Adjuvant chemotherapy with 5-fluorouracil, L-folinic acid and levamisole for patients with colorectal cancer: non-randomised comparison of weekly versus four-weekly schedules--less pain, same gain. QUASAR Colorectal Cancer Study Group.

PubMed

Kerr, D J; Gray, R; McConkey, C; Barnwell, J

2000-08-01

QUASAR is a large trial of adjuvant chemotherapy for colorectal cancer in which clinicians could choose to deliver a standard adjuvant cytotoxic chemotherapy regimen, 5-fluorouracil (5-FU) and L-folinic acid (L-FA), in either a once-weekly or a four-weekly schedule. We report results of a non-randomised comparison between these schedules with respect to survival, recurrence and differential toxicity. In a factorial (2 x 2) trial design, QUASAR compared high-dose (175 mg) versus low-dose (25 mg) L-FA and levamisole versus placebo. The dose of 5-FU was fixed at 370 mg/m2 and although the recommended schedule was i.v. bolus delivery, daily for 5 days repeated four-weekly for 6 months, a significant proportion of randomising clinicians were constrained to deliver once-weekly 5-FU-L-FA for 30 weeks. Four thousand nine hundred twenty-seven patients were entered into QUASAR between May 1994 and October 1997, eighteen hundred twenty-nine of whom have recurred and sixteen hundred eighty-nine died. Similar numbers 2370 vs. 2559 were treated with the once-weekly and four-weekly schedules and the demographic features of the 2 groups were well balanced: stage C, 73.3% once-weekly vs. 71.0% four-weekly; colon, 68.0% vs. 68.3%; high-dose FA, 50.1% vs. 49.9%; levamisole, 49.3% vs. 49.3%; females, 40.2% vs. 41.7%; median age (years) 62 vs. 61. The risk of recurrence and survival were similar regardless of schedule: three-year survival was 70.6% once-weekly vs. 71.0% four-weekly; three-year recurrence risk was 35.6% once-weekly vs. 35.5% four-weekly; But, the once-weekly regimen was much less toxic: number of patients for whom toxicity was reported (once-weekly: four-weekly), stomatitis, 37 vs. 337; diarrhoea, 260 vs. 440; neutropenia, 20 vs. 153. The once-weekly regimen is much less toxic than and, apparently, about as effective as the four-weekly schedule. This suggests that the toxicity of 5-FU-L-FA adjuvant chemotherapy could be reduced substantially by weekly scheduling without compromising efficacy. Alternatively, efficacy might be enhanced with equal toxicity by more dose-intense weekly FU-L-FA regimens. However, this conclusion from a non-randomised comparison needs confirmation in prospective randomised studies.

Effects of different periods of hypoxic training on glucose metabolism and insulin sensitivity.

PubMed

Morishima, Takuma; Hasegawa, Yuta; Sasaki, Hiroto; Kurihara, Toshiyuki; Hamaoka, Takafumi; Goto, Kazushige

2015-03-01

This study examined the effects of different periods of hypoxic training on glucose metabolism. Sedentary subjects underwent hypoxic training (FiO2 = 15.0%) for either 2 weeks (2-week group; n = 11) or 4 weeks (4-week group; n = 10). The 2-week group conducted training sessions on 6 days week(-1) for 2 weeks, whereas the 4-week group conducted training sessions on 3 days week(-1) for 4 weeks. Body fat mass or abdominal fat area did not change after training period in either group. VO2max increased in both groups after training period (42 ± 2 versus 43 ± 2 ml min(-1) kg(-1) in 2-week group, 41 ± 1 versus 42 ± 2 ml min(-1) kg(-1) in 4-week group). Both groups showed a reduction in mean blood pressure after training period (92 ± 3 versus 90 ± 3 mmHg in 2-week group, 91 ± 2 versus 87 ± 2 mmHg in 4-week group, P ≤ 0.05). No change was observed in blood glucose response after glucose ingestion after training period. However, area under the curve for serum insulin concentrations after glucose ingestion significantly decreased in only 4-week group (6910 ± 763 versus 5812 ± 872 μIU ml(-1) 120 min, P ≤ 0.05). In conclusion, hypoxic training reduced blood pressure with independent on training duration. However, a longer period of hypoxic training led to greater improvements in insulin sensitivity compared with equivalent training over a shorter period, suggesting that hypoxic training programmes for more than 4 weeks might be more beneficial for improving insulin sensitivity. © 2014 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

Can we identify mothers at-risk for postpartum anxiety in the immediate postpartum period using the State-Trait Anxiety Inventory?

PubMed

Dennis, Cindy-Lee; Coghlan, Michelle; Vigod, Simone

2013-09-25

This study assessed the stability of maternal anxiety and concordance between State-Trait Anxiety Inventory (STAI) scores in the immediate postpartum period to 8 weeks postpartum. A population-based sample of 522 mothers completed the STAI at 1, 4, and 8 weeks postpartum. Sensitivity, specificity, and predictive power of the 1-week STAI in relation to identifying mothers with elevated STAI scores at 4 and 8 weeks was determined. Predictive power of the STAI was further assessed using odds ratios and receiver operator characteristic (ROC) curves. At 1 week postpartum, 22.6% of mothers scored >40 on the STAI, decreasing to 17.2% at 4 weeks and 14.8% at 8 weeks. Using the cut-off score of >40, the 1-week STAI accurately classified 84.0% mothers at 4 weeks and 83.6% at 8 weeks with or without anxiety symptomatology. The 1-week STAI was significantly correlated to the 4-week (r=0.68, p<0.001) and 8-week (r=0.64, p<0.001) STAI. Mothers with a 1-week STAI score >40 were 15.2 times more likely at 4 weeks (95% CI=8.9-26.1) and 14.0 times more likely at 8 weeks (95% CI=7.9-24.8) to exhibit postpartum anxiety symptomatology. Psychiatric interviews were not completed in collaboration with the STAI and specific types of anxiety disorders were not identified. A cut-off score of >40 on the STAI administered early in the postpartum period is recommended in a 2-phase identification program in order to not miss mothers with postpartum anxiety. © 2013 Elsevier B.V. All rights reserved.

Safety and Efficacy of an Absorbable Filter in the Inferior Vena Cava to Prevent Pulmonary Embolism in Swine.

PubMed

Huang, Steven Y; Eggers, Mitchell; McArthur, Mark J; Dixon, Katherine A; McWatters, Amanda; Dria, Stephen; Hill, Lori R; Melancon, Marites P; Steele, Joseph R; Wallace, Michael J

2017-12-01

Purpose To evaluate the immediate and long-term safety as well as thrombus-capturing efficacy for 5 weeks after implantation of an absorbable inferior vena cava (IVC) filter in a swine model. Materials and Methods This study was approved by the institutional animal care and use committee. Eleven absorbable IVC filters made from polydioxanone suture were deployed via a catheter in the IVC of 11 swine. Filters remained in situ for 2 weeks (n = 2), 5 weeks (n = 2), 12 weeks (n = 2), 24 weeks (n = 2), and 32 weeks (n = 3). Autologous thrombus was administered from below the filter in seven swine from 0 to 35 days after filter placement. Fluoroscopy and computed tomography follow-up was performed after filter deployment from weeks 1-6 (weekly), weeks 7-20 (biweekly), and weeks 21-32 (monthly). The infrarenal IVC, lungs, heart, liver, kidneys, and spleen were harvested at necropsy. Continuous variables were evaluated with a Student t test. Results There was no evidence of IVC thrombosis, device migration, caval penetration, or pulmonary embolism. Gross pathologic analysis showed gradual device resorption until 32 weeks after deployment. Histologic assessment demonstrated neointimal hyperplasia around the IVC filter within 2 weeks after IVC filter deployment with residual microscopic fragments of polydioxanone suture within the caval wall at 32 weeks. Each iatrogenic-administered thrombus was successfully captured by the filter until resorbed (range, 1-4 weeks). Conclusion An absorbable IVC filter can be safely deployed in swine and resorbs gradually over the 32-week testing period. The device is effective for the prevention of pulmonary embolism for at least 5 weeks after placement in swine. © RSNA, 2017.

A Phase I and Pharmacokinetic Study of the Oral Histone Deacetylase Inhibitor, MS-275, in Patients with Refractory Solid Tumors and Lymphomas

PubMed Central

Gore, Lia; Rothenberg, Mace L.; O'Bryant, Cindy L.; Schultz, Mary Kay; Sandler, Alan B.; Coffin, Denise; McCoy, Candice; Schott, Astrid; Scholz, Catherine; Eckhardt, S. Gail

2010-01-01

Purpose To evaluate the toxicity profile, pharmacologic, and biological properties of 3-pyridylmethyl N-{4-[(2-aminophenyl)carbamoyl]benzyl}carbamate (MS-275), a histone deacetylase inhibitor, when administered orally on three different dosing schedules. Experimental Design Patients with advanced solid malignancies and lymphomas were treated on three dose schedules: once every other week, twice weekly for 3 weeks every 28 days, and once weekly for 3 weeks every 28 days. First-cycle plasma pharmacokinetics and peripheral blood mononuclear cell histone acetylation were determined. Results Twenty-seven patients received ≥149 courses of treatment. Hypophosphatemia and asthenia were dose limiting on the weekly and twice-weekly dosing schedules; there was no dose-limiting toxicity on the every other week schedule. Pharmacokinetic variables revealed dose-dependent and dose-proportional increases. Two of 27 patients showed partial remissions, including one patient with metastatic melanoma who had a partial response and has remained on study for >5 years. Six patients showed prolonged disease stabilization. Levels of histone H3 and H4 acetylation in peripheral blood mononuclear cells increased qualitatively but with a high degree of interpatient variation. Conclusions MS-275 is well tolerated at doses up to 6 mg/m2 every other week or 4 mg/m2 weekly for 3 weeks followed by 1 week of rest and results in biologically relevant plasma concentrations and antitumor activity. Twice-weekly dosing was not tolerable due to asthenia, and further evaluation of this schedule was halted. The recommended dose for further disease-focused studies is 4 mg/m2 given weekly for 3 weeks every 28 days or 2 to 6 mg/m2 given once every other week. PMID:18579665

Outcomes of infants born at 22 and 23 weeks' gestation.

PubMed

Ishii, Nozomi; Kono, Yumi; Yonemoto, Naohiro; Kusuda, Satoshi; Fujimura, Masanori

2013-07-01

To provide instructive information on death and neurodevelopmental outcomes of infants born at 22 and 23 weeks' gestational age. The study cohort consisted of 1057 infants born at 22 to 25 weeks in the Neonatal Research Network, Japan. Neurodevelopmental impairment (NDI) at 36 to 42 months' chronological age was defined as any of the following: cerebral palsy, hearing impairment, visual impairment, and a developmental quotient <70. A systematic review was performed by using databases of publications of cohort studies with neonatal and neurodevelopmental outcomes at 22 and 23 weeks. Numbers and incidences (%) of infants with death or NDI were 60 (80%) at 22 weeks and 156 (64%) at 23 weeks. In logistic regression analysis, gestational ages of 22 weeks (odds ratio [OR]: 5.40; 95% confidence interval [CI]: 2.48-11.76) and 23 weeks (OR: 2.14; 95% CI: 1.38-3.32) were associated with increased risk of death or NDI compared with 24 weeks, but a gestational age of 25 weeks (OR: 0.65; 95% CI: 0.45-0.95) was associated with decreased risk of death or NDI. In the systematic review, the medians (range) of the incidence of death or NDI in 8 cohorts were 99% (90%-100%) at 22 weeks and 98% (67%-100%) at 23 weeks. Infants born at 22 and 23 weeks' gestation were at higher risk of death or NDI than infants at born at 24 weeks. However, outcomes were improved compared with those in previous studies. There is a need for additional discussions on interventions for infants born at 22 or 23 weeks' gestation.

Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial.

PubMed

Bernard, Louis; Dinh, Aurélien; Ghout, Idir; Simo, David; Zeller, Valerie; Issartel, Bertrand; Le Moing, Vincent; Belmatoug, Nadia; Lesprit, Philippe; Bru, Jean-Pierre; Therby, Audrey; Bouhour, Damien; Dénes, Eric; Debard, Alexa; Chirouze, Catherine; Fèvre, Karine; Dupon, Michel; Aegerter, Philippe; Mulleman, Denis

2015-03-07

Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence. We aimed to establish whether 6 weeks of antibiotic treatment is non-inferior to 12 weeks in patients with pyogenic vertebral osteomyelitis. In this open-label, non-inferiority, randomised controlled trial, we enrolled patients aged 18 years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from 71 medical care centres across France. Patients were randomly assigned to either 6 weeks or 12 weeks of antibiotic treatment (physician's choice in accordance with French guidelines) by a computer-generated randomisation list of permuted blocks, stratified by centre. The primary endpoint was the proportion of patients who were classified as cured at 1 year by a masked independent validation committee, analysed by intention to treat. Non-inferiority would be declared if the proportion of cured patients assigned to 6 weeks of treatment was not less than the proportion of cured patients assigned to 12 weeks of treatment, within statistical variability, by an absolute margin of 10%. This trial is registered with EudraCT, number 2006-000951-18, and Clinical Trials.gov, number NCT00764114. Between Nov 15, 2006, and March 15, 2011, 359 patients were randomly assigned, of whom six in the 6-week group and two in the 12-week group were excluded after randomisation. 176 patients assigned to the 6-week treatment regimen and 175 to the 12-week treatment regimen were analysed by intention to treat. 160 (90·9%) of 176 patients in the 6-week group and 159 (90·9%) of 175 of those in the 12-week group met the criteria for clinical cure. The difference between the groups (0·05%, 95% CI -6·2 to 6·3) showed the non-inferiority of the 6-week regimen when compared with the 12-week regimen. 50 patients in the 6-week group and 51 in the 12-week group had adverse events, the most common being death (14 [8%] in the 6-week group vs 12 [7%] in the 12-week group), antibiotic intolerance (12 [7%] vs 9 [5%]), cardiorespiratory failure (7 [4%] vs 12 [7%]), and neurological complications (7 [4%] vs 3 [2%]). 6 weeks of antibiotic treatment is not inferior to 12 weeks of antibiotic treatment with respect to the proportion of patients with pyogenic vertebral osteomyelitis cured at 1 year, which suggests that the standard antibiotic treatment duration for patients with this disease could be reduced to 6 weeks. French Ministry of Health. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Four Day School Week. Research Brief

ERIC Educational Resources Information Center

Muir, Mike

2013-01-01

Can four-day school weeks help districts save money? How do districts overcome the barriers of moving to a four-day week? What is the effect of a four-day week on students, staff and the community? This paper enumerates the benefits for students and teachers of four-day school weeks. Recommendations for implementation of a four-day week are also…

Immunohistochemical study of Ki67, CD34 and p53 expression in human tooth buds.

PubMed

Muica Nagy-Bota, Monica Cristina; Pap, Zsuzsanna; Denes, Lóránd; Ghizdavăţ, Alexandru; Brînzaniuc, Klara; Lup Coşarcă, Adina Simona; Chibelean Cireş-Mărginean, Manuela; Păcurar, Mariana; Pávai, Zoltán

2014-01-01

Establishment of Ki67, p53 and CD34 expression in human tooth buds of different stages of odontogenetic development. Tissue samples containing tooth buds were removed from the incisor areas of human fetuses in different stages of development (weeks 9-10, 12-13, 13-16, 21-24), and from the canine and molar areas of 21-24 weeks fetuses. The tissue fragments were fixed using formalin and were processed using common histological techniques with paraffin embedding. Immunostaining for Ki67, p53 and CD34 has been performed using the dextran method and moist heat antigen retrieval (except for CD34). The resulting slides were photographed and quantitatively evaluated. Ki67 immunoexpression decreases with advancement of the developmental stage of the tooth bud: in the inner enamel epithelium, between weeks 9 and 16 (IEE), in the preameloblasts (PB) between weeks 13 and 16, in the ameloblasts (AB) between weeks 21 and 24; outer enamel epithelium (OEE); stratum intermedium (SI); in the dental papilla: between weeks 9 and 10 in the dental papilla (DP), between weeks 13 and 16 in the outer layer of the dental papilla (DP1) and in the central layer of the dental papilla (DP2). Likewise, we noted Ki67 expression in the odontoblast layer (O) and pulp (P), between weeks 21 and 24. Concerning CD34 expression, we observed a decrease from weeks 9-10 until weeks 13-16, followed by an increase until weeks 21-24 of intrauterine life. From weeks 9-10, we observed a constant decrease of expression until weeks 13-16, followed by an increase during weeks 21-24. All Ki67, p53 and CD34 have been identified in the tooth bud. Ki67 expression gradually decreases with the embryonic development of the tooth, while p53 and CD34 expression decreases from weeks 9-10 to weeks 13-16 of intrauterine life, followed by an increase until weeks 21-24.

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

PubMed Central

2011-01-01

Background To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Methods Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. Results From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. Conclusions In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. Trial registration ClinicalTrials.gov NCT00540800. PMID:21324184

Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial.

PubMed

Nuzzo, Francesco; Morabito, Alessandro; Gravina, Adriano; Di Rella, Francesca; Landi, Gabriella; Pacilio, Carmen; Labonia, Vincenzo; Rossi, Emanuela; De Maio, Ermelinda; Piccirillo, Maria Carmela; D'Aiuto, Giuseppe; Thomas, Renato; Rinaldo, Massimo; Botti, Gerardo; Di Bonito, Maurizio; Di Maio, Massimo; Gallo, Ciro; Perrone, Francesco; de Matteis, Andrea

2011-02-16

To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. ClinicalTrials.gov NCT00540800.

Efficacy and Safety of Escalation of Adalimumab Therapy to Weekly Dosing in Pediatric Patients with Crohn's Disease.

PubMed

Dubinsky, Marla C; Rosh, Joel; Faubion, William A; Kierkus, Jaroslaw; Ruemmele, Frank; Hyams, Jeffrey S; Eichner, Samantha; Li, Yao; Huang, Bidan; Mostafa, Nael M; Lazar, Andreas; Thakkar, Roopal B

2016-04-01

The efficacy of adalimumab in inducing and maintaining remission in children with moderately to severely active Crohn's disease was shown in the IMAgINE 1 trial (NCT00409682). As per protocol, nonresponders or patients experiencing flare(s) on every other week (EOW) maintenance dosing could escalate to weekly dosing; we aimed to determine the therapeutic benefits of weekly dose escalation in this subpopulation. Week 52 remission and response rates were assessed in patients who escalated to weekly dosing from their previous EOW schedule, which was according to randomized treatment dose (higher dose [HD] adalimumab [≥40 kg, 40 mg EOW; <40 kg, 20 mg EOW] or lower dose [LD; ≥40 kg, 20 mg EOW; <40 kg, 10 mg EOW]). Adverse events were reported for patients remaining on EOW dosing and patients receiving weekly dosing. Escalation to weekly dosing occurred in 48/95 (50.5%) patients randomized to LD and 35/93 (37.6%) patients randomized to HD adalimumab (P = 0.076). Week 52 remission and response rates were 18.8% and 47.9% for patients receiving LD adalimumab weekly and 31.4% and 57.1% for patients receiving HD adalimumab weekly, respectively (LD versus HD, P = 0.19 for remission; P = 0.41 for response). Adverse event rates were similar for patients receiving EOW and weekly adalimumab. Weekly adalimumab dosing was clinically beneficial for children with Crohn's disease who experienced nonresponse or flare on EOW dosing. No increased safety risks were observed with weekly dosing.

Maternal serum soluble fms-like tyrosine kinase-1 at 12, 22, 32 and 36 weeks' gestation in screening for pre-eclampsia.

PubMed

Tsiakkas, A; Mendez, O; Wright, A; Wright, D; Nicolaides, K H

2016-04-01

To examine the distribution of maternal serum soluble fms-like tyrosine kinase-1 (sFlt-1) at 12, 22, 32 and 36 weeks' gestation in singleton pregnancies that develop pre-eclampsia (PE) and examine the performance of this biomarker in screening for PE. Serum sFlt-1 was measured in 7066 cases at 11-13 weeks, 8079 cases at 19-24 weeks, 8472 at 30-34 weeks and 4043 at 35-37 weeks. Bayes' theorem was used to combine the a-priori risk from maternal characteristics and medical history with serum levels of sFlt-1. The performance of screening for PE in women requiring delivery < 32, between 32 + 0 and 36 + 6 and ≥ 37 weeks' gestation was estimated. In pregnancies that developed PE, serum sFlt-1 was increased and the separation in multiples of the median (MoM) values from normal was greater with earlier, compared to later, gestational age at which delivery for PE became necessary. In pregnancies that developed PE, the slope of the regression lines of sFlt-1 MoM with gestational age at delivery increased with advancing gestational age at screening. Measurement of sFlt-1 at 11-13 weeks did not improve the prediction of PE achieved by maternal factors alone, sFlt-1 at 19-24 weeks improved the prediction of PE delivering < 37 weeks but not for PE delivering ≥ 37 weeks, sFlt-1 at 30-34 weeks improved the prediction of PE delivering < 37 and PE delivering ≥ 37 weeks and sFlt-1 at 35-37 weeks improved the prediction of PE delivering ≥ 37 weeks. The detection rates (DRs), at a false-positive rate (FPR) of 10%, of PE delivering < 32 weeks were 52% and 65% with screening at 12 and 22 weeks, respectively. The DRs for PE delivering between 32 + 0 and 36 + 6 weeks were 44%, 44% and 93% with screening at 12, 22 and 32 weeks. The DR for PE delivering ≥ 37 weeks were 37%, 37%, 52% and 69% with screening at 12, 22, 32 and 36 weeks, respectively. The performance of combined screening with maternal factors, medical history and serum sFlt-1 is superior for detection of early, compared to late, PE and improves with advancing gestational age at screening. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

A randomised, open-label, parallel group phase 2 study of antisense oligonucleotide therapy in acromegaly.

PubMed

Trainer, Peter J; Newell-Price, John; Ayuk, John; Aylwin, Simon; Rees, D Aled; Drake, Wm; Chanson, Philippe; Brue, Thierry; Webb, Susan M; Montañana, Carmen Fajardo; Aller, Javier; McCormack, Ann I; Torpy, David J; Tachas, George; Atley, Lynne; Ryder, David; Bidlingmaier, Martin

2018-05-22

ATL1103 is a second-generation antisense oligomer targeting the human GH receptor. This phase 2 randomised, open-label, parallel-group study assessed the potential of ATL1103 as a treatment for acromegaly. 26 patients with active acromegaly (IGF-I >130% upper limit of normal) were randomised to subcutaneous ATL1103 200 mg either once- or twice-weekly for 13 weeks, and monitored for a further 8-week washout period. The primary efficacy measures were change in IGF-I at week 14, compared to baseline and between cohorts. For secondary endpoints (IGFBP3, ALS, GH, GHBP), comparison was between baseline and week 14. Safety was assessed by reported adverse events. Baseline median IGF-I was 447 and 649 ng/mL in the once- and twice-weekly groups, respectivey. Compared to baseline, at week 14 twice-weekly ATL1103 resulted in a median fall in IGF-I of 27.8% (p=0.0002). Between cohort comparison at week 14 demonstrated the median fall in IGF-I to be 25.8% (p=0.0012) greater with twice-weekly dosing. In the twice-weekly cohort, IGF-I was still declining at week 14, and at week 21 remained lower than at baseline by a median of 18.7% (p=0.0005). Compared to baseline, by week 14 IGFBP3 and ALS had declined by a median of 8.9% (p=0.027) and 16.7% (p=0.017) with twice-weekly ATL1103; GH had increased by a median of 46% at week 14 (p=0.001). IGFBP3, ALS and GH did not change with weekly ATL1103. GHBP fell by a median of 23.6% and 48.8% in the once- and twice-weekly cohorts (p=0.027 and p=0.005), respectively. ATL1103 was well tolerated, although 84.6% of patients experienced mild to moderate injection-site reactions (ISR). This study provides proof-of-concept that ATL1103 is able to significantly lower IGF-I in patients with acromegaly.

Use of Folic Acid Supplements in Early Pregnancy in Relation to Maternal Plasma Levels in Week 18 of Pregnancy

PubMed Central

Roth, Christine; Monsen, Anne Lise B.; Reichborn-Kjennerud, Ted; Nilsen, Roy M.; Smith, George Davey; Stoltenberg, Camilla; Surén, Pål; Susser, Ezra; Ueland, Per Magne; Vollset, Stein Emil; Magnus, Per

2013-01-01

We compared plasma-folate at week 18 of gestation with self-reported use of supplements containing folic acid from before pregnancy to 17 weeks gestation. Birth cohorts typically measure plasma-folate in mid-gestation, but effects of folic acid supplementation are sometimes specific to the periconceptional period. The relationship between mid-gestation plasma-folate and periconceptional supplementation is not known. The sample comprised 2911 women from The Norwegian Mother and Child Cohort Study. For women reporting continuous supplementation from gestational week -4-17 (N=238), median plasma-folate was 15.72 at week 18 (in nmol/L). This was about threefold higher than the median plasma-folate of 5.67 for women reporting no supplementation from week -4-17 (N=844), but only slightly higher than the median plasma-folate of 13.34 for all women reporting supplementation in week 13-17 (N=1158). Reported supplementation before week 8 was not associated with plasma-folate at week 18, in an analysis that adjusted for continued supplementation after week 8. Overall we found a strong and coherent relationship between self-reported folic acid use and plasma-folate at week 18. We also found that plasma-folate at week 18 did not reflect self-reported supplementation before 8 weeks. For periconceptional supplementation per se, self-report data may offer a better measure. PMID:23065724

Evaluation of testicular toxicity and sperm morphology in rats treated with methyl methanesulphonate (MMS).

PubMed

Kuriyama, Kazuya; Kitamura, Tsuyoshi; Yokoi, Ryohei; Hayashi, Morimichi; Kobayashi, Kazuo; Kuroda, Junji; Tsujii, Hirotada

2005-10-01

Methyl methanesulphonate (MMS), a potent alkylating agent and testicular toxicant, was orally administered to rats for 5 days at 40 mg/kg. During the recovery period of up to 5 weeks, males were evaluated for testicular toxicity and sperm morphology. The 5-week recovery period were designated as follows: Day 1 (the day after final treatment); Week 1, Week 2, Week 3, Week 4 and Week 5 (1, 2, 3, 4 and 5 weeks after final treatment). Morphologically abnormal sperm increased beginning in Week 3, peaked in Week 4 and declined slightly in Week 5. Histopathological examinations indicated retention of step 19 spermatids at stage IX from Day 1 through Week 3. Quantitative evaluation of spermatogenic cells indicated a decrease in the number of late pachytene spermatocytes and early spermatids on Day 1. TUNEL examination showed a significantly high frequency of apoptosis in the meiosis cells in Week 1. In the present study, genetic damage induced by treatment with MMS affected spermatogenesis and a wide variety of spermatogenic cells in the testis. Apoptosis in the course of meiosis seemed to be involved in the elimination process of genetically insulted germ cells, and this process seems to play an important role in eliminating and/or decreasing the germ cells with retention of spermatids and the potential to express morphologically abnormal spermatozoa.

Defense Advisory Committee on Women in the Services (DACOWITS)

Science.gov Websites

Reports & Meetings News Articles 2018 Weekly Articles 2017 Weekly Articles 2016 Weekly Articles 2015 Weekly Articles 2014 Weekly Articles Latest Updates: The Next Quarterly Business Meeting is June 19-20

Neuropathy and efficacy of once weekly subcutaneous bortezomib in multiple myeloma and light chain (AL) amyloidosis

PubMed Central

Sidana, Surbhi; Narkhede, Mayur; Elson, Paul; Hastings, Debbie; Faiman, Beth; Valent, Jason; Samaras, Christy; Hamilton, Kimberly; Liu, Hien K.; Smith, Mitchell R.; Reu, Frederic J.

2017-01-01

Introduction Randomized studies have shown that bortezomib (BTZ) can be given weekly via intravenous (IV) route or twice weekly via subcutaneous (SC) route with lower neuropathy risk and no loss of anti-myeloma efficacy compared to original standard IV twice weekly schedule. Weekly SC should therefore yield the best therapeutic index and is widely used but has not been compared to established administration schedules in the context of a clinical trial. Methods Comprehensive electronic medical record review was done for disease control and neuropathy symptoms of 344 consecutive patients who received their first BTZ-containing regimen for myeloma or AL amyloidosis before or after we changed to SC weekly in December 2010. Univariate and multivariable analyses were carried out that adjusted for age, underlying disease, concurrently used anticancer agents, underlying conditions predisposing to neuropathy, and number of prior regimens compared SC weekly to other schedules. Results Fifty-three patients received BTZ SC weekly, 17 SC twice weekly, 127 IV weekly and 147 IV twice weekly. Risk for neuropathy of any grade was higher with other schedules compared to SC weekly (44.3% vs. 26.9%, p = 0.001) while response rate was similar (72.1% vs. 76.6%, respectively, p = 0.15). Multivariable analyses upheld higher neuropathy risk (Odds ratio 2.45, 95% CI 1.26–4.76, p = 0.008) while the likelihood of not achieving a response (= partial response or better) was comparable (Odds ratio 1.25, 95% CI 0.58–2.71, p = 0.56) for other schedules compared to SC weekly, respectively. Lower neuropathy risk translated into longer treatment duration when BTZ was started SC weekly (p = 0.001). Conclusions Weekly SC BTZ has activity comparable to other schedules and causes low rates of neuropathy. PMID:28278302

Arteriovenous Fistula Development in the First 6 Weeks after Creation.

PubMed

Robbin, Michelle L; Greene, Tom; Cheung, Alfred K; Allon, Michael; Berceli, Scott A; Kaufman, James S; Allen, Matthew; Imrey, Peter B; Radeva, Milena K; Shiu, Yan-Ting; Umphrey, Heidi R; Young, Carlton J

2016-05-01

To assess the anatomic development of native arteriovenous fistula (AVF) during the first 6 weeks after creation by using ultrasonographic (US) measurements in a multicenter hemodialysis fistula maturation study. Each institutional review board approved the prospective study protocol, and written informed consent was obtained. Six hundred and two participants (180 women and 422 men, 459 with upper-arm AVF and 143 with forearm AVF) from seven clinical centers underwent preoperative artery and vein US mapping. AVF draining vein diameter and blood flow rate were assessed postoperatively after 1 day, 2 weeks, and 6 weeks. Relationships among US measurements were summarized after using multiple imputation for missing measurements. In 55% of forearm AVFs (68 of 124) and 83% of upper-arm AVFs (341 of 411) in surviving patients without thrombosis or AVF intervention prior to 6 weeks, at least 50% of their 6-week blood flow rate measurement was achieved at 1 day. Among surviving patients without thrombosis or AVF intervention prior to week 2, 70% with upper-arm AVFs (302 of 433) and 77% with forearm AVFs (99 of 128) maintained at least 85% of their week 2 flow rate at week 6. Mean AVF diameters of at least 0.40 cm were seen in 85% (389 of 459), 91% (419 of 459), and 87% (401 of 459) of upper-arm AVFs and in 40% (58 of 143), 73% (104 of 143), and 77% (110 of 143) of forearm AVFs at 1 day, 2 weeks, and 6 weeks, respectively. One-day and 2-week AVF flow rates and diameters were used to predict 6-week levels, with 2-week prediction of 6-week measures more accurate than those of 1 day (flow rates, R(2) = 0.47 and 0.61, respectively; diameters, R(2) = 0.49 and 0.82, respectively). AVF blood flow rate at 1 day is usually more than 50% of the 6-week blood flow rate. Two-week measurements are more predictive of 6-week diameter and blood flow than those of 1 day. US measurements at 2 weeks may be of value in the early identification of fistulas that are unlikely to develop optimally. (©) RSNA, 2015 Online supplemental material is available for this article.

76 FR 30491 - National Hurricane Preparedness Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... Hurricane Preparedness Week, 2011 Proclamation 8680--National Safe Boating Week, 2011 Proclamation 8681... Hurricane Preparedness Week, 2011 By the President of the United States of America A Proclamation National Hurricane Preparedness Week highlights the importance of planning ahead to protect our families and secure...

76 FR 29131 - Emergency Medical Services Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... Services Week, 2011 Proclamation 8675--National Defense Transportation Day and National Transportation Week, 2011 Proclamation 8676--Peace Officers Memorial Day and Police Week, 2011 Proclamation 8677--World Trade Week, 2011 Notice of May 17, 2011--Continuation of the National Emergency With Respect to the...

High rate of improvement in serum matrix metalloproteinase-3 levels at 4 weeks predicts remission at 52 weeks in RA patients treated with adalimumab.

PubMed

Hattori, Yosuke; Kojima, Toshihisa; Kaneko, Atsushi; Kida, Daihei; Hirano, Yuji; Fujibayashi, Takayoshi; Yabe, Yuichiro; Oguchi, Takeshi; Kanayama, Yasuhide; Miyake, Hiroyuki; Kato, Takefumi; Takagi, Hideki; Hayashi, Masatoshi; Ito, Takayasu; Shioura, Tomone; Takahashi, Nobunori; Ishikawa, Hisato; Funahashi, Koji; Ishiguro, Naoki

2018-01-01

This study aimed to determine whether serum matrix metalloproteinase-3 (MMP-3) levels can predict remission in rheumatoid arthritis (RA) patients treated with adalimumab (ADA). Subjects were 114 RA patients continuously treated with ADA for 52 weeks. Predictive factors at baseline and 4 weeks after initiation of ADA therapy for the achievement of remission (28-point count Disease Activity Score-CRP (DAS28-CRP) < 2.3) at 52 weeks were evaluated by multivariate logistic regression analysis. DAS28-CRP at 4 weeks (odds ratio (OR) 0.614, 95% confidence interval (CI) 0.382-0.988) and improvement in serum MMP-3 levels at 4 weeks (OR 1.057, 95% CI 1.002-1.032) were independent predictors of remission at 52 weeks. The best cut-off level of DAS28-CRP and improvement in serum MMP-3 levels at 4 weeks for predicting remission at 52 weeks was 3.73 (sensitivity: 90%, specificity: 50%, area under the receiver operating characteristic curve (AUC): 62%) and 39.93% (sensitivity: 47%, specificity: 83%, AUC: 64%), respectively. Our findings suggest that a high rate of improvement in serum MMP-3 levels at 4 weeks after initiation of ADA therapy can predict remission at 52 weeks in RA patients.

Tenascin-C Prevents Articular Cartilage Degeneration in Murine Osteoarthritis Models.

PubMed

Matsui, Yuriyo; Hasegawa, Masahiro; Iino, Takahiro; Imanaka-Yoshida, Kyoko; Yoshida, Toshimichi; Sudo, Akihiro

2018-01-01

Objective The objective of this study was to determine whether intra-articular injections of tenascin-C (TNC) could prevent cartilage damage in murine models of osteoarthritis (OA). Design Fluorescently labeled TNC was injected into knee joints and its distribution was examined at 1 day, 4 days, 1 week, 2 weeks, and 4 weeks postinjection. To investigate the effects of TNC on cartilage degeneration after surgery to knee joints, articular spaces were filled with 100 μg/mL (group I), 10 μg/mL (group II) of TNC solution, or control (group III). TNC solution of 10 μg/mL was additionally injected twice after 3 weeks (group IV) or weekly after 1 week, 2 weeks, and 3 weeks (group V). Joint tissues were histologically assessed using the Mankin score and the modified Chambers system at 2 to 8 weeks after surgery. Results Exogenous TNC was maintained in the cartilage and synovium for 1 week after administration. Histological scores in groups I and II were better than scores in group III at 4 and 6 weeks, but progressive cartilage damage was seen in all groups 8 weeks postoperatively. Sequential TNC injections (groups IV and V) showed significantly better Mankin score than single injection (group II) at 8 weeks. Conclusion TNC administered exogenously remained in the cartilage of knee joints for 1 week, and could decelerate articular cartilage degeneration in murine models of OA. We also showed that sequential administration of TNC was more effective than a single injection. TNC could be an important molecule for prevention of articular cartilage damage.

Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial.

PubMed

Espí-López, Gemma V; López-Martínez, Susana; Inglés, Marta; Serra-Añó, Pilar; Aguilar-Rodríguez, Marta

2018-04-22

To compare the effectiveness of a specific Manual Therapy (MT) protocol applied to field hockey players (FHP), versus a Proprioceptive Neuromuscular Facilitation (PNF) protocol, in the improvement of dynamic balance, active range of movement and lumbar flexibility one-week and four-weeks after the treatment. Randomized controlled trial. Participants were assigned to 2 groups: MT and PNF. 30 min' sessions were performed once a week for three weeks. Three evaluations were performed: basal, one-week and four-weeks post-treatment. University of Valencia (Spain). 22 in MT group and 20 in PNF group. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test. Both groups significantly improved in lateral and medial dynamic balance one-week post-treatment (p < 0.05); but the improvement in the MT group lasted until the fourth-week after treatment in both reaches (lateral and medial) (p < 0.05). MT group also obtained significant improvements in dorsal flexion of the ankle in the fourth-week post-treatment (p < 0.05) and in lumbar flexibility one-week post-treatment (p < 0.05). MT and PNF improve dynamic balance one-week post-treatment; however, the improvement obtained through MT is maintained four-weeks later. Only MT improves dorsal flexion of the ankle four-weeks post-treatment and lumbar flexibility one-week post-treatment. Copyright © 2018 Elsevier Ltd. All rights reserved.

Disease and predation: Sorting out causes of a bighorn sheep (Ovis canadensis) decline

USGS Publications Warehouse

Smith, Joshua B.; Jenks, Jonathan A.; Grovenburg, Troy W.; Klaver, Robert W.

2014-01-01

Estimating survival and documenting causes and timing of mortality events in neonate bighorn sheep (Ovis canadensis) improves understanding of population ecology and factors influencing recruitment. During 2010–2012, we captured and radiocollared 74 neonates in the Black Hills, South Dakota, of which 95% (70) died before 52 weeks of age. Pneumonia (36%) was the leading cause of mortality followed by predation (30%). We used known fate analysis in Program MARK to estimate weekly survival rates and investigate the influence of intrinsic variables on 52-week survival. Model {S1 wk, 2–8 wks, >8 wks} had the lowest AICc (Akaike’s Information Criterion corrected for small sample size) value, indicating that age (3-stage age-interval: 1 week, 2–8 weeks, and >8 weeks) best explained survival. Weekly survival estimates for 1 week, 2–8 weeks, and >8 weeks were 0.81 (95% CI = 0.70–0.88), 0.86 (95% CI = 0.81–0.90), and 0.94 (95% CI = 0.91–0.96), respectively. Overall probability of surviving 52 weeks was 0.02 (95% CI = 0.01–0.07). Of 70 documented mortalities, 21% occurred during the first week, 55% during weeks 2–8, and 23% occurred >8 weeks of age. We found pneumonia and predation were temporally heterogeneous with lambs most susceptible to predation during the first 2–3 weeks of life, while the greatest risk from pneumonia occurred from weeks 4–8. Our results indicated pneumonia was the major factor limiting recruitment followed by predation. Mortality from predation may have been partly compensatory to pneumonia and its effects were less pronounced as alternative prey became available. Given the high rates of pneumonia-caused mortality we observed, and the apparent lack of pneumonia-causing pathogens in bighorn populations in the western Black Hills, management activities should be geared towards eliminating contact between diseased and healthy populations.

Association between Frequency of Breakfast Consumption and Academic Performance in Healthy Korean Adolescents.

PubMed

So, Wi-Young

2013-01-01

The purpose of this study was to examine whether the frequency of breakfast consumption was related to academic performance in healthy Korean adolescents. We analyzed data from the seventh Korea Youth Risk Behavior Web-based Survey conducted in 2011, in which 75,643 adolescents from school grades 7-12 participated. We assessed the association between the frequency of breakfast consumption (per week) and academic performance using multivariate logistic regression analysis after adjusting for covariates such as age, body mass index, frequency of smoking, frequency of drinking, parents' education level, family economic status, frequency of vigorous physical activity (PA), frequency of moderate PA, frequency of muscular strength exercises, and level of mental stress. For male adolescents, the odds ratios (ORs) for achieving average or higher academic performance according to the breakfast frequency per week were once per week, 1.004 (P=0.945); twice per week, 0.915 (P=0.153); 3 days per week, 0.928 (P=0.237); 4 days per week, 1.087 (P=0.176); 5 days per week, 1.258 (P<0.001); 6 days per week, 1.473 (P<0.001); and every day, 1.700 (P<0.001), compared to no breakfast per week. For female adolescents, the ORs for achieving average or higher academic performance according to the breakfast frequency were once per week, 1.068 (P=0.320); twice per week, 1.140 (P=0.031); 3 days per week, 1.179 (P=0.004); 4 days per week, 1.339 (P<0.001); 5 days per week, 1.449 (P<0.001); 6 days per week, 1.768 (P<0.001); and every day, 1.922 (P<0.001), compared to no breakfast per week. The frequency of breakfast consumption is positively correlated with academic performance in both male and female healthy adolescents in Korea.

ACL/MCL transection affects knee ligament insertion distance of healing and intact ligaments during gait in the Ovine model.

PubMed

Tapper, Janet E; Funakoshi, Yusei; Hariu, Mitsuhiro; Marchuk, Linda; Thornton, Gail M; Ronsky, Janet L; Zernicke, Ron; Shrive, Nigel G; Frank, Cyril B

2009-08-25

The objective of this study was to assess the impact of combined transection of the anterior cruciate and medial collateral ligaments on the intact and healing ligaments in the ovine stifle joint. In vivo 3D stifle joint kinematics were measured in eight sheep during treadmill walking (accuracy: 0.4+/-0.4mm, 0.4+/-0.4 degrees ). Kinematics were measured with the joint intact and at 2, 4, 8, 12, 16 and 20 weeks after either surgical ligament transection (n=5) or sham surgery without transection (n=3). After sacrifice at 20 weeks, the 3D subject-specific bone and ligament geometry were digitized, and the 3D distances between insertions (DBI) of ligaments during the dynamic in vivo motion were calculated. Anterior cruciate ligament/medial collateral ligament (ACL/MCL) transection resulted in changes in the DBI of not only the transected ACL, but also the intact lateral collateral ligament (LCL) and posterior cruciate ligament (PCL), while the DBI of the transected MCL was not significantly changed. Increases in the maximal ACL DBI (2 week: +4.2mm, 20 week: +5.7mm) caused increases in the range of ACL DBI (2 week: 3.6mm, 20 week: +3.8mm) and the ACL apparent strain (2 week: +18.9%, 20 week: +24.0%). Decreases in the minimal PCL DBI (2 week: -3.2mm, 20 week: -4.3mm) resulted in increases in the range of PCL DBI (2 week: +2.7mm, 20 week: +3.2mm). Decreases in the maximal LCL DBI (2 week: -1.0mm, 20 week: -2.0mm) caused decreased LCL apparent strain (2 week: -3.4%, 20 week: -6.9%). Changes in the mechanical environment of these ligaments may play a significant role in the biological changes observed in these ligaments.

78 FR 30723 - National Safe Boating Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

... Boating Week, 2013 Proclamation 8982--Emergency Medical Services Week, 2013 Proclamation 8983--World Trade Week, 2013 Proclamation 8984--Armed Forces Day, 2013 Memorandum of May 17, 2013--Modernizing Federal... Boating Week, 2013 By the President of the United States of America A Proclamation Every year, the United...

Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth

PubMed Central

Woody, George E.; Poole, Sabrina A.; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G.; Fudala, Paul

2008-01-01

Context The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. Objective To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Design, Setting, and Patients Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Interventions Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Main Outcome Measure Opioid-positive urine test result at weeks 4, 8, and 12. Results The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 ( χ22 = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; χ12 = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use ( χ12 = 18.45, P < .001), less injecting ( χ12 = 6.00, P = .01), and less nonstudy addiction treatment ( χ12 = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. Conclusions Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. PMID:18984887

Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.

PubMed

Woody, George E; Poole, Sabrina A; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G; Fudala, Paul

2008-11-05

The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Opioid-positive urine test result at weeks 4, 8, and 12. The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12. Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence. clinicaltrials.gov Identifier: NCT00078130.

Chronic rotator cuff injury and repair model in sheep.

PubMed

Coleman, Struan H; Fealy, Stephen; Ehteshami, John R; MacGillivray, John D; Altchek, David W; Warren, Russell F; Turner, A Simon

2003-12-01

Most rotator cuff surgery is performed on chronic tears. As there is no animal model in which to examine the physiology of muscle and tendon injury and repair in this setting, we developed a chronic rotator cuff injury model in sheep. The infraspinatus tendon was released in thirty-six female sheep. Biopsy specimens were obtained from the muscle and were analyzed for fat content. The force generated by the muscle with supramaximal stimulation was recorded intraoperatively. A control group (twelve sheep) underwent an immediate tendon repair. In the remaining twenty-four sheep, the tendon was wrapped in a dura substitute to prevent scarring and was repaired at six weeks (eight sheep) and eighteen weeks (sixteen sheep) after release. In the immediate repair group, four animals were killed at six weeks; four, at twelve weeks; and four, at twenty weeks. In the six-week delayed repair group, four animals were killed at twelve weeks and four were killed at twenty weeks after the repair. In the eighteen-week delayed repair group, eight animals were killed at twelve weeks; four, at twenty weeks; and four, at thirty weeks after the repair. Muscle biopsies and testing were repeated prior to killing of the animals. The average force of muscle contraction decreased 3.6 lb (1.6 kg) by six weeks after the injury and 3.9 lb (1.8 kg) by eighteen weeks after the injury. After the repair, the force of contraction in the six-week group improved by 0.8 lb (0.4 kg) at twelve weeks postoperatively and by 1.3 lb (0.6 kg) at twenty weeks postoperatively. In contrast, no improvement occurred in the eighteen-week group until thirty weeks after the repair, at which time a 0.9-lb (0.4-kg) improvement was noted. There was a twelvefold increase in intramuscular fat concentration; this lipid infiltration was partially reversed after the tendon repair. Isolated tendon samples demonstrated an increase in the modulus of elasticity after chronic detachment that partially corrected after the tendon repair in the earlier (six-week) repair group. We found that earlier repair of the tendon results in a more rapid recovery of both muscle function and tendon elasticity compared with a more delayed repair. We concluded that there may be a "point of no return" in rotator cuff injury after which the elasticity of the muscle-tendon unit does not return to normal.

76 FR 20827 - National Crime Victims' Rights Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

... Victims' Rights Week, 2011 Proclamation 8651--Pan American Day and Pan American Week, 2011 Proclamation... Victims' Rights Week, 2011 By the President of the United States of America A Proclamation Though our... continue to fight crime wherever it exists. During National Crime Victims' Rights Week, we renew our...

43 CFR 2650.7 - Publication.

Code of Federal Regulations, 2011 CFR

2011-10-01

... shall be published once a week for 4 consecutive weeks in a newspaper of general circulation. (b) The... that publication has been had for 4 consecutive weeks. The applicant must pay the cost of publication... decision shall be published once in the Federal Register and, once a week, for four (4) consecutive weeks...

78 FR 30729 - World Trade Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

... Trade Week, 2013 By the President of the United States of America A Proclamation As a Nation, we need to... creates jobs and grows our economy. During World Trade Week, we recognize workers, growers, and... 25, 2013, as World Trade Week. I encourage all Americans to observe this week with events, trade...

76 FR 29139 - World Trade Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... Trade Week, 2011 By the President of the United States of America A Proclamation American businesses... world continues to grow more interdependent. World Trade Week is a time to highlight the vital... May 15 through May 21, 2011, as World Trade Week. I encourage all Americans to observe this week with...

76 FR 72601 - National Family Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... Family Week, 2011 Proclamation 8757--National Farm-City Week, 2011 Proclamation 8758--National Child's..., 2011 National Family Week, 2011 By the President of the United States of America A Proclamation For... courage to pursue their dreams. This week, we celebrate the threads of compassion and unity that tie our...

20 CFR 625.6 - Weekly amount; jurisdictions; reductions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DISASTER UNEMPLOYMENT ASSISTANCE § 625.6 Weekly amount; jurisdictions; reductions. (a) In all States... worker or unemployed self-employed individual for a week of total unemployment shall be the weekly amount... provisions of the applicable State law for a week of total unemployment. In no event shall such amount be in...

20 CFR 625.6 - Weekly amount; jurisdictions; reductions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DISASTER UNEMPLOYMENT ASSISTANCE § 625.6 Weekly amount; jurisdictions; reductions. (a) In all States... worker or unemployed self-employed individual for a week of total unemployment shall be the weekly amount... provisions of the applicable State law for a week of total unemployment. In no event shall such amount be in...

20 CFR 625.6 - Weekly amount; jurisdictions; reductions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DISASTER UNEMPLOYMENT ASSISTANCE § 625.6 Weekly amount; jurisdictions; reductions. (a) In all States... worker or unemployed self-employed individual for a week of total unemployment shall be the weekly amount... provisions of the applicable State law for a week of total unemployment. In no event shall such amount be in...

20 CFR 625.6 - Weekly amount; jurisdictions; reductions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DISASTER UNEMPLOYMENT ASSISTANCE § 625.6 Weekly amount; jurisdictions; reductions. (a) In all States... worker or unemployed self-employed individual for a week of total unemployment shall be the weekly amount... provisions of the applicable State law for a week of total unemployment. In no event shall such amount be in...

78 FR 69462 - Sunshine Act Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0001] Sunshine Act Meeting Notice DATE: Weeks of November...--Tentative There are no meetings scheduled for the week of November 25, 2013. Week of December 2, 2013--Tentative There are no meetings scheduled for the week of December 2, 2013. Week of December 9, 2013...

The Sky This Week, 2016 January 19 - 26 - Naval Oceanography Portal

Science.gov Websites

are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Week, 2016 January 19 - 26 USNO Logo USNO Navigation Tour Information USNO Scientific Colloquia Sky This Week The Sky This Week, 2016 January 19 - 26 Info The Sky This Week, 2016 January 19 - 26 See all the bright planets

The Sky This Week, 2016 April 19 - 26 - Naval Oceanography Portal

Science.gov Websites

are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Week, 2016 April 19 - 26 USNO Logo USNO Navigation Tour Information USNO Scientific Colloquia Sky This Week The Sky This Week, 2016 April 19 - 26 Info The Sky This Week, 2016 April 19 - 26 A bright and speedy star

The Sky This Week, 2015 December 8 - 15 - Naval Oceanography Portal

Science.gov Websites

are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Week, 2015 December 8 - 15 USNO Logo USNO Navigation Tour Information USNO Scientific Colloquia Sky This Week The Sky This Week, 2015 December 8 - 15 Info The Sky This Week, 2015 December 8 - 15 The year's best meteor

Glenohumeral range of motion (ROM) and isometric strength of professional team handball athletes, part III: changes over the playing season.

PubMed

Fieseler, Georg; Jungermann, Philipp; Koke, Alexander; Irlenbusch, Lars; Delank, Karl-Stefan; Schwesig, René

2015-12-01

The aim of our study was to investigate the relation of workload on range of motion and isometric strength of team handball athletes' shoulders over a competitive season. 31 Professional male handball athletes underwent clinical shoulder examinations. Athletes were examined subsequently during the complete playing season (week 0, 6, 22 and 40) to determine bilateral isometric shoulder rotational strength and active range of motion (ROM). In addition, relative (intraclass correlation coefficients (ICC) and absolute (standard error of measurement) reliability were calculated. Intraobserver reliability was excellent (ICC 0.76-0.98) for isometric strength and flexibility measurements. Internal rotation (IR) and total arc ROM in the throwing shoulder (TS) decreased significantly (p < 0.05) in both sequences (week 22 to week 40, week 0 to week 40). External rotation (ER) ROM and isometric strength in IR and ER did not change significantly. Glenohumeral internal rotation deficit (GIRD) and external rotation gain (ERG) of the TS decreased significantly between week 22 and week 40, but both did not change overall (week 0 to week 40). There was significant influence on IR ROM (week 22 to week 40) and strength in ER (week 0 to week 40) in the non-throwing shoulder. Several characteristics of handball players' shoulders changed significantly from the beginning to the end of a season. More specifically, the repetitive forces accumulated during the competitive season resulted in altered GIRD, ERG and isometric strength of the dominant glenohumeral joint.

WEEKLY RUNNING VOLUME AND RISK OF RUNNING‐RELATED INJURIES AMONG MARATHON RUNNERS

PubMed Central

Nielsen, Rasmus Oestergaard; Juul, Martin Serup; Rasmussen, Sten

2013-01-01

Purpose/Background: The purpose of this study was to investigate if the risk of injury declines with increasing weekly running volume before a marathon race. Methods: The study was a retrospective cohort study on marathon finishers. Following a marathon, participants completed a web‐based questionnaire. The outcome of interest was a self‐reported running‐related injury. The injury had to be severe enough to cause a reduction in distance, speed, duration or frequency of running for at least 14 days. Primary exposure was self‐reported average weekly volume of running before the marathon categorized into below 30 km/week, 30 to 60 km/week, and above 60 km/week. Results: A total of 68 of the 662 respondents sustained an injury. When adjusting for previous injury and previous marathons, the relative risk (RR) of suffering an injury rose by 2.02 [95% CI: 1.26; 3.24], p < 0.01, among runners with an average weekly training volume below 30 km/week compared with runners with an average weekly training volume of 30‐60 km/week. No significant differences were found between runners exceeding 60 km/week and runners running 30‐60 km/week (RR=1.13 [0.5;2.8], p=0.80). Conclusions: Runners may be advised to run a minimum of 30 km/week before a marathon to reduce their risk of running‐related injury. Level of Evidence: 2b PMID:23593549

Closure of the vertebral canal in human embryos and fetuses.

PubMed

Mekonen, Hayelom K; Hikspoors, Jill P J M; Mommen, Greet; Kruepunga, Nutmethee; Köhler, S Eleonore; Lamers, Wouter H

2017-08-01

The vertebral column is the paradigm of the metameric architecture of the vertebrate body. Because the number of somites is a convenient parameter to stage early human embryos, we explored whether the closure of the vertebral canal could be used similarly for staging embryos between 7 and 10 weeks of development. Human embryos (5-10 weeks of development) were visualized using Amira 3D ® reconstruction and Cinema 4D ® remodelling software. Vertebral bodies were identifiable as loose mesenchymal structures between the dense mesenchymal intervertebral discs up to 6 weeks and then differentiated into cartilaginous structures in the 7th week. In this week, the dense mesenchymal neural processes also differentiated into cartilaginous structures. Transverse processes became identifiable at 6 weeks. The growth rate of all vertebral bodies was exponential and similar between 6 and 10 weeks, whereas the intervertebral discs hardly increased in size between 6 and 8 weeks and then followed vertebral growth between 8 and 10 weeks. The neural processes extended dorsolaterally (6th week), dorsally (7th week) and finally dorsomedially (8th and 9th weeks) to fuse at the midthoracic level at 9 weeks. From there, fusion extended cranially and caudally in the 10th week. Closure of the foramen magnum required the development of the supraoccipital bone as a craniomedial extension of the exoccipitals (neural processes of occipital vertebra 4), whereas a growth burst of sacral vertebra 1 delayed closure until 15 weeks. Both the cranial- and caudal-most vertebral bodies fused to form the basioccipital (occipital vertebrae 1-4) and sacrum (sacral vertebrae 1-5). In the sacrum, fusion of its so-called alar processes preceded that of the bodies by at least 6 weeks. In conclusion, the highly ordered and substantial changes in shape of the vertebral bodies leading to the formation of the vertebral canal make the development of the spine an excellent, continuous staging system for the (human) embryo between 6 and 10 weeks of development. © 2017 Anatomical Society.

Parvovirus enteritis in vaccinated juvenile bush dogs.

PubMed

Janssen, D L; Bartz, C R; Bush, M; Marchwicki, R H; Grate, S J; Montali, R J

1982-12-01

Parvovirus enteritis developed in 10 of 17 vaccinated juvenile bush dogs (Speothos venaticus) from 4 litters in a 5-month period. Nine dogs died. The first outbreak involved 6 of 9 bush dogs from 2 litters. Each had been vaccinated with a killed feline-origin parvovirus vaccine at 11 and 14 weeks of age. The 6 affected dogs became ill at 29 weeks of age and died. The second outbreak involved a litter of 6 bush dogs. Each had been vaccinated every 2 weeks starting at 5 weeks of age. Two were isolated from the colony at 16 weeks of age for treatment of foot sores. Three of the 4 nonisolated dogs developed parvovirus enteritis at 20 weeks of age; 2 died at 6 and 8 days, respectively, after onset of signs. The 3rd outbreak involved a litter of 2 bush dogs. Both had been vaccinated every 2 to 3 weeks, starting at 6 weeks of age. One of these dogs became ill at 17 weeks and died 13 days later. A litter of 6 maned wolves (Chrysocyon brachyurus) and a litter of 3 bush dogs were isolated from their parent colonies at 13 and 15 weeks of age, respectively. Each animal had been vaccinated weekly, beginning at 8 weeks of age, using an inactivated canine-origin parvovirus vaccine. None of the isolated animals developed the disease. Serologic testing during isolation did not reveal protective titers (greater than or equal to 1:80) against canine parvovirus in the bush dogs until they were 23 weeks old, whereas protective titers developed in the maned wolves when they were 14 to 18 weeks old. One hand-raised bush dog was vaccinated weekly, beginning at 8 weeks of age, and a protective titer developed by 21 weeks of age. It was concluded that the juvenile bush dogs went through a period during which maternal antibodies interfered with immunization, yet did not protect against the disease. When the pups were isolated from the colony during this period, then vaccinated repeatedly until protective titers developed, the disease was prevented.

Four Weeks of IV Iron Supplementation Reduces Perceived Fatigue and Mood Disturbance in Distance Runners

PubMed Central

Woods, Amy; Garvican-Lewis, Laura A.; Saunders, Philo U.; Lovell, Greg; Hughes, David; Fazakerley, Ruth; Anderson, Bev; Gore, Christopher J.; Thompson, Kevin G.

2014-01-01

Purpose To determine the effect of intravenous iron supplementation on performance, fatigue and overall mood in runners without clinical iron deficiency. Methods Fourteen distance runners with serum ferritin 30–100 µg·L−1 were randomly assigned to receive three blinded injections of intravenous ferric-carboxymaltose (2 ml, 100 mg, IRON) or normal saline (PLACEBO) over four weeks (weeks 0, 2, 4). Athletes performed a 3,000 m time trial and 10×400 m monitored training session on consecutive days at week 0 and again following each injection. Hemoglobin mass (Hbmass) was assessed via carbon monoxide rebreathing at weeks 0 and 6. Fatigue and mood were determined bi-weekly until week 6 via Total Fatigue Score (TFS) and Total Mood Disturbance (TMD) using the Brief Fatigue Inventory and Brunel Mood Scale. Data were analyzed using magnitude-based inferences, based on the unequal variances t-statistic and Cohen's Effect sizes (ES). Results Serum ferritin increased in IRON only (Week 0: 62.8±21.9, Week 4: 128.1±46.6 µg·L−1; p = 0.002) and remained elevated two weeks after the final injection (127.0±66.3 µg·L−1, p = 0.01), without significant changes in Hbmass. Supplementation had a moderate effect on TMD of IRON (ES -0.77) with scores at week 6 lower than PLACEBO (ES -1.58, p = 0.02). Similarly, at week 6, TFS was significantly improved in IRON vs. PLACEBO (ES –1.54, p = 0.05). There were no significant improvements in 3,000 m time in either group (Week 0 vs. Week 4; Iron: 625.6±55.5 s vs. 625.4±52.7 s; PLACEBO: 624.8±47.2 s vs. 639.1±59.7 s); but IRON reduced their average time for the 10×400 m training session at week 2 (Week 0: 78.0±6.6 s, Week 2: 77.2±6.3; ES–0.20, p = 0.004). Conclusion During 6 weeks of training, intravenous iron supplementation improved perceived fatigue and mood of trained athletes with no clinical iron deficiency, without concurrent improvements in oxygen transport capacity or performance. PMID:25247929

The effect of group exercise frequency on health related quality of life in institutionalized elderly.

PubMed

Rugbeer, Nivash; Ramklass, Serela; Mckune, Andrew; van Heerden, Johan

2017-01-01

The study aimed to determine the effect of group exercise frequency on health related quality of life in institutionalized elderly. One hundred participants were recruited for voluntary participation from five aged care facilities, with inclusion being based on the outcome of a medical assessment by a sports physician. A quasi-experimental design was used to compare the effect of a 12 week group exercise programme on two groups of participants using pre-test and post-test procedures. A significant difference was noted in social function post training 2X/week (MD = -13.85, 95% CI [-24.66, -3.38], p = 0.017, d = 0.674) and 3X/week (MD = -13.30, 95% CI [-21.81, -5.59], p = 0.003, d = 0.712) a week. Training 3X/week a week provided an additional benefit in vitality (MD = -7.55, 95% CI [-13.16, -1.91], p = 0.018, d =0. 379). Improvements in mental component summary scale post training 2X/week (MD = -4.08, 95% CI [-7.67, -0.42], p = 0.033, d = 0.425) and 3X/week (MD = -6.67, 95% CI [-10.92, -2.33], p = 0.005, d = 0.567) a week was further noted. Mental health and social health benefits can be obtained irrespective of exercise frequency 2X/week or 3X/week. The exercise intervention at a frequency 3X/ week was more effective in improving mental component summary due to a larger effect size obtained compared to the exercise frequency of 2X/week. Additional benefits in vitality were achieved by exercising 3X/week. This may assist the elderly in preserving their independence.

The Sky This Week, 2016 March 15 - 23 - Naval Oceanography Portal

Science.gov Websites

are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Week, 2016 March 15 - 23 USNO Logo USNO Navigation Tour Information USNO Scientific Colloquia Sky This Week The Sky This Week, 2016 March 15 - 23 Info The Sky This Week, 2016 March 15 - 23 The equinox and the calendar

The Sky This Week, 2016 January 5 - 12 - Naval Oceanography Portal

Science.gov Websites

are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Week, 2016 January 5 - 12 USNO Logo USNO Navigation Tour Information USNO Scientific Colloquia Sky This Week The Sky This Week, 2016 January 5 - 12 Info The Sky This Week, 2016 January 5 - 12 Count the stars in Orion for

Oxidative stress, neurotoxicity, and metallothionein (MT) gene expression in juvenile rock fish Sebastes schlegelii under the different levels of dietary chromium (Cr(6+)) exposure.

PubMed

Kim, Jun-Hwan; Kang, Ju-Chan

2016-03-01

Juvenile Sebastes schlegelii were exposed for 4 weeks with the different levels of dietary chromium (Cr(6+)) concentration (0, 30, 60, 120 and 200mg/kg). The superoxide dismutase (SOD) activity, glutathione S-transferase (GST) activity, and glutathione (GSH) level of liver and gill were evaluated after 4 weeks exposure. The SOD and GST activity of liver and gill was significantly increased in the concentration of 240mg/kg after 2 weeks and over 120mg/kg after 4 weeks, whereas a considerable decrease in the concentration of 240mg/kg after 2 weeks and over 120mg/kg after 4 weeks was observed in the GSH levels of liver and gill. In neurotoxicity, AChE activity was significatly inhibited in brain in the concentration of 240mg/kg after 2 weeks and over 60mg/kg after 4 weeks and muscle in the concentration of 240mg/kg after 2 weeks and over 120mg/kg after 4 weeks. Metallothionein (MT) gene in liver was considerably increased over 120mg/kg after 2 weeks and at 30, 120, and 240mg/kg after 4 weeks by dietary chromium exposure. The results indicate that dietary Cr exposure over 120mg/kg can induce substantial alterations in antioxidant responses, AChE activity and MT gene expression. Copyright © 2015 Elsevier Inc. All rights reserved.

5 CFR 630.1203 - Leave entitlement.

Code of Federal Regulations, 2010 CFR

2010-01-01

... scheduled administrative workweek. If the number of hours in an employee's workweek varies from week to week, a weekly average of the hours scheduled over the 12 weeks prior to the date leave commences shall be... the 12-week entitlement to family and medical leave. (f) If the number of hours in an employee's...

77 FR 76569 - Sunshine Act Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-28

... Regulatory Commission [NRC-2012- 0002]. DATE: Weeks of December 24, 31, 2012, January 7, 14, 21, 28, 2013... Closed. Week of December 24, 2012 There are no meetings scheduled for the week of December 24, 2012. Week.... Week of January 7, 2013--Tentative Tuesday, January 8, 2013 9:00 a.m. Briefing on Fort Calhoun (Public...

Bone mineral density changes after ovariectomy in rats as an osteopenic model : stepwise description of double dorso-lateral approach.

PubMed

Park, Sung Bae; Lee, Yoon Jin; Chung, Chun Kee

2010-10-01

This study describes a method for inducing osteopenia using bilateral ovariectomy (OVX), which causes significant changes in bone mineral density (BMD) in rats. Twenty-five 10-week-old female Sprague Dawley rats were used. Five rats were euthanized after two weeks, and BMD was measured in their femora. The other 20 rats were assigned to one of two groups : a sham group (n = 10), which underwent a sham operation, and an OVX group (n = 10), which underwent bilateral OVX at 12 weeks of age. After six weeks, five rats from each group were euthanized, and BMD was measured in their femora. The same procedures were performed in the remaining rats form each group eight weeks later. The femur BMD was significantly lower in the six-week OVX group than in the six-week sham group, and in the eight-week OVX group than in the eight-week sham group. Bilateral OVX is a safe method for creating an osteopenic rat model. The significant decrease in BMD appears six weeks after bilateral OVX.

The effect of Tembusu virus infection in different week-old Cherry Valley breeding ducks.

PubMed

Lu, Yunjian; Dou, Yanguo; Ti, Jinfeng; Wang, Aihua; Cheng, Binghua; Zhang, Xin; Diao, Youxiang

2016-08-30

To study the effect of Tembusu virus (TMUV) infection on Cherry Valley Breeding ducks of different ages, 350 five-week-old ducks were divided into 14 groups. Ducks in seven experimental group were respectively infected with 1.265×10(5) mean embryo lethal dose (ELD50) of TMUV-AHQY strain (in 4.2mL) by intravenous route. Ducks in control groups were inoculated with Phosphate-buffered Saline (PBS) in the same way. Clinical symptoms, gross and microscopic lesions, viral loads and serum antibodies were detected and recorded for 20days after infection. Some ducks infected at 7 and 21 week s of age showed severe clinical symptoms including depression and inappetence, and no obvious clinical symptoms were seen in other week-old infected ducks. Severe gross lesions including hepatomegaly, meningeal congestion, myocardial hemorrhage, intestinal, myocardial and pulmonary edema were observed in ducks infected at 7, 18 and 21 weeks of age. No or mild gross lesions were observed in ducks infected at 14 and 16 weeks of age. The main microscopic lesions including hyperaemia, degeneration and necrosis of different cells and inflammatory cellular infiltration mainly consisting of mononuclear cells or lymphocytes were observed in ducks infected at 7 and 21 week of age. But relatively intact structures and rare lymphocytic infiltration were presented in ducks infected at 14 and 16 weeks of age. Viral antigen was more frequently observed in organ slices collected from 7 week-old infected ducks and few positive staining was found in 14 and 16 week-old infected ducks. Less viral loads in different tissues and swabs were detected by a quantitative real-time PCR assay. The level of viral loads in the tissues of ducks infected at 14 and 16 weeks of age was very lower than that of ducks infected at 7 and 21 weeks of age. Meanwhile, less viral copy numbers were detected in swab samples collected from 14 and 16 week-old infected ducks. Ducks infected at 14-week-old developed significantly higher serum neutralizing antibody titers than those infected at other week of age. These results indicated that the effect of TMUV infection on Cherry Valley ducks is partly related to weeks of age. 7-10 week-old and 18-21 week-old ducks were more susceptible to TMUV infection, but 14-16 week-old ducks were more resistant to this disease. Copyright © 2016 Elsevier B.V. All rights reserved.

Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion: The RELATE Trial.

PubMed

Campochiaro, Peter A; Hafiz, Gulnar; Mir, Tahreem A; Scott, Adrienne W; Solomon, Sharon; Zimmer-Galler, Ingrid; Sodhi, Akrit; Duh, Elia; Ying, Howard; Wenick, Adam; Shah, Syed Mahmood; Do, Diana V; Nguyen, Quan D; Kherani, Saleema; Sophie, Raafay

2015-07-01

To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. Randomized, double-masked, controlled clinical trial. Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P < 0.01) and week 96 (-2.0 vs. +4.8; P < 0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The risk of infant and fetal death by each additional week of expectant management in intrahepatic cholestasis of pregnancy by gestational age.

PubMed

Puljic, Anela; Kim, Elissa; Page, Jessica; Esakoff, Tania; Shaffer, Brian; LaCoursiere, Daphne Y; Caughey, Aaron B

2015-05-01

The objective of the study was to characterize the risk of infant and fetal death by each additional week of expectant management vs immediate delivery in pregnancies complicated by cholestasis. This was a retrospective cohort study of 1,604,386 singleton, nonanomalous pregnancies of women between 34 and 40 weeks' gestation with and without intrahepatic cholestasis of pregnancy (ICP) in the state of California during the years of 2005-2008. International Classification of Diseases, 9th version, codes and linked hospital discharge and vital statistics data were utilized. For each week of gestation, the following outcomes were assessed: the risk of stillbirth, the risk of delivery (represented by the risk of infant death at a given week of gestation), and the composite risk of expectant management for 1 additional week. Composite risk combines the risk of stillbirth at this gestational age week plus the risk of infant death if delivered at the subsequent week of gestation. Among women with ICP, the mortality risk of delivery is lower than the risk of expectant management at 36 weeks' gestation (4.7 vs 19.2 per 10,000). The risk of expectant management remains higher than delivery and continues to rise by week of gestation beyond 36 weeks. The risk of expectant management in women with ICP reaches a nadir at 35 weeks (9.1 per 10,000; 95% confidence interval, 1.4-16.9) and rises at 36 weeks (19.2 per 10,000; 95% confidence interval, 7.6-30.8). Among women with ICP, delivery at 36 weeks' gestation would reduce the perinatal mortality risk as compared with expectant management. For later diagnoses, this would also be true at gestational ages beyond 36 weeks. Timing of delivery must take into account both the reduction in stillbirth risk balanced with the morbidities associated with preterm delivery. Copyright © 2015 Elsevier Inc. All rights reserved.

Purification of chicken carbonic anhydrase isozyme-III (CA-III) and its measurement in White Leghorn chickens.

PubMed

Nishita, Toshiho; Tomita, Yuichiro; Yorifuji, Daisuke; Orito, Kensuke; Ochiai, Hideharu; Arishima, Kazuyosi

2011-11-26

The developmental profile of chicken carbonic anhydrase-III (CA-III) blood levels has not been previously determined or reported. We isolated CA-III from chicken muscle and investigated age-related changes in the levels of CA-III in blood. CA-III was purified from chicken muscle. The levels of CA-III in plasma and erythrocytes from 278 female chickens (aged 1-93 weeks) and 68 male chickens (aged 3-59 weeks) were determined by ELISA. The mean level of CA-III in female chicken erythrocytes (1 week old) was 4.6 μg/g of Hb, and the CA-III level did not change until 16 weeks of age. The level then increased until 63 weeks of age (11.8 μg/g of Hb), decreased to 4.7 μg/g of Hb at 73 weeks of age, and increased again until 93 weeks of age (8.6 μg/g of Hb). The mean level of CA-III in erythrocytes from male chickens (3 weeks old) was 2.4 μg/g of Hb, and this level remained steady until 59 weeks of age. The mean plasma level of CA-III in 1-week-old female chickens was 60 ng/mL, and this level was increased at 3 weeks of age (141 ng/mL) and then remained steady until 80 weeks of age (122 ng/mL). The mean plasma level of CA-III in 3-week-old male chickens was 58 ng/mL, and this level remained steady until 59 weeks of age. We observed both developmental changes and sex differences in CA-III concentrations in White Leghorn (WL) chicken erythrocytes and plasma. Simple linear regression analysis showed a significant association between the erythrocyte CA-III level and egg-laying rate in WL-chickens 16-63 weeks of age (p < 0.01).

Time-wise change in neck pain in response to rehabilitation with specific resistance training: implications for exercise prescription.

PubMed

Zebis, Mette K; Andersen, Christoffer H; Sundstrup, Emil; Pedersen, Mogens T; Sjøgaard, Gisela; Andersen, Lars L

2014-01-01

To determine the time-wise effect of specific resistance training on neck pain among industrial technicians with frequent neck pain symptoms. Secondary analysis of a parallel-group cluster randomized controlled trial of 20 weeks performed at two large industrial production units in Copenhagen, Denmark. Women with neck pain >30 mm VAS (N = 131) were included in the present analysis. The training group (N = 77) performed specific resistance training for the neck/shoulder muscles three times a week, and the control group (N = 54) received advice to stay active. Participants of both groups registered neck pain intensity (0-100 mm VAS) once a week. Neck pain intensity was 55 mm (SD 23) at baseline. There was a significant group by time interaction for neck pain (F-value 2.61, P<0.001, DF = 19). Between-group differences in neck pain reached significance after 4 weeks (11 mm, 95% CI 2 to 20). The time-wise change in pain showed three phases; a rapid decrease in the training group compared with the control group during the initial 7 weeks, a slower decrease in pain during the following weeks (week 8-15), and a plateau during the last weeks (week 16-20). Adherence to training followed a two-phase pattern, i.e. weekly participation rate was between 70-86% during the initial 7 weeks, dropping towards 55-63% during the latter half of the training period. Four weeks of specific resistance training reduced neck pain significantly, but 15 weeks is required to achieve maximal pain reduction. The time-wise change in pain followed a three-phase pattern with a rapid effect during the initial 7 weeks followed by a slower but still positive effect, and finally a plateau from week 15 and onwards. Decreased participation rate may explain the decreased efficacy during the latter phase of the intervention.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

PubMed

Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-10-01

While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial

PubMed Central

Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-01-01

Background While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this “Treatment of Early Neuropathy in Leprosy” (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. Methods In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient’s body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. Results We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. Conclusion In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment. PMID:28976976

Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

PubMed

Gonczi, Lorant; Vegh, Zsuzsanna; Golovics, Petra Anna; Rutka, Mariann; Gecse, Krisztina Barbara; Bor, Renata; Farkas, Klaudia; Szamosi, Tamás; Bene, László; Gasztonyi, Beáta; Kristóf, Tünde; Lakatos, László; Miheller, Pál; Palatka, Károly; Papp, Mária; Patai, Árpád; Salamon, Ágnes; Tóth, Gábor Tamás; Vincze, Áron; Biro, Edina; Lovasz, Barbara Dorottya; Kurti, Zsuzsanna; Szepes, Zoltan; Molnár, Tamás; Lakatos, Péter L

2017-06-01

Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary. Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6. A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were associated with short-and medium-term clinical response and remission. In UC, early TLs were predictive for short- and medium-term clinical efficacy, whereas in CD, Week 2 TLs were associated only with short-term clinical outcomes. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com

Effects of a 10-week weight control program on obese patients with schizophrenia or schizoaffective disorder: a 12-month follow up.

PubMed

Chen, Chih-Ken; Chen, Yi-Chih; Huang, Yu-Shu

2009-02-01

Weight gain secondary to antipsychotic medication is associated with many serious conditions, including type II diabetes mellitus, hypertension, and coronary heart disease, and also with poor medication compliance. Weight control programs may be of benefit to outpatients with schizophrenia, but also raise an issue of cost-effectiveness. We aimed to evaluate the effectiveness of a 10-week weight control program for outpatients taking atypical antipsychotics for treatment of schizophrenia, and to follow up the effects of this weight control program in controlling weight gain after termination of the program. A total of 33 patients with schizophrenia and antipsychotic-related obesity were enrolled in a 10-week multimodal weight control program. The patients' weights were recorded at baseline, week 4, week 8, week 10 (end of the intervention), week 12, week 24, and week 48. Secondary measures included blood sugar levels, cholesterol levels, triglyceride levels, quality of life and mental health. For those who completed the weight control program, there was a mean weight loss of 2.1 kg by the end of the intervention, 3.7 kg over 6 months, and 2.7 kg over 12 months. The mean body mass index decreased by 0.8, 1.5 and 1.1 at week 10, week 24 and week 48, respectively, all with statistical significance. The 10-week weight control program was effective in terms of weight reduction among obese patients with schizophrenia or schizoaffective disorder, and the weight reduction effect lasted for up to 6 months, and up to 12 months in some cases.

[A comparison between effects of aroma massage and meridian massage on constipation and stress in women college students].

PubMed

Chung, Miyoung; Choi, Euysoon

2011-02-01

This study was done to compare the effects of abdominal aroma massage and meridian massage on constipation and stress in college women with functional constipation. The participants were 38 college women, 18 were in the aroma group and 20 in the meridian group. The aroma massage was given using aroma oil which was a mixture of lemon, lavender, rosemary, and cyprus. The meridian massage was given at 9 accupoints which influence intestinal functions. The treatment was given 5 days a week for 4 weeks. A constipation severity score, weekly defecation frequency, and a stress response score were measured before and every week of 4 weeks of the experiment. While there was no significant difference between two groups, there was a significant difference within the groups in the constipation severity (aroma group: 1st week, meridian group: except 4th week), defecation frequency (aroma group: 3rd week, meridian group: 2nd and 3rd week), and stress (aroma group: all weeks, meridian group: except 4th week) after different duration of experiment. Based on these results, both abdominal massages relieved constipation and stress. Resorting to either types of massage will contribute to the reduction of use of stool softeners, suppositories, or enemas.

Premature infant

MedlinePlus

... infant is a baby born before 37 completed weeks of gestation (more than 3 weeks before the due date). ... one of the following: Premature (less than 37 weeks gestation) Full term (37 to 42 weeks gestation) ...

Depressed Adolescents Treated with Exercise (DATE): A pilot randomized controlled trial to test feasibility and establish preliminary effect sizes

PubMed Central

Hughes, Carroll W.; Barnes, Shauna; Barnes, Conrad; DeFina, Laura F.; Nakonezny, Paul; Emslie, Graham J.

2013-01-01

The Depressed Adolescents Treated with Exercise (DATE) study evaluated a standardized aerobic exercise protocol to treat nonmedicated adolescents that met DSM-IV-TR criteria for major depressive disorder. From an initial screen of 90 individuals, 30 adolescents aged 12-18 years were randomized to either vigorous exercise (EXER) (>12 kg/kcal/week [KKW]) or a control stretching (STRETCH) activity (< 4 KKW) for 12 weeks. The primary outcome measure was the blinded clinician rating of the Children's Depression Rating Scale – Revised (CDRS-R) to assess depression severity and Actical (KKW) accelerometry 24hr/7days a week to assess energy expenditure and adherence. Follow-up evaluations occurred at weeks 26 and 52. The EXER group averaged 77% adherence and the STRETCH group 81% for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements. There was a significant increase in overall weekly KKW expenditures (p < .001) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure. Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks (p < .016) and nine weeks (p < .001). Both groups continued to improve such that there were no group differences after 12 weeks (p = .07). By week 12, the exercise group had a 100% response rate (86% remission), whereas the stretch group response rate was 67% (50% remission) (p = .02). Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers. Anthropometry reflected decreased waist, hip and thigh measurements (p = .02), more so for females than males (p = .05), but there were no weight changes for either gender. The EXER group sustained 100% remission at week 26 and 52. The STRETCH group had 80% response and 70% remission rates at week 26 and by week 52 only one had not fully responded. The study provides support for the use of exercise as a non-medication intervention for adolescents with major depressive disorders when good adherence and energy expenditure (KKW) are achieved. PMID:24244220

[The application of contralateral acupuncture for rehabilitation after acute closed achilles tendon rupture].

