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Sample records for controlled 12-week clinical

  1. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

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    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  2. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

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    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

  3. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

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    Yu-Mi Lee

    Full Text Available Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D; however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46 or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47 for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017. When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%. The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.CRiS KCT0001771.

  4. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial

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    Caren Lau

    2015-01-01

    Full Text Available Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years were assigned to either the yoga intervention group (n=87 or the waitlist control group (n=86. 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR and maximal oxygen uptake (VO2max, muscular strength and endurance (curl-up and push-up tests, and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS test. Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P<0.01, curl-up (P<0.05 and push-up (P<0.001 tests, and the MBS left and right leg tests (both P<0.001 in both genders. Significant change was also found for resting HR between groups in women (P<0.05 but not in men. Further analysis comparing participants between younger and older subgroups yielded similar findings, except that the older participants in the yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89% and attendance (94% were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults.

  5. A randomized controlled trial of a 12-week intensive lifestyle intervention program at a primary care obesity clinic for adults in western Saudi Arabia.

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    Alghamdi, Riyad Q

    2017-08-01

    To assess the ability of a 12-week primary care-based intensive lifestyle intervention (ILI), to facilitate a 5% reduction in baseline weight compared with an education-only active comparator (AC).  Methods: A randomized clinical trial was conducted in a primary health care setting in Jeddah, Saudi Arabia between December 2014 and June 2015. Arab participants with obesity, but who were otherwise healthy (n=140), were randomized to the ILI (n=70) or AC (n=70) group. The ILI group received 8 clinical visits throughout the study. The AC group received only an initial health education session. The primary outcome was the proportion of participants who achieved clinically significant weight loss (≥5% of their baseline weight).  Results: Participants in the ILI group were significantly more likely than those in the AC group to achieve the primary outcome (p=0.008, relative risk: 1.8 [95% confidence interval [CI]: 1.15 to 2.93). At week 12, the ILI group exhibited a mean weight decrease of 5.58 ± 5.60 kg (-5.37 ± 5.31%), significantly greater than that observed in the AC group (-2.8 ± 4.96 kg, -2.62 ± 4.34%, p=0.002), and corresponding to a weight loss advantage of 2.77 kg (95% CI: 1.01 to 4.54 kg) or 2.75% (95% CI: 1.13% to 4.37%).  Conclusion: The 12-week primary care-based ILI program was effective in achieving a clinically meaningful weight reduction (≥5%) among Saudi and Arab patients with obesity.

  6. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

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    Nathalie Deckx

    2016-01-01

    Full Text Available Previously, we reported that patients with multiple sclerosis (MS demonstrate improved muscle strength, exercise tolerance, and lean tissue mass following a combined endurance and resistance exercise program. However, the effect of exercise on the underlying disease pathogenesis remains elusive. Since recent evidence supports a crucial role of dendritic cells (DC in the pathogenesis of MS, we investigated the effect of a 12-week combined exercise program in MS patients on the number and function of DC. We demonstrate an increased number of plasmacytoid DC (pDC following the exercise program. These pDC display an activated phenotype, as evidenced by increased numbers of circulating CD62L+ and CD80+ pDC. Interestingly, the number of CD80+ pDC positively correlates with the presence of IL-10-producing regulatory type 1 cells (Tr1, an important cell type for maintaining peripheral tolerance to self-antigens. In addition, decreased production of the inflammatory mediators, TNF-α and MMP-9, upon Toll-like receptor (TLR stimulation was found at the end of the exercise program. Overall, our findings suggest that the 12-week exercise program reduces the secretion of inflammatory mediators upon TLR stimulation and promotes the immunoregulatory function of circulating pDC, suggestive for a favorable impact of exercise on the underlying immunopathogenesis of MS.

  7. Evaluation of the efficacy and safety of β-d-mannuronic acid in patients with ankylosing spondylitis: A 12-week randomized, placebo-controlled, phase I/II clinical trial.

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    Fattahi, Mohammad Javad; Jamshidi, Ahmad Reza; Mahmoudi, Mahdi; Vojdanian, Mahdi; Yekaninejad, Mir Saeed; Jafarnezhad-Ansariha, Fahimeh; Ahmadi, Hossein; Rehm, Bernd H A; Matsuo, Hidenori; Cuzzocrea, Salvatore; Hosseini, Mostafa; Hashemi, Seyed Naser; Aghazadeh, Zahra; Mirshafiey, Abbas

    2018-01-01

    To evaluate the efficacy, safety and tolerability of β-d-mannuronic acid (M2000) in the treatment of ankylosing spondylitis (AS). The study was a 12-week randomized, double-blind, placebo-controlled, phase I/II clinical trial with 3 treatment arms: placebo, β-d-mannuronic acid and naproxen. Patients who had AS according to the modified New York criteria, with active disease at baseline were eligible for study. Primary outcome measure was the Assessment of SpondyloArthritis international Society (ASAS) 20 response rate at week 12. Of the 85 randomized patients, 27 were allocated to receive placebo, 28 naproxen, and 30 β-d-mannuronic acid. There were no statistically significant differences between treatment groups at baseline. Of the patients receiving β-d-mannuronic acid, 57.7% achieved an ASAS20 response at week 12, compared with 59% of the patients in the naproxen group (P>0.05) and 19% of the patients in the placebo group (P=0.007). In comparison with patients receiving placebo over the 12-week treatment period, those receiving β-d-mannuronic acid and naproxen demonstrated statistically significantly greater improvement in all secondary endpoints. Interestingly, β-d-mannuronic acid reduced some parameters associated with inflammation more effectively than naproxen and placebo. The incidence of gastrointestinal and other adverse events were higher on naproxen than on β-d-mannuronic acid and placebo. The present study demonstrated similar efficacy, but with a more favorable safety profile for β-d-mannuronic acid than naproxen and, therefore, suggest that β-d-mannuronic acid is suitable for the management of AS. Iranian registry of clinical trials; www.irct.ir; IRCT2013062213739N1. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis.

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    Grotz, V Lee; Pi-Sunyer, Xavier; Porte, Daniel; Roberts, Ashley; Richard Trout, J

    2017-08-01

    The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control. Copyright © 2017 Heartland Food Products Group. Published by Elsevier Inc. All rights reserved.

  9. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

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    Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-08-07

    Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients

  10. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.

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    Shanahan, William R; Rose, Jed E; Glicklich, Alan; Stubbe, Scott; Sanchez-Kam, Matilde

    2017-08-01

    Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological

  11. Tube feeding with a diabetes-specific feed for 12 weeks improves glycaemic control in type 2 diabetes patients.

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    Vaisman, Nachum; Lansink, Mirian; Rouws, Carlette H; van Laere, Katrien M; Segal, R; Niv, Eva; Bowling, Tim E; Waitzberg, Dan L; Morley, John E

    2009-10-01

    Assess longer-term (12 weeks) effects of a diabetes-specific feed on postprandial glucose response, glycaemic control (HbA1c), lipid profile, (pre)-albumin, clinical course and tolerance in diabetic patients. In this randomized, controlled, double-blind, parallel group study 25 type 2 diabetic patients on tube feeding were included. Patients received a soy-protein based, multi-fibre diabetes-specific feed or isocaloric, fibre-containing standard feed for 12 weeks, while continuing on their anti-diabetic medication. At the beginning, after 6 and 12 weeks, several (glycaemic) parameters were assessed. The postprandial glucose response (iAUC) to the diabetes-specific feed was lower at the 1st assessment compared with the standard feed (p=0.008) and this difference did not change over time. HbA1c decreased over time in the diabetes-specific and not in the standard feed group (treatment*time:p=0.034): 6.9+/-0.3% (mean+/-SEM) at baseline vs. 6.2+/-0.4% at 12 weeks in the diabetes-specific group compared to 7.9+/-0.3% to 8.7+/-0.4% in the standard feed group. No significant treatment*time effect was found for fasting glucose, insulin, (pre-) albumin or lipid profile, except for increase of HDL in the diabetes-specific group. The diabetes-specific feed studied significantly improved longer-term glycaemic control in diabetic patients. This was achieved in addition to on-going anti-diabetic medication and may affect clinical outcome.

  12. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program.

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    O'Neil, Patrick M; Theim, Kelly R; Boeka, Abbe; Johnson, Gail; Miller-Kovach, Karen

    2012-12-01

    Greater use of key self-regulatory behaviors (e.g., self-monitoring of food intake and weight) is associated with greater weight loss within behavioral weight loss treatments, although this association is less established within widely-available commercial weight loss programs. Further, high hedonic hunger (i.e., susceptibility to environmental food cues) may present a barrier to successful behavior change and weight loss, although this has not yet been examined. Adult men and women (N=111, body mass index M±SD=31.5±2.7kg/m(2)) were assessed before and after participating in a 12-week commercial weight loss program. From pre- to post-treatment, reported usage of weight control behaviors improved and hedonic hunger decreased, and these changes were inversely associated. A decrease in hedonic hunger was associated with better weight loss. An improvement in reported weight control behaviors (e.g., self-regulatory behaviors) was associated with better weight loss, and this association was even stronger among individuals with high baseline hedonic hunger. Findings highlight the importance of specific self-regulatory behaviors within weight loss treatment, including a commercial weight loss program developed for widespread community implementation. Assessment of weight control behavioral skills usage and hedonic hunger may be useful to further identify mediators of weight loss within commercial weight loss programs. Future interventions might specifically target high hedonic hunger and prospectively examine changes in hedonic hunger during other types of weight loss treatment to inform its potential impact on sustained behavior change and weight control. Copyright © 2012 Elsevier Ltd. All rights reserved.

  13. Effect of whitening toothpastes on tooth staining using two different colour-measuring devices--a 12-week clinical trial.

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    Raoufi, Shiva; Birkhed, Dowen

    2010-12-01

    To evaluate the potential of two whitening toothpastes on stain removal, using two different spectrophotometeric devices. In a randomised, double-blind clinical trial, 150 participants with tooth discolouration were assigned to use one of three toothpastes containing: hydroxyapatite, calcium peroxide and no active ingredient (placebo). They were examined at baseline and after 4, 8 and 12 weeks. Two methods of colour measurement were used: Vita Easyshade (Vita 3D-master scale) and Degudent Shadepilot (Classical Vitashade scale). No significant improvement was observed after using the two spectrophotometeric methods. However, a subjective lighter tooth colour and less staining were perceived by the participants in all three groups (not significant). Moreover, there was a significant improvement in the gingival and plaque index in all three groups after the 12 weeks. The toothpaste containing hydroxyapatite or calcium peroxide did not produce any reduction in tooth staining compared with a placebo fluoride toothpaste.

  14. Effect of 12 weeks of Tai Chi training on soleus Hoffmann reflex and control of static posture in older adults.

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    Chen, Yung-Sheng; Zhou, Shi; Cartwright, Colleen

    2011-06-01

    To investigate the effect of 12 weeks of Tai Chi training on soleus (SOL) Hoffmann reflex (H-reflex) modulation and postural control in standing under 4 sensory conditions in older adults. Experimental research design with pre- and posttraining tests in a training group and a control group. University biomechanics laboratory. Community-dwelling older adults (N=34) were assigned to a training (n=20; mean ± SD age, 72.9±4.4y) and a control (n=14; mean ± SD age, 72.9±6.5y) group. Tai Chi participants attended a 1-hour session of Yang style Tai Chi, 3 sessions a week, for 12 weeks, while control participants maintained their regular daily activities during the same period. SOL H-reflex (maximal amplitudes of H-reflex [H(max)] and M-wave [M(max)] waves) and mean displacement of the center of pressure (COP) in the anterior-posterior (COP(A-P)) and medial-lateral (COP(M-L)) directions were measured during bipedal standing, with the feet placed on a forceplate and the heels 6cm apart, under 4 sensory conditions: stable surface with eyes open, stable surface with eyes closed, unstable surface with eyes open, and unstable surface with eyes closed. SOL H(max)/M(max) ratio in the Tai Chi group was upregulated significantly in all 4 sensory tasks after the 12-week Tai Chi training (PTai Chi or control group after the 12-week period. An increase in SOL H(max)/M(max) ratio during static postural tasks is observed after 12 weeks of Tai Chi training in older adults under all 4 sensory conditions. However, training-induced changes in H-reflex were not accompanied by improvement of performance in the static postural control tasks. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  15. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

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    Sang Hyuk Park

    2016-01-01

    Full Text Available Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P=0.191 than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks.

  16. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

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    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  17. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial.

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    Nelly Romani Vestman

    Full Text Available Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear.Oral microbiota was characterized via 454-pyrosequencing of the 16S rDNA hypervariable region V3-V4 after 12 weeks of daily Lactobacillus reuteri DSM 17938 and PTA 5289 consumption. Forty-four adults were assigned to a test group (n = 22 that received lactobacilli lozenges (108 CFU of each strain/lozenge or a control group that received placebo (n = 22. Presence of L. reuteri was confirmed by cultivation and species specific PCR. Tooth biofilm samples from 16 adults before, during, and after exposure were analyzed by pyrosequencing. A total of 1,310,292 sequences were quality filtered. After removing single reads, 257 species or phylotypes were identified at 98.5% identity in the Human Oral Microbiome Database. Firmicutes, Bacteroidetes, Fusobacteria, Proteobacteria, and Actinobacteria were the most abundant phyla. Streptococcus was the most common genus and the S. oralis/S. mitis/S. mitis bv2/S. infantis group comprised the dominant species. The number of observed species was unaffected by L. reuteri exposure. However, subjects who had consumed L. reuteri were clustered in a principal coordinates analysis relative to scattering at baseline, and multivariate modeling of pyrosequencing microbiota, and culture and PCR detected L. reuteri separated baseline from 12-week samples in test subjects. L. reuteri intake correlated with increased S. oralis/S. mitis/S. mitis bv2/S. infantis group and Campylobacter concisus, Granulicatella adiacens, Bergeyella sp. HOT322, Neisseria subflava, and SR1 [G-1] sp. HOT874 detection and reduced S. mutans, S. anginosus, N. mucosa, Fusobacterium periodicum, F. nucleatum ss vincentii, and Prevotella maculosa detection. This effect had disappeared 1 month after exposure was terminated.L. reuteri consumption did not affect species richness but induced a shift in

  18. LA Sprouts: A 12-week gardening, nutrition, and cooking randomized control trial improves determinants of dietary behaviors

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    Davis, Jaimie N; Martinez, Lauren C.; Spruijt-Metz, Donna; Gatto, Nicole M.

    2015-01-01

    Objective To evaluate the effect of an exploratory 12-week nutrition, cooking and gardening RCT (“LA Sprouts”) on preference for fruit and vegetables (FV); willingness to try FV; identification of FV; self-efficacy to garden/eat/cook FV; motivation to garden/eat/cook FV; attitudes towards FV; nutrition and gardening knowledge; and home gardening habits. Design and Participants Four elementary schools with 304 predominately Hispanic/Latino 3rd–5th grade students were randomized to either the LA Sprouts (n=167 students) or Control group (n=137 students). LA Sprouts participants received 12 weeks of weekly 90-minute culturally tailored gardening, nutrition, and cooking classes after school. Questionnaire data examining dietary determinants were obtained at baseline and post-intervention. Results After the 12-week program, LA Sprouts participants compared with controls improved scores for identification of vegetables (+11% vs. +5%; P=.001), nutrition and gardening knowledge (+14.5% vs. −5.0%; P =.003), and were more likely to garden at home (+7.5% vs. −4.4%; P=.003). Conclusions The LA Sprouts program positively impacted a number of determinants of dietary behaviors, which suggest possible mechanisms by which gardening and nutrition education act to improve dietary intake and health outcomes. PMID:26453367

  19. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study).

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    Navarro-Sarabia, Federico; Fernández-Sueiro, José L; Torre-Alonso, Juan C; Gratacos, Jordi; Queiro, Rubén; Gonzalez, Carlos; Loza, Eduardo; Linares, Luis; Zarco, Pedro; Juanola, Xavier; Román-Ivorra, José; Martín-Mola, Emilio; Sanmartí, Raimon; Mulero, Juan; Diaz, Gema; Armendáriz, Yolanda; Collantes, Eduardo

    2011-10-01

    Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS. Adult patients with AS were randomized to receive etanercept 50 mg twice a week (biw), or etanercept 50 mg once a week (qw) for 12 weeks. The primary efficacy endpoint was Ankylosing Spondylitis Assessment Study (ASAS20) response at Week 12; secondary endpoints included ASAS40, ASAS50, ASAS70 and ASAS5/6 responses, partial remission and quality of life. Safety was assessed until 15 days after the last visit. A total of 108 patients were randomly selected and treated, 54 in each arm. At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). Other efficacy variables improved significantly over time, but not between treatment groups. Fifty-six patients experienced at least one adverse event (generally, infections and infestations, gastrointestinal disorders and injection site reactions), most of them mild or moderate. High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730.

  20. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

    Science.gov (United States)

    Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-04-25

    The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

  1. Fluoxetine treatment of alcoholic perpetrators of domestic violence: a 12-week, double-blind, randomized, placebo-controlled intervention study.

    Science.gov (United States)

    George, David T; Phillips, Monte J; Lifshitz, Mariel; Lionetti, Thomas A; Spero, David E; Ghassemzedeh, Niloofar; Doty, Linda; Umhau, John C; Rawlings, Robert R

    2011-01-01

    Behaviorally based therapies for the treatment of perpetrators who initiate intimate partner violence (IPV) have generally shown minimal therapeutic efficacy. To explore a new treatment approach for IPV, we examined the effects of a selective serotonin reuptake inhibitor on the irritability subscale score of the Modified Overt Aggression Scale. This score served as a surrogate marker for the anger and physical aggression that characterize perpetrators of IPV. A 12-week, double-blind, randomized, placebo-controlled intervention study employing fluoxetine, alcohol treatment, and cognitive-behavioral therapy was performed. Sixty (46 men) non-court-mandated, DSM-IV-diagnosed alcoholic perpetrators of IPV with a history of at least 2 episodes of IPV in the year prior to participation in the study were evaluated. The primary outcome measure was the score on the irritability subscale of the Modified Overt Aggression Scale. Secondary measures included anxiety, depression, and ratings by the perpetrator's spouse/significant other. The study was conducted from January 2002 through December 2007. A repeated-measures analysis of variance using the irritability subscale scores obtained from perpetrators who completed the 12-week study (n = 24) showed a significant drug effect (F(1,21) = 12.09, P = .002). Last observation carried forward (F(1,32) = 4.24, P = .048) as well as intent-to-treat analysis (F(1,54) = 5.0, P = .034) also showed a significant drug effect. Spouses'/significant others' physical and nonphysical Partner Abuse Scale ratings showed a significant reduction of abuse over time (F(1,11) = 10.2, P = .009 and F(1,11) = 24.2, P = .0005, respectively). This is the first controlled study to show that a pharmacologic intervention employing a selective serotonin reuptake inhibitor, in conjunction with alcohol treatment and cognitive-behavioral therapy, can reduce measures of anger and physical aggression in alcoholic perpetrators of IPV. © Copyright 2011 Physicians

  2. Lack of effects of fish oil supplementation for 12 weeks on resting metabolic rate and substrate oxidation in healthy young men: A randomized controlled trial.

    Science.gov (United States)

    Jannas-Vela, Sebastian; Roke, Kaitlin; Boville, Stephanie; Mutch, David M; Spriet, Lawrence L

    2017-01-01

    Fish oil (FO) has been shown to have beneficial effects in the body via incorporation into the membranes of many tissues. It has been proposed that omega-3 fatty acids in FO may increase whole body resting metabolic rate (RMR) and fatty acid (FA) oxidation in human subjects, but the results to date are equivocal. The purpose of this study was to investigate the effects of a 12 week FO supplementation period on RMR and substrate oxidation, in comparison to an olive oil (OO) control group, in young healthy males (n = 26; 22.8 ± 2.6 yr). Subjects were matched for age, RMR, physical activity, VO2max and body mass, and were randomly separated into a group supplemented with either OO (3 g/d) or FO containing 2 g/d eicosapentaenoic acid (EPA) and 1 g/d docosahexaenoic acid (DHA). Participants visited the lab for RMR and substrate oxidation measurements after an overnight fast (10-12 hr) at weeks 0, 6 and 12. Fasted blood samples were taken at baseline and after 12 weeks of supplementation. There were significant increases in the EPA (413%) and DHA (59%) levels in red blood cells after FO supplementation, with no change of these fatty acids in the OO group. RMR and substrate oxidation did not change after supplementation with OO or FO after 6 and 12 weeks. Since there was no effect of supplementation on metabolic measures, we pooled the two treatment groups to determine whether there was a seasonal effect on RMR and substrate oxidation. During the winter season, there was an increase in FA oxidation (36%) with a concomitant decrease (34%) in carbohydrate (CHO) oxidation (p oxidation in healthy young males. Resting FA oxidation was increased and CHO oxidation reduced over a 12 week period in the winter, with no change in RMR. ClinicalTrials.gov NCT02092649.

  3. A 12-week sports-based exercise programme for inactive Indigenous Australian men improved clinical risk factors associated with type 2 diabetes mellitus.

    Science.gov (United States)

    Mendham, Amy E; Duffield, Rob; Marino, Frank; Coutts, Aaron J

    2015-07-01

    This study assessed the effect of a 12-week sports-based exercise intervention on glucose regulation, anthropometry and inflammatory markers associated with the prevalence of type 2 diabetes mellitus (T2DM) in Indigenous Australian men. Twenty-six inactive Indigenous Australian men (48.6±6.6 years) were randomized into exercise (n=16) or control (n=10)conditions. Training included ∼2-3 days/week for 12 weeks of sports and gym exercises in a group environment, whilst control participants maintained normal activity and dietary patterns. Pre- and post-intervention testing included: anthropometry, peak aerobic capacity, fasting blood chemistry of inflammatory cytokines, adiponectin, leptin, cholesterol, glucose, insulin and C-peptide. An oral glucose tolerance test measured glucose, insulin and C-peptide 30, 60, 90 and 120min post 75g glucose ingestion. The exercise condition decreased insulin area under the curve (25±22%), increased estimated insulin sensitivity (35±62%) and decreased insulin resistance (9±35%; p0.05). The exercise condition decreased in body mass index, waist circumference and waist to hip ratio (p0.05). Leptin decreased in the exercise group, with no changes for adiponectin (p>0.05) or inflammatory markers (p>0.05) in either condition. Aerobic fitness variables showed significant increases in peak oxygen consumption for the exercise condition compared to no change in control (p>0.05). Findings indicate positive clinical outcomes in metabolic, anthropometric and aerobic fitness variables. This study provides evidence for sport and group-based activities leading to improved clinical risk factors associated with T2DM development in clinically obese Indigenous Australian men. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  4. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study.

    Science.gov (United States)

    Schulz, S Charles; Zanarini, Mary C; Bateman, Anthony; Bohus, Martin; Detke, Holland C; Trzaskoma, Quynh; Tanaka, Yoko; Lin, Daniel; Deberdt, Walter; Corya, Sara

    2008-12-01

    Despite the prevalence and clinical significance of borderline personality disorder, its treatment remains understudied. To evaluate treatment with variably dosed olanzapine in individuals with borderline personality disorder. In this 12-week randomised, double-blind trial, individuals received olanzapine (2.5-20 mg/day; n=155) or placebo (n=159) (trial registry: NCT00091650). The primary efficacy measure was baseline to end-point change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) using last-observation-carried-forward methodology. Both olanzapine and placebo groups showed significant improvements but did not differ in magnitude at end-point (-6.56 v. -6.25, P=0.661). Response rates (50% reduction in ZAN-BPD) were 64.7% with olanzapine and 53.5% with placebo (P=0.062); however, time to response was significantly shorter for olanzapine (P=0.022). Weight gain was significantly greater (2.86 v. -0.35 kg, P<0.001), with higher incidence of treatment-emergent abnormal high levels of prolactin for the olanzapine group. Individuals treated with olanzapine and placebo showed significant but not statistically different improvements on overall symptoms of borderline personality disorder. The types of adverse events observed with olanzapine treatment appeared similar to those observed previously in adult populations.

  5. A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

    Science.gov (United States)

    Klukowska, Malgorzata; Grender, Julie M; Conde, Erinn; Goyal, C Ram

    2013-01-01

    The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

  6. A 12-Week Commercial Web-Based Weight-Loss Program for Overweight and Obese Adults: Randomized Controlled Trial Comparing Basic Versus Enhanced Features

    Science.gov (United States)

    Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-01-01

    Background The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. Objective To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. Methods This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. Results We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: –0.72, SD 1.1 kg/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P 3.0, SD 4.1, control: 0.4, SD 2.3; P 2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033; http

  7. The effect of 1g of acetaminophen twice daily for 12 weeks on alanine transaminase levels--A randomized placebo-controlled trial.

    Science.gov (United States)

    Ioannides, Sally J; Siebers, Robert; Perrin, Kyle; Weatherall, Mark; Crane, Julian; Travers, Justin; Shirtcliffe, Philippa; Beasley, Richard

    2015-07-01

    Acetaminophen is often used on a regular, daily basis for the treatment of chronic pain; however, the safety of regular acetaminophen is still debated. This study determined whether 12 weeks of treatment with acetaminophen at half the maximum recommended daily dose causes an increase in alanine transaminase (ALT) in healthy adults participating in a clinical trial of the effect of acetaminophen on asthma control and severity. 94 healthy adults aged 18-65 years with mild to moderate asthma and with no history of previous liver dysfunction and an ALT within 1.5 times the upper limit of normal at baseline participated in a randomized, double-blind, placebo-controlled, parallel-group, clinical trial of 1g of acetaminophen twice daily or placebo twice daily for 12 weeks. Liver function monitoring was undertaken at baseline, weeks 2, 4, 6 and 12. The primary outcome variable was mean ALT levels at week 12 compared to baseline in the acetaminophen group versus placebo group. 94 participants were randomized and commenced study treatment. One participant in each treatment group was withdrawn due to an increase in ALT to greater than three times the upper limit of normal. Mean ALT at week 12 was 25.4I U/L (SD 9.7) in the acetaminophen group (N=31) and 19.0 IU/L (SD 6.0) in the placebo group (N=54). After controlling for baseline this represented a statistically significant difference of 3.6 IU/L (95% CI 1.3 to 6.0, P=0.003). There was no progressive increase in ALT demonstrated throughout the trial. Regular, daily use of acetaminophen at half the maximum recommended daily dose for 12 weeks in a healthy adult population is associated with a small elevation in mean ALT of no probable clinical significance. Further assessment of the effects on liver function of the maximum recommended dose of acetaminophen is required. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  8. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women.

    Science.gov (United States)

    Canuto, Karla J; McDermott, Robyn A; Cargo, Margaret; Esterman, Adrian J

    2011-08-19

    Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC) have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA), haemoglobin A1C (HbA1C), triglycerides and C-reactive protein (CRP). Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP) is designed to provide a rigorous physiological and client

  9. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women

    Directory of Open Access Journals (Sweden)

    Cargo Margaret

    2011-08-01

    Full Text Available Abstract Background Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. Methods/Design The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA, haemoglobin A1C (HbA1C, triglycerides and C-reactive protein (CRP. Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. Discussion The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP is designed

  10. Pragmatic randomised trial of a 12-week exercise and nutrition program for Aboriginal and Torres Strait Islander women: clinical results immediate post and 3 months follow-up.

    Science.gov (United States)

    Canuto, Karla; Cargo, Margaret; Li, Ming; D'Onise, Katina; Esterman, Adrian; McDermott, Robyn

    2012-10-31

    Aboriginal and Torres Strait Islander women experience higher rates of heart disease and type 2 diabetes than non-Indigenous Australian women. Increasing physical activity, improving diets and losing weight have been shown to reduce cardio metabolic risk. The primary aim was to evaluate the effectiveness of a 12-week structured exercise and nutrition program in a cohort of urban Indigenous Australian women on waist circumference, weight and biomedical markers of metabolic functioning from baseline (T1) to program completion (T2). The secondary aim assessed whether these outcomes were maintained at 3-month follow-up. One hundred Aboriginal and/or Torres Strait Islander women aged 18-64 years living in the Adelaide metropolitan area were recruited. The program included two 60-minute group cardiovascular and resistance training classes per week, and four nutrition education workshops. Participants were randomly assigned to an 'active' group or 'waitlisted' control group. Body weight, height, waist and hip circumference, blood pressure, fasting glucose, fasting insulin, glycated haemoglobin (HbA1C), lipid profile and C-reactive protein (CRP) were assessed at baseline (T1), immediately after the program (T2) and three months post program (T3). The active group showed modest reductions in weight and body mass index (BMI). Compared to the waitlisted group, the active group had a statistically significantly change in weight and BMI from baseline assessments; at T2, (-)1.65 kg and (-)0.66 kg/m(2) and at T3, (-)2.50 kg and (-)1.03 kg/m(2), respectively. Systolic and diastolic blood pressure also had a statistically significant difference from baseline in the active group compared to the waitlisted group at T2, (-)1.24 mmHg and (-)2.46 mmHg and at T3, (-)4.09 mmHg and (-)2.17 mmHg, respectively. The findings were independent of the baseline measure of the outcome variable, age, households with children and employment status. Changes in waist circumference and other clinical

  11. A randomised controlled trial comparing the effects of a 12-week supervised exercise versus usual care on outcomes in haematological cancer patients.

    Science.gov (United States)

    Furzer, Bonnie J; Ackland, Timothy R; Wallman, Karen E; Petterson, Anna S; Gordon, Sandy M; Wright, Kemi E; Joske, David J L

    2016-04-01

    Following treatment, haematological cancer (HEM) patients exhibit significant physical deconditioning and psychological distress. Exercise has been shown as a clinically effective and safe intervention for cancer patients, with the potential to reverse the deleterious effects following treatment. Our aim was to investigate the efficacy of a 12-week exercise rehabilitation on cancer-related fatigue (CRF) and associated outcomes in HEM patients post-treatment. Patients with a HEM were recruited to participate in a 12-week exercise rehabilitation intervention post-treatment. Pre-, post- and follow-up assessments were conducted on outcome measures including CRF, quality of life (QoL), psychological distress, cardiovascular fitness, muscle strength (MS) and body composition. Patients were given tailored exercise programmes comprising aerobic and resistance exercises, carried out three times per week for 12 weeks in local gyms and clinics. Usual-care participants were offered a delayed, tailored 12-week exercise intervention after the initial study period. Thirty-seven patients (49 % recruitment rate) were randomly assigned to the 12-week exercise rehabilitation (n = 18) or usual care (n = 19) with a 91 % adherence to the exercise intervention. Following the exercise programme, significant improvements were seen in CRF (p = 0.01), cardiovascular fitness (p ≤ 0.001), QoL (p ≤ 0.001), MS (p ≤ 0.001) and body composition (p = 0.001), with moderate to large effects for all primary outcomes. Patient follow-up at 24 weeks demonstrated outcome maintenance in the exercise rehabilitation group and significant improvements in outcomes in usual-care patients following participation in a delayed exercise programme. There were no adverse reactions or study withdrawals. A 12-week exercise rehabilitation programme resulted in significant statistical (p ≤ 0.05) and clinical improvements in CRF and additional outcomes in HEM patients following

  12. Evaluation of immediate and 12-week effects of a smartphone sun-safety mobile application: a randomized clinical trial.

    Science.gov (United States)

    Buller, David B; Berwick, Marianne; Lantz, Kathy; Buller, Mary Klein; Shane, James; Kane, Ilima; Liu, Xia

    2015-05-01

    Mobile applications on smartphones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether recipients can be convinced to use them. To evaluate a smartphone mobile application (Solar Cell) delivering real-time advice about sun protection for a second time in a randomized clinical trial. A previous trial conducted in 2012 used a randomized pretest-posttest design. For the present trial, we collected data from a volunteer sample of 202 adults 18 years or older who owned a smartphone. Participants were recruited nationwide through online promotions. Screening procedures and a 3-week run-in period were added to increase the use of the mobile application. We conducted follow-ups at 3 and 8 weeks after randomization to examine the immediate and the longer-term effects of the intervention. Use of the mobile application. The application gave feedback on sun protection (ie, sun-safety practices and the risk for sunburn) and alerted users to apply or to reapply sunscreen and to get out of the sun. The application also displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Percentage of days with the use of sun protection, time spent outdoors in the midday sun (days and hours), and the number of sunburns in the last 3 months. Participants in the intervention group used wide-brimmed hats more at 7 weeks than control participants (23.8% vs 17.4%; F = 4.07; P = .045). Women who used the mobile application reported using all sun protection combined more than men (46.4% vs 43.3%; F = 1.49; P = .04), whereas men and older individuals reported less use of sunscreen (32.7% vs 35.5%; F = 5.36; P = .02) and hats (15.6% vs 17.9%; F = 4.72; P = .03). The mobile application initially appeared to confer weak improvement of sun protection. Use of the mobile application was greater than in a previous trial and was

  13. The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Riiser

    Full Text Available Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL. Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents.In this controlled trial, participants (13-15 years were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test.Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04, and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02. Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (-0.39; 95% CI [-0.74;-0.03]; P = 0.03 for the intervention group.The results suggest that the Internet intervention with tailored physical activity counseling

  14. A 12-week low-carbohydrate, high-fat diet improves metabolic health outcomes over a control diet in a randomised controlled trial with overweight defence force personnel.

    Science.gov (United States)

    Zinn, Caryn; McPhee, Julia; Harris, Nigel; Williden, Micalla; Prendergast, Kate; Schofield, Grant

    2017-11-01

    Overweight, obesity, and poor health is becoming a global concern for defence force personnel. Conventional nutrition guidelines are being questioned for their efficacy in achieving optimal body composition and long-term health. This study compared the effects of a 12-week low-carbohydrate, high-fat diet with a conventional, high-carbohydrate, low-fat diet on weight reduction and metabolic health outcomes in at-risk New Zealand Defence Force personnel. In this randomised controlled trial, 41 overweight personnel were assigned to intervention and control groups. Weight, waist circumference, fasting lipids, and glycaemic control were assessed at baseline and at 12 weeks. Within-group change scores were analysed using the t statistic and interpreted using a p control). Both groups showed statistically significant weight and waist circumference reductions; the intervention group significantly reduced triglycerides and serum glucose and significantly increased high-density lipoprotein cholesterol (HDLc). Relative to control, the intervention group showed small, possibly to likely beneficial effects for weight, triglycerides, glucose, insulin, and homeostasis model assessment of insulin resistance; moderate, likely beneficial effects for HDL cholesterol, triglyceride:HDLc ratio and HbA1c; and a small, likely harmful effect for low-density lipoprotein cholesterol. This dietary approach shows promise for short-term weight loss and improved metabolic health outcomes conditions compared with mainstream recommendations. It should be offered to defence force personnel at least as a viable alternative means to manage their weight and health.

  15. A 12-week placebo-controlled study of rupatadine 10 mg once daily compared with cetirizine 10 mg once daily, in the treatment of persistent allergic rhinitis.

    Science.gov (United States)

    Fantin, S; Maspero, J; Bisbal, C; Agache, I; Donado, E; Borja, J; Mola, O; Izquierdo, I

    2008-07-01

    With the current increasing incidence of allergies worldwide, new treatments showing efficacy and long term safety are needed for chronic conditions such as persistent allergic rhinitis (PER). New generation H1-antihistamines have demonstrated anti-allergic properties, which could possibly enhance their effectiveness in long-term periods of treatment. To investigate the efficacy of rupatadine, in controlling symptoms of PER over a 12-week period. A randomized, double blind, parallel-group, placebo-controlled study was carried out in patients aged older than 12 years with PER. Main inclusion criteria were: instantaneous total symptom score (i6TSS) >or=45, nasal obstruction score or=2 as moderate during the first visit. The primary efficacy endpoint was the 12-week average change from baseline of the patients' i6TSS. In all, 736 patients were selected. Of them, 543 (73.8%) were randomized in three different groups: placebo (n = 185), cetirizine (n = 175) and rupatadine (n = 183). Rupatadine (P = 0.008) but not cetirizine (P = 0.07) statistically reduced the baseline i6TSS vs placebo (47.8%, 44.7% and 38.8%, respectively), after 12 weeks. Onset of action was observed at the first 24 h for both treatments (rupatadine vs placebo, P = 0.013; cetirizine vs placebo, P = 0.015). Furthermore, instantaneous total nasal symptoms score (iTNSS) (including nasal blockage) mean change from baseline showed a significant reduction with rupatadine 10 mg in comparison with placebo, along all treatment duration of 12 weeks. Study treatments were well tolerated. Rupatadine significantly relieves symptoms of PER, providing a rapid onset of action and maintains its effects over a long period of 12-weeks.

  16. Exploring the role of need for cognition, field independence and locus of control on the incidence of lucid dreams during a 12 week induction study

    OpenAIRE

    Saunders, David; Clegg, Helen; Roe, Chris A; Smith, G.D.

    2017-01-01

    This article reports an investigation of two proposed theories, the predispositional and experiential, regarding the association of personality variables to lucid dreaming incidence during a 12-week lucid dreaming induction programme. The study found no differences between those who did and did not report lucid dreams during the programme on baseline measures of Field Independence, Locus of Control or Need for Cognition. There was an observed significant change towards a Field Independent ori...

  17. Weekly self-measurement of FEV1 and PEF and its impact on ACQ (asthma control questionnaire)-scores: 12-week observational study with 76 patients.

    Science.gov (United States)

    Werner, Christoph Ulrich; Linde, Klaus; Schäffner, Julia; Storr, Constanze; Schneider, Antonius

    2017-12-08

    The "Asthma Control Questionnaire" (ACQ) is a very common questionnaire for assessing asthma control. This study compares different ACQ versions in a self-monitoring program over a 12-week period combining them with patients' self-measurements of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1). The objective was to test the feasibility of FEV1-self-measurements and to compare ACQ versions regarding possible additional information given by lung function. In this prospective multicenter observational study 100 adult asthma patients, recruited at six family practices and two pulmologists' private practices in Germany, completed the ACQ weekly, performing self-measurements of PEF and FEV1. Seventy-six patients were included into final analysis with only 3% missing values. Scores for all ACQ versions improved significantly (all P-values PEF with high Pearson's correlation coefficients of all scores (r between 0.96 and 0.99). ACQ7-FEV1 scores were significantly higher than others. Separated courses of lung function parameters showed nearly no change, but ACQ5 and ACQ6 as scores for symptoms and reliever medication improved constantly. ACQ5 and ACQ6 revealed higher percentages of patients classified as "controlled" than ACQ7-scores. In conclusion, with only a few missing data points, our results suggest feasibility of FEV1-self-measurements. Courses of symptom-related and lung function-related ACQ items differ clearly. Our results support the GINA recommendations to consider symptoms and lung function separately. FEV1-self-measurements for research purposes may be included with the ACQ, but in clinical practice seem to measure a different domain to symptomatic asthma control.

  18. Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study.

    Science.gov (United States)

    Park, Sung-Woo; Kim, Tae Nam; Nam, Jong-Kil; Ha, Hong Koo; Shin, Dong Gil; Lee, Wan; Kim, Mi-Sook; Chung, Moon Kee

    2012-08-01

    To examine the changes from a combined exercise intervention after radical prostatectomy (RP) in elderly patients with prostate cancer, because randomized controlled trials addressing exercise intervention after RP have been lacking. From May 2009 to May 2010, all patients who underwent laparoscopic RP were assessed for eligibility. A total of 66 patients were randomized to an exercise or a control group. The exercise group received a combined exercise intervention (resistance, flexibility, and Kegel exercises) twice a week for 12 weeks, and the control group received only Kegel exercises. The primary outcome was physical function, and the secondary outcomes were continence status and quality of life after the exercise intervention. A total of 49 patients completed follow-up to the end of study. After the 12-week exercise intervention, except for grip strength, all physical functions were better in the exercise group than in the control group. The 24-hour pad test results (12.2 g in the exercise group, 46.2 g in the control group) and continence rate (73.1% in exercise group, 43.5% in the control group) recovered more promptly in the exercise group. On a questionnaire study using the International Consultation on Incontinence questionnaire, Beck Depression Inventory, and Medical Outcomes Study 36-item short-form health survey, only the exercise group showed improvement at the last follow-up visit. A 12-week combined exercise intervention after RP results in improvement of physical function, continence rate, and quality of life. These results could help with prompt recovery of daily activities. Copyright © 2012 Elsevier Inc. All rights reserved.

  19. Effect of 12 Weeks of Yoga Therapy on Quality of Life and Indian Diabetes Risk Score in Normotensive Indian Young Adult Prediabetics and Diabetics: Randomized Control Trial.

    Science.gov (United States)

    Keerthi, Gorantla Shravya; Pal, Pravati; Pal, Gopal Krushna; Sahoo, Jaya Prakash; Sridhar, Magadi Gopalakrishna; Balachander, Jayaraman

    2017-09-01

    India has become the epicentre for diabetes, a stress-related disorder affecting the working skills and day-to-day lifestyle management of younger population. Most of the studies have reported the effect of yoga on improving Quality of Life (QoL) in diabetic patients with other comorbidities. Till date, no randomized control trial reports are available to show the effect of yoga therapy on QoL and Indian Diabetes Risk Score (IDRS) in normotensive prediabetic and diabetic young individuals. To determine the effect of 12 weeks of yoga therapy on QoL and IDRS among normotensive prediabetic and diabetic young Indian adults. A randomized control trial was conducted in Endocrinology Outpatient Department (OPD). Normotensive participants (n=310) aged 18-45 years were divided into healthy controls (n=62), prediabetics (n=124) and diabetics (n=124). Study group subjects were randomly assigned to Group II (n=62, prediabetes-standard treatment), Group III (n=62, prediabetes-standard treatment + yoga therapy), Group IV (n=62, diabetes-standard treatment) and Group V (n=62, diabetes-standard treatment + yoga therapy). Flanagan QoL scale, IDRS questionnaire, Fasting Plasma Glucose (FPG) and insulin were assessed pre and post 12 weeks of intervention. Statistical analysis was done using Student's paired t-test and one-way ANOVA. Pre-post intervention analysis showed significant improvement in QoL scale with ppV respectively. There was significant reduction in IDRS in Group II (ppV respectively. Significant difference (p<0.001) in QoL scale and IDRS were found when study groups with standard treatment along with yoga therapy were compared to standard treatment alone. Yoga therapy along with standard treatment for 12 weeks improved QoL and attenuated the diabetes risk among Indian prediabetics and diabetics compared to standard treatment alone.

  20. A 12-Week Physical and Cognitive Exercise Program Can Improve Cognitive Function and Neural Efficiency in Community-Dwelling Older Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Nishiguchi, Shu; Yamada, Minoru; Tanigawa, Takanori; Sekiyama, Kaoru; Kawagoe, Toshikazu; Suzuki, Maki; Yoshikawa, Sakiko; Abe, Nobuhito; Otsuka, Yuki; Nakai, Ryusuke; Aoyama, Tomoki; Tsuboyama, Tadao

    2015-07-01

    To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults. Randomized controlled trial. Kyoto, Japan. Community-dwelling older adults (N = 48) were randomized into an exercise group (n = 24) and a control group (n = 24). Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase. Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase. The outcome measures were global cognitive function, memory function, executive function, and brain activation (measured using functional magnetic resonance imaging) associated with visual short-term memory. Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group (P brain regions associated with visual short-term memory, including the prefrontal cortex, in the exercise group (P physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults, which is associated with improvements in memory and executive function. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  1. A dose comparison of olanzapine for the treatment of borderline personality disorder: a 12-week randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Zanarini, Mary C; Schulz, S Charles; Detke, Holland C; Tanaka, Yoko; Zhao, Fangyi; Lin, Daniel; Deberdt, Walter; Kryzhanovskaya, Ludmila; Corya, Sara

    2011-10-01

    To examine the efficacy and safety of olanzapine at low and moderate doses for the treatment of borderline personality disorder. In this 12-week randomized double-blind placebo-controlled trial, 451 outpatients aged 18-65 years with DSM-IV borderline personality disorder received olanzapine 2.5 mg/d (n = 150), olanzapine 5-10 mg/d (n = 148), or placebo (n = 153). The trial was conducted from February 2004 through January 2006 at 59 community-based and academic study centers in 9 countries (United States, Italy, Poland, Romania, Turkey, Chile, Peru, Argentina, and Venezuela). The primary efficacy measure was mean change from baseline to last-observation-carried-forward endpoint on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score. Secondary measures included the Montgomery-Asberg Depression Rating Scale, the Modified Overt Aggression Scale, the Global Assessment of Functioning, the Symptom Checklist-90-Revised, and the Sheehan Disability Scale. An overall mean baseline ZAN-BPD total score of 17.2 (SD = 4.9) indicated moderate symptom severity. Only treatment with olanzapine 5-10 mg/d was associated with significantly greater mean change from baseline to endpoint in ZAN-BPD total score relative to placebo (-8.5 vs -6.8, respectively; P = .010; effect size = 0.29; 95% CI, 0.06-0.52). Response rates (response indicated by ≥ 50% decrease from baseline in ZAN-BPD total score) were significantly higher for olanzapine 5-10 mg/d (73.6%) versus olanzapine 2.5 mg/d (60.1%; P = .018) and versus placebo (57.8%; P = .006). Time to response was also significantly shorter for patients taking olanzapine 5-10 mg/d than for placebo-treated patients (P = .028). Treatment-emergent adverse events reported significantly more frequently among olanzapine-treated patients included somnolence, fatigue, increased appetite, and weight increase (all P values < .05). Mean weight change from baseline to endpoint was significantly greater for olanzapine

  2. The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Laleh Koohi Habibi

    2007-06-01

    Full Text Available "nObjective: Exposure to traumatic stressors lead to activation of arousal responses mediated by serotonergic and noradrenergic systems and it may cause a change in numerous neurotransmitters and neuroendocrine systems. There is ample experimental and clinical evidence to suggest that Ginkgo biloba extract is neuroprotective and has antioxidant properties and can restore stress-induced elevation in brain levels of catecholamines, 5-HT and plasma corticosterone to normal level. "nMethod: In a 12-week, double-blind, placebo-controlled study, the efficacy and safety of adding-on a fixed-dose (200mg of Ginkgo TD to the previous treatment regime of adults with PTSD were examined. Subjects were forty male and female outpatients from a public-owned psychiatric clinic who met criteria for PTSD seven month after a 6.3 Richter earthquake in Bam city on December 26, 2003. The changes in five symptom domains including posttraumatic stress, anxiety and affective symptoms, general health and subjective stress after trauma were ssessed at weeks 0, 12 and 16 to examine effectiveness of the added-on Ginkgo TD and stability of its effects. "nResults: Ginkgo TD was associated with a significantly greater improvement than placebo in PTSD patients as measured by five symptom domain scales including: GHQ-28; Watson PTSD Scale; HAM-D; HAM-A and IES (p= 0.02, 0.01, 0.001, 0.01, 0.02 respectively Four weeks after the discontinuation of intervention, no significant difference was determined between the two groups in the five outcome measures (p= 0.005, 0.01, 0.004, 0.005, 0.01 respectively. No significant difference was observed between the two groups in terms of side effects. "nConclusions: We found Ginkgo TD to be superior to placebo as an adding-on in the treatment of PTSD. Although we did not examine the comparative efficacy of Ginkgo TD on the three main elements of PTSD, beneficial effects both on specific PTSD symptomatology and general conditions including

  3. Aloe sterol supplementation improves skin elasticity in Japanese men with sunlight-exposed skin: a 12-week double-blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tanaka M

    2016-11-01

    Full Text Available Miyuki Tanaka,1 Yuki Yamamoto,2 Eriko Misawa,1 Kazumi Nabeshima,1 Marie Saito,1 Koji Yamauchi,1 Fumiaki Abe,1 Fukumi Furukawa2 1Functional Food Ingredients Department, Food Ingredients & Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, 2Department of Dermatology, Wakayama Medical University, Kimiidera, Wakayama, Japan Background/objective: Recently, it was confirmed that the daily oral intake of plant sterols of Aloe vera gel (Aloe sterol significantly increases the skin barrier function, moisture, and elasticity in photoprotected skin. This study aimed to investigate whether Aloe sterol intake affected skin conditions following sunlight exposure in Japanese men. Methods: We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin conditions in 48 apparently healthy men (age range: 30–59 years; average: 45 years. The subjects were instructed to expose the measurement position of the arms to the sunlight outdoors every day for 12 weeks. The skin parameters were measured at 0 (baseline, 4, 8, and 12 weeks. Results: Depending on the time for the revelation of the sunlight, the b* value and melanin index increased and the skin moisture decreased. After taking an Aloe sterol tablet daily for 12 weeks, the skin elasticity index (R2, R5, and R7 levels were significantly higher than the baseline value. There were no differences between the groups in these skin elasticity values. In the subgroup analysis of subjects aged <46 years, the change in the R5 and R7 was significantly higher in the Aloe group than in the placebo group at 8 weeks (P=0.0412 and P=0.0410, respectively. There was a difference in the quantity of sun exposure between each subject, and an additional clinical study that standardizes the amount of ultraviolet rays is warranted. No Aloe sterol intake-dependent harmful phenomenon was observed during the intake period

  4. Dose-finding study of luseogliflozin in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, double-blind, placebo-controlled, phase II study.

    Science.gov (United States)

    Seino, Yutaka; Sasaki, Takashi; Fukatsu, Atsushi; Ubukata, Michito; Sakai, Soichi; Samukawa, Yoshishige

    2014-07-01

    Luseogliflozin is a selective sodium glucose cotransporter 2 inhibitor under development for the treatment of type 2 diabetes mellitus (T2DM). This phase II study was conducted to confirm the efficacy and safety of luseogliflozin monotherapy at doses of up to 10 mg in Japanese patients with T2DM. Patients with hemoglobin A1c (HbA1c) of 6.9-10.5% on diet therapy were randomized in a double-blind manner to treatment with 1, 2.5, 5, or 10 mg luseogliflozin or placebo for 12 weeks (n = 56, 56, 54, 58, and 58, respectively). Japan Pharmaceutical Information Center (identifier: Japic CTI-101191). The primary endpoint was the change in HbA1c from baseline to the end of treatment. Other endpoints included fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and body weight. Adverse events were recorded throughout the study. HbA1c decreased significantly at the end of treatment in the 1, 2.5, 5, and 10 mg luseogliflozin groups compared with placebo (-0.29, -0.39, -0.46, and -0.43%, respectively, versus +0.22%; all P < 0.001), as did FPG and PPG (all P < 0.001). Body weight also decreased significantly in all luseogliflozin groups compared with placebo (all P < 0.001). The incidence rates of adverse events (40.0-50.0%) were not significantly different among the five groups. The overall incidence of hypoglycemia was low. Limitations of this study include the short study duration and the relatively small sample size. In Japanese patients with T2DM, luseogliflozin was well tolerated, improved glycemic control, and reduced body weight over 12 weeks of treatment at all tested doses. Doses of ≥2.5 mg achieved similar improvements in glycemic control.

  5. A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks.

    Science.gov (United States)

    Chang, Anne Lynn S; Alora-Palli, Maria; Lima, Xinaida T; Chang, Tiffany C; Cheng, Carol; Chung, Connie M; Amir, Omar; Kimball, Alexa B

    2012-03-01

    Papulopustular acne rosacea is a chronic inflammatory condition which can be difficult to treat. Many patients are unwilling to use systemic medications, and single topical agents alone may not address all the symptoms of rosacea. A combination topical clindamycin phosphate 1.2% and tretinoin 0.025% gel is efficacious for acne vulgaris, and may be helpful for rosacea, since acne vulgaris and rosacea shares many similar clinical and histologic features. To assess the preliminary efficacy and safety of a combination gel consisting of clindamycin phosphate 1.2% and tretinoin 0.025% on papulopustular rosacea after 12 weeks of usage. Randomized, double-blind, placebo controlled two site study of 79 participants with moderate to severe papulopustular acne rosacea using both physician and subjects' validated assessment tools. Primary endpoint consisted of statistically significant reduction in absolute papule or pustule count after 12 weeks of usage. There was no significant difference in papule/pustule count between placebo and treated groups after 12 weeks (P=0.10). However, there was nearly significant improvement in physicians' assessments of the telangiectasia component of rosacea (P=0.06) and erythematotelangiectatic rosacea subtype (P=0.05) in treated versus placebo group after 12 weeks. The only significant adverse event different was facial scaling, which was significantly increased in treated group (P=0.01), but this did not result in discontinuation of study drug. A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025% may improve the telangiectatic component of rosacea and appears to better treat the erythemotelangiectatic subtype of rosacea rather than papulopustular subtype. Our preliminary study suggests that future studies with much larger sample size might confirm our findings.

  6. GLP-1-Based Therapies Have No Microvascular Effects in Type 2 Diabetes Mellitus: An Acute and 12-Week Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Diamant, Michaela; Serné, Erik H; van Raalte, Daniël H

    2016-10-01

    To assess the effects of glucagon-like peptide (GLP)-1-based therapies (ie, GLP-1 receptor agonists and dipeptidyl peptidase-4 inhibitors) on microvascular function in patients with type 2 diabetes mellitus. We studied 57 patients with type 2 diabetes mellitus (mean±SD age: 62.8±6.9 years; body mass index: 31.8±4.1 kg/m(2); HbA1c [glycated hemoglobin] 7.3±0.6%) in an acute and 12-week randomized, placebo-controlled, double-blind trial conducted at the Diabetes Center of the VU University Medical Center. In the acute study, the GLP-1 receptor agonist exenatide (therapeutic concentrations) or placebo (saline 0.9%) was administered intravenously. During the 12-week study, patients received the GLP-1 receptor agonist liraglutide (1.8 mg daily), the dipeptidyl peptidase-4 inhibitor sitagliptin (100 mg daily), or matching placebos. Capillary perfusion was assessed by nailfold skin capillary videomicroscopy and vasomotion by laser Doppler fluxmetry, in the fasting state and after a high-fat mixed meal. In neither study, treatment affected fasting or postprandial capillary perfusion compared with placebo (P>0.05). In the fasting state, acute exenatide infusion increased neurogenic vasomotion domain power, while reducing myogenic domain power (both Pdiabetes mellitus. Twelve-week treatment with liraglutide or sitagliptin has no effect on capillary perfusion or vasomotion in these patients. Our data suggest that the effects of GLP-1-based therapies on glucose are not mediated through microvascular responses. © 2016 American Heart Association, Inc.

  7. Can the Functional Movement Screen™ be used to capture changes in spine and knee motion control following 12 weeks of training?

    Science.gov (United States)

    Frost, David M; Beach, Tyson A C; Campbell, Troy L; Callaghan, Jack P; McGill, Stuart M

    2017-01-01

    To examine whether objective measures of spine and frontal plane knee motion exhibited during Functional Movement Screen™ (FMS) task performance changed following a movement-guided fitness (MOV) and conventional fitness (FIT) exercise intervention. Secondary analysis of a randomized controlled experiment. Before and after 12 weeks of exercise, participants' kinematics were quantified while performing the FMS and a series of general whole-body movement tasks. Biomechanics laboratory. Fifty-two firefighters were assigned to MOV, FIT, or a control (CON) group. Peak lumbar spine flexion/extension, lateral bend and axial twist, and frontal plane knee motion. The post-training kinematic changes exhibited by trainees while performing the FMS tasks were similar in magnitude (effect size spine and frontal plane knee motion control (effect size > 0.5). Whether graded qualitatively, or quantitatively via kinematic analyses, the FMS may not be a viable tool to detect movement-based exercise adaptations. Amendments to the FMS tasks and/or scoring method are needed before it can be used for reasons beyond appraising the ability to move freely, symmetrically, and without pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Fructose intervention for 12 weeks does not impair glycemic control or incretin hormone responses during oral glucose or mixed meal tests in obese men.

    Science.gov (United States)

    Matikainen, N; Söderlund, S; Björnson, E; Bogl, L H; Pietiläinen, K H; Hakkarainen, A; Lundbom, N; Eliasson, B; Räsänen, S M; Rivellese, A; Patti, L; Prinster, A; Riccardi, G; Després, J-P; Alméras, N; Holst, J J; Deacon, C F; Borén, J; Taskinen, M-R

    2017-06-01

    Incretin hormones glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP) are affected early on in the pathogenesis of metabolic syndrome and type 2 diabetes. Epidemiologic studies consistently link high fructose consumption to insulin resistance but whether fructose consumption impairs the incretin response remains unknown. As many as 66 obese (BMI 26-40 kg/m(2)) male subjects consumed fructose-sweetened beverages containing 75 g fructose/day for 12 weeks while continuing their usual lifestyle. Glucose, insulin, GLP-1 and GIP were measured during oral glucose tolerance test (OGTT) and triglycerides (TG), GLP-1, GIP and PYY during a mixed meal test before and after fructose intervention. Fructose intervention did not worsen glucose and insulin responses during OGTT, and GLP-1 and GIP responses during OGTT and fat-rich meal were unchanged. Postprandial TG response increased significantly, p = 0.004, and we observed small but significant increases in weight and liver fat content, but not in visceral or subcutaneous fat depots. However, even the subgroups who gained weight or liver fat during fructose intervention did not worsen their glucose, insulin, GLP-1 or PYY responses. A minor increase in GIP response during OGTT occurred in subjects who gained liver fat (p = 0.049). In obese males with features of metabolic syndrome, 12 weeks fructose intervention 75 g/day did not change glucose, insulin, GLP-1 or GIP responses during OGTT or GLP-1, GIP or PYY responses during a mixed meal. Therefore, fructose intake, even accompanied with mild weight gain, increases in liver fat and worsening of postprandial TG profile, does not impair glucose tolerance or gut incretin response to oral glucose or mixed meal challenge. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University

  9. Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.

    Science.gov (United States)

    Seino, Yutaka; Sasaki, Takashi; Fukatsu, Atsushi; Sakai, Soichi; Samukawa, Yoshishige

    2014-07-01

    Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients. Japanese T2DM patients aged 20-74 years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) ≥126 mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body weight. Drug safety was also assessed. Japan Pharmaceutical Information Center (identifier: JapicCTI-090908). Changes in HbA1c from baseline to end of treatment were -0.36, -0.62, and -0.75% in the 0.5, 2.5, and 5 mg luseogliflozin groups, respectively, versus +0.06% in the placebo group (all P < 0.001). The reductions in FPG and 2 h-PPG in the MTT were also significantly greater in the luseogliflozin groups (all P < 0.01) without increases in insulin levels from baseline. Luseogliflozin reduced body weight at all doses. There were no significant differences in the incidences of adverse events among groups. Most adverse events were mild in severity. There were no serious adverse events. Although this was a small-scale study with a short duration, all tested doses of luseogliflozin significantly improved glycemic control, reduced body weight, and were well tolerated in Japanese T2DM patients over the 12-week treatment period.

  10. Effects of Aloe Sterol Supplementation on Skin Elasticity, Hydration, and Collagen Score: A 12-Week Double-Blind, Randomized, Controlled Trial.

    Science.gov (United States)

    Tanaka, Miyuki; Yamamoto, Yuki; Misawa, Eriko; Nabeshima, Kazumi; Saito, Marie; Yamauchi, Koji; Abe, Fumiaki; Furukawa, Fukumi

    2016-01-01

    Our previous study confirmed that Aloe sterol stimulates collagen and hyaluronic acid production in human dermal fibroblasts. This study aims to investigate whether Aloe sterol intake affects skin conditions. We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin elasticity, hydration, and the collagen score in 64 healthy women (age range 30-59 years; average 44.3 years) who were randomly assigned to receive either a placebo or an Aloe sterol-supplemented yogurt. Skin parameters were measured and ultrasound analysis of the forearm was performed. ANCOVA revealed statistical differences in skin moisture, transepidermal water loss, skin elasticity, and collagen score between the Aloe sterol and placebo groups. The gross elasticity (R2), net elasticity (R5), and biological elasticity (R7) scores of the Aloe sterol group significantly increased with time. In addition, skin fatigue area F3, which is known to decrease with age and fatigue, also increased with Aloe sterol intake. Ultrasound echogenicity revealed that the collagen content in the dermis increased with Aloe sterol intake. The results suggest that continued Aloe sterol ingestion contributes to maintaining healthy skin. © 2017 S. Karger AG, Basel.

  11. Implementation of a 12-week disease management program improved clinical outcomes and quality of life in adults with asthma in a rural district hospital: pre- and post-intervention study.

    Science.gov (United States)

    Chamnan, Parinya; Boonlert, Kittipa; Pasi, Wanit; Yodsiri, Songkran; Pong-on, Sirinya; Khansa, Bhoonsab; Yongkulwanitchanan, Pichapat

    2010-03-01

    Despite the availability of effective medical treatment and disease management guidelines, asthma remains a poorly controlled disease in developing countries. There is little evidence of the effectiveness of disease management guidelines in rural clinical practice. The effect of disease management guidelines on clinical outcomes and quality of life in asthmatic patients in a rural community hospital was examined. Fifty-seven patients aged > or = 16 years with physician-diagnosed asthma from a hospital outpatient clinic in Ubon-ratchathani, Thailand, were recruited. Asthma diagnosis was confirmed by reviewing clinical records. We implemented a 12-week disease management program, including the use of written asthma treatment plan and asthma action plan tailored to individual patients. Using one-group pre- and post-intervention design, we compared the average number of emergency visits and hospitalizations from acute asthmatic attacks before and after the implementation of interventions using the Wilcoxon matched-pairs signed-rank test. We also compared patient's asthma quality of life (AQL) scores, measured using the 7-point scaled Mini Asthma Quality of Life Questionnaire. It was found that among the 57 patients, 38 (67%) were women, and the mean age (SD) of the patients was 47.6 (17.0) years. Sixteen patients (28%) had a family history of asthma. Emergency visits decreased from 0.48 (SD = 0.83) per patient before implementation of interventions to 0.11 (0.37) per patient after implementation of interventions (p = 0.003). Hospitalizations with acute asthma attacks reduced from 0.14 (0.35) per patient to 0.04 (0.27) per patient (p = 0.034). Overall AQL scores increased significantly from 3.7 to 5.4 (p emotions. It was concluded that implementation of a 12-week asthma disease management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  12. A randomized 12-week clinical comparison of an oscillating-rotating toothbrush to a new sonic brush in the reduction of gingivitis and plaque.

    Science.gov (United States)

    Klukowska, M; Grender, J M; Conde, E; Ccahuana-Vasquez, Renzo Alberto; Goyal, C R

    2014-01-01

    To evaluate the efficacy of a marketed oscillating-rotating (O-R) power toothbrush (Oral-B Triumph with SmartGuide and FlossAction brush head, D34/EB25) to a new sonic toothbrush (Sonicare FlexCare Platinum) in the reduction of gingivitis and plaque over a 12-week test period. This was a single center, randomized, open label, examiner-blind, two-treatment, parallel group study. Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group. Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at Baseline, Week 6, and Week 12. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI), and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA) with Baseline as the covariate. In total, 130 subjects (65 per group) were randomized to treatment and 127 subjects completed the study. Both brushes produced statistically significant (p gingivitis and plaque measures relative to Baseline. At Week 12, the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures (p = 0.007). Additionally, the O-R brush presented significantly fewer bleeding sites (p gingivitis, 19.8% for number of bleeding sites, and 12.2% for whole mouth plaque. There were no adverse events reported or observed for either brush. The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12, as well as significantly greater gingivitis reductions over the long-term (12 weeks), compared to the new sonic toothbrush.

