Safety Outcomes from an Open-Label Micronutrient Intervention for Pediatric Bipolar Spectrum Disorders

    PubMed Central

    Gracious, Barbara; Arnold, L. Eugene; Failla, Mark; Chitchumroonchokchai, Chureeporn; Habash, Diane; Fristad, Mary A.

    2013-01-01

    Abstract Objective The purpose of this study was to report the safety, tolerability, and serum micronutrient concentrations and their correlations with mood changes from an 8 week pilot feasibility study of a 36 ingredient multinutrient supplement, EMPowerplus (EMP+), for pediatric bipolar spectrum disorders (BPSD). Methods Ten children ages 6–12 received EMP+ escalating from one to four capsules t.i.d., with four children increased to the maximum suggested dose, five capsules t.i.d. Outcome measures were micronutrient concentrations in serum and red blood cells, vital signs, body mass index (BMI), dietary intake (Food Frequency Questionnaire and 24 hour dietary recall interview), and mood and global functioning ratings. Results Seven children (70%) completed the study. Three (30%) terminated early for tolerability and compliance issues. Adverse effects were mild and transient, and chiefly consisted of initial insomnia or gastrointestinal (GI) upset. No differences occurred in BMI (p=0.310) or waist–hip ratio (WHR; p=0.674) pre- to postsupplementation. Four of the tested serum vitamin concentrations increased from pre- to postsupplementation: vitamin A-retinol, vitamin B6, vitamin E-α-tocopherol; and folate (all p<0.05). The increase in serum 25-OH vitamin D approached significance (p=0.063). No differences were found in dietary intake pre- to postsupplementation, suggesting that blood nutrient level increases were caused by EMP+. Conclusions In this open prospective study, short-term use of EMP+ in children with BPSD appeared safe and well-tolerated, with a side effect profile preferable to first-line psychotropic drugs for pediatric bipolar spectrum disorders. A double-blind, randomized clinical trial is feasible, appears safe, and is warranted by open-label clinical outcomes and plausible mechanisms of action, combined with documentation of increased serum concentrations of specific micronutrients. PMID:24138009

  19. Three open-label studies of oral interferon alpha in the treatment of HIV disease.

    PubMed

    Jordan, W C

    1994-04-01

    Three open-label studies were conducted in which natural human interferon-alpha (nHuIFN-alpha) was given orally to human immunodeficiency virus (HIV)-infected patients at a daily dosage of 150 IU for 12 months in an attempt to assess the effects of this treatment on their CD4+ cell counts. In the first study, 110 patients received nHuIFN-alpha, and 142 patients received nHuIFN-alpha and azidothymidine (AZT). At 12 months, patients given nHuIFN-alpha alone had a mean increase of 14% in their CD4+ counts, although the mean increase in absolute CD4+ count was similar between the groups. Blacks in this study were more likely to experience an increase in CD4+ count than other ethnic groups (P < 0.001). In the second study, 40 black, male homosexuals with CD4+ count between 350 and 500/mm3 were enrolled in groups of 10 to receive either nHuIFN-alpha or AZT, or both nHuIFN-alpha and AZT, or nothing (untreated controls). At 12 months, the mean CD4+ counts of the patients in the group given nHuIFN-alpha alone were significantly higher than the mean CD4+ counts in both the group given AZT alone and the untreated controls (P < 0.01). In the third study, 38 patients with CD4+ cell counts > 700/mm3 were enrolled in groups of 19, matched by gender and ethnic group, to receive nHuIFN-alpha or nothing (untreated controls). Patients given nHuIFN-alpha experienced a mean increase of 12% in their CD4+ counts by the end of the 12-month study.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study

    PubMed Central

    Lorig, Kate; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

    2016-01-01

    Background Diabetes self-management education has been shown to be effective in controlled trials. However, few programs that meet American Association of Diabetes Educators standards have been translated into widespread practice. Objective This study examined the translation of the evidence-based Better Choices, Better Health-Diabetes program in both Internet and face-to-face versions. Methods We administered the Internet program nationally in the United States (n=1010). We conducted face-to-face workshops in Atlanta, Georgia; Indianapolis, Indiana; and St. Louis, Missouri (n=232). Self-report questionnaires collected health indicator, health behavior, and health care utilization measures. Questionnaires were administered on the Web or by mail. We determined hemoglobin A1c (HbA1c) from blood samples collected via mailed kits. Paired t tests determined whether changes between baseline and 6 months differed significantly from no change. Subgroup analyses determined whether participants with specific conditions benefited (high HbA1c, depression, hypoglycemia, nonadherence to medication taking, and no aerobic exercise). We calculated the percentage of participants with improvements of at least 0.4 effect size in at least one of the 5 above measures. Results Of the 1242 participants, 884 provided 6-month follow-up questionnaires. There were statistically significant improvements in 6 of 7 health indicators (including HbA1c) and in 7 of 7 behaviors. For each of the 5 conditions, there were significant improvements among those with the condition (effect sizes 0.59–1.1). A total of 662 (75.0%) of study participants improved at least 0.4 effect size in at least one criterion, and 327 (37.1%) improved in 2 or more. Conclusions The Diabetes Self-Management Program, offered in two modes, was successfully disseminated to a heterogeneous national population of members of either insured or administered health plans. Participants had small but significant benefits in multiple

  1. Prognostic Factors for Chronic Spontaneous Urticaria: A 6-Month Prospective Observational Study

    PubMed Central

    Ye, Young-Min; Park, Jung-Won; Kim, Sang-Ha; Ban, Ga-Young; Kim, Ji-Hye; Shin, Yoo-Seob; Lee, Hyun-Young

    2016-01-01

    Purpose Chronic urticaria (CU) has a substantial impact on the quality of life. Little clinical data on the prognosis of CU has been reported. This study aimed to investigate the control status and remission rate of CU and to explore potential predictors of good responses to the treatment during a 6-month treatment period. Methods A total of 75 patients with chronic spontaneous urticaria (CSU) were enrolled from 3 university hospitals in Korea. Urticaria control state was classified into 2 groups: group I (remission and well-controlled) and group II (partly and uncontrolled). CU-specific quality of life (CU-QoL) and the urticaria activity score (UAS) were measured before and after the treatment. Autologous serum skin test (ASST), and anti-nuclear and anti-thyroid antibodies were measured at the enrollment into the study. Aspirin intolerance was confirmed by an oral provocation test. Results Of 59 patients completing the study, 21 (35.6%) arrived at well-controlled status and only 2 (3.4%) achieved remission, whereas 26 (44.1%) remained at partly controlled status and 10 (16.9%) were at uncontrolled status. Mean changes in CU-QoL (36.5±2.7 vs 20.6±4.3, P=0.017) and UAS (-7.9±0.8 vs -3.0±1.0, P=0.001) were significantly different between groups I and II. The presence of serum autoantibodies and aspirin intolerance had no influence on the control of urticaria in this study. However, ASST positivity was identified as a significant predictor of CU control in multivariate analysis (OR=6.106, P=0.017). Conclusions The proportion of CSU patients that achieved remission or a well-controlled state was 39% for the 6 months of stepwise treatment. Longer observations are necessary to assess the exact prognosis of CSU. ASST results may be a useful parameter for predicting a better response to treatment and both UAS and CU-QoL are helpful to monitor therapeutic response. PMID:26739404

  2. Antiphospholipid antibodies during 6-month treatment with infliximab: A preliminary report

    PubMed Central

    Kolarz, Bogdan; Majdan, Maria; Darmochwał-Kolarz, Dorota A.; Dryglewska, Magdalena

    2014-01-01

    Background The introduction of tumor necrosis factor (TNF) antagonists (adalimumab, infliximab, and etanercept) was a major advance and was highly important and beneficial in most rheumatoid arthritis (RA) patients. The adverse effects of this treatment are infrequent, but include opportunistic intracellular infection (especially the reactivation of latent Mycobacterium tuberculosis); exacerbation of demyelinating disorders; and the production of various types of antibodies such as antinuclear antibodies (ANA) or double-stranded DNA autoantibodies (dsDNA) and antiphospholipid antibodies (aPL) such as anti-cardiolipin antibodies (aCL) and anti-B2GP-I antibodies (B2GP-I). The aim of the study was to determine the prevalence of aCL and B2GP-I in IgM and IgG classes, using ELISA tests, during 6 months of follow-up in patients with refractory RA successfully treated with infliximab. Material/Methods We determined the prevalence of aCL and B2GP-I in IgM and IgG classes, using ELISA tests, during 6 months of follow-up in patients with refractory RA successfully treated with infliximab. Results We observed a statistically important increase only in the group of B2GP-I IgM (p<0.05). There are contradictory results concerning the ability of infliximab to induce aPL, but most authors confirm this phenomenon. Conclusions Further investigations are needed to determine if the new aPL appears in patients with β2-GPI gene polymorphisms such as leucine-to-valine substitution at position 247, which can lead to a conformational changes in β2-GPI protein, leading to aPL synthesis. The role of aPL in pathogenesis of APS is still unclear, but we should remember the immunogenic aspect of TNF antagonist treatment. Therefore, we recommend early detection of aPL and observation of the patient, paying special attention to signs and symptoms of thromboembolism. PMID:25027437

  3. Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast-feeding infants from birth to 6 months.

    PubMed

    Shetty, Avinash K; Coovadia, Hoosen M; Mirochnick, Mark M; Maldonado, Yvonne; Mofenson, Lynne M; Eshleman, Susan H; Fleming, Thomas; Emel, Lynda; George, Kathy; Katzenstein, David A; Wells, Jennifer; Maponga, Charles C; Mwatha, Anthony; Jones, Samuel Adeniyi; Abdool Karim, Salim S; Bassett, Mary T

    2003-12-15

    Despite the success of antiretroviral prophylaxis in reducing mother-to-child HIV-1 transmission, postpartum transmission through breast milk remains a problem. Antiretroviral administration to the infant during the period of breast-feeding could protect against postnatal transmission. An open-label phase 1/2 study was designed to assess the safety and trough concentrations of nevirapine (NVP) given once weekly (OW), twice weekly (TW), or once daily (OD) to HIV-exposed breast-feeding infants for 24 weeks. Following maternal dosing with 200 mg NVP orally at onset of labor, breast-feeding infants were randomized within 48 hours of birth to 1 of 3 regimens: arm 1, NVP given OW (4 mg/kg from birth to 14 days, upward arrow to 8 mg/kg from 15 days to 24 weeks), arm 2, NVP given TW (4 mg/kg from birth to 14 days, upward arrow to 8 mg/kg from 15 days to 24 weeks), and arm 3, NVP given OD (2 mg/kg from birth to 14 days, upward arrow to 4 mg/kg from 15 days to 24 weeks). Trough NVP concentrations and clinical and laboratory abnormalities were monitored. Of the 75 infants randomized (26 to OW, 25 to TW, and 24 to OD dosing), 63 completed the 32-week follow-up visit. No severe skin, hepatic, or renal toxicity related to NVP was observed. Neutropenia occurred in 8 infants. Trough NVP levels were lower than the therapeutic target (100 ng/mL) in 48 of 75 (64.0%) samples from infants in the OW arm, 3 of 65 (4.6%) samples in the TW arm, and 0 of 72 samples in the OD arm. Median (range) trough NVP concentrations were 64 ng/mL (range: <25-1519 ng/mL) with OW dosing; 459 (range: <25-1386 ng/mL) with TW dosing; and 1348 (range: 108-4843 ng/ml) with OD dosing. Our data indicate that NVP prophylaxis for 6 months was safe and well tolerated in infants. OD NVP dosing resulted in all infants with trough concentration greater than the therapeutic target and maintenance of high drug concentrations. A phase 3 study is planned to assess the efficacy of OD infant NVP regimen to prevent breast

  4. Intensive Rehabilitation Treatment in Parkinsonian Patients with Dyskinesias: A Preliminary Study with 6-Month Followup

    PubMed Central

    Frazzitta, Giuseppe; Morelli, Micaela; Bertotti, Gabriella; Felicetti, Guido; Pezzoli, Gianni; Maestri, Roberto

    2012-01-01

    A major adverse effect of levodopa therapy is the development of dyskinesia, which affects 30–40% of chronically treated Parkinsonian patients. We hypothesized that our rehabilitation protocol might allow a reduction in levodopa dosage without worsening motor performances, thus reducing frequency and severity of dyskinesias. Ten Parkinsonian patients underwent a 4-week intensive rehabilitation treatment (IRT). Patients were evaluated at baseline, at the end of the rehabilitation treatment and at 6-month followup. Outcome measures were the Unified Parkinson's Disease Rating Scale Sections II, III, and IV (UPDRS II, III, IV) and the Abnormal Involuntary Movement Scale (AIMS). At the end of the IRT, levodopa dosage was significantly reduced (P = 0.0035), passing from 1016 ± 327 to 777 ± 333 mg/day. All outcome variables improved significantly (P < 0.0005 all) by the end of IRT. At followup, all variables still maintained better values with respect to admission (P < 0.02 all). In particular AIMS score improved passing from 11.90 ± 6.5 at admission to 3.10 ± 2.3 at discharge and to 4.20 ± 2.7 at followup. Our results suggest that it is possible to act on dyskinesias in Parkinsonian patients with properly designed rehabilitation protocols. Intensive rehabilitation treatment, whose acute beneficial effects are maintained over time, might be considered a valid noninvasive therapeutic support for Parkinsonian patients suffering from diskinesia, allowing a reduction in drugs dosage and related adverse effects. PMID:22701812

  5. [The effects of rape 6 months after the attack and factors associated with recovery].

    PubMed

    Streit-Forest, U; Goulet, M

    1987-02-01

    In this study a group of 27 victims seen approximately 6 months after the assault was compared to a matched control group. The results show significantly higher scores on two subscales of IPAT ("ego weakness" and "disposition to guilt") and on 4 scales of the MMPI ("denial", "hypochondriasis", "depression" and "conversion hysteria"); also, the victims' social adjustment seems inferior and the frequency of sexual relations has been reduced considerably for them. The following factors have been evaluated in order to test their relation to the adjustment to the assault: rape by a stranger versus someone known, degree of violence, feelings of self-blame, problems during the crisis, predominant thoughts, professional help, social support, stable relationship, allusion to victim's responsibility for rape and conviction or not of the aggressor. Even though most of these variables show a significant simple correlation with adjustment to rape only four among them remain significantly associated when sociodemographic variables, pre-rape psycho-social problems and life stressors are controlled; the very subjective variable "predominant thoughts" seems to best explain differences in adjustment. The importance of pre-assault variables and of the subjective reaction to rape is discussed.

  6. Development of Specific Aspects of Spirituality during a 6-Month Intensive Yoga Practice.

    PubMed

    Büssing, Arndt; Hedtstück, Anemone; Khalsa, Sat Bir S; Ostermann, Thomas; Heusser, Peter

    2012-01-01

    The majority of research on yoga focuses on its psychophysiological and therapeutic benefits, while the spiritual aspects are rarely addressed. Changes of specific aspects of spirituality were thus investigated among 160 individuals (91% women, mean age 40.9 ± 8.3 years; 57% Christians) starting a 2-year yoga teacher training. We used standardized questionnaires to measure aspects of spirituality (ASP), mindfulness (FMI-Freiburg Mindfulness Inventory), life satisfaction (BMLSS-Brief Multidimensional Life Satisfaction Scale), and positive mood (lightheartedness/relief). At the start of the course, scores of the respective ASP subscales for search for insight/wisdom, transcendence conviction, and conscious interactions/compassion were high, while those for religious orientation were low. Within the 6 month observation period, both conscious interactions/compassion (effect size, Cohen's d = .33), Religious orientation (d = .21), Lightheartedness/Relief (d = .75) and mindfulness (d = .53) increased significantly. Particularly non-religious/non-spiritual individuals showed moderate effects for an increase of conscious interactions/compassion. The results from this study suggest that an intensive yoga practice (1) may significantly increase specific aspects of practitioners' spirituality, mindfulness, and mood, (2) that these changes are dependent in part on their original spiritual/religious self-perception, and (3) that there are strong correlations amongst these constructs (i.e., conscious interactions/compassion, and mindfulness). PMID:22852023

  7. Object engagement and manipulation in extremely preterm and full term infants at 6 months of age.

    PubMed

    Zuccarini, Mariagrazia; Sansavini, Alessandra; Iverson, Jana M; Savini, Silvia; Guarini, Annalisa; Alessandroni, Rosina; Faldella, Giacomo; Aureli, Tiziana

    2016-08-01

    Delays in the motor domain have been frequently observed in preterm children, especially those born at an extremely low gestational age (ELGA;<28 weeks GA). However, early motor exploration has received relatively little attention despite its relevance for object knowledge and its impact on cognitive and language development. The present study aimed at comparing early object exploration in 20 ELGA and 20 full-term (FT) infants at 6 months of age during a 5-minute mother-infant play interaction. Object engagement (visual vs manual), visual object engagement (no act vs reach), manual object engagement (passive vs active), and active object manipulation (mouthing, transferring, banging, turn/rotating, shaking, fingering) were analyzed. Moreover, the Griffiths Mental Development Scales 0-2 years (1996) were administered to the infants. Relative to FT peers, ELGA infants spent more time in visual engagement, and less time in manual engagement, active manipulation, mouthing, and turning/rotating. Moreover, they had lower scores on general psychomotor development, eye & hand coordination, and performance abilities. Close relationships emerged between manual object engagement and psychomotor development. Clinical implications of these results in terms of early evaluation of action schemes in ELGA infants and the provision of intervention programs for supporting these abilities are discussed.

  8. Times to Discontinue Antidepressants Over 6 Months in Patients with Major Depressive Disorder

    PubMed Central

    Jung, Woo-Young; Jang, Sae-Heon; Jae, Young-Myo; Kong, Bo-Geum; Kim, Ho-Chan; Choe, Byeong-Moo; Kim, Jeong-Gee; Kim, Choong-Rak

    2016-01-01

    Objective The aim of the present study was to investigate differences in discontinuation time among antidepressants and total antidepressant discontinuation rate of patients with depression over a 6 month period in a naturalistic treatment setting. Methods We reviewed the medical records of 900 patients with major depressive disorder who were initially prescribed only one kind of antidepressant. The prescribed antidepressants and the reasons for discontinuation were surveyed at baseline and every 4 weeks during the 24 week study. We investigated the discontinuation rate and the mean time to discontinuation among six antidepressants groups. Results Mean and median overall discontinuation times were 13.8 and 12 weeks, respectively. Sertraline and escitalopram had longer discontinuation times than that of fluoxetine, and patients who used sertraline discontinued use significantly later than those taking mirtazapine. No differences in discontinuation rate were observed after 24 weeks among these antidepressants. About 73% of patients discontinued antidepressant treatment after 24 weeks. Conclusion Sertraline and escitalopram tended to have longer mean times to discontinuation, although no difference in discontinuation rate was detected between antidepressants after 24 weeks. About three-quarters of patients discontinued antidepressant maintenance therapy after 24 weeks. PMID:27482246

  9. Development of Specific Aspects of Spirituality during a 6-Month Intensive Yoga Practice

    PubMed Central

    Büssing, Arndt; Hedtstück, Anemone; Khalsa, Sat Bir S.; Ostermann, Thomas; Heusser, Peter

    2012-01-01

    The majority of research on yoga focuses on its psychophysiological and therapeutic benefits, while the spiritual aspects are rarely addressed. Changes of specific aspects of spirituality were thus investigated among 160 individuals (91% women, mean age 40.9 ± 8.3 years; 57% Christians) starting a 2-year yoga teacher training. We used standardized questionnaires to measure aspects of spirituality (ASP), mindfulness (FMI—Freiburg Mindfulness Inventory), life satisfaction (BMLSS—Brief Multidimensional Life Satisfaction Scale), and positive mood (lightheartedness/relief). At the start of the course, scores of the respective ASP subscales for search for insight/wisdom, transcendence conviction, and conscious interactions/compassion were high, while those for religious orientation were low. Within the 6 month observation period, both conscious interactions/compassion (effect size, Cohen's d = .33), Religious orientation (d = .21), Lightheartedness/Relief (d = .75) and mindfulness (d = .53) increased significantly. Particularly non-religious/non-spiritual individuals showed moderate effects for an increase of conscious interactions/compassion. The results from this study suggest that an intensive yoga practice (1) may significantly increase specific aspects of practitioners' spirituality, mindfulness, and mood, (2) that these changes are dependent in part on their original spiritual/religious self-perception, and (3) that there are strong correlations amongst these constructs (i.e., conscious interactions/compassion, and mindfulness). PMID:22852023

  10. A 6 month evaluation of a non-powered hybrid mattress replacement system.

    PubMed

    Newton, Heather

    2015-11-11

    In 2013, the Royal Cornwall Hospitals NHS Trust undertook a 6-week evaluation of the AtmosAir 4000 non-powered reactive pressure redistribution mattress replacement system to determine its suitability in supporting the prevention of pressure ulcers in high-risk patients (phase one). The results demonstrated that the AtmosAir 4000 mattress system, together with skin assessment and repositioning regimes, met the pressure ulcer preventative needs of patients at high and very high risk of developing pressure ulcers. It also resulted in a notable reduction in the use of dynamic air mattresses. Consequently, 50 AtmosAir 4000 mattresses were purchased for two acute medical wards in the evaluation site, where the majority of patients are elderly with an acute medical condition. This article discusses the second phase where an audit compares the number of hospital-acquired pressure ulcers reported over a 6-month period with the equivalent time period in 2014. Results show that the number of pressure ulcers reduced by 65% and 50% in the two wards. The number of dynamic mattresses used on the two wards reduced significantly from 28 to 7, which represents a 75% reduction in usage.

  11. [Twelve cases of total arthroplasty of lumbar disc. Preliminary results at 6 months].

    PubMed

    Morales, José Fernando Ramos; Palacios, Jesús López; Soriano, Juan Carlos Alvarado

    2008-01-01

    Lumbar pathology is a problem with growing incidence in developed countries. Lumbar pain caused by disc degeneration is the most frequently cause of functional restriction in patients under 45 years old. Discectomy, laminectomy and posterior spinal fusion have been the traditional surgery treatment. Many patients continue with pain as a consequence of mechanical damage at the functional unit, with different degrees of instability and adjacent disc damage. There are two types of strategies for disc replacement: disc nucleus arthroplasty and total disc arthroplasty. A clinical essay was made in Angeles Mocel Hospital during the period between October 2003 to March 2005. Eight patients with degenerative lumbar disc disease or contained disc herniation, were treated with 12 disc prosthesis, previously they showed no improvement with conservative treatment at minimum 4 months. Preoperative and postoperative pain was reported with the analogue visual score and the Oswestry score. Eighty percent presented immediate postoperative improvement and 100% after 6 months using Oswestry score. This procedure offers good outcome at short term, when its well indicated. This treatment requires a multidisciplinary team and elevates the costs. We need long term follow up results.

  12. Individual experiences following a 6-month exercise intervention: A qualitative study

    PubMed Central

    Kerkelä, Ellen Staveborg; Jonsson, Linus; Lindwall, Magnus; Strand, Jennifer

    2015-01-01

    Purpose Dropout is a common problem in various exercise interventions. The individual's experience is believed to greatly impact dropout, yet little is known about the individual experiences of taking part in exercise interventions. The aim of this study was to examine individuals’ experiences following a self-determination theory–based exercise intervention in order to gain understanding of how standardized interventions can be adjusted to fit individuals’ specific needs, capacities, and circumstances. Methods A qualitative approach with semi-structured interviews was conducted with eight informants (three male and five female) aged between 26 and 47 years, whom all had participated in a 6-month exercise intervention with individual coaching based on self-determination theory and motivational interviewing. The interviews were analyzed thematically with an inductive approach. Results Aspects that influenced the informants’ motivation and participation in the exercise intervention were linked to three themes: the frames of the intervention, measurable changes, and the individual's context. The themes present information about the process and to what extent the informants felt that the intervention was adapted to fit their lives and needs. Conclusions This study emphasizes the importance of individualizing exercise interventions to support individuals’ diverse capacities and psychological needs. PMID:26282865

  13. Differential brain shrinkage over 6 months shows limited association with cognitive practice.

    PubMed

    Raz, Naftali; Schmiedek, Florian; Rodrigue, Karen M; Kennedy, Kristen M; Lindenberger, Ulman; Lövdén, Martin

    2013-07-01

    The brain shrinks with age, but the timing of this process and the extent of its malleability are unclear. We measured changes in regional brain volumes in younger (age 20-31) and older (age 65-80) adults twice over a 6 month period, and examined the association between changes in volume, history of hypertension, and cognitive training. Between two MRI scans, 49 participants underwent intensive practice in three cognitive domains for 100 consecutive days, whereas 23 control group members performed no laboratory cognitive tasks. Regional volumes of seven brain structures were measured manually and adjusted for intracranial volume. We observed significant mean shrinkage in the lateral prefrontal cortex, the hippocampus, the caudate nucleus, and the cerebellum, but no reliable mean change of the prefrontal white matter, orbital-frontal cortex, and the primary visual cortex. Individual differences in change were reliable in all regions. History of hypertension was associated with greater cerebellar shrinkage. The cerebellum was the only region in which significantly reduced shrinkage was apparent in the experimental group after completion of cognitive training. Thus, in healthy adults, differential brain shrinkage can be observed in a narrow time window, vascular risk may aggravate it, and intensive cognitive activity may have a limited effect on it.

  14. Quit rates at 6 months in a pharmacist-led smoking cessation service in Malaysia

    PubMed Central

    Fai, Sui Chee; Yen, Gan Kim; Malik, Nurdiyana

    2016-01-01

    Background: Smoking cessation clinics have been established in Malaysia since 2004, but wide variations in success rates have been observed. This study aimed to evaluate the proposed pharmacist-led Integrated Quit Smoking Service (IQSS) in Sabah, Malaysia, and identify factors associated with successful smoking cessation. Methods: Data from 176 participants were collected from one of the quit-smoking centres in Sabah, Malaysia. Pharmacists, doctors and nurses were involved throughout the study. Any health care provider can refer patients for smoking cessation, and free pharmacotherapy and counselling was provided during the cessation period for up to 3 months. Information on demographic characteristics, smoking behaviours, follow-up and pharmacotherapy were collected. The main outcome measure was the abstinence from smoking, which was verified through carbon monoxide in expired air during the 6-month follow-up. Results: A 42.6% success rate was achieved in IQSS. Smoking behaviour such as lower cigarette intake and lower Fagerström score were identified as factors associated with success. On top of that, a longer duration of follow-up and more frequent visits were significantly associated with success in quitting smoking. Conclusion: Collaboration among health care practitioners should be the main focus, and we need a combination of proven effective modalities in order to create an ideal smoking cessation module. PMID:27708676

  15. Prospective predictors of adolescent suicidality: 6-month post-hospitalization follow-up

    PubMed Central

    Yen, S.; Weinstock, L. M.; Andover, M. S.; Sheets, E. S.; Selby, E. A.; Spirito, A.

    2013-01-01

    Background The aim of this study was to examine prospective predictors of suicide events, defined as suicide attempts or emergency interventions to reduce suicide risk, in 119 adolescents admitted to an in-patient psychiatric unit for suicidal behaviors and followed naturalistically for 6 months. Method Structured diagnostic interviews and self-report instruments were administered to adolescent participants and their parent(s) to assess demographic variables, history of suicidal behavior, psychiatric disorders, family environment and personality/temperament. Results Baseline variables that significantly predicted time to a suicide event during follow-up were Black race, high suicidal ideation in the past month, post-traumatic stress disorder (PTSD), childhood sexual abuse (CSA), borderline personality disorder (BPD), low scores on positive affectivity, and high scores on aggression. In a multivariate Cox regression analysis, only Black race, CSA, positive affect intensity and high aggression scores remained significant. Conclusions Our findings suggest the following for adolescent populations: (1) in a very high-risk population, risk factors for future attempts may be more difficult to ascertain and some established risk factors (e.g. past suicide attempt) may not distinguish as well; and (2) cross-cutting constructs (e.g. affective and behavioral dysregulation) that underlie multiple psychiatric disorders may be stronger predictors of recurrent suicide events than psychiatric diagnoses. Our finding with respect to positive affect intensity is novel and may have practical implications for the assessment and treatment of adolescent suicide attempters. PMID:22932393

  16. Femoral Arteriovenous Fistula Associated With Leg Swelling 6 Months After Removal of a Hemodialysis Catheter

    PubMed Central

    Jin, Lie; Wang, Jian; Wu, Chuifen; shao, Chuxiao; Yu, Xueping; Lei, Wenhui

    2015-01-01

    Abstract Double-lumen catheters have been used widely to obtain temporary access in patients who are in need of acute hemodialysis (HD) because of acute renal failure. Several complications are associated with the insertion of these catheters, including bleeding, infection, injuries to arteries, and deep venous thrombosis. An arteriovenous fistula (AVF) is a rare but significant complication following catheterization for temporary HD. Herein, we present a case of AVF associated with leg swelling 6 months after the removal of a double-lumen HD catheter. We describe a special case of a 42-year-old man who experienced acute renal failure secondary to diabetic ketoacidosis (DKA). A 12-Fr dialysis catheter was inserted in the right femoral vein. Six months after catheter removal, the patient was admitted for pain and swelling in the right leg. Color Doppler ultrasound and three-dimensional computed tomography (CT) revealed an AVF between the right femoral vein and the right femoral superficial artery. The fistula was repaired successfully by vascular surgeons. This case highlights that an AVF is a rare but significant complication after catheterization for temporary HD. The nephrologist should be wary of the potential of this complication and perform clinical and medical examinations at the insertion and removal of temporary HD catheters. PMID:26448032

  17. Becoming a role model: the breastfeeding trajectory of Hong Kong women breastfeeding longer than 6 months.

    PubMed

    Tarrant, Marie; Dodgson, Joan E; Choi, Vinkline Wing Kay

    2004-07-01

    While a substantial proportion of breastfeeding women stop early in the postpartum period, some women are able to breastfeed for longer periods. The aim of this research was to explore the experience of breastfeeding with a subsample of Hong Kong women who have breastfed for longer than 6 months. Participants (n=17) were recruited from a larger infant-feeding study (n=360) conducted in tertiary-care hospitals in Hong Kong. In-depth qualitative interviews were conducted and content analysis was used to analyse the data. Data analysis revealed four themes that encompassed the women's experiences: (1) making the decision, (2) maintaining family harmony, (3) overcoming barriers, and (4) sustaining lactation. Antenatally, participants anticipated that breastfeeding would be very 'difficult' and described how the practice did not fit with the image of a professional woman in Hong Kong. Despite family opposition, frequently from their mother-in-law, and lack of societal acceptance, difficulties were overcome by what the Chinese people call hung-sum or determination. This study highlights unique cultural and social findings affecting breastfeeding women in Hong Kong which may be useful to health-care providers working with Chinese women locally and internationally. PMID:15120982

  18. Exclusive or Partial Breastfeeding for 6 Months Is Associated With Reduced Milk Sensitization and Risk of Eczema in Early Childhood

    PubMed Central

    Chiu, Chih-Yung; Liao, Sui-Ling; Su, Kuan-Wen; Tsai, Ming-Han; Hua, Man-Chin; Lai, Shen-Hao; Chen, Li-Chen; Yao, Tsung-Chieh; Yeh, Kuo-Wei; Huang, Jing-Long

    2016-01-01

    Abstract There is insufficient evidence to confirm the association between breastfeeding and allergic outcomes later in life. This study aimed to determine the relationships between different breastfeeding patterns and allergen sensitizations and risk of developing atopic diseases in early childhood. A total of 186 children from a birth cohort in the Prediction of Allergies in Taiwanese Children study for a 4-year follow-up period were enrolled. Total serum immunoglobulin E (IgE) levels and specific IgE antibodies against food and inhalant allergens were measured sequentially at 6 months as well as at 1, 1.5, 2, 3, and 4 years of age. A significantly lower prevalence of milk sensitization was found in children at ages 1 and 1.5 years who were exclusively or partially breastfed for ≥6 months. Breastfeeding ≥6 months was significantly associated with a reduced risk of developing eczema but not allergic rhinitis and asthma at ages 1 and 2 years. Compared with exclusive breastfeeding ≥6 months, partial breastfeeding <6 months was significantly associated with an increased risk of developing eczema at ages 1 and 2 years. As with exclusive breastfeeding, partial breastfeeding for at least 6 months appears to be associated with a reduced prevalence of milk sensitization as well as a reduced risk of developing eczema in early childhood. PMID:27082611

  19. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 12-month, open-label results.

    PubMed

    Fernandez, Hubert H; Standaert, David G; Hauser, Robert A; Lang, Anthony E; Fung, Victor S C; Klostermann, Fabian; Lew, Mark F; Odin, Per; Steiger, Malcolm; Yakupov, Eduard Z; Chouinard, Sylvain; Suchowersky, Oksana; Dubow, Jordan; Hall, Coleen M; Chatamra, Krai; Robieson, Weining Z; Benesh, Janet A; Espay, Alberto J

    2015-04-01

    Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. L-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces L-dopa-plasma-level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, "on" time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. PMID:25545465

  20. Multisite, open-label, prospective trial of lamotrigine for geriatric bipolar depression: a preliminary report

    PubMed Central

    Sajatovic, Martha; Gildengers, Ariel; Jurdi, Rayan K Al; Gyulai, Laszlo; Cassidy, Kristin A; Greenberg, Rebecca L; Bruce, Martha L; Mulsant, Benoit H; Have, Thomas Ten; Young, Robert C

    2013-01-01

    Aims This is a multisite, 12-week, open-label trial of lamotrigine augmentation in 57 older adults (≥ 60 years; mean ± SD age = 66.5 ± 6.7 years) with either type I or type II bipolar depression. Methods Primary outcome measure was change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcome measures included Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression-Bipolar version (CGI-BP), and the WHO-Disability Assessment Schedule II (WHO-DAS II). The Udvalg for Kliniske Undersøgelser (UKU) was used to assess side effects. Results A total of 77.2% of the study subjects had bipolar I disorder. The mean (SD) lamotrigine dose was 150.9 (68.5) mg/day. There was significant improvement in the MADRS, HAM-D, CGI-BP, and in most domains on the WHO-DAS II. For patients for whom final MADRS score was available: 31 (57.4%) met remission criteria and 35 (64.8%) met response criteria. There were 19/57 (33.3%) who dropped out of the study prematurely, with 6 dropouts due to adverse events (4 cases of rash, 1 manic switch, and 1 hyponatremia). Two cases of rash were possibly drug related and were resolved with drug discontinuation. The most common UKU adverse effects were reduced sleep duration (n = 14, 24.6%), weight loss (n = 12, 21.1%), increased dream activity (n = 12, 21.1%), polyuria/polydipsia (n = 11, 19.3%), weight gain (n = 9, 15.8%), diminished sexual desire (n = 9, 15.8%), increased sleep (n = 9, 15.8%), lassitude/fatigue (n = 8, 14%), and unsteady gait (n = 8, 14%). No significant changes in electrocardiogram or laboratory tests were observed. Conclusions In bipolar depressed elders, lamotrigine was associated with improvement in depression, psychopathology, and functional status. There was a moderate number of adverse events, although relationship of adverse events (particularly falls) to study medication could not be clearly determined in this uncontrolled trial. Controlled studies are needed to further

  1. Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial

    PubMed Central

    Wang, Zhiqun; Dai, Yimin; Zheng, Mingming; Xu, Biyun; Hu, Yali

    2015-01-01

    Objective This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL) and the maximum time for cervical ripening (12 hours vs. 24 hours) to improve vaginal delivery rate within 24 hours of induction. Methods We conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6) were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1) 30-mL balloon for a maximum of 12 hours, (2) 30-mL balloon for a maximum of 24 hours, (3) 80-mL balloon for a maximum of 12 hours, and (4) 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis. Results Five hundred and four women were recruited and randomized (126 women in each group); nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%, p < 0.001). Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction. Conclusion For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate. Trial Registration Chinese Clinical trial registry (ChiCTR-TRC-13003044) PMID:26322635

  2. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial

    PubMed Central

    Aubin, H-J; Bobak, A; Britton, J R; Oncken, C; Billing, C B; Gong, J; Williams, K E; Reeves, K R

    2008-01-01

    Background: Varenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation. Methods: In this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, the Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide ⩽10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction. Results: A total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8–52; varenicline, weeks 9–52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%). Conclusions: The outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT. Trial registration number

  3. Greater weight loss and hormonal changes after 6 months diet with carbohydrates eaten mostly at dinner.

    PubMed

    Sofer, Sigal; Eliraz, Abraham; Kaplan, Sara; Voet, Hillary; Fink, Gershon; Kima, Tzadok; Madar, Zecharia

    2011-10-01

    This study was designed to investigate the effect of a low-calorie diet with carbohydrates eaten mostly at dinner on anthropometric, hunger/satiety, biochemical, and inflammatory parameters. Hormonal secretions were also evaluated. Seventy-eight police officers (BMI >30) were randomly assigned to experimental (carbohydrates eaten mostly at dinner) or control weight loss diets for 6 months. On day 0, 7, 90, and 180 blood samples and hunger scores were collected every 4 h from 0800 to 2000 hours. Anthropometric measurements were collected throughout the study. Greater weight loss, abdominal circumference, and body fat mass reductions were observed in the experimental diet in comparison to controls. Hunger scores were lower and greater improvements in fasting glucose, average daily insulin concentrations, and homeostasis model assessment for insulin resistance (HOMA(IR)), T-cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) levels were observed in comparison to controls. The experimental diet modified daily leptin and adiponectin concentrations compared to those observed at baseline and to a control diet. A simple dietary manipulation of carbohydrate distribution appears to have additional benefits when compared to a conventional weight loss diet in individuals suffering from obesity. It might also be beneficial for individuals suffering from insulin resistance and the metabolic syndrome. Further research is required to confirm and clarify the mechanisms by which this relatively simple diet approach enhances satiety, leads to better anthropometric outcomes, and achieves improved metabolic response, compared to a more conventional dietary approach.

  4. Systemic immunotoxicity in AJ mice following 6-month whole body inhalation exposure to diesel exhaust.

    PubMed

    Burchiel, Scott W; Lauer, Fredine T; McDonald, Jacob D; Reed, Matthew D

    2004-05-01

    The purpose of these studies was to determine the effects of subchronic diesel exposure on indicators of systemic immunity in mice. AJ mice were exposed daily for 6 months (6 h/day) to atmospheres containing one of four concentrations (30, 100, 300, and 1000 microg/m(3)) of diluted diesel exhaust (DE) in whole body exposure chambers. The effects of DE were compared to chamber exposure controls receiving fresh air. DE was assessed for effects on systemic immunity by measuring the proliferative response of spleen cells following stimulation with T cell (phytohemagglutinin, or PHA) or B cell (lipopolysaccharide, or LPS) mitogens. The results showed that DE at all exposure levels suppressed the proliferative response of T cells. B cell proliferation was increased at 30 microg/m(3) and was unaffected at the 100, 300, and 1000 microg/m(3) exposures. Polycyclic aromatic hydrocarbons (PAHs) are known to suppress spleen cell mitogenic responses, and it has been hypothesized by several groups that PAHs and perhaps benzo(a)pyrene (BaP)-quinones (BPQs) may be responsible for the effects of DE or diesel exhaust particles (DEP). Therefore, a second purpose of these studies was to determine the effects of in vitro BPQs on AJ mouse spleen cell mitogenic responses and compare to DE in preliminary studies. Unlike DE, BPQs were found to increase T cell proliferation. In addition, analysis of chamber atmospheres showed that there was little if any PAH and BPQs in DE. Therefore, these results demonstrate that because of the absence of BPQs in DE, they are likely not responsible for the immunosuppressive effect of DE on murine spleen cell responses.

  5. Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes

    PubMed Central

    Arner, M.; Pajardi, G.; Reichert, B.; Szabo, Z.; Masmejean, E. H.; Fores, J.; Chapman, D. S.; Gerber, R. A.; Huard, F.; Seghouani, A.; Szczypa, P. P.

    2015-01-01

    In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren’s contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman −0.18, 95% CI −0.32 to −0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population. PMID:24470559

  6. Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome.

    PubMed

    Tang, Jean Y; Chiou, Albert S; Mackay-Wiggan, Julian M; Aszterbaum, Michelle; Chanana, Anita M; Lee, Wayne; Lindgren, Joselyn A; Raphael, Maria Acosta; Thompson, Bobbye J; Bickers, David R; Epstein, Ervin H

    2014-03-01

    Sporadic human basal cell carcinomas (BCC) are generally well managed with current surgical modalities. However, in the subset of high-risk patients predisposed to developing large numbers of BCCs, there is an unmet need for effective, low-morbidity chemoprevention. This population includes fair-skinned patients with extensive sun exposure and those with genodermatoses such as the basal cell nevus (Gorlin) syndrome (BCNS). Tazarotene (Tazorac, Allergan) is a topical retinoid with relative specificity for RAR-β and RAR-γ receptors. We previously demonstrated tazarotene's robust anti-BCC efficacy in Ptch1(+/-) mice, a murine equivalent of BCNS, and others have found it to have some efficacy against sporadic human BCCs. We report here results of a randomized, double-blind, vehicle-controlled study in patients with BCNS evaluating the efficacy of topically applied tazarotene for BCC chemoprevention (N = 34 subjects), along with an open-label trial evaluating tazarotene's efficacy for chemotherapy of BCC lesions (N = 36 subjects) for a maximum follow-up period of 3 years. We found that only 6% of patients had a chemopreventive response and that only 6% of treated BCC target lesions were clinically cured. Our studies provide no evidence for either chemopreventive or chemotherapeutic effect of tazarotene against BCCs in patients with BCNS. PMID:24441673

  7. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.

    PubMed

    Warwick, D; Arner, M; Pajardi, G; Reichert, B; Szabo, Z; Masmejean, E H; Fores, J; Chapman, D S; Gerber, R A; Huard, F; Seghouani, A; Szczypa, P P

    2015-02-01

    In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

  8. Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome.

    PubMed

    Tang, Jean Y; Chiou, Albert S; Mackay-Wiggan, Julian M; Aszterbaum, Michelle; Chanana, Anita M; Lee, Wayne; Lindgren, Joselyn A; Raphael, Maria Acosta; Thompson, Bobbye J; Bickers, David R; Epstein, Ervin H

    2014-03-01

    Sporadic human basal cell carcinomas (BCC) are generally well managed with current surgical modalities. However, in the subset of high-risk patients predisposed to developing large numbers of BCCs, there is an unmet need for effective, low-morbidity chemoprevention. This population includes fair-skinned patients with extensive sun exposure and those with genodermatoses such as the basal cell nevus (Gorlin) syndrome (BCNS). Tazarotene (Tazorac, Allergan) is a topical retinoid with relative specificity for RAR-β and RAR-γ receptors. We previously demonstrated tazarotene's robust anti-BCC efficacy in Ptch1(+/-) mice, a murine equivalent of BCNS, and others have found it to have some efficacy against sporadic human BCCs. We report here results of a randomized, double-blind, vehicle-controlled study in patients with BCNS evaluating the efficacy of topically applied tazarotene for BCC chemoprevention (N = 34 subjects), along with an open-label trial evaluating tazarotene's efficacy for chemotherapy of BCC lesions (N = 36 subjects) for a maximum follow-up period of 3 years. We found that only 6% of patients had a chemopreventive response and that only 6% of treated BCC target lesions were clinically cured. Our studies provide no evidence for either chemopreventive or chemotherapeutic effect of tazarotene against BCCs in patients with BCNS.

  9. EXpanding Treatment for Existing Neurological Disease (EXTEND): An Open-Label Phase II Clinical Trial of Hydroxyurea Treatment in Sickle Cell Anemia

    PubMed Central

    Little, Courtney R; Reid, Marvin E; Soares, Deanne P; Taylor-Bryan, Carolyn; Knight-Madden, Jennifer M; Stuber, Susan E; Badaloo, Asha V; Aldred, Karen; Wisdom-Phipps, Margaret E; Latham, Teresa; Ware, Russell E

    2016-01-01

    Background Cerebral vasculopathy in sickle cell anemia (SCA) begins in childhood and features intracranial arterial stenosis with high risk of ischemic stroke. Stroke risk can be reduced by transcranial doppler (TCD) screening and chronic transfusion therapy; however, this approach is impractical in many developing countries. Accumulating evidence supports the use of hydroxyurea for the prevention and treatment of cerebrovascular disease in children with SCA. Recently we reported that hydroxyurea significantly reduced the conversion from conditional TCD velocities to abnormal velocities; whether hydroxyurea can be used for children with newly diagnosed severe cerebrovascular disease in place of starting transfusion therapy remains unknown. Objective The primary objective of the EXpanding Treatment for Existing Neurological Disease (EXTEND) trial is to investigate the effect of open label hydroxyurea on the maximum time-averaged mean velocity (TAMV) after 18 months of treatment compared to the pre-treatment value. Secondary objectives include the effects of hydroxyurea on serial TCD velocities, the incidence of neurological and non-neurological events, quality of life (QOL), body composition and metabolism, toxicity and treatment response, changes to brain magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), genetic and serologic markers of disease severity, and cognitive and pulmonary function. Methods This prospective Phase II trial will enroll children with SCA in Jamaica, between the ages of 2 and 17 years, with either conditional (170-199 cm/sec) or abnormal (≥ 200 cm/sec) TCD velocities. Oral hydroxyurea will be administered daily and escalated to the maximum tolerated dose (MTD). Participants will be seen in the Sickle Cell Unit (SCU) in Kingston, Jamaica monthly until achieving MTD, and then every 3 months. TCD will be performed every 6 months. Results Currently, 43 participants have been enrolled out of a projected 50. There was one

  10. Comparison of olanzapine long-acting injection and oral olanzapine: a 2-year, randomized, open-label study in outpatients with schizophrenia.

    PubMed

    Detke, Holland C; Weiden, Peter J; Llorca, Pierre-Michel; Choukour, Moutaz; Watson, Susan B; Brunner, Elizabeth; Ascher-Svanum, Haya

    2014-08-01

    We compared long-term treatment effectiveness of monthly olanzapine long-acting injection (LAI) with that of oral olanzapine. Outpatients with 2 or more episodes of psychotic worsening in the past 24 months with Positive and Negative Syndrome Scale total score of lower than 70 were randomized to 405 mg/4 weeks of olanzapine LAI (n = 264) or 10 mg/d of oral olanzapine (n = 260) for 2 years of open-label treatment. Dosing thereafter was flexible (150-405 mg/4 weeks of LAI vs 5-20 mg/d of oral). Primary outcome was time to all-cause discontinuation. At baseline, patients were clinically stable (mean Positive and Negative Syndrome Scale total score of 57). Seventeen percent of patients had been psychiatrically hospitalized in the previous 6 months, and 4.6% were rated nonadherent in the month before study entry. The groups did not differ significantly in median time to all-cause discontinuation (645 days for LAI, 678 days for oral; P = 0.61), discontinuation rate (53.8% for LAI, 51.2% for oral; P = 0.60), or relapse rate (20.1% for LAI, 18.5% for oral; P = 0.66). Postbaseline psychiatric hospitalization rate was low for both groups (7.6% for LAI, 9.2% for oral), but mean hospitalization duration was significantly longer for oral patients (1.80 days [20 for those hospitalized] vs 0.43 days [6 for those hospitalized], P = 0.02). There were no clinically significant group differences in adverse events or safety measures. No post-injection delirium/sedation syndrome events occurred. In conclusion, olanzapine LAI and oral olanzapine were similarly effective and well tolerated for up to 2 years of treatment in patients with schizophrenia. Treatment discontinuation for olanzapine LAI was similar to that of oral olanzapine, despite the 3-hour post-injection observation period and other precautionary procedures related to risk of post-injection delirium/sedation syndrome. PMID:24781441

  11. Epratuzumab (humanised anti-CD22 antibody) in primary Sjögren's syndrome: an open-label phase I/II study

    PubMed Central

    Steinfeld, Serge D; Tant, Laure; Burmester, Gerd R; Teoh, Nick KW; Wegener, William A; Goldenberg, David M; Pradier, Olivier

    2006-01-01

    This open-label, phase I/II study investigated the safety and efficacy of epratuzumab, a humanised anti-CD22 monoclonal antibody, in the treatment of patients with active primary Sjögren's syndrome (pSS). Sixteen Caucasian patients (14 females/2 males, 33–72 years) were to receive 4 infusions of 360 mg/m2 epratuzumab once every 2 weeks, with 6 months of follow-up. A composite endpoint involving the Schirmer-I test, unstimulated whole salivary flow, fatigue, erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) was devised to provide a clinically meaningful assessment of response, defined as a ≥20% improvement in at least two of the aforementioned parameters, with ≥20% reduction in ESR and/or IgG considered as a single combined criterion. Fourteen patients received all infusions without significant reactions, 1 patient received 3, and another was discontinued due to a mild acute reaction after receiving a partial infusion. Three patients showed moderately elevated levels of Human anti-human (epratuzumab) antibody not associated with clinical manifestations. B-cell levels had mean reductions of 54% and 39% at 6 and 18 weeks, respectively, but T-cell levels, immunoglobulins, and routine safety laboratory tests did not change significantly. Fifty-three percent achieved a clinical response (at ≥20% improvement level) at 6 weeks, with 53%, 47%, and 67% responding at 10, 18, and 32 weeks, respectively. Approximately 40%–50% responded at the ≥30% level, while 10%–45% responded at the ≥50% level for 10–32 weeks. Additionally, statistically significant improvements were observed in fatigue, and patient and physician global assessments. Further, we determined that pSS patients have a CD22 over-expression in their peripheral B cells, which was downregulated by epratuzumab for at least 12 weeks after the therapy. Thus, epratuzumab appears to be a promising therapy in active pSS, suggesting that further studies be conducted. PMID:16859536

  12. Maternal fatty acid desaturase genotype correlates with infant immune responses at 6 months.

    PubMed

    Muc, Magdalena; Kreiner-Møller, Eskil; Larsen, Jeppe M; Birch, Sune; Brix, Susanne; Bisgaard, Hans; Lauritzen, Lotte

    2015-09-28

    Breast milk long-chain PUFA (LCPUFA) have been associated with changes in early life immune responses and may modulate T-cell function in infancy. We studied the effect of maternal fatty acid desaturase (FADS) genotype and breast milk LCPUFA levels on infants' blood T-cell profiles and ex vivo-produced cytokines after anti-CD3/CD28 stimulation of peripheral blood mononuclear cells in 6-month-old infants from the Copenhagen Prospective Study of Asthma in Childhood birth cohort. LCPUFA concentrations of breast milk were assessed at 4 weeks of age, and FADS SNP were determined in both mothers and infants (n 109). In general, breast milk arachidonic acid (AA) levels were inversely correlated with the production of IL-10 (r -0.25; P=0.004), IL-17 (r -0.24; P=0.005), IL-5 (r -0.21; P=0.014) and IL-13 (r -0.17; P=0.047), whereas EPA was positively correlated with the counts of blood regulatory T-cells and cytotoxic T-cells and decreased T-helper cell counts. The minor FADS alleles were associated with lower breast milk AA and EPA, and infants of mothers carrying the minor allele of FADS SNP rs174556 had higher production of IL-10 (r -0.23; P=0.018), IL-17 (r -0.25; P=0.009) and IL-5 (r -0.21; P=0.038) from ex vivo-activated immune cells. We observed no association between T-cell distribution and maternal or infant FADS gene variants. We conclude that increased maternal LCPUFA synthesis and breast milk AA are associated with decreased levels of IL-5, IL-13 (type-2 related), IL-17 (type-17 related) and IL-10 (regulatory immune responses), but not with interferon-γ and TNF-α, which could be due to an effect of the maternal FADS variants on the offspring immune response transferred via breast milk LCPUFA. PMID:26283408

  13. Death of a 6-month-old due to a tracheal bronchus.

    PubMed

    Hansen-Welches, Lauren; Slabach, Rachel; Landrum, Jeffry E; Prahlow, Joseph A

    2011-09-01

    The death of an infant younger than 1 year requires a thorough scene investigation and autopsy. Most infant deaths investigated by forensic pathologists can be placed into 2 general categories: sudden infant death syndrome and accidental asphyxial deaths. Despite the fact that most infant deaths occur within these 2 categories, it is important to remember that other entities may be responsible for death. In this report, we present a developmental pulmonary abnormality that was ultimately responsible for the death of an infant. A 6-month-old male infant with a prior history of pneumonia was brought to an emergency department for evaluation of fever. Antibiotics were prescribed, and the child was discharged and sent home with instructions to his mother to follow up with his pediatrician. Later that evening, the infant seemed to be in respiratory distress. His mother again transported him to the emergency department, where, on arrival, he became apneic. Despite vigorous resuscitative efforts, the infant died. Of note at autopsy was the presence of low-set abnormal ears and bilateral inward-turning ankles. Internally, an abnormality of the tracheobronchial tree was evident, with the right upper lobe bronchus arising from the distal trachea, proximal to the carina. In addition, the right upper lobe was discolored and firm. Microscopically, pneumonia was present. The cause of death was pneumonia due to a right tracheal bronchus. Childhood pneumonia is a known cause of childhood hospitalization, morbidity, and mortality. Identifying the causes of recurrent pneumonia, be it structural, metabolic, or syndromic, aids in preventing recurrent infections and reducing the incidence of childhood mortality. A tracheal bronchus, also known as bronchus suis or "pig bronchus," is an anatomic variant of the tracheobronchial tree in which a bronchus arises proximal to the carina, most commonly on the right and predominantly in males. The incidence is around 0.2%. Although the tracheal

  14. Dynamic relation between working memory capacity and speech recognition in noise during the first 6 months of hearing aid use.

