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Sample records for 12-week randomized intervention-study

  1. 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 programme...

  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

    Science.gov (United States)

    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

    Objective 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. Materials and Methods 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. Results 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. Conclusion 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. Trial Registration CRiS KCT0001771 PMID:27253526

  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.

    Directory of Open Access Journals (Sweden)

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

    Directory of Open Access Journals (Sweden)

    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.

  5. 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

  6. 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

    OpenAIRE

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

    2016-01-01

    Objective 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. Materials and Methods P...

  7. Postural correction for kyphosis improves the dyspnea index and pulmonary functions in patients with chronic obstructive pulmonary disease: A randomized trial over 12 weeks

    Directory of Open Access Journals (Sweden)

    Gajanan S Gaude

    2014-01-01

    Full Text Available Background: Patients with chronic obstructive pulmonary disease (COPD tend to attain forward shoulder posture and kyphosis and this affects their respiratory functions. Correcting this posture leads to straightening of the spine leading to improvement in the lung functions. The present study was carried out to evaluate the additional effect of correction of kyphosis in COPD patients. Objectives: The objective of the following study is to evaluate the effect of postural correction with respiratory muscle training in patients with COPD. Settings and Study Design: A randomized controlled prospective study in a tertiary care hospital in out-patients for 12 weeks. Materials and Methods: Confirmed cases of COPD were randomly divided into two groups by computer generated randomization: Study and control group. Study group patients received combination of respiratory muscle training and postural correction by a brace, whereas the control group received only respiratory muscle training exercises. The outcome measures evaluated were maximal inspiratory pressure, spirometry values, dyspnea scores and 6-min walk distance (MWD. Statistical Analysis: Statistical analysis was performed using Statistical Package for the Social Sciences version 16. Descriptive statistics are reported as means and standard deviation. Results: A total of 120 patients were included in the study with 60 in each group. Both groups showed a significant improvement in the inspiratory muscle strength, lung functions, dyspnea index and functional capacity at 8 weeks and 12 weeks of intervention. However, the interscapular distance, percentage of kyphotic index (KI and grades of a plumb line (PL measurement reduced significantly in the study group when compared to the control group (P < 0.01. There was also significant improvement in the 6-MWD and reduction of Borg scale of dyspnea when compared to the control group (P < 0.01. The pulmonary functions improvement was better in the study

  8. 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

  9. 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 management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  10. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

    Directory of Open Access Journals (Sweden)

    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.

  11. Perspectives on randomization and readiness for change in a workplace intervention study

    DEFF Research Database (Denmark)

    Nabe-Nielsen, Kirsten; Persson, Roger; Nielsen, Karina;

    2015-01-01

    , it is important to investigate differences between study groups in readiness for change. To meet this aim, we used data from an intervention study of the effects of work-time control. The study design entailed both self-selection (i.e. non-random) and random allocation into intervention and control groups. Some...... team leaders rejected randomization because they considered it to be fairest to increase work-time control among employees in most need. Others accepted randomization arguing that it was fairer to allocate a potential benefi t by random. We found no difference in readiness for changes when comparing...

  12. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  13. Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

    Directory of Open Access Journals (Sweden)

    Kanamoto T

    2012-03-01

    Full Text Available Shunsuke Nakakura1, Hitoshi Tabuchi1, Yukio Baba2, Futoshi Maruiwa2, Nobuko Ando2, Takashi Kanamoto3, Yoshiaki Kiuchi31Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Hyogo Prefecture, Japan; 2Department of Ophthalmology, Baba Eye Clinic, Hiroshima, Japan, 3Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima City, JapanObjective: To compare the safety and effectiveness of fixed-combination regimes (latanoprost–timolol and brinzolamide 1% compared to dorzolamide 1%/timolol and latanoprost in open-angle glaucoma patients after switching from a combination of three topical antiglaucoma eye drops.Methods: We conducted an open, randomized 12-week multicenter prospective study. We randomly allocated 39 patients who had been treated with three antiglaucoma eye drops (prostaglandin F2α analogues plus beta-blockers and carbonic anhydrase inhibitors into two groups. Group A (n = 20 were treated with latanoprost–timolol and brinzolamide 1% therapy and Group B (n = 16 were treated with dorzolamide 1%/timolol and latanoprost. Thirty-six patients completed all 12 weeks of this study. The major clinical parameters measured were intraocular pressure (IOP, conjunctive hyperemia, superficial punctate keratopathy and hyperpigmentation of eyelid at baseline, 4, and 12 weeks. Additionally noted were adverse events and patient preferences, measured using a questionnaire at study initiation and at 12 weeks.Results: At baseline, IOPs were (Group A: 14.1 ± 2.9 mmHg, B: 14.5 ± 2.9 mmHg; P = 0.658, (Group A: 13.8 ± 2.6 mmHg, B: 14.3 ± 2.8 mmHg; P = 0.715 at 4 weeks, and (Group A: 14.1 ± 2.7 mmHg, B: 14.2 ± 2.7 mmHg; P = 0.538 at 12 weeks. Among the groups, there was no significant difference at any time point after baseline (P = 0.923, 0.951, respectively. All adverse events were not remarkably different after therapy. In regards to patient preference before and after

  14. Early rehabilitation of cancer patients – a randomized controlled intervention study

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    Arving Cecilia

    2013-01-01

    Full Text Available Abstract Background Faced with a life-threatening illness, such as cancer, many patients develop stress symptoms, i.e. avoidance behaviour, intrusive thoughts and worry. Stress management interventions have proven to be effective; however, they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. Method Patients (≥ 18 years with a recent diagnosis of breast cancer, colorectal cancer, lymphoma, prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment, will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach, patients will be randomized to control, treatment as usual, or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention, given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses, 300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level, sleep duration and quality recorded objectively, and anxiety, depression, quality of life, fatigue, stress in daily living, and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be

  15. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers - a randomized controlled intervention study

    DEFF Research Database (Denmark)

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen;

    2012-01-01

    tailored exercise programs on their physical fitness and muscular capacity. METHOD: The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week......) of 28.3 (SD 4.7). Compared to representative data on employees in Denmark (N=78), this study population (N=67) had significantly lower relative aerobic capacity [difference in z-score -1.13 (SE 0.1), P...

  16. 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

  17. 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

    OpenAIRE

    Ishikawa, Shusaku; Nakamura, Yoshimi; Nakamura, Yuko; Sakai, Hiroshi; Sawaguchi, Shoichi; Terashima, Kazuo; Kanno, Makoto; Yamashita, Hidetoshi

    2008-01-01

    Purpose 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 (SD)y] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol...

  18. 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, placeb

  19. A randomized multifactorial intervention study for prevention of ischaemic heart disease (Inter99): The long-term effect on physical activity

    DEFF Research Database (Denmark)

    Smith, L.V.H.; Ladelund, S.; Borch-Johnsen, K.;

    2008-01-01

    AIM: To examine the effect of a randomized multiple risk factor intervention study for prevention of ischaemic heart disease (IHD) on the development in physical activity over a 36-month period. METHODS: Two random samples (high intensity intervention, group A, n=11,708; low intensity interventio...

  20. 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 c...

  1. Moderate alcohol consumption and changes in postprandial lipoproteins of premenopausal and postmenopausal women : a diet-controlled, randomized intervention study

    NARCIS (Netherlands)

    Gaag, van der M.S.; Sierksma, A.; Schaafsma, G.; Bakker, M.; Hendriks, J.F.J.

    2000-01-01

    Moderate alcohol consumption is associated with a reduced risk of coronary heart disease. Earlier studies in men have shown that moderate alcohol consumption affects lipoprotein metabolism and hemostasis. In this diet-controlled, randomized, crossover trial, we investigated the effect on lipoprotein

  2. Factors Associated with High Use of a Workplace Web-Based Stress Management Program in a Randomized Controlled Intervention Study

    Science.gov (United States)

    Hasson, H.; Brown, C.; Hasson, D.

    2010-01-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program…

  3. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    Science.gov (United States)

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  4. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    Science.gov (United States)

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  5. The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

    Science.gov (United States)

    Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

    2011-01-01

    Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (vitamin D levels (vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

  6. Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER—A Randomized Controlled Lifestyle Trial

    Directory of Open Access Journals (Sweden)

    Tiia Ngandu

    2014-09-01

    Full Text Available Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER study population. Potential study participants (age 60–77 years, the dementia risk score ≥6 were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496, 48% (n = 2654 attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1. The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD age of the randomized participants was 69.4 (4.7 years, Mini-Mental State Examination 26.7 (2.0 points, systolic blood pressure 140.1 (16.2 mmHg, total serum cholesterol 5.2 (1.0 mmol/L for, and fasting glucose 6.1 (0.9 mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

  7. Recruitment and Baseline Characteristics of Participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)—A Randomized Controlled Lifestyle Trial †

    Science.gov (United States)

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-01-01

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60–77 years, the dementia risk score ≥6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

  8. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

    Science.gov (United States)

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-09-01

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons. PMID:25211775

  9. 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

  10. 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

    .45, 0.60, or 0.75 mg), placebo, or open-label sulfonylurea (glimepiride, 1-4 mg). The primary end point was HbA(1c) after 12 weeks; secondary end points were fasting serum glucose, fasting C-peptide, fasting glucagon, fasting insulin, beta-cell function, body weight, adverse events, and hypoglycemic....... 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...

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

    DEFF Research Database (Denmark)

    Svenningsen, Helle; Sørensen, Dorthe

    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...

  12. Design of the study: How can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care

    Directory of Open Access Journals (Sweden)

    Nordin Karin

    2012-05-01

    Full Text Available Abstract Background A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. Method Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance assessed by the Impact of Event Scale (IES. According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. Discussion This randomized clinical trial will provide

  13. The efficacy of 12 weeks supervised exercise in obesity management.

    Science.gov (United States)

    Herring, L Y; Wagstaff, C; Scott, A

    2014-08-01

    The objective of this randomized controlled trial was to investigate the effect of adding either aerobic training (AT) or resistance training (RT) to a multidisciplinary teamed (MDT) educational weight management programme on the health-related fitness of morbidly obese individuals. Males (n = 9) and females (n = 24) aged between 24 and 68 years with a body mass index (BMI) of ≥40 kg m(2) (≥35 kg m(2) with comorbidities) undertaking a weight management programme were recruited (Completion: M = 8, F = 19). Participants were randomly allocated to either AT (n = 12), RT (n = 11) or CON (n = 10). AT and RT undertook three structured ∼60 min moderate intensity sessions weekly, two supervised gym-based and one structured home-based session for 12 weeks; CON undertook usual care alone. Anthropometric, psychological and functional capacity measures were obtained pre- and post-intervention. Both exercise interventions elicited improvements compared with CON in the: shuttle walk test (AT [Δ 207.0 ± 123.0 metres, 68.0%, P = 0.04], RT [Δ 165.0 ± 183.3 m, 48.8%, P = 0.06], CON [Δ -14.3 ± 38.7 m, -6.2%]), triceps skin-fold (P ≤ 0.001), self-efficacy (P = 0.005) and interest/enjoyment (P = 0.006). RT displayed additional improvements compared with CON in BMI (RT [Δ -1.02 ± 0.91 kg·m(2) , -2.5%, P = 0.033], AT [Δ -1.84 ± 2.70 kg·m(2) , -4.3%, P = 0.142], CON [Δ -0.31 ± 1.47 kg·m(2) , -0.6%]), waist circumference (P = 0.022), competence (P = 0.019), biceps skin-fold (P = 0.012) and medial calf skin-fold (P = 0.013). No significant differences were observed between exercise modalities. Regardless of exercise mode, the addition of supervised and structured exercise to a MDT weight management programme significantly improved anthropometric, functional and psychological measures in obese participants with a BMI of ≥35 kg·m(2) . PMID

  14. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    Science.gov (United States)

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  15. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients

    Science.gov (United States)

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-01-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  16. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    Science.gov (United States)

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy. PMID:27512271

  17. Promotion of exclusive breastfeeding is not likely to be cost effective in West Africa. A randomized intervention study from Guinea-Bissau

    DEFF Research Database (Denmark)

    Jakobsen, Marianne S; Sodemann, Morten; Biai, Sidu;

    2008-01-01

    cohort of 1721 infants were randomized to receive health education: promotion of exclusive breastfeeding for the first 4-6 months of life according to WHO recommendations at the time of the study. All children were followed from birth to 6 months of age. RESULTS: Introduction of both water and weaning...