  13. Evolution of substance use, neurological and psychiatric symptoms in schizophrenia and substance use disorder patients: a 12-week, pilot, case-control trial with quetiapine

    Directory of Open Access Journals (Sweden)

    Simon eZhornitsky

    2011-05-01

    Full Text Available Neurological and psychiatric symptoms are consequences of substance abuse in schizophrenia and non-schizophrenia patients. The present case-control study examined changes in substance abuse/dependence and neurological and psychiatric symptoms in substance abusers with (DD group, n=26 and without schizophrenia (SUD group, n=24 and in non-abusing schizophrenia patients (SCZ group, n=23 undergoing 12-week treatment with the atypical antipsychotic, quetiapine. Neurological and psychiatric symptoms were evaluated with the Positive and Negative Syndrome Scale, the Calgary Depression Scale for Schizophrenia, the Extrapyramidal Symptoms Rating Scale and the Barnes Akathisia Rating Scale. At endpoint, DD and SCZ patients were receiving significantly higher doses of quetiapine (mean = 554mg/d and 478mg/d, respectively, relative to SUD patients (mean = 150mg/d. We found that SUD patients showed greater improvement in weekly dollars spent on alcohol and drugs and SUD severity, compared to DD patients. At endpoint, there was no significant difference in dollars spent, but DD patients still had a higher mean SUD severity. Interestingly, DD patients had significantly higher Parkinsonism and depression than SCZ patients at baseline and endpoint. On the other hand, we found that SUD patients had significantly more akathisia at baseline, improved more than SCZ patients and this was related to cannabis abuse/dependence. Finally, SUD patients improved more in PANSS positive scores than DD and SCZ patients. Taken together, our results provide evidence for increased vulnerability to the adverse effects of alcohol and drugs in schizophrenia patients. They also suggest that substance abuse/withdrawal may mimic some symptoms of schizophrenia. Future studies will need to determine the role quetiapine played in these improvements.

  14. ROSSO-in-praxi: a self-monitoring of blood glucose-structured 12-week lifestyle intervention significantly improves glucometabolic control of patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Kempf, Kerstin; Kruse, Johannes; Martin, Stephan

    2010-07-01

    As healthy diet and physical activity can improve glucometabolic control in patients with type 2 diabetes, lifestyle changes should be the basis for each therapy. The only tool to visualize immediate effects of food pattern and exercise on blood glucose levels is self-monitoring of blood glucose (SMBG). Therefore, the aim of the 12-week lifestyle intervention ROSSO-in-praxi was to evaluate the impact of an SMBG-structured motivation and education program on glucometabolic and health parameters in diabetes patients not treated with insulin. Participants (n = 405) generated a seven-point blood glucose diurnal profile every 4 weeks, including actual weight, waist circumference, and steps/day. At baseline and the end of the study, glycated hemoglobin A1c (HbA1c), blood pressure, and cholesterol levels, lifestyle changes, and well-being (SF36 and Center for Epidemiologic Studies Depression Scale questionnaires) were assessed. Three hundred twenty-seven participants (81%) completed the program and significantly improved quality of diet and physical activity, accompanied by an increase of >2,300 steps/day. Participants significantly reduced weight, body mass index, waist circumference, blood glucose, blood pressure, low-density lipoprotein cholesterol, and HbA1c by 0.3% (all P < 0.001), accompanied by increased physical and mental health and reduced depression measurements. Weight loss was significantly associated with overall improvements of glucometabolic and health parameters and mean reduction of 0.05% HbA1c/kg. The evaluated SMBG-structured lifestyle intervention is applicable to motivate individuals with type 2 diabetes for lifestyle changes. Integration of this short-term, highly motivational, and low-cost intervention into basic therapy for patients without insulin therapy could strengthen patient empowerment in order to change lifestyle and to improve glucometabolic and general health.

  15. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

    Science.gov (United States)

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-10-24

    Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours. This is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16). This study will determine the effect of yoga practice on negative affective states

  16. Reduced muscular fatigue after a 12-week leucine-rich amino acid supplementation combined with moderate training in elderly: a randomised, placebo-controlled, double-blind trial

    OpenAIRE

    Reule, Claudia A; Scholz, Claudia; Schoen, Christiane; Brown, Niklas; Siepelmeyer, Anne; Alt, Wilfried W

    2017-01-01

    Background Age-related muscle loss is characterised by a progressing decrease in muscle mass, strength and function. Besides resistance training and physical activity, appropriate nutrition that is rich in protein, especially branched-chain amino acids, is very important to support training effects and positively influence the protein synthesis to degradation ratio. Aim The purpose of this study was to evaluate the effect of a 12-week leucine-rich amino acid supplementation in combination wit...

  17. History of depressive and/or anxiety disorders as a predictor of treatment response: a post hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release in patients with fibromyalgia.

    Science.gov (United States)

    Pae, Chi-Un; Masand, Prakash S; Marks, David M; Krulewicz, Stan; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A

    2009-08-31

    Despite of a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited but antidepressants are commonly prescribed to treat fibromyalgia in clinical practice. We investigated whether a history of depressive and/or anxiety disorders was associated with response to paroxetine controlled release (CR) in the treatment of fibromyalgia. One hundred sixteen (116) fibromyalgia subjects were randomized to receive paroxetine CR or placebo for 12 weeks. The primary outcome was treatment response defined as >or=25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. In multivariate logistic regression, we determined if a history of depression and/or anxiety disorders was an independent predictor of response to paroxetine CR. In logistic regression, the history of depression and/or anxiety did not predict treatment response as measured by >or=25% reduction in Fibromyalgia Impact Questionnaire (FIQ) score (OR=0.66, 95% CI=.29-1.49, Wald=0.97, p=0.32), while the drug status (paroxetine CR) was significantly associated with treatment response (OR=2.57, CI=1.2-5.61, Wald=5.5, p=0.02). A significant proportion of patients with fibromyalgia had a history of anxiety and or depressive disorders. However response to treatment of fibromyalgia symptoms with paroxetine CR was not associated with a history of depressive and/or anxiety disorders. Our findings need to be confirmed in more adequately-powered and well-designed subsequent studies.

  18. Fructose intervention for 12 weeks does not impair glycemic control or incretin hormone responses during oral glucose or mixed meal tests in obese men

    DEFF Research Database (Denmark)

    Matikainen, N; Söderlund, S; Björnson, E

    2017-01-01

    responses during OGTT or GLP-1, GIP or PYY responses during a mixed meal. Therefore, fructose intake, even accompanied with mild weight gain, increases in liver fat and worsening of postprandial TG profile, does not impair glucose tolerance or gut incretin response to oral glucose or mixed meal challenge.......BACKGROUND AND AIMS: Incretin hormones glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP) are affected early on in the pathogenesis of metabolic syndrome and type 2 diabetes. Epidemiologic studies consistently link high fructose consumption to insulin resistance...... but whether fructose consumption impairs the incretin response remains unknown. METHODS AND RESULTS: As many as 66 obese (BMI 26-40 kg/m(2)) male subjects consumed fructose-sweetened beverages containing 75 g fructose/day for 12 weeks while continuing their usual lifestyle. Glucose, insulin, GLP-1 and GIP...

  19. Comparative effects of 12 weeks of equipment based and mat Pilates in patients with Chronic Low Back Pain on pain, function and transversus abdominis activation. A randomized controlled trial.

    Science.gov (United States)

    Cruz-Díaz, David; Bergamin, M; Gobbo, S; Martínez-Amat, Antonio; Hita-Contreras, Fidel

    2017-08-01

    Pilates method has been recommended for patients with chronic low back pain (CLBP) and the activation of transversus abdominis has been deemed to play an important role in the improvement of these patients. Nevertheless, the evidence of the activation of TrA in Pilates practitioners remains unclear. To assess the effectiveness of 12 weeks of Pilates practice in disability, pain, kinesiophobia and transversus abdominis activation in patients with chronic nonspecific Low Back Pain. A randomized controlled trial was carried out. A single-blind randomized controlled trial with repeated measures at 6 and 12 weeks was carried out. A total of ninety eight patients with low back pain were included and randomly allocated to a Pilates Mat group (PMG) equipment based with apparatus Pilates (PAG) or control group (CG). Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) Tampa Scale of Kinesiophobia (TSK), and transversus abdominis (TrA) activation assessed by real time ultrasound measurement (US) were assessed as outcome measures. Improvement were observed in both intervention groups in all the included variables at 6 and 12 weeks (ppain, function and kinesiophobia. Significant differences were observed after 12 weeks of intervention in PMG and PAG with faster improvement in PAG suggesting that, feedback provided by equipment could help in the interiorization of Pilates principles. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Reduced muscular fatigue after a 12-week leucine-rich amino acid supplementation combined with moderate training in elderly: a randomised, placebo-controlled, double-blind trial.

    Science.gov (United States)

    Reule, Claudia A; Scholz, Claudia; Schoen, Christiane; Brown, Niklas; Siepelmeyer, Anne; Alt, Wilfried W

    2016-01-01

    Age-related muscle loss is characterised by a progressing decrease in muscle mass, strength and function. Besides resistance training and physical activity, appropriate nutrition that is rich in protein, especially branched-chain amino acids, is very important to support training effects and positively influence the protein synthesis to degradation ratio. The purpose of this study was to evaluate the effect of a 12-week leucine-rich amino acid supplementation in combination with moderate training. Forty-eight healthy subjects exercised for 30 min three times per week and received either a leucine-rich amino acid supplementation or a placebo. Before and after supplementation, volunteers performed an exhaustive eccentric exercise protocol. Maximal concentric strength, muscle soreness, creatine kinase (CK), type II collagen collagenase cleavage neoepitope (C2C), C propeptide of type II procollagen (CP2) and safety assessments were performed before exercise and after 3, 24, 48 and 72 hours. The supplementation with leucine resulted in reduced loss of strength at 0 and 3 hours after downhill walking compared with the placebo (p=0.0439). The reduction of C2C/CP2 ratio deflection was significantly increased (p=0.038) due to leucine compared with the placebo. The same tendency could be observed for the recovery phase. No significant supplement effects for muscle soreness and CK could be observed. The principle findings show that leucine-rich amino acid supplementation can counteract the negative effects of eccentric exercise. The treatment resulted in a reduction of exercise-induced strength loss.

  1. The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba) Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

    National Research Council Canada - National Science Library

    Laleh Koohi Habibi; Behzad Ghorbani; Ali Reza Norouzi; Sharokh S.P. Gudarzi; Jamal Shams; Mohammad-Taghi Yasami

    2007-01-01

    .... There is ample experimental and clinical evidence to suggest that Ginkgo biloba extract is neuroprotective and has antioxidant properties and can restore stress-induced elevation in brain levels...

  2. Persian: 12 Week Course. Volume 6: Dictionary.

    Science.gov (United States)

    Defense Language Inst., Monterey, CA.

    This two-way dictionary is a supplement to the Persian 12-Week Course. It consists of a Persian-English and an English-Persian section. Phonetic symbols are used for indicating Persian pronunciations. In addition to vocabulary, the Persian-English section contains idioms and expressions. With the infinitives, the present and past simple roots of…

  3. A 12-week intervention with protein-enriched foods and drinks improved protein intake but not physical performance of older patients during the first 6 months after hospital release: a randomised controlled trial.

    Science.gov (United States)

    Beelen, Janne; de Roos, Nicole M; de Groot, Lisette C P G M

    2017-06-01

    During and after hospitalisation, older adults are recommended to consume 1·2-1·5 g of protein/kg body weight per d (g/kg per d) to improve recovery. This randomised controlled trial studied the effectiveness of a 12-week intervention with protein-enriched foods and drinks by following-up seventy-five older patients (mean age: 76·8 (sd 6·9) years) during their first 6 months after hospital discharge. Primary outcomes were protein intake and physical performance (measured with Short Physical Performance Battery (SPPB)). Secondary outcomes for physical recovery were gait speed, chair-rise time, leg-extension strength, hand-grip strength, body weight, nutritional status (Mini Nutritional Assessment), independence in activities of daily living (ADL) and physical activity. The intervention group consumed more protein during the 12-week intervention period compared with the control group (Pprotein-enriched products enabled older adults to increase their protein intake to levels that are higher than their required intake. In these older adults with already adequate protein intakes and limited physical activity, protein enrichment did not enhance physical recovery in the first 6 months after hospital discharge.

  4. In a randomized case-control trial with 10-years olds suffering from attention deficit/hyperactivity disorder (ADHD) sleep and psychological functioning improved during a 12-week sleep-training program.

    Science.gov (United States)

    Keshavarzi, Zahra; Bajoghli, Hafez; Mohamadi, Mohammad Reza; Salmanian, Maryam; Kirov, Roumen; Gerber, Markus; Holsboer-Trachsler, Edith; Brand, Serge

    2014-12-01

    We tested the hypothesis that sleep training would improve emotional, social and behavioural functioning in children with attention-deficit/hyperactivity disorder (ADHD) compared to children with ADHD without such intervention and to healthy controls. Forty children with ADHD were randomly assigned to intervention and control conditions. Parents of 20 children with ADHD were instructed and thoroughly supervised in improving their children's sleep schedules and sleep behaviour. Parents of the other 20 children with ADHD and parents of 20 healthy children received general information about sleep hygiene. At baseline and 12 weeks later, parents and children completed questionnaires related to children's sleep and psychological functioning. Relative to the control groups, children in the intervention group improved sleep quantitatively and qualitatively (F values intervention group children reported improvements in mood, emotions, and relationships (F values ADHD in regulating and supervising children's sleep schedules leads to positive changes in the emotions, behaviour and social lives of these children.

  5. The effects of 12 weeks of beta-hydroxy-beta-methylbutyrate free acid supplementation on muscle mass, strength, and power in resistance-trained individuals: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Wilson, Jacob M; Lowery, Ryan P; Joy, Jordan M; Andersen, J C; Wilson, Stephanie M C; Stout, Jeffrey R; Duncan, Nevine; Fuller, John C; Baier, Shawn M; Naimo, Marshall A; Rathmacher, John

    2014-06-01

    Studies utilizing beta-hydroxy-beta-methylbutyrate (HMB) supplementation in trained populations are limited. No long-term studies utilizing HMB free acid (HMB-FA) have been conducted. Therefore, we investigated the effects of 12 weeks of HMB-FA supplementation on skeletal muscle hypertrophy, body composition, strength, and power in trained individuals. We also determined the effects of HMB-FA on muscle damage and performance during an overreaching cycle. A three-phase double-blind, placebo- and diet-controlled randomized intervention study was conducted. Phase 1 was an 8-week-periodized resistance-training program; Phase 2 was a 2-week overreaching cycle; and Phase 3 was a 2-week taper. Muscle mass, strength, and power were examined at weeks 0, 4, 8, and 12 to assess the chronic effects of HMB-FA; and assessment of these, as well as cortisol, testosterone, and creatine kinase (CK) was performed at weeks 9 and 10 of the overreaching cycle. HMB-FA resulted in increased total strength (bench press, squat, and deadlift combined) over the 12-week training (77.1 ± 18.4 vs. 25.3 ± 22.0 kg, p mass gain (7.4 ± 4.2 vs. 2.1 ± 6.1 kg, p < 0.001) in HMB-FA- and placebo-supplemented groups, respectively. During the overreaching cycle, HMB-FA attenuated increases in CK (-6 ± 91 vs. 277 ± 229 IU/l, p < 0.001) and cortisol (-0.2 ± 2.9 vs. 4.5 ± 1.7 μg/dl, p < 0.003) in the HMB-FA- and placebo-supplemented groups, respectively. These results suggest that HMB-FA enhances hypertrophy, strength, and power following chronic resistance training, and prevents decrements in performance following the overreaching.

  6. Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial.

    Science.gov (United States)

    Ikenaga, Masahiro; Yamada, Yosuke; Kose, Yujiro; Morimura, Kazuhiro; Higaki, Yasuki; Kiyonaga, Akira; Tanaka, Hiroaki

    2017-01-01

    We developed a short-interval, low-intensity, slow-jogging (SJ) program consisting of sets of 1 min of SJ at walking speed and 1 min of walking. We aimed to examine the effects of an easily performed SJ program on skeletal muscle, fat infiltration, and fitness in older adults. A total of 81 community-dwelling, independent, older adults (70.8 ± 4.0 years) were randomly assigned to the SJ or control group. The SJ group participants were encouraged to perform 90 min of SJ at their anaerobic threshold (AT) intensity and 90 min of walking intermittently per week. Aerobic capacity at the AT and sit-to-stand (STS) scores were measured. Intracellular water (ICW) in the legs was assessed by segmental multi-frequency bioelectrical impedance analysis. Subcutaneous (SAT) and intermuscular (IMAT) adipose tissue and muscle cross-sectional area (CSA) were measured at the mid-thigh using computed tomography. A total of 75 participants (37 SJ group, 38 controls) completed the 12-week intervention. The AT and STS improved in the SJ group compared with the controls (AT 15.7 vs. 4.9 %, p SJ group (9.7 %, p SJ group (p SJ program was easily performed by older adults with low skeletal muscle mass, improved aerobic capacity, muscle function, and muscle composition in older adults.

  7. Body composition, dietary composition, and components of metabolic syndrome in overweight and obese adults after a 12-week trial on dietary treatments focused on portion control, energy density, or glycemic index

    Directory of Open Access Journals (Sweden)

    Melanson Kathleen J

    2012-08-01

    Full Text Available Abstract Background Given the rise in obesity and associated chronic diseases, it is critical to determine optimal weight management approaches that will also improve dietary composition and chronic disease risk factors. Few studies have examined all these weight, diet, and disease risk variables in subjects participating in recommended multi-disciplinary weight loss programs using different dietary strategies. Methods This study compared effects of three dietary approaches to weight loss on body composition, dietary composition and risk factors for metabolic syndrome (MetS. In a 12-week trial, sedentary but otherwise healthy overweight and obese adults (19 M & 138 F; 38.7 ± 6.7 y; BMI 31.8 ± 2.2 who were attending weekly group sessions for weight loss followed either portion control, low energy density, or low glycemic index diet plans. At baseline and 12 weeks, measures included anthropometrics, body composition, 3-day food diaries, blood pressure, total lipid profile, HOMA, C-reactive protein, and fasting blood glucose and insulin. Data were analyzed by repeated measures analysis of variance. Results All groups significantly reduced body weight and showed significant improvements in body composition (p  Conclusion Different dietary approaches based on portion control, low energy density, or low glycemic index produced similar, significant short-term improvements in body composition, diet compositin, and MetS components in overweight and obese adults undergoing weekly weight loss meetings. This may allow for flexibility in options for dietary counseling based on patient preference.

  8. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy.

    Science.gov (United States)

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-06-26

    Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3 × 75 min sessions per week, made up of 5 lower limb resistance exercises and 2-3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations' media. Australian and New Zealand Clinical Trials Registry (ACTRN12614001217695). Published by the BMJ Publishing Group Limited. For permission

  9. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    Science.gov (United States)

    Gillett, Jarred G; Lichtwark, Glen A; Boyd, Roslyn N; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks or motor skills. This study aims to determine the efficacy of combined functional anaerobic and strength training in (1) influencing muscle strength, structure and function and (2) to determine if any changes in muscle strength and structure following training impact on walking ability and gross motor functional capacity and performance in the short (following 3 months of training) and medium terms (a further 3 months post-training). Methods and analysis 40 adolescents and young adults with CP will be recruited to undertake a 12-week training programme. The training programme will consist of 3×75 min sessions per week, made up of 5 lower limb resistance exercises and 2–3 functional anaerobic exercises per session. The calf muscles will be specifically targeted, as they are the most commonly impacted muscles in CP and are a key muscle group involved in walking. If, as we believe, muscle properties change following combined strength and functional training, there may be long-term benefits of this type of training in slowing the deterioration of muscle function in people with spastic-type CP. Ethics and dissemination Ethical approval has been obtained from the ethics committees at The University of Queensland (2014000066) and Children's Health Queensland (HREC/15/QRCH/30). The findings will be disseminated by publications in peer-reviewed journals, conferences and local research organisations’ media. Trial registration number Australian and New Zealand Clinical Trials

  10. A placebo-controlled, double-blind, randomized, multicenter study to assess the effects of dronedarone 400 mg twice daily for 12 weeks on atrial fibrillation burden in subjects with permanent pacemakers.

    Science.gov (United States)

    Ezekowitz, Michael D; Ellenbogen, Kenneth A; DiMarco, John P; Kaszala, Karoly; Boddy, Alexander; Geba, Gregory P; P, Gregory Geba; Koren, Andrew

    2015-03-01

    Dronedarone is a benzofuran derivative with a pharmacological profile similar to amiodarone but has a more rapid onset of action and a much shorter half-life (13-19 h). Our goal was to evaluate the efficacy of dronedarone in atrial fibrillation (AF) patients using dual-chamber pacemakers capable of quantifying atrial fibrillation burden. Pacemakers were adjusted to optimize AF detection. Patients with AF burden >1% were randomized to dronedarone 400 mg twice daily (BID) or placebo. Pacemakers were interrogated after 4 and 12 weeks of treatment. The primary endpoint was the change in AF burden from baseline over the 12-week treatment period. Patients with permanent AF, severe/recently decompensated heart failure, and current use of antiarrhythmic drugs were excluded. AF burden was assessed by a core laboratory blinded to treatment assignment. From 285 patients screened, 112 were randomized (mean age 76 years, 60% male, 84% hypertensive, 65% with sick sinus syndrome, 26% with diabetes mellitus type II, 15% with heart failure). Baseline mean (SEM) AF burden was 8.77% (0.16) for placebo and 10.14% (0.17) for dronedarone. Over the 12-week study period, AF burden compared to baseline decreased by 54.4% (0.22) (P = 0.0009) with dronedarone and trended higher by 12.8% (0.16) (P = 0.450) with placebo. The absolute change in burden was decreased by 5.5% in the dronedarone group and increased by 1.1% in the placebo group. Heart rate during AF was reduced to approximately 4 beats/min with dronedarone (P = 0.285). Adverse events were higher with dronedarone compared to placebo (65 vs 56%). Dronedarone reduced pacemaker-assessed the relative AF burden compared to baseline and placebo by over 50% during the 12-week observation period.

  11. Effect of 12-Week Pilates Trainning on EDSS in Women Suffering fromMultiple Sclerosis

    Directory of Open Access Journals (Sweden)

    Z Shanazari

    2013-04-01

    Full Text Available Abstract Background & aim: Multiple sclerosis is a debilitating disease that strikes the immune system. Multiple sclerosis is a chronic disease which debilitates the nervous system. The study was evaluated the effects of Pilates exercise on women with physical disabilities suffering from multiple sclerosis for 12 weeks .The aim of this study was to investigating the effects of Pilates trainning on EDSS of women suffering from Multiple Sclerosis (MS for 12 weeks. Methods: In the present clinical trial study, 38 patients age 20-40 years (mean disease duration of 8±2 years with multiple sclerosis grade 0-4.5 were selected. The Patients were randomly divided into two groups: experimental and control groups. The training program for pilates, 12 weeks, three sessions a week, with each session consisting of 60 minutes. Patients' physical disability was measured using Krutzke Expanded Disability Status Scale, before and after exercise. Data were analyzed by ANCOVA test. Results: Physical disability scores before and after the exercise in intervention was 47.1 and 37 and in the control group, was 93.1 and 43.1 respectively, which was significantly different in the intervention group before and after training (p<0.05. Conclusion: Pilates training improves the physical disability of MS patients. Therefore, this exercise can be used as a complementary treatment alongside drug treatments. Key Words: Multiple Sclerosis, Women, Pilates, EDSS

  12. Decreased frequency of adenoidectomy by a 12-week nasal budesonide treatment

    Directory of Open Access Journals (Sweden)

    Hong H

    2017-10-01

    Full Text Available Haiyu Hong,1,* Fenghong Chen,2,* Xiaobin Zheng,3 Wei Liao,1 Zhenpeng Liao,1 Yujie Cao,2 Haixin He,1 Zhe Zhu,4,5 Yunping Fan1 1Department of Otolaryngology and Head Neck Surgery of 5th Hospital, Affiliated with Sun Yat-sen University, Zhuhai, 2Department of Otolaryngology and Head Neck Surgery of 1st Hospital, Affiliated with Sun Yat-sen University, Guangzhou, 3Department of Respiration of 5th Hospital, Affiliated with Sun Yat-sen University, Zhuhai, China; 4Department of Stem Cell Biology and Regenerative Medicine, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, 5Sanford Consortium, Regenerative Medicine, University of California, San Diego, La Jolla, CA, USA *These authors contributed equally to this work Objective: There is little evidence on the role of topical budesonide in reducing the frequency of adenoidectomy, although it was reported that topical budesonide can effectively ameliorate the symptoms of adenoid hypertrophy (AH. This study was aimed to investigate the possibility and safety of alternatives to adenoidectomy with a 12-week treatment with nasal budesonide. Materials and methods: One hundred patients with AH were randomized to receive either a double-blind budesonide (1 mg once daily or placebo treatment for 2 weeks by transnasal nebulization. A further 12-week open study, budesonide spray (64 µg per nostril at bedtime was administered to the treatment group. During the final 12 weeks of follow-up, the frequency of adenotonsillectomy, side effects, the degree of nasal obstruction, nasal discharge, and snoring were assessed. Results: Out of the 100 total enrolled patients, 92 children with AH completed the study. After the 2-week treatment with transnasal budesonide nebulization, the symptoms of AH significantly decreased compared to the control group. Responders (n=26 who had initially improved showed significantly decreased symptoms of AH, and the frequency of adenotonsillectomy during the follow-up (14 and 26

  13. [The efficacy and safety of pioglitazone hydrochloride in combination with sulphonylureas and metfomin in the treatment of type 2 diabetes mellitus a 12-week randomized multi-centres placebo-controlled parallel study].

    Science.gov (United States)

    Pan, Changyu; Gao, Yan; Gao, Xin; Li, Guangwei; Luo, Bangyao; Shi, Hongli; Tian, Hui; Jia, Peihong; Lin, Huandong; Xing, Xiaoyan; Zhao, Yongju; Zhou, Linuo

    2002-06-01

    To evaluate the efficacy and safety of pioglitazone hydrochloride 30 mg/day with sulphonylureas and metfomin in the treatment of patients with type 2 diabetes mellitus. There were 283 patients treated with sulphonylureas and metfomin randomized in this multicenter double-blind placebo-controlled clinical trial. Patients who had 7.0 mmol/L metfomin. It provides a safety and tolerance profile for type 2 diabetes mellitus in this trial.

  14. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

  15. Chronic flexibility improvement after 12 week of stretching program utilizing the ACSM recommendations: hamstring flexibility.

    Science.gov (United States)

    Sainz de Baranda, P; Ayala, F

    2010-06-01

    The ACSM flexibility training recommendations emphasize proper stretching of muscles supporting the major joints, but there is a little evidence to support this recommendation in terms of effectiveness, and which stretching parameters (technique and single stretch duration) are more adequate. A randomized controlled clinical trial design was use to investigate whether the ACSM flexibility training recommendation parameters improve hip flexion range of motion. A total of 173 subjects, 122 men (21.3+/-2.5 years; 176.33+/-8.35 cm; 74.42+/-10.80 kg) and 51 women (20.7+/-1.6 years; 163.43+/-6.57 cm; 60.12+/-7.88 kg), classified as recreationally active young adult university students were randomly assigned to 1 of 7 groups: 1 control group (no stretching) or 1 of 6 stretching groups. All stretching groups performed 12 weeks of flexibility training with a consistent stretch daily dose (180 s) and frequency (3 days per week) parameters and different stretch technique (passive or active) and single stretch duration (15, 30, or 45 s). Hip flexion passive range of motion (PROM) was determined through the bilateral straight-leg raise test before, during (at 4 and 8 weeks), and after the program (12 weeks). All stretching groups performed hip flexion PROM after flexibility training. A significant improvement was identified in mean PROM for each stretching group, but no significant differences were found between stretch technique and single stretch duration (p>0.05). The control group's mean PROM decreased (Delta PROM: -0.08 degrees, 95% confidence interval [CI]=-2.3 to 5.3), whereas all stretching groups increased PROM (Delta PROM: 15.14 degrees, 95% CI=10.19 to 23.56) in hip flexion after 12 weeks of stretching (pflexibility training recommendations are effective for improving hip flexion ROM in recreationally active young adults.

  16. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas

    2004-01-01

    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel......-group, placebo-controlled trial with an open-label comparator arm was conducted among 193 outpatients with type 2 diabetes. The mean age was 56.6 years and the mean HbA(1c) was 7.6% across the treatment groups. Patients were randomly assigned to one of five fixed-dosage groups of liraglutide (0.045, 0.225, 0....... Patients treated with glimepiride had decreased HbA(1c) and fasting glucose, but slightly increased body weight. No safety issues were raised for liraglutide; observed adverse events were mild and transient. CONCLUSIONS: A once-daily dose of liraglutide provides efficacious glycemic control...

  17. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

    Science.gov (United States)

    Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

    2017-02-01

    Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  18. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks.

    Science.gov (United States)

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 weeks later. Additionally, his adrenals showed no evidence of metastasis. Hence his adrenal insufficiency had been a paraneoplastic manifestation of the lung cancer, and it had also preceded the primary by 12 weeks.

  19. Moderate Walking Enhances the Effects of an Energy-Restricted Diet on Fat Mass Loss and Serum Insulin in Overweight and Obese Adults in a 12-Week Randomized Controlled Trial.

    Science.gov (United States)

    Kleist, Bernadette; Wahrburg, Ursel; Stehle, Peter; Schomaker, Ralph; Greiwing, Andreas; Stoffel-Wagner, Birgit; Egert, Sarah

    2017-08-09

    Background: Increased physical activity may be advantageous for weight loss.Objective: We investigated the effects of an energy-restricted diet with and without moderate walking on body weight, body composition, resting energy expenditure (REE), and endocrine and cardiometabolic risk variables in overweight and obese participants.Methods: A 12-wk, randomized, 2-arm, parallel, controlled, energy-restricted (500-800 kcal/d) dietary intervention study was conducted in 82 men and women [mean baseline characteristics: age, 39.4 y; weight, 99.3 kg; body mass index (in kg/m(2)), 31.9]. Participants were divided into 2 groups. One group received a hypoenergetic diet (DI) only (n = 44). The second group received the same DI and participated in a regular walking program of 2.5 h/wk (DI + walking; n = 38).Results: After the 12-wk intervention, body weight was significantly decreased in the DI + walking group and the DI group (-8.8 compared with -7.0 kg, P = 0.064 for intergroup differences). The decrease in body weight was accompanied by a significant reduction in total fat mass, which was significantly more pronounced in the DI + walking group than in the DI group (-6.4 ± 3.1 compared with -4.8 ± 3.0 kg; P = 0.020). REE after 12 wk was not significantly different compared with the baseline REE. Diastolic blood pressure, mean arterial pressure, LDL cholesterol, and non-HDL cholesterol were similarly significantly improved by both interventions. In the DI + walking group, insulin and the homeostasis model assessment of insulin resistance index were also significantly reduced. Serum free triiodothyronine was significantly decreased and serum cortisol was significantly increased in both groups.Conclusions: Participation in a 12-wk weight-loss study resulted in significant reductions in body weight and fat mass and was associated with significant improvements in biomarkers for cardiovascular disease risk. Moderate weight loss was not accompanied by a reduction in REE

  20. Does 12-Week Latin Dance Training Affect the Self-Confidence of the University Students?

    Science.gov (United States)

    Meric, Odemis; Ilhan, Adilogullari

    2016-01-01

    In this research, it is aimed to investigate the effect of 12-week Latin dance training on the self-confidence of university students. This research was conducted with a total of 60 students, including 30 students as control and 30 students as the working group. A 33-item self-confidence scale developed by Akin (2007) was applied to both control…

  1. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes

    DEFF Research Database (Denmark)

    Kilen, Anders; Larsson, Tanja Hultengren; Jørgensen, Majke

    2014-01-01

    It was investigated if high-intensity interval training (HIT) at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON) or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT...

  2. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome.

    Directory of Open Access Journals (Sweden)

    Caren Lau

    Full Text Available To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL in Chinese adults with and without metabolic syndrome (MetS.We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87 or the control group (n = 86. Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks.The mean age of participants was 52.0 (SD 7.4, range 31-71 years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p0.05. There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05.A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS.Australian New Zealand Clinical Trials Registry ACTRN12613000816752.

  3. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients.

    Science.gov (United States)

    Sarıfakıoğlu, Banu; Güzelant, Aliye Yıldırım; Güzel, Eda Celik; Güzel, Savaş; Kızıler, Ali Rıza

    2014-10-01

    The aims of this study were to investigate the effect of exercise therapy on the oxidative stress in fibromyalgia patients and relationship between oxidative stress and fibromyalgia symptoms. Thirty women diagnosed with fibromyalgia according to the American College of Rheumatology preliminary criteria, and 23 healthy women whose age- and weight-matched women were enrolled the study. Pain intensity with visual analog scale (VAS), the number of tender points, the fibromyalgia impact questionnaire (FIQ), the Beck depression inventory (BDI) were evaluated. The oxidative stress parameters thiobarbituric acid reactive substances, protein carbonyls, and nitric oxide, and antioxidant parameters thiols and catalase were investigated in patients and control group. After, combined aerobic and strengthen exercise regimen was given to fibromyalgia group. Exercise therapy consisted of a warming period of 10 min, aerobic exercises period of 20 min, muscle strengthening exercises for 20 min, and 10 min cooling down period. Therapy was lasting 1 h three times per week over a 12-week period. All parameters were reevaluated after the treatment in the patient group. The oxidative stress parameters levels were significantly higher, and antioxidant parameters were significantly lower in patients with fibromyalgia than in the controls. VAS, FIQ, and BDI scores decreased significantly with exercise therapy. The exercise improved all parameters of oxidative stress and antioxidant parameters. Also, all clinical parameters were improved with exercise. We should focus on oxidative stress in the treatment for fibromyalgia with the main objective of reducing oxidative load.

  4. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.

    Science.gov (United States)

    Kowdley, Kris V; Gordon, Stuart C; Reddy, K Rajender; Rossaro, Lorenzo; Bernstein, David E; Lawitz, Eric; Shiffman, Mitchell L; Schiff, Eugene; Ghalib, Reem; Ryan, Michael; Rustgi, Vinod; Chojkier, Mario; Herring, Robert; Di Bisceglie, Adrian M; Pockros, Paul J; Subramanian, G Mani; An, Di; Svarovskaia, Evguenia; Hyland, Robert H; Pang, Phillip S; Symonds, William T; McHutchison, John G; Muir, Andrew J; Pound, David; Fried, Michael W

    2014-05-15

    High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir-sofosbuvir) for 8 weeks, ledipasvir-sofosbuvir plus ribavirin for 8 weeks, or ledipasvir-sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir-sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir-sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir-sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, -4 to 6) and the rate in the group that received 8 weeks of ledipasvir-sofosbuvir with ribavirin was 1 percentage point lower (95% CI, -6 to 4); these results indicated noninferiority of the 8-week ledipasvir-sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir-sofosbuvir discontinued treatment owing to adverse events. Ledipasvir-sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded

  5. Self-rating level of perceived exertion for guiding exercise intensity during a 12-week cardiac rehabilitation programme and the influence of heart rate reducing medication

    DEFF Research Database (Denmark)

    Tang, Lars; Zwisler, Ann-Dorthe; Taylor, Rod S.

    2016-01-01

    OBJECTIVES: To investigate whether self-rating level of perceived exertion can adequately guide exercise intensity during a 12-week cardiac rehabilitation programme. DESIGN: Linear regression analysis using rehabilitation data from two randomised controlled trials. METHODS: Patients undergoing ra......-led and self-regulated model using rating of perceived exertion can help guide exercise intensity in everyday clinical practice among patients with heart disease, irrespective if they are taking heart rate-reducing medication.......OBJECTIVES: To investigate whether self-rating level of perceived exertion can adequately guide exercise intensity during a 12-week cardiac rehabilitation programme. DESIGN: Linear regression analysis using rehabilitation data from two randomised controlled trials. METHODS: Patients undergoing...

  6. The Effect of 12 Weeks Dance Education on Physical Fitness Values At Mentally Retarded Children

    Directory of Open Access Journals (Sweden)

    Asena DORSAN

    2014-08-01

    Full Text Available The purpose of the study was to examine the effect of 12 weeks of dance education on the values of physical fitness at children with mental retarded. 22 educable mentally retarded children from Dr. Günseli - Dr. Bülent Akınsal Secondary School and Working Sc hool participated in this study. Mentally Disabled children who participated voluntarily were grouped as the average age of 16.27± 1.00 year with11 people (9 males, 2females of the experimental group and the average age of 15.90± 0.83 year to 11people(7 males, 4 females as the control group. Participants in the experimental group was implemented 12 - weekdance education program including 2 days a week, 2 hours a day. Program contents included the basic posture correction, flexibility, ability to maintain a rhythm, motion diversity and self - expression skills, pair work and group work. Physical fitness values of experimental and control group were measured in before and after studies. After the 12 - week dance education, It was determined that there was st atistically significant differences in vertical jump, flexibility, sprint and balance parameters between the experimental and control groups.(p<0.05. In the study of comparing the experimental group in itself, statistically significant differences were fo und of the specified physical fitness parameters (p<0.01. As a result; physical fitness levels of the educable mentally retarded individuals who regularly participated in dance activities showed significant improvements. The results of this study, it was observed that after 12 - week education program there was more development of many physical fitness parameters in the experimental group than the control group and this revealed that the importance of dance education on educable mentally retarded children.

  7. Postplacental intrauterine device expulsion by 12 weeks: a prospective cohort study.

    Science.gov (United States)

    Goldthwaite, Lisa M; Sheeder, Jeanelle; Hyer, Jennifer; Tocce, Kristina; Teal, Stephanie B

    2017-12-01

    significant difference in median distance from the intrauterine device to the fundus between intrauterine device types or between those who did or did not experience expulsion. Of expulsions, 86% occurred ≤6 weeks' postpartum. All complete expulsions were clinically identified, but of the partial expulsions, only 4/10 (40%) were clinically suspected prior to ultrasound. The only independent predictor of expulsion was intrauterine device type. Including reinsertions, intrauterine device use at 12 weeks was not significantly different for levonorgestrel intrauterine system and copper intrauterine device users (80% vs 93%; P = .14). Women initiating postplacental levonorgestrel intrauterine system are more likely to experience complete expulsion than those initiating copper intrauterine device. Using sonographic criteria results in higher expulsion rates than previously reported. It is unclear if such high expulsion rates would be identified following standard clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Response of Leptin and C-reactive Protein Serum Levels to 12 Weeks Moderate Intensity Aerobic Exercise in Obese Men

    Directory of Open Access Journals (Sweden)

    Sonia Ghiasi

    2017-01-01

    Full Text Available The aim of this study was to investigate the effect of 12 weeks moderate intensity aerobic exercise on leptin and C-reactive protein serum levels in obese men. The study was conducted in Urmia- Iran in 2015. Twenty-four obese men with an aged range 40-50 yrs. were enrolled into the study. Subjects were randomized to one of 2 groups exercise (n=12 and control groups (n=12. The exercise group performed aerobic exercise training up to 50-70 % heart rate reserve, three times a week for 12 weeks. Leptin and CRP serum level was measured by ELISA method before and after the 12 weeks. After 12 weeks exercise training, leptin and CRP serum level in the exercise group compared to the control group, were decreased significantly (P<0.05. To sum up, 12 weeks moderate intensity aerobic exercise in the reduction of CRP and leptin concentration had a prominent role that might be effective in reducing weight and improving cardiovascular risk factors.

  9. A 12-week aerobic training programme reduced plasmatic allantoin in adolescents with Down syndrome.

    Science.gov (United States)

    Rosety-Rodriguez, M; Rosety, I; Fornieles-Gonzalez, G; Diaz, A; Rosety, M; Ordonez, F J

    2010-07-01

    To assess the influence of a 12-week training programme on plasmatic levels of allantoin, an in vivo marker for oxidative stress, in adolescents with Down syndrome. This finding would be of great interest, since oxidative damage has been proposed as a pathogenic mechanism of several pathologies in this population. To reach this goal, 31 male adolescents with Down syndrome (16.3 (1.1) years; 155.2 (5.7) cm; 70.8 (4.5) kg) performed a 12-week training programme, three sessions per week, consisting of warm-up (15 min) followed by a main part (20-35 min (increasing 5 min each 3 weeks)) at a work intensity of 60-75% of peak heart rate (increasing by 5% each 3 weeks) and then a cool-down period (10 min). According to previous studies, it should be emphasised that the maximal heart rate for individuals with Down syndrome was predicted by the equation HRmax = 194.5-(0.56 age). The control group included seven age-, sex- and BMI-matched adolescents with trisomy 21 that did not perform any training programme. The levels uric acid and allantoin were assayed in plasma by HPLC. This protocol was approved by an institutional ethics committee. When compared with baseline, plasmatic levels of allantoin were decreased significantly (22.09 (1.62) vs 18.74 (1.38) micromol/l; p<0.001) after being exercised. Furthermore, the allantoin/uric acid ratio was decreased significantly (0.071 (0.006) vs 0.059 (0.004); p<0.05). On the contrary, no changes were reported in controls. A 12-week aerobic programme significantly reduced oxidative damage expressed in terms of plasmatic allantoin content in adolescents with Down syndrome. Further studies on this topic are required.

  10. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies.

    Science.gov (United States)

    Buse, John B; DeFronzo, Ralph A; Rosenstock, Julio; Kim, Terri; Burns, Colleen; Skare, Sharon; Baron, Alain; Fineman, Mark

    2016-02-01

    Delayed-release metformin (Met DR) is formulated to deliver the drug to the lower bowel to leverage the gut-based mechanisms of metformin action with lower plasma exposure. Met DR was assessed in two studies. Study 1 compared the bioavailability of single daily doses of Met DR to currently available immediate-release metformin (Met IR) and extended-release metformin (Met XR) in otherwise healthy volunteers. Study 2 assessed glycemic control in subjects with type 2 diabetes (T2DM) over 12 weeks. Study 1 was a phase 1, randomized, four-period crossover study in 20 subjects. Study 2 was a 12-week, phase 2, multicenter, placebo-controlled, dose-ranging study in 240 subjects with T2DM randomized to receive Met DR 600, 800, or 1,000 mg administered once daily; blinded placebo; or unblinded Met XR 1,000 or 2,000 mg (reference). The bioavailability of 1,000 mg Met DR b.i.d. was ∼50% that of Met IR and Met XR (study 1). In study 2, 600, 800, and 1,000 mg Met DR q.d. produced statistically significant, clinically relevant, and sustained reductions in fasting plasma glucose (FPG) levels over 12 weeks compared with placebo, with an ∼40% increase in potency compared with Met XR. The placebo-subtracted changes from baseline in HbA1c level at 12 weeks were consistent with changes in FPG levels. All treatments were generally well tolerated, and adverse events were consistent with Glucophage/Glucophage XR prescribing information. Dissociation of the glycemic effect from plasma exposure with gut-restricted Met DR provides strong evidence for a predominantly lower bowel-mediated mechanism of metformin action. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  11. Cognitive and mood effects in healthy children during 12 weeks' supplementation with multi-vitamin/minerals.

    Science.gov (United States)

    Haskell, Crystal F; Scholey, Andrew B; Jackson, Philippa A; Elliott, Jade M; Defeyter, Margaret A; Greer, Joanna; Robertson, Bernadette C; Buchanan, Tom; Tiplady, Brian; Kennedy, David O

    2008-11-01

    Adequate levels of vitamins and minerals are essential for optimal neural functioning. A high proportion of individuals, including children, suffer from deficiencies in one or more vitamins or minerals. This study investigated whether daily supplementation with vitamins/minerals could modulate cognitive performance and mood in healthy children. In this randomised, double-blind, placebo-controlled, parallel groups investigation, eighty-one healthy children aged from 8 to 14 years underwent laboratory assessments of their cognitive performance and mood pre-dose and at 1 and 3 h post-dose on the first and last days of 12 weeks' supplementation with a commercially available vitamins/mineral product (Pharmaton Kiddi). Interim assessments were also completed at home after 4 and 8 weeks at 3 h post-dose. Each assessment comprised completion of a cognitive battery, delivered over the Internet, which included tasks assessing mood and the speed and accuracy of attention and aspects of memory (secondary, semantic and spatial working memory). The vitamin/mineral group performed more accurately on two attention tasks: 'Arrows' choice reaction time task at 4 and 8 weeks; 'Arrow Flankers' choice reaction time task at 4, 8 and 12 weeks. A single task outcome (Picture Recognition errors) evinced significant decrements at 12 weeks. Mood was not modulated in any interpretable manner. Whilst it is possible that the significant improvements following treatment were due to non-significant numerical differences in performance at baseline, these results would seem to suggest that vitamin/mineral supplementation has the potential to improve brain function in healthy children. This proposition requires further investigation.

  12. A Double-Blind, 12-Week Study to Evaluate the Antiaging Efficacy of a Cream Containing the NFκB Inhibitor 4-Hexyl-1, 3-Phenylenediol and Ascorbic Acid-2 Glucoside in Adult Females.

    Science.gov (United States)

    Roure, Romain; Nollent, Virginie; Dayan, Liliane; Camel, Etienne; Bertin, Christiane

    2016-06-01

    The 5 main physical manifestations of aged skin are wrinkles, uneven tone, brown spots, loss of elasticity, and dryness. One mechanism resulting in these physical manifestations is increased activity of the nuclear factor kappa B (NFκB) protein. This 12-week, double-blind, placebo-controlled, randomized split-face study compared the antiaging effect and safety of a face cream containing 4-Hexyl-1, 3-phenylenediol, an NFκB inhibitor, and ascorbic acid-2 glucoside versus placebo in adult females aged 45-70 years old. Subjects (n=42) applied active treatment or placebo to the same half face twice daily at home for 12 weeks. Clinical evaluation was carried out by a dermatologist. Subjects carried out similar self-grading assessments. Colorimetric measurements analyzed skin color, and biomechanical skin properties were evaluated. Clinical grading showed that most wrinkle parameters were significantly improved after 8 weeks of active treatment compared with baseline and placebo (P≤.05), with improvements maintained after 12 weeks. Only Marionette wrinkles did not show a significant improvement. Brown spots (color intensity/number), overall photodamage, and most complexion parameters improved significantly after 8 and 12 weeks compared with baseline and placebo (P≤.05). Self-grading yielded similar results compared with baseline. Self-grading did not demonstrate improvements with active treatment versus placebo, except for skin firmness at 8 and 12 weeks (P≤.05). A significant difference was seen with active treatment compared with placebo in all colorimetric parameters (L*, b*, and ITA°) after 8 weeks, and in spot coloration (b*) after 12 weeks (P<.05). Improvements in skin elasticity were not significantly different between treatments. Overall tolerability of active treatment was judged as good. In conclusion, a cream containing 4-Hexyl-1, 3-phenylenediol and ascorbic acid-2 glucoside improves the clinical appearance of aged skin, validating the potential use

  13. Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

    Science.gov (United States)

    Novák, Zoltán; Yáñez, Anahí; Kiss, Ildikó; Kuna, Piotr; Tortajada-Girbés, Miguel; Valiente, Román

    2016-08-01

    Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria. © 2016 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

  14. Increased Brain Glucose Uptake After 12 Weeks of Aerobic High-Intensity Interval Training in Young and Older Adults.

    Science.gov (United States)

    Robinson, Matthew M; Lowe, Val J; Nair, K Sreekumaran

    2018-01-01

    Aerobic exercise training can increase brain volume and blood flow, but the impact on brain metabolism is less known. We determined whether high-intensity interval training (HIIT) increases brain metabolism by measuring brain glucose uptake in younger and older adults. Brain glucose uptake was measured before and after HIIT or a sedentary (SED) control period within a larger exercise study. Study procedures were performed at the Mayo Clinic in Rochester, MN. Participants were younger (18 to 30 years) or older (65 to 80 years) SED adults who were free of major medical conditions. Group sizes were 15 for HIIT (nine younger and six older) and 12 for SED (six younger and six older). Participants completed 12 weeks of HIIT or SED. HIIT was 3 days per week of 4 × 4 minute intervals at over 90% of peak aerobic capacity (VO2peak) with 2 days per week of treadmill walking at 70% VO2peak. Resting brain glucose uptake was measured using 18F-fluorodeoxyglucose positron emission tomography scans at baseline and at week 12. Scans were performed at 96 hours after exercise. VO2peak was measured by indirect calorimetry. Glucose uptake increased significantly in the parietal-temporal and caudate regions after HIIT compared with SED. The gains with HIIT were not observed in all brain regions. VO2peak was increased for all participants after HIIT and did not change with SED. We demonstrate that brain glucose metabolism increased after 12 weeks of HIIT in adults in regions where it is reduced in Alzheimer's disease.

  15. A 12-week, multicenter, randomized, partially blinded, active-controlled, parallel-group study of budesonide inhalation suspension in adolescents and adults with moderate to severe persistent asthma previously receiving inhaled corticosteroids with a metered-dose or dry powder inhaler.

    Science.gov (United States)

    Murphy, Kevin; Noonan, Michael; Silkoff, Philip E; Uryniak, Thomas

    2007-06-01

    Nebulized budesonide inhalation suspension (BIS) is approved in the United States for children with asthma aged 1 to 8 years. The primary objective of this study was to compare the efficacy of BIS 0.5 mg QD and 2.0 mg BID in terms of the mean change from baseline to end of treatment in predose forced expiratory volume in 1 second (FEV1). In this 12-week, partially blinded, randomized study, subjects aged >or=12 years with moderate to severe persistent asthma previously receiving inhaled corticosteroids (ICSs) by dry powder inhaler (DPI) or metered-dose inhaler (MDI) continued therapy during a 2- to 3-week run-in period and then switched to BIS 0.5 mg QD, 1.0 mg QD, 1.0 mg BID, or 2.0 mg BID, or budesonide DPI 400 microg BID (active reference arm). Besides FEV1 (the primary variable), other outcome variables included changes in forced vital capacity (FVC) from baseline to weeks 4, 8, and 12 and to the average over the treatment period; as well as changes from baseline to the end of treatment in diary-collected daytime and nighttime asthma symptom scores, rescue medication use, nighttime awakenings due to asthma, morning and evening peak expiratory flow (PEF), percentages of symptom-free and medication-free periods, and the incidence of predefined asthma events. Adverse events were recorded by subjects. Steady-state pharmacokinetics of budesonide were assessed in all treatment arms. Efficacy analyses included data in a modified intent-to-treat approach. Differences in the change from baseline to end of treatment in FEV1 were assessed using analysis of covariance (ANCOVA). For secondary variables, changes from baseline to each visit or to the treatmentperiod average were compared among groups using an ANCOVA model. P or=65 years. There was no significant difference in mean change in predose FEV1 between BIS 0.5 mg QD and BIS 2.0 mg BID (0.02 vs 0.01 L). On average, mean values for the BIS dosage groups did not indicate any deterioration from baseline to the treatment

  16. Effects of 12 weeks nutrition education on nutritional status in hemodialysis patients

    Directory of Open Access Journals (Sweden)

    Harin Rhee

    2012-06-01

    Full Text Available Protein-energy malnutrition is present in a large proportion of patients with end stage renal disease and, is a strong risk factor for mortality in these patients. This study was aimed to evaluate the effectiveness of 12-weeks nutrition education during the hemodialysis session for the improvement of nutritional status. From the June 2011 to the September 2011, patients who were on regular hemodialysis in Pusan National University Hospital were enrolled in this study. In education group, intensive nutrition education was performed by the hemodialysis nurse, for fifty to sixty minutes during the hemodialysis session, once a week. Curriculum for renal nutrition includes regular taking of their medication, intake of moderate amount of protein and sufficient calories, reduction of water, salt, potassium and phosphate intake. Otherwise, any education program was not performed in patients of control group. Nutrition status was assessed by the subjective global assessment (SGA,body mass index (BMI, triceps skinfold thickness (TSF, arm muscle area(AMC and laboratory markers such as serum albumin, serum blood urea nitrogen(BUN and hemoglobin(Hb level before and after the education. Effect of nutrition education was analyzed using ANCOVA test. A total of 49 patients were enrolled in this study and nutrition education was provided to 25 hemodialysis patients. Their mean age was 57.20±15.49 in education group and 55.13±14.42 in control groupand male was 56.0% in education group and 50.0% in control group and, other baseline characteristics were not significantly different between two groups. After the 12-week education, significant improvement was found in SGA, serum albumin, BUN and Hb level. SGA score was improved from 6.36±0.99 to 6.72±0.61 in education group, compared to control group(6.38±0.88 to 6.42±0.88, p=0.029 . Improvement of serum albumin level, BUN and Hb was as follows: serum albumin(4.23±0.28 to 4.30±0.25 in education group, 4.28±0

  17. Right Breast Mastectomy and Reconstruction with Tissue Expander under Thoracic Paravertebral Blocks in a 12-Week Parturient

    OpenAIRE

    Webb, Christopher Allen-John; Weyker, Paul David; Cohn, Shara; Wheeler, Amanda; Lee, Jennifer

    2015-01-01

    Paravertebral blocks are becoming increasingly utilized for breast surgery with studies showing improved postoperative pain control, decreased need for opioids, and less nausea and vomiting. We describe the anesthetic management of an otherwise healthy woman who was 12 weeks pregnant presenting for treatment of her breast cancer. For patients undergoing breast mastectomy and reconstruction with tissue expanders, paravertebral blocks offer an anesthetic alternative when general anesthesia is n...

  18. Right Breast Mastectomy and Reconstruction with Tissue Expander under Thoracic Paravertebral Blocks in a 12-Week Parturient

    Directory of Open Access Journals (Sweden)

    Christopher Allen-John Webb

    2015-01-01

    Full Text Available Paravertebral blocks are becoming increasingly utilized for breast surgery with studies showing improved postoperative pain control, decreased need for opioids, and less nausea and vomiting. We describe the anesthetic management of an otherwise healthy woman who was 12 weeks pregnant presenting for treatment of her breast cancer. For patients undergoing breast mastectomy and reconstruction with tissue expanders, paravertebral blocks offer an anesthetic alternative when general anesthesia is not desired.

  19. Right Breast Mastectomy and Reconstruction with Tissue Expander under Thoracic Paravertebral Blocks in a 12-Week Parturient.

    Science.gov (United States)

    Webb, Christopher Allen-John; Weyker, Paul David; Cohn, Shara; Wheeler, Amanda; Lee, Jennifer

    2015-01-01

    Paravertebral blocks are becoming increasingly utilized for breast surgery with studies showing improved postoperative pain control, decreased need for opioids, and less nausea and vomiting. We describe the anesthetic management of an otherwise healthy woman who was 12 weeks pregnant presenting for treatment of her breast cancer. For patients undergoing breast mastectomy and reconstruction with tissue expanders, paravertebral blocks offer an anesthetic alternative when general anesthesia is not desired.

  20. Effects of 12-weeks physical activity and omega-3 supplementation on serum ghrelin and insulin levels in young women

    Directory of Open Access Journals (Sweden)

    Eskandar Rahimi

    2014-05-01

    Full Text Available Background: Normal levels of ghrelin and insulin hormones play an important role in energy-balance, weight control and preventing type 2 diabetes. The purpose of this study was to evaluate the effects of twelve weeks physical activity with omega-3 supplementation consumption on insulin and ghrelin hormones in young women. Materials and methods: In this semi-experimental study 60 young women aged 19-25 years randomly divided into four groups including. (Exercise with supplementation, exercise alone, supplementation alone and control group. Exercise group and exercise- supplementation group followed the basketball training for 12 weeks under the supervision of skillful trainers. Supplementation group and exercise- supplementation group were asked to take 3gram omega-3 capsules per day for 12 weeks. Anthropometric indicators and blood samples were obtained in the morning after an 8-12 hr fast prior to the start of the study and again 12weeks after at the end of the study under the same conditions to measure plasma ghrelin and insulin hormones (Elisa method. Data analysis using tests of Kolmogorov-Smirnov t-test, one-way analysis of variance (ANOVA conducted through SPSS-16 software. Results: The results of ANOVA test showed that after 12 weeks of study ghrelin and insulin levels in exercise-supplement group, (P=0.000, P=0.000, exercise group (P=0.000, P=0.000, and supplement group (P=0.044, P=0.017 significantly increase and decrease respectively. But no significant changes were observed in control group for ghrelin (P=0.740 and insulin (P= 0.108 levels before and after the study. Conclusion: Based on the results of this study, physical activity with omega-3 supplementation can create significant changes on the levels of ghrelin and insulin hormones in young women. These changes may help to control and prevent diabetes and its, complications.

  1. Effects of a 12-week physical activities programme on sleep in female university students.

    Science.gov (United States)

    Hurdiel, Rémy; Watier, Timothée; Honn, Kimberly; Pezé, Thierry; Zunquin, Gautier; Theunynck, Denis

    2017-01-01

    Lack of sleep is known to negatively affect adolescent's health and the links between regular physical activity and sleep are unclear.This pilot study investigated whether the regular practice of physical activities among sedentary female students would improve their sleep. Nineteen female students, identified as sedentary and having poor subjective sleep quality were assigned in two groups to a 12-week university physical activities programme in accordance with the recommendations of World Health Organisation (N = 10) or to a control condition (N = 9). Sleep was assessed with actigraphy before and after the study and with the Pittsburg Sleep Quality 15 Index (PSQI) at the beginning, middle, and end of the study. The intensity of physical activities was controlled by heart rate monitor. The analysis showed that sleep quality in the physical activities group improved, with the mean ± SD PSQI score decreasing from 9.1 ± 1.7 to 4.8 ± 2.0. Despite some limitations, these pilot data indicate that a physical activities programme is feasible to implement in students, and that participation in such a programme improves sleep in 18- 24 -year-old female adolescents. Further potential benefits remain to be investigated in follow-up research.

  2. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study

    Directory of Open Access Journals (Sweden)

    Morillas-Arques Piedad

    2010-09-01

    Full Text Available Abstract Background Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. Methods A flexible dose of trazodone (50-300 mg/day, was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI. Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ, the Beck Depression Inventory (BDI, the Hospital Anxiety and Depression Scale (HADS, the Brief Pain Inventory (BPI, the Short-Form Health Survey (SF-36, and the Patients' Global Improvement Scale (PGI. Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. Results Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI, and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2% patients. Conclusions In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. Trial registration This trial has been registered with ClinicalTrials.gov number NCT-00791739.

  3. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes.

    Directory of Open Access Journals (Sweden)

    Anders Kilen

    Full Text Available It was investigated if high-intensity interval training (HIT at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT comprised ∼5 h vs. 1 h and total distance was ∼17 km vs. 35 km per week for HIT and CON, respectively. HIT was performed as 6-10×10-30 s maximal effort interspersed by 2-4 minutes of rest. Performance of 100 m all-out freestyle and 200 m freestyle was similar before and after the intervention in both HIT (60.4±4.0 vs. 60.3±4.0 s; n = 13 and 133.2±6.4 vs. 132.6±7.7 s; n = 14 and CON (60.2±3.7 vs. 60.6±3.8 s; n = 15 and 133.5±7.0 vs. 133.3±7.6 s; n = 15. Maximal oxygen uptake during swimming was similar before and after the intervention in both the HIT (4.0±0.9 vs. 3.8±1.0 l O2×min-1; n = 14 and CON (3.8±0.7 vs. 3.8±0.7 l O2×min-1; n = 11 group. Oxygen uptake determined at fixed submaximal speed was not significantly affected in either group by the intervention. Body fat % tended to increase (P = 0.09 in the HIT group (15.4±1.6% vs. 16.3±1.6%; P = 0.09; n = 16 and increased (P<0.05 in the CON group (13.9±1.5% vs. 14.9±1.5%; n = 17. A distance reduction of 50% and a more than doubled HIT amount for 12 weeks did neither improve nor compromise performance or physiological capacity in elite swimmers.

  4. Effectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patients.

    Science.gov (United States)

    Curry, M P; Tapper, E B; Bacon, B; Dieterich, D; Flamm, S L; Guest, L; Kowdley, K V; Lee, Y; Milligan, S; Tsai, N; Younossi, Z; Afdhal, N H

    2017-09-01

    Treatment of genotype 1 hepatitis C virus (HCV) infection with combination direct acting anti-virals is associated with very high rates of sustained virological response (SVR). Daily combination of ledipasvir and sofosbuvir for 12 weeks is approved for the treatment of genotype 1 HCV patients, though noncirrhotic patients who are naïve to treatment with a baseline HCV RNA ledipasvir and sofosbuvir with or without ribavirin for 8 or 12 weeks. To compare the SVR for 8 weeks vs 12 weeks of ledipasvir and sofosbuvir in HCV infected patients in a real-world setting. We performed an observational real-world cohort study of treatment success following 8 or 12 weeks of ledipasvir and sofosbuvir for treatment-naïve genotype 1 HCV patients. A total of 826 patients were treated for either 8 (n=252) or 12 weeks (n=574) with ledipasvir and sofosbuvir and achieved SVR rate of 95.3% and there was no statistical difference in SVR rates in the two groups irrespective of any clinical or virological variables. In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen. © 2017 John Wiley & Sons Ltd.

  5. The effect of stopping water exercise for 12 weeks on the functional fitness of elderly women

    Directory of Open Access Journals (Sweden)

    Michelle Flores da Rosa

    2008-07-01

    Full Text Available http://dx.doi.org/10.5007/1980-0037.2008v10n3p237 The objective of this study was to investigate the effect of a 12-week pause in exercising in water on the functional fitness of elderly women. The sample was 31 elderly women, with x _ = 68.97 years (SD = 5.34, all participants in a water exercise program. The women were tested in November 2005 and, after a 12-week pause in water exercises, in March2006, using the American Alliance for Health, Physical Education, Recreation and Dance – AAHPERD test battery. The statistical analysis was descriptive, using simple frequencies and percentages, plus the t test for paired samples. A statistically significant difference was observed between mean scores for coordination, agility and the general functional fitness index (GFFI at the end of the exercise program and 12 weeks later. The GFFI and coordination scores had reduced after the 12-week period, but the participants’ agility had improved. It was concluded that a 12-week pause in water exercise impacted the GFFI of these elderly women. These results emphasize the importance of physical exercise during the ageing process and of raising awareness of the need for the elderly to keep physically active even during the holiday period in order to improve and/or maintain functional fitness levels.

  6. Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study.