PubMed

Zhang, Dawei; Ye, Xiangming; Zhang, Xiaofeng; Zhang, Wenjie

2017-03-12

To observe the differences of affected-side ankle plantar flexors function and clinical efficacy between contralateral acupuncture combined with rehabilitation training and rehabilitation training alone for patients with acute closed achilles tendon rupture. Seventy-four patients with acute closed achilles tendon rupture were randomly assigned to an observation group and a control group, 37 cases in each group. Patients in the both groups were treated with routine rehabilitation training after the operation for 12 weeks; besides, patients in the observation group were treated with contralateral acupuncture at Zusanli (ST 36), Yanglingquan (GB 34), Chengshan (BL 57), Taixi (KI 3) before rehabilitation training in the first 6 weeks. The treatment were given once a day, 5 times as 1 course with 2 d at the interval. The Biodex System 4 multi-joint dynamometers system was applied to test and compare affected-side plantar flexion peak torque (PFPT), peak torque/body weight (PT/BW) and total work (TW) after 6 weeks, 8 weeks and 12 weeks. The efficacy evaluation was conducted after 6 weeks and 12 weeks, and the follow-up visit was conducted 12 weeks after end of treatment. The PFPT, PT/BW, TW in the observation group were significantly superior to those in the control group after 8 weeks and 12 weeks of treatment (all P <0.05); compared with those after 6 weeks, the PFPT, PT/BW, TW were significantly increased after 8 weeks of treatment (all P <0.05); compared with those after 6 weeks and 8 weeks, the PFPT, PT/BW, TW were significantly increased after 12 weeks of treatment (all P <0.05). After 12 weeks of treatment and at follow-up visit, the clinical excellent and effective rates in the observation group were higher than those in the control group[89.2% (33/37) vs 70.3% (26/37), 94.6% (35/37) vs 75.7% (28/37), both P <0.05]. During the postoperative rehabilitation of acute closed achilles tendon rupture, the contralateral acupuncture combined with rehabilitation training could improve ankle plantar flexors function and clinical efficacy better than rehabilitation training only.

Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial.

PubMed

Arnold, Lesley M; Wang, Fujun; Ahl, Jonna; Gaynor, Paula J; Wohlreich, Madelaine M

2011-06-13

Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life. Fatigue was assessed as a secondary objective in a 2-phase, 24-week study in outpatients with American College of Rheumatology-defined fibromyalgia. Patients were randomized to duloxetine 60-120 mg/d (N = 263) or placebo (N = 267) for the 12-week acute phase. At Week 12, all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase. Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory (MFI) scales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation. Other assessments that may be associated with fatigue included Brief Pain Inventory (BPI) average pain, numerical scales to rate anxiety, depressed mood, bothered by sleep difficulties, and musculoskeletal stiffness. Treatment-emergent fatigue-related events were also assessed. Changes from baseline to Week 12, and from Week 12 to Week 24, were analyzed by mixed-effects model repeated measures analysis. At Week 12, duloxetine versus placebo significantly (all p < .05) reduced ratings on each MFI scale, BPI pain, anxiety, depressed mood, and stiffness. Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8. At Week 24, mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks (n = 176). Placebo-treated patients switched to duloxetine (n = 187) had significant within-group improvement in Physical Fatigue (Weeks 16, 20, and 24); General Fatigue (Weeks 20 and 24); Mental Fatigue (Week 20); and Reduced Activity (Weeks 20 and 24). These patients also experienced significant within-group improvement in BPI pain, anxiety, depressed mood, bothered by sleep difficulties, and stiffness. Overall, the most common (> 5% incidence) fatigue-related treatment-emergent adverse events were fatigue, somnolence, and insomnia. Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia, and improvement was maintained for up to 24 weeks. ClinicalTrials.gov registry NCT00673452.

Burosumab Therapy in Children with X-Linked Hypophosphatemia.

PubMed

Carpenter, Thomas O; Whyte, Michael P; Imel, Erik A; Boot, Annemieke M; Högler, Wolfgang; Linglart, Agnès; Padidela, Raja; Van't Hoff, William; Mao, Meng; Chen, Chao-Yin; Skrinar, Alison; Kakkis, Emil; San Martin, Javier; Portale, Anthony A

2018-05-24

X-linked hypophosphatemia is characterized by increased secretion of fibroblast growth factor 23 (FGF-23), which leads to hypophosphatemia and consequently rickets, osteomalacia, and skeletal deformities. We investigated burosumab, a monoclonal antibody that targets FGF-23, in patients with X-linked hypophosphatemia. In an open-label, phase 2 trial, we randomly assigned 52 children with X-linked hypophosphatemia, in a 1:1 ratio, to receive subcutaneous burosumab either every 2 weeks or every 4 weeks; the dose was adjusted to achieve a serum phosphorus level at the low end of the normal range. The primary end point was the change from baseline to weeks 40 and 64 in the Thacher rickets severity total score (ranging from 0 to 10, with higher scores indicating greater disease severity). In addition, the Radiographic Global Impression of Change was used to evaluate rachitic changes from baseline to week 40 and to week 64. Additional end points were changes in pharmacodynamic markers, linear growth, physical ability, and patient-reported outcomes and the incidence of adverse events. The mean Thacher rickets severity total score decreased from 1.9 at baseline to 0.8 at week 40 with every-2-week dosing and from 1.7 at baseline to 1.1 at week 40 with every-4-week dosing (P<0.001 for both comparisons); these improvements persisted at week 64. The mean serum phosphorus level increased after the first dose in both groups, and more than half the patients in both groups had levels within the normal range (3.2 to 6.1 mg per deciliter [1.0 to 2.0 mmol per liter]) by week 6. Stable serum phosphorus levels were maintained through week 64 with every-2-week dosing. Renal tubular phosphate reabsorption increased from baseline in both groups, with an overall mean increase of 0.98 mg per deciliter (0.32 mmol per liter). The mean dose of burosumab at week 40 was 0.98 mg per kilogram of body weight with every-2-week dosing and 1.50 mg per kilogram with every-4-week dosing. Across both groups, the mean serum alkaline phosphatase level decreased from 459 U per liter at baseline to 369 U per liter at week 64. The mean standing-height z score increased in both groups, with greater improvement seen at all time points with every-2-week dosing (an increase from baseline of 0.19 at week 64) than with every-4-week dosing (an increase from baseline of 0.12 at week 64). Physical ability improved and pain decreased. Nearly all the adverse events were mild or moderate in severity. In children with X-linked hypophosphatemia, treatment with burosumab improved renal tubular phosphate reabsorption, serum phosphorus levels, linear growth, and physical function and reduced pain and the severity of rickets. (Funded by Ultragenyx Pharmaceutical and Kyowa Hakko Kirin; ClinicalTrials.gov number, NCT02163577 ; EudraCT number, 2014-000406-35 ).

Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study.

PubMed

Heier, Jeffrey S; Clark, W Lloyd; Boyer, David S; Brown, David M; Vitti, Robert; Berliner, Alyson J; Kazmi, Husain; Ma, Yu; Stemper, Brigitte; Zeitz, Oliver; Sandbrink, Rupert; Haller, Julia A

2014-07-01

To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO). Randomized, double-masked, phase 3 trial. A total of 188 patients with macular edema secondary to CRVO. Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN. The primary efficacy end point was the proportion of patients who gained ≥ 15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results. The proportion of patients gaining ≥ 15 letters was 56.1% versus 12.3% (P<0.001) at week 24, 55.3% versus 30.1% (P<0.001) at week 52, and 49.1% versus 23.3% (P<0.001) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 (+17.3 vs. -4.0 letters; P<0.001), week 52 (+16.2 vs. +3.8 letters; P<0.001), and week 100 (+13.0 vs. +1.5 letters; P<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 μm (P<0.001) at week 24, 413.0 versus 381.8 μm at week 52 (P = 0.546), and 390.0 versus 343.3 μm at week 100 (P = 0.366) in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively. The mean number (standard deviation) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7 ± 1.7 versus 3.9 ± 2.0 during weeks 24 to 52 and 3.3 ± 2.1 versus 2.9 ± 2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + PRN and sham + IAI PRN groups, respectively). The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing, with a reduced monitoring frequency from weeks 52 to 100. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Effect of High-Volume Injection, Platelet-Rich Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study.

PubMed

Boesen, Anders Ploug; Hansen, Rudi; Boesen, Morten Ilum; Malliaras, Peter; Langberg, Henning

2017-07-01

Injection therapies are often considered alongside exercise for chronic midportion Achilles tendinopathy (AT), although evidence of their efficacy is sparse. To determine whether eccentric training in combination with high-volume injection (HVI) or platelet-rich plasma (PRP) injections improves outcomes in AT. Randomized controlled trial; Level of evidence, 1. A total of 60 men (age, 18-59 years) with chronic (>3 months) AT were included and followed for 6 months (n = 57). All participants performed eccentric training combined with either (1) one HVI (steroid, saline, and local anesthetic), (2) four PRP injections each 14 days apart, or (3) placebo (a few drops of saline under the skin). Randomization was stratified for age, function, and symptom severity (Victorian Institute of Sports Assessment-Achilles [VISA-A]). Outcomes included function and symptoms (VISA-A), self-reported tendon pain during activity (visual analog pain scale [VAS]), tendon thickness and intratendinous vascularity (ultrasonographic imaging and Doppler signal), and muscle function (heel-rise test). Outcomes were assessed at baseline and at 6, 12, and 24 weeks of follow-up. VISA-A scores improved in all groups at all time points ( P < .05), with greater improvement in the HVI group (mean ± SEM, 6 weeks = 27 ± 3 points; 12 weeks = 29 ± 4 points) versus PRP (6 weeks = 14 ± 4; 12 weeks = 15 ± 3) and placebo (6 weeks = 10 ± 3; 12 weeks = 11 ± 3) at 6 and 12 weeks ( P < .01) and in the HVI (22 ± 5) and PRP (20 ± 5) groups versus placebo (9 ± 3) at 24 weeks ( P < .01). VAS scores improved in all groups at all time points ( P < .05), with greater decrease in HVI (6 weeks = 49 ± 4 mm; 12 weeks = 45 ± 6 mm; 24 weeks = 34 ± 6 mm) and PRP (6 weeks = 37 ± 7 mm; 12 weeks = 41 ± 7 mm; 24 weeks = 37 ± 6 mm) versus placebo (6 weeks = 23 ± 6 mm; 12 weeks = 30 ± 5 mm; 24 weeks = 18 ± 6 mm) at all time points ( P < .05) and in HVI versus PRP at 6 weeks ( P < .05). Tendon thickness showed a significant decrease only in HVI and PRP groups during the intervention, and this was greater in the HVI versus PRP and placebo groups at 6 and 12 weeks ( P < .05) and in the HVI and PRP groups versus the placebo group at 24 weeks ( P < .05). Muscle function improved in the entire cohort with no difference between the groups. Treatment with HVI or PRP in combination with eccentric training in chronic AT seems more effective in reducing pain, improving activity level, and reducing tendon thickness and intratendinous vascularity than eccentric training alone. HVI may be more effective in improving outcomes of chronic AT than PRP in the short term. Registration: NCT02417987 ( ClinicalTrials.gov identifier).

Ultrasound-guided subacromial injections of sodium hyaluronate for the management of rotator cuff tendinopathy: a prospective comparative study with rehabilitation therapy.

PubMed

Merolla, G; Bianchi, P; Porcellini, G

2013-06-01

Rotator cuff (RC) tendinopathy is a common cause of pain and shoulder dysfunction. The literature evidence suggests that a combination of overuse and extrinsic compression may induce chronic RC tendinopathy. Aim of the current study was to compare the results of subacromial sodium hyaluronate injections with rehabilitation therapy. We enrolled 48 patients (M/F: 26/22; mean age: 50 years; shoulder right/left: 29/19) with persistent shoulder pain for at least 4 months. Exclusion criteria were as follows: RC tear, calcifying tendinitis, glenohumeral instability, osteoarthritis, rheumatic diseases, physical therapy and/or injection in the previous 4 months, shoulder surgery, anesthetic nerve block, trauma, and severe medical diseases. The included subjects received either two ultrasound-guided subacromial hyaluronic acid (HA) injections (25 patients, HA group) at baseline and 14 days, or underwent rehabilitation therapy (23 patients, Physio group) including active shoulder mobilization, soft tissue stretching and humeral head positioner and propeller muscles strengthening for 30 days (3 sessions every week). Clinical assessment of shoulder function was performed with visual analog scale score for pain (0-100), Oxford Shoulder Score (OSS), and Constant-Murley Score (CS). Overall, patients were examined at baseline, week 2, week 4, week 12, and week 24. Statistical significance was set at 5 % (p < 0.05). Reduction in overall pain in the HA group was statistically significant at week 2 (p < 0.05) week 4 (p < 0.05), week 12 comparing to baseline. Similarly, pain subscores (at night and with activity) were significantly lower at week 2 (p < 0.05), week 4 (p < 0.05), and week 12 (p < 0.05), respectively. In the Physio group, pain decreased significantly at week 2 (p < 0.05) but not maintained at week 4 (p > 0.05), week 12 (p > 0.05), and week 24 (p > 0.05). CS and OSS in the HA group increased significantly at week 2 (p < 0.05), week 4 (p < 0.05), and week 12 (p < 0.05). A non-statistically significant increase in clinical scores was found at week 24 (p > 0.05). A significant improvement of CS and OSS we found in the Physio group at week 2 (p < 0.05), but not at weeks 4, 12, and 24 (p > 0.05). Subacromial HA injections could be an effective and safe alternative treatment for patients suffering from RC tendinopathy. We believe that the results of this study are encouraging but not lasting and we might suppose that a series of three to four subacromial sodium hyaluronate injections could provide good mid- and long-term clinical benefits.

29 CFR 548.305 - Excluding certain additions to wages.

Code of Federal Regulations, 2010 CFR

2010-07-01

... weeks in the 13-week period, and in each of these overtime weeks he works 50 hours. He is therefore... never works more than 50 hours a week. It is obvious that exclusion of this attendance bonus from the... hours an employee might work each week during the bonus period. In such situations the employer and...

78 FR 35071 - Sunshine Federal Register Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

...: Nuclear Regulatory Commission [NRC-2013- 0001] DATES: Weeks of June 10, 17, 24, July 1, 8, 15, 2013. PLACE...--Tentative There are no meetings scheduled for the week of June 17, 2013. Week of June 24, 2013--Tentative There are no meetings scheduled for the week of June 24, 2013. Week of July 1, 2013--Tentative There are...

COURSE OUTLINE FOR THIRD SIX WEEKS OF SCIENCE-LEVEL II, TALENT PRESERVATION CLASSES.

ERIC Educational Resources Information Center

Houston Independent School District, TX.

UNIT III (SIX WEEKS) CONCERNS PLANT LIFE, AND DEALS WITH THALLUS PLANTS, MOSSES, FERNS, AND SEED PLANTS. UNIT IV (SIX WEEKS) COVERS AIR AND SPACE, WITH SUBTOPICS ON ASTRONOMY AND WEATHER. "THE CHANGING EARTH," DEALING WITH GEOLOGY AND CONSERVATION, COMPRISES UNIT V (6WEEKS). THE LAST, UNIT VI (6 WEEKS), DEALS WITH CONSUMER…

Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week‐112 Efficacy and Safety Results of the Open‐Label Long‐Term Extension of a Phase III, Double‐Blind, Randomized, Placebo‐Controlled Trial

PubMed Central

Mendelsohn, Alan M.; Kim, Lilianne; Xu, Zhenhua; Leu, Jocelyn; Han, Chenglong; Lo, Kim Hung; Westhovens, Rene; Weinblatt, Michael E.

2015-01-01

Objective To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab plus methotrexate (MTX) in an open‐label extension of a phase III trial of patients with active rheumatoid arthritis (RA) despite MTX therapy. Methods In the phase III, double‐blind, randomized, placebo‐controlled GO‐FURTHER trial, 592 patients with active RA were randomized (2:1) to intravenous golimumab 2 mg/kg plus MTX (Group 1) or placebo plus MTX (Group 2) at weeks 0 and 4, then every 8 weeks thereafter; placebo patients crossed over to golimumab at week 16 (early escape) or week 24 (crossover). The final golimumab infusion was at week 100. Assessments included American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) response criteria, 28‐joint count disease activity score using the C‐reactive protein level (DAS28‐CRP), physical function and quality of life measures, and changes in the modified Sharp/van der Heijde scores (SHS). Safety was monitored through week 112. Results In total, 486 patients (82.1%) continued treatment through week 100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at week 100. Clinical response and improvements in physical function and quality of life were generally maintained from week 24 through 2 years. Mean change from baseline to week 100 in SHS score was 0.74 in Group 1 and 2.10 in Group 2 (P = 0.005); progression from week 52 to week 100 was clinically insignificant in both groups. A total of 481 patients completed the safety followup through week 112; 79.1% had an adverse event, and 18.2% had a serious adverse event. Conclusion Clinical response to IV golimumab plus MTX was maintained through week 100. Radiographic progression following golimumab treatment was clinically insignificant between week 52 and week 100. No unexpected adverse events occurred through week 112, and the safety profile was consistent with anti–tumor necrosis factor therapy. PMID:25623393

Once-a-Week Versus Once-Every-3-Weeks Cisplatin Chemoradiation for Locally Advanced Head and Neck Cancer: A Phase III Randomized Noninferiority Trial.

PubMed

Noronha, Vanita; Joshi, Amit; Patil, Vijay Maruti; Agarwal, Jaiprakash; Ghosh-Laskar, Sarbani; Budrukkar, Ashwini; Murthy, Vedang; Gupta, Tejpal; D'Cruz, Anil K; Banavali, Shripad; Pai, Prathamesh S; Chaturvedi, Pankaj; Chaukar, Devendra; Pande, Nikhil; Chandrasekharan, Arun; Talreja, Vikas; Vallathol, Dilip Harindran; Mathrudev, Vijayalakshmi; Manjrekar, Aparna; Maske, Kamesh; Bhelekar, Arati Sanjay; Nawale, Kavita; Kannan, Sadhana; Gota, Vikram; Bhattacharjee, Atanu; Kane, Shubhada; Juvekar, Shashikant L; Prabhash, Kumar

2018-04-10

Purpose Chemoradiation with cisplatin 100 mg/m 2 given once every 3 weeks is the standard of care in locally advanced head and neck squamous cell cancer (LAHNSCC). Increasingly, low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience. However, there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks. Patients and Methods In this phase III randomized trial, we assessed the noninferiority of cisplatin 30 mg/m 2 given once a week compared with cisplatin 100 mg/m 2 given once every 3 weeks, both administered concurrently with curative intent radiotherapy in patients with LAHNSCC. The primary end point was locoregional control (LRC); secondary end points included toxicity, compliance, response, progression-free survival, and overall survival. Results Between 2013 and 2017, we randomly assigned 300 patients, 150 to each arm. Two hundred seventy-nine patients (93%) received chemoradiotherapy in the adjuvant setting. At a median follow-up of 22 months, the estimated cumulative 2-year LRC rate was 58.5% in the once-a-week arm and 73.1% in the once-every-3-weeks arm, leading to an absolute difference of 14.6% (95% CI, 5.7% to 23.5%); P = .014; hazard ratio (HR), 1.76 (95% CI, 1.11 to 2.79). Acute toxicities of grade 3 or higher occurred in 71.6% of patients in the once-a-week arm and in 84.6% of patients in the once-every-3-weeks arm ( P = .006). Estimated median progression-free survival in the once-a-week arm was 17.7 months (95% CI, 0.42 to 35.05 months) and in the once-every-3-weeks arm, 28.6 months (95% CI, 15.90 to 41.30 months); HR, 1.24 (95% CI, 0.89 to 1.73); P = .21. Estimated median overall survival in the once-a-week arm was 39.5 months and was not reached in the once-every-3-weeks arm (HR, 1.14 [95% CI, 0.79 to 1.65]; P = .48). Conclusion Once-every-3-weeks cisplatin at 100 mg/m 2 resulted in superior LRC, albeit with more toxicity, than did once-a-week cisplatin at 30 mg/m 2 , and should remain the preferred chemoradiotherapy regimen for LAHNSCC in the adjuvant setting.

[Comparison between manual acupuncture and electroacupuncture for hot flashes and sex hormone of perimenopausal syndrome].

PubMed

Cao, Zhiliang; Tang, Jian; Xue, Yuting; Wang, Qiong; Li, Saiqun; Zhou, Youjun; Zhang, Wei

2017-03-12

To compare the effect and differences sex the influence of hormone levels of perimenopau-sal syndrome patients between manual acupuncture and electroacupuncture (EA). A total of 50 cases with perimenopausal syndrome were randomly assigned into an manual acupuncture group (27 cases) and an EA group (23 cases), and 1 case dropped in the EA group. The acupoints in the two groups were Guanyuan (CV 4), Zigong (EX-CA 1), Tianshu (ST 25), and Sanyinjiao (SP 6). Acupuncture with 3-time small and even manipulation of lifting, thrusting and twirling was used in the acupuncture group, once 10 min. EA with sparse-dense wave and 10 Hz/50 Hz was applied in the EA group for 30 min. The treatments in the two groups were for continuous 8 weeks (24 times in total), once the other day, 3 times a week. The scores of 24-hour hot flashes even, menopausal rating scale (MRS) and menopause-specific quality of life questionnaire (MENQOL) were recorded before treatment and after 4-week and 8-week treatment, as well as 12 and 24 weeks after treatment. Serum sex hormone levels were tested before and after 8-week treatment as well as 12 weeks after treatment, including serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estracliol (E 2 ). Compared with those before treatment, the 24-hour hot flashes even score, MRS and MENQOL scores were significantly lower after 4-week and 8-week treatments, 12 and 24 weeks after treatment (all P <0.05). All the above scores after 8-week treatment were lower than those after 4-week treatment (all P <0.05); and the scores 12 and 24 weeks after treatment were lower than those after 4-week and 8-week treatments (all P <0.05); all the scores after treatment were not significantly different at any time between the two groups (all P >0.05). Compared with those before treatment, serum FSH and E 2 apparently improved in the two groups after 8-week treatment and 12 weeks after treatment (all P <0.05). LH levels did not significantly change in the two groups (all P >0.05). All the serum sex hormone levels showed no significant difference between the two groups (all P >0.05). Both acupuncture and EA can improve perimenopausal symptoms and serum sex hormone. The effects are similar.

Fetal development

MedlinePlus

WEEK BY WEEK CHANGES Gestation is the period of time between conception and birth when a baby grows and develops inside ... to the current date. It is measured in weeks. This means that during weeks 1 and 2 ...

Work-leave rotation pattern and incidence of offshore workplace injury.

PubMed

Massey, S

2018-05-17

Studies on work-leave rotation pattern and work place injuries among offshore oil and gas workers have been few and limited to a 2- or 3-week rotation schedule. To examine incidence of workplace injury in relation to the duration of time into work rotation for extended work schedules up to 24 weeks. Six-year injury data on four offshore installations were extracted. Data were analysed for incidence of injury over time and relative risk using linear trend lines and regression. In total, 311 injuries for 1302 workers were analysed, 39% with rotation schedule of 4 weeks work and 4 weeks rest, 27% 8 weeks work and 4 weeks rest, 23% 16 weeks work and 4 weeks rest and 10% 24 weeks work and 4 weeks rest. Incidence of injury decreased as duration of time into the work rotation increased, corrected for exposure, and this was statistically significant for all rotations in first 4 weeks (P < 0.01). Negative correlation between time offshore and injury was observed in all schedules and consistent for age groups, categories of work, shifts and severity of injury. There was no difference in relative risk of injuries between the four schedules, when corrected for exposure and occupational risk of injury. These results are at variance with previous studies, although no prior study has looked beyond 3-week rotation schedule. Longer offshore schedules are safely possible and this could help decrease manpower and logistics costs for oil and gas companies coping with unprecedented low oil prices.

Fetal Cortical Transplants in Adult Rats Subjected to Experimental Brain Injury

PubMed Central

Soares, Holly; McIntosh, Tracy K.

1991-01-01

Fetal cortical tissue was injected into injured adult rat brains following concussive fluid percussion (FP) brain injury. Rats subjected to moderate FP injury received E16 cortex transplant injections into lesioned motor cortex 2 days, 1 week, 2 weeks, and 4 weeks post injury. Histological assessment of transplant survival and integration was based upon Nissl staining, glial fibrillary acidic protein (GFAP) immunocytochemistry, and staining for acetylcholinesterase. In addition to histological analysis, the ability of the transplants to attenuate neurological motor deficits associated with concussive FP brain injury was also tested. Three subgroups of rats receiving transplant 1 week, 2 weeks, and 4 weeks post injury Were chosen for evaluation of neurological motor function. Fetal cortical tissue injected into the injury site 4 weeks post injury failed to incorporate with injured host brain, did not affect glial scar formation, and exhibited extensive GFAP immunoreactivity. No improvement in neurological motor function was observed in animals receiving transplants 4 weeks post injury. Conversely, transplants injected 2 days, 1 week, or 2 weeks post injury survived, incorporated with host brain, exhibited little GFAP immunoreactivity, and successfully attenuated glial scarring. However, no significant improvement in motor function was observed at the one week or two week time points. The inability of the transplants to attenuate motor function may indicate inappropriate host/transplant interaction. Our results demonstrate that there exists a temporal window in which fetal cortical transplants can attenuate glial scarring as well as be successfully incorporated into host brains following FP injury. PMID:1782253

Mineral to matrix ratio determines biomaterial and biomechanical properties of rat femur--application of Fourier transform infrared spectroscopy.

PubMed

Takata, Shinjiro; Yonezu, Hiroshi; Shibata, Akira; Enishi, Tetsuya; Sato, Nori; Takahashi, Mitsuhiko; Nakao, Shigetaka; Komatsu, Koji; Yasui, Natsuo

2011-08-01

We studied the changes of biomaterial and biomechanical properties of the rat femur during development. Thirty male Wistar rats were allocated to 6 groups: aged 6 weeks (n=5), 9 weeks (n=5), 12 weeks (n=5), 15 weeks (n=5), 24 weeks (n=5), and 36 weeks (n=5). The mineral to matrix ratio (M/M ratio) of rat femur by Fourier transform infrared spectroscopy was 0.97 ± 0.10 at the age of 6 weeks, and reached the maximum of 1.52 ± 0.17 at the age of 36 weeks. Total bone mineral density (BMD) by peripheral quantitative computed tomography of the femoral shaft aged 6 weeks was 479.1 ± 58.7 mg/cm(3), and reached the maximum of 1022.2 ± 42.3 mg/cm(3) at the age of 36 weeks. The ultimate load to failure of the femur of the rat aged 6 weeks by the three-point bending test was 29.6 ± 6.1 N. At the age of 36 weeks, the ultimate load to failure of the rat femur increased to the maximum of 283.5 ± 14.7 N. The results showed that the M/M ratio increased with development as total BMD and bone strength increased. The results suggest that the M/M ratio is one of the determinants of the biomaterial and biomechanical properties of bone.

Skin Punctures in Preterm Infants in the First 2 Weeks of Life.

PubMed

Finn, Daragh; Butler, Daryl; Sheehan, Orla; Livingstone, Vicki; Dempsey, Eugene M

2018-05-23

 The objective of this study was to investigate frequency and trends of skin punctures in preterm infants.  A prospective audit of preterm infants less than 35 weeks admitted over a 6-month period to a tertiary neonatal intensive care unit. Each skin puncture performed in the first 2 weeks of life was documented in a specifically designed audit sheet.  Ninety-nine preterm infants were enrolled. Infants born at < 32 weeks' gestation had significantly more skin punctures than infants > 32 weeks (median skin punctures 26.5 vs. 17, p -value < 0.05). The highest frequency of skin punctures occurred during the first week of life for infants > 28 weeks' gestation (medians 17.5 in 28-31 + 6 weeks' gestation, and 15 in > 32 weeks), and during the second week of life for those born at < 28 weeks (median 17.5). Infants with sepsis had more skin punctures ( p -value < 0.001), but this was not significant on multivariate analysis. Median skin punctures in the second week of life were statistically higher in the sepsis group on multivariate analysis (odds ratio: 1.07, 95% confidence interval: 1.00-1.14, p  = 0.041).  Frequency of skin punctures is influenced by gestational age and postnatal age. Skin punctures were not an independent risk factor for sepsis. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Using Search Engine Data as a Tool to Predict Syphilis.

PubMed

Young, Sean D; Torrone, Elizabeth A; Urata, John; Aral, Sevgi O

2018-07-01

Researchers have suggested that social media and online search data might be used to monitor and predict syphilis and other sexually transmitted diseases. Because people at risk for syphilis might seek sexual health and risk-related information on the internet, we investigated associations between internet state-level search query data (e.g., Google Trends) and reported weekly syphilis cases. We obtained weekly counts of reported primary and secondary syphilis for 50 states from 2012 to 2014 from the US Centers for Disease Control and Prevention. We collected weekly internet search query data regarding 25 risk-related keywords from 2012 to 2014 for 50 states using Google Trends. We joined 155 weeks of Google Trends data with 1-week lag to weekly syphilis data for a total of 7750 data points. Using the least absolute shrinkage and selection operator, we trained three linear mixed models on the first 10 weeks of each year. We validated models for 2012 and 2014 for the following 52 weeks and the 2014 model for the following 42 weeks. The models, consisting of different sets of keyword predictors for each year, accurately predicted 144 weeks of primary and secondary syphilis counts for each state, with an overall average R of 0.9 and overall average root mean squared error of 4.9. We used Google Trends search data from the prior week to predict cases of syphilis in the following weeks for each state. Further research could explore how search data could be integrated into public health monitoring systems.

Cost-effectiveness analysis of docetaxel versus weekly paclitaxel in adjuvant treatment of regional breast cancer in New Zealand.

PubMed

Webber-Foster, Rachel; Kvizhinadze, Giorgi; Rivalland, Gareth; Blakely, Tony

2014-07-01

There have been recent important changes to adjuvant regimens and costs of taxanes for the treatment of early breast cancer, requiring a re-evaluation of comparative cost effectiveness. In particular, weekly paclitaxel is now commonly used but has not been subjected to cost-effectiveness analysis. Our aim was to estimate the cost effectiveness of adjuvant docetaxel and weekly paclitaxel versus each other, and compared with standard 3-weekly paclitaxel, in women aged ≥25 years diagnosed with regional breast cancer in New Zealand. A macrosimulation Markov model was used, with a lifetime horizon and health system perspective. The model compared 3-weekly docetaxel and weekly paclitaxel versus standard 3-weekly paclitaxel (E1199 regimen) in the hospital setting. Data on overall survival and toxicities (febrile neutropenia and peripheral neuropathy) were derived from relevant published clinical trials. Epidemiological and cost data were derived from New Zealand datasets. Health outcomes were measured with health-adjusted life-years (HALYs), similar to quality-adjusted life-years (QALYs). Costs included intervention and health system costs in year 2011 values, with 3% per annum discounting on costs and HALYs. The mean HALY gain per patient compared with standard 3-weekly paclitaxel was 0.51 with weekly paclitaxel and 0.21 with docetaxel, while incremental costs were $NZ 12,284 and $NZ 4,021, respectively. The incremental cost-effectiveness ratio (ICER) of docetaxel versus 3-weekly paclitaxel was $NZ 19,400 (purchasing power parity [PPP]-adjusted $US 13,100) per HALY gained, and the ICER of weekly paclitaxel versus docetaxel was $NZ 27,100 ($US 18,300) per HALY gained. In terms of net monetary benefit, weekly paclitaxel was the optimal strategy for willingness-to-pay (WTP) thresholds >$NZ 27,000 per HALY gained. However, the model was highly sensitive to uncertainty around survival differences, while toxicity-related morbidity had little impact. Thus, if it was assumed that weekly paclitaxel and docetaxel had the same efficacy, docetaxel would be favoured over weekly paclitaxel. Both weekly paclitaxel and docetaxel are likely to be cost effective compared with standard 3-weekly paclitaxel. Weekly paclitaxel was the optimal choice for WTP thresholds greater than $NZ27,000 per HALY gained (PPP-adjusted $US 18,000). However, uncertainty remains around relative survival benefits, and weekly paclitaxel becomes cost ineffective versus docetaxel if it is assumed that the two regimens have equal effectiveness. Reduced uncertainty about the relative survival benefits may improve decision making for funding.

29 CFR 3.4 - Submission of weekly statements and the preservation and inspection of weekly payroll records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... inspection of weekly payroll records. 3.4 Section 3.4 Labor Office of the Secretary of Labor CONTRACTORS AND... STATES § 3.4 Submission of weekly statements and the preservation and inspection of weekly payroll... subcontractor, within seven days after the regular payment date of the payroll period, to a representative of a...

77 FR 15976 - Additional Changes to the Schedule of Operations Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

..., inspection program personnel on the cattle slaughter line who work 4 or more days a week would need 15... days per week, 4 percent work in beef establishments that operate less than 4 days per week, 36 percent... work 3 days or less a week would need 15 minutes once a week to sharpen their knife, if the...

76 FR 21869 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-19

... tentatively estimates that each staff member will spend approximately six hours per work week for six months... determined as follows: Seven employees x (six hours/week/employee x 24 weeks) = 1,008 hours. Assuming the... employees x (six hours/week/employee x 24 weeks) = 432 hours. Assuming the employees are at the Level III...

Enhancing the English-Language Oral Skills of International Students through Drama

ERIC Educational Resources Information Center

Gill, Chamkaur

2013-01-01

Ten non-English-speaking-background students of Bond University were observed to identify the effects of drama on oral English. Over a period of twelve weeks (two hours per week), elements of their oral English communication were measured. The weeks were divided into four lots of three weeks each, with the first three weeks made up entirely of…

Comparing the Rigor of Compressed Format Courses to Their Regular Semester Counterparts

ERIC Educational Resources Information Center

Lutes, Lyndell; Davies, Randall

2013-01-01

This study compared workloads of undergraduate courses taught in 16-week and 8-week sessions. A statistically significant difference in workload was found between the two. Based on survey data from approximately 29,000 students, on average students spent about 17 minutes more per credit per week on 16-week courses than on similar 8-week courses.…

Diagnostic yield and optimal duration of continuous-loop event monitoring for the diagnosis of palpitations. A cost-effectiveness analysis

NASA Technical Reports Server (NTRS)

Zimetbaum, P. J.; Kim, K. Y.; Josephson, M. E.; Goldberger, A. L.; Cohen, D. J.

1998-01-01

BACKGROUND: Continuous-loop event recorders are widely used for the evaluation of palpitations, but the optimal duration of monitoring is unknown. OBJECTIVE: To determine the yield, timing, and incremental cost-effectiveness of each week of event monitoring for palpitations. DESIGN: Prospective cohort study. PATIENTS: 105 consecutive outpatients referred for the placement of a continuous-loop event recorder for the evaluation of palpitations. MEASUREMENTS: Diagnostic yield, incremental cost, and cost-effectiveness for each week of monitoring. RESULTS: The diagnostic yield of continuous-loop event recorders was 1.04 diagnoses per patient in week 1, 0.15 diagnoses per patient in week 2, and 0.01 diagnoses per patient in week 3 and beyond. Over time, the cost-effectiveness ratio increased from $98 per new diagnosis in week 1 to $576 per new diagnosis in week 2 and $5832 per new diagnosis in week 3. CONCLUSIONS: In patients referred for evaluation of palpitations, the diagnostic yield of continuous-loop event recording decreases rapidly after 2 weeks of monitoring. A 2-week monitoring period is reasonably cost-effective for most patients and should be the standard period for continuous-loop event recording for the evaluation of palpitations.

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study

PubMed Central

Maksymowych, Walter P; Dougados, Maxime; Sieper, Joachim; Braun, Jürgen; Citera, Gustavo; Van den Bosch, Filip; Logeart, Isabelle; Wajdula, Joseph; Jones, Heather; Marshall, Lisa; Bonin, Randi; Pedersen, Ron; Vlahos, Bonnie; Kotak, Sameer; Bukowski, Jack F

2016-01-01

Objective To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). Methods Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. Results 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by −1.1 for ETN/ETN and by −3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. Conclusions Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. Trial registration number NCT01258738. PMID:26269397

Should we fear "flu fear" itself? Effects of H1N1 influenza fear on ED use.

PubMed

McDonnell, William M; Nelson, Douglas S; Schunk, Jeff E

2012-02-01

Surges in patient volumes compromise emergency departments' (EDs') ability to deliver care, as shown by the recent H1N1 influenza (flu) epidemic. Media reports are important in informing the public about health threats, but the effects of media-induced anxiety on ED volumes are unclear. The aim of this study is to examine the effect of widespread public concern about flu on ED use. We reviewed ED data from an integrated health system operating 18 hospital EDs. We compared ED visits during three 1-week periods: (a) a period of heightened public concern regarding flu before the disease was present ("Fear Week"), (b) a subsequent period of active disease ("Flu Week"), and (c) a week before widespread concern ("Control Week"). Fear Week was identified from an analysis of statewide Google electronic searches for "swine flu" and from media announcements about flu. Flu Week was identified from statewide epidemiological data. Data were reviewed from 22 608 visits during the study periods. Fear Week (n = 7712) and Flu Week (n = 7687) were compared to Control Week (n = 7209). Fear Week showed a 7.0% increase in visits (95% confidence interval, 6-8). Pediatric visits increased by 19.7%, whereas adult visits increased by 1%. Flu Week showed an increase over Control Week of 6.6% (95% confidence interval, 6-7). Pediatric visits increased by 10.6%, whereas adult visits increased by 4.8%. At a time of heightened public concern regarding flu but little disease prevalence, EDs experienced substantial increases in patient volumes. These increases were significant and comparable to the increases experienced during the subsequent epidemic of actual disease. Copyright © 2012 Elsevier Inc. All rights reserved.

Effect of minoxidil topical foam on frontotemporal and vertex androgenetic alopecia in men: a 104-week open-label clinical trial.

PubMed

Kanti, V; Hillmann, K; Kottner, J; Stroux, A; Canfield, D; Blume-Peytavi, U

2016-07-01

Topical minoxidil formulations have been shown to be effective in treating androgenetic alopecia (AGA) for 12 months. Efficacy and safety in both frontotemporal and vertex regions over longer application periods have not been studied so far. To evaluate the effect of 5% minoxidil topical foam (5% MTF) in the frontotemporal and vertex areas in patients with moderate AGA over 104 weeks. An 80-week, open-label extension phase was performed, following a 24-week randomized, double-blind, placebo-controlled study in men with AGA grade IIIvertex to VI. Group 1 (n = 22) received ongoing 5% MTF for 104 weeks, Group 2 (n = 23) received placebo topical foam (plaTF) until week 24, followed by 5% MTF until week 104 during the extension phase. Frontotemporal and vertex target area non-vellus hair counts (f-TAHC, v-TAHC) and cumulative hair width (f-TAHW, v-TAHW) were assessed at baseline and at weeks 24, 52, 76 and 104. In Group 1, f-TAHW and f-TAHC showed a statistically significant increase from baseline to week 52 and week 76, respectively, returning to values comparable to baseline at week 104. No significant differences were found between baseline and week 104 in v-TAHC in Group 1 as well as f-TAHC, v-TAHC, f-TAHW and v-TAHW values in Group 2. 5% MTF is effective in stabilizing hair density, hair width and scalp coverage in both frontotemporal and vertex areas over an application period of 104 weeks, while showing a good safety and tolerability profile with a low rate of irritant contact dermatitis. © 2015 European Academy of Dermatology and Venereology.

Infectious Disease in a Warming World: How Weather Influenced West Nile Virus in the United States (2001–2005)

PubMed Central

Soverow, Jonathan E.; Wellenius, Gregory A.; Fisman, David N.; Mittleman, Murray A.

2009-01-01

Background The effects of weather on West Nile virus (WNV) mosquito populations in the United States have been widely reported, but few studies assess their overall impact on transmission to humans. Objectives We investigated meteorologic conditions associated with reported human WNV cases in the United States. Methods We conducted a case–crossover study to assess 16,298 human WNV cases reported to the Centers for Disease Control and Prevention from 2001 to 2005. The primary outcome measures were the incidence rate ratio of disease occurrence associated with mean weekly maximum temperature, cumulative weekly temperature, mean weekly dew point temperature, cumulative weekly precipitation, and the presence of ≥ 1 day of heavy rainfall (≥ 50 mm) during the month prior to symptom onset. Results Increasing weekly maximum temperature and weekly cumulative temperature were similarly and significantly associated with a 35–83% higher incidence of reported WNV infection over the next month. An increase in mean weekly dew point temperature was significantly associated with a 9–38% higher incidence over the subsequent 3 weeks. The presence of at least 1 day of heavy rainfall within a week was associated with a 29–66% higher incidence during the same week and over the subsequent 2 weeks. A 20-mm increase in cumulative weekly precipitation was significantly associated with a 4–8% increase in incidence of reported WNV infection over the subsequent 2 weeks. Conclusions Warmer temperatures, elevated humidity, and heavy precipitation increased the rate of human WNV infection in the United States independent of season and each others’ effects. PMID:19654911

Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey.

PubMed

Vavricka, Stephan R; Schoepfer, Alain M; Bansky, Georg; Binek, Janek; Felley, Christian; Geyer, Martin; Manz, Michael; Rogler, Gerhard; de Saussure, Philippe; Sauter, Bernhard; Scharl, Michael; Seibold, Frank; Straumann, Alex; Michetti, Pierre

2011-07-01

Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines. Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and 43% to adalimumab. A significant decrease of the Harvey-Bradshaw Index (HBI) was observed under CZP therapy (12.2 ± 4.9 at week 0 versus 6.3 ± 4.7 at week 6 and 6.7 ± 5.3 at week 26, both P < 0.001). Response and remission rates were 70% and 40% (week 6) and 67% and 36%, respectively (week 26). The complete perianal fistula closure rate was 36% at week 6 and 55% at week 26. The frequency of adverse drug reactions attributed to CZP was 5%. CZP was continued in 88% of patients beyond week 6 and in 67% beyond week 26. In a population of CD patients with predominantly complicated disease behavior, CZP proved to be effective in induction and maintenance of response and remission. This series provides the first evidence of CZP's effectiveness in perianal fistulizing CD in clinical practice. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

The AT{sub 1} Receptor Antagonist, L-158,809, Prevents or Ameliorates Fractionated Whole-Brain Irradiation-Induced Cognitive Impairment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Robbins, Mike E.; Brain Tumor Center of Excellence, Wake Forest University School of Medicine, Winston-Salem, NC; Payne, Valerie B.S.

2009-02-01

Purpose: We hypothesized that administration of the angiotensin type 1 (AT1) receptor antagonist, L-158,809, to young adult male rats would prevent or ameliorate fractionated whole-brain irradiation (WBI)-induced cognitive impairment. Materials and Methods: Groups of 80 young adult male Fischer 344 x Brown Norway (F344xBN) rats, 12-14 weeks old, received either: (1) fractionated WBI; 40 Gy of {gamma} rays in 4 weeks, 2 fractions/week, (2) sham-irradiation; (3) WBI plus L-158,809 (20 mg/L drinking water) starting 3 days prior, during, and for 14, 28, or 54 weeks postirradiation; and (4) sham-irradiation plus L-158,809 for 14, 28, or 54 weeks postirradiation. An additionalmore » group of rats (n = 20) received L-158,809 before, during, and for 5 weeks postirradiation, after which they received normal drinking water up to 28 weeks postirradiation. Results: Administration of L-158,809 before, during, and for 28 or 54 weeks after fractionated WBI prevented or ameliorated the radiation-induced cognitive impairment observed 26 and 52 weeks postirradiation. Moreover, giving L-158,809 before, during, and for only 5 weeks postirradiation ameliorated the significant cognitive impairment observed 26 weeks postirradiation. These radiation-induced cognitive impairments occurred without any changes in brain metabolites or gross histologic changes assessed at 28 and 54 weeks postirradiation, respectively. Conclusions: Administering L-158,809 before, during, and after fractionated WBI can prevent or ameliorate the chronic, progressive, cognitive impairment observed in rats at 26 and 52 weeks postirradiation. These findings offer the promise of improving the quality of life for brain tumor patients.« less

An In-Depth Study of the Four-Day College Week. Part I; The Four-Day College Week: Revolution or Evolution. Part II; A Survey of Common Practices of Texas Colleges Utilizing the Four-Day College Week.

ERIC Educational Resources Information Center

Riley, Bob E.

This two-part report discusses the implementation of the four-day week on college campuses and summarizes the results of a survey conducted to investigate: (1) the history of the four-day college week in Texas; (2) how Texas colleges using this system integrate their operations into the four-day week; and (3) the future acceptance of the four-day…

Audit of thrice- versus twice-weekly ECT.

PubMed

Roche, Eric; Lope, Jasmin; Hughes, Helen; McCullagh, Niamh; Larkin, Terence; Feeney, Larkin

2012-09-01

There is a lack of knowledge regarding some basic differences between different electroconvulsive therapy (ECT) treatment schedules. To examine differences, including ECT technical parameters and length of stay, between thrice- and twice-weekly ECT treatment schedules. Prospective audit of the changeover period of administering thrice- to twice-weekly ECT in a Dublin psychiatric hospital. Twice-weekly ECT was associated with significantly lower total electricity dosage administered, a tendency toward shorter overall hospital stay and fewer ECT treatments compared to thrice-weekly ECT. Our results support the current international trend toward giving ECT twice weekly.

Time course of disassociation of bone formation signals with bone mass and bone strength in sclerostin antibody treated ovariectomized rats.

PubMed

Ma, Yanfei L; Hamang, Matthew; Lucchesi, Jonathan; Bivi, Nicoletta; Zeng, Qianqiang; Adrian, Mary D; Raines, Sarah E; Li, Jiliang; Kuhstoss, Stuart A; Obungu, Victor; Bryant, Henry U; Krishnan, Venkatesh

2017-04-01

Sclerostin antibodies increase bone mass by stimulating bone formation. However, human and animal studies show that bone formation increases transiently and returns to pre-treatment level despite ongoing antibody treatment. To understand its mechanism of action, we studied the time course of bone formation, correlating the rate and extent of accrual of bone mass and strength after sclerostin antibody treatment. Ovariectomized (OVX) rats were treated with a sclerostin-antibody (Scle-ab) at 20mg/kg sc once weekly and sacrificed at baseline and 2, 3, 4, 6, and 8weeks post-treatment. In Scle-ab treated rats, serum PINP and OCN rapidly increased at week 1, peaked around week 3, and returned to OVX control levels by week 6. Transcript analyses from the distal femur revealed an early increase in bone formation followed by a sustained decrease in bone resorption genes. Lumbar vertebral (LV) osteoblast surface increased 88% by week 2, and bone formation rate (BFR/BS) increased 138% by week 4. Both parameters were below OVX control by week 8. Bone formation was primarily a result of modeling based formation. Endocortical and periosteal BFR/BS peaked around week 4 at 313% and 585% of OVX control, respectively. BFR/BS then declined but remained higher than OVX control on both surfaces through week 8. Histomorphometric analyses showed LV-BV/TV did not further increase after week 4, while BMD continued to increase at LV, mid femur (MF), and femoral neck (FN) through week 8. Biomechanical tests showed a similar improvement in bone strength through 8weeks in MF and FN, but bone strength plateaued between weeks 6 and 8 for LV. Our data suggest that bone formation with Scle-ab treatment is rapid and modeling formation dominated in OVX rats. Although transient, the bone formation response persists longer in cortical than trabecular bone. Copyright © 2016 Elsevier Inc. All rights reserved.

[Correlation between growth rate of corpus callosum and neuromotor development in preterm infants].

PubMed

Liu, Rui-Ke; Sun, Jie; Hu, Li-Yan; Liu, Fang

2015-08-01

To investigate the growth rate of corpus callosum by cranial ultrasound in very low birth weight preterm infants and to provide a reference for early evaluation and improvement of brain development. A total of 120 preterm infants under 33 weeks' gestation were recruited and divided into 26-29(+6) weeks group (n=64) and 30-32(+6) weeks group (n=56) according to the gestational age. The growth rate of corpus callosum was compared between the two groups. The correlation between the corpus callosum length and the cerebellar vermis length and the relationship of the growth rate of corpus callosum with clinical factors and the neuromotor development were analyzed. The growth rate of corpus callosum in preterm infants declined since 2 weeks after birth. Compared with the 30-32(+6) weeks group, the 26-29(+6) weeks group had a significantly lower growth rate of corpus callosum at 3-4 weeks after birth, at 5-6 weeks after birth, and from 7 weeks after birth to 40 weeks of corrected gestational age. There was a positive linear correlation between the corpus callosum length and the cerebellar vermis length. Small-for-gestational age infants had a low growth rate of corpus callosum at 2 weeks after birth. The 12 preterm infants with severe abnormal intellectual development had a lower growth rate of corpus callosum compared with the 108 preterm infants with non-severe abnormal intellectual development at 3-6 weeks after birth. The 5 preterm infants with severe abnormal motor development had a significantly lower growth rate of corpus callosum compared with the 115 preterm infants with non-severe abnormal motor development at 3-6 weeks after birth. The decline of growth rate of corpus callosum in preterm infants at 2-6 weeks after birth can increase the risk of severe abnormal neuromotor development.

Efficacy on the risk of vertebral fracture with administration of once-weekly 17.5 mg risedronate in Japanese patients of established osteoporosis with prevalent vertebral fractures: a 156-week longitudinal observational study in daily practice.

PubMed

Soen, Satoshi; Umemura, Takashi; Ando, Tsuyoshi; Kamisaki, Toshiaki; Nishikawa, Masahiko; Muraoka, Ryoichi; Ikeda, Yoshinori; Takeda, Kyoko; Osawa, Mitsuharu; Nakamura, Toshitaka

2017-07-01

Currently, the only available evidence for the efficacy of once-weekly 17.5 mg risedronate in preventing vertebral fractures was obtained in a 48-week study in Japan. We performed a 156-week prospective, longitudinal, observational study to determine the efficacy of the 17.5 mg risedronate in preventing vertebral fractures. We included Japanese patients with established osteoporosis who were older than 50 years and had radiographically confirmed vertebral fractures. The primary endpoint was the incidence of vertebral fractures every 24 weeks, with the final interval spanning 36 weeks. We also calculated the change in bone mineral density of the lumbar spine (L 2-4 BMD) and urinary N-telopeptide of type I collagen (u-NTX), and assessed the incidence of adverse drug reactions and the drug adherence rate. Data from 241 patients were available for analysis of vertebral fracture prevention. The incidence rate of vertebral fractures decreased in a time-dependent manner (P = 0.0006; Poisson regression analysis). The risk ratio (fracture incidence per 100 person-years in the final 36 weeks versus that in the first 24 weeks) was 0.21 (95 % confidence interval 0.08-0.55). Compared to baseline values, L 2-4 BMD increased by 6.41 % at 156 weeks, while u-NTX decreased by 36 % at 24 weeks and was maintained thereafter (P < 0.0001). The incidence rate of adverse drug reactions was 9.18 %. Drug adherence rates assessed every 4 weeks were over 90 %. Our results indicate that 156 weeks of treatment with once-weekly 17.5 mg risedronate effectively reduced the risk of vertebral fracture in Japanese patients with established osteoporosis older than 50 years.

Maximum Dynamic Lower-Limb Strength Was Maintained During 24-Week Reduced Training Frequency in Previously Sedentary Older Women.

PubMed

Walker, Simon; Serrano, Javier; Van Roie, Evelien

2018-04-01

Walker, S, Serrano, J, and Van Roie, E. Maximum dynamic lower-limb strength was maintained during 24-week reduced training frequency in previously sedentary older women. J Strength Cond Res 32(4): 1063-1071, 2018-There is little study into the effects of reducing strength training below the recommended twice weekly frequency, particularly in older women, despite the possibility that individuals will encounter periods of reduced training frequency. The purpose of the present study was to determine the effects of a period of reduced training frequency on maximum strength and muscle mass of the lower limbs in comparison with the recommended training frequency of twice per week. After an initial 12-week period, where all subjects trained twice per week, a reduced strength training group (RST) trained once per week, whereas another strength training group (ST) continued to train twice per week for 24 weeks. A nontraining age-matched control group (CON) was used for comparison. All subjects were tested for leg press 1-repetition maximum (1RM), electromyogram (EMG) amplitude of vastus lateralis and medialis, and quadriceps cross-sectional area (CSA) measured by panoramic ultrasound at weeks 0, 12, and 36. Both ST and RST continued to increase 1RM during the reduced training frequency period compared with control (∼8% and ∼5% vs. ∼-3%, respectively; p ≤ 0.05). Accompanying these changes were significant increases in EMG amplitude in both ST and RST (p ≤ 0.05). However, the initial gains in quadriceps CSA made from week 0 to week 12 in RST were lost when training once per week (RST ∼-5%). Therefore, reduced training frequency in this population does not adversely affect maximum strength or muscle activity but can negatively affect muscle mass, even reversing training-induced gains. Older individuals not training at least twice per week may compromise potential increases in muscle mass, important in counteracting effects of aging.

Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

PubMed Central

Zhao, Jingyuan; Song, Xueqin; Ai, Xiaoqing; Gu, Xiaojing; Huang, Guangbiao; Li, Xue; Pang, Lijuan; Ding, Minli; Ding, Shuang; Lv, Luxian

2015-01-01

Objective The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia. Methods One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8. Results One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia. Trial Registration chictr.org ChiCTR-IOR-15006278 PMID:26448615

Differences in the direction of change of cerebral function parameters are evident over three years in HIV-infected individuals electively commencing initial cART.

PubMed

Winston, Alan; Puls, Rebekah; Kerr, Stephen J; Duncombe, Chris; Li, Patrick; Gill, John M; Ramautarsing, Reshmie; Taylor-Robinson, Simon D; Emery, Sean; Cooper, David A

2015-01-01

Changes in cerebral metabolite ratios (CMR) measured on 1H-MRS and changes in cognitive function (CF) are described in subjects commencing combination antiretroviral therapy (cART), although the dynamics of such changes are poorly understood. Neuroasymptomatic, HIV-infected subjects electively commencing cART were eligible. CMR were assessed in three anatomical voxels and CF assessed at baseline, week 48 and week 144. Overall differences in absolute change in CMRs and CF parameters between 0-48 and 48-144 weeks were assessed. Twenty-two subjects completed study procedures. Plasma HIV-RNA was <50 copies/mL in all at week 48 and in all, but two subjects at week 144. In general, between weeks 0-48 a rise in N-acetyl-aspartate(NAA)/Creatine(Cr) ratio and a decline in myo-Inositol(mI)/Cr ratio were observed. Between weeks 48-144, small rises in NAA/Cr ratio were observed in two anatomical voxels, whereas a rise in mI/Cr ratio was observed in all anatomical locations (0.31 (0.66) and -0.27 (1.35) between weeks 0-48 and 0.13 (0.91) and 1.13 (1.71) between weeks 48-144 for absolute changes in NAA/Cr and mI/Cr (SD) in frontal-grey voxel, respectively). Global CF score improved between weeks 0-48 and then declined between weeks 48-144 (0.63 (1.16) and -0.63 (0.1.41) for mean absolute change (SD) between weeks 0-48 and weeks 48-144, respectively). The direction of change of cerebral function parameters differs over time in HIV-infected subjects commencing cART, highlighting the need for long-term follow-up in such studies. The changes we have observed between weeks 48-144 may represent the initial development of cerebral toxicities from cART.

Neural systemic impairment from whole-body vibration.

PubMed

Yan, Ji-Geng; Zhang, Lin-ling; Agresti, Michael; LoGiudice, John; Sanger, James R; Matloub, Hani S; Havlik, Robert

2015-05-01

Insidious brain microinjury from motor vehicle-induced whole-body vibration (WBV) has not yet been investigated. For a long time we have believed that WBV would cause cumulative brain microinjury and impair cerebral function, which suggests an important risk factor for motor vehicle accidents and secondary cerebral vascular diseases. Fifty-six Sprague-Dawley rats were divided into seven groups (n = 8): 1) 2-week normal control group, 2) 2-week sham control group (restrained in the tube without vibration), 3) 2-week vibration group (exposed to whole-body vibration at 30 Hz and 0.5g acceleration for 4 hr/day, 5 days/week, for 2 weeks), 4) 4-week sham control group, 5) 4-week vibration group, 6) 8-week sham control group, and 7) 8-week vibration group. At the end point, all rats were evaluated in behavior, physiological, and brain histopathological studies. The cerebral injury from WBV is a cumulative process starting with vasospasm squeezing of the endothelial cells, followed by constriction of the cerebral arteries. After the 4-week vibration, brain neuron apoptosis started. After the 8-week vibration, vacuoles increased further in the brain arteries. Brain capillary walls thickened, mean neuron size was obviously reduced, neuron necrosis became prominent, and wide-ranging chronic cerebral edema was seen. These pathological findings are strongly correlated with neural functional impairments. © 2014 Wiley Periodicals, Inc.

Early prediction of olanzapine-induced weight gain for schizophrenia patients.

PubMed

Lin, Ching-Hua; Lin, Shih-Chi; Huang, Yu-Hui; Wang, Fu-Chiang; Huang, Chun-Jen

2018-05-01

The aim of this study was to determine whether weight changes at week 2 or other factors predicted weight gain at week 6 for schizophrenia patients receiving olanzapine. This study was the secondary analysis of a six-week trial for 94 patients receiving olanzapine (5 mg/d) plus trifluoperazine (5 mg/d), or olanzapine (10 mg/d) alone. Patients were included in analysis only if they had completed the 6-week trial (per protocol analysis). Weight gain was defined as a 7% or greater increase of the patient's baseline weight. The receiver operating characteristic curve was employed to determine the optimal cutoff points of statistically significant predictors. Eleven of the 67 patients completing the 6-week trial were classified as weight gainers. Weight change at week 2 was the statistically significant predictor for ultimate weight gain at week 6. A weight change of 1.0 kg at week 2 appeared to be the optimal cutoff point, with a sensitivity of 0.92, a specificity of 0.75, and an AUC of 0.85. Using weight change at week 2 to predict weight gain at week 6 is favorable in terms of both specificity and sensitivity. Weight change of 1.0 kg or more at 2 weeks is a reliable predictor. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy and tolerability of six-week extended dosing interval with tocilizumab therapy in a prospective cohort as remission maintenance in patients with rheumatoid arthritis.

PubMed

Kikuchi, Jun; Kondo, Tsuneo; Shibata, Akiko; Sakai, Ryota; Okada, Yusuke; Chino, Kentaro; Okuyama, Ayumi; Kurasawa, Takahiko; Takei, Hirofumi; Amano, Koichi

2018-05-01

To prospectively evaluate the efficacy and tolerability of a six-week extended dosing interval with tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in sustained remission. Patients who received over six doses of intravenous TCZ in clinical remission (disease activity score [DAS] 28 - erythrocyte sedimentation rate [ESR] ≤ 2.6) maintained over 3 months between December 2013 and December 2015 were included. Flare was defined as DAS28-ESR >3.2 at two consecutive visits. Twenty-five patients were enrolled; 87.5% achieved clinical remission at week 54 after six-week extension and 95.5% achieved a van der Heijde modified total Sharp score (ΔmTSS) ≤0.5. The Health Assessment Questionnaire Disability Index (HAQ-DI) did not increase during 54 weeks. HAQ-DI at baseline and ΔDAS28-ESR at week six positively correlated with increase in DAS28-ESR at week 54. ΔSwollen joint count at week six positively correlated with ΔmTSS at week 54. A total of 12 adverse events occurring in 10 patients did not lead to cessation of TCZ except for one case of recurrent lymphoproliferative disorder at week five. A six-week extended dosing interval of TCZ for patients with RA in sustained remission is proposed as an acceptable treatment option for maintaining efficacy and tolerability.

Twice versus thrice weekly ECT in a clinical population: an evaluation of patient outcomes.

PubMed

Siskind, Dan; Charlson, Fiona; Saraf, Sudeep; Scheurer, Roman; Lie, David Charles

2012-10-30

Increasing demand on electroconvulsive therapy (ECT) services led to a recommendation that low risk patients be considered for twice weekly ECT rather than the usual thrice weekly. We evaluated whether practice changed and compared patient clinical outcomes for twice and thrice weekly ECT. Medical records for all patients receiving ECT in the 2-year study period (1/9/08 to 30/8/10) were reviewed to determine ECT protocol, diagnosis, admission duration and readmission rates. During the study period, 119 patients received 150 treatment courses. Patient outcomes were compared for twice weekly ECT and thrice weekly ECT protocols, as well as for 1 year before and after the recommendation (1/9/09). Twice weekly ECT courses increased (8-20) after the recommendation while thrice weekly ECT courses decreased (64-30). The recommendation had no significant effect on patient outcomes. Comparing twice and thrice weekly ECT, patient clinical outcomes were similar between the two groups, though non-affective twice weekly patients waited longer before starting ECT. In the context of resource constraints, psychiatrists can be influenced to examine and change their ECT prescribing practice. This bodes well for the implementation of evidence-based treatment into mental health services. Secondly, for adults, there appear to be no significant differences in clinical outcomes for twice versus thrice weekly ECT. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial.

PubMed

Thaçi, Diamant; Simpson, Eric L; Beck, Lisa A; Bieber, Thomas; Blauvelt, Andrew; Papp, Kim; Soong, Weily; Worm, Margitta; Szepietowski, Jacek C; Sofen, Howard; Kawashima, Makoto; Wu, Richard; Weinstein, Steven P; Graham, Neil M H; Pirozzi, Gianluca; Teper, Ariel; Sutherland, E Rand; Mastey, Vera; Stahl, Neil; Yancopoulos, George D; Ardeleanu, Marius

2016-01-02

Data from early-stage studies suggested that interleukin (IL)-4 and IL-13 are requisite drivers of atopic dermatitis, evidenced by marked improvement after treatment with dupilumab, a fully-human monoclonal antibody that blocks both pathways. We aimed to assess the efficacy and safety of several dose regimens of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments. In this randomised, placebo-controlled, double-blind study, we enrolled patients aged 18 years or older who had an Eczema Area and Severity Index (EASI) score of 12 or higher at screening (≥16 at baseline) and inadequate response to topical treatments from 91 study centres, including hospitals, clinics, and academic institutions, in Canada, Czech Republic, Germany, Hungary, Japan, Poland, and the USA. Patients were randomly assigned (1:1:1:1:1:1), stratified by severity (moderate or severe, as assessed by Investigator's Global Assessment) and region (Japan vs rest of world) to receive subcutaneous dupilumab: 300 mg once a week, 300 mg every 2 weeks, 200 mg every 2 weeks, 300 mg every 4 weeks, 100 mg every 4 weeks, or placebo once a week for 16 weeks. We used a central randomisation scheme, provided by an interactive voice response system. Drug kits were coded, providing masking to treatment assignment, and allocation was concealed. Patients on treatment every 2 weeks and every 4 weeks received volume-matched placebo every week when dupilumab was not given to ensure double blinding. The primary outcome was efficacy of dupilumab dose regimens based on EASI score least-squares mean percentage change (SE) from baseline to week 16. Analyses included all randomly assigned patients who received one or more doses of study drug. This trial is registered with ClinicalTrials.gov, number NCT01859988. Between May 15, 2013, and Jan 27, 2014, 452 patients were assessed for eligibility, and 380 patients were randomly assigned. 379 patients received one or more doses of study drug (300 mg once a week [n=63], 300 mg every 2 weeks [n=64], 200 mg every 2 weeks [n=61], 300 mg every 4 weeks [n=65], 100 mg every 4 weeks [n=65]; placebo [n=61]). EASI score improvements favoured all dupilumab regimens versus placebo (p<0·0001): 300 mg once a week (-74% [SE 5·16]), 300 mg every 2 weeks (-68% [5·12]), 200 mg every 2 weeks (-65% [5·19]), 300 mg every 4 weeks (-64% [4·94]), 100 mg every 4 weeks (-45% [4·99]); placebo (-18% [5·20]). 258 (81%) of 318 patients given dupilumab and 49 (80%) of 61 patients given placebo reported treatment-emergent adverse events; nasopharyngitis was the most frequent (28% and 26%, respectively). Dupilumab improved clinical responses in adults with moderate-to-severe atopic dermatitis in a dose-dependent manner, without significant safety concerns. Our findings show that IL-4 and IL-13 are key drivers of atopic dermatitis. Sanofi and Regeneron Pharmaceuticals. Copyright © 2016 Elsevier Ltd. All rights reserved.

Interpreting the Impact of the Four-Day School Week: An Examination of Performance before and after Switching to the Four-Day School Week

ERIC Educational Resources Information Center

Gower, Matthew Lee

2017-01-01

As four-day school weeks continue to gain popularity among school districts across the United States, determining the potential impact associated with the unconventional school week has become increasingly important (Johnson, 2013). The four-day school week has been credited with producing a number of potential benefits and consequences, but there…

Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis.

PubMed

Ogata, Atsushi; Atsumi, Tatsuya; Fukuda, Takaaki; Hirabayashi, Yasuhiko; Inaba, Masaaki; Ishiguro, Naoki; Kai, Motokazu; Kawabata, Daisuke; Kida, Daihei; Kohsaka, Hitoshi; Matsumura, Ryutaro; Minota, Seiji; Mukai, Masaya; Sumida, Takayuki; Takasugi, Kiyoshi; Tamaki, Shigenori; Takeuchi, Tsutomu; Ueda, Atsuhisa; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Yoshifuji, Hajime; Nomura, Akira

2015-10-01

To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight. © 2015 The Authors. Arthritis Care & Research is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

Cost-Effectiveness Analysis of Ixekizumab vs Etanercept and Their Manufacturer-Recommended Dosing Regimens in Moderate to Severe Plaque Psoriasis.

PubMed

Udkoff, Jeremy; Eichenfield, Lawrence F

2017-10-01

Biologic therapies have revolutionized the treatment of psoriasis; however, their use is limited by costs. Ixekizumab was more effective than etanercept in the UNCOVER trials, and the Food and Drug Administration (FDA) approved ixekizumab for treating psoriasis. Evaluating the cost-effectiveness of these therapies is crucial for medical decision making and our objective was to determine the cost-effectiveness of various ixekizumab dosing frequencies compared with etanercept. We utilized published data from the UNCOVER comparative efficacy trials, including transitional probabilities and treatment response rates, to create a Markov model simulating the clinical course and cost-effectiveness of three treatment algorithms for patients with moderate to severe plaque psoriasis over 60-weeks: (1) ixekizumab every 2 weeks for 12 weeks then every 4 weeks, (2) ixekizumab every 4 weeks throughout the treatment period, (3) biweekly etanercept for 12 weeks then once weekly. We utilized a standard willingness-to-pay (WTP) threshold of $150,000 per quality adjusted life year (QALY) and Medicaid drug acquisition costs for our calculations. Ixekizumab every 4 weeks was $28,681 (USD) less expensive than biweekly etanercept, and $21,375 less expensive, and 0.006 QALY less effective, than ixekizumab every 2 weeks-- a savings of $28.7 and $21.4 million, respectively, per 1,000 patients. A 95.6% cost reduction to $197.83 per dose is required for ixekizumab every 2 weeks to be more cost-effective than every 4 weeks. Biweekly etanercept requires a 29.5% cost reduction ($743.82 per dose) to be competitive with ixekizumab every 4 weeks. This cost-effectiveness model utilizes strong input data but is a limited approximation of real-life scenarios. Treatment with ixekizumab every 2 weeks is unlikely to be cost-effective compared with ixekizumab every 4 weeks at current U.S. market prices. Yet, the U.S. FDA approval and manufacturer's recommendation are for ixekizumab every 2 weeks. Accordingly, we suggested selecting biologic therapies using cost-effectiveness analyses.

J Drugs Dermatol. 2017;16(10):964-970.

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).

PubMed

Gottlieb, Alice B; Strand, Vibeke; Kishimoto, Mitsumasa; Mease, Philip; Thaçi, Diamant; Birt, Julie; Lee, Chin H; Shuler, Catherine L; Lin, Chen-Yen; Gladman, Dafna D

2018-06-25

To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks. In SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP. In biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity. ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49.

Incidence of skeletal related events in patients with bone metastasis receiving denosumab every four weeks compared to intervals greater than every four weeks.

PubMed

Yerram, Prakirthi; Moore, Russell; Wolf, Steven; Barbour, Sally Y

2017-01-01

Objective Denosumab is a monoclonal antibody used for prevention of skeletal related events in patients with bone metastasis from solid tumors and is administered every four weeks. In our practice, denosumab is often given at different frequencies more similar to patient's chemotherapy regimens to decrease frequency of clinic visits. The purpose of this study is to compare the incidence of skeletal related events, incidence of hypocalcemia, and cost with denosumab given at every four weeks and denosumab given at other frequencies. Methods This retrospective study at Duke University Health System included solid tumor patients with an age ≥18 years who received denosumab for prevention of skeletal related events. Results A total of 94 patients were included, with 29 in the every four-week group and 65 in the greater than every four-week group. Patients who received denosumab every four weeks had a 41.4% incidence of skeletal related events compared to 26.2% incidence of skeletal related events in patients who received denosumab at intervals greater than every four weeks (OR: 0.50; p = 0.14). There was no statistically significant difference in incidence of hypocalcemia. Based on average wholesale price, when the frequency of denosumab is extended to greater than every four weeks, annual cost savings per patient ranged from $4700 (every 5 weeks) to $18,800 (every 12 weeks). Conclusion While this study raises the possibility of decreasing the frequency of denosumab administration, further data are necessary to confirm that less frequent administration is non-inferior to every four-week administration.

Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study.

PubMed

Hwang, Jin Soon; Lee, Hae Sang; Lee, Kee-Hyoung; Yoo, Han-Wook; Lee, Dae-Yeol; Suh, Byung-Kyu; Ko, Cheol Woo; Chung, Woo Yeong; Jin, Dong-Kyu; Shin, Choong Ho; Han, Heon-Seok; Han, Song; Kim, Ho-Seong

2018-06-20

To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH. © 2018 S. Karger AG, Basel.

Effects of weight loss with a moderate-protein, high-fiber diet on body composition, voluntary physical activity, and fecal microbiota of obese cats.

PubMed

Pallotto, Marissa R; de Godoy, Maria R C; Holscher, Hannah D; Buff, Preston R; Swanson, Kelly S

2018-02-01

OBJECTIVE To determine effects of restriction feeding of a moderate-protein, high-fiber diet on loss of body weight (BW), voluntary physical activity, body composition, and fecal microbiota of overweight cats. ANIMALS 8 neutered male adult cats. PROCEDURES After BW maintenance for 4 weeks (week 0 = last week of baseline period), cats were fed to lose approximately 1.5% of BW/wk for 18 weeks. Food intake (daily), BW (twice per week), body condition score (weekly), body composition (every 4 weeks), serum biochemical analysis (weeks 0, 1, 2, 4, 8, 12, and 16), physical activity (every 6 weeks), and fecal microbiota (weeks 0, 1, 2, 4, 8, 12, and 16) were assessed. RESULTS BW, body condition score, serum triglyceride concentration, and body fat mass and percentage decreased significantly over time. Lean mass decreased significantly at weeks 12 and 16. Energy required to maintain BW was 14% less than National Research Council estimates for overweight cats and 16% more than resting energy requirement estimates. Energy required for weight loss was 11% more, 6% less, and 16% less than American Animal Hospital Association recommendations for weight loss (80% of resting energy requirement) at weeks 1 through 4, 5 through 8, and 9 through 18, respectively. Relative abundance of Actinobacteria increased and Bacteroidetes decreased with weight loss. CONCLUSIONS AND CLINICAL RELEVANCE Restricted feeding of a moderate-protein, high-fiber diet appeared to be a safe and effective means for weight loss in cats. Energy requirements for neutered cats may be overestimated and should be reconsidered.

Preliminary evaluation of cytosine-phosphate-guanine oligodeoxynucleotides bound to gelatine nanoparticles as immunotherapy for canine atopic dermatitis.

PubMed

Wagner, I; Geh, K J; Hubert, M; Winter, G; Weber, K; Classen, J; Klinger, C; Mueller, R S

2017-07-29

Cytosine-phosphate-guanine oligodeoxynucleotides (CpG ODN) are a promising new immunotherapeutic treatment option for canine atopic dermatitis (AD). The aim of this uncontrolled pilot study was to evaluate clinical and immunological effects of gelatine nanoparticle (GNP)-bound CpG ODN (CpG GNP) on atopic dogs. Eighteen dogs with AD were treated for 8 weeks (group 1, n=8) or 18 weeks (group 2, n=10). Before inclusion and after 2 weeks, 4 weeks, 6 weeks (group 1+2), 8 weeks, 12 weeks and 16 weeks (group 2) 75 µg CpG ODN/dog (bound to 1.5 mg GNP) were injected subcutaneously. Pruritus was evaluated daily by the owner. Lesions were evaluated and serum concentrations and mRNA expressions of interferon-γ, tumour necrosis factor-α, transforming growth factor-β, interleukin (IL) 10 and IL-4 (only mRNA expression) were determined at inclusion and after 8 weeks (group 1+2) and 18 weeks (group 2). Lesions and pruritus improved significantly from baseline to week 8. Mean improvements from baseline to week 18 were 23 per cent and 44 per cent for lesions and pruritus, respectively, an improvement of ≥50 per cent was seen in six out of nine and three out of six dogs, respectively. IL-4 mRNA expression decreased significantly. The results of this study show a clinical improvement of canine AD with CpG GNP comparable to allergen immunotherapy. Controlled studies are needed to confirm these findings. British Veterinary Association.

A prospective longitudinal study of the prevalence of post-traumatic stress disorder resulting from childbirth events.

PubMed

Alcorn, K L; O'Donovan, A; Patrick, J C; Creedy, D; Devilly, G J

2010-11-01

Childbirth has been linked to postpartum impairment. However, controversy exists regarding the onset and prevalence of post-traumatic stress disorder (PTSD) after childbirth, with seminal studies being limited by methodological issues. This longitudinal prospective study examined the prevalence of PTSD following childbirth in a large sample while controlling for pre-existing PTSD and affective symptomatology. Pregnant women in their third trimester were recruited over a 12-month period and interviewed to identify PTSD and anxiety and depressive symptoms during the last trimester of pregnancy, 4-6 weeks postpartum, 12 weeks postpartum and 24 weeks postpartum. Of the 1067 women approached, 933 were recruited into the study. In total, 866 (93%) were retained to 4-6 weeks, 826 (89%) were retained to 12 weeks and 776 (83%) were retained to 24 weeks. Results indicated that, uncontrolled, 3.6% of women met PTSD criteria at 4-6 weeks postpartum, 6.3% at 12 weeks postpartum and 5.8% at 24 weeks postpartum. When controlling for PTSD and partial PTSD due to previous traumatic events as well as clinically significant anxiety and depression during pregnancy, PTSD rates were less at 1.2% at 4-6 weeks, 3.1% at 12 weeks and 3.1% at 24 weeks postpartum. This is the first study to demonstrate the occurrence of full criteria PTSD resulting from childbirth after controlling for pre-existing PTSD and partial PTSD and clinically significant depression and anxiety in pregnancy. The findings indicate that PTSD can result from a traumatic birth experience, though this is not the normative response.

Prediction of the therapeutic response to methotrexate at 24 weeks by methotrexate-polyglutamates concentration in erythrocytes at 8 weeks in patients with rheumatoid arthritis.

PubMed

Murosaki, Takamasa; Nagatani, Katsuya; Sato, Takeo; Akiyama, Yoichiro; Ushijima, Kentaro; Lefor, Alan Kawarai; Fujimura, Akio; Minota, Seiji

2017-05-01

The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of methotrexate-polyglutamates (MTX-PGs) in erythrocytes in patients with rheumatoid arthritis and correlate them with the efficacy. MTX-PG concentrations in erythrocytes were measured in 42 MTX-naïve patients repeatedly for 24 weeks by high-performance liquid chromatography. In 56 patients receiving stable MTX doses for at least 12 weeks, the correlation between MTX doses and MTX-PG concentrations was examined. The efficacy was measured by the change of DAS28CRP (ΔDAS28CRP). There were moderate correlations between MTX dose and MTX-PG 3, 4, and 5. At 24 weeks, MTX-PG2, 3, 4, and 1-5 were higher in patients with ΔDAS28CRP >1.2 than in those with ≤1.2. The cutoff value of MTX-PG1-5 to discriminate ΔDAS28CRP >1.2 from ≤1.2 at 24 weeks was 68.7 nM. Among 20 patients with MTX-PG1-5 > 50.6 nM at 8 weeks, seven already improved at 8 weeks and additional 11 improved at 24 weeks (p < 0.001). On the contrary, among the nine patients with MTX-PG1-5 ≤ 50.6 nM at 8 weeks, none improved at 8 weeks and only one improved at 24 weeks (p = 0.500). Erythrocyte MTX-PGs might be a potential indicator and predictor of MTX efficacy.

Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis.

PubMed

Paglia, Margaret; Peterson, Janet; Fisher, Alan C; Qin, Zhihai; Nicholson, Susan C; Kahn, James B

2010-06-01

To compare the safety and efficacy of levofloxacin 750 mg QD for 2 weeks or levofloxacin 750 mg QD for 3 weeks to levofloxacin 500 mg QD for 4 weeks in treating chronic bacterial prostatitis (CBP). This was a randomized, multicenter, double-blind, noninferiority study. The primary efficacy end point was investigator assessment of clinical success in the modified intent-to-treat (mITT) population at post-therapy. National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) scores were utilized to evaluate subject-reported responses post-therapy. A total of 241 subjects were enrolled. At post-therapy (test of cure [TOC]), clinical success rates for levofloxacin-treated subjects (750 mg QD for 3 weeks [64.9%, 48/74]) were noninferior to 500 mg QD for 4 weeks (69.3%, 52/75: 95% CI, -19.5%, 10.6%). Success rates with levofloxacin 750 mg QD for 2 weeks (63.0%, 46/73) were not noninferior to therapy with levofloxacin 500 mg QD for 4 weeks (95% CI, -21.5%, 8.9%) at TOC. At 3 and 6 months post-therapy, clinical success rates were clinically higher for the 500-mg, 4-week treatment group, and statistical analysis demonstrated both groups were not noninferior to standard therapy with levofloxacin 500 mg (95% CI, -32.5%, -0.6% for both 750-mg groups at 6 months). NIH-CPSI scores showed similar trends. Overall, adverse event (AE) rates were similar for the three treatment groups; however, discontinuation of therapy due to AEs was higher with the 750-mg dose (p = 0.02, and p = 0.13 for 750 mg, 2 weeks and 750 mg, 3 weeks versus 500 mg for 4 weeks, respectively). The main limitation of this study was that no bacterial cultures were required. Higher doses for shorter durations were determined to be no worse than standard therapy with levofloxacin 500 mg for a longer duration at the TOC visit. However, at the 6-month follow-up visit, the levofloxacin 750-mg dose administered for either 2 weeks or 3 weeks was inferior to the standard therapy, suggesting that a longer duration of treatment may help extend the relapse-free interval in patients with CBP. clinicaltrials.gov, nct00402688.

45-Year Trends in Women’s Use of Time and Household Management Energy Expenditure

PubMed Central

Archer, Edward; Shook, Robin P.; Thomas, Diana M.; Church, Timothy S.; Katzmarzyk, Peter T.; Hébert, James R.; McIver, Kerry L.; Hand, Gregory A.; Lavie, Carl J.; Blair, Steven N.

2013-01-01

Context Relationships between socio-environmental factors and obesity are poorly understood due to a dearth of longitudinal population-level research. The objective of this analysis was to examine 45-year trends in time-use, household management (HM) and energy expenditure in women. Design and Participants Using national time-use data from women 19–64 years of age, we quantified time allocation and household management energy expenditure (HMEE) from 1965 to 2010. HM was defined as the sum of time spent in food preparation, post-meal cleaning activities (e.g., dish-washing), clothing maintenance (e.g., laundry), and general housework. HMEE was calculated using body weights from national surveys and metabolic equivalents. Results The time allocated to HM by women (19–64 yrs) decreased from 25.7 hr/week in 1965 to 13.3 hr/week in 2010 (P<0.001), with non-employed women decreasing by 16.6 hr/week and employed women by 6.7 hr/week (P<0.001). HMEE for non-employed women decreased 42% from 25.1 Mj/week (6004 kilocalories per week) in 1965 to 14.6 Mj/week (3486 kcal/week) in 2010, a decrement of 10.5 Mj/week or 1.5 Mj/day (2518 kcal/week; 360 kcal/day) (P<0.001), whereas employed women demonstrated a 30% decrement of 3.9 Mj/week, 0.55 Mj/day (923 kcal/week, 132 kcal/day) (P<0.001). The time women spent in screen-based media use increased from 8.3 hr/week in 1965 to 16.5 hr/week in 2010 (P<0.001), with non-employed women increasing 9.6 hr/week and employed women 7.5 hr/week (P<0.001). Conclusions From 1965 to 2010, there was a large and significant decrease in the time allocated to HM. By 2010, women allocated 25% more time to screen-based media use than HM (i.e., cooking, cleaning, and laundry combined). The reallocation of time from active pursuits (i.e., housework) to sedentary pastimes (e.g., watching TV) has important health consequences. These results suggest that the decrement in HMEE may have contributed to the increasing prevalence of obesity in women during the last five decades. PMID:23437187

Biochemical and developmental characterization of carbonic anhydrase II from chicken erythrocytes.