  18. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    Science.gov (United States)

    Thorup, Anne Cathrine; Lambert, Max Norman; Kahr, Henriette Strøm; Bjerre, Mette; Jeppesen, Per Bendix

    2015-01-01

    Objective. To investigate the effect by which daily consumption of a novel red clover (RC) extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones) or placebo. Methods. Bone parameters were changes in bone mineral density (BMD), bone mineral content (BMC), and T-score at the lumbar spine and femoral neck. Bone turnover (CTx) and inflammatory markers were measured in plasma and finally blood pressure (BP) was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed. PMID:26265926

  19. 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.

  20. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

    OpenAIRE

    Ruzek Josef I; Rosen Raymond C; Marceau Lisa; Larson Mary; Garvert Donn W; Smith Lauren; Stoddard Anne

    2012-01-01

    Abstract This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic...

  1. How can health care help female breast cancer patients reduce their stress symptoms? : A randomized intervention study with stepped-care

    OpenAIRE

    Nordin, Karin; Rissanen, Ritva; Ahlgren, Johan; Burell, Gunilla; Fjällskog, Marie-Louise; Borjesson, Susanne; Arving, Cecilia

    2012-01-01

    Background: A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized stu...

  2. Histological changes in the bone structure induced at 12 weeks by experimental administration of bisphosphonates

    OpenAIRE

    ALMAŞAN, Horea Artimoniu; BACIUT, MIHAELA; ALMAŞAN, Oana Cristina; Bran, Simion; BACIUT, GRIGORE

    2013-01-01

    Histological changes in bone structure were induced at 12 weeks by experimental administration of bisphosphonates, which have been associated with osteonecrosis of the jaws. The purpose of this study was to determine the effect of local administration of bisphosphonate on bone formation in rats. Surgically created bone defects were evaluated at 12 weeks by histological examination after bisphosphonate administration. Fifteen Wistar rats that underwent surgery to create a bone defect at the ri...

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

    OpenAIRE

    Z Shanazari; SM Marandi; S Samie

    2013-01-01

    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 pres...

  4. The effect of 12-week Pilates exercises on wellness in the elderly

    OpenAIRE

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P

  5. Effects of Tai Chi and resistance training on cardiovascular risk factors in elderly Chinese subjects: A 12-month longitudinal, randomized, controlled intervention study

    OpenAIRE

    Hong, AWL; Woo, J.; Thomas, GN; Tomlinson, B; Lau, E.; Lam, CWK; Sanderson, JE

    2005-01-01

    Background: Tai Chi is rapidly gaining in popularity, worldwide. This study was performed to assess its impact on cardiovascular risk factors in comparison with resistance training exercises in elderly Chinese subjects. Methods: A total of 207 healthy elderly participants (65-74 years, 113/207 (55%) men) were randomly assigned to one of three intervention groups: (1) Tai Chi, three times/week for 1 h/session (n = 64); (2) resistance training exercise, three times/week for 1 h/session (n = 65)...

  6. A randomized multifactorial intervention study for prevention of ischaemic heart disease (Inter99): the long-term effect on physical activity

    DEFF Research Database (Denmark)

    von Huth Smith, Lisa; Ladelund, Steen; Borch-Johnsen, Knut;

    2008-01-01

    , group B, n=1,308) were invited for a health examination, an assessment of absolute risk of developing IHD, and an individualized lifestyle intervention. The participation rate was 52.5%. High-risk persons in group A were also offered diet/physical activity and/or smoking cessation group counselling....... High-risk persons in group B were referred to their GP. High-risk persons were re-counselled after 12 and 36 months. The control group (group C, n=5,264, response rate=61.3%) answered a mailed questionnaire. Data were analysed using longitudinal linear regression models with random effects. MAIN...

  7. Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

    Directory of Open Access Journals (Sweden)

    Ruzek Josef I

    2012-05-01

    Full Text Available Abstract This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD were assigned to web-based training plus supervision, web-based training, or training-as-usual (control. A novel standardized patient (SP assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems.

  8. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861

    Directory of Open Access Journals (Sweden)

    Theorell Töres

    2005-07-01

    Full Text Available Abstract Background The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. Methods A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23–64 from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. Results After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor α (TNFα decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference remained a significant factor in five out of nine predictive models. Conclusion The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  9. EFFECTS OF 12 WEEKS OF COMBINED EXERCISE TRAINING ON VISFATIN AND METABOLIC SYNDROME FACTORS IN OBESE MIDDLE-AGED WOMEN

    Directory of Open Access Journals (Sweden)

    Dong-il Seo

    2011-03-01

    Full Text Available Visfatin is a highly expressed protein with insulin-like functions located predominantly in visceral adipose tissue and has been linked to obesity and increased health risks. The purpose of this study was to examine the effects of 12 weeks of combined exercise training on visfatin and metabolic syndrome factors in obese middle-aged women. Subjects were randomly assigned to either a training (n = 10 or control (n = 10 group. The training group exercised for 1 hour, 3 days per week during the 12 week supervised training program. The training program included 3 sets of 10 repetition maximum (10RM resistance exercise as well as aerobic exercise at an intensity of 60-70% of their heart rate reserve (HRR. The control group was asked to maintain their normal daily activities. Two-way (group X time repeated measured analysis of variance revealed no significant main effects, but there was a significant group X time interaction for the following variables: body weight (p < 0.01, percent body fat (% fat (p < 0.01, waist hip ratio (WHR (p < 0.01, diastolic blood pressure (DBP (p < 0.05, fasting glucose level (p < 0.01, triglyceride levels (TG (p < 0.01, high density lipoprotein cholesterol levels (HDL-C (p < 0.05, and visfatin (p < 0.01. In conclusion, the 12 week combined resistance and aerobic training program used in this study was very effective for producing significant benefits to body composition and metabolic syndrome factors, as well as lowering visfatin levels in these obese middle-aged women.

  10. 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.

  11. The effect of 12-week Pilates exercises on wellness in the elderly.

    Science.gov (United States)

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, PPilates exercises helped improve wellness of the elderly. PMID:27162774

  12. Early management of type 2 diabetes based on a SMBG strategy: the way to diabetes regression--the St Carlos study : a 3-year, prospective, randomized, clinic-based, interventional study with parallel groups.

    Science.gov (United States)

    García de la Torre, Nuria; Durán, Alejandra; Del Valle, Laura; Fuentes, Manuel; Barca, Idoya; Martín, Patricia; Montañez, Carmen; Perez-Ferre, Natalia; Abad, Rosario; Sanz, Fuencisla; Galindo, Mercedes; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2013-08-01

    The aims are to define the regression rate in newly diagnosed type 2 diabetes after lifestyle intervention and pharmacological therapy based on a SMBG (self-monitoring of blood glucose) strategy in routine practice as compared to standard HbA1c-based treatment and to assess whether a supervised exercise program has additional effects. St Carlos study is a 3-year, prospective, randomized, clinic-based, interventional study with three parallel groups. Hundred and ninety-five patients were randomized to the SMBG intervention group [I group; n = 130; Ia: SMBG (n = 65) and Ib: SMBG + supervised exercise (n = 65)] and to the HbA1c control group (C group) (n = 65). The primary outcome was to estimate the regression rate of type 2 diabetes (HbA1c 4 kg was 3.6 (1.8-7); p < 0.001. This study shows that the use of SMBG in an educational program effectively increases the regression rate in newly diagnosed type 2 diabetic patients after 3 years of follow-up. These data suggest that SMBG-based programs should be extended to primary care settings where diabetic patients are usually attended.

  13. The Treatment for Adolescents with Depression Study (TADS): Methods and Message at 12 Weeks

    Science.gov (United States)

    March, John; Silva, Susan; Vitiello, Benedetto

    2006-01-01

    Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is intended to evaluate the short-term (12 weeks) and longer-term (36 weeks) effectiveness of four treatments for adolescents with DSM-IV major depressive disorder: clinical management with fluoxetine (FLX), cognitive-behavioral therapy…

  14. 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...

  15. The effects of 12 weeks of step aerobics training on functional fitness of elderly women.

    Science.gov (United States)

    Hallage, Tatiane; Krause, Maressa P; Haile, Luke; Miculis, Cristiane P; Nagle, Elizabeth F; Reis, Rodrigo S; Da Silva, Sergio G

    2010-08-01

    The purpose of this study was to determine the effects of 12 weeks of step aerobics (SA) training on the functional fitness of apparently healthy older women. Thirteen previously sedentary elderly women (mean age 63.14 years) participated in this study. Subjects performed 3 training sessions per week for 30-60 minutes per session. All measurements were assessed at baseline, after 12 weeks of training (posttest), and after 1 month of detraining. Assessments included the evaluation of body mass index (BMI), waist circumference (WC), strength of the upper (arm-curl [AC] test) and lower body (30-second chair-stand test [CS]), dynamic balance and agility (8 foot up and go [8 ft]), flexibility (chair sit-and-reach [CSR]), and cardiorespiratory fitness (6-minute walk test [6MW]). Step aerobics significantly improved all functional fitness components except for BMI. The 12 weeks of SA promoted a large effect size in the following measurements: WC (d = 1.6); CSR (d = 1.51); CS (d = 1.49); AC (d = 1.41); 8 ft (d = 1.32); and 6MW (d = 1.06) (p < 0.05). These results indicate that 12 weeks of SA had a positive effect on the functional fitness components of these older women. Furthermore, these findings were confirmed by the reverse effect observed after 1 month of detraining, except for upper body strength (AC test). In conclusion, 12 weeks of SA training can promote improvements in the functional fitness of apparently healthy older women. Therefore, SA can be considered an effective exercise modality to prevent the loss of functional fitness and its associated consequences. PMID:20634751

  16. Lateralization of infant holding by mothers: A longitudinal evaluation of variations over the first 12 weeks.

    Science.gov (United States)

    Todd, Brenda K; Banerjee, Robin

    2016-01-01

    The maternal preference to hold infants on the left rather than right side of the body was examined longitudinally, with attention to 4 explanations: maternal monitoring of infant state, maternal handedness, infant proximity to the mother's heartbeat, and preferred infant head position. The side and site of holding were measured over the first 12 weeks of the lives of 24 infants. Information about group and individual consistency in holding side allowed novel evaluation of the theories. A strong bias to hold on the left dropped below significance when the infants were aged 12 weeks and was limited to specific holding positions. Findings were generally consistent with the monitoring hypothesis, and little support was found for the 3 alternative explanations.

  17. The Danish Alzheimer intervention study

    DEFF Research Database (Denmark)

    Waldemar, G; Waldorff, F B; Buss, D V;

    2011-01-01

    Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteri......Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline...

  18. 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.