    PubMed

    Ng, Elaine H N; Classon, Elisabet; Larsby, Birgitta; Arlinger, Stig; Lunner, Thomas; Rudner, Mary; Rönnberg, Jerker

    2014-01-01

    The present study aimed to investigate the changing relationship between aided speech recognition and cognitive function during the first 6 months of hearing aid use. Twenty-seven first-time hearing aid users with symmetrical mild to moderate sensorineural hearing loss were recruited. Aided speech recognition thresholds in noise were obtained in the hearing aid fitting session as well as at 3 and 6 months postfitting. Cognitive abilities were assessed using a reading span test, which is a measure of working memory capacity, and a cognitive test battery. Results showed a significant correlation between reading span and speech reception threshold during the hearing aid fitting session. This relation was significantly weakened over the first 6 months of hearing aid use. Multiple regression analysis showed that reading span was the main predictor of speech recognition thresholds in noise when hearing aids were first fitted, but that the pure-tone average hearing threshold was the main predictor 6 months later. One way of explaining the results is that working memory capacity plays a more important role in speech recognition in noise initially rather than after 6 months of use. We propose that new hearing aid users engage working memory capacity to recognize unfamiliar processed speech signals because the phonological form of these signals cannot be automatically matched to phonological representations in long-term memory. As familiarization proceeds, the mismatch effect is alleviated, and the engagement of working memory capacity is reduced. PMID:25421088

  15. Dynamic relation between working memory capacity and speech recognition in noise during the first 6 months of hearing aid use.

    PubMed

    Ng, Elaine H N; Classon, Elisabet; Larsby, Birgitta; Arlinger, Stig; Lunner, Thomas; Rudner, Mary; Rönnberg, Jerker

    2014-11-23

    The present study aimed to investigate the changing relationship between aided speech recognition and cognitive function during the first 6 months of hearing aid use. Twenty-seven first-time hearing aid users with symmetrical mild to moderate sensorineural hearing loss were recruited. Aided speech recognition thresholds in noise were obtained in the hearing aid fitting session as well as at 3 and 6 months postfitting. Cognitive abilities were assessed using a reading span test, which is a measure of working memory capacity, and a cognitive test battery. Results showed a significant correlation between reading span and speech reception threshold during the hearing aid fitting session. This relation was significantly weakened over the first 6 months of hearing aid use. Multiple regression analysis showed that reading span was the main predictor of speech recognition thresholds in noise when hearing aids were first fitted, but that the pure-tone average hearing threshold was the main predictor 6 months later. One way of explaining the results is that working memory capacity plays a more important role in speech recognition in noise initially rather than after 6 months of use. We propose that new hearing aid users engage working memory capacity to recognize unfamiliar processed speech signals because the phonological form of these signals cannot be automatically matched to phonological representations in long-term memory. As familiarization proceeds, the mismatch effect is alleviated, and the engagement of working memory capacity is reduced.

  16. Dynamic Relation Between Working Memory Capacity and Speech Recognition in Noise During the First 6 Months of Hearing Aid Use

    PubMed Central

    Classon, Elisabet; Larsby, Birgitta; Arlinger, Stig; Lunner, Thomas; Rudner, Mary; Rönnberg, Jerker

    2014-01-01

    The present study aimed to investigate the changing relationship between aided speech recognition and cognitive function during the first 6 months of hearing aid use. Twenty-seven first-time hearing aid users with symmetrical mild to moderate sensorineural hearing loss were recruited. Aided speech recognition thresholds in noise were obtained in the hearing aid fitting session as well as at 3 and 6 months postfitting. Cognitive abilities were assessed using a reading span test, which is a measure of working memory capacity, and a cognitive test battery. Results showed a significant correlation between reading span and speech reception threshold during the hearing aid fitting session. This relation was significantly weakened over the first 6 months of hearing aid use. Multiple regression analysis showed that reading span was the main predictor of speech recognition thresholds in noise when hearing aids were first fitted, but that the pure-tone average hearing threshold was the main predictor 6 months later. One way of explaining the results is that working memory capacity plays a more important role in speech recognition in noise initially rather than after 6 months of use. We propose that new hearing aid users engage working memory capacity to recognize unfamiliar processed speech signals because the phonological form of these signals cannot be automatically matched to phonological representations in long-term memory. As familiarization proceeds, the mismatch effect is alleviated, and the engagement of working memory capacity is reduced. PMID:25421088

  17. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women

    PubMed Central

    Bredella, Miriam A.; Gerweck, Anu V.; Barber, Lauren A.; Breggia, Anne; Rosen, Clifford J.; Torriani, Martin; Miller, Karen K.

    2014-01-01

    Purpose Abdominal adiposity is associated with low BMD and decreased growth hormone (GH) secretion, an important regulator of bone homeostasis. The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity. Materials and Methods In a 6-month, randomized, double-blind, placebo-controlled trial we studied 79 abdominally obese premenopausal women (21–45y) who underwent daily sc injections of GH vs. placebo. Main outcome measures were body composition by DXA and CT, bone marrow fat by proton MR spectroscopy, P1NP, CTX, 25(OH)D, hsCRP, undercarboxylated osteocalcin (ucOC), preadipocyte factor 1 (Pref 1), apolipoprotein B (ApoB), and IGF-1. Results GH increased IGF-1, P1NP, 25(OH)D, ucOC, bone marrow fat and lean mass, and decreased abdominal fat, hsCRP, and ApoB compared with placebo (p<0.05). There was a trend toward an increase in CTX and Pref-1. Among all participants, 6-month increase in IGF-1 correlated with 6-month increase in P1NP (p=0.0005), suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation. Six-month decrease in abdominal fat, hsCRP, and ApoB inversely predicted 6-month change in P1NP, and 6-month increase in lean mass and 25(OH)D positively predicted 6-month change in P1NP (p≤0.05), suggesting that subjects with greatest decreases in abdominal fat, inflammation and ApoB, and the greatest increases in lean mass and 25(OH)D experienced the greatest increases in bone formation. Six-month increase in bone marrow fat correlated with 6-month increase in P1NP (trend), suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat. Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP. When IGF-1 was added to the model, it became the only predictor

  18. Cinnarizine in migraine prophylaxis: efficacy, tolerability and predictive factors for therapeutic responsiveness. An open-label pilot trial.

    PubMed

    Rossi, Paolo; Fiermonte, Giancarlo; Pierelli, Francesco

    2003-01-01

    The efficacy and tolerability of cinnarizine (75 mg, at bedtime) in migraine prophylaxis and the presence of possible predictive factors for therapeutic responsiveness were evaluated in an open-label pilot trial. Eighty consecutive outpatients suffering from migraine with or without aura participated in the study. After 12 weeks of therapy, 55 patients experienced a greater than 66% reduction in headache frequency and were considered responders. A significant reduction in the number of migraine days (mean reduction 58 +/- 8%) and in intake of medication to treat acute attacks (mean reduction 55 +/- 11%) was also observed. Cinnarizine was well tolerated, as documented by the low number of adverse effects. Failure to respond to previous prophylactic treatments was a negative predictive factor correlated with a poor prognosis. This study, even bearing in mind its limitations as an open-label trial, suggests that cinnarizine might be an effective prophylactic anti-migraine agent. The clinical characteristics of migraine patients do not help to predict response to treatment. PMID:14703897

  19. Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder

    PubMed Central

    Berlant, Jeffrey L

    2004-01-01

    Background In order to confirm therapeutic effects of topiramate on posttraumatic stress disorder (PTSD) observed in a prior study, a new prospective, open-label study was conducted to examine acute responses in chronic, nonhallucinatory PTSD. Methods Thirty-three consecutive newly recruited civilian adult outpatients (mean age 46 years, 85% female) with DSM-IV-diagnosed chronic PTSD, excluding those with concurrent auditory or visual hallucinations, received topiramate either as monotherapy (n = 5) or augmentation (n = 28). The primary measure was a change in the PTSD Checklist-Civilian Version (PCL-C) score from baseline to 4 weeks, with response defined as a ≥ 30% reduction of PTSD symptoms. Results For those taking the PCL-C at both baseline and week 4 (n = 30), total symptoms declined by 49% at week 4 (paired t-test, P < 0.001) with similar subscale reductions for reexperiencing, avoidance/numbing, and hyperarousal symptoms. The response rate at week 4 was 77%. Age, sex, bipolar comorbidity, age at onset of PTSD, duration of symptoms, severity of baseline PCL-C score, and monotherapy versus add-on medication administration did not predict reduction in PTSD symptoms. Median time to full response was 9 days and median dosage was 50 mg/day. Conclusions Promising open-label findings in a new sample converge with findings of a previous study. The use of topiramate for treatment of chronic PTSD, at least in civilians, warrants controlled clinical trials. PMID:15315714

  20. Gait characteristics of individuals with multiple sclerosis before and after a 6-month aerobic training program.

    PubMed

    Rodgers, M M; Mulcare, J A; King, D L; Mathews, T; Gupta, S C; Glaser, R M

    1999-07-01

    Individuals who have multiple sclerosis (MS) typically experience problems with physical activities such as walking, resulting from the combined effects of skeletal muscle weakness, sensory disturbances, spasticity, gait ataxia, and reduction in aerobic capacity. The aim of this study was to determine whether a 6-mo exercise program designed for aerobic conditioning might also affect gait abnormalities in individuals with MS. Subjects included 18 individuals with MS who presented a range of disability. Passive range of motion (PROM) in the lower limbs was measured and gait analyzed before and after exercise conditioning. Three-dimensional kinematics, ground reaction forces (GRF), and electromyographic information were acquired as subjects walked at self-selected velocities. Hip PROM increased following conditioning. Mean walking velocity, cadence, and posterior shear GRF (push-off force) decreased. During walking, maximum ankle dorsiflexion decreased and ankle plantarflexion increased. Total knee flexion/extension range during the walking cycle decreased slightly as did maximum hip extension. Results suggest this 6-mo training program had minimal effect on gait abnormalities. PMID:10659801

  1. Cognitive-Behaviorally-Oriented Group Rehabilitation of Adults with ADHD: Results of a 6-Month Follow-Up

    ERIC Educational Resources Information Center

    Salakari, Anita; Virta, Maarit; Gronroos, Nina; Chydenius, Esa; Partinen, Markku; Vataja, Risto; Kaski, Markus; Iivanainen, Matti

    2010-01-01

    Objective: Recently, novel psychological treatments for adult ADHD have been reported with promising results. However, studies about long-term treatment effects are scanty. The authors study effects of cognitive-behaviorally-oriented group rehabilitation during a 6-month follow-up. Method: Participating in the rehabilitation were 29 adults, of…

  2. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    PubMed Central

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; Cho, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS). Results In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention. PMID:27403134

  3. Stability and Transitions in Mother-Infant Face-to-Face Communication during the First 6 Months: A Microhistorical Approach

    ERIC Educational Resources Information Center

    Hsu, Hui-Chin; Fogel, Alan

    2003-01-01

    In this study the authors attempted to unravel the relational, dynamical, and historical nature of mother-infant communication during the first 6 months. Thirteen mothers and their infants were videotaped weekly from 4 to 24 weeks during face-to-face interactions. Three distinct patterns of mother-infant communication were identified: symmetrical,…

  4. Touching up Mental Rotation: Effects of Manual Experience on 6-Month-Old Infants' Mental Object Rotation

    ERIC Educational Resources Information Center

    Möhring, Wenke; Frick, Andrea

    2013-01-01

    In this study, 6-month-olds' ability to mentally rotate objects was investigated using the violation-of-expectation paradigm. Forty infants watched an asymmetric object being moved straight down behind an occluder. When the occluder was lowered, it revealed the original object (possible) or its mirror image (impossible) in one of five…

  5. 6-Month Outcomes from a Randomized Controlled Trial to Prevent Perinatal Depression in Low-Income Home Visiting Clients

    PubMed Central

    Tandon, S. Darius; Leis, Julie A.; Mendelson, Tamar; Perry, Deborah F.; Kemp, Karen

    2013-01-01

    Objectives Perinatal depression (PD) has negative consequences for mothers and children and is more prevalent among women of low socioeconomic status. Home visitation programs serve low-income pregnant women at risk for PD. This study tested the efficacy of a group-based cognitive behavioral intervention (Mothers and Babies Course; MB) in reducing depressive symptoms and preventing the onset of perinatal depression among low-income women enrolled in home visitation. Methods A randomized controlled trial was conducted. Seventy-eight women who were pregnant or had a child less than 6 months of age and who were assessed as at risk for PD were randomized to the MB intervention or usual home visiting services. Depressive symptoms were assessed at baseline and 1-week, 3- and 6-months post-intervention; depressive episodes were assessed with a clinical interview at the 6-month follow-up. Results Depressive symptoms declined at a significantly greater rate for intervention participants than usual care participants between baseline and 1-week, 3 months, and 6 months post-intervention. At the six-month follow-up, 15% of women who received the MB intervention had experienced a major depressive episode as compared with 32% of women receiving usual care. Conclusions Integrating mental health interventions into home visitation appears to be a promising approach for preventing PD. Cognitive behavioral techniques can be effective in preventing depression in perinatal populations and treating it. PMID:23793487

  6. Relationship of cravings with weight loss and hunger: results from a 6 month worksite weight loss intervention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We examined the association of food cravings with weight loss and eating behaviors in a 6 month worksite lifestyle weight loss program. This randomized controlled trial of the intervention versus a wait-listed control was conducted at 4 worksites, and 95 participants completed outcome assessments ...

  7. A Longitudinal Investigation of the Still-Face Effect at 6 Months and Joint Attention at 12 Months

    ERIC Educational Resources Information Center

    Yazbek, Aimee; D'Entremont, Barbara

    2006-01-01

    An understanding of intentionality is thought to underlie developing joint attention. Similarly, early social-communicative behaviours have been argued to reflect an appreciation of adult intentionality. This study explored the relation between social-communicative behaviours during the still-face effect at 6 months and joint attention at 12…

  8. Idiosyncratic Drug-Induced Liver Injury Is Associated With Substantial Morbidity and Mortality Within 6 Months From Onset

    PubMed Central

    Fontana, Robert J.; Hayashi, Paul H.; Gu, Jiezhun; Reddy, K. Rajender; Barnhart, Huiman; Watkins, Paul B.; Serrano, Jose; Lee, William M.; Chalasani, Naga; Stolz, Andrew; Davern, Timothy; Talwakar, Jayant A.

    2014-01-01

    BACKGROUND & AIMS Little is known about the incidence of drug-induced liver injury (DILI) and risk factors for adverse outcomes. We evaluated short-term outcomes of a large cohort of patients with DILI enrolled in an ongoing multicenter prospective study. METHODS Data were collected from 660 adults with definite, highly likely, or probable DILI. Regression methods were used to identify risk factors for early liver-related death or liver transplantation and chronic liver injury. RESULTS Patients’ median age was 51.4 years; 59.5% were female and 59.1% required hospitalization. Within 6 months of DILI onset, 30 patients received liver transplants (4.5%; 95% confidence interval [CI], 3.0%–6.1%) and 32 died (5%; 95% CI, 3.2%–6.5%); 53% of the deaths were liver related. Asian race, itching, lung disease, low serum albumin levels, low platelet counts, and high serum levels of alanine aminotransferase and total bilirubin at presentation were independent risk factors for reduced times to liver-related death or liver transplantation (C-statistic = 0.87). At 6 months after DILI onset, 18.9% of the 598 evaluable subjects had persistent liver damage. African-American race, higher serum levels of alkaline phosphatase, and earlier heart disease or malignancy requiring treatment were independent risk factors for chronic DILI (C-statistic = 0.71). CONCLUSIONS Nearly 1 in 10 patients die or undergo liver transplantation within 6 months of DILI onset and nearly 1 in 5 of the remaining patients have evidence of persistent liver injury at 6 months. The profile of liver injury at presentation, initial severity, patient’s race, and medical comorbidities are important determinants of the likelihood of death/transplantation or persistent liver injury within 6 months. PMID:24681128

  9. Energy intake from human milk covers the requirement of 6-month-old Senegalese exclusively breast-fed infants.

    PubMed

    Agne-Djigo, Anta; Kwadjode, Komlan M; Idohou-Dossou, Nicole; Diouf, Adama; Guiro, Amadou T; Wade, Salimata

    2013-11-01

    Exclusive breast-feeding until 6 months is advised by the WHO as the best practice to feed infants. Yet, some studies have suggested a gap between energy requirements and the energy provided by human milk for many infants at 6 months. In order to assess the adequacy of WHO recommendations in 6-month-old Senegalese lactating infants, a comprehensive study was designed to measure human milk intake by the dose-to-the mother 2H2O turnover method. Infants’ energy intakes were calculated using daily breast milk intake and the energy content of milk was estimated on the basis of creamatocrit. Of the fifty-nine mother–infant pairs enrolled, fifteen infants were exclusively breast-fed (Ex) while forty-four were partially breast-fed (Part). Infants’ breast milk intake was significantly higher in the Ex group (993 (SD 135) g/d, n 15) compared with the Part group (828 (SD 222) g/d, n 44, P¼0·009). Breast milk energy content as well as infants' growth was comparable in both groups. However, infants’ energy intake from human milk was significantly higher (364 (SD 50) kJ/kg per d (2586 (SD 448) kJ/d)) in the Ex group than in the Part group (289 (SD 66) kJ/kg per d (2150 (SD 552) kJ/d), P,0·01). Compared with WHO recommendations, the results demonstrate that energy intake from breast milk was low in partially breast-fed infants while exclusively breast-fed 6-month-old Senegalese infants received adequate energy from human milk alone, the most complete food for infants. Therefore, advocacy of exclusive breast-feeding until 6 months should be strengthened.

  10. Effects of a 6-month infliximab treatment on plasma levels of leptin and adiponectin in patients with rheumatoid arthritis.

    PubMed

    Derdemezis, Christos S; Filippatos, Theodosios D; Voulgari, Paraskevi V; Tselepis, Alexandros D; Drosos, Alexandros A; Kiortsis, Dimitrios N

    2009-10-01

    Patients with rheumatoid arthritis (RA) appear to have increased plasma levels of leptin and adiponectin. These adipokines may be implicated in the pathophysiology of RA. Tumour necrosis factor alpha (TNF-alpha) is a potential modulator of adipokines. The effects of long-term anti-TNF treatment on plasma levels of leptin and adiponectin are not clear. The aim of this study was to assess the effects of 6-month anti-TNF treatment (infliximab) on leptin and adiponectin plasma levels in RA patients. Thirty women with RA were included in the study. Patients with diabetes mellitus, any endocrine disorder or receiving any hypolipidemic or antidiabetic medication were not included. Thirty healthy age- and body mass index-matched women served as controls. Plasma levels of leptin and adiponectin were measured with enzyme immunoassay methods prior to and after the 6-month treatment with infliximab. Mean age and disease duration of patients were 51.8 +/- 14.4 and 12.2 +/- 6.7 years, respectively. Body weight did not change significantly over the 6-month period. Plasma levels of leptin and adiponectin were higher in patients than controls and did not change significantly after 6-month treatment. Interestingly, in the tertile of patients with the highest baseline adiponectin concentrations, adiponectin levels were significantly reduced (P < 0.05). Infliximab treatment did not change plasma levels of leptin and adiponectin after 6-month treatment in the whole study population. However, a reduction of adiponectin levels was observed in patients with higher baseline adiponectin levels. PMID:19563510

  11. High resolution imaging science experiment (HiRISE) images of volcanic terrains from the first 6 months of the Mars reconnaissance orbiter primary science phase

    USGS Publications Warehouse

    Keszthelyi, L.; Jaeger, W.; McEwen, A.; Tornabene, L.; Beyer, R.A.; Dundas, C.; Milazzo, M.

    2008-01-01

    In the first 6 months of the Mars Reconnaissance Orbiter's Primary Science Phase, the High Resolution Imaging Science Experiment (HiRISE) camera has returned images sampling the diversity of volcanic terrains on Mars. While many of these features were noted in earlier imaging, they are now seen with unprecedented clarity. We find that some volcanic vents produced predominantly effusive products while others generated mostly pyroclastics. Flood lavas were emplaced in both turbulent and gentle eruptions, producing roofed channels and inflation features. However, many areas on Mars are too heavily mantled to allow meter-scale volcanic features to be discerned. In particular, the major volcanic edifices are extensively mantled, though it is possible that some of the mantle is pyroclastic material rather than atmospheric dust. Support imaging by the Context Imager (CTX) and topographic information derived from stereo imaging are both invaluable in interpreting the HiRISE data. Copyright 2008 by the American Geophysical Union.

  12. Differential Gene Expression in the Liver of the African Lungfish, Protopterus annectens, after 6 Months of Aestivation in Air or 1 Day of Arousal from 6 Months of Aestivation

    PubMed Central

    Hiong, Kum C.; Ip, Yuen K.; Wong, Wai P.; Chew, Shit F.

    2015-01-01

    The African lungfish, Protopterus annectens, can undergo aestivation during drought. Aestivation has three phases: induction, maintenance and arousal. The objective of this study was to examine the differential gene expression in the liver of P. annectens after 6 months (the maintenance phase) of aestivation as compared with the freshwater control, or after 1 day of arousal from 6 months aestivation as compared with 6 months of aestivation using suppression subtractive hybridization. During the maintenance phase of aestivation, the mRNA expression of argininosuccinate synthetase 1 and carbamoyl phosphate synthetase III were up-regulated, indicating an increase in the ornithine-urea cycle capacity to detoxify ammonia to urea. There was also an increase in the expression of betaine homocysteine-S-transferase 1 which could reduce and prevent the accumulation of hepatic homocysteine. On the other hand, the down-regulation of superoxide dismutase 1 expression could signify a decrease in ROS production during the maintenance phase of aestivation. In addition, the maintenance phase was marked by decreases in expressions of genes related to blood coagulation, complement fixation and iron and copper metabolism, which could be strategies used to prevent thrombosis and to conserve energy. Unlike the maintenance phase of aestivation, there were increases in expressions of genes related to nitrogen, carbohydrate and lipid metabolism and fatty acid transport after 1 day of arousal from 6 months aestivation. There were also up-regulation in expressions of genes that were involved in the electron transport system and ATP synthesis, indicating a greater demand for metabolic energy during arousal. Overall, our results signify the importance of sustaining a low rate of waste production and conservation of energy store during the maintenance phase, and the dependence on internal energy store for repair and structural modification during the arousal phase, of aestivation in the liver

  13. Differential gene expression in the liver of the African lungfish, Protopterus annectens, after 6 months of aestivation in air or 1 day of arousal from 6 months of aestivation.

    PubMed

    Hiong, Kum C; Ip, Yuen K; Wong, Wai P; Chew, Shit F

    2015-01-01

    The African lungfish, Protopterus annectens, can undergo aestivation during drought. Aestivation has three phases: induction, maintenance and arousal. The objective of this study was to examine the differential gene expression in the liver of P. annectens after 6 months (the maintenance phase) of aestivation as compared with the freshwater control, or after 1 day of arousal from 6 months aestivation as compared with 6 months of aestivation using suppression subtractive hybridization. During the maintenance phase of aestivation, the mRNA expression of argininosuccinate synthetase 1 and carbamoyl phosphate synthetase III were up-regulated, indicating an increase in the ornithine-urea cycle capacity to detoxify ammonia to urea. There was also an increase in the expression of betaine homocysteine-S-transferase 1 which could reduce and prevent the accumulation of hepatic homocysteine. On the other hand, the down-regulation of superoxide dismutase 1 expression could signify a decrease in ROS production during the maintenance phase of aestivation. In addition, the maintenance phase was marked by decreases in expressions of genes related to blood coagulation, complement fixation and iron and copper metabolism, which could be strategies used to prevent thrombosis and to conserve energy. Unlike the maintenance phase of aestivation, there were increases in expressions of genes related to nitrogen, carbohydrate and lipid metabolism and fatty acid transport after 1 day of arousal from 6 months aestivation. There were also up-regulation in expressions of genes that were involved in the electron transport system and ATP synthesis, indicating a greater demand for metabolic energy during arousal. Overall, our results signify the importance of sustaining a low rate of waste production and conservation of energy store during the maintenance phase, and the dependence on internal energy store for repair and structural modification during the arousal phase, of aestivation in the liver

  14. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

    PubMed Central

    Chan, Kam Wa; Ip, Tai Pang; Kwong, Alfred Siu Kei; Lui, Sing Leung; Chan, Gary Chi Wang; Cowling, Benjamin John; Yiu, Wai Han; Wong, Dickson Wai Leong; Liu, Yang; Feng, Yibin; Tan, Kathryn Choon Beng; Chan, Loretta Yuk Yee; Leung, Joseph Chi Kam; Lai, Kar Neng; Tang, Sydney Chi Wai

    2016-01-01

    Introduction Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin–angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese–Western medicine protocol for the management of DN. Objective To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2–3 chronic kidney disease and macroalbuminuria. Methods and analysis This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. Ethics and registration This protocol is approved by the Institutional

  15. Tazarotene: Randomized, Double-Blind, Vehicle-Controlled and Open-Label Concurrent Trials for Basal Cell Carcinoma Prevention and Therapy in Patients with Basal Cell Nevus Syndrome

    PubMed Central

    Tang, Jean Y.; Chiou, Albert S.; Mackay-Wiggan, Julian M.; Aszterbaum, Michelle; Chanana, Anita M.; Lee, Wayne; Lindgren, Joselyn A.; Raphael, Maria Acosta; Thompson, Bobbye J.; Bickers, David R.; Epstein, Ervin H.

    2014-01-01

    Sporadic human basal cell carcinomas (BCCs) are generally well managed with current surgical modalities. However in the subset of high-risk patients predisposed to developing large numbers of BCCs, there is an unmet need for effective, low morbidity chemoprevention. This population includes fair-skinned patients with extensive sun exposure and those with genodermatoses such as the basal cell nevus (Gorlin) syndrome (BCNS). Tazarotene (Tazorac, Allergan) is a topical retinoid with relative specificity for RAR-β and RAR-γ receptors. We previously demonstrated tazarotene’s robust anti-BCC efficacy in Ptch1+/- mice, a murine equivalent of BCNS, and others have found it to have some efficacy against sporadic human BCCs. We report here results of a randomized, double-blind, vehicle-controlled study in BCNS patients evaluating the efficacy of topically applied tazarotene for BCC chemoprevention (N=34 subjects), along with an open-label trial evaluating tazarotene’s efficacy for chemotherapy of BCC lesions (N=36 subjects) for a maximum follow-up period of 3 years. We found that only 6% of patients had a chemopreventive response and that only 6% of treated BCC target lesions were clinically cured. Our studies provide no evidence for either chemopreventive or chemotherapeutic effect of tazarotene against BCCs in patients with BCNS. We hypothesize that the discrepancy between the efficacy seen in Ptch1+/- mice as compared to that seen in PTCH1+/-, BCNS patients, may relate to the superior barrier function of human skin and the greater depth of human BCCs. PMID:24441673

  16. The effects of amisulpride on five dimensions of psychopathology in patients with schizophrenia: a prospective open- label study

    PubMed Central

    Herrera-Estrella, Miguel; Apiquian, Rogelio; Fresan, Ana; Sanchez-Torres, Isabel

    2005-01-01

    Background The efficacy of antipsychotics can be evaluated using the dimensional models of schizophrenic symptoms. The D2/D3-selective antagonist amisulpride has shown similar efficacy and tolerability to other atypical antipsychotics. The aim of the present study was to determine the efficacy of amisulpride on the dimensional model of schizophrenic symptoms and tolerability in latin schizophrenic patients. Method Eighty schizophrenic patients were enrolled and 70 completed a prospective open-label 3-month study with amisulpride. The schizophrenic symptoms, psychosocial functioning and side-effects were evaluated with standardized scales. Results The patients showed significant improvement in the five dimensions evaluated. Amisulpride (median final dose 357.1 mg/d) was well-tolerated without treatment-emergent extrapyramidal side-effects. Conclusion Amisulpride showed efficacy on different psychopathological dimensions and was well tolerated, leading to consider this drug a first line choice for the treatment of schizophrenia. PMID:15869707

  17. INSIG2 is Associated with Lower Gain in Weight-for-Length Between Birth and Age 6 Months

    PubMed Central

    Wu, Ann Chen; Gillman, Matthew W.; Taveras, Elsie M.; Litonjua, Augusto A.

    2009-01-01

    Researchers have described the association of a common DNA polymorphism, rs7566605, near INSIG2 (insulin-induced gene 2) with obesity in multiple independent populations that include subjects ages 11–60 years.1 To our knowledge, no studies have examined the association of this polymorphism with weight status during early childhood. We explored the association of the rs7566605 polymorphism with weight-for-length among 319 children at 6 months and 3 years participating in Project Viva, a pre-birth cohort study. In contrast to studies of older individuals, CC homozygosity was associated with lower gain in weight-for-length z-score between birth and age 6 months than GG homozygosity or GC heterozygosity. At age 3, we did not find an association. The association of INSIG2 gene with obesity may change direction with age. PMID:20354568

  18. Ramelteon for Insomnia Symptoms in a Community Sample of Adults with Generalized Anxiety Disorder: An Open Label Study

    PubMed Central

    Gross, Paul K.; Nourse, Rosemary; Wasser, Thomas E.

    2009-01-01

    Objective: Prior research confirms the relationship between insomnia and psychiatric disorders, particularly anxiety and depression. The effectiveness and tolerability of ramelteon was examined in adult generalized anxiety disorder (GAD) patients with insomnia symptoms. Methods: Twenty-seven adults with sleep disturbance meeting DSM-IV diagnostic criteria for GAD and partially responsive on an SSRI or SNRI by randomization visit (as signified by a Hamilton Anxiety scale [HAMA] maximum score of 15 and minimum of 8, Clinical Global Impressions Severity of Illness [CGI-S] scale of ≤ 4 and ≥ 2 [measuring anxiety symptoms], CGI-S of ≥ 4 [measuring insomnia symptoms], ≥ 5 on the Pittsburgh Sleep Quality Index [PSQI], and ≥ 10 on the Epworth Sleepiness Scale [ESS]) were treated openly for 10 weeks on ramelteon 8 mg at bedtime. Analysis was conducted using repeated measures methodology. Patient reported sleep diaries were maintained throughout the study. Results: Significant symptom reduction was observed on all scales (HAMA, ESS, CGI-I, CGI-S), with subjects falling asleep faster and sleeping longer. Headache upon stopping ramelteon, daytime tiredness, agitation, and depression were the most commonly reported side effects and were cited as transient. Conclusion: Data from this 12-week open-label study suggests ramelteon is an effective and generally well tolerated treatment for insomnia symptoms in this community sample of adults with GAD. Citation: Gross PK; Nourse R; Wasser TE. Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study. J Clin Sleep Med 2009;5(1):28–33. PMID:19317378

  19. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study

    PubMed Central

    Sasaki, Tsuyoshi; Hashimoto, Kenji; Tachibana, Masumi; Kurata, Tsutomu; Okawada, Keiko; Ishikawa, Maki; Kimura, Hiroshi; Komatsu, Hideki; Ishikawa, Masatomo; Hasegawa, Tadashi; Shiina, Akihiro; Hashimoto, Tasuku; Kanahara, Nobuhisa; Shiraishi, Tetsuya; Iyo, Masaomi

    2014-01-01

    Background Tipepidine (3-[di-2-thienylmethylene]-1-methylpiperidine) has been used solely as a nonnarcotic antitussive in Japan since 1959. The safety of tipepidine in children and adults has already been established. It is reported that tipepidine inhibits G-protein-coupled inwardly rectifying potassium (GIRK)-channel currents. The inhibition of GIRK channels by tipepidine is expected to modulate the level of monoamines in the brain. We put forward the hypothesis that tipepidine can improve attention deficit/hyperactivity disorder (ADHD) symptoms by modulating monoaminergic neurotransmission through the inhibition of GIRK channels. The purpose of this open-label trial was to confirm whether treatment with tipepidine can improve symptoms in pediatric patients with ADHD. Subjects and methods This was a 4-week, open-label, proof-of-efficacy pilot study for pediatric subjects with ADHD. Ten pediatric ADHD subjects (70% male; mean age, 9.9 years; combined [inattentive and hyperactive/impulsive] subtype, n=7; inattentive subtype, n=3; hyperimpulsive subtype, n=0) received tipepidine hibenzate taken orally at 30 mg/day for 4 weeks. All subjects were assessed using the ADHD Rating Scale IV (ADHD-RS), Japanese version, and the Das–Naglieri Cognitive Assessment System (DN-CAS), Japanese version. Results A comparison of baseline scores and 4-week end-point scores showed that all the ADHD-RS scores (total scores, hyperimpulsive subscores, and inattentive subscores) improved significantly (P<0.001). Furthermore, a comparison of baseline DN-CAS total scores and 4-week end-point scores showed a mild trend of improvement (P=0.093). Tipepidine was well tolerated, with no patients discontinuing medication because of side effects. Conclusion Our pilot study suggests that tipepidine therapy may prove to be an effective alternative treatment for pediatric patients with ADHD. Nonetheless, more detailed randomized, double-blind trials are needed to confirm tipepidine’s efficacy

  20. Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study

    PubMed Central

    Xu, Yichen; Chen, Yanzhi

    2015-01-01

    Abstract Objectives: This open-label, prospective, phase I/II trial was performed to establish the safety and efficacy of Traditional Chinese Medicine (TCM) herbal products for treating non–anemia-related fatigue in patients with cancer. Although this practice is widespread in China, it has not been confirmed in a prospective clinical study. Design: Thirty-three patients who had completed cancer treatment, had stable disease and no anemia, and reported moderate to severe fatigue (rated ≥4 on a 0–10 scale) were enrolled in a TCM outpatient clinic. Patients took Ren Shen Yangrong Tang (RSYRT) decoction, a soup containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct qi deficiency. Fatigue was assessed before and after RSYRT therapy, which all patients completed. Results: No discomfort or toxicity was observed. Before the study, all patients had had fatigue for at least 4 months. Fatigue severity decreased significantly from before therapy to 6 weeks after therapy: from 7.06 to 3.30 on a 0–10 scale (p<0.001). Fatigue category (mild, moderate, severe) shifted significantly (p=0.024): Of 22 patients with severe fatigue (rated ≥7) before therapy, 11 had mild fatigue and 11 had moderate fatigue after TCM treatment. The time-to-fatigue-alleviation was 2–3 weeks. Conclusion: RSYRT therapy was safe and was associated with fatigue improvement in nonanemic cancer survivors, consistent with historical TCM clinical practice experience. Because of a possible placebo effect in this open-label study, decoction RSYRT warrants further study in randomized clinical trials to confirm its effectiveness for managing moderate to severe fatigue. PMID:25918996

  1. Escitalopram in the treatment of patients with schizophrenia and obsessive-compulsive disorder: an open-label, prospective study.

    PubMed

    Stryjer, Rafael; Dambinsky, Yael; Timinsky, Igor; Green, Tamar; Kotler, Moshe; Weizman, Abraham; Spivak, Baruch

    2013-03-01

    The current data suggest that up to 50% of patients with schizophrenia have obsessive-compulsive (OC) symptoms coexisting with psychosis and between 7.8 and 46% of schizophrenia patients also have full-blown obsessive-compulsive disorder (OCD). The aim of this study was to examine the efficacy of the most selective serotonin reuptake inhibitor escitalopram in the management of OCD in schizophrenia patients. The study was an open-label prospective trial of 12 weeks' duration in which escitalopram at a dose of up to 20 mg/day was added to the existing antipsychotic drug regimen in schizophrenia patients with OCD. Fifteen patients (10 men/five women) with the diagnosis of schizophrenia and OCD were recruited for the study (mean age: 39±14, range 21-61 years) and received escitalopram according to the study design. A significant improvement was observed in the total Yale Brown Obsessive-Compulsive Scale (Y-BOCS) scores and in the scores of both the Y-BOCS-Obsession and the Y-BOCS-Compulsion subscale at the end point. In addition, a significant improvement was observed in the total scores of the Positive and Negative Syndrome Scale and particularly in scores of anxiety, tension, depression, and preoccupation items. No adverse effects of escitalopram were reported by patients during the trial. In our prospective 12-week open-label study, escitalopram 20 mg/day was well tolerated and improved OC symptoms in schizophrenia patients. Our preliminary results are encouraging and a double-blind randomized study is required to confirm our results.

  2. Distinguishing Mother-Infant Interaction from Stranger-Infant Interaction at 2, 4, and 6 Months of Age

    ERIC Educational Resources Information Center

    Bigelow, Ann E.; Power, Michelle; Mcquaid, Nancy; Ward, Ashley; Rochat, Philippe

    2008-01-01

    Observers watched videotaped face-to-face mother-infant and stranger-infant interactions of 12 infants at 2, 4, or 6 months of age. Half of the observers saw each mother paired with her own infant and another infant of the same age (mother tapes) and half saw each infant paired with his or her mother and with a stranger (infant tapes). Observers…

  3. MRI Assessment of Uterine Artery Patency and Fibroid Infarction Rates 6 Months after Uterine Artery Embolization with Nonspherical Polyvinyl Alcohol

    SciTech Connect

    Das, Raj Gonsalves, Michael; Vlahos, Ioannis; Manyonda, Issac; Belli, Anna-Maria

    2013-10-15

    Purpose: We have observed significant rates of uterine artery patency after uterine artery embolization (UAE) with nonspherical polyvinyl alcohol (nsPVA) on 6 month follow-up MR scanning. The study aim was to quantitatively assess uterine artery patency after UAE with nsPVA and to assess the effect of continued uterine artery patency on outcomes. Methods: A single centre, retrospective study of 50 patients undergoing bilateral UAE for uterine leiomyomata was undertaken. Pelvic MRI was performed before and 6 months after UAE. All embolizations were performed with nsPVA. Outcome measures included uterine artery patency, uterine and dominant fibroid volume, dominant fibroid percentage infarction, presence of ovarian arterial collaterals, and symptom scores assessed by the Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). Results: Magnetic resonance angiographic evidence of uterine artery recanalization was demonstrated in 90 % of the patients (64 % bilateral, 26 % unilateral) at 6 months. Eighty percent of all dominant fibroids demonstrated >90 % infarction. The mean percentage reduction in dominant fibroid volume was 35 %. No significant difference was identified between nonpatent, unilateral, and bilateral recanalization of the uterine arteries with regard to percentage dominant fibroid infarction or dominant fibroid volume reduction. The presence of bilaterally or unilaterally patent uterine arteries was not associated with inferior clinical outcomes (symptom score or UFS-QOL scores) at 6 months. Conclusion: The high rates of uterine artery patency challenge the current paradigm that nsPVA is a permanent embolic agent and that permanent uterine artery occlusion is necessary to optimally treat uterine fibroids. Despite high rates of uterine artery recanalization in this cohort, satisfactory fibroid infarction rates and UFS-QOL scores were achieved.

  4. The non-thyroidal illness syndrome after coronary artery bypass grafting: a 6-month follow-up study.

    PubMed

    Cerillo, Alfredo Giuseppe; Storti, Simona; Mariani, Massimiliano; Kallushi, Enkel; Bevilacqua, Stefano; Parri, Maria Serena; Clerico, Aldo; Glauber, Mattia

    2005-01-01

    The non-thyroidal illness syndrome (NTIS) is considered a transient and completely reversible phenomenon, but it has been shown that it may last for several days postoperatively after coronary artery bypass grafting (CABG) surgery. This study was undertaken to assess thyroid function 6 months after uncomplicated CABG. The thyroid profile was evaluated in 40 consecutive patients undergoing CABG preoperatively, at 0, 12, 48, and 120 h postoperatively, and at 6-month follow-up. Triiodothyronine (T3), free T3 (FT3), free thyroxine (FT4) and thyroid stimulating hormone (TSH) were assayed using a microparticle enzyme immunoassay. T4 and total serum thyroid hormone-binding capacity (T-uptake) were measured on the same samples using a fluorescence polarization immunoassay. Patients with severe systemic illness and patients treated with amiodarone were excluded. All patients were euthyroid at admission. Mean age was 67.4+/-9.0 years. There were 31 (77.5%) men. Typical NTIS was observed in all patients, and the FT3 concentration was still reduced by postoperative day 5 (p<0.0001). At 6-month follow-up, all patients were free from cardiac symptoms, and no new cardiac events were recorded. The thyroid profile was normal in 35 patients (87.5%). One patient (4.5%) had developed overt hypothyroidism. Two patients had isolated low T3 and FT3 levels with normal TSH. Two patients had moderately increased FT3 levels with suppressed TSH. In most uncomplicated patients, thyroid function returns to normal 6 months after CABG. However, we observed significant alterations of the thyroid profile in 5 out of 40 patients. Further studies are needed to define the long-term consequences of postoperative NTIS.

  5. Effects of fixed orthodontic treatment on hair nickel and chromium levels: a 6-month prospective preliminary study.

    PubMed

    Amini, Fariborz; Mollaei, Mobina; Harandi, Saghar; Rakhshan, Vahid

    2015-03-01

    Although nickel and chromium are known as allergen and cytotoxic orthodontic metals, very few and controversial studies have assessed the effect of orthodontic treatment on their systemic levels reflected by their best biomarker of exposure, hair. This prospective preliminary study was conducted to evaluate hair nickel and chromium levels in fixed orthodontic patients. Scalp hair nickel/chromium concentrations of 12 female and 12 male fixed orthodontic patients were measured before treatment and 6 months later, using atomic absorption spectrophotometry. The effects of treatment, gender, and age on hair ions were analyzed statistically (α = 0.05). The patients' mean age was 18.38 ± 3.98 years. The mean nickel levels were 0.1380 ± 0.0570 and 0.6715 ± 0.1785 μg/g dry hair mass, respectively, in the baseline and sixth month of treatment. Chromium concentrations were 0.1455 ± 0.0769 and 0.1683 ± 0.0707 μg/g dry hair mass, respectively. After 6 months, nickel increased for 387 % (paired t test P = 0.0000) and chromium increased for 16 % (P = 0.0002). No significant correlations were observed between any ion levels with age or gender (Spearman P > 0.2). Within the limitations of this preliminary study, it seems that 6 months of fixed orthodontic treatment might increase levels of hair nickel and chromium. Future larger studies are necessary to validate these results.

  6. Coordination and symmetry patterns during the drop vertical jump, 6-months after first-time lateral ankle sprain.

    PubMed

    Doherty, Cailbhe; Bleakley, Chris; Hertel, Jay; Caulfield, Brian; Ryan, John; Sweeney, Kevin; Patterson, Matthew R; Delahunt, Eamonn

    2015-10-01

    To evaluate the adaptive movement and motor control patterns of a group with a 6-month history of first-time lateral ankle sprain (LAS) injury during a drop vertical jump (DVJ) task. Fifty-one participants with a 6-month history of first-time acute LAS injury and twenty controls performed a DVJ task. 3D kinematic and sagittal plane kinetic profiles were plotted for the lower extremity joints of both limbs for the drop jump (phase 1) and drop landing (phase 2) phases of the DVJ. Inter-limb symmetry and the rate of impact modulation (RIM) relative to bodyweight (BW) during both phases of the DVJ were also determined. LAS participants displayed bilateral increases in knee flexion and an increase in ankle inversion during phases 1 and 2, respectively. They also displayed reduced ankle plantar flexion on their injured limb during both phases of the DVJ (p < 0.05); increased inter-limb asymmetry of RIM was noted for both phases of the DVJ, while the moment-of-force profile exhibited bilaterally greater hip extensor dominance during phase 1. Participants with a 6-month history of first-time LAS display some movement patterns consistent with those observed in chronic ankle instability populations during similar tasks. PMID:25940807

  7. Coordination and symmetry patterns during the drop vertical jump, 6-months after first-time lateral ankle sprain.

    PubMed

    Doherty, Cailbhe; Bleakley, Chris; Hertel, Jay; Caulfield, Brian; Ryan, John; Sweeney, Kevin; Patterson, Matthew R; Delahunt, Eamonn

    2015-10-01

    To evaluate the adaptive movement and motor control patterns of a group with a 6-month history of first-time lateral ankle sprain (LAS) injury during a drop vertical jump (DVJ) task. Fifty-one participants with a 6-month history of first-time acute LAS injury and twenty controls performed a DVJ task. 3D kinematic and sagittal plane kinetic profiles were plotted for the lower extremity joints of both limbs for the drop jump (phase 1) and drop landing (phase 2) phases of the DVJ. Inter-limb symmetry and the rate of impact modulation (RIM) relative to bodyweight (BW) during both phases of the DVJ were also determined. LAS participants displayed bilateral increases in knee flexion and an increase in ankle inversion during phases 1 and 2, respectively. They also displayed reduced ankle plantar flexion on their injured limb during both phases of the DVJ (p < 0.05); increased inter-limb asymmetry of RIM was noted for both phases of the DVJ, while the moment-of-force profile exhibited bilaterally greater hip extensor dominance during phase 1. Participants with a 6-month history of first-time LAS display some movement patterns consistent with those observed in chronic ankle instability populations during similar tasks.

  8. Legal medical consideration of Alzheimer’s disease patients’ dysgraphia and cognitive dysfunction: a 6 month follow up

    PubMed Central

    Onofri, Emanuela; Mercuri, Marco; Archer, Trevor; Rapp-Ricciardi, Max; Ricci, Serafino

    2016-01-01

    Background The purpose of this study was to investigate the ability of Alzheimer’s disease (AD) patients to express intentions and desires, and their decision-making capacity. This study examines the findings from a 6-month follow-up of our previous results in which 30 patients participated. Materials and methods The patient’s cognition was examined by conducting the tests of 14 questions and letter-writing ability over a period of 19 days, and it was repeated after 6 months. The difference between these two cognitive measures (PQ1 before–PQ2 before), tested previously and later the writing test, was designated DΔ before. The test was repeated after 6 months, and PQ1 after–PQ2 after was designated DΔ after. Results Several markedly strong relationships between dysgraphia and other measures of cognitive performance in AD patients were observed. The most aged patients (over 86 years), despite less frequency, maintain the cognitive capacity manifested in the graphic expressions. A document, written by an AD patient presents an honest expression of the patient’s intention if that document is legible, clear, and comprehensive. Conclusion The identification of impairment/deficits in writing and cognition during different phases of AD may facilitate the understanding of disease progression and identify the occasions during which the patient may be considered sufficiently lucid to make decisions. PMID:27022252

  9. A Study of the Sexual Function, Sleep, and Weight Status of Patients after 6 Months of Methadone Maintenance Treatment

    PubMed Central

    Parvaresh, Noushin; Sabahi, Abdol Reza; Mazhari, Shahrzad; Gilani, Hoda

    2015-01-01

    Background Methadone is a synthetic opioid and receptor agonist morphine; thus, its consumption has the effects and side effects of opioid. Methadone maintenance treatment (MMT) is used as an alternative treatment for people who are suffering from substance abuse and do not have the ability to withdraw. Despite its benefits, this drug also has side effects. The purpose of this study was to investigate the effects of methadone treatment on sexual function, sleep, and weight after 6 months. Methods The study subjects consisted of 200 patients who had referred to the Methadone Clinic of Shahid Beheshti Training Hospital, Kerman, Iran, during a 6-month period and were treated using MMT. Data collection tools consisted of the demographic questionnaire, Pittsburgh sleep quality index (PSQI), and Arizona sexual experience scale (ASEX). The questionnaires were completed by the participants before and 6 months after the treatment. Findings The results of this study showed that methadone consumption has significant effects on sexual dysfunction, sleep disorders, and weight gain. Conclusion The consideration of the side effects of MMT can result in consumers’ commitment to the treatment. PMID:26322207

  10. Effects of fixed orthodontic treatment on hair nickel and chromium levels: a 6-month prospective preliminary study.

    PubMed

    Amini, Fariborz; Mollaei, Mobina; Harandi, Saghar; Rakhshan, Vahid

    2015-03-01

    Although nickel and chromium are known as allergen and cytotoxic orthodontic metals, very few and controversial studies have assessed the effect of orthodontic treatment on their systemic levels reflected by their best biomarker of exposure, hair. This prospective preliminary study was conducted to evaluate hair nickel and chromium levels in fixed orthodontic patients. Scalp hair nickel/chromium concentrations of 12 female and 12 male fixed orthodontic patients were measured before treatment and 6 months later, using atomic absorption spectrophotometry. The effects of treatment, gender, and age on hair ions were analyzed statistically (α = 0.05). The patients' mean age was 18.38 ± 3.98 years. The mean nickel levels were 0.1380 ± 0.0570 and 0.6715 ± 0.1785 μg/g dry hair mass, respectively, in the baseline and sixth month of treatment. Chromium concentrations were 0.1455 ± 0.0769 and 0.1683 ± 0.0707 μg/g dry hair mass, respectively. After 6 months, nickel increased for 387 % (paired t test P = 0.0000) and chromium increased for 16 % (P = 0.0002). No significant correlations were observed between any ion levels with age or gender (Spearman P > 0.2). Within the limitations of this preliminary study, it seems that 6 months of fixed orthodontic treatment might increase levels of hair nickel and chromium. Future larger studies are necessary to validate these results. PMID:25503776

  11. An Open-Label Study of Controlled-Release Melatonin in Treatment of Sleep Disorders in Children with Autism

    ERIC Educational Resources Information Center

    Giannotti, F.; Cortesi, F.; Cerquiglini, A.; Bernabei, P.