PubMed

Nishita, Toshiho; Tomita, Yuichiro; Imanari, Takao; Ichihara, Nobutsune; Orito, Kensuke; Arishima, Kazuyoshi

2011-03-07

Carbonic anhydrase (CA) of the chicken has attracted attention for a long time because it has an important role in the eggshell formation. The developmental profile of CA-II isozyme levels in chicken erythrocytes has not been determined or reported. Furthermore, the relations with CA-II in erythrocyte and egg production are not discussed. In the present study, we isolated CA-II from erythrocytes of chickens and determined age-related changes of CA-II levels in erythrocytes. Chicken CA-II was purified by a combination of column chromatography. The levels of CA-II in the hemolysate of the chicken were determined using the ELISA system in blood samples from 279 female chickens, ages 1 to 93 weeks, 69 male chickens, ages 3 to 59 weeks and 52 weeks female Araucana-chickens. The mean concentration of CA-II in hemolysate from 1-week-old female was 50.8 ± 11.9 mg/g of Hb. The mean levels of CA-II in 25-week-old (188.1 ± 82.6 mg/g of Hb), 31-week-old (193.6 ± 69.7 mg/g of Hb) and 49-week-old (203.8 ± 123.5 mg/g of Hb) female-chickens showed the highest level of CA-II. The levels of CA-II in female WL-chickens significantly decreased at 63 week (139.0 ± 19.3 mg/g of Hb). The levels of CA-II in female WL-chicken did not change from week 63 until week 93.The mean level of CA-II in hemolysate of 3-week-old male WL-chickens was 78.3 ± 20.7 mg/g of Hb. The levels of CA-II in male WL-chickens did not show changes in the week 3 to week 59 timeframe. The mean level of CA-II in 53-week-old female Araucana-chickens was 23.4 ± 1.78 mg/g of Hb. These levels of CA-II were about 11% of those of 49-week-old female WL-chickens. Simple linear regression analysis showed significant associations between the level of CA-II and egg laying rate from 16 week-old at 63 week-old WL-chicken (p<0.01). Developmental changes and sexual differences of CA-II concentration in WL-chicken erythrocytes were observed. The concentration of CA-II in the erythrocyte of WL-chicken was much higher than that in Araucana-chicken (p<0.01). © 2011 Nishita et al; licensee BioMed Central Ltd.

Ethinyl Estradiol and Norelgestromin Transdermal Patch

MedlinePlus

... the skin. One patch is applied once a week for 3 weeks, followed by a patch-free week. Follow the directions on your prescription label carefully, ... new patch on the same day of the week (the Patch Change Day). Apply a new patch ...

The Effect of Designated Pollutants on Plant Species

DTIC Science & Technology

1981-01-01

49 33 Dry weight of marigolds exposed to four weekly acid sprays and harvested on fifth week o . . . . . . 0 .. . .. .. 49 34...fertilizer and 12 kg pre-emergence weed killer (Dacthal) per hectare during plowing. Two-week-old zinnia and marigold plants, started in peat pots in the...study described below. Effect on Yield Zinnia and marigold plants transplanted to a Riverside field were exposed weekly for 6 successive weeks to one

Advances in Tissue Regeneration

DTIC Science & Technology

2010-01-01

Conference Hand Transplants Face transplants Skin Graft Stretching 33 www.afirm.mil Josh Maloney 1st AFIRM Hand Transplant 2010 MHS Conference...34www.afirm.mil Cell spraying in place of skin grafting for burn AFIRM: clinical trials scheduled for FY 10 2010 MHS Conference Before After patients...ReCell) Using Extracellular matrix to regrow lost muscle tissue. Weeks 6 & 7 Week 9 Week 8 Week 10 Week 11 Autologous engineered skin grafts Not

20 CFR 416.1861 - Deciding whether you are a child: Are you a student?

Code of Federal Regulations, 2010 CFR

2010-04-01

... hours a week under a semester or quarter system; (2) In grades 7-12 for at least 12 hours a week; (3) In... least 15 hours a week if the training involves shop practice or 12 hours a week if it does not involve... school law of the State or other jurisdiction in which you reside and for at least 12 hours a week. (c...

26 CFR 1.441-2 - Election of taxable year consisting of 52-53 weeks.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... For this purpose, a 52-53-week taxable year beginning on any of the days from June 25 to July 4... day of the week; and (iii) Ends always on— (A) Whatever date this same day of the week last occurs in a calendar month; or (B) Whatever date this same day of the week falls that is the nearest to the...

26 CFR 1.441-2 - Election of taxable year consisting of 52-53 weeks.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... For this purpose, a 52-53-week taxable year beginning on any of the days from June 25 to July 4... always on the same day of the week; and (iii) Ends always on— (A) Whatever date this same day of the week last occurs in a calendar month; or (B) Whatever date this same day of the week falls that is the...

Practical application of kangaroo mother care in preterm infants: clinical characteristics and safety of kangaroo mother care.

PubMed

Park, Hyun-kyung; Choi, Byeong Seon; Lee, Seung Jin; Son, In-A; Seol, In-Joon; Lee, Hyun Ju

2014-03-01

To determine the clinical characteristics and safety of kangaroo mother care (KMC) according to the gestational age (GA) or postmenstrual age (PMA). We conducted a prospective clinical study in 31 infants between 25 and 32 weeks' GA. The subjects were categorized into two groups (25-28 weeks' and 29-32 weeks' GA groups) to compare the clinical characteristics associated with KMC. Heart rate, respiratory rate, oxygen saturation, blood pressure and body temperature (BT) were longitudinally assessed for 60 min with respect to the PMA group (29-32 weeks' and 33-36 weeks' PMA groups). The authors analyzed 70 sessions with 31 infants (25-32 weeks' GA, birth weight 760-1740 g, 29-36 weeks' PMA). All infants had statistically significant higher temperatures during KMC than before KMC within clinically acceptable limits (P<0.001). We found a significantly lower variation of BT in the 25-28 weeks' GA group compared with the 29-32 weeks' GA group at 33-36 weeks' PMA, suggesting accelerated skin maturation in more premature infants (P<0.001). Our intermittent KMC was a safe and feasible method for preterm infants. Notably, at the same PMA, preterm infants in the lower at-birth GA group showed an advanced maturation of thermoregulation compared with those in the higher GA group.

Cohort study of depressed mood during pregnancy and after childbirth

PubMed Central

Evans, Jonathan; Heron, Jon; Francomb, Helen; Oke, Sarah; Golding, Jean

2001-01-01

Objective To follow mothers' mood through pregnancy and after childbirth and compare reported symptoms of depression at each stage. Design Longitudinal cohort study. Setting Avon. Participants Pregnant women resident within Avon with an expected date of delivery between 1 April 1991 and 31 December 1992. Main outcome measures Symptom scores from the Edinburgh postnatal depression scale at 18 and 32 weeks of pregnancy and 8 weeks and 8 months postpartum. Proportion of women above a threshold indicating probable depressive disorder. Results Depression scores were higher at 32 weeks of pregnancy than 8 weeks postpartum (difference in means 0.88, 95% confidence interval 0.79 to 0.97). There was no difference in the distribution of total scores or scores for individual items at the four time points. 1222 (13.5%) women scored above threshold for probable depression at 32 weeks of pregnancy, 821 (9.1%) at 8 weeks postpartum, and 147 (1.6%) throughout. More mothers moved above the threshold for depression between 18 weeks and 32 weeks of pregnancy than between 32 weeks of pregnancy and 8 weeks postpartum. Conclusions Symptoms of depression are not more common or severe after childbirth than during pregnancy. Research and clinical efforts need to be moved towards understanding, recognising, and treating antenatal depression. PMID:11485953

Effect of cutaneous and digestive colonization in the induction of anti-Candida albicans antibodies: experimental study.

PubMed

Nogueira, J M; Garcia-de-Lomas, J; Buesa, F J; Prat, J; Mir, A; Camarena, J J

1985-10-01

Candida albicans colonization induces antibodies, which must be taken into account in the serological diagnosis of candidiasis. In order to determine the degree of this effect, an experimental study in rabbits free of specific anti-Candida antibodies by cutaneous and digestive inoculation has been carried out. The evolution of humoral response was studied over 8 weeks by indirect immunofluorescence (IIF), direct agglutination (DA), counterimmunoelectrophoresis (CIE) and double diffusion (DD). The cutaneous colonization detectable by culture was maintained until the second week in 70% of the animals and the presence of antibodies detectable by IIF and DA was observed after the 2nd week. The highest antibody titre by IFF and DA was 1/64, and was reached in the 5th week, with a tendency to drop in the following weeks. Precipitins were only detected by CIE in 15% of the animals in the 7th week. Elimination of yeast in stools continued only in 20% of the animals in the 2nd week of the experiment. Antibodies were detected by IIF and DA after the 2nd week, with the highest titres detectable by IFF in the 5th week. Precipitant antibodies detectable by CIE appeared in 15% of the animals in the 8th week.

[Gymnema sylvestre leaf extract: a 52-week dietary toxicity study in Wistar rats].

PubMed

Ogawa, Yukio; Sekita, Kiyoshi; Umemura, Takashi; Saito, Minoru; Ono, Atsushi; Kawasaki, Yasushi; Uchida, Osayuki; Matsushima, Yuko; Inoue, Tohru; Kanno, Jun

2004-02-01

A 52-week study of oral-repeated-dose toxicity for the extraction powder of Gymnema sylvestre (GS), Indian-native genus, Metaplexis japonica, was conducted in both genders of Wistar rats. The rats were administered a graded dose of GS at 0.01, 0.10 and 1.00% of basal powder diet, along with a group fed solely with the basal powder diet without GS, for 52 weeks. General conditions were recorded daily. Body weights and food consumptions were recorded weekly up to 12 weeks, and thereafter at longer intervals. At 26 weeks, for an intermediate examination, and 52 weeks, for the final examination, animals were subjected to hematology, serum chemistry, and pathological examination. None of the animals died in the period up to 52 weeks. No exposure-related changes in body-weight, in the food consumption, in the hematological examinations, or in the serum biochemical examinations were recognized. No histopathological alterations were seen. Thus, it was concluded that there was no toxic effect in rats treated with GS at up to 1.00% in the diet for 52 weeks. The no-observable-effect level from this study is 1.00% GS, i.e., 504 mg/kg/day for male and 563 mg/kg/day for female as mean daily intake, for 52 weeks.

Detailed analysis of BALB/c mice challenged with wild type rotavirus EDIM provide an alternative for infection model of rotavirus.

PubMed

Du, Jialiang; Lan, Zhiling; Liu, Yueyue; Liu, Yan; Li, Yanchao; Li, Xiangming; Guo, Tai

2017-01-15

Mouse is one of the infection animal models for rotavirus. Since the optimal age of mouse sensitive to rotavirus infection thus far has not been unified, we elucidated clinical symptoms, immune responses and pathological changes of mice in different ages after challenged by murine rotavirus wild strain EDIM (Epidemic Diarrhea of Infant Mice) to provide data for the estimation. One-week-old, two-week-old, and three-week-old BALB/c mice were inoculated with EDIM in the challenge dose of 235 ID50, 470 ID50 and 705 ID50 respectively and were compared to mock-infected controls. Diarrhea illness, mobility, bodyweight were recorded, viral shedding and immune responses including serum IgA, fecal sIgA were detected, and small intestine tissue was evaluated for virus distribution and pathological changes. All the mice in one-week-old and two-week-old groups were completely unavoidable to be infected by EDIM and have been found to be malaise, activity reduced and even diarrhea, while three-week-old mice partly resist the challenge with 40% mice free from diarrhea. Meanwhile, EDIM infection has greater impact to the bodyweight of two-week-old group than those of one-week-old, three-week-old (0.9860 vs 1.2340, 1.2375g/day). One peak of virus shedding in three groups was observed in day 1-2 post infection, but the duration shortened with age increase. Feces sIgA in both two-week-old and three-week-old groups began to increase in day 4, 2-3days earlier than that in one-week-old group, and grow to the peak in day 8, which is about 2 fold of that in one-week-old group. Stronger serum IgA response was found in two-week-old group, it increased to the peak in day 15 and the level was 2 fold of three-week-old group and 4 fold of one-week-old group. The pathological changes included vacuolar degeneration, edema and congestion of intestinal wall, integrity destruction of enteric epithelium, and the changes relieved with the increase of age. Besides, rotavirus particles were found in small intestine tissues, especially in the surface and crypt of villi. In conclusion, the two-week-old mice were more sensitive to EDIM infection and initiated more effective immune response. In combination with that 14days old mice equals to 2 months infant when the first dose of rotavirus vaccine should be administrated, two-week-old mice is preferred to be used as infection model for the study of pathogenicity and immunogenicity of rotavirus. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response

PubMed Central

Terrault, Norah A.; Zeuzem, Stefan; Di Bisceglie, Adrian M.; Lim, Joseph K.; Pockros, Paul J.; Frazier, Lynn M.; Kuo, Alexander; Lok, Anna S.; Shiffman, Mitchell L.; Ben Ari, Ziv; Akushevich, Lucy; Vainorius, Monika; Sulkowski, Mark S.; Fried, Michael W.; Nelson, David R.

2017-01-01

BACKGROUND & AIMS The combination of ledipasvir and sofosbuvir has been approved for treatment of genotype 1 hepatitis C virus (HCV) infection, including an 8-week regimen for treatment-naïve patients without cirrhosis and a baseline level of HCV RNA <6 million IU/mL. We analyzed data from a multicenter, prospective, observational study to determine real-world sustained virologic responses 12 weeks after treatment (SVR12) with regimens containing ledipasvir and sofosbuvir and identify factors associated with treatment failure. METHODS We collected data from 2099 participants in the HCV-TARGET study with complete virologic data (per-protocol population). We analyzed data from 1788 patients receiving ledipasvir-sofosbuvir (282 for 8 weeks, 910 for 12 weeks, 510 for 24 weeks, and 86 for a different duration) and 311 receiving ledipasvir-sofosbuvir plus ribavirin (212 for 12 weeks and 81 for 24 weeks, 18 for other duration) to estimate SVR12 (with 95% confidence interval [CI]), and logistic regression methods to identify factors that predicted an SVR12. RESULTS The overall study population was 25% black, 66% with HCV genotype 1A infection, 41% with cirrhosis, 50% treatment-experienced, and 30% receiving proton pump inhibitors at start of treatment. In the per-protocol population, SVR12s were achieved by 96% of patients receiving ledipasvir-sofosbuvir for 8 weeks (95% CI, 93%–98%), 97% receiving the drugs for 12 weeks (95% CI, 96%–98%), and 95% receiving the drugs for 24 weeks (95% CI, 93%–97%). Among patients also receiving ribavirin, SVR12 was achieved by 97% of the patients receiving the drugs for 12 weeks (95% CI, 94%–99%) and 95% receiving the drugs for 24 weeks (95% CI, 88%–99%). Of the 586 patients who qualified for 8 weeks of treatment, only 255 (44%) received the drugs for 8 weeks. The rate of SVR12 among those who qualified for and received 8 weeks of therapy was similar in those who qualified for 8 weeks but received 12 weeks therapy (96%; 95% CI, 92%–99% vs 98%; 95% CI, 95%–99%). Factors that predicted SVR12 were higher albumin (≤3.5 g/dL), lower total bilirubin (≥1.2 g/dL), absence of cirrhosis, and absence of proton pump inhibitor use. CONCLUSIONS Regimens containing ledipasvir and sofosbuvir are highly effective for a broad spectrum of patients with HCV genotype 1 infection treated in different clinical practice settings. Expanded use of 8-week treatment regimens for eligible patients is supported by these real-world results. Modification of proton pump inhibitor use may increase rates of SVR. ClinicalTrials.gov no. NCT01474811. PMID:27565882

Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated With Sustained Virologic Response.

PubMed

Terrault, Norah A; Zeuzem, Stefan; Di Bisceglie, Adrian M; Lim, Joseph K; Pockros, Paul J; Frazier, Lynn M; Kuo, Alexander; Lok, Anna S; Shiffman, Mitchell L; Ben Ari, Ziv; Akushevich, Lucy; Vainorius, Monika; Sulkowski, Mark S; Fried, Michael W; Nelson, David R

2016-12-01

The combination of ledipasvir and sofosbuvir has been approved for treatment of genotype 1 hepatitis C virus (HCV) infection, including an 8-week regimen for treatment-naïve patients without cirrhosis and a baseline level of HCV RNA <6 million IU/mL. We analyzed data from a multicenter, prospective, observational study to determine real-world sustained virologic responses 12 weeks after treatment (SVR12) with regimens containing ledipasvir and sofosbuvir and identify factors associated with treatment failure. We collected data from 2099 participants in the HCV-TARGET study with complete virologic data (per-protocol population). We analyzed data from 1788 patients receiving ledipasvir-sofosbuvir (282 for 8 weeks, 910 for 12 weeks, 510 for 24 weeks, and 86 for a different duration) and 311 receiving ledipasvir-sofosbuvir plus ribavirin (212 for 12 weeks and 81 for 24 weeks, 18 for other duration) to estimate SVR12 (with 95% confidence interval [CI]), and logistic regression methods to identify factors that predicted an SVR12. The overall study population was 25% black, 66% with HCV genotype 1A infection, 41% with cirrhosis, 50% treatment-experienced, and 30% receiving proton pump inhibitors at start of treatment. In the per-protocol population, SVR12s were achieved by 96% of patients receiving ledipasvir-sofosbuvir for 8 weeks (95% CI, 93%-98%), 97% receiving the drugs for 12 weeks (95% CI, 96%-98%), and 95% receiving the drugs for 24 weeks (95% CI, 93%-97%). Among patients also receiving ribavirin, SVR12 was achieved by 97% of the patients receiving the drugs for 12 weeks (95% CI, 94%-99%) and 95% receiving the drugs for 24 weeks (95% CI, 88%-99%). Of the 586 patients who qualified for 8 weeks of treatment, only 255 (44%) received the drugs for 8 weeks. The rate of SVR12 among those who qualified for and received 8 weeks of therapy was similar in those who qualified for 8 weeks but received 12 weeks therapy (96%; 95% CI, 92%-99% vs 98%; 95% CI, 95%-99%). Factors that predicted SVR12 were higher albumin (≥3.5 g/dL), lower total bilirubin (≤1.2 g/dL), absence of cirrhosis, and absence of proton pump inhibitor use. Regimens containing ledipasvir and sofosbuvir are highly effective for a broad spectrum of patients with HCV genotype 1 infection treated in different clinical practice settings. Expanded use of 8-week treatment regimens for eligible patients is supported by these real-world results. Modification of proton pump inhibitor use may increase rates of SVR. ClinicalTrials.gov no. NCT01474811. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Initial Weekly HRV Response is Related to the Prospective Change in VO2max in Female Soccer Players.

PubMed

Esco, M R; Flatt, A A; Nakamura, F Y

2016-06-01

The aim of this study was to determine whether the early response in weekly measures of HRV, when derived from a smartphone application, were related to the eventual change in VO2max following an off-season training program in female soccer athletes. 9 female collegiate soccer players participated in an 11-week off-season conditioning program. In the week immediately before and after the training program, each participant performed a test on a treadmill to determine maximal oxygen consumption (VO2max). Daily measures of the log-transformed root mean square of successive R-R intervals (lnRMSSD) were performed by the participants throughout week 1 and week 3 of the conditioning program. The mean and coefficient of variation (CV) lnRMSSD values of week 1 showed small (r=- 0.13, p=0.74) and moderate (r=0.57, p=0.11), respectively, non-significant correlations to the change in VO2max at the end of the conditioning program (∆VO2max). Significant and near-perfect correlation was found between the change in the weekly mean lnRMSSD values from weeks 1 and 3 (∆lnRMSSDM) and ∆VO2max (r=0.90, p=0.002). The current results have identified that the initial change in weekly mean lnRMSSD from weeks 1 to 3 of a conditioning protocol was strongly associated with the eventual adaptation of VO2max. © Georg Thieme Verlag KG Stuttgart · New York.

Six weeks of continuous joint distraction appears sufficient for clinical benefit and cartilaginous tissue repair in the treatment of knee osteoarthritis.

PubMed

van der Woude, J A D; van Heerwaarden, R J; Spruijt, S; Eckstein, F; Maschek, S; van Roermund, P M; Custers, R J H; van Spil, W E; Mastbergen, S C; Lafeber, F P J G

2016-10-01

Knee joint distraction (KJD) is a surgical joint-preserving treatment in which the knee joint is temporarily distracted by an external frame. It is associated with joint tissue repair and clinical improvement. Initially, patients were submitted to an eight-week distraction period, and currently patients are submitted to a six-week distraction period. This study evaluates whether a shorter distraction period influences the outcome. Both groups consisted of 20 patients. Clinical outcome was assessed by WOMAC questionnaires and VAS-pain. Cartilaginous tissue repair was assessed by radiographic joint space width (JSW) and MRI-observed cartilage thickness. Baseline data between both groups were comparable. Both groups showed an increase in total WOMAC score; 24±4 in the six-week group and 32±5 in the eight-week group (both p<0.001). Mean JSW increased 0.9±0.3mm in the six-week group and 1.1±0.3mm in the eight-week group (p=0.729 between groups). The increase in mean cartilage thickness on MRI was 0.6±0.2mm in the eight-week group and 0.4±0.1mm in the six-week group (p=0.277). A shorter distraction period does not influence short-term clinical and structural outcomes statistically significantly, although effect sizes tend to be smaller in six week KJD as compared to eight week KJD. Copyright © 2016 Elsevier B.V. All rights reserved.

Breast feeding is associated with postpartum smoking abstinence among women who quit smoking due to pregnancy

PubMed Central

Businelle, Michael S.; Costello, Tracy J.; Castro, Yessenia; Reitzel, Lorraine R.; Vidrine, Jennifer I.; Mullen, Patricia Dolan; Velasquez, Mary M.; Cinciripini, Paul M.; Cofta-Woerpel, Ludmila M.; Wetter, David W.

2010-01-01

Introduction: The purpose of this study was to characterize the relationship between breast feeding and postpartum smoking abstinence among women who quit smoking due to pregnancy and who were participating in a randomized clinical trial of an intervention designed to prevent postpartum relapse. Methods: A total of 251 women were enrolled in the intervention between 30 and 33 weeks postpartum and were followed through 26 weeks postpartum. Participant characteristics were assessed at the prepartum baseline visit, any breast feeding was assessed at 8 weeks postpartum, and smoking abstinence was assessed at 8 and 26 weeks postpartum. Results: Although 79.1% of participants intended to breast feed, only 40.2% reported breast feeding at 8 weeks postpartum. Characteristics associated with breast feeding at 8 weeks postpartum included Caucasian race/ethnicity, greater education, higher household income, and being married/living with a significant other. Logistic regression analysis indicated that breast feeding at 8 weeks postpartum was significantly associated with smoking abstinence at 8 weeks postpartum, odds ratio (OR) = 7.27 (95% CI = 3.27, 16.13), p < .001. Breast feeding at 8 weeks postpartum was also associated with abstinence at 26 weeks postpartum after controlling for smoking status at 8 weeks postpartum, OR = 2.64 (95% CI = 1.14, 6.10), p = .02. Discussion: Encouraging breast feeding among women who quit smoking due to pregnancy may facilitate postpartum smoking abstinence while increasing adherence to current infant feeding guidelines. PMID:20713441

The effect of preseason training on mucosal immunity in male basketball players.

PubMed

Azarbayjani, M; Nikbakht, H; Rasaee, M J

2011-12-01

This study examined the effects of pre season training on restring level and acute response of mucosal immunity in male basketball players. Twenty male basketball players performed 8 weeks progressive exercise training, consisting of interval and continuous parts. Five mL un-stimulated saliva was collected from each subject before, immediately and one hour after the end of one bout of exercise to exhaustion on treadmill at the beginning of the first week and end of 8 weeks to determine the acute responses. At the beginning of each 2 weeks (resting state) induced changes in basal mucosal immunity was evaluated. The concentration of sIgA and total protein was measured by the ELISA and Bradford methods respectively. One bout exercise training at beginning of first week decreased significantly sIgA level but not at the end of 8th week. Total protein did not change significantly at 1st week after exercise, but at eight week significantly increased and remained at high level until one hour after exercise. sIgA to total protein ratio at first week significantly decreased and remained constant one hour after exercise. At the eight week sIgA decreased significantly immediately after exercise and remained low until one hour after exercise. The comparison of sIgA and total protein levels indicates significant decrease after eight weeks training. These results suggest that repetition of single bout of exercise training have a cumulative effect on the mucosal immune system.

Training Characteristics During Pregnancy and Postpartum in the World's Most Successful Cross Country Skier.

PubMed

Solli, Guro S; Sandbakk, Øyvind

2018-01-01

This case-study investigated the training characteristics, physiological capacity, and body composition of the world's most successful cross country skier during the 40-week pregnancy, and the 61-week postpartum. Training data was systemized by training form (endurance, strength, and speed), intensity [low- (LIT), moderate- (MIT), and high-intensity training (HIT)], and mode (running, cycling, and skiing/roller skiing). The training volume [mean ± standard deviation (median)] during pregnancy was 12.9 ± 7.3(10.0) h/week in the first- (weeks 1-12), 18.3 ± 2.9(18.0) h/week in the second- (weeks 13-28), and 8.8 ± 4.4(9.6) h/week in the third trimester (weeks 29-40). Endurance training time was distributed into 10.9 ± 6.2(9.9), 15.2 ± 2.3(15.6), and 7.6 ± 3.8(7.9) LIT and 0.4 ± 0.5(0.0), 1.3 ± 0.4(1.4), and 0.7 ± 0.6(0.8) h/week MIT during the three trimesters. Only 2.2 h of HIT was performed during the entire pregnancy. During the first two trimesters, the distribution of exercise modes were approximately the same as pre-pregnancy, but the amount of running was reduced during the third trimester. Training volume during the postpartum periods 1-4 was 6.6 ± 3.8(7.1) (PP1; weeks 1-6), 14.1 ± 3.4(14.3) (PP2; weeks 7-12), 10.6 ± 3.8(10.4) (PP3; weeks 13-18), and 13.6 ± 4.1(14.5) h/week (PP4; weeks 19-24), respectively. Training during PP3 and PP4 was interfered with two fractions in the sacrum, leading to decreased amount of running and MIT/HIT, compensated by increased amounts of cycling. Thereafter, training volume progressively approached the pre-pregnancy values, being 18.0 ± 3.9(18.7) h/week during the general preparation- (weeks 25-44), 17.6 ± 4.4(17.3) h/week during the specific preparation- (weeks 45-53), and 16.9 ± 3.5(17.2) h/week during the competition period (CP; weeks 54-61) leading up to the subsequent world championship. The oxygen uptake at the estimated lactate threshold (LT) decreased to 90% of pre-pregnancy values in the second trimester, but remained to ∼100% in PP3. Body weight and fat-% was higher, while lean body mass and bone mineral density was lower after delivery compared to pre-pregnancy. These measurements gradually changed and were back to ∼pre-pregnancy values during CP. This study indicates that high-level cross country skiers can tolerate high training loads during pregnancy. Although the participant had some postpartum setbacks in her training due to fractures in the sacrum, reduced overall training load, followed by a slower progression and utilization of alternative exercise modes, led to a successful return to competitions.

Association Between Low Trough Levels of Vedolizumab During Induction Therapy for Inflammatory Bowel Diseases and Need for Additional Doses Within 6 Months.

PubMed

Williet, Nicolas; Boschetti, Gilles; Fovet, Marion; Di Bernado, Thomas; Claudez, Pierre; Del Tedesco, Emilie; Jarlot, Camille; Rinaldi, Leslie; Berger, Anne; Phelip, Jean-Marc; Flourie, Bernard; Nancey, Stéphane; Paul, Stéphane; Roblin, Xavier

2017-11-01

We investigated whether serum trough levels of vedolizumab, a humanized monoclonal antibody against integrin α4β7, during the induction phase of treatment can determine whether patients will need additional doses (optimization of therapy) within the first 6 months. We conducted an observational study of 47 consecutive patients with Crohn's disease (CD; n = 31) or ulcerative colitis (UC; n = 16) who had not responded to 2 previous treatment regimens with antagonists of tumor necrosis factor and were starting therapy with vedolizumab at 2 hospitals in France, from June 2014 through April 2016. All patients were given a 300-mg infusion of vedolizumab at the start of the study, Week 2, Week 6, and then every 8 weeks; patients were also given corticosteroids during the first 4-6 weeks. Patients not in remission at Week 6 were given additional doses of vedolizumab at Week 10 and then every 4 weeks (extended therapy or optimization). Remission at Week 6 of treatment was defined as CD activity score below 150 points for patients with CD and a partial Mayo Clinic score of <3 points, without concomitant corticosteroids, for patients with UC. Blood samples were collected each week and serum levels of vedolizumab and antibodies against vedolizumab were measured using an enzyme-linked immunosorbent assay. Median trough levels of vedolizumab and interquartile ranges were compared using the nonparametric Mann-Whitney test. The primary objective was to determine whether trough levels of vedolizumab measured during the first 6 weeks of induction therapy associated with the need for extended treatment within the first 6 months. Based on response to therapy at Week 6, extended treatment was required for 30 of the 47 patients (23 patients with CD and 7 patients with UC). At Week 2, trough levels of vedolizumab for patients selected for extended treatment were 23.0 μg/mL (interquartile range, 14.0-37.0 μg/mL), compared with 42.5 μg/mL in patients who did not receive extended treatment (interquartile range, 33.5-50.7; P = .15). At Week 6, trough levels of vedolizumab <18.5 μg/mL were associated with need for extended therapy (100% positive predictive value, 46.2%; negative predictive value; area under the receiver operating characteristic curve, 0.72) within the first 6 months. Among patients who required extended treatment at Week 10, all of those with trough levels of vedolizumab <19.0 μg/mL at Week 6 had achieved clinical remission 4 weeks later (secondary responders). In a prospective study of patients with CD or UC receiving induction therapy with vedolizumab, low trough levels of vedolizumab at Week 6 (<19.0 μg/mL) are associated with need for additional doses (given at Week 10 and then every 4 weeks). All patients receiving these additional doses achieved a clinical response 4 weeks later. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Training Characteristics During Pregnancy and Postpartum in the World’s Most Successful Cross Country Skier

PubMed Central

Solli, Guro S.; Sandbakk, Øyvind

2018-01-01

This case-study investigated the training characteristics, physiological capacity, and body composition of the world’s most successful cross country skier during the 40-week pregnancy, and the 61-week postpartum. Training data was systemized by training form (endurance, strength, and speed), intensity [low- (LIT), moderate- (MIT), and high-intensity training (HIT)], and mode (running, cycling, and skiing/roller skiing). The training volume [mean ± standard deviation (median)] during pregnancy was 12.9 ± 7.3(10.0) h/week in the first- (weeks 1–12), 18.3 ± 2.9(18.0) h/week in the second- (weeks 13–28), and 8.8 ± 4.4(9.6) h/week in the third trimester (weeks 29–40). Endurance training time was distributed into 10.9 ± 6.2(9.9), 15.2 ± 2.3(15.6), and 7.6 ± 3.8(7.9) LIT and 0.4 ± 0.5(0.0), 1.3 ± 0.4(1.4), and 0.7 ± 0.6(0.8) h/week MIT during the three trimesters. Only 2.2 h of HIT was performed during the entire pregnancy. During the first two trimesters, the distribution of exercise modes were approximately the same as pre-pregnancy, but the amount of running was reduced during the third trimester. Training volume during the postpartum periods 1–4 was 6.6 ± 3.8(7.1) (PP1; weeks 1–6), 14.1 ± 3.4(14.3) (PP2; weeks 7–12), 10.6 ± 3.8(10.4) (PP3; weeks 13–18), and 13.6 ± 4.1(14.5) h/week (PP4; weeks 19–24), respectively. Training during PP3 and PP4 was interfered with two fractions in the sacrum, leading to decreased amount of running and MIT/HIT, compensated by increased amounts of cycling. Thereafter, training volume progressively approached the pre-pregnancy values, being 18.0 ± 3.9(18.7) h/week during the general preparation- (weeks 25–44), 17.6 ± 4.4(17.3) h/week during the specific preparation- (weeks 45–53), and 16.9 ± 3.5(17.2) h/week during the competition period (CP; weeks 54–61) leading up to the subsequent world championship. The oxygen uptake at the estimated lactate threshold (LT) decreased to 90% of pre-pregnancy values in the second trimester, but remained to ∼100% in PP3. Body weight and fat-% was higher, while lean body mass and bone mineral density was lower after delivery compared to pre-pregnancy. These measurements gradually changed and were back to ∼pre-pregnancy values during CP. This study indicates that high-level cross country skiers can tolerate high training loads during pregnancy. Although the participant had some postpartum setbacks in her training due to fractures in the sacrum, reduced overall training load, followed by a slower progression and utilization of alternative exercise modes, led to a successful return to competitions. PMID:29875693

Functional and Anatomical Outcomes of Facial Nerve Injury With Application of Polyethylene Glycol in a Rat Model.

PubMed

Brown, Brandon L; Asante, Tony; Welch, Haley R; Sandelski, Morgan M; Drejet, Sarah M; Shah, Kishan; Runge, Elizabeth M; Shipchandler, Taha Z; Jones, Kathryn J; Walker, Chandler L

2018-05-17

Functional and anatomical outcomes after surgical repair of facial nerve injury may be improved with the addition of polyethylene glycol (PEG) to direct suture neurorrhaphy. The application of PEG has shown promise in treating spinal nerve injuries, but its efficacy has not been evaluated in treatment of cranial nerve injuries. To determine whether PEG in addition to neurorrhaphy can improve functional outcomes and synkinesis after facial nerve injury. In this animal experiment, 36 rats underwent right facial nerve transection and neurorrhaphy with addition of PEG. Weekly behavioral scoring was done for 10 rats for 6 weeks and 14 rats for 16 weeks after the operations. In the 16-week study, the buccal branches were labeled and tissue analysis was performed. In the 6-week study, the mandibular and buccal branches were labeled and tissue analysis was performed. Histologic analysis was performed for 10 rats in a 1-week study to assess the association of PEG with axonal continuity and Wallerian degeneration. Six rats served as the uninjured control group. Data were collected from February 8, 2016, through July 10, 2017. Polyethylene glycol applied to the facial nerve after neurorrhaphy. Functional recovery was assessed weekly for the 16- and 6-week studies, as well as motoneuron survival, amount of regrowth, specificity of regrowth, and aberrant branching. Short-term effects of PEG were assessed in the 1-week study. Among the 40 male rats included in the study, PEG addition to neurorrhaphy showed no functional benefit in eye blink reflex (mean [SEM], 3.57 [0.88] weeks; 95% CI, -2.8 to 1.9 weeks; P = .70) or whisking function (mean [SEM], 4.00 [0.72] weeks; 95% CI, -3.6 to 2.4 weeks; P = .69) compared with suturing alone at 16 weeks. Motoneuron survival was not changed by PEG in the 16-week (mean, 132.1 motoneurons per tissue section; 95% CI, -21.0 to 8.4; P = .13) or 6-week (mean, 131.1 motoneurons per tissue section; 95% CI, -11.0 to 10.0; P = .06) studies. Compared with controls, neither surgical group showed differences in buccal branch regrowth at 16 (36.9 motoneurons per tissue section; 95% CI, -14.5 to 22.0; P = .28) or 6 (36.7 motoneurons per tissue section; 95% CI, -7.8 to 18.5; P = .48) weeks or in the mandibular branch at 6 weeks (25.2 motoneurons per tissue section; 95% CI, -14.5 to 15.5; P = .99). Addition of PEG had no advantage in regrowth specificity compared with suturing alone at 16 weeks (15.3% buccal branch motoneurons with misguided projections; 95% CI, -7.2% to 11.0%; P = .84). After 6 weeks, the number of motoneurons with misguided projections to the mandibular branch showed no advantage of PEG treatment compared with suturing alone (12.1% buccal branch motoneurons with misguided projections; 95% CI, -8.2% to 9.2%; P = .98). In the 1-week study, improved axonal continuity and muscular innervation were not observed in PEG-treated rats. Although PEG has shown efficacy in treating other nervous system injuries, PEG in addition to neurorraphy was not beneficial in a rat model of facial nerve injury. The addition of PEG to suturing may not be warranted in the surgical repair of facial nerve injury. NA.

Cumulative Brain Injury from Motor Vehicle-Induced Whole-Body Vibration and Prevention by Human Apolipoprotein A-I Molecule Mimetic (4F) Peptide (an Apo A-I Mimetic)

PubMed Central

Yan, Ji-Geng; Zhang, Lin-ling; Agresti, Michael; Yan, Yuhui; LoGiudice, John; Sanger, James R.; Matloub, Hani S.; Pritchard, Kirkwood A.; Jaradeh, Safwan S.; Havlik, Robert

2017-01-01

Background Insidious cumulative brain injury from motor vehicle-induced whole-body vibration (MV-WBV) has not yet been studied. The objective of the present study is to validate whether whole-body vibration for long periods causes cumulative brain injury and impairment of the cerebral function. We also explored a preventive method for MV-WBV injury. Methods A study simulating whole-body vibration was conducted in 72 male Sprague-Dawley rats divided into 9 groups (N = 8): (1) 2-week normal control; (2) 2-week sham control (in the tube without vibration); (3) 2-week vibration (exposed to whole-body vibration at 30 Hz and .5 G acceleration for 4 hours/day, 5 days/week for 2 weeks; vibration parameters in the present study are similar to the most common driving conditions); (4) 4-week sham control; (5) 4-week vibration; (6) 4-week vibration with human apolipoprotein A-I molecule mimetic (4F)-preconditioning; (7) 8-week sham control; (8) 8-week vibration; and (9) 8-week 4F-preconditioning group. All the rats were evaluated by behavioral, physiological, and histological studies of the brain. Results Brain injury from vibration is a cumulative process starting with cerebral vasoconstriction, squeezing of the endothelial cells, increased free radicals, decreased nitric oxide, insufficient blood supply to the brain, and repeated reperfusion injury to brain neurons. In the 8-week vibration group, which indicated chronic brain edema, shrunken neuron numbers increased and whole neurons atrophied, which strongly correlated with neural functional impairment. There was no prominent brain neuronal injury in the 4F groups. Conclusions The present study demonstrated cumulative brain injury from MV-WBV and validated the preventive effects of 4F preconditioning. PMID:26433438

Clinical Assessment of Weight Gain with Atypical Antipsychotics - Blonanserin vs Amisulpride.

PubMed

Deepak, T S; Raveesh, B N; Parashivamurthy, B M; Kumar, Ms Narendra; Majgi, Sumanth Mallikarjuna; Nagesh, H N

2015-06-01

Atypical antipsychotics appear to have the greatest potential to induce weight gain. Antipsychotic-induced weight gain is the one of main cause of non-compliance and discontinuation of treatment, often resulting in the relapse of psychosis. To compare the weight gain between amisulpride and blonanserin treatment, in persons with psychosis. Fifty six subjects with psychosis attending psychiatry department at KR Hospital, Mysore were randomized into two equal groups. After obtaining informed consent, subjects of group I received amisulpride tablets 200 mg BD, and group II received blonanserin tablets 4 mg BD, for eight weeks. Body weight, Body Mass Index (BMI) and Waist Hip Ratio (WHR) were measured at baseline, 4 weeks and 8 weeks. The mean weight gain with amisulpride at 4 weeks was 2.73 kg (5.21%) and at 8 weeks was 4.34 kg (8.28%) from the baseline. The mean weight gain with blonanserin at 4 weeks was 1.77 kg (3.46%) and at 8 weeks was 3.46 kg (6.75%) from the baseline. The mean BMI increase at 8 weeks with amisulpride was 1.66 ± 0.56 and with blonanserin was 1.34 ± 0.77. The mean WHR increase at 8 weeks with amisulpride was 0.036 ± 0.026 and with blonanserin was 0.029 ± 0.020. There was statistically significant increase in weight, BMI and WHR associated with both blonanserin and amisulpride at 8 weeks. But there was no statistically significant difference in those parameters between blonanserin and amisulpride, at eight weeks. Even though there was no significant difference in the weight gain caused by blonanserin, in comparison with amisulpride, both these drugs individually caused significant weight gain at 8 weeks, which is in contrast with the earlier studies, which needs to be further evaluated.

Transfer from blue light or green light to white light partially reverses changes in ocular refraction and anatomy of developing guinea pigs.

PubMed

Qian, Yi-Feng; Liu, Rui; Dai, Jin-Hui; Chen, Min-Jie; Zhou, Xing-Tao; Chu, Ren-Yuan

2013-09-26

Relative to the broadband white light (BL), postnatal guinea pigs develop myopia in a monochromic middle-wavelength light (ML, 530 nm) environment and develop hyperopia in a monochromic short-wavelength light (SL, 430 nm) environment. We investigated whether transfer from SL or ML to BL leads to recuperation of ocular refraction and anatomy of developing guinea pigs. Two-week-old guinea pigs were given (a) SL for 20 weeks, (b) SL recuperation (SLR, SL for 10 weeks then BL for 10 weeks), (c) ML for 20 weeks, (d) ML recuperation (MLR, ML for 10 weeks then BL for 10 weeks), or (e) BL for 20 weeks. Two weeks after transfer from ML to BL (MLR group), ocular refraction increased from 1.95 ± 0.35 D to 2.58 ± 0.24 D, and vitreous length decreased from 3.48 ± 0.06 mm to 3.41 ± 0.06 mm. Two weeks after transfer from SL to BL (SLR group), ocular refraction decreased from 5.65 ± 0.61 D to 4.33 ± 0.49 D, and vitreous length increased from 3.18 ± 0.07 mm to 3.26 ± 0.11 mm. The MLR and SLR groups had final ocular refractions that were significantly different from those of the ML and SL groups at 20 weeks (ML vs. MLR: p < 0.0001; SL vs. SLR: p < 0.0001) but were still significantly different from the BL group (BL vs. MLR: p = 0.0120; BL vs. SLR: p = 0.0010). These results suggest that recuperation was not complete after return to BL for 10 weeks.

The effect of exercise hypertrophy and disuse atrophy on muscle contractile properties: a mechanomyographic analysis.

PubMed

Than, Christian; Tosovic, Danijel; Seidl, Laura; Mark Brown, J

2016-12-01

To determine whether mechanomyographic (MMG) determined contractile properties of the biceps brachii change during exercise-induced hypertrophy and subsequent disuse atrophy. Healthy subjects (mean ± SD, 23.7 ± 2.6 years, BMI 21.8 ± 2.4, n = 19) performed unilateral biceps curls (9 sets × 12 repetitions, 5 sessions per week) for 8 weeks (hypertrophic phase) before ceasing exercise (atrophic phase) for the following 8 weeks (non-dominant limb; treatment, dominant limb; control). MMG measures of muscle contractile properties (contraction time; T c , maximum displacement; D max , contraction velocity; V c ), electromyographic (EMG) measures of muscle fatigue (median power frequency; MPF), strength measures (maximum voluntary contraction; MVC) and measures of muscle thickness (ultrasound) were obtained. Two-way repeated measures ANOVA showed significant differences (P < 0.05) between treatment and control limbs. During the hypertrophic phase treatment MVC initially declined (weeks 1-3), due to fatigue (decline in MPF), followed by improvement against control during weeks 6-8. Between weeks 5 and 8 treatment, muscle thickness was greater than control, reflecting gross hypertrophy. MMG variables Dmax (weeks 2, 7) and Vc (weeks 7, 8) declined. During the atrophic phase, MVC (weeks 9-12) and muscle thickness (weeks 9, 10) initially remained high before declining to control levels, reflecting gross atrophy. MMG variables D max (weeks 9, 14) and V c (weeks 9, 14, 15) also declined during the atrophic phase. No change in T c was found throughout the hypertrophic or atrophic phases. MMG detects changes in contractile properties during stages of exercise-induced hypertrophy and disuse atrophy suggesting its applicability as a clinical tool in musculoskeletal rehabilitation.

A New Spontaneously Diabetic Non-obese Torii Rat Strain With Severe Ocular Complications

PubMed Central

Masuyama, Taku; Shoda, Toshiyuki; Takahashi, Tadakazu; Katsuda, Yoshiaki; Komeda, Kajuro; Kuroki, Masatoshi; Kakehashi, Akihiro; Kanazaw, Yasunori

2000-01-01

A new spontaneously diabetic strain of the Sprague-Dawley rat was established in 1997 and named the SDT (Spontaneously Diabetic Torii) rat. In this research, we investigated the characteristics of the disease condition in the SDT rats. The time of onset of glucosuria was different between male and female SDT rats; glucosuria appeared at approximately 20 weeks of age in male rats and at approximately 45 weeks of age in female rats. A cumulative incidence of diabetes of 100% was noted by 40 weeks of age in male rats, while it was only 33.3% even by 65 weeks of age in female rats. The survival rate up to 65 weeks of age was 92.9% in male rats and 97.4% in female rats. Glucose intolerance was observed in male rats from 16 weeks of age. The clinical characteristics of the male SDT rats were (1) hyperglycemia and hypoinsulinemia (from 25 weeks of age); (2) long-term survival without insulin treatment; (3) hypertriglyceridemia (by 35 weeks of age); however, no obesity was noted in any of the male rats. The histopathological characteristics of the male rats with diabetes mellitus (DM) were (1) fibrosis of the pancreatic islets (by 25 weeks of age); (2) cataract (by 40 weeks of age); (3) tractional retinal detachment with fibrous proliferation (by 70 weeks of age) and (4) massive hemorrhaging in the anterior chamber (by 77 weeks of age). These clinical and histopathological characteristics of the disease in SDT rats resemble those of human Type 2 diabetes with insulin hyposecretion. In conclusion, SDT rat is considered to be a potentially useful model for studies of diabetic retinopathy encountered in humans. PMID:11469401

The organised chaos of English adolescent rugby union: Influence of weekly match frequency on the variability of match and training loads.

PubMed

Phibbs, Padraic J; Jones, Ben; Roe, Gregory; Read, Dale; Darrall-Jones, Joshua; Weakley, Jonathon; Rock, Andrew; Till, Kevin

2018-04-01

The aims of this study were to determine the variability of weekly match and training loads in adolescent rugby union players across a competitive season, and to investigate the effect of match frequency on load distribution across different activities. Internal match and training load data (i.e. session-rating of perceived exertion (sRPE)) were collected daily from 20 players from a regional academy across a 14-week season. Data were analysed using a mixed-effects linear model, and variability was reported as a coefficient of variation (CV). Differences between 0-, 1-, 2-, and 3-match weeks were assessed using Cohen's d effect sizes and magnitude-based inferences. Mean weekly total match and training sRPE load was 1425 ± 545 arbitrary units (AU), with a between-player CV of 10 ± 6% and within-player CV of 37 ± 3%. Mean week-to-week change in total sRPE load was 497 ± 423 AU (35%), and 40% of weekly observations were outside the suggested acute:chronic workload ratio 'safe zone'. Total weekly sRPE loads increased substantially with match frequency (1210 ± 571, 1511 ± 489, and 1692 ± 517 AU, for 0-, 1-, and 2-match weeks, respectively), except for 3-match weeks (1520 ± 442 AU). Weekly match and training loads were highly variable for adolescent rugby players during the competitive season, and match frequency has a substantial effect on the distribution of loads. Therefore, match and training loads should be coordinated, monitored, and managed on an individual basis to protect players from negative training consequences, and to promote long-term athlete development.

Periodontal status during pregnancy and postpartum.

PubMed

González-Jaranay, Maximino; Téllez, Luís; Roa-López, Antonio; Gómez-Moreno, Gerardo; Moreu, Gerardo

2017-01-01

Different studies have documented an association between periodontal disease and low birth-weight delivery. Hence, knowledge of periodontal status during pregnancy and postpartum is important in order to reduce the risks of both diseases. This study aimed to analyze periodontal status at successive stages of pregnancy and 3-6 weeks postpartum in women with initial periodontal alterations. Ninety-six pregnant women were examined at 8-10 weeks (pregnancy diagnosis, baseline), 21-23 weeks and 34-36 weeks of gestation and at 40 days postpartum to record plaque scores, clinically assessed gingival inflammation and probing depth (mean depth and % sites with depth >3 mm). Bivariate and multivariate analyses were performed. Type 1 (α) error was established at 0.05. Plaque Index increased (p = 0.043) throughout pregnancy (baseline, 42%±0.18); 21-23 weeks, 42.6%±0.14; 34-36 weeks, 45.6%±0.13 and decreased postpartum (44.8%±0-13). Gingival Index increased (p<0.001) throughout pregnancy (baseline, 56.7%±0.20; 21-23 weeks, 66.36%±0.17; 34-36 weeks, 74.5%±0.18) and decreased postpartum (59.3%±0.21). Probing Depth increased (p<0.001) throughout pregnancy (baseline, 2.51±0.05; 21-23 weeks, 2.63±0.053; 34-36 weeks 2.81±0.055) and decreased postpartum (2.54±0.049). Percentage of sites with Probing Depth >3 mm increased (p<0.001) throughout pregnancy (baseline, 17.6%±0.16; 21-23 weeks, 23.9%±0.17; 34-36 weeks, 31.1%±0.17) and decreased postpartum (21.2%±0.17) but remained significantly (p<0.02) higher than at baseline. Periodontal status deteriorates during gestation but improves postpartum.

Short, frequent, 5-days-per-week, in-center hemodialysis versus 3-days-per week treatment: a randomized crossover pilot trial through the Midwest Pediatric Nephrology Consortium.

PubMed

Laskin, Benjamin L; Huang, Guixia; King, Eileen; Geary, Denis F; Licht, Christoph; Metlay, Joshua P; Furth, Susan L; Kimball, Tom; Mitsnefes, Mark

2017-08-01

No controlled trials in children with end-stage kidney disease have assessed the benefits of more frequently administered hemodialysis (HD). We conducted a multicenter, crossover pilot trial to determine if short, more frequent (5 days per week) in-center HD was feasible and associated with improvements in blood pressure compared with three conventional HD treatments per week. Because adult studies have not controlled for the weekly duration of dialysis, we fixed the total treatment time at 12 h a week of dialysis during two 3-month study periods; only frequency varied from 5 to 3 days per week between study periods. Eight children (median age 16.7 years) consented at three children's hospitals. The prespecified primary composite outcome was a sustained 10% decrease in systolic blood pressure and/or a decrease in antihypertensive medications relative to each study period's baseline. Among the six patients completing both study periods, five (83.3%) experienced the primary outcome during HD performed 5 days per week but not 3 days per week; one of the six (16.7%) achieved that outcome during 3-day but not 5-day (p = 0.22) per week HD. During 5-day HD, all patients had significantly more treatments during which their pre-HD systolic (p = 0.01) or diastolic (p = 0.01) blood pressure was 10% lower than baseline. We observed that more frequent HD sessions per week was feasible and associated with improved blood pressure control, but barriers to changing thrice-weekly standard of care include financial reimbursement and the time demands associated with more frequent treatments.

Treatment of cutaneous leishmaniasis with aminosidine (paromomycin) ointment: double-blind, randomized trial in the Islamic Republic of Iran.

PubMed Central

Asilian, A.; Jalayer, T.; Nilforooshzadeh, M.; Ghassemi, R. L.; Peto, R.; Wayling, S.; Olliaro, P.; Modabber, F.

2003-01-01

OBJECTIVE: To compare the parasitological and clinical efficacy of four weeks versus two weeks of treatment with aminosidine (paromomycin) ointment in patients with cutaneous leishmaniasis caused by Leishmania major in the Islamic Republic of Iran. METHODS: Double-blind, randomized trial of four weeks of aminosidine ointment (n = 108) vs two weeks of aminosidine ointment and two weeks of placebo (n = 108). Patients were assessed on days 15, 29, 45, and 105 for clinical cures and clinical and parasitological cures. FINDINGS: Four weeks' treatment gave significantly better cure rates than two weeks' treatment: on day 29, there were 80/108 (74%) vs 64/108 (59%) clinical cures (P = 0.05) and 47 (44%) vs 26 (24%) clinical and parasitological cures (P = 0.005). By day 45, fewer patients who received four weeks' treatment had required rescue treatment with antimonials than those who received two weeks' treatment: 20 (19%) vs 36 (33%) (P = 0.02). On day 105, the results still favoured those who had been allocated four weeks of active treatment, but the differences were no longer as clearly significant. No side-effects were observed or reported. CONCLUSION: Approximately two-thirds of patients given ointment for four weeks were cured clinically. Although about half of those cured might have recovered spontaneously even without treatment, four weeks of aminosidine ointment could become the first-line treatment for uncomplicated cutaneous leishmaniasis due to L. major, with antimonials needed in only the one-third of patients not cured by the end of treatment with aminosidine. This would considerably reduce the costs and side-effects associated with antimonial drugs. PMID:12856053

Extension of knee immobilization delays recovery of histological damages in the anterior cruciate ligament insertion and articular cartilage in rabbits.

PubMed

Mutsuzaki, Hirotaka; Nakajima, Hiromi; Sakane, Masataka

2018-01-01

[Purpose] To investigate the influence of knee immobilization period on recovery of histological damages in the anterior cruciate ligament (ACL) insertion and articular cartilage in rabbits. This knowledge is important for determining the appropriate rehabilitation approach for patients with ligament injuries, fracture, disuse atrophy, and degenerative joint disease. [Materials and Methods] Forty-eight male Japanese white rabbits were divided equally into the remobilization and control groups. The remobilization group had the right knee surgically immobilized, and was divided equally into four subgroups according to the duration of immobilization (1, 2, 4 and 8 weeks). After the immobilization was removed, the rabbits moved freely for 8 weeks. The control group underwent sham operation and followed the same time course as the remobilization group. The chondrocyte apoptosis rate and chondrocyte proliferation rate in the ACL insertion and articular cartilage were analyzed after remobilization. [Results] In the ACL insertion, the remobilization group had a higher chondrocyte apoptosis rate than the control group after 8 weeks of immobilization, and a lower chondrocyte proliferation rate than the control group after 4 and 8 weeks of immobilization. In the articular cartilage, the remobilization group had a lower chondrocyte proliferation rate than the control group after 8 weeks of immobilization. After 8 weeks of remobilization, the ACL insertion and articular cartilage are not completely recovered after 4 and 8 weeks of immobilization, respectively. [Conclusion] Our results suggest that 8 weeks of remobilization will result in recovery of the ACL insertion after 2 weeks of knee immobilization, and recovery of the articular cartilage after 4 weeks of knee immobilization. If 8 weeks of immobilization occurs, a remobilization duration of more than 8 weeks may be necessary.

Are Visceral Proteins Valid Markers for Nutritional Status in the Burn Intensive Care Unit?

DTIC Science & Technology

2015-05-01

serum CRP, haptoglobin, and α-1-antitrypsin) were measured weekly. Serum creatinine was measured daily. Urinary urea nitrogen (UUN) was measured weekly...using 24-hour urine col- lections. Nitrogen losses were calculated weekly (using UUN × 1.25) to estimate the total urinary nitrogen excretion.16...Subject Weeks Nitrogen Intake Wound Losses per Waxman Equation Urinary Urea Nitrogen Total Nitrogen Loss Nitrogen Balance % of Weeks in

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.

PubMed

Maksymowych, Walter P; Dougados, Maxime; van der Heijde, Désirée; Sieper, Joachim; Braun, Jürgen; Citera, Gustavo; Van den Bosch, Filip; Logeart, Isabelle; Wajdula, Joseph; Jones, Heather; Marshall, Lisa; Bonin, Randi; Pedersen, Ron; Vlahos, Bonnie; Kotak, Sameer; Bukowski, Jack F

2016-07-01

To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. NCT01258738. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The productivity of Washington State's obstetrician-gynecologist workforce: does gender make a difference?

PubMed

Benedetti, Thomas J; Baldwin, Laura-Mae; Andrilla, C Holly A; Hart, L Gary

2004-03-01

To compare the practice productivity of female and male obstetrician-gynecologists in Washington State. The primary data collection tool was a practice survey that accompanied each licensed practitioner's license renewal in 1998-1999. Washington State birth certificate data were linked with the licensure data to obtain objective information regarding obstetric births. Of the 541 obstetrician-gynecologists identified, two thirds were men and one third were women. Women were significantly younger than men (mean age 43.3 years versus 51.7 years). Ten practice variables were evaluated: total weeks worked per year, total professional hours per week, direct patient care hours per week, nondirect patient care hours per week, outpatient visits per week, inpatient visits per week, percent practicing obstetrics, number of obstetrical deliveries per year, percentage working less than 32 hours per week, and percentage working 60 or more hours per week. Of these, only 2 variables showed significant differences: inpatient visits per week (women 10.1 per week, men 12.8 per week, P < or =.01) and working 60 or more hours per week (women 22.1% versus men 31.5%, P < or =.05). After controlling for age, analysis of covariance and multiple logistic regression confirmed these findings and in addition showed that women worked 4.1 fewer hours per week than men (P <.01). When examining the ratio of female-to-male practice productivity in 10-year age increments from the 30-39 through the 50-59 age groups, a pattern emerged suggesting lower productivity in many variables in the women in the 40-49 age group. Only small differences in practice productivity between men and women were demonstrated in a survey of nearly all obstetrician-gynecologists in Washington State. Changing demographics and behaviors of the obstetrician-gynecologist workforce will require ongoing longitudinal studies to confirm these findings and determine whether they are generalizable to the rest of the United States. II-3

Rate of atherosclerosis progression in ApoE-/- mice long after discontinuation of cola beverage drinking.

PubMed

Otero-Losada, Matilde; Cao, Gabriel; Mc Loughlin, Santiago; Rodríguez-Granillo, Gastón; Ottaviano, Graciela; Milei, José

2014-01-01

This study was conducted in order to evaluate the effect of cola beverages drinking on atherosclerosisand test the hypothesis whether cola beverages consumption at early life stages might affect the development and progression of atherosclerosis later in life. ApoE-/- C57BL/6J mice (8 week-old) were randomized in 3 groups (n = 20 each) according to free accessto water (W), sucrose sweetened carbonated cola drink(C) or aspartame-acesulfame K sweetened carbonated 'light' cola drink (L)for the next 8 weeks. Drinking treatment was ended by switching C and L groups to drinking water. Four mice per group and time were sequentially euthanized: before treatment (8 weeks-old), at the end of treatment (16 weeks-old) and after treatment discontinuation (20 weeks-old, 24 weeks-old, 30 week-old mice). Aortic roots and livers were harvested, processed for histology and serial cross-sections were stained. Aortic plaque area was analyzed and plaque/media-ratio was calculated. Early consumption of cola drinks accelerated atherosclerotic plaque progression favoring the interaction between macrophages and myofibroblasts, without the participation of either T lymphocytes or proliferative activity. Plaque/media-ratio varied according to drink treatment (F2,54 = 3.433, p<0.04) and mice age (F4,54 = 5.009, p<0.03) and was higher in C and L groups compared with age-matched W group (p<0.05 at 16 weeks and 20 weeks, p<0.01 at 24 weeks and 30 weeks). Natural evolution of atherosclerosis in ApoE-/- mice (W group) evidenced atherosclerosis acceleration in parallel with a rapid increase in liver inflammation around the 20 weeks of age. Cola drinking within the 8-16 weeks of age accelerated atherosclerosis progression in ApoE-/- mice favoring aortic plaque enlargement (inward remodeling) over media thinning all over the study time. Data suggest that cola drinking at early life stages may predispose to atherosclerosis progression later in life in ApoE-/- mice.

Arginine and antioxidant supplement on performance in elderly male cyclists: a randomized controlled trial.

PubMed

Chen, Steve; Kim, Woosong; Henning, Susanne M; Carpenter, Catherine L; Li, Zhaoping

2010-03-23

Human exercise capacity declines with advancing age. These changes often result in loss of physical fitness and more rapid senescence. Nitric oxide (NO) has been implicated in improvement of exercise capacity through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms. Antioxidants may prevent nitric oxide inactivation by oxygen free radicals. The purpose of this study was to investigate the effects of an L-arginine and antioxidant supplement on exercise performance in elderly male cyclists. This was a two-arm prospectively randomized double-blinded and placebo-controlled trial. Sixteen male cyclists were randomized to receive either a proprietary supplement (Niteworks(R), Herbalife International Inc., Century City, CA) or a placebo powder. Exercise parameters were assessed by maximal incremental exercise testing performed on a stationary cycle ergometer using breath-by-breath analysis at baseline, week one and week three. There was no difference between baseline exercise parameters. In the supplemented group, anaerobic threshold increased by 16.7% (2.38 +/- 0.18 L/min, p < 0.01) at week 1, and the effect was sustained by week 3 with a 14.2% (2.33 +/- 0.44 L/min, p < 0.01). In the control group, there was no change in anaerobic threshold at weeks 1 and 3 compared to baseline (1.88 +/- 0.20 L/min at week 1, and 1.86 +/- 0.21 L/min at week 3). The anaerobic threshold for the supplement groups was significantly higher than that of placebo group at week 1 and week 3. There were no significant changes noted in VO2 max between control and intervention groups at either week 1 or week 3 by comparison to baseline. An arginine and antioxidant-containing supplement increased the anaerobic threshold at both week one and week three in elderly cyclists. No effect on VO2 max was observed. This study indicated a potential role of L-arginine and antioxidant supplementation in improving exercise performance in elderly.

Quantification of training load during one-, two- and three-game week schedules in professional soccer players from the English Premier League: implications for carbohydrate periodisation.

PubMed

Anderson, Liam; Orme, Patrick; Di Michele, Rocco; Close, Graeme L; Morgans, Ryland; Drust, Barry; Morton, James P

2016-01-01

Muscle glycogen is the predominant energy source for soccer match play, though its importance for soccer training (where lower loads are observed) is not well known. In an attempt to better inform carbohydrate (CHO) guidelines, we quantified training load in English Premier League soccer players (n = 12) during a one-, two- and three-game week schedule (weekly training frequency was four, four and two, respectively). In a one-game week, training load was progressively reduced (P < 0.05) in 3 days prior to match day (total distance = 5223 ± 406, 3097 ± 149 and 2912 ± 192 m for day 1, 2 and 3, respectively). Whilst daily training load and periodisation was similar in the one- and two-game weeks, total accumulative distance (inclusive of both match and training load) was higher in a two-game week (32.5 ± 4.1 km) versus one-game week (25.9 ± 2 km). In contrast, daily training total distance was lower in the three-game week (2422 ± 251 m) versus the one- and two-game weeks, though accumulative weekly distance was highest in this week (35.5 ± 2.4 km) and more time (P < 0.05) was spent in speed zones >14.4 km · h(-1) (14%, 18% and 23% in the one-, two- and three-game weeks, respectively). Considering that high CHO availability improves physical match performance but high CHO availability attenuates molecular pathways regulating training adaptation (especially considering the low daily customary loads reported here, e.g., 3-5 km per day), we suggest daily CHO intake should be periodised according to weekly training and match schedules.

Maternal serum placental growth factor at 12, 22, 32 and 36 weeks' gestation in screening for pre-eclampsia.

PubMed

Tsiakkas, A; Cazacu, R; Wright, A; Wright, D; Nicolaides, K H

2016-04-01

To examine the distribution of maternal serum placental growth factor (PlGF) at 12, 22, 32 and 36 weeks' gestation in singleton pregnancies which develop pre-eclampsia (PE) and examine the performance of this biomarker in screening for PE. Serum PlGF was measured in 40 212 cases at 11-13 weeks, in 10 282 cases at 19-24 weeks, in 10 400 at 30-34 weeks and 4043 at 35-37 weeks. Bayes' theorem was used to combine the a-priori risk from maternal characteristics and medical history with serum PlGF. The performance of screening for PE requiring delivery < 32, at 32 + 0 to 36 + 6 and ≥ 37 weeks' gestation was estimated. In pregnancies that developed PE, serum PlGF was decreased and the separation in multiples of the median (MoM) values from normal was greater with earlier, compared to later, gestational age at which delivery for PE became necessary. Additionally, the slope of the regression lines of PlGF MoM with gestational age at delivery in pregnancies that developed PE increased with advancing gestational age at screening. The detection rates (DRs), at a false-positive rate (FPR) of 10%, for PE delivering < 32 weeks were 79% and 97% with screening at 12 and 22 weeks, respectively. The DRs for PE delivering at 32 + 0 to 36 + 6 weeks were 57%, 65% and 90% with screening at 12, 22 and 32 weeks. The DRs for PE delivering ≥ 37 weeks were 40%, 37%, 54% and 64% with screening at 12, 22, 32 and 36 weeks, respectively. The performance of combined screening with maternal factors, medical history and PlGF is superior in screening for early, compared to late, PE and improves with advancing gestational age at screening. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial.

PubMed

Dorleijn, Desirée M J; Luijsterburg, Pim A J; Reijman, Max; Kloppenburg, Margreet; Verhaar, Jan A N; Bindels, Patrick J E; Bos, Pieter Koen; Bierma-Zeinstra, Sita M A

2018-06-01

Guidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis. Patients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0-10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis. Of the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference -1.3, 95% CI -2.3 to -0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up. An intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up. NTR2966. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An Attempt to Standardize the Calculation of Growth Velocity of Preterm Infants-Evaluation of Practical Bedside Methods.

PubMed

Fenton, Tanis R; Anderson, Diane; Groh-Wargo, Sharon; Hoyos, Angela; Ehrenkranz, Richard A; Senterre, Thibault

2018-05-01

To examine how well growth velocity recommendations for preterm infants fit with current growth references: Fenton 2013, Olsen 2010, INTERGROWTH 2015, and the World Health Organization Growth Standard 2006. The Average (2-point), Exponential (2-point), Early (1-point) method weight-gains were calculated for 1,4,8,12, and 16-week time-periods. Growth references' weekly velocities (g/kg/d, gram/day and cm/week) were illustrated graphically with frequently-quoted 15 g/kg/d, 10-30 grams/day and 1 cm/week rates superimposed. The 15 g/kg/d and 1 cm/week growth velocity rates were calculated from 24-50 weeks, superimposed on the Fenton and Olsen preterm growth charts. The Average and Exponential g/kg/d estimates showed close agreement for all ages (range 5.0-18.9 g/kg/d), while the Early method yielded values as high as 41 g/kg/d. All 3 preterm growth references were similar to 15 g/kg/d rate at 34 weeks, but rates were higher prior and lower at older ages. For gram/day, the growth references changed from 10 to 30 grams/day for 24-33 weeks. Head growth rates generally fit the 1 cm/week velocity for 23-30 weeks, and length growth rates fit for 37-40 weeks. The calculated g/kg/d curves deviated from the growth charts, first downward, then steeply crossed the median curves near term. Human growth is not constant through gestation and early infancy. The frequently-quoted 15 g/kg/d, 10-30 gram/day and 1 cm/week only fit current growth references for limited time periods. Rates of 15-20 g/kg/d (calculated using average or exponential methods) are a reasonable goal for infants 23-36 weeks, but not beyond. Copyright © 2017 Elsevier Inc. All rights reserved.

Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up

PubMed Central

Michaelides, Andreas; Major, Jennifer; Pienkosz Jr, Edmund; Wood, Meghan; Kim, Youngin

2018-01-01

Background It is widely recognized that the prevalence of obesity and comorbidities including prediabetes and type 2 diabetes continue to increase worldwide. Results from a 24-week Diabetes Prevention Program (DPP) fully mobile pilot intervention were previously published showing promising evidence of the usefulness of DPP-based eHealth interventions on weight loss. Objective This pilot study extends previous findings to evaluate weight loss results of core (up to week 16) and maintenance (postcore weeks) DPP interventions at 65 weeks from baseline. Methods Originally, 140 participants were invited and 43 overweight or obese adult participants with a diagnosis of prediabetes signed up to receive a 24-week virtual DPP with human coaching through a mobile platform. At 65 weeks, this pilot study evaluates weight loss and engagement in maintenance participants by means of repeated measures analysis of variances and backward multiple linear regression to examine predictors of weight loss. Last observation carried forward was used for endpoint measurements. Results At 65 weeks, mean weight loss was 6.15% in starters who read 1 or more lessons per week on 4 or more core weeks, 7.36% in completers who read 9 or more lessons per week on core weeks, and 8.98% in maintenance completers who did any action in postcore weeks (all P<.001). Participants were highly engaged, with 80% (47/59) of the sample completing 9 lessons or more and 69% (32/47) of those completing the maintenance phase. In-app actions related to self-monitoring significantly predicted weight loss. Conclusions In comparison to eHealth programs, this pilot study shows that a fully mobile DPP can produce transformative weight loss. A fully mobile DPP intervention resulted in significant weight loss and high engagement during the maintenance phase, providing evidence for long-term potential as an alternative to in-person DPP by removing many of the barriers associated with in-person and other forms of virtual DPP. PMID:29724709

Variability in the management and outcomes of extremely preterm births across five European countries: a population-based cohort study.

PubMed

Smith, Lucy K; Blondel, Beatrice; Van Reempts, Patrick; Draper, Elizabeth S; Manktelow, Bradley N; Barros, Henrique; Cuttini, Marina; Zeitlin, Jennifer

2017-09-01

To explore international variations in the management and survival of extremely low gestational age and birthweight births. Area-based prospective cohort of births SETTING: 12 regions across Belgium, France, Italy, Portugal and the UK PARTICIPANTS: 1449 live births and fetal deaths between 22 +0 and 25 +6 weeks gestation born in 2011-2012. Percentage of births; recorded live born; provided antenatal steroids or respiratory support; surviving to discharge (with/without severe morbidities). The percentage of births recorded as live born was consistently low at 22 weeks and consistently high at 25 weeks but varied internationally at 23 weeks for those weighing 500 g and over (range 33%-70%) and at 24 weeks for those under 500 g (range 5%-71%). Antenatal steroids and provision of respiratory support at 22-24 weeks gestation varied between countries, but were consistently high for babies born at 25 weeks. Survival to discharge was universally poor at 22 weeks gestation (0%) and at any gestation with birth weight <500 g, irrespective of treatment provision. In contrast, births at 23 and 24 weeks weighing 500 g and over showed significant international variation in survival (23 weeks: range: 0%-25%; 24 weeks range: 21%-50%), reflecting levels of treatment provision. Wide international variation exists in the management and survival of extremely preterm births at 22-24 weeks gestation. Universally poor outcomes for babies at 22 weeks and for those weighing under 500 g suggest little impact of intervention and support the inclusion of birth weight along with gestational age in ethical decision-making guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The potential of prolonged tissue culture to reduce stress generation and retraction in engineered heart valve tissues.

PubMed

van Vlimmeren, Marijke A A; Driessen-Mol, Anita; Oomens, Cees W J; Baaijens, Frank P T

2013-03-01

In tissue-engineered (TE) heart valves, cell-mediated processes cause tissue compaction during culture and leaflet retraction at time of implantation. We have quantified and correlated stress generation, compaction, retraction, and tissue quality during a prolonged culture period of 8 weeks. Polyglycolic acid/poly-4-hydroxybutyrate strips were seeded with vascular-derived cells and cultured for 4-8 weeks. Compaction in width, generated force, and stress was measured during culture. Retraction in length, generated force, and stress was measured after release of constraints at weeks 4, 6, and 8. Further, the amount of DNA, glycosaminoglycans (GAGs), collagen, and collagen cross-links was assessed. During culture, compaction and force generation increased to, respectively, 63.9% ± 0.8% and 43.7 ± 4.3 mN at week 4, after which they remained stable. Stress generation reached 27.7 ± 3.2 kPa at week 4, after which it decreased to ∼8.5 kPa. At release of constraints, tissue retraction was 44.0% ± 3.7% at week 4 and decreased to 29.2% ± 2.8% and 26.1% ± 2.2% at, respectively, 6 and 8 weeks. Generated force (8-16 mN) was lower at week 6 than at weeks 4 and 8. Generated stress decreased from 11.8 ± 0.9 kPa at week 4 to 1.4 ± 0.3 and 2.4 ± 0.4 kPa at, respectively, weeks 6 and 8. The amount of GAGs increased at weeks 6 and 8 compared to week 4 and correlated to the reduced stress and retraction. In summary, prolonged culture resulted in decreased stress generation and retraction, likely as a result of the increased amount of GAGs. These results demonstrate the potential of prolonged tissue culture in developing functional, nonretracting, TE heart valves.

Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: a randomized trial.

PubMed

Bernard, Caitlin; Wan, Leping; Peipert, Jeffrey F; Madden, Tessa

2018-05-17

To investigate whether an early 3-week postpartum visit in addition to the standard 6-week visit increases LARC initiation by 8weeks postpartum compared to the routine 6-week visit alone. We enrolled pregnant and immediate postpartum women into a prospective randomized, non-blinded trial comparing a single 6-week postpartum visit (routine care) to two visits at 3 and 6weeks postpartum (intervention), with initiation of contraception at the 3-week visit, if desired. All participants received structured contraceptive counseling. Participants completed surveys in-person at baseline and at the time of each postpartum visit. A sample size of 200 total participants was needed to detect a 2-fold difference in LARC initiation (20% vs. 40%). Between May 2016 and March 2017, 200 participants enrolled; outcome data are available for 188. The majority of LARC initiation occurred immediately postpartum (25% of the intervention arm and 27% of the routine care arm). By 8weeks postpartum,34% of participants in the intervention arm initiated LARC, compared to 41% in the routine care arm (p=.35). Overall contraceptive initiation by 8weeks was 83% and84% in the intervention and routine care arms, respectively (p=.79). There was no difference between the arms in the proportion of women who attended at least one postpartum visit (70% vs. 74%, p=.56). The addition of a 3-week postpartum visit to routine care does not increase LARC initiation by 8weeks postpartum. The majority of LARC users desired immediate rather than interval postpartum initiation. Clinicaltrials.govNCT02769676 Implications. The addition of a 3-week postpartum visit to routine care does not increase LARC or overall contraceptive initiation by 8weeks post-partum when the option of immediate postpartum placement is available. The majority of LARC users desired immediate rather than interval postpartum initiation. Copyright © 2018. Published by Elsevier Inc.

Weekly and every 2 weeks cetuximab maintenance therapy after platinum-based chemotherapy plus cetuximab as first-line treatment for non-small cell lung cancer: randomized non-comparative phase IIIb NEXT trial.

PubMed

Heigener, David F; Pereira, José Rodrigues; Felip, Enriqueta; Mazal, Juraj; Manzyuk, Lyudmila; Tan, Eng Huat; Merimsky, Ofer; Sarholz, Barbara; Esser, Regina; Gatzemeier, Ulrich

2015-06-01

The First-Line Erbitux in Lung Cancer (FLEX) trial showed that the addition of cetuximab to chemotherapy followed by weekly cetuximab maintenance significantly improved survival in the first-line treatment of advanced non-small cell lung cancer (NSCLC). The phase IIIb NSCLC Erbitux Trial (NEXT) trial (NCT00820755) investigated the efficacy and safety of weekly and every 2 weeks cetuximab maintenance therapy in this setting. Patients were treated with platinum-based chemotherapy plus cetuximab, and those progression-free after four to six cycles were randomized to every 2 weeks (500 mg/m(2)) or weekly (250 mg/m(2)) cetuximab maintenance. Randomization was stratified for tumor histology and response status. The primary endpoint for a regimen would be reached if the lower boundary of the 95 % confidence interval (CI) for the 1-year survival rate exceeded 55 %. A planned 480 patients were to be randomized. However, enrollment was curtailed following a negative opinion from the European Medicines Agency with regard to the use of cetuximab in this setting. After combination therapy, 311/583 (53.3 %) patients without progression were randomized to maintenance therapy: 157 to every 2 weeks cetuximab and 154 to weekly cetuximab. Baseline characteristics were balanced between these groups and exposure to cetuximab was similar. The 1-year survival rate was 62.8 % (95 % CI, 54.7-70.0) for every 2 weeks cetuximab and 64.4 % (95 % CI, 56.2-71.4) for weekly cetuximab. Safety profiles were similar, manageable, and in line with expectations. Therefore, in patients with advanced NSCLC who were progression-free after four to six cycles of first-line chemotherapy plus cetuximab, weekly and every 2 weeks cetuximab maintenance therapy were associated with similar survival outcomes.

Time Course of Change in Blood Pressure From Sodium Reduction and the DASH Diet.

PubMed

Juraschek, Stephen P; Woodward, Mark; Sacks, Frank M; Carey, Vincent J; Miller, Edgar R; Appel, Lawrence J

2017-11-01

Both sodium reduction and the Dietary Approaches to Stop Hypertension (DASH) diet lower blood pressure (BP); however, the patterns of their effects on BP over time are unknown. In the DASH-Sodium trial, adults with pre-/stage 1 hypertension, not using antihypertensive medications, were randomly assigned to either a typical American diet (control) or DASH. Within their assigned diet, participants randomly ate each of 3 sodium levels (50, 100, and 150 mmol/d, at 2100 kcal) over 4-week periods. BP was measured weekly for 12 weeks; 412 participants enrolled (57% women; 57% black; mean age, 48 years; mean systolic BP [SBP]/diastolic BP [DBP], 135/86 mm Hg). For those assigned control, there was no change in SBP/DBP between weeks 1 and 4 on the high-sodium diet (weekly change, -0.04/0.06 mm Hg/week) versus a progressive decline in BP on the low-sodium diet (-0.94/-0.70 mm Hg/week; P interactions between time and sodium <0.001 for SBP and DBP). For those assigned DASH, SBP/DBP changed -0.60/-0.16 mm Hg/week on the high- versus -0.42/-0.54 mm Hg/week on the low-sodium diet ( P interactions between time and sodium=0.56 for SBP and 0.10 for DBP). When comparing DASH to control, DASH changed SBP/DBP by -4.36/-1.07 mm Hg after 1 week, which accounted for most of the effect observed, with no significant difference in weekly rates of change for either SBP ( P interaction=0.97) or DBP ( P interaction=0.70). In the context of a typical American diet, a low-sodium diet reduced BP without plateau, suggesting that the full effects of sodium reduction are not completely achieved by 4 weeks. In contrast, compared with control, DASH lowers BP within a week without further effect thereafter. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000608. © 2017 American Heart Association, Inc.

Instrumental evaluation of anti-aging effects of cosmetic formulations containing palmitoyl peptides, Silybum marianum seed oil, vitamin E and other functional ingredients on aged human skin.

PubMed

Hahn, Hyung Jin; Jung, Ho Jung; Schrammek-Drusios, Med Christine; Lee, Sung Nae; Kim, Ji-Hyun; Kwon, Seung Bin; An, In-Sook; An, Sungkwan; Ahn, Kyu Joong

2016-08-01

Anti-aging cosmetics are widely used for improving signs of aged skin such as skin wrinkles, decreased elasticity, low dermal density and yellow skin tone. The present study evaluated the effects of cosmetic formulations, eye cream and facial cream, containing palmitoyl peptides, Silybum marianum ( S. marianum ) seed oil, vitamin E and other functional ingredients on the improvement of facial wrinkles, elasticity, dermal density and skin tone after 4 weeks period of application on aged human skin. Healthy volunteers (n=20) with aged skin were recruited to apply the test materials facially twice per day for 4 weeks. Skin wrinkles, elasticity, dermal density and skin tone were measured instrumentally for assessing the improvement of skin aging. All the measurements were conducted prior to the application of test materials and at 2 and 4 weeks of treatment. Crow's feet wrinkles were decreased 5.97% after 2 weeks of test material application and 14.07% after 4 weeks of application in comparison of pre-application. Skin elasticity was increased 6.81% after 2 weeks and 8.79% after 4 weeks. Dermal density was increased 16.74% after 2 weeks and 27.63% after 4 weeks. With the L* value indicating skin brightness and the a* value indicating erythema (redness), the results showed that brightness was increased 1.70% after 2 weeks and 2.14% after 4 weeks, and erythema was decreased 10.45% after 2 weeks and 22.39% after 4 weeks. Hence, the test materials appear to exert some degree of anti-aging effects on aged human skin. There were no abnormal skin responses from the participants during the trial period. We conclude that the facial and eye cream containing palmitoyl peptides and S. marianum seed oil, vitamin E and other ingredients have effects on the improvement of facial wrinkles, elasticity, dermal density and skin tone.