  19. Efficacy of neonatal HBV vaccination on liver cancer and other liver diseases over 30-year follow-up of the Qidong hepatitis B intervention study: a cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chunfeng Qu

    2014-12-01

    Full Text Available BACKGROUND: Neonatal hepatitis B vaccination has been implemented worldwide to prevent hepatitis B virus (HBV infections. Its long-term protective efficacy on primary liver cancer (PLC and other liver diseases has not been fully examined. METHODS AND FINDINGS: The Qidong Hepatitis B Intervention Study, a population-based, cluster randomized, controlled trial between 1985 and 1990 in Qidong, China, included 39,292 newborns who were randomly assigned to the vaccination group in which 38,366 participants completed the HBV vaccination series and 34,441 newborns who were randomly assigned to the control group in which the participants received neither a vaccine nor a placebo. However, 23,368 (67.8% participants in the control group received catch-up vaccination at age 10-14 years. By December 2013, a total of 3,895 (10.2% in the vaccination group and 3,898 (11.3% in the control group were lost to follow-up. Information on PLC incidence and liver disease mortality were collected through linkage of all remaining cohort members to a well-established population-based tumor registry until December 31, 2013. Two cross-sectional surveys on HBV surface antigen (HBsAg seroprevalence were conducted in 1996-2000 and 2008-2012. The participation rates of the two surveys were 57.5% (21,770 and 50.7% (17,204 in the vaccination group and 36.3% (12,184 and 58.6% (17,395 in the control group, respectively. Using intention-to-treat analysis, we found that the incidence rate of PLC and the mortality rates of severe end-stage liver diseases and infant fulminant hepatitis were significantly lower in the vaccination group than the control group with efficacies of 84% (95% CI 23%-97%, 70% (95% CI 15%-89%, and 69% (95% CI 34%-85%, respectively. The estimated efficacy of catch-up vaccination on HBsAg seroprevalence in early adulthood was 21% (95% CI 10%-30%, substantially weaker than that of the neonatal vaccination (72%, 95% CI 68%-75%. Receiving a booster at age 10

  20. EFFECTS OF A 12 WEEK SAQ TRAINING PROGRAMME ON AGILITY WITH AND WITHOUT THE BALL AMONG YOUNG SOCCER PLAYERS

    Directory of Open Access Journals (Sweden)

    Zoran Milanovic

    2013-03-01

    Full Text Available 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 < 0.05 between pre and post training were evident for almost all measures of 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

  1. 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...

  2. 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.

  3. 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.

  4. 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.

  5. Effects of cognitive and skilled rehabilitative training on deficiencies of theory of mind in patients with traumatic brain injury: A 12-week random, single-blind clinical trial%脑外伤患者心理推理能力缺陷的认知性和技巧性干预:一项12周随机单盲对照试验

    Institute of Scientific and Technical Information of China (English)

    张登科; 徐水琴; 苏巧荣; 潘一楠; 沈雪艳; 陈三妹; 葛建荣; 单兴尧

    2012-01-01

    cognitive and skilled rehabilitative training on theory of mind and social function deficiencies in traumatic brain injury patients. Methods: Totally 90 brain injury patients who were injured six or more months ago and whose condition was stable were selected. They were randomly assigned into cognitive intervention group (n = 30), skilled intervention group (n = 30) and control group ( n = 30). The cognitive intervention group received the cognitive orientated training focused on their real life behaviors, including life events discussing, contextual play and home works. The skill intervention group received the training focused on their examination skills, including the theory of mind stories comprehension, graph comprehension. The control group received normal outpatient follow-up health services. The classic Theory of Mind Tasks, Family Member Evaluated Scale of Theory of Mind in Traumatic Brain Injuries and Social Disability Screening Schedule (SDSS) were used to access the subjects' theory of mind and social function before and after intervention, and 3 months after intervention. Results: Before intervention, there was no significant difference between the three groups on all scores. After intervention, both intervention groups had higher scores of theory of mind classic tasks [ (14. 7 ±1. 3), (15. 2 ± 1. 7) vs. (12. 5 ± 1. 6), P 0. 05). Three months after the intervention, both intervention groups had higher scores of theory of mind classic tasks [ (16. 5 ± 1. 4), (15. 9 ± 1. 2) vs. (13. 3 ± 1. 5), P <0. 05] and family evaluated scale [ (146. 6 ± 15. 7), (134. 5 ± 14. 6) vs. (115. 8 ± 21. 2), P < 0. 05] than the control group, and their SDSS scores were lower than control group [(7. 1 ± 1. 2), (8. 0 ±0. 9) vs. (11.4 ±0. 8), P <0.05]. The scores of family evaluated scale was higher in the cognitive intervention group than in the skill intervention group [(146. 6 ± 15. 7) vs. (134. 5 ± 14. 6), P <0.05], the SDSS scores was lower in the cognitive

  6. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    Science.gov (United States)

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease. PMID:24704650

  7. 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 (Pskin 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 of NFκB inhibition as a

  8. 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.

  9. 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...

  10. Physiological changes following a 12 week gym based stair-climbing, elliptical trainer and treadmill running program in females

    OpenAIRE

    EGANA, MIKEL

    2004-01-01

    PUBLISHED Despite the growing popularity of the elliptical trainer aerobic exercise modality the physiological changes induced following a training program using elliptical trainers remains unknown. Donne investigates the metabolic and cardiorespiratory improvements following a 12-week aerobic training program using elliptical trainer, treadmill or stair-climbing modalities. Findings reveal that in moderately active females similar physiological improvements were observed using stair-climb...

  11. Antioxidants and muscle growth in elderly : the effect of supplementation with vitamin C and E on muscle growth and maximal strength during 12 weeks of resistance exercise in eldery men

    OpenAIRE

    Bjørnsen, Thomas

    2013-01-01

    INTRODUCTION: Supplementation with antioxidants could either facilitate or hamper adaptations to resistance exercise due to redox-sensitive signaling pathways that regulate protein synthesis. Thus, the aim of the present study was to investigate the effect supplementation with vitamin C and E on muscle growth and maximal strength during 12 weeks of resistance exercise in elderly men. METHODS: Thirty-four elderly males (60 – 81 years) were randomized to either an antioxidant group (N=17; 1000 ...

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

    OpenAIRE

    Cinthya Campos Salazar; Norbel Román Garita

    2009-01-01

    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 arteria...

  13. 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....

  14. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study

    OpenAIRE

    Bisson, Michèle; Alméras, Natalie; Sébastien S Dufresne; Robitaille, Julie; Rhéaume, Caroline; Bujold, Emmanuel; Frenette, Jérôme; Tremblay, Angelo; Marc, Isabelle

    2015-01-01

    Objective To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity. Methods In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2) were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2) at the anaerobic threshold), nutrition (caloric ...

  15. Experiences of training-adherence in a 12 weeks home-based IMT program 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....

  16. 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?

    Directory of Open Access Journals (Sweden)

    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.

  17. 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.

  18. Quality assurance in non-interventional studies.

    Science.gov (United States)

    Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

    2009-01-01

    Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP) were published by the U.S. Food and Drug Administration (FDA) and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM) together with the Paul Ehrlich Institute (PEI) and the German Association of Research-Based Pharmaceutical Companies (VFA) have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF) and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV) should be performed in randomly selected centres - in between 2% and 5% of the centres depending on the number of participating centres. Before start of

  19. Quality assurance in non-interventional studies

    Directory of Open Access Journals (Sweden)

    Capan, Müge

    2009-11-01

    Full Text Available Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bias of results by using an appropriate study design and an adequate data analysis, second to assure authenticity, completeness and validity of the data and third to identify and resolve deficiencies at an early stage. Basic principles are laid down in corresponding guidelines and recommendations of authorities, institutes and societies. Various guidelines for good epidemiological practice (GEP were published by the U.S. Food and Drug Administration (FDA and international and regional societies for epidemiology. In addition in Germany the Federal Institute for Drugs and Medical Devices (BfArM together with the Paul Ehrlich Institute (PEI and the German Association of Research-Based Pharmaceutical Companies (VFA have published respectively recommendations dealing with quality aspects of non-interventional observational studies. Key points are the advanced publishing of information about the project, developing of a study plan/protocol containing the scientific objectives, a sample size justification and a description of the planned analyses and the publishing of a summary of the results timely after completion of the study. The quality of the data can be improved by using standardized case report forms (CRF and the CRF should be reviewed and tested before start of study by some participants. A source data verification (SDV should be performed in randomly selected centres – in between 2% and 5% of the centres depending on the number of participating centres

  20. The Effects of a 12-Week Faculty and Staff Exercise Program on Health-Related Variables in a University Setting

    OpenAIRE

    Michael J Rebold; KOBAK, MALLORY S.; PEROUTKY, KYLENE; GLICKMAN, ELLEN L.

    2015-01-01

    The obesity epidemic has grown in the past decade due to physical inactivity (i.e., having a sedentary job) and an increase in caloric intake. This problem combined with the reluctance of many faculty and staff members exercising in the same environment as student’s presents a unique challenge in an academic setting. The purpose of this study was to examine the effectiveness of a 12-week exercise program focused toward the faculty and staff in improving several health-related variables such a...

  1. Effect of 12 Weeks of Accelerated Rehabilitation Exercise on Muscle Function of Patients with ACL Reconstruction of the Knee Joint.

    Science.gov (United States)

    Lee, Joong-Chul; Kim, Ji Youn; Park, Gi Duck

    2013-12-01

    [Purpose] To examine changes in the knee joint's isokinetic muscle functions following systematic and gradual rehabilitation exercises lasting for 12 weeks for male and female patients who underwent anterior cruciate ligament (ACL) reconstruction. Differences in muscle functions between the uninvolved side (US) and the involved side (IS) before surgery, differences in muscle functions between US and IS after rehabilitation exercises lasting for 12 weeks, and changes in muscle functions on US and IS between before and after surgery were analyzed to examine the effects of accelerated rehabilitation exercises after ACL reconstruction. [Subjects] The study subjects were 10 patients, five females and five males, who underwent ACL reconstruction performed by the same surgeon. [Methods] As a measuring tool, a Biodex Multi-joint system 3pro (USA), which is an isokinetic measuring device, was used to examine the flexion and extension forces of the knee joint. During isokinetic muscle strength evaluation, the ROM of US was set to be the same as that of IS for consistency of measurement. [Results] At 60°/s, the isokinetic muscle functions of the females did not show any significant change between before and after surgery in any of the variables on both US and IS. At 60°/s, the isokinetic muscle functions of the males did not show any significant change between before and after surgery in the peak torque, average power, and entire work done on US. In extension, peak torque on IS did not show any significant change.

  2. 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

  3. 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

    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.......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...... (Pmuscle mass (11%), mean fiber area (10%) and citrate synthase activity (18%) were higher (P

  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. The influence of maternal age on the outcomes of pregnancies complicated by bleeding at less than 12 weeks.

    Science.gov (United States)

    Mbugua Gitau, Godfrey; Liversedge, Helen; Goffey, Dawn; Hawton, Annemarie; Liversedge, Neil; Taylor, Myles

    2009-01-01

    The effect of maternal age on the outcome of threatened miscarriage after ultrasound has confirmed fetal heart (FH) pulsation was assessed. At a university teaching hospital, 138 women presenting with bleeding before 12 weeks' gestation were followed up until delivery or pregnancy loss. Those with multiple or ectopic pregnancy, social termination of pregnancy, assisted conception and temporary residence were excluded. Outcome measures were pregnancy loss, fetal abnormalities, preterm delivery, low birthweight and cesarean delivery. Age over 35 years was significantly associated with reduced live-birth and increased miscarriage rates. Women over 35 years of age had higher cesarean section and pregnancy loss rates than the younger women. The combination of bleeding in early pregnancy and advanced age increases risk of pregnancy loss even after ultrasound has confirmed FH pulsation. PMID:19140048

  6. 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......, adenine nucleotides as well as Hexokinase II mRNA levels were all reduced after exercise training. Increased exercise-induced muscle AMPK activation and ACC2 Ser(221) phosphorylation in LBW subjects may indicate a more sensitive AMPK system in this population. Long term exercise training may reduce...

  7. 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

    Background/Objectives: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.Subjects/Methods: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.Results:No significant differences in microbiota composition were observed between the two dietary groups; however, the whole...

  8. 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.