    2006-01-01

    Long-term effectiveness of controlled-release melatonin in 25 children, aged 2.6-9.6 years with autism without other coexistent pathologies was evaluated openly. Sleep patterns were studied using Children's Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, after 1-3-6 months melatonin treatment and 1 month after discontinuation.…

  12. An Analysis of Patient Adherence to Treatment during a 1-Year, Open-Label Study of OROS[R] Methylphenidate in Children with ADHD

    ERIC Educational Resources Information Center

    Faraone, Stephen V.; Biederman, Joseph; Zimmerman, Brenda

    2007-01-01

    Objective: Treatment adherence is an important aspect of ADHD symptom management, but there are many factors that may influence adherence. Method: This analysis assessed adherence to OROS methylphenidate during a 1-year, open-label study in children. Adherence was defined as the number of days medication was taken divided by the number of days in…

  13. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    ERIC Educational Resources Information Center

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found…

  14. No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a Phase I Open Label Study to assess safety, tolerability and cytokine responses

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed since the mid 1990s by between 2 and 5 million people daily, the scientific literature lacks rigorous clinical trials that describe the potential harms of LGG, particularly in the elderly. The primary objective of this open label...

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

    PubMed

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

    2015-01-01

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

  16. Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: open-label and randomized-withdrawal phases.

    PubMed

    Lasser, Robert A; Dirks, Bryan; Nasrallah, Henry; Kirsch, Courtney; Gao, Joseph; Pucci, Michael L; Knesevich, Mary A; Lindenmayer, Jean-Pierre

    2013-10-01

    Negative symptoms of schizophrenia (NSS), related to hypodopaminergic activity in the mesocortical pathway and prefrontal cortex, are predictive of poor outcomes and have no effective treatment. Use of dopamine-enhancing drugs (eg, psychostimulants) has been limited by potential adverse effects. This multicenter study examined lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, as adjunctive therapy to antipsychotics in adults with clinically stable schizophrenia and predominant NSS. Outpatients with stable schizophrenia, predominant NSS, limited positive symptoms, and maintained on stable atypical antipsychotic therapy underwent a 3-week screening, 10-week open-label adjunctive LDX (20-70 mg/day), and 4-week, double-blind, randomized, placebo-controlled withdrawal. Efficacy measures included a modified Scale for the Assessment of Negative Symptoms (SANS-18) and Positive and Negative Syndrome Scale (PANSS) total and subscale scores. Ninety-two participants received open-label LDX; 69 received double-blind therapy with placebo (n=35) or LDX (n=34). At week 10 (last observation carried forward; last open-label visit), mean (95% confidence interval) change in SANS-18 scores was -12.9 (-15.0, -10.8; P<0.0001). At week 10, 52.9% of participants demonstrated a minimum of 20% reduction from baseline in SANS-18 score. Open-label LDX was also associated with significant improvement in PANSS total and subscale scores. During the double-blind/randomized-withdrawal phase, no significant differences (change from randomization baseline) were found between placebo and LDX in SANS-18 or PANSS subscale scores. In adults with clinically stable schizophrenia, open-label LDX appeared to be associated with significant improvements in negative symptoms without positive symptom worsening. Abrupt LDX discontinuation was not associated with positive or negative symptom worsening. Confirmation with larger controlled trials is warranted. PMID:23756608

  17. Injectable Chemically Crosslinked Hydrogel for the Controlled Release of Bevacizumab in Vitreous: A 6-Month In Vivo Study

    PubMed Central

    Yu, Yu; Lau, Laurence Chi Ming; Lo, Amy Cheuk-yin; Chau, Ying

    2015-01-01

    Purpose To evaluate the biocompatibility and 6-month in vivo release of bevacizumab from a hyaluronic acid/dextran-based in situ hydrogel after intravitreal injection in rabbit eye. Methods The in situ hydrogel was formed by the catalyst-free chemical crosslinking between vinylsulfone functionalized hyaluronic acid (HA-VS) and thiolated dextran (Dex-SH) at physiological condition. The pH 7.4 buffered mixture containing HA-VS, Dex-SH, and bevacizumab were injected into the vitreous of rabbit eyes by a 30-G needle. The biocompatibility was evaluated by intraocular pressure measurement, binocular indirect ophthalmoscope (BIO), full-field electroretinogram (ERG), and histology. The concentrations of both total and active bevacizumab in rabbit vitreous were determined by enzyme-linked immunosorbent assay. The concentration of bevacizumab in rabbit vitreous after bolus injection was simulated by one-compartment first order elimination model. Results A transparent gel was seen in the vitreous after injection. BIO images, ERG, and histology showed that the gel does not induce hemorrhage, retinal detachment, inflammation, or other gross pathological changes in rabbit eyes after injection. While the bolus intravitreal injected bevacizumab follows the first order elimination kinetics in rabbit eye, the in situ gel formation was able to prolong the retention of bevacizumab in rabbit eye at therapeutic relevant concentration for at least 6 months. The concentration of bevacizumab 6 months after injection was about 107 times higher than bolus injection. Conclusions The new in situ hydrogel formulation of bevacizumab was biocompatible and able to prolong the retention of drug in rabbit eyes in vivo at therapeutic relevant concentration for at least 6 months. Translational Relevance Although proven to be effective, monthly intravitreal injection of bevacizumab or other protein drugs may cause various complications. Extending the residence time of protein therapeutics in the eye

  18. Artemether-Lumefantrine versus Dihydroartemisinin-Piperaquine for Treatment of Uncomplicated Plasmodium falciparum Malaria in Children Aged Less than 15 Years in Guinea-Bissau – An Open-Label Non-Inferiority Randomised Clinical Trial

    PubMed Central

    Ursing, Johan; Rombo, Lars; Rodrigues, Amabelia; Kofoed, Poul-Erik

    2016-01-01

    Background Artemether-lumefantrine (AL) was introduced for treatment of uncomplicated malaria in Guinea-Bissau in 2008. Malaria then resurged and recurrent malaria after treatment with AL and stock-outs of AL were common. This study therefore aimed to assess the efficacy of AL and identify an alternative second line antimalarial. Dihydroartemisinin-piperaquine (DP) was chosen as it has been shown to be safe and efficacious and to reduce the incidence of recurrent malaria. Methods and Findings In a multicentre randomised open-label non-inferiority clinical trial, AL or DP were given over 3 days to children aged 6 months-15 years with uncomplicated P. falciparum mono-infection. Intake was observed and AL was given with milk. Children were seen on days 0, 1, 2 and 3 and then weekly days 7–42. Recurring P. falciparum were classified as recrudescence or new infections by genotyping. Between November 2012 and July 2015, 312 children were randomised to AL (n = 155) or DP (n = 157). The day 42 PCR adjusted per protocol adequate clinical and parasitological responses were 95% and 100% in the AL and DP groups respectively, Mantel-Haenszel weighted odds ratio (OR) 0.22 (95% CI 0–0.68), p = 0.022. In a modified intention to treat analysis in which treatment failures day 0 and reinfections were also considered as treatment failures adequate clinical and parasitological responses were 94% and 97% (OR 0.42 [95% CI, 0.13–1.38], p = 0.15). Parasite clearance and symptom resolution were similar with both treatments. Conclusions Both treatments achieved the WHO recommended efficacy for antimalarials about to be adopted as policy. DP was not inferior to AL for treatment of uncomplicated P. falciparum malaria in Guinea-Bissau. Trial Registration ClinicalTrials.gov NTC01704508 PMID:27649561

  19. A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.

    PubMed

    Leuschen, M Patricia; Filipi, Mary; Healey, Kathleen

    2004-12-01

    Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in < or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.

  20. An open-label pilot study of quetiapine plus mirtazapine for heavy drinkers with alcohol use disorder.

    PubMed

    Brunette, Mary F; Akerman, Sarah C; Dawson, Ree; O'Keefe, Christopher D; Green, Alan I

    2016-06-01

    Animal research suggests that medications that produce a weak dopamine D2 receptor blockade and potentiate noradrenergic activity may decrease alcohol drinking. In an open-label pilot study of subjects with alcohol dependence, we tested whether the combination of quetiapine, a weak dopamine D2 receptor antagonist, whose primary metabolite, desalkylquetiapine, is a norepinephrine reuptake inhibitor, and mirtazapine, a potent α2 norepinephrine receptor antagonist, would decrease alcohol drinking and craving. Twenty very heavy drinkers with alcohol dependence entered a trial of 8 weeks of treatment with quetiapine followed by 8 weeks of treatment with a combination of quetiapine plus mirtazapine. Alcohol use was assessed weekly with a Timeline Follow-Back interview and craving with the Penn Alcohol Craving Scale. Among the 11 completers, subjects reported improved outcomes in the quetiapine plus mirtazapine period compared to the quetiapine alone period: fewer very heavy drinking days per week (1.3 [SD = 2.4] vs. 2.1 [SD = 2.8]; t = 2.3, df = 10, p = 0.04); fewer total number of drinks per week (39.7 [SD = 61.6] vs. 53.4 [SD = 65.0]; t = 2.8, df = 10, p = 0.02); and lower craving scores (2.5 [SD = 1.4] vs. 3.2 [SD = 1.2]; t = 2.4, df = 10, p = 0.04). All subjects reported at least one adverse event; 72.7% reported somnolence. In this open-label pilot study, treatment with quetiapine plus mirtazapine was associated with a decrease in alcohol drinking and craving. These findings are consistent with our previous work in animal models of alcohol use disorders and suggest that further study of medications or combinations of medications with this pharmacologic profile is warranted.

  1. Efficacy of fetal stem cell transplantation in autism spectrum disorders: an open-labeled pilot study.

    PubMed

    Bradstreet, James Jeffrey; Sych, Nataliia; Antonucci, Nicola; Klunnik, Mariya; Ivankova, Olena; Matyashchuk, Irina; Demchuk, Mariya; Siniscalco, Dario

    2014-01-01

    Autism spectrum disorders (ASDs) are heterogeneous complex neurodevelopmental pathologies defined by behavioral symptoms, but which have well-characterized genetic, immunological, and physiological comorbidities. Despite extensive research efforts, there are presently no agreed upon therapeutic approaches for either the core behaviors or the associated comorbidities. In particular, the known autoimmune disorders associated with autism are appealing targets for potential stem cell therapeutics. Of the various stem cell populations, fetal stem cells (FSCs) offer the potent immunoregulatory functions found in primordial mesenchymal stem cells, while exhibiting rapid expansion capacity and recognized plasticity. These properties enhance their potential for clinical use. Furthermore, FSCs are potent and implantable "biopharmacies" capable of delivering trophic signals to the host, which could influence brain development. This study investigated the safety and efficacy of FSC transplantations in treating children diagnosed with ASDs. Subjects were monitored at pre, and then 6 and 12 months following the transplantations, which consisted of two doses of intravenously and subcutaneously administered FSCs. The Autism Treatment Evaluation Checklist (ATEC) test and Aberrant Behavior Checklist (ABC) scores were performed. Laboratory examinations and clinical assessment of adverse effects were performed in order to evaluate treatment safety. No adverse events of significance were observed in ASD children treated with FSCs, including no transmitted infections or immunological complications. Statistically significant differences (p < 0.05) were shown on ATEC/ABC scores for the domains of speech, sociability, sensory, and overall health, as well as reductions in the total scores when compared to pretreatment values. We recognize that the use of FSCs remains controversial for the present. The results of this study, however, warrant additional investigations into the mechanisms

  2. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial

    PubMed Central

    Haahr, Martha Kirstine; Jensen, Charlotte Harken; Toyserkani, Navid Mohamadpour; Andersen, Ditte Caroline; Damkier, Per; Sørensen, Jens Ahm; Lund, Lars; Sheikh, Søren Paludan

    2016-01-01

    Background Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory and this condition presents an unmet medical need. Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with autologous adipose-derived regenerative cells (ADRCs) freshly isolated after a liposuction. Methods Seventeen men suffering from post RP ED, with no recovery using conventional therapy, were enrolled in a prospective phase 1 open-label and single-arm study. All subjects had RP performed 5–18 months before enrolment, and were followed for 6 months after intracavernosal transplantation. ADRCs were analyzed for the presence of stem cell surface markers, viability and ability to differentiate. Primary endpoint was the safety and tolerance of the cell therapy while the secondary outcome was improvement of erectile function. Any adverse events were reported and erectile function was assessed by IIEF-5 scores. The study is registered with ClinicalTrials.gov, NCT02240823. Findings Intracavernous injection of ADRCs was well-tolerated and only minor events related to the liposuction and cell injections were reported at the one-month evaluation, but none at later time points. Overall during the study period, 8 of 17 men recovered their erectile function and were able to accomplish sexual intercourse. Post-hoc stratification according to urinary continence status was performed. Accordingly, for continent men (median IIEFinclusion = 7 (95% CI 5–12), 8 out of 11 men recovered erectile function (IIEF6months = 17 (6–23)), corresponding to a mean difference of 0.57 (0.38–0.85; p = 0.0069), versus inclusion. In contrast, incontinent men did not regain erectile function (median IIEF1/3/6

  3. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial

    PubMed Central

    Mao, Ying; Yao, Yu; Zhang, Li-Wei; Lu, Yi-Cheng; Chen, Zhong-Ping; Zhang, Jian-Min; Qi, Song-Tao; You, Chao; Wang, Ren-Zhi; Yang, Shu-Yuan; Zhang, Xiang; Wang, Ji-Sheng; Chen, Ju-Xiang; Yang, Qun-Ying; Shen, Hong; Li, Zhi-Yong; Wang, Xiang; Ma, Wen-Bin; Yang, Xue-Jun; Zhen, Hai-Ning; Zhou, Liang-Fu

    2015-01-01

    Background: The radiochemotherapy regimen concomitantly employing temozolomide (TMZ) chemotherapy and radiotherapy (RT) 4 weeks after surgery, followed by 6 cycles of TMZ is a common treatment for glioblastoma (GBM). However, its median overall survival (OS) is only 14.6 months. This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Methods: A randomized, parallel group, open-label study of 99 newly diagnosed GBM patients was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide (early TMZ group) or standard concomitant radiochemotherapy regimen (control group). Overall response was assessed based on objective tumor assessments, administration of corticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event (AE), and neurological condition were measured for 24 months of follow-up. The primary efficacy endpoint of this study was overall survival (OS). The secondary endpoint was progression free survival (PFS). Results: The median OS time in the early TMZ group was 17.6 months, compared with 13.2 months in the control group (log-rank test P = 0.021). In addition, the OS rate in the early TMZ group was higher at 6, 12, and 18 months than in the control group, respectively (P < 0.05). The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group (log-rank test P = 0.695). AEs occurred in 29 (55.8%) and 31(73.8%) patients respectively in early and control groups, including nausea (15.4% vs. 33.3%), vomiting (7.7% vs. 28.6%), fever (7.7% vs. 11.9%), and headache (3.8% vs. 23.8%). Only 30.8% and 33.3% were drug-related, respectively. Conclusions: Addition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen

  4. Treatment of the Developmental Dysplasia of the Hip with an Abduction Brace in Children up to 6 Months Old

    PubMed Central

    Wahlen, Raphaël; Zambelli, Pierre-Yves

    2015-01-01

    Introduction. Use of Pavlik harness for the treatment of DDH can be complicated for parents. Any misuse or failure in the adjustments may lead to significant complications. An abduction brace was introduced in our institution, as it was thought to be easier to use. Aim. We assess the results for the treatment of DDH using our abduction brace in children of 0–6 months old and compare these results with data on treatments using the Pavlik harness. Method. Retrospective analysis of patients with DDH from 0 to 6 months old at diagnosis, performed from 2004 to 2009. Outcomes were rates of reduction of the hip and avascular necrosis of the femoral head (AVN). Follow-up was at one year and up to 4 years old. Results. Hip reduction was successful in 28 of 33 patients (85%), with no AVN. Conclusion. Our results in terms of hip reduction rate and AVN rate are similar to those found in literature assessing Pavlik harness use, with a simpler and comfortable treatment procedure. PMID:25815214

  5. Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study.

    PubMed

    Reisman, Y; Hind, A; Varaneckas, A; Motil, I

    2015-01-01

    Low-intensity shockwaves (LISW) are known to produce revascularization and have been in evaluation and in use to treat erectile dysfunction (ED). The present single-arm pilot study is aimed to assess the safety and efficacy of a dedicated shockwave device (Renova) on vasculogenic ED patients. Fifty-eight patients with mild to severe ED were treated by LISW and their erectile function was evaluated by the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), Sexual Encounter Profile and Global Assessment Questions questionnaires, at baseline and at 1, 3 and 6 months post treatment. The average IIEF-EF increased significantly from 14.78 at baseline to 21.93 at 3 months post treatment and stabilized at 22.26 at 6 months post treatment. Out of 58 patients, 47 (81%) had a successful treatment. No adverse events were reported during the treatment and the follow-up duration. In conclusion, it suggests that the performance of LISW could add a new advanced treatment for ED.

  6. Clinical efficacy of a dentifrice and oral rinse containing sanguinaria extract and zinc chloride during 6 months of use.

    PubMed

    Harper, D S; Mueller, L J; Fine, J B; Gordon, J; Laster, L L

    1990-06-01

    The efficacy of combined use of toothpaste and oral rinse containing sanguinaria extract and zinc chloride was compared to placebo products in a 6-month clinical trial. Sixty subjects with moderate levels of plaque and gingivitis were randomly assigned to active and placebo groups. Noninvasive measures of plaque and gingivitis were assessed at baseline and at 2, 6, 8, 14, 20, and 28 weeks. Bleeding on probing was measured at baseline and 6, 14, and 28 weeks. Active group scores were significantly lower (P less than .0001) than placebo scores at each post-baseline time point for all indices, with the exception of plaque at 2 weeks. The 28 week active group scores were 21% lower than the placebo group for plaque, 25% lower for gingivitis, and 43% lower for bleeding on probing. No dental staining or taste alteration was reported in the active group. Three of 30 active group subjects exhibited minor soft tissue irritations that resolved spontaneously without discontinuation of product use. Results indicate that the test products showed good levels of safety and efficacy when administered in a combined use regimen for 6 months.

  7. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase.

    PubMed

    Bergenstal, Richard M; Tamborlane, William V; Ahmann, Andrew; Buse, John B; Dailey, George; Davis, Stephen N; Joyce, Carol; Perkins, Bruce A; Welsh, John B; Willi, Steven M; Wood, Michael A

    2011-11-01

    OBJECTIVE To examine the effects of crossing over from optimized multiple daily injection (MDI) therapy to sensor-augmented pump (SAP) therapy for 6 months, and the effects of 18 months' sustained use of SAP. RESEARCH DESIGN AND METHODS The 6-month, single-crossover continuation phase of Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) provided SAP therapy to 420 subjects who completed the 1-year randomized study. The primary outcome was change in A1C in the crossover group. RESULTS A1C values were initially lower in the continuing-SAP group than in the crossover group (7.4 vs. 8.0%, P < 0.001). A1C values remained reduced in the SAP group. After 3 months on the SAP system, A1C decreased to 7.6% in the crossover group (P < 0.001); this was a significant and sustained decrease among both adults and children (P < 0.05). CONCLUSIONS Switching from optimized MDI to SAP therapy allowed for rapid and safe A1C reductions. Glycemic benefits of SAP therapy persist for at least 18 months.

  8. Sexual victimization history, depression, and task physiology as predictors of sexual revictimization: results from a 6-month prospective pilot study.

    PubMed

    Waldron, Jonathan C; Wilson, Laura C; Patriquin, Michelle A; Scarpa, Angela

    2015-02-01

    The current study examined depression and physiological reactivity to a sexual threat task as longitudinal predictors of sexual revictimization in women with sexual victimization histories. The sample included 14 young adult women (M(age) = 19.15) who reported child sexual abuse. Heart rate and root mean square of the successive differences were measured at baseline and during the presentation of sexual victimization-related words during an Emotional Stroop task. Results indicated that women who reported a greater history of childhood sexual abuse and adult sexual victimization were at increased risk for sexual revictimization 6 months after initial data collection. Furthermore, even after accounting for their childhood and adult sexual victimization histories and depression symptoms, women who exhibited reduced, or blunted, physiological activity during the sexual victimization stimuli of the Stroop task were more likely to report sexual revictimization during the 6-month follow-up. The findings suggest that sexual victimization survivors may benefit from interventions that address physiological blunting and the recognition of sexual threat cues in their environment. PMID:24923892

  9. Hardwood smoke alters murine splenic T cell responses to mitogens following a 6-month whole body inhalation exposure

    SciTech Connect

    Burchiel, Scott W. . E-mail: Sburchiel@salud.unm.edu; Lauer, Fredine T.; Dunaway, Sandy L.; Zawadzki, Jerome; McDonald, Jacob D.; Reed, Matthew D.

    2005-02-01

    The purpose of these studies was to assess the effects of hardwood smoke (HWS) inhalation (30-1000 {mu}g/m{sup 3}) on the systemic immune responses of A/J mice evaluated after 6 months of daily exposures. Spleen cells obtained from mice were assessed for changes in cell number, cell surface marker expression [B, T, macrophage, and natural killer (NK) cells], and responses to B cell (LPS, endotoxin) and T cell (Con A) mitogens. Results showed that HWS smoke increased T cell proliferation in the 100 {mu}g/m{sup 3} exposure group and produced a concentration-dependent suppression of T cell proliferation at concentrations >300 {mu}g/m{sup 3}. There were no effects on B cell proliferation or in spleen cell surface marker expression. Analyses of the exposure atmospheres revealed the presence of significant levels of naphthalene and methylated napthalenes, fluorene, phenanthrene, and anthracene in the exposure chambers, as well as low concentrations of several metals (K, Ca, and Fe). Our results demonstrate that environmentally relevant concentrations of HWS may be immunosuppressive to the immune system of mice exposed during a 6-month period.

  10. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes

    PubMed Central

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-01-01

    “Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes” is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community –academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study. PMID:25364622

  11. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes.

    PubMed

    Mango, Joseph; Cabiling, Eileen; Jones, Loretta; Lucas-Wright, Aziza; Williams, Pluscedia; Wells, Kenneth; Pulido, Esmeralda; Meldrum, Marcia; Ramos, Ana; Chung, Bowen

    2014-02-25

    "Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes" is a 2 minute, 46 second video summarizing the study rationale, study approach, and the 6-month outcomes. The video was produced by four agencies: Healthy African American Families II, a health advocacy organization in South Los Angeles; Behavioral Health Services, the largest substance/alcohol abuse service provider in LA County; UCLA; and RAND Health; contract filmmakers Eileen Cabiling and Joe Mango handled cinematography, editing, and video support. The individuals appearing in the video are key CPIC community and academic partners. The celebratory tone of the video is consistent with a Community Partnered Participatory Research approach, a local variant of participatory action research, where study findings are celebrated by the partners, and dissemination efforts include approaches intended for general audiences, especially from low-income, low-literacy, minority communities, in addition to traditional academic products like peer-reviewed scientific manuscripts. The CPIC video offers a community perspective on the study results to our partners, the general public, other scientists and policy makers. We designed the video to teach community and healthcare partners how to adapt and implement the CPIC depression care model and to offer other community -academic partnerships an example of a non-traditional product developed for dissemination from an NIH-funded research study. PMID:25364622

  12. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    PubMed

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-01-01

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism. PMID:27338456

  13. Brief Report: An Open-Label Study of the Neurosteroid Pregnenolone in Adults with Autism Spectrum Disorder

    PubMed Central

    Libove, Robin A.; Phillips, Jennifer; Haddad, Francois; Hardan, Antonio Y.

    2014-01-01

    The objective of this study was to assess the tolerability and efficacy of pregnenolone in reducing irritability in adults with autism spectrum disorder (ASD). This was a pilot, open-label, 12-week trial that included twelve subjects with a mean age of 22.5 ± 5.8 years. Two participants dropped out of the study due to reasons unrelated to adverse effects. Pregnenolone yielded a statistically significant improvement in the primary measure, Aberrant Behavior Checklist (ABC)-Irritability [from 17.4 ± 7.4 at baseline to 11.2 ± 7.0 at 12 weeks (p = 0.028)]. Secondary measures were not statistically significant with the exception of ABC-lethargy (p = 0.046) and total Short Sensory Profile score (p = 0.009). No significant vital sign changes occurred during this study. Pregnenolone was not associated with any severe side effects. Single episodes of tiredness, diarrhea and depressive affect that could be related to pregnenolone were reported. Overall, pregnenolone was modestly effective and well-tolerated in individuals with ASD. PMID:24849255

  14. Brief report: an open-label study of the neurosteroid pregnenolone in adults with autism spectrum disorder.

    PubMed

    Fung, Lawrence K; Libove, Robin A; Phillips, Jennifer; Haddad, Francois; Hardan, Antonio Y

    2014-11-01

    The objective of this study was to assess the tolerability and efficacy of pregnenolone in reducing irritability in adults with autism spectrum disorder (ASD). This was a pilot, open-label, 12-week trial that included twelve subjects with a mean age of 22.5 ± 5.8 years. Two participants dropped out of the study due to reasons unrelated to adverse effects. Pregnenolone yielded a statistically significant improvement in the primary measure, Aberrant Behavior Checklist (ABC)-Irritability [from 17.4 ± 7.4 at baseline to 11.2 ± 7.0 at 12 weeks (p = 0.028)]. Secondary measures were not statistically significant with the exception of ABC-lethargy (p = 0.046) and total Short Sensory Profile score (p = 0.009). No significant vital sign changes occurred during this study. Pregnenolone was not associated with any severe side effects. Single episodes of tiredness, diarrhea and depressive affect that could be related to pregnenolone were reported. Overall, pregnenolone was modestly effective and well-tolerated in individuals with ASD.

  15. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial.

    PubMed

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-06-07

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism.

  16. Bupropion for interferon-alpha-induced depression in patients with hepatitis C viral infection: an open-label study.

    PubMed

    Chen, Wei-Chun; Lai, Hsueh-Chou; Su, Wen-Pang; Palani, Mahalakshmi; Su, Kuan-Pin

    2015-01-01

    Interferon (IFN)-α therapy for chronic hepatitis C virus (HCV) infection is frequently associated with major depressive episodes. Bupropion, a commonly used antidepressant agent, has recently found to have strong anti-inflammatory effects in animal models. Despite of the theoretical relevancy, the antidepressant effect of bupropion in IFN-alpha-induced depression has never been studied. Ten HCV patients with IFN-α-induced depression were recruited to receive 8-week bupropion treatment and were assessed every 2 weeks for depressive symptoms by the Hamilton rating scale for depression (HAMD) and somatic symptoms by the Neurotoxicity Rating Scale (NRS). Four of the 10 patients met the criteria for remission (total HAMD scores≤7), and 5 patients met the criteria for response (at least 50% reduction in total HAMD scores). In addition, 5 patients had 50% decreases in NRS for neuropsychiatric symptoms. This preliminary open-label study suggests that bupropion is effective in treating IFN-alpha-induced depressive and somatic symptoms.

  17. Open-label treatment with risperidone of 26 psychiatrically-hospitalized children and adolescents with mixed diagnoses and aggressive behavior.

    PubMed

    Buitelaar, J K

    2000-01-01

    Open-label risperidone was administered to 26 subjects (24 boys: 19 with borderline IQ and 5 with mild mental retardation), 10-18 years old, who were hospitalized for treatment of psychiatric disorders associated with aggressive behavior. Risperidone was given in daily doses ranging from 0.5 to 4 mg for periods of 2-12 months. Treatment response was monitored by means of the improvement scale of the CGI and the modified OAS. Extrapyramidal side effects were measured on the ESRS. Fourteen (54%) of 26 subjects had a marked reduction in aggression; 10 subjects had a moderate reduction; two subjects had mild changes; and none worsened. Two subjects had a marked weight gain in the first 8 weeks of treatment. In seven of the 22 children who continued taking risperidone after week 8, tiredness and sedation that necessitated dose reduction emerged between weeks 8 and 16. These results suggest that risperidone may be useful when treating severe aggressive behavior in children and adolescents. Weight gain and sedation can be troublesome side effects.

  18. A Prospective, Open-Label Study of Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides

    SciTech Connect

    Kamstrup, Maria R.; Specht, Lena; Skovgaard, Gunhild L.; Gniadecki, Robert

    2008-07-15

    Purpose: To determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of Stage IB-II mycosis fungoides in a prospective, open-label study. Methods and Materials: Ten patients (6 men, 4 women, average age 68.7 years [range, 55-82 years]) with histopathologically confirmed mycosis fungoides T2-T4 N0-N1 M0 who did not achieve complete remission or relapsed within 4 months after treatment with psoralen plus ultraviolet-A were included. Treatment consisted of low-dose total skin electron beam therapy administered at a total skin dose of 4 Gy given in 4 fractions over 4 successive days. Results: Two patients had a complete clinical response but relapsed after 3.5 months. Six patients had partial clinical responses, with a mean duration of 2.0 months. One patient had no clinical response. Median time to relapse was 2.7 months. One patient died of unrelated causes and did not complete treatment. Acute side effects included desquamation, xerosis, and erythema of the skin. No severe side effects were observed. Conclusion: Low-dose total skin electron beam therapy can induce complete and partial responses in Stage IB-II mycosis fungoides; however, the duration of remission is short. Low-dose total skin electron beam therapy may find application in palliative treatment of mycosis fungoides because of limited toxicity and the possibility of repeating treatments for long-term disease control.

  19. An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

    PubMed Central

    Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

    2011-01-01

    Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

  20. Effects of Shenfu Injection in the Treatment of Septic Shock Patients: A Multicenter, Controlled, Randomized, Open-Label Trial

    PubMed Central

    Zhang, Xinchao; Lin, Peihong; Wei, Jie; Cao, Yu; Pan, Shuming; Walline, Joseph; Qian, Chuanyun; Shan, Zhigang

    2016-01-01

    The effect of Shenfu on biochemical parameters and survival during resuscitation in patients with septic shock was examined. This was a multicenter, controlled, randomized, open-label trial carried out in 210 patients with septic shock from seven medical centers in China. They were randomized to Shenfu or saline. The primary outcome was lactate clearance. The secondary outcomes were shock index normalization, dose of vasopressors, ICU stay, hospital stay, and mortality. A total of 199 patients completed the trial. Blood pressure, heart rate, and other routine lab tests showed no difference between the groups. Lactate levels and lactate clearance were similar between the two groups. Hospital and ICU stay were similar between the two groups. When considering all patients, the 7- and 28-day mortality were similar between the two groups, but when considering only patients with lactate levels ≥4.5 mmol/L, the Shenfu group showed a better 7-day survival than the control group (7 days: 83.3% versus 54.5%, P = 0.034; 28 days: 72.7% versus 47.6%, P = 0.092). Shenfu may improve the 7-day survival in patients with impaired lactate clearance (≥4.5 mmol/L), but the mechanism for this effect is unclear. Additional studies are necessary to characterize the hemodynamic changes after Shenfu infusion. This trial is registered with ChiCTR-TRC-11001369. PMID:27446222

  1. Efficacy of Folic Acid Supplementation in Autistic Children Participating in Structured Teaching: An Open-Label Trial

    PubMed Central

    Sun, Caihong; Zou, Mingyang; Zhao, Dong; Xia, Wei; Wu, Lijie

    2016-01-01

    Autism spectrum disorders (ASD) are recognized as a major public health issue. Here, we evaluated the effects of folic acid intervention on methylation cycles and oxidative stress in autistic children enrolled in structured teaching. Sixty-six autistic children enrolled in this open-label trial and participated in three months of structured teaching. Forty-four children were treated with 400 μg folic acid (two times/daily) for a period of three months during their structured teaching (intervention group), while the remaining 22 children were not given any supplement for the duration of the study (control group). The Autism Treatment Evaluation Checklist (ATEC) and Psychoeducational Profile-third edition (PEP-3) were measured at the beginning and end of the treatment period. Folic acid, homocysteine, and glutathione metabolism in plasma were measured before and after treatment in 29 autistic children randomly selected from the intervention group and were compared with 29 age-matched unaffected children (typical developmental group). The results illustrated folic acid intervention improved autism symptoms towards sociability, cognitive verbal/preverbal, receptive language, and affective expression and communication. Furthermore, this treatment also improved the concentrations of folic acid, homocysteine, and normalized glutathione redox metabolism. Folic acid supplementation may have a certain role in the treatment of children with autism. PMID:27338456

  2. The 5-HT1D receptor agonist zolmitriptan for neuroleptic-induced akathisia: an open label preliminary study.

    PubMed

    Gross-Isseroff, Ruth; Magen, Ayelet; Shiloh, Roni; Hermesh, Haggai; Weizman, Abraham

    2005-01-01

    Neuroleptic-induced akathisia (NIA) is a common, sometimes incapacitating, adverse side-effect of antipsychotic drugs (APDs). Several non-selective post-synaptic 5-HT2 blockers have shown a beneficial antiakathisic effect. We hypothesized that selective stimulation of the presynaptic 5-HT1D serotonergic inhibitory autoreceptor could also be beneficial in NIA. The study group included eight schizophrenia inpatients with acute or chronic NIA who were treated with unchanged doses of APDs. Participants received, in an open-labelled design, 7.5 mg/day of zolmitriptan (selective 5-HT1D agonist) for 3 consecutive days. Positive and Negative Syndrome Scale and Barnes akathisia scale (BAS) scores were monitored before and at the end of the study. BAS score decreased by 5.25 points following zolmitriptan administration (9.0+/-2.27 to 3.75+/-2.55, t=6.1, d.f.=7, P=0.0005). In one case, the BAS score dropped from a 3-year score >or=9 points (while relatively non-responsive to numerous antiakathisic agents) to 4 points at endpoint. In conclusion, zolmitriptan appears to exert significant and rapid beneficial antiakathisic effect, even in chronic and resistant NIA. Larger, long-term, double-blind, placebo- and comparator- (e.g. propranolol) controlled studies are required to substantiate the efficacy, safety and tolerability of zolmitriptan, as well as the role of serotonergic neurotransmission in NIA.

  3. Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study

    PubMed Central

    Møller, Eigild; Pedersen, Søren Anker; Vinicoff, Pablo Gustavo; Bardow, Allan; Lykkeaa, Joan; Svendsen, Pia; Bakke, Merete

    2015-01-01

    The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive method. A/Ona was injected in 14 children, Mean age 9 years, SD 3 years, under ultrasonic guidance in six successive Series, with at least six months between injections. Doses and gland involvement increased from Series A to F (units (U) per submandibular/parotid gland: A, 10/0; B, 15/0; C, 20/0; D, 20/20; E, 30/20; and F, 30/30). The effect was assessed 2, 4, 8, 12, and 20 weeks after A/Ona (drooling problems (VAS), impact (0–7), treatment effect (0–5), unstimulated whole saliva (UWS) flow and composition)) and analyzed by two-way ANOVA. The effect was unchanged–moderate in A to moderate–marked in F. Changes in all parameters were significant in E and F, but with swallowing problems ≤5 weeks in 3 of 28 treatments. F had largest VAS and UWS reduction (64% and 49%). We recommend: Start with dose D A/Ona (both submandibular and parotid glands and a total of 80 U) and increase to E and eventually F (total 120 U) without sufficient response. PMID:26134257

  4. A Phase 4, Pilot, Open-Label Study of VIVITROL® (Extended-Release Naltrexone XR-NTX) for Prisoners.

    PubMed

    Gordon, Michael S; Kinlock, Timothy W; Vocci, Frank J; Fitzgerald, Terrence T; Memisoglu, Asli; Silverman, Bernard

    2015-12-01

    This was a Phase 4, pilot, open-label feasibility study of extended-release injectable naltrexone (XR-NTX) administered to pre-release prisoners having a history of pre-incarceration opioid disorder. We evaluated the relationship between XR-NTX adherence and criminal recidivism (re-arrest and re-incarceration) and opioid and cocaine use. Twenty-seven pre-release male and female prisoners who had opioid disorders during the year prior to index incarceration were recruited and received one XR-NTX injection once each month for 7 months (1 injection pre-release from prison and 6 injections in the community) and of those 27, 10 (37%) were retained in treatment at 7-months post release. Results indicate those completing 6 compared to those completing <6 injections were less likely to test positive for opioids in the community (0% vs. 62.5%, respectively; p=0.003). Although not statistically significant, individuals who did not complete all 6 injections were more likely to be re-arrested compared to those completing all 6 community injections (31.3% vs. 0%, respectively; p=0.123). Contingent upon further study of a randomized controlled trial, XR-NTX may be a feasible option in the prison setting in view of the lack of potential for diversion. Furthermore, these data suggest that completing the entire course of treatment (6 injections) may reduce opioid use and, to a lesser degree, re-arrest and re-incarceration. PMID:26299956

  5. Open-Label Study of Craving in Smokers With Schizophrenia Using Nicotine Nasal Spray Compared to Nicotine Patch

    PubMed Central

    Williams, Jill M.; Gandhi, Kunal K.; Karavidas, Maria Katsamanis; Steinberg, Marc L.; Lu, Shou-En; Foulds, Jonathan

    2009-01-01

    Rationale: Nicotine nasal spray (NNS) may be better for relieving acute cigarette cravings than other nicotine replacement and it may help smokers with schizophrenia because of its rapid onset of action. Objectives: We tested whether NNS was more effective than a nicotine patch (NP; 21 mg) in reducing cue-induced craving during a 3-day abstinence. Methods: Twenty-five smokers with schizophrenia or schizoaffective disorder (SA) were randomized to open-label NNS or NP treatment after baseline measures of craving were assessed. NNS users were instructed to dose at a minimum of 1/hour and up to a maximum of 40/day. Averages from a 4-item visual analogue scale (need, urge, want to smoke, crave a cigarette) measured craving. Results: Five subjects who smoked (4 NP, 1 NNS) were excluded, leaving 21 (11 NP, 10 NNS) for analyses. No differences were detected between groups on baseline craving. On day 3, NNS users reported significantly less craving in response to smoking cues compared to NP users (mean craving scores: NNS, 7.0; NP, 20.3; p = .014). A repeated measure ANCOVA demonstrated significantly reduced craving in the NNS group compared to the NP group from baseline to day 3 (F = 5.09; p = .037). NNS users took an average of 20 doses/day, and NNS was rated as being as easy to use as NP. Conclusions: The potential utility of NNS in smokers with schizophrenia supports the need for placebo-controlled studies. PMID:19763279

  6. Effect of topical vitamin D on chronic kidney disease-associated pruritus: An open-label pilot study.

    PubMed

    Jung, Kyung Eun; Woo, Yu Ri; Lee, Joong Sun; Shin, Jong Ho; Jeong, Jin Uk; Koo, Dae Won; Bang, Ki Tae

    2015-08-01

    Chronic kidney disease-associated pruritus (CKD-aP) is a troublesome symptom in patients with end-stage renal disease (ESRD). Recently, vitamin D deficiency has been known to be one of the possible etiologic factors in CKD-aP. However, limited data is available on whether topical vitamin D treatment is effective for relieving CKD-aP. Therefore, the purpose of this study is to evaluate the effectiveness of topically vitamin D for CKD-aP. Twenty-three patients with CKD-aP were enrolled in a single center, open-label study. Patients were instructed to apply a topical vitamin D (calcipotriol) agent (Daivonex solution; LEO Pharma) or vehicle solution twice daily for a month. We assessed the efficacy and safety of topical vitamin D on CKD-aP using clinical and dermoscopic photographs, and questionnaires including the validated modified pruritus assessment score (VMPAS) and visual analog scale (VAS) every 2 weeks. Dry dermoscopic findings showed significant improvement of scale (dryness) on the skin of topical vitamin D-treated patients compared with those of the vehicle group. Both VMPAS and VAS were significantly decreased after 2 and 4 weeks of the topical vitamin D treatment compared with the vehicle, respectively (P < 0.05). No significant side-effects were observed. Topical vitamin D may be one of the safe and effective therapeutic candidates for CKD-aP.

  7. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study.

    PubMed

    Petersenn, Stephan; Bollerslev, Jens; Arafat, Ayman M; Schopohl, Jochen; Serri, Omar; Katznelson, Laurence; Lasher, Janet; Hughes, Gareth; Hu, Ke; Shen, George; Reséndiz, Karina Hermosillo; Giannone, Vanessa; Beckers, Albert

    2014-11-01

    Pasireotide (SOM230), a multireceptor-targeted somatostatin analogue, has exhibited favorable safety/tolerability in several clinical studies. A long-acting-release (LAR) formulation of pasireotide may offer advantages over the subcutaneous formulation. This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study. Steady-state pasireotide concentrations were achieved following three monthly injections. Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group). At study end, 51% and 57% of patients achieved GH levels ≤2.5 μg/L and IGF-1 levels below ULN, respectively. Compared with baseline, fasting blood glucose and HbA1c levels increased, whereas fasting blood insulin levels decreased. Acromegaly symptoms were generally improved. Adverse events were mostly gastrointestinal and mild/moderate. Pasireotide LAR was generally well tolerated. Steady-state PK was achieved after three monthly doses; exposures were approximately dose proportional. Control of GH, IGF-1, and symptoms improved, suggesting that pasireotide LAR may be an effective treatment for acromegaly.

  8. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  9. Effect of 6-months of physical exercise on the nitrate/nitrite levels in hypertensive postmenopausal women

    PubMed Central

    Zaros, Pedro R; Pires, Carla EM Romero; Bacci, Mauricio; Moraes, Camila; Zanesco, Angelina

    2009-01-01

    Background Evidences have showed that the incidence of arterial hypertension is greater in postmenopausal women as compared to premenopausal. Physical inactivity has been implicated as a major contributor to weight gain and abdominal obesity in postmenopausal women and the incidence of cardiovascular disease increases dramatically after menopause. Additionally, more women than men die each year of coronary heart disease and are twice as likely as men to die within the first year after a heart attack. A healthy lifestyle has been strongly associated with the regular physical activity and evidences have shown that physically active subjects have more longevity with reduction of morbidity and mortality. Nitric oxide (NO) produced by endothelial cells has been implicated in this beneficial effect with improvement of vascular relaxing and reduction in blood pressure in both laboratory animals and human. Although the effect of exercise training in the human cardiovascular system has been largely studied, the majority of these studies were predominantly conducted in men or young volunteers. Therefore, the aim of this work was to investigate the effects of 6 months of dynamic exercise training (ET) on blood pressure and plasma nitrate/nitrite concentration (NOx-) in hypertensive postmenopausal women. Methods Eleven volunteers were submitted to the ET consisting in 3 days a week, each session of 60 minutes during 6 months at moderate intensity (50% of heart rate reserve). Anthropometric parameters, blood pressure, NOx- concentration were measured at initial time and after ET. Results A significant reduction in both systolic and diastolic blood pressure values was seen after ET which was accompanied by markedly increase of NOx- levels (basal: 10 ± 0.9; ET: 16 ± 2 μM). Total cholesterol was significantly reduced (basal: 220 ± 38 and ET: 178 ± 22 mg/dl), whereas triglycerides levels were not modified after ET (basal: 141 ± 89 and ET: 147 ± 8 mg/dl). Conclusion Our study

  10. Reversal of functional changes in the brain associated with obstructive sleep apnoea following 6 months of CPAP.

    PubMed

    Fatouleh, Rania H; Lundblad, Linda C; Macey, Paul M; McKenzie, David K; Henderson, Luke A; Macefield, Vaughan G

    2015-01-01

    Obstructive sleep apnoea (OSA) is associated with an increase in the number of bursts of muscle sympathetic nerve activity (MSNA), leading to neurogenic hypertension. Continuous positive airway pressure (CPAP) is the most effective and widely used treatment for preventing collapse of the upper airway in OSA. In addition to improving sleep, CPAP decreases daytime MSNA towards control levels. It remains unknown how this restoration of MSNA occurs, in particular whether CPAP treatment results in a simple readjustment in activity of those brain regions responsible for the initial increase in MSNA or whether other brain regions are recruited to over-ride aberrant brain activity. By recording MSNA concurrently with functional Magnetic Resonance Imaging (fMRI), we aimed to assess brain activity associated with each individual subject's patterns of MSNA prior to and following 6 months of CPAP treatment. Spontaneous fluctuations in MSNA were recorded via tungsten microelectrodes inserted into the common peroneal nerve in 13 newly diagnosed patients with OSA before and after 6 months of treatment with CPAP and in 15 healthy control subjects while lying in a 3 T MRI scanner. Blood Oxygen Level Dependent (BOLD) contrast gradient echo, echo-planar images were continuously collected in a 4 s ON, 4 s OFF (200 volumes) sampling protocol. MSNA was significantly elevated in newly diagnosed OSA patients compared to control subjects (55 ± 4 vs 26 ± 2 bursts/min). Fluctuations in BOLD signal intensity in multiple regions covaried with the intensity of the concurrently recorded bursts of MSNA. There was a significant fall in MSNA after 6 months of CPAP (39 ± 2 bursts/min). The reduction in resting MSNA was coupled with significant falls in signal intensity in precuneus bilaterally, the left and right insula, right medial prefrontal cortex, right anterior cingulate cortex, right parahippocampus and the left and right retrosplenial cortices. These data support our contention that

  11. Validation of CRASH Model in Prediction of 14-day Mortality and 6-month Unfavorable Outcome of Head Trauma Patients

    PubMed Central

    Hashemi, Behrooz; Amanat, Mahnaz; Baratloo, Alireza; Forouzanfar, Mohammad Mehdi; Rahmati, Farhad; Motamedi, Maryam; Safari, Saeed

    2016-01-01

    Introduction: To date, many prognostic models have been proposed to predict the outcome of patients with traumatic brain injuries. External validation of these models in different populations is of great importance for their generalization. The present study was designed, aiming to determine the value of CRASH prognostic model in prediction of 14-day mortality (14-DM) and 6-month unfavorable outcome (6-MUO) of patients with traumatic brain injury. Methods: In the present prospective diagnostic test study, calibration and discrimination of CRASH model were evaluated in head trauma patients referred to the emergency department. Variables required for calculating CRASH expected risks (ER), and observed 14-DM and 6-MUO were gathered. Then ER of 14-DM and 6-MUO were calculated. The patients were followed for 6 months and their 14-DM and 6-MUO were recorded. Finally, the correlation of CRASH ER and the observed outcome of the patients was evaluated. The data were analyzed using STATA version 11.0. Results: In this study, 323 patients with the mean age of 34.0 ± 19.4 years were evaluated (87.3% male). Calibration of the basic and CT models in prediction of 14-day and 6-month outcome were in the desirable range (P < 0.05). Area under the curve in the basic model for prediction of 14-DM and 6-MUO were 0.92 (95% CI: 0.89-0.96) and 0.92 (95% CI: 0.90-0.95), respectively. In addition, area under the curve in the CT model for prediction of 14-DM and 6-MUO were 0.93 (95% CI: 0.91-0.97) and 0.93 (95% CI: 0.91-0.96), respectively. There was no significant difference between the discriminations of the two models in prediction of 14-DM (p = 0.11) and 6-MUO (p = 0.1). Conclusion: The results of the present study showed that CRASH prediction model has proper discrimination and calibration in predicting 14-DM and 6-MUO of head trauma patients. Since there was no difference between the values of the basic and CT models, using the basic model is recommended to simplify the risk

  12. Tibial bone responses to 6-month calcium and vitamin D supplementation in young male jockeys: A randomised controlled trial.