    Science.gov (United States)

    Pae, Chi-Un; Jeon, Hong Jin; Lee, Boung Chul; Seo, Ho-Jun; Kim, Shin Gyeom; Park, E-Jin; Kim, Won; Kwak, Kyung-Phil; Han, Changsu; Cho, Seong-Jin; Hahn, Sang-Woo; Jon, Duk-In; Choi, Jin-Hyuk; Jun, Tae-Youn

    2013-11-01

    Patients with chronic or recurrent major depressive disorder (MDD) have faced a dearth of treatment options. The present study evaluated the effectiveness and tolerability of aripiprazole augmentation for the treatment of chronic or recurrent MDD. This was the first 12-week prospective, multicentre, open-label study of the effectiveness and tolerability of flexibly dosed aripiprazole as an augmentation to ongoing antidepressant treatment in patients with chronic or recurrent MDD. The primary outcome measure for effectiveness was changes between baseline and endpoint (week 12) in total scores on the Montgomery-Asberg Depression Rating Scale. Adverse events (AEs) occurring throughout the trial are also reported. The Montgomery-Asberg Depression Rating Scale total scores decreased significantly between the baseline and the endpoint (magnitude of difference=-11.6, Precurrent MDD. Adequately powered and controlled clinical trials should be conducted to confirm our open-label study findings.

  7. The effect of a 12-week exercise programme on bone mineral ...

    African Journals Online (AJOL)

    A longer lifespan has increased the emphasis on bone health, which is often compromised with age. Studies have shown that exercise yields a positive influence on bone mineral density (BMD), especially when done during the early years of life (second to third decades). A 12-week study was undertaken using ...

  8. The response of the lactate minimum test to a 12-week swimming training

    DEFF Research Database (Denmark)

    Campos, Eduardo Zapaterra; Nordsborg, Nikolai Baastrup; Da Silva, Adelino Sanchez Ramos

    2014-01-01

    Despite the utilization of lactate minimum test (LMT) in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessmen...

  9. Negative Input for Grammatical Errors: Effects after a Lag of 12 Weeks

    Science.gov (United States)

    Saxton, Matthew; Backley, Phillip; Gallaway, Clare

    2005-01-01

    Effects of negative input for 13 categories of grammatical error were assessed in a longitudinal study of naturalistic adult-child discourse. Two-hour samples of conversational interaction were obtained at two points in time, separated by a lag of 12 weeks, for 12 children (mean age 2;0 at the start). The data were interpreted within the framework…

  10. Estimated analysis criteria of hatched weight and body weight 12 weeks of Kampung chicken selection

    Directory of Open Access Journals (Sweden)

    Fitra Aji Pamungkas

    2005-12-01

    Full Text Available Genetic parameter estimation for production traits are important in designing genetic selection program for Kampung chicken. The aimed of this research is to study heritability, accuracy of selection, and phenotypic and genotypic correlation of hatched weight and body weight at 12 weeks of Kampung chicken. Five hundred and fourteen head of Kampung chicken consist of 13 cocks, 65 hens, and 436 chicks were used in this study. Nested design analysis were used as described by Becker. The heritability estimation of hatched weight was calculated based on paternal half-sib, maternal half-sib, and full-sib corelation and it’s values were 0.35, 0.37, and 0.36 respectively. Heritability of body weight at 12 weeks based on paternal half-sib, maternal half-sib, and full-sib corelation were 0.27, 0.18, and 0.22 respectively. Selection accuracy of hatched weight were 59-61%, and selection accuracy of body weight at 12 weeks were 42 up to 52%. Genotypic and phenotypic correlation of hatched weight and body weight at 12 weeks estimation based on paternal half-sib, maternal half-sib, full-sib corelation were 0.29, 0.78, 0.51, and 0.17 respectively, indicated selection on one trait will affected the response on other traits positively.

  11. Agomelatine in the treatment of fibromyalgia: a 12-week, open-label, uncontrolled preliminary study.

    Science.gov (United States)

    Bruno, Antonio; Micò, Umberto; Lorusso, Simona; Cogliandro, Nadia; Pandolfo, Gianluca; Caminiti, Maurizio; Zoccali, Rocco A; Muscatello, Maria R A

    2013-08-01

    Pharmacological therapy for fibromyalgia syndrome (FMS) is actually unsatisfactory; analgetic and nonsteroidal anti-inflammatory drugs are not very effective. On the other hand, it is opportune to underline that antidepressant drugs produce positive response on pain in patients with FMS. Furthermore, many studies showed that using variable doses of melatonin (3-6 mg/d) in subjects affected from FMS had significantly been effective on pain, sleep, daytime fatigue, and depression. This study was aimed to evaluate the efficacy of agomelatine on depression, anxiety, cognition, and pain in a sample of drug-free FMS patients. Agomelatine was administered at the single daily dose of 25 mg/d to 15 fibromyalgia "drug-free" female subjects during 12 weeks. Outcome measures included the Hamilton Rating Scale for Depression, the Hamilton Rating Scale for Anxiety, the Zung Self-Rating Depression Scale, the Zung Self-Rating Anxiety Scale, the Visual Analog Scale of Pain, the Quality of Life Index, the Wisconsin Card Sorting Test, the Verbal Fluency Task-Controlled Oral Word Association Test, and the Stroop Color-Word Test. Treatment with agomelatine significantly improved depression, anxiety, and pain in patients with FMS. Regarding executive/cognitive symptoms, treatment with agomelatine did not have a significant impact on the explored neuropsychological domains, although there was a trend toward the improvement of performances. The findings showed that agomelatine was effective and well tolerated in patients with FMS. Further research is needed to fully evaluate the role of agomelatine as a potential pharmacological strategy for the treatment of FMS.

  12. Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles and an ADA Reference Toothbrush on Established Gingivitis and Supragingival Plaque over a 12-Week Period.

    Science.gov (United States)

    Gallob, John; Petrone, Dolores M; Mateo, Luis R; Chaknis, Patricia; Morrison, Boyce M; Williams, Malcolm; Panagakos, Foti

    2016-06-01

    Evaluation of the efficacy of a soft toothbrush with tapered-tip bristles (Test Toothbrush) and an ADA reference soft toothbrush (ADA Toothbrush) on established gingivitis and supragingival plaque over a 12-week period. This randomized, single-center, examiner-blind, two-cell, parallel clinical research study assessed plaque removal by the comparison of pre- to- post-brushing after a single use, and again after six- and 12-weeks' use, using the Quigley-Hein Plaque Index, Turesky Modification. The study also assessed gingivitis after six weeks and 12 weeks using the Löe & Silness Gingival Index. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Subjects had the study procedure explained to them both orally and by written instructions. Subjects then gave written consent to participate before entry into the study. Following an examination for plaque (pre-brushing) and gingivitis (baseline), the subjects were randomized into two balanced groups, each group assigned to one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. Seventy-one (71) subjects complied with the protocol and completed the clinical study. Compared to the ADA Toothbrush, the Test Toothbrush provided

  13. Location and severity of spasticity in the first 1-2 weeks and at 3 and 18 months after stroke.

    Science.gov (United States)

    Welmer, A-K; Widén Holmqvist, L; Sommerfeld, D K

    2010-05-01

    There is no consensus concerning the location or severity of spasticity, or how this changes with time after stroke. The purpose was to describe: the location and severity of spasticity, in different muscle groups, during the first 1-2 weeks and at 3 and 18 months after stroke; the association between the severity of spasticity and control of voluntary movements; and the occurrence of spasticity in younger versus older patients. In a cohort of consecutive patients, the following parameters were assessed during the first 1-2 weeks (n = 109) and at 3 (n = 95) and 18 (n = 66) months after first-ever stroke: spasticity, by the Modified Ashworth Scale in different muscle groups; plantar-flexor clonus, by physical examination; and movement function, by the Lindmark Motor Assessment Scale. During the first 1-2 weeks and at 3 months after stroke, spasticity was most common in the anti-gravity muscles. The severity of upper extremity spasticity increased over time (P < 0.05). Upper extremity spasticity and movement scores were moderately associated (r = -0.61, P < 0.05). At 3 months, spasticity was more common amongst the younger patients (P < 0.05). The results confirm that spasticity is most common in the anti-gravity muscles and is associated with the control of voluntary movements. As the severity of spasticity also increased after 3 months, when neurally mediated spasticity is expected to have passed its peak, intrinsic muscle changes may play a larger role than neural components with the passage of time after stroke.

  14. Positive performance and health effects of a football training program over 12 weeks can be maintained over a 1-year period with reduced training frequency

    DEFF Research Database (Denmark)

    Randers, Morten Bredsgaard; Nielsen, Jens Jung; Krustrup, Birgitte Rejkjær

    2010-01-01

    We examined whether improvements in the performance and health profile of an intensive 12-week football intervention could be maintained with a reduced training frequency. Seventeen healthy untrained males completed the study. Ten subjects trained 2.4 times/week for 12 weeks and another 52 weeks...... with 1.3 sessions/week [football group (FG)] and seven subjects acted as controls [control group (CG)]. For FG, fat mass (3.2 kg) and systolic blood pressure (8 mmHg) were lower (Pintermittent endurance level 2 test performance (49%) were higher...... unaltered for CG. In conclusion, positive adaptations in cardiovascular fitness obtained over 12 weeks of regular recreational football training can be maintained over a 1-year period with a reduced training frequency, with further development in musculo-skeletal fitness....

  15. Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles to an ADA Reference Toothbrush on Gingival Abrasion over a 12-Week Period.

    Science.gov (United States)

    Gallob, John; Petrone, Dolores M; Mateo, Luis R; Chaknis, Patricia; Morrison, Boyce M; Panagakos, Foti; Williams, Malcolm

    2016-06-01

    Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period. This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion. Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively). The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as

  16. Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia.

    Science.gov (United States)

    Krystal, Andrew D; Durrence, H Heith; Scharf, Martin; Jochelson, Philip; Rogowski, Roberta; Ludington, Elizabeth; Roth, Thomas

    2010-11-01

    to evaluate the efficacy and safety of doxepin 1 mg and 3 mg in elderly subjects with chronic primary insomnia. the study was a randomized, double-blind, parallel-group, placebo-controlled trial. Subjects meeting DSM-IV-TR criteria for primary insomnia were randomized to 12 weeks of nightly treatment with doxepin (DXP) 1 mg (n = 77) or 3 mg (n = 82), or placebo (PBO; n = 81). Efficacy was assessed using polysomnography (PSG), patient reports, and clinician ratings. Objective efficacy data are reported for Nights (N) 1, 29, and 85; subjective efficacy data during Weeks 1, 4, and 12; and Clinical Global Impression (CGI) scale and Patient Global Impression (PGI) scale data after Weeks 2, 4, and 12 of treatment. Safety assessments were conducted throughout the study. DXP 3 mg led to significant improvement versus PBO on N1 in wake time after sleep onset (WASO; P treatment groups. There were no significant next-day residual effects; additionally, there were no reports of memory impairment, complex sleep behaviors, anticholinergic effects, weight gain, or increased appetite. DXP 1 mg and 3 mg administered nightly to elderly chronic insomnia patients for 12 weeks resulted in significant and sustained improvements in most endpoints. These improvements were not accompanied by evidence of next-day residual sedation or other significant adverse effects. DXP also demonstrated improvements in both patient- and physician-based ratings of global insomnia outcome. The efficacy of DXP at the doses used in this study is noteworthy with respect to sleep maintenance and early morning awakenings given that these are the primary sleep complaints of the elderly. This study, the longest placebo-controlled, double-blind, polysomnographic trial of nightly pharmacotherapy for insomnia in the elderly, provides the best evidence to date of the sustained efficacy and safety of an insomnia medication in older adults.

  17. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study

    DEFF Research Database (Denmark)

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke

    2011-01-01

    It was hypothesised that increased exercise capacity is related to improved quality of life (QoL) in patients with cystic fibrosis (CF). A 12-week individually tailored unsupervised aerobic exercise programme was offered to 42 patients with CF. At the start and at the end of the exercise programm......-week individually tailored unsupervised aerobic exercise programme where HR monitors were used significantly affected VO(2max). Improvement in QoL could not be demonstrated in this study....

  18. Effects of 12-week core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescents with idiopathic scoliosis.

    Science.gov (United States)

    Ko, Kwang-Jun; Kang, Seol-Jung

    2017-04-01

    To identify the effects of core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescent patients with idiopathic scoliosis. Subjects in the present study consisted of primary school students who were confirmed to have scoliosis on radiologic examination performed during their visit to the National Fitness Center in Seoul, Korea. Depending on whether they participated in a 12-week core stabilization exercise program, subjects were divided into the exercise (n=14, age 12.71±0.72 years) or control (n=15, age 12.80±0.86 years) group. The exercise group participated in three sessions of core stabilization exercise per week for 12 weeks. The Cobb angle, flexibility, and lumbar muscle strength tests were performed before and after core stabilization exercise. Repeated-measure two-way analysis of variance was performed to compare the treatment effects between the exercise and control groups. There was no significant difference in thoracic Cobb angle between the groups. The exercise group had a significant decrease in the lumbar Cobb angle after exercise compared to before exercise (Pstrength after exercise compared to before exercise (PCore stabilization exercise can be an effective therapeutic exercise to decrease the Cobb angle and improve lumbar muscle strength in adolescents with idiopathic scoliosis.

  19. The Health Benefits of a 12-Week Home-Based Interval Training Cardiac Rehabilitation Program in Patients With Heart Failure.

    Science.gov (United States)

    Safiyari-Hafizi, Hedieh; Taunton, Jack; Ignaszewski, Andrew; Warburton, Darren E R

    2016-04-01

    Recently, high-intensity interval training has been advocated for the rehabilitation of persons living with heart failure (HF). Home-based training is more convenient for many patients and could augment compliance. However, the safety and efficacy of home-based interval training remains unclear. We evaluated the safety and efficacy of a supervised home-based exercise program involving a combination of interval and resistance training. Measures of aerobic power, endurance capacity, ventilatory threshold, and quality of life in 40 patients with HF, were taken at baseline and after 12 weeks. Patients were matched and randomized to either control (CTL; n = 20) or experimental (EXP; n = 20) conditions. The EXP group underwent a 12-week high-intensity interval and resistance training program while the CTL group maintained their usual activities of daily living. In the EXP group, we found a significant improvement in aerobic power, endurance capacity, ventilatory threshold, and quality of life. There were no significant changes in the CTL group. We have shown that a home-based cardiac rehabilitation program involving interval and resistance training is associated with improved aerobic capacity and quality of life in patients with HF. This research has important implications for the treatment of HF. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  20. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial

    Directory of Open Access Journals (Sweden)

    Ho Suleen S

    2012-08-01

    Full Text Available Abstract Background Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Methods Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16; Group 2 (Aerobic, n = 15; Group 3 (Resistance, n = 16; Group 4 (Combination, n = 17. Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Results Significant improvements in body weight (−1.6%, p = 0.044 for the Combination group compared to Control and Resistance groups and total body fat compared to Control (−4.4%, p = 0.003 and Resistance (−3%, p = 0.041. Significant improvements in body fat percentage (−2.6%, p = 0.008, abdominal fat percentage (−2.8%, p = 0.034 and cardio-respiratory fitness (13.3%, p = 0.006 were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04. Conclusion A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese

  1. The effect of 12 weeks of aerobic, resistance or combination exercise training on cardiovascular risk factors in the overweight and obese in a randomized trial.

    Science.gov (United States)

    Ho, Suleen S; Dhaliwal, Satvinder S; Hills, Andrew P; Pal, Sebely

    2012-08-28

    Evidence suggests that exercise training improves CVD risk factors. However, it is unclear whether health benefits are limited to aerobic training or if other exercise modalities such as resistance training or a combination are as effective or more effective in the overweight and obese. The aim of this study is to investigate whether 12 weeks of moderate-intensity aerobic, resistance, or combined exercise training would induce and sustain improvements in cardiovascular risk profile, weight and fat loss in overweight and obese adults compared to no exercise. Twelve-week randomized parallel design examining the effects of different exercise regimes on fasting measures of lipids, glucose and insulin and changes in body weight, fat mass and dietary intake. Participants were randomized to either: Group 1 (Control, n = 16); Group 2 (Aerobic, n = 15); Group 3 (Resistance, n = 16); Group 4 (Combination, n = 17). Data was analysed using General Linear Model to assess the effects of the groups after adjusting for baseline values. Within-group data was analyzed with the paired t-test and between-group effects using post hoc comparisons. Significant improvements in body weight (-1.6%, p = 0.044) for the Combination group compared to Control and Resistance groups and total body fat compared to Control (-4.4%, p = 0.003) and Resistance (-3%, p = 0.041). Significant improvements in body fat percentage (-2.6%, p = 0.008), abdominal fat percentage (-2.8%, p = 0.034) and cardio-respiratory fitness (13.3%, p = 0.006) were seen in the Combination group compared to Control. Levels of ApoB48 were 32% lower in the Resistance group compared to Control (p = 0.04). A 12-week training program comprising of resistance or combination exercise, at moderate-intensity for 30 min, five days/week resulted in improvements in the cardiovascular risk profile in overweight and obese participants compared to no exercise. From our observations, combination exercise gave greater benefits for weight loss

  2. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  3. The feasibility and benefits of a 12-week yoga intervention for pediatric cancer out-patients.

    Science.gov (United States)

    Wurz, Amanda; Chamorro-Vina, Carolina; Guilcher, Gregory M T; Schulte, Fiona; Culos-Reed, S Nicole

    2014-10-01

    Increasing rates of survival present a new set of psychosocial and physical challenges for children undergoing treatment for cancer. Physical activity (PA) has been shown to be a safe and effective strategy to mitigate the significant burden of cancer and its treatments, with yoga increasingly gaining recognition as a gentle alternative. The purpose of this study was to determine the feasibility and benefits of a 12-week community-based yoga intervention on health-related quality of life (HRQL), select physical fitness outcomes and PA levels (PAL). Eight pediatric cancer out-patients (4 male; 4 female; Mage  = 11.88, SD = 4.26) participated in the 12-week intervention consisting of supervised yoga sessions 2 times/week. Participants (patients and parent proxies) completed measures assessing HRQL, physical fitness and PAL at baseline and post-intervention. Rates of recruitment, retention, attendance and adverse events indicated the program was feasible. Wilcoxon Signed Rank tests indicated significant improvements for patient (P = 0.02) and parent reported HRQL (P = 0.03), functional mobility (P = 0.01), hamstring flexibility (left, P = 0.01 and right P = 0.02), and total PAL (P = 0.02) pre to post intervention. This 12-week community-based yoga intervention was feasible and provides preliminary evidence for the benefits of yoga on HRQL, physical fitness and PAL in pediatric cancer out-patients. In a population where sedentary behavior and the associated co-morbidities are a growing concern, these results promote the continued exploration of yoga programming. © 2014 Wiley Periodicals, Inc.

  4. Coadministration of lorcaserin and phentermine for weight management: A 12?week, randomized, pilot safety study

    OpenAIRE

    Smith, Steven R.; Garvey, W. Timothy; Greenway, Frank L.; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J.

    2017-01-01

    Objective To assess the short?term tolerability of lorcaserin alone or with two dose regimens of phentermine. Methods This was a 12?week, randomized, double?blind, pilot safety study of N?=?238 nondiabetic patients with obesity or overweight with ?1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting???1 of 9 potentially serotonergic adverse events (AE...

  5. Malignant uveal schwannoma with peripheral nerve extension in a 12-week-old color-dilute Labrador Retriever.

    Science.gov (United States)

    Duke, F D; Teixeira, L B C; Galle, L E; Green, N; Dubielzig, R R

    2015-01-01

    The formalin-fixed, amber-colored right globe from a 12-week-old female silver Labrador Retriever dog was submitted to the Comparative Ocular Pathology Laboratory of Wisconsin for light microscopic evaluation. The clinical history described a collapsed anterior chamber and multifocal nodular lesions in the peripheral iris. Histologically, immunohistochemically, and ultrastructurally, the uveal mass was consistent with a malignant schwannoma; there was extension along peripheral nerves within the sclera. The signalment and behavior of the neoplasm distinguish it from the uveal schwannoma of blue-eyed dogs and bear some resemblance to the ocular lesions in human neurofibromatosis. The dilute color mutation may contribute to the cause. Six weeks later, the dog did not develop any additional masses. © The Author(s) 2014.

  6. Altered spontaneous neuronal activity in chronic posttraumatic stress disorder patients before and after a 12-week paroxetine treatment.

    Science.gov (United States)

    Zhu, Hongru; Qiu, Changjian; Meng, Yajing; Cui, Haofei; Zhang, Yan; Huang, Xiaoqi; Zhang, Junran; Li, Tao; Gong, Qiyong; Zhang, Wei; Lui, Su

    2015-03-15

    Abnormal functional brain activity has been revealed in patients with Posttraumatic Stress Disorder (PTSD) in recent years, while the recovery neuromechanism of PTSD has not yet been elucidated. The aim of this study was to investigate the altered spontaneous brain activity in treatment-naïve chronic PTSD patients before and after 12 weeks׳ treatment with paroxetine. Twenty-one earthquake-related PTSD patients and seventeen traumatized controls underwent a resting functional magnetic resonance imaging (Rs-fMRI) scan at baseline. Amplitude of low-frequency fluctuation (ALFF) was calculated and compared between PTSD patients and controls. Then, the PTSD group completed 12 weeks of treatment with paroxetine, and Rs-fMRI was repeated to compare with the baseline. Lastly, correlation analyses of ALFF values within altered brain areas were conducted. Hyperactive function of visual cortex was observed in PTSD patients before and after treatment. After treatment, significantly increased ALFF values were observed in the left orbitofrontal cortex (OFC), while decreased ALFF values were found in the precuneus. Interestingly, a negative correlation between the mean ALFF values of OFC and those of precuneus and visual cortex was only observed in controls, but not in PTSD patients pre- or post-treatment. A corresponding control condition was absent in this study. The findings showed that manipulating regional spontaneous activity of precuneus and OFC could be a potential prognostic indicator of PTSD. However, hyperactive function of visual cortex and disrupted connections between OFC, precuneus and visual cortex did not reverse after treatment, which could be a potential target for further treatment. Copyright © 2014 Elsevier B.V. All rights reserved.

  7. The Effect of 12 Weeks of High-Intensity Interval Training (HIIT on Homocysteine and CRP Cardiovascular Risk Factors and Body Composition in Overweight Men

    Directory of Open Access Journals (Sweden)

    Mohammad Ebrahim Bahram

    2016-12-01

    Full Text Available Background & Objective: High levels of homocysteine inflammatory markers and C-Reactive Protein (CRP cause many complications, including atherosclerosis, venous thrombosis, and cardiovascular problems. The objective of the present study was to investigate the effect of 12-weekHigh Intensity Interval Training (HIIT on homocysteine, CRP, and body composition in overweight men. Materials & Methods: In this quasi-experimental study, 20 students of Kashan University of Medical Sciences with a body mass index between 25 and 30 kg/m2, were purposefully selected and were randomly divided into experimental and control groups. The experimental group had practiced in the HIIT program with the intensity of up to 90 percent of maximum heart rate for 12 weeks. Before and after exercise, the amount of homocysteine, CRP, weight, body fat percentage, body mass index, and waist-to-hip ratio were calculated. The data were analyzed by using dependent and independent t-test at a significance level of P<0.05. Results: The results showed that12 weeks of HIIT had significant effects on reducing serum levels of homocysteine and HSCRP, body weight, body fat percentage, BMI, and WHR in the experimental group compared to the control group (P<0.05. Conclusion: It seems that 12 weeks of intense interval training as a non-invasive method can have a positive effect on reducing the amount of homocysteine, HS-CRP, and some anthropometric indexes of obesity and overweight.

  8. Effect of a 12-Week Physical Activity Program on Gross Motor Skills in Children.

    Science.gov (United States)

    Burns, Ryan D; Fu, You; Fang, Yi; Hannon, James C; Brusseau, Timothy A

    2017-12-01

    This study examined the effects of a 12-week Comprehensive School Physical Activity Program (CSPAP) on gross motor skill development in children from low-income families. Participants were 1,460 school-aged children (mean age = 8.4 ± 1.8 years; 730 girls, 730 boys) recruited from three schools receiving U.S. governmental financial assistance. Students were recruited from grades K-6. CSPAP was implemented over one semester during the 2014-2015 school year. Select gross motor skill items were assessed during each student's physical education class at baseline and at a 12-week follow-up using the Test for Gross Motor Development-2nd Edition (TGMD-2). Each student's TGMD-2 score was converted to a percentage of the total possible score. A 7 × 2 × 2 analysis of variance test with repeated measures was employed to examine the effects of age, sex, and time on TGMD-2 percent scores, adjusting for clustering within the data structure. There were greater TGMD-2 percent scores at follow-up compared with baseline (82.4% vs. 72.6%, mean difference = 9.8%, p < .001, Cohen's d = 0.67), and greater improvements were seen in younger children compared with older children (mean difference of change = 4.0%-7.5%, p < .01, Cohen's d = 0.30-0.55).

  9. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

    Directory of Open Access Journals (Sweden)

    Abdessalem Koubaa

    2015-02-01

    Full Text Available Introduction: Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim: To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods: Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (VO2max. Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results: As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved VO2max (4.4 and 4.7%, respectively, v VO2max (6.7 and 5.6%, respectively, and the recovery index (7.9 and 10.5%, respectively. Conclusions: After 12 weeks of interval training program, the increase of VO2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only

  10. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training.

    Science.gov (United States)

    Koubaa, Abdessalem; Triki, Moez; Trabelsi, Hajer; Masmoudi, Liwa; Zeghal, Khaled N; Sahnoun, Zouhair; Hakim, Ahmed

    2015-01-01

    Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest) three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (VO2max). Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF) in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved VO2max (4.4 and 4.7%, respectively), v VO2max (6.7 and 5.6%, respectively), and the recovery index (7.9 and 10.5%, respectively). After 12 weeks of interval training program, the increase of VO2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only partially, both aerobic capacity and life quality were improved

  11. The effect of stopping water exercise for 12 weeks on the functional fitness of elderly women

    Directory of Open Access Journals (Sweden)

    Aline Huber da Silva

    2008-06-01

    Full Text Available The objective of this study was to investigate the effect of a 12-week pause in exercising in water on the functional fitness of elderly women. The sample was 31 elderly women, with x _ = 68.97 years (SD = 5.34, all participants in a water exercise program. The women were tested in November 2005 and, after a 12-week pause in water exercises, in March2006, using the American Alliance for Health, Physical Education, Recreation and Dance – AAHPERD test battery. The statistical analysis was descriptive, using simple frequencies and percentages, plus the t test for paired samples. A statistically significant difference was observed between mean scores for coordination, agility and the general functional fitness index (GFFI at the end of the exercise program and 12 weeks later. The GFFI and coordination scores had reduced after the 12-week period, but the participants’ agility had improved. It was concluded that a 12-week pause in water exercise impacted the GFFI of these elderly women. These results emphasize the importance of physical exercise during the ageing process and of raising awareness of the need for the elderly to keep physically active even during the holiday period in order to improve and/or maintain functional fitness levels. ResumoEsse estudo teve como objetivo verificar a influência do período de interrupção de 12 semanas na aptidão funcional de mulheres idosas, praticantes de atividades aquáticas. A amostra foi composta por 31 idosas, com x _ = 68,97 anos (DP = 5,34, praticantes de atividades aquáticas, que fizeram os testes da Bateria da American Alliance for Health, Physical Education, Recreation and Dance – AAHPERD, em novembro de 2005 e após 12 semanas de interrupção (março de 2006. Os resultados dos testes foram comparados com os valores normativos para essa bateria. O tratamento estatístico foi descritivo, mediante a freqüência simples e percentagem, e o teste t para amostras emparelhadas/pareadas, com n

  12. Effect of 12 weeks of Chosen Pilates Exercise on the Quality of Iife of Healthy Nonathletic People

    Directory of Open Access Journals (Sweden)

    ME Bahram

    2014-05-01

    Results:There was a significant difference in the quality of life and the following results emerged (P≥0.05: physical health (P=0.0001, F=146.929, mental health (P=0.0001, F=186.508, social contacts (P=0.0001, F=335.657, environmental health (P=0.0001, F=287.57 and the quality of life (P=0.0001, F=69.317. However, no significant differences was found in the control group (P≥0.05. Conclusion:Totally, the results showed that 12 weeks of Pilates Exercises leads to better quality of life and related variables in nonathletic men. This can be regarded as a nonaggressive way to improve the quality of life of the older people.

  13. A 12-week exercise program performed during the second trimester does not prevent gestational diabetes in healthy pregnant women.

    Science.gov (United States)

    Ramírez-Vélez, Robinson

    2012-01-01

    Does a 12-week exercise program prevent gestational diabetes and improve insulin resistance in healthy pregnant women with normal body mass index (BMI)? Randomised, controlled trial with concealed allocation and blinded outcome assessment. Two University hospitals in Norway. White adult women with a single fetus. High-risk pregnancies or diseases that would interfere with participation were exclusion criteria. Randomisation of 855 participants allocated 429 to the exercise group and 426 to a control group. Both groups received written advice on pelvic floor muscle exercises, diet, and lumbo-pelvic pain. In addition, the intervention group participated in a standardised group exercise program led by a physiotherapist, once a week for 12 weeks, between 20 and 36 weeks gestation. The program included 30-35 minutes low impact aerobics, 20-25 minutes of strength exercises using body weight as resistance and 5-10 minutes of stretching, breathing, and relaxation exercises. They were also encouraged to follow a 45-minute home exercise program at least twice a week. The control group received standard antenatal care and the customary information given by their midwife or general practitioner. The primary outcomes were the prevalence of gestational diabetes, insulin resistance estimated by the homeostasis model assessment method (HOMA-IR), and fasting insulin and oral glucose tolerance tests at baseline and at the end of the training period. Fasting and 2-hour glucose levels were measured in serum by the routine methods. Gestational diabetes was diagnosed as fasting glucose level 2-hour value ≥7.8mmol/L. Secondary outcome measures were weight, BMI, and pregnancy complications and outcomes. 702 participants completed the study. At the end of the 12-week program, there was no difference in the prevalence of gestational diabetes (25 (7%) of intervention group compared with 18 (6%) of control group), HOMA-IR (-0.15, 95% CI -0.33 to 0.03), or oral glucose tolerance tests at 2

  14. The effect of a 12 week plyometric and soccer training on the cardiac structure and function among the 13-15 years old boys

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    Bakhtiar Tartibian

    2017-04-01

    Full Text Available Background: Exercise plays an important role in improving cardiovascular function. Due to the increasing tendency of children to the soccer the purpose of this investigation was to examine the effects of a 12 week plyometric and soccer training on the cardiac structure and function of healthy 13-15 years old boys. Materials and Methods: This quasi- experimental study was conducted with a pre-test and post-test design. The participants (n=20 were selected among the non-athletic healthy boys (13-15 years from Miyaneh (East Azerbaijan, Iran. After taking informed consent the participants were voluntarily participated in two equal Training and Control groups. The participants in the Exercise group performed a 12 week plyometric and soccer training. Under basic conditions and after a 12 week follow-up using the echocardiography both groups were examined for left ventricular end-diastolic dimension (LVEDD, left ventricular end-systolic dimension (LVESD, left ventricular end diastolic posterior wall dimension¬ (LVPWd, inter-ventricular septal end diastolic dimension (IVSd, stroke volume (SV, ejection fraction (EF and cardiac output (CO. Results: After a 12 week training program the LVEDD, LVPWd and SV were significantly increased (P<0.05. The EF in the Exercise group had no increase. Moreover, LVESD and IVSd were similar in both groups. Conclusion: A twelve week plyometric and soccer training in 13-15 years old boys result in significant changes in some cardiac structural and functional indexes.

  15. Myogenic response of human skeletal muscle to 12 weeks of resistance training at light loading intensity

    DEFF Research Database (Denmark)

    Mackey, Abigail; Holm, L; Reitelseder, S

    2011-01-01

    There is strong evidence for enhanced numbers of satellite cells with heavy resistance training. The satellite cell response to very light muscle loading is, however, unknown. We, therefore, designed a 12-week training protocol where volunteers trained one leg with a high load (H) and the other leg...... with a light load (L). Twelve young healthy men [mean age 25 ± 3 standard deviation (SD) years] volunteered for the study. Muscle biopsies were collected from the m. vastus lateralis of both legs before and after the training period and satellite cells were visualized by CD56 immunohistochemistry....... A significant main effect of time was observed (Ptraining skeletal muscle even with very light loads can induce an increase in the number of satellite...

  16. Effect of a 12-week yoga therapy program on mental health status in elderly women inmates of a hospice.

    Science.gov (United States)

    Ramanathan, Meena; Bhavanani, Ananda Balayogi; Trakroo, Madanmohan

    2017-01-01

    This study was undertaken to evaluate the effectiveness of yoga on the mental health status of elderly women inmates residing in a hospice in Puducherry. Forty elderly women were randomly divided into yoga and wait-listed control group. A yoga therapy program of 60 min was given twice a week for 12 weeks. This protocol was specially designed for senior citizens, keeping in mind their health status and physical limitations that included simple warm-up and breath-body movement coordination practices (jathis and kriyas), static stretching postures (asanas), breathing techniques (pranayamas), and relaxation. Hamilton anxiety scale for measuring anxiety, Hamilton rating scale for depression, and Rosenberg self-esteem scale to measure self-esteem were administered to both groups before and after the 12-week study period. Data were assessed for normality, and appropriate parametric and nonparametric statistical methods were applied for intra- and inter-group comparisons. Overall, intra- and inter-group comparison of prepost data showed statistically significant (P self-esteem after the yoga therapy program. The influence of yoga in the reduction of depression and anxiety scores and improvement in self-esteem scores in elderly women subjects is evident from this study. As reported in earlier studies, this may be attributed to changes in central neurotransmitters such as gamma-aminobutyric-acid coupled with increased parasympathetic tone and decreased sympatho-adrenal activity. It is recommended that yoga should be a part of health-care facilities for elderly as it can enhance the quality of life by improving their overall mental health status. It could provide a healthy and positive alternative from depressing negative thoughts, and give them a sense of purpose and hope.

  17. The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    William Stokes

    2017-01-01

    Full Text Available Background. The recommended therapy for patients with chronic hepatitis C (CHC, genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF, ledipasvir (LDV, and ribavirin (RBV. This recommendation is based on expert opinion, and the efficacy of 12 weeks of SOF/LDV compared to SOF/LDV/RBV in this patient population has not yet been established. Methods. We conducted a systematic review and meta-analysis. Two investigators independently searched electronic databases and relevant conference proceedings for randomized controlled trials comparing rates of sustained virologic response 12 weeks after therapy (SVR12 when using 12 weeks of SOF/LDV versus 12 weeks of SOF/LDV/RBV in patients with CHC, genotype 1, who have cirrhosis and failed previous therapy. Results. Our search strategy yielded 596 studies of which four met criteria for inclusion. The pooled RR of not achieving SVR12 with SOF/LDV versus SOF/LDV/RBV was 1.21 (95% CI: 0.42–3.48. Adverse events were lower in the SOF/LDV compared to the SOF/LDV/RBV arms (pooled RR: 0.11, 95% CI: 0.04–0.29. Conclusions. Our findings suggest that 12 weeks of SOF/LDV cannot be considered noninferior to 12 weeks of SOF/LDV/RBV to achieve SVR12 in patients with CHC who have cirrhosis and failed prior therapy.

  18. The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Stokes, William; Fenton, Carol; Clement, Fiona; James, Matthew; Ronksley, Paul; Tang, Karen L

    2017-01-01

    Background. The recommended therapy for patients with chronic hepatitis C (CHC), genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF), ledipasvir (LDV), and ribavirin (RBV). This recommendation is based on expert opinion, and the efficacy of 12 weeks of SOF/LDV compared to SOF/LDV/RBV in this patient population has not yet been established. Methods . We conducted a systematic review and meta-analysis. Two investigators independently searched electronic databases and relevant conference proceedings for randomized controlled trials comparing rates of sustained virologic response 12 weeks after therapy (SVR12) when using 12 weeks of SOF/LDV versus 12 weeks of SOF/LDV/RBV in patients with CHC, genotype 1, who have cirrhosis and failed previous therapy. Results. Our search strategy yielded 596 studies of which four met criteria for inclusion. The pooled RR of not achieving SVR12 with SOF/LDV versus SOF/LDV/RBV was 1.21 (95% CI: 0.42-3.48). Adverse events were lower in the SOF/LDV compared to the SOF/LDV/RBV arms (pooled RR: 0.11, 95% CI: 0.04-0.29). Conclusions. Our findings suggest that 12 weeks of SOF/LDV cannot be considered noninferior to 12 weeks of SOF/LDV/RBV to achieve SVR12 in patients with CHC who have cirrhosis and failed prior therapy.

  19. A 12-week subchronic intramuscular toxicity study of risperidone-loaded microspheres in rats.

    Science.gov (United States)

    Zhang, J; Ye, L; Wang, W; Du, G; Yu, X; Zhu, X; Dong, Q; Cen, X; Guan, X; Fu, F; Tian, J

    2015-02-01

    Long-acting injectable formulations of antipsychotics have been an important treatment option to increase the compliance of the patient with schizophrenia by monitoring drug administration and identifying medication noncompliance and to improve the long-term management of schizophrenia. Risperidone, a serotoninergic 5-HT2 and dopaminergic D2 receptor antagonist, was developed to be a long-acting sustained-release formulation for the treatment of schizophrenia. In this study, 12-week subchronic toxicity study of risperidone-loaded microspheres (RMs) in rats by intramuscular injection with an 8-week recovery phase was carried out to investigate the potential subchronic toxicity of a novel long-acting sustained-release formulation. The results indicated that the dosage of 10-90 mg/kg of RM for 2 weeks did not cause treatment-related mortality. The main drug-related findings were contributed to the dopamine D2 receptor and α1-adrenoceptor antagonism of risperidone such as elevation of serum and pituitary prolactin levels and ptosis and changes in reproductive system (uterus, ovary, vagina, mammary gland, testis, seminal vesicle, epididymis, and prostate). In addition, foreign body granuloma in muscle at injection sites caused by poly-lactide-co-glycolide was observed. At the end of the recovery phase, these changes mostly returned to normal. The results indicated that RM had a good safety profile in rats. © The Author(s) 2015.

  20. Ledipasvir plus sofosbuvir for 12 weeks in patients with hepatitis C genotype 4 infection.

    Science.gov (United States)

    Abergel, Armand; Metivier, Sophie; Samuel, Didier; Jiang, Deyuan; Kersey, Kathryn; Pang, Phillip S; Svarovskaia, Evguenia; Knox, Steven J; Loustaud-Ratti, Veronique; Asselah, Tarik

    2016-10-01

    Genotype 4 hepatitis C virus (HCV) was considered difficult to treat in the era of pegylated interferon-alpha (Peg-IFN-α) and ribavirin regimens. We evaluated the efficacy and safety of therapy with the nonstructural (NS) 5A inhibitor, ledipasvir, combined with the NS5B polymerase inhibitor, sofosbuvir, in patients with HCV genotype 4. In this phase 2, open-label study, 44 patients (22 treatment naïve and 22 treatment experienced) received a fixed-dose combination tablet of 90 mg of ledipasvir and 400 mg of sofosbuvir orally once-daily for 12 weeks. The primary endpoint was the percentage of patients with HCV RNA ledipasvir and sofosbuvir is an effective and safe treatment for a wide range of HCV 4 subtypes in both treatment-naïve and -experienced patients, including those with compensated cirrhosis. (EudraCT number: 2013-003978-27; Clinicaltrials.gov NCT02081079) (Hepatology 2016;64:1049-1056). © 2016 by the American Association for the Study of Liver Diseases.

  1. The response of the lactate minimum test to a 12-week swimming training

    Directory of Open Access Journals (Sweden)

    Eduardo Zapaterra Campos

    2014-09-01

    Full Text Available Despite the utilization of lactate minimum test (LMT in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessments: beginning of the season, T0; after four, T4; and twelve weeks, T12. The LMT consisted of a 200m maximal effort and, after eight minutes of passive rest, five incremental stages of 200m swimming. The intensities of the incremental stages were defined subjectively ("very light," "light," "moderate," "hard," and "all-out". The training was divided in two blocks of periodization: endurance training period (ETP, T0 - T4, and quality plus taper period (QTP, T4 - T12. The LMT intensity of T4 and T12 were significantly higher than T0. We conclude that LMT is modified due to swimming training and can be used for training prescription and detection of aerobic capacity alterations during a season.

  2. Exercise Training in Treatment and Rehabilitation of Hip Osteoarthritis: A 12-Week Pilot Trial

    Directory of Open Access Journals (Sweden)

    Kirsti Uusi-Rasi

    2017-01-01

    Full Text Available Introduction. Osteoarthritis (OA of the hip is one of the major causes of pain and disability in the older population. Although exercise is an effective treatment for knee OA, there is lack of evidence regarding hip OA. The aim of this trial was to test the safety and feasibility of a specifically designed exercise program in relieving hip pain and improving function in hip OA participants and to evaluate various methods to measure changes in their physical functioning. Materials and Methods. 13 women aged ≥ 65 years with hip OA were recruited in this 12-week pilot study. Results. Pain declined significantly over 30% from baseline, and joint function and health-related quality of life improved slightly. Objective assessment of physical functioning showed statistically significant improvement in the maximal isometric leg extensor strength by 20% and in the hip extension range of motion by 30%. Conclusions. The exercise program was found to be safe and feasible. The present evidence indicates that the exercise program is effective in the short term. However, adequate powered RCTs are needed to determine effects of long-term exercise therapy on pain and progression of hip OA.

  3. Better understanding of homologous recombination through a 12-week laboratory course for undergraduates majoring in biotechnology.

    Science.gov (United States)

    Li, Ming; Shen, Xiaodong; Zhao, Yan; Hu, Xiaomei; Hu, Fuquan; Rao, Xiancai

    2017-07-08

    Homologous recombination, a central concept in biology, is defined as the exchange of DNA strands between two similar or identical nucleotide sequences. Unfortunately, undergraduate students majoring in biotechnology often experience difficulties in understanding the molecular basis of homologous recombination. In this study, we developed and implemented a 12-week laboratory course for biotechnology undergraduates in which gene targeting in Streptococcus suis was used to facilitate their understanding of the basic concept and process of homologous recombination. Students worked in teams of two to select a gene of interest to create a knockout mutant using methods that relied on homologous recombination. By integrating abstract knowledge and practice in the process of scientific research, students gained hands-on experience in molecular biology techniques while learning about the principle and process of homologous recombination. The learning outcomes and survey-based assessment demonstrated that students substantially enhanced their understanding of how homologous recombination could be used to study gene function. Overall, the course was very effective for helping biotechnology undergraduates learn the theory and application of homologous recombination, while also yielding positive effects in developing confidence and scientific skills for future work in research. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):329-335, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.

  4. No effects of a 12-week supervised exercise therapy program on gait in patients with mild to moderate osteoarthritis: a secondary analysis of a randomized trial.

    Science.gov (United States)

    Eitzen, Ingrid; Fernandes, Linda; Nordsletten, Lars; Risberg, May Arna

    2015-03-05

    It is unknown whether gait biomechanics in hip osteoarthritis patients with mild to moderate symptoms change following exercise therapy interventions. The aim of the present study was to compare stance phase gait characteristics in hip osteoarthritis patients with mild to moderate symptoms participating in a randomized trial with two different interventions; patient education only or patient education followed by a 12-week supervised exercise therapy program. The study was conducted as a secondary analysis of a single-blinded randomized controlled trial. Patients aged 40 to 80 years, with hip osteoarthritis verified from self-reported pain and radiographic changes, were included. The final material comprised 23 patients (10 males/13 females, mean (SD) age 58.2 (10.02) years) in the patient education only group, and 22 patients (9 males/13 females, mean (SD) age 60.2 (9.49) years) in the patient education + exercise therapy group. Three-dimensional gait analysis was conducted at baseline and at four month follow-up. Sagittal and frontal plane joint angle displacement and external joint moments of the hip, knee and ankle were compared from a one-way analysis of covariance between the groups at follow-up, with baseline values as covariates (p gait velocity, joint angle displacement, or moments. As the compliance in the exercise therapy group was inadequate, we calculated possible associations between the number of completed exercise sessions and change in each of the kinematic or kinetic variables. Associations were weak to neglible. Thus, the negative findings in this study cannot be explained from inadequate compliance alone, but most likely also suggest the exercise therapy program itself to be insufficient to engender gait alterations. Adding a 12-week supervised exercise therapy program to patient education did not induce changes in our selected biomechanical variables during the stance phase of gait, even when adjusting for poor compliance. Thus, we did not find

  5. A 12-week randomized double-blind parallel pilot trial of Sinetrol XPur on body weight, abdominal fat, waist circumference, and muscle metabolism in overweight men.

    Science.gov (United States)

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Rouanet, Jean Max

    2015-01-01

    Overweight and obesity are associated to increased risk of developing non-communicable diseases that might dramatically affect life expectancy according World Health Organization. Overweight, obesity, and decline in physical activity are correlated to a significant propensity to lose skeletal muscle mass as a result of prolonged inflammation and oxidative stress whereas cohort surveys and clinical investigations have demonstrated health benefits of Citrus-based polyphenols to reverse such regression. Overweight men were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a Citrus-based polyphenol extract, Sinetrol® XPur. Body composition, anthropometric, and blood parameters were assessed before and at the end of the intervention period. After 12 weeks, while the silhouette slimmed down, metabolic parameters were significantly improved and skeletal muscle catabolism held back. These data suggest that over a 12-week period, the efficacy of the supplement improve both overweight process and correlated skeletal muscle mass metabolism.

  6. Morphological and health-related changes associated with a 12-week self-guided exercise programme in overweight adults: a pilot study.

    Science.gov (United States)

    Stewart, Arthur D; Rolland, Catherine; Gryka, Ania; Findlay, Sally; Smith, Sara; Jones, Jacklyn; Davidson, Isobel M

    2014-01-01

    Over 12 weeks, supervised physical activity (PA) interventions have demonstrated improvements in morphological and health parameters, whereas community walking programmes have not. The present study piloted a self-guided programme for promoting PA and reducing sedentary behaviour in overweight individuals and measured its effect on a range of health outcomes. Six male and 16 female sedentary adults aged 48.5 ± 5.5 years with body mass index (BMI) 33.4 ± 6.3 kg m(-2) were assessed for anthropometric variables, blood pressure, functional capacity, well-being and fatigue. After an exercise consultation, participants pursued their own activity and monitored PA points weekly. At baseline, mid-point and 12 weeks, eight participants wore activity monitors, and all participants undertook a 5-day food diary to monitor dietary intake. In 17 completers, mass, BMI, sit-to-stand, physical and general fatigue had improved by 6 weeks. By 12 weeks, waist, sagittal abdominal diameter (SAD), diastolic blood pressure, well-being and most fatigue dimensions had also improved. Throughout the intervention, PA was stable, energy intake and lying time decreased and standing time increased; thus, changes in both energy intake and expenditure explain the health-related outcomes. Observed changes in function, fatigue and quality of life are consistent with visceral fat loss and can occur at levels of weight loss which may not be considered clinically significant.

  7. Effects of a 12-week, school-based obesity management program on obese primary school children

    Directory of Open Access Journals (Sweden)

    Han Gyu Kim

    2010-03-01

    Full Text Available Purpose:This study was designed to determine the effects of a school-based obesity-management program on obese primary school children. Methods:A total of 995 children (6&#8211;12 years old in a primary school were screened in March 2008, and of those, 101 obese students (44 boys and 57 girls, body mass index (BMI ?#249;5 percentile were enrolled for a study group. The school- based, obesity management program, which includes physical exercise and nutritional education, was conducted as part of an extracurricular program for 12 weeks. The measurement of height, weight, waist circumference, blood pressure (BP, and bioelectrical impedance analysis (BIA was performed before and after the program. Results:Height and weight increased significantly (P&lt;0.05. The BMI and obesity index decreased significantly (P&lt;0.01. Systolic and diastolic BP decreased significantly (P&lt;0.01. BMI decreased in 61.4% of boys and 66.7% of girls. Protein and basal metabolic rate (BMR increased significantly on the BIA (P&lt;0.01. Fat decreased significantly (P&lt;0.05. The total body water (TBW and percent body fat (PBF decreased significantly (P&lt;0.01. The changes in protein, fat, TBW, PBF, and BMR significantly correlated to the change in BMI (P&lt;0.05. In a multiple logistic regression analysis, BMI change was significantly correlated to the changes in protein and fat content (P&lt;0.01. Conclusion:The school-based obesity management program is a very effective way to manage obesity for obese primary school children.

  8. Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

    Science.gov (United States)

    Smith, Steven R; Garvey, W Timothy; Greenway, Frank L; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J

    2017-05-01

    To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine. This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported. N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. © 2017 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  9. Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors.

    Science.gov (United States)

    Sellar, Christopher M; Bell, Gordon J; Haennel, Robert G; Au, Heather-Jane; Chua, Neil; Courneya, Kerry S

    2014-06-01

    Exercise training improves health-related physical fitness and patient-reported outcomes in cancer survivors, but few interventions have targeted colorectal cancer (CRC) survivors. This investigation aimed to determine the feasibility and efficacy of a 12-week supervised exercise training program for CRC survivors. Feasibility was assessed by tracking participant recruitment, loss to follow-up, assessment completion rates, participant evaluation, and adherence to the intervention. Efficacy was determined by changes in health-related physical fitness. Over a 1-year period, 72 of 351 (21%) CRC survivors screened were eligible for the study and 29 of the 72 (40%) were enrolled. Two participants were lost to follow-up (7%) and the completion rate for all study assessments was ≥93%. Mean adherence to the exercise intervention was 91% (standard deviation = ±18%), with a median of 98%. Participants rated the intervention positively (all items ≥ 6.6/7) and burden of testing low (all tests ≤ 2.4/7). Compared with baseline, CRC survivors showed improvements in peak oxygen uptake (mean change (MC) = +0.24 L·min(-1), p < 0.001), upper (MC = +7.0 kg, p < 0.001) and lower (MC = +26.5 kg, p < 0.001) body strength, waist circumference (MC = -2.1 cm, p = 0.005), sum of skinfolds (MC = -7.9 mm, p = 0.006), and trunk forward flexion (MC = +2.5 cm, p = 0.019). Exercise training was found to be feasible and improved many aspects of health-related physical fitness in CRC survivors that may be associated with improved quality of life and survival in these individuals.

  10. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    Science.gov (United States)

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  11. Cloacal and surface temperatures of tom turkeys exposed to different rearing temperature regimes during the first 12 weeks of growth.

    Science.gov (United States)

    Mayes, S L; Strawford, M L; Noble, S D; Classen, H L; Crowe, T G

    2015-06-01

    Years of genetic selection have caused an increase in growth rate and market body mass in agricultural poultry species compared to earlier genetic strains, potentially altering their physiological requirements. The objective of this study was to expose Hybrid Converter tom turkeys on a weekly basis to the recommended rearing temperature regime (TCON: control) or 4°C below the recommended standard (TTRT: treatment) to determine their thermal responses. Once per week for 12 weeks, 12 turkeys were individually exposed to either TCON or TTRT for a 2-h period. Surface temperatures of the breast (TBREAST), wing (TWING), drumstick (TDRUM), head (THEAD), and shank (TSHANK) were measured at 20-min intervals using an infrared camera, while a thermal data logger measured the skin surface temperature under the wing (TLOGGER) at 30-s intervals. The cloacal temperature (TCORE) was measured using a medical thermometer at the start and end of the exposure period. Regardless of exposure temperature, the TBREAST (TCON: Ptemperatures. The data demonstrated that the degree of thermal response expressed is dependent on the location of measurement, age, and exposure temperature.

  12. Effects of a 12 Week SAQ Training Programme on Agility with and without the Ball among Young Soccer Players.

    Science.gov (United States)

    Milanović, Zoran; Sporiš, Goran; Trajković, Nebojša; James, Nic; Samija, Krešimir

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p agility, with and without the ball, with the exception being the Sprint with backward and forward running. This suggests that SAQ training is an effective way of improving agility, with and without the ball, for young soccer players and can be included in physical conditioning programmes. Key pointsSAQ training appears to be an effective way of improving agility with and without the ball in young soccer playersSoccer coaches could use this training during pre-season and in-season trainingCompared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training.

  13. Effect of 12 Weeks High Oleic Peanut Consumption on Cardio-Metabolic Risk Factors and Body Composition

    Directory of Open Access Journals (Sweden)

    Jayne A. Barbour

    2015-09-01

    Full Text Available Epidemiological evidence indicates an inverse association between nut consumption and obesity, inflammation, hyperlipidaemia and glucose intolerance. We investigated effects of high oleic peanut consumption vs. a nut free diet on adiposity and cardio-metabolic risk markers. In a randomised cross-over design, 61 healthy subjects (65 ± 7 years, body mass index (BMI 31 ± 4 kg/m2 alternated either high oleic peanuts (15%–20% of energy or a nut free diet for 12 weeks. Body composition and mass, waist circumference, C-reactive protein (CRP, lipids, glucose and insulin were assessed at baseline and after each phase. Repeated measures analysis of variance (ANOVA compared the two diets. Consistent with other nut studies, there were no differences in lipids, CRP, glucose and insulin with peanut consumption. In contrast, some reports have demonstrated benefits, likely due to differences in the study cohort. Energy intake was 10% higher (853 kJ, p < 0.05, following peanut consumption vs. control, attributed to a 30% increase in fat intake (p < 0.001, predominantly monounsaturated (increase 22 g, p < 0.05. Despite greater energy intake during the peanut phase, there were no differences in body composition, and less than predicted increase (0.5 kg in body weight for this additional energy intake, possibly due to incomplete nutrient absorption and energy utilisation.

  14. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension

    DEFF Research Database (Denmark)

    Knoepfli-Lenzin, C.; Sennhauser, C.; Toigo, M.

    2010-01-01

    /L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as continuous running......The present study examined the effect of football (F, n=15) training on the health profile of habitually active 25-45-year-old men with mild hypertension and compared it with running (R, n=15) training and no additional activity (controls, C, n=17). The participants in F and R completed a 1-h...... training session 2.4 times/week for 12 weeks. Systolic and diastolic blood pressure decreased in all groups but the decrease in diastolic blood pressure in F (-9 +/- 5 (+/- SD) mmHg) was higher than that in C (-4 +/- 6 mmHg). F was as effective as R in decreasing body mass (-1.6 +/- 1.8 vs-1.5 +/- 2.1 kg...

  15. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection.

    Science.gov (United States)

    Gane, Edward J; Hyland, Robert H; An, Di; Svarovskaia, Evguenia; Pang, Phillip S; Brainard, Diana; Stedman, Catherine A

    2015-11-01

    We performed a phase 2 clinical trial to evaluate the efficacy and safety of ledipasvir and sofosbuvir, with or without ribavirin, in patients infected with hepatitis C virus (HCV) genotype 3 or 6. We performed an open-label study of 126 patients with HCV genotype 3 or 6 infections at 2 centers in New Zealand from April 2013 through October 2014. Subjects were assigned 1 of 4 groups that received 12 weeks of treatment. Previously untreated patients with HCV genotype 3 were randomly assigned to groups given fixed-dose combination tablet of ledipasvir and sofosbuvir (n = 25) or ledipasvir and sofosbuvir along with ribavirin (n = 26). Treatment-experienced patients with HCV genotype 3 (n = 50) received ledipasvir and sofosbuvir and ribavirin. Treatment-naïve or treatment-experienced patients with HCV genotype 6 (n = 25) received ledipasvir and sofosbuvir. The primary end point was the percentage of patients with HCV RNA ≤15 IU/mL 12 weeks after stopping therapy (sustained virologic response at 12 weeks [SVR12]). Among treatment-naïve genotype 3 patients, 16 of 25 (64%) receiving ledipasvir and sofosbuvir alone achieved SVR12 compared with all 26 patients (100%) receiving ledipasvir and sofosbuvir and ribavirin. Among treatment-experienced patients with HCV genotype 3, forty-one of fifty achieved an SVR12 (82%). Among patients with HCV genotype 6, the rate of SVR12 was 96% (24 of 25 patients). The most common adverse events were headache, upper respiratory infection, and fatigue. One patient with HCV genotype 3 discontinued ledipasvir and sofosbuvir because of an adverse event (diverticular perforation), which was not considered treatment related. In an uncontrolled, open-label trial, high rates of SVR12 were achieved by patients with HCV genotype 3 infection who received 12 weeks of ledipasvir and sofosbuvir plus ribavirin, and by patients with HCV genotype 6 infection who received 12 weeks of sofosbuvir and ledipasvir without ribavirin. Current guidelines do

  16. The Effect of 12 Weeks Aerobic, Resistance, and Combined Exercises on Omentin-1 Levels and Insulin Resistance among Type 2 Diabetic Middle-Aged Women.

    Science.gov (United States)

    AminiLari, Zeinab; Fararouei, Mohammad; Amanat, Sasan; Sinaei, Ehsan; Dianatinasab, Safa; AminiLari, Mahmood; Daneshi, Nima; Dianatinasab, Mostafa

    2017-06-01

    Recent studies have shown that omentin-1 derived from adipokines can affect physiological regulations and some metabolic dis-eases such as type 2 diabetes mellitus (T2DM). The purpose of this study was to examine the impact of 12 weeks of aerobic (cycle ergometer), resistance, and combined exercises on omentin-1 level, glucose and insulin resistance indices in overweight middle age women with T2DM. In this study, 60 overweight middle age diabetic women were selected using simple random sampling and they were assigned to three groups of aerobic exercise (n=12), resistant exercise (n=12) and combined exercise (n=13), and one control group (n=15). Exercises were done in a three times per week sessions for a total of 12 weeks. Blood samples were collected before each exercise session and 24 hours after of the last session. Present study showed that fasting blood sugar decreased significantly in all intervention groups, while homeostasis model assessment of insulin resistance (HOMA-IR) decreased only in the aerobic and combined exercises groups. Furthermore, there was a significant increase in the omentin-1 level only in the combined exercise group. Compared to aerobic and resistance exercises, 12 weeks of combined exercise was more efficient in improving HOMA-IR and increasing serum omentin-1 among women with T2DM.

  17. A 12-week rehabilitation program improves body composition, pain sensation, and internal/external torques of baseball pitchers with shoulder impingement symptom.

    Science.gov (United States)

    Cha, Jun-Youl; Kim, Jae-Hak; Hong, Ju; Choi, Young-Tae; Kim, Min-Ho; Cho, Ji-Hyun; Ko, Il-Gyu; Jee, Yong-Seok

    2014-02-01

    The aim of this study was to investigate the effects of a 12-week rehabilitation program on body composition, shoulder pain, and isokinetic internal/external torques of pitchers with impingement syndrome. A total of 30 pitchers were divided into 2 groups: experimental group (EG, n = 16) and control group (CG, n= 14). The rehabilitation program consisted of physical therapy, warm-up, work-out, and cool-down. As results, body weight and fat mass of EG were decreased whereas muscle mass of EG was significantly increased after the experiment. The pain degrees in resting, normal daily activity, and strenuous activity on the numeric pain rating scale were significantly decreased in the EG. The internal and external peak torques (PTs) of uninvolved and involved sides of EG were increased in EG after 12 weeks. Such results provide a deficit ratio of both sides in EG close to normal values. The ratios of internal/external PTs in EG were also close to the reference values. The internal and external total works of both sides in EG were similar to the values of PT. The fatigue indices of internal and external rotators of both sides in EG were decreased. As a conclusion, a 12-week rehabilitation program reduced the shoulder pain, improved the body composition and enhanced the isokinetic shoulder internal/external rotators in EG with impingement symptoms. Also the study suggested that the rehabilitation program evened out the ratio between internal and external rotators and lowered the fatigue level after the experiment.

  18. Efficacy and safety of indacaterol 150 μg once-daily in COPD: a double-blind, randomised, 12-week study

    Directory of Open Access Journals (Sweden)

    Piggott Simon

    2010-03-01

    Full Text Available Abstract Background Indacaterol is a novel, once-daily (o.d. inhaled, long-acting β2-agonist in development for chronic obstructive pulmonary disease (COPD. This 12-week, double-blind study compared the efficacy, safety, and tolerability of indacaterol to that of placebo in patients with moderate-to-severe COPD. Methods Efficacy variables included 24-h trough FEV1 (mean of 23 h 10 min and 23 h 45 min post-dose at Week 12 (primary endpoint and after Day 1, and the percentage of COPD days with poor control (i.e., worsening symptoms. Safety was assessed by adverse events (AEs, mean serum potassium and blood glucose, QTc (Fridericia, and vital signs. Results Patients were randomised (n = 416, mean age 63 years to receive either indacaterol 150 μg o.d. (n = 211 or placebo (n = 205 via a single-dose dry-powder inhaler; 87.5% completed the study. Trough FEV1 (LSM ± SEM at Week 12 was 1.48 ± 0.018 L for indacaterol and 1.35 ± 0.019 L for placebo, a clinically relevant difference of 130 ± 24 mL (p 1 after one dose was significantly higher with indacaterol than placebo (p 1 than placebo, both on Day 1 and at Week 12, with indacaterol-placebo differences (LSM ± SEM of 190 ± 28 (p 1 (between 5 min and 4 h, 5 min and 1 h, and 1 and 4 h post-dose at Week 12 were all significantly greater with indacaterol than placebo (p 500 ms. Conclusions Indacaterol 150 μg o.d. provided clinically significant and sustained bronchodilation, reduced rescue medication use, and had a safety and tolerability profile similar to placebo. Trial registration NCT00624286

  19. Influences of 12-Week Physical Activity Interventions on TMS Measures of Cortical Network Inhibition and Upper Extremity Motor Performance in Older Adults—A Feasibility Study

    Directory of Open Access Journals (Sweden)

    Keith M. McGregor

    2018-01-01

    Full Text Available Objective: Data from previous cross-sectional studies have shown that an increased level of physical fitness is associated with improved motor dexterity across the lifespan. In addition, physical fitness is positively associated with increased laterality of cortical function during unimanual tasks; indicating that sedentary aging is associated with a loss of interhemispheric inhibition affecting motor performance. The present study employed exercise interventions in previously sedentary older adults to compare motor dexterity and measure of interhemispheric inhibition using transcranial magnetic stimulation (TMS after the interventions.Methods: Twenty-one community-dwelling, reportedly sedentary older adults were recruited, randomized and enrolled to a 12-week aerobic exercise group or a 12-week non-aerobic exercise balance condition. The aerobic condition was comprised of an interval-based cycling “spin” activity, while the non-aerobic “balance” exercise condition involved balance and stretching activities. Participants completed upper extremity dexterity batteries and estimates of VO2max in addition to undergoing single (ipsilateral silent period—iSP and paired-pulse interhemispheric inhibition (ppIHI in separate assessment sessions before and after study interventions. After each intervention during which heart rate was continuously recorded to measure exertion level (load, participants crossed over into the alternate arm of the study for an additional 12-week intervention period in an AB/BA design with no washout period.Results: After the interventions, regardless of intervention order, participants in the aerobic spin condition showed higher estimated VO2max levels after the 12-week intervention as compared to estimated VO2max in the non-aerobic balance intervention. After controlling for carryover effects due to the study design, participants in the spin condition showed longer iSP duration than the balance condition. Heart rate

  20. Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei

    2016-09-01

    Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  1. Feasibility of web-based protocol in a 12 weeks home-based IMT program for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Svenningsen, Helle

    2016-01-01

    of a web-based protocol with feedback function using mechanical threshold loading (MTL) as a home-based IMT in individuals with COPD. Thirty-six individuals with inspiratory muscle weakness were randomly selected from a pulmonary rehabilitation program to perform 12 weeks of MTL with either a web...