  9. 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

  10. 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

  11. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-01-01

    BACKGROUND: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. AIM: To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAI

  12. Utility of imaging for nutritional intervention studies in Alzheimer's disease.

    Science.gov (United States)

    de Wilde, Martijn C; Kamphuis, Patrick J G H; Sijben, John W C; Scheltens, Phillip

    2011-09-01

    Alzheimer's disease (AD) is a multi-factorial neurodegenerative disorder and the leading cause of dementia, wherein synapse loss is the strongest structural correlate with cognitive impairment. Basic research has shown that dietary supply of precursors and co-factors for synthesis of neuronal membranes enhances the formation of synapses. Daily intake of a medical food containing a mix of these nutrients for 12 weeks in humans improved memory, measured as immediate and delayed verbal recall by the Wechsler Memory Scale-revised, in patients with very mild AD (MMSE 24-26). An improvement of immediate verbal recall was noted following 24 weeks of intervention in an exploratory extension of the study. These data suggest that the intervention may improve synaptic formation and function in early AD. Here we review emerging technologies that help identify changes in pathological hallmarks in AD, including synaptic function and loss of connectivity in the early stages of AD, before cognitive and behavioural symptoms are observable. These techniques include the detection of specific biomarkers in the cerebrospinal fluid, as well as imaging procedures such as fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET), amyloid PET, structural/functional magnetic resonance imaging, diffusion tensor imaging, magnetoencephalography (MEG) and electroencephalography (EEG). Such techniques can provide new insights into the functional and structural changes in the brain over time, and may therefore help to develop more effective AD therapies. In particular, nutritional intervention studies that target synapse formation and function may benefit from these techniques, especially FDG-PET and EEG/MEG employed in the preclinical or early stages of the disease. PMID:21816137

  13. Treatment of feline lymphoma using a 12-week, maintenance-free combination chemotherapy protocol in 26 cats.

    Science.gov (United States)

    Limmer, S; Eberle, N; Nerschbach, V; Nolte, I; Betz, D

    2016-08-01

    The aim of this prospective clinical trial was to investigate the efficacy and toxicity of a short-term, maintenance-free chemotherapy protocol in feline lymphoma. Twenty-six cats with confirmed diagnosis of high-/intermediate-grade lymphoma were treated with a 12-week protocol consisting of cyclic administration of l-asparaginase, vincristine, cyclophosphamide, doxorubicin and prednisolone. Complete (CR) and partial remission (PR) rates were 46 and 27%, respectively. Median duration of first CR was 394 days compared with a median PR duration of 41 days. No factor was identified to significantly influence the likelihood to reach CR. Overall survival amounted to 78 days (range: 9-2230 days). Median survival in CR cats was 454 days and in PR cats was 82 days. Toxicosis was mainly low grade with anorexia seen most frequently. In cats achieving CR, maintenance-free chemotherapy may be sufficient to attain long-term remission and survival. Factors aiding in prognosticating the likelihood for CR, strategies enhancing response and targeting chemotherapy-induced anorexia need to be identified in future. PMID:24548273

  14. 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.

  15. Evaluating the effect of a haemoglobin spray on size reduction in chronic DFUs: clinical outcomes at 12 weeks.

    Science.gov (United States)

    Dawn Hunt, Sharon; Haycocks, Samantha; McCardle, Joanne; Guttormsen, Karl

    2016-06-23

    A recent multi-centre observational evaluation investigated the effect of a topical haemoglobin spray (Granulox, Infirst), used as an adjunct to standard care, on wound size reduction in 17 patients (4 females/13 males) with 20 chronic diabetic foot ulcers (DFUs) over a 4-week period. In 14 of the 18 wounds that completed the evaluation (one patient dropped out due to an infection) there was a mean reduction of 53.8% (range: 11.9-100%). The product was acceptable to both patients and clinicians, who all found it easy to use. This article describes the outcomes for the remaining 13 patients (with 15 wounds) who continued using the spray after the 4-week evaluation ended. (Data are not available for two patients and the one patient who healed during the 4-week evaluation.) By 12 weeks, three wounds (20%) had healed, eight (53%) were progressing towards healing, three (20%) increased in size and one (7%) was slow healing. PMID:27345086

  16. Quality assurance in non-interventional studies

    OpenAIRE

    Theobald, Karlheinz; Capan, Müge; Herbold, Marlis; Schinzel, Stefan; Hundt, Ferdinand

    2009-01-01

    Nowadays, drug research and surveillance after authorisation becomes more and more important for several reasons. Non-interventional studies (NIS) investigate various aspects of drug use including efficacy and safety under real life conditions. Such kind of health services research should be on a high scientific, methodological and organisational level. Therefore accompanying measures to improve or to keep the quality are highly recommended. The aim of quality management is: first to avoid bi...

  17. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    Science.gov (United States)

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  18. Effect of 12 Weeks of Periodized Resistance Training Upon Total Plasma Adiponectin Concentration in Healthy Young Men.

    Science.gov (United States)

    Davis, Greggory R; Stephens, Jacqueline M; Nelson, Arnold G

    2015-11-01

    The effects of resistance training on adiponectin have thus far yielded equivocal results. However, the effect of periodized resistance training on plasma adiponectin in offspring of type 2 diabetic and nondiabetic (ND) parents (first-degree family history) has yet to be determined. Untrained healthy young men with and without a first-degree family history of type 2 diabetes were assigned to an exercise intervention group (E) or an active control group (C). The E group performed a 12-week periodized resistance training program, whereas the C group did not participate in any structured exercise program. Fasting plasma samples were obtained pre- and posttraining. Total plasma adiponectin changed significantly in the E group (33.7 ± 14.7%, p = 0.025) but not in the C group (10.8 ± 19.2%). Offspring of type 2 diabetic parents subjects had significantly greater improvements in plasma adiponectin (69.3 ± 34.8%) compared with ND subjects (-3.2 ± 29.9%, p = 0.046). Regular aerobic exercise was significantly correlated with average plasma adiponectin (r = 0.32), whereas first-degree family history of type 2 diabetes (r = -0.58) and decreases in body fat percentage (r = -0.77) were inversely correlated with average plasma adiponectin. Periodized high-intensity resistance training seems to increase plasma adiponectin, particularly in individuals with a first-degree family history of type 2 diabetes or those who experience a significant loss of fat mass. The direct correlation between regular aerobic exercise and adiponectin further suggests that a combination of aerobic and resistance training yields greater improvements in plasma adiponectin compared with resistance training alone. PMID:26274372

  19. Telaprevir-based triple-therapy in patients with chronic hepatitis C in Germany: a 12-week interim analysis of real-life data

    Directory of Open Access Journals (Sweden)

    T Berg

    2012-11-01

    Full Text Available Telaprevir (TVR-based triple therapy in patients (pts with chronic hepatitis C (HCV in daily practice in Germany is investigated in this non-interventional study. Aims are the evaluation of the implementation of futility rules, as well as safety and efficacy of TVR-based therapy. This prospective, multi-center study investigates TVR-based therapy in therapy-naïve and pretreated pts with genotype 1 chronic HCV in Germany, including pts with HIV co-infection. Patients are treated with a combination of TVR, ribavirin and peg-interferon. This interim analysis includes data from the first 100 pts (12.5% of the planned total at 32 sites completing 12 weeks (W of treatment. 66% of pts were pretreated for HCV. 36.4% of pts with pre-treatment were prior relapsers and 30.3% null or partial responders. Cirrhosis was present in 11% of all pts at baseline. HCV RNA levels below 800.000 IU/ml at baseline were present in 50% of pts. 67% of pts showed rapid virological response (RVR, undetectable HCV RNA at W4. Adherence to the futility rule (treatment stop if HCV-RNA>1000 IU/ml at W4 was 100% (N=9. At W12, 91.4% of pts had undetectable HCV RNA. 57.7% of therapy-naïve pts and 86.4% of previous relapsers were HCV-RNA negative at both W4 and 12 (70.8% in total. Only one patient achieving RVR at W4 suffered a virologic breakthrough. Nearly all pts (99% had adverse events (AE during the first 12W, 6% reported serious adverse events (SAE. AEs were mostly mild (63.9% or moderate (34.6% and frequently mentioned dry skin/pruritus (54%, gastrointestinal disorders (48%, anorectal discomfort (30%, rash (29% and anemia (23%. Rash was mostly rated as mild or moderate (97.1%. An Hb decrease<12 g/dl (female or<13 g/dl (male was reported in 87% of pts. Mean Hb levels decreased from 14.8 g/dl at baseline to 10.6 g/dl at W12; Hb levels<8.5 g/dl at any time within the first 12W of treatment were present in 11% of anemia cases and 6.6% required transfusion. Only one patient

  20. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study.

    Directory of Open Access Journals (Sweden)

    Michèle Bisson

    Full Text Available To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity.In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2 were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2 at the anaerobic threshold, nutrition (caloric intake and macronutrients percentage and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA.A total of fifty (50 women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064, but the exercise group's levels were higher than controls' at all times (pgroup effect = 0.014. A significant time-group interaction was found for daily physical activity (p = 0.023; similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3 x 10(4 counts/day the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5 x 10(4 counts/day, p = 0.020 and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5 x 10(4 counts/day, p = 0.034. Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016 and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041.Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy.ClinicalTrials.gov NCT01610323.

  1. Residual F-18-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    NARCIS (Netherlands)

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-01-01

    Purpose: To investigate the prognostic value of [F-18]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically

  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. A 12 Week, Open Label, Phase I/IIa Study Using Apatone® for the Treatment of Prostate Cancer Patients Who Have Failed Standard Therapy

    Directory of Open Access Journals (Sweden)

    Basir Tareen, Jack L. Summers, James M. Jamison, Deborah R. Neal, Karen McGuire, Lowell Gerson, Ananias Diokno

    2008-01-01

    Full Text Available Purpose: To evaluate the safety and efficacy of oral Apatone® (Vitamin C and Vitamin K3 administration in the treatment of prostate cancer in patients who failed standard therapy. Materials and Methods: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day for a period of 12 weeks. Prostate Specific Antigen (PSA levels, PSA velocity (PSAV and PSA doubling times (PSADT were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients. Results: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p ≤ 0.05. There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment. Conclusion: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.

  4. 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.

  5. Colesevelam Added to Combination Therapy With a Statin and Ezetimibe in Patients With Familial Hypercholesterolemia : A 12-Week, Multicenter, Randomized, Double-Blind, Controlled Trial

    NARCIS (Netherlands)

    Huijgen, Roeland; Abbink, Evertine J.; Bruckert, Eric; Stalenhoef, Anton F. H.; Imholz, Ben P. M.; Durrington, Paul N.; Trip, M. D.; Eriksson, Mats; Visseren, Frank L. J.; Schaefer, Juergen R.; Kastelein, John J. P.

    2010-01-01

    Background: Familial hypercholesterolemia (FH) has been associated with increased cardiovascular risk when untreated or when normal LDL-C concentrations are not reached. Some patients with FH do not reach LDL-C goals despite intensive combination therapy. Objective: This study assessed the efficacy

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

    OpenAIRE

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

    2016-01-01

    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 we...

  7. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study

    OpenAIRE

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

    2015-01-01

    To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR) and Superoxide dismutase (SOD) is significant only for cigarette smok...

  8. 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

    2016-01-01

    (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

  9. 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

  10. Improving the Quality of Students' Academic Writing: An Intervention Study

    Science.gov (United States)

    Boscolo, Pietro; Arfe, Barbara; Quarisa, Mara

    2007-01-01

    An intervention aimed at improving academic writing--in particular, synthesis writing - was conducted with 52 undergraduate students of psychology of the University of Padua (Italy). Before and after the intervention, which lasted 12 weeks, participants were administered a questionnaire on beliefs about writing and a synthesis writing task. During…

  11. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis

    Science.gov (United States)

    Lawitz, Eric; Poordad, Fred; Brainard, Diana M; Hyland, Robert H; An, Di; Dvory-Sobol, Hadas; Symonds, William T; McHutchison, John G; Membreno, Fernando E

    2015-01-01

    Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia. Conclusion: In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified. (Hepatology 2015;61:769–775) PMID:25322962

  12. The Effect of 12 Weeks Aerobic Exercise Training on Visfatin, Chemerin Serum Changes in 45-60 year old Obese Women with Type2 Diabetes

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    L Seifi

    2016-04-01

    Full Text Available Introduction: Adipocytokine including chemerin and visfatin have a key role in metabolic regulations, as well as obesity-related disorders such as type 2 diabetes. The aim of this study was to investigate the effect of the 12-week exercise training on changes in levels of visfatin and chemerin in obese women with type 2 diabetes. Methods: In this study, 30 overweight women with the age range of 45-60 years old were selected and ther were divided into the control group (n = 15, and the experimental group (n = 15 which had no significant differences based on the body fat percentage and the body mass index. Exercise program consisted of increasing aerobic exercise three times were for 12 weeks. To measure Chemerin and Visfatin, blood samples before and 24 hours after the last training session were collected. Data evaluation was performed using ANCOVA to compare the pre-test and post-test in each group. Results: According to the obtained results, there was no significant difference between weight, body mass index, lean body weight, fat mass and fat percentage, but the chemerin levels have been increased significantly (p=0.0001 and also visfatin and glucose levels have been decreased (respectively p=0.0001 and p=0.001. Conclusion: Aerobic activities are a stimulating factor for increasing in the chemerin hormone and also a stimulating factor for decreasing in the Visfatin hormone. It could be said that regular aerobic activities in 12 weeks are a good stimulating factor for creating changes in these hormones in women with diabetes and it is probably one of the contributing factors of physiologic changes resulted from these exercise activities is changes in these hormones.