    PubMed

    Silk, Leslie N; Greene, David A; Baker, Michael K; Jander, Caron B

    2015-12-01

    Young male jockeys compromise bone health by engaging in caloric restriction and high volumes of physical activity during periods of musculoskeletal growth and development. The aim of this randomised, double-blinded, placebo-controlled trial was to establish whether calcium and vitamin D supplementation would improve bone properties of young male jockeys. We conducted a 6-month trial with two groups of weight-, height- and age-matched apprentice male jockeys (age=20.2 ± 3.2 yrs). Participants were supplemented with 800 mg of calcium and 400 IU of vitamin D (S, n=8) or a placebo (cellulose) (P, n=9) daily for 6-months. Baseline calcium intake was (669.7 ± 274.3 (S) vs 790.4 ± 423.9 (P) and vitamin D 64.6 ± 19.5 (S) vs 81.2 ± 24.4 (P) with no statistical differences. Peripheral quantitative computed tomography (pQCT) measured ultra-distal (4%) and proximal (66%) tibial bone properties at baseline and 6 months. Blood-borne markers of bone turnover, P1NP and CTX and vitamin D concentration were assessed. After co-varying for height, weight and baseline bone measurements, the supplemented group displayed greater post-intervention bone properties at the 66% proximal site with cortical content (mgmm) 6.6% greater (p<0.001), cortical area (mm(2)) 5.9% larger (p<0.001), cortical density (mgcm(2)) 1.3% greater (p=0.001), and total area (mm(2)) 4% larger (p=0.003). No other between group differences in bone variables were observed. Blood analysis indicated higher vitamin D levels (18.1%, p=0.014) and lower CTx (ng/L) (-24.8%, p=0.011) in the supplemented group with no differences observed in P1NP. This is the first randomised controlled trial to examine the efficacy of calcium and vitamin D supplementation in improving bone properties in a highly vulnerable, young athletic, weight-restricted population. Results using pQCT indicate beneficial effects of supplementation on bone properties in as little as six months. Although the study size is small, this intervention

  13. Reversal of functional changes in the brain associated with obstructive sleep apnoea following 6 months of CPAP.

    PubMed

    Fatouleh, Rania H; Lundblad, Linda C; Macey, Paul M; McKenzie, David K; Henderson, Luke A; Macefield, Vaughan G

    2015-01-01

    Obstructive sleep apnoea (OSA) is associated with an increase in the number of bursts of muscle sympathetic nerve activity (MSNA), leading to neurogenic hypertension. Continuous positive airway pressure (CPAP) is the most effective and widely used treatment for preventing collapse of the upper airway in OSA. In addition to improving sleep, CPAP decreases daytime MSNA towards control levels. It remains unknown how this restoration of MSNA occurs, in particular whether CPAP treatment results in a simple readjustment in activity of those brain regions responsible for the initial increase in MSNA or whether other brain regions are recruited to over-ride aberrant brain activity. By recording MSNA concurrently with functional Magnetic Resonance Imaging (fMRI), we aimed to assess brain activity associated with each individual subject's patterns of MSNA prior to and following 6 months of CPAP treatment. Spontaneous fluctuations in MSNA were recorded via tungsten microelectrodes inserted into the common peroneal nerve in 13 newly diagnosed patients with OSA before and after 6 months of treatment with CPAP and in 15 healthy control subjects while lying in a 3 T MRI scanner. Blood Oxygen Level Dependent (BOLD) contrast gradient echo, echo-planar images were continuously collected in a 4 s ON, 4 s OFF (200 volumes) sampling protocol. MSNA was significantly elevated in newly diagnosed OSA patients compared to control subjects (55 ± 4 vs 26 ± 2 bursts/min). Fluctuations in BOLD signal intensity in multiple regions covaried with the intensity of the concurrently recorded bursts of MSNA. There was a significant fall in MSNA after 6 months of CPAP (39 ± 2 bursts/min). The reduction in resting MSNA was coupled with significant falls in signal intensity in precuneus bilaterally, the left and right insula, right medial prefrontal cortex, right anterior cingulate cortex, right parahippocampus and the left and right retrosplenial cortices. These data support our contention that

  14. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial

    PubMed Central

    Berton, Linda; Bano, Giulia; Carraro, Sara; Veronese, Nicola; Pizzato, Simona; Bolzetta, Francesco; De Rui, Marina; Valmorbida, Elena; De Ronch, Irene; Perissinotto, Egle; Coin, Alessandra; Manzato, Enzo; Sergi, Giuseppe

    2015-01-01

    Although older people are particularly liable to sarcopenia, limited research is available on beta-hydroxy-beta-methylbutyrate (HMB) supplementation in this population, particularly in healthy subjects. In this parallel-group, randomized, controlled, open-label trial, we aimed to evaluate whether an oral supplement containing 1.5 g of calcium HMB for 8 weeks could improve physical performance and muscle strength parameters in a group of community-dwelling healthy older women. Eighty healthy women attending a twice-weekly mild fitness program were divided into two equal groups of 40, and 32 of the treated women and 33 control completed the study. We considered a change in the Short Physical Performance Battery (SPPB) score as the primary outcome and changes in the peak torque (PT) isometric and isokinetic strength of the lower limbs, 6-minute walking test (6MWT), handgrip strength and endurance as secondary outcomes. Body composition was assessed with dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computerized tomography (pQCT). The mean difference between the two groups on pre-post change were finally calculated (delta) for each outcome. After 8 weeks, there were no significant differences between the groups’ SPPB, handgrip strength or DXA parameters. The group treated with HMB scored significantly better than the control group for PT isokinetic flexion (delta = 1.56±1.56 Nm; p = 0.03) and extension (delta = 3.32±2.61 Nm; p = 0.03), PT isometric strength (delta = 9.74±3.90 Nm; p = 0.02), 6MWT (delta = 7.67±8.29 m; p = 0.04), handgrip endurance (delta = 21.41±16.28 s; p = 0.02), and muscle density assessed with pQCT. No serious adverse effects were reported in either group. In conclusion, a nutritional supplement containing 1.5 g of calcium HMB for 8 weeks in healthy elderly women had no significant effects on SPPB, but did significantly improve several muscle strength and physical performance parameters. Trial Registration Clinical

  15. Safety of Repeated Open-Label Treatment Courses of Intravenous Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, in Rheumatoid Arthritis: Results from Three Clinical Trials

    PubMed Central

    Østergaard, Mikkel; Taylor, Peter C.; van Vollenhoven, Ronald F.; Chu, Myron; Mallett, Stephen; Perry, Hayley; Kurrasch, Regina

    2016-01-01

    Objectives To investigate the safety of ofatumumab retreatment in rheumatoid arthritis. Methods Patients with active rheumatoid arthritis participating in two phase III trials (OFA110635 and OFA110634) and a phase II extension trial (OFA111752) received individualised open-label ofatumumab retreatment (700 mg X 2 intravenous infusions two weeks apart) ≥24 weeks following the first course and ≥16 weeks following further courses. Retreatment required evidence of clinical response followed by disease relapse. These studies were prematurely terminated by the sponsor to refocus development on subcutaneous delivery. Due to differences in study designs and populations, data are summarised separately for each study. Results 483 patients (243, 148 and 92 in OFA110635, OFA110634 and OFA111752 respectively) received up to 7 treatment courses of intravenous ofatumumab; cumulative duration of exposure was 463, 182 and 175 patient-years, respectively. Mean time between courses was 17–47 weeks. Ofatumumab induced a profound depletion of peripheral B-lymphocytes. Retreated patients derived benefit based on improvement in DAS28. Adverse events were reported for 93% (226/243), 91% (134/148) and 76% (70/92), serious adverse events for 18% (44/243), 20% (30/148) and 12% (11/92) and serious infections for 3% (8/243), 5% (7/148) and 1% (1/92) of patients in OFA110635, OFA110634 and OFA111752, respectively. The most common adverse events were infusion-related reactions during the first infusion of the first course (48–79%); serious infusion-related reactions were rare (<1% [1/243], 5% [8/148], and 1% [1/92] of patients). Two deaths occurred (fulminant hepatitis B virus infection and interstitial lung disease). Conclusions Ofatumumab was generally well tolerated with no evidence of increased safety risks with multiple retreatments. Serious infections were uncommon and did not increase over time. Trial Registration ClinicalTrials.gov 110635 ClinicalTrials.gov 110634 Clinical

  16. Improved adherence with PTH(1–84) in an extension trial for 24 months results in enhanced BMD gains in the treatment of postmenopausal women with osteoporosis

    PubMed Central

    Bilezikian, J. P.; Greenspan, S. L.; Wüster, C.; Muñoz-Torres, M.; Bone, H. G.; Rosen, C. J.; Andersen, H. S.; Hanley, D. A.

    2016-01-01

    Summary The purpose of this study is to examine the effect of PTH(1–84) treatment over 24 months followed by 12 months discontinuation on BMD, bone turnover markers, fractures and the impact of adherence on efficacy. Introduction There is limited information about the effect of PTH(1-84) after 18 months and limited data about the impact of compliance on response to anabolic therapy. Methods Seven hundred and eighty-one subjects who received active PTH(1–84) in the Treatment of Osteoporosis with Parathyroid hormone trial for approximately 18 months were entered into a 6-month open-label extension. Thereafter, they were followed for 12 additional months after discontinuation of treatment. Endpoints examined included changes in BMD and biochemical markers. Results PTH(1–84) treatment over 24 months increased BMD at the lumbar spine by 6.8 % above baseline (p < 0.05). The total corresponding BMD increases at the hip and femoral neck were 1.1 and 2.2% above baseline. Larger increases in spine BMD were observed in participants with ≥80 % adherence to daily injections of PTH(1–84) (8.3% in adherent vs 4.9 % in poorly adherent patients). Total hip BMD gains were 1.7 % in adherent vs 0.6 % in poorly adherent participants. Markers of bone turnover (BSAP and NTx) peaked 6 months after starting PTH(1–84) treatment and declined slowly but remained above baseline at 24 months. After discontinuation of PTH(1–84) treatment (at 24 months), bone turnover markers returned to near baseline levels by 30 months. The adherent group sustained significantly fewer fractures than the poorly adherent group. Conclusions PTH(1–84) treatment over 24 months results in continued increases in lumbar spine BMD. Adherence to treatment with PTH(1–84) for up to 24 months is also associated with greater efficacy. PMID:22930240

  17. Limited fine motor and grasping skills in 6-month-old infants at high risk for autism.

    PubMed

    Libertus, Klaus; Sheperd, Kelly A; Ross, Samuel W; Landa, Rebecca J

    2014-01-01

    Atypical motor behaviors are common among children with autism spectrum disorders (ASD). However, little is known about onset and functional implications of differences in early motor development among infants later diagnosed with ASD. Two prospective experiments were conducted to investigate motor skills among 6-month-olds at increased risk (high risk) for ASD (N1  = 129; N2  = 46). Infants were assessed using the Mullen Scales of Early Learning (MSEL) and during toy play. Across both experiments, high-risk infants exhibited less mature object manipulation in a highly structured (MSEL) context and reduced grasping activity in an unstructured (free-play) context than infants with no family history of ASD. Longitudinal assessments suggest that between 6 and 10 months, grasping activity increases in high-risk infants.

  18. Relationships between regulatory temperament dimensions and self-regulatory behaviors at 4 and 6 months of age.

    PubMed

    Aureli, Tiziana; Coppola, Gabrielle; Picconi, Laura; Grazia, Annalisa; Ponzetti, Silvia

    2015-02-01

    The present study focused on relationships between temperament and behavior in early regulation development. Unlike most studies on the topic, we observed infant behavior in a naturalistic playful situation rather than in experimental stressful procedure, and employed temperament measures uniquely reflecting regulatory dispositions rather than a global measure of reactivity. The infant's self-regulatory behaviors were observed at 4 and 6 months during face-to-face interactions and regulatory dimensions were assessed at 4 months. We found that low intensity pleasure and soothability dimensions, related to the infant physical and social experience, respectively, significantly affected regulatory behavior and their influence showed to depend on the infant's age, with the former dimension being influential at the earlier age and the latter being influential when the behavior was observed at the later age. Results are interpreted on the light of a dynamic view of regulation development.

  19. Stability and transitions in mother-infant face-to-face communication during the first 6 months: a microhistorical approach.

    PubMed

    Hsu, Hui-Chin; Fogel, Alan

    2003-11-01

    In this study the authors attempted to unravel the relational, dynamical, and historical nature of mother-infant communication during the first 6 months. Thirteen mothers and their infants were videotaped weekly from 4 to 24 weeks during face-to-face interactions. Three distinct patterns of mother-infant communication were identified: symmetrical, asymmetrical, and unilateral. Guided by a dynamic systems perspective, the authors explored the stability of and transitions between these communication patterns. Findings from event history analysis showed that (a) there are regularly recurring dyadic communication patterns in early infancy, (b) these recurring patterns show differential stabilities and likelihoods of transitions, (c) dynamic stability in dyadic communication is shaped not only by individual characteristics (e.g., infant sex and maternal parity) but also by the dyad's communication history, and (d) depending on their recency, communication histories varying in temporal proximity exert differential effects on the self-organization processes of a dyadic system. PMID:14584985

  20. Cortisol Reactivity, Maternal Sensitivity, and Infant Preference for Mother's Familiar Face and Rhyme in 6-Month-Old Infants

    PubMed Central

    Thompson, Laura A.; Trevathan, Wenda R.

    2009-01-01

    This study investigated how cortisol (stress) reactivity and mothers' behavioral sensitivity affect familiarity preferences in 6-month-old infants. Relations between sensitivity and stress were explored using saliva samples taken from mothers and infants before, and 20-min after, two preferential looking experiments. Photographs and voice recordings from infants' mothers were incorporated into standard visual preference tasks. Sensitivity was assessed by determining the degree of behavioral synchrony between mother and infant from a 10-min interaction period preceding the preferential looking experiments. Results showed that decreasing infant cortisol reactivity and greater maternal sensitivity were associated with familiarity preferences for mother's face stimuli. For the experiment with voice stimuli, a sex difference was obtained in the relationship between the directionality of cortisol reactivity and familiarity preferences. Results are related to a parallel study with 3-month-old infants (Thompson & Trevathan, 2008), and issues are discussed in terms of infants' developing emotional independence from mother. PMID:20046939

  1. Emotional Experiences Predict the Conversion of Individuals with Attenuated Psychosis Syndrome to Psychosis: A 6-Month Follow up Study

    PubMed Central

    Chen, Fa Zhan; Wang, Yi; Sun, Xi Rong; Yao, Yu Hong; Zhang, Ning; Qiao, Hui Fen; Zhang, Lan; Li, Zhan Jiang; Lin, Hong; Lu, Zheng; Li, Jing; Chan, Raymond C. K.; Zhao, Xu Dong

    2016-01-01

    The present study explored the conversion rate in individuals with Attenuated Psychosis Syndrome (APS) and potential predictor for transition in mainland China. Sixty-three participants identified as APS were followed up 6 months later. The results showed that 17% of individuals with APS converted to full-blown psychosis. The converters exhibited significantly poorer emotional experience and expression than the non-converters at baseline. A further binary logistic regression analysis showed that emotional experience could predict the transition (Wald = 4.18, p = 0.041, 95% CI = 1.04~6.82). The present study suggests an important role of emotional processing in the prediction of the development of full-blown psychosis. PMID:27313553

  2. Immunoglobulin G2 deficiency with transient hypogammaglobulinemia and chronic respiratory disease in a 6-month-old Holstein heifer.

    PubMed

    Francoz, David; Lapointe, Jean-Martin; Wellemans, Vincent; Desrochers, André; Caswell, Jeff L; Stott, Jeff L; Dubreuil, Pascal

    2004-09-01

    A 6-month-old Holstein heifer that was nonresponsive to medical treatment was evaluated for chronic respiratory disease. Complete blood count and serum chemistry revealed neutrophilic leukocytosis and low globulin levels. Assays for bovine leukemia virus, bovine virus diarrhea, and bovine leukocyte adhesion deficiency were negative. Serum globulin subclass assays revealed transient low concentrations of immunoglobulin (Ig) G1 and IgA, persistent low IgG2, and subnormal IgM. Vaccination with 2 doses of multiple, inactived viruses induced seroconversion for most viruses. Flow cytometric analysis of blood lymphocyte subpopulation demonstrated an increase in CD5+ B-cells. Blood lymphocyte proliferation and neutrophil function tests were normal. Results of immunologic assays indicated IgG2 deficiency with transient hypogammaglobulinemia. PMID:15460327

  3. The Rhythmic, Sonorous and Melodic Components of Adult-Child-Object Interactions Between 2 and 6 Months Old.

    PubMed

    Moreno-Núñez, Ana; Rodríguez, Cintia; Del Olmo, María Jesús

    2015-12-01

    Adults mediate the relationship between material reality and children, according to functional units of cultural relevance. This paper explores early development of semiotic systems in infants, analyzing rhythmic, sonorous and melodic components, which enable adult-child interaction with and about objects. The triads (with sonorous and non-sonorous objects) was studied longitudinally at age 2, 4 and 6 months. We propose that rhythmic, sonorous and melodic components conformed one of the basic semiotic systems upon the adult's action relies (through gestures and uses of objects) in order to segment and organize objects in the world. Likewise, children actively respond to these presentations and seek sounds for themselves when they are able to interact with the object more autonomously. PMID:25715826

  4. The Rhythmic, Sonorous and Melodic Components of Adult-Child-Object Interactions Between 2 and 6 Months Old.

    PubMed

    Moreno-Núñez, Ana; Rodríguez, Cintia; Del Olmo, María Jesús

    2015-12-01

    Adults mediate the relationship between material reality and children, according to functional units of cultural relevance. This paper explores early development of semiotic systems in infants, analyzing rhythmic, sonorous and melodic components, which enable adult-child interaction with and about objects. The triads (with sonorous and non-sonorous objects) was studied longitudinally at age 2, 4 and 6 months. We propose that rhythmic, sonorous and melodic components conformed one of the basic semiotic systems upon the adult's action relies (through gestures and uses of objects) in order to segment and organize objects in the world. Likewise, children actively respond to these presentations and seek sounds for themselves when they are able to interact with the object more autonomously.

  5. Remineralization of demineralized bone matrix in critical size cranial defects in rats: A 6-month follow-up study.

    PubMed

    Horváthy, Dénes B; Vácz, Gabriella; Toró, Ildikó; Szabó, Tamás; May, Zoltán; Duarte, Miguel; Hornyák, István; Szabó, Bence T; Dobó-Nagy, Csaba; Doros, Attila; Lacza, Zsombor

    2016-10-01

    The key drawback of using demineralized bone matrix (DBM) is its low initial mechanical stability due to the severe depletion of mineral content. In the present study, we investigated the long-term regeneration of DBM in a critical size bone defect model and investigated the remineralization after 6 months. Bone defects were created in the cranium of male Wistar rats which were filled with DBM or left empty as negative control. In vivo bone formation was monitored with computed tomography after 11, 19, and 26 weeks postoperatively. After 6 months, parietal bones were subjected to micro-CT. Mineral content was determined with spectrophotometric analysis. After 11 weeks the DBM-filled bone defects were completely closed, while empty defects were still open. Density of the DBM-treated group increased significantly while the controls remained unchanged. Quantitative analysis by micro-CT confirmed the in vivo results, bone volume/tissue volume was significantly lower in the controls than in the DBM group. The demineralization procedure depleted the key minerals of the bone to a very low level. Six months after implantation Ca, P, Na, Mg, Zn, and Cr contents were completely restored to the normal level, while K, Sr, and Mn were only partially restored. The remineralization process of DBM is largely complete by the 6th month after implantation in terms of bone density, structure, and key mineral levels. Although DBM does not provide sufficient sources for any of these minerals, it induces a faster and more complete regeneration process. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1336-1342, 2016.

  6. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial

    PubMed Central

    Dondorp, Arjen M; Fanello, Caterina I; Hendriksen, Ilse CE; Gomes, Ermelinda; Seni, Amir; Chhaganlal, Kajal D; Bojang, Kalifa; Olaosebikan, Rasaq; Anunobi, Nkechinyere; Maitland, Kathryn; Kivaya, Esther; Agbenyega, Tsiri; Nguah, Samuel Blay; Evans, Jennifer; Gesase, Samwel; Kahabuka, Catherine; Mtove, George; Nadjm, Behzad; Deen, Jacqueline; Mwanga-Amumpaire, Juliet; Nansumba, Margaret; Karema, Corine; Umulisa, Noella; Uwimana, Aline; Mokuolu, Olugbenga A; Adedoyin, Olanrewaju T; Johnson, Wahab BR; Tshefu, Antoinette K; Onyamboko, Marie A; Sakulthaew, Tharisara; Ngum, Wirichada Pan; Silamut, Kamolrat; Stepniewska, Kasia; Woodrow, Charles J; Bethell, Delia; Wills, Bridget; Oneko, Martina; Peto, Tim E; von Seidlein, Lorenz; Day, Nicholas PJ; White, Nicholas J

    2010-01-01

    Summary Background Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa. Quinine is still the established treatment of choice, although evidence from Asia suggests that artesunate is associated with a lower mortality. We compared parenteral treatment with either artesunate or quinine in African children with severe malaria. Methods This open-label, randomised trial was undertaken in 11 centres in nine African countries. Children (<15 years) with severe falciparum malaria were randomly assigned to parenteral artesunate or parenteral quinine. Randomisation was in blocks of 20, with study numbers corresponding to treatment allocations kept inside opaque sealed paper envelopes. The trial was open label at each site, and none of the investigators or trialists, apart from for the trial statistician, had access to the summaries of treatment allocations. The primary outcome measure was in-hospital mortality, analysed by intention to treat. This trial is registered, number ISRCTN50258054. Findings 5425 children were enrolled; 2712 were assigned to artesunate and 2713 to quinine. All patients were analysed for the primary outcome. 230 (8·5%) patients assigned to artesunate treatment died compared with 297 (10·9%) assigned to quinine treatment (odds ratio [OR] stratified for study site 0·75, 95% CI 0·63–0·90; relative reduction 22·5%, 95% CI 8·1–36·9; p=0·0022). Incidence of neurological sequelae did not differ significantly between groups, but the development of coma (65/1832 [3·5%] with artesunate vs 91/1768 [5·1%] with quinine; OR 0·69 95% CI 0·49–0·95; p=0·0231), convulsions (224/2712 [8·3%] vs 273/2713 [10·1%]; OR 0·80, 0·66–0·97; p=0·0199), and deterioration of the coma score (166/2712 [6·1%] vs 208/2713 [7·7%]; OR 0·78, 0·64–0·97; p=0·0245) were all significantly less frequent in artesunate recipients than in quinine recipients. Post

  7. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  8. An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain

    PubMed Central

    Harper, Wayne L; Schmidt, William K; Kubat, Nicole J; Isenberg, Richard A

    2015-01-01

    Persistent pain following back surgery remains a major treatment challenge. The primary objective of this open-label exploratory study was to investigate the analgesic effectiveness of pulsed electromagnetic field therapy administered twice daily over a 45-day period in 34 subjects (68% female) with persistent or recurrent pain following back surgery. A secondary goal was to guide the design of future randomized controlled trials that could target responsive subpopulations. All predefined primary and secondary outcomes, including change in pain intensity (PI), physical function (Oswestry Disability Index), analgesic consumption, and overall well-being (Patient Global Impression of Change), are reported. A responder analysis (≥30% reduction in PI versus baseline) was added as a post hoc evaluation. Safety outcomes, as well as results of a cost-avoidance survey, are also summarized. Of the 30 per-protocol subjects who completed the study, 33% reported a clinically meaningful (≥30%) reduction in PI. A higher response rate (60%) was reported for subjects who had undergone discectomy prior to the trial compared to subjects who had undergone other types of surgical interventions (decompression or fusion) without discectomy. Improvements in PI were paralleled by improvements in secondary outcomes. Relative to baseline, responders reported an average 44% and 55% reduction in back PI and leg PI (respectively), and an average 13% improvement in Oswestry Disability Index scores. In the per-protocol population, 50% of responders and 12% of nonresponders reported less analgesia consumption at the end of treatment versus baseline. Sixty-seven percent of per-protocol responders and 0% of nonresponders reported clinically meaningful improvement in overall well-being on the Patient Global Impression of Change scale. PMID:25678825

  9. An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain.

    PubMed

    Harper, Wayne L; Schmidt, William K; Kubat, Nicole J; Isenberg, Richard A

    2015-01-01

    Persistent pain following back surgery remains a major treatment challenge. The primary objective of this open-label exploratory study was to investigate the analgesic effectiveness of pulsed electromagnetic field therapy administered twice daily over a 45-day period in 34 subjects (68% female) with persistent or recurrent pain following back surgery. A secondary goal was to guide the design of future randomized controlled trials that could target responsive subpopulations. All predefined primary and secondary outcomes, including change in pain intensity (PI), physical function (Oswestry Disability Index), analgesic consumption, and overall well-being (Patient Global Impression of Change), are reported. A responder analysis (≥30% reduction in PI versus baseline) was added as a post hoc evaluation. Safety outcomes, as well as results of a cost-avoidance survey, are also summarized. Of the 30 per-protocol subjects who completed the study, 33% reported a clinically meaningful (≥30%) reduction in PI. A higher response rate (60%) was reported for subjects who had undergone discectomy prior to the trial compared to subjects who had undergone other types of surgical interventions (decompression or fusion) without discectomy. Improvements in PI were paralleled by improvements in secondary outcomes. Relative to baseline, responders reported an average 44% and 55% reduction in back PI and leg PI (respectively), and an average 13% improvement in Oswestry Disability Index scores. In the per-protocol population, 50% of responders and 12% of nonresponders reported less analgesia consumption at the end of treatment versus baseline. Sixty-seven percent of per-protocol responders and 0% of nonresponders reported clinically meaningful improvement in overall well-being on the Patient Global Impression of Change scale.

  10. Effects of probiotic Lactobacillus brevis KB290 on incidence of influenza infection among schoolchildren: an open-label pilot study

    PubMed Central

    Waki, N; Matsumoto, M; Fukui, Y; Suganuma, H

    2014-01-01

    Abstract We investigated the efficacy of dietary consumption of Lactobacillus brevis KB290 (KB290) against influenza in humans by a preliminary intervention study on elementary schoolchildren, using a commercially available probiotic drink. Subjects were divided into Groups A and B, and an open-label, parallel-group trial was conducted in two 8-week periods at a 1-month interval in winter 2013/2014. Group A was provided with a bottle of the test drink containing KB290 (about 6 billion colony-forming units) every school day in the first period and had no treatment in the second period, and vice versa for Group B. Epidemic influenza was not observed during the first period and only two of 1783 subjects were diagnosed. In the second period, the incidence of influenza in Groups A (no treatment) and B (provided the test drink) was 23·9 and 15·7%, respectively, and the difference was statistically significant (P < 0·001). The reduction in the incidence of influenza by KB290 consumption was especially remarkable in unvaccinated individuals. This is believed to be the first study to show a probiotic food reducing the incidence of influenza in schoolchildren, although further studies are needed to confirm the effectiveness of the probiotic strain KB290. Significance and Impact of the Study We demonstrated a reduction in the incidence of influenza in 1089 schoolchildren by continual intake of a probiotic drink containing Lactobacillus brevis KB290 (KB290), isolated from a traditional Japanese pickle ‘Suguki’. The effect was especially evident in subjects not inoculated with influenza vaccine. This is believed to be the first report to show reduced incidence of influenza in schoolchildren taking a probiotic food. Further studies are needed to confirm the effectiveness of the probiotic strain KB290, which may be useful in the development of potential anti-influenza agents derived from common foods. PMID:25294223

  11. An Open Label Comparison of Calfactant and Poractant Alfa Administration Traits and Impact on Neonatal Intensive Care Unit Resources

    PubMed Central

    Gerdes, Jeffrey S.; Seiberlich, William; Sivieri, Emidio M.; Marsh, Wallace; Varner, Dwight L.; Turck, Charles J; York, John M.

    2006-01-01

    OBJECTIVE To compare calfactant (CA) and poractant alfa (PA) administration traits, short-term clinical responses, and resource use in the neonatal respiratory distress syndrome (RDS) setting. METHODS An open label series of 277 (213 PA and 64 CA) infants was evaluated for 445 administrations. Registered respiratory therapists collected patient, surfactant administration, and postadministration clinical data. Economic analysis involved labor costs of surfactant administration and usage, wastage, and product average wholesale price. Analysis utilized the Mann-Whitney rank sum test for differences in administration time and either the chi-square or Fisher's exact test for categorical variables. RESULTS PA had a statistically lower bedside administration time than CA (3.8 minutes vs. 5.3 minutes; P = .006) and a higher percentage of doses administered in less than five minutes (58.9% vs. 4.3%; P < .001). Doses administered per patient were similar (1.67 vs. 1.72). PA and CA were similar in time to recovery (81.4% vs. 74.3%), percent desaturation (24.8% vs. 26.7%), and bradycardia (3.8% vs. 8.5%). Reflux was significantly higher (13.2% vs. 3.5%; P < .001) with CA. Economic analyses found total administration costs per dose were $2.21 for PA and $3.08 for CA. Mean wastage costs were $141.21 for PA and $337.34 for CA (P < .001). CONCLUSIONS PA appeared to utilize fewer neonatal intensive care unit resources than CA due to reduced administration time and less wastage of drug product. Future studies should more closely evaluate time, resource, wastage, and post-administrative clinical effects to fully assess the impact of surfactant products in this setting. PMID:23118647

  12. Eldecalcitol improves muscle strength and dynamic balance in postmenopausal women with osteoporosis: an open-label randomized controlled study.

    PubMed

    Saito, Kimio; Miyakoshi, Naohisa; Matsunaga, Toshiki; Hongo, Michio; Kasukawa, Yuji; Shimada, Yoichi

    2016-09-01

    The antifracture efficacy of vitamin D in osteoporosis is due to its direct action on bones and indirect extraskeletal effects to prevent falls. Eldecalcitol is an analog of active vitamin D3 that improves bone mineral density and reduces the risk of osteoporotic fractures. However, the effects of eldecalcitol on muscle strength and static and dynamic postural balance are unclear. In this open-label randomized controlled study, we assessed the effects of eldecalcitol on muscle strength and static and dynamic postural balance in 50 postmenopausal women (mean age 74 years) with osteoporosis treated with bisphosphonate. Participants were randomly divided into a bisphosphonate group (alendronate at 35 mg/week; n = 25) or an eldecalcitol group (eldecalcitol at 0.75 μg/day and alendronate at 35 mg/week; n = 25) and were followed up for 6 months. Trunk muscle strength, including back extensor strength and iliopsoas muscle strength, was measured. Static standing balance was evaluated and the one leg standing test was performed to assess static postural balance. Dynamic sitting balance was evaluated and the 10-m walk test, functional reach test, and timed up and go test were performed to assess dynamic postural balance. At 6 months, there were no significant changes in any measure of muscle strength or balance in the bisphosphonate group, whereas eldecalcitol significantly increased back extensor strength (p = 0.012) and iliopsoas muscle strength (p = 0.035). Eldecalcitol also significantly improved findings on the timed up and go test (p = 0.001) and dynamic sitting balance (p = 0.015) at 6 months. These results with eldecalcitol may have an impact on prevention of falls.

  13. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis.

    PubMed

    Serpell, Michael G; Notcutt, William; Collin, Christine

    2013-01-01

    Sativex is an endocannabinoid system modulator principally containing Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD). During a 6-week randomised controlled trial, Sativex had a clinically relevant effect on spasticity associated with multiple sclerosis (MS). Patients self-titrated oromucosal Sativex to symptom relief or maximum tolerated dose (maximum of 130 mg THC and 120 mg CBD daily). The primary objective was to evaluate the safety and tolerability of long-term treatment by recording the incidence and severity of adverse events (AEs). Secondary outcomes were to determine evidence of developing tolerance and to assess the long-term dosing profile of Sativex. A validated 11-point Numerical Rating Scale of spasticity severity was used to assess efficacy. A total of 146 patients elected to enter this open-label follow-up safety trial. Mean treatment exposure was 334 days (standard deviation, SD = 209 days), and patients administered on average 7.3 (SD = 4.42) actuations per day. Fifty-two (36 %) patients withdrew from the study in the first year, 14 % due to AEs and 9 % due to lack of efficacy. Most AEs were mild/moderate in severity. Common (>10 %) treatment-related AEs were dizziness (24.7 %) and fatigue (12.3 %). Serious AEs occurred in five patients (3.4 %), with two psychiatric events reported by one patient. No psychoses, psychiatric AE trends, or withdrawal symptoms occurred following abrupt cessation of treatment. Baseline symptoms including spasticity did not deteriorate but were maintained to study completion in those patients who did not withdraw. No new safety concerns were identified with chronic Sativex treatment, and serious AEs were uncommon. There was no evidence of tolerance developing, and patients who remained in the study reported continued benefit. PMID:22878432

  14. Sevoflurane versus propofol sedation during periocular anesthetic injections in oculoplastic procedures: An open-label randomized comparison

    PubMed Central

    Tawfik, Hatem A.; Mostafa, Mohsen

    2014-01-01

    Purpose The purpose of the current investigation was to make an objective controlled comparison of pain tolerance, patient satisfaction and potential complications during the injection of local anesthesia in oculoplastic procedures under short-term sedation using inhalational versus parenteral sedatives. Methods This was an open-label, randomized clinical trial where patients were randomized to 3 groups. Group I: Sedation with intravenous propofol. Group II: Sedation with inhaled sevoflurane. Group 3: Control group receiving no sedation. Results A total of 396 patients were randomly assigned, and 375 were included in the final analysis. Study groups were similar in age, gender, and distribution of operative procedures performed. There was no statistically significant difference in the adjusted primary composite outcome measure between propofol and sevoflurane (pain scores and patient satisfaction). Significantly more patients in group I required restraining during periocular injections than group II or III (p < 0.001). Significantly more patients sneezed in group I than group II (p < 0.001) and none in the control group. Three patients in group II suffered severe excitation–disinhibition during emergence from sedation which was rapidly reversible, and 3 more suffered a severe bout of postoperative nausea and vomiting (PONV). Conclusion Sevoflurane and propofol during periocular anesthetic injections produce an equally favorable experience. Sevoflurane is introduced painlessly, and offers better patient control with less induction of the sneezing reflex which may provide a higher safety profile, however short-term aggression/disinhibition and PONV may be an issue in some patients. PMID:25892931

  15. Safety and efficacy of polycalcium for improving biomarkers of bone metabolism: a 4-week open-label clinical study.

    PubMed

    Choi, Jae-Suk; Park, Mi-Yeon; Kim, Jong-Dae; Cho, Hyung Rae; Choi, In Soon; Kim, Joo-Wan

    2013-03-01

    Polycalcium is a mixture of Polycan and calcium lactate-gluconate 1:9 (w/w) with demonstrated antiosteoporosis activity in vitro and in vivo studies. These studies were a 4-week open-label, single-center trial to evaluate the efficacy of oral Polycalcium on bone metabolism and safety. In total, 30 healthy women (range 40-60 years) were administered 400 mg of Polycalcium for 4 weeks. The primary efficacy parameter was urinary deoxypyridinoline (DPYR) levels, and serum osteocalcin (OSC), bone-specific alkaline phosphatase (BALP), urinary cross-linked C-telopeptide of type-1 collagen (CTx), urinary cross-linked N-telopeptide of type-1 collagen (NTx), calcium (Ca), and phosphorus (P) levels, which were evaluated for comparison before and after administration of Polycalcium. After 4 weeks of Polycalcium administration, 27 subjects completed the test plan. Three subjects withdrew their consent to participate. The values of blood OSC, BALP, serum Ca, and serum P from baseline to 4 weeks of treatment were changed by -28.44%, 14.37%, 6.11%, and 1.42%, respectively. Biomarkers of bone resorption: urinary DPYR, serum CTx, serum NTx, urinary Ca, and urinary P, at baseline after 4 weeks of treatment were changed by -13.40%, 6.67%, -5.13%, -22.43%, and -3.04%, respectively. Additionally, when considering the subjects' adverse effects and the results of the blood and urine tests over the 4-week trial period, the dose of 400  mg Polycalcium showed efficacy for improving bone metabolism and was well tolerated and safe. Polycalcium was apparently safe and efficacious.

  16. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America.

    PubMed

    Nucci, Marcio; Colombo, Arnaldo L; Petti, Marco; Magana, Martin; Abreu, Paula; Schlamm, Haran T; Sanchez, Sonia P

    2014-01-01

    Incidence and mortality of candidaemia/invasive candidiasis (C/IC) is relatively high in Latin America versus North America and Europe. To assess efficacy and safety of intravenous (IV) anidulafungin in Latin American adults with documented C/IC. All patients in this open-label study received initial IV anidulafungin with optional step-down to oral voriconazole after 5 days; total treatment duration was 14-42 days. The primary endpoint was global response (clinical + microbiological response) at end of treatment (EOT); missing/indeterminate responses were failures. The study enrolled 54 patients; 44 had confirmed C/IC within 96 h before study entry and comprised the modified intent-to-treat population. Global response at EOT was 59.1% (95% CI: 44.6, 73.6), with 13 missing/indeterminate assessments. Thirty-day all-cause mortality was 43.1%. Fourteen patients (31.8%) were able to step-down to oral voriconazole; these patients had lower baseline acute physiological assessment and chronic health evaluation (APACHE) II scores and were less likely to have solid tumours or previous abdominal surgery. Anidulafungin was generally well tolerated with few treatment-related adverse events. Anidulafungin was associated with relatively low response rates influenced by a high rate of missing/indeterminate assessments and mortality comparable to other recent candidaemia studies in Latin America. In a subset of patients with lower APACHE II scores, short-course anidulafungin followed by oral voriconazole was successful.

  17. Antithrombotic properties of rafigrelide: a phase 1, open-label, non-randomised, single-sequence, crossover study.

    PubMed

    Balasubramaniam, K; Viswanathan, G; Dragone, J; Grose-Hodge, R; Martin, P; Troy, S; Preston, P; Zaman, A G

    2014-07-01

    Platelets play a central role in atherothrombotic events. We investigated the effect of a novel platelet-lowering agent, rafigrelide, on thrombus formation and characteristics. In this phase 1, open-label, non-randomised, single-sequence, crossover study, healthy male volunteers received rafigrelide for 14 days (Period 1). Following a ≥6-week washout period, they then received rafigrelide + acetylsalicylic acid (ASA) for 14 days (Period 2). Thrombus formation was assessed ex vivo using the Badimon perfusion chamber, and thrombus characteristics were assessed using thromboelastography. A total of 15 volunteers were enrolled in the study and were assigned to Panel A or Panel B, which had different schedules of assessments. In Panel A, after treatment with rafigrelide alone (Period 1), mean (± standard deviation) platelet count was reduced from 283 (± 17) × 10⁹/l at Day 1, to 125 (± 47) × 10⁹/l at Day 14 (n=6) and thrombus area reduced under high and low shear conditions. Reductions in thrombus area under high shear conditions correlated with reductions in platelet count (r²=0.11, p=0.022; n=12). Rafigrelide treatment prolonged clot formation time and reduced clot strength. The addition of ASA to rafigrelide (Period 2) had no additional effect on platelet count or thrombus area under high or low shear conditions. Similar results were seen in Panel B for all parameters. The most common adverse events (≥3 participants per period) were thrombocytopenia and headache. While confirming the platelet-lowering effects of rafigrelide, this early phase study also indicates that rafigrelide has antithrombotic properties under both high and low shear conditions. PMID:24553755

  18. Influence of Two Colloidal Extracorporeal Primes on Coagulation of Cardiac Surgical Patients: A Prospectively Randomized Open-Label Pilot Trial.

    PubMed

    Bethlehem, Irene; Wierda, Korry; Visser, Cornelis; Jekel, Lilian; Koopmans, Matty; Kuiper, Michael A

    2014-12-01

    The search for the ideal priming fluid continues as more evidence is discovered about side effects of volume expanders. With the availability of modern, balanced hydroxyethyl starch (HES) solutions with less side effects than former HES solutions, we considered to replace our gelatin- (modified gelatin) based extracorporeal circuit prime for a HES (130/.42) prime. Therefore, we studied the influence of two colloidal priming fluids on postoperative coagulation in patients undergoing cardiac surgery. The primary endpoint was to compare clot formation time between the HES group and the gelatin group with rotational thromboelastometry (ROTEM). Additionally we compared colloid osmotic pressure and fluid balance of both groups. Forty patients, undergoing elective first time coronary artery bypass grafting or single-valve surgery, were included in this prospectively randomized open-label pilot study. Laboratory data and ROTEM data were collected and analyzed for differences between the two groups. ROTEM data show significantly more prolongation in Extem clot formation time and significant more decrease in Extem alpha in the HES group. Fibtem maximum clot firmness was significantly smaller in the HES group; this was consistent with fibrinogen concentration measurement, which decreased more in the HES group than in the gelatin group and recovered more over time in the gelatin group. We found no significant difference in colloid. osmotic pressure between the groups. In this trial, HES (130/.42) impairs coagulation significantly more compared with gelatin. These differences in influence on coagulation did not lead to a difference in blood loss or fluid balance, so clinical relevance could not be proven. PMID:26357798

  19. A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex

    PubMed Central

    Myers, Stephen P; O’Connor, Joan; Fitton, J Helen; Brooks, Lyndon; Rolfe, Margaret; Connellan, Paul; Wohlmuth, Hans; Cheras, Phil A; Morris, Carol

    2011-01-01

    Background: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study. Methods: Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity. Results: The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes. Conclusion: The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration. PMID:21383915

  20. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    PubMed Central

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  1. Maternal Nutrition and Glycaemic Index during Pregnancy Impacts on Offspring Adiposity at 6 Months of Age—Analysis from the ROLO Randomised Controlled Trial

    PubMed Central

    Horan, Mary K.; McGowan, Ciara A.; Gibney, Eileen R.; Byrne, Jacinta; Donnelly, Jean M.; McAuliffe, Fionnuala M.

    2016-01-01

    Childhood obesity is associated with increased risk of adult obesity and metabolic disease. Diet and lifestyle in pregnancy influence fetal programming; however the influence of specific dietary components, including low glycaemic index (GI), remains complex. We examined the effect of a maternal low GI dietary intervention on offspring adiposity at 6 months and explored the association between diet and lifestyle factors in pregnancy and infant body composition at 6 months. 280 6-month old infant and mother pairs from the control (n = 142) and intervention group (n = 138), who received low GI dietary advice in pregnancy, in the ROLO study were analysed. Questionnaires (food diaries and lifestyle) were completed during pregnancy, followed by maternal lifestyle and infant feeding questionnaires at 6 months postpartum. Maternal anthropometry was measured throughout pregnancy and at 6 months post-delivery, along with infant anthropometry. No difference was found in 6 months infant adiposity between control and intervention groups. Maternal trimester three GI, trimester two saturated fats and trimester one and three sodium intake were positively associated with offspring adiposity, while trimester two and three vitamin C intake was negatively associated. In conclusion associations were observed between maternal dietary intake and GI during pregnancy and offspring adiposity at 6 months of age. PMID:26742066

  2. Maternal Nutrition and Glycaemic Index during Pregnancy Impacts on Offspring Adiposity at 6 Months of Age--Analysis from the ROLO Randomised Controlled Trial.

    PubMed

    Horan, Mary K; McGowan, Ciara A; Gibney, Eileen R; Byrne, Jacinta; Donnelly, Jean M; McAuliffe, Fionnuala M

    2016-01-04

    Childhood obesity is associated with increased risk of adult obesity and metabolic disease. Diet and lifestyle in pregnancy influence fetal programming; however the influence of specific dietary components, including low glycaemic index (GI), remains complex. We examined the effect of a maternal low GI dietary intervention on offspring adiposity at 6 months and explored the association between diet and lifestyle factors in pregnancy and infant body composition at 6 months. 280 6-month old infant and mother pairs from the control (n = 142) and intervention group (n = 138), who received low GI dietary advice in pregnancy, in the ROLO study were analysed. Questionnaires (food diaries and lifestyle) were completed during pregnancy, followed by maternal lifestyle and infant feeding questionnaires at 6 months postpartum. Maternal anthropometry was measured throughout pregnancy and at 6 months post-delivery, along with infant anthropometry. No difference was found in 6 months infant adiposity between control and intervention groups. Maternal trimester three GI, trimester two saturated fats and trimester one and three sodium intake were positively associated with offspring adiposity, while trimester two and three vitamin C intake was negatively associated. In conclusion associations were observed between maternal dietary intake and GI during pregnancy and offspring adiposity at 6 months of age.

  3. A prospective randomized longitudinal study involving 6 months of endurance or resistance exercise. Conduit artery adaptation in humans

    PubMed Central

    Spence, Angela L; Carter, Howard H; Naylor, Louise H; Green, Daniel J

    2013-01-01

    This randomized trial evaluated the impact of different exercise training modalities on the function and size of conduit arteries in healthy volunteers. Young (27 ± 5 years) healthy male subjects were randomized to undertake 6 months of either endurance training (ET; n= 10) or resistance training (RT; n= 13). High-resolution ultrasound was used to determine brachial, femoral and carotid artery diameter and wall thickness (IMT) and femoral and brachial flow-mediated dilatation (FMD) and glyceryl trinitrate (GTN)-mediated dilatation. Improvements in peak oxygen uptake occurred with ET (from 3.6 ± 0.7 to 3.8 ± 0.6 l min−1, P= 0.024) but not RT. Upper body muscular strength increased following RT (from 57.8 ± 17.7 to 69.0 ± 19.5 kg, P < 0.001), but not ET. Both groups exhibited increases in lean body mass (ΔET, 1.4 ± 1.8 kg and ΔRT, 2.3 ± 1.3 kg, P < 0.05). Resistance training increased brachial artery resting diameter (from 3.8 ± 0.5 to 4.1 ± 0.4 mm, P < 0.05), peak FMD diameter (+0.2 ± 0.2 mm, P < 0.05) and GTN-mediated diameter (+0.3 ± 0.3 mm, P < 0.01), as well as brachial FMD (from 5.1 ± 2.2 to 7.0 ± 3.9%, P < 0.05). No improvements in any brachial parameters were observed following ET. Conversely, ET increased femoral artery resting diameter (from 6.2 ± 0.7 to 6.4 ± 0.6 mm, P < 0.05), peak FMD diameter (+0.4 ± 0.4 mm, P < 0.05) and GTN-induced diameter (+0.3 ± 0.3 mm, P < 0.05), as well as femoral FMD-to-GTN ratio (from 0.6 ± 0.3 to 1.1 ± 0.8, P < 0.05). Resistance training did not induce changes in femoral artery parameters. Carotid artery IMT decreased in response to both forms of training. These findings indicate that 6 months of supervised exercise training induced changes in brachial and femoral artery size and function and decreased carotid artery IMT. These impacts of both RT and ET would be expected to translate to decreased cardiovascular risk. PMID:23247114

  4. Safety, Tolerability, and Efficacy of Quetiapine in Youth with Schizophrenia or Bipolar I Disorder: A 26-Week, Open-Label, Continuation Study

    PubMed Central

    Pathak, Sanjeev; Earley, Willie R.; Liu, Sherry; DelBello, Melissa

    2013-01-01

    Abstract Objective The purpose of this study was to describe the safety, tolerability, and efficacy of quetiapine monotherapy continued for up to 26-weeks in youth with schizophrenia or bipolar I disorder. Methods Medically healthy boys and girls with a baseline Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV-TR) diagnosis of schizophrenia (ages 13–17 years) or a manic episode of bipolar I disorder (ages 10–17 years) who participated in one of two acute, double-blind, placebo-controlled studies of immediate-release quetiapine were potentially eligible to enroll in a 26-week, open-label study. During the open-label study, quetiapine was flexibly dosed at 400–800 mg/day, with options to reduce dosing to 200 mg/day based on tolerability. Safety and tolerability outcomes assessed from open-label baseline to week 26 included adverse events (AEs), metabolic/laboratory parameters, extrapyramidal symptoms, suicidality, and vital signs. Results Of 381 patients enrolled in the open-label study (n=176, schizophrenia; n=205, bipolar disorder diagnosis), 237 patients (62.2%) completed the 26-week study period (71.0%, schizophrenia; 54.6%, bipolar disorder). The most common AEs reported during the study included somnolence, headache, sedation, weight increase, and vomiting. A total of 14.9% of patients experienced a shift to potentially clinically significant low levels of high-density lipoprotein cholesterol and 10.2% of patients experienced a shift to potentially clinically significant high triglyceride levels. Weight gain ≥7% was reported in 35.6% of patients between open-label baseline and final visit. After adjustment for normal growth, 18.3% of study participants experienced clinically significant weight gain (i.e., increase in body mass index ≥0.5 standard deviations from baseline). Conclusions In this 26-week study, quetiapine flexibly dosed at 400–800 mg/day, with options to reduce dosing based on tolerability, was generally safe

  5. [The morphofunctional cellular evaluation of liver and kidney in rats in dynamics of 6-month consumption of water produced with the use of noncontact activation after electrochemical treatment].

    PubMed

    Beliaeva, N N; Rakhmanin, Iu A; Mikhailova, R I; Savostikova, O N; Gasimova, Z M; Kamenetskaia, D B; Alekseeva, A V; Vasina, D A; Ryzhova, I N

    2015-01-01

    There were investigated morphofunctional indices of liver and kidney in male outbred rats in the dynamics of the 6-months consumption of water after its noncontact activation. There were studied 4 experimental groups of animals consumed waters named as "Anolyte" and in dependence on the activation time, 3 types of catholyte water ("Catholyte--5", "Catholyte--25", "Catholyte--40"). Moscow tap water settled for a week served as control. "Anolyte" water was found to increase in the kidney the number of hypertrophied gromeruli only in 6 months, while the consumption of "Catholyte--25" water and especially, "Catholyte--40" in 1 and 6 months caused the damage of liver and kidney, and for the index of alteration of renal glomeruli after 6 months of water consumption there was revealed the dependence on the activation time of "Catalytes".

  6. Prevalence of Corneal Astigmatism in Tohono O'odham Native American Children 6 Months to 8 Years of Age

    PubMed Central

    Dobson, Velma; Miller, Joseph M.; Schwiegerling, Jim; Clifford-Donaldson, Candice E.; Green, Tina K.; Messer, Dawn H.

    2011-01-01

    Purpose. To describe the prevalence of corneal astigmatism in infants and young children who are members of a Native American tribe with a high prevalence of refractive astigmatism. Methods. The prevalence of corneal astigmatism was assessed by obtaining infant keratometer (IK4) measurements from 1235 Tohono O'odham children, aged 6 months to 8 years. Results. The prevalence of corneal astigmatism >2.00 D was lower in the 1- to <2-year-old age group when compared with all other age groups, except the 6- to <7-year-old group. The magnitude of mean corneal astigmatism was significantly lower in the 1- to <2-year age group than in the 5- to <6-, 6- to <7-, and 7- to <8-year age groups. Corneal astigmatism was with-the-rule (WTR) in 91.4% of astigmatic children (≥1.00 D). Conclusions. The prevalence and mean amount of corneal astigmatism were higher than reported in non–Native American populations. Mean astigmatism increased from 1.43 D in 1-year-olds to nearly 2.00 D by school age. PMID:21460261

  7. No harmful effect of different Coca-cola beverages after 6 months of intake on rat testes.

    PubMed

    Tóthová, Lubomíra; Hodosy, Július; Mettenburg, Kathryn; Fábryová, Helena; Wagnerová, Alexandra; Bábíčková, Janka; Okuliarová, Monika; Zeman, Michal; Celec, Peter

    2013-12-01

    Our laboratory recently reported that a 3-month exposure of rats to cola-like beverages induced sex hormone changes. The aim of the study was to investigate the effects of various types of Coca-cola intake with different composition for 6 months on oxidative status in testes and testosterone in adult male rats. Fifty adult male Wistar rats were divided into control group drinking water, and groups drinking different Coca-cola beverages (regular Coca-cola, Coca-cola caffeine-free, Coca-cola Light and Coca-cola Zero). Oxidative and carbonyl stress markers were measured in the testicular tissue to assess oxidative status together with testicular and plasma testosterone. StAR expression in testes as a marker of steroidogenesis was quantified. No significant differences were found between the groups in any of the measured parameters. In conclusion, oxidative and carbonyl stress in testicular tissue were not influenced by drinking any type of Coca-cola. Additionally, testosterone in testes and in plasma, as well as testicular StAR expression were comparable among the groups.