  2. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Rasmussen, Sten; Laursen, Mogens Berg

    2015-01-01

    secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication...

  3. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273

    Directory of Open Access Journals (Sweden)

    Zhao Peng

    2002-05-01

    Full Text Available Abstract Background Etoricoxib is a highly selective COX-2 inhibitor which was evaluated for the treatment of rheumatoid arthritis (RA. Methods Double-blind, randomized, placebo and active comparator-controlled, 12-week study conducted at 67 sites in 28 countries. Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of prestudy NSAIDs. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio. Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints, and patient and investigator global assessments of disease activity. Key secondary measures included the Stanford Health Assessment Questionnaire, patient global assessment of pain, and the percentage of patients who achieved ACR20 responder criteria response (a composite of pain, inflammation, function, and global assessments. Tolerability was assessed by adverse events and routine laboratory evaluations. Results 1171 patients were screened, 891 patients were randomized (N = 357 for placebo, N = 353 for etoricoxib, and N = 181 for naproxen, and 687 completed 12 weeks of treatment (N = 242 for placebo, N = 294 for etoricoxib, and N = 151 for naproxen. Compared with patients receiving placebo, patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints (p Conclusions In this study, etoricoxib 90 mg once daily was more effective than placebo and similar in efficacy to naproxen 500 mg twice daily for treating patients with RA over 12 weeks. Etoricoxib 90 mg was generally well tolerated in RA patients.

  4. Effect of 12 weeks of yoga training on the somatization, psychological symptoms, and stress-related biomarkers of healthy women.

    Science.gov (United States)

    Yoshihara, Kazufumi; Hiramoto, Tetsuya; Oka, Takakazu; Kubo, Chiharu; Sudo, Nobuyuki

    2014-01-03

    Previous studies have shown that the practice of yoga reduces perceived stress and negative feelings and that it improves psychological symptoms. Our previous study also suggested that long-term yoga training improves stress-related psychological symptoms such as anxiety and anger. However, little is known about the beneficial effects of yoga practice on somatization, the most common stress-related physical symptoms, and stress-related biomarkers. We performed a prospective, single arm study to examine the beneficial effects of 12 weeks of yoga training on somatization, psychological symptoms, and stress-related biomarkers. We recruited healthy women who had no experience with yoga. The data of 24 participants who were followed during 12 weeks of yoga training were analyzed. Somatization and psychological symptoms were assessed before and after 12 weeks of yoga training using the Profile of Mood State (POMS) and the Symptom Checklist-90-Revised (SCL-90-R) questionnaires. Urinary 8-hydroxydeoxyguanosine (8-OHdG), biopyrrin, and cortisol levels were measured as stress-related biomarkers. The Wilcoxon signed-rank test was used to compare the stress-related biomarkers and the scores of questionnaires before and after 12 weeks of yoga training. After 12 weeks of yoga training, all negative subscale scores (tension-anxiety, depression, anger-hostility, fatigue, and confusion) from the POMS and somatization, anxiety, depression, and hostility from the SCL-90-R were significantly decreased compared with those before starting yoga training. Contrary to our expectation, the urinary 8-OHdG concentration after 12 weeks of yoga training showed a significant increase compared with that before starting yoga training. No significant changes were observed in the levels of urinary biopyrrin and cortisol after the 12 weeks of yoga training. Yoga training has the potential to reduce the somatization score and the scores related to mental health indicators, such as anxiety, depression

  5. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    Directory of Open Access Journals (Sweden)

    Leite MR

    2015-11-01

    Full Text Available Marceli Rocha Leite,1 Ercy Mara Cipulo Ramos,1 Carlos Augusto Kalva-Filho,2 Ana Paula Coelho Figueira Freire,1 Bruna Spolador de Alencar Silva,1 Juliana Nicolino,1 Alessandra Choqueta de Toledo-Arruda,3 Marcelo Papoti,4 Luiz Carlos Marques Vanderlei,1 Dionei Ramos1 1Department of Physiotherapy, São Paulo State University, Presidente Prudente, 2Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, 3Department of Medicine, São Paulo University, 4School of Physical Education and Sport of Ribeirão Preto, São Paulo University, Ribeirão Preto, São Paulo, Brazil Introduction: Patients with chronic obstructive pulmonary disease (COPD exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization, require further investigation.Aim: To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD.Methods: Sixteen patients with COPD were divided into an aerobic (continuous and interval training group (AT (n=10 and a control group (CG (n=6. An incremental test (initial speed of 2.0 km·h-1, constant slope of 3%, and increments of 0.5 km·h-1 every 2 minutes was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak (50 minutes of continuous effort, followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort, and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery. Intensities were adjusted through an incremental test performed at the end of each period.Results: The AT presented

  6. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial.

    Science.gov (United States)

    Pradeep, A R; Agarwal, Esha; Bajaj, Pavan; Naik, Savitha B; Kumari, Minal; Guruprasad, C N

    2012-07-01

    The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF) as the active ingredient on gingivitis. NINETY SUBJECTS DIAGNOSED WITH CHRONIC GENERALIZED GINGIVITIS WERE SELECTED AND RANDOMLY DIVIDED IN THREE GROUPS: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  7. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    A R Pradeep

    2012-01-01

    Full Text Available Background: The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF as the active ingredient on gingivitis. Materials and Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided in three groups: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. Results: AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. Conclusions: AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  8. The effects of 12-week psyllium fibre supplementation or healthy diet on blood pressure and arterial stiffness in overweight and obese individuals.

    Science.gov (United States)

    Pal, Sebely; Khossousi, Alireza; Binns, Colin; Dhaliwal, Satvinder; Radavelli-Bagatini, Simone

    2012-03-01

    Endothelial dysfunction and increased arterial stiffness occur early in the pathogenesis of the metabolic syndrome and they are both powerful independent predictors of cardiovascular risk. A high-fibre diet has been correlated with lower BMI and a lower incidence of hyperlipidaemia, CVD, hypertension and diabetes. The present randomised, parallel-design study compared the effects of fibre intake from a healthy diet v. fibre supplement diets on blood pressure (BP) and vascular function over 12 weeks. Overweight and obese adults were randomised to one of three groups: control (with placebo), fibre supplement (FIB) or healthy eating group with placebo (HLT). Systolic blood pressure (SBP) was lower in the FIB group compared with the control group at week 6, but not at week 12. However, SBP was lower in the HLT group compared with control group at week 12. At week 6, the FIB group presented lower diastolic blood pressure and augmentation index compared with the control group, but this result did not persist to the end of the study. The present study did not show any improvements in BP or vascular function in overweight and obese individuals with psyllium fibre supplementation over 12 weeks of intervention. However, a healthy diet provided the greatest improvements in BP in overweight and obese subjects. Further research with hypertensive individuals is necessary to elucidate whether increased fibre consumption in the form of psyllium supplementation may provide a safe and acceptable means to reduce BP, vascular function and the risk of developing CVD.

  9. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection.

    Science.gov (United States)

    Gane, Edward J; Hyland, Robert H; Yang, Yin; Svarovskaia, Evguenia; Stamm, Luisa M; Brainard, Diana M; McHutchison, John G; Stedman, Catherine A M

    2017-05-01

    Patients with chronic hepatitis C virus (HCV) genotype 2 have high rates of response to treatment with sofosbuvir and ribavirin. However, ribavirin is associated with hemolytic events and is poorly tolerated by some patients. We evaluated the effectiveness of sofosbuvir and ledipasvir in treatment-naïve and treatment-experienced patients with HCV genotype 2, comparing 12 versus 8 weeks of treatment. This Phase 2, open-label study included 2 cohorts in New Zealand. The first received a fixed-dose combination tablet of ledipasvir-sofosbuvir (90/400 mg) once daily for 12 weeks. If this cohort had a 90% rate of sustained virologic response (SVR) 4 weeks after treatment, a second cohort receiving 8 weeks of ledipasvir-sofosbuvir was to be enrolled. The primary endpoint in both cohorts was the percentage of patients with HCV RNA ledipasvir-sofosbuvir. The single patient receiving 12 weeks of ledipasvir-sofosbuvir who did not reach SVR12 did not complete treatment because of withdrawing consent after receiving 1 dose of study drug. Six of the 7 patients who did not reach SVR12 after 8 weeks of treatment experienced virologic relapse after stopping therapy. The most common adverse events were headache (26% of patients), fatigue (21%), and nausea (17%). No patients discontinued treatment because of an adverse event. For treatment-naïve and -experienced patients, ledipasvir-sofosbuvir for 12 weeks is highly effective for the treatment of HCV genotype 2 (ClinicalTrials.gov: NCT02202980). Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  10. Modeling Day-to-Day Variability of Glucose-Insulin Regulation Over 12-Week Home Use of Closed-Loop Insulin Delivery.

    Science.gov (United States)

    Yue Ruan; Wilinska, Malgorzata E; Thabit, Hood; Hovorka, Roman

    2017-06-01

    Parameters of physiological models of glucose-insulin regulation in type 1 diabetes have previously been estimated using data collected over short periods of time and lack the quantification of day-to-day variability. We developed a new hierarchical model to relate subcutaneous insulin delivery and carbohydrate intake to continuous glucose monitoring over 12 weeks while describing day-to-day variability. Sensor glucose data sampled every 10-min, insulin aspart delivery and meal intake were analyzed from eight adults with type 1 diabetes (male/female 5/3, age 39.9 ± 9.5 years, BMI 25.4 ± 4.4kg/m2, HbA1c 8.4 ± 0.6% ) who underwent a 12-week home study of closed-loop insulin delivery. A compartment model comprised of five linear differential equations; model parameters were estimated using the Markov chain Monte Carlo approach within a hierarchical Bayesian model framework. Physiologically, plausible a posteriori distributions of model parameters including insulin sensitivity, time-to-peak insulin action, time-to-peak gut absorption, and carbohydrate bioavailability, and good model fit were observed. Day-to-day variability of model parameters was estimated in the range of 38-79% for insulin sensitivity and 27-48% for time-to-peak of insulin action. In conclusion, a linear Bayesian hierarchical approach is feasible to describe a 12-week glucose-insulin relationship using conventional clinical data. The model may facilitate in silico testing to aid the development of closed-loop insulin delivery systems.

  11. Paraneoplastic (non-metastatic) adrenal insufficiency preceded the onset of primary lung cancer by 12 weeks

    OpenAIRE

    Shantha, Ghanshyam Palamaner Subash; Kumar, Anita A.; Jeyachandran, Vijay; Rajamanickam, Deepan; Bhaskar, Emmanuel; Paniker, Vinod K; Abraham, Georgi

    2009-01-01

    Clinically evident adrenal insufficiency associated with lung cancer is a rare entity. Among reported cases, adrenal insufficiency has occurred with or succeeded the primary lung cancer. Adrenal insufficiency has also been secondary to metastasis to the adrenal gland. The present report concerns a 61-year-old man, a chronic smoker, who presented to us with symptomatic adrenal insufficiency. He had no evidence of lung cancer during this visit. The primary lung cancer was only identified 12 wee...

  12. A 12-week rehabilitation program improves body composition, pain sensation, and internal/external torques of baseball pitchers with shoulder impingement symptom

    Science.gov (United States)

    Cha, Jun-Youl; Kim, Jae-Hak; Hong, Ju; Choi, Young-Tae; Kim, Min-Ho; Cho, Ji-Hyun; Ko, Il-Gyu; Jee, Yong-Seok

    2014-01-01

    The aim of this study was to investigate the effects of a 12-week rehabilitation program on body composition, shoulder pain, and isokinetic internal/external torques of pitchers with impingement syndrome. A total of 30 pitchers were divided into 2 groups: experimental group (EG, n = 16) and control group (CG, n= 14). The rehabilitation program consisted of physical therapy, warm-up, work-out, and cool-down. As results, body weight and fat mass of EG were decreased whereas muscle mass of EG was significantly increased after the experiment. The pain degrees in resting, normal daily activity, and strenuous activity on the numeric pain rating scale were significantly decreased in the EG. The internal and external peak torques (PTs) of uninvolved and involved sides of EG were increased in EG after 12 weeks. Such results provide a deficit ratio of both sides in EG close to normal values. The ratios of internal/external PTs in EG were also close to the reference values. The internal and external total works of both sides in EG were similar to the values of PT. The fatigue indices of internal and external rotators of both sides in EG were decreased. As a conclusion, a 12-week rehabilitation program reduced the shoulder pain, improved the body composition and enhanced the isokinetic shoulder internal/external rotators in EG with impingement symptoms. Also the study suggested that the rehabilitation program evened out the ratio between internal and external rotators and lowered the fatigue level after the experiment. PMID:24678503

  13. A 12-week interdisciplinary rehabilitation trial in patients with gliomas – a feasibility study

    DEFF Research Database (Denmark)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek

    2018-01-01

    that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences......PURPOSE: This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. METHOD: We conducted an outpatient two-part rehabilitation intervention......%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive...

  14. Changes in physical activity levels following 12-week family intervention in Hispanic girls: Bounce study

    Science.gov (United States)

    Pediatric obesity is a major health problem among Hispanic girls. Physical activity guidelines recommend that children engage in at least 60 min of moderate to vigorous activity daily. To examine the changes in physical activity level pre- and post-intervention. Hispanic girls in control (CG; N=26, ...

  15. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students

    OpenAIRE

    Kim, Seungsuk; Han, Gunsoo

    2016-01-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30?min 5 times a week for 12 weeks) according to the ...

  16. Behavioural pattern of training-adherence in a 12 weeks home-based IMT intervention for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

    . Data were collected by semi-structured face-to-face and telephone interviews with participants after completion of the 12 weeks IMT program. Maintaining self-esteem resulted from the participants' behavioural patterns, through which they resolved their main concern: avoiding to disappoint themselves...... of Maintaining Self-esteem provides knowledge of participant's variation in their need for professional support, and should be targeted specifically at participants in the Misgiving Mode....

  17. Eksperiences of training-adherence in a 12 weeks home-based IMT intervention for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

    . Data were collected by semi-structured face-to-face and telephone interviews with participants after completion of the 12 weeks IMT program. Maintaining self-esteem resulted from the participants' behavioural patterns, through which they resolved their main concern: avoiding to disappoint themselves...... of Maintaining Self-esteem provides knowledge of participant's variation in their need for professional support, and should be targeted specifically at participants in the Misgiving Mode....

  18. Effects of 12-week core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescents with idiopathic scoliosis

    OpenAIRE

    Ko, Kwang-Jun; Kang, Seol-Jung

    2017-01-01

    To identify the effects of core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescent patients with idiopathic scoliosis. Subjects in the present study consisted of primary school students who were confirmed to have scoliosis on radiologic examination performed during their visit to the National Fitness Center in Seoul, Korea. Depending on whether they participated in a 12-week core stabilization exercise program, subjects were divided into the exercise (n=14, age ...

  19. Motivational effects of 12-week moderately restrictive diets with or without special attention to the Glycaemic Index of foods.

    Science.gov (United States)

    Bellisle, F; Dalix, A M; De Assis, M A; Kupek, E; Gerwig, U; Slama, G; Oppert, J M

    2007-04-01

    Low glycaemic index (GI) diets may facilitate weight loss via behavioural and/or endocrine mechanisms. This study investigated whether the outcomes of the Weight Watchers POINTS Weight-Loss System could be improved by encouraging dieters to select low GI, high-carbohydrate foods. Ninety-six women (age 20-72 years; BMI 25-40 kg/m2) were recruited as they started the Weight Watchers POINTS programme for 12 weeks. Weekly classes were randomized so that seven (forty-five women) followed the regular programme while seven others (fifty-one women) followed a revised programme encouraging the selection of low GI foods. Anthropometric and biochemical parameters were measured before and after the 12-week diets. Participants rated hunger and desire to eat using visual analogue scales on 1 d per week, several times per d. Attrition was the same in both groups (32 v. 30 %), as well as many benefits (5 % weight loss, decreases in insulinaemia and blood lipids, waist and hip circumferences, blood pressure). Hunger and desire to eat were rated consistently lower in the low GI group over the 12-week diet. Group differences in subjective sensations were especially large in the afternoon. The 12-week weight management yielded many significant anthropometric and biochemical benefits that were not improved by encouraging dieters to select low GI foods. The subjective benefits (lower hunger and desire to eat) of the low GI diet may be a worthwhile contribution to the motivation of dieters that might affect adherence to the diet over the long term.

  20. Effect of a 12-week complex training on the body composition and cardiorespiratory system of female college students.

    Science.gov (United States)

    Kim, Seungsuk; Han, Gunsoo

    2016-08-01

    [Purpose] The aim of this study was to examine the effects of a complex exercise program on the body composition and cardiorespiratory system of female college students. [Subjects and Methods] This study included 20 female college students who had not participated in any particular sports in the last 3 months. The complex exercise program consisted of two parts, aerobic exercise and weight training. First, aerobic exercise was implemented (30 min 5 times a week for 12 weeks) according to the participants' exercise tolerance. Second, weight training was implemented (40 min 5 times a week for 12 weeks) with 60% of 1 repetition maximum (RM). [Results] The t-test results showed significant differences in body composition between the before and after the complex exercise program. The subjects' body weights and body fat percentages were decreased, and their skeletal muscle masses were increased. Increased levels of maximal oxygen uptake (VO2max), maximal expiratory volume (VEmax), and maximal heart rate (HRmax) were also observed. [Conclusion] In conclusion, the 12-week complex exercise program, including aerobic and weight training, had positive effects on the body composition and cardiorespiratory system of the female college students.

  1. Low Baseline Interleukin-17A Levels Are Associated with Better Treatment Response at 12 Weeks to Tocilizumab Therapy in Rheumatoid Arthritis Patients

    Directory of Open Access Journals (Sweden)

    Sang Jin Lee

    2015-01-01

    Full Text Available T helper 17-related cytokines have been implicated in rheumatoid arthritis (RA pathogenesis. The study aimed to identify cytokines associated with the treatment response of RA patients to tocilizumab (TCZ, a humanized monoclonal antibody against the interleukin- (IL- 6 receptor. As an independent substudy of the 24-week, randomized, double-blinded CWP-TCZ301 trial of TCZ in RA patients with an inadequate response to disease-modifying antirheumatic drugs, serum levels of cytokines including tumor necrosis factor-alpha, IL-17A, IL-21, IL-23, IL-6, and soluble IL-6 receptor were measured. Baseline IL-17A levels were significantly lower in RA patients who achieved disease activity score 28 (DAS28 remission at 12 weeks of TCZ treatment, compared to patients not in remission. Patients were stratified into IL-17A low group and IL-17A high group. Significantly more patients in the IL-17A low group achieved remission as compared to the IL-17A high group (47.6 versus 17.4%, P=0.032. DAS28 improvement was significantly better in the IL-17A low group than in the IL-17A high group at 12 weeks (P=0.045 and 24 weeks (P=0.046 after adjustment. Other baseline cytokines were not associated with treatment response to TCZ. The data demonstrate that low baseline IL-17A levels are associated with better clinical response to TCZ treatment in RA patients.

  2. Influence of anxiety symptoms on improvement of neurocognitive functions in patients with major depressive disorder: A 12-week, multicenter, randomized trial of tianeptine versus escitalopram, the CAMPION study.

    Science.gov (United States)

    Yoo, Ikki; Woo, Jong-Min; Lee, Seung-Hwan; Fava, Maurizio; Mischoulon, David; Papakostas, George I; Kim, Eui-Joong; Chung, Seockhoon; Ha, Jee Hyun; Jeon, Hong Jin

    2015-10-01

    Previous research has reported evidence that patients with major depressive disorder (MDD) show anxiety symptoms and neurocognitive impairments. However, the influence of anxiety on neurocognitive function in MDD patients during antidepressant treatment is unclear. MDD patients (n=164) completed a 12-week, multicenter, randomized trial assigned in a 1:1 ratio to either tianeptine or escitalopram. Changes of anxiety symptoms were assessed by the Hamilton Anxiety Rating Scale (HAM-A), and the Hamilton Depression Rating Scale (HAM-D), self-rated subjective cognitive impairment on memory and concentration, the Mini-Mental Status Examination (MMSE), Continuous Performance Test (CPT), Verbal Learning Test (VLT), and Raven's Progressive Matrices (RPM) were assessed every 4 weeks. During 12 weeks of treatment, decrease in the HAM-A score was significantly associated with improvement of subjective cognitive impairments on memory (panxiety. Improvement of anxiety symptoms was significantly associated with improvement in subjective and objective neurocognitive functions such as delayed memory and reasoning ability in elderly MDD patients during antidepressant treatment, but not significantly associated with improvement of immediate memory and commission error. ClinicalTrials.gov identifier NCT01309776. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. A 12-week interdisciplinary rehabilitation trial in patients with gliomas - a feasibility study.

    Science.gov (United States)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek; Jarden, Jens Ole

    2017-03-12

    This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.

  4. Yokukansan (TJ-54) for irritability associated with pervasive developmental disorder in children and adolescents: a 12-week prospective, open-label study.

    Science.gov (United States)

    Wake, Rei; Miyaoka, Tsuyoshi; Inagaki, Takuji; Furuya, Motohide; Ieda, Masa; Liaury, Kristian; Kishi, Kazuko; Horiguchi, Jun

    2013-06-01

    Autistic disorder is a neuropsychiatric syndrome characterized by deficits in social interaction; qualitative impairments in communication; and restricted, repetitive, and stereotyped patterns of behavior, interests, or activities. It is classified as a type of pervasive developmental disorder (PDD). All PDDs have a qualitative impairment in social relatedness. However, many individuals with PDDs have interfering symptoms, including irritability (aggression, self-injurious behavior, and severe tantrums). Behavioral therapy is often helpful in decreasing these behaviors; however, sometimes adjunctive medications are needed, because of the intensity and severity of irritability. Numerous medications have been tested on patients with PDDs. Although many of these medications have been demonstrated to be useful, no clear main treatment for PDD has emerged. Despite the efficacy of some of the medicines, acceptability and side effects have proven to be barriers to their use. Yokukansan (TJ-54), a traditional Japanese medicine, is composed of seven kinds of dried herbs. It is widely prescribed in clinical situations for treating psychiatric disorders by acting mainly on the glutamatergic and serotonergic nervous system. Recent studies indicate that TJ-54 may be safe and useful in treating behavioral and psychological symptoms in dementia patients. We aimed at evaluating both the efficacy and the safety of TJ-54 in patients with PDDs. This was a 12 week prospective, open-label investigation of TJ-54 in 20 children and adolescents ages 6-17 years diagnosed with PDDs. Primary outcome measures included the Clinical Global Impressions-Improvement of Illness Scale (CGI-I), Children's Global Assessment Score (CGAS), and the Aberrant Behavior Checklist (ABC) irritability subscale. Twenty subjects, ages 6-17 years, received TJ-54 in the dosage range of 2.5-7.5 g/day. The CGI-I was significantly improved from 8 weeks (p54.52 (p54 was well tolerated. No subject left the study

  5. Clinical trials of antihypertensives: Nature of control and design

    Science.gov (United States)

    Chakraborty, Bhaswat S.

    2011-01-01

    This paper reviews the critical issues in the control and design of antihypertension (anti-HT) clinical trials. The international guidelines and current clinical and biostatistical practices were reviewed for relevant clinical, design, end-point assessments and regulatory issues. The results are grouped mainly into ethical, protocol and assessment issues. Ethical issues arise as placebo-controlled trials (PCTs) for HT-lowering agents in patients with moderate to severe HT are undertaken. Patients with organ damage due to HT should not be included in long-term PCT. Active-control trials, however, are suitable for all randomized subsets of patients, including men and women, and different ethnic and age groups. Severity subgroups must be studied separately with consideration to specific study design. Mortality and morbidity outcome studies are not required in anti-HT trials except when significant mortality and cardiovascular morbidity are suspected. Generally, changes in both systolic and diastolic blood pressures (BP) at the end of the dosing interval from the baseline are compared between the active and the control arms as the primary endpoint of anti-HT effect. Onset of the anti-HT effect can be studied as the secondary endpoint. For maintenance of efficacy, long-term studies of ≥6 months need to be undertaken. Error-free measurement of BP is a serious issue as spontaneous changes in BP are large and active drug effect on diastolic BP is often small. Placebo-controlled short-term studies (of ~12 weeks) for dose-response and titration are very useful. Safety studies must be very vigilant on hypotension, orthostatic hypotension and effects on heart. In dose-response studies, at least three doses in addition to placebo should be used to well characterize the benefits and side-effects. PMID:21455414

  6. Effects of 12-week concurrent high-intensity interval strength and endurance training programme on physical performance in healthy older people.

    Science.gov (United States)

    García-Pinillos, Felipe; Laredo-Aguilera, José A; Muñoz-Jiménez, Marcos; Latorre-Román, Pedro A

    2017-03-13

    This study aimed to analyse the effect of 12-week low-volume HIIT-based concurrent training programme on body composition, upper- and lower-body muscle strength, mobility and balance in older adults, as well as to compare it with a low- moderate-intensity continuous training. 90 active older adults were randomly assigned to experimental (EG, n=47), and control (CG, n=43) groups. Body composition and physical functioning were assessed before (pre-test) and after (post-test) a 12-week intervention. A 2-way repeated measures ANOVA was used to test for an interaction between training programme and groups. The time x group interaction revealed no significant between-group differences at pre-test (p≥0.05). The group x time interaction showed significant improvements for the EG in body composition parameters (pconcurrent training programme led to greater improvements in body composition, muscle strength, mobility and balance in healthy older people than a regular low- moderate-intensity continuous training, despite the reduction in overall training volume.

  7. A 12-week resistance training program elicits positive changes in hemodynamic responses in the elderly

    Directory of Open Access Journals (Sweden)

    Cinthya Campos Salazar

    2009-03-01

    Full Text Available The aim of the study was to determine the effect of a resistance training program in hemodynamic responses and adaptations in 60 yr. old elderly. Volunteers were 60 healthy-elderly who underwent a training program 3 times/wk. for 12 wk. Participants were randomly assigned to either a control group, an exercise group who trained at 30% intensity of 5 maximal repetitions (5RM (30% of 5RM or an exercise group at an intensity of 70% (70% of 5RM. Hemodynamic variables measured were mean arterial pressure (MAP, calculated before and immediately after the training session, and rate pressure product (RPP, estimated once a month and before and after finishing the program. Results indicated that resistance exercise training at 30% and 70% of 5RM, with a total exercise work of 872.7 and 890.9 kg did not elicited cardiovascular risks for the elderly. A 12-wk resistance exercise training reduced the cardiovascular strain as shown by the RPP (~16% and the MAP (~9%, with no adverse effects throughout the program. Unfortunately, all the hemodynamic benefits were reverted 6 days following completion of the program. In conclusion, a healthy elderly population must perform resistance training exercises to significantly reduce the cardiovascular stress. We suggest to conduct further research that looks into different exercise intensities in longer program duration and to determine the mechanisms responsible for the deleterious effects of the detraining by using physiological, biochemical and biomechanical variables.

  8. A 12-week intervention with protein-enriched foods and drinks improved protein intake but not physical performance of older patients during the first 6 months after hospital release

    NARCIS (Netherlands)

    Beelen, J.; Roos, de N.M.; Groot, de C.P.G.M.

    2017-01-01

    During and after hospitalisation, older adults are recommended to consume 1·2–1·5 g of protein/kg body weight per d (g/kg per d) to improve recovery. This randomised controlled trial studied the effectiveness of a 12-week intervention with protein-enriched foods and drinks by following-up

  9. A 12-week intervention with protein-enriched foods and drinks improved protein intake but not physical performance of older patients during the first 6 months after hospital release

    National Research Council Canada - National Science Library

    Beelen, J; Roos, de, N.M; Groot, de, C.P.G.M

    2017-01-01

    ...) to improve recovery. This randomised controlled trial studied the effectiveness of a 12-week intervention with protein-enriched foods and drinks by following-up seventy-five older patients (mean age: 76·8 (sd 6·9) years...

  10. Yokukansan (TJ-54) for treatment of pervasive developmental disorder not otherwise specified and Asperger's disorder: a 12-week prospective, open-label study.

    Science.gov (United States)

    Miyaoka, Tsuyoshi; Wake, Rei; Furuya, Motohide; Liaury, Kristian; Ieda, Masa; Kawakami, Kazunori; Tsuchie, Keiko; Inagaki, Takuji; Horiguchi, Jun

    2012-11-29

    Numerous medications have been tested on patients with pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder. Although many of these medications have been demonstrated to be useful, no clear primary treatment for PDD-NOS and Asperger's disorder has emerged. Despite the efficacy of some of the medicines, the acceptability and side effects have proven to be barriers to their use. Recent studies indicate that the traditional Japanese herbal medicine yokukansan (TJ-54) may be safe and useful in treating behavioral and psychological symptoms in dementia and some neuropsychiatric disorders. We aimed at evaluating both the efficacy and safety of TJ-54 in patients with well-defined PDD-NOS and Asperger's disorder. This was a 12-week prospective, open-label investigation of TJ-54 in 40 children, adolescents, and adults diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Severity of Illness Scale (CGI-S) and the Aberrant Behavior Checklist-Iritability subscale score (ABC-I). Forty subjects, ages 8-40 years (mean 22.7 ± 7.3 years) received a mean final TJ-54 dosage of 6.4 ± 1.3 g/day (range 2.5-7.5 g/day). Full-scale intelligence quotient (IQ) scores ranged from 70 to 110 (mean 88.9 ± 13.2). Thirty-six (90%) of 40 subjects showed fewer interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-S of 1 or 2 (normal, not at all ill or borderline mentally ill) and a 80% or greater improvement on the ABC-I. The mean CGI-S score at baseline was 6.8 ± 0.8 whereas scores at end point was 1.9 ± 0.1 (54 was well tolerated. No subject exited the study due to a drug-related adverse event. These preliminary data suggest that TJ-54 may be effective and well tolerated for treatment of severe irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech in patients with PDD-NOS or Asperger

  11. Heterotropic pregnancy: Rare occurrence of a 12- week ruptured right isthmo-cornual ectopic along with a viable intrauterine pregnancy

    Directory of Open Access Journals (Sweden)

    Priya Selvaraj

    2012-01-01

    Full Text Available Heterotropic pregnancy, although a rare condition, is associated with a greater frequency in assisted reproduction. It occurs in approximately 1 in 100 pregnancies conceived by in vitro fertilization (IVF particularly when multiple embryos are transferred into the uterus. We report a case of heterotropic pregnancy following IVF with the rupture of an isthmo-cornual pregnancy at 12 weeks of gestation with uneventful progression of the intrauterine pregnancy. Laparotomy was performed for the excision of the isthmo-cornual pregnancy. The intrauterine pregnancy continued uneventfully. A female baby was delivered by elective cesarean section at 33 weeks.

  12. Effect of birth weight and 12 weeks of exercise training on exercise-induced AMPK signaling in human skeletal muscle

    DEFF Research Database (Denmark)

    Mortensen, Brynjulf; Hingst, Janne Rasmuss; Frederiksen, Nicklas

    2013-01-01

    Subjects with a low birth weight (LBW) display increased risk of developing type 2 diabetes (T2D). We hypothesized that this is associated with defects in muscle adaptations following acute and regular physical activity, evident by impairments in the exercise-induced activation of AMPK signaling....... We investigated 21 LBW and 21 normal birth weight (NBW) subjects during 1 hour of acute exercise performed at the same relative workload before and after 12 weeks of exercise training. Multiple skeletal muscle biopsies were obtained before and after exercise. Protein levels and phosphorylation status...

  13. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial

    DEFF Research Database (Denmark)

    Lublin, Henrik; Haug, Hans-Joachim; Koponen, Hannu

    2009-01-01

    The efficacy, safety and tolerability of ziprasidone versus the comparators olanzapine, risperidone or quetiapine were investigated in adult patients with chronic schizophrenia, schizoaffective and schizophreniform disorders, with lack of efficacy or intolerance to their previous antipsychotic......), risperidone 4-8 mg/day (n=22) or quetiapine 300-750 mg/day (n=97). The study comprised four visits including a baseline examination prior to randomization and further examinations at the end of weeks 1, 4 and 12. Ziprasidone was non-inferior (defined as a difference of 7 units or less on the PANSS scale...... to the disadvantage of ziprasidone) to the composite group (olanzapine, risperidone or quetiapine) on the total PANSS score as well as on all subscores (P

  14. Effects of 12 weeks of block periodization on performance and performance indices in well-trained cyclists.

    Science.gov (United States)

    Rønnestad, B R; Ellefsen, S; Nygaard, H; Zacharoff, E E; Vikmoen, O; Hansen, J; Hallén, J

    2014-04-01

    The purpose of this study was to compare the effects of two different methods of organizing endurance training in trained cyclists during a 12-week preparation period. One group of cyclists performed block periodization (BP; n = 8), wherein every fourth week constituted five sessions of high-intensity aerobic training (HIT), followed by 3 weeks of one HIT session. Another group performed a more traditional organization (TRAD; n = 7), with 12 weeks of two weekly HIT sessions. The HIT was interspersed with low-intensity training (LIT) so that similar total volumes of both HIT and LIT were performed in the two groups. BP achieved a larger relative improvement in VO2max than TRAD (8.8 ± 5.9% vs 3.7 ± 2.9%, respectively, training (ES range was 0.62-1.12). The present study suggests that BP of endurance training has superior effects on several endurance and performance indices compared with TRAD. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study.

    Science.gov (United States)

    Altman, Roy; Hochberg, Marc; Gibofsky, Allan; Jaros, Mark; Young, Clarence

    2015-12-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs). SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses. This phase 3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam capsules 5 mg and 10 mg administered once daily for 12 weeks in patients with OA-related pain. This randomized, double-blind study enrolled patients ≥40 years of age with confirmed hip or knee OA (Kellgren-Lawrence grade II-III) who were chronic users of NSAIDs and/or acetaminophen for OA pain and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale mean scores ≥40 mm. Eligible patients experienced an OA pain flare (defined as a ≥15 mm increase in the WOMAC pain subscale score) following discontinuation of NSAIDs/acetaminophen. Patients were randomized to receive once-daily SoluMatrix meloxicam 5 mg or 10 mg, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01787188. The primary outcome measure was the mean change from baseline in WOMAC pain subscale score at week 12. Low-dose SoluMatrix meloxicam 5 mg (-36.52 [2.49]; P = 0.0005) and 10 mg (-34.41 [2.68]; P = 0.0059) once-daily treatment significantly reduced the mean (standard error) WOMAC pain subscale score from baseline at week 12 compared with placebo (-25.68 [2.64]). Patients treated with SoluMatrix meloxicam 5 mg or 10 mg reported significantly greater improvements in total WOMAC score and in WOMAC stiffness and function subscale scores at 12 weeks compared with placebo. The most common AEs in the combined low-dose SoluMatrix meloxicam group were headache, diarrhea, nausea, osteoarthritis, and urinary tract infection. Low-dose SoluMatrix meloxicam may have a potential role as a new therapeutic option for the management of OA-related pain.

  16. All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase III Study

    Science.gov (United States)

    Nelson, David R; Cooper, James N; Lalezari, Jacob P; Lawitz, Eric; Pockros, Paul J; Gitlin, Norman; Freilich, Bradley F; Younes, Ziad H; Harlan, William; Ghalib, Reem; Oguchi, Godson; Thuluvath, Paul J; Ortiz-Lasanta, Grisell; Rabinovitz, Mordechai; Bernstein, David; Bennett, Michael; Hawkins, Trevor; Ravendhran, Natarajan; Sheikh, Aasim M; Varunok, Peter; Kowdley, Kris V; Hennicken, Delphine; McPhee, Fiona; Rana, Khurram; Hughes, Eric A

    2015-01-01

    Treatment options for patients with hepatitis C virus (HCV) genotype 3 infection are limited, with the currently approved all-oral regimens requiring 24-week treatment and the addition of ribavirin (RBV). This phase III study (ALLY-3; http://ClinicalTrials.gov: NCT02032901) evaluated the 12-week regimen of daclatasvir (DCV; pangenotypic nonstructural protein [NS]5A inhibitor) plus sofosbuvir (SOF; pangenotypic NS5B inhibitor) in patients infected with genotype 3. Patients were either treatment naïve (n = 101) or treatment experienced (n = 51) and received DCV 60 mg plus SOF 400 mg once-daily for 12 weeks. Coprimary endpoints were the proportions of treatment-naïve and treatment-experienced patients achieving a sustained virological response (SVR) at post-treatment week 12 (SVR12). SVR12 rates were 90% (91 of 101) and 86% (44 of 51) in treatment-naïve and treatment-experienced patients, respectively; no virological breakthrough was observed, and ≥99% of patients had a virological response (VR) at the end of treatment. SVR12 rates were higher in patients without cirrhosis (96%; 105 of 109) than in those with cirrhosis (63%; 20 of 32). Five of seven patients who previously failed treatment with an SOF-containing regimen and 2 of 2 who previously failed treatment with an alisporivir-containing regimen achieved SVR12. Baseline characteristics, including gender, age, HCV-RNA levels, and interleukin-28B genotype, did not impact virological outcome. DCV plus SOF was well tolerated; there were no adverse events (AEs) leading to discontinuation and only 1 serious AE on-treatment, which was unrelated to study medications. The few treatment-emergent grade 3/4 laboratory abnormalities that were observed were transient. Conclusion: A 12-week regimen of DCV plus SOF achieved SVR12 in 96% of patients with genotype 3 infection without cirrhosis and was well tolerated. Additional evaluation to optimize efficacy in genotype 3–infected patients with cirrhosis is underway

  17. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial.

    Science.gov (United States)

    O'Byrne, Paul M; Woodcock, Ashley; Bleecker, Eugene R; Bateman, Eric D; Lötvall, Jan; Forth, Richard; Medley, Hilary; Jacques, Loretta; Busse, William W

    2014-08-11

    Fluticasone furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy. This 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study randomized 248 patients (aged ≥12 years) to once-daily FF 50 mcg administered via the ELLIPTA™a dry powder inhaler or placebo. The primary endpoint was change from baseline in pre-dose evening trough forced expiratory volume in one second (FEV1). Secondary endpoints were change from baseline in percentage of rescue-free 24-h periods (powered), evening and morning peak expiratory flow, symptom-free 24-h periods and withdrawals due to lack of efficacy. Other endpoints included Asthma Control Test™, Asthma Quality of Life Questionnaire and ELLIPTA ease of use questions. Safety was assessed throughout the study. There was a significant difference in evening trough FEV1 between FF 50 mcg and placebo (treatment difference: 120 mL; p = 0.012). There was also a significant difference in rescue-free 24-h periods (11.6%; p = 0.004) vs. placebo. There were numerically greater improvements with FF vs. placebo for all remaining secondary endpoints. The incidence of adverse events was lower with FF (31%) than with placebo (38%); few were treatment-related (FF 50 mcg: n = 1, <1%; placebo: n = 4, 3%). FF 50 mcg once daily significantly improved FEV1 and percentage of rescue-free 24-h periods experienced over 12 weeks vs. placebo, and was well tolerated. www.clinicaltrials.gov, registration number: NCT01436071.

  18. The Effect of 12-Week Aerobic Training on Protein Tyrosine Phosphatase 1B Gene Expression and Insulin Resistance in Diabetic Rats

    Directory of Open Access Journals (Sweden)

    Rahman Soori

    2017-02-01

    Full Text Available Abstract Background: Protein tyrosine phosphatase 1B (PTP1B is a key enzyme in dephosphorylation of the insulin receptor (IR and it is a central factor to induce the insulin resistance. The purpose of this study was to evaluate the effect of 12-week aerobic training on protein tyrosine phosphatase 1B gene expression and insulin resistance in diabetic rats. Materials and Methods: In this study, 16 Wistar rats were divided into aerobic training and control groups. After inducing diabetes intra protaneally, aerobic training group performed training protocol for 12 weeks and 5 session/week. The duration and speed of each session increased progressively as 18 to 26 m/min and 10 to 55 min, respectively. Then, blood and tissue (from gastrocnemius sampling were carried out in diabetic rats. Insulin resistance markers and PTP1B gene expression were evaluated by commercial kits and Real-Time PCR method, respectively. Results: Findings showed that PTP1B significantly was decreased in diabetic rats of aerobic training group (p=0.0001. Also, glucose and insulin resistance significantly was decreased in aerobic training groups (p=0.02 and p=0.006, respectively. However, insulin in control rats was significantly increased (p=0.015. Conclusion: It seems that, current aerobic training protocol has capability to decrease PTP1B and insulin resistance in diabetic rats. Furthermore, the direct correlation between PTP1B and insulin illustrated that any changes in insulin resistance due to exercise training associated with diminution of negative regulation of insulin signaling pathway.

  19. Clinical and histologic outcomes of socket grafting after flapless tooth extraction: a systematic review of randomized controlled clinical trials.

    Science.gov (United States)

    Jambhekar, Shantanu; Kernen, Florian; Bidra, Avinash S

    2015-05-01

    Several biomaterials and techniques have been reported for socket grafting and alveolar ridge preservation. However, the evidence for clinical and histologic outcomes for socket grafting with different types of materials in flapless extraction is not clear. The purpose of this systematic review was to analyze the outcomes of a socket grafting procedure performed with flapless extraction of teeth in order to determine which graft material results in the least loss of socket dimensions, the maximum amount of vital bone, the least remnant graft material, and the least amount of connective tissue after a minimum of 12 weeks of healing. Secondary outcomes, including the predictability of regenerating deficient buccal bone, necessity of barrier membranes, and coverage with autogenous soft tissue graft, were also evaluated. An electronic search for articles in the English-language literature was performed independently by multiple investigators using a systematic search process with the PubMed search engine. After applying predetermined inclusion and exclusion criteria, the final list of randomized controlled clinical trials (RCTs) for flapless extraction and socket grafting was analyzed to derive results for the various objectives of the study. The initial electronic search resulted in 2898 titles. The systematic application of inclusion and exclusion criteria resulted in 32 RCTs studying 1354 sockets, which addressed the clinical and histologic outcomes of flapless extraction with socket grafting and provided dimensional and histologic information at or beyond the 12-week reentry period. From these RCTs, the mean loss of buccolingual width at the ridge crest was lowest for xenografts (1.3 mm), followed by allografts (1.63 mm), alloplasts (2.13 mm), and sockets without any socket grafting (2.79 mm). Only 3 studies reported on loss of width at 3 mm below the ridge crest. The mean loss of buccal wall height from the ridge crest was lowest for xenografts (0.57 mm) and

  20. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study.

    Science.gov (United States)

    Li, Zhaoping; Karp, Hannah; Zerlin, Alona; Lee, Tsz Ying Amy; Carpenter, Catherine; Heber, David

    2010-10-14

    Decreased bone mineral density and osteoporosis in postmenopausal women represents a growing source of physical limitations and financial concerns in our aging population. While appropriate medical treatments such as bisphosphonate drugs and hormone replacement therapy exist, they are associated with serious side effects such as osteonecrosis of the jaw or increased cardiovascular risk. In addition to calcium and vitamin D supplementation, previous studies have demonstrated a beneficial effect of dietary silicon on bone health. This study evaluated the absorption of silicon from bottled artesian aquifer water and its effect on markers of bone metabolism. Seventeen postmenopausal women with low bone mass, but without osteopenia or osteoporosis as determined by dual x-ray absorptiometry (DEXA) were randomized to drink one liter daily of either purified water of low-silicon content (PW) or silicon-rich artesian aquifer water (SW) (86 mg/L silica) for 12 weeks. Urinary silicon and serum markers of bone metabolism were measured at baseline and after 12 weeks and analyzed with two-sided t-tests with p water group compared to the purified water group (p water supplementation. No significant change was observed in the serum markers of bone formation compared to baseline measurements for either group. These findings indicate that bottled water from artesian aquifers is a safe and effective way of providing easily absorbed dietary silicon to the body. Although the silicon did not affect bone turnover markers in the short-term, the mineral's potential as an alternative prevention or treatment to drug therapy for osteoporosis warrants further longer-term investigation in the future. ClinicalTrials.gov Identifier: NCT01067508.

  1. Effect of combining therapy with traditional chinese medicine-based psychotherapy and herbal medicines in women with menopausal syndrome: a randomized controlled clinical trial.

    Science.gov (United States)

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

  2. Muscular strength and physical function in elderly adults 6-18 months after a 12-week resistance exercise program.

    Science.gov (United States)

    Geirsdottir, Olof Gudny; Arnarson, Atli; Ramel, A; Briem, Kristin; Jonsson, Palmi V; Thorsdottir, Igna

    2015-02-01

    Benefits of resistance exercise in elderly people are well documented; however, sustaining these benefits can be difficult and adherence is often poor. Muscular strength and physical function usually decline after a supervised resistance exercise program (REP). We investigated these changes in older adults during an observational follow-up and whether leisure time physical activity (LTPA) or unsupervised resistance exercise (RE) limit these changes. Subjects (N = 236, 73.7 ± 5.7 years, 58.2% female) had participated in a supervised 12-week REP. Quadriceps strength and timed-up-and-go performance (TUG) at follow-up were compared to values before and after REP. Multivariate statistics were used to predict changes in strength or function. Two hundred and eleven (90.3%) participants completed REP and 149 (63.1%) completed follow-up (11.4 ± 2.9 months). Quadriceps strength at follow-up decreased significantly compared to after REP (-27N), but was higher than before REP (+ 30N). TUG did not decrease during follow-up and was better than before REP (-0.9 seconds). LTPA (+ 38.0N, p < 0.001) and RE (+31.6N, p = 0.006) predicted strength at follow-up, although they did not completely prevent loss of strength during follow-up. quadriceps strength declines after a 12-week resistance exercise program in older adults. Neither LTPA nor RE completely prevents loss of quadriceps strength during follow-up, although they limited the loss. TUG did not change during follow-up and was better at follow-up than before the start of the resistance exercise program. © 2014 the Nordic Societies of Public Health.

  3. Nutrition and inflammation serum biomarkers are associated with 12-week mortality among malnourished adults initiating antiretroviral therapy in Zambia.

    Science.gov (United States)

    Koethe, John R; Blevins, Meridith; Nyirenda, Christopher; Kabagambe, Edmond K; Shepherd, Bryan E; Wester, C William; Zulu, Isaac; Chiasera, Janelle M; Mulenga, Lloyd B; Mwango, Albert; Heimburger, Douglas C

    2011-04-10

    A low body mass index (BMI) at antiretroviral therapy (ART) initiation is a strong predictor of mortality among HIV-infected adults in resource-constrained settings. The relationship between nutrition and inflammation-related serum biomarkers and early treatment outcomes (e.g., less than 90 days) in this population is not well described. An observational cohort of 142 HIV-infected adults in Lusaka, Zambia, with BMI under 16 kg/m2 or CD4+ lymphocyte counts of less than 50 cells/mm3, or both, was followed prospectively during the first 12 weeks of ART. Baseline and serial post-treatment phosphate, albumin, ferritin and highly sensitive C-reactive protein (hsCRP) serum levels were measured. The primary outcome was mortality. Lower baseline phosphate and albumin serum levels, and higher ferritin and hsCRP, were significantly associated with mortality prior to 12 weeks (pART-associated mortality in sub-Saharan Africa. The time-dependent interval change in albumin was associated with mortality after adjusting for the baseline value (AHR 0.62 [0.43, 0.89] per 5 g/L increase), but changes in the other biomarkers were not. The predictive value of serum biomarkers for early mortality in a cohort of adults with malnutrition and advanced HIV in a resource-constrained setting was primarily driven by pre-treatment values, rather than post-ART changes. Interventions to promote earlier HIV diagnosis and treatment, address nutritional deficiencies, and identify the etiologies of increased systemic inflammation may improve ART outcomes in this vulnerable population.

  4. The effect of 12 weeks vitamin E supplemention and aerobic training on liver enzymes of non-alcoholic steatohepatitis patients

    Directory of Open Access Journals (Sweden)

    M Aghah

    2017-01-01

    Full Text Available Background and aim: Non-alcoholic steatohepatitis is a part of broad spectrum of chronic non-alcoholic fatty liver disease. The aim of present study was to evaluate the effect of 12 weeks vitamin E supplementation and aerobic training on liver enzymes level of non-alcoholic steatohepatitis patients (NASH.   Methods: In the present quasi-experimental study, 30 NASH patients, aged 25-50 years were participated, and divided into three groups of vitamin E (n=10, aerobic training (n=10 and combination (aerobic training plus vitamin E, n=10 randomly. Vitamin E Supplementation and aerobic training combination groups consumed 400 IU per day of Vitamin E Supplementation. Also in the group of aerobic exercise and combined, exercise program including the increasing activity of anaerobic (running on a treadmill with increasing intensity every two weeks 5% was carried out three times a week for 12 weeks. Data evaluation were analyzed using t-test, ANOVA and Scheffe. Results: A significant differences was observed  ALT (intra-group of vitamin E (0001/0 = p aerobic exercise (0001/0 = p and combination (001/0 = p, respectively.There was a significant difference was seen among pre – post training in AST in supplementation(P=0.001, aerobic training(P=0.001 and combination (P=0.002 groups. But no significant difference in ALP level observed(P>0.05. In comparison among the groups, a significant differences was observed between groups ALP vitamin E, combination aerobic exercise but no significant difference was observed among the groups at the levels of ALT and AST. Conclusion: The results of this study showed that vitamin E supplementation and aerobic training can improve non-alcoholic steatohepatitis Patients (NASH.  

  5. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa.

    Science.gov (United States)

    Zembe-Mkabile, Wanga; Doherty, Tanya; Sanders, David; Jackson, Debra

    2014-01-01

    Cash transfers (CTs) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG) is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30). Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. At the 12-week visit, half (52%) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327) of all children had received the CSG. In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery.

  6. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

    Directory of Open Access Journals (Sweden)

    Wanga Zembe-Mkabile

    2014-08-01

    Full Text Available Background: Cash transfers (CTs are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30. Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods: This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results: At the 12-week visit, half (52% of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327 of all children had received the CSG. Conclusions: In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery.

  7. Opioid detoxification: from controlled clinical trial to clinical practice.

    NARCIS (Netherlands)

    Dijkstra, B.A.; Jong, C.A.J. de; Wensing, M.J.P.; Krabbe, P.F.M.; Staak, C.P. van der

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  8. Opioid Detoxification: From Controlled Clinical Trial to Clinical Practice

    NARCIS (Netherlands)

    Dijkstra, B.A.G.; Jong, C.A.J. de; Wensing, M.J.P.; Krabbe, P.F.M.; Staak, C.P.F. van der

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  9. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  10. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273].

    Science.gov (United States)

    Collantes, Eduardo; Curtis, Sean P; Lee, Ka Wing; Casas, Noemi; McCarthy, Timothy; Melian, Agustin; Zhao, Peng L; Rodgers, Diana B; McCormick, Calogera L; Lee, Michael; Lines, Christopher R; Gertz, Barry J

    2002-05-22

    Etoricoxib is a highly selective COX-2 inhibitor which was evaluated for the treatment of rheumatoid arthritis (RA). Double-blind, randomized, placebo and active comparator-controlled, 12-week study conducted at 67 sites in 28 countries. Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of prestudy NSAIDs. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio). Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints, and patient and investigator global assessments of disease activity. Key secondary measures included the Stanford Health Assessment Questionnaire, patient global assessment of pain, and the percentage of patients who achieved ACR20 responder criteria response (a composite of pain, inflammation, function, and global assessments). Tolerability was assessed by adverse events and routine laboratory evaluations. 1171 patients were screened, 891 patients were randomized (N = 357 for placebo, N = 353 for etoricoxib, and N = 181 for naproxen), and 687 completed 12 weeks of treatment (N = 242 for placebo, N = 294 for etoricoxib, and N = 151 for naproxen). Compared with patients receiving placebo, patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints (p<0.05). Treatment responses were similar between the etoricoxib and naproxen groups for all endpoints. The percentage of patients who achieved ACR20 responder criteria response was 41% in the placebo group, 59% in the etoricoxib group, and 58% in the naproxen group. Etoricoxib and naproxen were both generally well tolerated. In this study, etoricoxib 90 mg once daily was more effective than placebo and similar in efficacy to naproxen 500 mg twice daily for treating patients with RA over 12 weeks. Etoricoxib 90 mg was generally well tolerated in RA patients.

  11. Dose response of Gabapentin Enacarbil versus placebo in subjects with moderate-to-severe primary restless legs syndrome: an integrated analysis of three 12-week studies.

    Science.gov (United States)

    VanMeter, Susan A; Kavanagh, Sarah T; Warren, Samantha; Barrett, Ronald W

    2012-09-01

    The efficacy and tolerability of gabapentin enacarbil (Horizant®; GlaxoSmithKline, Brentford, UK) has been demonstrated in several restless legs syndrome (RLS) phase II and phase III clinical studies at various doses from 600 mg to 2400 mg. The objective of this study was to evaluate key efficacy and safety outcomes in subjects with RLS treated with once-daily gabapentin enacarbil 600 mg, 1200 mg, 1800 mg and 2400 mg, providing supportive evidence of the efficacy of gabapentin enacarbil 600 mg compared with higher doses and placebo. Integrated post hoc analysis of three 12-week, randomized, double-blind, placebo-controlled trials in subjects with RLS. The three studies were carried out at multiple centres in the US. In total, 760 subjects were included in the pooled analysis (placebo, n = 245; gabapentin enacarbil 600 mg, n = 163; gabapentin enacarbil 1200 mg, n = 269; gabapentin enacarbil 1800 mg, n = 38; gabapentin enacarbil 2400 mg, n = 45). In all studies, gabapentin enacarbil or placebo was administered once daily at approximately 5 p.m. with food. Gabapentin enacarbil was initiated at a dose of 600 mg with subsequent titration in 600 mg increments every 3 days up to the randomized dose. The efficacy endpoints analysed for the purpose of this integrated analysis were change from baseline in International Restless Legs Scale (IRLS) total score and the proportion of responders (subjects rated as 'much' or 'very much' improved) on the investigator-rated Clinical Global Impression-Improvement (CGI-I) scale. Safety endpoints assessed were the incidence of treatment-emergent adverse events (AEs) and serious AEs. Gabapentin enacarbil 600 mg significantly improved IRLS total score compared with placebo (adjusted mean [standard error] change in IRLS total score from baseline to week 12 last observation carried forward: -13.6 [0.71] vs -9.3 [0.55]; adjusted mean treatment difference: -4.3; 95% CI -6.01, -2.52; p < 0

  12. Effects of aminaftone 75 mg TID on soluble adhesion molecules: a 12-week, randomized, open-label pilot study in patients with systemic sclerosis.

    Science.gov (United States)

    Scorza, Raffaella; Santaniello, Alessandro; Salazar, Giulia; Lenna, Stefania; Della Bella, Silvia; Antonioli, Rita; Toussoun, Karen; Beretta, Lorenzo

    2008-05-01

    Vasculopathy is one of the hallmarks of systemic sclerosis (SSc), characterized by endothelial activation and over expression of adhesion molecules. A preliminary in vitro study has suggested that aminaftone, a naphtohydrochinone used in the treatment of capillary disorders, may downregulate the expression of adhesion molecules in endothelial cells. This study investigated the ex vivo effects of aminaftone on soluble adhesion molecule concentrations in patients with SSc. This randomized, open-label pilot study was conducted in patients with SSc. Patients received baseline treatment for Raynaud's phenomenon (eg, calcium channel blockers and IV cyclic iloprost) with (test) or without (control) aminaftone 75 mg or placebo TID for 12 weeks. Standard treatment for Raynaud's phenomenon was allowed as long as the dose was stable for >or=3 months prior to randomization. Concentrations of soluble E-selectin adhesion molecule 1 (sELAM-1), soluble vascular cell adhesion molecule 1 (sVCAM-1), and soluble intracellular adhesion molecule 1 (sICAM-1) were measured at baseline and 12 weeks, and their variation was tested using the analysis of variance for repeated measures with statistical correction. Laboratory analyses were performed by experienced personnel blinded to treatment assignment. A total of 24 patients were enrolled (21 women, 3 men; mean age, 53.4 years; aminaftone, 12 patients; control, 12 patients). Decreases in mean (SD) sELAM-1 and sVCAM-1 concentrations were significantly greater in treated patients (sELAM-1, from 17.0 [7.8] to 11.9 [9.0] pg/mL; sVCAM-1, from 51.2 [12.9] to 40.8 [13.8] ng/mL) compared with controls (sELAM-1, from 20.3 [9.9] to 20.4 [10.5] pg/mL; sVCAM-1, from 56.8 [49.6] to 62.7 [40.6] ng/mL) (both, P < 0.05 [analysis of variance or repeated measures after Bonferroni correction]). No significant changes in sICAM-1 concentrations versus controls were observed. In this small pilot study in this select group of patients with SSc, aminaftone was

  13. Effects of 12-week high-intensity interval training on plasma visfatin concentration and insulin resistance in overweight men

    Directory of Open Access Journals (Sweden)

    Hasan Matinhomaee

    2014-06-01

    Full Text Available The purpose of this study was to determine the effects of 12 weeks of high-intensity interval training (HIIT on visfatin and insulin resistance (IR in overweight adult men during a weight-loss program. Eighteen overweight men (age = 31.8 ± 9.2 years; body mass index = 28.6 ± 1.4 kg/m2 were randomly recruited into one of the two groups, namely, HIIT (3 days/week, 20 minutes/day; 85–95% peak oxygen uptake and diet-induced weight-loss combined (DHIIT; n = 10 and diet-induced weight loss only (DIO; n = 8. The DHIIT and DIO groups undertook a 12-week weight-loss intervention using a moderate isocaloric energy-deficit diet. Both DHIIT and DIO groups demonstrated a significant reduction in body weight (p < 0.01. Total fat mass (p < 0.05 and lean body mass (p < 0.05 were decreased in the DIO group with no significant changes in abdominal fat mass, plasma insulin concentration, homeostasis model assessment-estimated IR (HOMA-IR, blood glucose level, and plasma visfatin. In the DHIIT group, total fat mass (p < 0.01, abdominal fat mass (p < 0.05, plasma insulin concentration (p < 0.05, plasma visfatin (p < 0.01, and HOMA-IR (p < 0.05 were reduced and lean body mass remained unchanged. In conclusion, adding a low-volume 20-minute HIIT (three times/week to an energy-deficit diet not only can improve the efficiency of weight-loss program in the reduction of body fat, plasma visfatin levels, and HOMA-IR, but also has a reservation effect on lean body mass.

  14. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study.

    Science.gov (United States)

    Kerwin, Edward M; Kalberg, Chris J; Galkin, Dmitry V; Zhu, Chang-Qing; Church, Alison; Riley, John H; Fahy, William A

    2017-01-01

    Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV 1 ]: 50%-70% of predicted; modified Medical Research Council [mMRC] score ≥1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV 1 at Day 85 (primary end point), 0-3 h serial FEV 1 , rescue medication use, Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). Compared with TIO, UMEC/VI produced greater improvements in trough FEV 1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45-131]; P <0.001) and FEV 1 after 5 min on Day 1 (50 mL [95% CI: 27-72]; P <0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2-0.0]; P ≤0.05). More patients achieved clinically meaningful improvements in TDI score (≥1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21-2.64]; P ≤0.01). Improvements in SGRQ and CAT scores were similar between treatments. The incidence of AEs was similar with UMEC/VI (30%) and TIO (31%). UMEC/VI step-up therapy provides clinical benefit over TIO monotherapy in patients with moderate COPD who are symptomatic on TIO alone.

  15. Promoting healthful diets and exercise: efficacy of a 12-week after-school program in urban African Americans.

    Science.gov (United States)

    Engels, Hermann-J; Gretebeck, Randall J; Gretebeck, Kimberlee A; Jiménez, Linda

    2005-03-01

    This study examined the effectiveness of a unique extracurricular after-school initiative designed to promote healthy diets and exercise in urban African Americans. The Students and Parents Actively Involved in Being Fit after-school program was offered for 12 weeks to students and their parents/guardians at an urban middle school. Specific aims of the intervention were to increase participants' vegetable and fruit intake by using established 5 A Day for Better Health educational resource materials/activities and to affect their health-related fitness through dance, games, and fitness activities. Fifty-six children and 25 parents/guardians completed a standard battery of evaluations before and after the program. Pre-post pairwise t test revealed that both children and their parents/guardians showed an increase in fruit consumption and a reduction in diastolic blood pressure (P potato consumption while parents/guardians showed a decrease in body fat, body mass index, and endurance walk/run time (P <.05). Overall, findings indicate that children tended to gain more diet-related benefits while parents/guardians tended to derive more fitness-related benefits. After-school programs like the Students and Parents Actively Involved in Being Fit initiative can potentially contribute to improved health levels in urban African Americans.

  16. DEXA-assessed regional body composition changes in young female military soldiers following 12-weeks of periodised training.

    Science.gov (United States)

    Wood, Paola S; Krüger, Pieter E; Grant, Catharina C

    2010-04-01

    Dual-energy X-ray absorptiometry (DEXA) was used to assess whole body and regional soft tissue mass, fat mass and lean body mass compositional changes in 68 female recruits (age 20.8 +/- 1.14 years; body mass 59.5 +/- 8.79 kg; stature 159.57 +/- 5.53 cm) pre- and post 12-weeks of military basic training. A decrease in total body fat tissue mass (10.2%) and regional percent fat (10.9%) was measured with an increase in total lean body mass (8.7%). Of interest were the differences in the responses in the tissue composition of the arms (16.2% loss in fat mass with an 11.6% gain in lean mass), trunk (17.0% decrease in fat mass with a 10.4% increase in lean mass) and the legs (10.5% increase in lean mass but no change in fat mass). These findings show the importance of considering regional rather than whole body composition changes when assessing the effects of a training programme. STATEMENT OF RELEVANCE: Female soldiers experienced a change in total body fat tissue (-10.2%) and lean body mass (+8.7%) after basic training; however, no significant fat mass decrease was evident in the leg region. Regional rather than whole body composition changes need to be considered when assessing the effects of a training programme.

  17. A 12-week, randomized, parallel-group, proof-of-concept study of tulobuterol patch and salmeterol inhaler as add-on therapy in adult-onset mild-to-moderate asthma.