  13. 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

    OpenAIRE

    Abdessalem Koubaa; Moez Triki; Hajer Trabelsi; Hamza Baati; Zouhair Sahnoun; Ahmed Hakim

    2015-01-01

    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), gluta...

  14. Optimized design and analysis of preclinical intervention studies in vivo

    Science.gov (United States)

    Laajala, Teemu D.; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  15. The design and methodology of premature ejaculation interventional studies.

    Science.gov (United States)

    McMahon, Chris G

    2016-08-01

    Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

  16. Optimized design and analysis of preclinical intervention studies in vivo.

    Science.gov (United States)

    Laajala, Teemu D; Jumppanen, Mikael; Huhtaniemi, Riikka; Fey, Vidal; Kaur, Amanpreet; Knuuttila, Matias; Aho, Eija; Oksala, Riikka; Westermarck, Jukka; Mäkelä, Sari; Poutanen, Matti; Aittokallio, Tero

    2016-01-01

    Recent reports have called into question the reproducibility, validity and translatability of the preclinical animal studies due to limitations in their experimental design and statistical analysis. To this end, we implemented a matching-based modelling approach for optimal intervention group allocation, randomization and power calculations, which takes full account of the complex animal characteristics at baseline prior to interventions. In prostate cancer xenograft studies, the method effectively normalized the confounding baseline variability, and resulted in animal allocations which were supported by RNA-seq profiling of the individual tumours. The matching information increased the statistical power to detect true treatment effects at smaller sample sizes in two castration-resistant prostate cancer models, thereby leading to saving of both animal lives and research costs. The novel modelling approach and its open-source and web-based software implementations enable the researchers to conduct adequately-powered and fully-blinded preclinical intervention studies, with the aim to accelerate the discovery of new therapeutic interventions. PMID:27480578

  17. Spillovers of Prosocial Motivation: Evidence from an Intervention Study on Blood Donors

    OpenAIRE

    Bruhin, Adrian; Götte, Lorenz; Haenni, Simon; Jiang, Lingqing

    2014-01-01

    Spillovers of prosocial motivation are crucial for the formation of social capital. They facilitate interactions among individuals and create social multipliers that amplify the effects of policy interventions. We conducted a large-scale intervention study among dyads of blood donors to investigate whether social ties lead to motivational spillovers in the decision to donate. The intervention is a randomized phone call making donors aware of a current shortage of their blood type and serving ...

  18. Male and Female Pathways to Psychopathology: Findings from a Preventive Intervention Study

    OpenAIRE

    Vuijk, P.

    2006-01-01

    textabstractThe objective of the present study was to extent the knowledge on the pathways to male and female psychopathology from childhood into early adolescence. In Chapter 1, the background of the Good Behavior Game (GBG) study was presented. The GBG study is a randomized controlled intervention study that started in 1998 when 666 children from 13 elementary schools in the metropolitan area of Rotterdam and Amsterdam were enrolled in the study at age 6. The GBG intervention is a universal...

  19. Effects of a 12-week rehabilitation program with music & exercise groups on range of motion in young children with severe burns.

    Science.gov (United States)

    Neugebauer, Christine Tuden; Serghiou, Michael; Herndon, David N; Suman, Oscar E

    2008-01-01

    Previous studies indicate that rehabilitation programs supplemented with a strength and endurance-based exercise program improve lean body mass, pulmonary function, endurance, strength, and functional outcomes in severely burned children over the age of 7-years when compared with standard of care (SOC). To date, supplemental exercise programming for severely burned children under the age of 7-years has not yet been explored. The purpose of this study was to determine if a 12-week rehabilitation program supplemented with music & exercise, was more effective in improving functional outcomes than the SOC alone. This is a descriptive study that measured elbow and knee range of motion (ROM) in 24 severely burned children between ages 2 and 6 years. Groups were compared for demographics as well as active and passive ROM to bilateral elbows and knees. A total of 15 patients completed the rehabilitation with supplemental music and exercise, and data was compared with 9 patients who received SOC. Patients receiving the 12-week program significantly improved ROM in all joints assessed except for one. Patients receiving SOC showed a significant improvement in only one of the joints assessed. Providing a structured supplemental music and exercise program in conjunction with occupational and physical therapy seems to improve both passive and active ROM to a greater extent than the SOC alone. PMID:18849852

  20. 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 vegetarian diet. As for the changes in bowel habit, the number of the 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. PMID:27152300

  1. 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

  2. Efficacy and tolerability of carbamazepine for the treatment of painful diabetic neuropathy in adults: a 12-week, open-label, multicenter study

    Directory of Open Access Journals (Sweden)

    Saeed T

    2014-07-01

    Full Text Available Tariq Saeed,1 Muhammad Nasrullah,2 Adnan Ghafoor,3 Riaz Shahid,4 Nadeem Islam,5 Mohammad Usman Khattak,6 Neeta Maheshwary,7 Ahson Siddiqi,7 Muhammad Athar Khan81Pakistan Telecommunication Company Ltd, Karachi, Pakistan; 2Cavalary Hospital, Gulberg, Lahore, Pakistan; 3Fauji Foundation Hospital, Rawalpindi, Pakistan; 4Dr Riaz Shahid Clinic, Peshawar Cantt, Peshawar, Pakistan; 5Punjab Employs Social Security Institution, Islamabad, Pakistan; 6Medical B Unit, Hayat Abad Medical Complex, Peshawar, Pakistan; 7Novartis Pharma Pakistan, Karachi, Pakistan; 8Department of Medical Education, King Saud bin Abdulaziz University, Riyadh, Kingdom of Saudi ArabiaObjective: Anticonvulsants are increasingly being used in the symptomatic management of several neuropathic pain disorders. The present observational study was designed to evaluate the efficacy, tolerability, and quality of life (QoL of carbamazepine use for 12 weeks in patients with painful diabetic neuropathy, in Pakistan.Methods: This was a 12-week, multicenter, open-label, uncontrolled trial in adult type 2 diabetic patients (aged 18–65 years suffering from clinically confirmed neuropathic pain (Douleur Neuropathique en 4 [DN4] score ≥4. Change in neuropathic pain at week 12 compared with baseline was assessed using the Brief Pain Inventory Scale–Short Form (pain severity score and pain interference score. QoL was determined by the American Chronic Pain Association QoL scale. Safety was assessed based on patient reported adverse events (AEs and serious AEs.Results: Of the total 500 screened patients, 452 enrolled and completed the study. The mean (± standard deviation [SD] pain interference score decreased from 4.5±2.0 at baseline to 3.1±1.9 at week 12 (P<0.001. The mean (± SD pain severity score decreased from 5.8±2.0 at baseline to 3.6±2.2 at week 12 (P<0.001. There was a decrease of ≥30% in the pain severity score between visits. The mean (± SD QoL scale score improved from 5.9±1

  3. Efficacy and tolerability of carbamazepine for the treatment of painful diabetic neuropathy in adults: a 12-week, open-label, multicenter study

    Science.gov (United States)

    Saeed, Tariq; Nasrullah, Muhammad; Ghafoor, Adnan; Shahid, Riaz; Islam, Nadeem; Khattak, Mohammad Usman; Maheshwary, Neeta; Siddiqi, Ahson; Khan, Muhammad Athar

    2014-01-01

    Objective Anticonvulsants are increasingly being used in the symptomatic management of several neuropathic pain disorders. The present observational study was designed to evaluate the efficacy, tolerability, and quality of life (QoL) of carbamazepine use for 12 weeks in patients with painful diabetic neuropathy, in Pakistan. Methods This was a 12-week, multicenter, open-label, uncontrolled trial in adult type 2 diabetic patients (aged 18–65 years) suffering from clinically confirmed neuropathic pain (Douleur Neuropathique en 4 [DN4] score ≥4). Change in neuropathic pain at week 12 compared with baseline was assessed using the Brief Pain Inventory Scale–Short Form (pain severity score and pain interference score). QoL was determined by the American Chronic Pain Association QoL scale. Safety was assessed based on patient reported adverse events (AEs) and serious AEs. Results Of the total 500 screened patients, 452 enrolled and completed the study. The mean (± standard deviation [SD]) pain interference score decreased from 4.5±2.0 at baseline to 3.1±1.9 at week 12 (P<0.001). The mean (± SD) pain severity score decreased from 5.8±2.0 at baseline to 3.6±2.2 at week 12 (P<0.001). There was a decrease of ≥30% in the pain severity score between visits. The mean (± SD) QoL scale score improved from 5.9±1.6 at baseline to 8.0±1.7 at week 12. A total of ten (2.2%) patients reported AEs during the study period. No patient discontinued the study due to AEs. Conclusion In this real-life experience study, carbamazepine, when prescribed for 12 weeks to adult diabetic patients suffering from neuropathic pain, showed pain-relief effect, with reduced mean pain severity and mean pain interference scores and with improved QoL and good tolerability profile. PMID:25061334

  4. School, Community, and Family Working Together to Address Childhood Obesity: Perceptions from the KOALA Lifestyle Intervention Study

    Science.gov (United States)

    Smibert, Asa; Abbott, Rebecca; Macdonald, Doune; Hogan, Anna; Leong, Gary

    2010-01-01

    Epidemiological data on childhood obesity has prompted a significant response from both governments and academics seeking to recommend solutions to the reported "crisis". The "Kinder Overweight Active Living Action" (KOALA) healthy lifestyle programme is a randomized obesity prevention and intervention study designed to provide an understanding of…

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

    Science.gov (United States)

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    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. PMID:26783415

  6. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    Science.gov (United States)

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  7. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    Science.gov (United States)

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases. PMID:24611630

  8. Changes in Antioxidant Defense Capability and Lipid Profile after 12-Week Low- Intensity Continuous Training in Both Cigarette and Hookah Smokers: A Follow-Up Study.

    Directory of Open Access Journals (Sweden)

    Abdessalem Koubaa

    Full Text Available To examine the impact of low-intensity continuous training program on antioxidant defense capability and lipid profile in male cigarette or hookah smokers. Forty-three male adults participated in a 12-week continuous training program at an intensity of 40% of VO2max. All subjects were subjected to anthropometric, physical and biochemical tests before and after the training program. The increase of Glutathione reductase (GR and Superoxide dismutase (SOD is significant only for cigarette smokers (CS and hookah smokers (HS groups. The Malondialdehyde (MDA decrease and α-tocopherol increase are significant only for HS group. GPx was increased in NS, CS and HS by 2.6% (p< 0.01, 2% (p< 0.05 and 1.7% (p< 0.05 respectively. Likewise, significant improvements of high-density lipoprotein cholesterol (HDL-C, low-density lipoprotein cholesterol (LDL-C and TC/HDL-C ratio were observed in three groups. En contrast no significant changes were recorded in triglycerides (TG. Also, significant reduction of total cholesterol (TC for CS group (p< 0.01 and HS groups (p< 0.05. This continuous training program appears to have an important role in lipid levels improving and oxidative stress attenuation.