20 CFR 617.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (e) Average weekly hours means a figure obtained by dividing: (1) Total hours worked (excluding... employment. (f) Average weekly wage means one-thirteenth of the total wages paid to an individual in the... preceding the individual's appropriate week. (g) Average weekly wage in adversely affected employment means...

75 FR 62451 - National Physician Assistants Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... National Physician Assistants Week, 2010 By the President of the United States of America A Proclamation In... clinics, and other settings with provider shortages. During National Physician Assistants Week, we honor... heart-wrenching circumstances. As we recognize their countless contributions this week, we also pay...

76 FR 25525 - National Charter Schools Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... Charter Schools Week, 2011 By the President of the United States of America A Proclamation In communities... of students, parents, teachers, and administrators. During National Charter Schools Week, we... Charter School Week. I commend our Nation's charter schools, teachers, and administrators, and I call on...

75 FR 27917 - Emergency Medical Services Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... Part III The President Proclamation 8519--Emergency Medical Services Week, 2010 Executive Order... Medical Services Week, 2010 By the President of the United States of America A Proclamation Every day of... enhancing our country's preparedness and resilience. During Emergency Medical Services Week, we recommit to...

Recovery of high speed memory scanning after transient global amnesia: a case report.

PubMed

Okura, M; Tomotake, M; Mori, K; Ikuta, T

1996-12-01

We described the case of a 59 year old female with transient global amnesia (TGA) who had been examined neuropsychologically using Sternberg's paradigm and a random number generation (RNG) task on the following day, 1 week and 4 weeks after a TGA episode. The slope value of the linear function, a measure of cognitive memory scanning speed, decreased with time and showed a marked decrease 1 week after TGA, suggesting that the stage of serial and exhaustive scanning recovered within 1 week. The zero-intercept value, on the other hand, increased during 1 week but decreased 4 weeks later and was not related directly to recovery from TGA. The performance in RNG task improved 1 week later, but deteriorated 4 weeks after the episode. Such a change in RNG was in accordance with that of the zero-intercept value, predicting a relationship. It is concluded that the subclinical memory deficit, detected with these tasks, persisted longer than clinical recovery from TGA.

Effect of temperature on soluble invertase activity, and glucose, fructose and sucrose status of onion bulbs (Allium cepa) in store.

PubMed

Benkeblia, Noureddine; Onodera, Shuichi; Yoshihira, Taiki; Kosaka, Shinichi; Shiomi, Norio

2004-06-01

The activity of soluble invertase, and the variation in glucose, fructose and sucrose contents in onion bulbs (Allium cepa) during long-term storage at 10 degrees C and 20 degrees C were investigated. Invertase activity increased progressively after 8 weeks to 0.084 and 0.092 nkat/g fresh weight (FW), then sharply to 0.29 and 0.35 nkat/g FW at 20 degrees C and 10 degrees C, respectively, and remained high during 5 weeks. Then, activity decreased abruptly to 0.039 and 0.041 nkat/g, and remained low during the last 8 weeks and close to that observed initially. Glucose increased to 17.73 and 14.62 mg/g FW after 4 weeks at 20 degrees C and 10 degrees C, respectively, then decreased sharply between week 5 and week 7 to 4.13 and 4.91 mg/g FW, respectively, and remained rather stable ranging from 9 and 10 mg/g FW at both temperatures. Fructose showed a similar pattern and was 14.8 and 21.68 mg/g FW at 20 degrees C and 10 degrees C, respectively. Between week 10 and week 24, fructose ranged from 5 and 6 mg/g FW, and from 6 and 7 mg/g FW at 20 degrees C and 10 degrees C, respectively. Sucrose increased to 19.63 and 14.43 mg/g FW at 20 degrees C and 10 degrees C, respectively, decreased during 3 weeks, and then increased randomly from 5.69 to 9.42 mg/g FW at 20 degrees C, but remained in a steady state at 10 degrees C ranging 5.03 +/- 0.78 mg/g FW. During the last 6 weeks, the sucrose content was higher at 20 degrees C than at 10 degrees C. The fructose-glucose ratio varied during the first 8 weeks but remained at a steady level during the last 16 weeks. The (glucose+fructose)/sucrose ratio increased randomly at 10 degrees C, whereas at 20 degrees C the ratio increased during 10 weeks then decreased progressively during the final 14 weeks.

Evaluation of retinal nerve fiber layer thickness and axonal transport 1 and 2 weeks after 8 hours of acute intraocular pressure elevation in rats.

PubMed

Abbott, Carla J; Choe, Tiffany E; Lusardi, Theresa A; Burgoyne, Claude F; Wang, Lin; Fortune, Brad

2014-02-04

To compare in vivo retinal nerve fiber layer thickness (RNFLT) and axonal transport at 1 and 2 weeks after an 8-hour acute IOP elevation in rats. Forty-seven adult male Brown Norway rats were used. Procedures were performed under anesthesia. The IOP was manometrically elevated to 50 mm Hg or held at 15 mm Hg (sham) for 8 hours unilaterally. The RNFLT was measured by spectral-domain optical coherence tomography. Anterograde and retrograde axonal transport was assessed from confocal scanning laser ophthalmoscopy imaging 24 hours after bilateral injections of 2 μL 1% cholera toxin B-subunit conjugated to AlexaFluor 488 into the vitreous or superior colliculi, respectively. Retinal ganglion cell (RGC) and microglial densities were determined using antibodies against Brn3a and Iba-1. The RNFLT in experimental eyes increased from baseline by 11% at 1 day (P < 0.001), peaked at 19% at 1 week (P < 0.0001), remained 11% thicker at 2 weeks (P < 0.001), recovered at 3 weeks (P > 0.05), and showed no sign of thinning at 6 weeks (P > 0.05). There was no disruption of anterograde transport at 1 week (superior colliculi fluorescence intensity, 75.3 ± 7.9 arbitrary units [AU] for the experimental eyes and 77.1 ± 6.7 AU for the control eyes) (P = 0.438) or 2 weeks (P = 0.188). There was no obstruction of retrograde transport at 1 week (RCG density, 1651 ± 153 per mm(2) for the experimental eyes and 1615 ± 135 per mm(2) for the control eyes) (P = 0.63) or 2 weeks (P = 0.25). There was no loss of Brn3a-positive RGC density at 6 weeks (P = 0.74) and no increase in microglial density (P = 0.92). Acute IOP elevation to 50 mm Hg for 8 hours does not cause a persisting axonal transport deficit at 1 or 2 weeks or a detectable RNFLT or RGC loss by 6 weeks but does lead to transient RNFL thickening that resolves by 3 weeks.

Evaluation of Retinal Nerve Fiber Layer Thickness and Axonal Transport 1 and 2 Weeks After 8 Hours of Acute Intraocular Pressure Elevation in Rats

PubMed Central

Abbott, Carla J.; Choe, Tiffany E.; Lusardi, Theresa A.; Burgoyne, Claude F.; Wang, Lin; Fortune, Brad

2014-01-01

Purpose. To compare in vivo retinal nerve fiber layer thickness (RNFLT) and axonal transport at 1 and 2 weeks after an 8-hour acute IOP elevation in rats. Methods. Forty-seven adult male Brown Norway rats were used. Procedures were performed under anesthesia. The IOP was manometrically elevated to 50 mm Hg or held at 15 mm Hg (sham) for 8 hours unilaterally. The RNFLT was measured by spectral-domain optical coherence tomography. Anterograde and retrograde axonal transport was assessed from confocal scanning laser ophthalmoscopy imaging 24 hours after bilateral injections of 2 μL 1% cholera toxin B-subunit conjugated to AlexaFluor 488 into the vitreous or superior colliculi, respectively. Retinal ganglion cell (RGC) and microglial densities were determined using antibodies against Brn3a and Iba-1. Results. The RNFLT in experimental eyes increased from baseline by 11% at 1 day (P < 0.001), peaked at 19% at 1 week (P < 0.0001), remained 11% thicker at 2 weeks (P < 0.001), recovered at 3 weeks (P > 0.05), and showed no sign of thinning at 6 weeks (P > 0.05). There was no disruption of anterograde transport at 1 week (superior colliculi fluorescence intensity, 75.3 ± 7.9 arbitrary units [AU] for the experimental eyes and 77.1 ± 6.7 AU for the control eyes) (P = 0.438) or 2 weeks (P = 0.188). There was no obstruction of retrograde transport at 1 week (RCG density, 1651 ± 153 per mm2 for the experimental eyes and 1615 ± 135 per mm2 for the control eyes) (P = 0.63) or 2 weeks (P = 0.25). There was no loss of Brn3a-positive RGC density at 6 weeks (P = 0.74) and no increase in microglial density (P = 0.92). Conclusions. Acute IOP elevation to 50 mm Hg for 8 hours does not cause a persisting axonal transport deficit at 1 or 2 weeks or a detectable RNFLT or RGC loss by 6 weeks but does lead to transient RNFL thickening that resolves by 3 weeks. PMID:24398096

The development of lower respiratory tract microbiome in mice.

PubMed

Singh, Nisha; Vats, Asheema; Sharma, Aditi; Arora, Amit; Kumar, Ashwani

2017-06-21

Although culture-independent methods have paved the way for characterization of the lung microbiome, the dynamic changes in the lung microbiome from neonatal stage to adult age have not been investigated. In this study, we tracked changes in composition and diversity of the lung microbiome in C57BL/6N mice, starting from 1-week-old neonates to 8-week-old mice. Towards this, the lungs were sterilely excised from mice of different ages from 1 to 8 weeks. High-throughput DNA sequencing of the 16S rRNA gene followed by composition and diversity analysis was utilized to decipher the microbiome in these samples. Microbiome analysis suggests that the changes in the lung microbiome correlated with age. The lung microbiome was primarily dominated by phyla Proteobacteria, Firmicutes, Bacteroidetes, and Actinobacteria in all the stages from week 1 to week 8 after birth. Although Defluvibacter was the predominant genus in 1-week-old neonatal mice, Streptococcus became the dominant genus at the age of 2 weeks. Lactobacillus, Defluvibacter, Streptococcus, and Achromobacter were the dominant genera in 3-week-old mice, while Lactobacillus and Achromobacter were the most abundant genera in 4-week-old mice. Interestingly, relatively greater diversity (at the genus level) during the age of 5 to 6 weeks was observed as compared to the earlier weeks. The diversity of the lung microbiome remained stable between 6 and 8 weeks of age. In summary, we have tracked the development of the lung microbiome in mice from an early age of 1 week to adulthood. The lung microbiome is dominated by the phyla Proteobacteria, Firmicutes, Bacteroidetes, and Actinobacteria. However, dynamic changes were observed at the genus level. Relatively higher richness in the microbial diversity was achieved by age of 6 weeks and then maintained at later ages. We believe that this study improves our understanding of the development of the mice lung microbiome and will facilitate further analyses of the role of the lung microbiome in chronic lung diseases.

Reproducibility of objectively measured physical activity and sedentary time over two seasons in children; Comparing a day-by-day and a week-by-week approach

PubMed Central

Andersen, Lars Bo; Skrede, Turid; Ekelund, Ulf; Anderssen, Sigmund Alfred; Resaland, Geir Kåre

2017-01-01

Introduction Knowledge of reproducibility of accelerometer-determined physical activity (PA) and sedentary time (SED) estimates are a prerequisite to conduct high-quality epidemiological studies. Yet, estimates of reproducibility might differ depending on the approach used to analyze the data. The aim of the present study was to determine the reproducibility of objectively measured PA and SED in children by directly comparing a day-by-day and a week-by-week approach to data collected over two weeks during two different seasons 3–4 months apart. Methods 676 11-year-old children from the Active Smarter Kids study conducted in Sogn og Fjordane county, Norway, performed 7 days of accelerometer monitoring (ActiGraph GT3X+) during January-February and April-May 2015. Reproducibility was calculated using a day-by-day and a week-by-week approach applying mixed effect modelling and the Spearman Brown prophecy formula, and reported using intra-class correlation (ICC), Bland Altman plots and 95% limits of agreement (LoA). Results Applying a week-by-week approach, no variables provided ICC estimates ≥ 0.70 for one week of measurement in any model (ICC = 0.29–0.66 not controlling for season; ICC = 0.49–0.67 when controlling for season). LoA for these models approximated a factor of 1.3–1.7 of the sample PA level standard deviations. Compared to the week-by-week approach, the day-by-day approach resulted in too optimistic reliability estimates (ICC = 0.62–0.77 not controlling for season; ICC = 0.64–0.77 when controlling for season). Conclusions Reliability is lower when analyzed over different seasons and when using a week-by-week approach, than when applying a day-by-day approach and the Spearman Brown prophecy formula to estimate reliability over a short monitoring period. We suggest a day-by-day approach and the Spearman Brown prophecy formula to determine reliability be used with caution. Trial Registration The study is registered in Clinicaltrials.gov 7th April 2014 with identification number NCT02132494. PMID:29216318

Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomized controlled trial.

PubMed

Clark, Julia; Holgan, Nikki; Craig, Leone; Morgan, Heather; Danielian, Peter; Devereux, Graham

2016-11-01

Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16-19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1-4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41-8.77) at 12 weeks, 6.41 mg/d (5.07-7.75) at 20 weeks, and 6.67 mg/d (5.38-7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21-7.79) at 12 weeks to 14.9 mg/d (13.3-16.4) at 20 weeks and 15.2 mg/d (12.9-17.5) at 34 weeks, P  < 0.001. Qualitative interviewing provided clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16-25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.

Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial.

PubMed

Yatham, L N; Beaulieu, S; Schaffer, A; Kauer-Sant'Anna, M; Kapczinski, F; Lafer, B; Sharma, V; Parikh, S V; Daigneault, A; Qian, H; Bond, D J; Silverstone, P H; Walji, N; Milev, R; Baruch, P; da Cunha, A; Quevedo, J; Dias, R; Kunz, M; Young, L T; Lam, R W; Wong, H

2016-08-01

Atypical antipsychotic adjunctive therapy to lithium or valproate is effective in treating acute mania. Although continuation of atypical antipsychotic adjunctive therapy after mania remission reduces relapse of mood episodes, the optimal duration is unknown. As many atypical antipsychotics cause weight gain and metabolic syndrome, they should not be continued unless the benefits outweigh the risks. This 52-week double-blind placebo-controlled trial recruited patients with bipolar I disorder (n=159) who recently remitted from a manic episode during treatment with risperidone or olanzapine adjunctive therapy to lithium or valproate. Patients were randomized to one of three conditions: discontinuation of risperidone or olanzapine and substitution with placebo at (i) entry ('0-weeks' group) or (ii) at 24 weeks after entry ('24-weeks' group) or (iii) continuation of risperidone or olanzapine for the full duration of the study ('52-weeks' group). The primary outcome measure was time to relapse of any mood episode. Compared with the 0-weeks group, the time to any mood episode was significantly longer in the 24-weeks group (hazard ratio (HR) 0.53; 95% confidence interval (CI): 0.33, 0.86) and nearly so in the 52-weeks group (HR: 0.63; 95% CI: 0.39, 1.02). The relapse rate was similar in the 52-weeks group compared with the 24-weeks group (HR: 1.18; 95% CI: 0.71, 1.99); however, sub-group analysis showed discordant results between the two antipsychotics (HR: 0.48, 95% CI: 0.17; 1.32 olanzapine patients; HR: 1.85, 95% CI: 1.00, 3.41 risperidone patients). Average weight gain was 3.2 kg in the 52-weeks group compared with a weight loss of 0.2 kg in the 0-weeks and 0.1 kg in the 24-weeks groups. These findings suggest that risperidone or olanzapine adjunctive therapy for 24 weeks is beneficial but continuation of risperidone beyond this period does not reduce the risk of relapse. Whether continuation of olanzapine beyond this period reduces relapse risk remains unclear but the potential benefit needs to be weighed against an increased risk of weight gain.

Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial.

PubMed

Foster, Graham R; Agarwal, Kosh; Cramp, Matthew E; Moreea, Sulleman; Barclay, Stephen; Collier, Jane; Brown, Ashley S; Ryder, Stephen D; Ustianowski, Andrew; Forton, Daniel M; Fox, Ray; Gordon, Fiona; Rosenberg, William M; Mutimer, David J; Du, Jiejun; Gilbert, Christopher L; Asante-Appiah, Ernest; Wahl, Janice; Robertson, Michael N; Barr, Eliav; Haber, Barbara

2018-06-01

Many direct-acting antiviral regimens have reduced activity in people with hepatitis C virus (HCV) genotype (GT) 3 infection and cirrhosis. The C-ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants with GT3 infection. This was a phase 2, randomized, open-label study. Treatment-naive participants received EBR/GZR + SOF + RBV for 8 weeks or EBR/GZR + SOF for 12 weeks, and peginterferon/RBV treatment-experienced participants received EBR/GZR + SOF ± RBV for 12 weeks or EBR/GZR + SOF for 16 weeks. The primary endpoint was HCV RNA <15 IU/mL 12 weeks after the end of treatment (sustained virologic response at 12 weeks [SVR12]). Among treatment-naive participants, SVR12 was 91% (21/23) in those treated with RBV for 8 weeks and 96% (23/24) in those treated for 12 weeks. Among treatment-experienced participants, SVR12 was 94% (17/18) and 100% (17/17) in the 12-week arm, with and without RBV, respectively, and 94% (17/18) in the 16-week arm. Five participants failed to achieve SVR: 2 relapsed (both in the 8-week arm), 1 discontinued due to vomiting/cellulitis (16-week arm), and 2 discontinued (consent withdrawn/lost to follow-up). SVR12 was not affected by the presence of resistance-associated substitutions (RASs). There was no consistent change in insulin resistance, and 5 participants reported serious adverse events (pneumonia, chest pain, opiate overdose, cellulitis, decreased creatinine). High efficacy was demonstrated in participants with HCV GT3 infection and cirrhosis. Treatment beyond 12 weeks was not required, and efficacy was maintained regardless of baseline RASs. Data from this study support the use of EBR/GZR plus SOF for 12 weeks without RBV for treatment-naive and peginterferon/RBV-experienced people with GT3 infection and cirrhosis (ClinicalTrials.gov NCT02601573). (Hepatology 2018;67:2113-2126). © 2018 by the American Association for the Study of Liver Diseases.

Additional 4-week capecitabine during the resting periods after 6-week neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer: long-term oncologic outcomes.

PubMed

Park, Sang Woo; Kim, Jin Soo; Kim, Ji Yeon; Lee, Kyung Ha

2018-06-01

The aim of this study was to evaluate the long-term outcome of additional 4-week chemotherapy with capecitabine during the resting periods following a 6-week neoadjuvant chemoradiotherapy (NCRT) regimen, in patients with locally advanced rectal cancer. Radiotherapy was delivered to the whole pelvis at a total dose of 50.4 Gy for 6 weeks. Oral capecitabine was administered at a dose of 825 mg/m 2 twice daily for 10 weeks. Surgery was performed 2-4 weeks following the completion of chemotherapy. Between January 2010 and September 2011, 41 patients completed the scheduled neoadjuvant therapy and surgery. The pathologic complete response rate, 5-year overall survival, and 5-year disease-free survival rates were 22%, 85.4%, and 78.0%, respectively. The 5-year systemic recurrence and 5-year local recurrence rates were 22% and 0%, respectively. Additional 4-week chemotherapy with capecitabine, during the resting periods following a 6-week NCRT regimen, has favorable long-term oncologic outcomes. Further randomized controlled trials are however necessary to evaluate if substantial improvement in local control is achieved with this additional chemotherapy modality for locally advanced rectal cancer.

Effect of German chamomile oil application on alleviating atopic dermatitis-like immune alterations in mice

PubMed Central

Lee, Soon-Hee; Heo, Yong

2010-01-01

Historically, German chamomile (GC) oil has been used for treatment of skin disorders. BALB/c mice were sensitized twice a week with 100 µL of 1% 2,4-dinitrochlorobenzene (DNCB) and challenged twice the following week with 100 µL of 0.2% DNCB for atopic dermatitis induction. Thereafter, 3% GC oil was applied daily (70 µL, 6 times week) on the dorsal skin for 4 weeks. Saline or jojoba oil was used for the control mice. Blood was collected after second DNCB challenge, and at 2 and 4 weeks after initiating oil application. Serum IgE levels were significantly lowered in the GC oil application group at the end of the 4-week application period. The GC oil application for 4 weeks resulted in reduction in serum IgG1 level compared with that after 2-week application. The GC oil application group showed a significantly lower serum histamine level than the control group 2 weeks after oil application. Scratching frequency of the GC oil application group was significantly lower than either control groups. This study is to demonstrate GC oil's immunoregulatory potential for alleviating atopic dermatitis through influencing of Th2 cell activation. PMID:20195063

Effect of German chamomile oil application on alleviating atopic dermatitis-like immune alterations in mice.

PubMed

Lee, Soon-Hee; Heo, Yong; Kim, Young-Chul

2010-03-01

Historically, German chamomile (GC) oil has been used for treatment of skin disorders. BALB/c mice were sensitized twice a week with 100 microL of 1% 2,4-dinitrochlorobenzene (DNCB) and challenged twice the following week with 100 microL of 0.2% DNCB for atopic dermatitis induction. Thereafter, 3% GC oil was applied daily (70 microL, 6 times week) on the dorsal skin for 4 weeks. Saline or jojoba oil was used for the control mice. Blood was collected after second DNCB challenge, and at 2 and 4 weeks after initiating oil application. Serum IgE levels were significantly lowered in the GC oil application group at the end of the 4-week application period. The GC oil application for 4 weeks resulted in reduction in serum IgG1 level compared with that after 2-week application. The GC oil application group showed a significantly lower serum histamine level than the control group 2 weeks after oil application. Scratching frequency of the GC oil application group was significantly lower than either control groups. This study is to demonstrate GC oil's immunoregulatory potential for alleviating atopic dermatitis through influencing of Th2 cell activation.

The effects of yoga on stress and psychological health among employees: an 8- and 16-week intervention study.

PubMed

Maddux, Rachel E; Daukantaité, Daiva; Tellhed, Una

2018-03-01

The stresses of modern work life necessitate effective coping strategies that are accessible and affordable to the general public. Yoga has been found to reduce stress in clinical samples, but studies are needed to examine standard gym yoga classes among functional individuals. This study investigated the effects of 8- and 16-week gym yoga on stress and psychological health. Ninety individuals reporting moderate-to-high stress were randomly assigned to 16 consecutive weeks of yoga, or to a waitlist crossover group who did not practice yoga for 8 weeks then practiced yoga for 8 weeks. Stress and psychological health variables were assessed at baseline, 8 weeks, and 16 weeks. Significant reductions in stress and all psychological health measures were found within the Yoga group over 16 weeks. When compared to the control group, yoga practitioners showed significant decreases in stress, anxiety, and general psychological health, and significant increases in well-being. The group who did not practice yoga showed significant decreases in stress, anxiety, depression, and insomnia after they crossed over and practiced yoga for 8 weeks. Gym yoga appears to be effective for stress amelioration and promotion of psychological health among workers experiencing stress.

Novel Rat Model of Repetitive Portal Venous Embolization Mimicking Human Non-Cirrhotic Idiopathic Portal Hypertension.

PubMed

Klein, Sabine; Hinüber, Christian; Hittatiya, Kanishka; Schierwagen, Robert; Uschner, Frank Erhard; Strassburg, Christian P; Fischer, Hans-Peter; Spengler, Ulrich; Trebicka, Jonel

2016-01-01

Non-cirrhotic idiopathic portal hypertension (NCIPH) is characterized by splenomegaly, anemia and portal hypertension, while liver function is preserved. However, no animal models have been established yet. This study assessed a rat model of NCIPH and characterized the hemodynamics, and compared it to human NCIPH. Portal pressure (PP) was measured invasively and coloured microspheres were injected in the ileocecal vein in rats. This procedure was performed weekly for 3 weeks (weekly embolization). Rats without and with single embolization served as controls. After four weeks (one week after last embolization), hemodynamics were investigated, hepatic fibrosis and accumulation of myofibroblasts were analysed. General characteristics, laboratory analyses and liver histology were collected in patients with NCIPH. Weekly embolization induced a hyperdynamic circulation, with increased PP. The mesenteric flow and hepatic hydroxyproline content was significantly higher in weekly embolized compared to single embolized rats (mesenteric flow +54.1%, hydroxyproline +41.7%). Mesenteric blood flow and shunt volumes increased, whereas splanchnic vascular resistance was decreased in the weekly embolization group. Fibrotic markers αSMA and Desmin were upregulated in weekly embolized rats. This study establishes a model using repetitive embolization via portal veins, comparable with human NCIPH and may serve to test new therapies.

Muscle contractility decrement and correlated morphology during the pathogenesis of streptozotocin-diabetic mice.

PubMed

Fahim, M A; el-Sabban, F; Davidson, N

1998-06-01

Peripheral neuropathy of both motor and sensory nerves has been well documented in diabetes mellitus, but the evidence for physiological and correlated morphological changes during the pathogenesis of myopathy is scarce. In the present report, we have chosen the dorsiflexor muscle of adult male mice as a model for studying in situ muscle contraction and neuromuscular ultrastructure during the pathogenesis of streptozotocin-induced diabetes. Thirty mice (30 g bodyweight) were injected once i.p. with streptozotocin solution (200 mg/Kg) to induce experimental diabetes mellitus. Comparative analyses of in situ muscle isometric contractile characteristics were studied (at 1 Hz, 5 Hz and 30 Hz nerve stimulation) in urethane-anesthetized (2 mg/g, i.p.) control and diabetic mice at three time points, 2 weeks, 4 weeks, and 8 weeks postinjection. Synaptic delay was also recorded in diabetic and age-matched control mice. There was a significant increase in synaptic delay in both 4-week and 8-week diabetic mice compared with control mice (8.9 +/- 1.2 msec and 7.6 +/- 0.6 msec, respectively, compared with 6.1 +/- 0.5 msec). At all three stimulation frequencies, diabetes did not affect muscle contractile speed but significantly reduced the twitch tension after 8 weeks, with no changes at 2 weeks or 4 weeks. The recorded single-twitch tension values were 2.6 +/- 0.3 g, 2.1 +/- 0.6 g, 2.2 +/- 0.7 g, and 1.2 +/- 0.1 g for control, 2 weeks, 4 weeks, and 8 weeks, respectively. At 30 Hz, the recorded tension values were 4.6 +/- 1.6 g, 3.1 +/- 1.2 g, 3.1 +/- 1.1 g, and 2.1 +/- 1.0 g for control, 2 weeks, 4 weeks, and 8 weeks, respectively. Ultrastructural changes in neuromuscular junctions were similar to those that have been described in disuse and aging. These changes were observed after 8 weeks and included serve loss of synaptic vesicles, electron-dense bodies, and myelin-like figures as well as degeneration of mitochondria. The results reveal that streptozotocin-induced diabetes affects presynaptically the neuromuscular junction as well as muscle itself. Actions at both sites may contribute to the functional alterations seen in muscle contractile properties and may play a role in the pathogenesis of diabetic neuromyopathy.

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis

PubMed Central

Landewé, Robert B.; Mease, Philip J.; McInnes, Iain B.; Conaghan, Philip G.; Pricop, Luminita; Ligozio, Greg; Richards, Hanno B.; Mpofu, Shephard

2016-01-01

Objective To assess whether secukinumab treatment in patients with active psoriatic arthritis (PsA) is associated with sustained inhibition of radiographic progression. Methods In this phase III, double‐blind, placebo‐controlled study, 606 patients with PsA were randomized to receive intravenous (IV) secukinumab at a dose of 10 mg/kg (weeks 0, 2, 4) followed by subcutaneous secukinumab at a dose of 150 mg or 75 mg (the IV→150 mg and IV→75 mg groups, respectively) or placebo. Patients were stratified according to prior anti–tumor necrosis factor (anti‐TNF) exposure (71% were anti‐TNF naive). At week 16, placebo‐treated patients who had at least a 20% reduction in the tender and swollen joint counts (responders) continued to receive placebo until week 24; nonresponders were re‐randomized to receive secukinumab at a dose of 150 mg or 75 mg. The modified total Sharp/van der Heijde score (SHS) was determined at baseline, week 16 or 24, and week 52. Results In the overall population, radiographic progression was inhibited through 52 weeks; efficacy was demonstrated for both erosion and joint space narrowing scores and in patients who switched from placebo to secukinumab at week 24. Subgroup analyses showed that secukinumab reduced radiographic progression at week 24, regardless of previous anti‐TNF treatment. Among anti‐TNF–naive patients, the mean changes from baseline to week 24 in the modified total SHS were 0.05 in the pooled secukinumab group and 0.57 in the placebo group; among patients with an inadequate response or intolerance to anti‐TNF treatment, the mean changes were 0.16 and 0.58, respectively. Anti‐TNF–naive patients showed negligible progression through week 52. Inhibition of structural damage was observed through week 52 irrespective of concomitant methotrexate use. A high proportion of patients receiving secukinumab showed no progression (change in SHS of ≤ 0.5) from baseline to week 24 (82.3% of the IV→150 mg group and 92.3% of the IV→75 mg group) and from week 24 to week 52 (85.7% of the IV→150 mg group and 85.8% of the IV→75 mg group). Conclusion Secukinumab inhibited radiographic progression over 52 weeks of treatment in patients with active PsA. PMID:27014997

The relationship between gestational age and compliance in human umbilical vein and its possible application in vascular grafting.

PubMed

Li, Wenchun; Huang, Tiezhu; Zeng, Yanjun; Yao, Zhongjun

2006-03-01

The aim of this study was to provide a theoretical basis, using biomechanical properties, for the clinical application of human umbilical vein (HUV) as material for vascular grafting. This was a nonrandomized, non-controlled in vitro study. The experiment was conducted in the Laboratory of Medical Biomechanics, Yunyang Medical College. HUVs of 50 normal fetuses were collected on spontaneous miscarriage or labor with the pregnant women's permission by the Department of Obstetrics and Gynecology, Taihe Hospital, Shiyan, Hubei Province. Gestational aged ranged 24-42 weeks, and parturients were 20-30 years old. The pressure-volume (P-V) relationship of HUV was measured on the biomechanical experiment stand for soft tissues, and then compliance was calculated. The P-V relationship of HUV corresponded to a parabolic curve. The compliance of HUV increased gradually with gestational age [24-27 weeks (2.22+/-0.34) x 10(-4) mL/(kPa * cm), 28-32 weeks (3.65+/-0.46) x 10(-4) mL/(kPa * cm), 33-36 weeks (4.22+/-0.55) x 10(-4) mL/(kPa * cm), 37 weeks (7.63+/-0.48) x 10(-4) mL/(kPa * cm), 38 weeks (8.32+/-0.76) x 10(-4) mL/(kPa * cm)]. However, after 39 weeks of gestation, compliance decreased gradually with gestational age [39 weeks 7.61+/-0.46) x 10(-4) mL/(kPa * cm), 40 weeks (7.53+/-0.72) x 10(-4) mL/(kPa * cm), 41 weeks (4.13+/-0.35) x 10(-4) mL/(kPa * cm), 42 weeks (2.25+/-0.62) x 10(-4) mL/(kPa * cm)]. The compliance of HUVs collected at 37-40 weeks of gestational age was similar. When the HUVs older than 42 weeks or under 28 weeks were compared, there was significant difference in their compliance (F=65.84-86.52, p<0.01). The results of the present study suggest that HUVs collected at 37-40 weeks of gestational age have good compliance, i.e., a good P-V relationship, and therefore may be a suitable material for vascular grafting. HUV is one of several graft materials that may be used when autogenous saphenous vein is absent or inadequate. HUV is very biocompatible and shows promise for use in orthopedic implants.

20 CFR 625.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... week during which the individual works less than regular, full-time hours for the individual's regular... week of total unemployment is a week during which the individual performs no work and earns no wages... compensation payable to an individual for weeks of unemployment in an extended benefit period, under those...

76 FR 57615 - National Health Information Technology Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

... Health Information Technology Week, 2011 #0; #0; #0; Presidential Documents #0; #0; #0;#0;Federal... Technology Week, 2011 By the President of the United States of America A Proclamation Technological advances... Week, we highlight the critical importance of secure and efficient information systems to improving the...

77 FR 72679 - Minority Enterprise Development Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-05

... Minority Enterprise Development Week, 2012 By the President of the United States of America A Proclamation... of Minority Enterprise Development Week, let us honor the role America's minority-owned businesses... through December 8, 2012, as Minority Enterprise Development Week. I call upon all Americans to celebrate...

78 FR 37423 - National Small Business Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Business Week, 2013 Proclamation 8995--World Elder Abuse Awareness Day, 2013 Proclamation 8996--Father's... of June 14, 2013 National Small Business Week, 2013 By the President of the United States of America... startups that keep our country on the cutting edge. This week, we celebrate America's entrepreneurial...

78 FR 70598 - Sunshine Act Meetings Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-26

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0001] Sunshine Act Meetings Notice DATES: Weeks of..., Rockville, Maryland. STATUS: Public and Closed. Week of November 25, 2013 There are no meetings scheduled for the week of November 25, 2013. Week of December 2, 2013--Tentative There are no meetings scheduled...

Changes in rates of salivary estriol increases before parturition at term.

PubMed

Hedriana, H L; Munro, C J; Eby-Wilkens, E M; Lasley, B L

2001-01-01

The aim of this study was to characterize the increases of salivary estriol concentrations before the onset of labor at term. Salivary estriol concentrations were measured in weekly patient-collected samples by means of a sensitive (mean +/- SD threshold, 0.025 +/- 0.001 ng/mL; coefficient of variation, 3.8%) direct enzyme immunoassay in a microtiter plate format. The salivary estriol concentrations in 16 healthy pregnant women were characterized from 30 weeks' gestation until the time of parturition and delivery. Samples were stored frozen at collection and analyzed in batches after delivery. The median salivary estriol concentration profile revealed a nonlinear rise beginning from 30 weeks' gestation (0.89 ng/mL) until term (2.70 ng/mL, an increase of 201%). At 35 weeks' gestation the salivary estriol concentration median value increased sharply (positive inflection point, 50%-93% increase) at a demarcation between a slower increase during early pregnancy and a more rapid increase during late pregnancy. This positive inflection point associated with a late pregnancy increase characterized subgroups of pregnancies according to the lengths of gestation as follows: early term (delivered at <38 weeks 1 day's gestation), middle term (delivered at 38 weeks 1 day-40 weeks' gestation), and late term (delivered at >40 weeks' gestation). Five weeks before delivery the mean (+/-SEM) rate of rise in salivary estriol concentration was 0.50 +/- 0.13 ng/mL per week to 0.84 +/- 0.26 ng/mL per week in the early term group. The increase in rate for the middle term group was 0.32 +/- 0.06 ng/mL per week to 0.37 +/- 0.26 ng/mL per week, whereas in the late term group the rate of salivary estriol concentration rise was 0.37 +/- 0.03 ng/mL per week to -0.03 +/- 0.25 ng/mL per week. These data demonstrate in normal pregnancies (1) that a direct, nonradiometric measure of salivary estriol concentration can be used to monitor the late pregnancy increase in estriol production, (2) that 35 weeks' gestation marks a positive inflection point of the onset of increased estriol production, and (3) that the late pregnancy rise in salivary estriol concentration shows distinct patterns that tend to be characteristic of the length of pregnancy. These data support the concept that the rate of increase of estriol production is related to the timing of the onset of labor.

Remission and Recovery in the Treatment for Adolescents with Depression Study (TADS): Acute and Long-term Outcomes

PubMed Central

Kennard, Betsy D.; Silva, Susan G.; Tonev, Simon; Rohde, Paul; Hughes, Jennifer L.; Vitiello, Benedetto; Kratochvil, Christopher J.; Curry, John F.; Emslie, Graham J.; Reinecke, Mark; March, John

2010-01-01

Objective We examine remission rate probabilities, recovery rates, and residual symptoms across 36 weeks in the Treatment for Adolescents with Depression Study (TADS). Method TADS, a multisite clinical trial, randomized 439 adolescents with major depressive disorder (MDD) to 12 weeks of treatment to fluoxetine (FLX), cognitive behavioral therapy (CBT), their combination (COMB), or pill placebo (PBO). The PBO group, treated openly after week 12, was not included in the subsequent analyses. Treatment differences in remission rates and probabilities of remission over time are compared. Recovery rates in remitters at week 12 (acute phase remitters) and week 18 (continuation phase remitters) are summarized. We also examined whether residual symptoms at the end of 12 weeks of acute treatment predicted later remission. Results At Week 36, the estimated remission rates for intention-to-treat cases were: COMB: 60%, FLX: 55%; CBT: 64%; overall: 60%. Paired comparisons reveal that at week 24 all active treatments converge on remission outcomes. The recovery rate at Week 36 was 65% for acute phase remitters and 71% for continuation phase remitters, with no significant between-treatment differences in recovery rates. Residual symptoms at the end of acute treatment predicted failure to achieve remission at weeks 18 and 36. Conclusions The majority of depressed adolescents in all three treatment modalities achieved remission at the end of nine months of treatment. PMID:19127172

A 4-Week Model of House Dust Mite (HDM) Induced Allergic Airways Inflammation with Airway Remodeling.

PubMed

Woo, L N; Guo, W Y; Wang, X; Young, A; Salehi, S; Hin, A; Zhang, Y; Scott, J A; Chow, C W

2018-05-02

Animal models of allergic airways inflammation are useful tools in studying the pathogenesis of asthma and potential therapeutic interventions. The different allergic airways inflammation models available to date employ varying doses, frequency, duration and types of allergen, which lead to the development of different features of asthma; showing varying degrees of airways inflammation and hyper-responsiveness (AHR) and airways remodeling. Models that also exhibit airway remodeling, a key feature of asthma, in addition to AHR and airway inflammation typically require 5-12 weeks to develop. In this report, we describe a 4-week mouse model of house dust mite (HDM)-induced allergic airways inflammation, and compare the phenotypic features of two different doses of HDM exposures (10 µg and 25 µg) for 5 days/week with a well-characterized 8-week chronic HDM model. We found that 4 weeks of intranasal HDM (25 µg in 35 µl saline; 5 days/week) resulted in AHR, airway inflammation and airway remodeling that were comparable to the 8-week model. We conclude that this new 4-week HDM model is another useful tool in studies of human asthma that offers advantages of shorter duration for development and decreased costs when compared to other models that require longer durations of exposure (5-12 weeks) to develop.

Criteria for screening and diagnosis of gestational diabetes mellitus in the first trimester of pregnancy.

PubMed

Plasencia, Walter; Garcia, Raquel; Pereira, Susana; Akolekar, Ranjit; Nicolaides, Kypros H

2011-01-01

To propose new cutoffs in plasma glucose levels in screening and diagnosis of gestational diabetes mellitus (GDM) in the first trimester of pregnancy. A 50-gram oral glucose challenge test (GCT) was performed in 1,716 singleton pregnancies at 6-14 weeks' gestation. In those with a positive GCT, a 100-gram glucose tolerance test (GTT) was carried out. The GCT and as necessary the GTT were repeated at 20-30 weeks. The relation of the results of the GCT and GTT at 6-14 weeks to that at 20-30 weeks was examined. The diagnosis of GDM was made in 85 cases. In the GCT, there was a significant association between 1-hour plasma glucose levels at 6-14 weeks and at 20-30 weeks (r = 0.558, p < 0.0001), and in all cases of GDM, the level was 130 mg/dl or more at 6-14 weeks and 140 mg/dl or more at 20-30 weeks. In the GTT, the plasma glucose 1, 2 and 3 h after the 100-gram glucose load at 6-14 weeks was, respectively, 18, 29 and 35% lower than at 20-30 weeks. Effective diagnosis of GDM in the first trimester can be achieved by lowering the GCT and GTT plasma glucose cutoffs. 2011 S. Karger AG, Basel.

[Effects of educational program of manual lymph massage on the arm functioning and the quality of life in breast cancer patients].

PubMed

Lee, Eun Sook; Kim, Sung Hyo; Kim, Sun Mi; Sun, Jeong Ju

2005-12-01

The purpose of this study was to determine the effect of EPMLM (educational program of manual lymph massage) on the arm functioning and QOL (quality of life) in breast cancer patients with lymphedema. Subjects in the experimental group (n=20) participated in EPMLM for 6 weeks from June to July, 2005. The EPMLM consisted of training of lymph massage for 2 weeks and encourage and support of self-care using lymph massage for 4 weeks. The arm functioning assessed at pre-treatment, 2 weeks, and 6 weeks using Arm functioning questionnaire. The QOL assessed at pre-treatment and 6 weeks using SF-36. The outcome data of experimental group was compared with control group (n=20). The collected data was analyzed by using SPSS 10.0 statistical program. The arm functioning of experimental group was increased from 2 weeks after (W=.224, p=.011) and statistically differenced with control group at 2 weeks (Z=-2.241, p=.024) and 6 weeks (Z=-2.453, p=.013). Physical function of QOL domain increased in experimental group (Z=-1.162, p=.050), also statistically differenced with control group (Z=-2.182, p= .030) at 6 weeks. The results suggest that the educational program of manual lymph massage can improve arm functioning and physical function of QOL domain in breast cancer patients with lymphedema.

Effects of Oral L-Carnitine on Liver Functions after Transarterial Chemoembolization in Intermediate-Stage HCC Patients.

PubMed

Hassan, Abeer; Tsuda, Yasuhiro; Asai, Akira; Yokohama, Keisuke; Nakamura, Ken; Sujishi, Tetsuya; Ohama, Hideko; Tsuchimoto, Yusuke; Fukunishi, Shinya; Abdelaal, Usama M; Arafa, Usama A; Hassan, Ali T; Kassem, Ali M; Higuchi, Kazuhide

2015-01-01

Transarterial chemoembolization (TACE) is usually followed by hepatic dysfunction. We evaluated the effects of L-carnitine on post-TACE impaired liver functions. Methods. 53 cirrhotic hepatocellular carcinoma patients at Osaka Medical College were enrolled in this study and assigned into either L-carnitine group receiving 600 mg oral L-carnitine daily or control group. Liver functions were evaluated at pre-TACE and 1, 4, and 12 weeks after TACE. Results. The L-carnitine group maintained Child-Pugh (CP) score at 1 week after TACE and exhibited significant improvement at 4 weeks after TACE (P < 0.01). Conversely, the control group reported a significant CP score deterioration at 1 week (P < 0.05) and 12 weeks after TACE (P < 0.05). L-carnitine suppressed serum albumin deterioration at 1 week after TACE. There were significant differences between L-carnitine and control groups regarding mean serum albumin changes from baseline to 1 week (P < 0.05) and 4 weeks after TACE (P < 0.05). L-carnitine caused prothrombin time improvement from baseline to 1, 4 (P < 0.05), and 12 weeks after TACE. Total bilirubin mean changes from baseline to 1 week after TACE exhibited significant differences between L-carnitine and control groups (P < 0.05). The hepatoprotective effects of L-carnitine were enhanced by branched chain amino acids combination. Conclusion. L-carnitine maintained and improved liver functions after TACE.

Biking for Health: Results of a Pilot Randomized Controlled Trial Examining the Impact of a Bicycling Intervention on Lower-Income Adults.

PubMed

Bernstein, Rebecca; Schneider, Robert; Welch, Whitney; Dressel, Anne; DeNomie, Melissa; Kusch, Jennifer; Sosa, Mirtha

2017-08-01

This pilot study tested the efficacy of a bicycling intervention targeting inactive, low-income, overweight adults on reducing perceived barriers to bicycling, increasing physical activity, and improving health. A nonblinded 2-site randomized controlled trial was conducted in Milwaukee, Wisconsin, in summer 2015. Participants included members from 1 largely Latino community and a second primarily African American neighborhood. A certified bicycling instructor led a 12-week bicycling intervention. Outcome measures including biking-related attitudes, self-reported physical activity, fitness as measured by the 6-minute step test, and biometric data were collected at baseline, 12 weeks, and 20 weeks. Thirty-eight participants completed the study. Barriers to bicycling declined significantly among intervention group participants at 12 weeks with some declines persisting to 20 weeks. Bicycling for leisure or non work transportation increased significantly more in the intervention than control group from baseline to 12 weeks but this difference attenuated by 20 weeks. Both groups increased their fitness between baseline and 12 weeks, with a trend towards greater gains in the bicycling intervention group. No significant change in biometric measurements was seen at either 12 weeks or 20 weeks. Despite the small study size, this bicycling intervention decreased perceived barriers to bicycling and increased bicycling activity in low-income minority participants. These findings support a larger-scale study to measure fitness and health changes from bicycling interventions.

Analysis of the weekly cycle in the atmosphere near Moscow

NASA Astrophysics Data System (ADS)

Gruzdev, A. N.

2013-03-01

Using the spectral method and the method of grouping by days of week, we analyzed the weekly cycles by standard air sounding data obtained at the Dolgoprudny station near Moscow and by the results of measurements of NO2 content in the stratosphere and the atmospheric boundary layer at the Zvenigorod Research Station of the Obukhov Institute of Atmospheric Physics, Russian Academy of Sciences, in 1990-2010. We revealed weekly cycles of the NO2 content in the vertical column of the stratosphere, temperature, geopotential, meridional wind velocity in the troposphere and lower stratosphere, and the tropopause height in the warm half of the year (mid-April to mid-October). The weekly variations in temperature in the troposphere are positive in the first half of the week and negative in the second half, and the variations in temperature in the tropopause layer and in the lower stratosphere are opposite in sign to the tropospheric variations. The weekly cycle of the tropopause height is approximately in phase with the cycle of tropospheric temperature, and the weekly cycle of the NO2 content in the stratospheric column is opposite in phase to the cycle of the tropopause height. Weekly variations were also observed in the total ozone content over Moscow. This finding was confirmed by calculations based on regression relationships between the vertical distribution of ozone and tropopause height. Conceptual mechanisms of weekly cycles were proposed.

Method‐of‐use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity

PubMed Central

Shan, Kevin; Walsh, Brandon; Gilder, Kye; Fujioka, Ken

2016-01-01

Objective This study assessed the effects of 32 mg naltrexone sustained release (SR)/360 mg bupropion SR (NB) on body weight in adults with obesity, with comprehensive lifestyle intervention (CLI), for 78 weeks. Methods In this phase 3b, randomized, open‐label, controlled study, subjects received NB + CLI or usual care (standard diet/exercise advice) for 26 weeks. NB subjects not achieving 5% weight loss at week 16 were discontinued, as indicated by product labeling. After week 26, usual care subjects began NB + CLI. Assessments continued through week 78. The primary end point was percent change in weight from baseline to week 26 in the per protocol population. Other end points included percentage of subjects achieving ≥5%, ≥10%, and ≥15% weight loss, percent change in weight at week 78, and adverse events (AEs) necessitating study medication discontinuation. Results NB + CLI subjects lost significantly more weight than usual care subjects at week 26 (8.52% difference; P < 0.0001). Weight loss persisted through 78 weeks. In total, 20.7% of subjects discontinued medication for AEs, including 7.0% for nausea. Conclusions Treatment with NB, used as indicated by prescribing information and with CLI, significantly improved weight loss over usual care alone. NB‐facilitated weight loss was sustained for 78 weeks and was deemed safe and well tolerated. PMID:28026920

Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial.

PubMed

Nash, Peter; Kirkham, Bruce; Okada, Masato; Rahman, Proton; Combe, Benard; Burmester, Gerd-Ruediger; Adams, David H; Kerr, Lisa; Lee, Chin; Shuler, Catherine L; Genovese, Mark

2017-06-10

Patients who have had inadequate response to tumour necrosis factor inhibitors have fewer treatment options and are generally more treatment refractory to subsequent therapeutic interventions than previously untreated patients. We report the efficacy and safety of ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, in patients with active psoriatic arthritis and previous inadequate response to tumour necrosis factor inhibitors. In this double-blind, multicentre, randomised, placebo-controlled, phase 3 study (SPIRIT-P2), patients were recruited from 109 centres across ten countries in Asia, Australia, Europe, and North America. Patients were aged 18 years or older, had a confirmed diagnosis of psoriatic arthritis for at least 6 months, and had a previous inadequate response, distinguished by being refractory to therapy or had loss of efficacy, or were intolerant to tumour necrosis factor inhibitors. Patients were randomly assigned (1:1:1) by a computer-generated random sequence to receive a subcutaneous injection of 80 mg ixekizumab every 4 weeks or every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was the proportion of patients who attained at least 20% improvement in the American College of Rheumatology response criteria (ACR-20) at week 24. This study is registered with ClinicalTrials.gov, number NCT02349295. Between March 3, 2015, to March 22, 2016, 363 patients were randomly assigned to placebo (n=118), ixekizumab every 4 weeks (n=122), or ixekizumab every 2 weeks (n=123). At week 24, a higher proportion of patients attained ACR-20 with ixekizumab every 4 weeks (65 [53%] patients; effect size vs placebo 33·8% [95% CI 22·4-45·2]; p<0·0001) and ixekizumab every 2 weeks (59 [48%] patients; 28.5% [17·1-39.8]; p<0·0001) than did patients with placebo (23 [20%] patients). Up to week 24, serious adverse events were reported in three (3%) patients with ixekizumab every 4 weeks, eight (7%) with ixekizumab every 2 weeks, and four (3%) with placebo; no deaths were reported. Infections were reported in 47 (39%) patients with ixekizumab every 4 weeks, 47 (38%) with ixekizumab every 2 weeks, and 35 (30%) with placebo. Three (2%) serious infections, all in patients in the ixekizumab every 2 weeks group, were reported. Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab. Eli Lilly and Company. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prediction of small-for-gestational-age neonates: screening by uterine artery Doppler and mean arterial pressure at 19-24 weeks.

PubMed

Lesmes, C; Gallo, D M; Saiid, Y; Poon, L C; Nicolaides, K H

2015-09-01

To investigate the potential value of uterine artery (UtA) pulsatility index (PI) and mean arterial pressure (MAP) at 19-24 weeks' gestation, in combination with maternal characteristics and medical history and fetal biometry in the prediction of delivery of small-for-gestational-age (SGA) neonates in the absence of pre-eclampsia (PE) and to examine the potential value of such assessment in deciding whether the third-trimester scan should be performed at 32 and/or 36 weeks' gestation. This was a screening study in 63 975 singleton pregnancies, including 3702 (5.8%) that delivered SGA neonates with birth weight < 5(th) percentile (SGA < 5(th) ) in the absence of PE. Multivariable logistic regression analysis was used to determine if screening by a combination of maternal factors, fetal head circumference (HC), abdominal circumference (AC), femur length (FL), UtA-PI and MAP had significant contribution in predicting SGA neonates. A model was developed to select gestational age for the third-trimester assessment, at 32 and/or 36 weeks, based on the results of screening at 19-24 weeks. The detection rates (DRs) of combined screening by maternal factors, fetal biometry and UtA-PI at 19-24 weeks were 90%, 68% and 44% for SGA < 5(th) delivering < 32, 32-36 and ≥ 37 weeks' gestation, respectively, at a false-positive rate (FPR) of 10%. The performance of screening was not improved by the addition of MAP. The DR of SGA < 5(th) delivering at 32-36 weeks improved from 68% to 90% with screening at 32 rather than at 19-24 weeks. Similarly, the DR of SGA < 5(th) delivering ≥ 37 weeks improved from 44% with screening at 19-24 weeks to 59% and 76% when screening at 32 and 36 weeks, respectively. In a hypothetical model, it was estimated that if the desired objective of prenatal screening is to predict about 80% of the cases of SGA < 5(th) , it would be necessary to select 17% of the population at the 19-24-week assessment to be reassessed at 32 weeks and 38% to be reassessed at 36 weeks; 62% would not require a third-trimester scan. Prenatal prediction of a high proportion of SGA neonates necessitates the undertaking of screening in the third trimester of pregnancy in addition to assessment in the second trimester, and the timing of such screening, at 32 and/or 36 weeks, should be contingent on the results of the assessment at 19-24 weeks. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study.

PubMed

Calabresi, Peter A; Kieseier, Bernd C; Arnold, Douglas L; Balcer, Laura J; Boyko, Alexey; Pelletier, Jean; Liu, Shifang; Zhu, Ying; Seddighzadeh, Ali; Hung, Serena; Deykin, Aaron

2014-07-01

Subcutaneous pegylated interferon (peginterferon) beta-1a is being developed for treatment of relapsing multiple sclerosis, with less frequent dosing than currently available first-line injectable treatments. We assessed the safety and efficacy of peginterferon beta-1a after 48 weeks of treatment in the placebo-controlled phase of the ADVANCE trial, a study of patients with relapsing-remitting multiple sclerosis. We did this 2-year, double-blind, parallel group, phase 3 study, with a placebo-controlled design for the first 48 weeks, at 183 sites in 26 countries. Patients with relapsing-remitting multiple sclerosis (age 18-65 years, with Expanded Disability Status Scale score ≤5) were randomly assigned (1:1:1) via an interactive voice response or web system, and stratified by site, to placebo or subcutaneous peginterferon beta-1a 125 μg once every 2 weeks or every 4 weeks. The primary endpoint was annualised relapse rate at 48 weeks. This trial is registered with ClinicalTrials.gov, number NCT00906399. We screened 1936 patients and enrolled 1516, of whom 1512 were randomly assigned (500 to placebo, 512 to peginterferon every 2 weeks, 500 to peginterferon every 4 weeks); 1332 (88%) patients completed 48 weeks of treatment. Adjusted annualised relapse rates were 0·397 (95% CI 0·328-0·481) in the placebo group versus 0·256 (0·206-0·318) in the every 2 weeks group and 0·288 (0·234-0·355) in the every 4 weeks group (rate ratio for every 2 weeks group 0·644, 95% CI 0·500-0·831, p=0·0007; rate ratio for the every 4 weeks group 0·725, 95% CI 0·565-0·930, p=0·0114). 417 (83%) patients taking placebo, 481 (94%) patients taking peginterferon every 2 weeks, and 472 (94%) patients taking peginterferon every 4 weeks reported adverse events including relapses. The most common adverse events associated with peginterferon beta-1a were injection site reactions, influenza-like symptoms, pyrexia, and headache. 76 (15%) patients taking placebo, 55 (11%) patients taking study drug every 2 weeks, and 71 (14%) patients taking study drug every 4 weeks reported serious adverse events; relapse, pneumonia, and urinary tract infection were the most common. After 48 weeks, peginterferon beta-1a significantly reduced relapse rate compared with placebo. The drug might be an effective treatment for relapsing-remitting multiple sclerosis with less frequent administration than available treatments. Biogen Idec. Copyright © 2014 Elsevier Ltd. All rights reserved.

Solar Week: Learning from Experience

NASA Astrophysics Data System (ADS)

Alexander, D.; Hauck, K.

2003-12-01

Solar Week is a week-long set of games and activities allowing students to interact directly with solar science and solar scientists. Solar Week was developed as a spin-off of the highly successful Yohkoh Public Outreach Project (YPOP). While YPOP provided access to solar images, movies and activities, the main goal of Solar Week was to enhance the participation of women, who are under-represented in the physical sciences. Solar Week achieves this by providing young women, primarily in grades 6-8, with access to role models in the sciences. The scientists participating in Solar Week are women from a variety of backgrounds and with a variety of scientific expertise. In this paper, our aim is to provide some insight into developing activity-based space science for the web and to discuss the lessons-learned from tailoring to a specific group of participants.

Trajectories of 12-Month Usage Patterns for Two Smoking Cessation Websites: Exploring How Users Engage Over Time.

PubMed

Bricker, Jonathan B; Sridharan, Vasundhara; Zhu, Yifan; Mull, Kristin E; Heffner, Jaimee L; Watson, Noreen L; McClure, Jennifer B; Di, Chongzhi

2018-04-20

Little is known about how individuals engage with electronic health (eHealth) interventions over time and whether this engagement predicts health outcomes. The objectives of this study, by using the example of a specific type of eHealth intervention (ie, websites for smoking cessation), were to determine (1) distinct groups of log-in trajectories over a 12-month period, (2) their association with smoking cessation, and (3) baseline user characteristics that predict trajectory group membership. We conducted a functional clustering analysis of 365 consecutive days of log-in data from both arms of a large (N=2637) randomized trial of 2 website interventions for smoking cessation (WebQuit and Smokefree), with a primary outcome of 30-day point prevalence smoking abstinence at 12 months. We conducted analyses for each website separately. A total of 3 distinct trajectory groups emerged for each website. For WebQuit, participants were clustered into 3 groups: 1-week users (682/1240, 55.00% of the sample), 5-week users (399/1240, 32.18%), and 52-week users (159/1240, 12.82%). Compared with the 1-week users, the 5- and 52-week users had 57% higher odds (odds ratio [OR] 1.57, 95% CI 1.13-2.17; P=.007) and 124% higher odds (OR 2.24, 95% CI 1.45-3.43; P<.001), respectively, of being abstinent at 12 months. Smokefree users were clustered into 3 groups: 1-week users (645/1309, 49.27% of the sample), 4-week users (395/1309, 30.18%), and 5-week users (269/1309, 20.55%). Compared with the 1-week users, 5-week users (but not 4-week users; P=.99) had 48% higher odds (OR 1.48, 95% CI 1.05-2.07; P=.02) of being abstinent at 12 months. In general, the WebQuit intervention had a greater number of weekly log-ins within each of the 3 trajectory groups as compared with those of the Smokefree intervention. Baseline characteristics associated with trajectory group membership varied between websites. Patterns of 1-, 4-, and 5-week usage of websites may be common for how people engage in eHealth interventions. The 5-week usage of either website, and 52-week usage only of WebQuit, predicted a higher odds of quitting smoking. Strategies to increase eHealth intervention engagement for 4 more weeks (ie, from 1 week to 5 weeks) could be highly cost effective. ClinicalTrials.gov NCT01812278; https://www.clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/6yPO2OIKR). ©Jonathan B Bricker, Vasundhara Sridharan, Yifan Zhu, Kristin E Mull, Jaimee L Heffner, Noreen L Watson, Jennifer B McClure, Chongzhi Di. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.04.2018.

A short 2 week dose titration regimen reduces the severity of flu-like symptoms with initial interferon gamma-1b treatment.

PubMed

Devane, John G; Martin, Mary L; Matson, Mark A

2014-06-01

Flu-like symptoms (FLS) are commonly experienced by patients receiving interferon gamma-1b which may cause discontinuation or disruption of dosing during initial therapy or on re-initiation following a break in therapy. In contrast to Type I interferons, the impact of dose-titration on FLS has not been reported and is not a practice described or included in the approved prescribing information for interferon gamma-1b.The objective of this study was to assess the effect of a 2 week titration regimen on the severity of FLS during the initial 3 weeks of therapy with three times weekly subcutaneous injections of interferon gamma-1b. Healthy men and women were randomized into a double-blind, two-period, crossover study. Each study period was 3 weeks in duration and there was a minimum 15 day washout between treatment periods. Two treatment regimens were compared: No Titration dosing (full 50 mcg/m(2) subcutaneously [s.c.] three times weekly for 3 weeks) and Titration (15 mcg/m(2) s.c. three times weekly during week 1, 30 mcg/m(2) s.c. three times weekly during week 2 followed by the full dose of 50 mcg/m(2) s.c. three times weekly during week 3). Subjects remained in the clinic for at least 12 hours following each injection. FLS was based on a composite score for fever, chills, tiredness and muscle aches assessed at baseline and 4, 8 and 12 hours following each injection. Acetaminophen was allowed at the discretion of the PI. The primary endpoint was the change from baseline in FLS severity at 8 hours averaged over the 3 weeks of treatment. Additional endpoints included FLS at 4 and 12 hours, individual flu-like symptoms, rates of discontinuation, incidence of FLS and acetaminophen use. NCT 01929382. Of the 40 subjects randomized, there were 15 (37.5%) discontinuations. Titration resulted in a significant reduction in FLS severity at 8 hours (p = 0.023) averaged over the 3 week treatment period. The difference in 3 week FLS severity reflects differences during week 1 treatment, indicating an early peak in FLS severity during the No Titration treatment and subsequent development of tolerance. In contrast, titration results in near baseline severity scores throughout the treatment period. Similar trends were seen for 4 and 12 hour FLS severity scores. Of the individual FLS, difference in fever severity was most marked. Safety profiles for both regimens were consistent with the approved prescribing information for interferon gamma-1b. Study limitations included the use of healthy subjects rather than disease subjects, the lack of a validated assessment tool for evaluating FLS and the relatively high discontinuation rate. A short 2 week, dose-titration regimen reduces FLS severity following interferon gamma-1b treatment initiation in normal subjects.

Impact of the Mass Drug Administration for malaria in response to the Ebola outbreak in Sierra Leone.

PubMed

Aregawi, Maru; Smith, Samuel J; Sillah-Kanu, Musa; Seppeh, John; Kamara, Anitta R Y; Williams, Ryan O; Aponte, John J; Bosman, Andrea; Alonso, Pedro

2016-09-20

As emergency response to the Ebola epidemic, the Government of Sierra Leone and its partners implemented a large-scale Mass Drug Administration (MDA) with artesunate-amodiaquine (ASAQ) covering >2.7 million people in the districts hardest hit by Ebola during December 2014-January 2015. The World Health Organization (WHO) and the National Malaria Control Programme (NMCP) evaluated the impact of the MDA on malaria morbidity at health facilities and the number of Ebola alerts received at District Ebola Command Centres. The coverage of the two rounds of MDA with ASAQ was estimated by relating the number anti-malarial medicines distributed to the estimated resident population. Segmented time-series analysis was applied to weekly data collected from 49 primary health units (PHUs) and 11 hospitals performing malaria parasitological testing during the study period, to evaluate trends of malaria cases and Ebola alerts during the post-MDA weeks compared to the pre-MDA weeks in MDA- and non-MDA-cheifdoms. After two rounds of the MDA, the number of suspected cases tested with rapid diagnostic test (RDT) decreased significantly by 43 % (95 % CI 38-48 %) at week 1 and remained low at week 2 and 3 post-first MDA and at week 1 and 3 post-second MDA; RDT positive cases decreased significantly by 47 % (41-52 %) at week 1 post-first and remained lower throughout all post-MDA weeks; and the RDT test positivity rate (TPR) declined by 35 % (32-38 %) at week 2 and stayed low throughout all post-MDA weeks. The total malaria (clinical + confirmed) cases decreased significantly by 45 % (39-52 %) at week 1 and were lower at week 2 and 3 post-first MDA; and week 1 post-second MDA. The proportion of confirmed malaria cases (out of all-outpatients) fell by 33 % (29-38 %) at week 1 post-first MDA and were lower during all post-MDA weeks. On the contrary, the non-malaria outpatient cases (cases due to other health conditions) either remained unchanged or fluctuated insignificantly. The Ebola alerts decreased by 30 % (13-46 %) at week 1 post-first MDA and much lower during all the weeks post-second MDA. The MDA achieved its goals of reducing malaria morbidity and febrile cases that would have been potentially diagnosed as suspected Ebola cases with increased risk of nosocomial infections. The intervention also helped reduce patient case-load to the severely strained health services at the peak of the Ebola outbreak and malaria transmission. As expected, the effect of the MDA waned in a matter of few weeks and malaria intensity returned to the pre-MDA levels. Nevertheless, the approach was an appropriate public health intervention in the context of the Ebola epidemic even in high malaria transmission areas of Sierra Leone.

Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

PubMed

van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

2018-02-26

To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

Annual and Weekly Incidence Rates of Influenza and Pediatric Diseases Estimated from Infectious Disease Surveillance Data in Japan, 2002-2005

PubMed Central

Kawado, Miyuki; Hashimoto, Shuji; Murakami, Yoshitaka; Izumida, Michiko; Ohta, Akiko; Tada, Yuki; Shigematsu, Mika; Yasui, Yoshinori; Taniguchi, Kiyosu; Nagai, Masaki

2008-01-01

BACKGROUND The method for estimating incidence of infectious diseases from sentinel surveillance data has been proposed. In Japan, although the annual incidence rates of influenza and pediatric diseases estimated using the method were reported, their weekly incidence rates have not. METHODS The weekly sex- and age-specific numbers of cases in the sentinel medical institutions in the National Epidemiological Surveillance of Infectious Diseases in Japan in 2002-2005 were used. Annual and weekly incidence rates of influenza and 12 pediatric diseases were estimated by the above-mentioned method, under the assumption that sentinels are randomly selected from all medical institutions. RESULTS The annual incidence rate of influenza in 2002-2005 was 57.7-142.6 per 1,000 population. The highest weekly incidence rate was 7.4 at week 8 in 2002, 14.9 at week 4 in 2003, 14.1 at week 5 in 2004, and 21.2 at week 9 in 2005. The annual incidence rate per 1,000 population of 0-14 years old in 2002-2005 was less than 5.0 for pertussis, rubella and measles, 293.2-320.8 for infectious gastroenteritis, and 5.3-89.6 for 8 other diseases. The highest weekly incidence rate was less than 1.0 for exanthem subitum, and was more than 5.0 for infectious gastroenteritis, hand-foot-mouth disease and herpangina. CONCLUSION We estimated annual and weekly incidence rates of influenza and pediatric diseases in Japan in 2002-2005, and described their temporal variation. PMID:18239340

Patient-reported outcomes and health-care resource utilization in patients with psoriasis treated with etanercept: continuous versus interrupted treatment.

PubMed

Gelfand, Joel M; Kimball, Alexa B; Mostow, Eliot N; Chiou, Chiun-Fang; Patel, Vaishali; Xia, H Amy; Freundlich, Bruce; Stevens, Seth R

2008-01-01

The 24-week Etanercept Assessment of Safety and Effectiveness (EASE) study evaluated the effectiveness and tolerability of continuous versus interrupted etanercept treatment in patients with moderate to severe plaque psoriasis. The objective of this analysis was to assess patient-reported outcomes (PROs) and health-care resource utilization (HRU) data from the EASE study. Patients received open-label etanercept 50 mg twice weekly for 12 weeks and then received either continued or interrupted (single round of discontinuation and re-treatment with etanercept) etanercept 50 mg once weekly for the second 12 weeks. PROs included the following: 1) the patient global assessments of psoriasis, joint pain, and itching scores; 2) the Dermatology Life Quality Index; 3) the Medical Outcomes Study Short Form 36 vitality domain; 4) the Beck Depression Inventory; 5) the European Quality-of-Life Group Feeling Thermometer; and 6) a patient satisfaction survey. HRU was evaluated using the Economic Implications of Psoriasis patient questionnaire. Continuous treatment with etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks produced sustained and clinically important improvements in PROs and reductions in HRU. Reductions in some outcome measures after treatment discontinuation at week 12 were observed in the interrupted group; however, most changes did not revert to baseline levels, consistent with some residual clinical effect, and re-treatment produced improvements similar to week 12 levels. Continuous etanercept treatment provided greater sustained improvements in PROs than interrupted therapy; however, interrupting etanercept therapy, if needed, has predictable and manageable effects.

Termination of short term melatonin treatment in children with delayed Dim Light Melatonin Onset: effects on sleep, health, behavior problems, and parenting stress.

PubMed

van Maanen, Annette; Meijer, Anne Marie; Smits, Marcel G; Oort, Frans J

2011-10-01

To investigate the effects of termination of short term melatonin treatment on sleep, health, behavior, and parenting stress in children with delayed Dim Light Melatonin Onset. Forty-one children (24 boys, 17 girls; mean age=9.43 years) entered melatonin treatment for 3 weeks and then discontinued treatment by first taking a half dose for 1 week and then stopping completely for another week. Sleep was measured with sleep diaries filled in by parents and with actometers worn by children. Analyses were conducted with linear mixed models. Sleep latency was longer during the stop week compared to the treatment weeks. Sleep start was later and actual sleep time was shorter during the half dose and stop weeks compared to the treatment weeks. Sleep efficiency deteriorated in the stop week. Dim Light Melatonin Onset was earlier after treatment, but this effect disappeared after the stop week. In addition to the effects on sleep, results from questionnaires completed by parents showed that melatonin treatment also had positive effects on children's health and behavior problems and parenting stress. While health deteriorated after treatment discontinuation, the effects on behavior problems and parenting stress remained. Behavior problems at baseline did not influence the effect of melatonin treatment. This study showed that complete termination of treatment after 4 weeks of melatonin use was too early. However, clinicians may advise a lower dose after a successful treatment trial of several weeks. Copyright © 2011 Elsevier B.V. All rights reserved.

Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy compared with a standard 3-week regimen delivered in the UK FAST-Forward Trial.

PubMed

Brunt, A Murray; Wheatley, Duncan; Yarnold, John; Somaiah, Navita; Kelly, Stephen; Harnett, Adrian; Coles, Charlotte; Goodman, Andrew; Bahl, Amit; Churn, Mark; Zotova, Rada; Sydenham, Mark; Griffin, Clare L; Morden, James P; Bliss, Judith M

2016-07-01

FAST-Forward is a phase 3 clinical trial testing a 1-week course of whole breast radiotherapy against the UK standard 3-week regimen after primary surgery for early breast cancer. Two acute skin toxicity substudies were undertaken to test the safety of the test schedules with respect to early skin reactions. Patients were randomly allocated to 40Gy/15 fractions (F)/3-weeks, 27Gy/5F/1-week or 26Gy/5F/1-week. Acute breast skin reactions were graded using RTOG (first substudy) and CTCAE criteria v4.03 (second substudy) weekly during treatment and for 4weeks after treatment ended. Primary endpoint was the proportion of patients within each treatment group with grade ⩾3 toxicity (RTOG and CTCAE, respectively) at any time from the start of radiotherapy to 4weeks after completion. 190 and 162 patients were recruited. In the first substudy, evaluable patients with grade 3 RTOG toxicity were: 40Gy/15F 6/44 (13.6%); 27Gy/5F 5/51 (9.8%); 26Gy/5F 3/52 (5.8%). In the second substudy, evaluable patients with grade 3 CTCAE toxicity were: 40Gy/15F 0/43; 27Gy/5F 1/41 (2.4%); 26Gy/5F 0/53. Acute breast skin reactions with two 1-week schedules of whole breast radiotherapy under test in FAST-Forward were mild. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Respiratory muscle hemodynamic and metabolic adaptations to 16 weeks of training in varsity soccer players: near-infrared spectroscopy measurements during lung function tests (Conference Presentation)

NASA Astrophysics Data System (ADS)

Harris, R. Luke; Grob, Tanya; Sandhu, Komal; Schwab, Timothy

2017-02-01

The purpose of this study was to test the hypothesis that mobile, wireless near-infrared spectroscopy (NIRS) instruments can be used during standard lung function tests to measure adaptations in respiratory muscle metabolism over weeks to months. In eight varsity soccer players at 0 weeks and after 16 weeks of routine training, commercially available mobile, wireless NIRS instruments were used to measure oxygenation and hemodynamics in the sternocleidomastoid (SCM, accessory inspiration muscle). During maximal expiratory pressure (MEP) and forced vital capacity (FVC) maneuvers we determined peak or antipeak changes relative to baseline in oxygenation and hemodynamics: Δ%Sat (muscle oxygen saturation), ΔtHb (total hemoglobin), ΔO2Hb (oxygenated hemoglobin), and ΔHHb (deoxygenated hemoglobin). Subjects reported that the average training load was 13.3 h/week during the 16 study weeks, compared to 10.4 h/week during 12 prior weeks. After 16 weeks of training compared to 0 weeks we found statistically significant increases in SCM Δ%Sat (57.7%), ΔtHb (55.3%), and ΔO2Hb (56.7%) during MEP maneuvers, and in SCM Δ%Sat (64.8%), ΔtHb (29.4%), and ΔO2Hb (51.6%) during FVC maneuvers. Our data provide preliminary evidence that NIRS measurements during standard lung function tests are sufficiently sensitive to detect improvements or declines in respiratory muscle metabolism over periods of weeks to months due to training, disease, and rehabilitation exercise.

Understanding Infidelity: An Interview with Gerald Weeks

ERIC Educational Resources Information Center

Smith, Travis

2011-01-01

In this interview, Gerald Weeks shares his expertise on the topic of infidelity and couples counseling. Dr. Weeks defines infidelity, presents assessment strategies for treating the issue of infidelity, and discusses an intersystemic model for infidelity treatment when counseling couples. Dr. Weeks also provides insight into common mistakes made…

26 CFR 7.105-2 - Substantial gainful activity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... this nature generally are performed for remuneration or profit. Some weeks the taxpayer works 10 hours, some weeks 40 hours, and over the year the taxpayer works an average of 20 hours per week. Even though... the duties performed and the average number of hours worked per week conclusively establish the...

Morbidity and Mortality Weekly Report. Volume 61, Number 33

ERIC Educational Resources Information Center

Moolenaar, Ronald L., Ed.

2012-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This…

Morbidity and Mortality Weekly Report. Volume 61, Number 13

ERIC Educational Resources Information Center

Moolenaar, Ronald L., Ed.

2012-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This…

78 FR 57463 - National Farm Safety and Health Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

... National Farm Safety and Health Week, 2013 By the President of the United States of America A Proclamation... to generation--is central to the American story. During National Farm Safety and Health Week, we... Safety and Health Week. I call upon the agencies, organizations, businesses, and extension services that...

20 CFR 617.11 - Qualifying requirements for TRA.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the training program have been satisfied. (3)-(4) [Reserved] (b) First week of entitlement. The first... qualify for TRA for any week of unemployment an individual must meet each of the following requirements of... certification. (iii) Wages and employment. (A) In the 52-week period (i.e., 52 consecutive calendar weeks...

7 CFR 59.302 - Mandatory weekly reporting for lambs.

Code of Federal Regulations, 2011 CFR

2011-01-01

... on the second reporting day of the current slaughter week, and the following information applicable.... central time on the first reporting day of the current slaughter week categorized to clearly delineate...)(7) of this section on the second reporting day of the current slaughter week and information...

77 FR 42941 - Captive Nations Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... Week, 2012 Memorandum of July 11, 2012--Delegation of Certain Functions Under Section 570(e) of the..., 2012 Captive Nations Week, 2012 By the President of the United States of America A Proclamation When President Dwight D. Eisenhower first proclaimed Captive Nations Week amidst an escalating Cold War, he...

77 FR 32877 - National Hurricane Preparedness Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... Hurricane Preparedness Week, 2012 By the President of the United States of America A Proclamation Every year... tornadoes. During National Hurricane Preparedness Week, we rededicate ourselves to preventing loss of life... informed public. This week, I encourage all Americans living in areas that could be impacted by a hurricane...

75 FR 29393 - Small Business Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... Business Week, 2010 By the President of the United States of America A Proclamation Small business owners... past 15 years, they have created the majority of new private sector jobs. During Small Business Week... small business owners acquire loans and hire workers. This week, we celebrate the role of entrepreneurs...

76 FR 30495 - National Safe Boating Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-25

... Safe Boating Week, 2011 By the President of the United States of America A Proclamation As Americans... to watergoers. National Safe Boating Week is an opportunity to highlight the importance of safety... can save lives. Each year for National Safe Boating Week, the United States Coast Guard partners with...

75 FR 62307 - Fire Prevention Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

... Prevention Week, 2010 By the President of the United States of America A Proclamation During Fire Prevention Week, we reaffirm the importance of fire safety and awareness, and we pay tribute to our firefighters..., injuries, and lives lost to fire and its consequences. Fire Prevention Week also calls our attention to the...

78 FR 30727 - Emergency Medical Services Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

... Medical Services Week, 2013 By the President of the United States of America A Proclamation In every.... During Emergency Medical Services Week, we pause to offer our gratitude to these remarkable men and women, whose dedication is fundamental to our society's well-being. In recent weeks, we have again seen the...

78 FR 24321 - National Volunteer Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-24

... National Volunteer Week, 2013 By the President of the United States of America A Proclamation As Americans.... National Volunteer Week is a time to renew that fundamentally American idea of service and responsibility... other. We pull together. And we move forward as one. During National Volunteer Week, let us tap into...

75 FR 29391 - National Safe Boating Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... Safe Boating Week, 2010 By the President of the United States of America A Proclamation Our Nation's... National Safe Boating Week to practicing safe techniques so boaters of all ages can enjoy this pastime... annually the 7-day period prior to Memorial Day weekend as ``National Safe Boating Week.'' NOW, THEREFORE...

75 FR 77517 - National Influenza Vaccination Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... Part VIII The President Proclamation 8615--National Influenza Vaccination Week, 2010 #0; #0; #0..., 2010 National Influenza Vaccination Week, 2010 By the President of the United States of America A... Week, we remind all Americans that the flu vaccine is safe and effective in preventing the spread of...

77 FR 31151 - World Trade Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... Trade Week, 2012 By the President of the United States of America A Proclamation America has always been... by Americans. During World Trade Week, we reaffirm the essential role exports play in creating jobs... of the United States, do hereby proclaim May 20 through May 26, 2012, as World Trade Week. I...

78 FR 62957 - National Forest Products Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... National Forest Products Week, 2013 By the President of the United States of America A Proclamation Our.... During National Forest Products Week, we celebrate the sustainable uses of America's forests and the... forests will be vital to our progress in the years ahead. This week, we recommit to collaborating across...

75 FR 2049 - National Influenza Vaccination Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... Part IV The President Proclamation 8472--National Influenza Vaccination Week, 2010 #0; #0; #0..., 2010 National Influenza Vaccination Week, 2010 By the President of the United States of America A... vaccinated as well. This week presents a window of opportunity for us to prevent a possible third wave of...

75 FR 28183 - World Trade Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... Trade Week, 2010 By the President of the United States of America A Proclamation For our Nation to... prosperity and which support millions of American jobs. World Trade Week is an opportunity for us to reaffirm... work, ingenuity, optimism, and common purpose. This week, let us renew the enduring principles that...

Morbidity and Mortality Weekly Report. Volume 61, Number 17

ERIC Educational Resources Information Center

Moolenaar, Ronald L., Ed.

2012-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This…

Morbidity and Mortality Weekly Report. Volume 61, Number 31

ERIC Educational Resources Information Center

Moolenaar, Ronald L., Ed.

2012-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This…

75 FR 71523 - National Farm-City Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... National Farm-City Week, 2010 By the President of the United States of America A Proclamation America's... generations. During National Farm-City Week, we recognize the myriad contributions our Nation's farmers and... that graces our tables. During National Farm-City Week, as the bounty of agriculture moves from America...

Morbidity and Mortality Weekly Report. Volume 60, Number 15

ERIC Educational Resources Information Center

Moolenaar, Ronald L., Ed.

2011-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This…

78 FR 72931 - Sunshine Act Meeting Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0001] Sunshine Act Meeting Notice DATES: Weeks of December..., Rockville, Maryland. STATUS: Public and Closed. Week of December 2, 2013 There are no meetings scheduled for the week of December 2, 2013. Week of December 9, 2013--Tentative There are no meetings scheduled for...

Immunogenicity of type 2 monovalent oral and inactivated poliovirus vaccines for type 2 poliovirus outbreak response: an open-label, randomised controlled trial.