  8. Manual exploration of consistency (soft vs hard) and handedness in infants from 4 to 6 months old.

    PubMed

    Morange-Majoux, Francoise

    2011-05-01

    In infants the developmental course of haptic perception is constrained by the development of attention to object properties and of the ability to execute various movements with the hands. The purpose of this study is to consider how infants, aged 4 to 6 months, become able to use their hands to assess qualities of objects such as consistency (softness vs hardness). The object that the infants explored was a cylinder, divided into four equal parts that were alternately hard and soft. It was tactually heterogeneous but visually homogeneous. Two aspects of exploration according to age, hand used, and consistency touched were considered: (1) the mode of exploration, contact, pressure, and tapping; and (2) the means of exploration, whole hand or fingers. The results show that infants adjust their movements to the quality of the object they are testing. That is, the infant varies the distribution of investigative and manipulative behaviours according to the nature of the specific object being explored. Pressure movements were the predominant exploratory procedures used for the soft parts, whereas passive contacts were the predominant movements for the hard parts. Concerning manual laterality, the results show that the left hand is used for touching objects (passive contact) more than the right one, whereas the right hand is used to press the soft parts and tap the hard parts more than the left hand.

  9. Predicting mothers' decisions to introduce complementary feeding at 6 months. An investigation using an extended theory of planned behaviour.

    PubMed

    Hamilton, Kyra; Daniels, Lynne; White, Katherine M; Murray, Nicole; Walsh, Anne

    2011-06-01

    In Australia and other developed countries there is poor adherence to guidelines recommending the introduction of complementary feeding to infants at 6 months of age. We aimed to investigate, via adopting a theory of planned behaviour framework and incorporating additional normative and demographic influences, mothers' complementary feeding intentions and behaviour. Participants were 375 primiparas who completed an initial questionnaire (infant age 13±3 weeks) that assessed the theory of planned behaviour constructs of attitude, subjective norm, and perceived behavioural control, as well as group norm and additional maternal and infant variables of mothers' age, education level, weight status perception, current maternal feeding practices, and infant birth weight. Approximately, 3 months after completion of the main questionnaire, mothers completed a follow-up questionnaire that assessed the age in months at which the infant was first introduced to solids. The theory of planned behaviour variables of attitude and subjective norm, along with group norm, predicted intentions, with intention, mothers' age (older more likely), and weight status perception (overweight less likely) predicting behaviour. Overall, the results highlight the importance of attitudes, normative influences, and individual characteristics in complementary feeding decision-making which should be considered when designing interventions aimed at improving adherence to current maternal feeding guidelines.

  10. A Comparison of Endothelial Cell Loss in Combined Cataract and MIGS (Hydrus) Procedure to Phacoemulsification Alone: 6-Month Results

    PubMed Central

    Fea, Antonio M.; Consolandi, Giulia; Pignata, Giulia; Cannizzo, Paola Maria Loredana; Lavia, Carlo; Billia, Filippo; Rolle, Teresa; Grignolo, Federico M.

    2015-01-01

    Purpose. To compare the corneal endothelial cell loss after phacoemulsification, alone or combined with microinvasive glaucoma surgery (MIGS), in nonglaucomatous versus primary open angle glaucoma (POAG) eyes affected by age-related cataract. Methods. 62 eyes of 62 patients were divided into group 1 (n = 25, affected by age-related cataract) and group 2 (n = 37, affected by age-related cataract and POAG). All patients underwent cataract surgery. Group 2 was divided into subgroups A (n = 19, cataract surgery alone) and B (n = 18, cataract surgery and MIGS). Prior to and 6 months after surgery the patients' endothelium was studied. Main outcomes were CD (cell density), SD (standard deviation), CV (coefficient of variation), and 6A (hexagonality coefficient) variations after surgeries. Results. There were no significant differences among the groups concerning preoperative endothelial parameters. The differences in CD before and after surgery were significant in all groups: 9.1% in group 1, 17.24% in group 2A, and 11.71% in group 2B. All endothelial parameters did not significantly change after surgery. Conclusions. Phacoemulsification determined a loss of endothelial cells in all groups. After surgery the change in endothelial parameters after MIGS was comparable to the ones of patients who underwent cataract surgery alone. PMID:26664740

  11. Chronic Uterine Inversion Presenting as a Painless Vaginal Mass at 6 Months Post Partum: A Case Report.

    PubMed

    Ali, Eram; Kumar, Manisha

    2016-05-01

    Uterine inversion is an abnormal protrusion of internal surface of relaxed uterus through the vaginal orifice. Its causes can be broadly classified as puerperal and non-puerperal with puerperal uterine inversion more common than non-puerperal uterine inversion. Acute inversions occurring immediately, or within 24 hours post-partum are the most common type. Chronic Uterine Inversions (CUI) occurring more than four weeks after the delivery are rare identities. There differential diagnosis includes prolapsed fibroids and endometrial polyp. Chronic nature of these inversions makes the restoration of the normal position of the uterus per vaginal difficult contrary to acute inversions which can be reposited more easily. We hereby present a case of 28-year-old lady who presented with a painless vaginal mass at 6 months post-partum. She was diagnosed as a case of CUI based on clinical and sonographic examination. Inverted uterus was successfully restored through per abdominal approach. The presentation of CUI as a painless vaginal mass at delayed post-partum period is rare and therefore reported. PMID:27437313

  12. Chronic Uterine Inversion Presenting as a Painless Vaginal Mass at 6 Months Post Partum: A Case Report

    PubMed Central

    Kumar, Manisha

    2016-01-01

    Uterine inversion is an abnormal protrusion of internal surface of relaxed uterus through the vaginal orifice. Its causes can be broadly classified as puerperal and non-puerperal with puerperal uterine inversion more common than non-puerperal uterine inversion. Acute inversions occurring immediately, or within 24 hours post-partum are the most common type. Chronic Uterine Inversions (CUI) occurring more than four weeks after the delivery are rare identities. There differential diagnosis includes prolapsed fibroids and endometrial polyp. Chronic nature of these inversions makes the restoration of the normal position of the uterus per vaginal difficult contrary to acute inversions which can be reposited more easily. We hereby present a case of 28-year-old lady who presented with a painless vaginal mass at 6 months post-partum. She was diagnosed as a case of CUI based on clinical and sonographic examination. Inverted uterus was successfully restored through per abdominal approach. The presentation of CUI as a painless vaginal mass at delayed post-partum period is rare and therefore reported. PMID:27437313

  13. Risks and realities: dyadic interaction between 6-month-old infants and their mothers in opioid maintenance treatment.

    PubMed

    Sarfi, Monica; Smith, Lars; Waal, Helge; Sundet, Jon Martin

    2011-12-01

    A number of studies point to methadone exposure in utero as a possible risk factor in the developing mother-infant relationship in the first year of life. This study is part of a larger, national follow-up of 38 infants prenatally exposed to methadone or buprenorphine and 36 comparison, low-risk infants. The aim of the present paper is to assess the quality of mother-infant relationship when the infants are 6 months old. Videotaped mother-infant interactions were rated in a global scale (NICHD). Maternal and infant contributions collapsed into the variables "infant style" and "maternal style" showed that the only factor making significant contribution to the outcome measure "dyadic mutuality" was maternal style. The importance of group membership (exposed versus non-exposed), was reduced when controlling for maternal drug use prior to opioid maintenance treatment (OMT), maternal depression and parenting stress as well as infants' developmental status and sensory-integrative functions. This suggests that prediction of dyadic mutuality should be based on individual characteristics rather than group characteristics. These results support previous research findings that methadone and buprenorphine use per se does not have direct influence on the quality of early mother-infant relationship, but tailored follow-up procedures targeting drug-free pregnancies and parenting support are beneficial for women in OMT and their children.

  14. A Comparison of Endothelial Cell Loss in Combined Cataract and MIGS (Hydrus) Procedure to Phacoemulsification Alone: 6-Month Results.

    PubMed

    Fea, Antonio M; Consolandi, Giulia; Pignata, Giulia; Cannizzo, Paola Maria Loredana; Lavia, Carlo; Billia, Filippo; Rolle, Teresa; Grignolo, Federico M

    2015-01-01

    Purpose. To compare the corneal endothelial cell loss after phacoemulsification, alone or combined with microinvasive glaucoma surgery (MIGS), in nonglaucomatous versus primary open angle glaucoma (POAG) eyes affected by age-related cataract. Methods. 62 eyes of 62 patients were divided into group 1 (n = 25, affected by age-related cataract) and group 2 (n = 37, affected by age-related cataract and POAG). All patients underwent cataract surgery. Group 2 was divided into subgroups A (n = 19, cataract surgery alone) and B (n = 18, cataract surgery and MIGS). Prior to and 6 months after surgery the patients' endothelium was studied. Main outcomes were CD (cell density), SD (standard deviation), CV (coefficient of variation), and 6A (hexagonality coefficient) variations after surgeries. Results. There were no significant differences among the groups concerning preoperative endothelial parameters. The differences in CD before and after surgery were significant in all groups: 9.1% in group 1, 17.24% in group 2A, and 11.71% in group 2B. All endothelial parameters did not significantly change after surgery. Conclusions. Phacoemulsification determined a loss of endothelial cells in all groups. After surgery the change in endothelial parameters after MIGS was comparable to the ones of patients who underwent cataract surgery alone.

  15. Psychosocial sequelae of the 1989 Newcastle earthquake: I. Community disaster experiences and psychological morbidity 6 months post-disaster.

    PubMed

    Carr, V J; Lewin, T J; Webster, R A; Hazell, P L; Kenardy, J A; Carter, G L

    1995-05-01

    A stratified random sample of 3007 Australian adults completed a screening questionnaire 6 months after the 1989 Newcastle earthquake. Information was obtained on initial earthquake experiences and reactions, use of specific services, social support, coping strategies and psychological morbidity. This questionnaire was the first phase of the Quake Impact Study, a longitudinal project investigating the psychosocial impact of the earthquake. Two weighted indices of exposure were developed: a threat index, which measured exposure to injury or the possibility of injury; and a disruption index, which measured experiences of property damage, displacement and other losses. Levels of exposure to threat and disruption events were significant predictors of morbidity on both the General Health Questionnaire and Impact of Event Scale, as were coping style and gender. Effects of exposure to threat and disruption were largely additive, with higher exposure being associated with greater use of support services, higher perceived stressfulness and more severe psychological morbidity. Use of avoidance as a coping strategy, female gender, lower social support and being older were also associated with higher post-disaster psychological distress. It was estimated that 14.8% of the population was exposed to high levels of threat or disruption, of whom approximately 25% experienced moderate to severe psychological distress as a direct result of the disaster. It was further estimated that 18.3% of those exposed to high levels of threat were at risk of developing post-traumatic stress disorder, representing approximately 2% of the city's adult population.

  16. Impaired word stress pattern discrimination in very-low-birthweight infants during the first 6 months of life.

    PubMed

    Herold, Birgit; Höhle, Barbara; Walch, Elisabeth; Weber, Tanja; Obladen, Michael

    2008-09-01

    Prosodic information, such as word stress and speech rhythm, is important in language acquisition, and sensitivity to stress patterns is present from birth onwards. Exposure to prosodic properties of the native language occurs prenatally. Preterm birth and an associated lack of exposure to prosodic information are suspected to affect language acquisition in preterm infants. Fifty healthy very low birthweight (<1500 g) preterm German infants (24 males, 26 females; mean gestational age [GA] 27.6 wks, range 26.4-29.9) and 103 comparison term infants (48 males, 55 females; mean GA 40 wks, range 39.4-40.8) were recruited. Prosodic discrimination performance was assessed using the head-turn preference paradigm, an objective behavioural psycholinguistic test for measuring orientation time (OT) to auditory stress patterns. Among matched preterm and term infants, preterm infants (n=30) did not differentiate stress patterns at the corrected age of 4 or 6 months. In term infants (n=30), the OT was longer towards the trochaic (stress on first syllable, characteristic for German) than the iambic (second syllable) stress patterns (11.64 vs 9.18s, p<0.001, and 11.02 vs 8.32s, p<0.001, at 4 and 6 mo respectively). Neurodevelopmental scores (Bayley Scales of Infant Development, 2nd edn) were not different from reference values in both groups of infants. Preterm birth and deficient early prosodic information affect prosodic processing during the first half year of life.

  17. Mean Length of Utterance Levels in 6-month Intervals for Children 3 to 9 Years with and without Language Impairments

    PubMed Central

    Rice, Mabel L.; Smolik, Filip; Perpich, Denise; Thompson, Travis; Rytting, Nathan; Blossom, Megan

    2009-01-01

    Purpose The mean length of children’s utterances is a valuable estimate of their early language acquisition. The available normative data lacks documentation of language and nonverbal intelligence levels of the samples. This study reports age-referenced MLU data from children with specific language impairment and children without language impairments. Method 306 child participants were drawn from a data archive, ages 2;6–9;0 years, 170 with SLI and 136 control children. 1564 spontaneous language samples were collected, transcribed and analyzed for sample size and MLU in words and morphemes. Means, standard deviations, and effect sizes for group differences are reported for MLUs, along with concurrent language and nonverbal intelligence assessments, per 6-month intervals. Results The results document an age progression in MLU words and morphemes, and a persistent lower level of performance for children with SLI. Conclusions The results support the reliability and validity of MLU as an index of normative language acquisition and a marker of language impairment. The findings can be used for clinical benchmarking of deficits and language intervention outcomes, as well as comparisons across research samples. PMID:20360460

  18. ISSR and RAPD based evaluation of genetic stability of encapsulated micro shoots of Glycyrrhiza glabra following 6 months of storage.

    PubMed

    Mehrotra, Shakti; Khwaja, O; Kukreja, A K; Rahman, L

    2012-11-01

    In vitro grown axillary micro shoots of Glycyrrhiza glabra were encapsulated in alginate beads. Following 6 months of normal storage at 25 ± 2°C the re growth of encapsulated G. glabra micro shoots, reached 98% within 30 days of incubation on MS medium supplemented with 0.1 mg/l IAA. Re growth was characterized by the development of both shoot and root from single encapsulated micro shoot. Healthy plants were established to glass house with 95% survival. The genetic fidelity of plants obtained after conversion of alginate beads was ascertained through 10 RAPD and 13 ISSR primers. Of the 10 RAPD primers tested, 6 of them produced 14 clear and reproducible amplicons with an average of 2.3 bands per primer out of which 28.57% were polymorphic generated by only two primers. Eight ISSR primers produced total 37 bands ranging between 300 and 3,500 bp length. Number of scorable bands for each primer varied from 3 to 8 with an average of 4.6 bands per primer. Cluster analysis from ISSR and RAPD showed that all the tested plants including the mother plant distributed in two major groups with similarity coefficient ranging from 0.91 to 0.96 for RAPD and 0.89 to 0.97 for ISSR.

  19. Radiocesium concentrations in epigeic earthworms at various distances from the Fukushima Nuclear Power Plant 6 months after the 2011 accident.

    PubMed

    Hasegawa, Motohiro; Ito, Masamichi T; Kaneko, Shinji; Kiyono, Yoshiyuki; Ikeda, Shigeto; Makino, Shun'ichi

    2013-12-01

    We investigated the concentrations of radiocesium in epigeic earthworms, litter, and soil samples collected from forests in Fukushima Prefecture 6 months after the Fukushima Dai-ichi Nuclear Power Plant accident in 2011. Radiocesium concentrations in litter accumulated on the forest floor were higher than those in the soil (0-5 cm depth). The highest average (134+137)Cs concentrations in earthworms (approximately 19 Bq g(-1) of wet weight with gut contents and 108 Bq g(-1) of dry weight without gut contents) were recorded from a plot that experienced an air dose rate of 3.1 μSv h(-1), and earthworm concentrations were found to increase with litter and/or soil concentrations. Average (134)Cs and (137)Cs concentrations (with or without gut contents) were intermediate between accumulated litter and soil. Different species in the same ecological groups on the same plots had similar concentrations because of their use of the same habitats or their similar physiological characteristics. The contribution of global fallout (137)Cs to earthworms with gut contents was calculated to be very low, and most (137)Cs in earthworms was derived from the Fukushima accident. Transfer factors from accumulated litter to earthworms, based on their dry weights, ranged from 0.21 to 0.35, in agreement with previous field studies.

  20. [Treatment of bipolar disorder with lamotrigine -- relapse rate and suicidal behaviour during 6 month follow-up].

    PubMed

    Rihmer, Zoltán; Gonda, Xénia; Kálmán, János

    2015-03-01

    The present paper describes a 8-month prospective, observational, non-intervention multicentric study in 969 bipolar patients, where data were obtained on changes during lamotrigine treatment with special focus rates of relapse, suicidal behaviour and adverse events. 969 patients entered the study and 961 patients (99%) completed the study. Patients received lamotrigine mostly as an add-on treatment in addition to ongoing antidepressant and/or antipsychotic medication. By the end of the six-month treatment period 38% of patients achieved remission and rate of relapse after three months was 24%. Rate of adverse events was very low (1%) and they in no case led o termination of therapy. At baseline 17% of patients had clinically significant suicide risk which gradually decreased to 2.1% during the 6-month study period. No suicide attempt or completed suicide occurred during the study period. Results indicate that lamotrigine is an effective and well-tolerated treatment for the acute and long-term treatment of bipolar patients.

  1. Predominance and persistence of a single clone of Listeria ivanovii in a Manchego cheese factory over 6 months.

    PubMed

    Vázquez-Villanueva, J; Orgaz, B; Ortiz, S; López, V; Martínez-Suárez, J V; SanJose, C

    2010-09-01

    In an attempt to study the diversity and persistence of molecular subtypes of pathogenic Listeria spp. in a cheese factory at the La Mancha region of Spain, 43 samples were taken from incoming raw milk (cow's, ewe's, goat's and mixed species) and from certain food-contact and environmental surfaces before and/or after sanitation. Of these samples, 12 contained pathogenic Listeria. From the chromogenic agar plates corresponding to those, 46 phosphatidylinositol-specific phospholipase C-positive isolates were randomly taken for further analysis, including biochemical tests and pulsed-field gel electrophoresis (PFGE). They coincided in identifying all the 46 as Listeria ivanovii subsp. ivanovii, apparently a single PFGE type. Both ewe's and goat's raw milk batches from asymptomatic animals tested along the 6-month period persistently carried the same strain, which was also obtained from inner surfaces of raw milk truck tanks and the milk dump tank at the cheese factory. Biofilm-forming abilities of this L. ivanovii clone and interference against L. monocytogenes Scott A reference strain were tested, but failed to account for the clone's apparent pervasive presence. PMID:19486491

  2. A 6-month home usage trial of a 1% chlorhexidine toothpaste (1). Effects on plaque, gingivitis, calculus and toothstaining.

    PubMed

    Yates, R; Jenkins, S; Newcombe, R; Wade, W; Moran, J; Addy, M

    1993-02-01

    Research and development has been aimed towards the development of toothpastes for oral hygiene and gingival health benefits. The most effective antiplaque agent to date, chlorhexidine, is difficult to formulate into active toothpaste products. Despite some encouraging findings for experimental chlorhexidine toothpastes, there are to date no commercially available products. Based on positive findings from an experimental gingivitis study, this investigation evaluated 2 chlorhexidine toothpastes, one with fluoride, as adjuncts to oral hygiene. The study was a double-blind controlled, parallel, balanced group design, extending over 6 months. A total of 297 volunteers commenced the study after screening for a minimum acceptance level of gingivitis. At baseline, 6, 12 and 24 weeks, stain, gingival, bleeding and plaque indices were recorded, together with a calculus index at 6, 12 and 24 weeks. After a baseline prophylaxis, volunteers used the allocated product 2 x per day, with no other oral hygiene instructions given. Plaque, gingival and bleeding scores improved in all 3 groups, but to an overall significantly greater extent in the active groups. However, staining and calculus indices were significantly increased in the active compared to the control group. If the local side-effects of chlorhexidine are considered to be acceptable, these chlorhexidine toothpastes could be recommended for the same clinical applications as other chlorhexidine products. The apparent compatibility of fluoride with chlorhexidine in the one product may be pertinent to caries prevention.

  3. Evaluation of lactation support in the workplace or school environment on 6-month breastfeeding outcomes in Yolo County, California.

    PubMed

    Dabritz, Haydee A; Hinton, Bette G; Babb, Jan

    2009-05-01

    Six-month breastfeeding outcomes (almost exclusive breastfeeding, partial breastfeeding, and not breastfeeding) were analyzed for 201 infants born to Yolo County, California, mothers who returned to work or school. Twenty-two percent of workplaces and 17% of schools did not provide a lactation room. Although part- or full-time status, knowledge of breastfeeding rules, and support from colleagues were independently associated with the outcome, they were not significant in the multivariate analysis. In the selected model, maternal age (odds ratio [OR] = 2.3; 1.3-3.9 for a 10-year difference), college or above versus 6 months postpartum. Receipt of discharge gift packs containing formula (OR = 0.5; 0.3-1.0) was inversely associated with the degree of breastfeeding exclusivity. The 2 latter findings underscore the importance of hospitals adhering to specific guidelines of the Baby-Friendly Hospital Initiative. PMID:19088250

  4. Attention to Eyes is Present But in Decline in 2–6 Month-Olds Later Diagnosed with Autism

    PubMed Central

    Jones, Warren; Klin, Ami

    2014-01-01

    Deficits in eye contact have been a hallmark of autism1,2 since the condition’s initial description3. They are cited widely as a diagnostic feature4 and figure prominently in clinical instruments5; however, the early onset of these deficits has not been known. Here we show in a prospective longitudinal study that infants later diagnosed with autism spectrum disorders (ASD) exhibit mean decline in eye fixation within the first 2 to 6 months of life, a pattern not observed in infants who do not develop ASD. These observations mark the earliest known indicators of social disability in infancy, but also falsify a prior hypothesis: in the first months of life, this basic mechanism of social adaptive action—eye looking—is not immediately diminished in infants later diagnosed with ASD; instead, eye looking appears to begin at normative levels prior to decline. The timing of decline highlights a narrow developmental window and reveals the early derailment of processes that would otherwise play a key role in canalizing typical social development. Finally, the observation of this decline in eye fixation—rather than outright absence—offers a promising opportunity for early intervention, one that could build on the apparent preservation of mechanisms subserving reflexive initial orientation towards the eyes. PMID:24196715

  5. Exclusive or Partial Breastfeeding for 6 Months Is Associated With Reduced Milk Sensitization and Risk of Eczema in Early Childhood: The PATCH Birth Cohort Study.

    PubMed

    Chiu, Chih-Yung; Liao, Sui-Ling; Su, Kuan-Wen; Tsai, Ming-Han; Hua, Man-Chin; Lai, Shen-Hao; Chen, Li-Chen; Yao, Tsung-Chieh; Yeh, Kuo-Wei; Huang, Jing-Long

    2016-04-01

    There is insufficient evidence to confirm the association between breastfeeding and allergic outcomes later in life. This study aimed to determine the relationships between different breastfeeding patterns and allergen sensitizations and risk of developing atopic diseases in early childhood. A total of 186 children from a birth cohort in the Prediction of Allergies in Taiwanese Children study for a 4-year follow-up period were enrolled. Total serum immunoglobulin E (IgE) levels and specific IgE antibodies against food and inhalant allergens were measured sequentially at 6 months as well as at 1, 1.5, 2, 3, and 4 years of age. A significantly lower prevalence of milk sensitization was found in children at ages 1 and 1.5 years who were exclusively or partially breastfed for ≥6 months. Breastfeeding ≥6 months was significantly associated with a reduced risk of developing eczema but not allergic rhinitis and asthma at ages 1 and 2 years. Compared with exclusive breastfeeding ≥6 months, partial breastfeeding <6 months was significantly associated with an increased risk of developing eczema at ages 1 and 2 years. As with exclusive breastfeeding, partial breastfeeding for at least 6 months appears to be associated with a reduced prevalence of milk sensitization as well as a reduced risk of developing eczema in early childhood.

  6. Exclusive or Partial Breastfeeding for 6 Months Is Associated With Reduced Milk Sensitization and Risk of Eczema in Early Childhood: The PATCH Birth Cohort Study.

    PubMed

    Chiu, Chih-Yung; Liao, Sui-Ling; Su, Kuan-Wen; Tsai, Ming-Han; Hua, Man-Chin; Lai, Shen-Hao; Chen, Li-Chen; Yao, Tsung-Chieh; Yeh, Kuo-Wei; Huang, Jing-Long

    2016-04-01

    There is insufficient evidence to confirm the association between breastfeeding and allergic outcomes later in life. This study aimed to determine the relationships between different breastfeeding patterns and allergen sensitizations and risk of developing atopic diseases in early childhood. A total of 186 children from a birth cohort in the Prediction of Allergies in Taiwanese Children study for a 4-year follow-up period were enrolled. Total serum immunoglobulin E (IgE) levels and specific IgE antibodies against food and inhalant allergens were measured sequentially at 6 months as well as at 1, 1.5, 2, 3, and 4 years of age. A significantly lower prevalence of milk sensitization was found in children at ages 1 and 1.5 years who were exclusively or partially breastfed for ≥6 months. Breastfeeding ≥6 months was significantly associated with a reduced risk of developing eczema but not allergic rhinitis and asthma at ages 1 and 2 years. Compared with exclusive breastfeeding ≥6 months, partial breastfeeding <6 months was significantly associated with an increased risk of developing eczema at ages 1 and 2 years. As with exclusive breastfeeding, partial breastfeeding for at least 6 months appears to be associated with a reduced prevalence of milk sensitization as well as a reduced risk of developing eczema in early childhood. PMID:27082611

  7. A combined phase I and II open label study on the effects of a seaweed extract nutrient complex on osteoarthritis

    PubMed Central

    Myers, Stephen P; O’Connor, Joan; Fitton, J Helen; Brooks, Lyndon; Rolfe, Margaret; Connellan, Paul; Wohlmuth, Hans; Cheras, Phil A; Morris, Carol

    2010-01-01

    Background: Isolated fucoidans from brown marine algae have been shown to have a range of anti-inflammatory effects. Purpose: This present study tested a Maritech® extract formulation, containing a blend of extracts from three different species of brown algae, plus nutrients in an open label combined phase I and II pilot scale study to determine both acute safety and efficacy in osteoarthritis of the knee. Patients and methods: Participants (n = 12, five females [mean age, 62 ± 11.06 years] and seven males [mean age, 57.14 ± 9.20 years]) with a confirmed diagnosis of osteoarthritis of the knee were randomized to either 100 mg (n = 5) or 1000 mg (n = 7) of a Maritech® extract formulation per day. The formulation contained Maritech® seaweed extract containing Fucus vesiculosis (85% w/w), Macrocystis pyrifera (10% w/w) and Laminaria japonica (5% w/w) plus vitamin B6, zinc and manganese. Primary outcome was the average comprehensive arthritis test (COAT) score which is comprised of four sub-scales: pain, stiffness, difficulty with physical activity and overall symptom severity measured weekly. Safety measures included full blood count, serum lipids, liver function tests, urea, creatinine and electrolytes determined at baseline and week 12. All adverse events were recorded. Results: Eleven participants completed 12 weeks and one completed 10 weeks of the study. Using a multilevel linear model, the average COAT score was reduced by 18% for the 100 mg treatment and 52% for the 1000 mg dose at the end of the study. There was a clear dose response effect seen between the two treatments (P ≤ 0.0005) on the average COAT score and each of the four COAT subscales (pain, stiffness, difficulty with physical activity and overall symptom severity) (P ≤ 0.05). The preparation was well tolerated and the few adverse events were unlikely to be related to the study medication. There were no changes in blood parameters measured over the course of the study with the exception of

  8. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial

    PubMed Central

    Ellis, Paul; Barrett-Lee, Peter; Johnson, Lindsay; Cameron, David; Wardley, Andrew; O'Reilly, Susan; Verrill, Mark; Smith, Ian; Yarnold, John; Coleman, Robert; Earl, Helena; Canney, Peter; Twelves, Chris; Poole, Christopher; Bloomfield, David; Hopwood, Penelope; Johnston, Stephen; Dowsett, Mitchell; Bartlett, John MS; Ellis, Ian; Peckitt, Clare; Hall, Emma; Bliss, Judith M

    2009-01-01

    Summary Background Incorporation of a taxane as adjuvant treatment for early breast cancer offers potential for further improvement of anthracycline-based treatment. The UK TACT study (CRUK01/001) investigated whether sequential docetaxel after anthracycline chemotherapy would improve patient outcome compared with standard chemotherapy of similar duration. Methods In this multicentre, open-label, phase III, randomised controlled trial, 4162 women (aged >18 years) with node-positive or high-risk node-negative operable early breast cancer were randomly assigned by computer-generated permuted block randomisation to receive FEC (fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 600 mg/m2 at 3-weekly intervals) for four cycles followed by docetaxel (100 mg/m2 at 3-weekly intervals) for four cycles (n=2073) or control (n=2089). For the control regimen, centres chose either FEC for eight cycles (n=1265) or epirubicin (100 mg/m2 at 3-weekly intervals) for four cycles followed by CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 at 4-weekly intervals) for four cycles (n=824). The primary endpoint was disease-free survival. Analysis was by intention to treat (ITT). This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN79718493. Findings All randomised patients were included in the ITT population. With a median follow-up of 62 months, disease-free survival events were seen in 517 of 2073 patients in the experimental group compared with 539 of 2089 controls (hazard ratio [HR] 0·95, 95% CI 0·85–1·08; p=0·44). 75·6% (95% CI 73·7–77·5) of patients in the experimental group and 74·3% (72·3–76·2) of controls were alive and disease-free at 5 years. The proportion of patients who reported any acute grade 3 or 4 adverse event was significantly greater in the experimental group than in the control group (p<0·0001); the most frequent events were neutropenia (937 events vs 797 events

  9. Transarterial Chemoembolization of Unresectable Hepatocellular Carcinoma with Drug Eluting Beads: Results of an Open-Label Study of 62 Patients

    SciTech Connect

    Malagari, Katerina Chatzimichael, Katerina; Alexopoulou, Efthymia; Kelekis, Alexios; Hall, Brenda; Dourakis, Spyridon; Delis, Spyridon; Gouliamos, Athanasios; Kelekis, Dimitrios

    2008-03-15

    The purpose of this study was to assess the safety and efficacy of doxorubicin-loaded beads (DC Beads) delivered by transarterial embolization for the treatment of unresectable hepatocellular carcinoma (HCC). This open-label, single-center, single-arm study included 62 cirrhotic patients with documented single unresectable HCC. Mean tumor diameter was 5.6 cm (range, 3-9 cm) classified as Okuda stages 1 (n = 53) and 2 (n = 9). Patients received repeat embolizations with doxorubicin-loaded beads every 3 months (maximum of three). The maximum doxorubicin dose was 150 mg per embolization, loaded in DC Beads of 100-300 or 300-500 {mu}m. Regarding efficacy, overall, an objective response according to the European Association for the Study of the Liver criteria was observed in 59.6%, 81.8%, and 70.8% across three treatments. A complete response was observed in 4.8% after the first procedure and 3.6% and 8.3% after the second and third procedures, respectively. At 9 months a complete response was seen in 12.2%, an objective response in 80.7%, progressive disease in 6.8%, and 12.2% showed stable disease. Mean tumor necrosis ranged from 77.4% to 83.9% (range, 28.6%-100%) across three treatments. {alpha}-Fetoprotein levels showed a mean decrease of 1123 ng/ml (95% CI = 846-1399; p = 3 x 10{sup -11}) after the first session and remained stable after the second and third embolizations (42 and 70 ng/ml decrease, respectively). Regarding safety, bilirubin, {gamma}-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase showed only transient increases during the study period. Severe procedure-related complications were seen in 3.2% (cholecystitis, n 1; liver abscess, n = 1). Postembolization syndrome was observed in all patients. We conclude that hemoembolization using doxorubicin-loaded DC Beads is a safe and effective treatment of HCC as demonstrated by the low complication rate, increased tumor response, and sustained reduction of

  10. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial

    PubMed Central

    Geissler, Edward K.; Schnitzbauer, Andreas A.; Zülke, Carl; Lamby, Philipp E.; Proneth, Andrea; Duvoux, Christophe; Burra, Patrizia; Jauch, Karl-Walter; Rentsch, Markus; Ganten, Tom M.; Schmidt, Jan; Settmacher, Utz; Heise, Michael; Rossi, Giorgio; Cillo, Umberto; Kneteman, Norman; Adam, René; van Hoek, Bart; Bachellier, Philippe; Wolf, Philippe; Rostaing, Lionel; Bechstein, Wolf O.; Rizell, Magnus; Powell, James; Hidalgo, Ernest; Gugenheim, Jean; Wolters, Heiner; Brockmann, Jens; Roy, André; Mutzbauer, Ingrid; Schlitt, Angela; Beckebaum, Susanne; Graeb, Christian; Nadalin, Silvio; Valente, Umberto; Turrión, Victor Sánchez; Jamieson, Neville; Scholz, Tim; Colledan, Michele; Fändrich, Fred; Becker, Thomas; Söderdahl, Gunnar; Chazouillères, Olivier; Mäkisalo, Heikki; Pageaux, Georges-Philippe; Steininger, Rudolf; Soliman, Thomas; de Jong, Koert P.; Pirenne, Jacques; Margreiter, Raimund; Pratschke, Johann; Pinna, Antonio D.; Hauss, Johann; Schreiber, Stefan; Strasser, Simone; Klempnauer, Jürgen; Troisi, Roberto I.; Bhoori, Sherrie; Lerut, Jan; Bilbao, Itxarone; Klein, Christian G.; Königsrainer, Alfred; Mirza, Darius F.; Otto, Gerd; Mazzaferro, Vincenzo; Neuhaus, Peter; Schlitt, Hans J.

    2016-01-01

    Background We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC). Methods In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor–free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor–free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint. Results Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (P = 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (P = 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874). Conclusions Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC. PMID:26555945

  11. Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial

    PubMed Central

    Okubo, Kimihiro; Inoue, Yoichi; Numaguchi, Hirotaka; Tanaka, Kumi; Saito, Itori; Oshima, Nobuyuki; Matsumoto, Yuki; Prohn, Marita; Mehta, Anish; Nishida, Chisato; Philip, George

    2016-01-01

    Abstract Background: This study was conducted to evaluate the safety and tolerability, and population pharmacokinetics (PPK) of montelukast as well as efficacy in the treatment of perennial allergic rhinitis (PAR) in paediatric Japanese patients aged between 1 and 15 years. Methods: In this multi-centre, open-label trial, 87 paediatric Japanese patients with PAR received montelukast 4 mg oral granules (OG) for 4 weeks (1–5-year-olds, N = 15), 4 mg OG for 12 weeks (1–5-year-olds, N = 36), 5 mg chewable tablets (CT) for 12 weeks (6–9-year-olds, N = 18), or 5 mg CT for12 weeks (10–15-year-olds, N = 18). Clinical exams and laboratory assessments were conducted at study visits, and adverse events (AE) were monitored throughout the study up to 14 days after the last visit. Population pharmacokinetic approach was used to estimate AUC0–∞, Cmax, Tmax and apparent elimination half-life in each age group. Efficacy was assessed based on global evaluations by the subject’s caregiver. Results: There were no serious AEs and one discontinuation due to an AE. The most common AEs in any of the treatment groups were nasopharyngitis, pharyngitis, and acute sinusitis. Montelukast exposure (AUC0–∞) was similar in the 1–5-year-old group and the 6–9-year-old group, but 19% lower in the 10–15-year-old group. Among all patients, the total proportion of patients whose global evaluation was “very much better” was 5.7% (week 2), 11.5% (week 4), and 16.9% (week 12) reflecting improvement in symptoms over time. Conclusion: Montelukast was generally well tolerated in Japanese children with PAR. AUC0–∞was similar in 1–5 and 6–9-year-olds, while a lower exposure was observed in the 10–15-year-old group likely due to differences in bodyweight. The exposure in Japanese paediatric patients was generally consistent with that in non-Japanese paediatric and adult patients. As assessed by the patients’ caregivers, montelukast also

  12. Orally Formulated Artemisinin in Healthy Fasting Vietnamese Male Subjects: A Randomized, Four-Sequence, Open-Label, Pharmacokinetic Crossover Study

    PubMed Central

    Hien, Tran Tinh; Hanpithakpong, Warunee; Truong, Nguyen Thanh; Dung, Nguyen Thi; Toi, Pham Van; Farrar, Jeremy; Lindegardh, Niklas; Tarning, Joel; Ashton, Michael

    2011-01-01

    Background Artemisinin derivatives are used in antimalarial drug combination therapy. Artemisinin and piperaquine have recently been proven to be prospective candidates for combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Objective The goal of this study was to evaluate the relative bioavailability and to characterize the pharmacokinetic properties of a new micronized powder formulation of artemisinin against the previous standard Vietnamese formulation when administered as a single oral dose or in combination with piperaquine. Methods This was a single-center, randomized, 4-sequence, open-label, crossover study conducted in 15 healthy male Vietnamese volunteers under fasting conditions with a washout period of 3 weeks between study visits. A single oral dose of 160 or 500 mg of artemisinin was administered alone or in combination with piperaquine. Potential adverse events were monitored daily by the clinician and by using laboratory test results. Frequent blood samples were drawn for 12 hours after dose. Artemisinin was quantified in plasma using LC-MS/MS. Pharmacokinetic parameters were computed from the plasma concentration–time profiles using a noncompartmental analysis method. Results Pharmacokinetic parameters Tmax, Cmax, AUC0-∞, Vd/F, CL/F, and t1/2 (mean [SD]) for the new formulation of artemisinin were 1.83 (0.88) hours, 178 (97) ng/mL, 504 (210) h × ng/mL, 1270 (780) L, 401 (260) L/h, and 2.21 (0.29) hours, respectively. The mean percentage of the test/reference formulation ratio for the logarithmically transformed values of Cmax, AUC0–last, and AUC0–∞ were 121% (90% CI, 92.5–158), 122% (90% CI, 101–148), and 120% (90% CI, 98.0–146), respectively. Conclusions This single-dose study found that the dose-normalized Cmax, AUC0–last, and AUC0–∞ mean geometric differences between the test and reference formulations were relatively small (<40%) and will probably not have a clinical impact in the

  13. Open-label, randomized, comparative, phase III study on effects of reducing steroid use in combination with Palonosetron.

    PubMed

    Komatsu, Yoshito; Okita, Kenji; Yuki, Satoshi; Furuhata, Tomohisa; Fukushima, Hiraku; Masuko, Hiroyuki; Kawamoto, Yasuyuki; Isobe, Hiroshi; Miyagishima, Takuto; Sasaki, Kazuaki; Nakamura, Michio; Ohsaki, Yoshinobu; Nakajima, Junta; Tateyama, Miki; Eto, Kazunori; Minami, Shinya; Yokoyama, Ryoji; Iwanaga, Ichiro; Shibuya, Hitoshi; Kudo, Mineo; Oba, Koji; Takahashi, Yasuo

    2015-07-01

    The purpose of this study is to compare the efficacy of a single administration of dexamethasone (DEX) on day 1 against DEX administration on days 1-3 in combination with palonosetron (PALO), a second-generation 5-HT3 receptor antagonist, for chemotherapy-induced nausea and vomiting (CINV) in non-anthracycline and cyclophosphamide (AC) moderately-emetogenic chemotherapy (MEC). This phase III trial was conducted with a multi-center, randomized, open-label, non-inferiority design. Patients who received non-AC MEC as an initial chemotherapy were randomly assigned to either a group administered PALO (0.75 mg, i.v.) and DEX (9.9 mg, i.v.) prior to chemotherapy (study treatment group), or a group administered additional DEX (8 mg, i.v. or p.o.) on days 2-3 (control group). The primary endpoint was complete response (CR) rate. The CR rate difference was estimated by logistic regression with allocation factors as covariates. The non-inferiority margin was set at -15% (study treatment group - control group). From April 2011 to March 2013, 305 patients who received non-AC MEC were randomly allocated to one of two study groups. Overall, the CR rate was 66.2% in the study treatment group (N = 151) and 63.6% in the control group (N = 154). PALO plus DEX day 1 was non-inferior to PALO plus DEX days 1-3 (difference, 2.5%; 95% confidence interval [CI]: -7.8%-12.8%; P-value for non-inferiority test = 0.0004). There were no differences between the two groups in terms of complete control rate (64.9 vs 61.7%) and total control rate (49.7% vs 47.4%). Anti-emetic DEX administration on days 2-3 may be eliminated when used in combination with PALO in patients receiving non-AC MEC.

  14. Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson'd Disease: Final 12-Month, Open-Label Results

    PubMed Central

    Fernandez, Hubert H; Standaert, David G; Hauser, Robert A; Lang, Anthony E; Fung, Victor SC; Klostermann, Fabian; Lew, Mark F; Odin, Per; Steiger, Malcolm; Yakupov, Eduard Z; Chouinard, Sylvain; Suchowersky, Oksana; Dubow, Jordan; Hall, Coleen M; Chatamra, Krai; Robieson, Weining Z; Benesh, Janet A; Espay, Alberto J

    2015-01-01

    Motor complications in Parkinson's disease (PD) are associated with long-term oral levodopa treatment and linked to pulsatile dopaminergic stimulation. l-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous endoscopic gastrojejunostomy tube (PEG-J), which reduces l-dopa-plasma–level fluctuations and can translate to reduced motor complications. We present final results of the largest international, prospective, 54-week, open-label LCIG study. PD patients with severe motor fluctuations (>3 h/day “off” time) despite optimized therapy received LCIG monotherapy. Additional PD medications were allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured through adverse events (AEs), device complications, and number of completers. Secondary endpoints included diary-assessed off time, “on” time with/without troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) completed the study. Most AEs were mild/moderate and transient; complication of device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly complication of device insertion (6.5%). Mean daily off time decreased by 4.4 h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS and HRQoL outcomes were also improved throughout. In the advanced PD population, LCIG's safety profile consisted primarily of AEs associated with the device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well tolerated and demonstrated clinically significant improvements in motor function, daily activities, and HRQoL sustained over 54 weeks. © 2014 The Authors. Movement Disorders published by Wiley

  15. Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study

    PubMed Central

    2014-01-01

    Background This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis. Methods This was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron. Results Of 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p = 0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p = 0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p = 0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively. Conclusions Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less

  16. The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study

    PubMed Central

    Hosomi, Naohisa; Nagai, Yoji; Kohriyama, Tatsuo; Ohtsuki, Toshiho; Aoki, Shiro; Nezu, Tomohisa; Maruyama, Hirofumi; Sunami, Norio; Yokota, Chiaki; Kitagawa, Kazuo; Terayama, Yasuo; Takagi, Makoto; Ibayashi, Setsuro; Nakamura, Masakazu; Origasa, Hideki; Fukushima, Masanori; Mori, Etsuro; Minematsu, Kazuo; Uchiyama, Shinichiro; Shinohara, Yukito; Yamaguchi, Takenori; Matsumoto, Masayasu

    2015-01-01

    Background Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. Methods This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. Finding Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. Interpretation Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. Funding This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and

  17. 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

    2016-08-01

    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

  18. Correlation between vestibular and autonomous function after 6 months of spaceflight: Data of the SPIN and GAZE-SPIN experiments.

    NASA Astrophysics Data System (ADS)

    Wuyts, Floris; Clement, Gilles; Naumov, Ivan; Kornilova, Ludmila; Glukhikh, Dmitriy; Hallgren, Emma; MacDougall, Hamish; Migeotte, Pierre-Francois; Delière, Quentin; Weerts, Aurelie; Moore, Steven; Diedrich, Andre

    In 13 cosmonauts, the vestibulo-autonomic reflex was investigated before and after 6 months duration spaceflight. Cosmonauts were rotated on the mini-centrifuge VVIS, which is installed in Star City. Initially, this mini-centrifuge flew on board of the Neurolab mission (STS-90), and served to generate intermittent artificial gravity during that mission, with apparent very positive effects on the preservation of the orthostatic tolerance upon return to earth in the 4 crew members that were subjected to the rotations in space. The current experiments SPIN and GAZE-SPIN are control experiments to test the hypothesis that intermittent artificial gravity in space can serve as a counter measure against several deleterious effects of microgravity. Additionally, the effect of microgravity on the gaze holding system is studied as well. Cosmonauts from a long duration stay in the International Space Station were tested on the VVIS (1 g centripetal interaural acceleration; consecutive right-ear-out anti-clockwise and left-ear-out clockwise measurement) on 5 different days. Two measurements were scheduled about one month and a half prior to launch and the remaining three immediately after their return from space (typically on R+2, R+4, R+9; R = return day from space). The ocular counter roll (OCR) as a measure of otolith function was measured on before, during and after the rotation in the mini centrifuge, using infrared video goggles. The perception of verticality was monitored using an ultrasound system. Gaze holding was tested before, during and after rotation. After the centrifugation part, the crew was installed on a tilt table, and instrumented with several cardiovascular recording equipment (ECG, continuous blood pressure monitoring, respiratory monitoring), as well as with impedance measurement devices to investigate fluid redistribution throughout the operational tilt test. To measure heart rate variability parameters, imposed breathing periods were included in the

  19. Effects of Concurrent Topotecan and Radiation on 6-Month Progression-Free Survival in the Primary Treatment of Glioblastoma Multiforme

    SciTech Connect

    Grabenbauer, Gerhard G. Gerber, Klaus-Dieter; Ganslandt, Oliver; Richter, Andrea M.S.; Klautke, Gunther; Birkmann, Josef; Meyer, Martin

    2009-09-01

    Purpose: To report a prospective, randomized, Phase II trial of radiotherapy with and without topotecan for the treatment of glioblastoma. Patients and Methods: Inclusion criteria were histology of glioblastoma, age <60 years, and Eastern Cooperative Oncology Group status 0-2. Patients were stratified according to recursive partitioning analysis class, center, and enzyme-inducing antiepileptic medication. Magnetic resonance imaging scans, neurologic examinations, and quality of life assessments were done every 3 months. The primary endpoint was the progression-free survival rate at 6 months (6-m-PFS). This trial was designed as an exploratory, randomized, Phase II trial with an accrual of 140 patients to detect a difference of 15-20% in 6-m-PFS. An interim analysis was scheduled after 60 patients. Median follow-up was 14 months (range, 1-50 months). Results: The 6-m-PFS was 56% and 40% for patients with and without topotecan, respectively. This benefit disappeared within 2 months. Mean (range) progression-free survival time was 8 (5-10.9) months and 6.7 (4-9.5) months for patients with and without topotecan, respectively. The corresponding 2-year-overall survival rates were 28% vs. 22% (nonsignificant difference), and mean (range) survival time was 20.7 (13.9-27.5) months vs. 18.9 (13.5-24.4) months (nonsignificant difference). Conclusions: A slight but measurable increase of 16% was detected in 6-m-PFS for patients receiving topotecan with radiation as compared with patients having radiotherapy alone. These data might support further investigations into topotecan for the treatment of glioblastoma.

  20. Association of Daytime Somnolence With Executive Functioning in the First 6 Months After Adolescent Traumatic Brain Injury

    PubMed Central

    Osorio, Marisa B.; Kurowski, Brad G.; Beebe, Dean; Taylor, H. Gerry; Brown, Tanya M.; Kirkwood, Michael W.; Wade, Shari L.

    2014-01-01

    Objective To determine the relationship between severity of injury and self-reports and parent reports of daytime somnolence in adolescents after traumatic brain injury (TBI), and to determine the relationship between daytime somnolence and self-report and parent report of executive functioning in daily life. Design Cross-sectional study conducted within the first 6 months (mean ± standard deviation 14.97 ± 7.51 weeks) after injury. Partial correlation controlling for injury severity was used to examine the associations of TBI severity with daytime somnolence and the association of daytime somnolence with executive functioning. Setting Outpatient visits at 3 children’s hospitals and 2 general hospitals with pediatric trauma commitment. Participants A total of 102 adolescents, 12–18 years old, who sustained moderate-to-severe TBI (n = 60) or complicated mild TBI (n = 42). Main Outcome Measurements Parent-report Sleepiness Scale, Epworth Sleepiness Scale (youth report), Behavior Rating Inventory of Executive Function (BRIEF) (self-report and maternal report). Results Adolescents who sustained moderate-to-severe TBI had increased daytime somnolence compared with those with complicated mild injuries in the parent report but not in the youth report. Based on the parent report, 51% of adolescents with moderate-to-severe TBI showed significant daytime somnolence compared with 22% of those with complicated mild TBI. The parent report of daytime somnolence was associated with executive dysfunction on both the BRIEF self-report and parent report; however, the youth report of daytime somnolence was associated only with the BRIEF self-report. Conclusions The parent report of daytime somnolence correlated with TBI severity and predicted executive functioning difficulties of the teens in everyday circumstances. Although a correlation between daytime somnolence and executive dysfunction were also apparent on self-report, this did not differ based on injury severity. Teens

  1. Sex-Related Differences in Pulmonary Function following 6 Months of Cigarette Exposure: Implications for Sexual Dimorphism in Mild COPD

    PubMed Central

    Churg, Andrew; Wright, Joanne L.; Man, S. F. Paul; Sin, Don D.