    Science.gov (United States)

    Inoue, Hideki; Niimi, Akio; Matsumoto, Hisako; Ito, Isao; Oguma, Tsuyoshi; Otsuka, Kojiro; Takeda, Tomoshi; Nakaji, Hitoshi; Tajiri, Tomoko; Iwata, Toshiyuki; Nagasaki, Tadao; Mishima, Michiaki

    2017-01-01

    Patch formulation of tulobuterol has been used in asthma treatment as a long-acting β 2 -agonist (LABA) through sustained skin absorption. Its treatment efficacy, especially in small airways, remains poorly understood. The study aim was to investigate LABA add-on effects of tulobuterol patch (TP) and salmeterol inhaler (SA) on pulmonary function, asthma control and health status. Patients who had adult-onset under-control asthma, despite taking inhaled corticosteroids, were enrolled in a randomized, open-label, parallel-group, proof-of-concept study of 12-week add-on treatment with TP (n=16) or SA (n=17). Spirometry, impulse oscillometry (IOS), exhaled nitric oxide levels, and clinical questionnaires of asthma control, health status (St. George's Respiratory Questionnaire: SGRQ), and symptoms were evaluated every 4 weeks. Add-on treatment of SA significantly improved the spirometric indices of small airway obstruction (forced expiratory flow between 25% and 75% of FVC: FEF 25-75 , and maximum expiratory flow at 25% of FVC: MEF 25 ) and IOS indices of whole respiratory resistance (resistance at 5 Hz) as compared to TP. In intra-group comparisons, add-on treatment of TP improved the scores of the asthma control test and the total SGRQ, as well as the symptom and impact components of the SGRQ. SA add-on treatment improved FEV 1 and IOS parameters of resistance at 20 Hz and reactance at 5 Hz. Neither of the treatments improved exhaled nitric oxide levels. In conclusion, add-on treatment of TP improved asthma control and health status, whereas SA improved pulmonary function measures associated with large and small airway involvement among patients with adult-onset mild-to-moderate asthma. © 2016 John Wiley & Sons Australia, Ltd.

  18. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study

    Directory of Open Access Journals (Sweden)

    Lee Tsz

    2010-10-01

    Full Text Available Abstract Background Decreased bone mineral density and osteoporosis in postmenopausal women represents a growing source of physical limitations and financial concerns in our aging population. While appropriate medical treatments such as bisphosphonate drugs and hormone replacement therapy exist, they are associated with serious side effects such as osteonecrosis of the jaw or increased cardiovascular risk. In addition to calcium and vitamin D supplementation, previous studies have demonstrated a beneficial effect of dietary silicon on bone health. This study evaluated the absorption of silicon from bottled artesian aquifer water and its effect on markers of bone metabolism. Methods Seventeen postmenopausal women with low bone mass, but without osteopenia or osteoporosis as determined by dual x-ray absorptiometry (DEXA were randomized to drink one liter daily of either purified water of low-silicon content (PW or silicon-rich artesian aquifer water (SW (86 mg/L silica for 12 weeks. Urinary silicon and serum markers of bone metabolism were measured at baseline and after 12 weeks and analyzed with two-sided t-tests with p Results The urinary silicon level increased significantly from 0.016 ± 0.010 mg/mg creatinine at baseline to 0.037 ± 0.014 mg/mg creatinine at week 12 in the SW group (p = 0.003, but there was no change for the PW group (0.010 ± 0.004 mg/mg creatinine at baseline vs. 0.009 ± 0.006 mg/mg creatinine at week 12, p = 0.679. The urinary silicon for the SW group was significantly higher in the silicon-rich water group compared to the purified water group (p Conclusions These findings indicate that bottled water from artesian aquifers is a safe and effective way of providing easily absorbed dietary silicon to the body. Although the silicon did not affect bone turnover markers in the short-term, the mineral's potential as an alternative prevention or treatment to drug therapy for osteoporosis warrants further longer-term investigation

  19. Effect of a 12-Week Low vs. High Intensity Aerobic Exercise Training on Appetite-Regulating Hormones in Obese Adolescents: A Randomized Exercise Intervention Study.

    Science.gov (United States)

    Prado, Wagner Luiz; Lofrano-Prado, Mara Cristina; Oyama, Lila Missae; Cardel, Michelle; Gomes, Priscyla Praxedes; Andrade, Maria Laura S S; Freitas, Camila R M; Balagopal, Prabhakaran; Hill, James O

    2015-11-01

    Little is known about how the intensity of aerobic training influences appetite-regulating hormones in obese adolescents. Our goal was to assess the effect of low and high intensity aerobic trainings on food intake and appetite-regulating hormones in obese adolescents. Forty three obese adolescents (age: 13-18y, BMI: 34.48 ± 3.94 kg/m2) were randomized into high intensity training (HIT; n = 20) or low intensity training (LIT; n = 23) groups for 12 weeks. All participants also received the same nutritional, psychological and clinical counseling. Pre- and postintervention energy intake (EI) and circulating levels of insulin, leptin, peptide YY3-36 (PYY3-36) and ghrelin were measured. Adolescents in the HIT showed a reduction in total EI and an increase in PYY3-36 (p exercise training performed at ventilatory threshold 1 intensity, reduced EI and augmented PYY3-36 in obese adolescents, compared with LIT. The data suggest that HIT and LIT have differential effects in the regulation of appetite signals and subsequent EI in obese adolescents.

  20. Bifidogenic effect of whole-grain wheat during a 12-week energy-restricted dietary intervention in postmenopausal women.

    Science.gov (United States)

    Christensen, E G; Licht, T R; Kristensen, M; Bahl, M I

    2013-12-01

    Consumption of whole-grain products is known to have beneficial effects on human health. The effects of whole-grain products on the intestinal microbiota and intestinal integrity have, however, only been studied limitedly. We investigate changes of the human gut microbiota composition after consumption of whole-grain (WW) or refined wheat (RW) and further study effects on gut wall integrity. Quantitative PCR was used to determine changes in the gut bacterial composition in postmenopausal women following a 12-week energy-restricted dietary intervention with WW (N=38) or RW (N=34). Intestinal integrity was determined by measuring trans-epithelial resistance (TER) across a Caco-2 cell monolayer, following exposure to faecal water. No significant differences in microbiota composition were observed between the two dietary groups; however, the whole-grain intervention increased the relative abundance of Bifidobacterium compared to baseline, supporting a prebiotic effect of whole-grain wheat. Faecal water increased TER independent of dietary intervention, indicating that commensal bacteria produce metabolites that generally provide a positive effect on intestinal integrity. Combining microbiota composition data from the run-in period with its effect on TER revealed a tendency for a negative correlation between the relative abundance of Bifidobacterium and TER (P=0.09). This contradicts previous findings but supports observations of increased Salmonella infection in animal models following treatment with bifidogenic prebiotics. The present study shows that whole-grain wheat consumption increases the abundance of bifidobacteria compared to baseline and may have indirect effects on the integrity of the intestinal wall.

  1. Effects of a 12-week alpine skiing intervention on endothelial progenitor cells, peripheral arterial tone and endothelial biomarkers in the elderly.

    Science.gov (United States)

    Niederseer, David; Steidle-Kloc, Eva; Mayr, Matthias; Müller, Edith E; Cadamuro, Janne; Patsch, Wolfgang; Dela, Flemming; Müller, Erich; Niebauer, Josef

    2016-07-01

    Endothelial dysfunction occurs early during atherogenesis and it can be normalized by exercise training. Unfortunately, patients' compliance with exercise prescription remains low, often because the given choices do not appeal to them. In Alpine regions, skiing is a popular mode of exercise, and therefore we set out to assess whether it can induce antiatherogenic effects. We randomized 42 subjects into a group of 12weeks of guided skiing (intervention group, IG, n=22; 12 males/10 females; age: 66.6±2.1years) or a control group (CG, n=20; 10 males/10 females; age: 67.3±4.4years). Early (CD3-CD34+CD45+) and late endothelial progenitor cells (EPCs; CD45dimCD34+KDR+ peripheral blood mononuclear cells, PBMCs), peripheral arterial tonometry and endothelial biomarkers were assessed at the beginning and end of the study. In the IG, participants completed 28.5±2.6 skiing days at an average heart rate of 72.7±8.5% of their maximum heart rate. Changes in early (IG: +0.001±0.001% PBMC; CG: -0.001±0.001% PBMC; IG vs. CG: pskiing induces several beneficial effects on markers of atherogenesis including EPCs, peripheral arterial tone and homocysteine. Our findings suggest that recreational alpine skiing may serve as a further mode of preventive exercise training, which might result in improved compliance with current recommendations. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. Effects of 12-week lumbar stabilization exercise and sling exercise on lumbosacral region angle, lumbar muscle strength, and pain scale of patients with chronic low back pain.

    Science.gov (United States)

    Ko, Kwang-Jun; Ha, Gi-Chul; Yook, Young-Sook; Kang, Seol-Jung

    2018-01-01

    [Purpose] The purpose of this study is to investigate the effects of lumbar stabilization exercise and sling exercise on lumbosacral region angle, lumbar muscle strength, pain scale of patients with chronic low back pain. [Subjects and Methods] The subjects of this study were 29 chronic low back pain patient women who were selected among participants in exercise class at K Region Health Promotion Center in South Korea and were randomly assigned to the lumbar stabilization exercise group (n=10), sling exercise group (n=10), and the control group (n=9). Both lumbar stabilization and sling exercise programs were executed for 60 minutes, three times a week, for 12 weeks. Before and after exercise we measured lumbosacral region angle (lumbar lordosis angle, lumbosacral angle, sacral inclination angle), lumbar muscle strength, and pain scale in all subjects. Two-way analysis of variance was conducted to analyze experimental data. In order to analyze the interaction effect, we conducted paired t-test before and after treatment. [Results] Lumbar stabilization exercise group and sling exercises group did not affect lumbar lordosis angle, lumbosacral angle and sacral inclination angle. Whereas the lumbar flexion muscle strength and lumbar extension muscle strength significantly increased in the lumbar stabilization exercise group and sling exercise group. The flexibility increased in the lumbar stabilization exercise group and sling exercise group. The pain scale decreased in the lumbar stabilization exercise group and sling exercise group. [Conclusion] Both lumbar stabilization exercise and sling exercises are useful therapeutic approaches to chronic back pain.

  3. Motivation and ability to walk for a food reward in fast- and slow-growing broilers to 12 weeks of age.

    Science.gov (United States)

    Bokkers, Eddie A M; Koene, Paul

    2004-09-30

    Poor physical abilities of broilers may prevent them from performing behaviours for which they are motivated. The aim of this study was to measure the influence of physical ability and motivation on the performance of broilers in short physical tasks. We tested birds from a fast- and a slow-growing broiler strain in a runway to 12 weeks of age. To manipulate motivation, half of the birds of each strain was feed deprived for 3h and the other half for 24h before testing. Each bird was tested in a control and a slalom runway test once a week. With a similar motivation, slow growers had a shorter latency to start walking and walked faster through the runway than fast growers in both tests. In fast growers walking speed decreased faster with age than in slow growers. Slow growers vocalised more in both tests. In the slalom test, 24h deprived birds vocalised more than 3h deprived birds. Although the fast and slow growers have a different genetic background, the results indicated that motivation is the dominant determinative factor for walking in birds with a low body weight, while physical ability is the dominant determinative factor for walking in birds with a high body weight.

  4. Effects of 12-Week Bacopa monnieri Consumption on Attention, Cognitive Processing, Working Memory, and Functions of Both Cholinergic and Monoaminergic Systems in Healthy Elderly Volunteers

    Directory of Open Access Journals (Sweden)

    Tatimah Peth-Nui

    2012-01-01

    Full Text Available At present, the scientific evidence concerning the effect of Bacopa monnieri on brain activity together with working memory is less available. Therefore, we aimed to determine the effect of B. monnieri on attention, cognitive processing, working memory, and cholinergic and monoaminergic functions in healthy elderly. A randomized double-blind placebo-controlled design was utilized. Sixty healthy elderly subjects (mean age 62.62 years; SD 6.46, consisting of 23 males and 37 females, received either a standardized extract of B. monnieri (300 and 600 mg or placebo once daily for 12 weeks. The cholinergic and monoaminergic systems functions were determined using AChE and MAO activities. Working memory was assessed using percent accuracy and reaction time of various memory tests as indices, whereas attention and cognitive processing were assessed using latencies and amplitude of N100 and P300 components of event-related potential. All assessments were performed before treatment, every four weeks throughout study period, and at four weeks after the cessation of intervention. B. monnieri-treated group showed improved working memory together with a decrease in both N100 and P300 latencies. The suppression of plasma AChE activity was also observed. These results suggest that B. monnieri can improve attention, cognitive processing, and working memory partly via the suppression of AChE activity.

  5. Effect of 12 weeks aerobic exercise for along with folic acid supplementation on the levels of the ghrelin hormone amount of food intake and weight changes of female Wistar rats

    Directory of Open Access Journals (Sweden)

    A Parvizi

    2016-11-01

    Full Text Available Background & aim: Results of numerous studies have shown that approximately 1 to 78 percent of female athletes suffer from eating disorders. On the other hand, it has been mentioned that folic acid could increase appetite. The ghrelin hormone is known as a strong stimulant for appetite. Therefore, to clarify the role of exercise and food intake of folic acid on plasma acylated ghrelin the study aim was to evaluate the effect of 12 weeks of aerobic training on ghrelin supplementation of folic acid and quantity of food intake and weight change in female rats. Methods: In the present experimental study, 24 rats were randomly divided into three groups of 8 including: control, training and training along with folic acid supplementation. The training protocol consisted of aerobic exercise running on a treadmill for 12 weeks (5 days a week. Standard meal and water were freely provided for the subjects and in the supplement group 10 mg dissolved folic acid per liter of water were used and then the food intake and body weight was measured every week. 24 hours after the last session of training and 8 hours of overnight fasting, blood and tissue samples were collected and hormones levels were measured using Eliza method. To data analyzing, one way ANOVA and Tukey post hoc test was used. Results: The results showed that 12 weeks of  aerobic training with folic acid supplementation had significantly reduced serum acylated ghrelin levels (P0.05. The 12-week aerobic training with folic acid intake in comparison with other groups significantly increased food intake and body weight gain (p < 0.05. Conclusion: According to the acylated ghrelin reduction and lack of change in the stomach acylated ghrelin with increased food intake and body weight in rats, it seems that taking folic acid supplements inactive athletes with another strong mechanism, increasing consumption of food and influence on appetite center.

  6. Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

    Directory of Open Access Journals (Sweden)

    Shusaku Ishikawa

    2008-09-01

    Full Text Available Shusaku Ishikawa1, Yoshimi Nakamura1, Yuko Nakamura1, Hiroshi Sakai1, Shoichi Sawaguchi1, Kazuo Terashima2, Makoto Kanno2, Hidetoshi Yamashita21Department of Ophthalmology, University of the Ryukyus Faculty of Medicine, Okinawa, Japan; 2Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine, Yamagata, JapanPurpose: To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG or ocular hypertension (OH after a change from timolol in combination therapy with latanoprost.Methods: A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SDy] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol. Intraocular pressure (IOP was measured at baseline, 4, 8, and 12 weeks. Blood pressure (BP, pulse rate (PR, and adverse events were also recorded.Results: IOPs at baseline, 4, 8, and 12 weeks were 18.6 ± 2.1 mmHg, 17.8 ± 2.6 mmHg, 17.4 ± 2.5 mmHg, and 17.3 ± 3.5 mmHg, respectively. IOP reduction at 4 and 8 weeks was statistically significant (p < 0.05. The PR was significantly increased at 12 weeks (p < 0.01, but BP was not significantly affected. Four ocular adverse events were noted, but all were mild and transient.Conclusions: Substituting brinzolamide 1% for timolol 0.5% in combination therapy with latanoprost 0.005% demonstrated significant IOP reduction with improvement in PR with POAG or OH. Combination therapy using latanoprost and brinzolamide may be recommended for better IOP control with fewer systemic adverse events.Keywords: open-angle glaucoma, brinzolamide/latanprost combination therapy, timolol/latanoprost combination therapy, intraocular pressure

  7. Impact of 12 weeks of resistance training on physical and functional fitness in elderly women. http://dx.doi.org/10.5007/1980-0037.2013v15n2p145

    Directory of Open Access Journals (Sweden)

    Aline Mendes Gerage

    2013-03-01

    Full Text Available The objective of the study was to analyze the impact of 12 weeks of resistance training (RT on physical functional fitness in elderly women. Fifty-one elderly women (66.1±4.4 years, apparently healthy, insufficiently active, and without prior experience in RT were randomly assigned into two groups: Training Group (TG = 24 and Control Group (CG = 27. The TG was submitted to a standardized RT program composed of eight exercises, performed in two sets of 10 to 15 repetitions, three times a week, and the CG was submitted to a 12 week stretching exercise program composed by two sessions per week of 30 minutes each. Their physical and functional fitness level was analyzed before and after the intervention period by motor testing to assess Right and Left Upper Limb Endurance (RULE, LULE, Lower Limb Endurance (LLE, Flexibility (FLEX, Manual Skills (MS, Ability to Put on Socks (APS, and Coordination (COORD. The TG had improved performance in LLE (+13.8%, RULE (+24.3%, LULE (+22.9%, and MS (- 0.9 s, whereas the CG improved performance in RULE (+13.9% and LULE (+14.1%, but had increased time in COORD by (+1.5 s, and these were the only tests showing significant interactions of group vs. time (p<0.05. The results suggest that 12 weeks of RT seem to be sufficient to induce positive changes on physical and functional fitness of healthy and previously untrained elderly women.

  8. Quercetin and Green Tea Extract Supplementation Downregulates Genes Related to Tissue Inflammatory Responses to a 12-Week High Fat-Diet in Mice

    Directory of Open Access Journals (Sweden)

    Lynn Cialdella-Kam

    2017-07-01

    Full Text Available Quercetin (Q and green tea extract (E are reported to counter insulin resistance and inflammation and favorably alter fat metabolism. We investigated whether a mixture of E + Q (EQ could synergistically influence metabolic and inflammation endpoints in a high-fat diet (HFD fed to mice. Male C57BL/6 mice (n = 40 were put on HFD (fat = 60%kcal for 12 weeks and randomly assigned to Q (25 mg/kg of body weight (BW/day, E (3 mg of epigallocatechin gallate/kg BW/day, EQ, or control groups for four weeks. At 16 weeks, insulin sensitivity was measured via the glucose tolerance test (GTT, followed by area-under-the-curve (AUC estimations. Plasma cytokines and quercetin were also measured, along with whole genome transcriptome analysis and real-time polymerase chain reaction (qPCR on adipose, liver, and skeletal muscle tissues. Univariate analyses were conducted via analysis of variance (ANOVA, and whole-genome expression profiles were examined via gene set enrichment. At 16 weeks, plasma quercetin levels were higher in Q and EQ groups vs. the control and E groups (p < 0.05. Plasma cytokines were similar among groups (p > 0.05. AUC estimations for GTT was 14% lower for Q vs. E (p = 0.0311, but non-significant from control (p = 0.0809. Genes for cholesterol metabolism and immune and inflammatory response were downregulated in Q and EQ groups vs. control in adipose tissue and soleus muscle tissue. These data support an anti-inflammatory role for Q and EQ, a result best captured when measured with tissue gene downregulation in comparison to changes in plasma cytokine levels.

  9. Can active music-making ameliorate neglect? An assessor-blind, within-subject, controlled clinical trial

    DEFF Research Database (Denmark)

    Bodak, Rebeka; Mazhari-Jensen, Daniel; Evald, Lars

    functional gains. Drawing on recent successful case study pilot work, the aim of the present study is to investigate the impact of an active music-making intervention compared with a control. Stroke survivors with a diagnosis of neglect will be invited to participate in an assessor-blind, within......-subject, home program study that lasts 12 weeks and comprises four 3-week phases: baseline, control, intervention, and follow-up. The intervention and control each comprise six 30-minute sessions plus daily homework. The intervention involves playing scales and familiar melodies on a horizontally...... and on an assessment of their activities-of-daily-living. By validating and extending published case study work, the knowledge gained from this study has the capacity to pave the way for future clinical interventions and deepen our understanding of the use of music as a clinical tool in neurorehabilitation settings....

  10. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program.

    Science.gov (United States)

    Peters, John C; Wyatt, Holly R; Foster, Gary D; Pan, Zhaoxing; Wojtanowski, Alexis C; Vander Veur, Stephanie S; Herring, Sharon J; Brill, Carrie; Hill, James O

    2014-06-01

    To compare the efficacy of non-nutritive sweetened beverages (NNS) or water for weight loss during a 12-week behavioral weight loss treatment program. An equivalence trial design with water or NNS beverages as the main factor in a prospective randomized trial among 303 men and women was employed. All participants participated in a behavioral weight loss treatment program. The results of the weight loss phase (12 weeks) of an ongoing trial (1 year) that is also evaluating the effects of these two treatments on weight loss maintenance were reported. The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group (5.95 kg versus 4.09 kg; P water group during 12 weeks. These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program. Copyright © 2014 The Obesity Society.

  11. [Clinical study on the effect of anti-gingivitis IgY toothpaste in control of gingivitis and dental plaque].

    Science.gov (United States)

    Zhang, Wei; Feng, Xi-Ping; Tao, Dan-Ying; Chen, Jian-Fen

    2016-08-01

    To observe the effect of anti-gingivitis IgY toothpaste in control of gingivitis and plaque. The study was a double-blind, randomized, parallel-controlled clinical trail with a total of 100 subjects who were divided into two groups, experimental group and control group. The subjects in experimental group used anti-gingivitis IgY toothpaste to brush twice daily for 3 minutes, and the subjects in control group used none anti-gingivitis IgY toothpaste. The examiner recorded GI, PI and BOP index of all subjects at the baseline, 6-weeks and 12-weeks. SPSS21.0 software package was used for statistical analysis. Twelve weeks later, there were significant differences in GI and BOP between the two groups. Yet no significant difference was found in PI. Anti-gingivitis IgY toothpaste is effective in control of gingivitis.

  12. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.

    Science.gov (United States)

    Fransen, Marlene; Nairn, Lillias; Winstanley, Julie; Lam, Paul; Edmonds, John

    2007-04-15

    To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits. A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb). At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.

  13. Evaluation of a Physical Activity Intervention for Adults With Brain Impairment: A Controlled Clinical Trial.

    Science.gov (United States)

    Clanchy, Kelly M; Tweedy, Sean M; Trost, Stewart G

    2016-10-01

    Individuals with brain impairment (BI) are less active than the general population and have increased risk of chronic disease. This controlled trial evaluated the efficacy of a physical activity (PA) intervention for community-dwelling adults with BI. A total of 43 adults with BI (27 male, 16 female; age 38.1 ± 11.9 years; stage of change 1-3) who walked as their primary means of locomotion were allocated to an intervention (n = 23) or control (n = 20) condition. The intervention comprised 10 face-to-face home visits over 12 weeks, including a tailored combination of stage-matched behavior change activities, exercise prescription, community access facilitation, and relapse prevention strategies. The control group received 10 face-to-face visits over 12 weeks to promote sun safety, healthy sleep, and oral health. Primary outcomes were daily activity counts and minutes of moderate-to-vigorous-intensity PA (MVPA) measured with the ActiGraph GT1M at baseline (0 weeks), postintervention (12 weeks) and follow-up (24 weeks). Between-group differences were evaluated for statistical significance using repeated-measures ANOVA. MVPA for the intervention group increased significantly from baseline to 12 weeks (20.8 ± 3.1 to 31.2 ± 3.1 min/d; P = .01), but differences between baseline and 24 weeks were nonsignificant (20.8 ± 3.1 to 25.3 ± 3.2 min/d; P = .28). MVPA changes for the control group were negligible and nonsignificant. Between-group differences for change in MVPA were significant at 12 weeks (P = .03) but not at 24 weeks (P = .49). The 12-week intervention effectively increased adoption of PA in a sample of community-dwelling adults with BI immediately after the intervention but not at follow-up. Future studies should explore strategies to foster maintenance of PA participation. © The Author(s) 2016.

  14. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study.

    Science.gov (United States)

    Hirose, Takahisa; Suzuki, Manabu; Tsumiyama, Isao

    2015-12-01

    To assess the efficacy and safety of vildagliptin as add-on therapy in Japanese patients with type 2 diabetes mellitus (T2DM), inadequately controlled on stable long-acting, intermediate-acting, or pre-mixed insulin, with or without concomitant metformin. In this 12-week placebo-controlled study, patients were randomized to receive either vildagliptin 50 mg twice daily (bid) or placebo treatment in a 1:1 ratio. The primary endpoint was change in glycated hemoglobin A1c (HbA1c) from baseline to 12-week endpoint. Secondary endpoints included proportion of patients achieving pre-defined HbA1c targets of ≤6.5%, <7.0%, and HbA1c <7.0% in patients with baseline HbA1c ≤8.0% and change in fasting plasma glucose (FPG) after 12 weeks of treatment. Regular monitoring was performed to record any treatment-emergent adverse events (AEs) and serious adverse events or hypoglycemic episodes. Of the 156 patients randomized, 96.8% completed the study (vildagliptin, n = 76; placebo, n = 75). Patient demographics and clinical characteristics were comparable between the groups at baseline. Addition of vildagliptin resulted in statistically significant reductions in HbA1c after 12 weeks (-1.01 ± 0.06%), with a between-treatment difference of -0.91 ± 0.09% (p < 0.001). FPG levels reduced from baseline to 12 weeks in the vildagliptin group (-1.2 ± 0.2 mmol/L), with a between-treatment difference of -1.2 ± 0.3 mmol/L which was significant (p < 0.001). The proportion of patients achieving HbA1c targets was higher with vildagliptin treatment for all pre-defined responder rate categories. The overall incidence of AEs was comparable between groups (vildagliptin, 46.2% vs. placebo, 43.6%). The overall incidence of hypoglycemic events was low and all events were self-treatable without using drug therapy. No severe hypoglycemic events were reported. Treatment with vildagliptin 50 mg bid as add-on to insulin with or without metformin resulted in statistically

  15. A Randomized, Placebo-Controlled Clinical Trial of Efficacy and Safety: Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis.

    Science.gov (United States)

    Silveira, Marina G; Gossard, Andrea A; Stahler, Alisha C; Jorgensen, Roberta A; Petz, Janice L; Ali, Ahmad H; Lindor, Keith D

    Fatigue is a common symptom of primary biliary cirrhosis (PBC), and is associated with an impaired quality of life. No studies have assessed the use of modafinil in fatigue related to PBC in a controlled manner. A randomized, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of modafinil for the treatment of fatigue in PBC. Forty patients were randomized to modafinil (n = 20) or placebo (n = 20) for 12 weeks. A verbal report of fatigue for at least 6 months was required for enrollment. Modafinil was administered at 100 mg by mouth once daily; a change by 50 mg every 2 weeks (maximum: 200 mg once daily) was allowed, depending on the subject's response to treatment. The primary outcome was defined as a ≥50% improvement in fatigue severity [quantified by the Fisk Fatigue Impact Scale (FFIS)] after 12 weeks of treatment, compared with baseline values. Thirty-three PBC patients completed the study. After 12 weeks of therapy, only 5 patients had a ≥50% reduction in FFIS scores: 3 patients (17.6%) in the modafinil arm and 2 (12.5%) in the placebo arm (P = 1.00). Change in median FFIS score was not statistically different between patients in the 2 treatment groups (P = 0.36). Modafinil was associated with minimal adverse events (headaches, diarrhea, and rash). In patients with PBC who have fatigue, treatment with modafinil for 12 weeks was safe and fairly well tolerated; however, it did not result in beneficial effects on fatigue compared with patients treated with placebo (CONSORT Table 1). ClinicalTrials.gov identifier NCT00943176.

  16. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial.

    Science.gov (United States)

    Hancock, Mark J; Maher, Christopher G; Latimer, Jane; Herbert, Robert D; McAuley, James H

    2008-07-01

    A clinical prediction rule to identify patients most likely to respond to spinal manipulation has been published and widely cited but requires further testing for external validity. We performed a pre-planned secondary analysis of a randomised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute, non-specific, low back pain. Patients were randomised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks. All patients received general practitioner care (advice and paracetamol). Outcomes were pain and disability measured at 1, 2, 4 and 12 weeks. Status on the clinical prediction rule was measured at baseline. The clinical prediction rule performed no better than chance in identifying patients with acute, non-specific low back pain most likely to respond to spinal manipulative therapy (pain P = 0.805, disability P = 0.600). At 1-week follow-up, the mean difference in effect of spinal manipulative therapy compared to placebo in patients who were rule positive rather than rule negative was 0.3 points less on a 10-point pain scale (95% CI -0.8 to 1.4). The clinical prediction rule proposed by Childs et al. did not generalise to patients presenting to primary care with acute low back pain who received a course of spinal manipulative therapy.

  17. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens.

    Science.gov (United States)

    Luetkemeyer, Anne F; McDonald, Cheryl; Ramgopal, Moti; Noviello, Stephanie; Bhore, Rafia; Ackerman, Peter

    2016-06-15

    Highly effective hepatitis C virus (HCV) direct-acting antiviral therapies that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens are needed. We evaluated the efficacy and safety of daclatasvir + sofosbuvir (DCV + SOF) for 12 weeks by antiretroviral (ARV) regimen in HIV-HCV-coinfected patients. In the randomized, open-label ALLY-2 study, HIV-HCV-coinfected patients received 8 or 12 weeks of once-daily DCV 60 mg (dose-adjusted as-necessary for concomitant ARVs) + SOF 400 mg. Results were stratified by ARV class for the 151 patients who received 12 weeks of DCV + SOF. Fifty-one patients were HCV treatment experienced, 100 were treatment naive, 89% male and 33% black. HCV genotypes were: genotype 1a (GT1a; 69%), GT1b (15%), GT2 (8%), GT3 (6%), and GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across ARV regimens (P = .774): protease inhibitor-based, 97% (95% confidence interval [CI], 90%-99.7%); nonnucleoside reverse transcriptase inhibitor-based, 100% (95% CI, 91%-100%); and integrase inhibitor based, 95% (95% CI, 83%-99.4%). SVR12 among patients receiving either tenofovir disoproxil fumarate or abacavir as part of their antiretroviral therapy regimen was 98% (95% CI, 93%-99.5%) and 100% (95% CI, 85%-100%), respectively. Age, gender, race, cirrhosis, HCV treatment history, GT , and baseline HCV RNA did not affect SVR12. No discontinuations were attributed to treatment-related adverse events. DCV + SOF x12 weeks is a highly efficacious, all-oral, pan-GT HCV treatment for HIV-HCV coinfected patients across a broad range of ARV regimens. NCT02032888. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

  18. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury.

    Science.gov (United States)

    Flueck, Joelle Leonie; Schlaepfer, Max Walter; Perret, Claudio

    2016-09-22

    (1) BACKGROUND: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2) METHODS: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3) RESULTS: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4) CONCLUSION: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are associated with each

  19. Triple-Combination therapy with olmesartan, amlodipine, and hydrochlorothiazide in black and non-black study participants with hypertension: the TRINITY randomized, double-blind, 12-week, parallel-group study.

    Science.gov (United States)

    Chrysant, Steven G; Littlejohn, Thomas; Izzo, Joseph L; Kereiakes, Dean J; Oparil, Suzanne; Melino, Michael; Lee, James; Fernandez, Victor; Heyrman, Reinilde

    2012-08-01

    Although awareness of hypertension in Black patients has increased, blood pressure (BP) is frequently inadequately controlled. This prespecified subgroup analysis of the TRINITY study evaluated the efficacy and safety of olmesartan medoxomil (OM) 40 mg, amlodipine besylate (AML) 10 mg, and hydrochlorothiazide (HCTZ) 25 mg triple-combination treatment compared with the component dual-combination treatments in Black and non-Black study participants. TRINITY was a 12-week, randomized, double-blind, parallel-group evaluation. The first patient was enrolled in May 2008 and the last patient completed the study in February 2009. The study consisted of a 3-week washout period for participants receiving antihypertensive therapy and a 12-week double-blind treatment period. For the treatment phase, all study participants were stratified by age, race, and diabetes mellitus status and randomized to a treatment sequence that led to their final treatment assignment, which they received from weeks 4 to 12 (OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AML 10 mg, OM 40 mg/HCTZ 25 mg, or AML 10 mg/HCTZ 25 mg). In the first 2 weeks of the double-blind treatment period, all participants received either dual-combination treatment or placebo. Participants assigned to dual-combination treatment continued treatment until week 4, and participants receiving placebo were switched at week 2 to receive one of the dual-combination treatments until week 4. At week 4, participants either continued dual-combination treatment or randomly received triple-combination treatment until week 12. 317 clinical sites in the USA and Puerto Rico were included in the study. Study participants eligible for randomization (N = 2492) were ≥18 years of age with mean seated blood pressure (SeBP) ≥140/100 mmHg or ≥160/90 mmHg (off antihypertensive medication). The intervention was with dual- or triple-combination antihypertensive treatment: OM 40 mg/AML 10 mg/HCTZ 25 mg, OM 40 mg/AML 10 mg, OM 40 mg/HCTZ 25 mg, or

  20. Clinical effectiveness of bee venom acupuncture and physiotherapy in the treatment of adhesive capsulitis: a randomized controlled trial.

    Science.gov (United States)

    Koh, Pil Seong; Seo, Byung Kwan; Cho, Nam Su; Park, Hyung Soon; Park, Dong Suk; Baek, Yong Hyeon

    2013-08-01

    Bee venom acupuncture (BVA) has been used in the treatment of adhesive capsulitis (AC) in the clinical field. This study aimed to investigate whether the addition of BVA to physiotherapy (PT) would be more effective in the management of AC, and whether BVA would have a dose-dependent effect. Sixty-eight patients diagnosed with AC were recruited into 3 groups; BV 1 (1:10,000 BVA plus PT), BV 2 (1:30,000 BVA plus PT), and group 3 (normal saline (NS) injection, as a control, plus PT). PT was composed of 15 minutes of transcutaneous electrical nerve stimulation (TENS), transcutaneous infrared thermotherapy (TDP), and manual PT. Treatments were given in 16 sessions within 2 months. Shoulder pain and disability index (SPADI), pain visual analogue scale (VAS), and 3) active/passive range of motion (ROM) were measured before treatment and at 2, 4, 8, and 12 weeks after the treatment. All 3 groups showed statistically significant improvements in SPADI, pain VAS scores, and active/passive ROM. The BV 1 group showed significantly better outcomes in SPADI at 8 and 12 weeks, in pain VAS (at rest) at 8 weeks, and in pain VAS (during exercise) at 12 weeks than the NS group. No significant differences were found in active/passive ROM among all the groups. BVA in combination with PT can be more effective in improving pain and function than PT alone in AC. However, the effectiveness of BVA was not shown in a dose-dependent manner. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  1. The effect of a high- intensity running (12weeks with bee pollen on gastrocnemius muscle ABCA1 and apoA1 mRNA expression in male rats

    Directory of Open Access Journals (Sweden)

    2016-10-01

    Full Text Available Abstract Background & Aims: The purpose of the current study was to investigate the effect of a high- intensity running (12weeks with bee pollen on gastrocnemius muscle ABCA1 and apoA1 mRNA expression in male rats. Materials & Methods: Twenty_ four Wistar male rats (4-6 weeks old, 90-110 g weight were used. Animals were randomly assigned into saline-control (SC, n=6, saline-training (ST, n=6, bee pollen- Control (BPC, n=6, and bee pollen-training (BPT, n=6 groups. Training groups have performed a high-intensity running program (30 m/min on 0% grade, 90min/day and 5 days/week on a motor-driven treadmill for 12 weeks. Animals were orally fed with bee pollen extraction (500 mg/kg body weight and saline solution for last 12 weeks. Rats were sacrificed 48 h after the last exercise session. A portion of gastrocnemius muscle were excised, cleaned and immediately frozen in liquid nitrogen and stored at -80 ° C until RNA extraction. Statistical analysis was performed using a two way ANOVA, and significance was accepted at P < 0.05. Results: A significant differences have found in gastrocnemius muscle ABCA1 gene expression between SC and BPC groups (P<0.000, ST with BPC groups (P< 0.000, ST with BPT groups (P< 0.040 and BPC with BPT groups (P< 0.000. Conclusion: The current results show that high-intensity running affected gastrocnemius muscle ABCA1 mRNA expression in different directions in saline (decrease and BPT (increase treated animals. Findings also indicate bee pollen consumption increase gastrocnemius muscle ABCA1 mRNA expression in rat.  Also apoA1 was not expressed in the gastrocnemius muscle of rat. Keywords: ABCA1, apoA1, Bee pollen, high- intensity running

  2. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  3. A 12-week supervised exercise therapy program for young adults with a meniscal tear: Program development and feasibility study

    DEFF Research Database (Denmark)

    Skou, Søren T.; Thorlund, Jonas B.

    2018-01-01

    interview. Feedback from patients was included to finalize the exercise therapy program. Median improvements (Range) in KOOS subscales were 15 (0–33) for Pain, 11 (−11 to 50) for Symptoms, 16 (3–37) for Function in daily living, 23 (10–45) for Function in sport and recreation, and 9 (−6 to 31) for Quality...... on clinical expertise and available evidence. Six patients (age range 22–39 years) considered eligible for meniscal surgery by an orthopedic surgeon underwent the program. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) and evaluated the program during a semi-structured qualitative...... of life. The patients found the program relevant and effective with only a few short-lasting adverse events and important clinical improvements after four to ten weeks. Physical therapist supervision was considered important. No patients wanted surgery up to 6 month after the exercise therapy program...

  4. The Effect of 12 Weeks Aerobic, Resistance, and Combined Exercises on Omentin-1 Levels and Insulin Resistance among Type 2 Diabetic Middle-Aged Women

    OpenAIRE

    AminiLari, Zeinab; Fararouei, Mohammad; Amanat, Sasan; Sinaei, Ehsan; Dianatinasab, Safa; AminiLari, Mahmood; Daneshi, Nima; Dianatinasab, Mostafa

    2017-01-01

    Background Recent studies have shown that omentin-1 derived from adipokines can affect physiological regulations and some metabolic dis-eases such as type 2 diabetes mellitus (T2DM). Methods The purpose of this study was to examine the impact of 12 weeks of aerobic (cycle ergometer), resistance, and combined exercises on omentin-1 level, glucose and insulin resistance indices in overweight middle age women with T2DM. In this study, 60 overweight middle age diabetic women were selected using s...

  5. Effects of a 12-week aerobic exercise intervention on eating behaviour, food cravings, and 7-day energy intake and energy expenditure in inactive men.

    Science.gov (United States)

    Rocha, Joel; Paxman, Jenny; Dalton, Caroline; Winter, Edward; Broom, David R

    2016-11-01

    This study examined effects of 12 weeks of moderate-intensity aerobic exercise on eating behaviour, food cravings, and weekly energy intake and expenditure in inactive men. Eleven healthy men (mean ± SD: age, 26 ± 5 years; body mass index, 24.6 ± 3.8 kg·m -2 ; maximum oxygen uptake, 43.1 ± 7.4 mL·kg -1 ·min -1 ) completed the 12-week supervised exercise programme. Body composition, health markers (e.g., blood pressure), eating behaviour, food cravings, and weekly energy intake and expenditure were assessed before and after the exercise intervention. There were no intervention effects on weekly free-living energy intake (p = 0.326, d = -0.12) and expenditure (p = 0.799, d = 0.04) or uncontrolled eating and emotional eating scores (p > 0.05). However, there was a trend with a medium effect size (p = 0.058, d = 0.68) for cognitive restraint to be greater after the exercise intervention. Total food cravings (p = 0.009, d = -1.19) and specific cravings of high-fat foods (p = 0.023, d = -0.90), fast-food fats (p = 0.009, d = -0.71), and carbohydrates/starches (p = 0.009, d = -0.56) decreased from baseline to 12 weeks. Moreover, there was a trend with a large effect size for cravings of sweets (p = 0.052, d = -0.86) to be lower after the exercise intervention. In summary, 12 weeks of moderate-intensity aerobic exercise reduced food cravings and increased cognitive restraint, but these changes were not accompanied by changes in other eating behaviours or weekly energy intake and expenditure. The results indicate the importance of exercising for health improvements even when reductions in body mass are modest.

  6. Safety and efficacy of exercise training in adults with Pompe disease: evalution of endurance, muscle strength and core stability before and after a 12?week training program

    OpenAIRE

    van den Berg, Linda E. M.; Favejee, Marein M.; Wens, Stephan C. A.; Kruijshaar, Michelle E.; Praet, Stephan F. E.; Reuser, Arnold J. J.; Bussmann, Johannes B. J.; van Doorn, Pieter A.; van der Ploeg, Ans T.

    2015-01-01

    textabstractBackground: Pompe disease is a proximal myopathy. We investigated whether exercise training is a safe and useful adjuvant therapy for adult Pompe patients, receiving enzyme replacement therapy. Methods: Training comprised 36 sessions of standardized aerobic, resistance and core stability exercises over 12 weeks. Before and after, the primary outcome measures safety, endurance (aerobic exercise capacity and distance walked on the 6 min walk test) and muscle strength, and secondary ...

  7. Incidence and Contributing Factors of Persistent Hyperglycemia at 6–12 Weeks Postpartum in Iranian Women with Gestational Diabetes: Results from LAGA Cohort Study

    OpenAIRE

    Sedigheh Nouhjah; Hajieh Shahbazian; Nahid Shahbazian; Alireza Jahanshahi; Shayesteh Jahanfar; Bahman Cheraghian

    2017-01-01

    Background. A history of gestational diabetes is an important predictor of many metabolic disturbances later in life. Method. Life after gestational diabetes Ahvaz Study (LAGAs) is an ongoing population-based cohort study. Up to February 2016, 176 women with gestational diabetes underwent a 75?g oral glucose tolerance test (OGTT) at 6?12 weeks postpartum in Ahvaz (southwestern of Iran). Gestational diabetes was diagnosed according to the International Association of Diabetes and Pregnancy Stu...

  8. Effects of a 12-week exercise training on insulin sensitivity, quality of life, and depression status in patients with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Chia-Huei Lin

    2017-01-01

    Full Text Available Background: Exercise is one of the optimal and alternative treatments for type 2 diabetes (T2DM. Although the effect of a single bout of exercise on insulin sensitivity is reported to persist only for 2–3 days, effects remain unclear of a 12-week aerobic exercise training on insulin sensitivity, quality of life (QOL, and depression status over time as exercise training duration increases in patients with T2DM. Objectives: To investigate the effects over time in patients with T2DM of a 12-week aerobic exercise training on insulin sensitivity, QOL, and depression status. Materials and Methods: Purposive sampling was used to recruit 17 T2DM patients. Participants underwent a 12-week, supervised, moderate-intensity aerobic exercise training three times per week, 30 min per session. Outcome indicators including insulin sensitivity (measured by a 2-h oral glucose tolerance test [OGTT] and homeostatic model assessment-insulin resistance [HOMA-IR], QOL (Medical Outcomes Study Short Form 36, and depression status (beck depression inventory scale were evaluated at baseline and at 4-week intervals. Results: A final 13 eligible participants completed the study. For every 4-week increase in duration of exercise training, there was an increase over time in insulin sensitivity, including a decrease over time in OGTT glucose area under the curve of 66.92 min/mmol/L. Glucose concentrations decreased over time at 60, 90, and 120 min after an oral glucose challenge. Further, the HOMA-IR decreased over time as the duration of exercise training increased. QOL and depression status improved significantly during the training. Conclusions: Moderate-intensity exercise training improves insulin sensitivity, QOL, and depression status in T2DM patients, particularly over time within a 12-week exercise training course.

  9. Bifidogenic effect of whole-grain wheat during a 12-week energy-restricted dietary intervention in postmenopausal women

    DEFF Research Database (Denmark)

    Christensen, Ellen Gerd; Licht, Tine Rask; Kristensen, M.

    2013-01-01

    =38) or RW (N=34). Intestinal integrity was determined by measuring trans-epithelial resistance (TER) across a Caco-2 cell monolayer, following exposure to faecal water.Results:No significant differences in microbiota composition were observed between the two dietary groups; however, the whole......-grain intervention increased the relative abundance of Bifidobacterium compared to baseline, supporting a prebiotic effect of whole-grain wheat. Faecal water increased TER independent of dietary intervention, indicating that commensal bacteria produce metabolites that generally provide a positive effect...... infection in animal models following treatment with bifidogenic prebiotics.Conclusions:The present study shows that whole-grain wheat consumption increases the abundance of bifidobacteria compared to baseline and may have indirect effects on the integrity of the intestinal wall.European Journal of Clinical...

  10. Results of a randomized, double-blind, placebo-controlled study of mirabegron in a Taiwanese population with overactive bladder and comparison with other clinical trials

    Directory of Open Access Journals (Sweden)

    Hann-Chorng Kuo

    2015-03-01

    Conclusion: Mirabegron at a dose of 50 mg once daily for 12 weeks is superior to placebo in reducing the frequency of micturitions in Taiwanese patients with symptoms of OAB. No clinically relevant, serious adverse events were identified.

  11. Quality Control in Clinical Laboratory Samples

    Science.gov (United States)

    2015-01-01

    standards. Product Development Custom and OEM Research, Design & Development Bulk Manufacturing I Component Manufacturing I Custom Microorganism ...that controls were well within established parameters and calibrations were valid . The laboratories queried the analyzer manufacturer and expressed...experience includes 18 years in clinical laboratory medicine as well as three years as a research toxicologist. Maj. Cordy F. Herring Ill, USAF, MT

  12. Effect of 12-Week Vitamin D Supplementation on 25[OH]D Status and Performance in Athletes with a Spinal Cord Injury

    Directory of Open Access Journals (Sweden)

    Joelle Leonie Flueck

    2016-09-01

    Full Text Available (1 Background: studies with able-bodied athletes showed that performance might possibly be influenced by vitamin D status. Vitamin D seems to have a direct impact on neuromuscular function by docking on vitamin D receptors in the muscle tissue. Additionally, a high prevalence of vitamin D deficiency was shown not only in infants and in the elderly but also in healthy adults and spinal cord injured individuals. Therefore, the aim of our study was to investigate whether a vitamin D dose of 6000 IU daily over 12 weeks would be sufficient to increase vitamin D status in indoor wheelchair athletes to a normal or optimal vitamin D level and whether vitamin D deficiency is associated with an impairment in muscle performance in these individuals; (2 Methods: vitamin D status was assessed in indoor elite wheelchair athletes in order to have a baseline measurement. If vitamin D status was below 75 nmol/L, athletes were supplemented with 6000 IU of vitamin D daily over 12 weeks. A vitamin D status over 75 nmol/L was supplemented with a placebo supplement. Vitamin D status, as well as a Wingate test and an isokinetic dynamometer test, were performed at baseline and after six and 12 weeks; (3 Results: 20 indoor elite wheelchair athletes participated in this double-blind study. All of these athletes showed an insufficient vitamin D status at baseline and were, therefore, supplemented with vitamin D. All athletes increased vitamin D status significantly over 12 weeks and reached an optimal level. Wingate performance was not significantly increased. Isokinetic dynamometer strength was significantly increased but only in the non-dominant arm in isometric and concentric elbow flexion; (4 Conclusion: a dose of 6000 IU of vitamin D daily over a duration of 12 weeks seems to be sufficient to increase vitamin D status to an optimal level in indoor wheelchair athletes. It remains unclear, whether upper body performance or muscle strength and vitamin D status are

  13. A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush.

    Science.gov (United States)

    Nathoo, Salim; Mankodi, Suru; Mateo, Luis R; Chaknis, Patricia; Panagakos, Foti

    2012-01-01

    This study was designed to evaluate the efficacy of a new specially engineered sonic powered toothbrush with unique sensing and control technologies, as compared to a manual flat-trim toothbrush on supragingival plaque and established gingivitis. This examiner-blind, two-treatment, parallel clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use, and again after four- and 12-weeks' use using the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis at four and 12 weeks using the Löe and Silness Gingival Index. Qualifying adult male and female subjects from the southern Florida area reported to the study site after refraining from any oral hygiene procedures for 24 hours, and from eating, drinking, and smoking for four hours. Following an examination for plaque (pre-brushing) and gingivitis, they were randomized (for both plaque and gingivitis) into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush according to the manufacturer's instructions, and commercially available toothpaste (Colgate Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 12 weeks. They again reported to the study site after four and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. Seventy-six out of 82 enrolled subjects complied with the protocol and completed the clinical study. The new specially engineered sonic powered toothbrush with unique sensing and control technologies provided statistically significant reductions in gingival and gingivitis severity index scores after four and 12 weeks of product use. The manual toothbrush provided a statistically

  14. EFFECTS OF A 12-WEEK AEROBIC EXERCISE PROGRAM COMBINED WITH MUSIC THERAPY AND MEMORY EXERCISES ON COGNITIVE AND FUNCTIONAL ABILITY IN PEOPLE WITH MIDDLE TYPE OF ALZHEIMER'S DISEASE

    Directory of Open Access Journals (Sweden)

    Christina Kampragkou

    2017-10-01

    Full Text Available Background: The Alzheimer's disease is the most common form of dementia and represents 60% of its cases. The disease is characterized by cognitive, non-cognitive and functional deficits and it’s incurable. The main of this study was to examine the effects of the aerobic exercise in combination with the music therapy and memory exercises in functional and cognitive ability on a patient with that have been affected by middle type (Second stage of Alzheimer's disease. Methods: Thirty patients from Chronic Diseases Center, with Alzheimer's disease, divided between an intervention and a control group, participated in this randomized controlled study. (Thirty patients with Alzheimer's were chosen from chronic disease center, and are divided into an intervention and a control group. The intervention requires 30 minutes of aerobic exercise, 10 minutes of memory games and music therapy, three times a week, for the duration of 12 weeks. The outcome measures the “Mini Mental State Examination” (MMSE scale and the “Alzheimer's Disease Assessment Scale cognitive test” (ADAS for the cognitive ability, “Katz Index Independence in Activities of Daily Living” (ADL, “Get up and Go test” and “One leg standing balance test” (OLST for the functionality. A three-way analysis of variance designs was applied to compare changes in each outcome measure before and after the intervention between the groups. Results: The MMSE score decrease significantly for the control group (males: 16.00 ± 4.04 to 15.14 ± 4.01 and for females: 16.00 ± 1.85 to 15.25 ± 1.98 before and after intervention but not for the intervention group (p > 0.05 (males: 16.25 ± 2.71 to 16.12 ± 2.94 and females: 12.85 ± 2.67 to 12.57 ± 2.93. The ADAS score on intervention experimental therapy group was significantly low (males: 39.00 ± 7.98 to 37.50 ± 8.12 and females: 49.85 ± 6.54 to 48.28 ± 6.79. In the Get up and Go test (males: 18.87 ± 5.24 to 17.87 ± 4.15 and

  15. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  16. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  17. Effects of 12 weeks of treatment with fermented milk on blood pressure, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Hove, K D; Brøns, C; Færch, K

    2015-01-01

    ) (n=23) or 300 ml artificially acidified milk (placebo yogurt) (n=18) for 12 weeks. BPs were measured over 24-h, and blood samples were collected in the fasting state and during a meal test before and after the intervention. RESULTS: Cardi04 yogurt did not reduce 24-h, daytime or nighttime systolic...... or diastolic BPs compared with placebo (P>0.05). Daytime and 24-h heart rate (HR) were significantly reduced in the group treated by Cardi04 yogurt compared with the placebo group (P

  18. Effects of 12-week Vegetarian Diet on the Nutritional Status, Stress Status and Bowel Habits in Middle School Students and Teachers.

    Science.gov (United States)

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran; Kye, Seung Hee; Park, Yoo Kyoung

    2016-04-01

    This study investigated the effect of switching normal diet to vegetarian diet rich in vegetables and fruits for school foodservice and home meal on the nutritional status, bowel habit improvement and stress reduction of teachers and adolescents. A total of 40 research subjects (26 students, 14 teachers) from one middle school voluntarily participated in the research. Questionnaire surveys and blood analysis were conducted before and after a 12-week vegetarian diet period. The participants were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m(2)) in the students (p students (p students and teachers (p stress level was reduced (p students and teachers classified as experiencing functional constipation was decreased respectively from 10 to 7, from 7 to 5. Based on the result, it is considered that the vegetarian diet rich in fruits and vegetables improved general health status of study subjects suggesting that such a dietary habit would substantially contribute to improving nutritional status and bowel habit.

  19. Effect of a 12-Week Summer Break on School Day Physical Activity and Health-Related Fitness in Low-Income Children from CSPAP Schools.

    Science.gov (United States)

    Fu, You; Brusseau, Timothy A; Hannon, James C; Burns, Ryan D

    2017-01-01

    Background . The purpose of this study was to examine the effect of a 12-week summer break on school day physical activity and health-related fitness (HRF) in children from schools receiving a Comprehensive School Physical Activity Program (CSPAP). Methods . Participants were school-aged children ( N = 1,232; 624 girls and 608 boys; mean age = 9.5 ± 1.8 years) recruited from three low-income schools receiving a CSPAP. Physical activity and HRF levels were collected during the end of spring semester 2015 and again during the beginning of fall semester 2015. Physical activity was assessed using the Yamax DigiWalker CW600 pedometer. HRF measures consisted of body mass index (BMI) and the Progressive Aerobic Cardiovascular Endurance Run (PACER). Results . Results from a doubly MANCOVA analysis indicated that pedometer step counts decreased from 4,929 steps in the spring to 4,445 steps in the fall (mean difference = 484 steps; P schools receiving a CSPAP intervention had lower levels of school day physical activity and cardiorespiratory endurance following a 12-week summer break.

  20. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Capozzi Lauren C

    2012-10-01

    Full Text Available Abstract Background Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck (HN cancer populations. This translates into a lack of clinical programming available for these patient populations. HN cancer patients deal with severe weight loss, with more than 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL, and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Our pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Methods/Design Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, we will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects, as well as return to work. Discussion This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical-activity and wellness-education model that can be implemented in other cancer centers. Trial registration Current Controlled Trials NCT01681654

  1. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia

    DEFF Research Database (Denmark)

    Stender, Steen; Budinski, Dragos; Gosho, Masahiko

    2013-01-01

    Aim: To compare the safety and efficacy of once-daily pitavastatin (1, 2, and 4 mg) and pravastatin (10, 20, and 40 mg) in elderly patients (≥65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia.Design: After a 6-8-week washout/dietary period, patients were...... randomized to six treatment groups (1, 2, or 4 mg pitavastatin vs. 10, 20, or 40 mg pravastatin) in a 12-week multicentre double-blind study. Patients (n = 942; men, 44.3%; Caucasian, 99.3%; mean age, 70 years; age range, 65-89 years) in all groups were well matched for duration of disease and diagnosis...... provides superior efficacy and comparable tolerability to pravastatin in elderly patients....

  2. Changes of Achilles tendon properties via 12-week PNF based robotic rehabilitation of ankle joints with spasticity and/or contracture.

    Science.gov (United States)

    Zhou, Zhihao; Zhou, Yuan; Wang, Ninghua; Gao, Fan; Wang, Long; Wei, Kunlin; Wang, Qining

    2014-01-01

    Ankle joint with spasticity and/or contracture can severely affect mobility and independence of stroke survivors. Due to that, the Achilles tendon(AT) is affected. In this paper, we aim to study changes of AT properties via proprioceptive neuromuscular facilitation (PNF) treatment. A robotic ankle-foot rehabilitation system has been proposed, which consists of a robotic ankle-foot platform and a graphic user interface. In this pilot study, two post-stroke patients participated and carried out a 12-week PNF treatment with the robotic system. The treatment is evaluated quantitatively in AT properties. The evaluation shows that after the PNF treatment, the average decrease of AT length is 4.1 mm (6.5%) and the recovery ratio is 30.4%, while the thickness has no change. The results indicate that the PNF based robotic rehabilitation for ankle joints with spasticity and/or contracture is effective to improve the ankle spasticity/contracture.

  3. Effects of a 12-week lifestyle intervention on health outcome and serum adipokines in middle-aged Korean men with borderline high blood pressure.

    Science.gov (United States)

    Kim, Eun Jin; Cho, Sang Woon; Kang, Ji Yeon; Choi, Tae In; Park, Yoo Kyoung

    2012-10-01

    High blood pressure, in relation to blood levels of adipokines such as adiponectin and leptin, is highly associated with an unhealthy lifestyle including sedentary behaviors, poor dietary habits such as excess sodium intake, and heavy drinking. Strategies to reduce blood pressure may benefit the levels of adipokines. Thus, we aimed to investigate the effects of lifestyle intervention on blood pressure and serum adipokines in middle-aged Korean men with borderline high blood pressure (systolic blood pressure [SBP] ≥ 130 mm Hg or diastolic blood pressure [DBP] ≥ 85 mm Hg). Fifty-two men (aged 42.5 ± 8.5 years) with normal weight (body mass index [BMI] sodium diet, how to understand calorie requirements, and strategies to implement regular exercise for blood pressure regulation over 12 weeks. In order to increase the awareness of sodium education, a salt sensory test using an unseasoned soup was performed. Anthropometrics, blood pressure measurements, 24-hour recalls were performed, and blood levels of lipids, fasting plasma glucose, C-reactive protein (CRP), leptin, and adiponectin were analyzed at week 0 and at week 12. Sodium consumption was roughly estimated using the Dish-based Frequency Questionnaire-15. Weight, BMI, body fat (kg and %), waist circumference, hip circumference, and blood pressure were significantly decreased after 12 weeks (p leptin were significantly higher in the obese subjects than in the normal weight subjects. In the obese subjects, a significantly negative correlation was found between leptin levels at baseline and percentage change in DBP (r = -0.338, p leptin was negatively associated with the changes in blood pressure after this short-term intervention.

  4. New approaches to the management of peripheral vertigo: efficacy and safety of two calcium antagonists in a 12-week, multinational, double-blind study.

    Science.gov (United States)

    Pianese, Carlo Pane; Hidalgo, Lourdes Olivia Vales; González, Ramón Hinojosa; Madrid, Cecilia Esteinou; Ponce, Jorge Enrique Cruz; Ramírez, Alberto Mañé; Morán, Luis Martínez; Arenas, José Enrique Poó; Rubio, Arturo Torres y Gutiérrez; Uribe, Jorge Olguin; Abiuso, José; Hanuch, Enrique; Alegría, Juan; Volpi, Claudio; Flaskamp, Renate; Sanjuán, Augusto Peñaranda; Gómez, Juan Manuel García; Hernández, Jaime; Pedraza, Alvaro; Quijano, Diana; Martínez, Carolina; Castañeda, Juan Ramón; Guerra, Oscar Jorge Cardeñosa; F, G Valencia

    2002-05-01

    To evaluate the efficacy and safety profile of one 30-mg nimodipine oral tablet taken three times per day (one tablet with breakfast, one with lunch, and one with dinner) or one 150-mg cinnarizine verum oral capsule taken once each day with dinner for 12 weeks. Comparative in a double-blind, multinational pilot study. Tertiary referral center. A total of 221 patients met the study criteria; of that total, 181 adult patients completed the study, including 135 women and 46 men whose ages ranged from 20 to 80 years. Two calcium antagonists were used to treat vertigo (nimodipine, 89 patients; cinnarizine, 92 patients), and all patients were maintained on the same dosage regimen until they completed 12 weeks of treatment. Patients were evaluated at 2-and 4-week intervals; an additional evaluation was made at Week 14 to determine vertigo recurrence in the posttreatment period. The response was evaluated by using the vertigo severity index, a count of vertigo episodes in a given time period. Each episode is weighted according to its intensity. Nimodipine treatment decreased the incidence of moderate vertigo episodes by 78.8% and decreased severe vertigo episodes by 85.0%. Cinnarizine treatment decreased the incidence of moderate vertigo episodes by 65.8% and decreased severe vertigo episodes by 89.8%. Nimodipine and cinnarizine exhibited similar safety profiles. Only two patients withdrew from the study because of adverse events possibly related to the study drug. One patient withdrew from the cinnarizine group because of headache, and one patient withdrew from the nimodipine group because of lipothymia. These data confirm the marked efficacy of both nimodipine and cinnarizine in the treatment of vestibular vertigo.

  5. Dentinal hypersensitivity: a 12-week study of a novel dentifrice delivery system comparing different brushing times and assessing the efficacy for hard-to-reach molar teeth.

    Science.gov (United States)

    Leight, R S; Sufi, F; Gross, R; Mason, S C; Barlow, A P

    2008-01-01

    This study was undertaken to confirm the efficacy of a novel 5% KNO3 gel-to-foam dentifrice, and to determine the effect of brushing duration on the relief offered from the novel dentifrice to subjects with sensitive molars. This was a randomized, examiner-blind, two-arm, parallel-group, 12-week, longitudinal study of 141 subjects, stratified into four groups based on the number of sensitive teeth ( or = 6) and the presence or absence of sensitive molars. Subjects brushed with the test product twice daily for either 45 seconds or two minutes for eight weeks, and then continued for four weeks with their regular dentifrice. At baseline, four, eight, and 12 weeks, subjects provided subjective evaluations of their sensitivity, and their sensitive teeth were stimulated by air and Yeaple probe. Both brushing groups and all four subgroups exhibited statistically significant reductions from baseline at each post-baseline visit in both their air and tactile sensitivity (p brushing groups for "maximum," "typical," and "minimum" subjective pain over the previous seven days (p brushing groups at any visit. For the subgroups with sensitive molars, there were significant decreases from baseline at each post-baseline visit, but no statistically significant differences between brushing groups. In the subgroups without sensitive molars, consistent reductions from baseline were only observed for "maximum" and "typical" pain levels, and at Week 4, the two-minute group had a statistically greater reduction in "minimum" pain level (p = 0.039). Both brushing groups and all four subgroups exhibited statistically significant reductions from baseline at each post-baseline visit in how much they were "bothered" by sensitivity in the previous week (p teeth. This study confirms that with this new dentifrice technology, the desensitizing efficacy from a 5% KNO3 dentifrice is independent of brushing duration.

  6. Incidence and Contributing Factors of Persistent Hyperglycemia at 6–12 Weeks Postpartum in Iranian Women with Gestational Diabetes: Results from LAGA Cohort Study

    Science.gov (United States)

    Jahanshahi, Alireza; Jahanfar, Shayesteh; Cheraghian, Bahman

    2017-01-01

    Background. A history of gestational diabetes is an important predictor of many metabolic disturbances later in life. Method. Life after gestational diabetes Ahvaz Study (LAGAs) is an ongoing population-based cohort study. Up to February 2016, 176 women with gestational diabetes underwent a 75 g oral glucose tolerance test (OGTT) at 6–12 weeks postpartum in Ahvaz (southwestern of Iran). Gestational diabetes was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria and the American Diabetes Association (ADA) criteria applied for diagnosis of postpartum prediabetes and diabetes. Univariate and multivariate regression analysis were done. Results. Overall incidence of early postpartum glucose intolerance was 22.2% (95% CI, 16.3–29.0), 17.6% prediabetes (95% CI, 12.3–24.1) and 4.5% diabetes (95% CI, 2.0–8.8%). Independent risk factors for glucose intolerance were FPG ≥ 100 at the time of OGTT (OR 3.86; 95% CI; 1.60–9.32), earlier diagnosis of GDM (OR 0.92; 95% CI; 0.88–0.97), systolic blood pressure (OR 1.02; 95% CI; 1.002–1.04), and insulin or metformin therapy (OR 3.14; 95% CI; 1.20–8.21). Conclusion. Results determined a relatively high rate of glucose intolerance at 6–12 weeks after GDM pregnancy. Early postpartum screening of type 2 diabetes is needed particularly in women at high risk of type 2 diabetes. PMID:28491872

  7. Benefits of a 12-week lifestyle modification program including diet and combined aerobic and resistance exercise on albuminuria in diabetic and non-diabetic Japanese populations.