PubMed

Zaman, Khalequ; Estívariz, Concepción F; Morales, Michelle; Yunus, Mohammad; Snider, Cynthia J; Gary, Howard E; Weldon, William C; Oberste, M Steven; Wassilak, Steven G; Pallansch, Mark A; Anand, Abhijeet

2018-06-01

Monovalent type 2 oral poliovirus vaccine (mOPV2) and inactivated poliovirus vaccine (IPV) are used to respond to type 2 poliovirus outbreaks. We aimed to assess the effect of two mOPV2 doses on the type 2 immune response by varying the time interval between mOPV2 doses and IPV co-administration with mOPV2. We did a randomised, controlled, parallel, open-label, non-inferiority, inequality trial at two study clinics in Dhaka, Bangladesh. Healthy infants aged 6 weeks (42-48 days) at enrolment were randomly assigned (1:1:1:1) to receive two mOPV2 doses (each dose consisting of two drops [0·1 mL in total] of about 10 5 50% cell culture infectious dose of type 2 Sabin strain) at intervals of 1 week, 2 weeks, 4 weeks (standard or control group), or 4 weeks with IPV (0·5 mL of type 1 [Mahoney, 40 D-antigen units], type 2 [MEF-1, 8 D-antigen units], and type 3 [Saukett, 32 D-antigen units]) administered intramuscularly with the first mOPV2 dose. We used block randomisation, randomly selecting blocks of sizes four, eight, 12, or 16 stratified by study sites. We concealed randomisation assignment from staff managing participants in opaque, sequentially numbered, sealed envelopes. Parents and clinic staff were unmasked to assignment after the randomisation envelope was opened. Laboratory staff analysing sera were masked to assignment, but investigators analysing data and assessing outcomes were not. The primary outcome was type 2 immune response measured 4 weeks after mOPV2 administration. The primary modified intention-to-treat analysis included participants with testable serum samples before and after vaccination. A non-inferiority margin of 10% and p=0·05 (one-tailed) was used. This trial is registered at ClinicalTrials.gov, number NCT02643368, and is closed to accrual. Between Dec 7, 2015, and Jan 5, 2016, we randomly assigned 760 infants to receive two mOPV2 doses at intervals of 1 week (n=191), 2 weeks (n=191), 4 weeks (n=188), or 4 weeks plus IPV (n=190). Immune responses after two mOPV2 doses were observed in 161 (93%) of 173 infants with testable serum samples in the 1 week group, 169 (96%) of 177 in the 2 week group, and 176 (97%) of 181 in the 4 week group. 1 week and 2 week intervals between two mOPV2 doses were non-inferior to 4 week intervals because the lower bound of the absolute differences in the percentage of immune responses were greater than -10% (-4·2% [90% CI -7·9 to -0·4] in the 1 week group and -1·8% [-5·0 to 1·5] in the 2 week group vs the 4 week group). The immune response elicited by two mOPV2 doses 4 weeks apart was not different when IPV was added to the first dose (176 [97%] of 182 infants with IPV vs 176 [97%] of 181 without IPV; p=1·0). During the trial, two serious adverse events (pneumonia; one [1%] of 186 patients in the 1 week group and one [1%] of 182 in the 4 week group) and no deaths were reported; the adverse events were not attributed to the vaccines. Administration of mOPV2 at short intervals does not interfere with its immunogenicity. The addition of IPV to the first mOPV2 dose did not improve poliovirus type 2 immune response. US Centers for Disease Control and Prevention. Copyright © 2018 Elsevier Ltd. All rights reserved.

The Sky This Week, 2016 January 27 - February 2 - Naval Oceanography

Science.gov Websites

Oceanography Ice You are here: Home › USNO › News, Tours & Events › Sky This Week › The Sky This Sky This Week The Sky This Week, 2016 January 27 - February 2 Info The Sky This Week, 2016 January 27 - February 2 Lest we forget. NOFS_Winter_2016_01small.jpg Dome of the Kaj Strand 1.55-meter (61-inch

Weekly Cycle of Lightning: Evidence of Storm Invigoration by Pollution

NASA Technical Reports Server (NTRS)

Bell, Thomas L.; Rosenfeld, Daniel; Kim, Kyu-Myong

2009-01-01

We have examined summertime 1998 2009 U.S. lightning data from the National Lightning Detection Network (NLDN) to look for weekly cycles in lightning activity. As was found by Bell et al. (2008) for rain over the southeast U.S., there is a significant weekly cycle in afternoon lightning activity that peaks in the middle of the week there. The weekly cycle appears to be reduced over population centers. Lightning activity peaks on weekends over waters near the SE U.S. The statistical significance of weekly cycles over the western half of the country is generally small. We found no evidence of a weekly cycle of synoptic-scale forcing that might explain these patterns. The lightning behavior is entirely consistent with the explanation suggested by Bell et al. (2008) for the cycles in rainfall and other atmospheric data from the SE U.S., that aerosols can cause storms to intensify in humid, convectively unstable environments.

Effect of porcine parvovirus serostatus on the reproductive performance of mated gilts in an infected herd.

PubMed

Cutler, R S; Molitor, T W; Leman, A D; Sauber, T E

1982-06-01

Gifts from 2 commercial swine operations (farm A and farm B) that were bred each week were tested for porcine parvovirus antibody. On farm A, 21.9% (weekly, 2% to 35%) of the 657 gilts tested over a 16-week period were seronegative within 1 week of mating. On farm B, 17.7% (weekly, o to 40%) of the 164 gilts tested over a 10 week period were seronegative within 1 week of mating. Eighty-one gilts from farm A which were seronegative at time of mating were retested at the end of the gestation. Of the 81 gilts, 4 1 had developed antibody titers. The litter size decreased by 1.3 live pigs/litter. The percentage of small litters (less than or equal to 6 born alive) in the group that seroconverted was 36.6% compared with 10% in the gilts that remained seronegative throughout gestation.

The Sky This Week - Naval Oceanography Portal

Science.gov Websites

section Advanced Search... Sections Home Time Earth Orientation Astronomy Meteorology Oceanography Ice You . Read More... The Sky This Week, 2018 April 17 - 24 Celebrate Dark-sky Week and Astronomy Day! Read More More... The Sky This Week, 2018 April 3 - 10 April is Astronomy Month...no fooling. Read More... The

76 FR 64400 - Sunshine Federal Register Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

...: Nuclear Regulatory Commission, [NRC-2011- 0006]. DATE: Weeks of October 17, 24, 31, November 7, 14, 21... meeting will be webcast live at the Web address-- http://www.nrc.gov . Week of October 24, 2011--Tentative There are no meetings scheduled for the week of October 24, 2011. Week of October 31, 2011--Tentative...

76 FR 11290 - Sunshine Federal Register Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... MEETINGS: Nuclear Regulatory Commission. DATES: Weeks of February 28, March 7, 14, 21, 28, April 4, 2011... the Web address--http:// www.nrc.gov . Week of March 7, 2011--Tentative There are no meetings scheduled for the week of March 7, 2011. Week of March 14, 2011--Tentative There are no meetings scheduled...

76 FR 66095 - Sunshine Federal Register Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

...: Nuclear Regulatory Commission, [NRC-2011- 0006]. DATE: Weeks of October 24, 31, November 7, 14, 21, 28... and Closed. Week of October 24, 2011 There are no meetings scheduled for the week of October 24, 2011... live at the Web address-- http://www.nrc.gov . Week of November 7, 2011--Tentative There are no...

77 FR 73694 - Sunshine Federal Register Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

...: Nuclear Regulatory Commission [NRC-2012- 0002]. DATES: Weeks of December 10, 17, 24, 31, 2012, January 7..., 2012. Week of December 24, 2012--Tentative There are no meetings scheduled for the week of December 24..., 2012. Week of January 7, 2013--Tentative Tuesday, January 8, 2013 9:00 a.m. Briefing on Fort Calhoun...

Morbidity and Mortality Weekly Report. Volume 60, Number 23

ERIC Educational Resources Information Center

Centers for Disease Control and Prevention, 2011

2011-01-01

The "Morbidity and Mortality Weekly Report" ("MMWR") Series is prepared by the Centers for Disease Control and Prevention (CDC). Data presented by the Notifiable Disease Data Team and 122 Cities Mortality Data Team in the weekly "MMWR" are provisional, based on weekly reports to CDC by state health departments. This issue of "Morbidity and…

3 CFR 9017 - Proclamation 9017 of September 13, 2013. National Farm Safety and Health Week, 2013

Code of Federal Regulations, 2014 CFR

2014-01-01

... Farm Safety and Health Week, 2013 9017 Proclamation 9017 Presidential Documents Proclamations Proclamation 9017 of September 13, 2013 Proc. 9017 National Farm Safety and Health Week, 2013By the President.... During National Farm Safety and Health Week, we celebrate our agricultural producers' values, experiences...

47 CFR 73.3594 - Local public notice of designation for hearing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... once daily for 4 days in the second week immediately following the release of the FCC's order... newspaper once a week for 3 consecutive weeks within the 4-week period immediately following the release of... 47 Telecommunication 4 2011-10-01 2011-10-01 false Local public notice of designation for hearing...

47 CFR 73.3594 - Local public notice of designation for hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... once daily for 4 days in the second week immediately following the release of the FCC's order... newspaper once a week for 3 consecutive weeks within the 4-week period immediately following the release of... 47 Telecommunication 4 2010-10-01 2010-10-01 false Local public notice of designation for hearing...

Adult Learning Week Planning Packet.

ERIC Educational Resources Information Center

New York State Education Dept., Albany. Office of Adult Learning Services.

Each year one week is designated by the Governor of New York as Adult Learning Week because of the growing importance of adult education to society and the economy of New York State. The major purpose of Adult Learning Week is to promote greater public awareness of the availability and variety of learning opportunities for adults. In practical…

Four Day School Week for Small Rural Schools. Small Schools Fact Sheet.

ERIC Educational Resources Information Center

Culbertson, Jeanne

The four-day school week is a Monday-Thursday or Tuesday-Friday alternative to the traditional four-day week, which can be implemented with many variables and differing objectives. The four-day week saves heating, transportation, maintenance, electricity and some instructional costs, while providing better educational opportunities and use of…

76 FR 22033 - National Maritime Week Tugboat Races, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

... Maritime Week Tugboat Races, Seattle, WA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of... Maritime Week Tugboat Races in Elliott Bay, WA from 12 p.m. through 4:30 p.m. on May 14, 2011. This action... will enforce the Special Local Regulation for the annual National Maritime Week Tugboat Races, Seattle...

77 FR 31147 - National Safe Boating Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... Safe Boating Week, 2012 By the President of the United States of America A Proclamation For generations... friends and family a well- loved tradition. During National Safe Boating Week, we renew our commitment to... mark National Safe Boating Week, let us reflect on that important mission and resolve to do our part to...

75 FR 64617 - National Forest Products Week, 2010

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... National Forest Products Week, 2010 By the President of the United States of America A Proclamation Since... settings for contemplation. As we mark the 50th anniversary of National Forest Products Week, we recognize... our daily lives, from the houses we live in to the paper we write on. National Forest Products Week...

78 FR 24323 - National Park Week, 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-24

... National Park Week, 2013 By the President of the United States of America A Proclamation For generations... something to be used up, but as a treasure to be passed on. During National Park Week, we celebrate the... spaces embody the best of the American spirit, and they summon us to experience it firsthand. This week...

77 FR 65095 - National Forest Products Week, 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-24

... National Forest Products Week, 2012 By the President of the United States of America A Proclamation Since... Products Week, we celebrate sustainable uses of the lands we share and recommit to protecting them for... making our Nation what it is today, and they remain vital to our progress in the years ahead. This week...

75 FR 8563 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-25

...-AA00 Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA AGENCY: Coast Guard... Fleet Week Maritime Festival. Entry into, transit through, mooring, or anchoring within these zones is... Fleet Week Maritime Festival. This safety zone is necessary as these events have historically resulted...

75 FR 71638 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliot Bay, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

...-AA00 Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliot Bay, Seattle, WA AGENCY: Coast Guard...) entitled ``Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliot Bay, Seattle, WA'' (Docket number...; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington. (a) Location. The following...

Storytelling on Capitol Hill: Recollections and Recommendations on Tribal College Week

ERIC Educational Resources Information Center

Máxkii, Robin

2016-01-01

Every winter, during the second week of February, tribal college presidents, student representatives, and a myriad of others passionate about tribal education trek out to Washington, DC to visit Capitol Hill for National Tribal College Week. This week, also referred to as the American Indian Higher Education Consortium (AIHEC) Winter Meeting, is…

75 FR 24400 - National Maritime Week Tugboat Races, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

... Maritime Week Tugboat Races, Seattle, WA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of... Maritime Week Tugboat Races in Elliott Bay, WA on May 8, 2010. This action is necessary to ensure the... the Special Local Regulation for the annual National Maritime Week Tugboat Races, Seattle, WA in 33...

Making the Connection: Some People, Programs and Ideas Highlighted by Adult Learners Week 2001.

ERIC Educational Resources Information Center

Cross, John; Della, Jennie

This document profiles selected people, programs, and ideas highlighted by Australia's Adult Learners Week 2001 and begins with these papers: "Adult Learners Week: A National Celebration" (Ned Dennis); "A Message from the Adult Learners Week Patron" (Peter Hollingworth); "A Message of Support from the Prime Minister of…

3 CFR 8605 - Proclamation 8605 of November 19, 2010. National Farm-City Week, 2010

Code of Federal Regulations, 2011 CFR

2011-01-01

... Farm-City Week, 2010 8605 Proclamation 8605 Presidential Documents Proclamations Proclamation 8605 of November 19, 2010 Proc. 8605 National Farm-City Week, 2010By the President of the United States of America... sustainable way of life for future generations. During National Farm-City Week, we recognize the myriad...

76 FR 72605 - National Farm-City Week, 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... National Farm-City Week, 2011 By the President of the United States of America A Proclamation With tenacity... National Farm-City Week, we celebrate the essential contributions of farmers and ranchers to our country's... November 18 through November 24, 2011, as National Farm-City Week. I call upon all Americans to reflect on...

PERSISTENT EFFECTS OF REPEATED INHALATION OF TOLUENE: 4 WEEKS VS. 13 WEEKS.

EPA Science Inventory

Understanding and predicting the extent of neurotoxic damage from repeated exposure to volatile organic compounds (VOCs) is a problem for many EPA programs. Eighty adult, male Long-Evans rats inhaled toluene (0, 10, 100, or 1000 ppm) 6 hr/day, 5 days/week for 4 weeks in a systema...

Habituation of 10-year-old hockey players to treadmill skating.

PubMed

Lockwood, Kelly L; Frost, Gail

2007-05-01

This study assessed changes in selected physiological and kinematic variables over 6 weeks of treadmill skating in an effort to understand the process of habituation to this novel training modality. Seven male, Atom-A hockey players who were injury-free and had no previous treadmill skating experience participated in the study. Players performed four 1-min skating bouts at progressively increasing speeds, each week, for 6 weeks. One speed (10.5 km/h) was repeated weekly to allow for assessment of the habituation process. Our criteria for habituation were: a decrease in stride rate, heart rate and rating of perceived exertion, and an increase in stride length, trunk angle and vertical movement of the centre of mass, leading to a plateau, over the course of the 6-week study. Significant decreases were seen in stride rate, heart rate and ratings of perceived exertion, and significant increases were found in stride length. Some of these changes were evident after only one week of training and all were present by week 4. After 6 weeks (24 min) of exposure to treadmill skating, all participants displayed a visibly more efficient skating style.

Early consumption of human milk oligosaccharides is inversely related to subsequent risk of respiratory and enteric disease in infants.

PubMed

Stepans, Mary Beth Flanders; Wilhelm, Susan L; Hertzog, Melody; Rodehorst, T Kim Callahan; Blaney, Susan; Clemens, Beth; Polak, Josef J; Newburg, David S

2006-01-01

A pilot study tested the relationship between human milk oligosaccharide consumption, oligosaccharide content of feces, and subsequent disease in breastfed infants. Forty-nine (49) mother-infant pairs provided milk and fecal samples 2 weeks postpartum; infant health was assessed through 2, 6, 12, and 24 weeks. LNF-II (lacto-N-fucopentaose II), a major human milk oligosaccharide, was measured to represent levels of total oligosaccharides consumed in milk and remaining in feces. LNF-II levels in milk at 2 weeks postpartum were associated with fewer infant respiratory problems by 6 weeks (p = 0.010), as were LNF-II levels in infant feces (p = 0.003). LNF-II levels in milk at 2 weeks were also associated with fewer respiratory problems by 12 weeks (p = 0.038), and fewer enteric problems by 6 weeks (p = 0.004) and 12 weeks (p = 0.045). Thus, consumption of human milk oligosaccharides through breastfeeding, represented by LNF-II, was associated with less reported respiratory and gastrointestinal illness in infants.

Optical analysis of cirrhotic liver by near infrared time resolved spectroscopy

NASA Astrophysics Data System (ADS)

Nishio, Toshihiro; Kitai, Toshiyuki; Miwa, Mitsuharu; Takahashi, Rei; Yamaoka, Yoshio

1999-10-01

The severity of liver cirrhosis was related with the optical properties of liver tissue. Various grades of liver cirrhosis were produced in rats by intraperitoneal injection of thioacetamide (TAA) for different periods: 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Optical properties of the liver, absorption, coefficient ((mu) a) and scattering coefficient (microsecond(s) '), were measured by near-infrared time- resolved spectroscopy. Histological examination confirmed cirrhotic changes in the liver, which were more severe in rats with TAA administration for longer periods. The (mu) a increased in 4- and 8-week rats, and then decreased in 12- and 16-week rats. The (mu) a of blood-free liver decreased as liver cirrhosis progressed. The hemoglobin content in the liver calculated from the (mu) a values increased in 4- and 8-week rats and decreased in 12- and 16-week rats. The microsecond(s) ' decreased in the cirrhotic liver, probably reflecting the decrease in the mitochondria content. It was shown that (mu) a and microsecond(s) ' determination is useful to assess the severity of liver cirrhosis.

Advertising, price, income and publicity effects on weekly cigarette sales in New Zealand supermarkets.

PubMed

Laugesen, M; Meads, C

1991-01-01

Total cigarettes (all brands) sold weekly by a panel of 60 New Zealand supermarkets were monitored electronically for 42 weeks, a period when cigarette advertisements were in plain format with strong, varied disease warnings. Real cigarette price, newspaper advertising of old, regular and upmarket brands, and the number of newspaper news items on smoking issues were inversely associated with cigarette sales. Tending to increase total sales (all brands) were: more non-shopping days in the current week, and in the week following; volume of grocery items purchased, to indicate income and store traffic; and real advertising expenditure in newspapers for new downmarket cigarette brands, particularly one heavily-advertised brand (Peter Jackson) which was in late 1989 smoked by 4% of teenage smokers. All factors when interacting, explained 93% of changes in weekly cigarette sales. Most of the change occurred in the same week, and was 90% in place after a further 3 weeks. Newspapers, by doubling news coverage of smoking issues or by banning cigarette advertisements, can lower cigarette consumption as much as can a 10% price increase.

Effect of winter school breaks on influenza-like illness, Argentina, 2005-2008.

PubMed

Garza, Roberto C; Basurto-Dávila, Ricardo; Ortega-Sanchez, Ismael R; Carlino, Luis Oreste; Meltzer, Martin I; Albalak, Rachel; Balbuena, Karina; Orellano, Pablo; Widdowson, Marc-Alain; Averhoff, Francisco

2013-06-01

School closures are used to reduce seasonal and pandemic influenza transmission, yet evidence of their effectiveness is sparse. In Argentina, annual winter school breaks occur during the influenza season, providing an opportunity to study this intervention. We used 2005-2008 national weekly surveillance data of visits to a health care provider for influenza-like illness (ILI) from all provinces. Using Serfling-specified Poisson regressions and population-based census denominators, we developed incidence rate ratios (IRRs) for the 3 weeks before, 2 weeks during, and 3 weeks after the break. For persons 5-64 years of age, IRRs were <1 for at least 1 week after the break. Observed rates returned to expected by the third week after the break; overall decrease among persons of all ages was 14%. The largest decrease was among children 5-14 years of age during the week after the break (37% lower IRR). Among adults, effects were weaker and delayed. Two-week winter school breaks significantly decreased visits to a health care provider for ILI among school-aged children and nonelderly adults.

Effect of Winter School Breaks on Influenza-like Illness, Argentina, 2005–2008

PubMed Central

Basurto-Dávila, Ricardo; Ortega-Sanchez, Ismael R.; Carlino, Luis Oreste; Meltzer, Martin I.; Albalak, Rachel; Balbuena, Karina; Orellano, Pablo; Widdowson, Marc-Alain; Averhoff, Francisco

2013-01-01

School closures are used to reduce seasonal and pandemic influenza transmission, yet evidence of their effectiveness is sparse. In Argentina, annual winter school breaks occur during the influenza season, providing an opportunity to study this intervention. We used 2005–2008 national weekly surveillance data of visits to a health care provider for influenza-like illness (ILI) from all provinces. Using Serfling-specified Poisson regressions and population-based census denominators, we developed incidence rate ratios (IRRs) for the 3 weeks before, 2 weeks during, and 3 weeks after the break. For persons 5–64 years of age, IRRs were <1 for at least 1 week after the break. Observed rates returned to expected by the third week after the break; overall decrease among persons of all ages was 14%. The largest decrease was among children 5–14 years of age during the week after the break (37% lower IRR). Among adults, effects were weaker and delayed. Two-week winter school breaks significantly decreased visits to a health care provider for ILI among school-aged children and nonelderly adults. PMID:23735682

PubMed Central

Labrecque, M.; Rhéault, C.; Bergeron, M.; Bergeron, S.; Paquet, F.

1995-01-01

OBJECTIVE: To assess the effectiveness of a tetanus immunization poster at a medical clinic in encouraging patients to request immunization against tetanus with d2T5. DESIGN: Quasi-experimental study. SETTING: The Family Medicine Unit (F.M.U.) at the Centre hospitalier de l'Université Laval (C.H.U.L.), a tertiary hospital in the region of Quebec City. PARTICIPANTS: All patients over 7 years of age at CHUL's FMU between February 22 and March 19, 1993. INTERVENTIONS: Poster promoting tetanus immunization displayed in waiting room during test weeks 2 and 4 and withdrawn during control weeks 1 and 3. MAIN OUTCOME MEASURE: Proportion of patients vaccinated with d2T5. RESULTS: The proportion of patients vaccinated during the test weeks was the same as the proportion vaccinated during the control weeks. Week 1: 1/507 (0.20); Week 2: 1/394 (0.25); Week 3: 1/441 (0.23); Week 4: 1/486 (0.21). CONCLUSION: The presence of the posters in the waiting room had no impact on tetanus immunization at CHUL's FMU. Images Figure 1, Figure 2 PMID:7534530

The Seated Inactivity Trial (SIT): Physical Activity and Dietary Outcomes Associated With 8 Weeks of Imposed Sedentary Time.

PubMed

Cull, Brooke J; Haub, Mark D; Rosenkranz, Richard R; Lawler, Thomas; Rosenkranz, Sara K

2016-03-01

Sedentary time is an independent risk factor for chronic diseases and mortality. It is unknown whether active adults alter their dietary and/or physical activity behaviors in response to imposed sedentary time, possibly modifying risk. The aim of this study was to determine whether imposed sedentary time would alter typical behaviors of active adults. Sixteen physically active, young adults were randomized to the no-intervention control (CON, n = 8) group or the sedentary-intervention (SIT, n = 8) group. SIT participants attended monitored sedentary sessions (8 wk, 10 h/wk). Assessments including diet and physical activity occurred at baseline, week 4, and week 9. There were no differences (P > .05) between CON and SIT groups for step counts or time spent in sedentary, light, moderate, or vigorous physical activity when comparing a week during imposed sedentary time (week 4) to baseline and week 9. At week 4, caloric intake was not different from baseline (P > .05) in either group. Caloric intake decreased significantly (P > .05) in SIT from baseline to week 9. Active adults did not alter physical activity or dietary behaviors during the imposed sedentary intervention. However, SIT reduced caloric intake from baseline to week 9, indicating a possible compensatory response to imposed sitting in active adults.

Quantitative analysis of development and aging of genital corpuscles in glans penis of the rat.

PubMed

Shiino, Mizuho; Hoshi, Hideo; Kawashima, Tomokazu; Ishikawa, Youichi; Takayanagi, Masaaki; Murakami, Kunio; Kishi, Kiyoshi; Sato, Fumi

2015-02-01

The aim of the present postnatal developmental study was to determine densities of unique genital corpuscles (GCs) in glans penis of developing and aged rats. GCs were identified as corpuscular endings consisting of highly branched and coiled axons with many varicosities, which were immunoreactive for protein gene product 9.5. In addition, GCs were immunoreactive for calcitonin gene-related peptide and substance P, but not for vasoactive intestinal polypeptide and neuropeptide Y. GCs were not found in the glans penis of 1 week old rats. Densities of GCs were low at 3 weeks, significantly increased at 5 and 10 weeks, reached the peak of density at 40 weeks, and tended to decrease at 70 and 100 weeks. Sizes of GCs were small in 3 weeks old rats, increased at 5 and 10 weeks, reached the peak-size at 40 weeks and reduced in size at 70 and 100 weeks. Considering sexual maturation of the rat, the results reveal that GCs of the rat begins to develop postnatal and reaches to the peak of their development after puberty and continues to exist until old age, in contrast to prenatal and early postnatal development of other sensory receptors of glabrous skin. Copyright © 2014 Elsevier Ltd. All rights reserved.

Salt and stress synergize H. pylori-induced gastric lesions, cell proliferation, and p21 expression in Mongolian gerbils.

PubMed

Gamboa-Dominguez, Armando; Ubbelohde, Tom; Saqui-Salces, Milena; Romano-Mazzoti, Luis; Cervantes, Minerva; Domínguez-Fonseca, Claudia; de la Luz Estreber, Maria; Ruíz-Palacios, Guillermo M

2007-06-01

Our aim was to determine if salt and stress enhance Helicobacter pylori (Hp) lesions in Meriones unguiculatus. Two hundred seventy-eight pathogen-free gerbils were allocated to seven groups: Hp-Sydney strain (45), 8% higher-salt diet (38), stress (60% space reduction/water immersion; 36), Hp + salt (33), Hp + stress (34), N-methyl-N-nitro-N-nitrosoguanidine (34), and sham (58). Gerbils were sacrificed at 1 week (67), 12 weeks (73), 52 weeks (65), and 68 weeks (73). Sydney, Padova, and Lauren classifications were blindly used. Proliferation, p53, p21, and apoptosis were assessed. Follicular active gastritis (grade 2/3) was observed in 10% of Hp gerbils, 38% of Hp + salt gerbils, and 29% of Hp + stress gerbils at 52 weeks and 67%, 83%, and 43% at 68 weeks (P < 0.05). Heterotopic proliferative glands were identified in synergy groups from 52 weeks, with increases in their number and size by 68 weeks. Higher proliferative rates were observed in Hp+salt gerbils (P < 0.0001), and p21 overexpression in Hp+salt and Hp+stress gerbils (both P's < 0.0001), by 68 weeks, without p53 increases. We conclude that salt and stress synergize Hp damage and increase pseudo-invasive gland foci.

A Telephone-based Physiotherapy Intervention for Patients with Osteoarthritis of the Knee

PubMed Central

Odole, Adesola C.; Ojo, Oluwatobi D.

2013-01-01

This study assessed the effects of a 6-week telephone based intervention on the pain intensity and physical function of patients with knee osteoarthritis (OA), and compared the results to physiotherapy conducted in the clinic. Fifty randomly selected patients with knee OA were assigned to one of two treatment groups: a clinic group (CG) and a tele-physiotherapy group (TG). The CG received thrice-weekly physiotherapist administered osteoarthritis-specific exercises in the clinic for six weeks. The TG received structured telephone calls thrice-weekly at home, to monitor self-administered osteoarthritis-specific exercises. Participants’ pain intensity and physical function were assessed at baseline, two, four, and six weeks, in the clinic environment. Within group comparison showed significant improvements across baseline, and at weeks two, four, and six for both TG and CG’s pain intensity and physical function. Between-group comparison of CG and TG’s pain intensity and physical function at baseline and weeks two, four, and six showed no significant differences. This study demonstrated that a six-week course of structured telephone calls thrice-weekly to patients at their home, to monitor self-administered osteoarthritis-specific exercises for patients with knee OA (i.e., tele-physiotherapy) achieved comparable results to physiotherapy conducted in the clinic. PMID:25945214

Birth weight by gestational age in twin pregnancies: analysis of 661 pairs.

PubMed

Hsieh, T T; Chen, C J; Hsu, J J

1992-02-01

The mortality of twin infants is four to five times higher than that of singletons, and one-half to two-thirds of all twins weigh < 2,500 g at birth. The appropriate interpretation of fetal growth throughout pregnancy is dependent upon the availability of adequate standards. We reviewed 661 pairs of live twin infants born at Chang Gung Memorial Hospital from 1979 to 1990. The frequency of twin births was 1.17% (1:86), and the ratio of males to females was 1.03. The frequency of preterm births (< 37 weeks) was 36.9%, the frequency of low birth weight (< 2,500 g) was 47.9% and very low birth weight (< 1,500 g) was 6.7%. A fetus grows most rapidly from the 32nd to the 35th week of gestation (200 g per week). The growth was 145 g per week from the 28th to the 32nd week and from the 35th to the 38th week of gestation. After the 38th week, the mean birth weight increased by only 35 g per week. Compared with a singleton birth, the mean birth weight of twins was about 100 g lighter during the 28th to the 32nd week, then the difference increased gradually to about 500 g at term.

2-Dimensional changes of the soft tissue profile of augmented and non-augmented human extraction sockets: a randomized pilot study.

PubMed

Flügge, Tabea; Nelson, Katja; Nack, Claudia; Stricker, Andres; Nahles, Susanne

2015-04-01

This study identified the soft tissue changes of the alveolar ridge at different time points within 12 weeks after tooth extraction with and without socket augmentation. In 38 patients with single tooth extractions, 40 sockets were augmented and 39 extraction sockets were not augmented. At 2, 4, 6, 8 and 12 weeks impressions were taken and casts digitized with a laser scanner. The horizontal and vertical changes were compared between augmented and non-augmented sites. A p-value <0.05 was considered statistically significant. The mean changes of augmented sockets were between 0.4 mm (2 weeks) and 0.8 mm (12 weeks). In non-augmented sockets changes of 0.7 mm (2 weeks) and of 1.0 mm (12 weeks) were demonstrated. The mean values differed significantly between the buccal and oral region (p < 0.01). Overall, there were significant differences of the mean dimensional changes regarding time (p < 0.01) and augmentation (p < 0.01). Augmented sockets showed less resorption within 4 weeks after extraction compared to non-augmented sockets. Non-augmented sockets showed a continuous dimensional loss with a great variation over 12 weeks whereas augmented sockets had the highest degree of resorption between 4 and 6 weeks. At 12 weeks a comparable resorption in augmented and non-augmented sockets was observed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Dose-dense weekly chemotherapy in advanced ovarian cancer: An updated meta-analysis of randomized controlled trials.

PubMed

Marchetti, C; De Felice, F; Di Pinto, A; D'Oria, O; Aleksa, N; Musella, A; Palaia, I; Muzii, L; Tombolini, V; Benedetti Panici, P

2018-05-01

The use of dose-dense weekly chemotherapy in the management of advanced ovarian cancer (OC) remains controversial. The aim of this meta-analysis was to evaluate the efficacy of dose-dense regimen to improve clinical outcomes in OC patients with the inclusion of new trials. For this updated meta-analysis, PubMed Medline and Scopus databases and meeting proceedings were searched for eligible studies with the limitation of randomized controlled trials, comparing dose-dense chemotherapy versus standard treatment. Trials were grouped in two types of dose-dense chemotherapy: weekly dose-dense (both paclitaxel and carboplatin weekly administration) and semi-weekly dose-dense (weekly paclitaxel and three weekly carboplatin administration). Data were extracted independently and were analyzed using RevMan statistical software version 5.3 (http://www.cochrane.org). Primary end-point was progression-free survival (PFS). Four randomized controlled trials comprising 3698 patients were identified as eligible. Dose-dense chemotherapy had not a significant benefit on PFS (HR 0.92, 95% CI 0.81-1.04, p = 0.20). When the analysis was restricted to both weekly and semi-weekly dose-dense data, a no significant interaction between dose-dense and standard regimen was confirmed (HR 1.01, 95% CI 0.93-1.10 and HR 0.82, 95% CI 0.63-1.08, respectively). In the absence of PFS superiority of dose-dense schedule, three weekly schedule should remain the standard of care for advanced OC. Copyright © 2018 Elsevier B.V. All rights reserved.

What Are the Clinical Implications of New Onset or Worsening Anxiety During the First Two Weeks of SSRI Treatment for Depression?

PubMed Central

Gollan, Jackie K; Fava, Maurizio; Kurian, Benji; Wisniewski, Stephen R.; Rush, A. John; Daly, Ella; Miyahara, Sachiko; Trivedi, Madhukar H.

2013-01-01

Objective To evaluate the prevalence of new onset or worsening of anxiety symptoms, as well as their clinical implications, during the first two weeks of Selective Serotonin Reuptake Inhibitor (SSRI) pharmacotherapy for depression. Method Adult outpatients with non-psychotic major depressive disorder were enrolled in an 8-week acute phase SSRI treatment trial at 15 clinical sites across the US. Worsening anxiety was defined as a greater than 2 point increase on the Beck Anxiety Inventory (BAI) between baseline and Week 2. New onset of anxiety symptoms was ascribed when the BAI baseline rating was 0 and the Week 2 value was greater or equal to 2 points on the BAI. Results Overall, after two weeks of treatment, 48.8% (98 of 201 participants) reported improvement in anxiety symptoms, 36.3% (73 of 201) reported minimal symptom change, and 14.9% (30 of 201) reported worsening of anxiety symptoms. No association was found between change in anxiety symptoms within the first two weeks and change in depressive symptoms or remission at the end of 8 weeks of treatment. For participants with clinically meaningful anxiety symptoms at baseline, however, worsening of anxiety during the first two weeks of treatment was associated with worsening depressive symptoms by 8 weeks (p = .054). Conclusions The trajectory of anxiety symptom change early in SSRI treatment is an important indicator of eventual outcome for outpatients with major depression and baseline anxiety symptoms. PMID:22147631

Serum concentrations of oestradiol and progesterone and frequency of sexual behaviour during the normal oestrous cycle in the snow leopard (Panthera uncia).

PubMed

Schmidt, A M; Hess, D L; Schmidt, M J; Lewis, C R

1993-05-01

Serum oestradiol and progesterone concentrations were measured at weekly intervals for six months, and correlated with daily behavioural observations in two adult female snow leopards (Panthera uncia). Three oestradiol peaks (> 21 pg ml-1; interval 3.6 weeks) were identified in a snow leopardess housed alone (two more were probably missed because of the weekly sampling schedule), and three oestradiol peaks were identified in a snow leopardess housed with a male as a breeding pair (interval 6 weeks). Daily frequencies of feline reproductive behaviour averaged 1.77 observations per observation period during weeks of high oestradiol and 0.62 during weeks of low oestradiol. Progesterone concentrations did not rise above baseline values (< 2 ng ml-1) in the isolated animal, but 6 weeks of high progesterone concentrations (4.9-38.8 ng ml-1) was recorded in the paired snow leopardess following mating. No offspring were produced. Snow leopards were observed daily for an additional 4.5 years. Sexual behaviour peaks could be clearly identified from December through April, and average daily sexual behaviour scores were higher during these months than during the rest of the year. Intervals between sexual behaviour peaks for the isolated snow leopardess averaged 3.03 weeks. The sexual behaviour of the paired snow leopards decreased for 8-9 weeks following mating when no offspring were produced, and decreased for 13 weeks in one year when a single cub was born.

Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain.

PubMed

Chye, Cien-Leong; Liang, Cheng-Loong; Lu, Kang; Chen, Ya-Wen; Liliang, Po-Chou

2015-01-01

Chronic hip pain is a common symptom experienced by many people. Often, surgery is not an option for patients with multiple comorbidities, and conventional drugs either have many side effects or are ineffective. Pulsed radiofrequency (PRF) is a new method in the treatment of pain. We attempt to compare the efficacy of PRF relative to conservative management for chronic hip pain. Between August 2011 and July 2013, 29 patients with chronic hip pain were divided into two groups (PRF and conservative treatment) according to consent or refusal to undergo PRF procedure. Fifteen patients received PRF of the articular branches of the femoral and obturator nerves, and 14 patients received conservative treatment. Visual analog scale (VAS), Oxford hip scores (OHS), and pain medications were used for outcome measurement before treatment and at 1 week, 4 weeks, and 12 weeks after treatment. At 1 week, 4 weeks, and 12 weeks after treatment initiation, improvements in VAS were significantly greater with PRF. Improvements in OHS were significantly greater in the PRF group at 1 week, 4 weeks, and 12 weeks. Patients in the PRF group also used less pain medications. Eight subjects in the conservative treatment group switched to the PRF group after 12 weeks, and six of them had >50% improvement. When compared with conservative treatment, PRF of the articular branches of the femoral and obturator nerves offers greater pain relief for chronic hip pain and can augment physical functioning.

GC-MS Metabolomics Identifies Metabolite Alterations That Precede Subclinical Mastitis in the Blood of Transition Dairy Cows.

PubMed

Dervishi, Elda; Zhang, Guanshi; Dunn, Suzanna M; Mandal, Rupasri; Wishart, David S; Ametaj, Burim N

2017-02-03

The objectives of this study were to determine alterations in the serum metabolites related to amino acid (AA), carbohydrate, and lipid metabolism in transition dairy cows before diagnosis of subclinical mastitis (SCM), during, and after diagnosis of disease. A subclinical mastitis case was determined as a cow having somatic cell count (SCC) > 200 000/mL of milk for two or more consecutive reports. Blood samples were collected from 100 Holstein dairy cows at five time points at -8 and -4 weeks before parturition, at the week of SCM diagnosis, and +4 and +8 weeks after parturition. Twenty healthy control cows (CON) and six cows that were diagnosed with SCM were selected for serum analysis with GC-MS. At -8 weeks a total of 13 metabolites were significantly altered in SCM cows. In addition, at the week of SCM diagnosis 17 metabolites were altered in these cows. Four weeks after parturition 10 metabolites were altered in SCM cows and at +8 weeks 11 metabolites were found to be different between the two groups. Valine (Val), serine (Ser), tyrosine (Tyr), and phenylalanine (Phe) had very good predictive abilities for SCM and could be used at -8 weeks and -4 weeks before calving. Combination of Val, isoleucine (Ile), Ser, and proline (Pro) can be used as diagnostic biomarkers of SCM during early stages of lactation at +4 to +8 weeks after parturition. In conclusion, SCM is preceded and followed by alteration in AA metabolism.

Ten month outcome of cognitive behavioural therapy v. interpersonal psychotherapy in patients with major depression: a randomised trial of acute and maintenance psychotherapy.

PubMed

Mulder, R; Boden, J; Carter, J; Luty, S; Joyce, P

2017-10-01

Cognitive behaviour therapy (CBT) and interpersonal psychotherapy (IPT) are the most studied psychotherapies for treatment of depression, but they are rarely directly compared particularly over the longer term. This study compares the outcomes of patients treated with CBT and IPT over 10 months and tests whether there are differential or general predictors of outcome. A single centre randomised controlled trial (RCT) of depressed outpatients treated with weekly CBT or IPT sessions for 16 weeks and then 24 weeks of maintenance CBT or IPT. The principle outcome was depression severity measured using the MADRS. Pre-specified predictors of response were in four domains: demographic depression, characteristics, comorbidity and personality. Data were analysed over 16 weeks and 40 weeks using general linear mixed effects regression models. CBT was significantly more effective than IPT in reducing depressive symptoms over the 10 month study largely because it appeared to work more quickly. There were no differential predictors of response to CBT v. IPT at 16 weeks or 40 weeks. Personality variables were most strongly associated with overall outcome at both 16 weeks and 40 weeks. The number of personality disorder symptoms and lower self-directness and reward dependence scores were associated with poorer outcome for both CBT and IPT at 40 weeks. CBT and IPT are effective treatments for major depression over the longer term. CBT may work more quickly. Personality variables are the most relevant predictors of outcome.

A light and scanning electron microscopic evaluation of electro-discharge-compacted porous titanium implants in rabbit tibia.

PubMed

Drummond, J F; Dominici, J T; Sammon, P J; Okazaki, K; Geissler, R; Lifland, M I; Anderson, S A; Renshaw, W

1995-01-01

This study used light and scanning electron microscopic (SEM) histomorphometric methods to quantitate the rate of osseointegration of totally porous titanium alloy (Ti-6Al-4V) implants prepared by a novel fabrication technique--electrodischarge compaction (EDC). EDC was used to fuse 150-250-micrometer spherical titanium alloy beads into 4 X 6 mm cylindrical implants through application of a 300-microsecond pulse of high-voltage/high-current density. Two sterilized implants were surgically placed into each tibia of 20 New Zealand white rabbits and left in situ for periods corresponding to 2, 4, 8, 12, and 24 weeks. At each time point, 4 rabbits were humanely killed, and the implants with surrounding bone were removed, fixed, and sectioned for light and SEM studies. The degree of osseointegration was quantitated by means of a True Grid Digitizing Pad and Jandel Scan Version 3.9 software on an IBM PS/2 computer. The total pore area occupied by bone was divided by the total pore area available for bone ingrowth, and a Bone Ingrowth Factor (BIF) was calculated as a percent. The light microscopic results showed BIFs of 4% at week 2, 47% at week 4, 62% at week 8, 84% at week 12, and greater than 90% at week 24. The SEM results showed BIFs of 5% at week 2, 34% at week 4, 69% at week 8, 75% at week 12, and in excess of 90% at week 24. The results of this study show that EDC implants are biocompatible and support rapid osseointegration in the rabbit tibia and suggest that, after additional studies, they may be suitable for use as dental implants in humans.

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice.

PubMed

Buschemeyer, W Cooper; Klink, Joseph C; Mavropoulos, John C; Poulton, Susan H; Demark-Wahnefried, Wendy; Hursting, Stephen D; Cohen, Pinchas; Hwang, David; Johnson, Tracy L; Freedland, Stephen J

2010-07-01

Caloric restriction (CR) delays cancer growth in animals, though translation to humans is difficult. We hypothesized intermittent fasting (i.e., intermittent extreme CR), may be better tolerated and prolong survival of prostate cancer (CaP) bearing mice. We conducted a pilot study by injecting 105 male individually-housed SCID mice with LAPC-4 cells. When tumors reached 200 mm(3), 15 mice/group were randomized to one of seven diets and sacrificed when tumors reached 1,500 mm(3): Group 1: ad libitum 7 days/week; Group 2: fasted 1 day/week and ad libitum 6 days/week; Group 3: fasted 1 day/week and fed 6 days/week via paired feeding to maintain isocaloric conditions to Group 1; Group 4: 14% CR 7 days/week; Group 5: fasted 2 days/week and ad libitum 5 days/week; Group 6: fasted 2 day/week and fed 5 days/week via paired feeding to maintain isocaloric conditions to Group 1; Group 7: 28% CR 7 days/week. Sera from mice at sacrifice were analyzed for IGF-axis hormones. There were no significant differences in survival among any groups. However, relative to Group 1, there were non-significant trends for improved survival for Groups 3 (HR 0.65, P = 0.26), 5 (0.60, P = 0.18), 6 (HR 0.59, P = 0.16), and 7 (P = 0.59, P = 0.17). Relative to Group 1, body weights and IGF-1 levels were significantly lower in Groups 6 and 7. This exploratory study found non-significant trends toward improved survival with some intermittent fasting regimens, in the absence of weight loss. Larger appropriately powered studies to detect modest, but clinically important differences are necessary to confirm these findings.

Effect of life-style modification on postmenopausal overweight and obese Indian women: A randomized controlled 24 weeks preliminary study.

PubMed

Tandon, Vishal R; Sharma, Sudhaa; Mahajan, Annil; Mahajan, Shagun

2014-01-01

The aim of the following study is to evaluate the effect of life-style modification on postmenopausal (PM) overweight and obese Indian women in a randomized controlled 24 week study. Two groups were formed Group I (n = 30) was designated as intervention (dietary and exercise group) and Group II (n = 24) served as control. Comparison of weight, waist circumference (WC) and body mass index (BMI) were made and compared among two groups at 4, 8, 16 and 24 weeks. Mean age at menopause was 48.35 years versus 49.65 years; mean number of menopausal symptoms were 5.70 ± 1.76 versus 5.10 ± 1.56 and mean duration since menopause was 2.70 versus 2.90 years in Groups I and II respectively. When the effect of Group I and control on weight was compared at 4, 8, 16 and 24 weeks, there was no significant difference between them up to 8 week. At 8 weeks Group I caused a significant decrease in weight (P ≤ 0.05) when compared with control arm and which continued throughout the study period (P < 0.05) at both 16 and 24 weeks. Group I produced a significant reduction in WC from 8 weeks onwards up to 24 weeks (P ≤ 0.05). BMI was statistically significant in Group I and the effect started at 4(th) week (P ≤ 0.05) and the differences in BMI reduction were highly significant at 16(th) and 24(th) weeks (P ≤ 0.001). The results of the present study strongly recommend the life-style management to be incorporated in daily style of postmenopausal women under controlled supervision.

Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation

PubMed Central

Lobley, Grace; Worrall, Sandra; Powell, Richard; Kimani, Peter K; Banerjee, Prithwish; Barker, Thomas

2018-01-01

Introduction Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy. Methods and analysis In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2–3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness. Ethics and dissemination Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals. Trial registration number NCT03223558; Pre-results. PMID:29574443

Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)).

PubMed

Emery, P; Deodhar, A; Rigby, W F; Isaacs, J D; Combe, B; Racewicz, A J; Latinis, K; Abud-Mendoza, C; Szczepanski, L J; Roschmann, R A; Chen, A; Armstrong, G K; Douglass, W; Tyrrell, H

2010-09-01

This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Patients with active disease on stable MTX (10-25 mg/week) were randomised to rituximab 2 x 500 mg (n=168), rituximab 2 x 1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) > or =2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2 x 500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2 x 500 mg) + MTX, rituximab (2 x 1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Rituximab (at 2 x 500 mg and 2 x 1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses.

Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE))

PubMed Central

Emery, P; Deodhar, A; Rigby, W F; Isaacs, J D; Combe, B; Racewicz, A J; Latinis, K; Abud-Mendoza, C; Szczepański, L J; Roschmann, R A; Chen, A; Armstrong, G K; Douglass, W; Tyrrell, H

2010-01-01

Objectives This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. Methods Patients with active disease on stable MTX (10–25 mg/week) were randomised to rituximab 2×500 mg (n=168), rituximab 2×1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) ≥2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2×500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. Results At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2×500 mg) + MTX, rituximab (2×1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. Conclusions Rituximab (at 2×500 mg and 2×1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses. PMID:20488885

A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers

PubMed Central

Zelen, Charles M; Serena, Thomas E; Snyder, Robert J

2014-01-01

The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. PMID:24618401

Effect on 12-week Intensive Dietary and Exercise Program on Weight Reduction and Maintenance in Obese Women with Weight Cycling History.

PubMed

Kwon, Ha Nui; Nam, Sang-Seok; Park, Yoo Kyoung

2017-07-01

This study examined the effect of 12-week intensive dietary and exercise intervention program on body composition and stress-related hormones in obese women and to examine the residual effect after the intervention. The participants of this study were 30 obese women who had a body mass index of over 25 kg/m 2 and over 30% in body fat. They were classified into 2 groups depending on the history of weight cycling (WC); the WC group (≥ ±5% of the original body weight) and the non-weight cycling (NWC) group. Both groups were subject to a nutritional intervention program every 2 weeks with a mandatory exercise intervention for 12 weeks. Thereafter, the nutrition/exercise interventions were ceased for 12 weeks, after which the participants' levels of the hormones relating to energy metabolism and stress, meal intakes, dietary habits, level of knowledge on sodium intake, frequency of sodium intake, and quality of life (QOL) were checked. The changes of body weight were 71.3 ± 5.5 kg (week 0) vs. 65.0 ± 6.6 kg (week 12) vs. 65.6 ± 7.1 kg (week 24) in WC group and 71.6 ± 8.6 kg (week 0) vs. 68.8 ± 9.7 kg (week 12) vs. 70.3 ± 9.4 kg (week 24) in the NWC group. The levels of hormones, meal intakes, and QOL scores were better in the WC group, as adherence to the nutritional intervention was higher. We suggest that that adherence to dietary habits heavily influences weight loss and maintenance in individuals who frequently attempt to lose weight and consequently go through a vicious cycle of weight recycling.

Range of motion and isometric strength of shoulder joints of team handball athletes during the playing season, Part II: changes after midseason.

PubMed

Fieseler, Georg; Jungermann, Philipp; Koke, Alexander; Irlenbusch, Lars; Delank, Karl-Stefan; Schwesig, Rene

2015-03-01

Our objective was to investigate the influence of workload and consecutive changes on active range of motion and isometric strength of team handball athletes' throwing shoulders (TSs) because the available data are insufficient. In a longitudinal investigation, 31 professional male handball athletes underwent a clinical shoulder examination. Athletes were examined at the beginning (week 0), at the end (week 6) of the preseasonal training, and at the end of the half-season (week 22) on both shoulders to determine isometric rotational strength (hand held dynamometer) and active range of motion (goniometer). This analysis demonstrates the results subsequently from week 6 to week 22 and from week 0 to week 22. The glenohumeral internal rotation (IR) deficit (GIRD), external rotation (ER) gain, and ER at the TS increased significantly (P < .05, η(2) > 0.10, d > 0.30) in the first sequence (week 6 to week 22) but not significantly from week 0 to week 22. The total range of motion remained stable, and IR changed but not significantly. There was no influence on IR, ER, and total range of motion at the non-TS. The isometric strength of the TS and non-TS IR did not change. The isometric strength in ER significantly increased bilaterally during the investigation period. Our data verify changes and influences, such as an increasing GIRD, at the overhead TS joint in accordance with the workload during team handball season. ER gain did improve after the half-season period but did not fully compensate the GIRD at the TS. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Contractile reserve and intracellular calcium regulation in mouse myocytes from normal and hypertrophied failing hearts

NASA Technical Reports Server (NTRS)

Ito, K.; Yan, X.; Tajima, M.; Su, Z.; Barry, W. H.; Lorell, B. H.; Schneider, M. (Principal Investigator)

2000-01-01

Mouse myocyte contractility and the changes induced by pressure overload are not fully understood. We studied contractile reserve in isolated left ventricular myocytes from mice with ascending aortic stenosis (AS) during compensatory hypertrophy (4-week AS) and the later stage of early failure (7-week AS) and from control mice. Myocyte contraction and [Ca(2+)](i) transients with fluo-3 were measured simultaneously. At baseline (0.5 Hz, 1.5 mmol/L [Ca(2+)](o), 25 degrees C), the amplitude of myocyte shortening and peak-systolic [Ca(2+)](i) in 7-week AS were not different from those of controls, whereas contraction, relaxation, and the decline of [Ca(2+)](i) transients were slower. In response to the challenge of high [Ca(2+)](o), fractional cell shortening was severely depressed with reduced peak-systolic [Ca(2+)](i) in 7-week AS compared with controls. In response to rapid pacing stimulation, cell shortening and peak-systolic [Ca(2+)](i) increased in controls, but this response was depressed in 7-week AS. In contrast, the responses to both challenge with high [Ca(2+)](o) and rapid pacing in 4-week AS were similar to those of controls. Although protein levels of Na(+)-Ca(2+) exchanger were increased in both 4-week and 7-week AS, the ratio of SR Ca(2+)-ATPase to phospholamban protein levels was depressed in 7-week AS compared with controls but not in 4-week AS. This was associated with an impaired capacity to increase sarcoplasmic reticulum Ca(2+) load during high work states in 7-week AS myocytes. In hypertrophied failing mouse myocytes, depressed contractile reserve is related to an impaired augmentation of systolic [Ca(2+)](i) and SR Ca(2+) load and simulates findings in human failing myocytes.

Beneficial Effects of Silymarin After the Discontinuation of CCl4-Induced Liver Fibrosis.

PubMed

Clichici, Simona; Olteanu, Diana; Filip, Adriana; Nagy, Andras-Laszlo; Oros, Adrian; Mircea, Petru A

2016-08-01

Silymarin (Si) is a herbal product with hepatoprotective potential, well-known for its antioxidant, anti-inflammatory, and immunomodulatory properties. We have recently demonstrated that the usual therapeutic doses of Si are capable of inhibiting the progression of incipient liver fibrosis. We aimed at further investigating the benefits of Si administration upon liver alterations after the hepatotoxin discontinuation, using CCl4 to induce liver injuries on rats. CCl4 administration induces first of all oxidative stress, but other mechanisms, such as inflammation and liver fibrosis are also triggered. Fifty Wistar rats were randomly divided into five groups (n = 10). The control group received sunflower oil twice a week for 8 weeks. Carboxymethyl cellulose group received sunflower oil twice a week, for 8 weeks and CMC daily, for the next 2 weeks. CCl4 group received CCl4 in sunflower oil, by gavage, twice a week, for 8 weeks. CCl4 + Si 50 group received CCl4 twice a week, for 8 weeks, and then 50 mg/body weight (b.w.) Silymarin for the next 2 weeks. CCl4 + Si 200 group was similar to the previous group, but with Si 200 mg/b.w. Ten weeks after the experiment had begun, we assessed inflammation (IL-6, MAPK, NF-κB, pNF-κB), fibrosis (hyaluronic acid), TGF-β1, MMP-9, markers of hepatic stellate cell activation (α-SMA expression), and proliferative capacity (proliferating cell nuclear antigen). Our data showed that Silymarin administered after the toxic liver injury is capable of reducing inflammation and liver fibrosis. The benefits were more important for the higher dose than for the usual therapeutic dose.

Approach to infants born at 22 to 24 weeks' gestation: relationship to outcomes of more-mature infants.

PubMed

Smith, P Brian; Ambalavanan, Namasivayam; Li, Lei; Cotten, C Michael; Laughon, Matthew; Walsh, Michele C; Das, Abhik; Bell, Edward F; Carlo, Waldemar A; Stoll, Barbara J; Shankaran, Seetha; Laptook, Abbot R; Higgins, Rosemary D; Goldberg, Ronald N

2012-06-01

We sought to determine if a center's approach to care of premature infants at the youngest gestational ages (22-24 weeks' gestation) is associated with clinical outcomes among infants of older gestational ages (25-27 weeks' gestation). Inborn infants of 401 to 1000 g birth weight and 22 0/7 to 27 6/7 weeks' gestation at birth from 2002 to 2008 were enrolled into a prospectively collected database at 20 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Markers of an aggressive approach to care for 22- to 24-week infants included use of antenatal corticosteroids, cesarean delivery, and resuscitation. The primary outcome was death before postnatal day 120 for infants of 25 to 27 weeks' gestation. Secondary outcomes were the combined outcomes of death or a number of morbidities associated with prematurity. Our study included 3631 infants 22 to 24 weeks' gestation and 5227 infants 25 to 27 weeks' gestation. Among the 22- to 24-week infants, use of antenatal corticosteroids ranged from 28% to 100%, cesarean delivery from 13% to 65%, and resuscitation from 30% to 100% by center. Centers with higher rates of antenatal corticosteroid use in 22- to 24-week infants had reduced rates of death, death or retinopathy of prematurity, death or late-onset sepsis, death or necrotizing enterocolitis, and death or neurodevelopmental impairment in 25- to 27-week infants. This study suggests that physicians' willingness to provide care to extremely low gestation infants as measured by frequency of use of antenatal corticosteroids is associated with improved outcomes for more-mature infants.

Flame retardant exposure assessment: findings from a behavioral intervention study.

PubMed

Gibson, Elizabeth A; Stapleton, Heather M; Calero, Lehyla; Holmes, Darrell; Burke, Kimberly; Martinez, Rodney; Cortes, Boris; Nematollahi, Amy; Evans, David; Herbstman, Julie B

2018-06-28

Polybrominated diphenyl ethers (PBDEs) have been largely replaced by organophosphate flame retardants (OPFRs) and alternative brominated flame retardants (Alt-BFRs) to meet flammability requirements. Humans are ubiquitously exposed to some variety of flame retardants through contact with consumer products directly or through household dust. To evaluate the effectiveness of house cleaning and hand washing practices to reduce exposure to flame retardants, we measured concentrations in dermal hand wipes and urinary metabolites before and after assignment to two consecutive interventions. We selected 32 mother and child dyads from an existing cohort. This analysis focuses on mothers. Participants provided baseline measurements (urine, hand wipes, and questionnaires) and were then assigned for 1 week to either a house cleaning (including instruction on proper technique and cleaning supplies) or hand washing (including instruction on proper technique and soaps) intervention arm. For the second week, participants were assigned to the second intervention in addition to their initial assignment, thus all subjects both washed their hands and cleaned according to the intervention guidelines during week 2. We collected measurements at the end of weeks 1 and 2. We found reductions in urinary analytes after week 1 of house cleaning (BCIPHIPP and ip-DPHP), week 1 of hand washing (BCIPP, BCIPHIPP, and tbutyl-DPHP), and week 2 of combined interventions (BCIPHIPP and tbutyl-DPHP), compare to baseline. We found no significant decline in hand wipes in the entire sample but did find reductions after week 1 of house cleaning (BDE 209), week 1 of hand washing (TCEP), and week 2 of combined interventions (TDCIPP and BDE 209) in women with exposure above the median at baseline (verified through simulations). Exposure to individual flame retardants was reduced by about half, in some cases, by 1 week of increased hand washing, house cleaning to reduce dust, or combined activities.

The effect of exercise on the severity of the fatigue in colorectal cancer patients who received chemotherapy in Ahwaz.

PubMed

Shariati, Abdolali; Haghighi, Shayesteh; Fayyazi, Seddigheh; Tabesh, Hamed; Kalboland, Mehrnaz Moradi

2010-01-01

One of the common side effects of cancer is fatigue that affects patients' life quality and leads to disability. Exercise has an important role in improving these patients' life quality and can be used as a complementary treatment. Moreover, there are few studies on the impact of exercise on fatigue among patients with colon cancer. Therefore, the present study investigated the effects of exercise on the severity of fatigue in patients with colorectal cancer who underwent chemotherapy in Ahwaz. In a quasi-experimental study, the adults with colorectal cancer were enrolled. The sample included 36 people. The study environment included adult hematology and chemotherapy wards of Shefa Hospital in Ahwaz. Data were collected using a demographic form and a questionnaire in order to measure the severity of fatigue. Then, the patients had 40 minutes of exercise, 3 times a week for 4 weeks. The effect of exercise versus fatigue intensity was measured at the end of every week. Data were analyzed using SPSS software. The mean of the fatigue severity in the weeks after exercise was significantly different from the week before it. Friedman test showed significant differences between all the weeks before and after the exercise. The mean of the fatigue severity was 3.69 on the week 0 (before the exercise), and decreased to 3.57 on the first week after exercise, 3.46 on the second week, 2.58 on the third week, and 1.69 on the forth week. Considering the results of this study, exercise and work-out can be an effective factor in reducing fatigue in patients.

The effect of exercise on the severity of the fatigue in colorectal cancer patients who received chemotherapy in Ahwaz

PubMed Central

Shariati, Abdolali; Haghighi, Shayesteh; Fayyazi, Seddigheh; Tabesh, Hamed; Kalboland, Mehrnaz Moradi

2010-01-01

BACKGROUND: One of the common side effects of cancer is fatigue that affects patients’ life quality and leads to disability. Exercise has an important role in improving these patients’ life quality and can be used as a complementary treatment. Moreover, there are few studies on the impact of exercise on fatigue among patients with colon cancer. Therefore, the present study investigated the effects of exercise on the severity of fatigue in patients with colorectal cancer who underwent chemotherapy in Ahwaz. METHODS: In a quasi-experimental study, the adults with colorectal cancer were enrolled. The sample included 36 people. The study environment included adult hematology and chemotherapy wards of Shefa Hospital in Ahwaz. Data were collected using a demographic form and a questionnaire in order to measure the severity of fatigue. Then, the patients had 40 minutes of exercise, 3 times a week for 4 weeks. The effect of exercise versus fatigue intensity was measured at the end of every week. Data were analyzed using SPSS software. RESULTS: The mean of the fatigue severity in the weeks after exercise was significantly different from the week before it. Friedman test showed significant differences between all the weeks before and after the exercise. The mean of the fatigue severity was 3.69 on the week 0 (before the exercise), and decreased to 3.57 on the first week after exercise, 3.46 on the second week, 2.58 on the third week, and 1.69 on the forth week. CONCLUSIONS: Considering the results of this study, exercise and work-out can be an effective factor in reducing fatigue in patients. PMID:21589787

Delivery at Term: Impact of University Education by Week of Gestation.

PubMed

Auger, Nathalie; Leduc, Line; Naimi, Ashley I; Fraser, William D

2016-02-01

Data on risk factors for early term delivery are scant despite greater complications in infants born at 37 and 38 weeks' gestation. We determined the probability of delivery by gestational week at term according to level of maternal education, an established risk factor for preterm birth. We analyzed 2 319 697 live singleton births at term (≥37 weeks) in Quebec from 1981 to 2010. We estimated hazard ratios with 95% confidence intervals (CI) of delivery according to level of maternal education, adjusting for individual characteristics. The main outcome measure was the probability of delivery at term by week of gestation for women with university education versus high school education. Early term birth at 37 and 38 weeks of gestation was less common for university-educated women (23.1%) than for high school-educated women (25.8%; P < 0.001). Compared with women with a high school education, university-educated women had a 15% lower probability of delivery at 37 to 38 weeks (95% CI: 0.84 to 0.86), a 4% lower probability of delivery at 39 weeks (95% CI: 0.96 to 0.97) and a 2% lower probability of delivery at 40 weeks (95% CI: 0.97 to 0.98). University-educated women were, however, more likely to deliver at 41 weeks. A higher level of education was associated with longer duration of pregnancy at term. Women who were university-educated had a lower chance of delivery at 37, 38, 39, and even 40 weeks of gestation. Clinicians should be aware that women with lower levels of education are more likely to deliver earlier at term. Copyright © 2016 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Randomised trial of two nicotine patch protocols distributed through a state quitline.

PubMed

Burns, Emily K; Hood, Nancy E; Goforth, Emma; Levinson, Arnold H

2016-03-01

Most telephone quitlines provide free nicotine replacement therapy (NRT). An 8-week course is recommended, but few users complete it. Information is needed to help quitlines distribute NRT cost-effectively. Randomised two-group trial. Colorado QuitLine callers who smoked 16-20 cigarettes per day at enrolment and who were eligible for and agreed to receive free NRT. Provision of 4-week versus 8-week NRT supply; the 8-week supply was shipped in halves and required participants to request the second half (split-shipment protocol). Enrolment occurred during March 2010-February 2011, follow-up concluded in November 2011, and analysis was performed in 2012. Point abstinence (7 and 30 day) and prolonged abstinence (6 month) from tobacco use. Overall, 1495 study participants were enrolled and 57.7% completed follow-up. Abstinence rates did not differ significantly between study conditions: 13.8% versus 12.4% in 4-week versus 8-week arms, respectively, (30-day point abstinence, non-respondents treated as smokers). NRT duration was similar in both groups, due in part to purchase of additional patches in the 4-week group. About one-third of the 8-week group requested the full 8-week supply and had higher abstinence rates. Cost per quit was lower in the 4-week (compared to 8-week) group. A randomised trial did not find worse cessation outcomes among quitline users who received half the minimum recommended course of NRT, but offering the full recommended course using a split-shipment protocol may be reasonably cost-effective and supportive of NRT adherers. NCT01889771. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Bisphosphonates inhibit bone remodeling in the jaw bones of rats and delay healing following tooth extractions.

PubMed

Jabbour, Zaher; El-Hakim, Michel; Henderson, Janet E; de Albuquerque, Rubens F

2014-05-01

This study aimed to evaluate the impact of concurrent administration of clinically relevant doses of zoledronic acid (ZA) and dexamethasone (DX) on bone healing after tooth extraction (EXO). Forty-four Sprague-Dawley rats (6-8 month old) were randomized into five groups: ZA + DX = weekly injection of ZA with DX for 7 weeks; WD = ZA with DX for 3 weeks then DX alone for 4 weeks; C = control saline for 7 weeks; ZA = ZA alone for 7 weeks and DX = DX alone for 7 weeks. ZA was administered at 0.13 mg/kg/week and DX at 3.8 mg/kg/week and body weights recorded at the time of injection. All rats underwent extraction (EXO) of the mandibular and maxillary first molars at 3 weeks and were euthanized at 7 weeks. The extracted and non-extracted sides of both jaws were harvested for micro-CT analyses. All rats, particularly those injected with ZA, exhibited weight gain till EXO followed by decline then recovery. ZA + DX group demonstrated highest fractional bone to tissue volume (BV/TV) in the non-extracted side. ZA + DX rats exhibited also highest volume and surface of sequestra. Only sequestra volume was statistically higher in the WD group compared to C group. Combined treatment with ZA and DX over a prolonged period inhibits bone remodeling and increased sequestra formation to a greater extent than either drug alone. Trauma caused by these sequestra cutting through the mucosa could play a key role in the development of BRONJ by potentially facilitating infection. ZA withdrawal may promote bone-remodeling reactivation following EXO. Copyright © 2014 Elsevier Ltd. All rights reserved.

Safety and Efficacy of Baricitinib Through 128 Weeks in an Open-label, Longterm Extension Study in Patients with Rheumatoid Arthritis.

PubMed

Keystone, Edward C; Genovese, Mark C; Schlichting, Douglas E; de la Torre, Inmaculada; Beattie, Scott D; Rooney, Terence P; Taylor, Peter C

2018-01-01

To assess the safety and efficacy of baricitinib in patients with rheumatoid arthritis (RA) up to 128 weeks in a phase IIb study (NCT01185353). After a 24-week blinded period, eligible patients entered an initial 52-week open-label extension (OLE); patients receiving 8 mg once daily (QD) continued with that dose and all others received 4 mg QD. Doses could be escalated to 8 mg QD at 28 or 32 weeks at investigator discretion when ≥ 6 tender and ≥ 6 swollen joints were present. Patients completing the first OLE were eligible to enter a second 52-week OLE and receive 4 mg QD regardless of previous dose. In the 4-mg (n = 108) and 8-mg (n = 93) groups, treatment-emergent adverse events (AE) occurred in 63% and 67%, serious AE in 16% and 13%, infections in 35% and 40%, and serious infections in 5% and 3% of patients, respectively. Exposure-adjusted incidence rates for AE for all baricitinib groups in the second OLE were similar to or lower than rates observed in the first OLE. No opportunistic infections, tuberculosis cases, or lymphomas were observed through 128 weeks; 1 death occurred during the first OLE. Among all patients in both OLE, the proportions who achieved disease improvement at Week 24 were similar or increased at weeks 76 and 128. In a phase IIb study in RA, the safety and tolerability profile of baricitinib, up to 128 weeks, remained consistent with earlier observations, without unexpected late signals. Clinical improvements seen in the 24-week blinded period were maintained during the OLE.

Factors associated with dropout in a group weight-loss programme: a longitudinal investigation.

PubMed

Yackobovitch-Gavan, M; Steinberg, D M; Endevelt, R; Benyamini, Y

2015-02-01

Attrition is a major limitation of most weight management intervention programmes. The present study aimed to conduct an extensive investigation of personal, sociodemographic and treatment-related factors associated with attrition at different stages of a 10-week group weight-loss programme. The present study is part of a longitudinal, clinical intervention study comparing three conditions in a 10-week group programme: Control, Behavioural Intentions and Implementation Intentions. The study included 587 participants with a mean (SD) age of 46 (11) years (range 18-78 years) and a mean (SD) body mass index (BMI) of 31.9 (5.5) kg m(-2), with 90% being female. To characterise dropout in each week separately, as well as overall dropout (dropout until week 9, the median time of dropout), we tested several logistic regression models, including multiple imputations to cope with missing data. The results of the different dropout models consistently showed that a smaller reduction in BMI in the first 2 weeks of the programme was the strongest predictor of dropout. Dropout in the tenth and last week differed from the earlier weeks both in the relatively high dropout rate (56% of total dropout) and in that, in contrast to earlier weeks, the week 10 model included the reduction in BMI during the last 2 weeks before dropout but did not include the reduction in BMI at the initiation of the intervention. Weight-loss in the beginning of the programme is a crucial independent determinant of dropout in each week except the last one. This finding is important because it suggests a simple assessment for a major dropout risk factor in adult weight-loss intervention programmes. © 2014 The British Dietetic Association Ltd.

Evaluating the dose effects of a longitudinal micro-CT study on pulmonary tissue in C57BL/6 mice

NASA Astrophysics Data System (ADS)

Detombe, Sarah A.; Dunmore-Buyze, Joy; Petrov, Ivailo E.; Drangova, Maria

2012-03-01

Background: Micro-computed tomography offers numerous advantages for small animal imaging, including the ability to monitor the same animals throughout a longitudinal study. However, concerns are often raised regarding the effects of x-ray dose accumulated over the course of the experiment. In this study, we scan C57BL/6 mice multiple times per week for six weeks, to determine the effect of the cumulative dose on pulmonary tissue at the end of the study. Methods/Results: C57BL/6 male mice were split into two groups (irradiated group=10, control group=10). The irradiated group was scanned (80kVp/50mA) each week for 6 weeks; the weekly scan session had three scans. This resulted in a weekly dose of 0.84 Gy, and a total study dose of 5.04 Gy. The control group was scanned on the final week. Scans from weeks 1 and 6 were reconstructed and analyzed: overall, there was no significant difference in lung volume or lung density between the control group and the irradiated group. Similarly, there were no significant differences between the week 1 and week 6 scans in the irradiated group. Histological samples taken from excised lung tissue also showed no evidence of inflammation or fibrosis in the irradiated group. Conclusion: This study demonstrates that a 5 Gy x-ray dose accumulated over six weeks during a longitudinal micro-CT study has no significant effects on the pulmonary tissue of C57BL/6 mice. As a result, the many advantages of micro- CT imaging, including rapid acquisition of high-resolution, isotropic images in free-breathing mice, can be taken advantage of in longitudinal studies without concern for negative dose-related effects.

Does pregnancy have an impact on the subgingival microbiota?

PubMed

Adriaens, Laurence M; Alessandri, Regina; Spörri, Stefan; Lang, Niklaus P; Persson, G Rutger

2009-01-01

We investigated clinical and subgingival microbiologic changes during pregnancy in 20 consecutive pregnant women > or =18 years not receiving dental care. Bacterial samples from weeks 12, 28, and 36 of pregnancy and at 4 to 6 weeks postpartum were processed for 37 species by checkerboard DNA-DNA hybridization. Clinical periodontal data were collected at week 12 and at 4 to 6 weeks postpartum, and bleeding on probing (BOP) was recorded at sites sampled at the four time points. The mean BOP at week 12 and postpartum was 40.1% +/- 18.2% and 27.4% +/- 12.5%, respectively. The corresponding mean BOP at microbiologic test sites was 15% (week 12) and 21% (postpartum; not statistically significant). Total bacterial counts decreased between week 12 and postpartum (P <0.01). Increased bacterial counts over time were found for Neisseria mucosa (P <0.001). Lower counts (P <0.001) were found for Capnocytophaga ochracea, Capnocytophaga sputigena, Eubacterium saburreum, Fusobacterium nucleatum naviforme, Fusobacterium nucleatum polymorphum, Leptotrichia buccalis, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Prevotella intermedia, Prevotella melaninogenica, Staphylococcus aureus, Streptococcus anginosus, Streptococcus intermedius, Streptococcus mutans, Streptococcus oralis, Streptococcus sanguinis, Selenomonas noxia, and Veillonella parvula. No changes occurred between weeks 12 and 28 of pregnancy. Counts of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Tannerella forsythia (previously T. forsythensis), and Treponema denticola did not change. Counts of P. gingivalis and T. forsythia at week 12 were associated with gingivitis (P <0.001). Subgingival levels of bacteria associated with periodontitis did not change. P. gingivalis and T. forsythia counts were associated with BOP at week 12. A decrease was found in 17 of 37 species from week 12 to postpartum. Only counts of N. mucosa increased.

Weekly agricultural emissions and ambient concentrations of ammonia: Validation of an emission inventory

NASA Astrophysics Data System (ADS)

Bittman, Shabtai; Jones, Keith; Vingarzan, Roxanne; Hunt, Derek E.; Sheppard, Steve C.; Tait, John; So, Rita; Zhao, Johanna

2015-07-01

Weekly inventories for emissions of agricultural ammonia were calculated for 139 4 × 4 km grid cells over 52 weeks in the intensely farmed Lower Fraser Valley, BC. The grid cells were located both inside and outside an area that had been depopulated of poultry due to an outbreak of Avian Influenza prior to the start of the study. During the study period, ambient ammonia concentrations were measured hourly at two locations outside the cull area and one location inside the cull area. Large emission differences between grid cells and differences in temporal variation between cells were related to farming practices and meteorological factors such as temperature and rainfall. Weekly average ambient concentrations at the three sampling locations were significantly correlated with estimates of weekly emissions for many of the grid cells in the study area. Inside the cull area, ambient concentrations during the cull (week 1) were 37% of the concentrations after the cull (week 52), while outside the cull there was almost no difference between week 1 and week 52, suggesting that in normal (non-cull) conditions, about 60% of the ambient ammonia was due to poultry farms. Estimated emissions in weeks 1 and 52 for grid cells affected by the cull indicated that over 90% of the emissions came from poultry. The discrepancy in difference between week 1 and 52 for emissions and ambient concentrations could be due to atmospheric factors like transport, atmospheric reactions, dispersion or deposition; to errors in the inventory including farming data, emission factors; and omission of some non-poultry emission sources. Overall the study supports the ammonia emission inventory estimates. Detailed emission data helps in modeling ammonia in the atmosphere and is useful for developing abatement policy.

Parameters for abolishing conditioned place preference for cocaine from running and environmental enrichment in male C57BL/6J mice.

PubMed

Mustroph, M L; Pinardo, H; Merritt, J R; Rhodes, J S

2016-10-01

Evidence suggests that 4 weeks of voluntary wheel running abolishes conditioned place preference (CPP) for cocaine in male C57BL/6J mice. To determine the duration and timing of exposure to running wheels necessary to reduce CPP, and the extent to which the running per se influences CPP as compared to environmental enrichment without running. A total of 239 males were conditioned for 4days twice daily with cocaine (10mg/kg) and then split into 7 intervention groups prior to 4days of CPP testing. Experiment 1 consisted of two groups housed as follows: short sedentary group (SS; n=20) in normal cages for 1 week; the short running group (SR; n=20) with running wheels for 1 week. Experiment 2 consisted of five groups housed as follows; short 1 week of running followed by a 3 week sedentary period (SRS; n=20); a 3 week sedentary period followed by 1 week of running (SSR; n=20); long sedentary group (LS; n=66) in normal cages for 4 weeks; long running group (LR; n=66) with running wheels for 4 weeks; and long environmental enrichment group (EE; n=27) with toys for 4 weeks. Levels of running were similar in all running groups. Both running and environmental enrichment reduced CPP relative to sedentary groups. Results suggest that the abolishment of cocaine CPP from running is robust and occurs with as low as 1 week of intervention but may be related to enrichment component of running rather than physical activity. Copyright © 2016 Elsevier B.V. All rights reserved.

Maternal perinatal diet induces developmental programming of bone architecture.

PubMed

Devlin, M J; Grasemann, C; Cloutier, A M; Louis, L; Alm, C; Palmert, M R; Bouxsein, M L

2013-04-01

Maternal high-fat (HF) diet can alter offspring metabolism via perinatal developmental programming. This study tests the hypothesis that maternal HF diet also induces perinatal programming of offspring bone mass and strength. We compared skeletal acquisition in pups from C57Bl/6J mice fed HF or normal diet from preconception through lactation. Three-week-old male and female pups from HF (HF-N) and normal mothers (N-N) were weaned onto normal diet. Outcomes at 14 and 26 weeks of age included body mass, body composition, whole-body bone mineral content (WBBMC) via peripheral dual-energy X-ray absorptiometry, femoral cortical and trabecular architecture via microcomputed tomography, and glucose tolerance. Female HF-N had normal body mass and glucose tolerance, with lower body fat (%) but higher serum leptin at 14 weeks vs. N-N (P<0.05 for both). WBBMC was 12% lower at 14 weeks and 5% lower at 26 weeks, but trabecular bone volume fraction was 20% higher at 14 weeks in female HF-N vs. N-N (P<0.05 for all). Male HF-N had normal body mass and mildly impaired glucose tolerance, with lower body fat (%) at 14 weeks and lower serum leptin at 26 weeks vs. N-N (P<0.05 for both). Serum insulin was higher at 14 weeks and lower at 26 weeks in HF-N vs. N-N (P<0.05). Trabecular BV/TV was 34% higher and cortical bone area was 6% higher at 14 weeks vs. N-N (P<0.05 for both). These data suggest that maternal HF diet has complex effects on offspring bone, supporting the hypothesis that maternal diet alters postnatal skeletal homeostasis.

Memantine and constraint-induced aphasia therapy in chronic poststroke aphasia.

PubMed

Berthier, Marcelo L; Green, Cristina; Lara, J Pablo; Higueras, Carolina; Barbancho, Miguel A; Dávila, Guadalupe; Pulvermüller, Friedemann

2009-05-01

We conducted a randomized, double-blind, placebo-controlled, parallel-group study of both memantine and constraint-induced aphasia therapy (CIAT) on chronic poststroke aphasia followed by an open-label extension phase. Patients were randomized to memantine (20 mg/day) or placebo alone during 16 weeks, followed by combined drug treatment with CIAT (weeks 16-18), drug treatment alone (weeks 18-20), and washout (weeks 20-24), and finally, an open-label extension phase of memantine (weeks 24-48). After baseline evaluations, clinical assessments were done at two end points (weeks 16 and 18), and at weeks 20, 24, and 48. Outcome measures were changes in the Western Aphasia Battery-Aphasia Quotient and the Communicative Activity Log. Twenty-eight patients were included, and 27 completed both treatment phases. The memantine group showed significantly better improvement on Western Aphasia Battery-Aphasia Quotient compared with the placebo group while the drug was taken (week 16, p = 0.002; week 18, p = 0.0001; week 20, p = 0.005) and at the washout assessment (p = 0.041). A significant increase in Communicative Activity Log was found in favor of memantine-CIAT relative to placebo-CIAT (week 18, p = 0.040). CIAT treatment led to significant improvement in both groups (p = 0.001), which was even greater under additional memantine treatment (p = 0.038). Beneficial effects of memantine were maintained in the long-term follow-up evaluation, and patients who switched to memantine from placebo experienced a benefit (p = 0.02). Both memantine and CIAT alone improved aphasia severity, but best outcomes were achieved combining memantine with CIAT. Beneficial effects of memantine and CIAT persisted on long-term follow-up.

Workload and non-contact injury incidence in elite football players competing in European leagues.

PubMed

Delecroix, Barthelemy; McCall, Alan; Dawson, Brian; Berthoin, Serge; Dupont, Gregory

2018-06-02

The aim of this study was to analyse the relationship between absolute and acute:chronic workload ratios and non-contact injury incidence in professional football players and to assess their predictive ability. Elite football players (n = 130) from five teams competing in European domestic and confederation level competitions were followed during one full competitive season. Non-contact injuries were recorded and using session rate of perceived exertion (s-RPE) internal absolute workload and acute:chronic (A:C) workload ratios (4-weeks, 3-weeks, 2-weeks and week-to-week) were calculated using a rolling days method. The relative risk (RR) of non-contact injury was increased (RR = 1.59, CI95%: 1.18-2.15) when a cumulative 4-week absolute workload was greater than 10629 arbitrary units (AU) in comparison with a workload between 3745 and 10628 AU. When the 3-week absolute workload was more than 8319 AU versus between 2822 and 8318 AU injury risk was also increased (RR= 1.46, CI95% 1.08-1.98). Injury incidence was higher when the 4-week A:C ratio was <0.85 versus >0.85 (RR = 1.31, CI95%: 1.02-1.70) and with a 3-week A:C ratio >1.30 versus <1.30 (RR = 1.37, CI95%: 1.05-1.77). Importantly, none of the A:C workload combinations showed high sensitivity or specificity. In elite European footballers, using internal workload (sRPE) revealed that cumulative workloads over 3 and 4 weeks were associated with injury incidence. Additionally, A:C workloads, using combinations of 2, 3 and 4 weeks as the C workloads were also associated with increased injury risk. No A:C workload combination was appropriate to predict injury.