    2016-01-01

    Female smokers have increased risk of chronic obstructive pulmonary disease (COPD) compared with male smokers who have a similar history of cigarette smoke exposure. We have shown previously that chronic smoke exposure for 6 months leads to increased airway wall remodeling in female C57BL/6 mice compared with male C57BL/6 mice. These differences, however, were not evident in female ovariectomized mice exposed to cigarette smoke. Herein, we report on the pulmonary function test results from the flexiVent system, which was used to determine the potential functional consequences of the histologic changes observed in these mice. We found that tissue damping (G) was increased in female compared to male or ovariectomized female mice after smoke exposure. At low oscillating frequencies, complex input resistance (Zrs) and impedance (Xrs) of the respiratory system was increased and decreased, respectively, in female but not in male or ovariectomized female mice after smoke exposure. Quasistatic pressure-volume curves revealed a reduction in inspiratory capacity in female mice but not in male or ovariectomized female mice after smoke exposure. The remaining lung function measurements including quasistatic compliance were similar amongst all groups. This is the first study characterizing a sexual dimorphism in respiratory functional properties in a mouse model of COPD. These findings demonstrate that increased airway remodeling in female mice following chronic smoke exposure is associated with increased tissue resistance in the peripheral airways. These data may explain the importance of female sex hormones and the increased risk of airway disease in female smokers. PMID:27788167

  2. A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia

    PubMed Central

    2013-01-01

    Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease, lifestyle and the use of medications, which are related to weight gain. Methods A multicentric, randomized, controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program (LWP). The program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives. Patients were randomized into two groups: standard care (SC) and standard care plus intervention (LWP). Primary outcome was defined as the weight and body mass index (BMI). Results 160 patients participated in the study (81 in the intervention group and 79 in the SC group). On an intent to treat analysis, after three months the patients in the intervention group presented a decrease of 0.48 kg (CI 95% -0.65 to 1.13) while the standard care group showed an increase of 0.48 kg (CI 95% 0.13 to 0.83; p=0.055). At six-month follow-up, there was a significant weight decrease of −1.15 kg, (CI 95% -2.11 to 0.19) in the intervention group compared to a weight increase in the standard care group (+0.5 kg, CI 95% -0.42–1.42, p=0.017). Conclusion In conclusion, this was a multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight. Clinicaltrials.gov identifier NCT01368406 PMID:23418863

  3. Safety and efficacy of a 6-month home-based exercise program in patients with facioscapulohumeral muscular dystrophy

    PubMed Central

    Bankolé, Landry-Cyrille; Millet, Guillaume Y.; Temesi, John; Bachasson, Damien; Ravelojaona, Marion; Wuyam, Bernard; Verges, Samuel; Ponsot, Elodie; Antoine, Jean-Christophe; Kadi, Fawzi; Féasson, Léonard

    2016-01-01

    Abstract Background: Previous randomized controlled trials investigating exercise training programs in facioscapulohumeral muscular dystrophy (FSHD) patients are scarce and of short duration only. This study assessed the safety and efficacy of a 6-month home-based exercise training program on fitness, muscle, and motor function in FSHD patients. Methods: Sixteen FSHD patients were randomly assigned to training (TG) and control (CG) groups (both n = 8) in a home-based exercise intervention. Training consisted of cycling 3 times weekly for 35 minutes (combination of strength, high-intensity interval, and low-intensity aerobic) at home for 24 weeks. Patients in CG also performed an identical training program (CTG) after 24 weeks. The primary outcome was change in peak oxygen uptake (VO2 peak) measured every 6 weeks. The principal secondary outcomes were maximal quadriceps strength (MVC) and local quadriceps endurance every 12 weeks. Other outcome measures included maximal aerobic power (MAP) and experienced fatigue every 6 weeks, 6-minute walking distance every 12 weeks, and muscle characteristics from vastus lateralis biopsies taken pre- and postintervention. Results: The compliance rate was 91% in TG. Significant improvements with training were observed in the VO2 peak (+19%, P = 0.002) and MAP by week 6 and further to week 24. Muscle endurance, MVC, and 6-minute walking distance increased and experienced fatigue decreased. Muscle fiber cross-sectional area and citrate synthase activity increased by 34% (P = 0.008) and 46% (P = 0.003), respectively. Dystrophic pathophysiologic patterns were not exacerbated. Similar improvements were experienced by TG and CTG. Conclusions: A combined strength and interval cycling exercise-training program compatible with patients’ daily professional and social activities leads to significant functional benefits without compromising muscle tissue. PMID:27495097

  4. The 6-Month Prevalence of Posttraumatic Stress Syndrome (PTSS) Among Older Adults: Validity and Reliability of the PTSS Scale

    PubMed Central

    Préville, Michel; Lamoureux-Lamarche, Catherine; Vasiliadis, Helen-Maria; Grenier, Sébastien; Potvin, Olivier; Quesnel, Louise; Gontijo-Guerra, Samantha; Mechakra-Tahiri, Samia Djemaa; Berbiche, Djamal

    2014-01-01

    Objective: To document the 6-month prevalence of posttraumatic stress syndrome (PTSS) in the older adult population and the validity of a PTSS Scale in an epidemiologic setting. Method: Data came from the Enquête sur la santé des aînés et l’utilisation des services de santé (ESA Services Study) conducted during 2012–2013 using a probability sample of older adults seeking medical services in primary health clinics. Results: Results showed that a first-order PTSS measurement model consisting of 3 indicators—the number of lifetime traumatic events, the frequency of reactions and symptoms of distress associated with the traumatic events, and the presence of consequences on the social functioning—was plausible. Reliability of the PTSS was 0.82. According to the PTSS, 11.1% of the older adult patients presented with PTSS, but only 21.7% of them reported an impact of their symptoms on their social functioning. The prevalence of older adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for full posttraumatic stress disorder (PTSD) reached 1.8%, and 1.8% of older adults reached criteria for partial PTSD. Our results also showed that women were more at risk to report PTSS than men and that older adults aged 75 years and older were less likely to report these symptoms than those aged between 65 and 74 years. Conclusions: PTSS is a common mental health problem among adults aged 65 and older and seeking health services in the general medical sector. PMID:25565688

  5. Immunosuppressive therapy of cyclosporin A for severe benzene-induced haematopoietic disorders and a 6-month follow-up.

    PubMed

    Song, Yuguo; Du, Xuqin; Hao, Fentong; Gu, Xiaoxin; Zhang, Zhenghua; Zhang, Songquan; Li, Chunsheng; Li, Huiling; Ma, Jing

    2010-06-01

    Long-term exposure to benzene can potentially result in severe haematotoxicities, including pancytopaenia, aplastic anaemia and myelodysplastic syndrome, which are often accompanied by life-threatening symptoms and high mortality. Previous studies demonstrate that benzene-induced haematotoxicities are immune-mediated and that cyclosporin A is a prominent treatment in acquired aplastic anaemia. This study aims to evaluate the potential role of cyclosporin A immunosuppressive therapy for severe benzene-induced haematotoxicity. Between January 2002 and December 2008, 41 patients with severe benzene-induced haematopoietic disorders from five hospitals were enrolled in the study, 22 patients received cyclosporin A, supportive treatments and/or oral testosterone undecanoate, 19 patients were treated with supportive treatments and/or oral testosterone undecanoate as the control group, and a 6-month follow-up was conducted. The results showed that in the cyclosporin A group, 19 of 22 patients (86.36%) had responded to the treatments completely or partially with increased platelets, white blood cells and hemoglobulin counts by the fourth week (P=0.005), the sixth week (P=0.001) and the third month post-treatment (P=0.034), respectively. However, in the control group treated by supportive methods, only 5 of 19 patients (26.32%) responded to the treatments partially (P<0.001). Cyclosporin A in conjunction with supportive treatments may be an effective treatment modality for patients with severe benzene-induced haematopoietic disorders, which in turn implies that these haematotoxicities are immune-mediated. PMID:20381478

  6. Lactation and appetite-regulating hormones: increased maternal plasma peptide YY concentrations 3-6 months postpartum.

    PubMed

    Vila, Greisa; Hopfgartner, Judith; Grimm, Gabriele; Baumgartner-Parzer, Sabina M; Kautzky-Willer, Alexandra; Clodi, Martin; Luger, Anton

    2015-10-28

    Breast-feeding is associated with maternal hormonal and metabolic changes ensuring adequate milk production. In this study, we investigate the impact of breast-feeding on the profile of changes in maternal appetite-regulating hormones 3-6 months postpartum. Study participants were age- and BMI-matched lactating mothers (n 10), non-lactating mothers (n 9) and women without any history of pregnancy or breast-feeding in the previous 12 months (control group, n 10). During study sessions, young mothers breast-fed or bottle-fed their babies, and maternal blood samples were collected at five time points during 90 min: before, during and after feeding the babies. Outcome parameters were plasma concentrations of ghrelin, peptide YY (PYY), leptin, adiponectin, prolactin, cortisol, insulin, glucose and lipid values. At baseline, circulating PYY concentrations were significantly increased in lactating mothers (100·3 (se 6·7) pg/ml) v. non-lactating mothers (73·6 (se 4·9) pg/ml, P=0·008) and v. the control group (70·2 (se 9) pg/ml, P=0·021). We found no differences in ghrelin, leptin and adiponectin values. Baseline prolactin concentrations were over 4-fold higher in lactating mothers (P<0·001). Lactating women had reduced TAG levels and LDL-cholesterol:HDL-cholesterol ratio, but increased waist circumference, when compared with non-lactating women. Breast-feeding sessions further elevated circulating prolactin (P<0·001), but induced no acute effects on appetite-regulating hormones. In summary, one single breast-feeding session did not acutely modulate circulating appetite-regulating hormones, but increased baseline PYY concentrations are associated with prolonged lactation. PYY might play a role in the coordination of energy balance during lactation, increasing fat mobilisation from maternal depots and ensuring adequate milk production for the demands of the growing infant.

  7. Preschool Children’s Memory for Word Forms Remains Stable Over Several Days, but Gradually Decreases after 6 Months

    PubMed Central

    Gordon, Katherine R.; McGregor, Karla K.; Waldier, Brigitte; Curran, Maura K.; Gomez, Rebecca L.; Samuelson, Larissa K.

    2016-01-01

    Research on word learning has focused on children’s ability to identify a target object when given the word form after a minimal number of exposures to novel word-object pairings. However, relatively little research has focused on children’s ability to retrieve the word form when given the target object. The exceptions involve asking children to recall and produce forms, and children typically perform near floor on these measures. In the current study, 3- to 5-year-old children were administered a novel test of word form that allowed for recognition memory and manual responses. Specifically, when asked to label a previously trained object, children were given three forms to choose from: the target, a minimally different form, and a maximally different form. Children demonstrated memory for word forms at three post-training delays: 10 mins (short-term), 2–3 days (long-term), and 6 months to 1 year (very long-term). However, children performed worse at the very long-term delay than the other time points, and the length of the very long-term delay was negatively related to performance. When in error, children were no more likely to select the minimally different form than the maximally different form at all time points. Overall, these results suggest that children remember word forms that are linked to objects over extended post-training intervals, but that their memory for the forms gradually decreases over time without further exposures. Furthermore, memory traces for word forms do not become less phonologically specific over time; rather children either identify the correct form, or they perform at chance. PMID:27729880

  8. Early end-tidal carbon monoxide levels and neurodevelopmental outcome at 3 years 6 months of age in preterm infants

    PubMed Central

    Blok, Cornelie A; Krediet, Tannette G; Kavelaars, Annemiek; Koopman-Esseboom, Corine; Vreman, Hendrik J; Van Bel, Frank

    2011-01-01

    Aim Increased end-tidal carbon monoxide (ETCOc) and cytokines in preterm infants are related to bronchopulmonary dysplasia and intraventricular haemorrhages. The aim was to study the predictive value of ETCOc and cytokine levels for long-term outcome. Methods This study comprised 105 very preterm infants (57 males, 48 females; gestational age range 25wk 5d–31wk 4d; birthweight 610–2100g) who were admitted to a neonatal intensive care unit between 1 February and 31 December 2002. ETCOc, plasma tumour necrosis factor alpha (TNF-α) and interleukins (IL) 6 and 8, and malondialdehyde (MDA, a marker of lipid peroxidation), were measured at days 1, 3, and 5 of life and related to outcome at 3 years 6 months of age (Griffiths Mental Developmental Scales). Results Of the 105 infants, 69 were eligible for follow-up (37 male; 32 female; bronchopulmonary dysplasia, n=12). ETCOc at 0 to 24 hours was higher in infants with adverse outcome (Griffiths developmental quotient <85, n=15) compared with favourable outcome (2.7 SD 0.7 vs 2.0 SD 0.5; p<0.05). MDA and cytokines did not differ between groups. Regression analysis with bootstrapping of independent variables (gestational age, birthweight, ETCOc, TNF-α, IL-6, IL-8, and bronchopulmonary dysplasia) showed that ETCOc was the only parameter that correlated with outcome. The sensitivity and negative predictive value of ETCOc for adverse outcome were 93% and 85% respectively. Interpretation Adverse neurodevelopmental outcome is associated with increased endogenous carbon monoxide. ETCOc less than 2.0ppm during the first day indicates a favourable outcome. PMID:21933176

  9. Exploratory study describing 6 month outcomes for young children with autism who receive treatment as usual in Italy

    PubMed Central

    Muratori, Filippo; Narzisi, Antonio

    2014-01-01

    Background In the last few years, the results of different studies have confirmed, in different ways, the importance of early intervention for autism. This study aims to evaluate the role of early “as usual” interventions in the outcome of toddlers diagnosed with autism spectrum disorder (ASD). Method Seventy children with ASD aged between 24 and 48 months were recruited at different centers in Italy. They were evaluated by blind researchers at baseline and after 6 months of using Autism Diagnostic Observation Schedule-Generic (ADOS-G), Griffiths Mental Developmental Scales, and Vineland Adaptive Behavior scales. Parents filled out the MacArthur Inventory, Social Communication Questionnaire, and Child Behavior Check List. All children were referred to community providers for available interventions. Results At the endpoint, most of the children were still classified as having an ADOS-G classification of ASD. However, 21 (34.2%) passed from autism to autism spectrum, and 3 (4.2%) passed from autism spectrum to no spectrum. Treatment effects were obtained for cognitive functioning, language, adaptive behavior, and child behavior without differences between development-oriented and behavior-oriented interventions. Parent involvement was a mediator for the best clinical outcome. Baseline low impairments of communication, language comprehension, and gesture were predictors of positive outcome. Conclusion Treatment as usual, composed of individual therapy plus school-supported inclusion, may be an effective intervention in ASD. Better initial levels of communication in child and parent involvement during treatment have an important role for a positive outcome. PMID:24748794

  10. 6-month aortic valve implantation of an off-the-shelf tissue-engineered valve in sheep.

    PubMed

    Syedain, Zeeshan; Reimer, Jay; Schmidt, Jillian; Lahti, Matthew; Berry, James; Bianco, Richard; Tranquillo, Robert T

    2015-12-01

    Diseased aortic valves often require replacement, with over 30% of the current aortic valve surgeries performed in patients who will outlive a bioprosthetic valve. While many promising tissue-engineered valves have been created in the lab using the cell-seeded polymeric scaffold paradigm, none have been successfully tested long-term in the aortic position of a pre-clinical model. The high pressure gradients and dynamic flow across the aortic valve leaflets require engineering a tissue that has the strength and compliance to withstand high mechanical demand without compromising normal hemodynamics. A long-term preclinical evaluation of an off-the-shelf tissue-engineered aortic valve in the sheep model is presented here. The valves were made from a tube of decellularized cell-produced matrix mounted on a frame. The engineered matrix is primarily composed of collagen, with strength and organization comparable to native valve leaflets. In vitro testing showed excellent hemodynamic performance with low regurgitation, low systolic pressure gradient, and large orifice area. The implanted valves showed large-scale leaflet motion and maintained effective orifice area throughout the duration of the 6-month implant, with no calcification. After 24 weeks implantation (over 17 million cycles), the valves showed no change in tensile mechanical properties. In addition, histology and DNA quantitation showed repopulation of the engineered matrix with interstitial-like cells and endothelialization. New extracellular matrix deposition, including elastin, further demonstrates positive tissue remodeling in addition to recellularization and valve function. Long-term implantation in the sheep model resulted in functionality, matrix remodeling, and recellularization, unprecedented results for a tissue-engineered aortic valve. PMID:26409002

  11. Energy expenditure, nutritional status, body composition and physical fitness of Royal Marines during a 6-month operational deployment in Afghanistan.

    PubMed

    Fallowfield, Joanne L; Delves, Simon K; Hill, Neil E; Cobley, Rosalyn; Brown, Pieter; Lanham-New, Susan A; Frost, Gary; Brett, Stephen J; Murphy, Kevin G; Montain, Scott J; Nicholson, Christopher; Stacey, Michael; Ardley, Christian; Shaw, Anneliese; Bentley, Conor; Wilson, Duncan R; Allsopp, Adrian J

    2014-09-14

    Understanding the nutritional demands on serving military personnel is critical to inform training schedules and dietary provision. Troops deployed to Afghanistan face austere living and working environments. Observations from the military and those reported in the British and US media indicated possible physical degradation of personnel deployed to Afghanistan. Therefore, the present study aimed to investigate the changes in body composition and nutritional status of military personnel deployed to Afghanistan and how these were related to physical fitness. In a cohort of British Royal Marines (n 249) deployed to Afghanistan for 6 months, body size and body composition were estimated from body mass, height, girth and skinfold measurements. Energy intake (EI) was estimated from food diaries and energy expenditure measured using the doubly labelled water method in a representative subgroup. Strength and aerobic fitness were assessed. The mean body mass of volunteers decreased over the first half of the deployment ( - 4·6 (sd 3·7) %), predominately reflecting fat loss. Body mass partially recovered (mean +2·2 (sd 2·9) %) between the mid- and post-deployment periods (P< 0·05). Daily EI (mean 10 590 (sd 3339) kJ) was significantly lower than the estimated daily energy expenditure (mean 15 167 (sd 1883) kJ) measured in a subgroup of volunteers. However, despite the body mass loss, aerobic fitness and strength were well maintained. Nutritional provision for British military personnel in Afghanistan appeared sufficient to maintain physical capability and micronutrient status, but providing appropriate nutrition in harsh operational environments must remain a priority.

  12. Intrastromal Corneal Ring Segment Implantation (Keraring 355°) in Patients with Central Keratoconus: 6-Month Follow-Up

    PubMed Central

    Jadidi, Khosrow; Mosavi, Seyed Aliasghar; Nejat, Farhad; Naderi, Mostafa; Janani, Leila; Serahati, Sara

    2015-01-01

    We evaluate the efficacy and safety of Keraring 355° intrastromal corneal ring segment (ICRS) implantation aided by PocketMaker microkeratome for the correction of keratoconus. Patients underwent ICRS insertion using mechanical dissection with PocketMaker microkeratome and completed 6 months of follow-up. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, topographic findings, safety, efficacy index, and adverse events were reported for six months postoperatively. We evaluated 15 eyes of 15 patients (12 men) with a mean age of 28.87 ± 6.94 years (range 21–49 years). At final postoperative examination, there was a statistically significant reduction in the spherical equivalent refractive error compared to preoperative measurements (−5.46 ± 1.52 to −2.01 ± 1.63 D, P < 0.001). Mean preoperative UCVA (logMAR) before implantation was 0.79 ± 0.48, and postoperative UCVA was 0.28 ± 0.15, P = 0.001. Mean preoperative BSCVA (logMAR) before implantation was 0.36 ± 0.21; at final follow-up examination BSCVA was 0.18 ± 0.9, P = 0.009. Mean K decreased from 48.33 to 43.31 D, P < 0.001. All patients were satisfied with ICRS implantation; 86.7% were moderately to very happy with the results. No intraoperative or postoperative complications were demonstrated. This preliminary study shows that ICRS (Keraring 355°) implantation is an efficient, cost-effective, and minimally invasive procedure for improving visual acuity in nipple type keratoconic corneas. PMID:25685395

  13. Lactation and appetite-regulating hormones: increased maternal plasma peptide YY concentrations 3-6 months postpartum.

    PubMed

    Vila, Greisa; Hopfgartner, Judith; Grimm, Gabriele; Baumgartner-Parzer, Sabina M; Kautzky-Willer, Alexandra; Clodi, Martin; Luger, Anton

    2015-10-28

    Breast-feeding is associated with maternal hormonal and metabolic changes ensuring adequate milk production. In this study, we investigate the impact of breast-feeding on the profile of changes in maternal appetite-regulating hormones 3-6 months postpartum. Study participants were age- and BMI-matched lactating mothers (n 10), non-lactating mothers (n 9) and women without any history of pregnancy or breast-feeding in the previous 12 months (control group, n 10). During study sessions, young mothers breast-fed or bottle-fed their babies, and maternal blood samples were collected at five time points during 90 min: before, during and after feeding the babies. Outcome parameters were plasma concentrations of ghrelin, peptide YY (PYY), leptin, adiponectin, prolactin, cortisol, insulin, glucose and lipid values. At baseline, circulating PYY concentrations were significantly increased in lactating mothers (100·3 (se 6·7) pg/ml) v. non-lactating mothers (73·6 (se 4·9) pg/ml, P=0·008) and v. the control group (70·2 (se 9) pg/ml, P=0·021). We found no differences in ghrelin, leptin and adiponectin values. Baseline prolactin concentrations were over 4-fold higher in lactating mothers (P<0·001). Lactating women had reduced TAG levels and LDL-cholesterol:HDL-cholesterol ratio, but increased waist circumference, when compared with non-lactating women. Breast-feeding sessions further elevated circulating prolactin (P<0·001), but induced no acute effects on appetite-regulating hormones. In summary, one single breast-feeding session did not acutely modulate circulating appetite-regulating hormones, but increased baseline PYY concentrations are associated with prolonged lactation. PYY might play a role in the coordination of energy balance during lactation, increasing fat mobilisation from maternal depots and ensuring adequate milk production for the demands of the growing infant. PMID:26299586

  14. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    PubMed

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

  15. Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder.

    PubMed

    Husted, David S; Shapira, Nathan A; Murphy, Tanya K; Mann, Giselle D; Ward, Herbert E; Goodman, Wayne K

    2007-01-01

    Currently, there are limited published data evaluating the effects of tics on serotonin reuptake inhibitor (SRI) monotherapy responses in treating obsessive-compulsive disorder (OCD). One retrospective case-controlled analysis of OCD patients treated with SRI monotherapy showed lesser improvement in OCD symptoms in patients with tics than those without. However, more recently there were preliminary reports of OCD subjects treated with SRI monotherapy which did not demonstrate poorer response in subjects with tics or Tourette's Syndrome (TS). The specific aim of this study was to investigate whether the presence of comorbid chronic tics affected "clinically meaningful improvement" [McDougle, C.J., Goodman, W.K., Leckman, J.F., Barr, L.C., Heninger, G.R., Price, L.H., 1993. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. Journal of Clinical Psychopharmacology 13, 354-358] of OCD in an 8-week open-label trial of fluoxetine monotherapy. Seventy-four adult subjects (13 patients with comorbid chronic tics and 61 patients without tics) with a primary DSM-IV OCD diagnosis were treated with up to 40mg fluoxetine for 8 weeks and had at least one post-baseline evaluation. The results indicate that there was a significant response by time in both fluoxetine-with-tic subjects and fluoxetine-without-tic subjects. Additionally, there were 3 (23.0%) OCD subjects with tics who had clinically meaningful improvement versus 16 (26.2%) OCD subjects without tics that demonstrated similar levels of improvement. These findings indicate that OCD patients with or without chronic tic disorders did not have a differential response to an 8-week open-label trial of fluoxetine. Limitations include the relatively low number of tic subjects and the open-label nature of the study. Additional data are needed on how comorbid tics may affect SRI treatment response in OCD.

  16. Projected outcomes of 6-month delay in exception points versus an equivalent Model for End-Stage Liver Disease score for hepatocellular carcinoma liver transplant candidates.

    PubMed

    Alver, Sarah K; Lorenz, Douglas J; Marvin, Michael R; Brock, Guy N

    2016-10-01

    The United Network for Organ Sharing (UNOS) recently implemented a 6-month delay before granting exception points to liver transplantation candidates with hepatocellular carcinoma (HCC) to address disparity in transplantation access between HCC and non-HCC patients. An HCC-specific scoring scheme, the Model for End-Stage Liver Disease equivalent (MELDEQ ), has also been developed. We compared projected dropout and transplant probabilities and posttransplant survival for HCC and non-HCC patients under the 6-month delay and the MELDEQ using UNOS data from October 1, 2009, to June 30, 2014, and multistate modeling. Overall (combined HCC and non-HCC) wait-list dropout was similar under both schemes and slightly improved (though not statistically significant) compared to actual data. Projected HCC wait-list dropout was similar between the MELDEQ and 6-month delay at 6 months but thereafter started to differ, with the 6-month delay eventually favoring HCC patients (3-year dropout 10.0% [9.0%-11.0%] for HCC versus 14.1% [13.6%-14.6%]) for non-HCC) and the MELDEQ favoring non-HCC patients (3-year dropout 16.0% [13.2%-18.8%] for HCC versus 12.3% [11.9%-12.7%] for non-HCC). Projected transplant probabilities for HCC patients were substantially lower under the MELDEQ compared to the 6-month delay (26.6% versus 83.8% by 3 years, respectively). Projected HCC posttransplant survival under the 6-month delay was similar to actual, but slightly worse under the MELDEQ (2-year survival 82.9% [81.7%-84.2%] versus actual of 85.5% [84.3%-86.7%]). In conclusion, although the 6-month delay improves equity in transplant and dropout between HCC and non-HCC candidates, disparity between the 2 groups may still exist after 6 months of wait-list time. Projections under the MELDEQ , however, appear to disadvantage HCC patients. Therefore, modification to the exception point progression or refinement of an HCC prioritization score may be warranted. Liver Transplantation 22 1343-1355 2016 AASLD.

  17. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial

    PubMed Central

    Arjyal, Amit; Basnyat, Buddha; Nhan, Ho Thi; Koirala, Samir; Giri, Abhishek; Joshi, Niva; Shakya, Mila; Pathak, Kamal Raj; Mahat, Saruna Pathak; Prajapati, Shanti Pradhan; Adhikari, Nabin; Thapa, Rajkumar; Merson, Laura; Gajurel, Damodar; Lamsal, Kamal; Lamsal, Dinesh; Yadav, Bharat Kumar; Shah, Ganesh; Shrestha, Poojan; Dongol, Sabina; Karkey, Abhilasha; Thompson, Corinne N; Thieu, Nga Tran Vu; Thanh, Duy Pham; Baker, Stephen; Thwaites, Guy E; Wolbers, Marcel; Dolecek, Christiane

    2016-01-01

    Summary Background Because treatment with third-generation cephalosporins is associated with slow clinical improvement and high relapse burden for enteric fever, whereas the fluoroquinolone gatifloxacin is associated with rapid fever clearance and low relapse burden, we postulated that gatifloxacin would be superior to the cephalosporin ceftriaxone in treating enteric fever. Methods We did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2–13 years) and adult (aged 14–45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2–13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed. Findings Between Sept 18, 2011, and July 14, 2014, we screened 725 patients for eligibility. On July 14, 2014, the trial was stopped early by the data safety and monitoring board because S Typhi

  18. Noninvasive brain stimulation by radioelectric asymmetric conveyor in the treatment of agoraphobia: open-label, naturalistic study

    PubMed Central

    Mannu, Piero; Rinaldi, Salvatore; Fontani, Vania; Castagna, Alessandro; Margotti, Matteo Lotti

    2011-01-01

    Background Agoraphobia is considered to be the most serious complication of panic disorder. It involves progressive development of debilitating anxiety symptoms related to being in situations where one would be extremely embarrassed and could not be rescued in the case of a panic attack. This study aimed to investigate the efficacy of noninvasive brain stimulation using a radioelectric asymmetric conveyor (REAC) for agoraphobia. Patients and methods Twenty-three patients (3 males and 20 females) suffering from agoraphobia and without a history of panic disorder were evaluated by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, and the Agoraphobia Scale (AS). The patients were subjected to two 18-session cycles of noninvasive brain stimulation with the REAC, according to an established therapeutic protocol called neuropsycho-physical optimization. Results Analyzing the anxiety and avoidance parameters of the AS after the first and second cycles of REAC treatment revealed variation in levels of response to treatment, including weak (AS item 7), moderate (AS items 10 and 13), and good responses (AS items 1–6, 8, 9, 11, 12, and 14–20). Conclusion These results highlight the potential of the REAC to treat complex clinical situations such as agoraphobia, which is typically resistant to pharmacologic treatments. Furthermore, these data show the advantages of REAC treatment, even compared with modern cognitive behavioral therapy, including a relatively rapid and “stable” clinical response (just over 6 months) and economic cost. PMID:22163156

  19. Is 6 months still the best for exclusive breastfeeding and introduction of solids? A literature review with consideration to the risk of the development of allergies.

    PubMed

    Anderson, Joy; Malley, Kathryn; Snell, Robynne

    2009-07-01

    Health professionals advising mothers on the introduction of solid foods to infants need evidence-based guidelines. A literature review on this topic was undertaken to examine the current international recommendations of expert bodies and evidence-based research published since 2003. Particular reference in this review is made to the timing of introducing food allergens and the risk of development of allergy in the child. Recommendations in developed countries of reducing this risk by avoidance of allergenic foods until the child is of varying ages past 6 months have been challenged by recent population studies. Where the risk of allergy is a key consideration, currently-available research suggests that introducing solids at 4-6 months may result in the lowest allergy risk. When all aspects of health are taken into account, the recommended duration of exclusive breastfeeding and age of introduction of solids were confirmed to be 6 months, but no later.

  20. An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy

    PubMed Central

    Bai, Wen-Jun; Li, Hong-Jun; Dai, Yu-Tian; He, Xue-You; Huang, Yi-Ran; Liu, Ji-Hong; Sorsaburu, Sebastian; Ji, Chen; Jin, Jian-Jun; Wang, Xiao-Feng

    2015-01-01

    The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naïve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naïve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe. PMID:25370206

  1. Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer

    PubMed Central

    Twelves, Chris; Awada, Ahmad; Cortes, Javier; Yelle, Louise; Velikova, Galina; Olivo, Martin S.; Song, James; Dutcus, Corina E.; Kaufman, Peter A.

    2016-01-01

    PURPOSE AND METHODS Our secondary analyses compared survival with eribulin versus capecitabine in various patient subgroups from a phase 3, open-label, randomized study. Eligible women aged ≥18 years with advanced/metastatic breast cancer and ≤3 prior chemotherapies (≤2 for advanced/metastatic disease), including an anthracycline and taxane, were randomized 1:1 to intravenous eribulin mesylate 1.4 mg/m2 on days 1 and 8 or twice-daily oral capecitabine 1250 mg/m2 on days 1–14 (21-day cycles). RESULTS In the intent-to-treat population (eribulin 554 and capecitabine 548), overall survival appeared longer with eribulin than capecitabine in various subgroups, including patients with human epidermal growth factor receptor 2-negative (15.9 versus 13.5 months, respectively), estrogen receptor-negative (14.4 versus 10.5 months, respectively), and triple-negative (14.4 versus 9.4 months, respectively) disease. Progression-free survival was similar between the treatment arms. CONCLUSIONS Patients with advanced/metastatic breast cancer and human epidermal growth factor receptor 2-, estrogen receptor-, or triple-negative disease may gain particular benefit from eribulin as first-, second-, and third-line chemotherapies. TRIAL REGISTRATION (PRIMARY STUDY) This study reports the subgroup analyses of eribulin versus capecitabine from a phase 3, open-label, randomized study (www.clinicaltrials.gov; ClinicalTrials.gov identifier: NCT00337103). PMID:27398025

  2. Remission Rate and Functional Outcomes During a 6-Month Treatment With Osmotic-Release Oral-System Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder.

    PubMed

    Su, Yi; Li, Haibo; Chen, Yixin; Fang, Fang; Xu, Tong; Lu, Haiping; Xie, Ling; Zhuo, Jianmin; Qu, Jiazhi; Yang, Li; Wang, Yufeng

    2015-10-01

    Many definitions have been used to evaluate remission in patients with attention-deficit/hyperactivity disorder (ADHD) in different studies resulting with varied remission rates. This open-label, multicenter study investigated the remission rate in Chinese children (n = 239; aged 6-16 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), treated with osmotic-release oral-system methylphenidate at doses of 18, 36, and 54 mg, once daily. Two definitions of remission were used: (1) (primary end point): average scores of SNAP-IV (Swanson, Nolan, and Pelham, Fourth Edition) items of 1 or less (0-3 rating scale for each item) according to the subtype of ADHD (inattentive [1-9], hyperactive-impulsive [10-18], and combined type [1-18]), and (2) total score of SNAP-IV items 1 to 18 of 18 or less, at week 8. The study consisted of screening/baseline, titration/open-label treatment (8 weeks), and extended observation (up to 24 weeks) phases. Secondary efficacy assessments were Clinical Global Impression-Improvement (clinical efficacy), Behavior Rating Inventory of Executive Function Scale (BRIEF; executive function behaviors), and Weiss Functional Impairment Rating Scale (social function). Validity of remission was assessed by comparing the function measures (BRIEF and Weiss's) between patients who achieved remission and those who did not. At week 8, 69.3% (151/218) of patients achieved remission by definition 1, and 73.2% (161/220) by definition 2. At weeks 8 and 24, the remission group had significantly lower BRIEF, Weiss's, and Clinical Global Impression-Improvement scores (P < 0.001 for all) compared with the nonremission group. Overall, treatment with osmotic-release oral-system methylphenidate was well tolerated, with increased remission rates in children with ADHD.

  3. Remission Rate and Functional Outcomes During a 6-Month Treatment With Osmotic-Release Oral-System Methylphenidate in Children With Attention-Deficit/Hyperactivity Disorder.

    PubMed

    Su, Yi; Li, Haibo; Chen, Yixin; Fang, Fang; Xu, Tong; Lu, Haiping; Xie, Ling; Zhuo, Jianmin; Qu, Jiazhi; Yang, Li; Wang, Yufeng

    2015-10-01

    Many definitions have been used to evaluate remission in patients with attention-deficit/hyperactivity disorder (ADHD) in different studies resulting with varied remission rates. This open-label, multicenter study investigated the remission rate in Chinese children (n = 239; aged 6-16 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), treated with osmotic-release oral-system methylphenidate at doses of 18, 36, and 54 mg, once daily. Two definitions of remission were used: (1) (primary end point): average scores of SNAP-IV (Swanson, Nolan, and Pelham, Fourth Edition) items of 1 or less (0-3 rating scale for each item) according to the subtype of ADHD (inattentive [1-9], hyperactive-impulsive [10-18], and combined type [1-18]), and (2) total score of SNAP-IV items 1 to 18 of 18 or less, at week 8. The study consisted of screening/baseline, titration/open-label treatment (8 weeks), and extended observation (up to 24 weeks) phases. Secondary efficacy assessments were Clinical Global Impression-Improvement (clinical efficacy), Behavior Rating Inventory of Executive Function Scale (BRIEF; executive function behaviors), and Weiss Functional Impairment Rating Scale (social function). Validity of remission was assessed by comparing the function measures (BRIEF and Weiss's) between patients who achieved remission and those who did not. At week 8, 69.3% (151/218) of patients achieved remission by definition 1, and 73.2% (161/220) by definition 2. At weeks 8 and 24, the remission group had significantly lower BRIEF, Weiss's, and Clinical Global Impression-Improvement scores (P < 0.001 for all) compared with the nonremission group. Overall, treatment with osmotic-release oral-system methylphenidate was well tolerated, with increased remission rates in children with ADHD. PMID:26267421

  4. The effects of a 6-month resistance training and dried plum consumption intervention on strength, body composition, blood markers of bone turnover, and inflammation in breast cancer survivors.

    PubMed

    Simonavice, Emily; Liu, Pei-Yang; Ilich, Jasminka Z; Kim, Jeong-Su; Arjmandi, Bahram; Panton, Lynn B

    2014-06-01

    The purpose of this study was to examine the effects of resistance training (RT) and dried plum (DP) consumption on strength, body composition, blood markers of bone, and inflammation in breast cancer survivors (BCS). Twenty-three BCS (RT, n = 12; RT+DP, n = 11), aged 64 ± 7 years, were evaluated at baseline and after 6 months of intervention on the following: muscular strength (chest press and leg extension) via 1-repetition maximums (1RMs); body composition, specifically bone mineral density (BMD) by dual energy X-ray absorptiometry; biochemical markers of bone turnover (bone-specific alkaline phosphatase (BAP), tartrate resistant acid phosphatase (TRAP-5b)); and inflammation (C-reactive protein (CRP)). Target RT prescription was 2 days/week of 10 exercises, including 2 sets of 8-12 repetitions at ∼60%-80% of 1RM. RT+DP also consumed 90 g of DP daily. There were no baseline differences between groups or any group-by-time interactions for any of the variables. BCS increased upper (p < 0.05) (RT: 64 ± 14 to 80 ± 17 kg; RT+DP: 72 ± 23 to 91 ± 20 kg) and lower (p < 0.05) (RT: 69 ± 20 to 87 ± 28 kg; RT+DP: 78 ± 19 to 100 ± 21 kg) body strength. Body composition and BMD improvements were not observed. TRAP-5b decreased in the RT group (p < 0.05) (4.55 ± 1.57 to 4.04 ± 1.63 U/L) and the RT+DP group (p = 0.07) (5.10 ± 2.75 to 4.27 ± 2.03 U/L). Changes in BAP and CRP were not observed. RT was effective for improving biochemical markers of bone turnover and muscular strength in BCS. A longer and higher intensity intervention may be needed to reveal the true effects of RT and DP on body composition and biochemical markers of inflammation.

  5. Gaze Behavior and Affect at 6-Months: Predicting Clinical Outcomes and Language Development in Typically Developing Infants and Infants At-Risk for Autism

    PubMed Central

    Young, Gregory S.; Merin, Noah; Rogers, Sally J.; Ozonoff, Sally

    2009-01-01

    This paper presents follow-up longitudinal data to research that previously suggested the possibility of abnormal gaze behavior marked by decreased eye contact in a subgroup of 6-month-old infants at risk for autism (Merin et al., 2007). Using eye-tracking data and behavioral data recorded during a live mother-infant interaction involving the still-face procedure, the predictive utility of gaze behavior and affective behaviors at 6 months was examined using diagnostic outcome data obtained longitudinally over the following 18 months. Results revealed that none of the infants previously identified as showing lower rates of eye-contact had any signs of autism at outcome. In contrast, three infants who were diagnosed with autism demonstrated consistent gaze to the eye region and typical affective responses at 6 months. Individual differences in face scanning and affective responsivity during the live interaction were not related to any continuous measures of symptom frequency or symptom severity. In contrast, results of growth curve models for language development revealed significant relationships between face scanning and expressive language. Greater amounts of fixation to the mother’s mouth during live interaction predicted higher levels of expressive language at outcome and greater rates of growth. These findings suggest that although gaze behavior at 6 months may not provide early markers for autism as initially conceived, gaze to the mouth in particular may be useful in predicting individual differences in language development. PMID:19702771

  6. Effect of a 6-month school-based physical activity program on body composition and physical fitness in lean and obese schoolchildren.

    PubMed

    Thivel, David; Isacco, Laurie; Lazaar, Nordine; Aucouturier, Julien; Ratel, Sébastien; Doré, Eric; Meyer, Martine; Duché, Pascale

    2011-11-01

    Few studies have investigated the impact of school-based physical activity interventions on anthropometric characteristics concomitantly with aerobic and anaerobic capacities in young children. The present study aimed to assess the effect of a 6-month physical activity program on body composition and physical fitness among primary schoolchildren. Four hundred fifty-seven children aged 6 to 10 years were randomly assigned to the intervention group (229 children) or observational group (228 children). Participants' height and weight were assessed, and obesity was determined using French reference curves for BMI. The sum of the four skinfolds and fat-free mass were determined. Ground tests were used to assess aerobic (20-m shuttle run test) and anaerobic (cycling peak power) fitness before and after a 6-month physical activity intervention. The anthropometric modifications obtained over the 6 months cannot be attributed to the intervention as the ANOVA revealed no group effect (intervention vs. group). However, anaerobic and aerobic fitness were significantly improved, thanks to the program in both lean and obese children. A 6-month school-based physical activity intervention in 6- to 10-year-old children did not yield positive anthropometric improvements, but appears effective in terms of aerobic and anaerobic physical fitness. Two physical activity sessions per week in addition to standard physical education classes in primary schoolchildren bring effective results for the prevention of childhood obesity. PMID:21475968

  7. Health Status, Cognitive and Motor Development of Young Children Adopted from China, East Asia, and Russia across the First 6 Months after Adoption

    ERIC Educational Resources Information Center

    Pomerleau, Andree; Malcuit, Gerard; Chicoine, Jean-Francois; Seguin, Renee; Belhumeur, Celine; Germain, Patricia; Amyot, Isabelle; Jeliu, Gloria

    2005-01-01

    We compared health status, anthropometric and psychological development of 123 children adopted before 18 months of age from China, East Asia (Vietnam, Taiwan, Thailand, South Korea, Cambodia), and Eastern Europe (mostly Russia). Data were collected close to the time of arrival, and 3 and 6 months later. Anthropometric measures included weight,…

  8. Calcium supplementation, bone mineral density and bone mineral content. Predictors of bone mass changes in adolescent mothers during the 6-month postpartum period.

    PubMed

    Malpeli, Agustina; Apezteguia, María; Mansur, José L; Armanini, Alicia; Macías Couret, Melisa; Villalobos, Rosa; Kuzminczuk, Marta; Gonzalez, Horacio F

    2012-03-01

    We determined the effect of calcium supplementation on bone mineral density (BMD) and bone mineral content (BMC) and identified predictors of bone mass changes in adolescent mothers 6 months postpartum. A prospective, analytical, clinical study was performed in adolescent mothers (< or = 19 years old; n = 37) from La Plata, Argentina. At 15 days postpartum, mothers were randomly assigned into one of two groups and started with calcium supplementation; one group received dairy products (932 mg Ca; n = 19) and the other calcium citrate tablets (1000 mg calcium/day; n = 18). Weight, height and dietary intake were measured and BMD was determined by DEXA at 15 days (baseline) and 6 months postpartum. BMC, total body BMD and BMD were assessed in lumbar spine, femoral neck, trochanter and total hip. Regression models were used to identify the relationship of total body BMD and BMC with independent variables (calcium supplementation, months of lactation, weight at 6 months, percent weight change, lean mass at 6 months, percent lean mass change, total calcium intake). Results showed that changes in BMD and BMC at the different sites were similar in both groups, and changes in percent body weight and total calcium intake were the main predictive factors. In conclusion, the effect of calcium was similar with either form of supplementation, i.e., dairy products or tablets, and changes in percent body weight and total calcium intake were predictors of total body BMD and BMC changes. PMID:23477205

  9. Effects of breast milk and milk formula on synthesized speech sound-induced event-related potentials at 3 and 6 months of age

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Effects of breast milk and milk formula supplemented with docosahexaenoic acid and arachidonic acid on speech processing were investigated by recording event-related potentials (ERPs) to synthesized /pa/ and /ba/ (oddball paradigm, 80%:20%) at 3 and 6 months of age. Behavioral assessment was also ob...

  10. Emerging Perception of Causality in Action-and-Reaction Sequences from 4 to 6 Months of Age: Is It Domain-Specific?

    ERIC Educational Resources Information Center

    Schlottmann, Anne; Ray, Elizabeth D.; Surian, Luca

    2012-01-01

    Two experiments (N=136) studied how 4- to 6-month-olds perceive a simple schematic event, seen as goal-directed action and reaction from 3 years of age. In our causal reaction event, a red square moved toward a blue square, stopping prior to contact. Blue began to move away before red stopped, so that both briefly moved simultaneously at a…

  11. Effect of a 6-month school-based physical activity program on body composition and physical fitness in lean and obese schoolchildren.

    PubMed

    Thivel, David; Isacco, Laurie; Lazaar, Nordine; Aucouturier, Julien; Ratel, Sébastien; Doré, Eric; Meyer, Martine; Duché, Pascale

    2011-11-01

    Few studies have investigated the impact of school-based physical activity interventions on anthropometric characteristics concomitantly with aerobic and anaerobic capacities in young children. The present study aimed to assess the effect of a 6-month physical activity program on body composition and physical fitness among primary schoolchildren. Four hundred fifty-seven children aged 6 to 10 years were randomly assigned to the intervention group (229 children) or observational group (228 children). Participants' height and weight were assessed, and obesity was determined using French reference curves for BMI. The sum of the four skinfolds and fat-free mass were determined. Ground tests were used to assess aerobic (20-m shuttle run test) and anaerobic (cycling peak power) fitness before and after a 6-month physical activity intervention. The anthropometric modifications obtained over the 6 months cannot be attributed to the intervention as the ANOVA revealed no group effect (intervention vs. group). However, anaerobic and aerobic fitness were significantly improved, thanks to the program in both lean and obese children. A 6-month school-based physical activity intervention in 6- to 10-year-old children did not yield positive anthropometric improvements, but appears effective in terms of aerobic and anaerobic physical fitness. Two physical activity sessions per week in addition to standard physical education classes in primary schoolchildren bring effective results for the prevention of childhood obesity.

  12. Face Detection in Complex Visual Displays: An Eye-Tracking Study with 3- and 6-Month-Old Infants and Adults

    ERIC Educational Resources Information Center

    Di Giorgio, Elisa; Turati, Chiara; Altoe, Gianmarco; Simion, Francesca

    2012-01-01

    The ability to detect and prefer a face when embedded in complex visual displays was investigated in 3- and 6-month-old infants, as well as in adults, through a modified version of the visual search paradigm and the recording of eye movements. Participants "(N" = 43) were shown 32 visual displays that comprised a target face among 3 or 5…

  13. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up.

    PubMed

    Carlson, L E; Ursuliak, Z; Goodey, E; Angen, M; Speca, M

    2001-03-01

    The goals of this work were to assess the effects of participation in a mindfulness meditation-based stress reduction program on mood disturbance and symptoms of stress in cancer outpatients immediately after and 6 months after program completion. A convenience sample of eligible cancer patients were enrolled after they had given informed consent. All patients completed the Profile of Mood States (POMS) and Symptoms of Stress Inventory (SOSI) both before and after the intervention and 6 months later. The intervention consisted of a mindfulness meditation group lasting 1.5 h each week for 7 weeks, plus daily home meditation practice. A total of 89 patients, average age 51, provided pre-intervention data. Eighty patients provided post-intervention data, and 54 completed the 6-month follow-up The participants were heterogeneous with respect to type and stage of cancer. Patients' scores decreased significantly from before to after the intervention on the POMS and SOSI total scores and most subscales, indicating less mood disturbance and fewer symptoms of stress, and these improvements were maintained at the 6-month follow-up. More advanced stages of cancer were associated with less initial mood disturbance, while more home practice and higher initial POMS scores predicted improvements on the POMS between the pre- and post-intervention scores. Female gender and more education were associated with higher initial SOSI scores, and improvements on the SOSI were predicted by more education and greater initial mood disturbance. This program was effective in decreasing mood disturbance and stress symptoms for up to 6 months in both male and female patients with a wide variety of cancer diagnoses, stages of illness, and educational background, and with disparate ages.

  14. Comparative clinical evaluation of laterally positioned pedicle graft and subepithelial connective tissue graft in the treatment of Miller's Class I and II gingival recession: A 6 months study

    PubMed Central

    Dulani, Kirti Satish; Bhavsar, Neeta Vijay; Trivedi, Sakshee Rahul; Trivedi, Rahul Anil

    2015-01-01

    Aim: The purpose of the study was to compare clinical outcomes of laterally positioned pedicle graft (LPPG) and subepithelial connective tissue graft (SCTG) for treatment of Miller's Class I and II gingival recession defects, at the end of 6 months. Materials and Methods: Sixty Miller's Class I or II gingival recession defects (≥3 mm) (n = 30 each) on the labial aspect of anterior teeth were treated by either of the above techniques. Clinical parameters including recession depth (RD), width of keratinized gingiva (WKG), percentage of root coverage (%RC), and complete RC were recorded at baseline and 6 months postoperatively. Data were recorded and statistical analysis was done for both intergroup and intragroup. Statistical Analysis Used: Paired t-test intragroup and Student's t-test intergroup. Results: In LPPG, RD decreased from 4.9 ± 0.99 mm to 1.1 ± 0.3 mm and WKG increased from 0.7 ± 0.87 to 4.5 ± 0.86 mm at 6 months, while in SCTG, RD decreased from 4.67 ± 1.12 mm to 0.46 ± 0.68 mm and WKG increased from 1.1 ± 0.99 to 5.33 ± 0.72 mm at 6 months postoperatively. The values of the soft tissue coverage remained stable for 6 months. Conclusions: Highly significant and effective soft tissue coverage was obtained by both techniques. LPPG resulted in effective soft tissue coverage for isolated deep narrow defects while SCTG in isolated and multiple, deep narrow and wide defects. PMID:26941517

  15. The evolution of untreated borderline and subclinical rejections at first month kidney allograft biopsy in comparison with histological changes at 6 months protocol biopsies.

    PubMed

    Masin-Spasovska, J; Spasovski, G; Dzikova, S; Petrusevska, G; Dimova, B; Lekovski, Lj; Popov, Z; Ivanovski, N; Polenakovic, M

    2005-08-01

    Our study sought to identify the possible implications of histological findings of borderline and subclinical rejections as well as histological markers of chronic allograft nephropathy (CAN) in protocol biopsies at 1 and 6 months after living-related kidney transplantation. Twenty-eight paired allograft biopsies were blindly reviewed using Banff '97 criteria, among which only 10.7% (6/56) showed no histopathological lesions. BR was found in 9/28 (32.1%) and 6/28 (21.4%), and SR in 3/28 (10.7%) and 10/28 (35.7%) of the patients, in the 1 and 6 month biopsies, respectively. The mean CAN score (sum of histological markers for chronicity) increased significantly at 6 months biopsy, 1.57 +/- 1.36 vs. 4.36 +/- 2.32 (p < 0.01). When compared according to chronicity index (CI < 5 >), the high CI group had a mean CAN score of 2.36 +/- 1.15 at 1 month, which increased to 5.14 +/- 1.99 at 6 months biopsy (188.9%). The proportion of these changes in low CI group were also increased from 0.79 +/- 1.12 to 3.57 +/- 2.38 (451.9%). In conclusion, a protocol 1 month biopsy may uncover a high prevalence of BR or SR in stable allografts. The presence of an untreated BR or SR in biopsies with low chronicity index showed greater susceptibility to histological deterioration on the 6 month biopsy, associated with rapid impairment of graft function and chronic allograft nephropathy.

  16. An immersive “simulation week” enhances clinical performance of incoming surgical interns improved performance persists at 6 months follow-up

    PubMed Central

    Singh, Pritam; Aggarwal, Rajesh; Pucher, Philip H.; Hashimoto, Daniel A.; Beyer-Berjot, Laura; Bharathan, Rasiah; Middleton, Katherine E.; Jones, Joanne; Darzi, Ara

    2015-01-01

    Background The transition from student to intern can be challenging. The “August” or “July effect” describes increased errors and reduced patient safety during this transition. The study objectives were to develop, pilot, and evaluate clinical performance after an immersive simulation course for incoming interns. Methods Graduating students were recruited for a 1-week immersive simulation course. Controls received no simulation training. Primary outcome (at baseline, and 1 and 6 months) was clinical performance on Objective Structured Clinical Examinations (OSCE) of clinical procedures and surgical technical skills. Secondary outcomes were self-reported confidence and clinical procedure logbook data. Results Nineteen students were recruited. Sixteen completed the 6-month follow-up, 10 in the intervention group and 6 in the control group. No differences were demonstrated between interventions and controls at baseline (OSCE [median, 66 vs 78; P = .181], technical skills [48 vs 52.5; P = .381], and confidence [101 vs 96; P = .368]). Interventions outperformed controls at 1 month (OSCE [111 vs 82; P = .001], technical skills [78.5 vs 63; P = .030], and confidence [142 vs 119; P < .001]), and 6 months (OSCE [107 vs 93; P = .007], technical skills [92.5 vs 69; P = .044], and confidence [148 vs 129; P = .022]). No differences were observed in numbers of clinical procedures performed at 1 (P = .958), 4 (P = .093), or 6 months (P = .713). Conclusion The immersive simulation course objectively improved subjects’ clinical skills, technical skills, and confidence. Despite similar clinical experience as controls, the intervention group’s improved performance persisted at 6 months follow-up. This feasible and effective intervention to ease transition from student to intern could reduce errors and enhance patient safety. PMID:25633735

  17. Maintenance of Cognitive Performance and Mood for Individuals with Alzheimer's Disease Following Consumption of a Nutraceutical Formulation: A One-Year, Open-Label Study.