  9. 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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    Tong, Tomas K; Kong, Zhaowei; Lin, Hua; He, Yeheng; Lippi, Giuseppe; Shi, Qingde; Zhang, Haifeng; Nie, Jinlei

    2016-01-01

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

  12. Exercise-training intervention studies in competitive swimming.

    Science.gov (United States)

    Aspenes, Stian Thoresen; Karlsen, Trine

    2012-06-01

    Competitive swimming has a long history and is currently one of the largest Olympic sports, with 16 pool events. Several aspects separate swimming from most other sports such as (i) the prone position; (ii) simultaneous use of arms and legs for propulsion; (iii) water immersion (i.e. hydrostatic pressure on thorax and controlled respiration); (iv) propulsive forces that are applied against a fluctuant element; and (v) minimal influence of equipment on performance. Competitive swimmers are suggested to have specific anthropometrical features compared with other athletes, but are nevertheless dependent on physiological adaptations to enhance their performance. Swimmers thus engage in large volumes of training in the pool and on dry land. Strength training of various forms is widely used, and the energetic systems are addressed by aerobic and anaerobic swimming training. The aim of the current review was to report results from controlled exercise training trials within competitive swimming. From a structured literature search we found 17 controlled intervention studies that covered strength or resistance training, assisted sprint swimming, arms-only training, leg-kick training, respiratory muscle training, training the energy delivery systems and combined interventions across the aforementioned categories. Nine of the included studies were randomized controlled trials. Among the included studies we found indications that heavy strength training on dry land (one to five repetitions maximum with pull-downs for three sets with maximal effort in the concentric phase) or sprint swimming with resistance towards propulsion (maximal pushing with the arms against fixed points or pulling a perforated bowl) may be efficient for enhanced performance, and may also possibly have positive effects on stroke mechanics. The largest effect size (ES) on swimming performance was found in 50 m freestyle after a dry-land strength training regimen of maximum six repetitions across three

  13. The Importance of Risk and Subgroup Analysis of Nonparticipants in a Geriatric Intervention Study

    Directory of Open Access Journals (Sweden)

    Elizabeth Rosted

    2016-01-01

    Full Text Available Background. A major concern in intervention studies is the generalizability of the findings due to refusal of intended participants to actually take part. In studies including ill older people the number of those declining to participate may be large and the concern is therefore relevant. Objectives. To compare patients characteristics, rates of acute readmission, and mortality after one and six months among older persons who agreed and those who declined to participate in a randomized controlled trial and to describe subgroups of nonparticipants. Design. Comparative study based on a randomized controlled trial. Setting. University hospital in the Capital Region of Denmark. Participants. Patients ≥70 years discharged home after a short Emergency Department stay. 399 were requested to participate; 271 consented, whereas 128 refused. Results. Refusers were more likely to be readmitted (p<0.001 or die (p=0.006. The largest subgroup of refusers described as “too ill” had the highest risk of readmission (OR = 3.00, 95% CI = 1.61–5.47, p=0.001 and of mortality within six months (OR = 3.50, 95% CI = 1.64–7.49, p=0.002. However, this seems not to have affected the results of our randomized study. Conclusion. We recommend that intervention studies among older people or other fragile patient groups include analysis of relevant risk and subgroup analyses of refusers.

  14. Designing Intervention Studies: Selected Populations, Range Restrictions, and Statistical Power

    Science.gov (United States)

    Miciak, Jeremy; Taylor, W. Pat; Stuebing, Karla K.; Fletcher, Jack M.; Vaughn, Sharon

    2016-01-01

    An appropriate estimate of statistical power is critical for the design of intervention studies. Although the inclusion of a pretest covariate in the test of the primary outcome can increase statistical power, samples selected on the basis of pretest performance may demonstrate range restriction on the selection measure and other correlated…

  15. Morphology in Malay-English Biliteracy Acquisition: An Intervention Study

    Science.gov (United States)

    Zhang, Dongbo

    2016-01-01

    This intervention study examined the effect of English morphological instruction on the development of English as well as Malay morphological awareness and word reading abilities among Malay-English bilingual fourth graders in Singapore, where English is the medium of instruction. The intervention group experienced semester-long instruction in…

  16. 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

  17. 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.

  18. Effects of trans- and n-3 unsaturated fatty acids on cardiovascular risk markers in healthy males. An 8 weeks dietary intervention study

    DEFF Research Database (Denmark)

    Dyerberg, J; Eskesen, D C; Andersen, P W;

    2004-01-01

    of dietary enrichment with TFA or n-3 PUFA. DESIGN: Randomized, double-blind, parallel intervention trial. SETTING: Department of Human Nutrition, The Royal Veterinary and Agricultural University. SUBJECTS: In all, 87 healthy males included, 79 completed. INTERVENTION: Subjects were randomly assigned to 8...... pressure, heart rate variability (HRV), arterial dilatory capacity, compliance, and distensibility were recorded before and after intervention and at follow-up 12 weeks after the intervention. RESULTS: High-density lipoprotein cholesterol (HDL-C) decreased in the TFA group and triglycerides and mean...

  19. 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

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

    Directory of Open Access Journals (Sweden)

    Miyaoka Tsuyoshi

    2012-11-01

    Full Text Available Abstract Background 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. Methods 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. Results 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 ( Conclusions 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’s disorder. However

  1. Developing Pedagogical Content Knowledge: Lessons Learned from Intervention Studies

    Directory of Open Access Journals (Sweden)

    Marie Evens

    2015-01-01

    Full Text Available Pedagogical content knowledge (PCK is generally accepted as positively impacting teaching quality and student learning. Therefore, research on PCK development in (prospective teachers is highly relevant. Based on a search in three databases (ERIC, PsycInfo, and Web of Science, a systematic review is conducted on intervention studies aiming at PCK development. The research questions are threefold: (1 How are the studies designed? (2 How are the interventions designed? and (3 What elements of interventions contribute to PCK development? The results show that most intervention studies are conducted in math and science education and use a qualitative methodology. Reflection, PCK courses, contact with other teachers, and experiences in educational practice are typically part of effective interventions. The review enables the identification of clear guidelines that may strengthen future research on stimulating PCK.

  2. Observational and interventional study design types; an overview

    OpenAIRE

    Thiese, Matthew S.

    2014-01-01

    The appropriate choice in study design is essential for the successful execution of biomedical and public health research. There are many study designs to choose from within two broad categories of observational and interventional studies. Each design has its own strengths and weaknesses, and the need to understand these limitations is necessary to arrive at correct study conclusions. Observational study designs, also called epidemiologic study designs, are often retrospective and are used...

  3. Improving the diet of employees at blue-collar worksites: results from the "Food at work" intervention study.

    OpenAIRE

    Lassen, Anne Dahl; Thorsen, Anne Vibeke; Sommer, Helle Mølgaard; Fagt, Sisse; Trolle, Ellen; Biltoft-Jensen, Anja Pia; Tetens, Inge

    2011-01-01

    Objective. To examine the impact of a 6-month participatory and empowerment-based intervention study on employees' dietary habits and on changes in the canteen nutrition environment. Design. Worksites were stratified by company type and by the presence or absence of an in-house canteen, and randomly allocated to either an intervention group (five worksites) or a minimum intervention control group (three worksites). The study was carried out in partnership with a trade union and guided by an e...

  4. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

    Science.gov (United States)

    Asselah, Tarik; Moreno, Christophe; Sarrazin, Christoph; Gschwantler, Michael; Foster, Graham R.; Craxí, Antonio; Buggisch, Peter; Ryan, Robert; Lenz, Oliver; Scott, Jane; Van Dooren, Gino; Lonjon-Domanec, Isabelle; Schlag, Michael; Buti, Maria

    2016-01-01

    Background Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0–F2 fibrosis, patients with HCV-RNA 12-week regimen. Conclusions Overall SVR12 rate (66%) was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen. Trial Registration ClinicalTrials.gov NCT01846832 PMID:27428331

  5. 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 < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  6. 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

  7. Adding Qualitative and Mixed Methods Research to Health Intervention Studies: Interacting With Differences.

    Science.gov (United States)

    Johnson, R Burke; Schoonenboom, Judith

    2016-04-01

    The purpose of this article is to explain how to improve intervention designs, such as randomized controlled trials (RCTs), in health science research using a process philosophy and theory known as dialectical pluralism (DP). DP views reality as plural and uses dialectical, dialogical, and hermeneutical approaches to knowledge construction. Using DP and its "both/and" logic, and its attempt to produce new creative syntheses, researchers on heterogeneous teams can better dialogue with qualitative and mixed methods approaches, concepts, paradigms, methodologies, and methods to improve their intervention research studies. The concept of reflexivity is utilized but is expanded when it is a component of DP. Examples of strategies for identifying, inviting, and creating divergence and integrative strategies for producing strong mixed methods intervention studies are provided and illustrated using real-life examples. PMID:26657970

  8. Adding Qualitative and Mixed Methods Research to Health Intervention Studies: Interacting With Differences.

    Science.gov (United States)

    Johnson, R Burke; Schoonenboom, Judith

    2016-04-01

    The purpose of this article is to explain how to improve intervention designs, such as randomized controlled trials (RCTs), in health science research using a process philosophy and theory known as dialectical pluralism (DP). DP views reality as plural and uses dialectical, dialogical, and hermeneutical approaches to knowledge construction. Using DP and its "both/and" logic, and its attempt to produce new creative syntheses, researchers on heterogeneous teams can better dialogue with qualitative and mixed methods approaches, concepts, paradigms, methodologies, and methods to improve their intervention research studies. The concept of reflexivity is utilized but is expanded when it is a component of DP. Examples of strategies for identifying, inviting, and creating divergence and integrative strategies for producing strong mixed methods intervention studies are provided and illustrated using real-life examples.

  9. Effekt of a two-stage nursing assesment and intervention - a randomized intervention study

    DEFF Research Database (Denmark)

    Rosted, Elizabeth Emilie; Poulsen, Ingrid; Hendriksen, Carsten;

    ; health related quality of life; and hours of help received from the community. Conclusion: Results collected at one and six months follow-up, will show if a two-stage intervention consisting of screening with the ISAR 1 tool followed by structured nursing assessment and intervention in the ED could......Background: Geriatric patients recently discharged from hospital are at risk of unplanned readmissions and admission to nursing home. When discharged directly from Emergency Department (ED) the risk increases, as time pressure often requires focus on the presenting problem, although 80...... % of geriatric patients have complex and often unresolved caring needs. The objective was to examine the effect of a two-stage nursing assessment and intervention to address the patients uncompensated problems given just after discharge from ED and one and six months after. Method: We conducted a prospective...

  10. Morphological adaptation of muscle collagen and receptor of advanced glycation end product (RAGE) in osteoarthritis patients with 12 weeks of resistance training: influence of anti-inflammatory or glucosamine treatment.

    Science.gov (United States)

    Mattiello-Sverzut, Ana Claudia; Petersen, Susanne G; Kjaer, Michael; Mackey, Abigail L

    2013-09-01

    The aim of this study was to investigate the effect of 12-week resistance training on morphological presence of collagen and RAGE (receptor for advanced glycation end products) in skeletal muscle of patients with knee osteoarthritis (OA). Little is known about the influence of exercise on the skeletal muscle matrix that supports joints affected by OA mainly when it is associated with medication taken by OA patients (non-steroid anti-inflammatory drugs (NSAID) and glucosamine). A biopsy was collected from the vastus lateralis muscle in all patients before and after 12-week period of training. The patients (age 55-69 years) were divided into three groups, treated with NSAID, glucosamine or placebo. In addition, the muscle samples were analysed by immunohistochemistry for collagen types, RAGE and capillaries ratio. An increment in immunoreactivity for type IV collagen after the training period was observed in 72 % of all biopsies when compared with their respective baseline samples. Reduced immunoreactivity of collagen type I was observed in all patients treated with glucosamine. A significant increase with training in the amount of RAGE was detected in the placebo group only (p muscle fibres after 12 weeks of resistance training. Glucosamine with training appeared to attenuate RAGE accumulation more than was seen with NSAID or placebo in skeletal muscle of OA patients.