Effects of briakinumab treatment for moderate to severe psoriasis on health-related quality of life and work productivity and activity impairment: results from a randomized phase III study.

PubMed

Papp, K A; Sundaram, M; Bao, Y; Williams, D A; Gu, Y; Signorovitch, J E; Wang, Y; Valdes, J M; Mulani, P M

2014-06-01

Psoriasis is known to have a significant negative impact on a patient's health-related quality of life, including social, recreational and work activities. To evaluate the effects of briakinumab on quality of life and work productivity measures in patients with moderate to severe psoriasis. Patients received either briakinumab (n = 981) or placebo (n = 484) during the 12-week induction phase of trial M06-890. At week 12, patients with a Physician's Global Assessment score of 'Clear' or 'Minimal' entered the 40-week maintenance phase and were to receive briakinumab every 4 weeks, briakinumab every 12 weeks, or placebo. At weeks 12 and 52, treatment groups were compared using mean change from baseline in health-related quality of life and Work Productivity and Activity Impairment Questionnaire scores and the percentage of patients with minimum clinically important differences. At week 12, more than half of the briakinumab-treated patients achieved improvements meeting or exceeding minimum clinically important differences for Dermatology Life Quality Index (75.9%), and psoriasis- (64.8%), and psoriatic arthritis-related (54.1%) pain scores; 48.4% achieved improvements for activity impairment. Although improvements in quality of life and work productivity measures were maintained at week 52 for both briakinumab regimens, responder rates were consistently greater in the every-4-week group than in the every-12-week group. Briakinumab treatment resulted in clinically significant improvements in quality of life and work productivity in adults with moderate to severe psoriasis. Maintenance therapy was associated with a more pronounced benefit for the every-4-week briakinumab regimen. © 2013 European Academy of Dermatology and Venereology.

Comparing the Efficacy of 8 Weeks Treatment of Cipram® and its Generic Citalopram in Patients With Mixed Anxiety-Depressive Disorder.

PubMed

Khoonsari, Hasan; Oghazian, Mohammad Bagher; Kargar, Mona; Moin, Mahdiyeh; Khalili, Hossein; Alimadadi, Abbas; Torkamandi, Hassan; Ghaeli, Padideh

2015-06-01

Patients with mixed anxiety-depressive disorder (MADD) suffer both anxiety and depression. Antidepressants, especially, selective serotonin reuptake inhibitors are among agents of choice for treating this condition. This study compared the efficacy of Cipram® with its generic, citalopram. Forty adult outpatients (between 18 to 55 years of age) with a diagnosis of MADD who met the trial criteria, entered this double-blind, randomized study. Subjects were assigned to receive either generic citalopram or Cipram® for 8 weeks. Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) were utilized to assess depression and anxiety at baseline, weeks 4 and 8 of the study. Statistical analysis was performed using SPSS 14.0. Twenty patients received citalopram (mean dosages of 22 mg/day during the first 4 weeks and 33 mg/day during weeks 4 to 8) and 20 received Cipram® (mean dosages of 22 mg/day during the first 4 weeks and 29 mg/day during weeks 4 to 8). Both treatments were noted to be effective in improving the symptoms of MADD at weeks 4 and 8. The mean differences of HAM-D and HAM-A between Citalopram and Cipram® groups were significantly different at the end of week 4 (HAM-D: P = 0.038, HAM-A: P = 0.025), but not at the end of week 8 (HAM-D: P = 0.239, HAM-A: P = 0.204). Both medications were tolerated well by the patients. This study suggests that the efficacy of citalopram is similar to that of Cipram® in the treatment of MADD after 8 weeks. Meanwhile, Cipram® may reduce depression and anxiety quicker than its generic, citalopram.

Cumulative Brain Injury from Motor Vehicle-Induced Whole-Body Vibration and Prevention by Human Apolipoprotein A-I Molecule Mimetic (4F) Peptide (an Apo A-I Mimetic).

PubMed

Yan, Ji-Geng; Zhang, Lin-ling; Agresti, Michael; Yan, Yuhui; LoGiudice, John; Sanger, James R; Matloub, Hani S; Pritchard, Kirkwood A; Jaradeh, Safwan S; Havlik, Robert

2015-12-01

Insidious cumulative brain injury from motor vehicle-induced whole-body vibration (MV-WBV) has not yet been studied. The objective of the present study is to validate whether whole-body vibration for long periods causes cumulative brain injury and impairment of the cerebral function. We also explored a preventive method for MV-WBV injury. A study simulating whole-body vibration was conducted in 72 male Sprague-Dawley rats divided into 9 groups (N = 8): (1) 2-week normal control; (2) 2-week sham control (in the tube without vibration); (3) 2-week vibration (exposed to whole-body vibration at 30 Hz and .5 G acceleration for 4 hours/day, 5 days/week for 2 weeks; vibration parameters in the present study are similar to the most common driving conditions); (4) 4-week sham control; (5) 4-week vibration; (6) 4-week vibration with human apolipoprotein A-I molecule mimetic (4F)-preconditioning; (7) 8-week sham control; (8) 8-week vibration; and (9) 8-week 4F-preconditioning group. All the rats were evaluated by behavioral, physiological, and histological studies of the brain. Brain injury from vibration is a cumulative process starting with cerebral vasoconstriction, squeezing of the endothelial cells, increased free radicals, decreased nitric oxide, insufficient blood supply to the brain, and repeated reperfusion injury to brain neurons. In the 8-week vibration group, which indicated chronic brain edema, shrunken neuron numbers increased and whole neurons atrophied, which strongly correlated with neural functional impairment. There was no prominent brain neuronal injury in the 4F groups. The present study demonstrated cumulative brain injury from MV-WBV and validated the preventive effects of 4F preconditioning. Copyright © 2015 National Stroke Association. All rights reserved.

Preterm infant outcomes in relation to the gestational age of onset and duration of prelabour rupture of membranes: a retrospective cohort study.

PubMed

Pharande, Pramod; Mohamed, Abdel-Latif; Bajuk, Barbara; Lui, Kei; Bolisetty, Srinivas

2017-01-01

To determine the hospital outcomes of liveborn infants at 23-31 weeks following prelabour preterm rupture of membranes (PPROM). A regional retrospective cohort study of 4454 infants of 23-31 weeks' gestation admitted to a tertiary neonatal network between 2007 and 2011. Primary outcome was the composite chronic lung disease (CLD) or mortality at discharge. 225 (5%) neonates had a history of PPROM occurring prior to 24 +0 weeks (Early-PPROM), 829 (19%) had a history of PPROM at or after 24 +0 weeks' gestation (Late-PPROM) and 3400 (76%) had no history of PPROM (No-PPROM). In comparison to No-PPROM, Early-PPROM group had higher CLD/mortality in infants born at 23-27 weeks (OR 1.95; 95% CI 1.34 to 2.85) and 28-31 weeks (OR 4.98; 95% CI 2.99 to 8.28). Within Early-PPROM group, the latency of PPROM >14 days had lower CLD/mortality in comparison to latency ≤14 days (57.6% vs 77%, OR 0.40; 95% CI 0.21 to 0.76). Late-PPROM group had significantly lower CLD/mortality in comparison to No-PPROM group at 23-27 weeks (OR 0.50; 95% CI 0.37 to 0.69) and 28-31 weeks (OR 0.50; 95% CI 0.36 to 0.71). Within Late-PPROM group, latency >14 days was associated with an increased CLD/mortality in 28-31 weeks (14.1% vs 5.4%, OR 2.88; 95% CI 1.31 to 6.38). Early-PPROM prior to 24 weeks' gestation had high incidence of CLD/mortality even after correcting for gestational age. Late-PPROM at or after 24 weeks had lower CLD/mortality compared with No-PPROM. Latency >14 days in Late-PPROM group at 28-31 week group increased the odds of CLD/mortality.

Intravenous immunoglobulin for maintenance treatment of chronic inflammatory demyelinating polyneuropathy: a multicentre, open-label, 52-week phase III trial

PubMed Central

Mori, Masahiro; Misawa, Sonoko; Suzuki, Miki; Nishiyama, Kazutoshi; Mutoh, Tatsuro; Doi, Shizuki; Kokubun, Norito; Kamijo, Mikiko; Yoshikawa, Hiroo; Abe, Koji; Nishida, Yoshihiko; Okada, Kazumasa; Sekiguchi, Kenji; Sakamoto, Ko; Kusunoki, Susumu; Sobue, Gen; Kaji, Ryuji

2017-01-01

Objective Short-term efficacy of induction therapy with intravenous immunoglobulin (Ig) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) is well established. However, data of previous studies on maintenance therapy were limited up to 24-week treatment period. We aimed to investigate the efficacy and safety of longer-term intravenous Ig therapy for 52 weeks. Methods This study was an open-label phase 3 clinical trial conducted in 49 Japanese tertiary centres. 49 patients with CIDP who fulfilled diagnostic criteria were included. After an induction intravenous Ig therapy (0.4 g/kg/day for five consecutive days), maintenance dose intravenous Ig (1.0 g/kg) was given every 3 weeks for up to 52 weeks. The primary outcome measures were the responder rate at week 28 and relapse rate at week 52. The response and relapse were defined with the adjusted Inflammatory Neuropathy Cause and Treatment scale. Results At week 28, the responder rate was 77.6% (38/49 patients; 95% CI 63% to 88%), and the 38 responders continued the maintenance therapy. At week 52, 4 of the 38 (10.5%) had a relapse (95% CI 3% to 25%). During 52 weeks, 34 (69.4%) of the 49 enrolled patients had a maintained improvement. Adverse events were reported in 94% of the patients; two patients (66-year-old and 76-year-old men with hypertension or diabetes) developed cerebral infarction (lacunar infarct with good recovery), and the other adverse effects were mild and resolved by the end of the study period. Conclusions Maintenance treatment with 1.0 g/kg intravenous Ig every 3 weeks is an efficacious therapy for patients with CIDP, and approximately 70% of them had a sustained remission for 52 weeks. Thrombotic complications should be carefully monitored, particularly in elderly patients with vascular risk factors. Trial registration number ClinicalTrials.gov (NCT01824251). PMID:28768822

Clinical Assessment of Weight Gain with Atypical Antipsychotics - Blonanserin vs Amisulpride

PubMed Central

Raveesh, BN; Parashivamurthy, BM; Kumar, MS Narendra; Majgi, Sumanth Mallikarjuna; Nagesh, HN

2015-01-01

Background Atypical antipsychotics appear to have the greatest potential to induce weight gain. Antipsychotic-induced weight gain is the one of main cause of non-compliance and discontinuation of treatment, often resulting in the relapse of psychosis. Objective To compare the weight gain between amisulpride and blonanserin treatment, in persons with psychosis. Materials and Methods Fifty six subjects with psychosis attending psychiatry department at KR Hospital, Mysore were randomized into two equal groups. After obtaining informed consent, subjects of group I received amisulpride tablets 200 mg BD, and group II received blonanserin tablets 4 mg BD, for eight weeks. Body weight, Body Mass Index (BMI) and Waist Hip Ratio (WHR) were measured at baseline, 4 weeks and 8 weeks. Results The mean weight gain with amisulpride at 4 weeks was 2.73 kg (5.21%) and at 8 weeks was 4.34 kg (8.28%) from the baseline. The mean weight gain with blonanserin at 4 weeks was 1.77 kg (3.46%) and at 8 weeks was 3.46 kg (6.75%) from the baseline. The mean BMI increase at 8 weeks with amisulpride was 1.66 ± 0.56 and with blonanserin was 1.34 ± 0.77. The mean WHR increase at 8 weeks with amisulpride was 0.036 ± 0.026 and with blonanserin was 0.029 ± 0.020. There was statistically significant increase in weight, BMI and WHR associated with both blonanserin and amisulpride at 8 weeks. But there was no statistically significant difference in those parameters between blonanserin and amisulpride, at eight weeks. Conclusion Even though there was no significant difference in the weight gain caused by blonanserin, in comparison with amisulpride, both these drugs individually caused significant weight gain at 8 weeks, which is in contrast with the earlier studies, which needs to be further evaluated. PMID:26266134

Effectiveness of the U.S. National HIV Testing Day Campaigns in Promoting HIV Testing: Evidence from CDC-Funded HIV Testing Sites, 2010

PubMed Central

Mulatu, Mesfin S.

2014-01-01

Objectives We assessed if HIV testing and diagnoses increased during the week of National HIV Testing Day (NHTD) and if characteristics of people who were tested varied compared with control weeks. Methods We analyzed HIV testing data from the 2010 National HIV Prevention Program Monitoring and Evaluation system to compare NHTD week (June 24–30, 2010) with two control weeks (January 7–13, 2010, and August 12–18, 2010) for the number of HIV testing events and new HIV-positive diagnoses, by demographics and other HIV-related variables. Characteristics associated with testing during NHTD week compared with control weeks were identified using Chi-square analyses. Results In 2010, an average of 15,000 more testing events were conducted and 100 more new HIV-positive diagnoses were identified during NHTD week than during the control weeks (p<0.001). Compared with control weeks, people tested during NHTD week were significantly less likely to be aged 20–29 years and non-Hispanic white and significantly more likely to be (1) aged ≥50 years, (2) non-Hispanic black or African American, (3) men who have sex with men, (4) low-risk heterosexuals, (5) tested with a rapid HIV test, or (6) tested in a non-health-care setting. Conclusion In 2010, CDC-funded HIV testing events and new HIV-positive diagnoses increased during NHTD week compared with control weeks. HIV testing programs increased the use of rapid tests and returned a high percentage of test results. NHTD campaigns reached populations disproportionately affected by HIV and further expanded testing to people traditionally less likely to be tested. Incorporating strategies used during NHTD in programs conducted throughout the year may assist in increasing HIV testing and the number of HIV-positive diagnoses. PMID:25177056

A risk of waiting: the weekly incidence of hypertensive disorders and associated maternal and neonatal morbidity in low-risk term pregnancies.

PubMed

Gibson, Kelly S; Waters, Thaddeus P; Bailit, Jennifer L

2016-03-01

Elective induction of labor (eIOL) prior to 39 weeks' gestation is discouraged because of presumed fetal benefits. However, few data exist on the maternal risks of expectant management. To date, no study has evaluated the maternal risk of developing a hypertensive disorder of pregnancy with expectant management of a low-risk gravid at term. We sought to evaluate the development of hypertensive disorders in term low-risk expectantly managed patients. This is a retrospective cross-sectional study from 19 US hospitals, from 2002 to 2008 (Safe Labor Consortium) including all nonanomalous, cephalic, singleton pregnancies at 37-41 weeks. Women with a history of hypertension, diabetes mellitus, cardiovascular disease, or planned cesarean delivery or from centers with incomplete hypertensive data were excluded. Women with eIOL in each week were compared with women managed expectantly until the next week of gestation or beyond. The primary outcome was the frequency of hypertensive complications. Of 114,651 low-risk deliveries, 12,772 (11.1%) had eIOL. The cohort was 49.2% nulliparous, 51.1% white, and obese (mean body mass index 30.2 kg/m(2)). The risk of developing any hypertension in expectantly managed women was 4.1% after 37 weeks, 3.5% after 38 weeks, 3.2% after 39 weeks, and 2.6% after 40 weeks. Compared with eIOL, women with hypertensive disorders had significantly higher rates of cesarean delivery and maternal morbidities (intensive care unit admission or death, third- or fourth-degree lacerations, maternal infections, and bleeding complications) at each week of gestation and the composite neonatal morbidity at 38 and 39 weeks of gestation. For women at low risk expectantly managed at term, there is a risk of developing hypertensive complications for each additional week of pregnancy, with associated increases in maternal and neonatal morbidities. Copyright © 2016 Elsevier Inc. All rights reserved.

Impact of Baseline Disease Severity Over 26 and 52 Weeks of Treatment with Calcitriol Ointment 3µg/g in Patients with Mild-to-moderate Plaque Psoriasis.

PubMed

Lebwohl, Mark; Preston, Norman; Gottschalk, Ronald W

2012-02-01

Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adults with mild-to-moderate plaque psoriasis. This analysis evaluated the response to calcitriol 3µg/g ointment relative to baseline disease. Retrospective analysis of data from a 12-month safety and tolerability trial. At baseline, 40.1 percent (130/324) of patients had an affected body surface area of 11 to 20 percent, and 55.2 percent (179/324) had moderate and 25.9 percent (84/324) had severe disease according to global severity score. Patients applied calcitriol 3µg/g ointment twice daily for up to 52 weeks. Change in investigator's global severity scores and involved body surface area at Week 26 (N=249) and Week 52 (N=130) relative to baseline. Compared with baseline, most patients experienced at least a 1-grade improvement in global severity score at Weeks 26 (195/249, 78.3%) and 52 (109/130, 83.8%). Stabilization (i.e., no change in global severity score) was reported in 19.3 percent (48/249) at Week 26 and in 12.3 percent (16/130) at Week 52. Most patients also experienced at least a 1-grade improvement in body surface area involved at Weeks 26 (152/249, 61.0%) and 52 (95/130, 73.1%). Stabilization (no change in affected body surface area) was reported in 32.5 percent (81/249) at Week 26 and 24.6 percent (32/130) at Week 52. The proportion of patients experiencing improvement in global severity score and body surface area was comparable across all categories of severity and disease extent at baseline. This analysis suggests that calcitriol 3µg/g ointment use for 26 weeks (N=249) and 52 weeks (N=130) was associated with disease improvement or stabilization in most patients with plaque psoriasis.

High Versus Low Load Resistance Training: The Effect of 24 Weeks Detraining on Serum Brain Derived-Neurotrophic Factor (BDNF) in Older Adults.

PubMed

Nuvagah Forti, L; Van Roie, E; Njemini, R; Coudyzer, W; Beyer, I; Delecluse, C; Bautmans, I

2017-01-01

Previously we showed that 12 weeks of mixed-low resistance training (LOW+) significantly increased circulating BDNF in older male individuals. To examine the impact of 24 weeks detraining on circulating BDNF. Randomized intervention study. Community-dwelling older adults. Forty-seven out of 56 participants stopped training (detraining) after 12 weeks of resistance exercise (3x/week) at either HIGH-resistance (5 Males, 5 Females, 2x10-15 repetitions at 80%1RM), LOW-resistance (6 Males, 7 Females, 1x80-100 repetitions at 20%1RM), or mixed-low LOW+-resistance (6 Males, 8 Females, 1x60 repetitions at 20%1RM followed by 1x10-20 repetitions at 40%1RM), of whom 37 (aged 68±5 years) provided sufficient serum samples for BDNF analysis at baseline, 12 week and at 36 weeks (24 weeks detraining). BDNF had initially increased by 31% (from 33.4±10.9 ng/mL to 44.5±13.2 ng/mL, p=0.005) after 12 weeks in the LOW+ exercise group in males and decreased by 26% (from 44.5±13.2 ng/mL to 32.9±10.7 ng/mL) after detraining, though not statistically significant (p=0.082). In females, no significant change in BDNF was found in any of the intervention groups (p>0.05), neither after training, nor detraining. At 36 weeks all of the subgroups showed BDNF levels comparable (all p>0.10) to baseline (before the exercise intervention). Our results show that a 12-weeks LOW+ resistance exercise increases circulating BDNF in older male subjects but that this reduces back to baseline levels after 24 weeks of detraining. Continuous exercise adherence seems to be needed to sustain the training-induced effects on BDNF in older persons. Additional studies are needed to unravel the underlying mechanisms, as well as to confirm the observed sex difference.

Angiogenic Factor Profiles in Pregnant Women With a History of Early-Onset Severe Preeclampsia Receiving Low-Molecular-Weight Heparin Prophylaxis.

PubMed

Lecarpentier, Edouard; Gris, Jean Christophe; Cochery-Nouvellon, Eva; Mercier, Erick; Touboul, Cyril; Thadhani, Ravi; Karumanchi, S Ananth; Haddad, Bassam

2018-01-01

To evaluate whether daily low-molecular-weight (LMW) heparin prophylaxis during pregnancy alters profile of circulating angiogenic factors that have been linked with the pathogenesis of preeclampsia and fetal growth restriction. This is a planned ancillary study of the Heparin-Preeclampsia trial, a randomized trial in pregnant women with a history of severe early-onset preeclampsia (less than 34 weeks of gestation). In the parent study, all women were treated with aspirin and then randomized to receive LMW heparin or aspirin alone. In this study, we measured serum levels of circulating angiogenic factors (soluble fms-like tyrosine kinase-1, placental growth factor, and soluble endoglin by immunoassay) at the following gestational windows: 10-13 6/7 weeks, 14-17 6/7 weeks, 18-21 6/7 weeks, 22-25 6/7 weeks, 26-29 6/7 weeks, 30-33 6/7 weeks, and 34-37 6/7 weeks. Samples were available from 185 patients: LMW heparin+aspirin (n=92) and aspirin alone (n=93). The two groups had comparable baseline characteristics and had similar adverse composite outcomes (35/92 [38.0%] compared with 36/93 [38.7%]; P=.92). There were no significant differences in serum levels of soluble fms-like tyrosine kinase-1, placental growth factor, and soluble endoglin in the participants who received LMW heparin and aspirin compared with those who received aspirin alone regardless of gestational age period. Finally, women who developed an adverse composite outcome at less than 34 weeks of gestation demonstrated significant alterations in serum angiogenic profile as early as 10-13 6/7 weeks that was most dramatic 6-8 weeks preceding delivery. Prophylactic LMW heparin therapy when beginning from before 14 weeks of gestation with aspirin during pregnancy is not associated with an improved angiogenic profile. This may provide a molecular explanation for the lack of clinical benefit noted in recent trials. ClinicalTrials.gov, NCT00986765.

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

PubMed Central

Ehlers, Anke; Hackmann, Ann; Grey, Nick; Wild, Jennifer; Liness, Sheena; Albert, Idit; Deale, Alicia; Stott, Richard; Clark, David M.

2014-01-01

Objective Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to investigate whether cognitive therapy has specific treatment effects by comparing intensive and standard weekly cognitive therapy with an equally credible alternative treatment. Method Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and diagnosis as assessed by independent assessors and self-report. Secondary outcomes were disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6 weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were intent-to-treat. Results At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all outcome measures, with the exception of no difference between supportive therapy and waitlist on quality of life. For primary outcomes, disability and general anxiety, intensive and standard cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster symptom reduction and comparable overall outcomes to standard cognitive therapy. Conclusions Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered over 3 months. Both had specific effects and were superior to supportive therapy. Intensive cognitive therapy for PTSD is a feasible and promising alternative to traditional weekly treatment. PMID:24480899

Effectiveness of a baking soda toothpaste delivering calcium and phosphate in reducing dentinal hypersensitivity.

PubMed

Ghassemi, A; Hooper, W; Winston, A E; Sowinski, J; Bowman, J; Sharma, N

2009-01-01

The purpose of this controlled clinical trial was to determine the effectiveness and safety of a single-phase dentifrice that delivers calcium, phosphate, and fluoride to the tooth surface (Arm & Hammer Enamel Care for Sensitive Teeth toothpaste, United Kingdom) in reducing dentinal hypersensitivity. Two-hundred and eight qualifying subjects were randomly assigned to either the Enamel Care dentifrice group or a control dentifrice group, and brushed twice daily with their assigned dentifrice for eight weeks. Pain/discomfort in response to a thermal stimulus was assessed at baseline, week 4, and week 8 using a Visual Analogue Scale (VAS; primary outcome variable) and the Schiff Thermal Sensitivity Scale (STSS; secondary outcome variable). After eight weeks, volunteers from the Enamel Care group were switched to the control dentifrice and participated in a second eight-week study to determine the degree of persistence of pain reduction. Both groups had statistically significant VAS score reductions from baseline at weeks 4 and 8, with mean VAS scores in the Enamel Care group decreasing by 45.6% at week 4 and 61.1% at week 8 (p < 0.0001). Enamel Care was statistically significantly more effective than the control at weeks 4 and 8, with respective mean VAS reductions of 63% (p < 0.0001) and 33% (p = 0.0004) greater than the control. Consistent with the VAS score results, the Enamel Care group had respective statistically significant STSS score reductions of 77% and 58% greater than the control group (p < 0.0001). The reductions in dentinal hypersensitivity seen in the Enamel Care group at week 8 persisted for an additional eight weeks, during which the subjects discontinued use of Enamel Care and brushed with the control dentifrice. Enamel Care for Sensitive Teeth toothpaste (United Kingdom) is an effective dentifrice for the management of dentinal hypersensitivity, and its efficacy persists for a least eight weeks following discontinued product use.

Run Clever – No difference in risk of injury when comparing progression in running volume and running intensity in recreational runners: A randomised trial

PubMed Central

Rasmussen, Sten; Sørensen, Henrik; Parner, Erik Thorlund; Lind, Martin; Nielsen, Rasmus Oestergaard

2018-01-01

Background/aim The Run Clever trial investigated if there was a difference in injury occurrence across two running schedules, focusing on progression in volume of running intensity (Sch-I) or in total running volume (Sch-V). It was hypothesised that 15% more runners with a focus on progression in volume of running intensity would sustain an injury compared with runners with a focus on progression in total running volume. Methods Healthy recreational runners were included and randomly allocated to Sch-I or Sch-V. In the first eight weeks of the 24-week follow-up, all participants (n=839) followed the same running schedule (preconditioning). Participants (n=447) not censored during the first eight weeks entered the 16-week training period with a focus on either progression in intensity (Sch-I) or volume (Sch-V). A global positioning system collected all data on running. During running, all participants received real-time, individualised feedback on running intensity and running volume. The primary outcome was running-related injury (RRI). Results After preconditioning a total of 80 runners sustained an RRI (Sch-I n=36/Sch-V n=44). The cumulative incidence proportion (CIP) in Sch-V (reference group) were CIP2 weeks 4.6%; CIP4 weeks 8.2%; CIP8 weeks 13.2%; CIP16 weeks 28.0%. The risk differences (RD) and 95% CI between the two schedules were RD2 weeks=2.9%(−5.7% to 11.6%); RD4 weeks=1.8%(−9.1% to 12.8%); RD8 weeks=−4.7%(−17.5% to 8.1%); RD16 weeks=−14.0% (−36.9% to 8.9%). Conclusion A similar proportion of runners sustained injuries in the two running schedules. PMID:29527322

Concurrence of Serum Creatinine and Albumin with Lower Risk for Death in Twice-Weekly Hemodialysis Patients

PubMed Central

Wang, Jialin; Streja, Elani; Soohoo, Melissa; Chen, Joline L.T.; Rhee, Connie M.; Kim, Taehee; Molnar, Miklos Z.; Kovesdy, Csaba P.; Mehrotra, Rajnish; Kalantar-Zadeh, Kamyar

2016-01-01

Objective Markers of better nutritional status including both higher levels of serum albumin (as a measure of visceral proteins) and creatinine (as a measure of the muscle mass) are associated with lower mortality in conventional (thrice-weekly) hemodialysis patients. However, data for these associations in twice-weekly hemodialysis patients, in whom less frequent hemodialysis may confound nutritional predictors, are lacking. Design, Settings and Subjects We identified 1,113 twice-weekly and matched 4,448 thrice-weekly hemodialysis patients from a large national dialysis cohort of incident hemodialysis patients over 5 years (2007-2011). Mortality risk, adjusted for potential confounders, was examined across two-by-two combinations of serum creatinine (<6 mg/dl vs. ≥6 mg/dl) and albumin (<3.5 g/dl vs. ≥3.5 g/dl) for each treatment frequency yielding a total of eight groups. Results Patients were 70±14 years old and included 48% women, and 55% diabetics. Using the thrice-weekly hemodialysis patients with creatinine≥6mg/dl and albumin≥3.5g/dl as reference, patients with creatinine<6mg/dl and albumin<3.5g/dl had a 1.8-fold higher risk of mortality (HR: 1.75, 95%CI: 1.33-2.30) in twice-weekly and 2.2-fold increased risk of mortality (HR: 2.21, 95%CI: 1.81-2.70) in thrice-weekly hemodialysis patients, respectively in fully adjusted models adjusted for demographics, comorbidities and markers of malnutrition and inflammation. A test for interaction showed there was no significant difference in albumin creatinine mortality associations between twice-weekly and thrice-weekly hemodialysis patients (p-for-interaction 0.7667). Conclusions Surrogate markers of higher visceral protein and muscle mass combined may confer greatest survival in both twice-weekly and thrice-weekly hemodialysis patients. PMID:27528412

Return to normal activities and work after living donor laparoscopic nephrectomy.

PubMed

Larson, Dawn B; Jacobs, Cheryl; Berglund, Danielle; Wiseman, Jennifer; Garvey, Catherine; Gillingham, Kristen; Ibrahim, Hassan N; Matas, Arthur J

2017-01-01

Transplant programs inform potential donors that they should be able to return to normal activities within ~2 weeks and to work by 6 weeks after laparoscopic nephrectomy. We studied actual time. Between 10/2004 and 9/2014, 911 donors having laparoscopic nephrectomy were surveyed 6 months post-donation. Surveys asked questions specific to their recovery experience, including time to return to normal activities and work and a description of their recovery time relative to pre-donation expectations. Of the 911, 646 (71%) responded: mean age at donation was 43.5±10.6 years; 65% were female, 95% were white, 51% were biologically related to their recipient, and 83% reported education beyond high school. Of the 646 respondents, a total of 35% returned to normal activities by 2 weeks post-donation; 79% by 4 weeks post-donation; 94% by 5-6 weeks; however, 6% took >6 weeks. Of the 646, 551 (85%) were working for pay; of these, mean time to return to work was 5.3±2.8 weeks; median, 5 weeks. Of the 551, a total of 14% returned to work in 1-2 weeks, 46% by 3-4 weeks, and 76% by 5-6 weeks. Importantly, 24% required >6 weeks before returning to work with the highest rates for donors in manual labor or a skilled trade. Significantly longer return to work was reported by females (vs males; P=.01), those without (vs those with) post-high school education (P=.010, those with longer hospital stay (P=.01), and those with a postoperative complication (P=.02). Of respondents, 37% described their recovery time as longer than expected. During the donor informed consent process, additional emphasis on realistic expectations around recovery to baseline activities and return to work is warranted. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Periodontal status during pregnancy and postpartum

PubMed Central

2017-01-01

Objectives Different studies have documented an association between periodontal disease and low birth-weight delivery. Hence, knowledge of periodontal status during pregnancy and postpartum is important in order to reduce the risks of both diseases. This study aimed to analyze periodontal status at successive stages of pregnancy and 3–6 weeks postpartum in women with initial periodontal alterations. Materials and methods Ninety-six pregnant women were examined at 8–10 weeks (pregnancy diagnosis, baseline), 21–23 weeks and 34–36 weeks of gestation and at 40 days postpartum to record plaque scores, clinically assessed gingival inflammation and probing depth (mean depth and % sites with depth >3 mm). Bivariate and multivariate analyses were performed. Type 1 (α) error was established at 0.05 Results Plaque Index increased (p = 0.043) throughout pregnancy (baseline, 42%±0.18); 21–23 weeks, 42.6%±0.14; 34–36 weeks, 45.6%±0.13 and decreased postpartum (44.8%±0–13). Gingival Index increased (p<0.001) throughout pregnancy (baseline, 56.7%±0.20; 21–23 weeks, 66.36%±0.17; 34–36 weeks, 74.5%±0.18) and decreased postpartum (59.3%±0.21). Probing Depth increased (p<0.001) throughout pregnancy (baseline, 2.51±0.05; 21–23 weeks, 2.63±0.053; 34–36 weeks 2.81±0.055) and decreased postpartum (2.54±0.049). Percentage of sites with Probing Depth >3 mm increased (p<0.001) throughout pregnancy (baseline, 17.6%±0.16; 21–23 weeks, 23.9%±0.17; 34–36 weeks, 31.1%±0.17) and decreased postpartum (21.2%±0.17) but remained significantly (p<0.02) higher than at baseline. Conclusion Periodontal status deteriorates during gestation but improves postpartum. PMID:28538740

Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: Rheumatoid Arthritis with Orencia Trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial—an open-label, one-year, prospective study—Interim analysis of 32 patients for 24 weeks

PubMed Central

Tsuboi, Hiroto; Matsumoto, Isao; Hagiwara, Shinya; Hirota, Tomoya; Takahashi, Hiroyuki; Ebe, Hiroshi; Yokosawa, Masahiro; Hagiya, Chihiro; Asashima, Hiromitsu; Takai, Chinatsu; Miki, Haruka; Umeda, Naoto; Kondo, Yuya; Ogishima, Hiroshi; Suzuki, Takeshi; Hirata, Shintaro; Saito, Kazuyoshi; Tanaka, Yoshiya; Horai, Yoshiro; Nakamura, Hideki; Kawakami, Atsushi

2015-01-01

Objective To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion Abatacept seems to be effective for both RA and RA-related secondary SS. PMID:25211401

Effect of heart failure reversal treatment as add-on therapy in patients with chronic heart failure: A randomized, open-label study.

PubMed

Sane, Rohit; Aklujkar, Abhijeet; Patil, Atul; Mandole, Rahul

The present study was designed to evaluate effect of heart failure reversal therapy (HFRT) using herbal procedure (panchakarma) and allied therapies, as add-on to standard CHF treatment (SCT) in chronic heart failure (CHF) patients. This open-label, randomized study conducted in CHF patients (aged: 25-65 years, ejection fraction: 30-65%), had 3-phases: 1-week screening, 6-week treatment (randomized [1:1] to HFRT+SCT or SCT-alone) and follow-up (12-week). Twice weekly HFRT (60-75min) consisting of snehana (external oleation), swedana (passive heat therapy), hrudaydhara (concoction dripping treatment) and basti (enema) was administered. Primary endpoints included evaluation of change in metabolic equivalents of task (MET) and peak oxygen uptake (VO 2peak ) from baseline, at end of 6-week treatment and follow-up at week-18 (non-parametric rank ANCOVA analysis). Safety and quality of life (QoL) was assessed. Seventy CHF patients (n=35, each treatment-arm; mean [SD] age: 53.0 [8.6], 80% men) were enrolled in the study. All patients completed treatment phase. Add-on HFRT caused a significant increase in METs (least square mean difference [LSMD], 6-week: 1.536, p=0.0002; 18-week: -1.254, p=0.0089) and VO 2peak (LSMD, 6-week: -5.52, p=0.0002; 18-week: -4.517, p=0.0089) as compared with SCT-alone. Results were suggestive of improved functional capacity in patients with HFRT (QoL; Mean [SD] HFRT+SCT vs. SCT-alone; 6-week: -0.44 [0.34] vs. -0.06 [0.25], p<0.0001 and 18-week: -0.53 [0.35] vs. -0.29 [0.26], p=0.0013). Seven treatment-emergent adverse events (mild severity) were reported in HFRT-arm. Findings of this study highlight therapeutic efficacy of add-on HFRT vs. SCT-alone in CHF patients. The non-invasive HFRT showed no safety concerns. Copyright © 2016. Published by Elsevier B.V.

Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial.

PubMed

Hangody, Laszlo; Szody, Robert; Lukasik, Piotr; Zgadzaj, Wojciech; Lénárt, Endre; Dokoupilova, Eva; Bichovsk, Daniela; Berta, Agnes; Vasarhelyi, Gabor; Ficzere, Andrea; Hangody, György; Stevens, Gary; Szendroi, Miklos

2017-05-01

To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis. This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks. A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported. Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II).

PubMed

Kavakli, K; Yang, R; Rusen, L; Beckmann, H; Tseneklidou-Stoeter, D; Maas Enriquez, M

2015-03-01

BAY 81-8973 is a new full-length human recombinant factor VIII product manufactured with technologies to improve consistency in glycosylation and expression to optimize clinical performance. To demonstrate superiority of prophylaxis vs. on demand therapy with BAY 81-8973 in patients with severe hemophilia A. In this multinational,randomized, open-label crossover study (LEOPOLD II;ClinicalTrials.gov identifier: NCT01233258), males aged 12–65 years with severe hemophilia A were randomized to twice-weekly prophylaxis (20-30 IU kg(-1)), 3-times-weekly prophylaxis (30-40 IU kg(-1)), or on-demand treatment with BAY 81-8973. Potency labeling for BAY 81-8973 was based on the chromogenic substrate assay or adjusted to the one-stage assay. Primary efficacy endpoint was annualized number of all bleeds (ABR). Adverse events (AEs)and immunogenicity were also assessed. Eighty patients (on demand, n = 21; twice-weekly prophylaxis, n = 28; 3-times-weekly prophylaxis, n = 31) were treated and analyzed. Mean ± SD ABR was significantly lower with prophylaxis (twice-weekly, 5.7 ± 7.2; 3-times-weekly, 4.3 ± 6.5; combined, 4.9 ± 6.8) vs. on-demand treatment (57.7 ± 24.6; P < 0.0001, ANOVA). Median ABR was reduced by 97% with prophylaxis (twice-weekly, 4.0;3-times-weekly, 2.0; combined, 2.0) vs. on-demand treatment (60.0). Median ABR was higher with twice-weekly vs. 3-times-weekly prophylaxis during the first 6-month treatment period (4.1 vs. 2.0) but was comparable in the second 6-month period (1.1 vs. 2.0). Few patients reported treatment-related AEs (4%); no treatment-related serious AEs or inhibitors were reported. Twice weekly or 3-times-weekly prophylaxis with BAY 81-8973 reduced median ABR by 97% compared with on-demand therapy, confirming the superiority of prophylaxis. Treatment with BAY 81-8973 was well tolerated.

Surgeon distress as calibrated by hours worked and nights on call.

PubMed

Balch, Charles M; Shanafelt, Tait D; Dyrbye, Lotte; Sloan, Jeffrey A; Russell, Thomas R; Bechamps, Gerald J; Freischlag, Julie A

2010-11-01

The relationships of working hours and nights on call per week with various parameters of distress among practicing surgeons have not been previously examined in detail. More than 7,900 members of the American College of Surgeons responded to an anonymous, cross-sectional survey. The survey included self-assessment of their practice setting, a validated depression screening tool, and standardized assessments of burnout and quality of life. There was a clear gradient between hours and burnout, with the prevalence of burnout ranging from 30% for surgeons working <60 hours/week, 44% for 60 to 80 hours/week, and 50% for those working >80 hours/week (p < 0.001). When correlated with number of nights on call, burnout exhibited a threshold effect at ≥2 nights on call/week (≤1 nights on call/week, 30%; ≥2 nights on call/week, 44% to 46%; p < 0.0001). Screening positive for depression rate also correlated strongly with hours and nights on call (both p < 0.0001). Those who worked >80 hours/week reported a higher rate of medical errors compared with those who worked <60 hours/week (10.7% versus 6.9%; p < 0.001), and were twice as likely to attribute the error to burnout (20.1% versus 8.9%; p = 0.001). Not surprisingly, work and home conflicts were higher among surgeons who worked longer hours or had ≥2 nights on call. A significantly higher proportion of surgeons who worked >80 hours/week or had >2 nights on call/week would not become a surgeon again (p < 0.0001). Number of hours worked and nights on call per week appear to have a substantial impact on surgeons, both professionally and personally. These factors are strongly related to burnout, depression, career satisfaction, and work and home conflicts. Copyright © 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Rapid Improvement of Glycemic Control in Type 2 Diabetes Using Weekly Intensive Multifactorial Interventions: Structured Glucose Monitoring, Patient Education, and Adjustment of Therapy—A Randomized Controlled Trial

PubMed Central

Rodbard, David; Zanella, Maria Teresa

2011-01-01

Abstract Background We evaluated intensive intervention in poorly controlled patients with type 2 diabetes mellitus involving weekly clinic visits and adjustment of therapy with analysis of three seven-point glucose profiles and intervention from an interdisciplinary staff. Methods Sixty-three patients were randomized to an intensive treatment group that obtained self-monitoring of blood glucose (SMBG) profiles (six or seven values per day, 3 days/week) and were seen in the clinic at Weeks 1–6 and 12. SMBG results were downloaded, analyzed using Accu-Chek® 360° software (Roche Diagnostics, Indianapolis, IN), and used to adjust therapy. Control group subjects obtained glucose profiles and had clinic visits only at Weeks 0, 6, and 12. Results There were highly statistically significant improvements in the intensive treatment group compared with the control group between Weeks 0 and 6 with greater reductions in weekly mean glycemia (WMG) (−76.7±8.9 mg/dL vs. −20.5±8.1 mg/dL), glycemic variability (SD) (−16.3±3.1 mg/dL vs. −5.0±3.1 mg/dL), and glycated hemoglobin (−1.82±0.16% vs. −0.66±0.22%) without significant changes in frequency of hypoglycemia or weight. Improvements were sustained in the intensive treatment group through Week 12. A minimal but statistically significant degree of improvement was seen in the control group at Week 12. Conclusions This short-term pilot study of an intensive monitoring, educational, and pharmacological interventions program resulted in dramatic improvement of glycemic control within 6 weeks, and these effects are sustained through Week 12. SMBG glucose profiles, calculation of WMG and SD, and graphical displays of glucose data can improve the effectiveness of adjustment of therapy at weekly clinic visits when combined with intensive support from a multidisciplinary team. PMID:21751888

Reloading partly recovers bone mineral density and mechanical properties in hind limb unloaded rats

NASA Astrophysics Data System (ADS)

Zhao, Fan; Li, Dijie; Arfat, Yasir; Chen, Zhihao; Liu, Zonglin; Lin, Yu; Ding, Chong; Sun, Yulong; Hu, Lifang; Shang, Peng; Qian, Airong

2014-12-01

Skeletal unloading results in decreased bone formation and bone mass. During long-term space flight, the decreased bone mass is impossible to fully recover. Therefore, it is necessary to develop the effective countermeasures to prevent spaceflight-induced bone loss. Hindlimb Unloading (HLU) simulates effects of weightlessness and is utilized extensively to examine the response of musculoskeletal systems to certain aspects of space flight. The purpose of this study is to investigate the effects of a 4-week HLU in rats and subsequent reloading on the bone mineral density (BMD) and mechanical properties of load-bearing bones. After HLU for 4 weeks, the rats were then subjected to reloading for 1 week, 2 weeks and 3 weeks, and then the BMD of the femur, tibia and lumbar spine in rats were assessed by dual energy X-ray absorptiometry (DXA) every week. The mechanical properties of the femur were determined by three-point bending test. Dry bone and bone ash of femur were obtained through Oven-Drying method and were weighed respectively. Serum alkaline phosphatase (ALP) and serum calcium were examined through ELISA and Atomic Absorption Spectrometry. The results showed that 4 weeks of HLU significantly decreased body weight of rats and reloading for 1 week, 2 weeks or 3 weeks did not recover the weight loss induced by HLU. However, after 2 weeks of reloading, BMD of femur and tibia of HLU rats partly recovered (+10.4%, +2.3%). After 3 weeks of reloading, the reduction of BMD, energy absorption, bone mass and mechanical properties of bone induced by HLU recovered to some extent. The changes in serum ALP and serum calcium induced by HLU were also recovered after reloading. Our results indicate that a short period of reloading could not completely recover bone after a period of unloading, thus some interventions such as mechanical vibration or pharmaceuticals are necessary to help bone recovery.

Long-term effects of asenapine or olanzapine in patients with persistent negative symptoms of schizophrenia: a pooled analysis.

PubMed

Potkin, Steven G; Phiri, Phillip; Szegedi, Armin; Zhao, Jun; Alphs, Larry; Cazorla, Pilar

2013-11-01

A Phase 2 efficacy study suggested that asenapine (ASE) was superior to risperidone in decreasing negative symptoms in schizophrenia at 6 weeks, prompting design of two negative symptom studies. Two 26-week core studies with 26-week extensions compared asenapine (ASE: 5-10mg twice-daily] and olanzapine (OLA: 5-20mg once-daily) as monotherapies in reducing persistent negative symptoms (PNS). While neither study met the primary endpoint of superiority of ASE over OLA, ASE was statistically superior to OLA in one extension study. This prompted a pooled analysis of the treatment effects of both drugs. Data were pooled from two 26-week core studies and extensions. Efficacy endpoints: change in Negative Symptom Assessment scale-16 (NSA-16) total score at Week 26 (prespecified primary endpoint) and Week 52. Additional measures: change in Positive and Negative Syndrome Scale (PANSS)-total, Marder factors, negative subscale scores, Clinical Global Impression Severity of Illness score (CGI-S) assessments, NSA-16 factor domains, NSA global score, and individual items. Pooled data from the extension studies (n=502) showed no differences between ASE and OLA at Week 26. At Week 52, ASE showed superiority over OLA in NSA-16 total score, NSA global, PANSS Marder negative and PANSS negative subscales, some NSA-16 items, and four of five factor domains. In addition, pooled data for patients who entered the core trials (n=949) were analyzed over 52weeks (whether or not patients entered the extension). No significant differences between groups were observed in change in NSA-16 total score at 26-weeks. At Week 52, ASE was significantly superior over OLA in this measure, NSA global score and PANSS Marder negative factor. There were more early dropouts due to AEs, including worsening of the disease, in the ASE group. In this pooled analysis, ASE and OLA did not differ significantly over 26 weeks, but indicated a signal of superiority for ASE with continued treatment up to 52 weeks. © 2013.

Synovial and systemic pharmacokinetics (PK) of triamcinolone acetonide (TA) following intra-articular (IA) injection of an extended-release microsphere-based formulation (FX006) or standard crystalline suspension in patients with knee osteoarthritis (OA).

PubMed

Kraus, V B; Conaghan, P G; Aazami, H A; Mehra, P; Kivitz, A J; Lufkin, J; Hauben, J; Johnson, J R; Bodick, N

2018-01-01

Intra-articular (IA) corticosteroids relieve osteoarthritis (OA) pain, but rapid absorption into systemic circulation may limit efficacy and produce untoward effects. We compared the pharmacokinetics (PK) of IA triamcinolone acetonide (TA) delivered as an extended-release, microsphere-based formulation (FX006) vs a crystalline suspension (TAcs) in knee OA patients. This Phase 2 open-label study sequentially enrolled 81 patients who received a single IA injection of FX006 (5 mL, 32 mg delivered dose, N = 63) or TAcs (1 mL, 40 mg, N = 18). Synovial fluid (SF) aspiration was attempted in each patient at baseline and one post-IA-injection visit (FX006: Week 1, Week 6, Week 12, Week 16 or Week 20; TAcs: Week 6). Blood was collected at baseline and multiple post-injection times. TA concentrations (validated LC-MS/MS, geometric means (GMs)), PK (non-compartmental analysis models), and adverse events (AEs) were assessed. SF TA concentrations following FX006 were quantifiable through Week 12 (pg/mL: 231,328.9 at Week 1; 3590.0 at Week 6; 290.6 at Week 12); post-TAcs, only two of eight patients had quantifiable SF TA at Week 6 (7.7 pg/mL). Following FX006, plasma TA gradually increased to peak (836.4 pg/mL) over 24 h and slowly declined to <110 pg/mL over Weeks 12-20; following TAcs, plasma TA peaked at 4 h (9628.8 pg/mL), decreased to 4991.1 pg/mL at 24 h, and was 149.4 pg/mL at Week 6, the last post-treatment time point assessed. AEs were similar between groups. In knee OA patients, microsphere-based TA delivery via a single IA injection prolonged SF joint residency, diminished peak plasma levels, and thus reduced systemic TA exposure relative to TAcs. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Material Testing of Coated Alloys in a Syngas Combustion Environment Year 6 - Activity 1.13 - Development of a National Center for Hydrogen Technology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Swanson, Michael

Modifications were made to the inlet of the existing Energy & Environmental Research Center (EERC) thermal oxidizer to accommodate side-by-side coupon holders for exposure testing. Two 5-day tests with over 200 hours of total exposure time were completed. The first week of testing was conducted in enriched air-blown mode, with coupon temperatures ranging from 128° to 272°F. Carbonyl sampling was conducted, but it was discovered after the fact that the methodology used was producing very low recoveries of iron and nickel carbonyl. Therefore, the data generated during this week of testing were not considered accurate. The second week of testingmore » was conducted in oxygen-blown mode, with coupon temperatures ranging from 220° to 265°F. Two improved methods were used to measure carbonyl concentration during this week of testing. These methods produced results closer to equilibrium calculations. Since both weeks of testing mostly produced a product gas with approximately 15%–18% carbon monoxide, it was felt that actual carbonyl concentrations for Week 1 should be very similar to those measured during Week 2. The revised carbonyl sampling methodology used during the second week of testing greatly improved the recovery of iron and nickel carbonyl in the sample. Even though the sampling results obtained from the first week were inaccurate, the results from the second week can be used as an estimate for the periods during which the gasifier was operating under similar conditions and producing similar product gas compositions. Specifically, Test Periods 2 and 3 from the first week were similar to the conditions run during the second week. For a product gas containing roughly 15%–18% CO and a coupon temperature of approximately 220°–270°F, the nickel carbonyl concentration should be about 0.05–0.1 ppm and the iron carbonyl concentration should be about 0.1–0.4 ppm. After each week of testing the coupons were recovered from the coupon holder, weighed, and shipped back to Siemens for analysis.« less

Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE).

PubMed

Nash, Peter; Ohson, Kamal; Walsh, Jessica; Delev, Nikolay; Nguyen, Dianne; Teng, Lichen; Gómez-Reino, Juan J; Aelion, Jacob A

2018-05-01

Evaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA. Patients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52. Among 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast's safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0-24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo). In biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports. NCT01925768; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naive patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated study.

PubMed

Detert, Jacqueline; Bastian, Hans; Listing, Joachim; Weiß, Anja; Wassenberg, Siegfried; Liebhaber, Anke; Rockwitz, Karin; Alten, Rieke; Krüger, Klaus; Rau, Rolf; Simon, Christina; Gremmelsbacher, Eva; Braun, Tanja; Marsmann, Bettina; Höhne-Zimmer, Vera; Egerer, Karl; Buttgereit, Frank; Burmester, Gerd-R

2013-06-01

To investigate the long-term effects of induction therapy with adalimumab (ADA) plus methotrexate (MTX) in comparison with placebo (PBO) plus MTX in DMARD-naïve patients with active early rheumatoid arthritis (RA). Patients with active early RA (disease duration of ≤12 months) were randomly assigned to receive 40 mg ADA subcutaneously every other week (eow) plus MTX 15 mg/week subcutaneously or PBO plus MTX subcutaneously at 15 mg/week over 24 weeks. Thereafter, all patients received MTX monotherapy up to week 48. The primary outcome was the Disease Activity Score 28 (DAS28) at week 48. Secondary outcomes included proportions of patients in remission (DAS28<2.6), ACR responses, Health Assessment Questionnaire (HAQ) score and radiographic progression. 87 patients were assigned to ADA/MTX and 85 patients to PBO/MTX. At baseline, DAS28 was 6.2±0.8 in the ADA/MTX and 6.3±0.9 in the PBO/MTX groups. At week 24, treatment with ADA/MTX compared with PBO/MTX resulted in a greater reduction in DAS28 (3.0±1.2 vs 3.6±1.4; p=0.009) and other secondary outcomes such as DAS28 remission rate (47.9% vs 29.5%; p=0.021) and HAQ (0.49±0.6 vs 0.72±0.6; p=0.0014). At week 48, the difference in clinical outcomes between groups was not statistically significant (DAS28: 3.2±1.4 vs 3.4±1.6; p=0.41). Radiographic progression at week 48 was significantly greater in patients administered PBO/MTX (Sharp/van der Heijde score: ADA/MTX 2.6 vs PBO/MTX 6.4; p=0.03, Ratingen score: 1.7 vs 4.2; p=0.01). A greater reduction in radiographic progression after initial combination therapy with ADA and MTX was seen at week 48, even after discontinuation of ADA treatment at week 24. This sustained effect was not found at the primary endpoint (DAS28 reduction).

Arginine and antioxidant supplement on performance in elderly male cyclists: a randomized controlled trial

PubMed Central

2010-01-01

Background Human exercise capacity declines with advancing age. These changes often result in loss of physical fitness and more rapid senescence. Nitric oxide (NO) has been implicated in improvement of exercise capacity through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms. Antioxidants may prevent nitric oxide inactivation by oxygen free radicals. The purpose of this study was to investigate the effects of an L-arginine and antioxidant supplement on exercise performance in elderly male cyclists. Methods This was a two-arm prospectively randomized double-blinded and placebo-controlled trial. Sixteen male cyclists were randomized to receive either a proprietary supplement (Niteworks®, Herbalife International Inc., Century City, CA) or a placebo powder. Exercise parameters were assessed by maximal incremental exercise testing performed on a stationary cycle ergometer using breath-by-breath analysis at baseline, week one and week three. Results There was no difference between baseline exercise parameters. In the supplemented group, anaerobic threshold increased by 16.7% (2.38 ± 0.18 L/min, p < 0.01) at week 1, and the effect was sustained by week 3 with a 14.2% (2.33 ± 0.44 L/min, p < 0.01). In the control group, there was no change in anaerobic threshold at weeks 1 and 3 compared to baseline (1.88 ± 0.20 L/min at week 1, and 1.86 ± 0.21 L/min at week 3). The anaerobic threshold for the supplement groups was significantly higher than that of placebo group at week 1 and week 3. There were no significant changes noted in VO2 max between control and intervention groups at either week 1 or week 3 by comparison to baseline. Conclusion An arginine and antioxidant-containing supplement increased the anaerobic threshold at both week one and week three in elderly cyclists. No effect on VO2 max was observed. This study indicated a potential role of L-arginine and antioxidant supplementation in improving exercise performance in elderly. PMID:20331847

Grizzly bear denning chronology and movements in the Greater Yellowstone Ecosystem

USGS Publications Warehouse

Haroldson, Mark A.; Ternent, Mark A.; Gunther, Kerry A.; Schwartz, Charles C.

2002-01-01

Den entrance and emergence dates of grizzly bears (Ursus arctos) in the Greater Yellowstone Ecosystem are important to management agencies that wish to minimize impacts of human activities on bears. Current estimates for grizzly bear denning events use data that were collected from 1975–80. We update these estimates by including data obtained from 1981–99. We used aerial telemetry data to estimate week of den entry and emergence by determining the midpoint between the last known active date and the first known date denned, as well as the last known date denned and the first known active date. We also investigated post emergence movement patterns relative to den locations. Mean earliest and latest week of den entry and emergence were also determined. Den entry for females began during the fourth week in September, with 90% denned by the fourth week of November. Earliest den entry for males occurred during the second week of October, with 90% denned by the second week of December. Mean week of den entry for known pregnant females was earlier than males. Earliest week of den entry for known pregnant females was earlier than other females and males. Earliest den emergence for males occurred during the first week of February, with 90% of males out of dens by the fourth week of April. Earliest den emergence for females occurred during the third week of March; by the first week of May, 90% of females had emerged. Male bears emerged from dens earlier than females. Denning period differed among classes and averaged 171 days for females that emerged from dens with cubs, 151 days for other females, and 131 days for males. Known pregnant females tended to den at higher elevations and, following emergence, remained at higher elevation until late May. Females with cubs remained relatively close (<3 km) to den sites until the last 2 weeks in May. Timing of denning events was similar to previous estimates for this and other grizzly bear populations in the southern Rocky Mountains. 

Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.

PubMed

Luo, Xiaoping; Hou, Ling; Liang, Li; Dong, Guanping; Shen, Shuixian; Zhao, Zhuhui; Gong, Chun Xiu; Li, Yuchuan; Du, Min-Lian; Su, Zhe; Du, Hongwei; Yan, Chaoying

2017-08-01

We assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD). Phase II and III, multicenter, open-label, randomized controlled trials. 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored. The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment ( P  < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment ( P  < 0.05). Adverse event rates and treatment compliance were comparable between the two groups. Jintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH. © 2017 The authors.

Feasibility of oral administration of S-1 as adjuvant chemotherapy in gastric cancer: 4-week S-1 administration followed by 2-week rest vs. 2-week administration followed by 1-week rest

PubMed Central

YAMATSUJI, TOMOKI; FUJIWARA, YASUHIRO; MATSUMOTO, HIDEO; HATO, SHINJI; NAMIKAWA, TSUTOMU; HANAZAKI, KAZUHIRO; TAKAOKA, MUNENORI; HAYASHI, JIRO; SHIGEMITSU, KAORI; YOSHIDA, KAZUHIRO; URAKAMI, ATSUSHI; UNO, FUTOSHI; NISHIZAKI, MASAHIKO; KAGAWA, SHUNSUKE; NINOMIYA, MOTOKI; FUJIWARA, TOSHIYOSHI; HIRAI, TOSHIHIRO; NAKAMURA, MASAFUMI; HAISA, MINORU; NAOMOTO, YOSHIO

2015-01-01

In 2006, the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC) demonstrated that S-1 is an effective adjuvant therapy for gastric cancer. Following that study, S-1 has been used as the standard adjuvant therapy for gastric cancer in Japan. However, the 1-year completion rate was only 65.8% in the ACTS-GC study and feasibility remains a critical issue. We conducted a study to evaluate the feasibility of 2 weekly administration regimens of S-1 as adjuvant chemotherapy in gastric cancer. The criteria for eligibility included histologically proven stage II (excluding T1), IIIA or IIIB gastric cancer with D2 lymph-node dissection. The patients were randomly assigned to either arm A (S-1 administration for 4 weeks followed by 2 weeks of rest) or arm B (S-1 administration for 2 weeks followed by 1 week of rest). In each arm, treatment was continued for 12 months unless recurrence or severe adverse events were observed. The primary endpoint was feasibility (protocol treatment completion rate). The secondary endpoints were safety, relapse-free survival and overall survival. A total of 47 patients were assigned to arms A or B between May, 2008 and February, 2010. During the first interim analysis, the protocol treatment completion rates in arms A and B were 83 and 100%, respectively at 6 months and 49 and 89%, respectively, at 12 months (P=0.0046). Therefore, S-1 administration for 2 weeks followed by 1 week rest was more feasible as adjuvant chemotherapy in gastric cancer. Grade 3 adverse events in arm A included fatigue (8.0%), anorexia (8.0%), nausea (4.0%), vomiting (4.0%) and hand-foot syndrome (4.0%), whereas none were observed in arm B. There were no reported grade 4 adverse events in either arm. In conclusion, the 2-week S-1 administration followed by 1-week rest regimen appears to be a more feasible oral administration regimen for S-1 as adjuvant chemotherapy in gastric cancer. PMID:26137261

Maintenance of Clinical Efficacy and Radiographic Benefit Through Two Years of Ustekinumab Therapy in Patients With Active Psoriatic Arthritis: Results From a Randomized, Placebo‐Controlled Phase III Trial

PubMed Central

Puig, Lluís; Gottlieb, Alice B.; Ritchlin, Christopher; Li, Shu; Wang, Yuhua; Mendelsohn, Alan M.; Song, Michael; Zhu, Yaowei; Rahman, Proton; McInnes, Iain B.

2015-01-01

Objective To evaluate the efficacy and safety of ustekinumab through 2 years in adult patients with active psoriatic arthritis (PsA). Methods A total of 615 adult patients with active PsA were randomized to placebo, ustekinumab 45 mg, or ustekinumab 90 mg, at weeks 0, 4, and every 12 weeks through week 88 (last dose). At week 16, patients with <5% improvement in both tender and swollen joint counts entered blinded early escape (placebo to 45 mg, 45 mg to 90 mg, and 90 mg to 90 mg). All remaining placebo patients crossed over to ustekinumab 45 mg at week 24. Clinical efficacy measures included American College of Rheumatology criteria for 20% improvement (ACR20), Disease Activity Score in 28 joints using the C‐reactive protein level (DAS28‐CRP), and ≥75% improvement in the Psoriasis Area and Severity Index (PASI75). Radiographic progression was evaluated using the modified Sharp/van der Heijde score (SHS). Results At week 100, ACR20, DAS28‐CRP moderate/good response, and PASI75 rates ranged from 56.7–63.6%, 71.9–76.7%, and 63.9–72.5%, respectively, across the 3 treatment groups. In both ustekinumab groups, the median percent improvement in dactylitis and enthesitis was 100% at week 100. The mean changes in SHS score from week 52 to week 100 were similar to those observed from week 0 to week 52 in the ustekinumab groups. Through week 108, 70.7% and 9.7% of patients had an adverse event (AE) or serious AE, respectively. The rates and type of AEs were similar between the dose groups. Conclusion Clinical and radiographic benefits from ustekinumab treatment were maintained through week 100 in the PSUMMIT 1 study. No unexpected safety events were observed; the safety profile of ustekinumab in this population was similar to that previously observed in psoriasis patients treated with ustekinumab. PMID:26097039

An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

PubMed Central

Asselah, Tarik; Moreno, Christophe; Sarrazin, Christoph; Gschwantler, Michael; Foster, Graham R.; Craxí, Antonio; Buggisch, Peter; Ryan, Robert; Lenz, Oliver; Scott, Jane; Van Dooren, Gino; Lonjon-Domanec, Isabelle; Schlag, Michael; Buti, Maria

2016-01-01

Background Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0–F2 fibrosis, patients with HCV-RNA <25 IU/mL (detectable/undetectable) at Week 2, and undetectable HCV-RNA at Weeks 4 and 8, stopped all treatment at Week 12. All other patients continued PR for a further 12 weeks. Baseline factors significantly associated with SVR12 were identified through logistic regression. Results Of 163 patients who participated in the study, 123 (75%) qualified for 12-week treatment; of these, 81 (66%) achieved SVR12. Baseline factors positively associated with SVR12 rates in patients receiving the 12-week regimen were: IL28B CC genotype: (94% SVR12); HCV RNA ≤800,000 IU/mL (82%); F0–F1 fibrosis (74%). Among all 163 patients, 94% experienced ≥1 adverse event (AE), 4% a serious AE, and 2.5% discontinued due to an AE. Reduced impairment in patient-reported outcomes was observed in the 12-week vs >12-week regimen. Conclusions Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen. Trial Registration ClinicalTrials.gov NCT01846832 PMID:27428331

Rate of Atherosclerosis Progression in ApoE−/− Mice Long After Discontinuation of Cola Beverage Drinking

PubMed Central

Otero-Losada, Matilde; Cao, Gabriel; Mc Loughlin, Santiago; Rodríguez-Granillo, Gastón; Ottaviano, Graciela; Milei, José

2014-01-01

This study was conducted in order to evaluate the effect of cola beverages drinking on atherosclerosisand test the hypothesis whether cola beverages consumption at early life stages might affect the development and progression of atherosclerosis later in life. ApoE−/− C57BL/6J mice (8 week-old) were randomized in 3 groups (n = 20 each) according to free accessto water (W), sucrose sweetened carbonated cola drink(C) or aspartame-acesulfame K sweetened carbonated ‘light’ cola drink (L)for the next 8 weeks. Drinking treatment was ended by switching C and L groups to drinking water. Four mice per group and time were sequentially euthanized: before treatment (8weeks-old), at the end of treatment (16 weeks-old) and after treatment discontinuation (20 weeks-old, 24 weeks-old, 30 week-old mice). Aortic roots and livers were harvested, processed for histology and serial cross-sections were stained. Aortic plaque area was analyzed and plaque/media-ratio was calculated. Early consumption of cola drinks accelerated atherosclerotic plaque progression favoring the interaction between macrophages and myofibroblasts, without the participation of either T lymphocytes or proliferative activity. Plaque/media-ratio varied according to drink treatment (F2,54 = 3.433, p<0.04) and mice age (F4,54 = 5.009, p<0.03) and was higher in C and L groups compared with age-matched W group (p<0.05 at 16 weeks and 20 weeks, p<0.01 at 24 weeks and 30 weeks). Natural evolution of atherosclerosis in ApoE−/− mice (W group) evidenced atherosclerosis acceleration in parallel with a rapid increase in liver inflammation around the 20 weeks of age. Cola drinking within the 8–16 weeks of age accelerated atherosclerosis progression in ApoE−/− mice favoring aortic plaque enlargement (inward remodeling) over media thinning all over the study time. Data suggest that cola drinking at early life stages may predispose to atherosclerosis progression later in life in ApoE−/− mice. PMID:24670925

Tumor-targeting Salmonella typhimurium A1-R combined with recombinant methioninase and cisplatinum eradicates an osteosarcoma cisplatinum-resistant lung metastasis in a patient-derived orthotopic xenograft (PDOX) mouse model: decoy, trap and kill chemotherapy moves toward the clinic.

PubMed

Igarashi, Kentaro; Kawaguchi, Kei; Kiyuna, Tasuku; Miyake, Kentaro; Miyake, Masuyo; Li, Shukuan; Han, Qinghong; Tan, Yuying; Zhao, Ming; Li, Yunfeng; Nelson, Scott D; Dry, Sarah M; Singh, Arun S; Elliott, Irmina A; Russell, Tara A; Eckardt, Mark A; Yamamoto, Norio; Hayashi, Katsuhiro; Kimura, Hiroaki; Miwa, Shinji; Tsuchiya, Hiroyuki; Eilber, Fritz C; Hoffman, Robert M

2018-01-01

In the present study, a patient-derived orthotopic xenograft (PDOX) model of recurrent cisplatinum (CDDP)-resistant metastatic osteosarcoma was treated with Salmonella typhimurium A1-R (S. typhimurium A1-R), which decoys chemoresistant quiescent cancer cells to cycle, and recombinant methioninase (rMETase), which selectively traps cancer cells in late S/G 2 , and chemotherapy. The PDOX models were randomized into the following groups 14 days after implantation: G1, control without treatment; G2, CDDP (6 mg/kg, intraperitoneal (i.p.) injection, weekly, for 2 weeks); G3, rMETase (100 unit/mouse, i.p., daily, for 2 weeks). G4, S. typhimurium A1-R (5 × 10 7 CFU/100 μl, i.v., weekly, for 2 weeks); G5, S. typhimurium A1-R (5 × 10 7 CFU/100 μl, i.v., weekly, for 2 weeks) combined with rMETase (100 unit/mouse, i.p., daily, for 2 weeks); G6, S. typhimurium A1-R (5 × 10 7 CFU/100 μl, i.v., weekly, for 2 weeks) combined with rMETase (100 unit/mouse, i.p., daily, for 2 weeks) and CDDP (6 mg/kg, i.p. injection, weekly, for 2 weeks). On day 14 after initiation, all treatments except CDDP alone, significantly inhibited tumor growth compared to untreated control: (CDDP: p = 0.586; rMETase: p = 0.002; S. typhimurium A1-R: p = 0.002; S. typhimurium A1-R combined with rMETase: p = 0.0004; rMETase combined with both S. typhimurium A1-R and CDDP: p = 0.0001). The decoy, trap and kill combination of S. typhimurium A1-R, rMETase and CDDP was the most effective of all therapies and was able to eradicate the metastatic osteosarcoma PDOX.

Multiple-modality exercise and mind-motor training to improve cardiovascular health and fitness in older adults at risk for cognitive impairment: A randomized controlled trial.

PubMed

Boa Sorte Silva, Narlon C; Gregory, Michael A; Gill, Dawn P; Petrella, Robert J

The effects of multiple-modality exercise on arterial stiffening and cardiovascular fitness has not been fully explored. To explore the influence of a 24-week multiple-modality exercise program associated with a mind-motor training in cardiovascular health and fitness in community-dwelling older adults, compared to multiple-modality exercise (M2) alone. Participants (n=127, aged 67.5 [7.3] years, 71% females) were randomized to either M4 or M2 groups. Both groups received multiple-modality exercise intervention (60min/day, 3days/week for 24-weeks); however, the M4 group underwent additional 15min of mind-motor training, whereas the M2 group received 15min of balance training. Participants were assessed at 24-weeks and after a 28-week non-contact follow-up (52-weeks). at 52-weeks, the M4 group demonstrated a greater VO2max (ml/kg/min) compared to the M2 group (mean difference: 2.39, 95% CI: 0. 61 to 4.16, p=0.009). Within-group analysis indicated that the M4 group demonstrated a positive change in VO2max at 24-weeks (mean change: 1.93, 95% CI: 0.82 to 3.05, p=0.001) and 52-weeks (4.02, 95% CI: 2.71 to 5.32, p=0.001). Similarly, the M2 group increased VO2max at 24-weeks (2.28, 95% CI: 1.23 to 3.32, p<0.001) and 52-weeks (1.63, 95% CI: 0.43 to 2.83, p=0.008). Additionally, the M2 group decreased 24h SBP (mmHg) at 24-weeks (-2.31, 95% CI: -4.61 to -0.01, p=0.049); whereas the M4 group improved 24h DBP (-1.6, 95% CI: -3.03 to -0.17, p=0.028) at 52-weeks. Mind-motor training associated with multiple-modality exercise can positively impact cardiovascular fitness to the same extent as multiple-modality exercise alone. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies

PubMed Central

Hou, Ling; Liang, Li; Dong, Guanping; Shen, Shuixian; Zhao, Zhuhui; Gong, Chun Xiu; Li, Yuchuan; Du, Min-lian; Su, Zhe; Du, Hongwei; Yan, Chaoying

2017-01-01

Objective We assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD). Design Phase II and III, multicenter, open-label, randomized controlled trials. Methods 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored. Results The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment (P < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment (P < 0.05). Adverse event rates and treatment compliance were comparable between the two groups. Conclusion Jintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH. PMID:28566441

At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).

PubMed

Phibbs, Ciaran S; Love, Sean R; Jacobson, Alan K; Edson, Robert; Su, Pon; Uyeda, Lauren; Matchar, David B

2016-09-01

Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Clinical Impact and Cost-effectiveness of Diagnosing HIV Infection During Early Infancy in South Africa: Test Timing and Frequency.

PubMed

Francke, Jordan A; Penazzato, Martina; Hou, Taige; Abrams, Elaine J; MacLean, Rachel L; Myer, Landon; Walensky, Rochelle P; Leroy, Valériane; Weinstein, Milton C; Parker, Robert A; Freedberg, Kenneth A; Ciaranello, Andrea

2016-11-01

 Diagnosis of human immunodeficiency virus (HIV) infection during early infancy (commonly known as "early infant HIV diagnosis" [EID]) followed by prompt initiation of antiretroviral therapy dramatically reduces mortality. EID testing is recommended at 6 weeks of age, but many infant infections are missed.  We simulated 4 EID testing strategies for HIV-exposed infants in South Africa: no EID (diagnosis only after illness; hereafter, "no EID"), testing once (at birth alone or at 6 weeks of age alone; hereafter, "birth alone" and "6 weeks alone," respectively), and testing twice (at birth and 6 weeks of age; hereafter "birth and 6 weeks"). We calculated incremental cost-effectiveness ratios (ICERs), using discounted costs and life expectancies for all HIV-exposed (infected and uninfected) infants.  In the base case (guideline-concordant care), the no EID strategy produced a life expectancy of 21.1 years (in the HIV-infected group) and 61.1 years (in the HIV-exposed group); lifetime cost averaged $1430/HIV-exposed infant. The birth and 6 weeks strategy maximized life expectancy (26.5 years in the HIV-infected group and 61.4 years in the HIV-exposed group), costing $1840/infant tested. The ICER of the 6 weeks alone strategy versus the no EID strategy was $1250/year of life saved (19% of South Africa's per capita gross domestic product); the ICER for the birth and 6 weeks strategy versus the 6 weeks alone strategy was $2900/year of life saved (45% of South Africa's per capita gross domestic product). Increasing the proportion of caregivers who receive test results and the linkage of HIV-positive infants to antiretroviral therapy with the 6 weeks alone strategy improved survival more than adding a second test.  EID at birth and 6 weeks improves outcomes and is cost-effective, compared with EID at 6 weeks alone. If scale-up costs are comparable, programs should add birth testing after strengthening 6-week testing programs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation.

PubMed

Davidson, M; Epstein, M; Burt, R; Schaefer, C; Whitworth, G; McDonald, A

1998-01-01

To evaluate the efficacy and safety of a transdermal nicotine patch as an aid for smoking cessation in an over-the-counter setting. Multicenter, double-blind, randomized, placebo-controlled trial of 6-week duration with 18 weeks of follow-up. Four shopping mall precincts. The randomized sample consisted of 802 adults (mean age, 39 years) and was 89% white and 54% female. A smoking history of at least 20 cigarettes per day for 1 year and a score of 5 (on a 10-point scale) on a motivational assessment questionnaire were required for enrollment. Poststudy follow-up was limited to those who had quit smoking at the end of 6 weeks. Nicotine patches were provided at the shopping mall. Guidance consisted only of package instructions and a smoking cessation self-help booklet. Quit rates were defined as total abstinence from smoking for 4 consecutive weeks (treatment weeks 3-6), point prevalence smoking status at week 6, or nonsmoker at week 6 and week 24 (6-month postquit date). Smoking status was assessed by diaries, and verification for the first 2 quit rates was obtained by confirmation of carbon monoxide of 8 ppm or less in expired breath. Safety was evaluated by self-reported adverse events. Quit rate was 12% for the active treatment group and 5.5% for the placebo group, based on total abstinence for 4 consecutive weeks (P = .001) compared with quit rates of 19.5% and 7.5% for active treatment and placebo groups, respectively, based on point prevalence data at week 6. At 24 weeks, 8.2% of nonsmokers in the active treatment group and 4.0% in the placebo group remained nonsmokers. At least 1 adverse event was reported by 57% receiving the nicotine patch and 39% receiving placebo (P<.001). When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate advantage was achieved at week 6 and was maintained at 24 weeks.

Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up.

PubMed

Michaelides, Andreas; Major, Jennifer; Pienkosz, Edmund; Wood, Meghan; Kim, Youngin; Toro-Ramos, Tatiana

2018-05-03

It is widely recognized that the prevalence of obesity and comorbidities including prediabetes and type 2 diabetes continue to increase worldwide. Results from a 24-week Diabetes Prevention Program (DPP) fully mobile pilot intervention were previously published showing promising evidence of the usefulness of DPP-based eHealth interventions on weight loss. This pilot study extends previous findings to evaluate weight loss results of core (up to week 16) and maintenance (postcore weeks) DPP interventions at 65 weeks from baseline. Originally, 140 participants were invited and 43 overweight or obese adult participants with a diagnosis of prediabetes signed up to receive a 24-week virtual DPP with human coaching through a mobile platform. At 65 weeks, this pilot study evaluates weight loss and engagement in maintenance participants by means of repeated measures analysis of variances and backward multiple linear regression to examine predictors of weight loss. Last observation carried forward was used for endpoint measurements. At 65 weeks, mean weight loss was 6.15% in starters who read 1 or more lessons per week on 4 or more core weeks, 7.36% in completers who read 9 or more lessons per week on core weeks, and 8.98% in maintenance completers who did any action in postcore weeks (all P<.001). Participants were highly engaged, with 80% (47/59) of the sample completing 9 lessons or more and 69% (32/47) of those completing the maintenance phase. In-app actions related to self-monitoring significantly predicted weight loss. In comparison to eHealth programs, this pilot study shows that a fully mobile DPP can produce transformative weight loss. A fully mobile DPP intervention resulted in significant weight loss and high engagement during the maintenance phase, providing evidence for long-term potential as an alternative to in-person DPP by removing many of the barriers associated with in-person and other forms of virtual DPP. ©Andreas Michaelides, Jennifer Major, Edmund Pienkosz Jr, Meghan Wood, Youngin Kim, Tatiana Toro-Ramos. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 03.05.2018.

Prevalence of neuro-musculoskeletal pain and dysfunction in open-heart surgical patients preoperatively and at 6 and 12 weeks postoperatively: a prospective longitudinal observation study.

PubMed

Bellet, R Nicole; Lamb, Rhonda L; Gould, Tonya D; Bartlett, Harold J

2017-01-01

Chronic neuro-musculoskeletal pain is an important complication of open-heart surgery (OHS). To better understand the development and natural course of neuro-musculoskeletal pain in the immediate post-OHS period, this prospective longitudinal study assessed the prevalence and degree of pain and shoulder disability, and areas of pain pre- and post-OHS. Usual medical, nursing, and physiotherapy care was provided including early extubation, education, walking, sitting out of bed, and upper, lower limb, and trunk exercises from day 1 post-operation. Of 114 elective patients who provided consent, 98 subjects were surveyed preoperatively, and at week 6 and week 12 post-OHS. Open and closed questions encompassed numerical rating of pain scales for various body areas summed as a total pain score (TPS), the shoulder disability score (SDS), exercise compliance, and sternal clicking. Usual care comprised mobility exercises, walking program, and cardiac rehabilitation referral. Survey return rates were 100%, 88%, and 82%, respectively. Of the 76 (78%) subjects with complete data sets, 68% subjects reported a history of previous neuro-musculoskeletal injuries/conditions preoperatively while prevalence for neuro-musculoskeletal pain was 64%, 88%, and 67% and 38%, 63%, and 42% for shoulder disability, at the three assessments. In all, 11% subjects reported sternal clicking at week 6 and 7% at week 12. Pain commonly occurred in the lower back and neck preoperatively, and in front of the chest, neck, rib cage, upper back, and left shoulder at week 6. Rib cage pain alone remained significantly greater than preoperative levels by week 12 post-OHS. Preoperative SDS was positively correlated with post-OHS length of stay; women had higher SDSs than men at week 6 and week 12 and week 12 SDS was negatively correlated with height. Surgical risk score was negatively correlated with change in SDS and TPS from pre-operation to week 12. In conclusion, neuro-musculoskeletal pain and shoulder disability were common preoperatively and while prevalence increased at week 6 post-OHS, overall preoperative levels were restored by week 12.

Prevalence of neuro-musculoskeletal pain and dysfunction in open-heart surgical patients preoperatively and at 6 and 12 weeks postoperatively: a prospective longitudinal observation study

PubMed Central

Bellet, R Nicole; Lamb, Rhonda L; Gould, Tonya D; Bartlett, Harold J

2017-01-01

Chronic neuro-musculoskeletal pain is an important complication of open-heart surgery (OHS). To better understand the development and natural course of neuro-musculoskeletal pain in the immediate post-OHS period, this prospective longitudinal study assessed the prevalence and degree of pain and shoulder disability, and areas of pain pre- and post-OHS. Usual medical, nursing, and physiotherapy care was provided including early extubation, education, walking, sitting out of bed, and upper, lower limb, and trunk exercises from day 1 post-operation. Of 114 elective patients who provided consent, 98 subjects were surveyed preoperatively, and at week 6 and week 12 post-OHS. Open and closed questions encompassed numerical rating of pain scales for various body areas summed as a total pain score (TPS), the shoulder disability score (SDS), exercise compliance, and sternal clicking. Usual care comprised mobility exercises, walking program, and cardiac rehabilitation referral. Survey return rates were 100%, 88%, and 82%, respectively. Of the 76 (78%) subjects with complete data sets, 68% subjects reported a history of previous neuro-musculoskeletal injuries/conditions preoperatively while prevalence for neuro-musculoskeletal pain was 64%, 88%, and 67% and 38%, 63%, and 42% for shoulder disability, at the three assessments. In all, 11% subjects reported sternal clicking at week 6 and 7% at week 12. Pain commonly occurred in the lower back and neck preoperatively, and in front of the chest, neck, rib cage, upper back, and left shoulder at week 6. Rib cage pain alone remained significantly greater than preoperative levels by week 12 post-OHS. Preoperative SDS was positively correlated with post-OHS length of stay; women had higher SDSs than men at week 6 and week 12 and week 12 SDS was negatively correlated with height. Surgical risk score was negatively correlated with change in SDS and TPS from pre-operation to week 12. In conclusion, neuro-musculoskeletal pain and shoulder disability were common preoperatively and while prevalence increased at week 6 post-OHS, overall preoperative levels were restored by week 12. PMID:29066939

Single dose parenteral hyposensitization to poison ivy urushiol in guinea pigs.