    PubMed

    Remington, Ruth; Bechtel, Cynthia; Larsen, David; Samar, Annemarie; Page, Robert; Morrell, Christopher; Shea, Thomas B

    2016-01-01

    Nutritional interventions have shown varied efficacy on cognitive performance during Alzheimer's disease (AD). Twenty-four individuals diagnosed with AD received a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) under open-label conditions (ClinicalTrials.gov NCT01320527). Primary outcome was cognitive performance. Secondary outcomes were behavioral and psychological symptoms of dementia (BPSD) and activities of daily living. Participants maintained their baseline cognitive performance and BPSD over 12 months. These findings are consistent with improvement in cognitive performance and BPSD in prior placebo-controlled studies with NF, and contrast with the routine decline for participants receiving placebo.

  18. Aripiprazole once-monthly 400 mg for long-term maintenance treatment of schizophrenia: a 52-week open-label study

    PubMed Central

    Peters-Strickland, Timothy; Baker, Ross A; McQuade, Robert D; Jin, Na; Eramo, Anna; Perry, Pamela; Johnson, Brian R; Duca, Anna; Sanchez, Raymond

    2015-01-01

    Background: Long-term maintenance treatment with an antipsychotic is often required to prevent relapse and mitigate functional deterioration in patients with schizophrenia. Aims: This study assessed the long-term safety, tolerability, and maintenance of the therapeutic effect of aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia. Methods: This 52-week, open-label study included patients previously enrolled in 1 of 2 AOM 400 randomized controlled trials (RCTs) and de novo patients. Safety endpoints included adverse events (AEs), suicidality, extrapyramidal symptoms, injection-site pain, and clinically relevant changes in clinical and laboratory values. The primary efficacy endpoint was the percentage of stable patients at baseline who remained stable at the last visit of the AOM 400 maintenance phase. All endpoints were assessed with descriptive statistics; there were no formal planned statistical analyses. Results: Of 1,247 patients screened, 1,178 enrolled in the study (194 de novo and 984 patients from the RCTs) and 1,081 received maintenance treatment with AOM 400. The maintenance phase completion rate was 79.4% at 52 weeks. Treatment-emergent AEs in ⩾5% of patients during open-label AOM 400 treatment were headache (7.6%), nasopharyngitis (7.0%), anxiety (6.8%), and insomnia (6.6%). There were no clinically relevant changes in safety parameters of interest. Ninety-five percent of stable patients at baseline remained stable at their last visit during the AOM 400 maintenance phase. Conclusions: The long-term safety and tolerability profile of AOM 400 was comparable to the RCTs, and the long-term therapeutic effect was maintained. PMID:27336044

  19. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study

    PubMed Central

    Dash, Amitabh; Ravat, Sangeeta; Srinivasan, Avathvadi Venkatesan; Shetty, Ashutosh; Kumar, Vivek; Achtani, Renu; Mathur, Vivek Narain; Maramattom, Boby Varkey; Bajpai, Veeresh; Manjunath, Nanjappa C; Narayana, Randhi Venkata; Mehta, Suyog

    2016-01-01

    A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed. PMID:27013882

  20. Adjunctive Triple Chronotherapy (Combined Total Sleep Deprivation, Sleep Phase Advance, and Bright Light Therapy) Rapidly Improves Mood and Suicidality in Suicidal Depressed Inpatients: An Open Label Pilot Study

    PubMed Central

    Sahlem, Gregory L.; Kalivas, Benjamin; Fox, James B.; Lamb, Kayla; Roper, Amanda; Williams, Emily N.; Williams, Nolan R.; Korte, Jeffrey E.; Zuschlag, Zachary D.; El Sabbagh, Salim; Guille, Constance; Barth, Kelly S.; Uhde, Thomas W.; George, Mark S.; Short, E.Baron

    2014-01-01

    Previous studies have demonstrated that combined total sleep deprivation (Wake therapy), sleep phase advance, and bright light therapy (Triple Chronotherapy) produce a rapid and sustained antidepressant effect in acutely depressed individuals. To date no studies have explored the impact of the intervention on unipolar depressed individuals with acute concurrent suicidality. Participants were suicidal inpatients (N=10, Mean age=44±16.4SD, 6F) with unipolar depression. In addition to standard of care, they received open label Triple Chronotherapy. Participants underwent one night of total sleep deprivation (33–36 hours), followed by a three-night sleep phase advance along with four 30-minute sessions of bright light therapy (10,000 lux) each morning. Primary outcome measures included the 17 item Hamilton depression scale (HAM17), and the Columbia Suicide Severity Rating Scale (CSSRS), which were recorded at baseline prior to total sleep deprivation, and at protocol completion on day five. Both HAM17, and CSSRS scores were greatly reduced at the conclusion of the protocol. HAM17 scores dropped from a mean of 24.7±4.2SD at baseline to a mean of 9.4±7.3SD on day five (p=.002) with six of the ten individuals meeting criteria for remission. CSSRS scores dropped from a mean of 19.5±8.5SD at baseline to a mean of 7.2±5.5SD on day five (p=.01). The results of this small pilot trial demonstrate that adjunctive Triple Chronotherapy is feasible and tolerable in acutely suicidal and depressed inpatients. Limitations include a small number of participants, an open label design, and the lack of a comparison group. Randomized controlled studies are needed. PMID:25231629

  1. Adjunctive triple chronotherapy (combined total sleep deprivation, sleep phase advance, and bright light therapy) rapidly improves mood and suicidality in suicidal depressed inpatients: an open label pilot study.

    PubMed

    Sahlem, Gregory L; Kalivas, Benjamin; Fox, James B; Lamb, Kayla; Roper, Amanda; Williams, Emily N; Williams, Nolan R; Korte, Jeffrey E; Zuschlag, Zachary D; El Sabbagh, Salim; Guille, Constance; Barth, Kelly S; Uhde, Thomas W; George, Mark S; Short, E Baron

    2014-12-01

    Previous studies have demonstrated that combined total sleep deprivation (Wake therapy), sleep phase advance, and bright light therapy (Triple Chronotherapy) produce a rapid and sustained antidepressant effect in acutely depressed individuals. To date no studies have explored the impact of the intervention on unipolar depressed individuals with acute concurrent suicidality. Participants were suicidal inpatients (N = 10, Mean age = 44 ± 16.4 SD, 6F) with unipolar depression. In addition to standard of care, they received open label Triple Chronotherapy. Participants underwent one night of total sleep deprivation (33-36 h), followed by a three-night sleep phase advance along with four 30-min sessions of bright light therapy (10,000 lux) each morning. Primary outcome measures included the 17 item Hamilton depression scale (HAM17), and the Columbia Suicide Severity Rating Scale (CSSRS), which were recorded at baseline prior to total sleep deprivation, and at protocol completion on day five. Both HAM17, and CSSRS scores were greatly reduced at the conclusion of the protocol. HAM17 scores dropped from a mean of 24.7 ± 4.2 SD at baseline to a mean of 9.4 ± 7.3 SD on day five (p = .002) with six of the ten individuals meeting criteria for remission. CSSRS scores dropped from a mean of 19.5 ± 8.5 SD at baseline to a mean of 7.2 ± 5.5 SD on day five (p = .01). The results of this small pilot trial demonstrate that adjunctive Triple Chronotherapy is feasible and tolerable in acutely suicidal and depressed inpatients. Limitations include a small number of participants, an open label design, and the lack of a comparison group. Randomized controlled studies are needed.

  2. Comparison of AIK-C measles vaccine in infants at 6 months with Schwarz vaccine at 9 months: a randomized controlled trial in Ghana.

    PubMed Central

    Nkrumah, F. K.; Osei-Kwasi, M.; Dunyo, S. K.; Koram, K. A.; Afari, E. A.

    1998-01-01

    In a randomized controlled trial in a measles endemic area, standard-dose (4.0 log10pfu) AIK-C measles vaccine administered at 6 months of age was compared to standard-dose Schwarz vaccine (3.7log10pfu) given at 9 months. Seroconversion rates at 3 and 6 months after immunization in the two groups were comparable and similar. The geometric mean titres achieved were, however, significantly higher in the Schwarz group (P < 0.05). No immediate serious side-effects were observed with either vaccine. We conclude that standard-dose AIK-C measles vaccine can be recommended for measles immunization in children below 9 months of age, especially in highly endemic and high-risk areas in developing countries. PMID:9803586

  3. Clinical and microbiological effects of a sanguinaria-containing mouthrinse and dentifrice with and without fluoride during 6 months of use.

    PubMed

    Kopczyk, R A; Abrams, H; Brown, A T; Matheny, J L; Kaplan, A L

    1991-10-01

    The purpose of this study was to test the efficacy and safety of sanguinaria-containing regimens with and without fluoride using the American Dental Association guidelines for evaluating chemotherapeutic agents. The study was a 6-month, double-blind, 4-cell, placebo-controlled, parallel investigation involving 120 subjects. Following screening procedures, subjects were randomly assigned to 4 groups. Group 1 received a dentifrice containing 0.075% sanguinaria extract (SaE) and 2.0% zinc chloride (ZnCl2) in a dicalcium phosphate base, plus an oral rinse containing 0.03% SaE and 0.2% ZnCl2. Group 2 received identical products without SaE or ZnCl2. Group 3 received a dentifrice containing 0.8% sodium monofluorophosphate, 0.075% SaE, and 0.05% ZnCl2 in a silica base, plus an oral rinse containing 0.03% SaE and 0.2% ZnCl2. Group 4 products were identical to those of Group 3 but without SaE and ZnCl2. Supragingival plaque and gingival inflammation were scored at 0, 1, 2, 1.5, 3, 4.5, and 6 months; bleeding upon probing was measured at 1, 1.5, 3, and 6 months. Microbiological samples were taken from plaque, tongue, and cheek areas. The active products produced statistically significantly lower scores than the placebo agents for all indices (P less than .0001). Six-month plaque scores were 13.1% lower for Group 1 and 17.4% lower for Group 3 compared to placebo products. When the Plaque Severity Index was applied, the percentage reductions were 33% for Group 1 and 41% for Group 3 compared to placebos. Gingival inflammation scores were 16.7% lower for Group 1 and 18.1% lower for Group 3 at 6 months compared to placebo scores.(ABSTRACT TRUNCATED AT 250 WORDS)

  4. Risk and Protective Factors for Suicidality at 6-Month Follow-up in Adolescent Inpatients Who Attempted Suicide: An Exploratory Model

    PubMed Central

    Consoli, Angèle; Cohen, David; Bodeau, Nicolas; Guilé, Jean-Marc; Mirkovic, Bojan; Knafo, Alexandra; Mahé, Vincent; Laurent, Claudine; Renaud, Johanne; Labelle, Réal; Breton, Jean-Jacques; Gérardin, Priscille

    2015-01-01

    Objective: To assess risk and protective factors for suicidality at 6-month follow-up in adolescent inpatients after a suicide attempt. Methods: One hundred seven adolescents from 5 inpatient units who had a suicide attempt were seen at 6-month follow-up. Baseline measures included sociodemographics, mood and suicidality, dependence, borderline symptomatology, temperament and character inventory (TCI), reasons for living, spirituality, and coping scores. Results: At 6-month follow-up, 41 (38%) subjects relapsed from suicidal behaviours. Among them, 15 (14%) had repeated a suicide attempt. Higher depression and hopelessness scores, the occurrence of a new suicide attempt, or a new hospitalization belonged to the same factorial dimension (suicidality). Derived from the best-fit structural equation modelling for suicidality as an outcome measure at 6-month follow-up, risk factors among the baseline variables included: major depressive disorder, high depression scores, and high scores for TCI self-transcendence. Only one protective factor emerged: coping–hard work and achievement. Conclusion: In this very high-risk population, some established risk factors (for example, a history of suicide attempts) may not predict suicidality. Our results suggest that adolescents who retain high scores for depression or hopelessness, who remain depressed, or who express a low value for life or an abnormally high connection with the universe are at higher risk for suicidality and should be targeted for more intense intervention. Improving adolescent motivation in school and in work may be protective. Given the sample size, the model should be regarded as exploratory. PMID:25886668

  5. Personality profile among symptomatic and recovered patients with neck sprain injury, measured by MCMI-I acutely and 6 months after car accidents.

    PubMed

    Borchgrevink, G E; Stiles, T C; Borchgrevink, P C; Lereim, I

    1997-04-01

    The relationships between personality and psychiatric symptoms and long-lasting physical symptoms were assessed in 88 neck sprain patients injured in car accidents. The Millon Clinical Multiaxial Inventory (MCMI-I) was completed at time of occurrence (intake) and 6 months after the injury. The neck sprain patients were divided into three subgroups according to symptoms 6 months after the accident. In addition, the total neck sprain group was compared with three other subject groups. The results indicated that the three neck sprain subgroups did not differ on the MCMI-I neither at intake nor 6 months later. The total neck sprain patients group was significantly different from patients with major depression on all scales of the MCMI-I, but not significantly different compared to patients with localized musculoskeletal pain. Compared to a group of health personnel, there were only a few significant differences. The study does not support the view that premorbid personality traits can predict outcome for neck sprain patients.

  6. Repairing the Brain by SCF+G-CSF Treatment at 6 Months Postexperimental Stroke: Mechanistic Determination of the Causal Link Between Neurovascular Regeneration and Motor Functional Recovery.

    PubMed

    Cui, Lili; Wang, Dandan; McGillis, Sandra; Kyle, Michele; Zhao, Li-Ru

    2016-06-01

    Stroke, a leading cause of adult disability in the world, is a severe medical condition with limited treatment. Physical therapy, the only treatment available for stroke rehabilitation, appears to be effective within 6 months post-stroke. Here, we have mechanistically determined the efficacy of combined two hematopoietic growth factors, stem cell factor (SCF) and granulocyte-colony stimulating factor (G-CSF; SCF + G-CSF), in brain repair 6 months after cortical infarct induction in the transgenic mice carrying yellow fluorescent protein in Layer V pyramidal neurons (Thy1-YFP-H). Using a combination of live brain imaging, whole brain imaging, molecular manipulation, synaptic and vascular assessments, and motor function examination, we found that SCF + G-CSF promoted mushroom spine formation, enlarged postsynaptic membrane size, and increased postsynaptic density-95 accumulation and blood vessel density in the peri-infarct cavity cortex; and that SCF + G-CSF treatment improved motor functional recovery. The SCF + G-CSF-enhanced motor functional recovery was dependent on the synaptic and vascular regeneration in the peri-infarct cavity cortex. These data suggest that a stroke-damaged brain is repairable by SCF + G-CSF even 6 months after the lesion occurs. This study provides novel insights into the development of new restorative strategies for stroke recovery. PMID:27511907

  7. Handgrip strength is an independent predictor of functional outcome in hip-fracture women: a prospective study with 6-month follow-up.

    PubMed

    Di Monaco, Marco; Castiglioni, Carlotta; De Toma, Elena; Gardin, Luisa; Giordano, Silvia; Tappero, Rosa

    2015-02-01

    The objective of this study was to investigate the contribution of handgrip strength in predicting the functional outcome after hip fracture in women.We prospectively investigated white women (N = 193 of 207) who were consecutively admitted to a rehabilitation hospital after a hip fracture. We measured handgrip strength with a Jamar dynamometer (Lafayette Instrument Co, Lafayette, IN), on admission to rehabilitation. Ability to function in activities of daily living was assessed by the Barthel index both on discharge from rehabilitation and at a 6-month follow-up.We found significant correlations between handgrip strength measured before rehabilitation and Barthel index scores assessed both on discharge from rehabilitation (ρ = 0.52, P < 0.001) and after 6 months (ρ = 0.49, P < 0.001). Significant associations between handgrip strength and Barthel index scores persisted after adjustment for age, comorbidities, pressure ulcers, medications in use, concomitant infections, body mass index, hip-fracture type, and Barthel index scores assessed both preinjury and on admission to rehabilitation (P = 0.001). Further adjustments for both Barthel index scores and Timed Up-and-Go test assessed at rehabilitation ending did not erase the significant association between handgrip strength and the Barthel index scores at the 6-month evaluation (P = 0.007). To define successful rehabilitation, we categorized the Barthel index scores as either high (85 or higher) or low (<85). The adjusted odds ratio for 1 SD increase in grip strength was 1.73 (95% confidence interval [CI] 1.05-2.84, P = 0.032) for having a high Barthel index score at the end of inpatient rehabilitation and 2.24 (95% CI 1.06-5.18) for having a high Barthel index score at the 6-month follow-up.Handgrip strength assessed before rehabilitation independently predicted the functional outcome both after inpatient rehabilitation and at a 6-month follow-up in hip-fracture women.

  8. The Relationship Between Balance Measured With a Modified Bathroom Scale and Falls and Disability in Older Adults: A 6-Month Follow-Up Study

    PubMed Central

    2015-01-01

    Background There are indications that older adults who suffer from poor balance have an increased risk for adverse health outcomes, such as falls and disability. Monitoring the development of balance over time enables early detection of balance decline, which can identify older adults who could benefit from interventions aimed at prevention of these adverse outcomes. An innovative and easy-to-use device that can be used by older adults for home-based monitoring of balance is a modified bathroom scale. Objective The objective of this paper is to study the relationship between balance scores obtained with a modified bathroom scale and falls and disability in a sample of older adults. Methods For this 6-month follow-up study, participants were recruited via physiotherapists working in a nursing home, geriatricians, exercise classes, and at an event about health for older adults. Inclusion criteria were being aged 65 years or older, being able to stand on a bathroom scale independently, and able to provide informed consent. A total of 41 nursing home patients and 139 community-dwelling older adults stepped onto the modified bathroom scale three consecutive times at baseline to measure their balance. Their mean balance scores on a scale from 0 to 16 were calculated—higher scores indicated better balance. Questionnaires were used to study falls and disability at baseline and after 6 months of follow-up. The cross-sectional relationship between balance and falls and disability at baseline was studied using t tests and Spearman rank correlations. Univariate and multivariate logistic regression analyses were conducted to study the relationship between balance measured at baseline and falls and disability development after 6 months of follow-up. Results A total of 128 participants with complete datasets—25.8% (33/128) male—and a mean age of 75.33 years (SD 6.26) were included in the analyses of this study. Balance scores of participants who reported at baseline that

  9. An Open-Label Study of Risperidone in the Improvement of Quality of Life and Treatment of Symptoms of Violent and Self-Injurious Behaviour in Adults with Intellectual Disability

    ERIC Educational Resources Information Center

    Read, Stephen G.; Rendall, Maureen

    2007-01-01

    Background: We examined the benefits of risperidone, including quality of life (QoL), in the treatment of violent and self-injurious behaviour in adults with moderate, severe or profound intellectual disability. Methods: Twenty-four participants received open-label, oral, flexible-dose risperidone of 0.5-6 mg/day for 12 weeks. Efficacy was…

  10. A Multicenter, Open-Label Trial to Evaluate the Quality of Life in Adults with ADHD Treated with Long-Acting Methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) Study

    ERIC Educational Resources Information Center

    Mattos, Paulo; Rodrigues Louza, Mario; Fernandes Palmini, Andre Luis; de Oliveira, Irismar Reis; Lopes Rocha, Fabio

    2013-01-01

    The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. Objective: To assess the effectiveness of Methyphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. Method: A 12-week, multicenter, open-label trial involving 60 patients was used. The…

  11. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

    PubMed Central

    Awasthi, Shally; Peto, Richard; Read, Simon; Richards, Susan M; Pande, Vinod; Bundy, Donald; the DEVTA (Deworming and Enhanced Vitamin A) team

    2013-01-01

    Summary Background In north India many pre-school children are underweight, many have intestinal worms, and 2–3% die at ages 1·0–6·0 years. We used the state-wide Integrated Child Development Service (ICDS) infrastructure to help to assess any effects of regular deworming on mortality. Methods Participants in this cluster-randomised study were children in catchment areas of 8338 ICDS-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks were cluster-randomly allocated in Oxford between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of albendazole effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial deworming to sample faeces (for presence of worm eggs, reliably assessed only after mid-study), weigh children, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at age 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly albendazole was 86%. Among 2589 versus 2576 children surveyed during the second half of the study, nematode egg prevalence was 16% versus 36%, and most infection was light. After at least 2 years of treatment, weight at ages 3·0–6·0 years (standardised to age 4·0 years, 50% male) was 12·72 kg albendazole versus 12·68 kg control (difference 0·04 kg, 95% CI −0·14 to 0·21, p=0·66). Comparing the 36 albendazole-allocated versus 36 control blocks in analyses of the primary outcome, deaths

  12. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

    PubMed Central

    Awasthi, Shally; Peto, Richard; Read, Simon; Clark, Sarah; Pande, Vinod; Bundy, Donald; the DEVTA (Deworming and Enhanced Vitamin A) team

    2013-01-01

    Summary Background In north India, vitamin A deficiency (retinol <0·70 μmol/L) is common in pre-school children and 2–3% die at ages 1·0–6·0 years. We aimed to assess whether periodic vitamin A supplementation could reduce this mortality. Methods Participants in this cluster-randomised trial were pre-school children in the defined catchment areas of 8338 state-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks (clusters) were cluster-randomly allocated in Oxford, UK, between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of retinol effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial vitamin A to sample blood (for retinol assay, technically reliable only after mid-study), examine eyes, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at ages 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly retinol supplements was 86%. Among 2581 versus 2584 children surveyed during the second half of the study, mean plasma retinol was one-sixth higher (0·72 [SE 0·01] vs 0·62 [0·01] μmol/L, increase 0·10 [SE 0·01] μmol/L) and the prevalence of severe deficiency was halved (retinol <0·35 μmol/L 6% vs 13%, decrease 7% [SE 1%]), as was that of Bitot's spots (1·4% vs 3·5%, decrease 2·1% [SE 0·7%]). Comparing the 36 retinol-allocated versus 36 control blocks in analyses of the primary outcome, deaths per child

  13. Long-term oxandrolone treatment increases muscle protein net deposition via improving amino acid utilization in pediatric patients 6 months after burn injury

    PubMed Central

    Tuvdendorj, D.; Chinkes, DL.; Zhang, XJ.; Suman, OE.; Aarsland, A.; Ferrando, A.; Kulp, GA; Jeschke, MG.; Wolfe, RR.; Herndon, DN.

    2011-01-01

    Background We recently showed that mechanisms of protein turnover in skeletal muscle are unresponsive to amino acid (AA) infusion in severely burned pediatric patients at 6 months postinjury. In the current study, we evaluated if oxandrolone treatment affects mechanisms of protein turnover in skeletal muscle and whole-body protein breakdown in pediatric burn patients 6 months postinjury. Methods At the time of admission, patients were randomized to control or oxandrolone treatments. The treatment regimens were continued until 6 months postinjury, at which time patients (n = 26) underwent study with a stable isotope tracer infusion to measure muscle and whole-body protein turnover. Results Protein kinetics in leg muscle were expressed in nmol/min/100 ml leg volume (mean±SE). During AA infusion, rates of protein synthesis in leg muscle were increased (p < .05) in both groups (Basal vs. AA: control, 51±8 vs. 86±21; oxandrolone, 56±7 vs. 96±12). In the control group, there was also a simultaneous increase in breakdown (Basal vs. AA: 65±10 vs. 89±25), which resulted in no change in the net balance of leg muscle protein (Basal vs. AA: − 15±4 vs. − 2±10). In the oxandrolone group, protein breakdown did not change (Basal vs. AA: 80±12 vs. 77±9), leading to increased net balance (Basal vs. AA: − 24±7 vs. 19±7, p < .05). Protein breakdown at the whole-body level was not different between the groups. Conclusion Long-term oxandrolone treatment increased net deposition of leg muscle protein during AA infusion by attenuating protein breakdown, but did not affect whole-body protein breakdown. PMID:21333314

  14. Evaluation of the teratological and dominant lethal potential of N,N-bis-(2-hydroxyethyl)-p-phenylenediamine sulphate in a 6-month feeding study in rats.

    PubMed

    Burnett, C M; Re, T A; Loehr, R F; Rodriguez, S C; Corbett, J F

    1986-08-01

    N,N-Bis-(2-hydroxyethyl)-p-phenylenediamine sulphate (N,N-Bis) was administered to 40 male and 45 female Sprague-Dawley rats per group by admixture with their diets at levels of 0.03, 0.1 and 0.3% for periods up to 6 months. Methaemoglobin levels were determined at wk 6. After 90 days ten animals/sex/group were killed for studies of possible target organs, haematology and blood chemistry. After 90 days, 25 females in each group were mated to untreated males in a teratology study. At wk 20, 20 males in each group were transferred from the test diets containing N,N-Bis to the control diet and were mated to untreated females in a dominant lethal study. The remaining animals were killed after 6 months for terminal studies (gross examination of organs, haematology and blood chemistry). The males used in the dominant lethal study were also killed at month 6, to serve as a comparison recovery group (gross examination of organs). Feeding of N,N-Bis at levels up to 0.3% in the diet caused a significant reduction in the body weight of male rats. The only signs of gross pathology after either 3 or 6 months of N,N-Bis feeding were darkened thyroids. This effect was noted in the high-dose group at both time intervals and, to a lesser extent, in the mid-dose group at month 6, and it was also seen in most of the high-dose recovery males and in a small number of mid-dose recovery males. No pathological effects were detected microscopically after the feeding of N,N-Bis for 90 days. N,N-Bis was not teratogenic, nor did it induce a dominant lethal effect in this study when administered to rats at levels including those causing borderline toxicity. PMID:3781436

  15. Reliability of ACR criteria over time to differentiate classic fibromyalgia from nonspecific widespread pain syndrome: a 6-month prospective cohort study.

    PubMed

    Bidari, Ali; Ghavidel-Parsa, Banafsheh; Ghalehbaghi, Babak

    2009-01-01

    American College of Rheumatology (ACR) 1990 criteria, initially introduced to classify fibromyalgia (FM) syndrome, has gained popularity in research and clinical grounds for diagnostic purposes. The objectives of this study were designed to assess the consistency of ACR criteria against the time in classifying FM. This was a prospective cohort study performed in a multidisciplinary pain clinic from October 2002 to June 2005. Patients who were clinically suspected of having FM and had a normal screening laboratory evaluation were scheduled for dolorimetry. Those found to have 6 or more tender points were considered eligible and labeled as either classic or atypical FM if they did or did not, respectively, fulfil ACR criteria. The 2 groups were assessed using the Fibromyalgia Impact Questionnaire (FIQ) and compared using baseline characteristics. We reassessed dolorimetric exam and FIQ 6 months later. Of 91 patients who participated in this study,70 completed the follow-up. Of them, 34 (49%) patients were identified as atypical, and 36 (51%) were labeled as classic FM. At first visit, the classic FM group had higher scores on sleep quality, stiffness, anxiety, depression, and total FIQ score (p\\0.05) but not for other variables. At 6 months, there was no significant difference between the 2 groups in all measured variables. Labeling shift from classic to atypical FM and vice versa occurred at a rate of 36.1 and 32.4%, respectively. This study showed the ACR 1990 criteria was not able to consistently classify affected patients with FM syndrome within a group of patients having nonspecific body pain and multiple tender points over 6 months of follow-up.

  16. Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up.

    PubMed

    Olivan-Blázquez, Bárbara; Herrera-Mercadal, Paola; Puebla-Guedea, Marta; Pérez-Yus, Mari-Cruz; Andrés, Eva; Fayed, Nicolas; López-Del-Hoyo, Yolanda; Magallon, Rosa; Roca, Miquel; Garcia-Campayo, Javier

    2014-12-01

    Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen's d=1.43 at 6 months) and pain measured with a sphygmomanometer (d=1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval=2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval=3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.

  17. Comparison of Physical Examination and Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography 4-6 Months After Radiotherapy to Assess Residual Head-and-Neck Cancer

    SciTech Connect

    Zundel, M. Tracy; Michel, Michelle A.; Schultz, Christopher J.; Maheshwari, Mohit; Wong, Stuart J.; Campbell, Bruce H.; Massey, Becky L.; Blumin, Joel; Wilson, J. Frank; Wang, Dian

    2011-12-01

    Purpose: To retrospectively compare fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) and physical examination 4-6 months after radiotherapy for assessing residual head-and-neck cancer (HNC). Methods and Materials: From July 2002 through March 2006, 52 HNC patients underwent definitive radiotherapy or chemoradiotherapy. Categoric assessments of residual tumor by PET/CT and physical examination 4-6 months after therapy were correlated and compared with clinical outcomes. Pretreatment data, including tumor stage and primary site standardized uptake value, were also gathered retrospectively and correlated with clinical outcomes. Median follow-up time was 58 months. Results: Twenty-one patients had either locoregionally 'positive' (17 of 21) or 'equivocal' (4 of 21) PET/CT scans, whereas 31 patients had locoregionally negative scans. Four patients failed treatment and had biopsy-confirmed residual or recurrent local disease. All patients, including patients with locally suspicious scans or examinations who refused biopsies, were followed clinically for a minimum of 29 months after therapy, with no other cases of treatment failure detected during this time. No patient had residual nodal disease after therapy. Sensitivities of PET/CT vs. physical examination for early detection of treatment failure were 100% vs. 50%, whereas the specificities of the two modalities were 64.6% vs. 89.6%, respectively. Higher initial T stage and American Joint Commission on Cancer stage correlated with increased incidence of positive/equivocal PET/CT results and treatment failure. Maximal standardized uptake value was not predictive of any clinical outcome. Conclusions: A negative result on PET/CT obtained 4-6 months after radiotherapy is highly sensitive and correlates with successful locoregional control. Patients with negative scans may reasonably be spared invasive diagnostic procedures, such as biopsy and neck dissection, unless recurrent disease is suspected

  18. Oxidoreductive homeostasis in alcohol-dependent male patients and the risk of alcohol drinking relapse in a 6-month follow-up.

    PubMed

    Budzyński, Jacek; Ziółkowski, Marcin; Kłopocka, Maria; Czarnecki, Damian

    2016-02-01

    Disturbances in the central signaling of reactive oxygen species (ROS) in response to energy intake are recognized as taking part in appetitive and consummative phases of eating disorders. This study aimed to verify the hypothesis that blood oxidoreductive balance can also affect demand for energy substances, such as alcoholic beverages in alcohol-dependent individuals, as well as the severity of their alcohol dependence and risk of drinking relapse. The following values were determined in the blood of 54 alcohol-dependent male patients after alcohol withdrawal, again after 4 weeks and after 6 months: the aldehyde products of lipid peroxidation (malonyl dialdehyde [MDA] and 4-hydroxynonenal [4-HNE]), nitric oxide (NO) metabolites, total antioxidant status (TAS), the blood activities of glutathione peroxidase (GSHpx), superoxide dismutase (SOD), glutathione reductase (GSHred), blood glucose, and lipids. Alcoholics who relapsed during 6 months of observation (n = 31, 57%) compared with patients who maintained alcohol abstinence for 6 months (n = 23, 43%) differed only in relation to initial and final NO metabolite serum concentrations. The risk of alcohol drinking relapse was lower in patients with an above-median initial blood concentration of NO metabolites and TAS. The oxidative stress parameters correlated with alcohol-dependence severity markers. No significant correlations between the studied antioxidant balance parameters and markers of nutritional status, including blood glucose and lipids, were found. Although the results of our study have some limitations and require further investigation, they suggest the role of oxidoreductive balance in the pathomechanisms of alcohol dependence and drinking relapse. In addition, due to a lack of association found between blood oxidative stress parameters and BMI, blood glucose, and lipid concentrations, they show the presence of disturbances in systemic ROS signaling in response to energy availability in alcoholics after

  19. Emerging perception of causality in action-and-reaction sequences from 4 to 6 months of age: is it domain-specific?

    PubMed

    Schlottmann, Anne; Ray, Elizabeth D; Surian, Luca

    2012-06-01

    Two experiments (N=136) studied how 4- to 6-month-olds perceive a simple schematic event, seen as goal-directed action and reaction from 3 years of age. In our causal reaction event, a red square moved toward a blue square, stopping prior to contact. Blue began to move away before red stopped, so that both briefly moved simultaneously at a distance. Primarily, our study sought to determine from what age infants see the causal structure of this reaction event. In addition, we looked at whether this causal percept depends on an animate style of motion and whether it correlates with tasks assessing goal perception and goal-directed action. Infants saw either causal reactions or noncausal delayed control events in which blue started some time after red stopped. These events involved squares that moved either rigidly or nonrigidly in an apparently animate manner. After habituation to one of the four events, infants were tested on reversal of the habituation event. Spatiotemporal features reversed for all events, but causal roles changed only in reversed reactions. The 6-month-olds dishabituated significantly more to reversal of causal reaction events than to noncausal delay events, whereas younger infants reacted similarly to reversal of both. Thus, perceptual causality for reaction events emerges by 6 months of age, a younger age than previously reported but, crucially, the same age at which perceptual causality for launch events has emerged in prior research. On our second question, animate/inanimate motion had no effect at any age, nor did significant correlations emerge with our additional tasks assessing goal perception or goal-directed object retrieval. Available evidence, here and elsewhere, is as compatible with a view that infants initially see A affecting B, without differentiation into physical or psychological causality, as with the standard assumption of distinct physical/psychological causal perception.

  20. [Infant nutrition in Switzerland 1978. A prospective study on the nutritional habits during the first 6 months of life. I. Natural nutrition: breast feeding].

    PubMed

    Tönz, O; Schwaninger, U; Holzherr, E; Schafroth, M

    1980-06-14

    With the help of 55 nurses counseling young mothers in northern, central and eastern Switzerland the feeding habits of 371 infants born in March and April 1978 were studied during the first 6 months of life. Infants who were still breastfed at the end of the observation period were monitored for another 6 months. 92% of all infants were breastfed during the puerperium (62% receiving exclusively mother's milk). At the end of the second month some 60% of the infants were breast-fed (40% exclusively). At the end of the fourth month the numbers were 30% (15%) and after 6 months 18% (2%). The "mean corrected nursing period" was 10.25 weeks. The length of this period showed a direct correlation with the socioeconomic class of the family and especially with the educational status of the mother. A small difference in duration of the nursing period between male and female infants was not statistically significant, although during childbed there was a significant difference in favour of boys. There appeared to be a relationship between duration of nursing and age, parity and bodyweight of the mother. There were marked differences in frequency and duration of breast-feeding according to whether rooming-in was practiced during childbed or not. At the end of the first half year of life babies with a long nursing period had a significantly lower body weight than those with partial or no breastfeeding. A much smaller difference in body length resulted in a lower and probably more favourable weight/length ratio. There was no difference in head circumference. As compared with other industralized European countries, the authors regard current nursing habits in Switzerland as satisfactory.

  1. Increased cancer awareness among British adolescents after a school-based educational intervention: a controlled before-and-after study with 6-month follow-up

    PubMed Central

    2013-01-01

    Background There is a lack of evidence around the effectiveness of school-based interventions designed to raise adolescents’ cancer awareness. To address this deficit this study assessed the impact of an intervention delivered in the United Kingdom by Teenage Cancer Trust on: recall (open question) and recognition (closed question) of cancer warning signs; knowledge of common childhood, teenage, male and female cancers; awareness of the relationship between cancer and age; anticipated medical help-seeking delay; perceived barriers to seeking medical advice about cancer; and examined variation of intervention effect by gender and whether adolescents reported that they knew someone with cancer. Methods The Cancer Awareness Measure (CAM) was completed by 422 adolescents (male: 221, 52.4%) aged 11-17 years old (mean age=13.8, standard deviation=1.26) two weeks before and two weeks after the intervention in three schools, and on two occasions four weeks apart in a fourth (control) school. Intervention schools were followed-up 6-months post-intervention. Results Recognition of nine common cancer warning signs significantly increased two weeks after the intervention (4.6 to 6.8, p<0.001) and was maintained at 6-month follow-up (6.2, p<0.001). Endorsement of emotional barriers to help-seeking ‘not confident to talk about symptoms’ (53% to 45%, p=0.021) and ‘worried about what the doctor might find’ (70% to 63%, p=0.021) significantly decreased two weeks after the intervention but changes were not maintained at 6-months. The intervention had a greater impact on females and those who knew someone with cancer. Conclusions The intervention is an effective way to raise adolescents’ cancer awareness, especially of cancer symptoms. Further development and evaluation is required to maximise intervention impact, particularly on barriers to help-seeking behaviour. PMID:23496855

  2. A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes

    PubMed Central

    Soare, A; Del Toro, R; Khazrai, Y M; Di Mauro, A; Fallucca, S; Angeletti, S; Skrami, E; Gesuita, R; Tuccinardi, D; Manfrini, S; Fallucca, F; Pianesi, M; Pozzilli, P

    2016-01-01

    Background: In the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. Subjects: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27–45 kg m−2; age, 40–75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel. Results: A significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (−11.27% (95% confidence interval (CI): −10.17; −12.36)) compared with the control group (−5.88% (95% CI: −3.79; −7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI: 2.56; 7.61) and body weight (95% CI: 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI: −1.52; −33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl−1 and <100 mg dl−1, respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol−1)) at 6 months. Conclusions: Both the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow

  3. Unusual pediatric co-morbility: autoimmune thyroiditis and cortico-resistant nephrotic syndrome in a 6-month-old Italian patient.

    PubMed

    Urbano, Flavia; Acquafredda, Angelo; Aceto, Gabriella; Penza, Rosa; Cavallo, Luciano

    2012-10-23

    We report on a case of autoimmune thyroiditis in a 6-month-old patient with cortico-resistant nephrotic syndrome. Normal serum levels of thyroid hormons and thyroid-stimulating hormone were detected with high titers of circulant antithyroid antibodies and a dysomogeneous ultrasound appearance of the gland, typical of autoimmune thyroiditis. The research of maternal thyroid antibodies was negative. This is the first case of autoimmune thyroiditis found in such a young patient with pre-existing nephrotic syndrome ever described in literature. This association is random because nephrotic syndrome does not have an autoimmune pathogenesis and the genes involved in autoimmune thyroiditis are not related to those of nephrotic syndrome.

  4. Verapamil-sensitive idiopathic left ventricular tachycardia in a 6-month-old: unique considerations in diagnosis and management in an infant.

    PubMed

    Hiremath, Gurumurthy; Li, Walter; Foltz, Rhonda; Roy-Burman, Arup; Cocalis, Mark; Tanel, Ronn E

    2015-01-01

    Idiopathic left ventricular tachycardia of the Belhassen type is rare in infants. We present a 6-month-old infant girl with a wide-complex tachycardia with right bundle branch block QRS morphology, a superior axis, and atrioventricular dissociation, consistent with a left anterior fascicular tachycardia. Initial echocardiogram revealed depressed ventricular function. The tachycardia was unresponsive to therapeutic trials of adenosine, esmolol, procainamide, and lidocaine. There was brief conversion of the tachycardia to sinus rhythm with transesophageal atrial overdrive pacing, suggesting a reentrant mechanism of the arrhythmia. Ultimately, the judicious administration of intravenous verapamil resulted in termination of the arrhythmia, which has been sustained on oral therapy. PMID:25526021

  5. The use of a virtual reality surgical simulator for cataract surgical skill assessment with 6 months of intervening operating room experience

    PubMed Central

    Sikder, Shameema; Luo, Jia; Banerjee, P Pat; Luciano, Cristian; Kania, Patrick; Song, Jonathan C; Kahtani, Eman S; Edward, Deepak P; Towerki, Abdul-Elah Al

    2015-01-01

    Purpose To evaluate a haptic-based simulator, MicroVisTouch™, as an assessment tool for capsulorhexis performance in cataract surgery. The study is a prospective, unmasked, nonrandomized dual academic institution study conducted at the Wilmer Eye Institute at Johns Hopkins Medical Center (Baltimore, MD, USA) and King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Methods This prospective study evaluated capsulorhexis simulator performance in 78 ophthalmology residents in the US and Saudi Arabia in the first round of testing and 40 residents in a second round for follow-up. Results Four variables (circularity, accuracy, fluency, and overall) were tested by the simulator and graded on a 0–100 scale. Circularity (42%), accuracy (55%), and fluency (3%) were compiled to give an overall score. Capsulorhexis performance was retested in the original cohort 6 months after baseline assessment. Average scores in all measured metrics demonstrated statistically significant improvement (except for circularity, which trended toward improvement) after baseline assessment. A reduction in standard deviation and improvement in process capability indices over the 6-month period was also observed. Conclusion An interval objective improvement in capsulorhexis skill on a haptic-enabled cataract surgery simulator was associated with intervening operating room experience. Further work investigating the role of formalized simulator training programs requiring independent simulator use must be studied to determine its usefulness as an evaluation tool. PMID:25653496

  6. A preliminary 6-month prospective study examining self-reported religious preference, religiosity/spirituality, and retention at a Jewish residential treatment center for substance-related disorders.

    PubMed

    Parhami, Iman; Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W

    2014-07-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients' R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders.

  7. Histological and Histomorphometric Human Results of HA-Beta-TCP 30/70 Compared to Three Different Biomaterials in Maxillary Sinus Augmentation at 6 Months: A Preliminary Report

    PubMed Central

    Annibali, Susanna; Iezzi, Giovanna; Sfasciotti, Gian Luca; Cristalli, Maria Paola; Vozza, Iole; Mangano, Carlo; La Monaca, Gerardo; Polimeni, Antonella

    2015-01-01

    Objective. The aim of this investigation was to examine the bone regenerative potential of newly biphasic calcium phosphate ceramics (HA-β-TCP 30/70), by assessing histological and histomorphometric results of human specimens retrieved from sinuses augmented with HA-β-TCP 30/70, and comparing them to anorganic bovine bone (ABB), mineralized solvent-dehydrated bone allograft (MSDBA), and equine bone (EB), after a healing period of 6 months. Materials and Methods. Four consecutive patients with edentulous atrophic posterior maxilla were included in this report. A two-stage procedure was carried out for sinus augmentation with HA-β-TCP 30/70, ABB, MSDBA, and EB. After 6 months, specimens were retrieved at the time of implant placement and processed for histological and histomorphometric analyses. Results. At histological examination, all biomaterials were in close contact with the newly formed bone and showed the same pattern of bone formation; the grafted granules were surrounded by a bridge-like network of newly formed bone. A limited number of ABB particles were partially covered by connective tissue. The histomorphometric analysis revealed 30.2% newly formed bone for Ha-β-TCP 30/70, 20.1% for ABB, 16.4% for MSDBA, and 21.9% for EB. Conclusions. Within the limitations of the present investigation, these results support the successful use of HA-β-TCP 30/70 for sinus augmentation. PMID:26273589

  8. Effect of 6 months use of a dentifrice and oral rinse containing sanguinaria extract and zinc chloride upon the microflora of the dental plaque and oral soft tissues.

    PubMed

    Harper, D S; Mueller, L J; Fine, J B; Gordon, J; Laster, L L

    1990-06-01

    This study documented the effect upon the oral flora of twice daily brushing with a dentifrice containing 0.075% sanguinaria extract and 2% zinc chloride, followed by use of a mouthrinse containing 0.03% sanguinaria extract and 0.2% zinc chloride. Sixty subjects were randomly assigned to treatment or placebo groups and monitored in a 6-month double-blind clinical trial. Bacteriological samples from the tongue, buccal mucosa, and supra- and subgingival plaque were characterized at 0, 14, and 28 weeks. Microbiological monitoring showed no increases in populations of yeast, staphylococci, coliform organisms, or Pseudomonas. Total Gram-negative counts in supragingival plaque samples decreased 83% in the active group compared to a 232% increase for the control group. Populations of B. intermedius in supragingival plaque were significantly lower in the active group at 3 months and significantly lower counts of Fusobacterium sp. were observed at 3 and 6 months. Results indicate that use of the test products did not promote opportunistic overgrowth of pathogens in the oral flora. Additionally, the alterations in organisms associated with gingivitis may account for reductions in gingivitis seen in the active group.

  9. A Preliminary 6-Month Prospective Study Examining Self-reported Religious Preference, Religiosity/Spirituality, and Retention at a Jewish Residential Treatment Center for Substance-Related Disorders

    PubMed Central

    Davtian, Margarit; Collard, Michael; Lopez, Jean; Fong, Timothy W.

    2012-01-01

    Although there is a substantial amount of research suggesting that higher levels of religiosity/spirituality (R/S) are associated with better treatment outcomes of substance-related disorders, no studies have explored this relationship at a faith-based residential treatment center. The objective of this prospective study is to explore the relationship between R/S, self-reported religious preference, and retention at a Jewish residential treatment center for substance-related disorders. Using the Daily Spiritual Experience Scale, R/S levels were assessed for 33 subjects at baseline, 1 month, 3 months, and 6 months. Results demonstrated a significant relationship between baseline R/S level and retention at 6 months, while R/S levels were unchanged during the course of treatment. Notably, no relationship was found between self-reported religious affiliation and retention. This study demonstrates that patients’ R/S level, rather than religious affiliation, is a possible predictor for better outcome at faith-based residential centers for substance-related disorders. PMID:22460083

  10. Antimicrobial comparison on effectiveness of endodontic therapy and endodontic therapy combined with photo-disinfection on patients with periapical lesion: a 6 month follow-up

    NASA Astrophysics Data System (ADS)

    Garcez, Aguinaldo S.; Núñez, Silvia C.; Hamblin, Michael R.; Ribeiro, Martha S.

    2008-03-01

    This study compares the antimicrobial effect of photodynamic therapy (PDT) combined to endodontic treatment with conventional endodontic treatment alone in patients with necrotic pulp and has a 6-month radiographic follow up comparing the healing of periapical lesions. Fifteen patients with periapical lesion and requiring root canal treatment were selected. Microbiological samples were taken after accessing the root canal, conventional manual endodontic therapy (group 1 n=5) and after accessing the canal, endodontic therapy and PDT (group 2 n=10). All the root canals were filled with a calcium hydroxide paste for 1 week. Radiographs were taken after obturation and following 6 months. Endodontic therapy alone presented an 87% reduction in microorganisms while the combination with PDT had a 95% reduction. Radiographic follow up showed 32% higher reduction in the lesion area in PDT group. Results suggest that the use of PDT added to conventional endodontic treatment leads to a further major reduction of microbial load. PDT is an efficient alternative to chemical antimicrobial agents. It is a non-cumulative local treatment, which may be an appropriate approach for the treatment of infections in the oral cavity.

  11. Infant feeding practices in the first 6 months and associated factors in a rural and semiurban community in Mangochi District, Malawi.

    PubMed

    Kamudoni, Penjani; Maleta, Kenneth; Shi, Zumin; Holmboe-Ottesen, Gerd

    2007-11-01

    This cross-sectional study aimed at investigating infant feeding practices and their sociodemographic correlates in Mangochi District, Malawi. Questionnaire data from 157 rural and 192 semiurban mother-infant pairs were obtained. Early breastfeeding (< 1 hour after delivery) was practiced among 68.2% of the rural and 63% of the semiurban mothers. Colostrum was given by 96% of the sampled mothers. Exclusive breastfeeding rates in the sample at 2, 4, and 6 months were 39.1%, 27.5%, and 7.5%, respectively. At 4 months, exclusive breastfeeding was significantly higher in the semiurban (46.8%) than in the rural (4.7%) group. Living in the rural area (OR = 1.87; 95% CI 1.26-2.76) and giving birth outside a health facility (OR = 1.36; 95% CI 1.00-1.85) were risk factors for stopping exclusive breastfeeding before 6 months. The results suggest that semiurban mothers are more likely to practice optimum breastfeeding and that health facilities have an important role in its promotion.

  12. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial.

    PubMed

    Nelissen, Rik C; den Besten, Christine A; Mylanus, Emmanuel A M; Hol, Myrthe K S

    2016-01-01

    The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test-control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.

  13. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study

    PubMed Central

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun

    2016-01-01

    Objective The purpose of this study was to investigate the efficacy and tolerability of atypical antipsychotics (AAPs) with augmentation by blonanserin in schizophrenic patients. Methods aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study. Blonanserin was added to their existing AAP regimen, which was maintained during the study period. Efficacy was primarily evaluated using the Positive and Negative Syndrome Scale (PANSS) at baseline and at weeks 2, 4, 8, and 12. Predictors for PANSS response (≥20% reduction) were investigated. Results The PANSS total score was significantly decreased at 12 weeks of blonanserin augmentation (-21.0±18.1, F=105.849, p<0.001). Moreover, 51.0% of participants experienced a response at week 12. Premature discontinuation of blonanserin occurred in 17 patients (17.0%); 4 of these patients dropped out due to adverse events. The patients who benefited the most from blonanserin were those with severe symptoms despite a treatment with a higher dose of AAP. Conclusion Blonanserin augmentation could be an effective strategy for patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP. PMID:27482249

  14. Efficacy and Tolerability of Paliperidone Extended-release in the Treatment of First-episode Psychosis: An Eight-week, Open-label, Multicenter Trial

    PubMed Central

    Kang, Nam-In; Koo, Bon-Hoon; Kim, Sung-Wan; Kim, Jong-Hoon; Nam, Beomwoo; Lee, Bong-Ju; Lee, Sang-Hyuk; Lee, Seung Jae; Lee, Seung-Hwan; Jung, Myung Hun; Hahn, Sang Woo; Chung, Young-Chul

    2016-01-01

    Objective We investigated the efficacy and tolerability of paliperidone extended-release (ER) tablets in patients with first-episode psychosis (n=75). Methods This was an 8-week, open-label, multicenter trial. The primary outcome variable was scores on the Positive and Negative Syndrome Scale (PANSS); secondary measures included the Scale for the Assessment of Negative Symptoms (SANS), the Cognitive Assessment Interview (CAI), and the Global Assessment of Functioning (GAF). To assess safety, we measured drug-related adverse events, weight, lipid-related variables, and prolactin and administered the Simpson–Angus Rating Scale (SARS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Scale (BAS), the Arizona Sexual Experiences Scale (ASEX), and the Udvalg for Kliniske Undersogelser side effect rating scale (UKU). Results The administration of paliperidone ER resulted in significant improvement in the PANSS, SANS, CAI, and GAF scores (p<0.001) over time. This improvement was evident as early as 1 week. The most frequent adverse events were akathisia, somnolence, anxiety, and sedation, which were well tolerated. Modest increases in weight and lipid profiles were also noted. Prolactin levels were substantially increased at the endpoint in both male and female patients. Conclusion These results indicate that paliperidone ER is effective and is characterized by good tolerability in the treatment of positive and negative symptoms and cognitive functioning in first-episode psychosis. PMID:27489380

  15. Omega-3 fatty acids in the management of autism spectrum disorders: findings from an open-label pilot study in Singapore.