    Science.gov (United States)

    Yamamoto-Kabasawa, Keiko; Hosojima, Michihiro; Yata, Yusuke; Saito, Mariko; Tanaka, Noriko; Tanaka, Junta; Tanabe, Naohito; Narita, Ichiei; Arakawa, Masaaki; Saito, Akihiko

    2015-12-01

    Albuminuria is a biomarker for chronic kidney disease and an independent predictor of cardiovascular and all-cause mortality. A recent meta-analysis concluded that these risks increase with urinary albumin concentration, even when below the microalbuminuria threshold. Thus, minimizing urinary albumin may be a valuable therapeutic goal regardless of disease status. We investigated the benefits and safety of a 12-week lifestyle modification program including diet and combined aerobic and resistance exercise for reducing albuminuria in 295 normoalbuminuric or microalbuminuric Japanese adults, including 30 with type 2 diabetes mellitus (T2DM), 104 with metabolic syndrome (MS), and 145 with hypertension (HT). In the study population, the urinary albumin:creatinine ratio (UACR) was reduced significantly (ΔUACR -3.8 ± 16.8 mg/g, P < 0.001) with no change in estimated glomerular filtration rate (eGFR) (ΔeGFR -0.4 ± 7.4 mL/min/1.73 m(2), P = 0.343). The reduction in UACR was associated with decreased fasting plasma glucose (P < 0.05). The UACR was also reduced in the T2DM, MS, and HT groups with no change in eGFR. Reduced UACR was associated with decreased fasting plasma glucose in the MS group and decreased systolic blood pressure in the HT group. The UACR was also reduced in 46 subjects using renin-angiotensin system inhibitors with no change in eGFR. Our 12-week lifestyle modification program reduced UACR, maintained eGFR, and improved multiple fitness findings in Japanese subjects including T2DM, MS, and HT patients.

  8. The Phytoestrogen Genistein Produces Similar Effects as 17β-Estradiol on Anxiety-Like Behavior in Rats at 12 Weeks after Ovariectomy

    Directory of Open Access Journals (Sweden)

    Juan Francisco Rodríguez-Landa

    2017-01-01

    Full Text Available The phytoestrogen genistein produces anxiolytic-like effects in ovariectomized rats, which highlights its potential therapeutic effect in ameliorating anxiety in surgical menopausal women. However, no studies have directly compared the effects of identical doses of genistein and 17β-estradiol, the main estrogen used in hormone replacement therapy in menopausal women. The present study evaluated the anxiolytic-like effects of identical doses of genistein and 17β-estradiol (0.045, 0.09, and 0.18 mg/kg/7 days, s.c. in a surgical menopause model in rats in the elevated plus maze and locomotor activity tests at 12 weeks after ovariectomy. Additionally, the participation of estrogen receptor-β in the anxiolytic-like effect of genistein and 17β-estradiol was explored by previous administration of the 5 mg/kg tamoxifen antagonist. Genistein and 17β-estradiol (0.09 and 0.18 mg/kg similarly reduced anxiety-like behavior in the elevated plus maze and also increased the time spent grooming and rearing, without affecting crossing in locomotor activity test. These effects were blocked by tamoxifen. Present results indicate that the phytoestrogen genistein has a similar behavioral profile as 17β-estradiol in rats at 12 weeks after ovariectomy through action at the estrogen receptor-β. Thus genistein has potential for reducing anxiety-like behavior associated with low concentrations of ovarian hormones, which normally occurs during natural and surgical menopause.

  9. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  10. Online video improves clinical outcomes in adults with atopic dermatitis: a randomized controlled trial.

    Science.gov (United States)

    Armstrong, April W; Kim, Randie H; Idriss, Nayla Z; Larsen, Larissa N; Lio, Peter A

    2011-03-01

    Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by intense pruritus that causes significant disease and psychosocial burden in patients. Patient education has the potential to improve clinical outcomes and patient knowledge of this condition. We sought to assess the effectiveness of online video education at improving AD knowledge and disease severity compared with a written pamphlet, and to determine the usefulness and appeal of the two educational delivery vehicles. In a randomized controlled trial, 80 participants were randomized to receive either online video-based patient education or written pamphlet education about AD and its management. We assessed AD disease severity using the patient-oriented eczema measure (POEM) scale. AD knowledge was assessed with standardized questionnaires at baseline and after the 12-week intervention. All participants had similar baseline knowledge and AD severity at the beginning of the study. On study completion, improvements in AD knowledge assessed by questionnaire were significantly greater in the video group than the pamphlet group (3.05 vs 1.85, P = .011). Online video-based education resulted in greater improvement in clinical outcome, as measured by POEM, compared with pamphlet-based education (POEM score reduction of 3.30 vs 1.03, P = .0043). Finally, although the usefulness of both interventions was rated equally (P = .77), the online video was significantly more appealing than the pamphlet (P = .0086). This study is limited to AD in adults. Online video for patient education is an effective and appealing tool for improving clinical outcomes in adult patients with AD. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  11. The effects of a 12-week program of static upper extremity weight bearing exercises on weight bearing in children with hemiplegic type of cerebral palsy

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    P. Jayaraman

    2010-02-01

    Full Text Available The  major  objective  of  this  study  was  to  quantify  the  effects  of a  12-week  program  of  weight  bearing  exercises  on  weight  borne  through  the hand and grip pressures in children with hemiplegic cerebral palsy. This study also sought to monitor the change in spasticity immediately following weight-bearing  exercises.  A  quasi-experimental,  one  group  pre-test,  post-test  study  was used. Eleven children with hemiplegic type of cerebral palsy from a special school in KwaZulu Natal participated after fully informed written consent. The intervention consisted of a 12-week program of weight bearing. The Tekscan Grip system was used to quantify weight borne through the hand during extended arm prone and quadruped positions and whilst holding a pencil and a tumbler. The modified Ashworth grading of spasticity was used to monitor spasticity. The data was analysed using the random effects GLS model Wald Chi Square test. Significant increases in contact pressure in extended arms prone (p=0,012 and quadruped (p=0,002 and when holding a pencil (p=0,045 was noted post-test compared to pre-test. Significant increases in contact area of the hand was also noted in prone (p=0,000, quadruped (p=0, 03 at assessment 7 and when holding a pencil (p=0,035.  A significant decrease in spasticity during elbow extension (p=0,004, and wrist flexion (p=0,026 and extension (p=0,004 was noted. An overall significant effect of static weight bearing exercises on weight borne through the hands, grip strength and spasticity justifies the use of static weight-bearing in therapy.

  12. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty.

    Science.gov (United States)

    Brach, Jennifer S; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A; VanSwearingen, Jessie M

    2015-03-01

    To test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Single-blinded randomized clinical trial. University research laboratory. Adults (N=40) aged ≥65 years with gait speed >1.0m/s and impaired motor skill (figure-of-8 walk time >8s). The 2 interventions included a task-oriented motor learning and a standard exercise program; both interventions included strength training. Both lasted 12 weeks, with twice-weekly, 1-hour, physical therapist-supervised sessions. Two measures of the motor control of gait, gait variability and smoothness of walking, were assessed pre- and postintervention by assessors masked to the treatment arm. Of 40 randomized subjects, 38 completed the trial (mean age ± SD, 77.1±6.0y). The motor learning group improved more than the standard group in double-support time variability (.13m/s vs .05m/s; adjusted difference [AD]=.006, P=.03). Smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions (usual: AD=.53, P=.05; narrow: AD=.56, P=.01; dual task: AD=.57, P=.04). Smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path (AD=.71, P=.01) and dual-task (AD=.89, P=.01) conditions. Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  13. Dairy Food Consumption and Meal-Induced Cortisol Response Interacted to Influence Weight Loss in Overweight Women Undergoing a 12-Week, Meal-Controlled, Weight Loss Intervention1234

    OpenAIRE

    Witbracht, Megan G.; Loan, Marta Van; Adams, Sean H.; Keim, Nancy L.; Laugero, Kevin D.

    2012-01-01

    Dairy food enhances weight loss in animal models, possibly by modifying the metabolic effects of cortisol. This study determined in overweight women (ages 20.0–45.9 y; n = 51) whether including dairy food in an energy-restricted diet affects cortisol concentrations and whether differences in provoked cortisol explain the magnitude of weight loss. Women received either an adequate amount of dairy food (AD), the equivalent of ≥711 mL/d milk, or a low amount of dairy food (LD), the equivalent to...

  14. Dairy Food Consumption and Meal-Induced Cortisol Response Interacted to Influence Weight Loss in Overweight Women Undergoing a 12-Week, Meal-Controlled, Weight Loss Intervention1234

    Science.gov (United States)

    Witbracht, Megan G.; Van Loan, Marta; Adams, Sean H.; Keim, Nancy L.; Laugero, Kevin D.

    2013-01-01

    Dairy food enhances weight loss in animal models, possibly by modifying the metabolic effects of cortisol. This study determined in overweight women (ages 20.0–45.9 y; n = 51) whether including dairy food in an energy-restricted diet affects cortisol concentrations and whether differences in provoked cortisol explain the magnitude of weight loss. Women received either an adequate amount of dairy food (AD), the equivalent of ≥711 mL/d milk, or a low amount of dairy food (LD), the equivalent to ≤238 mL/d milk, in a 12-wk, energy-restricted dietary intervention. Participants were tested in a 12-h laboratory visit, which included 2 standard meals and a dinner buffet that was consumed ad libitum. Salivary cortisol was measured from waking to bedtime. Energy restriction increased (P ≤ 0.04) the minimum and decreased (P ≤ 0.02) the diurnal amplitude in the salivary cortisol concentration from baseline to postintervention. Energy restriction enhanced the dinner meal–stimulated salivary cortisol response (DMR) (P ≤ 0.02) but only in the LD group. Compared with the LD treatment, the AD treatment induced (P ≤ 0.04) greater reductions in body weight and fat, but only in women characterized as having a baseline DMR (responders) (n = 26); weight and fat lost in the AD and LD groups were similar in nonresponders (n = 25). Overall, energy restriction dampened diurnal salivary cortisol fluctuations [symptomatic of hypothalamic-pituitary-adrenal (HPA) axis dysfunction] and enhanced dinner meal–stimulated salivary cortisol concentrations. The AD treatment prevented the latter. Furthermore, certain phenotypic markers of HPA axis function may help to expose the weight-reducing effects of consuming dairy food. PMID:23190756

  15. Dairy food consumption and meal-induced cortisol response interacted to influence weight loss in overweight women undergoing a 12-week, meal-controlled, weight loss intervention.

    Science.gov (United States)

    Witbracht, Megan G; Van Loan, Marta; Adams, Sean H; Keim, Nancy L; Laugero, Kevin D

    2013-01-01

    Dairy food enhances weight loss in animal models, possibly by modifying the metabolic effects of cortisol. This study determined in overweight women (ages 20.0-45.9 y; n = 51) whether including dairy food in an energy-restricted diet affects cortisol concentrations and whether differences in provoked cortisol explain the magnitude of weight loss. Women received either an adequate amount of dairy food (AD), the equivalent of ≥711 mL/d milk, or a low amount of dairy food (LD), the equivalent to ≤238 mL/d milk, in a 12-wk, energy-restricted dietary intervention. Participants were tested in a 12-h laboratory visit, which included 2 standard meals and a dinner buffet that was consumed ad libitum. Salivary cortisol was measured from waking to bedtime. Energy restriction increased (P ≤ 0.04) the minimum and decreased (P ≤ 0.02) the diurnal amplitude in the salivary cortisol concentration from baseline to postintervention. Energy restriction enhanced the dinner meal-stimulated salivary cortisol response (DMR) (P ≤ 0.02) but only in the LD group. Compared with the LD treatment, the AD treatment induced (P ≤ 0.04) greater reductions in body weight and fat, but only in women characterized as having a baseline DMR (responders) (n = 26); weight and fat lost in the AD and LD groups were similar in nonresponders (n = 25). Overall, energy restriction dampened diurnal salivary cortisol fluctuations [symptomatic of hypothalamic-pituitary-adrenal (HPA) axis dysfunction] and enhanced dinner meal-stimulated salivary cortisol concentrations. The AD treatment prevented the latter. Furthermore, certain phenotypic markers of HPA axis function may help to expose the weight-reducing effects of consuming dairy food.

  16. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women

    OpenAIRE

    Cargo Margaret; McDermott Robyn A; Canuto Karla J; Esterman Adrian J

    2011-01-01

    Abstract Background Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC) have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challe...

  17. Aloe sterol supplementation improves skin elasticity in Japanese men with sunlight-exposed skin: a 12-week double-blind, randomized controlled trial [Corrigendum

    Directory of Open Access Journals (Sweden)

    Tanaka M

    2016-12-01

    Full Text Available Tanaka M, Yamamoto Y, Misawa E, et al. Clin Cosmet Investig Dermatol. 2016;9:435–442.On page 438, Figure 1, the y-axis title should have read “ΔR2 (%” instead of “ΔR5 (%”.On page 439, Figure 2, the y-axis title should have read “ΔR5 (%” instead of “ΔR7 (%”.Read the original article here.

  18. Comparative effect of 12 weeks of slow and fast pranayama training on pulmonary function in young, healthy volunteers: A randomized controlled trial

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    T Dinesh

    2015-01-01

    Conclusion: Twelve weeks of pranayama training in young subjects showed improvement in the commonly measured PFT. This indicates that pranayama training improved pulmonary function and that this was more pronounced in the FPG.

  19. Dairy food consumption and meal-induced cortisol response interact to influence weight loss in overweight women undergoing a 12-week meal-controlled weight loss intervention

    Science.gov (United States)

    Dairy foods enhance weight loss in animal models possibly by modifying the metabolic effects of cortisol. This study aimed to determine in overweight women (ages 20-45; n=51) whether inclusion of dairy foods in an energy-restricted diet affects basal and stimulated cortisol concentrations, and whet...

  20. Reduced plasma glucose and leptin after 12 weeks of functional electrical stimulation-rowing exercise training in spinal cord injury patients.

    Science.gov (United States)

    Jeon, Justin Y; Hettinga, Dries; Steadward, Robert D; Wheeler, Garry D; Bell, Gordon; Harber, Vicki

    2010-12-01

    To investigate the effects of exercise training with a functional electrical stimulation (FES) rowing machine on insulin resistance, plasma leptin levels, and body composition in people with spinal cord injury (SCI). Experimental study. A fitness and research center for people with disabilities. Healthy male participants with paraplegia (N=6) participated in the study (mean age, 48.6±6y; mean weight, 70.06±3.28kg; injury levels between T4-5 and T10). Twelve weeks of FES-rowing exercise training 3 to 4 times a week (600-800kcal). Peak oxygen consumption, plasma leptin, insulin, and glucose levels, insulin sensitivity, body composition. Twelve weeks of FES-rowing training improved aerobic fitness significantly (P=.048). In addition, plasma glucose and leptin levels were significantly decreased after exercise training by 10% and 28% (P<.028), respectively. A trend toward fat mass reduction was seen in 4 of the 6 subjects; this change did not reach statistical significance (P=.08). A 12-week training program that included FES rowing improved aerobic fitness and fasting glucose and leptin levels in the absence of significant change to body composition, fasting insulin levels, or calculated insulin sensitivity in people with SCI. Copyright © 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  1. Influence of 12 weeks of jogging on magnetic resonance-determined left ventricular characteristics in previously sedentary subjects free of cardiovascular disease.

    Science.gov (United States)

    Sipola, Petri; Heikkinen, Jari; Laaksonen, David E; Kettunen, Raimo

    2009-02-15

    Hypertrophy of the left ventricle is a diagnostic dilemma in subjects who engage in regular endurance exercise. We studied prospectively whether endurance training in previously sedentary young and middle-aged men and women can alter left ventricular (LV) characteristics. We recruited 33 healthy young and middle-aged subjects (18 women, 15 men, ages 21 to 59 years) to undergo 12 weeks of home-based brisk walking and jogging at a target heart rate > or =120 beats/min for > or =30 minutes 3 times a week. LV characteristics were measured by cine magnetic resonance imaging. Training intensity as estimated by heart rate correlated positively with the increase in LV myocardial area (r = 0.51, p = 0.005) in the 28 men and women completing the study. In the 13 men and women who trained with heart rate of > or =120 beats/min, LV myocardial area was larger after than before training (17.7 +/- 2.9 vs 16.8 +/- 2.8 cm(2), p intensity (p moderate-to-vigorous endurance training at moderate volumes does not influence LV end-diastolic volume or ejection fraction, but has a minor influence on LV hypertrophy in previously sedentary young and middle-aged men and women.

  2. The first 12 weeks following discharge from hospital: the experience of Gujarati South Asian survivors of acute myocardial infarction and their families.

    Science.gov (United States)

    Webster, Rosemary A; Thompson, David R; Davidson, Patricia M

    2003-10-01

    The period following discharge from hospital after an acute myocardial infarction (MI) is associated with vulnerability and psychosocial and physical morbidity for many survivors and their families. It is reported that people experience interpersonal, family and financial problems, self-care obstacles, work and physical difficulties. Culture and ethnicity undeniably influence the illness experience and the process of recovery and adjustment. This study investigated the perceptions of Gujarati survivors of acute MI and their families in Leicester, United Kingdom in the first 12 weeks following discharge in order to develop a profile of their health seeking beliefs and needs. Thirty-one interviews with 19 Gujarati MI survivors and their families (representing approximately 31 hours of dialogue) were analysed using grounded theory. Qualitative data revealed a period of vulnerability not only for survivors but also their families as they processed recent events and faced the future. Data analysis revealed nine interrelated themes describing the post-discharge experience for Gujarati survivors and their families. Data revealed that normal life was often markedly changed by the MI experience. Reflection, contemplation and resignation characterize this period of vulnerability. Overwhelmingly, data analysis revealed that the Gujarati culture, beliefs and customs influenced the recovery experience.

  3. Assessing the Utility of Low-Cost Particulate Matter Sensors over a 12-Week Period in the Cuyama Valley of California.

    Science.gov (United States)

    Mukherjee, Anondo; Stanton, Levi G; Graham, Ashley R; Roberts, Paul T

    2017-08-05

    The use of low-cost air quality sensors has proliferated among non-profits and citizen scientists, due to their portability, affordability, and ease of use. Researchers are examining the sensors for their potential use in a wide range of applications, including the examination of the spatial and temporal variability of particulate matter (PM). However, few studies have quantified the performance (e.g., accuracy, precision, and reliability) of the sensors under real-world conditions. This study examined the performance of two models of PM sensors, the AirBeam and the Alphasense Optical Particle Counter (OPC-N2), over a 12-week period in the Cuyama Valley of California, where PM concentrations are impacted by wind-blown dust events and regional transport. The sensor measurements were compared with observations from two well-characterized instruments: the GRIMM 11-R optical particle counter, and the Met One beta attenuation monitor (BAM). Both sensor models demonstrated a high degree of collocated precision (R² = 0.8-0.99), and a moderate degree of correlation against the reference instruments (R² = 0.6-0.76). Sensor measurements were influenced by the meteorological environment and the aerosol size distribution. Quantifying the performance of sensors in real-world conditions is a requisite step to ensuring that sensors will be used in ways commensurate with their data quality.

  4. Effects of 12-Week Endurance Training at Natural Low Altitude on the Blood Redox Homeostasis of Professional Adolescent Athletes: A Quasi-Experimental Field Trial

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    Tomas K. Tong

    2016-01-01

    Full Text Available This field study investigated the influences of exposure to natural low altitude on endurance training-induced alterations of redox homeostasis in professional adolescent runners undergoing 12-week off-season conditioning program at an altitude of 1700 m (Alt, by comparison with that of their counterparts completing the program at sea-level (SL. For age-, gender-, and Tanner-stage-matched comparison, 26 runners (n=13 in each group were selected and studied. Following the conditioning program, unaltered serum levels of thiobarbituric acid reactive substances (TBARS, total antioxidant capacity (T-AOC, and superoxide dismutase accompanied with an increase in oxidized glutathione (GSSG and decreases of xanthine oxidase, reduced glutathione (GSH, and GSH/GSSG ratio were observed in both Alt and SL groups. Serum glutathione peroxidase and catalase did not change in SL, whereas these enzymes, respectively, decreased and increased in Alt. Uric acid (UA decreased in SL and increased in Alt. Moreover, the decreases in GSH and GSH/GSSG ratio in Alt were relatively lower compared to those in SL. Further, significant interindividual correlations were found between changes in catalase and TBARS, as well as between UA and T-AOC. These findings suggest that long-term training at natural low altitude is unlikely to cause retained oxidative stress in professional adolescent runners.

  5. The Effect of a 12-Week Moderate Intensity Interval Training Program on the Antioxidant Defense Capability and Lipid Profile in Men Smoking Cigarettes or Hookah: A Cohort Study

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    Abdessalem Koubaa

    2015-01-01

    Full Text Available Aim. To examine the impact of interval training program on the antioxidant defense capability and lipid profile in men smoking cigarettes or hookah unable or unwilling to quit smoking. Methods. Thirty-five participants performed an interval training (2 : 1 work : rest ratio 3 times a week for 12 weeks at an intensity of 70% of VO2max. All subjects were subjected to a biochemical test session before and after the training program. Results. The increase of total antioxidant status (TAS, glutathione peroxidase (GPx, and α-tocopherol, is significant only for cigarette smokers (CS and hookah smokers (HS groups. The decrease of malondialdehyde (MDA and the increase of glutathione reductase (GR are more pronounced in smokers groups compared to those of nonsmokers (NS. Superoxide dismutase (SOD increases in NS, CS, and HS groups by 10.1%, 19.5%, and 13.3%, respectively (P<0.001. Likewise, a significant improvement of high-density lipoprotein cholesterol (HDL-C and TC/HDL-C ratio was observed in CS and HS groups (P<0.05. Conclusion. Although the interval training program does not have a significant effect on blood lipid levels, it seems to be very beneficial in the defense and prevention programs of oxidative stress.

  6. 21 CFR 862.3280 - Clinical toxicology control material.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical toxicology control material. 862.3280 Section 862.3280 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test...

  7. Crossover clinical investigation of a whitening chewing gum for inhibiting dental stain formation in conjunction with tooth brushing.

    Science.gov (United States)

    Milleman, Jeffery L; Milleman, Kimberly R; Kleber, Carl J; Proskin, Howard M; Dodds, Michael; Kelley, Michael; Ramirez, Lilian

    2014-01-01

    The purpose of this clinical investigation was to evaluate the effectiveness of a marketed whitening chewing gum compared to a no-gum control in preventing the formation of extrinsic stains on the teeth of stain-forming subjects when chewed over a 12-week period of regular unsupervised use in conjunction with daily tooth brushing. This was a single-center, examiner-blind, randomized, 12-week crossover clinical trial. Stain-forming (after smoking or drinking coffee or tea) adults, starting with a stain-free baseline, either chewed the test gum (Orbit White) unsupervised four times per day, 15 minutes/chew, or used no gum along with daily brushing with a commercially available toothbrush and dentifrice for 12 weeks. At the crossover, all procedures were repeated with subjects assigned the opposite treatment. Extrinsic stain was measured at six and 12 weeks by both the Lobene Stain Index (LSI) and the Modified Lobene Stain Index (MLSI) using separate experienced examiners. After 12 weeks, LSI stain scores showed a significant 25% reduction (p = 0.0008) in new stain formation for subjects using the test chewing gum along with tooth brushing versus tooth brushing alone (no-gum control). The corresponding MLSI stain scores demonstrated a 36% reduction (p teeth. The overall findings of this clinical study demonstrated that regular use of Orbit White chewing gum, soon after smoking or drinking coffee or tea, will supplement daily tooth brushing in preventing unsightly stains from forming on the anterior teeth compared to brushing alone.

  8. Disagreement between therapist raters and independent evaluators in a controlled clinical trial of interpersonal psychotherapy for depressed pregnant women.

    Science.gov (United States)

    Spinelli, Margaret G; Endicott, Jean; Goetz, Raymond R

    2015-03-01

    The randomized controlled trial in which both the patient and the treating clinician are kept blinded to the treatment is the "gold standard" for treatment research assignment. However, in psychotherapy research, evaluations can only be single blind; thus, such studies are inherently more limited. A 12-week, bilingual, parallel-design, controlled clinical treatment trial compared interpersonal psychotherapy for antepartum depression (IPT-P) with a parenting education program (PEP) provided to a control group. An outpatient sample of 142 women who met DSM-IV criteria for major depressive disorder was randomly assigned to IPT-P or PEP between September 2005 and May 2011. Only 110 cases were assessed at baseline and had at least 1 other treatment week of paired ratings by a therapist and a blinded independent evaluator (IE). The 17-item Hamilton Depression Rating Scale and the Clinical Global Impressions Scale were administered weekly by a therapist and every 4 weeks by a blinded IE. We examined cross-informant agreement on ratings of mood and global improvement and severity. Nonblinded therapists consistently rated the IPT-P treatment group as more improved than the PEP control group throughout treatment, whereas the ratings by the blinded IE were significantly higher than the therapist ratings, indicating less improvement in the IPT-P group compared with the control group. The ratings suggest that rater bias may have caused the therapist raters to perceive subjects as more improved because of the expectation that IPT-P would be more effective than the PEP control condition. Ratings in psychotherapy research must be made by anonymous participation in treatment and an independent clinical evaluator who is blind to all therapy.

  9. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    Directory of Open Access Journals (Sweden)

    Myers JS

    2014-03-01

    Full Text Available Jonathan S Myers,1 Steven Vold,2 Fiaz Zaman,3 Julia M Williams,4 David A Hollander41Wills Eye Hospital, Philadelphia, PA, USA; 2Vold Vision, PLLC, Bentonville, AR, USA; 3Houston Eye Associates, Houston, TX, USA; 4Allergan, Inc., Irvine, CA, USABackground: The purpose of this study was to evaluate the intraocular pressure (IOP-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma.Methods: Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily. Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03% are presented.Results: Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957. In both treatment arms, mean (± standard error of the mean reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001, ranging from 3.7±0.4 (17.0% mmHg to 4.4±0.4 (19.9% mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8% mmHg to 3.9±0.5 (16.7% mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival

  10. Applying Statistical Process Control to Clinical Data: An Illustration.

    Science.gov (United States)

    Pfadt, Al; And Others

    1992-01-01

    Principles of statistical process control are applied to a clinical setting through the use of control charts to detect changes, as part of treatment planning and clinical decision-making processes. The logic of control chart analysis is derived from principles of statistical inference. Sample charts offer examples of evaluating baselines and…

  11. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    Science.gov (United States)

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P nutritional intervention promoting the adoption of the Mediterranean diet and based on the SDT led to greater improvements in dietary intakes in men than in women, which appear to have contributed to beneficial anthropometric and metabolic changes, more particularly in men. However, the more deteriorated metabolic profile found in men at baseline seems to contribute to a large extent to the more beneficial changes in CVD risk factors observed in men as compared with women.

  12. Patterns of Change in Weekend Drinking Cognitions Among Non–Treatment-Seeking Young Adults During Exposure to a 12-Week Text Message Intervention

    Science.gov (United States)

    Suffoletto, Brian; Chung, Tammy

    2016-01-01

    Objective: We sought to identify patterns of response (latent classes) to a text-message (short message service) intervention based on weekend drinking cognitions (e.g., drinking plans, commitment to a low consumption goal), and to examine how the latent classes differed in baseline characteristics and alcohol consumption outcomes. Method: We conducted a secondary analysis of 384 non–treatment seeking young adults with hazardous alcohol use randomly assigned to a 12-week short message service intervention. Responses to weekly short message service queries related to weekend drinking cognitions were categorized as (a) planned not to drink, (b) planned to drink but did not plan a heavy drinking episode (HDE), (c) planned to have an HDE but willing to limit alcohol consumption, (d) planned to have an HDE and not willing to limit alcohol consumption We used repeated-measures latent class analysis to identify distinct classes based on these categories and examined associations of the classes with baseline covariates and alcohol consumption outcomes through 6 months. Results: We identified the following three latent classes: planned not to drink (62%), willing to limit drinks (27%), and not willing to limit drinks (12%). The “not willing to limit drinks” class exhibited the least reductions in alcohol consumption and was more likely to include White individuals and those with higher baseline drinking severity. The “planned not to drink” class had the greatest reductions in alcohol consumption. Conclusions: Young adults who exhibited low likelihood of committing to goals to limit weekend drinking were less responsive to short message service intervention, suggesting the need for alternative interventions. PMID:27797693

  13. Modest weight loss through a 12-week weight management program with behavioral modification seems to attenuate inflammatory responses in young obese Koreans.

    Science.gov (United States)

    Lee, AeJin; Jeon, Kyeong Jin; Kim, Min Soo; Kim, Hye-Kyeong; Han, Sung Nim

    2015-04-01

    Obesity has been reported to impair immune functions and lead to low-grade long-term inflammation; however, studies that have investigated the impact of weight loss on these among the young and slightly obese are limited. Thus, we investigated the effect of a 12-week weight management program with behavioral modifications on cell-mediated immune functions and inflammatory responses in young obese participants. Our hypothesis was that weight loss would result in improved immune functions and decreased inflammatory responses. Sixty-four participants (45 obese and 19 normal weight) finished the program. Obese (body mass index ≥25) participants took part in 5 group education and 6 individual counseling sessions. Normal-weight (body mass index 18.5-23) participants only attended 6 individual sessions. The goal for the obese was to lose 0.5 kg/wk by reducing their intake by 300 to 500 kcal/d and increasing their physical activity. Program participation resulted in a modest but significant decrease in weight (2.7 ± 0.4 kg, P obese. In the obese group, increase in phytohemagglutinin-stimulated interleukin-10 production, a TH2 and anti-inflammatory cytokine, approached significance after program participation (from 6181 ± 475 to 6970 ± 632 pg/mL, P = .06). No significant changes in proliferative responses to the optimal concentration of concanavalin A or phytohemagglutinin were observed in the obese after program participation. Collectively, modest weight loss did not change the cell-mediated immune functions significantly but did attenuate the inflammatory response in young and otherwise healthy obese adults. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  15. A 12-week pilot study of acceptance of a computer-based chronic disease self-monitoring system among patients with type 2 diabetes mellitus and/or hypertension.

    Science.gov (United States)

    Yan, Mian; Or, Calvin

    2017-08-01

    This study tested a structural model examining the effects of perceived usefulness, perceived ease of use, attitude, subjective norm, perceived behavioral control, health consciousness, and application-specific self-efficacy on the acceptance (i.e. behavioral intention and actual usage) of a computer-based chronic disease self-monitoring system among patients with type 2 diabetes mellitus and/or hypertension. The model was tested using partial least squares structural equation modeling, with 119 observations that were obtained by pooling data across three time points over a 12-week period. The results indicate that all of the seven constructs examined had a significant total effect on behavioral intention and explained 74 percent of the variance. Also, application-specific self-efficacy and behavioral intention had a significant total effect on actual usage and explained 17 percent of the variance. This study demonstrates that technology acceptance is determined by patient characteristics, technology attributes, and social influences. Applying the findings may increase the likelihood of acceptance.

  16. Safety and efficacy of exercise training in adults with Pompe disease: evalution of endurance, muscle strength and core stability before and after a 12 week training program.

    Science.gov (United States)

    van den Berg, Linda E M; Favejee, Marein M; Wens, Stephan C A; Kruijshaar, Michelle E; Praet, Stephan F E; Reuser, Arnold J J; Bussmann, Johannes B J; van Doorn, Pieter A; van der Ploeg, Ans T

    2015-07-19

    Pompe disease is a proximal myopathy. We investigated whether exercise training is a safe and useful adjuvant therapy for adult Pompe patients, receiving enzyme replacement therapy. Training comprised 36 sessions of standardized aerobic, resistance and core stability exercises over 12 weeks. Before and after, the primary outcome measures safety, endurance (aerobic exercise capacity and distance walked on the 6 min walk test) and muscle strength, and secondary outcome measures core stability, muscle function and body composition, were evaluated. Of 25 patients enrolled, 23 successfully completed the training. Improvements in endurance were shown by increases in maximum workload capacity (110 W before to 122 W after training, [95 % CI of the difference 6 · 0 to 19 · 7]), maximal oxygen uptake capacity (69 · 4 % and 75 · 9 % of normal, [2 · 5 to 10 · 4]), and maximum walking distance (6 min walk test: 492 meters and 508, [-4 · 4 to 27 · 7] ). There were increases in muscle strength of the hip flexors (156 · 4 N to 180 · 7 N [1 · 6 to 13 · 6) and shoulder abductors (143 · 1 N to 150 · 7 N [13 · 2 to 35 · 2]). As an important finding in secondary outcome measures the number of patients who were able to perform the core stability exercises rose, as did the core stability balancing time (p climb four steps (2 · 4 sec to 2 · 1, [- 0 · 54 to -0 · 04 ]) and rise to standing position (5 · 8 sec to 4 · 8, [-2 · 0 to 0 · 0]), while time to run, the quick motor function test results and body composition remained unchanged. Our study shows that a combination of aerobic, strength and core stability exercises is feasible, safe and beneficial to adults with Pompe disease.

  17. Analysis of inflammatory periimplant lesions during a 12-week period of undisturbed plaque accumulation--a comparison between flapless and flap surgery in the mini-pig.

    Science.gov (United States)

    Mueller, Cornelia K; Thorwarth, Michael; Schultze-Mosgau, Stefan

    2012-04-01

    This study's aim was to clarify the influence of soft tissue management on the development of periimplant infection. Four weeks after removal of all maxillary premolars in 12 mini-pigs, four BEGO Semados RI implants were inserted in each maxillary quadrant. Employing a split-mouth design, one quadrant was randomized to flapless insertion while the contralateral side was chosen for flap surgery. Following 1, 2, 4 and 12 weeks of transmucosal implant, healing biopsies were retrieved from the periimplant soft tissue and subjected to further analysis. Histomorphometrically, a significant reduction of transmigration of polymorphonuclear neutrophils (week 1, p = 0.007; week 2, p = 0.021; week 4, p = 0.023; week 12, p = 0.013) as well as the density of the subepithelial inflammatory infiltrates (week 1, p = 0.007; week 2, p = 0.046; week 4, p = 0.003; week 12, p = 0.032) was verified following flapless surgery. Quantification of inducible nitric oxide synthase showed significantly reduced expression in the flapless group 2 (p = 0.027), 4 (p = 0.005) and 12 (p = 0.004) weeks post-insertion. Analysis of CD31 and collagen I immunostained sections revealed more regular capillary distribution as well as higher vessel and collagen density in the flapless group. The data of the present study indicate that flapless placement reduces the incidence of inflammatory periimplant soft tissue lesions during a 12-week period. Considering the beneficial effects of flapless placement on early soft tissue healing and stability, the technique might be preferred in case of an uncomplicated locoregional anatomy with sufficient hard and soft tissue. However, this positive effect might disappear after manipulation of the implant and soft tissue during impression taking or try in of the prosthodontic supraconstruction.

  18. Tratamento cognitivo-comportamental de grupo na fobia social: resultados de 12 semanas Cognitive-behavioral group treatment in social phobia: 12-week outcome

    Directory of Open Access Journals (Sweden)

    Gustavo J. Fonseca D'El Rey

    2008-01-01

    Full Text Available CONTEXTO: A fobia social é um dos transtornos mentais mais prevalentes na população geral. A terapia cognitivo-comportamental é o modelo não-farmacológico mais estudado nesse transtorno de ansiedade. OBJETIVOS: Este estudo teve como objetivo verificar a efetividade da terapia cognitivo-comportamental de grupo em pacientes com fobia social generalizada. MÉTODOS: Trinta e um pacientes com diagnóstico de fobia social generalizada foram randomicamente distribuídos em dois grupos: um de terapia cognitivo-comportamental de grupo - TCCG (n = 15 e um grupo-controle na Lista de Espera - LE (n = 16. Os pacientes preencheram quatro escalas de avaliação (Inventário de Fobia Social, Escala de Medo de Avaliação Negativa, Inventário de Ansiedade Beck e Escala de Impressão Clínica Global na semana 1 de tratamento e na semana 12. RESULTADOS: Em todas as medidas de avaliações, ao final de 12 semanas, os pacientes que receberam TCCG apresentaram melhoras superiores aos da LE. CONCLUSÕES: Neste ensaio clínico randomizado, simples-cego, a terapia cognitivo-comportamental de grupo foi superior à Lista de Espera no tratamento da fobia social generalizada.BACKGROUND: Social phobia is a widespread mental disorder in the general population. Cognitive-behavioral therapy is the most thoroughly studied nonpharmacologic approach in this anxiety disorder. OBJECTIVES: The aim of this study is to assess the effectiveness of cognitive-behavioral group therapy in patients with generalized social phobia. METHODS: Thirty one patients with diagnosis of generalized social phobia were randomly allocated in two groups. One group of cognitive-behavioral group therapy - CBGT (n = 15 and one Waiting List control group - WL (n = 16. The patients completed four rating scales (Social Phobia Inventory, Fear of Negative Evaluation Scale, Beck Anxiety Inventory and Clinical Global Impression Scale in the weeks 1 and 12. RESULTS: In all rating scales in the week 12 of

  19. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Thomas L. Sevier

    2015-05-01

    Full Text Available Introduction. Patients with chronic lateral elbow (LE tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1 to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE for patients with chronic LE tendinopathy, and (2 to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment.Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities.Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows or EE treatment (56 elbows. Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments.Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047 and in maximum grip strength (p = 0.008 than EE subjects. Astym therapy also resolved 20/21 (95.7% of the EE non-responders, who showed improvements in DASH scores (p < 0.005, pain with activity (p = 0.002, and function (p = 0.004 following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported.Conclusion. This study

  20. Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Moghtaderi, Alireza; Sajadiyeh, Sepideh; Khosrawi, Saeid; Dehghan, Farnaz; Bateni, Vahid

    2013-01-01

    Rotator cuff disease is a common cause of shoulder pain. There are studies about the effectiveness of sodium hyaluronate injection on shoulder and knee pain, but few studies demonstrating the efficacy of sodium hyaluronate ultrasonography guided injection for rotator cuff disease. This study evaluates effectiveness of ultrasonography guided subacromial sodium hyaluronate injection in patients with impingment syndrome without rotator cuff complete tear. This prospective, double-blind, placebo controlled clinical trial study was performed among 40 patients with subacromial impingement syndrome without complete tear of rotator cuff. Patients randomly injected ultrasonography guided in 2 groups: Case group by 20 mg of sodium hyaluronate (Fermathron™) and control group by 0.9% normal saline. Both groups received 3 weekly injections. The pain score (100 mm visual analogue score [VAS]) was evaluated before first injection and one week after each injection. The constant score was evaluated before first and 12 week after last injection. Data was analyzed statistically by Independent t-test. In both groups mean VAS has decreased, but more significantly in case group (P hyaluronate are effective in treating rotator cuff disease without complete tears.

  1. Bed Bugs: Clinical Relevance and Control Options

    Science.gov (United States)

    Dwyer, Dominic E.; Peñas, Pablo F.; Russell, Richard C.

    2012-01-01

    Summary: Since the late 1990s, bed bugs of the species Cimex lectularius and Cimex hemipterus have undergone a worldwide resurgence. These bed bugs are blood-sucking insects that readily bite humans. Cutaneous reactions may occur and can start out as small macular lesions that can develop into distinctive wheals of around 5 cm in diameter, which are accompanied by intense itching. Occasionally, bullous eruptions may result. If bed bugs are numerous, the patient can present with widespread urticaria or eythematous rashes. Often, bites occur in lines along the limbs. Over 40 pathogens have been detected in bed bugs, but there is no definitive evidence that they transmit any disease-causing organisms to humans. Anemia may result when bed bugs are numerous, and their allergens can trigger asthmatic reactions. The misuse of chemicals and other technologies for controlling bed bugs has the potential to have a deleterious impact on human health, while the insect itself can be the cause of significant psychological trauma. The control of bed bugs is challenging and should encompass a multidisciplinary approach utilizing nonchemical means of control and the judicious use of insecticides. For accommodation providers, risk management procedures should be implemented to reduce the potential of bed bug infestations. PMID:22232375

  2. The clinical efficacy of reminiscence therapy in patients with mild-to-moderate Alzheimer disease: Study protocol for a randomized parallel-design controlled trial.

    Science.gov (United States)

    Li, Mo; Lyu, Ji-Hui; Zhang, Yi; Gao, Mao-Long; Li, Wen-Jie; Ma, Xin

    2017-12-01

    Alzheimer disease (AD) is one of the most common diseases among the older adults. Currently, various nonpharmacological interventions are used for the treatment of AD. Such as reminiscence therapy is being widely used in Western countries. However, it is often used as an empirical application in China; the evidence-based efficacy of reminiscence therapy in AD patients remains to be determined. Therefore, the aim of this research is to assess the effectives of reminiscence therapy for Chinese elderly. This is a randomized parallel-design controlled trial. Mild and moderate AD patients who are in the Beijing Geriatric Hospital, China will be randomized into control and intervention groups (n = 45 for each group). For the intervention group, along with conventional drug therapy, participants will be exposed to a reminiscence therapy of 35 to 45 minutes, 2 times/wk for 12 consecutive weeks. Patients in the control group will undergo conventional drug therapy only. The primary outcome measure will be the differences in Alzheimer disease Assessment Scale-Cognitive Section Score. The secondary outcome measures will be the differences in the Cornell scale for depression in dementia, Neuropsychiatric Inventory score, and Barthel Index scores at baseline, at 4 and 12 weeks of treatment, and 12 weeks after treatment. The protocols have been approved by the ethics committee of Beijing Geriatric Hospital of China (approval no. 2015-010). Findings will be disseminated through presentation at scientific conferences and in academic journals. Chinese Clinical Trial Registry identifier ChiCTR-INR-16009505. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

  3. Effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women: A randomised controlled clinical trial.

    Science.gov (United States)

    Jafari, Tina; Faghihimani, Elham; Feizi, Awat; Iraj, Bijan; Javanmard, Shaghayegh Haghjooy; Esmaillzadeh, Ahmad; Fallah, Aziz A; Askari, Gholamreza

    2016-02-01

    Low levels of serum 25-hydroxy vitamin D (25(OH)D) are common in type 2 diabetic patients and cause several complications particularly, in postmenopausal women due to their senile and physiological conditions. This study aimed to assess the effects of vitamin D-fortified low fat yogurt on glycemic status, anthropometric indexes, inflammation, and bone turnover in diabetic postmenopausal women. In a randomized, placebo-controlled, double-blind parallel-group clinical trial, 59 postmenopausal women with type 2 diabetes received fortified yogurt (FY; 2000 IU vitamin D in 100 g/day) or plain yogurt (PY) for 12 weeks. Glycemic markers, anthropometric indexes, inflammatory, and bone turnover markers were assessed at baseline and after 12 weeks. After intervention, in FY group (vs PY group), were observed: significant increase in serum 25(OH)D and decrease of PTH (stable values in PY); significant improvement in serum fasting insulin, HOMA-IR, HOMA-B, QUICKI, and no changes in serum fasting glucose and HbA1c (significant worsening of all indexes in PY); significant improvement in WC, WHR, FM, and no change in weight and BMI (stable values in PY); significant increase of omentin (stable in PY) and decrease of sNTX (significant increase in PY). Final values of glycemic markers (except HbA1c), omentin, and bone turnover markers significantly improved in FY group compared to PY group. Regarding final values of serum 25(OH)D in FY group, subjects were classified in insufficient and sufficient categories. Glycemic status improved more significantly in the insufficient rather than sufficient category; whereas the other parameters had more amelioration in the sufficient category. Daily consumption of 2000 IU vitamin D-fortified yogurt for 12 weeks improved glycemic markers (except HbA1c), anthropometric indexes, inflammation, and bone turnover markers in postmenopausal women with type 2 diabetes. www.irct.ir (IRCT2013110515294N1). Copyright © 2015 Elsevier Ltd and European

  4. Efficacy and tolerability balance of oxycodone/naloxone and tapentadol in chronic low back pain with a neuropathic component: a blinded end point analysis of randomly selected routine data from 12-week prospective open-label observations

    Directory of Open Access Journals (Sweden)

    Ueberall MA

    2016-11-01

    Full Text Available Michael A Ueberall,1 Gerhard H H Mueller-Schwefe2 1Institute of Neurological Sciences, Nuernberg, Germany; 2Interdisciplinary Center for Pain and Palliative Care Medicine, Goeppingen, Germany Objective: To evaluate the benefit–risk profile (BRP of oxycodone/naloxone (OXN and tapentadol (TAP in patients with chronic low back pain (cLBP with a neuropathic component (NC in routine clinical practice. Methods: This was a blinded end point analysis of randomly selected 12-week routine/open-label data of the German Pain Registry on adult patients with cLBP-NC who initiated an index treatment in compliance with the current German prescribing information between 1st January and 31st October 2015 (OXN/TAP, n=128/133. Primary end point was defined as a composite of three efficacy components (≥30% improvement of pain, pain-related disability, and quality of life each at the end of observation vs baseline and three tolerability components (normal bowel function, absence of either central nervous system side effects, and treatment-emergent adverse event [TEAE]-related treatment discontinuation during the observation period adopted to reflect BRP assessments under real-life conditions. Results: Demographic as well as baseline and pretreatment characteristics were comparable for the randomly selected data sets of both index groups without any indicators for critical selection biases. Treatment with OXN resulted formally in a BRP noninferior to that of TAP and showed a significantly higher primary end point response vs TAP (39.8% vs 25.6%, odds ratio: 1.93; P=0.014, due to superior analgesic effects. Between-group differences increased with stricter response definitions for all three efficacy components in favor of OXN: ≥30%/≥50%/≥70% response rates for OXN vs TAP were seen for pain intensity in 85.2%/67.2%/39.1% vs 83.5%/54.1%/15.8% (P= ns/0.031/<0.001, for pain-related disability in 78.1%/64.8%/43.8% vs 66.9%/50.4%/24.8% (P=0.043/0.018/0.001, and for

  5. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial.

    Science.gov (United States)

    Mizokami, Masashi; Yokosuka, Osamu; Takehara, Tetsuo; Sakamoto, Naoya; Korenaga, Masaaki; Mochizuki, Hitoshi; Nakane, Kunio; Enomoto, Hirayuki; Ikeda, Fusao; Yanase, Mikio; Toyoda, Hidenori; Genda, Takuya; Umemura, Takeji; Yatsuhashi, Hiroshi; Ide, Tatsuya; Toda, Nobuo; Nirei, Kazushige; Ueno, Yoshiyuki; Nishigaki, Yoichi; Betular, Juan; Gao, Bing; Ishizaki, Akinobu; Omote, Masa; Mo, Hongmei; Garrison, Kim; Pang, Phillip S; Knox, Steven J; Symonds, William T; McHutchison, John G; Izumi, Namiki; Omata, Masao

    2015-06-01

    Compared with other countries, patients with chronic hepatitis C infection in Japan tend to be older, have more advanced liver disease, and are more likely to have been previously treated for hepatitis C. We aimed to assess the efficacy and safety of an all-oral, fixed-dose combination of the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with chronic genotype 1 hepatitis C virus infection. In this randomised, open-label study, we enrolled patients from 19 clinical Japanese centres. Patients were randomly assigned (1:1) to receive either ledipasvir (90 mg) and sofosbuvir (400 mg) or ledipasvir, sofosbuvir, and ribavirin (dosed according to the Japanese Copegus product label-ie, patients ≤60 kg received 600 mg daily, patients >60 kg to ≤80 kg received 800 mg daily, and patients >80 kg received 1000 mg daily) orally once daily for 12 weeks. After completion or early discontinuation of treatment, patients were followed up off-treatment for 24 weeks. Eligible patients were at least 20 years of age with chronic genotype 1 hepatitis C virus infection with serum hepatitis C virus RNA concentrations of at least 5 log10 IU/mL, creatinine clearance of at least 1·0 mL/s, and a platelet count of at least 50 × 10(9) per L. An interactive web response system was used to manage patient randomisation and treatment assignment. Randomisation was stratified by the presence or absence of cirrhosis for treatment-naive patients and stratified by presence or absence of cirrhosis and by previous treatment category (relapser or breakthrough, non-responder, or interferon-intolerant) for previously treated patients. Within each strata, patients were sequentially assigned to either treatment with ledipasvir-sofosbuvir or ledipasvir-sofosbuvir plus ribavirin in a 1:1 ratio with block size of 4. The primary endpoint was sustained

  6. Effects of a 12-Week Physical Activity Protocol Delivered by YMCA After-School Counselors (Youth Fit for Life) on Fitness and Self-Efficacy Changes in 5-12-Year-Old Boys and Girls

    Science.gov (United States)

    Annesi, James J.; Westcott, Wayne L.; Faigenbaum, Avery D.; Unruh, Jennifer L.

    2005-01-01

    To address reduced physical education (PE) in elementary schools, a 12-week physical activity protocol was tested on 5-12-year-old, primarily African American, girls (n = 226) and boys (n = 344) at 14 YMCA after-school care sites. The 3 times/week, 45-min session curriculum included cardiovascular, resistance, and flexibility training, in which…

  7. Effect of 12 Weeks of Intensive Interval and Combined Training on Apolipoprotein A and B, Visfatin and Insulin Resistance in Overweight Middle-Aged Women with Type 2 Diabetes

    Directory of Open Access Journals (Sweden)

    M. Hosseinian

    2016-09-01

    Full Text Available Aims: Probabely through improvements in the levels of apolipoproteins (ApoA and ApoB and visfatin, the sport activities helps to reduce the risks of cardio-vascular diseases in the diabetic persons. The aim of this study was to compare the effects of intensive interval and combined trainings on the levels of ApoA and ApoB, visfatin, and insulin resistance in the middle-aged women with Type II diabetes. Materials & Methods: In the semi-experimental study, 52 middle-aged female patients with Type II diabetes were studied in Shahr-e-Kord in 2015. The subjects, selected by convenience sampling method, were randomly divided into three groups, incluing simultaneous strength-endurance training, interval intensive training, and control groups. 12-week trainings, composed of three endurance training sessions per week with 60% of maximum heart rate and two resistance training sessions per week with 70% of one maximum repetition, were done in strength-endurance group. Three training sessions per week with 4-10 repetition of 30-second Wingate test on the ergometer were conducted in interval intensive training group with maximum effort. Data was analyzed by SPSS 21 software using dependent T test, covariance analysis, and LSD test. Findings: At the post-test stage and following interval intensive trainings, ApoA reduction (p=0.03 and ApoB/ApoA (p=0.01 were significant. However, no significant difference was observed in combined group. The levels of visfatin and serum insulin and insulin resistance index significantly decreased in both training groups (p<0.01. Conclusion: The interval intensive trainings further affect the levels of blood apolipoprotein, visfatin, and insulin resistance in the middle-aged women with Type II diabetes, than the combined endurance-resistance trainings.

  8. Lisuride treatment of Alzheimer's disease. A preliminary placebo-controlled clinical trial of safety and therapeutic efficacy.

    Science.gov (United States)

    Claus, J J; de Koning, I; van Harskamp, F; Breteler, M M; Voet, B; Gutzmann, H; Dahlke, F; van der Cammen, T; Hofman, A

    1998-01-01

    In this article, the authors examine the effect of lisuride on 22 patients with probable Alzheimer's disease (NINCDS/ADRDA criteria) in a randomized double-blind, placebo-controlled, parallel group design. Ten patients received lisuride and 12 patients received placebo. Lisuride was administered in a dose-finding phase of four weeks and an efficacy phase of eight weeks, with a maximum dose of 0.3 mg daily. Outcome measures included global clinical impression, general cognitive function, mood, verbal and visual memory, attention, and psychomotor function. Average decline in Mini-Mental State Examination score after 12 weeks treatment was less often statistically significant in lisuride treated patients than in patients receiving a placebo (p < 0.05). Patients treated with lisuride improved their average total score and short-delay cued recall score on the California Verbal Learning Test, a test of verbal memory, whereas placebo-treated patients showed worse performance compared with baseline. These differences approached statistical significance, with p = 0.06 and p = 0.05, respectively. No other differences between the treatment groups were evident. The authors failed to find a consistent effect of lisuride on symptoms of Alzheimer's disease. However, this study's sample size was relatively small, and larger studies are needed to ascertain the treatment effects of serotonergic antagonists on Alzheimer's disease.

  9. Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    A. A. Harandi

    2011-01-01

    Full Text Available Objective. To investigate the safety and efficacy of MLC601 (NeuroAid as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month ischemic stroke. All patients were given either MLC601 (100 patients or placebo (50 patients, 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05. Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001. Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

  10. From asthma severity to control: a shift in clinical practice

    DEFF Research Database (Denmark)

    Pedersen, Søren

    2009-01-01

    -treatment. Several validated asthma control assessment tools have been developed to facilitate correct assessment of the level of control in clinical practice. It is hoped that focusing on control will reduce the frequency of sub-optimal treatment in the primary care setting. Further validation of the best way......Variability is a characteristic feature of asthma, and the aim of asthma management is to eliminate or minimise disease variability. Controlled asthma shows little or no variability, and is achievable and sustainable in the majority of patients. New international guidelines recommend control...... involves the control of several outcomes. Its assessment should include components relevant to achievement of best possible clinical control and reduction of future risk of adverse outcomes. Focusing on a single or a few outcomes can lead to incorrect control assessment and increased risk of under...

  11. Clinical translation of controlled protein delivery systems for tissue engineering.

    Science.gov (United States)

    Spiller, Kara L; Vunjak-Novakovic, Gordana

    2015-04-01

    Strategies that utilize controlled release of drugs and proteins for tissue engineering have enormous potential to regenerate damaged organs and tissues. The multiple advantages of controlled release strategies merit overcoming the significant challenges to translation, including high costs and long, difficult regulatory pathways. This review highlights the potential of controlled release of proteins for tissue engineering and regenerative medicine. We specifically discuss treatment modalities that have reached preclinical and clinical trials, with emphasis on controlled release systems for bone tissue engineering, the most advanced application with several products already in clinic. Possible strategies to address translational and regulatory concerns are also discussed.

  12. Efficacy, Safety and Cost-Effectiveness of Thermotherapy in the Treatment of Leishmania donovani-Induced Cutaneous Leishmaniasis: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Refai, Wardha F; Madarasingha, Nayani P; Sumanasena, Buthsiri; Weerasingha, Sudath; De Silva, Amala; Fernandopulle, Rohini; Satoskar, Abhay R; Karunaweera, Nadira D

    2017-10-01

    Leishmania donovani causes cutaneous leishmaniasis (CL) in Sri Lanka. Standard treatment is multiple, painful doses of intralesional sodium stibogluconate (IL-SSG). Treatment failures are increasingly reported, hence the need to investigate alternatives. Efficacy, safety, and cost-effectiveness of thermotherapy were assessed for the first time for L. donovani CL. A single blinded noninferiority randomized controlled trial was conducted on new laboratory-confirmed CL patients with single lesions (N = 213). Selected patients were randomly assigned to 1) test group (N = 98; single session of radiofrequency-induced heat therapy (RFHT) given at 50°C for 30 seconds) and 2) control group (N = 115; 1-3 mL IL-SSG given weekly, until cure/10 doses). Patients were followed-up fortnightly for 12 weeks to assess clinical cure. Cost of treatment was assessed using scenario building technique. Cure rates by 8, 10, and 12 weeks in RFHT group were 46.5%, 56.5%, and 65.9% as opposed to 28%, 40.8%, and 59.4% in IL-SSG group, with no major adverse events. Cure rate by RFHT was significantly higher at 8 weeks (P = 0.009, odds ratio [OR]: 2.236, confidence interval [CI]: 1.217-4.108) and 10 weeks (P = 0.035, OR: 1.881, CI: 1.044-3.388), but comparable thereafter. Cost of RFHT was 7 times less (USD = 1.54/patient) than IL-SSG (USD = 11.09/patient). A single application of RFHT is safe, cost-effective, and convenient, compared with multiple doses of IL-SSG in the treatment of L. donovani CL. Therefore, RFHT would be considered noninferior as per trial outcome when compared with standard IL-SSG therapy with multiple benefits for the patient and the national health care system.

  13. Effects of feeding transgenic corn with mCry1Ac or maroACC gene to laying hens for 12 weeks on growth, egg quality and organ health.

    Science.gov (United States)

    Zhong, R Q; Chen, L; Gao, L X; Zhang, L L; Yao, B; Yang, X G; Zhang, H F

    2016-08-01

    The objective of the present study was to investigate the effect of feeding two transgenic corn lines containing the mCry1Ac gene from Bacillus thuringiensis strain (BT-799) and the maroACC gene from Agrobacterium tumefaciens strain (CC-2), respectively, on growth, egg quality and organ health indicators. Expression of the mCry1Ac gene confers resistance to Pyrausta nubilalis and the maroACC gene confers tolerance to herbicides. Healthy hens (n=96 placed in cages; 3 hens/cage) were randomly assigned to one of four corn-soybean meal dietary treatments (8 cages/treatment) formulated with the following corn: non-transgenic near-isoline control corn (control), BT-799 corn, CC-2 corn and commercially available non-transgenic reference corn (reference). The experiment was divided into three 4-week phases (week 1 to 4, week 5 to 8 and week 9 to 12), during which hens were fed mash diets. Performance (BW, feed intake and egg production) and egg quality were determined. Following slaughter at the end of 12 weeks of feeding (n=8/treatment), carcass yield and organ weights (heart, liver, spleen, lung, kidneys, stomach and ovary) were recorded; organs and intestines were sampled for histological analysis. Analysis of serum biochemistry parameters to assess the liver and kidney function were performed. No differences in BW, egg production and production efficiency were observed between hens consuming the control diet and hens consuming the BT-799 or CC-2 diet. Haugh unit measures and egg component weights were similar between the control and test groups. Carcass yield was not affected by the diet treatment. Similar organosomatic indices and serum parameters did not indicate the characteristics of organ dysfunction. All observed values of the BT-799 and CC-2 groups were within the calculated tolerance intervals. This research indicates that the performance, egg quality, organ health and carcass yield of laying hens fed diets containing the BT-799 or CC-2 corn line were similar

  14. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course

    Directory of Open Access Journals (Sweden)

    Mittal Suneeta

    2010-05-01

    Full Text Available Abstract Background and objectives Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. Methods The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand, involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online. The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs and a skills-assessing questionniare administered eletronically. These

  15. A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence -based medicine course.

    Science.gov (United States)

    Kulier, Regina; Khan, Khalid S; Gulmezoglu, A Metin; Carroli, Guillermo; Cecatti, Jose G; Germar, Maria J; Lumbiganon, Pisake; Mittal, Suneeta; Pattinson, Robert; Wolomby-Molondo, Jean-Jose; Bergh, Anne-Marie; May, Win

    2010-05-14

    Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online.The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been developed by using questions from

  16. Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50mg/day) and escitalopram (10-20mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study.

    Science.gov (United States)

    Udristoiu, T; Dehelean, P; Nuss, Ph; Raba, V; Picarel-Blanchot, F; de Bodinat, C

    2016-07-15

    A double-blind, randomized, study was conducted in 29 centers in Romania to evaluate the effect of agomelatine 25-50mg/day (n=144 patients) on general interest, overall clinical efficacy, and functionality in comparison with escitalopram 10-20mg/day (n=143 patients) in out-patients diagnosed with moderate to severe Major Depressive Disorder (MDD). The primary endpoint of the study was the score difference between agomelatine and escitalopram were assessed on the item 13 of the Quick Inventory of Depressive Symptomatology (16-Item) Self-Report (QIDS-SR16) over the first week period. Secondary measures include the primary criterion on the 12-week period, the within-group evolution over 12 weeks of the 17-item Hamilton Depression Scale (HAM-D17) total score, CGI severity of illness (CGI-S) and CGI-I scores, and functionality by using the self-rated Sheehan Disability Scale (SDS). After one week, the mean General Interest score showed no statistically significant difference between treatments. Over 12 weeks, patients felt more and more interested in other people and activities than before having taken medication. Both agomelatine and escitalopram improved depressive symptoms and symptom-related functional impairment of patients. Both agomelatine and escitalopram were well-tolerated by patients. The strength of our results would benefit from additional data from trials using a similar design and other active comparators. There was no difference in week 1 changes of interest between agomelatine and escitalopram. The relatively good tolerability of agomelatine and escitalopram is confirmed. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  18. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald

    2014-01-01

    these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  19. The clinical anti-aging effects of topical kinetin and niacinamide in Asians: a randomized, double-blind, placebo-controlled, split-face comparative trial.

    Science.gov (United States)

    Chiu, Pin-Chi; Chan, Chih-Chieh; Lin, Hui-Min; Chiu, Hsien-Ching

    2007-12-01

    Kinetin and niacinamide are used in the cosmetic industry as anti-aging agents. Neither the interactive/additive effects of these compounds nor the anti-aging efficacy on Asian skin has been studied. Objective To assess the clinical anti-aging effects and efficacy differences between kinetin plus niacinamide and niacinamide alone vs. vehicle placebo in an Asian cohort. Fifty-two Taiwanese subjects were enrolled in a randomized, double-blind, placebo-controlled, split-face comparative study. Group 1 subjects were treated with kinetin 0.03% plus niacinamide 4%, whereas group 2 subjects received niacinamide 4%. The treatment formulation was applied on one side of the face, whereas a placebo was applied on the other for a period of 12 weeks. We used noninvasive biometrological instruments to evaluate a variety of skin parameters at baseline and at weeks 4, 8, and 12. Persistent and significant reductions in spot, pore, wrinkle, and evenness counts were found at weeks 8 and 12 in group 1. A significant increase in corneal hydration status was also evident at week 12, whereas persistent decreases in erythema index were apparent at 8 and 12 weeks. In group 2, significant reductions in pore and evenness counts at week 8 and wrinkle counts at week 12 were noted. We found kinetin and niacinamide exert a synergistic anti-aging effect. Our data suggest that these compounds have multiactive, multifunctional, and pluripotent effects on skin. They are also both promising to be included in the cutaneous anti-aging cosmeceuticals in the future.

  20. Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial

    NARCIS (Netherlands)

    Iversen, T.; Solberg, T.K.; Romner, B.; Wilsgaard, T.; Twisk, J.W.; Anke, A.; Nygaard, O.; Hasvold, T.; Ingebrigtsen, T.