PubMed

Walker, L A; Watson, E S; elSohly, M A

1995-08-01

Studies were carried out in guinea pigs to evaluate the potential for single dose hyposensitization to poison ivy urushiol dermatitis. Sensitization was induced by topical application of 1 mg of poison ivy urushiol to the back of the neck. In the first series of studies, three different analogs of poison ivy urushiol were studied: 1) a mixture of pentadecyl and heptadecyl catechols (PDC/HDC), the saturated side chain analog of the natural urushiol mixture; 2) a mixture of the diacetate esters of PDC and HDC (PDC/HDC Ac), the esterified form of the saturated sidechain analogs; 3) 2-n-pentadecyl hydroquinone diacetate (HQ Ac). Each of these compounds was administered as 5 mg of the free catechol i.m. each week for three weeks. A vehicle group received only corn oil injections. Reactivity to poison ivy urushiol (PIU) challenge was evaluated in skin tests at 1 and 5 weeks post-treatment. PDC/HDC Ac induced a marked reduction in both the incidence and the severity of lesions induced by PIU at both 1 and at 5 weeks post-treatment. Other analogs were ineffective at 5 weeks post-treatment, and were less effective than PDC/HDC Ac at 1 week post-treatment. In a second series of experiments, the efficacy of PDC/HDC Ac was evaluated in both single and multiple dose regiments. One treatment group received 5 mg of PDC/HDC Ac intramuscularly each week for 4 weeks, while another treatment group received a single dose of 20 mg PDC/HDC Ac i.m. Corresponding vehicle control groups were also included. At 1 week post-treatment in the single dose group, the PDC/HDC Ac was only modestly effective, with some reduction of severity of lesions at the higher challenge doses of PIU. However, at 4 and 7 weeks post-treatment, both the incidence and the severity of the lesions at all challenge doses were reduced. In the multiple dose group, the incidence and severity of lesions are reduced at 1 week and 4 weeks post-treatment (4 weeks and 7 weeks after the initial dose) but were not significantly different from the single dose group. These findings indicate that the diacetate ester of PDC/HDC is an effective hyposensitizer to poison ivy urushiol, and that this hyposensitization can be reasonably accomplished in a single dose treatment regimen.

Plasma cytokine profiles in HIV-1 infected patients developing neuropathic symptoms shortly after commencing antiretroviral therapy: a case-control study.

PubMed

Van der Watt, Johan J; Wilkinson, Katalin A; Wilkinson, Robert J; Heckmann, Jeannine M

2014-02-10

In patients infected with human immunodeficiency virus 1 (HIV-1) neuropathic symptoms may develop within weeks of starting combination antiretroviral therapy (cART). This timing coincides with the occurrence of immune reconstitution inflammatory syndrome. Our objective was to investigate the longitudinal association of plasma cytokine and soluble receptor concentrations with incident neuropathic symptoms within 12 weeks of starting programme-based cART in a nested case-control study. One hundred and twenty adults without neuropathic symptoms and about to initiate cART were followed longitudinally for 24 weeks after cART initiation. Subjects were examined for peripheral neuropathy at baseline (pre-cART) and 2-, 4-, 12- and 24 weeks thereafter. Individuals developing neuropathic symptoms within 12 weeks of starting cART were matched in a nested case-control design with those remaining symptom-free for at least 24 weeks. Plasma was collected at each visit. Cytokines and soluble receptors were quantified using multiplex immunometric assays. Incident neuropathic symptoms occurred in 32 (27%) individuals within 12 weeks of starting cART for the first time. Cytokine concentrations increased at 2 weeks, irrespective of symptom-status, returning to baseline concentrations at 12 weeks. Compared to the control group, the symptomatic group had higher baseline levels of interleukin-1 receptor (IL-1R)-antagonist. The symptomatic group also showed greater increases in soluble interleukin-2 receptor-alpha and tumour necrosis factor (TNF) receptor-II levels at week 2 and soluble interleukin-6 receptor levels at week 12. Ratios of pro-inflammatory- vs anti-inflammatory cytokines were higher for TNF-alpha/IL-4 (p = 0.022) and interferon-gamma/IL-10 (p = 0.044) in those developing symptoms. After 24 weeks of cART, the symptomatic group showed higher CD4+ counts (p = 0.002). The initiation of cART in previously treatment naïve individuals was associated with a cytokine 'burst' between 2- and 4 weeks compared with pre-cART levels. Individuals developing neuropathic symptoms within 12 weeks of starting cART showed evidence of altered cytokine concentrations even prior to initiating cART, most notably higher circulating IL-1R-antagonist levels, and altered ratios of "pain-associated" cytokine and soluble receptors shortly after cART initiation.

Different Patterns in Muscular Strength and Hypertrophy Adaptations in Untrained Individuals Undergoing Nonperiodized and Periodized Strength Regimens.

PubMed

De Souza, Eduardo O; Tricoli, Valmor; Rauch, Jacob; Alvarez, Michael R; Laurentino, Gilberto; Aihara, André Y; Cardoso, Fabiano N; Roschel, Hamilton; Ugrinowitsch, Carlos

2018-05-01

De Souza, EO, Tricoli, V, Rauch, J, Alvarez, MR, Laurentino, G, Aihara, AY, Cardoso, FN, Roschel, H, and Ugrinowitsch, C. Different patterns in muscular strength and hypertrophy adaptations in untrained individuals undergoing non-periodized and periodized strength regimens. J Strength Cond Res 32(5): 1238-1244, 2018-This study investigated the effects of nonperiodized (NP), traditional periodization (TP), and daily undulating periodization (UP) regimens on muscle strength and hypertrophy in untrained individuals. Thirty-three recreationally active males were randomly divided into 4 groups: NP: n = 8; TP: n = 9; UP: n = 8, and control group (C): n = 8. Experimental groups underwent a 12-week strength training program consisting of 2 sessions per week. Muscle strength and quadriceps cross-sectional area (QCSA) were assessed at baseline, 6 weeks (i.e., mid-point) and after 12 weeks. All training groups increased squat 1RM from pre to 6 weeks mid (NP: 17.02%, TP: 7.7%, and UP: 12.9%, p ≤ 0.002) and pre to post 12 weeks (NP: 19.5%, TP: 17.9%, and UP: 20.4%, p ≤ 0.0001). Traditional periodization was the only group that increased squat 1RM from 6 weeks mid to 12-week period (9.4%, p ≤ 0.008). All training groups increased QCSA from pre to 6 weeks mid (NP: 5.1%, TP: 4.6%, and UP: 5.3%, p ≤ 0.0006) and from pre to post 12 weeks (NP: 8.1%, TP: 11.3%, and UP: 8.7%, p ≤ 0.0001). From 6 weeks mid to 12-week period, TP and UP were the only groups that increased QCSA (6.4 and 3.7%, p ≤ 0.02). There were no significant changes for all dependent variables in C group across the time (p ≥ 0.05). In conclusion, our results demonstrated similar training-induced adaptations after 12 weeks of NP and periodized regimens. However, our findings suggest that in the latter half of the study (i.e., after the initial 6 weeks), the periodized regimens elicited greater rates of muscular adaptations compared with NP regimens. Strength coaches and practitioners should be aware that periodized regimens might be advantageous at latter stages of training even for untrained individuals.

Diffusion MRI and MR spectroscopy reveal microstructural and metabolic brain alterations in chronic mild stress exposed rats: A CMS recovery study.

PubMed

Khan, Ahmad Raza; Hansen, Brian; Wiborg, Ove; Kroenke, Christopher D; Jespersen, Sune Nørhøj

2018-02-15

Chronic mild stress (CMS) induced depression elicits several debilitating symptoms and causes a significant economic burden on society. High variability in the symptomatology of depression poses substantial impediment to accurate diagnosis and therapy outcome. CMS exposure induces significant metabolic and microstructural alterations in the hippocampus (HP), prefrontal cortex (PFC), caudate-putamen (CP) and amygdala (AM), however, recovery from these maladaptive changes are limited and this may provide negative effects on the therapeutic treatment and management of depression. The present study utilized anhedonic rats from the unpredictable CMS model of depression to study metabolic recovery in the ventral hippocampus (vHP) and microstructural recovery in the HP, AM, CP, and PFC. The study employed 1 H MR spectroscopy ( 1 H MRS) and in-vivo diffusion MRI (d-MRI) at the age of week 18 (week 1 post CMS exposure) week 20 (week 3 post CMS) and week 25 (week 8 post CMS exposure) in the anhedonic group, and at the age of week 18 and week 22 in the control group. The d-MRI data have provided an array of diffusion tensor metrics (FA, MD, AD, and RD), and fast kurtosis metrics (MKT, W L and W T ). CMS exposure induced a significant metabolic alteration in vHP, and significant microstructural alterations were observed in the HP, AM, and PFC in comparison to the age match control and within the anhedonic group. A significantly high level of N-acetylaspartate (NAA) was observed in vHP at the age of week 18 in comparison to age match control and week 20 and week 25 of the anhedonic group. HP and AM showed significant microstructural alterations up to the age of week 22 in the anhedonic group. PFC showed significant microstructural alterations only at the age of week 18, however, most of the metrics showed significantly higher value at the age of week 20 in the anhedonic group. The significantly increased NAA concentration may indicate impaired catabolism due to astrogliosis or oxidative stress. The significantly increased W L in the AM and HP may indicate hypertrophy of AM and reduced volume of HP. Such metabolic and microstructural alterations could be useful in disease diagnosis and follow-up treatment intervention in depression and similar disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial

PubMed Central

2012-01-01

Background Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment. Methods/design In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks. Discussion A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836 PMID:22985134

Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial.

PubMed

Koegelenberg, Coenraad F N; Noor, Firdows; Bateman, Eric D; van Zyl-Smit, Richard N; Bruning, Axel; O'Brien, John A; Smith, Clifford; Abdool-Gaffar, Mohamed S; Emanuel, Shaunagh; Esterhuizen, Tonya M; Irusen, Elvis M

2014-07-01

Behavioral approaches and pharmacotherapy are of proven benefit in assisting smokers to quit, but it is unclear whether combining nicotine replacement therapy (NRT) with varenicline to improve abstinence is effective and safe. To evaluate the efficacy and safety of combining varenicline and a nicotine patch vs varenicline alone in smoking cessation. Randomized, blinded, placebo-controlled clinical trial with a 12-week treatment period and a further 12-week follow-up conducted in 7 centers in South Africa from April 2011 to October 2012. Four hundred forty-six generally healthy smokers were randomized (1:1); 435 were included in the efficacy and safety analyses. Nicotine or placebo patch treatment began 2 weeks before a target quit date (TQD) and continued for a further 12 weeks. Varenicline was begun 1 week prior to TQD, continued for a further 12 weeks, and tapered off during week 13. Tobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at TQD and at intervals thereafter up to 24 weeks. The primary end point was the 4-week exhaled carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 of treatment, ie, the proportion of participants able to maintain complete abstinence from smoking for the last 4 weeks of treatment, as assessed using multiple imputation analysis. Secondary end points included point prevalence abstinence at 6 months, continuous abstinence rate from weeks 9 through 24, and adverse events. Multiple imputation also was used to address loss to follow-up. The combination treatment was associated with a higher continuous abstinence rate at 12 weeks (55.4% vs 40.9%; odds ratio [OR], 1.85; 95% CI, 1.19-2.89; P = .007) and 24 weeks (49.0% vs 32.6%; OR, 1.98; 95% CI, 1.25-3.14; P = .004) and point prevalence abstinence rate at 6 months (65.1% vs 46.7%; OR, 2.13; 95% CI, 1.32-3.43; P = .002). In the combination treatment group, there was a numerically greater incidence of nausea, sleep disturbance, skin reactions, constipation, and depression, with only skin reactions reaching statistical significance (14.4% vs 7.8%; P = .03); the varenicline-alone group experienced more abnormal dreams and headaches. Varenicline in combination with NRT was more effective than varenicline alone at achieving tobacco abstinence at 12 weeks (end of treatment) and at 6 months. Further studies are needed to assess long-term efficacy and safety. clinicaltrials.gov Identifier: NCT01444131.

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis.

PubMed

van der Heijde, Désirée; Landewé, Robert B; Mease, Philip J; McInnes, Iain B; Conaghan, Philip G; Pricop, Luminita; Ligozio, Greg; Richards, Hanno B; Mpofu, Shephard

2016-08-01

To assess whether secukinumab treatment in patients with active psoriatic arthritis (PsA) is associated with sustained inhibition of radiographic progression. In this phase III, double-blind, placebo-controlled study, 606 patients with PsA were randomized to receive intravenous (IV) secukinumab at a dose of 10 mg/kg (weeks 0, 2, 4) followed by subcutaneous secukinumab at a dose of 150 mg or 75 mg (the IV→150 mg and IV→75 mg groups, respectively) or placebo. Patients were stratified according to prior anti-tumor necrosis factor (anti-TNF) exposure (71% were anti-TNF naive). At week 16, placebo-treated patients who had at least a 20% reduction in the tender and swollen joint counts (responders) continued to receive placebo until week 24; nonresponders were re-randomized to receive secukinumab at a dose of 150 mg or 75 mg. The modified total Sharp/van der Heijde score (SHS) was determined at baseline, week 16 or 24, and week 52. In the overall population, radiographic progression was inhibited through 52 weeks; efficacy was demonstrated for both erosion and joint space narrowing scores and in patients who switched from placebo to secukinumab at week 24. Subgroup analyses showed that secukinumab reduced radiographic progression at week 24, regardless of previous anti-TNF treatment. Among anti-TNF-naive patients, the mean changes from baseline to week 24 in the modified total SHS were 0.05 in the pooled secukinumab group and 0.57 in the placebo group; among patients with an inadequate response or intolerance to anti-TNF treatment, the mean changes were 0.16 and 0.58, respectively. Anti-TNF-naive patients showed negligible progression through week 52. Inhibition of structural damage was observed through week 52 irrespective of concomitant methotrexate use. A high proportion of patients receiving secukinumab showed no progression (change in SHS of ≤ 0.5) from baseline to week 24 (82.3% of the IV→150 mg group and 92.3% of the IV→75 mg group) and from week 24 to week 52 (85.7% of the IV→150 mg group and 85.8% of the IV→75 mg group). Secukinumab inhibited radiographic progression over 52 weeks of treatment in patients with active PsA. © 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

The efficacy of adjuvant trastuzumab in HER-2 positive breast cancer with axillary lymph node metastases according to the treatment duration.

PubMed

Sendur, Mehmet A N; Aksoy, Sercan; Ozdemir, Nuriye Y; Yazici, Ozan; Zengin, Nurullah; Altundag, Kadri

2014-12-01

Trastuzumab is the first anti-HER-2 humanized monoclonal antibody. The benefit of adjuvant trastuzumab has been shown in randomized phase III trials. Despite trastuzumab being recommended for 52 weeks in the adjuvant treatment of HER-2 positive breast cancer according to the current breast cancer guidelines, there is still no consensus on the optimal duration of adjuvant trastuzumab. The aim of our study is to investigate the efficacy and safety of adjuvant trastuzumab for 9 weeks and 52 weeks in axillary lymph node positive HER-2 positive breast cancer patients. A total of 271 HER-2 and axillary node positive breast cancer patients who received trastuzumab in adjuvant treatment between the years 2005 and 2013 were retrospectively analyzed. Patients with axillary node positive HER-2 positive breast cancer who were non-metastatic were enrolled to the study. Patients were allocated to the 9 week trastuzumab group (n = 155) or the 52 week trastuzumab group (n = 116). Kaplan-Meier survival analysis was carried out for disease free survival (DFS) and overall survival (OS). Two-sided p values of <0.05 were considered statistically significant. The most important limitation of our manuscript is the retrospective design. The median follow-up time for this analysis was 34 (4-95) months. Patients' clinical and pathological characteristics were well balanced between the two treatment arms. In the 9 week trastuzumab treatment group, the DFS rate was 96.7%, 84.8% and 74.9% in the first, third and fifth years respectively, whereas in the 52 week trastuzumab treatment group it was 94.3%, 80.0% and 80.0% (P = 0.76). In the 9 week trastuzumab treatment group, the OS rate was 99.3%, 92.2% and 88.3% in the first, third and fifth years respectively, whereas in the 52 week trastuzumab treatment group it was 99.0%, 94.7% and 78.6% (P = 0.99). In both groups, symptomatic heart failure was not reported but asymptomatic left ventricular ejection fraction (LVEF) decline was observed 3 (1.9%) and 18 (15.5%) patients in the 9 week and 52 week trastuzumab treatment groups, respectively (P < 0.001). In our study, the efficacy of trastuzumab for 52 weeks and 9 weeks was similar in node-positive HER-2 positive breast cancer. Cardiotoxicity was significantly increased in the 52 week trastuzumab arm compared to the 9 week trastuzumab arm.

Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studies.

PubMed

Moore, Tamanna; Hennessy, Enid M; Myles, Jonathan; Johnson, Samantha J; Draper, Elizabeth S; Costeloe, Kate L; Marlow, Neil

2012-12-04

To determine outcomes at age 3 years in babies born before 27 completed weeks' gestation in 2006, and to evaluate changes in outcome since 1995 for babies born between 22 and 25 weeks' gestation. Prospective national cohort studies, EPICure and EPICure 2. Hospital and home based evaluations, England. 1031 surviving babies born in 2006 before 27 completed weeks' gestation. Outcomes for 584 babies born at 22-25 weeks' gestation were compared with those of 260 surviving babies of the same gestational age born in 1995. Survival to age 3 years, impairment (2008 consensus definitions), and developmental scores. Multiple imputation was used to account for the high proportion of missing data in the 2006 cohort. Of the 576 babies evaluated after birth in 2006, 13.4% (n=77) were categorised as having severe impairment and 11.8% (n=68) moderate impairment. The prevalence of neurodevelopmental impairment was significantly associated with length of gestation, with greater impairment as gestational age decreased: 45% at 22-23 weeks, 30% at 24 weeks, 25% at 25 weeks, and 20% at 26 weeks (P<0.001). Cerebral palsy was present in 83 (14%) survivors. Mean developmental quotients were lower than those of the general population (normal values 100 (SD 15)) and showed a direct relation with gestational age: 80 (SD 21) at 22-23 weeks, 87 (19) at 24 weeks, 88 (19) at 25 weeks, and 91 (18) at 26 weeks. These results did not differ significantly after imputation. Comparing imputed outcomes between the 2006 and 1995 cohorts, the proportion of survivors born between 22 and 25 weeks' gestation with severe disability, using 1995 definitions, was 18% (95% confidence interval 14% to 24%) in 1995 and 19% (14% to 23%) in 2006. Fewer survivors had shunted hydrocephalus or seizures. Survival of babies admitted for neonatal care increased from 39% (35% to 43%) in 1995 to 52% (49% to 55%) in 2006, an increase of 13% (8% to 18%), and survival without disability increased from 23% (20% to 26%) in 1995 to 34% (31% to 37%) in 2006, an increase of 11% (6% to 16%). Survival and impairment in early childhood are both closely related to gestational age for babies born at less than 27 weeks' gestation. Using multiple imputation to account for the high proportion of missing values, a higher proportion of babies admitted for neonatal care now survive without disability, particularly those born at gestational ages 24 and 25 weeks.

Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE.

PubMed

Mendoza, Tito R; Dueck, Amylou C; Bennett, Antonia V; Mitchell, Sandra A; Reeve, Bryce B; Atkinson, Thomas M; Li, Yuelin; Castro, Kathleen M; Denicoff, Andrea; Rogak, Lauren J; Piekarz, Richard L; Cleeland, Charles S; Sloan, Jeff A; Schrag, Deborah; Basch, Ethan

2017-06-01

The US National Cancer Institute recently developed the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g. nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-, 2-, 3-, and 4-week recall periods, using daily reporting as the reference. English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four US cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-, 2-, 3-, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g. maximum of daily scores over 7 days vs 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores. A total of 127 subjects completed questionnaires (57% male; median age: 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size) was -0.20 (-0.20) for 1-week recall, -0.36 (-0.31) for 2-week recall, -0.45 (-0.39) for 3-week recall, and -0.47 (-0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54-0.82), for 2-week recall was 0.74 (range: 0.58-0.83), for 3-week recall was 0.72 (range: 0.61-0.84), and for 4-week recall was 0.72 (range: 0.64-0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores. A 1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss.

Long-term Immunogenicity of Elosulfase Alfa in the Treatment of Morquio A Syndrome: Results From MOR-005, a Phase III Extension Study.

PubMed

Long, Brian; Tompkins, Troy; Decker, Celeste; Jesaitis, Lynne; Khan, Shahid; Slasor, Peter; Harmatz, Paul; O'Neill, Charles A; Schweighardt, Becky

2017-01-01

Elosulfase alfa is an enzyme replacement therapy for the treatment of Morquio A syndrome (mucopolysaccharidosis IVA), a lysosomal storage disorder caused by a deficiency of the enzyme N-acetylgalactose-amine-6-sulfatase. We previously reported immunogenicity data from our 24-week placebo-controlled Phase III study, MOR-004. Here, we report the long-term immunogenicity profile of elosulfase alfa from MOR-005, the Phase III extension trial to assess potential correlations between antidrug antibodies and efficacy and safety profile outcomes throughout 120 weeks of treatment. The long-term immunogenicity of elosulfase alfa was evaluated in patients with Morquio A syndrome in an open-label extension study for a total of 120 weeks. All patients received 2.0 mg/kg elosulfase alfa either weekly or every other week before establishment of 2.0 mg/kg/wk as the recommended dose, at which time all patients received weekly treatment. Efficacy measures were compared with those from the MOR-004 baseline, enabling analysis of changes over 120 weeks. The primary efficacy measure was the change from baseline in 6-minute walk test. Secondary measures included changes from baseline in 3-minute stair climb test and normalized urine keratan sulfate, a pharmacodynamic metric. All patients treated with elosulfase alfa developed antidrug total antibodies (TAb) by week 24 of MOR-004. In the extension study, all patients, including those who had previously received placebo, were TAb positive by study week 36 (MOR-005 week 12). All patients remained TAb positive throughout the study, and TAb titers were similar across treatment groups at week 120. Nearly all patients tested positive for neutralizing antibodies (NAb) at least once, with incidence of NAb positivity peaking at 85.9% at study week 36, then steadily declining to 66.0% at study week 120. In all treatment groups, mean urine keratan sulfate remained below treatment-naive baseline despite the presence of antidrug antibodies. No relationship was observed between TAb titers or NAb positivity and changes in urine keratan sulfate, 6-minute walk test, or 3-minute stair climb test from baseline to week 120. No consistent associations were detected between antidrug antibodies and the occurrence of hypersensitivity adverse events or anaphylaxis over the course of the study. Immunogenicity results from this long-term study are consistent with previously reported 24-week results. Despite the sustained presence of antidrug antibodies, elosulfase alfa was well tolerated, and patients continued to benefit from treatment through week 120. No associations were detected between higher TAb titers or NAb positivity and reduced treatment effect or worsened safety profile measures. ClinicalTrials.gov identifier: NCT01415427. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of sofosbuvir-based treatments for chronic hepatitis C in the US.

PubMed

Zhang, Sai; Bastian, Nathaniel D; Griffin, Paul M

2015-08-05

The standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80% to 95%, though with a substantial increase in cost. In particular, current market pricing of a 12-week course of sofosbuvir is approximately US$84,000. We determine the cost-effectiveness of new treatments in comparison with the standard care of treatments. A Markov simulation model of CHC disease progression is used to evaluate the cost-effectiveness of different treatment strategies based on genotype. The model calculates the expected lifetime medical costs and quality adjusted life years (QALYs) of hypothetical cohorts of identical patients receiving certain treatments. For genotype 1, we compare: (1) peginterferon + ribavirin + telaprevir for 12 weeks, followed by 12 or 24 weeks treatment of peginterferon + ribavirin dependent on HCV RNA level at week 12; (2) Harvoni treatment, 12 weeks; (3) Olysio + Sovaldi, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (4) Viekira Pak + ribavirin, 12 weeks for patients without cirrhosis, 24 weeks for patients with cirrhosis; (5) sofosbuvir + peginterferon + ribavirin, 12 weeks for patients with or without cirrhosis. For genotypes 2 and 3, treatment strategies include: (1) peginterferon + ribavirin, 24 weeks for treatment-naïve patients; (2) sofosbuvir + ribavirin, 12 weeks for patients with genotype 2, 24 weeks for genotype 3; (3) peginterferon + ribavirin as initial treatment, 24 weeks for patients with genotype 2/3, follow-up treatment with sofosbuvir + ribavirin for 12/16 weeks are performed on non-responders and relapsers. Viekira Pak is cost-effective for genotype 1 patients without cirrhosis, whereas Harvoni is cost-effective for genotype 1 patients with cirrhosis. Sofosbuvir-based treatments for genotype 1 in general are not cost-effective due to its substantial high costs. Two-phase treatments with 12-week and 16-week follow-ups are cost-effective for genotype 3 patients and for genotype 2 patients with cirrhosis. The results were shown to be robust over a broad range of parameter values through sensitivity analysis. For genotype 1, sofosbuvir-based treatments are not cost-effective compared to Viekira Pak and Harvoni, although a 30% reduction in sofosbuvir price would change this result. Sofosbuvir + ribavirin are cost-effective as second-phase treatments following peginterferon + ribavirin initial treatment for genotypes 2 and 3. However, there is limited data on sofosbuvir-involved treatment, and the results obtained in this study must be interpreted within the model assumptions.

Lipid changes and tolerability in a cohort of adult HIV-infected patients who switched to rilpivirine/emtricitabine/tenofovir due to intolerance to previous combination ART: the PRO-STR study.

PubMed

Ocampo, A; Domingo, P; Fernández, P; Diz, J; Barberá, J R; Sepúlveda, M A; Salgado, X; Rodriguez, M; Santos, J; Yzusqui, M; Mayorga, M I; Lorenzo, J F; Bahamonde, A; Bachiller, P; Martínez, E; Rozas, N; Torres, C; Muñoz, A; Casado, A; Podzamczer, D

2018-05-16

To analyse lipid changes and tolerability in a cohort of HIV-infected patients who switched their antiretroviral regimens to rilpivirine/emtricitabine/tenofovir (RPV/FTC/TDF) in a real-world setting. PRO-STR is a 48 week prospective observational post-authorization study in 25 hospitals. Patients with a viral load <1000 copies/mL, receiving at least 12 months of combination ART (cART), with constant posology for at least the prior 3 months, were categorized according to previous treatment [NNRTI or ritonavir-boosted PI (PI/r)]. Analytical tests were performed at the baseline visit, between week 16 and week 32, and at week 48. A total of 303 patients were included (mean age 46.6 years; male 74.0%; previous treatment 74.7% NNRTI and 25.3% PI/r). Both groups exhibited significantly reduced lipid profiles, except for HDL cholesterol, for which a non-significant increase was observed. [NNRTI patients: total cholesterol (baseline: 195.5 ± 38.4 mg/dL; week 48: 171.0 ± 35.5 mg/dL), total cholesterol/HDL ratio (baseline: 4.2 ± 1.2; week 48: 4.0 ± 1.2), HDL (baseline: 49.1 ± 12.0 mg/dL; week 48: 49.2 ± 45.8 mg/dL), LDL (baseline: 119.2 ± 30.2 mg/dL; week 48: 114.2 ± 110.7 mg/dL), and triglycerides (baseline: 136.6 ± 86.8 mg/dL; week 48: 113.4 ± 67.8 mg/dL); PI/r patients: total cholesterol (baseline: 203.2 ± 48.8 mg/dL; week 48: 173.4 ± 36.9 mg/dL), total cholesterol/HDL ratio (baseline: 4.7 ± 1.6; week 48: 4.0 ± 1.2), HDL (baseline: 46.4 ± 12.5 mg/dL; week 48: 52.1 ± 54.4 mg/dL), LDL (baseline: 127.0 ± 36.3 mg/dL; week 48: 111.4 ± 35.8 mg/dL), and triglycerides (baseline: 167.6 ± 107.7 mg/dL; week 48: 122.7 ± 72.1 mg/dL)]. The most common intolerances were neuropsychiatric in the NNRTI patients and gastrointestinal and metabolic in the PI/r patients, and these intolerances were significantly reduced in both groups at week 48 [NNRTI: neuropsychiatric (baseline: 81.3%; week 48: 0.0%); PI/r: gastrointestinal (baseline: 48.7%; week 48: 0.0%) and metabolic (baseline: 42.1%; week 48: 0.0%)]. RPV/FTC/TDF improved the lipid profiles and reduced the intolerances after switching from NNRTI or PI-based regimens, in a cohort of HIV-infected patients.

Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial.

PubMed

Foa, Edna B; McLean, Carmen P; Zang, Yinyin; Rosenfield, David; Yadin, Elna; Yarvis, Jeffrey S; Mintz, Jim; Young-McCaughan, Stacey; Borah, Elisa V; Dondanville, Katherine A; Fina, Brooke A; Hall-Clark, Brittany N; Lichner, Tracey; Litz, Brett T; Roache, John; Wright, Edward C; Peterson, Alan L

2018-01-23

Effective and efficient treatment is needed for posttraumatic stress disorder (PTSD) in active duty military personnel. To examine the effects of massed prolonged exposure therapy (massed therapy), spaced prolonged exposure therapy (spaced therapy), present-centered therapy (PCT), and a minimal-contact control (MCC) on PTSD severity. Randomized clinical trial conducted at Fort Hood, Texas, from January 2011 through July 2016 and enrolling 370 military personnel with PTSD who had returned from Iraq, Afghanistan, or both. Final follow-up was July 11, 2016. Prolonged exposure therapy, cognitive behavioral therapy involving exposure to trauma memories/reminders, administered as massed therapy (n = 110; 10 sessions over 2 weeks) or spaced therapy (n = 109; 10 sessions over 8 weeks); PCT, a non-trauma-focused therapy involving identifying/discussing daily stressors (n = 107; 10 sessions over 8 weeks); or MCC, telephone calls from therapists (n = 40; once weekly for 4 weeks). Outcomes were assessed before and after treatment and at 2-week, 12-week, and 6-month follow-up. Primary outcome was interviewer-assessed PTSD symptom severity, measured by the PTSD Symptom Scale-Interview (PSS-I; range, 0-51; higher scores indicate greater PTSD severity; MCID, 3.18), used to assess efficacy of massed therapy at 2 weeks posttreatment vs MCC at week 4; noninferiority of massed therapy vs spaced therapy at 2 weeks and 12 weeks posttreatment (noninferiority margin, 50% [2.3 points on PSS-I, with 1-sided α = .05]); and efficacy of spaced therapy vs PCT at posttreatment. Among 370 randomized participants, data were analyzed for 366 (mean age, 32.7 [SD, 7.3] years; 44 women [12.0%]; mean baseline PSS-I score, 25.49 [6.36]), and 216 (59.0%) completed the study. At 2 weeks posttreatment, mean PSS-I score was 17.62 (mean decrease from baseline, 7.13) for massed therapy and 21.41 (mean decrease, 3.43) for MCC (difference in decrease, 3.70 [95% CI,0.72 to 6.68]; P = .02). At 2 weeks posttreatment, mean PSS-I score was 18.03 for spaced therapy (decrease, 7.29; difference in means vs massed therapy, 0.79 [1-sided 95% CI, -∞ to 2.29; P = .049 for noninferiority]) and at 12 weeks posttreatment was 18.88 for massed therapy (decrease, 6.32) and 18.34 for spaced therapy (decrease, 6.97; difference, 0.55 [1-sided 95% CI, -∞ to 2.05; P = .03 for noninferiority]). At posttreatment, PSS-I scores for PCT were 18.65 (decrease, 7.31; difference in decrease vs spaced therapy, 0.10 [95% CI, -2.48 to 2.27]; P = .93). Among active duty military personnel with PTSD, massed therapy (10 sessions over 2 weeks) reduced PTSD symptom severity more than MCC at 2-week follow-up and was noninferior to spaced therapy (10 sessions over 8 weeks), and there was no significant difference between spaced therapy and PCT. The reductions in PTSD symptom severity with all treatments were relatively modest, suggesting that further research is needed to determine the clinical importance of these findings. clinicaltrials.gov Identifier: NCT01049516.

America's Legislators Back to School Week--High School Lesson Plans. Trust for Representative Democracy.

ERIC Educational Resources Information Center

National Conference of State Legislatures, Denver, CO.

The National Conference of State Legislatures (NCSL) has designated the week of September 17-21, 2001, as "Back to School Week." During this week, state legislators from throughout the country are encouraged by NCSL to contact principals and teachers in their respective districts and arrange for classroom visits to help students…

America's Legislators Back to School Week--Elementary School Lesson Plans. Trust for Representative Democracy.

ERIC Educational Resources Information Center

Breckenridge, Leah; Stokley, Sandy

The National Conference of State Legislatures (NCSL) has designated the week of September 17-21, 2001, as "Back to School Week." During this week, state legislators from throughout the country are encouraged by NCSL to contact principals and teachers in their respective districts and arrange for classroom visits to help students…

Is the Four-Day School Week Detrimental to Student Success?

ERIC Educational Resources Information Center

Tharp, Timothy W.; Matt, John; O'Reilly, Frances L.

2016-01-01

School districts across the United States are implementing four-day school weeks. This study looks at the relationship between student achievement in the four-day school week compared to student achievement in the five-day school week. This analysis focused on a common criteria referenced test given to all students over a period of seven years in…

The 4-Day School Week. The Informed Educator Series

ERIC Educational Resources Information Center

Donis-Keller, Christine

2010-01-01

This "Informed Educator" examines the use of a 4-day school week as a way to reduce expenses while using limited resources most effectively. Discussion focuses on various models of 4-day week schedules, what to do during the fifth day, and how 4-day school weeks affect extracurricular activities. Detailed discussion of financial savings, student…

Four-Day Week Schedule. Research Brief

ERIC Educational Resources Information Center

Marx, Gary E.

2007-01-01

What does research say about the four-day week as an alternative school schedule? More than 100 districts in at least 12 states currently use a four-day week alternative schedule. Most are located in rural areas, serve less than 1000 students, and made the move to a shorter school week with longer instructional days for financial reasons. Although…

Practical Development of a High School Technical Theatre Course.

ERIC Educational Resources Information Center

Fetzer, Ronald C.

This document presents a week-by-week syllabus for an 18-week high school technical theatre course. This course, which may be expanded to one year or reduced to nine weeks, emphasizes having the student learn by doing, so that the teacher eventually becomes freer to concentrate on play-directing responsibilities. The document also discusses the…

An evidence-based approach to nurses week celebrations.

PubMed

Hensinger, Barbara; Parry, Juanita; Calarco, Margaret M; Fuhrmann, Sarah

2008-04-01

It is time to examine nurses week investments. With expenses increasingly scrutinized, healthcare leaders require data-driven decisions. Managing by instinct and intuition is both inadequate and reckless. This survey of 727 registered nurses identifies celebratory options for nurses week that nurses find meaningful. Knowing what registered nurses value will guide approaches to an effective nurses week activity planning.

20 CFR 25.202 - How is the Special Schedule applied for Japanese seamen?

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF LABOR FEDERAL EMPLOYEES' COMPENSATION ACT COMPENSATION FOR DISABILITY AND DEATH OF NONCITIZEN... total disability. Weekly compensation shall be paid at 75 percent of the weekly wage rate. (c) Temporary... compensation shall be paid at 75 percent of the weekly wage rate and that the number of weeks allowed for...

20 CFR 25.202 - How is the Special Schedule applied for Japanese seamen?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF LABOR FEDERAL EMPLOYEES' COMPENSATION ACT COMPENSATION FOR DISABILITY AND DEATH OF NONCITIZEN... total disability. Weekly compensation shall be paid at 75 percent of the weekly wage rate. (c) Temporary... compensation shall be paid at 75 percent of the weekly wage rate and that the number of weeks allowed for...

3 CFR 8827 - Proclamation 8827 of May 21, 2012. World Trade Week, 2012

Code of Federal Regulations, 2013 CFR

2013-01-01

... 3 The President 1 2013-01-01 2013-01-01 false Proclamation 8827 of May 21, 2012. World Trade Week.... 8827 World Trade Week, 2012By the President of the United States of America A Proclamation America has... and produced by Americans. During World Trade Week, we reaffirm the essential role exports play in...

75 FR 20778 - Security Zone; Portland Rose Festival Fleet Week, Willamette River, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

...-AA87 Security Zone; Portland Rose Festival Fleet Week, Willamette River, Portland, OR AGENCY: Coast... during the Portland Rose Festival Fleet Week from June 2, 2010, through June 7, 2010. The security zone... is a need to provide a security zone for the 2010 Portland Rose Festival Fleet Week, and there is...

76 FR 30014 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

...-AA00 Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA AGENCY: Coast Guard...) entitled ``Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, WA'' in the Federal... is added to read as follows: Sec. 165.1330 Safety Zone; Fleet Week Maritime Festival, Pier 66...

3 CFR 8455 - Proclamation 8455 of November 20, 2009. National Farm-City Week, 2009

Code of Federal Regulations, 2010 CFR

2010-01-01

... Farm-City Week, 2009 8455 Proclamation 8455 Presidential Documents Proclamations Proclamation 8455 of November 20, 2009 Proc. 8455 National Farm-City Week, 2009By the President of the United States of America... communities are critical to our economy and to the nourishment of our people. During National Farm-City Week...

77 FR 65241 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-25

... pursuant to the same strike price interval parameters that exist for Weekly options. Thus a related non... non-Weekly options and the availability of more granular strike price intervals. The Exchange notes... harmonization between of strike prices between Weekly and non-Weekly options on the same classes. With regard to...

The XactMice: A Xenochimaeric Mouse with Tumor and Hematopoietic System Obtained from the Same Patient

DTIC Science & Technology

2011-10-01

possible, with the limitation of the availability of humanized mice. d. We will test cetuximab , docetaxel and the combination in 8-10 cases. When...tumors reach the target volume we will distribute them in 4 groups (at least n=10 tumors per group): control, cetuximab 40 mg/kg 2/week IP, docetaxel...30 mg/kg 1/week IP, or cetuximab 40 mg/kg 2/week IP plus docetaxel 30 mg/kg 1/week IP. Treatment is planned to last 4 weeks. Tumor size will be

How Long Does the Benefit of Biologics Last? An Update on Time To Relapse and Potential for Rebound of Biologic Agents for Psoriasis.

PubMed

Kamaria, Monique; Liao, Wilson; Koo, J Y

2010-01-01

The biologic agents vary considerably in terms of their long-term duration of effect. Using the definitions provided by the National Psoriasis Foundation Medical Board, the objective of this review was to compare all biologic agents with respect to time to relapse and potential for rebound. Overall, alefacept had the longest off-treatment benefit (29.9 weeks in Psoriasis Area and Severity Index [PASI] 75 responders), followed by ustekinumab (22 weeks), infliximab (19.5 weeks), adalimumab (18 weeks), etanercept (12.1 weeks in PASI 50 responders), and, lastly, efalizumab (9.6 weeks). Rebound was reported commonly for efalizumab (14%) and, extremely rarely, for etanercept (0.002%).

Continuous animal exposure to dichloromethane

NASA Technical Reports Server (NTRS)

Macewen, J. D.; Vernot, E. H.; Haun, C. C.

1972-01-01

Continuous exposures of dogs, monkeys, rats and mice to 5000 ppm and 1000 ppm of dichloromethane vapor (CH2Cl2) produced severe toxic effects on dogs, rats and mice. Dogs died after 3 weeks exposure to 1000 ppm and after 6 weeks exposure to 5000 ppm. Thirty percent of the mice also succumbed during four weeks exposure to 5000 ppm CH2Cl2. Although rats survived 14 weeks exposure to 5000 ppm, they experienced subnormal weight gains. Significant gross and histopathological hepatic lesions were noted in all 3 species at death or experimental termination in 14 weeks. In addition, rats showed abnormal kidney histopathology. Fat stains disclosed mild fatty increase in monkey livers after 14 weeks exposure to 1000 ppm CH2Cl2.

Government-industry partnership in weekly iron-folic acid supplementation for women of reproductive age in the Philippines: impact on iron status.

PubMed

Angeles-Agdeppa, Imelda; Paulino, Lourdes S; Ramos, Adelisa C; Etorma, Unita Marie; Cavalli-Sforza, Tommaso; Milani, Silvano

2005-12-01

The effectiveness of weekly iron-folic acid supplements promoted through a government-industry partnership was assessed in pregnant and non-pregnant women in the Philippines. Compliance to both weekly and daily supplementation increased during the year-long study period, but was highest with weekly supplementation. Serum ferritin and hematocrit increased significantly, whereas the hemoglobin level showed minimal change, probably because of lack of other heme-forming nutrients such as vitamin A. Serum ferritin increments were significantly higher in women taking the iron-folic acid supplements for more than 6 weeks. Weekly iron-folic acid supplementation should be recommended as a preventive strategy to control iron deficiency among reproductive-age women in the Philippines.

Self-assessment and goal-setting is associated with an improvement in interviewing skills.

PubMed

Hanley, Kathleen; Zabar, Sondra; Charap, Joseph; Nicholson, Joseph; Disney, Lindsey; Kalet, Adina; Gillespie, Colleen

2014-01-01

Purpose Describe the relationship between medical students' self-assessment and goal-setting (SAGS) skills and development of interviewing skills during the first-year doctoring course. Method 157 first-year medical students completed three two-case standardized patient (SP) interviews. After each of the first two, students viewed videotapes of their interview, completed a SAGS worksheet, and reviewed a selected tape segment in a seminar. SAGS was categorized into good and poor quality and interviewing skills were rated by trained raters. Results SAGS improved over time (37% good week 1 vs. 61% good week 10). Baseline SAGS and interviewing skills were not associated. Initial SAGS quality was associated with change in interviewing skills - those with poor-quality SAGS demonstrated a decrease and those with good-quality SAGS demonstrated an increase in scores by 17 weeks (ANOVA F=4.16, p=0.024). For students whose SAGS skills were good at both week 1 and 10, interviewing skills declined in weeks 1-10 and then increased significantly at week 17. For those whose SAGS remained 'poor' in weeks 1-10, interviewing skills declined in weeks 10-17. Conclusions In general, the quality of students' SAGS improved over time. Poor baseline SAGS skills and failure to improve were associated with a decrease in interviewing skills at 17 weeks. For students with better SAGS, interviewing skills increased at week 17. Improvement in SAGS skills was not associated with improved interviewing skills. Understanding structured self-assessment skills helps identify student characteristics that influence progressive mastery of communication skills and therefore may inform curriculum and remediation tailoring.

A multicenter, open-label, 52-week study of 2% rebamipide (OPC-12759) ophthalmic suspension in patients with dry eye.

PubMed

Kinoshita, Shigeru; Awamura, Saki; Nakamichi, Norihiro; Suzuki, Hiroyuki; Oshiden, Kazuhide; Yokoi, Norihiko

2014-03-01

To investigate the efficacy and safety of 2% rebamipide ophthalmic suspension administered 4 times daily for 52 weeks in patients with dry eye. Multicenter (17 sites), open-label, single-arm study. A total of 154 patients with dry eye were enrolled in this study. After a 2-week screening period, patients received 2% rebamipide, instilled as 1 drop in each eye, 4 times daily for 52 weeks. The signs and symptoms measures were assessed at baseline, at weeks 2 and 4, and at every 4 weeks thereafter. The objective signs were fluorescein corneal staining score, lissamine green conjunctival staining score, and tear film break-up time, while subjective symptoms were dry eye-related ocular symptoms (foreign body sensation, dryness, photophobia, eye pain, and blurred vision). The safety variable was the occurrence of adverse events. For all objective signs and subjective symptoms, the scores significantly improved at week 2 compared with baseline (P < .001, paired t test). Interestingly, further improvements of those scores were observed at every visit up to week 52. No deaths were reported, yet serious adverse events that were not thought to be drug related were observed in 6 patients. The incidence of any of the adverse events did not markedly increase throughout the 52-week treatment period. The results of this study show that 2% rebamipide is effective in improving both the objective signs and subjective symptoms of dry eye patients for at least 52 weeks. In addition, 2% rebamipide treatment was generally well tolerated. Copyright © 2014. Published by Elsevier Inc.

Characterization of vascular complications in experimental model of fructose-induced metabolic syndrome.

PubMed

El-Bassossy, Hany M; Dsokey, Nora; Fahmy, Ahmed

2014-12-01

Vascular dysfunction is an important complication associated with metabolic syndrome (MS). Here we fully characterized vascular complications in a rat model of fructose-induced MS. MS was induced by adding fructose (10%) to drinking water to male Wistar rats of 6 weeks age. Blood pressure (BP) and isolated aorta responses phenylephrine (PE), KCl, acetylcholine (ACh), and sodium nitroprusside (SNP) were recorded after 6, 9, and 12 weeks of fructose administration. In addition, serum levels of glucose, insulin, uric acid, tumor necrosis factor α (TNFα), lipids, advanced glycation end products (AGEs), and arginase activity were determined. Furthermore, aortic reactive oxygen species (ROS) generation, hemeoxygenase-1 expression, and collagen deposition were examined. Fructose administration resulted in a significant hyperinslinemia after 6 weeks which continued for 12 weeks. It was also associated with a significant increase in BP after 6 weeks which was stable for 12 weeks. Aorta isolated from MS animals showed exaggerated contractility to PE and KCl and impaired relaxation to ACh compared with control after 6 weeks which were clearer at 12 weeks of fructose administration. In addition, MS animals showed significant increases in serum levels of lipids, uric acid, AGEs, TNFα, and arginase enzyme activity after 12 weeks of fructose administration. Furthermore, aortae isolated from MS animals were characterized by increased ROS generation and collagen deposition. In conclusion, adding fructose (10%) to drinking water produces a model of MS with vascular complications after 12 weeks that are characterized by insulin resistance, hypertension, disturbed vascular reactivity and structure, hyperuricemia, dyslipidemia, and low-grade inflammation.

Can a Lifestyle Intervention Increase Active Transportation in Women Aged 55-70 years? Secondary Outcomes From a Pilot Randomized Controlled Trial.

PubMed

Gray, Samantha M; Chen, Peggy; Fleig, Lena; Gardiner, Paul A; McAllister, Megan M; Puyat, Joseph H; Sims-Gould, Joanie; McKay, Heather A; Winters, Meghan; Ashe, Maureen C

2018-06-01

Physical activity confers many health benefits to older adults, and adopting activity into daily life routines may lead to better uptake. The purpose of this study was to test the effect of a lifestyle intervention to increase daily physical activity in older women through utilitarian walking and use of public transportation. In total, 25 inactive women with mean age (SD) of 64.1 (4.6) years participated in this pilot randomized controlled trial [intervention (n = 13) and control (n = 12)]. Seven-day travel diaries (trips per week) and the International Physical Activity Questionnaire (minutes per week) were collected at baseline, 3, and 6 months. At 3 months, intervention participants reported 9 walking trips per week and 643.5 minutes per week of active transportation, whereas control participants reported 4 walking trips per week and 49.5 minutes per week of active transportation. Adjusting for baseline values, there were significant group differences favoring Everyday Activity Supports You for walking trips per week [4.6 (0.5 to 9.4); P = .04] and active transportation minutes per week [692.2 (36.1 to 1323.5); P = .05]. At 6 months, significant group differences were observed in walking trips per week [6.1 (1.9 to 11.4); P = .03] favoring the intervention (9 vs 2 trips per week). Given these promising findings, the next step is to test Everyday Activity Supports You model's effectiveness to promote physical activity in older women within a larger study.

Vedolizumab Therapy in Severe Pediatric Inflammatory Bowel Disease.

PubMed

Conrad, Máire A; Stein, Ronen E; Maxwell, Elizabeth C; Albenberg, Lindsey; Baldassano, Robert N; Dawany, Noor; Grossman, Andrew B; Mamula, Petar; Piccoli, David A; Kelsen, Judith R

2016-10-01

Vedolizumab is effective for inducing and maintaining remission in adults with inflammatory bowel disease (IBD); however, there is limited pediatric data. This study aimed to describe the adverse events and clinical response to vedolizumab in refractory pediatric IBD. Disease activity indices, clinical response, concomitant medication use, and adverse events were measured over 22 weeks in an observational prospective cohort study of children with refractory IBD who had failed anti-tumor necrosis factor therapy and subsequently initiated vedolizumab therapy. Twenty-one subjects, 16 with Crohn disease, received vedolizumab. Clinical response was observed in 6/19 (31.6%) of the evaluable subjects at week 6 and in 11/19 (57.9%) by week 22. Before induction, 15/21 (71.4%) participants were treated with systemic corticosteroids, as compared with 7/21 (33.3%) subjects at 22 weeks. Steroid-free remission was seen in 1/20 (5.0%) subjects at 6 weeks, 3/20 (15.0%) at 14 weeks, and 4/20 (20.0%) at 22 weeks. There was statistically significant improvement in serum albumin and hematocrit; however, C-reactive protein increased by week 22 (P < 0.05). There were no infusion reactions. Vedolizumab was discontinued in 2 patients because of severe colitis, requiring surgical intervention. There is limited experience with vedolizumab therapy in pediatric IBD. There seems to be a marked number of subjects with clinical response in the first 6 weeks that increases further by week 22 despite the severity of disease in this cohort. Adverse events may not be directly related to vedolizumab. This study is limited by small sample size, and larger prospective studies are warranted.

4D ultrasound study of fetal facial expressions in the third trimester of pregnancy.

PubMed

AboEllail, Mohamed Ahmed Mostafa; Kanenishi, Kenji; Mori, Nobuhiro; Mohamed, Osman Abdel Kareem; Hata, Toshiyuki

2018-07-01

To evaluate the frequencies of fetal facial expressions in the third trimester of pregnancy, when fetal brain maturation and development are progressing in normal healthy fetuses. Four-dimensional (4 D) ultrasound was used to examine the facial expressions of 111 healthy fetuses between 30 and 40 weeks of gestation. The frequencies of seven facial expressions (mouthing, yawning, smiling, tongue expulsion, scowling, sucking, and blinking) during 15-minute recordings were assessed. The fetuses were further divided into three gestational age groups (25 fetuses at 30-31 weeks, 43 at 32-35 weeks, and 43 at ≥36 weeks). Comparison of facial expressions among the three gestational age groups was performed to determine their changes with advancing gestation. Mouthing was the most frequent facial expression at 30-40 weeks of gestation, followed by blinking. Both facial expressions were significantly more frequent than the other expressions (p < .05). The frequency of yawning decreased with the gestational age after 30 weeks of gestation (p = .031). Other facial expressions did not change between 30 and 40 weeks. The frequency of yawning at 30-31 weeks was significantly higher than that at 36-40 weeks (p < .05). There were no significant differences in the other facial expressions among the three gestational age groups. Our results suggest that 4D ultrasound assessment of fetal facial expressions may be a useful modality for evaluating fetal brain maturation and development. The decreasing frequency of fetal yawning after 30 weeks of gestation may explain the emergence of distinct states of arousal.

Hamstring Graft Technique for Stabilization of Canine Cranial Cruciate Ligament Deficient Stifles

PubMed Central

LOPEZ, MANDI J.; MARKEL, MARK D.; KALSCHEUR, VICKI; LU, YAN; MANLEY, PAUL A.

2007-01-01

Objective To investigate the harvest and application of hamstring grafts for canine cranial cruciate ligament (CrCL) reconstruction. Study Design Experimental study. Animals Four adult female hounds, weighing 26.3 ± 1.6 kg (mean ± SEM). Methods One stifle in each dog was randomly chosen for hamstring graft CrCL reconstruction after native CrCL transection. Arthroscopy was performed to evaluate graft integrity at 12 weeks. Gait analysis and stifle radiographs were performed preoperatively and up to 52 weeks after graft placement. Dogs were killed 12 (n = 2) or 52 weeks (n = 2) after CrCL reconstruction. Tissues were evaluated grossly and with light and confocal laser microscopy. Results Hamstring grafts were intact in all stifles at 12 weeks (n = 4) and 52 weeks (n = 2). Grossly, there was no osteoarthritis in stifles at 12 weeks and only chondrophytes along the trochlear ridges at 52 weeks. Minimal radiographic evidence of osteoarthritis developed in stifles with grafts during the study. Lameness in limbs with grafts resolved by 52 weeks. Graft tissue was highly vascular, ligamentized, and undergoing active remodeling at 12 weeks. Fifty-two weeks after graft placement, intraarticular graft tissue was well vascularized, mature, and encapsulated by synovium, and graft-bone interfaces were characterized by Sharpey’s fiber insertions. There was no evidence of graft necrosis using confocal laser microscopy at either time point. Conclusions The hamstring graft technique may be a viable method of canine CrCL reconstruction. Clinical Relevance Hamstring grafts may be an alternative technique for canine CrCL reconstruction. Further study is needed before clinical application. PMID:12866003

Orthodontic treatment modifies the oxidant-antioxidant balance in saliva of clinically healthy subjects.

PubMed

Buczko, Piotr; Knaś, Małgorzata; Grycz, Monika; Szarmach, Izabela; Zalewska, Anna

2017-03-01

The aim of our study was to analyse salivary markers of oxidative stress and an antioxidant response in clinically healthy subjects with fixed orthodontic appliances. 37 volunteers were included in the study. Unstimulated (UWS) and stimulated (SWS) whole saliva were analysed for oxidative and antioxidant status and nickel levels immediately before the insertion of the appliances, an one week after and twenty four weeks after the insertion of fixed appliances. A significant increase in tiobarbituric acid reactive substance (TBARS) and total oxidant status (TOS) one week, and total protein concentration twenty four weeks after the attachment of orthodontic appliances was found in the saliva. The markers of antioxidant status: superoxide dismutase (SOD), catalase (CAT), uric acid (UA), peroxidase (Px), and total antioxidant status (TAS) were not changed in all periods in UWS. In SWS a significant decrease in SOD1 and CAT was found whereas Px was increased one week after treatment and UA twenty four weeks following treatment. TAS was decreased in UWS and SWS twenty four weeks after orthodontic treatment. Oxidative status index (OSI) was elevated both in UWS and SWS one week after orthodontic treatment in comparison to the results obtained before and twenty four weeks. One week after treatment an increased concentration of nickel was also observed. Orthodontic treatment modifies the oxidative-antioxidative balance in the saliva of clinically healthy subjects. Increased nickel concentration in saliva, released from orthodontic appliances, seems to be responsible for changes in the oxidative status of the saliva. Copyright © 2017 Medical University of Bialystok. Published by Elsevier B.V. All rights reserved.

Effects of ammonium perchlorate on the reproductive performance and thyroid follicle histology of zebrafish

USGS Publications Warehouse

Patino, R.; Wainscott, M.R.; Cruz-Li, E. I.; Balakrishnan, S.; McMurry, C.; Blazer, V.S.; Anderson, T.A.

2003-01-01

Adult zebrafish were reared up to eight weeks in control water or in water containing ammonium perchlorate (AP) at measured perchlorate concentrations of 18 (environmentally relevant, high) and 677 ppm. Groups of eight females were paired with four males on a weekly basis to assess AP effects on spawned egg volume, an index of reproductive performance. All treatments were applied to four to five spawning replicates. At 677 ppm, spawn volume was reduced within one week and became negligible after four weeks. At 18 ppm, spawn volume was unaffected even after eight weeks. Also, perchlorate at 18 ppm did not affect percentage egg fertilization. Fish were collected at the end of the exposures (677 ppm, four weeks; control and 18 ppm, eight weeks) for whole-body perchlorate content and thyroid histopathological analysis. Fish perchlorate levels were about one-hundredth of those of treatment water levels, indicating that waterborne perchlorate does not accumulate in whole fish. At 677 ppm for four weeks, perchlorate caused thyroid follicle cell (nuclear) hypertrophy and angiogenesis, whereas at 18 ppm for eight weeks, its effects were more pronounced and included hypertrophy, angiogenesis, hyperplasia, and colloid depletion. In conclusion, an eight-week exposure of adult zebrafish to 18 ppm perchlorate (high environmentally relevant concentrations) affected the histological condition of their thyroid follicles but not their reproductive performance. The effect of 677 ppm perchlorate on reproduction may be due to extrathyroidal toxicity. Further research is needed to determine if AP at lower environmentally relevant concentrations also affects the thyroid follicles of zebrafish.

Characterizing the recovery trajectories of knee range of motion for one year after total knee replacement.

PubMed

Mehta, Saurabh; Rigney, Andrew; Webb, Kyle; Wesney, Jacob; Stratford, Paul W; Shuler, Franklin D; Oliashirazi, Ali

2018-06-13

Retrospective analysis of routinely collected clinical data. This study modeled the recovery in knee flexion and extension range of motion (ROM) over 1 year after total knee replacement (TKR). Recovery after TKR has been characterized for self-reported pain and functional status. Literature describing target knee ROM at different follow-up periods after TKR is scarce. Data were extracted for patients who had undergone TKR at a tertiary care hospital at 2, 8, 12, 26, and 52 weeks after TKR. A linear mixed-effects growth model was constructed that investigated the following covariates age, sex, pre-TKR range, body mass index, duration of symptoms, and their interaction with weeks post TKR. Of the 559 patients included (age 64.8 ± 8.5 years), 370 were women and 189 were men. Knee ROM showed the greatest change during the first 12 weeks after TKR, plateauing by 26 weeks. For an average patient, knee flexion increased from approximately 100º 2 weeks post TKR to 117º 52 weeks post TKR. Knee extension increased from approximately 3º knee flexion 2 weeks post TKR to 1º flexion 52 weeks post TKR. The results showed that the maximum gains in knee ROM should be expected within the first 12 weeks with small changes occurring up to 26 weeks after TKR. In addition, age and presurgery knee ROM are associated with the gains in knee ROM and should be factored into the estimation of expected knee ROM at a given follow-up interval after TKR.

Analysis of fracture healing in osteopenic bone caused by disuse: experimental study.

PubMed

Paiva, A G; Yanagihara, G R; Macedo, A P; Ramos, J; Issa, J P M; Shimano, A C

2016-03-01

Osteoporosis has become a serious global public health issue. Hence, osteoporotic fracture healing has been investigated in several previous studies because there is still controversy over the effect osteoporosis has on the healing process. The current study aimed to analyze two different periods of bone healing in normal and osteopenic rats. Sixty, 7-week-old female Wistar rats were randomly divided into four groups: unrestricted and immobilized for 2 weeks after osteotomy (OU2), suspended and immobilized for 2 weeks after osteotomy (OS2), unrestricted and immobilized for 6 weeks after osteotomy (OU6), and suspended and immobilized for 6 weeks after osteotomy (OS6). Osteotomy was performed in the middle third of the right tibia 21 days after tail suspension, when the osteopenic condition was already set. The fractured limb was then immobilized by orthosis. Tibias were collected 2 and 6 weeks after osteotomy, and were analyzed by bone densitometry, mechanical testing, and histomorphometry. Bone mineral density values from bony calluses were significantly lower in the 2-week post-osteotomy groups compared with the 6-week post-osteotomy groups (multivariate general linear model analysis, P<0.000). Similarly, the mechanical properties showed that animals had stronger bones 6 weeks after osteotomy compared with 2 weeks after osteotomy (multivariate general linear model analysis, P<0.000). Histomorphometry indicated gradual bone healing. Results showed that osteopenia did not influence the bone healing process, and that time was an independent determinant factor regardless of whether the fracture was osteopenic. This suggests that the body is able to compensate for the negative effects of suspension.

Expressive Suppression Tendencies, Projection Bias in Memory of Negative Emotions, and Well-Being.

PubMed

Chang, Valerie T; Overall, Nickola C; Madden, Helen; Low, Rachel S T

2018-02-01

The current research extends prior research linking negative emotions and emotion regulation tendencies to memory by investigating whether (a) naturally occurring negative emotions during routine weekly life are associated with more negatively biased memories of prior emotional experiences-a bias called projection; (b) tendencies to regulate emotions via expressive suppression are associated with greater projection bias in memory of negative emotions; and (c) greater projection bias in memory is associated with poorer future well-being. Participants (N = 308) completed a questionnaire assessing their general tendencies to engage in expressive suppression. Then, every week for 7 weeks, participants reported on (a) the negative emotions they experienced across the current week (e.g., "This week, I felt 'sad'"), (b) their memories of the negative emotions they experienced the prior week (e.g., "Last week, I felt 'sad'"), and (c) their well-being. First, participants demonstrated significant projection bias in memory: Greater negative emotions in a given week were associated with remembering emotions in the prior week more negatively than those prior emotions were originally reported. Second, projection bias in memory of negative emotions was greater for individuals who reported greater tendencies to regulate emotions via expressive suppression. Third, greater projection bias in memory of negative emotions was associated with reductions in well-being across weeks. These 3 novel findings indicate that (a) current negative emotions bias memory of past emotions, (b) this memory bias is magnified for people who habitually use expressive suppression to regulate emotions, and (c) this memory bias may undermine well-being over time. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Late effects of whole brain irradiation within the therapeutic range

DOE Office of Scientific and Technical Information (OSTI.GOV)

Caveness, W.F.; Carsten, A.L.

1978-01-01

Whole brain exposure with supervoltage x irradiation was carried out in three sets of Macaca mulatta. Two sets of 12 monkeys each, at puberty, received single and fractionated exposures, respectively. One set of 21 monkeys in adulthood received a fractionated exposure. Exposure to 1000 rads in a single dose, at puberty, caused no late effects. Exposure to 1500 rads caused small areas of necrosis in the forebrain white matter at 26 weeks, but a much more extensive involvement at and beyond 52 weeks that included confluent areas of necrosis in gray and white matter. Brain loss resulted in ventricular dilatation.more » Gliomas appeared in two out of three monkeys at or beyond 52 weeks. Exposure to 2000 rads caused such a wide scatter of focal areas of necrosis, including those in the brain stem, that survival beyond 20 to 26 weeks was not possible. All showed enlarged ventricular systems. Whole brain exposure, 200 rads a day, five days a week, for a course of 4000 rads, at puberty, resulted in no delayed effects. Whole brain exposure to 6000 rads in a six weeks course, in the adult, produced less effects than the same dose at puberty. The onset of the scattered necrotic lesions was later than expected, appearing in one out of three animals at 33 weeks, two out of three animals at 52 weeks, and two out of three at 104 weeks. The lesions at 104 weeks were predominantly mineralized, but were accompanied by a greater extent of telangiectasia than seen in the pubescent monkeys.« less

Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.

PubMed

Ogata, Atsushi; Amano, Koichi; Dobashi, Hiroaki; Inoo, Masayuki; Ishii, Tomonori; Kasama, Tsuyoshi; Kawai, Shinichi; Kawakami, Atsushi; Koike, Tatsuya; Miyahara, Hisaaki; Miyamoto, Toshiaki; Munakata, Yasuhiko; Murasawa, Akira; Nishimoto, Norihiro; Ogawa, Noriyoshi; Ojima, Tomohiro; Sano, Hajime; Shi, Kenrin; Shono, Eisuke; Suematsu, Eiichi; Takahashi, Hiroki; Tanaka, Yoshiya; Tsukamoto, Hiroshi; Nomura, Akira

2015-05-01

To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

Permanent stress may be the trigger of an acute myocardial infarction on the first work-day of the week.

PubMed

Bodis, Jozsef; Boncz, Imre; Kriszbacher, Ildiko

2010-10-29

Numerous studies have reported the weekly variation of an acute myocardial infarction. The Monday peek has been connected with higher rate of physical and mental, work-related stress. We wished to study the weekly variation of an acute myocardial infarction (AMI) in the group of workers and pensioners, and to find out whether National Holidays on the first day of the week could influence the weekly rhythm of an acute myocardial infarction. We carried out the retrospective analysis of patients admitted to Hungarian hospitals with the diagnose of an AMI (n=90,187) between 2002 and 2007. According to the morbidity data of an AMI, the weekly peek was detected on the first work-day of the week, showing a gradually decreasing tendency until the end of the week. Morbidity rates on Mondays being National Holidays were similar to the number of events on Saturdays and Sundays (Z=-24,431; p<0.001). There was a significant difference between the number of events on work-days and weekends (Z=-27,321; p<0.001). No marked difference was found between workers under the age of 65 and pensioners above the age of 65, or between the two sexes. The results of our study reveal that the occurrence of an AMI shows characteristic changes throughout the days of the week, and the first work-days of the week may be related to higher incidence of an acute myocardial infarction. Crown Copyright © 2009. Published by Elsevier Ireland Ltd. All rights reserved.

Weekly iron as a safe alternative to daily supplementation for nonanemic pregnant women.

PubMed

Casanueva, Esther; Viteri, Fernando E; Mares-Galindo, Mónica; Meza-Camacho, Carlos; Loría, Alvar; Schnaas, Lourdes; Valdés-Ramos, Roxana

2006-07-01

We undertook this study to compare the effectiveness and safety of antenatal daily and weekly supplementation with iron, folic acid, and vitamin B(12) in healthy, pregnant women who were not anemic at gestational week 20. Women with singleton pregnancies and blood hemoglobin (Hb) >115 g/L at gestational week 20 (equivalent to 105 g/L at sea level) were randomly assigned to two groups, one consuming one tablet containing 60 mg iron, 200 mug folic acid and 1 mug vitamin B(12) daily (DS, n = 56); the other consuming two tablets once weekly (WS, n = 60). Blood Hb and serum ferritin concentrations were measured every 4 weeks from weeks 20 to 36, and pregnancy outcomes were evaluated. Mild anemia and hypoferritinemia throughout pregnancy occurred less frequently in DS than WS. None of the 116 women had Hb concentrations <103 g/L at any evaluation point. In contrast, hemoconcentration (Hb >145 g/L) from gestational week 28 onwards occurred in 11% in DS and 2% in WS. We observed ex post facto that hemoconcentration at gestational week 28 was associated with a significantly higher relative risk of low birth weight (RR 6.23, 95% CI 1.46-26.57) and premature delivery (RR 7.78, 95% CI 1.45-24.74). In women who were nonanemic at gestational week 20, both schemes (DS and WS) prevented the occurrence of Hb levels <100 g/L. DS women had a higher incidence of hemoconcentration. Hemoconcentration was associated with increased risk of low birth weight and premature delivery.

Assessment of the efficacy and safety of a new complex skin cream in Asian women: A controlled clinical trial.

PubMed

Jung, Yu Seok; Lee, Ji Hae; Bae, Jung Min; Lee, Dong Won; Kim, Gyong Moon

2017-06-01

Medical products such as hydroquinone and tretinoin have been widely used to treat various types of skin hyperpigmentation. However, these products are limited in daily use given their adverse effects. Other alternative agents with fewer adverse side effects have been developed. However, single agents often do not produce satisfactory results. To evaluate the efficacy and safety of a new brightening complex cream containing niacinamide, tranexamic acid, oxyresveratrol, glutathione disulfide, and linoleic acid. A total of 26 Korean women seeking to lighten their skin were enrolled. The product was applied on the face two times per day for 12 weeks. Standardized photographs were taken at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was assessed using melanin index (MI), erythema index (EI), and chromatic aberration values (L*, a*, and b*). Improvement perceived by investigators and patients was measured as well. The L*-value was increased at 8 weeks (0.7±2.5, P<.05) and at 12 weeks (0.8±2.5, P<.05). The MI was significantly decreased at 8 weeks (-4.2±4.5, P<.05) and at 12 weeks (-3.8±4.8, P<.001). The EI was significantly improved at 12 weeks (-3.2±2.2, P<.001). More than 80% of patients were considered improved at 12 weeks based on the view of the investigators and patients. The new brightening complex cream was proved to be effective and safe in Asian women. © 2017 Wiley Periodicals, Inc.

Self-assessment and goal-setting is associated with an improvement in interviewing skills.

PubMed

Hanley, Kathleen; Zabar, Sondra; Charap, Joseph; Nicholson, Joseph; Disney, Lindsey; Kalet, Adina; Gillespie, Colleen

2014-01-01

Describe the relationship between medical students' self-assessment and goal-setting (SAGS) skills and development of interviewing skills during the first-year doctoring course. 157 first-year medical students completed three two-case standardized patient (SP) interviews. After each of the first two, students viewed videotapes of their interview, completed a SAGS worksheet, and reviewed a selected tape segment in a seminar. SAGS was categorized into good and poor quality and interviewing skills were rated by trained raters. SAGS improved over time (37% good week 1 vs. 61% good week 10). Baseline SAGS and interviewing skills were not associated. Initial SAGS quality was associated with change in interviewing skills - those with poor-quality SAGS demonstrated a decrease and those with good-quality SAGS demonstrated an increase in scores by 17 weeks (ANOVA F=4.16, p=0.024). For students whose SAGS skills were good at both week 1 and 10, interviewing skills declined in weeks 1-10 and then increased significantly at week 17. For those whose SAGS remained 'poor' in weeks 1-10, interviewing skills declined in weeks 10-17. In general, the quality of students' SAGS improved over time. Poor baseline SAGS skills and failure to improve were associated with a decrease in interviewing skills at 17 weeks. For students with better SAGS, interviewing skills increased at week 17. Improvement in SAGS skills was not associated with improved interviewing skills. Understanding structured self-assessment skills helps identify student characteristics that influence progressive mastery of communication skills and therefore may inform curriculum and remediation tailoring.

The relationships among spatiotemporal collagen gene expression, histology, and biomechanics following full-length injury in the murine patellar tendon.

PubMed

Dyment, Nathaniel A; Kazemi, Namdar; Aschbacher-Smith, Lindsey E; Barthelery, Nicolas J; Kenter, Keith; Gooch, Cynthia; Shearn, Jason T; Wylie, Christopher; Butler, David L

2012-01-01

Tendon injuries are major orthopedic problems that worsen as the population ages. Type-I (Col1) and type-II (Col2) collagens play important roles in tendon midsubstance and tendon-to-bone insertion healing, respectively. Using double transgenic mice, this study aims to spatiotemporally monitor Col1 and Col2 gene expression, histology, and biomechanics up to 8 weeks following a full-length patellar tendon injury. Gene expression and histology were analyzed weekly for up to 5 weeks while mechanical properties were measured at 1, 2, 5, and 8 weeks. At week 1, the healing region displayed loose granulation tissue with little Col1 expression. Col1 expression peaked at 2 weeks, but the ECM was highly disorganized and hypercellular. By 3 weeks, Col1 expression had reduced and by 5 weeks, the ECM was generally aligned along the tendon axis. Col2 expression was not seen in the healing midsubstance or insertion at any time point. The biomechanics of the healing tissue was inadequate at all time points, achieving ultimate loads and stiffnesses of 48% and 63% of normal values by 8 weeks. Future studies will further characterize the cells within the healing midsubstance and insertion using tenogenic markers and compare these results to those of tendon cells during normal development. Copyright © 2011 Orthopaedic Research Society.

"Dance Dance Revolution" Used by 7- and 8-Year-Olds to Boost Physical Activity: Is Coaching Necessary for Adherence to an Exercise Prescription?

PubMed

Errickson, Sadye Paez; Maloney, Ann E; Thorpe, Deborah; Giuliani, Carol; Rosenberg, Angela M

2012-02-01

To increase opportunities for physical activity (PA) for children in children's homes, we used a "Dance Dance Revolution" (DDR) (Konami of America, Redwood City, CA) coaching protocol for 7- and 8-year-olds. We randomly assigned youth to either an Enhanced (coaching) or Basic (no coaching) group. A DDR prescription of 120 minutes/week was provided to 40 children. Motor learning principles guided the coaching protocol, provided by adult graduate students, which took place weekly during weeks 1-5. PA was measured with accelerometry, DDR logs, and Sony (New York, NY) Playstation(®)2 memory cards at baseline and at week 10. Total accelerometer-measured PA was not significantly different between the groups at baseline or week 10; however, vigorous PA increased significantly in both groups at week 10. DDR logs showed a large range from 0 to 660 minutes/week of dance time. Respective playing time for each week (1 and 10) averaged 149 and 64 minutes for the Basic group and 184 and 47 minutes for the Enhanced group. Coaching significantly increased DDR use patterns in this population of youngsters during weeks 1 through 5 (P<0.001). Adult coaching deserves further study to determine how to maintain high levels of participation in exergames for youth who live in an obesogenic environment.

The influence of incubation time on adenovirus quantitation in A549 cells by most probable number.

PubMed

Cashdollar, Jennifer L; Huff, Emma; Ryu, Hodon; Grimm, Ann C

2016-11-01

Cell culture based assays used to detect waterborne viruses typically call for incubating the sample for at least two weeks in order to ensure that all the culturable virus present is detected. Historically, this estimate was based, at least in part, on the length of time used for detecting poliovirus. In this study, we have examined A549 cells infected with human adenovirus type 2, and have found that a three week incubation of virus infected cells results in a higher number of detected viruses by quantal assay than what is seen after two weeks of incubation, with an average 955% increase in Most Probable Number (MPN) from 2 weeks to 3 weeks. This increase suggests that the extended incubation time is essential for accurately estimating viral titer, particularly for slow-growing viruses, UV treated samples, or samples with low titers of virus. In addition, we found that for some UV-treated samples, there was no detectable MPN at 2 weeks, but after 3 weeks, MPN values were obtained. For UV-treated samples, the average increase in MPN from 2 weeks to 3 weeks was 1401%, while untreated samples averaged a change in MPN of 674%, leading us to believe that the UV-damaged viral DNA may be able to be repaired such that viral replication then occurs. Published by Elsevier B.V.

Results from the second year of a collaborative effort to forecast influenza seasons in the United States.

PubMed

Biggerstaff, Matthew; Johansson, Michael; Alper, David; Brooks, Logan C; Chakraborty, Prithwish; Farrow, David C; Hyun, Sangwon; Kandula, Sasikiran; McGowan, Craig; Ramakrishnan, Naren; Rosenfeld, Roni; Shaman, Jeffrey; Tibshirani, Rob; Tibshirani, Ryan J; Vespignani, Alessandro; Yang, Wan; Zhang, Qian; Reed, Carrie

2018-02-24

Accurate forecasts could enable more informed public health decisions. Since 2013, CDC has worked with external researchers to improve influenza forecasts by coordinating seasonal challenges for the United States and the 10 Health and Human Service Regions. Forecasted targets for the 2014-15 challenge were the onset week, peak week, and peak intensity of the season and the weekly percent of outpatient visits due to influenza-like illness (ILI) 1-4 weeks in advance. We used a logarithmic scoring rule to score the weekly forecasts, averaged the scores over an evaluation period, and then exponentiated the resulting logarithmic score. Poor forecasts had a score near 0, and perfect forecasts a score of 1. Five teams submitted forecasts from seven different models. At the national level, the team scores for onset week ranged from <0.01 to 0.41, peak week ranged from 0.08 to 0.49, and peak intensity ranged from <0.01 to 0.17. The scores for predictions of ILI 1-4 weeks in advance ranged from 0.02-0.38 and was highest 1 week ahead. Forecast skill varied by HHS region. Forecasts can predict epidemic characteristics that inform public health actions. CDC, state and local health officials, and researchers are working together to improve forecasts. Published by Elsevier B.V.

Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid.

PubMed

Clandinin, M Thomas; Van Aerde, John E; Merkel, Kimberly L; Harris, Cheryl L; Springer, Mary Alice; Hansen, James W; Diersen-Schade, Deborah A

2005-04-01

To evaluate safety and benefits of feeding preterm infants formulas containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) until 92 weeks postmenstrual age (PMA), with follow-up to 118 weeks PMA. This double-blinded study of 361 preterm infants randomized across three formula groups: (1) control, no supplementation; (2) algal-DHA (DHA from algal oil, ARA from fungal oil); and (3) fish-DHA (DHA from fish oil, ARA from fungal oil). Term infants breast-fed > or =4 months (n = 105) were a reference group. Outcomes included growth, tolerance, adverse events, and Bayley development scores. Weight of the algal-DHA group was significantly greater than the control group from 66 to 118 weeks PMA and the fish-DHA group at 118 weeks PMA but did not differ from term infants at 118 weeks PMA. The algal-DHA group was significantly longer than the control group at 48, 79, and 92 weeks PMA and the fish-DHA group at 57, 79, and 92 weeks PMA but did not differ from term infants from 79 to 118 weeks PMA. Supplemented groups had higher Bayley mental and psychomotor development scores at 118 weeks PMA than did the control group. Supplementation did not increase morbidity or adverse events. Feeding formulas with DHA and ARA from algal and fungal oils resulted in enhanced growth. Both supplemented formulas provided better developmental outcomes than unsupplemented formulas.

Spreading out or concentrating weekly consumption: alcohol problems and other consequences within a UK population sample.

PubMed

Miller, Patrick; Plant, Moira; Plant, Martin

2005-01-01

To consider the consequences, within a UK population sample, of consuming a given amount of alcohol weekly in one or two sessions as against spreading it out over several sessions. A new analysis of data from the UK components of the GENACIS survey of adults aged > or =18, was carried out. At low levels of weekly alcohol consumption those subjects whose usual drinking frequency was several times per week ('spreaders'), if anything, reported more alcohol problems than those who consumed alcohol only once or twice per week ('bingers'). As weekly consumption increased above approximately 11 units per week 'bingers' began to experience more problems than 'spreaders'. At the highest levels of consumption 'bingers' reported more positive experiences from drinking than did 'spreaders'. Subjects >54 years showed lower levels of weekly alcohol consumption than other subjects, and relationships between problems, drinking level, and drinking pattern were less in evidence. Females drank less alcohol and experienced fewer alcohol-related problems than did their male counterparts. However, at high-consumption levels, female 'bingers' experienced fewer problems than male 'bingers'. For most but not all the variables studied, both drinking level and drinking pattern are important determinants of problems experienced. Binge drinking for people who drink more than approximately 11 units per week is an obvious target for harm minimization.

A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum.

PubMed

Hale, Braden R; Owusu-Agyei, Seth; Fryauff, David J; Koram, Kwadwo A; Adjuik, Martin; Oduro, Abraham R; Prescott, W Roy; Baird, J Kevin; Nkrumah, Francis; Ritchie, Thomas L; Franke, Eileen D; Binka, Fred N; Horton, John; Hoffman, Stephen L

2003-03-01

Tafenoquine is a promising new 8-aminoquinoline drug that may be useful for malaria prophylaxis in nonpregnant persons with normal glucose-6-phosphate dehydrogenase (G6PD) function. A randomized, double-blind, placebo-controlled chemoprophylaxis trial was conducted with adult residents of northern Ghana to determine the minimum effective weekly dose of tafenoquine for the prevention of infection by Plasmodium falciparum. The primary end point was a positive malaria blood smear result during the 13 weeks of study drug coverage. Relative to the placebo, all 4 tafenoquine dosages demonstrated significant protection against P. falciparum infection: for 25 mg/week, protective efficacy was 32% (95% confidence interval [CI], 20%-43%); for 50 mg/week, 84% (95% CI, 75%-91%); for 100 mg/week, 87% (95% CI, 78%-93%); and for 200 mg/week, 86% (95% CI, 76%-92%). The mefloquine dosage of 250 mg/week also demonstrated significant protection against P. falciparum infection (protective efficacy, 86%; 95% CI, 72%-93%). There was little difference between study groups in the adverse events reported, and there was no evidence of a relationship between tafenoquine dosage and reports of physical complaints or the occurrence of abnormal laboratory parameters. Tafenoquine dosages of 50, 100, and 200 mg/week were safe, well tolerated, and effective against P. falciparum infection in this study population.

Dimensions of schizophrenia and their time course of response to a second generation antipsychotic olanzapine-A clinical study.

PubMed

Birur, Badari; Thirthalli, Jagadisha; Janakiramaiah, N; Shelton, Richard C; Gangadhar, Bangalore N

2016-12-01

The pattern of symptom response to second generation antipsychotics (SGAs) has not been studied extensively. Understanding the time course of symptom response would help to rationally monitor patient progress. To determine the short-term differential time course of response of symptom dimensions of first episode schizophrenia viz., negative, positive symptoms and 5 factors of anergia, thought disturbance, activation, paranoid-belligerence and depression to treatment with SGA olanzapine. 57 drug naive patients with schizophrenia were treated for 4 weeks with olanzapine 10mg/day, increased to 20mg/day in 1 week. Weight was recorded and ratings with the Positive and Negative Syndrome scale (PANSS), the Simpson Angus Scale (SAS) were performed weekly. 43 patients completed 4 weeks of assessment. Scores on all of the dimensions improved. By the end of week 1, only positive syndrome, thought disturbance and paranoid-belligerence dimensions improved. Maximum improvement was seen with paranoid-belligerence by week 1, followed by positive syndrome in week 2, and depression at week 3. The percentage improvement in positive syndrome was significantly greater than negative. Over 4 weeks there was a mean weight gain of 2kg and there were significant extrapyramidal symptoms. Olanzapine produced reduction in all dimensions, but the pace of responding of individual dimensions differed. Longer-term studies comparing SGAs with first generation antipsychotics are needed. Copyright © 2016 Elsevier B.V. All rights reserved.