  11. Effects of low carbohydrate diets on weight and glycemic control among type 2 diabetes individuals: a systemic review of RCT greater than 12 weeks Efectos de las dietas bajas en carbohidratos sobre el peso y el control glicémico en individuos con diabetes tipo 2: revisión sistemática de estudios aleatorizados de más de 12 semanas

    Directory of Open Access Journals (Sweden)

    L. M. Castañeda-González

    2011-12-01

    Full Text Available Introduction: Low carbohydrate diets (LCD have shown beneficial effects on short-term weight reduction programs for obese individuals without diabetes, but the long-term evidence of efficacy on individuals with type 2 diabetes is not conclusive. Objective: To evaluate, the effectiveness of 12 or more weeks of LCD compared to Low Fat Diet (LFD, Usual Care Diet (UCD or Low Glycemic Index Diet (LGID on weight reduction and AIC on type 2 diabetes individuals. Methods: A systematic review was conducted on randomized trials registered in PubMed, Cochrane and EBSCOhost from January 1st 2000 to January 1st 2010 including those with an intervention program with LCD in type 2 diabetes subjects and a follow-up ≥ 12 weeks. Available data on study design; carbohydrate composition of diet; duration of diet; and the outcomes of weight, lipid levels (total, low density lipoprotein and high-density lipoprotein cholesterol, and triglycerides, hemoglobin A1C percent and/or fasting glucose were extracted. Results: Five studies showed greater weight reduction with LCD, of which four demonstrated no significant difference. The longest trial intervention studies did not show a difference in weight change. Only two studies showed greater reduction of A1C with LCD, including the longest intervention trial with a low carbohydrate Mediterranean diet. Conclusions: This review shows that there are no consistent differences in weight and A1C changes over the long-term treatment with LCD and LFD, UCD or LGID.Introducción: Las dietas bajas en carbohidratos han demostrado, a corto plazo, efectos benéficos sobre la pérdida de peso en individuos obesos sin diabetes, sin embargo la evidencia sobre su efectividad a largo plazo en individuos con diabetes tipo 2 no es concluyente. Objetivo: Evaluar el efecto de dietas bajas en carbohidratos (DBC en intervenciones mayores a 12 semanas comparadas con dietas bajas en grasas (DBG, dietas de cuidado común (DCC o dietas con bajo

  12. 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

  13. 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

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    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

  14. 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.

  15. Results of a quality control on non-interventional studies

    Directory of Open Access Journals (Sweden)

    Hundt, Ferdinand

    2011-01-01

    Full Text Available Non-interventional studies (NIS have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM on the execution of non interventional (observational studies of 1998 and finally with the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP, with the VFA (Verband der forschenden Arzneimittelhersteller [German Association of Research-Based Pharmaceutical Companies] – Recommendations for the Improvement of Quality and Transparency of NIS and the joint recommendations of BfArM and PEI (Paul-Ehrlich-Institut on the execution of NIS, pharmaceutical companies are required to monitor and/or verify quality in the course of a project. According to a survey of pharmaceutical companies 2010, about one third of the companies surveyed to date carry out such quality controls on site, at participating study centres.This report deals with the results of such quality control measures in 4 completed projects. The control rates defined in the respective cohort study plans, the measures carried out on site and any consequent measures, such as adjustment of forms, reduction of consultation time and necessary organisational changes are described. A high level of agreement between the data collected and the original patient documents is found, comparable to that in clinical trials.

  16. Results of a quality control on non-interventional studies.

    Science.gov (United States)

    Wörz, Karl; Hundt, Ferdinand

    2011-01-01

    Non-interventional studies (NIS) have for decades been an established part of post-authorisation medicinal research. As early as the mid-nineties, there were at least rudimentary demands for controllable data quality. Beginning with the recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) on the execution of non interventional (observational) studies of 1998 and finally with the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP), with the VFA (Verband der forschenden Arzneimittelhersteller [German Association of Research-Based Pharmaceutical Companies]) - Recommendations for the Improvement of Quality and Transparency of NIS and the joint recommendations of BfArM and PEI (Paul-Ehrlich-Institut) on the execution of NIS, pharmaceutical companies are required to monitor and/or verify quality in the course of a project. According to a survey of pharmaceutical companies 2010, about one third of the companies surveyed to date carry out such quality controls on site, at participating study centres. This report deals with the results of such quality control measures in 4 completed projects. The control rates defined in the respective cohort study plans, the measures carried out on site and any consequent measures, such as adjustment of forms, reduction of consultation time and necessary organisational changes are described. A high level of agreement between the data collected and the original patient documents is found, comparable to that in clinical trials. PMID:21863135

  17. The application of near infrared spectroscopy in nutritional intervention studies

    Directory of Open Access Journals (Sweden)

    Philippa A Jackson

    2013-08-01

    Full Text Available Functional near infrared spectroscopy (NIRS is a non-invasive optical imaging technique used to monitor cerebral blood flow (CBF and by proxy neuronal activation. The use of NIRS in nutritional intervention studies is a relatively novel application of this technique, with only a small, but growing, number of trials published to date. These trials—in which the effects on CBF following administration of dietary components such as caffeine, polyphenols and omega-3 polyunsaturated fatty acids are assessed—have successfully demonstrated NIRS as a sensitive measure of change in haemodynamic response during cognitive tasks in both acute and chronic treatment intervention paradigms. The existent research in this area has been limited by the constraints of the technique itself however advancements in the measurement technology, paired with studies endeavouring increased sophistication in number and locations of channels over the head should render the use of NIRS in nutritional interventions particularly valuable in advancing our understanding of the effects of nutrients and dietary components on the brain.

  18. Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

    OpenAIRE

    Kanamoto T; Ando N; Maruiwa F; Baba Y; Nakakura S; Tabuchi H; Kiuchi Y

    2012-01-01

    Shunsuke Nakakura1, Hitoshi Tabuchi1, Yukio Baba2, Futoshi Maruiwa2, Nobuko Ando2, Takashi Kanamoto3, Yoshiaki Kiuchi31Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Hyogo Prefecture, Japan; 2Department of Ophthalmology, Baba Eye Clinic, Hiroshima, Japan, 3Department of Ophthalmology and Visual Sciences, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima City, JapanObjective: To compare the safety and effectiveness of fixed-combination regimes (latanopr...

  19. 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

    OpenAIRE

    Ishikawa, Shusaku

    2008-01-01

    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 fro...

  20. 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.

  1. Determining a Cut-Off Point for Scores of the Breastfeeding Self-Efficacy Scale-Short Form: Secondary Data Analysis of an Intervention Study in Japan.

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    Keiko Nanishi

    Full Text Available Breastfeeding self-efficacy can be measured with the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF. Mothers with low BSES-SF scores stop exclusive breastfeeding prematurely, but specific interventions can prevent that undesirable outcome. Because those interventions can be expensive, often one must decide which mothers will receive them. For that purpose, a cut-off BSES-SF score would be useful, but none is available. Therefore, we aimed to assess the overall accuracy of BSES-SF scores as predictors of not practicing post-discharge exclusive breastfeeding, and to choose an appropriate cut-off score for making that prediction.This is a secondary data analysis of an intervention study. Data from 378 women in two non-Baby-Friendly Hospitals were analyzed. Participants were women in their third trimester who were 16 years of age or older, were able to read and write Japanese, were expected to have a singleton birth, and had completed the BSES-SF before discharge. BSES-SF scores were measured before discharge. Breastfeeding status was assessed 4 weeks and 12 weeks postpartum. Receiver Operating Characteristic (ROC curves were used to assess the predictive ability of the BSES-SF and to inform the choice of a cut-off point.For both of the ROC curves (4 and 12 weeks postpartum the area under the curve was 0.74. To obtain a high sensitivity, a cut-off score of 50 was chosen. With that cut-off score the sensitivity was 79% and the specificity was 52% 4 weeks postpartum, and they were 77% and 52%, respectively, 12 weeks postpartum.In conclusion, the BSES-SF has moderate overall accuracy to distinguish women who will not practice exclusive breastfeeding after discharge from those who will. At non-Baby-Friendly hospitals in Japan, interventions to support exclusive breastfeeding might be considered for new mothers who have BSES-SF scores that are less than or equal to 50.

  2. Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy - Results from the randomized DAHANCA 25B trial

    DEFF Research Database (Denmark)

    Lønbro, Simon; Dalgas, Ulrik; Primdahl, Hanne;

    2013-01-01

    PURPOSE: The critical weight loss observed in head and neck squamous cell carcinoma (HNSCC) patients following radiotherapy is mainly due to loss of lean body mass. This is associated with decreases in muscle strength, functional performance and Quality of Life (QoL). The present study investigated...... the effect of progressive resistance training (PRT) on lean body mass, muscle strength and functional performance in HNSCC patients following radiotherapy. PATIENTS AND METHODS: Following radiotherapy HNSCC patients were randomized into two groups: Early Exercise (EE, n=20) initiated 12weeks of PRT followed...... by 12weeks of self-chosen physical activity. Delayed Exercise (DE, n=21) initiated 12weeks of self-chosen physical activity followed by 12weeks of PRT. Lean body mass, muscle strength, functional performance and QoL were evaluated at baseline and after week 12 and 24. RESULTS: In the first 12weeks lean...

  3. No effect of 12 weeks' supplementation with 1 g DHA-rich or EPA-rich fish oil on cognitive function or mood in healthy young adults aged 18-35 years.

    Science.gov (United States)

    Jackson, Philippa A; Deary, Michael E; Reay, Jonathon L; Scholey, Andrew B; Kennedy, David O

    2012-04-01

    The n-3 PUFA are a unique class of fatty acids that cannot be manufactured by the body, and must be acquired via dietary sources. In the UK, as well as in other Western nations, these 'essential' fatty acids are consumed in quantities that fall below government guidelines. The present study explored the effects of 12 weeks' dietary supplementation with 1 g/d of two types of fish oil (FO; DHA-rich and EPA-rich) in 159 healthy young adults aged 18-35 years. An assessment of performance on a battery of computerised cognitive tasks and mood measures took place before and following the 12-week treatment regimen. Venous blood samples were also supplied by participants at both time points which were later analysed for serum fatty acid concentrations. Despite good adherence to the study protocol - as reflected in increased concentrations of n-3 serum fatty acids - compared with placebo, the observed effects of both active treatments were minimal. The only finding of note revealed that supplementation with EPA-rich FO may reduce subjective mental fatigue at times of high cognitive demand, although further investigation is required. These findings, taken together with other recent reports of null effects, suggest that dietary supplementation with n-3 PUFA in healthy, normally developing and impairment-free populations is unlikely to result in cognitive enhancement.

  4. An interventional study (calcium supplementation & health education on premenstrual syndrome - effect on premenstrual and menstrual symptoms

    Directory of Open Access Journals (Sweden)

    Shailesh Sutariya, Nitiben Talsania, Chintul Shah, Mitesh Patel

    2011-01-01

    Full Text Available The study was conducted to study the effect of calcium supplementation on Premenstrual and Menstrual Symptoms. It was a one year follow-up prospective, randomized controlled interventional study. After the initial 2-cycle screening phase, a total of 215 healthy premenopausal women were enrolled in the study group calcium supplementation(500 BD of the trial and 140 subjects either the relatives or neighbors of the study population were enrolled as control group health, nutrition, hygiene education of the trial. By the second and third treatment months, all symptoms except for fatigue and insomnia showed a significant response to calcium. For the symptom of low backache, the mean screening score was significantly higher than the control group score (0.82±0.74 vs 0.69±0.66,p=0.033 and became significantly lower than the control group score by the end of third treatment cycle. (0.30±0.45 vs 0.49±0.59,p<0.01. Nearly half (55% of the women in the study group reported ?50% improvement and one-third (30% of the women in study group reported ?75% improvement. Significantly lower symptoms score was detected in the urban sites during the first treatment phase with calcium and during the final treatment phase

  5. Behavioural Spillover in the Environmental Domain: An Intervention Study

    DEFF Research Database (Denmark)

    Lanzini, Pietro; Thøgersen, John

    2014-01-01

    behaviours. However, the spillover mostly affects low-cost behaviours. Not unexpectedly, the monetary inducement had a stronger direct impact on "green" shopping than verbal encouragement and praise. However, contrary to popular beliefs, the spillover effects of a monetary inducement on other pro-environmental......This study tests hypotheses about behavioural spillover in the environmental domain as well as the impacts of monetary inducements and verbal praise on behavioural spillover by means of a field experiment. A sample of 194 students from a large university in Denmark were randomly allocated...... to a control group or to one of two experimental conditions where they were encouraged to purchase "green" products by means of either financial compensation and incentives or verbal encouragement and praise. Participants answered a baseline survey containing questions concerning a wide range...