    2011-01-01

    Objective: To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks). Design: Multicentre, blinded, randomised controlled trial. Setting: Outpatient multidisciplinary back clinics of

  1. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Hove, K D; Brøns, Cecilie; Færch, Kai Erik Vinther

    2013-01-01

    Recent studies suggest that proton pump inhibitor treatment may increase insulin secretion and improve glucose metabolism in type 2 diabetes. In a randomised double-blind prospective placebo-controlled 2 × 2 factorial study, we examined the effect of esomeprazole on insulin secretion, HbA(1c...

  2. Exploring the context for effective clinical governance in infection control.

    Science.gov (United States)

    Halton, Kate; Hall, Lisa; Gardner, Anne; MacBeth, Deborough; Mitchell, Brett G

    2017-03-01

    Effective clinical governance is necessary to support improvements in infection control. Historically, the focus has been on ensuring that infection control practice and policy is based on evidence, and that there is use of surveillance and auditing for self-regulation and performance feedback. There has been less exploration of how contextual and organizational factors mediate an infection preventionists (IP's) ability to engage with evidence-based practice and enact good clinical governance. A cross sectional Web-based survey of IPs in Australia and New Zealand was undertaken. Questions focused on engagement in evidence-based practice and perceptions about the context, culture, and leadership within the infection control team and organization. Responses were mapped against dimensions of Scally and Donaldson's clinical governance framework. Three hundred surveys were returned. IPs appear well equipped at an individual level to undertake evidence-based practice. The most serious set of perceived challenges to good clinical governance related to a lack of leadership or active resistance to infection control within the organization. Additional challenges included lack of information technology solutions and poor access to specialist expertise and financial resources. Focusing on strengthening contextual factors at the organizational level that otherwise undermine capacity to implement evidence-based practice is key to sustaining current infection control successes and promoting further practice improvements. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

  3. Synthetic sex pheromone in a long-lasting lure attracts the visceral leishmaniasis vector, Lutzomyia longipalpis, for up to 12 weeks in Brazil.

    Directory of Open Access Journals (Sweden)

    Daniel P Bray

    2014-03-01

    Full Text Available Current control methodologies have not prevented the spread of visceral leishmaniasis (VL across Brazil. Here, we describe the development of a new tool for controlling the sand fly vector of the disease: a long-lasting lure, which releases a synthetic male sex pheromone, attractive to both sexes of Lutzomyia longipalpis. This device could be used to improve the effectiveness of residual insecticide spraying as a means of sand fly control, attracting L. longipalpis to insecticide-treated animal houses, where they could be killed in potentially large numbers over a number of weeks. Different lure designs releasing the synthetic pheromone (±-9-methylgermacrene-B (CAS 183158-38-5 were field-tested in Araçatuba, São Paulo (SP. Experiments compared numbers of sand flies caught overnight in experimental chicken sheds with pheromone lures, to numbers caught in control sheds without pheromone. Prototype lures, designed to last one night, were first used to confirm the attractiveness of the pheromone in SP, and shown to attract significantly more flies to test sheds than controls. Longer-lasting lures were tested when new, and at fortnightly intervals. Lures loaded with 1 mg of pheromone did not attract sand flies for more than two weeks. However, lures loaded with 10 mg of pheromone, with a releasing surface of 15 cm2 or 7.5 cm2, attracted female L. longipalpis for up to ten weeks, and males for up to twelve weeks. Approximately five times more sand flies were caught with 7.5 cm2 10 mg lures when first used than occurred naturally in non-experimental chicken resting sites. These results demonstrate that these lures are suitably long-lasting and attractive for use in sand fly control programmes in SP. To our knowledge, this is the first sex pheromone-based technology targeting an insect vector of a neglected human disease. Further studies should explore the general applicability of this approach for combating other insect-borne diseases.

  4. Ethical considerations in placebo-controlled randomised clinical trials

    OpenAIRE

    Kaufman, Kenneth R.

    2015-01-01

    Summary Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raise...

  5. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study

    Directory of Open Access Journals (Sweden)

    Kerwin EM

    2017-02-01

    Full Text Available Edward M Kerwin,1 Chris J Kalberg,2 Dmitry V Galkin,2 Chang-Qing Zhu,3 Alison Church,2 John H Riley,4 William A Fahy4 1Clinical Research Institute of Southern Oregon, Medford, OR, 2Respiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA; 3Clinical Statistics, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, 4Respiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK Introduction: Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC/vilanterol (VI in patients with moderate COPD who remained symptomatic on tiotropium (TIO. Methods: In this randomized, blinded, double-dummy, parallel-group study (NCT01899742, patients (N=494 who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%–70% of predicted; modified Medical Research Council [mMRC] score ≥1 and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point, 0–3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI, St George’s Respiratory Questionnaire (SGRQ, and COPD Assessment Test (CAT. Safety evaluations included adverse events (AEs. Results: Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45–131]; P<0.001 and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27–72]; P<0.001. Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2–0.0]; P≤0.05. More patients achieved clinically meaningful improvements in TDI score (≥1 unit with UMEC/VI (63% versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21–2.64]; P≤0

  6. THE EFFECT OF A 12-WEEK PHYSIOTHERAPY PROGRAM WITH RESPIRATORY EXERCISES ON THE VITAL CAPACITY AND FORCED VITAL CAPACITY IN ADULT MALES AND FEMALES WITH CEREBRAL PALSY

    Directory of Open Access Journals (Sweden)

    Kitsios A

    2009-10-01

    Full Text Available The purpose of this study was to determine if breathing exercises can improve specific respiratoryparameters in adult males and females with cerebral palsy. 18 adults (11males/7 females with spastic cerebralpalsy consisted the experimental group and 18 (11males/7 females serving as control group took part in thestudy. A spirometer was used to measure vital capacity (VC and the forced vital capacity (FVC before and afterthe exercising protocol. The breathing exercises selected, emphasized strengthening of the muscles of inspirationand the muscles of expiration. The study revealed that a breathing exercise program can increase the VC andFVC in people with cerebral palsy. The pre-test and post-test examined variables of both groups were withinnormal limits The VC of the experimental group was increased by 0.20 litres and this of FVC increased by 0,25litres after exercising for five to seven minutes each day for a period of twelve weeks. The mean increase of theVC and FVC was 6% and 7% respectively over the baseline values. The control group showed no change in VCneither in FVC. The results support application and development of the treatment concept with respiratoryexercises and highlight that physical activity at its simple status can improve function and quality of life in adultswith cerebral palsy when added to standard care.

  7. Time-course investigation of infection with a low virulent Pasteurella multocida strain in normal and immune-suppressed 12-week-old free-range chickens.

    Science.gov (United States)

    Mbuthia, P G; Njagi, L W; Nyaga, P N; Bebora, L C; Minga, U; Christensen, J P; Olsen, J E

    2011-12-01

    Twelve-week-old indigenous chickens, either immune-suppressed using dexamethasone (IS) or non-immune-suppressed (NIS), were challenged with a low virulent strain, Pasteurella multocida strain NCTC 10322(T), and developed clinical signs and pathological lesions typical of chronic fowl cholera. NIS birds demonstrated much more severe signs of fowl cholera than IS birds. With few exceptions, signs recorded in IS and NIS birds were of the same types, but significantly milder in the IS birds, indicating that immune suppression does not change the course of infection but rather the severity of signs in fowl cholera. P. multocida signals by fluorescent in situ hybridization (FISH) were observed between 1 h and 14 days in the lungs, trachea, air sacs, liver, spleen, bursa of Fabricius and caecal tonsils, while signals from other organs mostly were observed after 24 h. More organs had FISH signals in NIS birds than in IS birds and at higher frequency per organ. Many organs were positive by FISH even 14 days post infection, and it is suggested that these organs may be likely places for long-term carriage of P. multocida following infection. The present study has demonstrated the spread of P. multocida in different tissues in chickens and distribution of lesions associated with chronic fowl cholera, and pointed to a decrease of pathology in IS birds. Since dexamethasone mostly affects heterophils, the study suggests that these cells play a role in the development of lesions associated with chronic fowl cholera in chickens.

  8. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial.

    Science.gov (United States)

    Álvarez, Cristian; Ramírez-Campillo, Rodrigo; Ramírez-Vélez, Robinson; Izquierdo, Mikel

    2017-04-01

    Our aim was to investigate the effects and prevalence of nonresponders (NR) to high-intensity interval training (HIIT) and resistance training (RT) in women with insulin resistance on cardiometabolic health parameters. Sedentary overweight/obese insulin-resistant women (age = 33.5 ± 6.5 yr; body mass index = 29.9 ± 3.7 kg/m 2 ) were randomly assigned to a triweekly HIIT program (HIIT; n = 18) or resistance training (RT; n = 17). Anthropometry (body mass, fat mass, muscle mass, waist circumference, and skinfold thickness), cardiovascular (blood pressure), metabolic [fasting glucose, fasting insulin, and homeostatic model of insulin resistance (HOMA-IR)], as well as muscle strength, and endurance performance covariables were measured before and after 12 wk in both intervention groups. The interindividual variability to exercise training of the subjects was categorized as responders and NR using as cut points two times the typical error of measurement in mean outcomes. After intervention, significant reduction in waist circumference, skinfold thicknesses, fat mass, blood pressure, fasting glucose, insulin, and HOMA-IR ( P HIIT and RT group, respectively. Both HIIT and RT groups exhibited a significant decrease in the endurance performance, whereas only RT exhibited increased muscle strength. Significant differences in the NR prevalence between the HIIT and RT groups were identified for a decrease in fat mass (HIIT 33.3% vs. RT 70.5%; P = 0.028), muscle mass (HIIT 100% vs. RT 52.9%; P = 0.001), and tricipital skinfold (HIIT 5.5% vs. RT 29.4%; P HIIT and RT groups (55.5% vs. 94.1; P = 0.009). However, there were no differences in the NR prevalence between HIIT and RT for decreasing fasting glucose. Twelve weeks of HIIT and RT have similar effects and NR prevalence to improve glucose control variables; however, there is different NR prevalence in other anthropometric, cardiovascular, strength, and endurance performance measurements in insulin-resistant women. These

  9. Planning of activities in the Laguna Verde Central planning at 12 weeks; Planeacion de Actividades en la Central Laguna Verde planeacion a doce semanas

    Energy Technology Data Exchange (ETDEWEB)

    Chimalpopoca, C. [Comision Federal de Electricidad, Central Laguna Verde, Subgerencia General de Operacion y Planeacion, Veracruz (Mexico)]. e-mail: carlos.chimalpopoca@cfe.gob.mx

    2007-07-01

    The universe of works that are carried out in a nuclear facility to maintain effective the structures, systems and components require of a continuous analysis, in the order of the maintenance frequencies that can be of the preventive, predictive or corrective type. Each component is associated to reserve parts, readiness of systems, in fulfillment to the operation technical specifications, to the environment of the one work; each component requires of a planning level, where it is distinguished with clarity when they are executed, in the operation stage, stop or recharge. This work has as end to show like the activities are planned during the operation, using planning methods to twelve weeks, where the reach of the task is conceptualized, operative requirements, of reserve parts, of the work environment analysis, of those radiological conditions, of the authorizations for their execution, the same execution and the evaluation post work like a technique to maintain in continuous improvement the tasks of the maintenance of the Units of the Power station. A motor valve to be worked in its internals requires access to the work point, it requires bill of the system, electric disconnection, maneuvers to disassemble actuators and retirement of thermal isolation if it applies, reserve parts of the caps joints, control mechanisms, personal, tools, radiological control. The success of the continuous operation of a power station is in the planning quality, the attention of each one of the details to assure that the components, structures and components stay effective to make their function when they are demanded. The planning task requires of experience and knowledge of each some of the components, the task of planning of activities and its execution is multidisciplinary This work has that purpose, to show the planning tools in the Laguna Verde Nuclear Power station, under the concept of twelve weeks. (Author)

  10. Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.

    Science.gov (United States)

    Ley, Chit Moy; Ni, Qing; Liao, Xing; Gao, Huai-Lin; Robinson, Nicola

    2016-10-01

    To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes. This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. This RCT failed to show a beneficial effect in reducing fibrinogen

  11. Control of clinical paratuberculosis in New Zealand pastoral livestock.

    Science.gov (United States)

    Gautam, M; Ridler, A; Wilson, P R; Heuer, C

    2018-01-01

    This review summarises current control measures for clinical paratuberculosis (Johne's disease; JD) in New Zealand pastoral livestock. Most New Zealand sheep, deer, beef and dairy cattle herds and flocks are infected by Mycobacterium avium ssp. paratuberculosis (Map). Dairy cattle and deer are mostly infected with bovine (Type II), and sheep and beef cattle with ovine (Type I) strains. Control in all industries is voluntary. While control in sheep and beef cattle is ad hoc, the dairy and deer industries have developed resources to assist development of farm-specific programmes. The primary target for all livestock is reduction of the incidence rate of clinical disease rather than bacterial eradication per se. For dairy farms, a nationally instituted JD-specific programme provides guidelines for risk management, monitoring and testing clinically suspect animals. While there is no formal programme for sheep farms, for those with annual prevalences of clinical disease >2%, especially fine wool breeds, vaccination may be a cost effective control option. The deer industry proactively monitors infection by a national abattoir surveillance programme and farmers with an apparent high disease incidence are encouraged to engage with a national network of trained consultants for management and control advice. Evaluation of the biological and economic effectiveness of control in all industries remains to be undertaken. Nevertheless, opportunities exist for farmers, who perceive significant JD problems in their herds/flocks, to participate in systematic best-practice activities that are likely to reduce the number of clinical infections with Map on their farms, and therefore the overall prevalence of JD in New Zealand's farming industries.

  12. Omega-3 Fatty Acid Supplementation for 12 Weeks Increases Resting and Exercise Metabolic Rate in Healthy Community-Dwelling Older Females.

    Directory of Open Access Journals (Sweden)

    Samantha L Logan

    Full Text Available Critical among the changes that occur with aging are decreases in muscle mass and metabolic rate and an increase in fat mass. These changes may predispose older adults to chronic disease and functional impairment; ultimately resulting in a decrease in the quality of life. Research has suggested that long chain omega-3 fatty acids, found predominantly in fatty fish, may assist in reducing these changes. The objective of this study was to evaluate the effect of fish oil (FO supplementation in a cohort of healthy, community-dwelling older females on 1 metabolic rate and substrate oxidation at rest and during exercise; 2 resting blood pressure and resting and exercise heart rates; 3 body composition; 4 strength and physical function, and; 5 blood measures of insulin, glucose, c-reactive protein, and triglycerides. Twenty-four females (66 ± 1 yr were recruited and randomly assigned to receive either 3g/d of EPA and DHA or a placebo (PL, olive oil for 12 wk. Exercise measurements were taken before and after 12 wk of supplementation and resting metabolic measures were made before and at 6 and 12 wk of supplementation. The results demonstrated that FO supplementation significantly increased resting metabolic rate by 14%, energy expenditure during exercise by 10%, and the rate of fat oxidation during rest by 19% and during exercise by 27%. In addition, FO consumption lowered triglyceride levels by 29% and increased lean mass by 4% and functional capacity by 7%, while no changes occurred in the PL group. In conclusion, FO may be a strategy to improve age-related physical and metabolic changes in healthy older females. Trial registration: ClinicalTrials.gov NCT01734538.

  13. Veterinary clinical research database for homeopathy: placebo-controlled trials.

    Science.gov (United States)

    Clausen, J; Albrecht, H; Mathie, R T

    2013-04-01

    Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. The effect of flaxseed powder on insulin resistance indices and blood pressure in prediabetic individuals: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Afrooz Javidi

    2016-01-01

    Full Text Available Background: Designing the effective and early interventions can prevent progression of prediabetes to diabetes. Few studies have shown the effect of flaxseed on glycemic control. This study aimed to assess the effect of flaxseed powder on insulin resistance (IR indices and blood pressure in prediabetic individuals. Materials and Methods: In a randomized clinical trial, 99 prediabetic individuals were randomly divided into three groups: two groups received 40 g (FG40 and 20 g (FG20 flaxseed powder daily for 12 weeks and the third group was the control (CG. Before and after the intervention, anthropometric measurements, blood pressure, fasting serum glucose (FSG, insulin, homeostasis model assessment IR index (HOMA-IR, beta-cell function, and insulin sensitivity were measured. Results: FSG significantly declined overall in all groups compared to the baseline (P = 0.002 in CG and FG20 groups and P = 0.001 in FG40. In contrast, mean of the changes in FSG was not significantly different between groups. Insulin concentration did not change significantly within and between the investigated groups. Although HOMA-IR reduced in FG20 (P = 0.033, the mean of changes was not significant between the three groups. Mean of beta-cell function increased in CG and FG40 groups compared to the baseline (P = 0.044 and P = 0.018, respectively, but mean of its changes did not show any difference between the three groups. The mean of changes in IR indices was not significant between the three groups. FG40 group had significantly lowered systolic blood pressure after the intervention (P = 0.005. Conclusion: Daily intake of flaxseed powder lowered blood pressure in prediabetes but did not improve glycemic and IR indices.

  15. A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Salaminios, George; Duffy, Larisa; Ades, Anthony; Araya, Ricardo; Button, Katherine S; Churchill, Rachel; Croudace, Tim; Derrick, Catherine; Dixon, Padraig; Dowrick, Christopher; Gilbody, Simon; Hollingworth, William; Jones, Vivien; Kendrick, Tony; Kessler, David; Kounali, Daphne; Lanham, Paul; Malpass, Alice; Peters, Tim J; Riozzie, Derek; Robinson, Jude; Sharp, Debbie; Thomas, Laura; Welton, Nicky J; Wiles, Nicola; Lewis, Glyn

    2017-10-24

    Depressive symptoms are usually managed within primary care and antidepressant medication constitutes the first-line treatment. It remains unclear at present which people are more likely to benefit from antidepressant medication. This paper describes the protocol for a randomised controlled trial (PANDA) to investigate the severity and duration of depressive symptoms that are associated with a clinically significant response to sertraline compared to placebo, in people presenting to primary care with depression. PANDA is a randomised, double blind, placebo controlled trial in which participants are individually randomised to sertraline or placebo. Eligible participants are those who are between the ages of 18 to 74; have presented to primary care with depression or low mood during the past 2 years; have not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there is clinical equipoise about the benefits of selective serotonin reuptake inhibitor (SSRI) medication. Participants who consent to participate in the trial are randomised to receive either sertraline or matching placebo, starting at 50 mg daily for 1 week, increasing to 100 mg daily for up to 11 weeks (with the option of increasing to 150 mg if required). Participants, general practitioners (GPs) and the research team will be blind to treatment allocation. The primary outcome will be depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks post randomisation, measured as a continuous outcome. Secondary outcomes include depressive symptoms measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome; follow-up scores on depressive symptoms measured with the Beck Depression Inventory-II, anxiety symptoms measured by the Generalized Anxiety Disorder-7 and quality of life measured with the Euroqol-5D-5L and Short Form-12; emotional processing task scores measured at baseline, 2 and 6

  16. Chicks change their pecking behaviour towards stationary and mobile food sources over the first 12 weeks of life: improvement and discontinuities

    Science.gov (United States)

    Hayden, Thomas J.; Kent, John P.

    2014-01-01

    Chicks (Gallus gallus domesticus) learn to peck soon after hatching and then peck in rapid bursts or bouts with intervals of non-pecking activity. The food sources may be static such as seeds and chick crumb, or mobile such as a mealworm. Here, changes with age in pecking toward chick crumb and a mealworm were measured. Chicks were reared in pairs and their pecking of crumb food was video recorded in their pair housed environment, from food presentation, every third day from day 8 (wk 2) to day 65 (wk 10). Peck rate at crumb food reached maximum levels at day 32 (wk 5), and then declined, fitting a quadratic model, with no sex, sex of cagemate, or box order effects. Within bouts the peck rate was higher and it increased to day 41 (wk 6) and then declined, and here males pecked faster than females. A change in dietary protein concentration from 22% to 18% at day 28 (wk 4) had no effect on subsequent peck rate. Pecking at and consumption of a mealworm in pair housed chicks were measured weekly from wks [5 to 12]. The latency to first worm peck and latency to swallow decreased to wk 8 and increased thereafter. The peck rate to first wormpeck and number of pecks to swallow increased to wk 8 and then declined paralleling the changes with crumb food. The increase in peck rate is coupled with an increase in efficiency in worm catching. The results are consistent with the view that the improvement in pecking ability and accuracy compliments change in nutritional requirement best served by an invertebrate food (IF) source requiring speed to achieve feeding success, especially with live prey. When this food source is no longer crucial these associated skill levels decline. An appreciation of the role of domestic fowl in controlling insect populations, at farm level, that are often vectors in disease spread is lacking. PMID:25374777

  17. Chicks change their pecking behaviour towards stationary and mobile food sources over the first 12 weeks of life: improvement and discontinuities

    Directory of Open Access Journals (Sweden)

    Kenneth J. Murphy

    2014-10-01

    Full Text Available Chicks (Gallus gallus domesticus learn to peck soon after hatching and then peck in rapid bursts or bouts with intervals of non-pecking activity. The food sources may be static such as seeds and chick crumb, or mobile such as a mealworm. Here, changes with age in pecking toward chick crumb and a mealworm were measured.Chicks were reared in pairs and their pecking of crumb food was video recorded in their pair housed environment, from food presentation, every third day from day 8 (wk 2 to day 65 (wk 10. Peck rate at crumb food reached maximum levels at day 32 (wk 5, and then declined, fitting a quadratic model, with no sex, sex of cagemate, or box order effects. Within bouts the peck rate was higher and it increased to day 41 (wk 6 and then declined, and here males pecked faster than females. A change in dietary protein concentration from 22% to 18% at day 28 (wk 4 had no effect on subsequent peck rate.Pecking at and consumption of a mealworm in pair housed chicks were measured weekly from wks [5 to 12]. The latency to first worm peck and latency to swallow decreased to wk 8 and increased thereafter. The peck rate to first wormpeck and number of pecks to swallow increased to wk 8 and then declined paralleling the changes with crumb food. The increase in peck rate is coupled with an increase in efficiency in worm catching.The results are consistent with the view that the improvement in pecking ability and accuracy compliments change in nutritional requirement best served by an invertebrate food (IF source requiring speed to achieve feeding success, especially with live prey. When this food source is no longer crucial these associated skill levels decline. An appreciation of the role of domestic fowl in controlling insect populations, at farm level, that are often vectors in disease spread is lacking.

  18. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training.

    Science.gov (United States)

    Currie, Katharine D; Rosen, Lee M; Millar, Philip J; McKelvie, Robert S; MacDonald, Maureen J

    2013-06-01

    Decreased heart rate variability and attenuated heart rate recovery following exercise are associated with an increased risk of mortality in cardiac patients. This study investigated the effects of 12 weeks of moderate-intensity endurance exercise (END) and a novel low-volume high-intensity interval exercise protocol (HIT) on measures of heart rate recovery and heart rate variability in patients with coronary artery disease (CAD). Fourteen males with CAD participated in 12 weeks of END or HIT training, each consisting of 2 supervised exercise sessions per week. END consisted of 30-50 min of continuous cycling at 60% peak power output (PPO). HIT involved ten 1-min intervals at 88% PPO separated by 1-min intervals at 10% PPO. Heart rate recovery at 1 min and 2 min was measured before and after training (pre- and post-training, respectively) using a submaximal exercise bout. Resting time and spectral and nonlinear domain measures of heart rate variability were calculated. Following 12 weeks of END and HIT, there was no change in heart rate recovery at 1 min (END, 40 ± 12 beats·min(-1) vs. 37 ± 19 beats·min(-1); HIT, 31 ± 8 beats·min(-1) vs. 35 ± 8 beats·min(-1); p ≥ 0.05 for pre- vs. post-training) or 2 min (END, 44 ± 18 beats·min(-1) vs. 43 ± 19 beats·min(-1); HIT, 42 ± 10 beats·min(-1) vs. 50 ± 6 beats·min(-1); p ≥ 0.05 for pre- vs. post-training). All heart rate variability indices were unchanged following END and HIT training. In conclusion, neither END nor HIT exercise programs elicited training-induced improvements in cardiac autonomic function in patients with CAD. The absence of improvements with training may be attributed to the optimal medical management and normative pretraining state of our sample.

  19. Long-term safety and efficacy of bilastine following up to 12 weeks or 52 weeks of treatment in Japanese patients with allergic rhinitis: Results of an open-label trial.

    Science.gov (United States)

    Okubo, Kimihiro; Gotoh, Minoru; Togawa, Michinori; Saito, Akihiro; Ohashi, Yoshihiro

    2017-06-01

    Bilastine is a novel second-generation antihistamine. This open-label, single-arm, phase III study evaluated the safety and efficacy of long-term treatment with bilastine in Japanese patients with seasonal (SAR) or perennial allergic rhinitis (PAR). Patients with SAR or PAR who met the registration criteria and did not violate the exclusion criteria received bilastine (20mg, once daily) for 12 weeks (treatment period). Patients with PAR who met the transition criteria could elect to continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks). Safety and tolerability were the primary outcomes, and the main secondary endpoint was to evaluate changes in efficacy variables from baseline measurements. Fifty-eight patients with SAR and 64 patients with PAR received bilastine (20mg/day) for 12 weeks. Fifty-five patients with PAR transitioned to the continuous treatment period. Adverse events (AEs) were reported by 17.2% of patients with SAR and by 31.3% of patients with PAR, and adverse drug reactions (ADRs) were reported by 6.3% of patients with PAR but by no patients with SAR during the 12-week treatment period. All of the ADRs were mild in severity. During the 52-week treatment period, AEs and ADRs were reported by 73.4% and 6.3% of patients with PAR, respectively. All of the ADRs occurred during the 12-week treatment period, and none during the continuous treatment period. The AEs were categorized using the System Organ Class of nervous system disorders; 4.7% of patients reported headache, but none reported somnolence. One serious AE was reported, but it was considered to be unrelated to the bilastine treatment. There were no deaths, and no patients withdrew from the study because of AEs. In patients with SAR, bilastine significantly decreased the total nasal symptom score (TNSS), total ocular symptom score (TOSS), and total symptom score (TSS) relative to baseline. Prolonged treatment with bilastine resulted in the

  20. THE EFFECT OF 12-WEEK FOOTBALL TRAINING ON DEVELOPMENT OF BODİLY KİNESTHETİC AND MUSİCAL İNTELLİGENCE CHILDREN GROUPS 8-10 YEARS OLD

    OpenAIRE

    Şebnem ŞARVAN CENGİZ; Atilla PULUR

    2008-01-01

    In this research, it has been analysed whether 12-week football training has had affect on level development of Bodily Kinesthetic and Musical Intelligence Fields of children of 8-10 year- old group. The student participated into the study were 2389 students who collected from 3rd and 4th grades in 13 schools in 6 counties of Ankara and 1060 students who play in the summer football programs in Ankara Sports Club and Gençlerbirliği Sports Club.In the research, to determine the multiple intelli...

  1. Comparison of preference for NovoPen(®) 4 with previous insulin pen treatments after 12 weeks in adult patients with type 1 and type 2 diabetes: a multicenter observational study.

    Science.gov (United States)

    Israël-Bultman, Harma; Hyllested-Winge, Jacob; Kolaczynski, Marcin; Steindorf, Jörg; Garon, Jean

    2011-03-01

    In separate randomized, crossover trials, patients with diabetes reported a preference for durable insulin pen NovoPen(®) 4 compared with NovoPen 3 and OptiClik(®). This large post-marketing observational study evaluated treatment satisfaction with NovoPen 4 versus previous treatments, which included NovoPen 3 and other devices, in insulin-treated and insulin-naive patients. During regular clinical practice in Canada, Germany, and the Netherlands, health care professionals assigned adult patients with type 1 or type 2 diabetes to treatment with insulin administered via NovoPen 4 after training according to the device's instruction manual. The primary end point was change in treatment satisfaction as determined by the Diabetes Treatment Satisfaction Questionnaire given to patients at the beginning and after 12 weeks of treatment. Two additional questionnaires were used at study end to identify why patients preferred either NovoPen 4 or their previously used insulin devices, which included NovoPen 3 and other devices (eg, HumaPen(®) Ergo and OptiPen(®) Pro). Adverse events were also recorded. Two thousand eighteen participants (mean age, 55 years; males, 53%; type 1/type 2 diabetes, 28%/71%; mean duration of disease, 13 years; previously on insulin, 89.8%; insulin-naïve, 2.9%) participated. NovoPen 3 was previously used by 1059, HumaPen Ergo by 256, OptiPen Pro by 217, and other devices by 385 patients. Diabetes Treatment Satisfaction Questionnaire scores increased from a mean (SD) baseline of 26.5 (7.2) to 30.5 (5.0) at study end for a median difference of 4.0 (95% CI, 3.5-4.5; Wilcoxon test score: 22.7; P < 0.0001). Over 70% of patients found NovoPen 4 easier to set, read, correct, inject the dose, and change the insulin cartridge than with their previously used device (P < 0.0001). A total of 83.8% rated NovoPen 4 easier to use overall (P < 0.0001). Health care professionals (97.2%) would recommend NovoPen 4 to other patients. No adverse events associated

  2. Unhealthy Weight Control Practices: Culprits and Clinical Recommendations

    Directory of Open Access Journals (Sweden)

    Zachary Michael Ferraro

    2015-01-01

    Full Text Available Preoccupation with weight status and a desire to lose weight appears common. Many individuals seek “magic bullet” approaches to weight loss and waive the risks of using these products. In this paper, we review the challenges of weight maintenance, highlight some unhealthy weight control practices, and discuss the futility and potential danger of unregulated weight control agents. Novel clinical strategies are discussed that health care providers may use to triage patients with obesity in an attempt to make ethical and personalized treatment decisions.

  3. Infection Control Measures in Private Dental Clinics in Lebanon

    OpenAIRE

    Jihad Dagher; Charles Sfeir; Ahmad Abdallah; Zeina Majzoub

    2017-01-01

    Purpose. Evaluate infection control knowledge, attitude, and practice in Lebanese private dental clinics. Materials and Methods. A survey including 46 questions related to routine safety procedures was sent to 1150 Lebanese dentists between July 1st and 2nd, 2015. The study sample was selected from the database of registered dentists based on a proportional random sampling ensuring equitable representation of the 5 geographic regions of Lebanon. A subset of 29 questions was used to generate a...

  4. Effect of a polysaccharide-rich hydrolysate from Saccharomyces cerevisiae (LipiGo®) in body weight loss: randomised, double-blind, placebo-controlled clinical trial in overweight and obese adults.

    Science.gov (United States)

    Santas, Jonathan; Lázaro, Elisabet; Cuñé, Jordi

    2017-09-01

    In the present study we evaluated the weight loss effect of a polysaccharide-rich food supplement, LipiGo®, comprising a specific β-glucan-chitin-chitosan fraction (BGCC) obtained from the chemical hydrolysis of Saccharomyces cerevisiae, resulting as a by-product of the brewing process. A randomised, double-blind, placebo-controlled clinical trial was performed enrolling 56 overweight and obese subjects (body mass index, BMI, 25-35 kg m -2 ) who were not following any specific diet, and were given placebo or BGCC (3 g d -1 ) for 12 weeks. Results were analysed by intention-to-treat (ITT) and per-protocol (PP) methods. Body weight increased in the placebo group compared to baseline (ITT: 1.0 kg, P weight and waist circumference in overweight and obese subjects, without relevant adverse effects. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  5. The concept of control of COPD in clinical practice

    Directory of Open Access Journals (Sweden)

    Soler-Cataluña JJ

    2014-12-01

    Full Text Available Juan José Soler-Cataluña,1,2 Bernardino Alcázar-Navarrete,3 Marc Miravitlles2,4 1Pneumology Department, Hospital Arnau de Vilanova, Valencia, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES, 3Respiratory Department, Hospital de Alta Resolucion, Granada, Spain; 4Pneumology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain Abstract: Treatment of chronic obstructive pulmonary disease (COPD requires a personalized approach according to the clinical characteristics of the patients, the level of severity, and the response to the different therapies. Furthermore, patients with the same level of severity measured by the degree of airflow obstruction or even with multidimensional indices may have very different symptoms and limitations for daily activities. The concept of control has been extensively developed in asthma but has not been defined in COPD. Here, we propose a definition of COPD control based on the concepts of impact and stability. Impact is a cross-sectional concept that can be measured by questionnaires such as the COPD Assessment Test or the Clinical COPD Questionnaire. Alternatively, impact can be assessed by the degree of dyspnea, the use of rescue medication, the level of physical activity, and sputum color. Stability is a longitudinal concept that requires the absence of exacerbations and deterioration in the aforementioned variables or in the COPD Assessment Test or Clinical COPD Questionnaire scores. Control is defined by low impact (adjusted for severity and stability. The concept of control in COPD can be useful in the decision making regarding an increase or decrease in medication in the stable state. Keywords: COPD, control, CAT, CCQ, exacerbations, prognosis

  6. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial.

    Science.gov (United States)

    Shin, Kyung-Min; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Kim, Tae-Hun; Park, Hyo-Ju; Lee, Min-Hee; Hong, Kwon-Eui; Lee, Seungdeok; Choi, Sun-Mi

    2013-06-14

    Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t-test and ANCOVA (P <0.05). The

  7. Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana Alves Firmeza

    Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

  8. Clinical psychology in general practice: a controlled trial evaluation

    Science.gov (United States)

    Earll, Louise; Kincey, John

    1982-01-01

    A controlled trial study is described in which 50 consecutive potential referrals for psychological treatment from one general practice were randomly allocated either to behavioural treatment or no-treatment conditions. Treatment-group patients received treatment from a clinical psychologist working within the practice; the control-group patients continued to be managed by their general practitioner. The patients' use of NHS resources was assessed during the treatment period (or its equivalent for the control group) and at a follow-up comparison point, when the patients' subjective ratings of their progress were also obtained. Between referral and the end of treatment the treated group received significantly less psychotropic medication than the control group. This difference was not, however, maintained at the longer-term follow-up. No differences in general practice consultation rates, in the subjective ratings of psychological distress, in control orientation or life satisfaction were found between the two groups, but the level of patient satisfaction was high. Implications for the design of future studies and for psychological health care delivery systems are discussed. PMID:7086742

  9. 300,000 IU or 600,000 IU of oral vitamin D3 for treatment of nutritional rickets: a randomized controlled trial.

    Science.gov (United States)

    Mittal, Hema; Rai, Sunita; Shah, Dheeraj; Madhu, S V; Mehrotra, Gopesh; Malhotra, Rajeev Kumar; Gupta, Piyush

    2014-04-01

    To evaluate the non-inferiority of a lower therapeutic dose (300,000 IU) in comparison to standard dose (600,000) IU of Vitamin D for increasing serum 25(OH) D levels and achieving radiological recovery in nutritional rickets. Randomized, open-labeled, controlled trial. Tertiary care hospital. 76 children (median age 12 mo) with clinical and radiologically confirmed rickets. Oral vitamin D3 as 300,000 IU (Group 1; n=38) or 600,000 IU (Group 2; n=38) in a single day. Primary: Serum 25(OH)D, 12 weeks after administration of vitamin D3; Secondary: Radiological healing and serum parathormone at 12 weeks; and clinical and biochemical adverse effects. Serum 25(OH)D levels [geometric mean (95% CI)] increased significantly from baseline to 12 weeks after therapy in both the groups [Group 1: 7.58 (5.50–10.44) to 16.06 (12.71– 20.29) ng/mL, Pchildren by 12 weeks. Both groups demonstrated significant (Pchildren after 12 weeks of intervention [Group 1: 20/32 (62.5%); Group 2: 18/28 (64.3%)]. No major clinical adverse effects were noticed in any of the children. Hypercalcemia was documented in 2 children at 4 weeks (1 in each Group) and 3 children at 12 weeks (1 in Group 1 and 2 in Group 2). None of the participants had hypercalciuria or hypervitaminosis D. A dose of 300,000 IU of vitamin D3 is comparable to 600,000 IU, administered orally, over a single day, for treating rickets in under-five children although there is an unacceptably high risk of hypercalcemia in both groups. None of the regime is effective in normalization of vitamin D status in majority of patients, 3 months after administering the therapeutic dose.

  10. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  11. Impulse control disorders in Parkinson's disease: clinical characteristics and implications

    Science.gov (United States)

    Leeman, Robert F; Potenza, Marc N

    2011-01-01

    SUMMARY Impulse control disorders (ICDs), specifically those related to excessive gambling, eating, sex and shopping, have been observed in a subset of people with Parkinson's disease (PD). Although some initial case reports claimed that dopamine replacement therapies, particularly dopamine agonists, cause ICDs, more recent, larger and better controlled studies indicate a more complicated picture. While dopamine replacement therapy use is related to ICDs, other vulnerabilities, some related to PD and/or its treatment directly and others seemingly unrelated to PD, have also been associated with ICDs in PD. This suggests a complex etiology with multiple contributing factors. As ICDs occur in a sizable minority of PD patients and can be associated with significant distress and impairment, further investigation is needed to identify factors that can predict who may be more likely to develop ICDs. Clinical implications are discussed and topics for future research are offered. PMID:21709778

  12. Additional Effects of an Individualized Risk Factor-Based Approach on Pain and the Function of Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Halabchi, Farzin; Mazaheri, Reza; Mansournia, Mohammad Ali; Hamedi, Zahra

    2015-11-01

    To investigate the clinical efficacy of adding risk factor-based approach (including appropriate exercises and orthoses) to routine quadriceps strengthening exercise with respect to pain and function in patients with patellofemoral pain syndrome (PFPS). A parallel group nonblinded randomized controlled trial with 12-week follow-up. An outpatient Sports Medicine Clinic of Tehran University of Medical Sciences, Tehran, Iran. Patients (both sexes, 18-40 years) with clinically diagnosed PFPS of the duration over 2 months. The intervention group received an individualized program, including exercise therapy plus risk factor modification, and was instructed to practice the tailored interventions at home for 12 weeks. The control group received an exercise program, only focusing on quadriceps strengthening. The primary outcomes were pain severity during the activities of daily living (0- to 100-point visual analog scale), and function (0- to 100-point Kujala patellofemoral score) at a 12-week follow-up. A total of 53 participants completed the trial: 26 in the intervention and 27 in the control group. After 12 weeks, both groups showed improvements in pain and function, but the changes were significantly greater in the intervention group with regard to pain [adjusted difference, -14.90; 95% confidence interval (CI), -5.86 to -23.93, P = 0.002], and function (adjusted difference, 6.82; 95% CI, 2.54-11.10, P = 0.002). Assessment and modification of the risk factors may add to the treatment effects on pain and function at a 12-week follow-up in patients with PFPS. These findings may lead to a more comprehensive clinical approach to this very common problem. It seems that incorporating risk factor assessment into our clinical practice may add to treatment effects with regard to pain and function in patients with PFPS.

  13. Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

    Science.gov (United States)

    Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

    2016-03-01

    The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Physiotherapy in patients with clinical signs of shoulder impingement syndrome: a randomized controlled trial.

    Science.gov (United States)

    Kromer, Thilo O; de Bie, Rob A; Bastiaenen, Caroline H G

    2013-05-01

    To investigate the effect of individualized manual physiotherapy and exercises compared with individualized exercises alone in patients with shoulder impingement syndrome. Randomized controlled trial. Patients with shoulder impingement of more than 4 weeks' duration. Patients in the intervention group were treated with individually adapted exercises and examination-based physiotherapy. Controls were treated with individually adapted exercises only. Both groups had 10 treatment sessions over a period of 5 weeks and subsequently continued their exercises at home for another 7 weeks. Results were analysed at 5 and 12 weeks after the start of the study. Primary outcome measures were: Shoulder Pain and Disability Index, and Patient's Global Impression of Change. Secondary outcome measures were: mean weekly pain score; Generic Patient-Specific Scale; and Patients' Satisfaction with Treatment. A total of 46 patients were randomized to the intervention group and 44 to the control group. Although both groups showed significant improvements, there was no difference between groups for the primary and secondary outcomes at any time. Only the results for mean pain differed at 5 weeks in favour of the intervention group. Individually adapted exercises were effective in the treatment of patients with shoulder impingement syndrome. Individualized manual physiotherapy contributed only a minor amount to the improvement in pain intensity. However, further research is necessary to confirm these results before definite recommendations can be made.

  15. What do patients value about spinal manipulation and home exercise for back-related leg pain? A qualitative study within a controlled clinical trial.

    Science.gov (United States)

    Maiers, Michele; Hondras, Maria A; Salsbury, Stacie A; Bronfort, Gert; Evans, Roni

    2016-12-01

    Patient perceptions may influence the effectiveness and utilization of healthcare interventions, particularly for complex health conditions such as sciatica or back-related leg pain (BRLP). To explore BRLP patients' perceptions of spinal manipulative therapy (SMT) and home exercise with advice (HEA). Qualitative study in a controlled clinical trial. Semi-structured interviews conducted after 12 weeks of treatment asked participants about satisfaction with care and whether treatment was worthwhile. An interdisciplinary research team conducted content analysis using qualitative data analysis software to identify and summarize themes. Of 192 trial participants, 174 (91%) completed interviews (66% female, age 57.0 ± 11.5 years). Participants identified interactions with providers and staff, perceived treatment effects, and information as key contributors to both their satisfaction and the worthwhile nature of treatment. HEA was liked for its convenience and ability to foster an exercise habit. SMT was liked for specific aspects of the modality (e.g. manipulation, stretching) and provider competency. Most participants reported no dislikes for SMT or HEA, but some noted the dose/time commitment for SMT and discipline of HEA as least liked aspects of the interventions. The quality of patient-provider interactions, perceived treatment effects, and information sharing influenced BRLP patients' satisfaction with care. Qualitative research describing patients' preferences can facilitate translation of study findings into practice and allow clinicians to tailor treatments to facilitate compliance and satisfaction with care. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Effects of isokinetic eccentric training on knee extensor and flexor torque and on gait of individuals with long term ACL reconstruction: A controlled clinical trial

    OpenAIRE

    Santos,Heleodório Honorato dos; Sousa,Catarina de Oliveira; Barela, José Angelo; Barela,Ana Maria Forti; Salvini, Tania de Fatima

    2014-01-01

    This study investigated the effects of the isokinetic eccentric training (IET) on the knee extensor and flexor torque and kinematic gait parameters in individuals with ACL reconstruction. Sixteen men with ACL reconstructed (ACLr) whose torque and the gait were evaluated, before and after 12 weeks of IET, was compared to a control group (14 individuals). Student t, MANOVA and ANOVA tests were performed with 5% of significance. The training increased the isometric, concentric at 30 and 120º/s (...

  17. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    Science.gov (United States)

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p 70%) compared with most published results with multifocal spectacles. Further studies are warranted to identify the critical factors and mechanisms underlying this myopia control effect.

  18. Nutritional screening; control of clinical undernutrition with analytical parameters.

    Science.gov (United States)

    de Ulíbarri Pérez, José Ignacio; Fernández, Guillermo; Rodríguez Salvanés, Francisco; Díaz López, Ana María

    2014-01-13

    To update the system for nutritional screening. The high prevalence of nutritional unstability that causes the Clinical Undernutrition (CU), especially within the hospitals and assisted residencies, makes it necessary to use screening tools for the constant control of undernutrition to combat it during its development. CU is not so much due to a nutritional deficiency but to the illness and its treatments. However, the screening systems currently used are aimed at detecting an already established undernutrition rather than at detecting any nutritional risk that may be present. The metabolic changes of the nutritional status that have a trophopathic effect, can be easily and automatically detected in plasma, which allows to make the necessary changes in treatments that might be too aggressive, as well as to apply nutritional support according to each case. The manual screening systems can detect those somatic changes typical of undernutrition only after many days or weeks, which might be too late. Plasma albumin is a very reliable parameter for nutritional control. A lowered amount of it, due to whatever reason, is a clear sign of a possible deficit as well as of a nutritional risk suffered by the cell way before the somatic signs of undernutrition will become apparent. A fast detection of nutritional risk, anticipating undernutrition, offers prognostic abilities, which makes screening tools based on analytic parameters the most useful, ergonomic, reliable and efficient system for nutritional screening and prognosis in the clinical practice. It is necessary to update some concepts, to leave behind old myths and to choose modern screening systems that have proven to be efficient. This is the only way achieving the dream of controlling CU among ill and vulnerable patients. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  19. High correlation of VAS pain scores after 2 and 6 weeks of treatment with VAS pain scores at 12 weeks in randomised controlled trials in rheumatoid arthritis and osteoarthritis : meta-analysis and implications

    OpenAIRE

    Karabis, Andreas; Nikolakopoulos, Stavros; Pandhi, Shaloo; Papadimitropoulou, Katerina; Nixon, Richard; Chaves, Ricardo L.; Moore, R Andrew

    2015-01-01

    Background Researchers in clinical trials in rheumatoid arthritis (RA) and osteoarthritis (OA) often measure pain levels with a visual analogue scale (VAS). Of interest to clinical practice and future clinical trial design are associations of change from baseline (CFB) between time points with predictive ability of earlier response for long-term treatment benefit. We assessed the association and predictive ability of CFB in VAS pain between 2, 6 and 12?weeks in randomised controlled trials (R...

  20. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

    Directory of Open Access Journals (Sweden)

    Lemon Stephenie C

    2009-12-01

    Full Text Available Abstract Background US Latinos have greater prevalence of type 2 diabetes (diabetes, uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. Methods and design This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control on glycemic control among low-income Latinos with diabetes, compared to usual care (control. Participants were recruited from five community health centers (CHCs in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c. Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need. Trial registration http://www.clinicaltrials.gov # NCT00848315

  1. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

    Science.gov (United States)

    Rosal, Milagros C; White, Mary Jo; Restrepo, Angela; Olendzki, Barbara; Scavron, Jeffrey; Sinagra, Elise; Ockene, Ira S; Thompson, Michael; Lemon, Stephenie C; Candib, Lucy M; Reed, George

    2009-12-09

    US Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.

  2. [Effects of immunomodulation on antineoplastic radiotherapy. A controlled clinical study].

    Science.gov (United States)

    Botturi, M; Panzarasa, R; Agostara, B; Armaroli, L; Belli, M; Barone, D; Boccone, F; Busutti, L; Catalano, E; Ciambellotti, E

    1993-09-01

    It is well known that thymic hormones can counteract immunodepression due to radiation therapy, preventing and reducing the severity and the number of myelotoxic and hematologic reactions. We tried to confirm these findings in a controlled multicenter clinical study involving 1,060 patients undergoing radiation therapy (580 treated with thymopentin 50 mg s.c. every other day, after irradiation and for at least 6 cycles of 4 weeks each, and 480 control patients). Highly statistically significant results (to the ANOVA test) were obtained in the protection against radiation-induced leukopenia in the treated group; furthermore, the treated patients had a marked reduction (p = 0.003 chi 2 test) in the early delayed reactions to irradiation, namely in the upper aero-digestive tract. In general, we observed a better, but not statistically significant recovery of the blood parameters, lymphocyte subsets and skin tests in the treated group versus the control group. Both of the treated groups showed the same trend for Karnofsky performance status and body weight. The local and general protection provided by thymopentin against the reactions to irradiation could be advantageously used for the administration of higher doses of radiation therapy.

  3. Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Samadi, Nazli; Mozaffari-Khosravi, Hassan; Rahmanian, Masoud; Askarishahi, Mohsen

    2017-03-01

    Propolis, a natural resinous substance made by bees from material extracted from plants, flowers and bee's wax, has shown great therapeutic effects and been widely used in food and drug industries. Recently, some researchers have studied the effect of this substance in the treatment of diabetes. The purpose of this trial was to determine the effect of bee propolis on glycemic control, serum lipid profile and insulin resistance indices in patients with type 2 diabetes (T2D). This randomized clinical trial involved 66 patients with T2D, which were randomly divided into two groups of intervention (IG) and placebo (PG). IG received 300 mg three times a day for a total of 900 mg/d of propolis pills, while PG received similar pills, lacking propolis, on the same schedule for 12 weeks. Fasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), serum insulin and insulin resistance indices were the main outcome measures. The mean change in FBG between the IG ((17.76 ± 27.72) mg/dL decrease) and the PG ((6.48 ± 42.77) mg/dL increase) was significantly different (P = 0.01). Change in mean HbA1c had a similar pattern to FBG. The mean change in TC between the IG ((5.16 ± 43.80) mg/dL increase) and the PG ((28.9 ± 27.4) mg/dL increase) was also significantly different (P = 0.01), showing the protective role of propolis against the increase in TC. The change in mean LDL was similar to mean TC. There was no significant difference in other lipids or insulin resistance indices between the two groups. Based on this study, the daily intake of 900 mg of bee propolis supplement for 12 weeks results in improvement of glycemic and some serum lipid levels in patients with T2D. This study is registered on the website of Iranian Ministry of Health (www.irct.ir) with proprietary code of IRCT2014080218659N1.

  4. Quality control of parasitology stool examination in Tabriz clinical laboratories

    Directory of Open Access Journals (Sweden)

    shahram Khademvatan

    2011-06-01

    Full Text Available The purpose of quality control program was to make doctors and laboratory personnel trust in laboratory results and consequently increasing confidence in laboratory achievements. The quality assurance means raising the level of quality in all tests that lead to raising the level of work efficiency and laboratories including minimum expense for society and minimum time for lab personnel. This study aimed to assess and determine the accuracy and precision of results in Tabriz medical diagnostic laboratories. Materials and Methods: In this retrospective study, 790 stool samples were selected randomly and tested by standard methods.Student t- test, SPSS software and sensitivity and accuracy formulas were used for data analysis. Results: The sensitivity was 62%, 22% and 8% with 95% confidence intervals for worm's eggs, protozoan cysts and trophozoite detection respectively. Conclusion: To elevate quality assurance in clinical diagnostic laboratory, monitoring and check of the laboratories by standard methods continually should be done.

  5. Infection Control Measures in Private Dental Clinics in Lebanon

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    Jihad Dagher

    2017-01-01

    Full Text Available Purpose. Evaluate infection control knowledge, attitude, and practice in Lebanese private dental clinics. Materials and Methods. A survey including 46 questions related to routine safety procedures was sent to 1150 Lebanese dentists between July 1st and 2nd, 2015. The study sample was selected from the database of registered dentists based on a proportional random sampling ensuring equitable representation of the 5 geographic regions of Lebanon. A subset of 29 questions was used to generate an overall score of compliance (excellent, good, fair, and poor. Comparisons according to gender, type, region, and years of practice were performed. Results. 417 dentists returned the completed questionnaires. 96% expressed concern about infection transmission, 90.6% were vaccinated against Hepatitis B, and 61.8% asked routinely about patients medical history. Only 43% used protective eyewear. Although most dentists (65% used autoclaves, dry heat was still used. Significant correlations were found between gender and use of personal protective equipment. Less compliance was shown by clinicians with fewer years of experience. In the overall compliance questionnaire, the mean percentage of correct answers was roughly 54% with <5% of the practitioners scoring “excellent.” Conclusions. The study found inadequacy of compliance in private Lebanese dental clinics necessitating improved educational training and sustained monitoring by regulatory bodies.

  6. [A clinic's experiences in postoperative patient controlled analgesia].

    Science.gov (United States)

    Atim, Abdulkadir; Deniz, Süleyman; Orhan, Mehmet Emin; Sizlan, Ali; Kurt, Ercan

    2009-10-01

    Postoperative analgesia technique varies depending on the operation, patient, anesthetist, and circumstances. PCA (patient controlled analgesia) is an effective way of supporting postoperative analgesia. In this study, we aimed to present the efficacy and safety of our postoperative PCA treatment and the patient profile along with the requirements, preferences and decision-making process. We discuss herein the PCA protocols of our clinic, the overall distribution of operations for which PCA was applied and the principles by which a pain team works. The operations for which PCA was applied included knee prosthesis, cesarean section, hip prosthesis, lower extremity trauma surgery, painless delivery, gastrointestinal surgery, multiple trauma surgery, thoracotomy, hysterectomy, laminectomy, and urogenital surgery. Postoperative PCA alone was successful in 89% of the patients, and with the supplemental analgesic agent, it was successful in an additional 6% of the patients, thus achieving a total success rate of 95%. We believe the epidural and intravenous PCA protocols applied in our clinic for postoperative analgesia are effective and safe.

  7. Topical 5% tranexamic acid for the treatment of melasma in Asians: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Kanechorn Na Ayuthaya, Pinyapat; Niumphradit, Nucha; Manosroi, Aranya; Nakakes, Artit

    2012-06-01

    Topical tranexamic acid has been claimed to lighten melasma without serious adverse effects. However, controlled studies assessing the efficacy and safety of topical tranexamic acid (TA) for the treatment of melasma is limited. To assess in a double blind, randomized, prospective study, the efficacy of topical 5% tranexamic acid versus vehicle for treatment of melasma. Twenty-three women with bilateral epidermal melasma enrolled in a split-face trial lasting 12 weeks. Patients blindly applied topical 5% tranexamic acid and its vehicle, to the designated sides of the face twice daily in addition to the assigned sunscreen each morning. Pigmentation and erythema were measured objectively using a mexameter and Melasma Area and Severity Index (MASI), in addition to physician and patient global assessments. Twenty-one patients completed the study. Eighteen out of twenty-three patients (78.2%) showed decrease in the melanin index on either or both sides of the face by the end of 12 weeks compared to baseline. The MASI scores were also significantly reduced on both tested sides. However, lightening of pigmentation induced by TA gel was neither superior nor different (p > 0.05) compared to its vehicle although erythema was significant on the TA-applied site (p < 0.05). Although lightening of pigmentation was obtained, the results were not significant between the two regimens. However, topical TA produced erythema.

  8. Evaluation of a Crataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    Science.gov (United States)

    Zeng, Weiwei; Tomlinson, Brian

    2014-01-01

    Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily), Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c), and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C) levels between placebo and active treatment (−9%) was significantly (P < 0.05) better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1%) (P = 0.098). There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects. PMID:24834096

  9. Evaluation of a Crataegus-Based Multiherb Formula for Dyslipidemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Miao Hu

    2014-01-01

    Full Text Available Background. We for the first time examined the effects of a multiherb formula containing Crataegus pinnatifida (1 g daily, Alisma orientalis, Stigma maydis, Ganoderma lucidum, Polygonum multiflorum, and Morus alba on plasma lipid and glucose levels in Chinese patients with dyslipidemia. Methods. In this randomized, double-blind, placebo-controlled study, 42 patients were randomized at a ratio of 1 : 1 to receive the herbal formula or placebo for 12 weeks and 40 patients completed the study. Lipid profiles, glucose, glycated haemoglobin (HbA1c, and laboratory safety parameters were performed before and after treatment. Results. The difference in the changes in low-density lipoprotein cholesterol (LDL-C levels between placebo and active treatment (−9% was significantly (P<0.05 better with active treatment. HbA1c levels significantly decreased by −3.9% in the active treatment group, but the change was not significantly different from that with placebo (−1.1% (P=0.098. There were no apparent adverse effects or changes in laboratory safety parameters with either treatment. Conclusions. The multiherb formula had mild beneficial effects on plasma LDL-C after 12-weeks treatment in subjects with dyslipidemia without any noticeable adverse effects.

  10. A Randomized Clinical Trial of Cognitive-Behavioral Therapy and Applied Relaxation for Adults With Generalized Anxiety Disorder

    OpenAIRE

    Dugas, Michel J.; Brillon, Pascale; Savard, Pierre; Turcotte, Julie; Gaudet, Adrienne; Ladouceur, Robert; Leblanc, Renée; Gervais, Nicole J.

    2009-01-01

    This randomized clinical trial compared cognitive-behavioral therapy (CBT), applied relaxation (AR), and wait-list control (WL) in a sample of 65 adults with a primary diagnosis of generalized anxiety disorder (GAD). The CBT condition was based on the intolerance of uncertainty model of GAD, whereas the AR condition was based on general theories of anxiety. Both manualized treatments were administered over 12 weekly 1-hour sessions. Standardized clinician ratings and self-report questionnaire...

  11. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Bharmal Murtuza

    2011-04-01

    Full Text Available Abstract Background Because of the subjective nature of Restless Legs Syndrome (RLS symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ, to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540. At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I, Profile of Mood States (POMS, Medical Outcomes Study Scale-Sleep (MOS-Sleep, and RLS-Quality of Life (RLSQoL. Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each. Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352.

  12. The clinical impact and cost-effectiveness of essential oils and aromatherapy for the treatment of acne vulgaris: a protocol for a randomized controlled trial.

    Science.gov (United States)

    Agnew, Tamara; Leach, Matthew; Segal, Leonie

    2014-05-01

    Acne is a prevalent, chronic, and sometimes severe skin disorder affecting an estimated 85% of adolescents and 50% of adults older than age 20 years. The psychosocial implications of acne can be considerable, often continuing long after physical symptoms resolve. Although effective acne medications are available, most exhibit adverse-effect profiles that can leave the patient with few effective treatment options. Emerging evidence indicates that plant-derived essential oils may be a biologically plausible treatment for acne, although high-quality evidence of effectiveness and safety is lacking. To examine the clinical effectiveness and cost-effectiveness of essential oils and aromatherapy for the treatment of acne. This randomized, wait-list controlled trial will have three parallel groups; 192 participants with acne vulgaris, aged 16-45 years, will be recruited primarily through eight Technical and Further Education campuses across Adelaide, South Australia. Participants will be randomly assigned to standard essential oil blend, customized aromatherapy treatment, or wait-list control. Changes in the physical and psychosocial symptoms of acne will be assessed at baseline and 6 and 12 weeks by using the Leeds Acne Grading System, Assessment of Quality of Life-8 Dimension instrument, and Acne-Specific Quality of Life instrument. Costs of treatment will be measured on the basis of resource inputs and unit costs and will be limited to acne treatment. The clinical effectiveness and cost-effectiveness will be compared between each intervention and against usual care, using standard health economic techniques. The provision of high-quality evidence of the effectiveness of essential oils and aromatherapy in the treatment of acne may help consumers make better-informed choices about acne management. Insights gained from this research will also contribute to the academic field of complementary medicine, specifically aromatherapy, for which the evidence base is extremely

  13. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  14. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  15. Effect of high dose vitamin D intake on interleukin-17 levels in multiple sclerosis: a randomized, double-blind, placebo-controlled clinical trial.

    Science.gov (United States)

    Toghianifar, Nafiseh; Ashtari, Fereshteh; Zarkesh-Esfahani, Sayyed Hamid; Mansourian, Marjan

    2015-08-15

    Vitamin D has immunomodulatory effects in multiple sclerosis (MS). Vitamin D acts through various mechanisms such as secretion of cytokines. Interleukin-17 (IL-17) is a critical interleukin in inflammatory response in MS. This study assessed the effect of oral high dose vitamin D intake on IL-17 levels in MS patients in a double blind randomized clinical trial. 94 patients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) were randomized to two groups. One group received 50,000 IU vitamin D3 every five days for 12weeks. The other group was given placebo. Both groups received interferon-β (IFN-β) treatment. Serum levels of IL-17 were measured at the beginning of the study and after 12weeks. IL-17 serum levels were 56.75±28.72pg/ml and 30.31±75.85pg/ml in the intervention and placebo group at the beginning of the study, respectively (Median±IQR, p=0.338). After 12weeks, IL-17 levels were 58.93±67.93pg/ml and 46.13±94.70pg/ml in the intervention and placebo group, respectively (Median±IQR, p=0.960). The multiple linear regression analysis indicated that the consumption of vitamin D3 was positively and significantly associated with the logarithm of IL-17 measures (β=1.719; p=0.002 and R2=0.91), adjusted by EDSS scores. IL-17 levels showed significant change in RRMS patients after receiving high dose vitamin D3 for 12weeks. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. Elbasvir plus grazoprevir in patients with hepatitis C virus infection and stage 4-5 chronic kidney disease: clinical, virological, and health-related quality-of-life outcomes from a phase 3, multicentre, randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Bruchfeld, Annette; Roth, David; Martin, Paul; Nelson, David R; Pol, Stanislas; Londoño, Maria-Carlota; Monsour, Howard; Silva, Marcelo; Hwang, Peggy; Arduino, Jean-Marie; Robertson, Michael; Nguyen, Bach-Yen; Wahl, Janice; Barr, Eliav; Greaves, Wayne

    2017-08-01

    In the C-SURFER study, therapy with the all-oral elbasvir plus grazoprevir regimen for 12 weeks in patients with chronic hepatitis C virus (HCV) infection and stage 4-5 chronic kidney disease resulted in a high rate of virological cure compared with placebo. Here, we report sustained virological response (SVR), safety data, health-related quality-of-life (HRQOL), and virological resistance analyses in patients in C-SURFER who received immediate antiviral therapy or who received placebo before therapy. In this phase 3, multicentre, randomised, placebo-controlled study, we randomly assigned adults with HCV genotype 1 infection and stage 4-5 chronic kidney disease enrolled at 68 centres worldwide to either elbasvir 50 mg plus grazoprevir 100 mg once per day for 12 weeks (immediate treatment group) or placebo for 12 weeks followed by elbasvir 50 mg plus grazoprevir 100 mg once per day for 12 weeks beginning at week 16 (deferred treatment group). The primary safety and efficacy endpoints for the immediate treatment group and placebo phase of the deferred treatment group have been reported previously. Here, we report safety and efficacy data for the treatment phase of the deferred treatment group, as well as HRQOL assessed using the 36-Item Short Form Health Survey for all groups, and baseline and treatment-emergent resistance-associated substitutions (RASs). SVR at 12 weeks (SVR12) was assessed in the modified full analysis set (FAS), defined as all patients excluding those who did not receive at least one dose of study drug, who died, or who discontinued the study before the end of treatment for reasons determined to be unrelated to HCV treatment. This trial is registered with ClinicalTrials.gov, Number NCT02092350. Between March 30 and Nov 28, 2014, 235 patients were enrolled and received at least one dose of study drug. The modified FAS included 116 patients assigned to immediate treatment and 99 assigned to deferred treatment. 115 (99·1%; 95% CI 95·3-100·0) of

  17. Efficacy and safety of permethrin 5% topical gel vs. placebo for rosacea: a double-blind randomized controlled clinical trial.