Onset of immunity in kittens after vaccination with a non-adjuvanted vaccine against feline panleucopenia, feline calicivirus and feline herpesvirus.

PubMed

Jas, D; Aeberlé, C; Lacombe, V; Guiot, A L; Poulet, H

2009-10-01

The induction of a quick onset of immunity against feline parvovirus (FPV), feline herpesvirus (FHV) and feline calicivirus (FCV) is critical both in young kittens after the decline of maternal antibodies and in cats at high risk of exposure. The onset of immunity for the core components was evaluated in 8-9 week old specific pathogen free kittens by challenge 1 week after vaccination with a combined modified live (FPV, FHV) and inactivated (FCV) vaccine. The protection obtained 1 week after vaccination was compared to that obtained when the challenge was performed 3-4 weeks after vaccination. The protocol consisted of a single injection for vaccination against FPV and two injections 4 weeks apart for FHV and FCV. At 1 week after vaccination, the kittens showed no FPV-induced clinical signs or leukopenia following challenge, and after FCV and FHV challenges the clinical score was significantly lower in vaccinated animals than in controls. Interestingly, the relative efficacy of the vaccination was comparable whether the animals were challenged 1 week or 3-4 weeks after vaccination, indicating that the onset of protection occurred within 7 days of vaccination. Following the 1-week challenge, excretion of FPV, FHV and FCV was significantly reduced in vaccinated cats compared to control kittens, confirming the onset of immunity within 7 days of vaccination.

Effects of counter torque and transposition (transfer) of installed implants timing on their integration in dog tibia

PubMed Central

Fathi, Shima; Ghanavati, Farzin

2015-01-01

PURPOSE The purpose of this research was to evaluate the amount of reosseointegration after counter torquing (reverse torque) and transposing the installed implants at different times. MATERIALS AND METHODS This study was done on ten tibiae of five cross-bred dogs. At the first day one implant was installed in each tibia. After one week half of the implants were randomly counter torqued (1WCT) and the other half were explanted and reimplanted in a new juxtaposition site (transposed)(1WT). At the same time three new implants were installed in each dog, one of them was considered as one week control (1WC) and remaining two as 8 week groups (8WCT&8WT). After eight weeks the 1WCT and 1WT implants were loosened by counter torque and the quantity of needed force for liberation was measured with the digital device (BGI). At the same time one implant was installed in each dog as eight week control (8WC) and the same protocol was repeated for 8 week groups after another 8 weeks. RESULTS All implants were osseointegrated. Mean quantities of osseointegration in case groups indicated better amounts rather than control groups. CONCLUSION Counter torque or transposition of the installed implants one week or eight weeks after the implantation did lead to osseointegration. PMID:25722840

Trajectories of Change in Emotion Regulation and Social Anxiety During Cognitive-Behavioral Therapy for Social Anxiety Disorder

PubMed Central

Goldin, Philippe R.; Lee, Ihno; Ziv, Michal; Jazaieri, Hooria; Heimberg, Richard G.; Gross, James J.

2014-01-01

Cognitive-behavioral therapy (CBT) for social anxiety disorder (SAD) may decrease social anxiety by training emotion regulation skills. This randomized controlled trial of CBT for SAD examined changes in weekly frequency and success of cognitive reappraisal and expressive suppression, as well as weekly intensity of social anxiety among patients receiving 16 weekly sessions of individual CBT. We expected these variables to (1) differ from pre-to-post-CBT vs. Waitlist, (2) have differential trajectories during CBT, and (3) covary during CBT. We also expected that weekly changes in emotion regulation would predict (4) subsequent weekly changes in social anxiety, and (5) changes in social anxiety both during and post-CBT. Compared to Waitlist, CBT increased cognitive reappraisal frequency and success, decreased social anxiety, but had no impact on expressive suppression. During CBT, weekly cognitive reappraisal frequency and success increased, whereas weekly expressive suppression frequency and social anxiety decreased. Weekly decreases in social anxiety were associated with concurrent increases in reappraisal success and decreases in suppression frequency. Granger causality analysis showed that only reappraisal success increases predicted decreases in subsequent social anxiety during CBT. Reappraisal success increases pre-to-post-CBT predicted reductions in social anxiety symptom severity post-CBT. The trajectory of weekly changes in emotion regulation strategies may help clinicians understand whether CBT is effective and predict decreases in social anxiety. PMID:24632110

Reduction in postnatal cumulative nutritional deficit and improvement of growth in extremely preterm infants.

PubMed

Senterre, Thibault; Rigo, Jacques

2012-02-01

To evaluate the influence of gestational age (GA) on cumulative nutritional deficit and postnatal growth in extremely preterm (EPT) infants after optimizing nutritional protocol as recently recommended. A prospective, nonrandomized, observational study in extremely preterm (EPT, <28 weeks) and very preterm (VPT, 28-30 weeks) infants. Eighty-four infants were included (BW: 978 ± 156 g, GA: 27.8 ± 1.3 weeks). Cumulative nutritional deficit increased during first week of life to -290 ± 84 and -285 ± 117 kcal/kg and -4.2 ± 3.1 and -4.8 ± 3.9 g/kg of protein in EPT and VPT groups, respectively. After 6 weeks, only cumulative energy deficit in EPT group remained significant (p < 0.05) even when 96% of theoretical energy intakes were provided. Weight z score decreased during first 3 days in average with initial weight loss, and then, the z score increased during the first 6 weeks of life in the majority (75%) of infants. Cumulative protein deficit during the first week of life was the major determinant of the postnatal growth during the first 6 weeks of life. Cumulative nutritional deficit may be drastically reduced in both EPT and VPT infants after optimizing nutritional policy during the first weeks of life, and the postnatal growth restriction could even be prevented. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

Effect of apolipoprotein-B synthesis inhibition on liver triglyceride content in patients with familial hypercholesterolemia

PubMed Central

Visser, Maartje E.; Akdim, Fatima; Tribble, Diane L.; Nederveen, Aart J.; Kwoh, T. Jesse; Kastelein, John J. P.; Trip, Mieke D.; Stroes, Erik S. G.

2010-01-01

To investigate the impact of mipomersen, an apolipoprotein B-100 (apoB) synthesis inhibitor, on intra-hepatic triglyceride content (IHTG content), we conducted a randomized, double-blind, placebo-controlled study in 21 patients with familial hypercholesterolemia (FH). Subjects received a weekly subcutaneous dose of 200 mg mipomersen or placebo for 13 weeks while continuing conventional lipid lowering therapy. The primary endpoint was change in IHTG content from week 0 to week 15 as measured by localized proton magnetic resonance spectroscopy (1H-MRS). Thirteen weeks of mipomersen administration reduced LDL-cholesterol by 22.0 (17.8) % and apoB by 19.9 (17.4) % (both P < 0.01). One of 10 patients (10%) in the mipomersen-treated group developed mild hepatic steatosis at week 15, which was reversible following mipomersen discontinuation. For the group, there was a trend toward an increase in IHTG content [placebo; baseline: 1.2% and week 15: 1.1%; change −0.1 (0.9). Mipomersen; baseline: 1.2% and week 15: 2.1%; change 0.8 (1.7) (P = 0.0513)]. Mipomersen administration for 13 weeks to subjects with FH is associated with a trend toward an increase in IHTG content. Future studies evaluating the effects of long-term use of mipomersen reaching more profound reductions in apoB are required prior to broader use of this compound. PMID:20008831

Effect of apolipoprotein-B synthesis inhibition on liver triglyceride content in patients with familial hypercholesterolemia.

PubMed

Visser, Maartje E; Akdim, Fatima; Tribble, Diane L; Nederveen, Aart J; Kwoh, T Jesse; Kastelein, John J P; Trip, Mieke D; Stroes, Erik S G

2010-05-01

To investigate the impact of mipomersen, an apolipoprotein B-100 (apoB) synthesis inhibitor, on intra-hepatic triglyceride content (IHTG content), we conducted a randomized, double-blind, placebo-controlled study in 21 patients with familial hypercholesterolemia (FH). Subjects received a weekly subcutaneous dose of 200 mg mipomersen or placebo for 13 weeks while continuing conventional lipid lowering therapy. The primary endpoint was change in IHTG content from week 0 to week 15 as measured by localized proton magnetic resonance spectroscopy (1H-MRS). Thirteen weeks of mipomersen administration reduced LDL-cholesterol by 22.0 (17.8) % and apoB by 19.9 (17.4) % (both P < 0.01). One of 10 patients (10%) in the mipomersen-treated group developed mild hepatic steatosis at week 15, which was reversible following mipomersen discontinuation. For the group, there was a trend toward an increase in IHTG content [placebo; baseline: 1.2% and week 15: 1.1%; change -0.1 (0.9). Mipomersen; baseline: 1.2% and week 15: 2.1%; change 0.8 (1.7) (P = 0.0513)]. Mipomersen administration for 13 weeks to subjects with FH is associated with a trend toward an increase in IHTG content. Future studies evaluating the effects of long-term use of mipomersen reaching more profound reductions in apoB are required prior to broader use of this compound.

Intermittent versus Continuous Physiotherapy in Children with Cerebral Palsy

ERIC Educational Resources Information Center

Christiansen, Annette Sandahl; Lange, Christa

2008-01-01

The aim of this study was to compare the effect of the delivery of the same amount of intermittent versus continuous physiotherapy given to children with cerebral palsy (CP). This was organized either in an intermittent regime four times a week for 4 weeks alternating with a 6-week treatment pause, or a continuous once or twice a week regime, both…

77 FR 59291 - Additional Changes to the Schedule of Operations Regulations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-27

... slaughtering inspectors, 56 percent work in beef establishments that operate 4 or 5 days per week, 4 percent work in beef establishments that operate less than 4 days per week, 36 percent work in swine... establishments that operate 4 days or more a week, and $888.2 ($17.08 per quarter-hour x 52 weeks per year) per...

29 CFR 778.114 - Fixed salary for fluctuating hours.

Code of Federal Regulations, 2010 CFR

2010-07-01

... in the workweek. If during the course of 4 weeks this employee works 40, 44, 50, and 48 hours, his... hours of work do not customarily follow a regular schedule but vary from week to week, whose overtime work is never in excess of 50 hours in a workweek, and whose salary of $250 a week is paid with the...

25 CFR 38.12 - Leave system for education personnel.

Code of Federal Regulations, 2010 CFR

2010-04-01

... employees on a part-time work schedule in excess of 20 hours per week. (1) Employees on a part-time work... with work weeks of 20 hours a week or less are not eligible for any type of paid leave. (g) For school... weeks. An employee may carry into succeeding years up to 200 hours of vacation leave. Leave unused at...

Does Shortening the School Week Impact Student Performance? Evidence from the Four-Day School Week

ERIC Educational Resources Information Center

Anderson, D. Mark; Walker, Mary Beth

2015-01-01

School districts use a variety of policies to close budget gaps and stave off teacher layoffs and furloughs. More schools are implementing four-day school weeks to reduce overhead and transportation costs. The four-day week requires substantial schedule changes as schools must increase the length of their school day to meet minimum instructional…

47 CFR 73.1740 - Minimum operating schedule.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., local time, each day of the week except Sunday. (i) Class D stations which have been authorized... any 5 broadcast days per calendar week and not less than a total of: (A) 12 hours per week during the... months of operation, not less than 2 hours in each day of the week and not less than a total of 28 hours...

47 CFR 73.1740 - Minimum operating schedule.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., local time, each day of the week except Sunday. (i) Class D stations which have been authorized... any 5 broadcast days per calendar week and not less than a total of: (A) 12 hours per week during the... months of operation, not less than 2 hours in each day of the week and not less than a total of 28 hours...

The Four-Day School Week: Impact on Student Academic Performance

ERIC Educational Resources Information Center

Hewitt, Paul M.; Denny, George S.

2011-01-01

Although the four-day school week originated in 1936, it was not widely implemented until 1973 when there was a need to conserve energy and reduce operating costs. This study investigated how achievement tests scores of schools with a four-day school week compared with schools with a traditional five-day school week. The study focused on student…

Multi-Cultural Competency-Based Vocational Curricula. Maintenance Mechanics. Multi-Cultural Competency-Based Vocational/Technical Curricula Series.

ERIC Educational Resources Information Center

Hepburn, Larry; Shin, Masako

This document, one of eight in a multi-cultural competency-based vocational/technical curricula series, is on maintenance mechanics. This program is designed to run 40 weeks and cover 5 instructional areas: basic electricity (14 weeks); maintenance and repair of heating (4 weeks); maintenance and repair of air conditioning (12 weeks); maintenance…

78 FR 27032 - National Maritime Week Tugboat Races, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... Maritime Week Tugboat Races, Seattle, WA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of... Maritime Week Tugboat Races in Elliott Bay, WA from 12 p.m. until 4:30 p.m. on May 11, 2013. This action is... for the annual National Maritime Week Tugboat Races, Seattle, WA listed in 33 CFR 100.1306 on May 11...

Teaching Module for Expanding Occupational Awareness of Preschool, Second, and Fourth Grade Children.

ERIC Educational Resources Information Center

Marotz-Baden, Ramona; Riley, Pamela

These three modular units for preschool children (eight-week unit), grade 2 (nine-week unit), and grade 4 (six-week unit) were developed to facilitate career education by reducing sex-role stereotyping of occupations. (Final progress report of the project is available as CE 024 425.) Within each unit an outline for each week's activities details…

Request for a Copy of the Decision in "Weeks v. The United States"

ERIC Educational Resources Information Center

Jones, Megan

2011-01-01

On December 21, 1911, Fremont Weeks, an employee of the Adams Express Company, was arrested while on the job at Union Station in Kansas City, Missouri. Police suspected that Weeks was selling and "transmitting chances" in a lottery, which at the time was considered gambling, an illegal action in Missouri. While Weeks was being held at…

Coral Bleaching Products - Office of Satellite and Product Operations

Science.gov Websites

weeks. One DHW is equivalent to one week of sea surface temperatures one degree Celsius greater than the expected summertime maximum. Two DHWs are equivalent to two weeks at one degree above the expected summertime maximum OR one week of two degrees above the expected summertime maximum. Also called Coral Reef

The Sky This Week, 2016 March 8 - 15 - Naval Oceanography Portal

Science.gov Websites

section Advanced Search... Sections Home Time Earth Orientation Astronomy Meteorology Oceanography Ice You This Week, 2016 March 8 - 15 Info The Sky This Week, 2016 March 8 - 15 Springing forward in time week, waxing to First Quarter on the 15th at 1:03 pm Eastern Daylight Time. She joins the stars of the

An Experimental Study of Scheduling and Duration of "Tier 2" First-Grade Reading Intervention

ERIC Educational Resources Information Center

Denton, Carolyn A.; Cirino, Paul T.; Barth, Amy E.; Romain, Melissa; Vaughn, Sharon; Wexler, Jade; Francis, David J.; Fletcher, Jack M.

2011-01-01

This study compared the effects on reading outcomes of delivering supplemental, small-group intervention to first-grade students at risk for reading difficulties randomly assigned to one of three different treatment schedules: extended (4 sessions per week, 16 weeks; n = 66), concentrated (4 sessions per week, 8 weeks; n = 64), or distributed (2…

3 CFR 8521 - Proclamation 8521 of May 14, 2010. World Trade Week, 2010

Code of Federal Regulations, 2011 CFR

2011-01-01

... 3 The President 1 2011-01-01 2011-01-01 false Proclamation 8521 of May 14, 2010. World Trade Week.... 8521 World Trade Week, 2010By the President of the United States of America A Proclamation For our... prosperity and which support millions of American jobs. World Trade Week is an opportunity for us to reaffirm...

Using Baidu Search Index to Predict Dengue Outbreak in China

NASA Astrophysics Data System (ADS)

Liu, Kangkang; Wang, Tao; Yang, Zhicong; Huang, Xiaodong; Milinovich, Gabriel J.; Lu, Yi; Jing, Qinlong; Xia, Yao; Zhao, Zhengyang; Yang, Yang; Tong, Shilu; Hu, Wenbiao; Lu, Jiahai

2016-12-01

This study identified the possible threshold to predict dengue fever (DF) outbreaks using Baidu Search Index (BSI). Time-series classification and regression tree models based on BSI were used to develop a predictive model for DF outbreak in Guangzhou and Zhongshan, China. In the regression tree models, the mean autochthonous DF incidence rate increased approximately 30-fold in Guangzhou when the weekly BSI for DF at the lagged moving average of 1-3 weeks was more than 382. When the weekly BSI for DF at the lagged moving average of 1-5 weeks was more than 91.8, there was approximately 9-fold increase of the mean autochthonous DF incidence rate in Zhongshan. In the classification tree models, the results showed that when the weekly BSI for DF at the lagged moving average of 1-3 weeks was more than 99.3, there was 89.28% chance of DF outbreak in Guangzhou, while, in Zhongshan, when the weekly BSI for DF at the lagged moving average of 1-5 weeks was more than 68.1, the chance of DF outbreak rose up to 100%. The study indicated that less cost internet-based surveillance systems can be the valuable complement to traditional DF surveillance in China.

Diet, physical exercise and Orlistat administration increase serum anti-Müllerian hormone (AMH) levels in women with polycystic ovary syndrome (PCOS).

PubMed

Vosnakis, Christos; Georgopoulos, Neoklis A; Rousso, David; Mavromatidis, Georgios; Katsikis, Ilias; Roupas, Nikolaos D; Mamali, Irene; Panidis, Dimitrios

2013-03-01

The present study investigates the combined effect of diet, physical exercise and Orlistat for 24 weeks, on serum anti-Müllerian hormone (AMH) levels in overweight and obese women with polycystic ovary syndrome (PCOS) and in overweight and obese controls. Sixty-one (61) selected women with PCOS and 20 overweight and obese controls followed an energy-restricted diet, physical exercise plus Orlistat administration (120 mg, 3 times per day) for 24 weeks. At baseline, week 12 and week 24, serum levels of AMH, FSH, LH, PRL, androgens, sex hormone-binding globulin (SHBG), glucose, and insulin were measured and Free Androgen Index (FAI) and Insulin Resistance (IR) indices were calculated. In PCOS women, serum AMH levels increased after 12 and 24 weeks of treatment. After 12 weeks LH and SHBG were increased, while Testosterone decreased. After 12 and 24 weeks, FAI was decreased and all indices of IR were significantly improved. We concluded that in overweight and obese women with PCOS Orlistat administration, combined with diet and physical exercise, for 24 weeks, resulted in significant weight loss, improvement of hyperandrogenism and insulin sensitivity, and increased serum AMH levels.

Bioelectrical activity of the pelvic floor muscles after 6-week biofeedback training in nulliparous continent women.

PubMed

Chmielewska, Daria; Stania, Magdalena; Smykla, Agnieszka; Kwaśna, Krystyna; Błaszczak, Edward; Sobota, Grzegorz; Skrzypulec-Plinta, Violetta

2016-01-01

The aim of the study was to evaluate the effects of a 6-week sEMG-biofeedback-assisted pelvic floor muscle training program on pelvic floor muscle activity in young continent women. Pelvic floor muscle activity was recorded using a vaginal probe during five experimental trials. Biofeedback training was continued for 6 weeks, 3 times a week. Muscle strenghtening and endurance exercises were performed alternately. SEMG (surface electromyography) measurements were recorded on four different occasions: before training started, after the third week of training, after the sixth week of training, and one month after training ended. A 6-week sEMG-biofeedback-assisted pelvic floor muscle training program significantly decreased the resting activity of the pelvic floor muscles in supine lying and standing. The ability to relax the pelvic floor muscles after a sustained 60-second contraction improved significantly after the 6-week training in both positions. SEMG-biofeedback training program did not seem to affect the activity of the pelvic floor muscles or muscle fatigue during voluntary pelvic floor muscle contractions. SEMG-biofeedback-assisted pelvic floor muscle training might be recommended for physiotherapists to improve the effectiveness of their relaxation techniques.

Maternal and perinatal outcomes during expectant management of 239 severe preeclamptic women between 24 and 33 weeks' gestation.

PubMed

Haddad, Bassam; Deis, Stéphanie; Goffinet, François; Paniel, Bernard J; Cabrol, Dominique; Siba, Baha M

2004-06-01

This study was undertaken to determine maternal and perinatal outcomes after expectant management of severe preeclampsia between 24 and 33 weeks' gestation. A prospective observational study of 239 women with severe preeclamptic and undelivered after antenatal steroid prophylaxis was performed. Pregnancy prolongation and maternal and perinatal morbidities were analyzed according to the gestational age at time of expectant management: 24 to 28, 29 to 31, and 32 to 33 weeks. Statistical analysis was performed by Student t test and chi(2) test. The days of pregnancy prolongation were significantly higher among those managed at less than 29 weeks (6) compared with the other groups (4). There were 13 perinatal deaths: 12 in those managed at less than 29 weeks and 1 in those managed at 29 to 31 weeks. Neonatal morbidities were significantly higher among those managed at less than 29 weeks compared with the other groups. There were no instances of maternal death or eclampsia. Maternal morbidities were similar among the groups. Expectant management of severe preeclampsia at 24 to 33 weeks in a tertiary care center is associated with good perinatal outcome with a minimal risk for the mother.

Differential effect of testosterone on pigmented spot, sebaceous glands and hair follicles in the Syrian hamster flank organ.

PubMed

Wuest, P A; Lucky, A W

1989-01-01

The androgen-dependent flank organ of the Golden Syrian hamster has been used as a model for acne and hair growth. 1-cm silastic capsules of testosterone (T) were implanted subcutaneously into female hamsters. Serum levels of T remained relatively constant after 1 week. Maximum growth of the pigmented spot occurred at 4 weeks but regressed by 6 weeks. In contrast, the growth of the pilosebaceous unit continued for 6 weeks. Total sebaceous area and number of sebaceous lobules increased by 3 weeks with a further increase in total area by 6 weeks. The distribution of lobule size shifted to more large lobules. Diameters of hair follicles increased at 3 and 6 weeks with a concomitant recruitment to large follicles. The density of hairs remained constant. The diminution in size of the pigmented spot between 4 and 6 weeks of T stimulation was not related to a reduction in serum T. In fact, there was persistent growth of the sebaceous glands and hair follicles at this time. The measurement of the pigmented spot of the flank organ is not a reliable indicator of the androgen responsiveness of sebaceous glands and/or hair follicles.

A comparison of the currency of secondary information sources in the biochemical literature. II. MEDLINE online and on CD-ROM.

PubMed

Grainger, F; Lyon, E

1992-12-01

The currency of selected versions of the MEDLINE database on CD-ROM and in online format was studied. The arrival of issues from 72 monthly journals and nine weekly titles during a 3-month period was monitored and their appearance in the various MEDLINE formats were recorded. Availability data for MEDLINE published by the National Library of Medicine were used as a baseline and subsequent distribution delays for the different MEDLINE formats were calculated. The study suggests a delay of approximately 2 weeks for indexing and mounting the MEDLINE file on to host computers for online access. A delay of 6-8 weeks was calculated for the MEDLINE data to be encoded on to compact disk, shipped and posted to the library customer. The currency of the MEDLINE database formats was compared with a weekly current-awareness service, CURRENT CONTENTS ON DISKETTE LIFE SCIENCES (CCOD). The majority of papers were indexed and distributed in CCOD within 10 weeks of publication date. Most papers appeared within 15 weeks in the online MEDLINE format and within 20 weeks in CD-ROM MEDLINE. The primary journal arrived at the library site within 5 weeks in most cases.

Adaptation to a long term (4 weeks) arginine- and precursor (glutamate, proline and aspartate)-free diet.

PubMed

Tharakan, John F; Yu, Yong M; Zurakowski, David; Roth, Rachel M; Young, Vernon R; Castillo, Leticia

2008-08-01

It is not known whether arginine homeostasis is negatively affected by a "long term" dietary restriction of arginine and its major precursors in healthy adults. To assess the effects of a 4-week arginine- and precursor-free dietary intake on the regulatory mechanisms of arginine homeostasis in healthy subjects. Ten healthy adults received a complete amino acid diet for 1 week (control diet) and following a break period, six subjects received a 4-week arginine, proline, glutamate and aspartate-free diet (APF diet). The other four subjects continued for 4 weeks with the complete diet. On days 4 and 7 of the first week and days 25 and 28 of the 4-week period, the subjects received 24-h infusions of arginine, citrulline, leucine and urea tracers. During the 4-week APF, plasma arginine fluxes for the fed state, were significantly reduced. There were no significant differences for citrulline, leucine or urea fluxes. Arginine de novo synthesis was not affected by the APF intake. However, arginine oxidation was significantly decreased. In healthy adults, homeostasis of arginine under a long term arginine- and precursor-free intake is achieved by decreasing catabolic rates, while de novo arginine synthesis is maintained.

Promoting participation in physical activity using framed messages: an application of prospect theory.

PubMed

Latimer, Amy E; Rench, Tara A; Rivers, Susan E; Katulak, Nicole A; Materese, Stephanie A; Cadmus, Lisa; Hicks, Althea; Keany Hodorowski, Julie; Salovey, Peter

2008-11-01

Messages designed to motivate participation in physical activity usually emphasize the benefits of physical activity (gain-framed) as well as the costs of inactivity (loss-framed). The framing implications of prospect theory suggest that the effectiveness of these messages could be enhanced by providing gain-framed information only. We compared the effectiveness of gain-, loss-, and mixed-framed messages for promoting moderate to vigorous physical activity. Randomized trial. Sedentary, healthy callers to the US National Cancer Institute's Cancer Information Service (N=322) received gain-, loss-, or mixed-framed messages on three occasions (baseline, Week 1, and Week 5). Social cognitive variables and self-reported physical activity were assessed at baseline, Week 2, and Week 9. Separate regression analyses were conducted to examine message effects at each assessment point. At Week 2, gain- and mixed-framed messages resulted in stronger intentions and greater self-efficacy than loss-framed messages. At Week 9, gain-framed messages resulted in greater physical activity participation than loss- or mixed-framed messages. Social cognitive variables at Week 2 did not mediate the Week 9 framing effects on physical activity participation. Using gain-framed messages exclusively may be a means of increasing the efficacy of physical activity materials.

Variation with age in the numbers of ovulated ova and follicles of Wistar-Imamichi adult rats superovulated with eCG-hCG.

PubMed

Kagabu, Satosi; Umezu, Motoaki

2006-01-01

There are large variations with age in the number of ovulated ova found in superovulated female Wistar-Imamichi rats. In this study we investigated the numbers of ovulated ova and follicles with the aim of developing a superovulation technique that minimises variations. We also examined the number of non-atretic follicles in untreated rats aged 7-14 weeks, for each week of age. The numbers of 250-549 microm non-atretic follicles in untreated rats and the numbers of ovulated ova in superovulated rats both reached a peak at 12 weeks of age. The coefficients of variation for both follicle numbers and ova numbers changed with each week of age, reaching a maximum at 9 weeks of age and a minimum at 12 weeks of age. In order to achieve stable numbers of ova from superovulated rats, satisfactory results will be achieved using 12-week-old rats, minimising individual variations, with high numbers of ova.

Prevention of disuse osteoporosis: Effect of sodium fluoride during five weeks of bed rest

NASA Technical Reports Server (NTRS)

Schneider, Victor S.

1987-01-01

An attempt was made to modify factors which promote disuse osteoporosis and thereby prevent it from occurring. Since fluoride is currently used to enhance bone formation in the treatment of low turnover osteoporosis, it was hypothesized that if the fluoride ion was available over a long period of time that it would slow the demonstrated loss of calcium by inhibiting bone resorption and enhancing bone formation. This study was used to determine whether oral medication with sodium F will modify or prevent 5 weeks of bed rest induced disuse osteoporosis, to determine the longitudinal effects of 5 weeks of bed rest on PTH, CT and calcitriol, to measure muscle volume changes and metabolic activity by magnetic resonance imaging and magnetic resonance spectroscopy during prolonged bed rest, to measure changes in peak muscle strength and fatigability, and to measure bone turnover in bone biopsies. Subjects were studied during 1 week of equilibration, 4 weeks of control ambulation, 5 weeks of bed rest, and 1 week of reambulation.

Foot pad dermatitis develops at an early age in commercial turkeys.

PubMed

Mayne, R K; Hocking, P M; Else, R W

2006-02-01

1. A field experiment was conducted to identify the macroscopic and histological changes associated with the development of foot pad dermatitis (FPD) in growing turkeys. Two affected and two unaffected turkeys were sampled weekly from 1 to 8 and at 10 and 21 weeks of age. 2. At one week old, birds with external signs of FPD (surface skin discolouration) showed abnormal cellular changes of the foot pad integument. As the flock aged the reactions intensified, with one sample exhibiting a fully developed macroscopic lesion at 3 weeks. 3. Major pathological changes had occurred by 6 weeks and all turkeys with external signs of lesions had fully developed microscopic inflammatory cellular lesions. From 6 weeks of age onwards lesions were increasingly numerous and became more overtly necrotic. 4. Externally normal foot pads showed microscopic evidence of lesions after the turkeys reached 4 weeks. 5. We conclude that FPD lesions become severe over a short period of time and at a very early age.

World Space Week: Linking Space and Humanity

NASA Astrophysics Data System (ADS)

Stone, D.

2002-01-01

World Space Week, October 4-10 annually, is an international celebration of the contribution that space science and technology makes to the betterment of the human condition. Since its official declaration in 1999 by the United Nation, World Space Week has rapidly grown to include over 40 nations. The dates of World Space Week commemorate key milestones in space. October 4, 1957 was the launch date of Sputnik I, the first artificial Earth satellite. The Outer Space Treaty took effect on October 10, 1967. During World Space Week, participants such as government agencies, companies, science museums, teachers, and individuals organize public events, school activities, and Web-based programs related to space. So many synchronized events attract media coverage which reaches a global audience about space. In this way, World Space Week truly links space and humanity. The global organization of World Space Week is discussed as well as the results to date. The benefits of participation and opportunities to do so also identified.

Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.

PubMed

Deodhar, Atul; Gottlieb, Alice B; Boehncke, Wolf-Henning; Dong, Bin; Wang, Yuhua; Zhuang, Yanli; Barchuk, William; Xu, Xie L; Hsia, Elizabeth C

2018-06-02

Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis. We did a randomised, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumour necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database lock at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (ie, all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received. This study is registered with ClinicalTrials.gov, number NCT02319759. Between March 27, 2015, and Jan 17, 2017, we randomly assigned 149 patients to treatment: 100 to guselkumab and 49 to placebo. 17 (35%) of 49 patients in the placebo group and ten (10%) of 100 patients in the guselkumab group were eligible for early escape to ustekinumab at week 16. 29 (59%) of 49 patients in the placebo group crossed over and received guselkumab at week 24. Three (6%) of 49 patients in the placebo group, one (3%) of 29 patients who crossed over from placebo to guselkumab, and six (6%) of 100 patients in the guselkumab group discontinued study treatment before week 44. 58 (58%) of 100 patients in the guselkumab group and nine (18%) of 49 patients in the placebo group achieved an ACR20 response at week 24 (percentage difference 39·7% [95% CI 25·3-54·1]; p<0·0001). Between week 0 and week 24, 36 (36%) of 100 guselkumab-treated patients and 16 (33%) of 49 placebo-treated patients had at least one adverse event. The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group). The prevalence of adverse events between week 0 and week 56 in guselkumab-treated patients (51 [40%] of 129) indicated no disproportional increase with longer guselkumab exposure. No deaths occurred. Guselkumab, a novel anti-interleukin 23p19 antibody, significantly improved signs and symptoms of active psoriatic arthritis and was well tolerated during 44 weeks of treatment. The results of this study support further development of guselkumab as a novel and comprehensive treatment in psoriatic arthritis. Janssen Research & Development. Copyright © 2018 Elsevier Ltd. All rights reserved.

Self-Esteem Depends on the Beholder: Effects of a Subtle Social Value Cue

PubMed Central

Weisbuch, Max; Sinclair, Stacey A.; Skorinko, Jeanine L.; Eccleston, Collette P.

2009-01-01

The idea that self-esteem functions as a gauge or “sociometer” of social value (Leary & Baumeister, 2000) is supported by research on direct social feedback. To examine if the sociometer model is relevant to more subtle social value cues, the implicit self-esteem of women was assessed a week after an interaction with an experimenter. Consistent with the sociometer model, Week 2 self-esteem depended on a subtle social value cue encountered during Week 1. When the Week 1 experimenter wore a t-shirt celebrating larger bodies (i.e., “everyBODY is beautiful”), heavier women had higher self-esteem than lighter women in Week 2. As hypothesized, this effect was relationship-specific, occurring only when the same experimenter administered Week 1 and 2 sessions. PMID:20047001

Effect of Time Lenght Fermentation to Katsuobushi Oxidation Rate As Fish Flavor Based

NASA Astrophysics Data System (ADS)

Amalia, U.; Rianingsih, L.; Wijayanti, I.

2018-02-01

Katsuobushi or dried smoked skipjack had a distinctive flavor and widely used in traditional Japanese cuisine. This study aimed to evaluate the oxidation rate of Katsuobushi with different lenght fermentation. The processing treatment of the product were the differences of fish boiling time (30 min and 60 min) and the lenght of fermentation: 1 week, 2 weeks and 3 weeks. The glutamic acid content, the oxidation rate (thiobarbituric acid and peroxide value) and Total Plate Count of katsuobushi were analyzed statistically using analysis of varians. Significant differences were found among 3 weeks of fermentation compare to 1 weeks fermentation (P < 0.05). The conclusion of this study was katsuobushi with 60 min boiling and 3 weeks fermentation was potential to be developed become basic ingredients for the fish flavor.

Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Mood Disorder.

PubMed

Correll, Christoph U; Josiassen, Richard C; Liang, Grace S; Burke, Joshua; O'Brien, Christopher F

2017-08-01

Valbenazine (VBZ, NBI-98854) is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD). The KINECT 3 study (NCT02274558) evaluated the effects of VBZ on TD in subjects with mood disorder or schizophrenia/schizoaffective disorder (SCHZ, presented separately) who received up to 48 weeks of treatment. KINECT 3 included: 6-week, double-blind, placebo (PBO)-controlled (DBPC) period (205 completers); 42-week VBZ extension (VE) period (124 completers); 4-week washout period (121 completers). Subjects entering the DBPC were randomized 1:1:1 to once-daily VBZ 80 mg, VBZ 40 mg, or PBO; stable concomitant antipsychotic medication regimens were allowed. Subjects completing the DBPC and entering the VE period were re-randomized (blinded) from PBO to VBZ (80 or 40 mg) or continued VBZ treatment at the same dose. Efficacy assessments included: mean changes from baseline in Abnormal Involuntary Movement Scale (AIMS) total score (items 1-7); mean Clinical Global Impression of Change (CGI-TD) scores; AIMS responders (subjects with ≥50% score reduction from baseline); and CGI-TD responders (subjects with score ≤2 ["much improved" or "very much improved"]). Treatment effect sizes (Cohen's d) and numbers needed to treat (NNTs) were analyzed for DBPC outcomes. Efficacy analyses were conducted in 77 subjects (DBPC) and 73 subjects (VE) with a mood disorder. At Week 6 (end of DBPC), AIMS mean score improvements were greater in the VBZ groups (in a dose-related pattern) than in the PBO group (80 mg, -3.6, d = 0.94; 40 mg, -2.4, d = 0.55; PBO, -0.7). AIMS mean score changes at Week 48 (end of VE) showed continued TD improvement during long-term VBZ treatment (80 mg, -5.8; 40 mg, -4.2). By Week 52 (end of washout), AIMS mean scores in both dose groups were returning toward baseline levels, indicating re-emergence of TD. CGI-TD scores showed a similar pattern: Week 6 (80 mg, 2.7, d = 0.64; 40 mg, 2.9, d = 0.39; PBO, 3.2), Week 48 (80 mg, 2.0; 40 mg, 2.2), Week 52 (80 mg, 3.6; 40 mg, 2.8). AIMS responder rates (≥50% score reduction) were greater with VBZ vs PBO at Week 6 (80 mg, 38.5%, NNT = 4; 40 mg, 19.0%, NNT = 9; PBO, 7.7%), were increased at Week 48 (80 mg, 56.0%; 40 mg, 33.3%), and lower after VBZ washout (Week 52 80 mg, 16.7%; 40 mg, 27.8%). CGI-TD responder rates followed a similar pattern: Week 6 (80 mg, 34.6%, NNT = 6; 40 mg, 28.6%, NNT = 8; PBO, 15.4%), Week 48 (80 mg, 80.0%; 40 mg, 61.1%), Week 52 (80 mg, 25.0%; 40 mg, 44.4%). Sustained TD improvements were found in subjects with a mood disorder who received up to 48 weeks of VBZ, with TD reverting toward baseline severity when assessed 4 weeks after treatment withdrawal. Together with results from SCHZ subjects and the long-term safety profile (presented separately), these results indicate that long-term VBZ can be beneficial for managing TD regardless of psychiatric diagnosis.

Efficacy of Valbenazine (NBI-98854) in Treating Subjects with Tardive Dyskinesia and Mood Disorder

PubMed Central

Correll, Christoph U.; Josiassen, Richard C.; Liang, Grace S.; Burke, Joshua; O’Brien, Christopher F.

2017-01-01

Background Valbenazine (VBZ, NBI-98854) is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia (TD). The KINECT 3 study (NCT02274558) evaluated the effects of VBZ on TD in subjects with mood disorder or schizophrenia/schizoaffective disorder (SCHZ, presented separately) who received up to 48 weeks of treatment. Methods KINECT 3 included: 6-week, double-blind, placebo (PBO)-controlled (DBPC) period (205 completers); 42-week VBZ extension (VE) period (124 completers); 4-week washout period (121 completers). Subjects entering the DBPC were randomized 1:1:1 to once-daily VBZ 80 mg, VBZ 40 mg, or PBO; stable concomitant antipsychotic medication regimens were allowed. Subjects completing the DBPC and entering the VE period were re-randomized (blinded) from PBO to VBZ (80 or 40 mg) or continued VBZ treatment at the same dose. Efficacy assessments included: mean changes from baseline in Abnormal Involuntary Movement Scale (AIMS) total score (items 1–7); mean Clinical Global Impression of Change (CGI-TD) scores; AIMS responders (subjects with ≥50% score reduction from baseline); and CGI-TD responders (subjects with score ≤2 [“much improved” or “very much improved”]). Treatment effect sizes (Cohen’s d) and numbers needed to treat (NNTs) were analyzed for DBPC outcomes. Results Efficacy analyses were conducted in 77 subjects (DBPC) and 73 subjects (VE) with a mood disorder. At Week 6 (end of DBPC), AIMS mean score improvements were greater in the VBZ groups (in a dose-related pattern) than in the PBO group (80 mg, -3.6, d = 0.94; 40 mg, -2.4, d = 0.55; PBO, -0.7). AIMS mean score changes at Week 48 (end of VE) showed continued TD improvement during long-term VBZ treatment (80 mg, -5.8; 40 mg, -4.2). By Week 52 (end of washout), AIMS mean scores in both dose groups were returning toward baseline levels, indicating re-emergence of TD. CGI-TD scores showed a similar pattern: Week 6 (80 mg, 2.7, d = 0.64; 40 mg, 2.9, d = 0.39; PBO, 3.2), Week 48 (80 mg, 2.0; 40 mg, 2.2), Week 52 (80 mg, 3.6; 40 mg, 2.8). AIMS responder rates (≥50% score reduction) were greater with VBZ vs PBO at Week 6 (80 mg, 38.5%, NNT = 4; 40 mg, 19.0%, NNT = 9; PBO, 7.7%), were increased at Week 48 (80 mg, 56.0%; 40 mg, 33.3%), and lower after VBZ washout (Week 52 80 mg, 16.7%; 40 mg, 27.8%). CGI-TD responder rates followed a similar pattern: Week 6 (80 mg, 34.6%, NNT = 6; 40 mg, 28.6%, NNT = 8; PBO, 15.4%), Week 48 (80 mg, 80.0%; 40 mg, 61.1%), Week 52 (80 mg, 25.0%; 40 mg, 44.4%). Conclusion Sustained TD improvements were found in subjects with a mood disorder who received up to 48 weeks of VBZ, with TD reverting toward baseline severity when assessed 4 weeks after treatment withdrawal. Together with results from SCHZ subjects and the long-term safety profile (presented separately), these results indicate that long-term VBZ can be beneficial for managing TD regardless of psychiatric diagnosis. PMID:28839340

Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial.

PubMed

Wu, Jiani; Liu, Baoyan; Li, Ning; Sun, Jianhua; Wang, Lingling; Wang, Liping; Cai, Yuying; Ye, Yongming; Liu, Jun; Wang, Yang; Liu, Zhishun

2014-12-01

Aupuncture is widely used for functional constipation. Effect of acupuncture might be related to the depth of needling; however, the evidence is limited. This trial aimed to evaluate the effect and safety of deep needling and shallow needling for functional constipation, and to assess if the deep needling and shallow needling are superior to lactulose. We conducted a prospective, superiority-design, 5-center, 3-arm randomized controlled trial. A total of 475 patients with functional constipation were randomized to the deep needling group (237), shallow needling group (119), and lactulose-controlled group (119) in a ratio of 2:1:1. Sessions lasted 30 minutes each time and took place 5 times a week for 4 weeks in 2 acupuncture groups. Participants in the lactulose group took lactulose orally for 16 continuous weeks. The primary outcome was the change from baseline of mean weekly spontaneous bowel movements (SBMs) during week 1 to 4 (changes from the baselines of the weekly SBMs at week 8 and week 16 in follow-up period were also assessed simultaneously). Secondary outcomes were the weekly SBMs of each assessing week, the mean score change from the baseline of constipation-related symptoms over week 1 to 4, and the time to the first SBM. Emergency drug usage and adverse effects were monitored throughout the study.SBMs and constipation-related symptoms were all improved in the 3 groups compared with baseline at each time frame (P<0.01, all). The changes in the mean weekly SBMs over week 1 to 4 were 2 (1.75) in the deep needling group, 2 (1.75) in the shallow needling group, and 2 (2) in the lactulose group (P>0.05, both compared with the lactulose group). The changes of mean weekly SBMs at week 8 and week 16 in the follow-up period were 2 (2), 2 (2.5) in the deep needling group, 2 (3), 1.5 (2.5) in the shallow needling group, and 1 (2), 1 (2) in the lactulose group (P<0.05, all compared with the lactulose group). No significant difference was observed among the 3 groups regarding the score changes of straining, incomplete evacuation, abdominal distention during spontaneous defecating, or Cleveland Clinic Scores over week 1 to 4. However, the lactulose group got better effect than other 2 acupuncture groups in improving stool consistency (P<0.01, both) and shortening the time to the first SBM (P<0.05, both). The percentage of emergency drugs used in the 2 acupuncture groups were both lower than in the lactulose group at each time frame (P<0.01, all). No obvious adverse event was observed in the deep or shallow needling group. Deep and shallow needling at Tianshu (ST25) can improve intestinal function remarkably and safely. Therapeutic effects of deep and shallow needling are not superior to that of lactulose; however, the sustained effects of deep and shallow needling after stopping the acupuncture treatments are superior to the therapeutic effect of lactulose, which might qualify the superiority of deep and shallow needling.

Radiofrequency tissue ablation of the inferior turbinates using a thermocouple feedback electrode.

PubMed

Smith, T L; Correa, A J; Kuo, T; Reinisch, L

1999-11-01

The objective of this clinical trial was to assess the safety and efficacy of radiofrequency (RF) tissue ablation of the inferior turbinates in the treatment of nasal obstruction using an RF energy delivery system with a thermocouple feedback electrode. A prospective, nonrandomized study of 11 patients (mean age, 47+/-12 y) with chronic nasal obstruction was conducted. Using patient-based visual analogue scales (VAS), symptom parameters were assessed. These included degree of nasal obstruction, frequency of nasal obstruction, and pain. Physician assessment of nasal obstruction was also collected by the principal investigator. Follow-up was conducted at 24 hours, 1 week, 4 weeks, 8 weeks, and 1 year. ANOVA was carried out to determine statistically significant differences in the data. Data were fit to a regression model, and confidence intervals were determined from a 95% confidence level. In patient-assessed degree of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.001, P<.0001, and P<.0008, respectively). There was no difference between 8 weeks and 1 year (P<.15). The data appeared to follow an exponential decay to a constant value. The pretreatment baseline average degree of obstruction was 7.5+/-0.5 on a scale of 0 to 10. The degree of obstruction after 8 weeks was 2.7+/-0.6. The time constant for this change was 21 days to reach 90% of the final value. At 1 year, degree of obstruction was 3.3+/-0.7. For frequency of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.0001, P<.0001, and P<.0001, respectively). There was no difference between 8 weeks and 1 year (P<.15). The pretreatment baseline average frequency of obstruction was 7.8+/-0.5. The remaining frequency of obstruction after 8 weeks was 2.9+/-0.6. The time constant was 18 days. At 1 year, frequency of obstruction was 3.3+/-0.6. Physician assessment of nasal obstruction revealed statistical significance among baseline and 4 weeks, and baseline and 8 weeks (P<.0055 and P<.0056, respectively). There was no difference between 4 weeks and 8 weeks (P<.24). The average initial obstruction was 83%+/-4%. The remaining obstruction after 8 weeks was 58% +/-5%. The time constant was 14 days. Mild pain was reported by 55% of patients during the procedure; the remaining 45% reported no pain. Only one patient required pain medication consisting of acetaminophen after the procedure. There were no significant complications. Degree and frequency of nasal obstruction, as reported by patients, decreased following RF tissue ablation of the inferior turbinates. This improvement in symptoms was still evident after 1 year (P<.001). Physician assessment of obstruction also correlated with patient reports for the initial 8-week study period. The procedure was safe and well tolerated. Thermocouples within the active electrode provided additional feedback to the operating surgeon allowing the use of relatively lower tissue temperatures, power, and energy as compared with traditional techniques. These results support the need for continued research to evaluate this modality as a treatment for chronic nasal obstruction.

Effect and Safety of Deep Needling and Shallow Needling for Functional Constipation

PubMed Central

Wu, Jiani; Liu, Baoyan; Li, Ning; Sun, Jianhua; Wang, Lingling; Wang, Liping; Cai, Yuying; Ye, Yongming; Liu, Jun; Wang, Yang; Liu, Zhishun

2014-01-01

Abstract Aupuncture is widely used for functional constipation. Effect of acupuncture might be related to the depth of needling; however, the evidence is limited. This trial aimed to evaluate the effect and safety of deep needling and shallow needling for functional constipation, and to assess if the deep needling and shallow needling are superior to lactulose. We conducted a prospective, superiority-design, 5-center, 3-arm randomized controlled trial. A total of 475 patients with functional constipation were randomized to the deep needling group (237), shallow needling group (119), and lactulose-controlled group (119) in a ratio of 2:1:1. Sessions lasted 30 minutes each time and took place 5 times a week for 4 weeks in 2 acupuncture groups. Participants in the lactulose group took lactulose orally for 16 continuous weeks. The primary outcome was the change from baseline of mean weekly spontaneous bowel movements (SBMs) during week 1 to 4 (changes from the baselines of the weekly SBMs at week 8 and week 16 in follow-up period were also assessed simultaneously). Secondary outcomes were the weekly SBMs of each assessing week, the mean score change from the baseline of constipation-related symptoms over week 1 to 4, and the time to the first SBM. Emergency drug usage and adverse effects were monitored throughout the study. SBMs and constipation-related symptoms were all improved in the 3 groups compared with baseline at each time frame (P < 0.01, all). The changes in the mean weekly SBMs over week 1 to 4 were 2 (1.75) in the deep needling group, 2 (1.75) in the shallow needling group, and 2 (2) in the lactulose group (P > 0.05, both compared with the lactulose group). The changes of mean weekly SBMs at week 8 and week 16 in the follow-up period were 2 (2), 2 (2.5) in the deep needling group, 2 (3), 1.5 (2.5) in the shallow needling group, and 1 (2), 1 (2) in the lactulose group (P < 0.05, all compared with the lactulose group). No significant difference was observed among the 3 groups regarding the score changes of straining, incomplete evacuation, abdominal distention during spontaneous defecating, or Cleveland Clinic Scores over week 1 to 4. However, the lactulose group got better effect than other 2 acupuncture groups in improving stool consistency (P < 0.01, both) and shortening the time to the first SBM (P < 0.05, both). The percentage of emergency drugs used in the 2 acupuncture groups were both lower than in the lactulose group at each time frame (P < 0.01, all). No obvious adverse event was observed in the deep or shallow needling group. Deep and shallow needling at Tianshu (ST25) can improve intestinal function remarkably and safely. Therapeutic effects of deep and shallow needling are not superior to that of lactulose; however, the sustained effects of deep and shallow needling after stopping the acupuncture treatments are superior to the therapeutic effect of lactulose, which might qualify the superiority of deep and shallow needling. PMID:25526462

Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

PubMed

Bennell, Kim L; Egerton, Thorlene; Martin, Joel; Abbott, J Haxby; Metcalf, Ben; McManus, Fiona; Sims, Kevin; Pua, Yong-Hao; Wrigley, Tim V; Forbes, Andrew; Smith, Catherine; Harris, Anthony; Buchbinder, Rachelle

2014-05-21

There is limited evidence supporting use of physical therapy for hip osteoarthritis. To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score for the active group was 32.3 (9.2) and the week-13 score was 27.5 (12.9) units, whereas the baseline score for the sham treatment group was 32.4 (8.4) units and the week-13 score was 26.4 (11.3) units, for a mean difference of 1.4 units favoring sham (95% CI, -3.8 to 6.5) at week 13. There were no between-group differences in secondary outcomes (except greater week-13 improvement in the balance step test in the active group). Nineteen of 46 patients (41%) in the active group reported 26 mild adverse effects and 7 of 49 (14%) in the sham group reported 9 mild adverse events (P = .003). Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients. anzctr.org.au Identifier: ACTRN12610000439044.

A Review of AA Psych Corps Involvement in the Allocation of Soldiers to corps and Employment. Executive Summary

DTIC Science & Technology

1990-11-01

Compiled I Lecture Additional Iation/ _____ Testing L J week 2 week 3- 4 week 5 wee 6 week 8 -9 week 10 wee: Allocation Guide: Shows suitability -:r - n cl...the Document box only (Document) la. A R Number lb. Establishment Number 2. Document Date AR-006-388 PSRU RR 4 /90 NOVEMBER 1990 UNCLASSIFIED 3. Title 4 ...of 7 Number of EMI4IIJYM [itl Pages References Title 17 15 8 . Author(s) 9. Downgrading or Delimiting Instructions LTCOL R.C. FURRY I Oa. Corporate

Patient Mortality During Unannounced Accreditation Surveys at US Hospitals.

PubMed

Barnett, Michael L; Olenski, Andrew R; Jena, Anupam B

2017-05-01

In the United States, hospitals receive accreditation through unannounced on-site inspections (ie, surveys) by The Joint Commission (TJC), which are high-pressure periods to demonstrate compliance with best practices. No research has addressed whether the potential changes in behavior and heightened vigilance during a TJC survey are associated with changes in patient outcomes. To assess whether heightened vigilance during survey weeks is associated with improved patient outcomes compared with nonsurvey weeks, particularly in major teaching hospitals. Quasi-randomized analysis of Medicare admissions at 1984 surveyed hospitals from calendar year 2008 through 2012 in the period from 3 weeks before to 3 weeks after surveys. Outcomes between surveys and surrounding weeks were compared, adjusting for beneficiaries' sociodemographic and clinical characteristics, with subanalyses for major teaching hospitals. Data analysis was conducted from January 1 to September 1, 2016. Hospitalization during a TJC survey week vs nonsurvey weeks. The primary outcome was 30-day mortality. Secondary outcomes were rates of Clostridium difficile infections, in-hospital cardiac arrest mortality, and Patient Safety Indicators (PSI) 90 and PSI 4 measure events. The study sample included 244 787 and 1 462 339 admissions during survey and nonsurvey weeks with similar patient characteristics, reason for admission, and in-hospital procedures across both groups. There were 811 598 (55.5%) women in the nonsurvey weeks (mean [SD] age, 72.84 [14.5] years) and 135 857 (55.5%) in the survey weeks (age, 72.76 [14.5] years). Overall, there was a significant reversible decrease in 30-day mortality for admissions during survey (7.03%) vs nonsurvey weeks (7.21%) (adjusted difference, -0.12%; 95% CI, -0.22% to -0.01%). This observed decrease was larger than 99.5% of mortality changes among 1000 random permutations of hospital survey date combinations, suggesting that observed mortality changes were not attributable to chance alone. Observed mortality reductions were largest in major teaching hospitals, where mortality fell from 6.41% to 5.93% during survey weeks (adjusted difference, -0.38%; 95% CI, -0.74% to -0.03%), a 5.9% relative decrease. We observed no significant differences in admission volume, length of stay, or secondary outcomes. Patients admitted to hospitals during TJC survey weeks have significantly lower mortality than during nonsurvey weeks, particularly in major teaching hospitals. These results suggest that changes in practice occurring during periods of surveyor observation may meaningfully affect patient mortality.

The Tolerability Profile of Clindamycin 1%/Benzoyl Peroxide 5% Gel vs. Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel for Facial Acne

PubMed Central

Cirigliano, Marcela; Gwazdauskas, Jennifer A; Gonzalez, Pablo

2012-01-01

Objective: To compare the first two weeks of tolerability of clindamycin/benzoyl peroxide gel versus adapalene/benzoyl peroxide gel followed by six weeks of open-label clindamycin/benzoyl peroxide gel therapy in subjects with mild-to-moderate acne who participated in two eight-week, identically designed, clinical studies. Methods: Using a split-face method, patients received both clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel once daily for two weeks (allocation to the right or left side of the face was randomized) in an investigator-blinded fashion. Patients then went on to receive a further six weeks of open-label, full-face clindamycin/benzoyl peroxide gel. The primary outcome was to compare signs and symptoms of tolerability during the first two weeks of treatment using an investigator-assessed 4-point rating scale. Secondary endpoints included assessment of acne severity (Investigator Static Global Assessment and lesion counts), quality of life, product acceptability/preference, and patient assessments of tolerability and safety. Results: Of the 76 subjects enrolled in the two studies, 72 completed them. Overall both products were well tolerated, but mean scores for erythema, dryness, and peeling were significantly higher with adapalene/benzoyl peroxide gel than with clindamycin/benzoyl peroxide gel at both Weeks 1 and 2 (p<0.03). Patients also rated clindamycin/benzoyl peroxide gel significantly more tolerable than adapalene/benzoyl peroxide gel for redness, dryness, burning, itching, and scaling at Weeks 1 and 2 (p 0.0073). Mean Investigator Static Global Assessment score improved with both products during the first two weeks of treatment and continued to show significant improvement versus baseline when treatment with clindamycin/benzoyl peroxide gel was continued for a further six weeks (p<0.001 at Week 8). Lesion counts improved throughout the study with significant reductions from baseline occurring at Weeks 5 and 8 (p<0.0001 for both time points for total lesion counts). Clindamycin/benzoyl peroxide gel and adapalene/benzoyl peroxide gel were well tolerated, with most adverse events of mild-to-moderate severity. Conclusion: Clindamycin/benzoyl peroxide gel had better tolerability with regard to erythema, dryness, and peeling than adapalene/benzoyl peroxide gel during the first two weeks of treatment. PMID:22808305

In vivo biocompatibility of new nano-calcium-deficient hydroxyapatite/poly-amino acid complex biomaterials.

PubMed

Dai, Zhenyu; Li, Yue; Lu, Weizhong; Jiang, Dianming; Li, Hong; Yan, Yonggang; Lv, Guoyu; Yang, Aiping

2015-01-01

To evaluate the compatibility of novel nano-calcium-deficient hydroxyapatite/poly-amino acid (n-CDHA/PAA) complex biomaterials with muscle and bone tissue in an in vivo model. Thirty-two New Zealand white rabbits were used in this study. Biomaterials were surgically implanted into each rabbit in the back erector spinae and in tibia with induced defect. Polyethylene was implanted into rabbits in the control group and n-CDHA/PAA into those of the experimental group. Animals were examined at four different points in time: 2 weeks, 4 weeks, 12 weeks, and 24 weeks after surgery. They were euthanized after embolization. Back erector spinae muscles with the surgical implants were examined after hematoxylin and eosin (HE) staining at these points in time. Tibia bones with the surgical implants were examined by X-ray and scanning electron microscopy (SEM) at these points in time to evaluate the interface of the bone with the implanted biomaterials. Bone tissues were sectioned and subjected to HE, Masson, and toluidine blue staining. HE staining of back erector spinae muscles at 4 weeks, 12 weeks, and 24 weeks after implantation of either n-CDHA/PAA or polyethylene showed disappearance of inflammation and normal arrangement in the peripheral tissue of implant biomaterials; no abnormal staining was observed. At 2 weeks after implantation, X-ray imaging of bone tissue samples in both experimental and control groups showed that the peripheral tissues of the implanted biomaterials were continuous and lacked bone osteolysis, absorption, necrosis, or osteomyelitis. The connection between implanted biomaterials and bone tissue was tight. The results of HE, Masson, toluidine blue staining and SEM confirmed that the implanted biomaterials were closely connected to the bone defect and that no rejection had taken place. The n-CDHA/PAA biomaterials induced differentiation of a large number of chondrocytes. New bone trabecula began to form at 4 weeks after implanting n-CDHA/PAA biomaterials, and lamellar bone gradually formed at 12 weeks and 24 weeks after implantation. Routine blood and kidney function tests showed no significant changes at 2 weeks and 24 weeks after implantation of both biomaterials. n-CDHA/PAA composites showed good compatibility in in vivo model. In this study, n-CDHA/PAA were found to be safe, nontoxic, and biologically active in bone repair.

Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study).

PubMed

Nguyen, Quan Dong; Schachar, Ronald A; Nduaka, Chudy I; Sperling, Marvin; Klamerus, Karen J; Chi-Burris, Katherine; Yan, Eric; Paggiarino, Dario A; Rosenblatt, Irit; Aitchison, Roger; Erlich, Shai S

2012-09-01

To evaluate the efficacy of different dosing paradigms of PF-04523655 (PF) versus ranibizumab (comparator) in subjects with neovascular age-related macular degeneration (AMD). Multicenter, open-label, prospective, randomized, comparator-controlled exploratory study. A total of 151 patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD who were naive to AMD therapy. In this phase 2 study, patients were randomized to 1 of 5 treatment groups with equal ratio. All groups received ranibizumab 0.5 mg at baseline and (a) PF 1 mg every 4 weeks (Q4W) from week 4 to week 12; (b) PF 3 mg Q4W from week 4 to week 12; (c) PF 3 mg every 2 weeks (Q2W) from week 4 to week 12; (d) PF 1 mg + ranibizumab (combination) Q4W from baseline to week 12; and (e) ranibizumab Q4W to week 12. All study treatments were given as intravitreal injections. The primary end point was the mean change in best-corrected visual acuity (BCVA) from baseline at week 16; secondary end points included the percentage of patients gaining ≥ 10 and ≥ 15 letters in BCVA and mean change in retinal central subfield thickness, lesion thickness, and CNV area. At week 16, the PF 1 mg + ranibizumab combination group achieved numerically greater improvement in mean BCVA from baseline (9.5 letters) than the ranibizumab group (6.8 letters). The difference was not statistically significant. The BCVA improvement in the PF monotherapy groups was less than in the ranibizumab group. Similar trends were observed in the percentage of patients who gained ≥ 10 and ≥ 15 letters. From baseline to week 16 (last observed carried forward), the combination and ranibizumab groups had similar mean reductions in central subfield retinal thickness and total CNV area, which were greater than in all PF monotherapy groups. There were no clinically meaningful differences in reduction of lesion thickness among treatment groups. In this early, underpowered study evaluating treatments for neovascular AMD, the combination of PF with ranibizumab led to an average gain in BCVA that was more than with ranibizumab monotherapy. No safety concerns were identified. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The Effects of an Amino Acid Supplement on Glucose Homeostasis, Inflammatory Markers, and Incretins after Laparoscopic Gastric Bypass

PubMed Central

Breitman, Igal; Saraf, Neha; Kakade, Manasi; Yellumahanthi, Kishore; White, Merritt; Hackett, Jo Ann; Clements, Ronald H.

2011-01-01

Background Protein supplements are routinely used after a laparoscopic gastric bypass (LGB). The aim of this study is to evaluate the impact of an amino acid supplement on glucose homeostasis, hormonal and inflammatory markers after LGB. Methods 30 patients undergoing LGB were randomized to receive or not to receive 24g of an oral supplement containing a leucine metabolite, glutamine and arginine twice daily for 8 weeks. Changes in weight, BMI, ghrelin, GLP-1, GIP, glucose, insulin, C-peptide, insulin sensitivity, IL-6, CRP, leptin and IGF-1 were assessed preoperatively, 2 weeks and 8-weeks postoperatively. Results 30 patients (96.7% females, 46.9 ± 8.4 years, 113.4 ± 11.6 kg and BMI 43.3 ± 4.1 kg/m2) were randomized. The experimental (N=14) and control groups (N=16) were not significantly different at baseline. Weight and BMI were decreased significantly at two weeks and at eight weeks (p<0.0001 for each variable), but no statistical significance was observed between the two groups. Fasting glucose decreased significantly at 2 & 8 weeks as compared to base line (p<0.0001) with no difference between experimental and control groups (p=0.8), but insulin and calculated insulin sensitivity, that were similar at baseline, become significantly worse in the experimental group 8 weeks after surgery ( p=0.02 for insulin, p=0.04 for the homeostasis model assessment (HOMA) index). CRP, which was similar at baseline, was found to be significantly lower at 8 weeks in control vs. experimental group, (P=0.018). IL-6 decreased significantly from baseline at 2 weeks and rebounded at 8 weeks in both groups, there was a trend of higher IL-6 in the experimental group that becomes significant at 8 weeks (p=0.05). Leptin and IGF-1 levels decreased significantly from baseline at 2 & 8 weeks (p<0.0001) but there was no difference between the two groups. No significant change in GLP-1, ghrelin or GIP were noticed after 8 weeks. Conclusion An amino acid supplement had no effect on the early postoperative incretins following LGB. It may have a negative influence on glycemic control and degree of inflammation. Future studies are needed to clarify these effects. PMID:21463799

Evaluation of gene expression profiles and pathways underlying postnatal development in mouse sclera.

PubMed

Lim, Wan'E; Kwan, Jia Lin; Goh, Liang Kee; Beuerman, Roger W; Barathi, Veluchamy A

2012-01-01

The aim of this study was to identify the genes and pathways underlying the growth of the mouse sclera during postnatal development. Total RNA was isolated from each of 30 single mouse sclera (n=30, 6 sclera each from 1-, 2-, 3-, 6-, and 8-week-old mice) and reverse-transcribed into cDNA using a T7-N(6) primer. The resulting cDNA was fragmented, labeled with biotin, and hybridized to a Mouse Gene 1.0 ST Array. ANOVA analysis was then performed using Partek Genomic Suite 6.5 beta and differentially expressed transcript clusters were filtered based on a selection criterion of ≥ 2 relative fold change at a false discovery rate of ≤ 5%. Genes identified as involved in the main biologic processes during postnatal scleral development were further confirmed using qPCR. A possible pathway that contributes to the postnatal development of the sclera was investigated using Ingenuity Pathway Analysis software. The hierarchical clustering of all time points showed that they did not cluster according to age. The highest number of differentially expressed transcript clusters was found when week 1 and week 2 old scleral tissues were compared. The peroxisome proliferator- activated receptor gamma coactivator 1-alpha (Ppargc1a) gene was found to be involved in the networks generated using Ingenuity Pathway Studio (IPA) from the differentially expressed transcript cluster lists of week 2 versus 1, week 3 versus 2, week 6 versus 3, and week 8 versus 6. The gene expression of Ppargc1a varied during scleral growth from week 1 to 2, week 2 to 3, week 3 to 6, and week 6 to 8 and was found to interact with a different set of genes at different scleral growth stages. Therefore, this indicated that Ppargc1a might play a role in scleral growth during postnatal weeks 1 to 8. Gene expression of eye diseases should be studied as early as postnatal weeks 1-2 to ensure that any changes in gene expression pattern during disease development are detected. In addition, we propose that Ppargc1a might play a role in regulating postnatal scleral development by interacting with a different set of genes at different scleral growth stages.

Preference and Expectation for Treatment Assignment in a Randomized Controlled Trial of Once- vs Twice-weekly Yoga for Chronic Low Back Pain

PubMed Central

Weinberg, Janice; Sherman, Karen J.; Saper, Robert B.

2015-01-01

Background: In studies involving nonpharmacological complementary and alternative medicine interventions, participant blinding is very difficult. Participant expectations may affect perceived benefit of therapy. In studies of yoga as treatment for chronic low back pain, little is known about the relationship between patient expectations and preferences on outcomes. This study was designed to identify baseline predictors of preference and to determine if expectations and preferences for different doses of yoga affect back-related function and low back pain intensity. Methods: This was a secondary data analysis of a 12-week randomized controlled trial comparing once-weekly vs twice-weekly yoga for treatment of chronic low back pain in 93 adults from a predominantly low-income minority population. At baseline, participants were asked about back function, back pain, treatment expectations, and treatment preferences. We created a variable “concordance” to describe the matching of participant preference to randomized treatment. Our outcome variables were change in back function and pain intensity after 12 weeks of yoga instruction. We performed logistic regression to identify predictors of preference for once- or twice-weekly yoga instruction. We created linear regression models to identify independent associations between expectations, preference, concordance, and outcomes. Results: Worse back function at baseline was associated with 20% higher odds of preferring twice-weekly yoga (OR 1.2, CI 1.1, 1.3). Individuals with higher expectation scores for twice-weekly yoga had 90% higher odds of preferring twice-weekly vs once-weekly yoga (OR 1.9, CI 1.3, 2.7). Individuals with higher expectation scores for once-weekly yoga had 40% less odds of preferring twice-weekly yoga (OR 0.6, CI 0.5, 0.9). After controlling for baseline characteristics, we found no statistically significant relationship between treatment outcomes, preference, expectation scores, or concordance. Conclusion: In a population of predominantly low-income minority participants with chronic low back pain, worse back function was associated with preference for more frequent yoga classes. Those who preferred more yoga classes had higher expectations for those classes. Twelve-week change in back pain intensity and back function were not affected by dosing preference, expectation score, or concordance. More research is needed to better measure and quantify preference, expectations, and their relationship to outcomes in yoga research. PMID:25694850

Preparation and biocompatibility evaluation of polypropylene mesh coated with electrospinning membrane for pelvic defects repair.

PubMed

Lu, Yao; Fu, Shaoju; Zhou, Shuanglin; Chen, Ge; Zhu, Chaoting; Li, Nannan; Ma, Ying

2018-05-01

Composite mesh with different materials composition could compensate for the drawbacks brought by single component mesh. Coating a membrane layer on the surface of macroporous mesh is a common method for preparing composite medical mesh. Electrospinning and dipping methods were introduced to form the two kinds of membrane-coated PP meshes (electro-mesh and dip-mesh); several properties were measured based on subcutaneous implantation model in rat. The results revealed that continuous tissue ingrowth could be observed for electro-mesh only with evidences of strength increase (electro-mesh: 0 week - 13.1 ± 0.88 N, 2 week - 16.87 ± 1.39 N, 4 week - 22.04 ± 2.05 N) and thickness increase (electro-mesh: 0 week - 0.437 ± 0.023 mm, 2 week - 0.488 ± 0.025 mm, 4 week - 0.576 ± 0.028 mm). However, no tissues were observed for dip-mesh in the first 2 weeks, both on macroscopic level and microscopic level, proved by strength data (dip-mesh: 0 week - 13.36 ± 1.06 N, 2 week - 13.4 ± 1.33 N, 4 week - 18.61 ± 1.89 N) and thickness data (dip-mesh: 0 week - 0.439 ± 0.018 mm, 2 week - 0.439 ± 0.019 mm, 4 week - 0.502 ± 0.032 mm). Electro-mesh had larger surface area decrease (10.74 ± 1.22%) than that of dip-mesh (2.78 ± 0.52%). The adhesion level of electro-mesh (medium adhesion) was also higher than that of dip-mesh (mild adhesion). Even if showing differences in several properties, both meshes were similar under histological observation, with the ability to support fresh tissues ingrowth. Considering operation environment, electro-mesh seems more suitable than dip-mesh with a rapid tissue growing, medium adhesion rate for repairing pelvic floor defects. Copyright © 2018 Elsevier Ltd. All rights reserved.

Duration of Androgen Suppression Before Radiotherapy for Localized Prostate Cancer: Radiation Therapy Oncology Group Randomized Clinical Trial 9910

PubMed Central

Pisansky, Thomas M.; Hunt, Daniel; Gomella, Leonard G.; Amin, Mahul B.; Balogh, Alexander G.; Chinn, Daniel M.; Seider, Michael J.; Duclos, Marie; Rosenthal, Seth A.; Bauman, Glenn S.; Gore, Elizabeth M.; Rotman, Marvin Z.; Lukka, Himanshu R.; Shipley, William U.; Dignam, James J.; Sandler, Howard M.

2015-01-01

Purpose To determine whether prolonged androgen suppression (AS) duration before radiotherapy improves survival and disease control in prostate cancer. Patients and Methods One thousand five hundred seventy-nine men with intermediate-risk prostate cancer were randomly assigned to 8 weeks of AS followed by radiotherapy with an additional 8 weeks of concurrent AS (16 weeks total) or to 28 weeks of AS followed by radiotherapy with an additional 8 weeks of AS (36 weeks total). The trial sought primarily to detect a 33% reduction in the hazard of prostate cancer death in the 28-week assignment. Time-to-event end points are reported for up to 10 years of follow-up. Results There were no between-group differences in baseline characteristics of 1,489 eligible patients with follow-up. For the 8- and 28-week assignments, 10-year disease-specific survival rates were 95% (95% CI, 93.3% to 97.0%) and 96% (95% CI, 94.6% to 98.0%; hazard ratio [HR], 0.81; P = .45), respectively, and 10-year overall survival rates were 66% (95% CI, 62.0% to 69.9%) and 67% (95% CI, 63.0% to 70.8%; HR, 0.95; P = .62), respectively. For the 8- and 28-week assignments, 10-year cumulative incidences of locoregional progression were 6% (95% CI, 4.3% to 8.0%) and 4% (95% CI, 2.5% to 5.7%; HR, 0.65; P = .07), respectively; 10-year distant metastasis cumulative incidences were 6% (95% CI, 4.0% to 7.7%) and 6% (95% CI, 4.0% to 7.6%; HR, 1.07; P = .80), respectively; and 10-year prostate-specific antigen–based recurrence cumulative incidences were 27% (95% CI, 23.1% to 29.8%) and 27% (95% CI, 23.4% to 30.3%; HR, 0.97; P = .77), respectively. Conclusion Extending AS duration from 8 weeks to 28 weeks before radiotherapy did not improve outcomes. A lower than expected prostate cancer death rate reduced ability to detect a between-group difference in disease-specific survival. The schedule of 8 weeks of AS before radiotherapy plus 8 weeks of AS during radiotherapy remains a standard of care in intermediate-risk prostate cancer. PMID:25534388

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Fleischer, Alan B; Avakian, Edward V; Plaum, Stefan; Hardas, Bhushan

2011-11-01

Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control. 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects. At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation. Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139). J Drugs Dermatol. 2011;10(11):1282-1288.

Physical and mental recovery after conventional aortic valve surgery.

PubMed

Petersen, Johannes; Vettorazzi, Eik; Winter, Lena; Schmied, Wolfram; Kindermann, Ingrid; Schäfers, Hans-Joachim

2016-12-01

Physical and mental recovery are important factors to consider in the treatment of aortic valve disease, and the process of recovery is not well known. We investigated the course of physical and mental recovery directly after conventional aortic valve surgery. In a longitudinal study, 60 patients undergoing elective aortic valve surgery were studied preoperatively and at intervals of 4 weeks after aortic valve surgery. The last measurement was taken 6 months postoperatively. Measurements included the 6-minute walk test and N-terminal pro-B-type natriuretic peptide. Mental recovery was assessed by the Short Form Health Survey and the Hospital Anxiety and Depression Scale. All parameters were compared with published healthy norms. All parameters except for the anxiety score showed a significant decline after the first postoperative measurement at 1 week after aortic valve surgery. The baseline level was restored at 1 to 3 weeks (anxiety, depression, mental quality of life, Borg scale), 4 to 6 weeks (6-minute walk test, physical quality of life), and 9 weeks (N-terminal pro-B-type natriuretic peptide) after the first postoperative week. Significantly better values than preoperatively for the first time were reached at 2 to 3 weeks (anxiety, depression, mental quality of life), 5 weeks (6-minute walk test), 8 weeks (physical quality of life), and 12 weeks (N-terminal pro-B-type natriuretic peptide) after the first postoperative week. At 3 months postoperatively, significant improvements (P < .001) were seen in walk distance (+212 m), dyspnea (-1.11), physical (+12.38) and mental quality of life (+7.71), anxiety (-3.74), and depression (-3.62) compared with the first week postoperatively. At 6 months postoperatively, all parameters were significantly improved compared with preoperative data and, except for the N-terminal pro-B-type natriuretic peptide value, significantly better or equal compared with published healthy norms. After conventional aortic valve surgery, the most pronounced recovery was seen in the first 6 weeks postoperatively. Physical quality of life and N-terminal pro-B-type natriuretic peptide required a prolonged time for a complete recovery. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Depressed Physical Performance Outlasts Hormonal Disturbances after Military Training.

PubMed

Hamarsland, Håvard; Paulsen, Gøran; Solberg, Paul A; Slaathaug, Ole Gunnar; Raastad, Truls

2018-06-21

The aim of this study was to investigate the effect of an arduous one-week military course on measures of physical performance, body composition and blood biomarkers. Participants were apprentices in an annual selection course for the Norwegian Special Forces. Fifteen soldiers (23±4 yrs., 1.81±0.06 m, 78±7 kg) completed a hell-week consisting of rigorous activity only interspersed by 2-3 hours of sleep per day. Testing was conducted before and 0, 1, 3, 7 and 14 days after the hell-week. Physical performance was measured as muscle strength and jump performance. Body composition was measured by bioelectrical impedance and blood samples were collected and analyzed for hormones, creatine kinase, and C-reactive protein. Body mass was reduced by 5.3±1.9 kg during the hell-week and returned to baseline within one week. Fat mass was reduced by 2.1±1.7 kg and muscle mass by 1.9±0.9 kg. Muscle strength in leg-press and bench-press was reduced by 20±9% and 9±7%, respectively, and both were ~10% lower than baseline after one week of recovery. Jump-height was reduced by 28±13% and was still 14±5% below baseline after 2 weeks of recovery. Testosterone was reduced by 70±12% and recovered gradually within a week. Cortisol was increased by 154±74%, and did not fully recover during the next week. IGF-1 was reduced by 51±10% and T3 and T4 by 12-30%, all recovered within a week. One-week arduous military exercise resulted in reductions in body mass and performance, as well as considerable hormonal disturbances. Our most important observation was that whereas the hormonal systems was normalized within one week of rest and proper nutrition, lower body strength and jump performance were still depressed after two weeks.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Evaluation of gene expression profiles and pathways underlying postnatal development in mouse sclera

PubMed Central

Lim, Wan’E.; Kwan, Jia Lin; Goh, Liang Kee; Beuerman, Roger W.

2012-01-01

Purpose The aim of this study was to identify the genes and pathways underlying the growth of the mouse sclera during postnatal development. Methods Total RNA was isolated from each of 30 single mouse sclera (n=30, 6 sclera each from 1-, 2-, 3-, 6-, and 8-week-old mice) and reverse-transcribed into cDNA using a T7-N6 primer. The resulting cDNA was fragmented, labeled with biotin, and hybridized to a Mouse Gene 1.0 ST Array. ANOVA analysis was then performed using Partek Genomic Suite 6.5 beta and differentially expressed transcript clusters were filtered based on a selection criterion of ≥2 relative fold change at a false discovery rate of ≤5%. Genes identified as involved in the main biologic processes during postnatal scleral development were further confirmed using qPCR. A possible pathway that contributes to the postnatal development of the sclera was investigated using Ingenuity Pathway Analysis software. Results The hierarchical clustering of all time points showed that they did not cluster according to age. The highest number of differentially expressed transcript clusters was found when week 1 and week 2 old scleral tissues were compared. The peroxisome proliferator- activated receptor gamma coactivator 1-alpha (Ppargc1a) gene was found to be involved in the networks generated using Ingenuity Pathway Studio (IPA) from the differentially expressed transcript cluster lists of week 2 versus 1, week 3 versus 2, week 6 versus 3, and week 8 versus 6. The gene expression of Ppargc1a varied during scleral growth from week 1 to 2, week 2 to 3, week 3 to 6, and week 6 to 8 and was found to interact with a different set of genes at different scleral growth stages. Therefore, this indicated that Ppargc1a might play a role in scleral growth during postnatal weeks 1 to 8. Conclusions Gene expression of eye diseases should be studied as early as postnatal weeks 1–2 to ensure that any changes in gene expression pattern during disease development are detected. In addition, we propose that Ppargc1a might play a role in regulating postnatal scleral development by interacting with a different set of genes at different scleral growth stages. PMID:22736935

A 1.5-Year Follow-Up of Parent Training and Atomoxetine for Attention-Deficit/Hyperactivity Disorder Symptoms and Noncompliant/Disruptive Behavior in Autism.

PubMed

Arnold, L Eugene; Ober, Nicole; Aman, Michael G; Handen, Benjamin; Smith, Tristram; Pan, Xueliang; Hyman, Susan L; Hollway, Jill; Lecavalier, Luc; Page, Kristin; Rice, Robert

2018-06-01

To examine status of children with autism spectrum disorder (ASD) 10 months after a 34-week clinical trial of atomoxetine (ATX) and parent training (PT). In a 2 × 2 design, 128 children with ASD and attention-deficit/hyperactivity disorder (ADHD) were randomly assigned ATX, PT+placebo, PT+ATX, or placebo alone. PT was weekly for 10 weeks, and then monthly. ATX/placebo was titrated over 6 weeks [≤1.8 mg/kg/d], and then maintained until week 10. Responders continued to week 34 or nonresponse. Placebo nonresponders had a 10-week ATX open trial; ATX nonresponders were treated clinically. All continued to week 34. With no further treatment from the study, all were invited to follow-up (FU) at 1.5 years postbaseline; 94 (73%) participated. Changes from Week 34 to FU and from baseline to FU were tested by one-way analysis of variance or chi-squared test. PT versus no PT was tested by chi-squared test, Fisher's exact test, Welch's t-test, Student's t-test, and Mann-Whitney's U test. For the whole sample, the primary outcomes (parent-rated ADHD on the Swanson, Nolan, and Pelham [SNAP] scale and noncompliance on the Home Situations Questionnaire [HSQ]) deteriorated mildly from week 34 to FU, but were still substantially better than baseline (SNAP: t = 12.177, df = 93, p < 0.001; HSQ: t = 8.999, df = 93, p < 0.001). On the SNAP, 61% improved ≥30% from baseline (67% did at week 34); on noncompliance, 56% improved ≥30% from baseline (77% did at week 34). Outcomes with PT were not significantly better than without PT (SNAP p = 0.30; HSQ p = 0.27). Originally assigned treatment groups did not differ significantly. Only 34% still took ATX; 27% were taking stimulants; and 25% took no medication. The majority retained their 34-week end-of-study improvement 10 months later, even though most participants stopped ATX. For some children, ATX continuation may not be necessary for continued benefit or other drugs may be necessary. Cautious individual clinical experimentation may be justified. Twelve sessions of PT made little long-term difference. ClinicalTrials.gov Identifier: Atomoxetine, Placebo and Parent Management Training in Autism (Strattera) (NCT00844753).