    PubMed

    Ooi, Y P; Weng, S-J; Jang, L Y; Low, L; Seah, J; Teo, S; Ang, R P; Lim, C G; Liew, A; Fung, D S; Sung, M

    2015-08-01

    The goal of this open-label trial was to examine the efficacy and safety of a 12-week omega-3 fatty acids supplementation among children suffering with Autism Spectrum Disorders (ASD). A total of 41 children and adolescents aged 7-18 years (36 boys, 5 girls; mean age = 11.66, s.d. = 3.05) diagnosed with ASD participated in the study. At post-treatment, participants showed significant improvements on all subscales of the Social Responsiveness Scale (P < 0.01) and the Social and Attention Problems syndrome scales of the Child Behavior Checklist (P < 0.05). Blood fatty acid levels were significantly correlated with changes in the core symptoms of ASD. Baseline levels of blood fatty acid levels were also predictive of response to the omega-3 treatment. Omega-3 fatty acids supplementation was well-tolerated and did not cause any serious side effects. Our findings lend some preliminary support for the use of omega-3 fatty acids supplementation in addressing ASD. Future randomized controlled trials of omega-3 fatty acids in ASD with blood fatty acid measurements with a larger sample and longer follow-up period is warranted.

  16. Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study.

    PubMed

    Simpson, Eric; Trookman, Nathan S; Rizer, Ronald L; Preston, Norman; Colón, Luz E; Johnson, Lori A; Gottschalk, Ronald W

    2012-01-01

    Improving skin barrier function and moisturizing without irritation are important components of managing patients with atopic dermatitis. This study evaluated the safety and tolerability of a body wash and moisturizer regimen for infants and toddlers with atopic dermatitis. This was an open-label study involving 56 children (3-36 months old) with a history of atopic dermatitis. The skin care regimen (Cetaphil Restoraderm Skin Restoring Body Wash and Cetaphil Restoraderm Skin Restoring Moisturizer; Galderma Laboratories, L.P.) was used at least once daily, but no more than twice daily, for 4 weeks. The primary variable of interest was the worst postbaseline scores for local tolerability (expressed as success or failure) using a 4-point scale for each component (erythema, edema, scaling and dryness, rash, and signs of discomfort upon application). Assessments of moisture content of the stratum corneum and transepidermal water loss were also performed. Fifty-three children completed the study. The percentage of subjects with no erythema increased from 33.9% to 50.0% by Week 4. The percentage of subjects with no scaling or dryness increased from 58.9% to 85.2% at Week 4. A statistically significant increase in corneometry from baseline (p < 0.001) and a statistically significant decrease in transepidermal water loss (p = .009) were observed. The body wash and moisturizer regimen was safe and well tolerated and improved hydration and skin barrier function in infants and toddlers as young as 3 months of age with a history of atopic dermatitis.

  17. FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis.

    PubMed

    Raghu, Ganesh; Scholand, Mary Beth; de Andrade, João; Lancaster, Lisa; Mageto, Yolanda; Goldin, Jonathan; Brown, Kevin K; Flaherty, Kevin R; Wencel, Mark; Wanger, Jack; Neff, Thomas; Valone, Frank; Stauffer, John; Porter, Seth

    2016-05-01

    FG-3019 is a fully human monoclonal antibody that interferes with the action of connective tissue growth factor, a central mediator in the pathogenesis of fibrosis.This open-label phase 2 trial evaluated the safety and efficacy of two doses of FG-3019 administered by intravenous infusion every 3 weeks for 45 weeks in patients with idiopathic pulmonary fibrosis (IPF). Subjects had a diagnosis of IPF within the prior 5 years defined by either usual interstitial pneumonia (UIP) pattern on a recent high-resolution computed tomography (HRCT) scan, or a possible UIP pattern on HRCT scan and a recent surgical lung biopsy showing UIP pattern. Pulmonary function tests were performed every 12 weeks, and changes in the extent of pulmonary fibrosis were measured by quantitative HRCT scans performed at baseline and every 24 weeks.FG-3019 was safe and well-tolerated in IPF patients participating in the study. Changes in fibrosis were correlated with changes in pulmonary function.Further investigation of FG-3019 in IPF with a placebo-controlled clinical trial is warranted and is underway.

  18. Evaluation of clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion in dermatophytosis : an open label, non comparative multicentre study.

    PubMed

    Jerajani, H R; Amladi, S T; Bongale, R; Adepu, V; Tendolkar, U M; Sentamilselvi, G; Janaki, V R; Janaki, C; Vidhya, S; Marfatia, Y S; Patel, K; Sharma, N; Cooverji, N D

    2000-01-01

    The clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion was assessed in an open label, non comparative trial in tinea cruris, tinea corporis and tinea pedis patients. In treated patients, severity scores of erythema, pruritus, scaling, vesicles, papules and burning showed a progressive fall over a period of 4 weeks at all the study centres. With lotion, mean percentage improvement of symptoms varied from 35% (week 1) to 87.6 - 98.7% (week 4). With cream, it varied from 35% (week 1) to 82.5 - 99.5% (week 4). Overall global evaluation response showed clear, excellent and good response in 60%, 21% and 17% of the patients treated with lotion respectively. With cream, excellent and good response was observed in 71%, 10% and 16% of the patients respectively. In T. pedis patients, clear, excellent and good response was observed in 4/8, 2/8 and 1/8 patients respectively with lotion. Cream showed clear (8/15), excellent (4/15) and good (1/15) in these patients. None of the patients out of 178 enrolled, reported any side effect during the trial.

  19. Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting – an open-label, multicenter study

    PubMed Central

    Kühne, Ulrich; Esmann, Jørgen; von Heimburg, Dennis; Imhof, Matthias; Weissenberger, Petra; Sattler, Gerhard

    2016-01-01

    Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications. PMID:27799807

  20. The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

    PubMed

    Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

    2015-11-01

    In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein.

  1. Combination treatment of fingolimod with antidepressants in relapsing–remitting multiple sclerosis patients with depression: a multicentre, open-label study – REGAIN

    PubMed Central

    Bayas, Antonios; Schuh, Katrin; Baier, Monika; Vormfelde, Stefan Viktor; Koppai-Reiner, Joachim

    2016-01-01

    Objectives: Approximately one in two patients with multiple sclerosis (MS) suffer from comorbid depression. The primary objective of this study was to evaluate the safety and tolerability of fingolimod and antidepressant combination in relapsing–remitting MS patients with mild-to-moderate depression. Efficacy outcome variables were quality of life (QoL), fatigue, disability and depression. Methods: Patients received open-label fingolimod 0.5 mg over 2 weeks, followed by fingolimod plus citalopram (40 mg), fluoxetine (40 mg) or venlafaxine (150 mg) over 16 weeks. The antidepressant was selected at the physician’s discretion. Results: In total, 54 patients were recruited at 25 centres across Germany. No new safety signals (including cardiac) emerged compared with previous clinical studies. Adverse events (mostly mild-to-moderate) were reported in 43 patients. A total of three patients had serious adverse events and 10 discontinued the study. QoL (mean [95% confidence interval]) improved by 2.2 (−3.3, −1.2; Patient Reported Indices for MS questionnaire), fatigue by 8.2 (−13.1, −3.3; modified Fatigue Impact Scale) and depression by 6.3 (−8.4, −4.2; Hamilton Depression Scale) points. However, the results must be interpreted cautiously owing to limited patient numbers. Conclusions: Combination of fingolimod with antidepressant medication showed no unexpected safety signals. Patient-reported outcomes (QoL, disability, fatigue and depression) remained stable or improved. PMID:27582893

  2. Effect of osmotic-release oral system methylphenidate on learning skills in adolescents with attention-deficit/hyperactivity disorder: an open-label study.

    PubMed

    Na, Kyoung-Sae; Lee, Soyoung Irene; Hong, Sungdo David; Kim, Ji-Hoon; Shim, Se-Hoon; Choi, Jeewook; Yang, Jaewon; Lee, Moon-Soo; Joung, Yoo-Sook; Kim, Eui-Jung; Park, Joon-Ho

    2013-07-01

    We evaluated the effect of osmotic-release oral system (OROS) methylphenidate on learning skills in adolescents with attention-deficit/hyperactivity disorder (ADHD). In an open-label study, 121 adolescents with ADHD were administered flexible doses of OROS methylphenidate for 12 weeks. The efficacy of methylphenidate on ADHD symptoms was evaluated by ADHD Rating Scale (ARS) and Clinical Global Impression Scale (CGI). Learning Skills Test (LST) was used to measure the learning skills of the participants at the baseline and the endpoint. Continuous performance test, visuospatial and verbal working memory, verbal fluency, and inhibition were evaluated before and after the 12 weeks of treatment. The mean total and subscores of LST were significantly increased after the 12-week treatment with OROS methylphenidate. Executive functions were also improved during the trial, with the exception of inhibition measured by the Stroop Test. To the best of our knowledge, this is the first study to examine the influence of OROS methylphenidate on learning skill. As a result, OROS methylphenidate was effective in enhancing learning skills in adolescents with ADHD.

  3. Wearing blue light-blocking glasses in the evening advances circadian rhythms in the patients with delayed sleep phase disorder: An open-label trial.

    PubMed

    Esaki, Yuichi; Kitajima, Tsuyoshi; Ito, Yasuhiro; Koike, Shigefumi; Nakao, Yasumi; Tsuchiya, Akiko; Hirose, Marina; Iwata, Nakao

    2016-01-01

    It has been recently discovered that blue wavelengths form the portion of the visible electromagnetic spectrum that most potently regulates circadian rhythm. We investigated the effect of blue light-blocking glasses in subjects with delayed sleep phase disorder (DSPD). This open-label trial was conducted over 4 consecutive weeks. The DSPD patients were instructed to wear blue light-blocking amber glasses from 21:00 p.m. to bedtime, every evening for 2 weeks. To ascertain the outcome of this intervention, we measured dim light melatonin onset (DLMO) and actigraphic sleep data at baseline and after the treatment. Nine consecutive DSPD patients participated in this study. Most subjects could complete the treatment with the exception of one patient who hoped for changing to drug therapy before the treatment was completed. The patients who used amber lens showed an advance of 78 min in DLMO value, although the change was not statistically significant (p = 0.145). Nevertheless, the sleep onset time measured by actigraph was advanced by 132 min after the treatment (p = 0.034). These data suggest that wearing amber lenses may be an effective and safe intervention for the patients with DSPD. These findings also warrant replication in a larger patient cohort with controlled observations. PMID:27322730

  4. Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

    PubMed Central

    Sonnemann, Uwe; Möller, Marcus

    2014-01-01

    Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray. PMID:24976831

  5. A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study

    PubMed Central

    Patel, Manish V.; Patel, Kalapi B.; Gupta, Shivenarain; Michalsen, Andreas; Stapelfeldt, Elmar; Kessler, Christian S.

    2015-01-01

    Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings. PMID:26339267

  6. Safety, Tolerability, and Efficacy of Tocilizumab in Rheumatoid Arthritis: An Open-Label Phase 4 Study in Patients from the Middle East

    PubMed Central

    Hammoudeh, Mohammed; Al Awadhi, Adel; Hasan, Eman Haji; Akhlaghi, Maassoumeh; Ahmadzadeh, Arman; Sadeghi Abdollahi, Bahar

    2015-01-01

    This open-label study investigated the safety and efficacy of tocilizumab in Middle Eastern patients with rheumatoid arthritis (RA). Patients whose Disease Activity Score based on 28 joints (DAS28) was >3.2 received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks. Patients receiving aTNF ± nonbiologic disease-modifying antirheumatic drug(s) (DMARD(s)) switched to tocilizumab; patients receiving nonbiologic DMARD monotherapy added tocilizumab. Primary end points were adverse events (AEs), serious AEs (SAEs), and laboratory parameters; secondary end points were DAS28, Health Assessment Questionnaire-Disability Index, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Eighty-eight of 95 patients completed 24 weeks. Overall, 125 AEs were reported in 43 (45%) patients; the most common were increased hepatic enzymes (16%) and cholesterol (11%). Eight patients experienced SAEs. Significant changes from baseline to week 24 occurred for hemoglobin, neutrophils, platelets, total cholesterol, and liver enzymes (P < 0.05). DAS28, CRP, and ESR decreased significantly from baseline at each visit (P < 0.0001). At week 24, the proportions of patients reporting DAS28 clinically meaningful improvement (decrease ≥1.2), low disease activity (DAS28 ≥2.6 to ≤3.2), and remission (DAS28 <2.6) were 92%, 23%, and 64%, respectively. Safety and efficacy of tocilizumab were consistent with values reported in Western patients. PMID:26089907

  7. Effectiveness of a single application of 0·25% fipronil solution for the treatment of hirstiellosis in captive green iguanas (Iguana iguana): an open-label study.

    PubMed

    Farmaki, Rania; Simou, Chrisa; Papadopoulos, Elias; Koutinas, Alexander F; Saridomichelakis, Manolis N

    2013-08-01

    Hirstiella spp. are common ectoparasites of captive green iguanas (Iguana iguana). Suggested treatments are empirical and some of them are of low efficacy and potentially toxic. The objective of this open-label study was to investigate the short-term efficacy and safety of a single application of 0·25% fipronil solution for the treatment of hirstiellosis. The skin of 50 green iguanas was thoroughly examined with the aid of bright light and magnifying lenses. A total of 21 iguanas were found to be infested, harbouring 1-24 mites (median: 5). All 35 mites collected from 17 iguanas were identified as Hirstiella sp. Both infested and non-infested lizards, sharing the same enclosure, were carefully wiped with 0·25% fipronil solution. The safety and the efficacy of the treatment were evaluated after 2 days in 47/50 (94%) and 7 days in 29/50 (58%) iguanas. Compared with pre-treatment levels, the parasitic load did not changed significantly on the second day but was significantly lower on day 7 (P = 0·006). No adverse reactions were noticed. Based on these results a single whole-body application of 0·25% fipronil solution can be considered a safe and effective treatment for the reduction of parasitic burden in captive green iguanas infested by Hirstiella sp. mites.

  8. Safety and tolerability of azilsartan medoxomil in subjects with essential hypertension: a one-year, phase 3, open-label study.

    PubMed

    Handley, Alison; Lloyd, Eric; Roberts, Andrew; Barger, Bruce

    2016-01-01

    This 56-week phase 3, open-label, treat-to-target study, involving 2 consecutive, non-randomized cohorts, evaluated the safety and tolerability of azilsartan medoxomil (AZL-M) in essential hypertension (mean baseline blood pressure [BP] 152/100 mmHg). All subjects (n = 669) initiated AZL-M 40 mg QD, force-titrated to 80 mg QD at week 4, if tolerated. From week 8, subjects could receive additional medications, starting with chlorthalidone (CLD) 25 mg QD (Cohort 1) or hydrochlorothiazide (HCTZ) 12.5-25 mg QD (Cohort 2), if required, to reach BP targets. Adverse events (AEs) were reported in 75.9% of subjects overall in the two cohorts (73.8% Cohort 1, 78.5% Cohort 2). The most common AEs were dizziness (14.3%), headache (9.9%) and fatigue (7.2%). Transient serum creatinine elevations were more frequent with add-on CLD. Clinic systolic/diastolic BP (observed cases at week 56) decreased by 25.2/18.4 mmHg (Cohort 1) and 24.2/17.9 mmHg (Cohort 2). These results demonstrate that AZL-M is well tolerated over the long term and provides stable BP improvements when used in a treat-to-target BP approach with thiazide-type diuretics. PMID:26817604

  9. Safety and tolerability of azilsartan medoxomil in subjects with essential hypertension: a one-year, phase 3, open-label study

    PubMed Central

    Handley, Alison; Lloyd, Eric; Roberts, Andrew; Barger, Bruce

    2016-01-01

    Abstract This 56-week phase 3, open-label, treat-to-target study, involving 2 consecutive, non-randomized cohorts, evaluated the safety and tolerability of azilsartan medoxomil (AZL-M) in essential hypertension (mean baseline blood pressure [BP] 152/100 mmHg). All subjects (n = 669) initiated AZL-M 40 mg QD, force-titrated to 80 mg QD at week 4, if tolerated. From week 8, subjects could receive additional medications, starting with chlorthalidone (CLD) 25 mg QD (Cohort 1) or hydrochlorothiazide (HCTZ) 12.5–25 mg QD (Cohort 2), if required, to reach BP targets. Adverse events (AEs) were reported in 75.9% of subjects overall in the two cohorts (73.8% Cohort 1, 78.5% Cohort 2). The most common AEs were dizziness (14.3%), headache (9.9%) and fatigue (7.2%). Transient serum creatinine elevations were more frequent with add-on CLD. Clinic systolic/diastolic BP (observed cases at week 56) decreased by 25.2/18.4 mmHg (Cohort 1) and 24.2/17.9 mmHg (Cohort 2). These results demonstrate that AZL-M is well tolerated over the long term and provides stable BP improvements when used in a treat-to-target BP approach with thiazide-type diuretics. PMID:26817604

  10. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)

    PubMed Central

    Rosati, Anna; Ilvento, Lucrezia; L'Erario, Manuela; De Masi, Salvatore; Biggeri, Annibale; Fabbro, Giancarlo; Bianchi, Roberto; Stoppa, Francesca; Fusco, Lucia; Pulitanò, Silvia; Battaglia, Domenica; Pettenazzo, Andrea; Sartori, Stefano; Biban, Paolo; Fontana, Elena; Cesaroni, Elisabetta; Mora, Donatella; Costa, Paola; Meleleo, Rosanna; Vittorini, Roberta; Conio, Alessandra; Wolfler, Andrea; Mastrangelo, Massimo; Mondardini, Maria Cristina; Franzoni, Emilio; McGreevy, Kathleen S; Di Simone, Lorena; Pugi, Alessandra; Mirabile, Lorenzo; Vigevano, Federico; Guerrini, Renzo

    2016-01-01

    Introduction Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. Methods and analysis A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. Ethics and dissemination The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences. Trial registration number NCT02431663; Pre-results. PMID:27311915

  11. Noninterventional open-label trial investigating the efficacy and safety of ectoine containing nasal spray in comparison with beclomethasone nasal spray in patients with allergic rhinitis.

    PubMed

    Sonnemann, Uwe; Möller, Marcus; Bilstein, Andreas

    2014-01-01

    Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

  12. Improvement in social and cognitive functioning associated with paliperidone extended-release treatment in patients with schizophrenia: a 24-week, single arm, open-label study

    PubMed Central

    Shi, Chuan; Yao, Shu Qiao; Xu, Yi Feng; Shi, Jian Guo; Xu, Xiu Feng; Zhang, Cong Pei; Jin, Hua; Yu, Xin

    2016-01-01

    Purpose This single-arm, open-label study aimed to explore the effects of extended-release paliperidone on social and cognitive function in patients with schizophrenia. Methods Paliperidone extended-release (flexible dose ranging from 3 to 12 mg/day orally) was administered for 24 weeks in patients with schizophrenia. Patient function was assessed using the personal and social performance scale, measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery, positive and negative syndrome scale, and clinical global impression-severity. Results Ninety patients were included in the full analysis set, while 72 patients were included in the per protocol set. The personal and social performance score was 54.3±14.3 at baseline, and significantly increased to 73.4±12.6 at week 24 (P<0.001). For the measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery assessment, six of the nine individual subtests, six of the seven cognitive domains, and total cognitive scores improved significantly (P<0.05) between baseline and endpoint. positive and negative syndrome scale total scores and clinical global impression-severity scores decreased gradually (P<0.001) from week 4 to the conclusion of the study. Conclusion Paliperidone extended-release treatment significantly improves social and neurocognitive function as well as symptoms in Chinese patients with schizophrenia. PMID:27601904

  13. The Beta-hCG + Erythropoietin in Acute Stroke (BETAS) study A three center, single dose, open label, non-controlled, Phase IIa safety trial

    PubMed Central

    Cramer, Steven C.; Fitzpatrick, Camille; Warren, Michael; Hill, Michael D.; Brown, David; Whitaker, Laura; Ryckborst, Karla J.; Plon, Lawrence

    2010-01-01

    Background Animal data suggest the utility beta-hCG followed by erythropoietin to promote brain repair after stroke. The current study directly translated these results by evaluating safety of this sequential growth factor therapy via a three center, single dose, open label, non-controlled, Phase IIa trial. Methods Patients with ischemic stroke 24–48 hours old and NIHSS score of 6–24 started a nine day course of beta-hCG (once-daily on days 1, 3 and 5 of study participation) followed by erythropoietin (once-daily on days 7, 8, and 9 of study participation). This study also evaluated performance of serially measured domain-specific endpoints. Results A total of 15 patients were enrolled. Two deaths occurred, neither related to study medications. No safety concerns were noted among clinical or laboratory measures, including screening for DVT and serial measures of serum hemoglobin. In several instances, domain-specific endpoints provided greater insight into impairments as compared to global outcome measures. Conclusions Results support the safety of this sequential, two growth factor therapy initiated 24–48 hours after stroke onset. PMID:20203320

  14. Comparison of Low-Dose Rosuvastatin with Atorvastatin in Lipid-Lowering Efficacy and Safety in a High-Risk Pakistani Cohort: An Open-Label Randomized Trial

    PubMed Central

    Arshad, Abdul Rehman

    2014-01-01

    Background. Treatment of hyperlipidemia is helpful in both primary and secondary prevention of coronary heart disease and stroke. Aim. To compare lipid-lowering efficacy of rosuvastatin with atorvastatin. Methodology. This open-label randomized controlled trial was carried out at 1 Mountain Medical Battalion from September 2012 to August 2013 on patients with type 2 diabetes, hypertension, myocardial infarction, or stroke, meriting treatment with a statin. Those with secondary causes of dyslipidemia were excluded. Blood samples for estimation of serum total cholesterol, triglycerides, HDL-C, and LDL-C were collected after a 12-hour fast. Patients were randomly allocated to receive either atorvastatin 10 mg HS or rosuvastatin 5 mg HS daily. Lipid levels were rechecked after six weeks. Results. Atorvastatin was used in 63 patients and rosuvastatin in 66. There was a greater absolute and percent reduction in serum LDL-C levels with rosuvastatin as compared to atorvastatin (0.96 versus 0.54 mg/dL; P = 0.011 and 24.34 versus 13.66%; P = 0.045), whereas reduction in all other fractions was equal. Myalgias were seen in 5 (7.94%) patients treated with atorvastatin and 8 (12.12%) patients treated with rosuvastatin (P: 0.432). Conclusion. Rosuvastatin produces a greater reduction in serum LDL-C levels and should therefore be preferred over atorvastatin. PMID:24800084

  15. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study.

    PubMed

    Si, Tianmei; Zhang, Kerang; Tang, Jisheng; Fang, Maosheng; Li, Keqing; Zhuo, Jianmin; Feng, Yu

    2015-01-01

    This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75-150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions-Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: -30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations.

  16. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    PubMed Central

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

  17. Augmentation of light therapy in difficult-to-treat depressed patients: an open-label trial in both unipolar and bipolar patients

    PubMed Central

    Camardese, Giovanni; Leone, Beniamino; Serrani, Riccardo; Walstra, Coco; Di Nicola, Marco; Della Marca, Giacomo; Bria, Pietro; Janiri, Luigi

    2015-01-01

    Objectives We investigated the clinical benefits of bright light therapy (BLT) as an adjunct treatment to ongoing psychopharmacotherapy, both in unipolar and bipolar difficult-to-treat depressed (DTD) outpatients. Methods In an open-label study, 31 depressed outpatients (16 unipolar and 15 bipolar) were included to undergo 3 weeks of BLT. Twenty-five completed the treatment and 5-week follow-up. Main outcome measures Clinical outcomes were evaluated by the Hamilton Depression Rating Scale (HDRS). The Snaith–Hamilton Pleasure Scale and the Depression Retardation Rating Scale were used to assess changes in anhedonia and psychomotor retardation, respectively. Results The adjunctive BLT seemed to influence the course of the depressive episode, and a statistically significant reduction in HDRS scores was reported since the first week of therapy. The treatment was well-tolerated, and no patients presented clinical signs of (hypo)manic switch during the overall treatment period. At the end of the study (after 5 weeks from BLT discontinuation), nine patients (36%, eight unipolar and one bipolar) still showed a treatment response. BLT augmentation also led to a significant improvement of psychomotor retardation. Conclusion BLT combined with the ongoing pharmacological treatment offers a simple approach, and it might be effective in rapidly ameliorating depressive core symptoms of vulnerable DTD outpatients. These preliminary results need to be confirmed in placebo-controlled, randomized, double-blind clinical trial on larger samples. PMID:26396517

  18. Improvement in social and cognitive functioning associated with paliperidone extended-release treatment in patients with schizophrenia: a 24-week, single arm, open-label study

    PubMed Central

    Shi, Chuan; Yao, Shu Qiao; Xu, Yi Feng; Shi, Jian Guo; Xu, Xiu Feng; Zhang, Cong Pei; Jin, Hua; Yu, Xin

    2016-01-01

    Purpose This single-arm, open-label study aimed to explore the effects of extended-release paliperidone on social and cognitive function in patients with schizophrenia. Methods Paliperidone extended-release (flexible dose ranging from 3 to 12 mg/day orally) was administered for 24 weeks in patients with schizophrenia. Patient function was assessed using the personal and social performance scale, measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery, positive and negative syndrome scale, and clinical global impression-severity. Results Ninety patients were included in the full analysis set, while 72 patients were included in the per protocol set. The personal and social performance score was 54.3±14.3 at baseline, and significantly increased to 73.4±12.6 at week 24 (P<0.001). For the measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery assessment, six of the nine individual subtests, six of the seven cognitive domains, and total cognitive scores improved significantly (P<0.05) between baseline and endpoint. positive and negative syndrome scale total scores and clinical global impression-severity scores decreased gradually (P<0.001) from week 4 to the conclusion of the study. Conclusion Paliperidone extended-release treatment significantly improves social and neurocognitive function as well as symptoms in Chinese patients with schizophrenia.

  19. Activation of heat shock response to treat obese subjects with type 2 diabetes: a prospective, frequency-escalating, randomized, open-label, triple-arm trial

    PubMed Central

    Kondo, Tatsuya; Goto, Rieko; Ono, Kaoru; Kitano, Sayaka; Suico, Mary Ann; Sato, Miki; Igata, Motoyuki; Kawashima, Junji; Motoshima, Hiroyuki; Matsumura, Takeshi; Kai, Hirofumi; Araki, Eiichi

    2016-01-01

    Activation of heat shock response (HSR) improves accumulated visceral adiposity and metabolic abnormalities in type 2 diabetes. To identify the optimal intervention strategy of the activation of the HSR provided by mild electrical stimulation (MES) with heat shock (HS) in type 2 diabetes. This study was a prospective, frequency-escalating, randomized, open-label, triple-arm trial in Japan. A total of 60 obese type 2 diabetes patients were randomized into three groups receiving two, four, or seven treatments per week for 12 weeks. No adverse events were identified. MES + HS treatment (when all three groups were combined), significantly improved visceral adiposity, glycemic control, insulin resistance, systemic inflammation, renal function, hepatic steatosis and lipid profile compared to baseline. The reduction in HbA1c was significantly greater among those treated four times per week (−0.36%) or seven times per week (−0.65%) than among those treated two times per week (−0.10%). The relative HbA1c levels in seven times per week group was significantly decreased when adjusted by two times per week group (−0.55%. p = 0.001). This research provides the positive impact of MES + HS to treat obese patients with type 2 diabetes mellitus. PMID:27759092

  20. A randomized, open-label, multicentre study to evaluate plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus and arteriosclerosis obliterans when treated with Probucol and Cilostazol

    PubMed Central

    Ma, Xiao-Wei; Guo, Xiao-Hui; Xiao, Xin-Hua; Guo, Li-Xin; Lv, Xiao-Feng; Li, Quan-Min; Gao, Yan

    2012-01-01

    Objectives To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. Methods In this open-label study, patients aged 40–75 years were randomized to receive conventional therapy alone, or with Cilostazol 100 mg bid, or with Probucol 250 mg bid, or with both in combination. Endpoints included changes in plasma biomarker and safety at 12 weeks. Results Of the 200 randomized patients, 165 for per-protocol and 160 for the safety (QTc intervals) were set, respectively. Probucol significantly reduced total cholesterol (P < 0.001), low-density lipoprotein cholesterol (LDL-C), (P = 0.01), and high-density lipoprotein cholesterol (HDL-C) (P < 0.001) compared with conventional therapy. Cilostazol was effective in increasing HDL-C (P = 0.002) and reducing triglycerides levels (P < 0.01) compared with conventional therapy. A trend towards significance was observed for the difference between conventional therapy alone and Probucol plus Cilostazol group for the change in oxidized low-density lipoprotein (Ox-LDL, P = 0.065). No significant effects on the majority of the remaining biomarkers were found across the treatment groups. Conclusions We have confirmed that Ox-LDL could be a possible plasma atherosclerotic biomarker among the evaluated biomarkers, which reflected the synergetic effect of Cilostazol plus Probucol in patients with T2DM and ASO shown previously in preclinical studies. PMID:23097651

  1. Effectiveness of 6 Months of Tailored Text Message Reminders for Obese Male Participants in a Worksite Weight Loss Program: Randomized Controlled Trial

    PubMed Central

    Oh, Sohee; Steinhubl, Steven; Kim, Sohye; Bae, Woo Kyung; Han, Jong Soo; Kim, Jeong-Hyun; Lee, Keehyuck; Kim, Mi Jin

    2015-01-01

    Background Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight, but costs and insufficient sustained motivation prevent the majority of these programs from succeeding. Tailored text messaging in aiding weight management has been effective in several studies, but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program. Objective We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration. Methods The study was an unblinded, randomized controlled trial. Men with a body mass index greater than 25 kg/m2 were recruited from the Korea District Heating Corporation, the Korea Expressway Corporation, and the Korea Gas Corporation. The participants were identified by nurse managers. Participants were randomly allocated to 1 of the following 2 groups for 24 weeks: (1) intervention group, which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and (2) control group, which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months. The primary outcome was the difference in weight loss at 6 months. A mixed-model repeated-measures analysis was performed to evaluate the effect of the intervention group’s weight loss compared with the control group. Results A total of 205 obese men were randomized into either the intervention (n=104) or the control group (n=101). At the end of 6 months, the intervention group (n=63) had lost 1.71 kg (95% CI –2.53 to –0.88) and the control group (n=59) had lost 1.56 kg (95% CI –2.45 to –0.66); the difference between the 2 groups was not significant (mean difference –0.15, 95% CI –1.36 to 1.07). At the end of

  2. Knee Contact Force Asymmetries in Patients Who Failed Return-to-Sport Readiness Criteria 6 Months After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Gardinier, Emily S.; Di Stasi, Stephanie; Manal, Kurt; Buchanan, Thomas S.; Snyder-Mackler, Lynn

    2015-01-01

    Background After anterior cruciate ligament (ACL) injury, contact forces are decreased in the injured knee when compared with the uninjured knee. The persistence of contact force asymmetries after ACL reconstruction may increase the risk of reinjury and may play an important role in the development of knee osteoarthritis in these patients. Functional performance may also be useful in identifying patients who demonstrate potentially harmful joint contact force asymmetries after ACL reconstruction. Hypothesis Knee joint contact force asymmetries would be present during gait after ACL reconstruction, and performance on a specific set of validated return-to-sport (RTS) readiness criteria would discriminate between those who demonstrated contact force asymmetries and those who did not. Study Design Descriptive laboratory study. Methods A total of 29 patients with ACL ruptures participated in gait analysis and RTS readiness testing 6 months after reconstruction. Muscle and joint contact forces were estimated using an electromyography (EMG)–driven musculoskeletal model of the knee. The magnitude of typical limb asymmetry in uninjured controls was used to define limits of meaningful limb asymmetry in patients after ACL reconstruction. The RTS testing included isometric quadriceps strength testing, 4 unilateral hop tests, and 2 self-report questionnaires. Paired t tests were used to assess limb symmetry for peak medial and tibiofemoral contact forces in all patients, and a mixed-design analysis of variance was used to analyze the effect of passing or failing RTS testing on contact force asymmetry. Results Among all patients, neither statistically significant nor meaningful contact force asymmetries were identified. However, patients who failed RTS testing exhibited meaningful contact force asymmetries, with tibiofemoral contact force being significantly lower for the involved knee. Conversely, patients who passed RTS testing exhibited neither significant nor meaningful

  3. Association between cord blood 25-hydroxyvitamin D concentrations and respiratory tract infections in the first 6 months of age in a Korean population: a birth cohort study (COCOA)

    PubMed Central

    Shin, Youn Ho; Yu, Jinho; Kim, Kyung Won; Ahn, Kangmo; Hong, Seo-Ah; Lee, Eun; Yang, Song-I; Jung, Young-Ho; Kim, Hyung Young; Seo, Ju-Hee; Kwon, Ji-Won; Kim, Byoung-Ju; Kim, Hyo-Bin; Shim, Jung Yeon; Kim, Woo Kyung; Song, Dae Jin; Lee, So-Yeon; Lee, Soo Young; Jang, Gwang Cheon; Suh, Dong In; Yang, Hyeon-Jong; Kim, Bong Sung; Choi, Suk-Joo; Oh, Soo-Young; Kwon, Ja-Young; Lee, Kyung-Ju; Park, Hee Jin; Lee, Pil Ryang; Won, Hye-Sung

    2013-01-01

    Purpose Previous studies suggest that the concentration of 25-hydroxyvitamin D [25(OH)D] in cord blood may show an inverse association with respiratory tract infections (RTI) during childhood. The aim of the present study was to examine the influence of 25(OH)D concentrations in cord blood on infant RTI in a Korean birth cohort. Methods The levels of 25(OH)D in cord blood obtained from 525 Korean newborns in the prospective COhort for Childhood Origin of Asthma and allergic diseases were examined. The primary outcome variable of interest was the prevalence of RTI at 6-month follow-up, as diagnosed by pediatricians and pediatric allergy and pulmonology specialists. RTI included acute nasopharyngitis, rhinosinusitis, otitis media, croup, tracheobronchitis, bronchiolitis, and pneumonia. Results The median concentration of 25(OH)D in cord blood was 32.0 nmol/L (interquartile range, 21.4 to 53.2). One hundred and eighty neonates (34.3%) showed 25(OH)D concentrations less than 25.0 nmol/L, 292 (55.6%) showed 25(OH)D concentrations of 25.0-74.9 nmol/L, and 53 (10.1%) showed concentrations of ≥75.0 nmol/L. Adjusting for the season of birth, multivitamin intake during pregnancy, and exposure to passive smoking during pregnancy, 25(OH)D concentrations showed an inverse association with the risk of acquiring acute nasopharyngitis by 6 months of age (P for trend=0.0004). Conclusion The results show that 89.9% of healthy newborns in Korea are born with vitamin D insufficiency or deficiency (55.6% and 34.3%, respectively). Cord blood vitamin D insufficiency or deficiency in healthy neonates is associated with an increased risk of acute nasopharyngitis by 6 months of age. More time spent outdoors and more intensified vitamin D supplementation for pregnant women may be needed to prevent the onset of acute nasopharyngitis in infants. PMID:24244212

  4. No significant steady state surface creep along the North Anatolian Fault offshore Istanbul: Results of 6 months of seafloor acoustic ranging

    NASA Astrophysics Data System (ADS)

    Sakic, P.; Piété, H.; Ballu, V.; Royer, J.-Y.; Kopp, H.; Lange, D.; Petersen, F.; Özeren, M. S.; Ergintav, S.; Geli, L.; Henry, P.; Deschamps, A.

    2016-07-01

    The submarine Istanbul-Silivri fault segment, within 15 km of Istanbul, is the only portion of the North Anatolian Fault that has not ruptured in the last 250 years. We report first results of a seafloor acoustic ranging experiment to quantify current horizontal deformation along this segment and assess whether the segment is creeping aseismically or accumulating stress to be released in a future event. Ten transponders were installed to monitor length variations along 15 baselines. A joint least squares inversion for across-fault baseline changes, accounting for sound speed drift at each transponder, precludes fault displacement rates larger than a few millimeters per year during the 6 month observation period. Forward modeling shows that the data better fit a locked state or a very moderate surface creep—less than 6 mm/yr compared to a far-field slip rate of over 20 mm/yr—suggesting that the fault segment is currently accumulating stress.

  5. Rural N(SO) and German middle-class mothers' interaction with their 3- and 6-month-old infants: A longitudinal cross-cultural analysis.

    PubMed

    Lamm, Bettina; Gudi, Helene; Fassbender, Ina; Freitag, Claudia; Graf, Frauke; Goertz, Claudia; Spangler, Sibylle; Teubert, Manuel; Knopf, Monika; Lohaus, Arnold; Schwarzer, Gudrun; Keller, Heidi

    2015-08-01

    This study aims to analyze culture-specific development of maternal interactional behavior longitudinally. Rural Cameroonian Nso mothers (n = 72) and German middle-class mothers (n = 106) were observed in free-play interactions with their 3- and 6-month-old infants. Results reveal the expected shift from a social to a nonsocial focus only in the German middle-class mothers' play interactions but not the rural Nso mothers' play. Nso mothers continue their proximal interactional style with a focus on body contact and body stimulation, whereas German middle-class mothers prefer a distal style of interaction with increasing object-centeredness. These cultural differences are in line with broader cultural models and become more accentuated as the infants grow older.

  6. Dental auscultation for nursing personnel as a model of oral health care education: development, baseline, and 6-month follow-up assessments.

    PubMed

    Wårdh, Inger; Berggren, Ulf; Hallberg, Lillemor R M; Andersson, Lars; Sörensen, Stefan

    2002-01-01

    Oral health care has been shown to have low priority in nursing and has been only partly successful. To create more positive effects than those achieved through traditional oral health care education, this project tested an educational model for nursing staff personnel. In addition to traditional oral health care education, some of the nursing staff members passed an additional dental auscultation period and served as oral care aides. The aides were responsible for the oral health care of the residents at their nursing facilities (intervention group). The intervention nursing facilities were compared with facilities where nursing personnel only received a traditional oral health care education program. Assessments were made at baseline and at a 6-month follow-up. At follow-up it was shown that the nursing staff in the intervention group gave higher priority to the oral health care work than the nursing staff in the control group. PMID:11905448

  7. Closure of oroantral communication with buccal fat pad after removing bilateral failed zygomatic implants: A case report and 6-month follow-up

    PubMed Central

    Peñarrocha-Oltra, David; Alonso-González, Rocio; Pellicer-Chover, Hilario; Aloy-Prósper, Amparo

    2015-01-01

    The aim of this study was to assess the use of buccal fat pad (BFP) technique as an option to close oroantral communications (OAC) after removing failed zygomatic implants in a patient with a severely resorbed maxilla, and to determine the degree of patient satisfaction. A 64-year-old woman presented recurrent sinusitis and permanent oroantral communication caused by bilateral failed zygomatic implants, 3 years after prosthetic loading. Zygomatic implants were removed previous antibiotic treatment and the BFP flap technique was used to treat the OAC and maxillary defect. The degree of patient satisfaction after treatment was assessed through a visual analogue scale (VAS). At 6-months follow-up, patient showed complete healing and good function and the results in terms of phonetics, aesthetics and chewing were highly rated by the patient. Key words:Bichat fat pad, buccal fat pad, zygomatic implants, oroantral communication. PMID:25810829

  8. Total hip arthroplasty in a 6-month-old acetabulum fracture-dislocation of the hip: an 8-year follow-up.

    PubMed

    Khan, Kashif Mahmood; Bhatti, Anisuddin; Rasheed, Khurram

    2013-06-01

    Old unreduced acetabulum fracture-dislocation is common in developing countries due to various factors. Different options including arthrodesis, Girdlestone arthroplasty and total hip replacement (THR) are used for its treatment. THR with reconstruction of the acetabulum is recommended, but not much work has been reported so far in our country. Till date, arthrodesis in youngsters and resection arthroplasty in the elders has been the treatment of choice.THR, however, is being done by a few, but the experience has not been published. We are reporting a case of a middle-aged woman, who had a 6-month-old acetabulum dislocation of the hip with fracture of the posterior wall of the acetabulum. It was treated by THR and acetabulum reconstruction and had good functional result 8 years after the surgery.

  9. Reduced platelet deposition on seeded versus unseeded segments of expanded polytetrafluoroethylene grafts: Clinical observations after a 6-month follow-up

    SciTech Connect

    Ortenwall, P.; Wadenvik, H.; Risberg, B. )

    1989-10-01

    The concept of autologous endothelial cell seeding has proved successful in animal models with respect to decrease of graft thrombogenicity and increase in patency. In the present study, application of this method in humans was explored. In 23 patients, random halves of expanded polytetrafluoroethylene grafts, used for lower limb arterial reconstructions, were seeded with endothelial cells at a seeding density of 3500 cells/cm{sup 2}. These cells were derived from the saphenous vein by enzymatic harvesting. The other half was sham seeded with culture medium. Graft thrombogenicity was estimated by measuring platelet deposition on graft surface 1 and 6 months after surgery, with indium 111-labeled platelets and external gamma-camera imaging. Seeded graft segments accumulated significantly (p less than 0.03) fewer platelets at all imaging times. It is concluded that seeding of expanded polytetrafluoroethylene vascular grafts in humans reduces graft surface thrombogenicity. The clinical implications of this remain to be demonstrated.

  10. Rural N(SO) and German middle-class mothers' interaction with their 3- and 6-month-old infants: A longitudinal cross-cultural analysis.

    PubMed

    Lamm, Bettina; Gudi, Helene; Fassbender, Ina; Freitag, Claudia; Graf, Frauke; Goertz, Claudia; Spangler, Sibylle; Teubert, Manuel; Knopf, Monika; Lohaus, Arnold; Schwarzer, Gudrun; Keller, Heidi

    2015-08-01

    This study aims to analyze culture-specific development of maternal interactional behavior longitudinally. Rural Cameroonian Nso mothers (n = 72) and German middle-class mothers (n = 106) were observed in free-play interactions with their 3- and 6-month-old infants. Results reveal the expected shift from a social to a nonsocial focus only in the German middle-class mothers' play interactions but not the rural Nso mothers' play. Nso mothers continue their proximal interactional style with a focus on body contact and body stimulation, whereas German middle-class mothers prefer a distal style of interaction with increasing object-centeredness. These cultural differences are in line with broader cultural models and become more accentuated as the infants grow older. PMID:26075741

  11. Recurrent neonatal herpes simplex virus infection with central nervous system disease after completion of a 6-month course of suppressive therapy: Case report.

    PubMed

    Kato, Koji; Hara, Shinya; Kawada, Jun-Ichi; Ito, Yoshinori

    2015-12-01

    A boy at 12 days of age developed neonatal herpes simplex virus (HSV) type 2 infection with central nervous system (CNS) disease. After a 21-day course of high-dose intravenous acyclovir, the patient recovered with negative results for HSV DNA in serum and cerebrospinal fluid. Two weeks after a 6-month course of oral valacyclovir suppressive therapy with negative virological assessment, the disease recurred. Another 21-day course of intravenous acyclovir and subsequent 1-year course of oral suppressive therapy were completed. He showed mild developmental delay in language-social skills at 18 months of age. Although recurrences of neonatal HSV infection with CNS disease after suppressive therapy are uncommon, both clinical and virological assessments at the end of the suppressive therapy may be required. Administration of extended long-term suppressive ACV therapy should be considered to reduce the rate of recurrence. PMID:26390826

  12. Independent development of the Reach and the Grasp in spontaneous self-touching by human infants in the first 6 months

    PubMed Central

    Thomas, Brittany L.; Karl, Jenni M.; Whishaw, Ian Q.

    2015-01-01

    The Dual Visuomotor Channel Theory proposes that visually guided reaching is a composite of two movements, a Reach that advances the hand to contact the target and a Grasp that shapes the digits for target purchase. The theory is supported by biometric analyses of adult reaching, evolutionary contrasts, and differential developmental patterns for the Reach and the Grasp in visually guided reaching in human infants. The present ethological study asked whether there is evidence for a dissociated development for the Reach and the Grasp in nonvisual hand use in very early infancy. The study documents a rich array of spontaneous self-touching behavior in infants during the first 6 months of life and subjected the Reach movements to an analysis in relation to body target, contact type, and Grasp. Video recordings were made of resting alert infants biweekly from birth to 6 months. In younger infants, self-touching targets included the head and trunk. As infants aged, targets became more caudal and included the hips, then legs, and eventually the feet. In younger infants hand contact was mainly made with the dorsum of the hand, but as infants aged, contacts included palmar contacts and eventually grasp and manipulation contacts with the body and clothes. The relative incidence of caudal contacts and palmar contacts increased concurrently and were significantly correlated throughout the period of study. Developmental increases in self-grasping contacts occurred a few weeks after the increase in caudal and palmar contacts. The behavioral and temporal pattern of these spontaneous self-touching movements suggest that the Reach, in which the hand extends to make a palmar self-contact, and the Grasp, in which the digits close and make manipulatory movements, have partially independent developmental profiles. The results additionally suggest that self-touching behavior is an important developmental phase that allows the coordination of the Reach and the Grasp prior to and

  13. Cognitive and affective changes in mild to moderate Alzheimer's disease patients undergoing switch of cholinesterase inhibitors: a 6-month observational study.

    PubMed

    Spalletta, Gianfranco; Caltagirone, Carlo; Padovani, Alessandro; Sorbi, Sandro; Attar, Mahmood; Colombo, Delia; Cravello, Luca

    2014-01-01

    Patients with Alzheimer's disease after an initial response to cholinesterase inhibitors may complain a later lack of efficacy. This, in association with incident neuropsychiatric symptoms, may worsen patient quality of life. Thus, the switch to another cholinesterase inhibitor could represent a valid therapeutic strategy. The aim of this study was to investigate the effectiveness of the switch from one to another cholinesterase inhibitor on cognitive and affective symptoms in mild to moderate Alzheimer disease patients. Four hundred twenty-three subjects were included from the EVOLUTION study, an observational, longitudinal, multicentre study conducted on Alzheimer disease patients who switched to different cholinesterase inhibitor due either to lack/loss of efficacy or response, reduced tolerability or poor compliance. All patients underwent cognitive and neuropsychiatric assessments, carried out before the switch (baseline), and at 3 and 6-month follow-up. A significant effect of the different switch types was found on Mini-Mental State Examination score during time, with best effectiveness on mild Alzheimer's disease patients switching from oral cholinesterase inhibitors to rivastigmine patch. Depressive symptoms, when measured using continuous Neuropsychiatric Inventory values, decreased significantly, while apathy symptoms remained stable over the 6 months after the switch. However, frequency of both depression and apathy, when measured categorically using Neuropsychiatric Inventory cut-off scores, did not change significantly during time. In mild to moderate Alzheimer disease patients with loss of efficacy and tolerability during cholinesterase inhibitor treatment, the switch to another cholinesterase inhibitor may represent an important option for slowing cognitive deterioration. The evidence of apathy stabilization and the positive tendency of depressive symptom improvement should definitively be confirmed in double-blind controlled studies.

  14. Cognitive and Affective Changes in Mild to Moderate Alzheimer’s Disease Patients Undergoing Switch of Cholinesterase Inhibitors: A 6-Month Observational Study

    PubMed Central

    Spalletta, Gianfranco; Caltagirone, Carlo; Padovani, Alessandro; Sorbi, Sandro; Attar, Mahmood; Colombo, Delia; Cravello, Luca

    2014-01-01

    Patients with Alzheimer’s disease after an initial response to cholinesterase inhibitors may complain a later lack of efficacy. This, in association with incident neuropsychiatric symptoms, may worsen patient quality of life. Thus, the switch to another cholinesterase inhibitor could represent a valid therapeutic strategy. The aim of this study was to investigate the effectiveness of the switch from one to another cholinesterase inhibitor on cognitive and affective symptoms in mild to moderate Alzheimer disease patients. Four hundred twenty-three subjects were included from the EVOLUTION study, an observational, longitudinal, multicentre study conducted on Alzheimer disease patients who switched to different cholinesterase inhibitor due either to lack/loss of efficacy or response, reduced tolerability or poor compliance. All patients underwent cognitive and neuropsychiatric assessments, carried out before the switch (baseline), and at 3 and 6-month follow-up. A significant effect of the different switch types was found on Mini-Mental State Examination score during time, with best effectiveness on mild Alzheimer’s disease patients switching from oral cholinesterase inhibitors to rivastigmine patch. Depressive symptoms, when measured using continuous Neuropsychiatric Inventory values, decreased significantly, while apathy symptoms remained stable over the 6 months after the switch. However, frequency of both depression and apathy, when measured categorically using Neuropsychiatric Inventory cut-off scores, did not change significantly during time. In mild to moderate Alzheimer disease patients with loss of efficacy and tolerability during cholinesterase inhibitor treatment, the switch to another cholinesterase inhibitor may represent an important option for slowing cognitive deterioration. The evidence of apathy stabilization and the positive tendency of depressive symptom improvement should definitively be confirmed in double-blind controlled studies. PMID

  15. Enhanced midbrain response at 6-month follow-up in cocaine addiction, association with reduced drug-related choice: Midbrain in drug choice

    SciTech Connect

    Moeller, Scott J.; Tomasi, Dardo; Woicik, Patricia A.; Maloney, Thomas; Alia-Klein, Nelly; Honorio, Jean; Telang, Frank; Wang, Gene-Jack; Wang, Ruiliang; Sinha, Rajita; Carise, Deni; Astone-Twerell, Janetta; Bolger, Joy; Volkow, Nora D.; Goldstein, Rita Z.

    2012-03-28

    Drug addiction is characterized by dysregulated dopamine neurotransmission. Although dopamine functioning appears to partially recover with abstinence, the specific regions that recover and potential impact on drug seeking remain to be determined. Here we used functional magnetic resonance imaging (fMRI) to study an ecologically valid sample of 15 treatment-seeking cocaine addicted ind