    Science.gov (United States)

    Raoufinejad, K; Mansouri, P; Rajabi, M; Naraghi, Z; Jebraeili, R

    2016-12-01

    Rosacea is a chronic, multifactorial, dermatological condition. Increased density of Demodex folliculorum mites in the skin of rosacea patients suggests a possible role for these mites in the pathophysiology of rosacea. To evaluate the effects of permethrin 5% topical gel vs. placebo on Demodex density (Dd) and clinical presentations of rosacea patients, and also to further refine the quantitative assessment of Dd in the non-invasive standard skin surface biopsy (SSSB). Twenty patients with bilateral papulopustular rosacea and ≥5 mites/cm2 were enrolled in the study. Participants and physicians were blinded to the group assignments. Each patient applied permethrin on one side and placebo on the other side of the face twice daily for 12 weeks. SSSB and photography and Rosacea Clinical Scorecard of the National Rosacea Society were used to assess the patients at the baseline, 2nd, 5th, 8th, and 12th weeks for both sides of the face. Causality and severity of adverse drug reactions (ADRs) were assessed by WHO Scale and Hartwig Scale, respectively. Dd was not significantly different between the two groups at the baseline. In both groups, Dd significantly decreased after 12 weeks compared to the baseline. At the end of the 12th week, the Dd in the permethrin group was significantly lower than the placebo group. Severity of the clinical presentations decreased in both groups at the end of week 12 in comparison to the baseline, particularly in the permethrin group. ADRs were all mild and in most cases unlikely related to permethrin. Permethrin 5% gel can significantly reduce the Dd and severity of presentations in rosacea patients and can be a safe and effective option in the management of this chronic disorder. This new SSSB technique offers an easy, quick, inexpensive, and non-invasive sampling method proper for quantitative assessment of Dd. © 2016 European Academy of Dermatology and Venereology.

  18. The effect of alpha-lipoic acid supplementation on anthropometric indices and food intake in patients who experienced stroke: A randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Vida Mohammadi

    2017-01-01

    Full Text Available Background: Stroke as a devastating condition is a major cause of death worldwide. It is accountable for long-term disability with high personal and social cost in adults. Alpha-lipoic acid (ALA is an eight-carbon, sulfur-containing compound with antioxidant properties which reduces body weight, changes other anthropometric indices, and regulates food intake by suppressing appetite and increasing metabolism This study was designed to evaluate the possible effects of ALA supplementation on anthropometric indices and dietary intake in patients with stroke. Materials and Methods: In this randomized, double-blind, placebo-controlled clinical trial, 67 patients with stroke were randomly allocated to two groups (taking a 600 mg ALA supplement or placebo daily for 12 weeks. Weight, waist circumference, energy, carbohydrate, protein, and fat intake were measured, and body mass index (BMI was calculated before and after intervention. Dietary intake and statistical analyses were carried out using Nutritionist IV and SPSS (version 16; SPSS Inc., Chicago, IL, USA software, respectively. Results: Primary features were similar in the intervention and placebo groups (P > 0.05. Waist circumference (P < 0.001, energy, carbohydrate, protein, and fat intake (P < 0.001 decreased significantly, after the intervention period, in ALA group compared with placebo. While no significant change was observed in weight (P = 0.26 and BMI (P = 0.56 in ALA supplementation group compared with placebo. Conclusion: Results of this trial indicated that 12-week supplementation with 600 mg ALA can decrease waist circumference and food intake (energy, carbohydrate, protein, and fat in patients with stroke.

  19. Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

    Science.gov (United States)

    Ahern, Amy L; Wheeler, Graham M; Aveyard, Paul; Boyland, Emma J; Halford, Jason C G; Mander, Adrian P; Woolston, Jennifer; Thomson, Ann M; Tsiountsioura, Melina; Cole, Darren; Mead, Bethan R; Irvine, Lisa; Turner, David; Suhrcke, Marc; Pimpin, Laura; Retat, Lise; Jaccard, Abbygail; Webber, Laura; Cohn, Simon R; Jebb, Susan A

    2017-06-03

    Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m 2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in

  20. [A randomized single-blind controlled clinical trial of tacrolimus mouth rinse on erosive oral lichen planus].

    Science.gov (United States)

    Zuo, Wen-xin; Li, Xiao-yu; Cai, Gan-ying; Chen, Yan-qing

    2013-12-01

    To evaluate the efficacy and safety of tacrolimus mouth rinse on the treatment of erosive and ulcerative oral lichen planus (OLP). A randomized single-blind open trial of tacrolimus mouth rinse with dexamethasone as control was designed. The VAS and REU scoring system was utilized to compare the signs and symptoms. The scores and therapeutic effects were analyzed with SPSS 17.0 software package. There was no significant difference in effective rate between the treatment group and control group (X(2)=0.295,0.413, P>0.01) at 4-week and 12-week after treatment. There was significant difference in REU scores between the 2 groups (P<0.01) 4 weeks after treatment. Tacrolimus mouth rinse effects quickly and is worthy of application in the treatment of erosive and ulcerative OLP.

  1. Spinal Manipulative Therapy for Chronic Lower Back Pain in Older Veterans: A Prospective, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Dougherty, Paul E; Karuza, Jurgis; Dunn, Andrew S; Savino, Dorian; Katz, Paul

    2014-12-01

    Chronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT. The purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics. Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups. The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

  2. Clinical spectrum of impulse control disorders in Parkinson's disease.

    Science.gov (United States)

    Weintraub, Daniel; David, Anthony S; Evans, Andrew H; Grant, Jon E; Stacy, Mark

    2015-02-01

    Impulse control disorders (ICDs), including compulsive gambling, buying, sexual behavior, and eating, are a serious and increasingly recognized psychiatric complication in Parkinson's disease (PD). Other impulsive-compulsive behaviors (ICBs) have been described in PD, including punding (stereotyped, repetitive, purposeless behaviors) and dopamine dysregulation syndrome (DDS; compulsive PD medication overuse). ICDs have been most closely related to the use of dopamine agonists (DAs), perhaps more so at higher doses; in contrast, DDS is primarily associated with shorter-acting, higher-potency dopaminergic medications, such as apomorphine and levodopa. Possible risk factors for ICDs include male sex, younger age and younger age at PD onset, a pre-PD history of ICDs, and a personal or family history of substance abuse, bipolar disorder, or gambling problems. Given the paucity of treatment options and potentially serious consequences, it is critical for PD patients to be monitored closely for development of ICDs as part of routine clinical care. © 2014 International Parkinson and Movement Disorder Society.

  3. Incremento de la glucosa-6-fosfato-deshidrogenasa eritrocitaria en jóvenes con síndrome de Down tras un programa de actividad física de 12 semanas A 12-week physical activity program increases glucose-6-phosphate-dehydrogenase activity in Down syndrome adolescents

    Directory of Open Access Journals (Sweden)

    Francisco J. Ordóñez

    2005-12-01

    Full Text Available Recientemente se ha publicado que las células trisómicas presentan una mayor sensibilidad al daño oxidativo, que podría justificar la frecuente asociación de síndrome de Down a aterosclerosis, envejecimiento precoz, etc. Para conocer el posible papel de la actividad física moderada en la mejora de la capacidad antioxidante se estudió el comportamiento de la enzima glucosa-6-fosfato-deshidrogenasa (G6PDH eritrocitaria en 31 adolescentes varones (16.3 ± 1.1 años tras desarrollar un programa de 12 semanas con tres sesiones (45-60 minutos y una intensidad del 60-75% frecuencia cardíaca máxima teórica. Nuestros resultados indican una mayor actividad de G6PDH en individuos con síndrome de Down cuando se compara con controles sin trisomía ajustados a su sexo, edad e índice de masa corporal. Asimismo observamos un incremento significativo de su actividad tras completar nuestro programa de 12 semanas. Podemos concluir que la actividad física moderada mejora la capacidad antioxidante en jóvenes con síndrome de Down.In recent years it has been claimed that trisomic cells are more sensitive to oxidative stress since there is an imbalance in the hydrogen peroxide metabolism. We designed the present study to assess the activity level of antioxidant enzyme glucose-6-phosphate-dehydrogenase (G6PDH of erythrocytes in 31 male adolescents with Down syndrome (mean age 16.3 ± 1.1 after performing a 12 week aerobic training program. First of all, a significant increase of 14.9% in the catalytic activity of G6PDH was observed in male adolescents with Down syndrome when compared with age, sex and body mass-matched controls without trisomy. After 12-wk program its activity increased significantly compared to baseline value in Down syndrome individuals. Our data are consistent with previous evidence of the existence of higher oxidative stress in adolescents with Down syndrome when compared to the general population. We may also conclude that G6PDH

  4. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Juturu V

    2016-10-01

    Full Text Available Vijaya Juturu,1 James P Bowman,2 Jayant Deshpande1 1Department of Scientific and Clinical Affairs, OmniActive Health Technologies Inc., Morristown, NJ, 2James P Bowman & Associates LLC, Loveland, OH, USA Purpose: Carotenoids, especially lutein and zeaxanthin isomers (L/Zi, filter blue light and protect skin from environmental factors including high-energy sources. These carotenoids may be able to block the formation of melanin pathways, decrease cytokines, and increase antioxidants.Subjects and methods: This is a randomized, double-blind, placebo-controlled clinical trial over a 12-week supplementation period. Fifty healthy people (50 healthy subjects were recruited and 46 subjects completed the study (males and females, age: 18–45 years with mild-to-moderate dry skin were included in this study. Skin type of the subjects was classified as Fitzpatrick skin type II–IV scale. Subjects were administered with either an oral dietary supplement containing 10 mg lutein (L and 2 mg zeaxanthin isomers (Zi (L/Zi: RR-zeaxanthin and RS (meso-zeaxanthin or a placebo daily for 12 weeks. The minimal erythemal dose and skin lightening (L* were measured via the Chromameter®. The individual typological angle was calculated. Subjective assessments were also recorded.Results: Overall skin tone was significantly improved in the L/Zi group compared to placebo (P<0.0237, and luminance (L* values were significantly increased in the L/Zi group. Mean minimal erythemal dose was increased with L/Zi supplementation after 12 weeks of supplementation. L/Zi supplementation significantly increased the individual typological angle.Conclusion: L/Zi supplementation lightens and improves skin conditions. Keywords: lutein, zeaxanthin isomers, skin lightening, minimal erythemal dose, individual typological angle, overall skin tone

  5. Níveis de sódio na ração de frangas de 7 a 12 semanas de idade Sodium levels for pullets aged between 7 and 12 weeks

    Directory of Open Access Journals (Sweden)

    Marcelo Luís Gomes Ribeiro

    2008-08-01

    Full Text Available O experimento foi realizado para estimar as exigências de sódio em frangas leves (LV e semipesadas (SP, durante a fase de recria (7 a 12 semanas de idade. O delineamento experimental foi inteiramente ao acaso, em esquema fatorial com seis níveis de sódio (0,04; 0,10; 0,16; 0,21; 0,27 e 0,32 % e duas linhagens (LV e SP, que resultaram em doze tratamentos, com cinco repetições de seis aves. Foram avaliados o consumo de ração (CR, consumo de água (CAG, ganho de peso diário (GPD, conversão alimentar (CA, temperatura retal (TR, comprimento da crista (CC, matéria seca das excretas (MSF e umidade das excretas (UF. Não houve interação dos níveis de sódio (NS com a linhagem sobre as variáveis estudadas. O CR não foi afetado pelos NS, porém as frangas SP consumiram mais ração que as LV. Os NS proporcionaram efeito quadrático para o GPD e CA, e a linhagem LV apresentou maior CC que a SP. O aumento do NS da ração elevou o CAG, a UF e diminuiu a MSF, mas a TR não foi alterada. Recomenda-se de 7 a 12 semanas de idade 0,22%, ou o consumo de 123 e 140 mg de sódio para as LV e SP, respectivamente.The experiments were carried out to determine sodium requirements for light (LS and egg-brown (EBS pullets from 7 to 12 weeks of age. It was used a completely randomized design according to a 6x2 factorial (sodium levels: 0.04; 0.10; 0.16; 0.21; 0.27 and 0.32% X 2 strains, with five replicates of six pullets per experimental unit. Feed intake, water intake, daily weight gain, feed: gain ratio, rectal temperature, and comb size were evaluated, as well as feces dry matter and humidity. In the two experiments, there was no interaction (P>0.05 between sodium levels (SL and strains on the studied variables. Feed intake was not affected by LS, but it was greater in EBS than in LS birds (P <0.05. LS had significant effects on daily weight gain and feed: gain ratio according to the quadratic model, and comb size was greater in LS compared to EBS birds

  6. Weight loss for women with and without polycystic ovary syndrome following a very low-calorie diet in a community-based setting with trained facilitators for 12 weeks.

    Science.gov (United States)

    Nikokavoura, Efsevia A; Johnston, Kelly L; Broom, John; Wrieden, Wendy L; Rolland, Catherine

    2015-01-01

    Polycystic ovary syndrome (PCOS) affects between 2% and 26% of reproductive-age women in the UK, and accounts for up to 75% of anovulatory infertility. The major symptoms include ovarian disruption, hyperandrogenism, insulin resistance, and polycystic ovaries. Interestingly, at least half of the women with PCOS are obese, with the excess weight playing a pathogenic role in the development and progress of the syndrome. The first-line treatment option for overweight/obese women with PCOS is diet and lifestyle interventions; however, optimal dietary guidelines are missing. Although many different dietary approaches have been investigated, data on the effectiveness of very low-calorie diets on PCOS are very limited. The aim of this paper was to investigate how overweight/obese women with PCOS responded to LighterLife Total, a commercial very low-calorie diet, in conjunction with group behavioral change sessions when compared to women without PCOS (non-PCOS). PCOS (n=508) and non-PCOS (n=508) participants were matched for age (age ±1 unit) and body mass index (body mass index ±1 unit). A 12-week completers analysis showed that the total weight loss did not differ significantly between PCOS (n=137) and non-PCOS participants (n=137) (-18.5±6.6 kg vs -19.4±5.7 kg, P=0.190). Similarly, the percentage of weight loss achieved by both groups was not significantly different (PCOS 17.1%±5.6% vs non-PCOS 18.2%±4.4%, P=0.08). Overall, LighterLife Total could be an effective weight-loss strategy in overweight/obese women with PCOS. However, further investigations are needed to achieve a thorough way of understanding the physiology of weight loss in PCOS.

  7. Effect of baseline glycosylated hemoglobin A1c on glycemic control and diabetes management following initiation of once-daily insulin detemir in real-life clinical practice.

    Science.gov (United States)

    Caputo, Salvatore; Andersen, Henning; Kaiser, Marcel; Karnieli, Eddy; Meneghini, Luigi F; Svendsen, Anne Louise

    2013-01-01

    The SOLVE study investigated the initiation of basal insulin in patients with type 2 diabetes on oral antidiabetic (OAD) treatment and outcomes in patients with varying levels of glycemic control at baseline. This was an observational cohort study conducted in 10 countries using insulin detemir. Data were collected at 3 clinic visits (baseline, 12-week interim, and 24-week final visit). A total of 13,526 (77.9%) patients were included in the glycosylated hemoglobin A1c (HbA1c) subset analysis. Patients were grouped according to pre-insulin HbA1c values as follows: HbA1c 9% (n = 5,363). A total of 27 patients experienced serious adverse drug reactions (SADRs) and/or severe hypoglycemia (3, 10, and 11 patients with pre-insulin HbA1c 9.0%, respectively). All patient subgroups realized improvements in HbA1c, with the pre-insulin HbA1c >9% subgroup having the largest HbA1c reduction (-2.4% versus -0.9% and -0.2% for HbA1c subgroups 7.6-9% and <7.6%, respectively). In the total cohort (n = 17,374), the incidence of severe hypoglycemia decreased from 4 events per 100 person years to <1 event per 100 person years by final visit; the incidence of minor hypoglycemia increased from 1.6 to 1.8 events per person year. In this study, insulin initiation was delayed until late in disease course, and overall concordance with internationally recognized guidelines was low. The initiation of once-daily insulin detemir was associated with substantial improvements in glycemic control and was not associated with an increase in severe hypoglycemia or weight gain.

  8. FAST CP: protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy

    OpenAIRE

    Gillett, Jarred G; Lichtwark, Glen A.; Boyd, Roslyn N.; Barber, Lee A

    2015-01-01

    Introduction Individuals with cerebral palsy (CP) have muscles that are smaller, weaker and more resistant to stretch compared to typically developing people. Progressive resistance training leads to increases in muscle size and strength. In CP, the benefits of resistance training alone may not transfer to improve other activities such as walking; however, the transfer of strength improvements to improved mobility may be enhanced by performing training that involves specific functional tasks ...

  9. Evaluation of the Effect of Lactobacillus paracasei (HF.A00232 in Children (6–13 years old with Perennial Allergic Rhinitis: A 12-week, Double-blind, Randomized, Placebo-controlled Study

    Directory of Open Access Journals (Sweden)

    Wen-Ya Lin

    2014-06-01

    Conclusion: Dietary supplementation with LP (HF.A00232 provided no additional benefit when used with regular levocetirizine in treating AR in the initial 8 weeks of our study, but there was a continuing decrease in PRQLQ scores, as well as a significant improvement in individual symptoms of sneezing, itchy nose, and swollen eyes, after discontinuing regular levocetirizine treatment.

  10. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial

    NARCIS (Netherlands)

    Foley, J.E.; Bunck, M.C.M.; Moller-Goede, D.L.; Poelma, M.; Nijpels, G.; Eekhoff, E.M.; Schweizer, A.; Heine, R.J.; Diamant, M.

    2011-01-01

    Aims/hypothesis: Traditional blood glucose lowering agents do not prevent the progressive loss of beta cell function in patients with type 2 diabetes. The dipeptidylpeptidase (DPP)-4 inhibitor vildagliptin improves beta cell function both acutely and chronically (up to 2 years). Whether this effect

  11. Is severe obesity a form of addiction? Rationale, clinical approach, and controlled clinical trial.

    Science.gov (United States)

    Riva, Giuseppe; Bacchetta, Monica; Cesa, Gianluca; Conti, Sara; Castelnuovo, Gianluca; Mantovani, Fabrizia; Molinari, Enrico

    2006-08-01

    For many, obesity is just a problem of energy input and expenditure: more energy input than expenditure. However, the clinical practice and epidemiological data clearly show that weight control is more complex than expected by this simple equation. This is particularly true in morbid obesity, a form of severe obesity in which a person's Body Mass Index (BMI, kg/m(2)) is over 40. If we compare the definitions and diagnostic criteria for "dependence" and "addiction" with the situation of many severe obese subjects, it is apparent that they match very well. Further, different neurological studies confirm this similarity: both addiction and obesity patients have a deficiency of dopamine receptors. Nevertheless, when we compare many of the actual obesity treatments with the ones used in the area of addictions it is possible to find relevant differences: obesity treatments neither consider different levels of type and intensity of care, nor a multidimensional approach. To overcome these limitations, in this paper we propose a bio-psychosocial approach in which the genetic influence (lack of dopamine receptors) is matched by psychosocial issues (pressure for thinness and diet as main body image dissatisfaction treatment). Further, the paper outlines how this approach may influence the treatment options, by focusing both on the lessons coming from actual addiction treatment and the opportunities offered by virtual reality. Finally, the paper presents and discusses the outcome of a controlled trial, based on the proposed approach, including a 6-month follow-up (211 morbid obese females with a BMI of >40 and a documented history of failures.

  12. An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

    Science.gov (United States)

    Berger, Rony; Gelkopf, Marc

    2011-05-01

    Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the

  13. Comparisons of the Clinical Outcomes and Urodynamic Effects of Mirabegron versus Tolterodine Treatment for Female Overactive Bladder Syndrome: A Subgroup Analysis of a Controlled, Randomised, Prospective Study.

    Science.gov (United States)

    Hsiao, Sheng-Mou; Chang, Ting-Chen; Chen, Chi-Hau; Wu, Wen-Yih; Lin, Ho-Hsiung

    2017-04-23

    The impact of mirabegron on clinical outcome and urodynamic parameters may be important for clinical practice. Thus, the aim of this study was to compare the clinical outcomes and urodynamic effects of mirabegron (Betmiga 50 mg) versus tolterodine (Detrusitol ER 4 mg) treatment for women with overactive bladder syndrome (OAB). Women with OAB were randomized to receive 12 weeks of mirabegron 50 mg, tolterodine extended-release 4 mg or placebo treatment. The clinical outcomes and urodynamic effects were compared between the subgroups. Thirty-three women completed 12 weeks of mirabegron (n = 12), tolterodine (n = 12) or placebo (n = 9) treatment. A significant increase in the volumes at strong desire to void and a decrease in the daytime frequency episodes were identified in the mirabegron and tolterodine groups (all P < 0.05). Nonetheless, a decrease in the total voided volume was identified following mirabegron treatment but not tolterodine (P = 0.02). Mirabegron and tolterodine exhibit similar changes in the urodynamics and bladder diary parameters. However, mirabegron may decrease the total voided volume. These findings may serve as an initial guide or assist in consultations regarding the treatment of OAB patients with mirabegron. © 2017 John Wiley & Sons Australia, Ltd.

  14. Does group training during pregnancy prevent lumbopelvic pain? A randomized clinical trial.

    Science.gov (United States)

    Mørkved, Siv; Salvesen, Kjell Asmund; Schei, Berit; Lydersen, Stian; Bø, Kari

    2007-01-01

    Prevention of lumbopelvic pain in pregnancy has been sparsely studied. One aim of this study was to assess if a 12-week training program during pregnancy can prevent and/or treat lumbopelvic pain. A randomized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics. Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and randomly allocated to a training group (148) or a control group (153). The outcome measures were self-reported symptoms of lumbopelvic pain (once per week or more), sick leave, and functional status. Pain drawing was used to document the painful area of the body. The intervention included daily pelvic floor muscle training at home, and weekly group training over 12 weeks including aerobic exercises, pelvic floor muscle and additional exercises, and information related to pregnancy. At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain: 65/148 (44%) versus 86/153 (56%) (p=0.03). Three months after delivery the difference was 39/148 (26%) in the training group versus 56/153 (37%) in the control group (p=0.06). There was no difference in sick leave during pregnancy, but women in the training group had significantly (p=0.01) higher scores on functional status. A 12-week specially designed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy.

  15. Hypothesis versus significance testing for controlled clinical trials: a dialogue.

    Science.gov (United States)

    Salsburg, D

    1990-03-01

    The mathematical formulations of Neyman-Pearson hypothesis testing and the Fisherian concept of significance tests are examined as alternative ways of applying statistical models to data from clinical trials.

  16. l-Carnosine supplementation attenuated fasting glucose, triglycerides, advanced glycation end products, and tumor necrosis factor-α levels in patients with type 2 diabetes: a double-blind placebo-controlled randomized clinical trial.

    Science.gov (United States)

    Houjeghani, Shiva; Kheirouri, Sorayya; Faraji, Esmaeil; Jafarabadi, Mohammad Asghari

    2018-01-01

    Considering the pathologic importance of metabolic disturbances, advanced glycation end products (AGEs), and chronic inflammation in diabetes mellitus and ameliorating potentials of l-carnosine in hampering these detritions and because these effects have not been investigated in patients with type 2 diabetes (T2D) so far, we conducted the current study. We hypothesized that l-carnosine would improve glycemic control, lipid profile, AGE, soluble receptor of AGEs (sRAGE), and inflammatory markers. In a randomized, double-blind, placebo-controlled clinical trial, 54 patients with T2D were recruited and assigned into either intervention group (n=27, receiving 2 capsules of l-carnosine 500 mg each) or control group (n=27). Blood samples and dietary intakes information were collected at baseline and after 12 weeks of intervention. l-Carnosine supplementation resulted in significant decrease in fat mass and an increase in fat-free mass in the intervention group compared with the placebo group (1.5% and 1.7%, respectively) (Pl-carnosine group compared with the placebo group (Pl-carnosine group, a significant reduction in serum pentosidine levels (2.8 ng/mL) was observed compared with those at baseline (P.05). Collectively, l-carnosine lowered fasting glucose, serum levels of triglycerides, AGEs, and tumor necrosis factor-α without changing sRAGE, IL-6, and IL-1β levels in T2D patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Tretinoin gel microspheres 0.04% versus 0.1% in adolescents and adults with mild to moderate acne vulgaris: a 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial.

    Science.gov (United States)

    Berger, Richard; Rizer, Ronald; Barba, Alicia; Wilson, David; Stewart, Daniel; Grossman, Rachel; Nighland, Marge; Weiss, Jonathan

    2007-06-01

    Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritation, including erythema, peeling, dryness, burning, and itching. Tretinoin gel microsphere (TGM) formulations were developed to minimize these effects. A lower-strength TGM formulation may be desirable to further reduce exposure to tretinoin. This study was conducted to assess the efficacy and safety profile of a lower-dose TGM (0.04%) formulation compared with TGM 0.1% for the treatment of mild to moderate acne vulgaris. In this multicenter, double-blind, parallel-group, Phase IV dose-ranging study, patients with facial acne were randomized to apply either TGM 0.04% or TGM 0.1% to the face each night for 12 weeks. Patients must have discontinued systemic retinoid treatment for at least 1 year before the study and were not to have used any topical retinoids, systemic antibiotics, nicotinamide, or systemic steroids for at least 1 month. All other topical medications applied to the face (including corticosteroids, antimicrobials, salicylic acid, and benzoyl peroxide) were to be discontinued at least 2 weeks before the study. End points were the acne lesion count (total, inflammatory, and noninflammatory lesions) and the investigators' and patients' assessments of improvement. Adverse events (including severity and relationship to treatment) and signs and symptoms of cutaneous irritation at the treatment site were monitored at each study visit. One hundred fifty-six patients (78 TGM 0.04%, 78 TGM 0.1%) were randomized and received treatment. Patients ranged in age from 12 to 41 years (mean, 18.4 years) and were predominantly white (n = 89 [57.1%]) and male (n = 80 [51.3%]). Both TGM 0.04% and TGM 0.1% were associated with a reduction from baseline in total, inflammatory, and noninflammatory lesions. The differences between groups in the change in lesion counts from baseline to weeks 2, 4, 8, and 12 were not statistically significant

  18. Weight loss for women with and without polycystic ovary syndrome following a very low-calorie diet in a community-based setting with trained facilitators for 12 weeks

    Directory of Open Access Journals (Sweden)

    Nikokavoura EA

    2015-10-01

    Full Text Available Efsevia A Nikokavoura,1 Kelly L Johnston,2 John Broom,1 Wendy L Wrieden,1 Catherine Rolland1 1Centre for Obesity Research and Epidemiology, Institute for Health & Wellbeing Research (IHWR, Robert Gordon University, Aberdeen, 2LighterLife UK Limited, Harlow, Essex, UK Background: Polycystic ovary syndrome (PCOS affects between 2% and 26% of reproductive-age women in the UK, and accounts for up to 75% of anovulatory infertility. The major symptoms include ovarian disruption, hyperandrogenism, insulin resistance, and polycystic ovaries. Interestingly, at least half of the women with PCOS are obese, with the excess weight playing a pathogenic role in the development and progress of the syndrome. The first-line treatment option for overweight/obese women with PCOS is diet and lifestyle interventions; however, optimal dietary guidelines are missing. Although many different dietary approaches have been investigated, data on the effectiveness of very low-calorie diets on PCOS are very limited. Materials and methods: The aim of this paper was to investigate how overweight/obese women with PCOS responded to LighterLife Total, a commercial very low-calorie diet, in conjunction with group behavioral change sessions when compared to women without PCOS (non-PCOS. Results: PCOS (n=508 and non-PCOS (n=508 participants were matched for age (age ±1 unit and body mass index (body mass index ±1 unit. A 12-week completers analysis showed that the total weight loss did not differ significantly between PCOS (n=137 and non-PCOS participants (n=137 (–18.5±6.6 kg vs –19.4±5.7 kg, P=0.190. Similarly, the percentage of weight loss achieved by both groups was not significantly different (PCOS 17.1%±5.6% vs non-PCOS 18.2%±4.4%, P=0.08. Conclusion: Overall, LighterLife Total could be an effective weight-loss strategy in overweight/obese women with PCOS. However, further investigations are needed to achieve a thorough way of understanding the physiology of weight

  19. Effects of Whey, Soy or Leucine Supplementation with 12 Weeks of Resistance Training on Strength, Body Composition, and Skeletal Muscle and Adipose Tissue Histological Attributes in College-Aged Males

    Directory of Open Access Journals (Sweden)

    C. Brooks Mobley

    2017-09-01

    Full Text Available We sought to determine the effects of L-leucine (LEU or different protein supplements standardized to LEU (~3.0 g/serving on changes in body composition, strength, and histological attributes in skeletal muscle and adipose tissue. Seventy-five untrained, college-aged males (mean ± standard error of the mean (SE; age = 21 ± 1 years, body mass = 79.2 ± 0.3 kg were randomly assigned to an isocaloric, lipid-, and organoleptically-matched maltodextrin placebo (PLA, n = 15, LEU (n = 14, whey protein concentrate (WPC, n = 17, whey protein hydrolysate (WPH, n = 14, or soy protein concentrate (SPC, n = 15 group. Participants performed whole-body resistance training three days per week for 12 weeks while consuming supplements twice daily. Skeletal muscle and subcutaneous (SQ fat biopsies were obtained at baseline (T1 and ~72 h following the last day of training (T39. Tissue samples were analyzed for changes in type I and II fiber cross sectional area (CSA, non-fiber specific satellite cell count, and SQ adipocyte CSA. On average, all supplement groups including PLA exhibited similar training volumes and experienced statistically similar increases in total body skeletal muscle mass determined by dual X-ray absorptiometry (+2.2 kg; time p = 0.024 and type I and II fiber CSA increases (+394 μm2 and +927 μm2; time p < 0.001 and 0.024, respectively. Notably, all groups reported increasing Calorie intakes ~600–800 kcal/day from T1 to T39 (time p < 0.001, and all groups consumed at least 1.1 g/kg/day of protein at T1 and 1.3 g/kg/day at T39. There was a training, but no supplementation, effect regarding the reduction in SQ adipocyte CSA (−210 μm2; time p = 0.001. Interestingly, satellite cell counts within the WPC (p < 0.05 and WPH (p < 0.05 groups were greater at T39 relative to T1. In summary, LEU or protein supplementation (standardized to LEU content does not provide added benefit in increasing whole-body skeletal muscle mass or strength above PLA

  20. Effects of Whey, Soy or Leucine Supplementation with 12 Weeks of Resistance Training on Strength, Body Composition, and Skeletal Muscle and Adipose Tissue Histological Attributes in College-Aged Males

    Science.gov (United States)

    Mobley, C. Brooks; Roberson, Paul A.; Mumford, Petey W.; Romero, Matthew A.; Kephart, Wesley C.; Anderson, Richard G.; Vann, Christopher G.; Osburn, Shelby C.; Pledge, Coree D.; Young, Kaelin C.; Goodlett, Michael D.; Pascoe, David D.; Lockwood, Christopher M.; Roberts, Michael D.

    2017-01-01

    We sought to determine the effects of L-leucine (LEU) or different protein supplements standardized to LEU (~3.0 g/serving) on changes in body composition, strength, and histological attributes in skeletal muscle and adipose tissue. Seventy-five untrained, college-aged males (mean ± standard error of the mean (SE); age = 21 ± 1 years, body mass = 79.2 ± 0.3 kg) were randomly assigned to an isocaloric, lipid-, and organoleptically-matched maltodextrin placebo (PLA, n = 15), LEU (n = 14), whey protein concentrate (WPC, n = 17), whey protein hydrolysate (WPH, n = 14), or soy protein concentrate (SPC, n = 15) group. Participants performed whole-body resistance training three days per week for 12 weeks while consuming supplements twice daily. Skeletal muscle and subcutaneous (SQ) fat biopsies were obtained at baseline (T1) and ~72 h following the last day of training (T39). Tissue samples were analyzed for changes in type I and II fiber cross sectional area (CSA), non-fiber specific satellite cell count, and SQ adipocyte CSA. On average, all supplement groups including PLA exhibited similar training volumes and experienced statistically similar increases in total body skeletal muscle mass determined by dual X-ray absorptiometry (+2.2 kg; time p = 0.024) and type I and II fiber CSA increases (+394 μm2 and +927 μm2; time p < 0.001 and 0.024, respectively). Notably, all groups reported increasing Calorie intakes ~600–800 kcal/day from T1 to T39 (time p < 0.001), and all groups consumed at least 1.1 g/kg/day of protein at T1 and 1.3 g/kg/day at T39. There was a training, but no supplementation, effect regarding the reduction in SQ adipocyte CSA (−210 μm2; time p = 0.001). Interestingly, satellite cell counts within the WPC (p < 0.05) and WPH (p < 0.05) groups were greater at T39 relative to T1. In summary, LEU or protein supplementation (standardized to LEU content) does not provide added benefit in increasing whole-body skeletal muscle mass or strength above PLA

  1. Evaluation of anticoagulant control in a pharmacist operated anticoagulant clinic.

    OpenAIRE

    Radley, A S; Hall, J.; Farrow, M.; Carey, P. J.

    1995-01-01

    AIMS--To compare the quality of outpatient anticoagulant control before and after the transfer of dosing responsibility to designated trained pharmacists from rotating junior medical staff. METHODS--All International Normalised Ratio (INR) values for an eight month period either side of the staff changeover were assessed for precision of therapeutic control according to described standards. Allowing for patient associated effects, observed and expected frequencies of "successful" control for ...

  2. Selection and measurement of control antidepressants in clinical tests for Chinese: A systematic review.

    Science.gov (United States)

    Liu, Hao; Yang, Zhi-Min; Geng, Ying; Yang, Huan; Zhao, De-Heng; Xiao, Wei-Dong; Wang, Gao-Hua

    2017-10-01

    The study aims to help domestic application units and research institutions improve their research quality of antidepressant clinical tests by studying and analyzing the current status and problems in selecting control drugs during domestic antidepressant clinical tests and illustrating some key problems that should be noted when selecting the control drug in such researches. Considering the current domestic and overseas status of control drug selection in antidepressant clinical tests, various considerations, and misunderstandings on control drug selection in domestic antidepressant clinical tests were clarified and described, and possible factors that may influence the absolute effect of antidepressants were analyzed. Furthermore, problems that should be noted in selecting control drugs for the antidepressant clinical test, especially the placebo control, were stated. During the antidepressant clinical research, selecting placebo controls conform to moral philosophy and safety requirements. To verify the absolute effect of a test drug, a placebo control should be set or 3-arm tests should be conducted as far as possible. Possible factors that may affect the absolute effect of the test drug, including illness severity of the subject at baseline and research scale, should be given consideration. Application units and research institutions should consider the selection of subjects, control the failure rate, strengthen safety risks, and control and intensify quality control to further improve the overall quality and research level of domestic antidepressant clinical tests.

  3. Ageratum conyzoides L. inhibits 5-alpha-reductase gene expression in human prostate cells and reduces symptoms of benign prostatic hypertrophy in otherwise healthy men in a double blind randomized placebo controlled clinical study.

    Science.gov (United States)

    Detering, Matthew; Steels, Elizabeth; Koyyalamudi, Sundar Rao; Allifranchini, Elena; Bocchietto, Elena; Vitetta, Luis

    2017-10-19

    A double-blind, randomized, placebo-controlled clinical trial assessed the efficacy and safety of Ageratum conyzoides in treating benign prostatic hypertrophy (BPH). In this study, 109 men with medically diagnosed BPH, aged 41-76 years, were administered the investigational product, A. conyzoides extract at a dose of 250 mg/d or placebo, q.d. for 12 weeks. The primary outcome measures were the International Prostate Symptom Score (IPSS), daily urinary frequency and safety evaluations. The secondary outcome measures were testosterone, dihydrotestosterone, oestradiol, sex hormone binding globulin (SHBG), Dehydroepiandrosterone sulfate (DHEA-S) and cortisol levels, and prostate specific antigen (PSA), lipids, blood glucose, the Aging Male's Symptom (AMS) Score and sexual function assessed by Derogatis Interview for Sexual Functioning-Self Report (DISF-SR). The effect of A. conyzoides L extract on gene expression of 5-alpha-reductase in human prostate cells was also investigated to elucidate a potential mechanism of action. The clinical study, showed a significant reduction in total IPSS score (p prostate epithelial cells. The overall results indicate that A. conyzoides may be an effective treatment for reducing symptoms of BPH in healthy men, in part, through inhibition of 5-alpha-reductase enzyme activity. © 2017 BioFactors, 2017. © 2017 International Union of Biochemistry and Molecular Biology.

  4. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two ...

  5. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    OpenAIRE

    amrutesh, sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hyg...

  6. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Kikkenborg Berg, Selina; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  7. Efficacy of functional microarray of microneedles combined with topical tranexamic acid for melasma: A randomized, self-controlled, split-face study.

    Science.gov (United States)

    Xu, Yang; Ma, Renyan; Juliandri, Juliandri; Wang, Xiaoyan; Xu, Bai; Wang, Daguang; Lu, Yan; Zhou, Bingrong; Luo, Dan

    2017-05-01

    To evaluate the efficacy of a functional microarray of microneedles (MNs) plus topical tranexamic acid (TA) for melasma in middle-aged women in China.Thirty female subjects with melasma were enrolled in this study. The left or right side of the face was chosen randomly to be pretreated with a functional microarray of MNs, followed by topical 0.5% TA solution once per week for 12 weeks. The other half-face was the control, treated with a sham device plus topical 0.5% TA solution. At baseline and at weeks 4, 8, and 12 of treatment, clinical (photographic) evaluations and parameters determined by Visia were recorded. At baseline and week 12, patient satisfaction scores and the biophysical parameters measured by Mexameter were also recorded. Side effects were evaluated at baseline and at the end of the 12 weeks.In total, 28 women (93.3%) completed the study. The brown spots' scores measured by Visia were significantly lower on the combined therapy side than on the control side at 12 weeks after starting treatment; there was no significant difference between sides at 4 or 8 weeks. After 12 weeks, melanin index (MI) decreased significantly in both 2 groups, and the MI was significantly less on the combined side at week 12. Transepidermal water loss, roughness, skin hydration, skin elasticity, and erythema index showed no significant differences between 2 sides at baseline, 4, 8, and 12 weeks after treatment. Physicians' evaluations of photographs showed better results at week 12 with combined therapy: >25% improvement was observed in the MNs plus TA side in 25 patients, and in the TA side in only 10 patients. Subjective satisfaction scores on both sides increased significantly. The participants were more satisfied with the results of the combined therapy side than the control side. No obvious adverse reactions were observed throughout the study.Combined therapy with a functional microarray of MNs and topical TA solution is a promising treatment for melasma.

  8. Role of the clinical microbiology laboratory in infection control - a Danish perspective

    DEFF Research Database (Denmark)

    Kolmos, H J

    2001-01-01

    Clinical microbiology laboratories in Denmark are located in hospitals and staffed by clinical microbiologists who are clinically trained medical doctors. Each county has its own clinical microbiology unit, serving a population of 0.3-0.6 million. The responsibilities of clinical microbiology unit...... for standardization and documentation of quality. Currently a national standard for infection control is being prepared. It consists of a main standard defining requirements for the management system and 12 subsidiary standards defining requirements for specific areas of infection control. Adoption of the standard...

  9. 78 FR 23958 - Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-04-23

    ...), a basic class of controlled substance in schedule II. The company plans to import the listed... Clinical Services, Inc., to import the basic class of controlled substance is consistent with the public... effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure that the company's...

  10. 77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

    Science.gov (United States)

    2012-12-21

    ... noroxymorphone (9668), a basic class of controlled substance in schedule II. The company plans to import the... registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance is consistent..., or protocols in effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure...

  11. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Science.gov (United States)

    2013-01-25

    ...), a basic class of controlled substance listed in schedule II. The company plans to import the listed... Clinical Services, Inc., to import the basic class of controlled substance is consistent with the public... effect on May 1, 1971. DEA has investigated Fisher Clinical Services, Inc., to ensure that the company's...

  12. Development of a clinical data warehouse for hospital infection control.

    Science.gov (United States)

    Wisniewski, Mary F; Kieszkowski, Piotr; Zagorski, Brandon M; Trick, William E; Sommers, Michael; Weinstein, Robert A

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse.

  13. Development of a Clinical Data Warehouse for Hospital Infection Control

    Science.gov (United States)

    Wisniewski, Mary F.; Kieszkowski, Piotr; Zagorski, Brandon M.; Trick, William E.; Sommers, Michael; Weinstein, Robert A.

    2003-01-01

    Existing data stored in a hospital's transactional servers have enormous potential to improve performance measurement and health care quality. Accessing, organizing, and using these data to support research and quality improvement projects are evolving challenges for hospital systems. The authors report development of a clinical data warehouse that they created by importing data from the information systems of three affiliated public hospitals. They describe their methodology; difficulties encountered; responses from administrators, computer specialists, and clinicians; and the steps taken to capture and store patient-level data. The authors provide examples of their use of the clinical data warehouse to monitor antimicrobial resistance, to measure antimicrobial use, to detect hospital-acquired bloodstream infections, to measure the cost of infections, and to detect antimicrobial prescribing errors. In addition, they estimate the amount of time and money saved and the increased precision achieved through the practical application of the data warehouse. PMID:12807807

  14. Exigência de lisina para aves de reposição de 7 a 12 semanas de idade Requirement of lysine for rearing egg-type pullets from 7 to 12 weeks of age

    Directory of Open Access Journals (Sweden)

    José Humberto Vilar da Silva

    2000-12-01

    Full Text Available Os objetivos deste trabalho foram estimar as exigências de lisina e avaliar seus efeitos na fase de produção de ovos em 200 poedeiras leves (PL Lohmann Selected Leghorn, e 200 poedeiras semipesadas (PSP Isa Brown de 7 a 12 semanas. As aves foram distribuídas em delineamento em blocos ao acaso e alimentadas com ração basal contendo 16,0% de proteína bruta (PB e 2900 kcal/kg de energia metabolizável (EM suplementada com L-lisina HCl para os níveis de 0,50; 0,55; 0,60; 0,65; e 0,70% de lisina total nas rações. Na fase de postura, 160 aves de cada linhagem foram alimentadas com ração de produção contendo 16,5% de PB, 2900 kcal de EM, 2,9% de Ca+2 e 0,755% de lisina. As estimativas das exigências de lisina obtidas pelo ganho de peso, para a fase de 7 a 12 semanas de idade, foram de 0,64%, ou consumo de 368 mg diário para as PL, e de 0,66%, ou consumo de 395 mg diário para as PSP. Produção de ovos, conversão por massa e conversão por dúzia de ovos das linhagens foram afetadas de forma quadrática pelos níveis de lisina da ração. O consumo de ração das PL em produção foi afetado de forma quadrática e das PSP de forma linear. Durante a fase de crescimento, as PL apresentaram menor ganho de peso e consumo de ração e pior conversão alimentar que as PSP. Durante a fase de postura, as PSP apresentaram maiores produção e massa de ovos, menor consumo e melhores conversões por massa e por dúzia de ovos que as PL.The objectives of this work were to estimate the requirement of lysine from 7 to 12 weeks and to evaluate their effect on the egg production phase. Two hundred egg-white pullets (EW, and two hundred egg-brown pullets (EB strains were allotted in randomized block design, and fed a basal diet with 16.0% of crude protein (CP and 2,900 kcal/kg metabolizable energy (ME, supplemented with L-lysine HCl for the level of 0.50, 0.55, 0.60, 0.65, and 0.70% of total lysine in the diet. In the laying period, 160 birds from each

  15. Effects of intensive strength-power training on sense of coherence among 60-85-year-old people with hip fracture: a randomized controlled trial.

    Science.gov (United States)

    Pakkala, Inka; Read, Sanna; Sipilä, Sarianna; Portegijs, Erja; Kallinen, Mauri; Heinonen, Ari; Alen, Markku; Kiviranta, Ilkka; Rantanen, Taina

    2012-06-01

    Older people with disabilities are at increased risk of psychological health decline. There are no earlier studies on the effects of resistance training on sense of coherence (SOC) among older people with a history of hip fracture. The aim of this study is to test the effects of intensive 12-week strength-power training on SOC among older adults after hip fracture. A clinical sample of 60-85-year-old community-dwelling men and women was studied, 0.5. to 7.0 years after hip fracture. Forty-six had no contraindications for participation and were randomized into training (n=24) and control groups (n=22). The training group participated in a 12-week, individually tailored, strength-power training program, twice a week in a senior gym and supervised by an experienced physiotherapist. SOC was assessed with Antonovsky's short 13-item scale. Data were collected at baseline and after intervention. Intensive 12-week strength-power training had no effect on participants' SOC level. Results indicated no change in SOC after 12-week physical exercise training among participants after hip fracture. Further studies on SOC among older people with disabilities and potential ways of increasing it are needed.

  16. NeuroControl: system identification approach for clinical benefit.

    Directory of Open Access Journals (Sweden)

    Carel G.M. Meskers

    2015-09-01

    Full Text Available Progress in diagnosis and treatment of movement disorders after neurological diseases like stroke, cerebral palsy, dystonia and at old age requires understanding of the altered capacity to adequately respond to physical obstacles in the environment. With posture and movement disorders, the control of muscles is hampered, resulting in aberrant force generation and improper impedance regulation. Understanding of this improper regulation not only requires the understanding of the role of the neural controller, but also attention for the 1 the interaction between the neural controller and the plant, comprising the biomechanical properties of the skeleton including the viscoelastic properties of the contractile (muscle and non-contractile (connective tissues: neuromechanics and 2 the closed loop nature of neural controller and biomechanical system in which cause and effect interact and are hence difficult to separate. Properties of the neural controller and the biomechanical system need to be addressed synchronously by the combination of haptic robotics, (closed loop system identification, and neuro-mechanical modelling. In this paper, we argue that assessment of neuromechanics in response to well defined environmental conditions and tasks may provide for key parameters to understand posture and movement disorders in neurological diseases and as biomarkers to increase accuracy of prediction models for functional outcome and effects of intervention.

  17. Effects of glucosamine sulfate and exercise therapy on serum leptin levels in patients with knee osteoarthritis: preliminary results of randomized controlled clinical trial.

    Science.gov (United States)

    Durmus, Dilek; Alayli, Gamze; Aliyazicioglu, Yuksel; Buyukakıncak, Ozlem; Canturk, Ferhan

    2013-03-01

    Osteoarthritis (OA) is a slow, chronic disease characterized by the focal deterioration and abrasion of articular cartilage. Leptin may play an important role in the pathophysiology of OA. Exercise and glucosamine sulfate therapy is one of the most commonly used in patients with knee OA. The goals of the present study are performed to investigate whether 12-week strength training program and glucosamine sulfate have an effect on serum leptin levels in knee OA and the relationship between leptin, clinical parameters, and radiographic severity of knee OA. Thirty-seven women with the diagnosis of knee OA were enrolled in the study. Patients were randomized into two groups. Group I (n = 19) received an exercise program, while group II (n = 18) received glucosamine sulfate (1,500 mg/day) in addition to the exercise therapy. Both groups were treated for 12 weeks. Leptin level was assessed at baseline and after 12 weeks. The concentration of leptin was measured by ELISA. The patients were evaluated regarding pain, disability, functional performance, and muscle strength. Both groups showed significant improvements in leptin levels, pain, disability, muscle strength, and functional performance with no statistically significant difference between the groups after the therapy. At basal time, plasma leptin levels were significantly correlated with body mass index and duration of disease, but no significant correlation was found with patient age, pain, disability, functional performance, muscle strength, and radiographic severity of knee OA. The results of this preliminary study revealed that exercise alone was adequate to prevent structural changes relieving the symptoms of OA. We also found that exercise alone could affect serum plasma levels of the leptin, important mediators of cartilage metabolism. Decreases in serum leptin may be one mechanism by which cartilage metabolism affects physical function and symptoms in OA patients.

  18. Severe Self-Injurious Behavior: The Problem of Clinical Control

    Science.gov (United States)

    Romanczyk, Raymond G.; Goren, Elizabeth R.

    1975-01-01

    The long-term treatment program and follow-up of a case of chronic, severe, multiple self-injurious behavior is presented. Contingent electric shock and differential reinforcement of other behavior were the primary techniques utilized. Total suppression was achieved in the laboratory setting, but extending control to the natural environment proved…

  19. Controlled clinical trial of cannabidiol in Huntington's disease.

    Science.gov (United States)

    Consroe, P; Laguna, J; Allender, J; Snider, S; Stern, L; Sandyk, R; Kennedy, K; Schram, K

    1991-11-01

    Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

  20. The effects of omega-3 fatty acids and vitamin E co-supplementation on clinical and metabolic status in patients with Parkinson's disease: A randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Tamtaji, Omid Reza; Dadgostar, Ehsan; Daneshvar Kakhaki, Reza; Bahmani, Fereshteh; Abolhassani, Javad; Aarabi, Mohammad Hossein; Kouchaki, Ebrahim; Memarzadeh, Mohammad Reza; Asemi, Zatollah

    2017-09-01

    The current research was performed to evaluate the effects of omega-3 fatty acids and vitamin E co-supplementation on clinical signs and metabolic status in people with Parkinson's disease (PD). This randomized double-blind placebo-controlled clinical trial was conducted in 60 patients with PD. Participants were randomly assigned into two groups to receive either 1000 mg omega-3 fatty acids from flaxseed oil plus 400 IU vitamin E supplements (n = 30) or placebo (n = 30) for 12 weeks. Unified Parkinson's disease rating stage (UPDRS) were recorded at baseline and the after 3-month intervention. After 12 weeks' intervention, compared with the placebo, omega-3 fatty acids and vitamin E co-supplementation led to a significant improve in UPDRS (-3.3 ± 10.0 vs. +4.4 ± 14.9, P = 0.02). Furthermore, co-supplementation decreased high-sensitivity C-reactive protein (hs-CRP) (-0.3 ± 0.6 vs. +0.3 ± 0.3 μg/mL, P glutathione (GSH) concentrations (+41.4 ± 80.6 vs. -19.6 ± 55.9 μmol/L, P = 0.001) compared with the placebo. Additionally, co-supplementation meaningfully decreased insulin (-2.1 ± 4.9 vs. +1.4 ± 6.2 μIU/mL, P = 0.01), homeostasis model of assessment-estimated insulin resistance (-0.7 ± 1.8 vs.+0.3 ± 1.6, P = 0.02) and Beta cell function (-5.9 ± 13.9 vs. +5.7 ± 25.5, P = 0.03), and increased quantitative insulin sensitivity check index (+0.009 ± 0.02 vs. -0.006 ± 0.03, P = 0.03) compared with the placebo. Overall, our study demonstrated that omega-3 fatty acids and vitamin E co-supplementation in people with PD had favorable effects on UPDRS, hs-CRP, TAC, GSH and markers of insulin metabolism. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Efficacy of metronidazole versus placebo in pain control after hemorrhoidectomy: results of a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Sergio Solorio-López

    2015-11-01

    Full Text Available Introduction: Hemorrhoidal disease occurs in 50% of people aged > 40 years and is the most common reason for anorectal surgery. Pain is the main complication. Multiple topical and systemic drugs have been investigated for pain control, but there is no ideal treatment. Metronidazole has been shown to decrease postoperative pain but is not used widely. Objective: To evaluate the effect of oral metronidazole versus placebo and to assess postoperative pain following hemorrhoidectomy. Material and methods: Controlled clinical trial in adult patients who underwent elective hemorrhoidectomy for grade III/IV hemorrhoids. Patients were assigned to receive metronidazole (500 mg q8 h orally; study group, SG or placebo (control group, CG for 7 days after surgery. Pain was assessed using a visual analog scale after surgery. Analgesic administration (time and use of analgesics and resumption of daily life activities were also assessed. Results: Forty-four patients were included, 22 in each group. Postoperative pain differed significantly between the SG and CG at 6 h (3.86 ± 0.56, 6.64 ± 1.49, 12 h (5.59 ± 1.33, 8.82 ± 0.79, 24 h (6.86 ± 1.49, 9.73 ± 0.45, day 4 (5.32 ± 2.10, 9.50 ± 0.59, day 7 (3.14 ± 1.03, 7.36 ± 1.39, and day 14 (2.14 ± 0.46, 5.45 ± 1.29. The first analgesia dose was required at 21.27 ± 5.47 h in the CG and 7.09 ± 2.36 h in the SG (p < 0.05, the time of analgesic use was 6.86 ± 1.61 days in the CG and 13.09 ± 2.48 days in the SG (p < 0.05, and resumption of daily activities occurred at 7.59 ± 1.56 days in the CG and 14.73 ± 3.76 days in the SG (p < 0.05. Conclusion: Oral administration of metronidazole is effective in pain management after hemorrhoidectomy.

  2. A Clinical Study Evaluating the Effects of Fluvastatin on Serum Osteoprotegerin Levels in Rheumatoid Arthritis Patients.

    Science.gov (United States)

    Hegazy, Sahar Kamal; El-Ghany El-Sayed, Salwa El-Morsy Abd; El-Hefnawy, Marwa El-Saeed

    2016-10-01

    Osteoprotegerin (OPG), a member of the tumor necrosis factor receptor family, has been identified as a critical regulator of bone resorption. Considering the possible role of OPG in rheumatoid arthritis (RA) and in the osteoclastogenesis suppression effects of statins, the present study aims to investigate the effects of fluvastatin on serum levels OPG and disease activity score (DAS) in patients with RA. Forty patients with RA were randomized in a placebo-controlled trial to receive 40 mg fluvastatin or placebo as an adjunct to existing disease-modifying antirheumatic drug (DMARD) therapy (methotrexate, leflunomide, hydroxychloroquine). Patients were followed up over 12 weeks. OPG and disease activity variables were measured at baseline and after 12 weeks of treatment. After 12 weeks, the OPG level was significantly increased in the fluvastatin group compared to the placebo group. DAS-28 was significantly decreased in the fluvastatin group compared to the placebo group. C-reactive protein (CRP), morning stiffness, swollen joint count (SJC), and tender joint count (TJC) were significantly decreased in the fluvastatin group compared to the placebo group; however, erythrocyte sedimentation rate (ESR), modified health assessment questionnaire (MHAQ), and visual analogue screen (VAS) were not changed significantly. In conclusion, fluvastatin administration could increase the OPG levels and improve disease activity variables in patients with RA. Therefore, fluvastatin may serve a potential benefit in the treatment of RA patients. © 2016, The American College of Clinical Pharmacology.

  3. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

    Directory of Open Access Journals (Sweden)

    Norio Sugawara

    Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

  4. Clinical and radiographic evaluation of pulpectomy in primary teeth: a 18-months clinical randomized controlled trial.

    Science.gov (United States)

    Chen, Xiaoxian; Liu, Xinggang; Zhong, Jie

    2017-10-27

    To avoid untoward changes when primary teeth are replaced by permanent teeth, resorption of the material used in primary teeth root canal filling should occur at the same rate as root resorption. The Aim of this study was to compare the success rates of a mixed primary root canal filling (MPRCF, ingredients: zinc oxide-eugenol [ZOE], iodoform, calcium hydroxide) to those of ZOE and Vitapex in pulpectomised primary molars. One hundred and sixty primary molars from 155 children (average age 5.88 ± 1.27 years) underwent two-visit pulpectomy using one of the three materials. The clinical and radiographic findings at 6, 12 and 18 months were assessed. At 6 and 12 months, the MPRCF and ZOE success rates were 100%. The Vitapex group showed clinical success rate and radiographic success rate of 100 and 94.5% at 6 months, and 80.4 and 60.7% at 12 months. The 18-month clinical success rates of the MPRCF, ZOE and Vitapex were 96.2, 92.2 and 71.4% and radiographic success rates were 92.5, 88.2 and 53.6%, respectively. There was a statistically significant difference in the success rates between MPRCF and Vitapex and no significant differences between MPRCF and ZOE. More MPRCF were resorbed at same rate with roots than ZOE and Vitapex. Early resorption of root filling resulted in more failure. The mixture of ZOE, iodoform and calcium hydroxide can be considered an effective root canal filling material in pulp involved primary teeth and had no adverse effect on tooth replacement. ChiCTR-TRC-14004938 . Registered 13 July 2014.

  5. Involving clinical librarians at the point of care: results of a controlled intervention.

    Science.gov (United States)

    Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

    2011-12-01

    To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

  6. Responsiveness and minimal clinically important change

    DEFF Research Database (Denmark)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah

    2015-01-01

    to assess shoulder outcomes. However, few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinically important change. Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after......Study Design A prospective cohort study nested in a randomized controlled trial. Objectives To determine and compare responsiveness and minimal clinically important change of the modified Constant score (CS) and the Oxford Shoulder Score (OSS). Background The OSS and the CS are commonly used....... The change scores of the CS and the OSS were more strongly correlated with the external anchor (PGIC scale) than the change score of the EQ-5D-3L index. The areas under the ROC curves exceeded 0.80 for both shoulder scores, with no significant differences between them, and comparable effect-size estimates...

  7. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  8. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation

    Science.gov (United States)

    Nikolis, Andreas; Bernstein, Steven; Kinney, Brian; Scuderi, Nicolo; Rastogi, Shipra; Sampalis, John S

    2016-01-01

    Purpose Many treatment modalities exist to counteract the effects of cutaneous aging. Ablative methods have been the mainstay for nonsurgical facial rejuvenation. In recent years, nonablative techniques have been developed with the aim of achieving facial rejuvenation without epidermal damage. Light-emitting diode (LED) photorejuvenation is a novel nonablative technique that induces collagen synthesis through biophotomodulatory pathways. Materials and methods A single-center, randomized, single-blinded, placebo-controlled, split-faced clinical trial was designed. Thirty-two patients were enrolled for a 12-week study. Patients were randomized into one of four groups: Group A, treatment with KLOX-001 gel formulation and white LED (placebo) light; Group B, treatment with a placebo/base gel (no active chromophore) formulation and KLOX LED light; Group C, treatment with KLOX-001 gel formulation and KLOX LED light; and Group D, treatment with the standard skin rejuvenating treatment (0.1% retinol-based cream). Patients received treatment at weeks 0, 1, 2, and 3, and returned to the clinic at weeks 4, 8, and 12 for clinical assessments performed by an independent, blinded committee of physicians using subjective clinician assessment scales. Tolerability, adverse outcomes, and patient satisfaction were also assessed. Results Analysis demonstrated that the KLOX LED light with KLOX placebo/base gel and the KLOX LED light + KLOX-001 gel formulation groups were superior to standard of care and KLOX-001 gel formulation with placebo light on subjective clinical assessment and multiple wrinkle scales, with statistically significant results obtained for brow positioning, perioral wrinkling, and total wrinkle score. Conclusion The study results show that KLOX LED light with KLOX-001 gel formulation and KLOX LED light with KLOX placebo/base gel are effective, safe, well-tolerated, and painless treatment modalities for skin rejuvenation. PMID:27257391

  9. [Medical treatment of hyperammoniemia in the elderly. Controlled clinical study].

    Science.gov (United States)

    Marchina, M M; Renzi, G; Serofilli, S

    1979-03-03

    After considering the physiopathological mechanisms of ammoniac metabolism and the different causes of hyperammonaemia in subjects whose organisms present the weak biological equilibrium of the elderly, the antiammonaemic activity of gamma-ethylester of glutamic acid and that of arginine have been compared in a controlled double-blind trial. 45 old patients suffering from hepatic insufficiency characterized by hyperammonaemia and correlated neurological symptomatology have been treated. The subjects, subdivided at random into groups of 15, were treated for an average of 8.8 days with gamma-ethylester of glutamic acid, arginine and placebo presented in identical 500 ml bottles. The posology of the active ingredients ranged form a maximum of 25 g to a minimum of 10 g. The results obtained show that gamma-ethylester of glutamic acid and arginine has significantly greater antiammonemic activity than placebo and that gamma-ethylester of glutamic acid is significantly more effective than arginine. As regards the improvement in neuropsychic symptomatology, the clear superiority of gamma-ethylester of glutamic acid versus both arginine and placebo non evident.

  10. A randomized controlled trial on the effects of combined aerobic-resistance exercise on muscle strength and fatigue, glycemic control and health-related quality of life of type 2 diabetes patients.

    Science.gov (United States)

    Tomas-Carus, Pablo; Ortega-Alonso, Alfredo; Pietilainen, Kirsi H; Santos, Vitoria; Goncalves, Helena; Ramos, Jorge; Raimundo, Armando

    2016-05-01

    The aim of this paper was to evaluate the effects of a 12-weeks combined aerobic-resistance exercise therapy on fatigue and isokinetic muscle strength, glycemic control and health-related quality of life (HRQoL) in moderately affected type 2 diabetes (T2DM) patients. A randomized controlled trial design was employed. Forty-three T2DM patients were assigned to an exercise group (N.=22), performing 3 weekly sessions of 60 minutes of combined aerobic-resistance exercise for 12-weeks; or a no exercise control group (N.=21). Both groups were evaluated at a baseline and after 12-weeks of exercise therapy for: 1) muscle strength and fatigue by isokinetic dynamometry; 2) plasma glycated hemoglobin A1C (HbA1C); and 3) HRQoL utilizing the SF-36 questionnaire. The exercise therapy led to improvements in muscle fatigue in knee extensors (-55%) and increased muscle strength in knee flexors and extensors (+15 to +30%), while HbA1C decreased (-18%). In addition, the exercising patients showed sizeable improvements in HRQoL: physical function (+53%), vitality (+21%) and mental health (+40%). Twelve-weeks of combined aerobic-resistance exercise was highly effective to improve muscle strength and fatigue, glycemic control and several aspects of HRQoL in T2DM patients. These data encourage the use of aerobic and resistance exercise in the good clinical care of T2DM.

  11. A randomized, double-blind, placebo-controlled, clinical study on the efficacy and safety of calcium dobesilate in the treatment of chronic venous insufficiency.

    Science.gov (United States)

    Rabe, Eberhard; Ballarini, Stefania; Lehr, Lorenz

    2016-05-01

    To show the superiority of 500 mg calcium dobesilate vs. placebo in reduction of edema of the lower limbs in patients with chronic venous insufficiency, Clinical, Etiological, Anatomical and Pathophysiological classes C3/C4. A total of 351 patients were randomized (n = 174 calcium dobesilate, n = 177 placebo). Active treatment was 500 mg calcium dobesilate, three times daily for 12 weeks, with a 12-week follow-up. At the end of treatment, the relative volume change in the most pathological leg was -0.6 ± 4.8% with calcium dobesilate compared to -0.3 ± 3.3% with placebo (p = 0.09). At the end of follow-up, this was -1.01 ± 5.4% for calcium dobesilate vs. -0.08 ± 3.5% for placebo (p = 0.002). Calcium dobesilate treatment resulted in no significant volume change in the most pathological leg between baseline and end of treatment. However, the calcium dobesilate group showed a significantly greater volume decrease in the most pathological leg at the end of follow-up. Calcium dobesilate was well-tolerated, with a safety profile consistent with previously published data. © The Author(s) 2015.

  12. Glucose control can be similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial.

    Science.gov (United States)

    Delevatti, Rodrigo S; Kanitz, Ana Carolina; Alberton, Cristine L; Marson, Elisa Corrêa; Lisboa, Salime Chedid; Pinho, Carolina Dertzbocher Feil; Lovatel, Gisele A; Korb, Arthiese; Bertoldi, Karine; Macedo, Rodrigo C O; Siqueira, Ionara R; Schaan, Beatriz D; Kruel, Luiz Fernando M

    2016-08-01

    To compare the effects of two aerobic training methods in water and on dry-land on glycemic, lipid, inflammatory, hormonal, cardio