  6. Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

    Science.gov (United States)

    Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

    2014-12-01

    Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM. PMID:25514391

  7. The influence of sample freezing at – 80 °C for 2–12 weeks on glycated haemoglobin (HbA1c) concentration assayed by HPLC method on Bio-Rad D-10® auto analyzer

    Science.gov (United States)

    Bergmann, Katarzyna; Sypniewska, Grazyna

    2016-01-01

    Introduction The aim of the study was to evaluate the effect of a single freeze/thaw cycle on HbA1c concentrations measured by commercially available HPLC method. Materials and methods Study included 128 whole blood samples collected from diabetic patients (N = 60) and healthy volunteers (N = 68). HbA1c concentrations were measured in fresh blood samples. Then samples were frozen at - 80 °C for up to 12 weeks. HbA1c was assayed by ion-exchange HPLC method on Bio-Rad D-10® analyzer. Variables were compared using Wilcoxon and ANOVA Kruskal-Wallis tests. Bias between HbA1c measured in fresh and frozen samples was calculated. The comparability of HbA1c concentrations was assessed by Bland-Altman plot. Results Median (IQR) HbA1c concentration was 45.3 (36.6–61.2) mmol/mol for fresh and 45.3 (36.6–60.6) mmol/mol for frozen/thawed samples. No significant difference in HbA1c concentrations was found comparing fresh and frozen/thawed samples (P = 0.070) in the whole group, as well as in healthy and diabetic subjects. The median calculated bias between fresh and frozen/thawed samples was 0% in whole group and healthy subjects, and 1.19% in diabetic patients. No significant difference was found between the biases according to baseline HbA1c values (P = 0.150). The Bland-Altman plot analysis showed a positive bias of 0.4% (95% CI: - 2.8 - 3.7%), which indicates high compliance between HbA1c values and no relevant influence of sample freezing on clinical significance of HbA1c measurement. Conclusions Storage for up to 12 weeks at – 80 °C with a single freeze/thaw cycle does not affect HbA1c concentrations measured with HPLC method on Bio-Rad D-10® analyzer. PMID:27812303

  8. The Danish Alzheimer Intervention Study: Rationale, Study Design and Baseline Characteristics of the Cohort

    DEFF Research Database (Denmark)

    Waldemar, G.; Waldorff, F.B.; Buss, D.V.;

    2011-01-01

    There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics...

  9. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review

    OpenAIRE

    Thoomes, Erik J.; Scholten-Peeters, Gwendolijne G. M.; de Boer, Alice J.; Olsthoorn, Remy A.; Verkerk, Karin; Lin, Christine; Verhagen, Arianne P

    2012-01-01

    Purpose Cervical radiculopathy (CR) is a common diagnosis. It is unclear if intervention studies use uniform definitions and criteria for patient selection. Our objective was to assess the uniformity of diagnostic criteria and definitions used in intervention studies to select patients with CR. Methods We electronically searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE and CINAHL. Studies were included when evaluating conservative interventions in randomised clinical trials (R...

  10. 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…

  11. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    Science.gov (United States)

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  12. Vestibular Stimulation for ADHD: Randomized Controlled Trial of Comprehensive Motion Apparatus

    Science.gov (United States)

    Clark, David L.; Arnold, L. Eugene; Crowl, Lindsay; Bozzolo, Hernan; Peruggia, Mario; Ramadan, Yaser; Bornstein, Robert; Hollway, Jill A.; Thompson, Susan; Malone, Krista; Hall, Kristy L.; Shelton, Sara B.; Bozzolo, Dawn R.; Cook, Amy

    2008-01-01

    Objective: This research evaluates effects of vestibular stimulation by Comprehensive Motion Apparatus (CMA) in ADHD. Method: Children ages 6 to 12 (48 boys, 5 girls) with ADHD were randomized to thrice-weekly 30-min treatments for 12 weeks with CMA, stimulating otoliths and semicircular canals, or a single-blind control of equal duration and…

  13. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    Science.gov (United States)

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  14. Mirtazapine in generalized social anxiety disorder: a randomized, double-blind, placebo-controlled study

    NARCIS (Netherlands)

    S.I.J. Schutters; H.J.G.M. van Megen; J.F. van Veen; D.A.J.P. Denys; H.G.M. Westenberg

    2010-01-01

    This study is aimed at investigating the efficacy and tolerability of mirtazapine in a generalized social anxiety disorder. Sixty patients with generalized social anxiety disorder were randomly allocated to receive mirtazapine (30-45 mg/day) (n = 30) or placebo (n = 30) for 12 weeks in a double-blin

  15. Outcome of Youth with Early-Phase Schizophrenia-Spectrum Disorders and Psychosis Not Otherwise Specified Treated with Second-Generation Antipsychotics: 12 Week Results from a Prospective, Naturalistic Cohort Study

    Science.gov (United States)

    Vernal, Ditte L.; Kapoor, Sandeep; Al-Jadiri, Aseel; Sheridan, Eva M.; Borenstein, Yehonathan; Mormando, Charles; David, Lisa; Singh, Sukhbir; Seidman, Andrew J.; Carbon, Maren; Gerstenberg, Miriam; Saito, Ema; Kane, John M.; Steinhausen, Hans-Christoph

    2015-01-01

    Abstract Objectives: The purpose of this study was to assess differences in the outcomes of youth with schizophrenia-spectrum disorders (SCZ-S) and psychotic disorder not otherwise specified (PsyNOS) during early antipsychotic treatment. Methods: The study was a prospective, naturalistic, inception cohort study of youth ≤19 years old with SCZ-S (schizophrenia, schizoaffective disorder, schizophreniform disorder) or PsyNOS (PsyNOS, brief psychotic disorder) and ≤24 months of lifetime antipsychotic treatment receiving clinician's choice antipsychotic treatment. Baseline demographic, illness and treatment variables, and effectiveness outcomes were compared at 12 weeks last-observation-carried-forward across SCZ-S and PsyNOS patients, adjusting for significantly different baseline variables. Results: Altogether, 130 youth with SCZ-S (n=42) or PsyNOS (n=88), mostly antipsychotic naïve (76.9%), were prescribed risperidone (47.7%), olanzapine (19.2%), aripiprazole (14.6%), quetiapine (11.5%), or ziprasidone (6.9%). Compared with those with PsyNOS, SCZ-S youth were older (16.4±2.1 vs. 14.8±3.2, p=0.0040), and less likely to be Caucasian (19.1% vs. 42.5%, p=0.009). At baseline, SCZ-S patients had significantly higher Clinical Global Impressions-Severity (CGI-S) scores (6.0±0.9 vs. 5.5±0.8, p=0.0018) and lower Children's Global Assessment Scale (CGAS) scores (29.6±9.2 vs. 36.1±8.9, p=0.0002) and were more likely to be in the severely ill CGAS group (i.e., CGAS≤40). SCZ-S and PsyNOS patients did not differ regarding all-cause discontinuation (40.5 vs. 40.3%. p=0.49), discontinuation because of adverse effects (12.2% vs. 12.4%, p=0.97), or nonadherence (29.3% vs. 30.9%, p=0.88), but somewhat more SCZ-S patients discontinued treatment for inefficacy (19.5% vs. 7.4%, p=0.063). CGI-S and CGAS scores improved significantly in both diagnostic groups (p=0.0001, each). Adjusting for baseline differences, PsyNOS patients experienced significantly better CGI-I improvement

  16. 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.

  17. Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

    Science.gov (United States)

    Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

    2016-01-01

    Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD.

  18. An intervention study to prevent gastric cancer by micro-selenium and large dose of allitridum

    Institute of Scientific and Technical Information of China (English)

    李颢; 李会庆; 王云; 许海修; 范万藤; 王美岭; 孙培洪; 谢晓燕

    2004-01-01

    Background People have more and more concerned about allitridum as studies have shown that taking more raw garlic associated with a lower risk for cancers of the alimentary system. In the present study, we tried to examine whether a large dose of allitridum and a microdose of selenium prevent gastric cancer. Methods A double-blind intervention study was performed on the participants aged (35-74) years, who had matched at least one of the following criteria: (1) a medical history of stomach disorder, (2) a family history of tumour, or (3) smoking and/or alcohol consumption. A total of 2526 and 2507 persons were randomly enrolled into intervention group and control group respectively from 288 natural villages of seven communities in Qixia County, Shandong Province, China. Each person of the intervention group orally took 200 mg synthetic allitridum every day and 100 μg selenium every other day for one month of each year during November 1989 to December 1991. At the same time, people in control group were given 2 placebo capsules containing corn oid with the identical appearance to that in the intervention group.Results For all subjects the large dose of allitridum was accepted and no harmful side effects were found during the study. In the first follow-up five years (1992-1997) after stopping the intervention, the morbidity rates of malignant tumours in the intervention group declined by 22%, in contrast to the control group, declined by 47.3%. After adjusting for age, gender, and other potential confounders, relative risks (RRs) for all tumours and gastric cancer of the whole population were 0.67 (95%CL: 0.43-1.03) and 0.48 (95%CL: 0.21-1.06), respectively, and for male group they were 0.51 (95%CL: 0.30-0.85) and 0.36 (95%CL: 0.14-0.92), respectively. No signigicantly protective effect was found for the female subgroup.Conclusion The present study proves that large doses of allitridum and microdorse of selenium may effectively prevent gastric cancer ,especially in

  19. Invited review: Recommendations for reporting intervention studies on reproductive performance in dairy cattle: Improving design, analysis, and interpretation of research on reproduction.

    Science.gov (United States)

    Lean, Ian J; Lucy, Matthew C; McNamara, John P; Bradford, Barry J; Block, Elliot; Thomson, Jennifer M; Morton, John M; Celi, Pietro; Rabiee, Ahmad R; Santos, José E P; Thatcher, William W; LeBlanc, Stephen J

    2016-01-01

    Abundant evidence from the medical, veterinary, and animal science literature demonstrates that there is substantial room for improvement of the clarity, completeness, and accuracy of reporting of intervention studies. More rigorous reporting guidelines are needed to improve the quality of data available for use in comparisons of outcomes (or meta-analyses) of multiple studies. Because of the diversity of factors that affect reproduction and the complexity of interactions between these, a systematic approach is required to design, conduct, and analyze basic and applied studies of dairy cattle reproduction. Greater consistency, clarity, completeness, and correctness of design and reporting will improve the value of each report and allow for greater depth of evaluation in meta-analyses. Each of these benefits will improve understanding and application of current knowledge and better identify questions that require additional modeling or primary research. The proposed guidelines and checklist will aid in the design, conduct, analysis, and reporting of intervention studies. We propose an adaptation of the REFLECT (Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety) statement to provide guidelines and a checklist specific to reporting intervention studies in dairy cattle reproduction. Furthermore, we provide recommendations that will assist investigators to produce studies with greater internal and external validity that can more often be included in systematic reviews and global meta-analyses. Such studies will also assist the development of models to describe the physiology of reproduction. PMID:26387020

  20. Effect of nurse-led medication reviews in psychiatric patients - an interventional study

    DEFF Research Database (Denmark)

    Sørensen, Ann Lykkegaard; Nielsen, Lars Peter; Poulsen, Birgitte Klindt;

    2013-01-01

    and conducting systematic medication reviews using computer based screening. The effect is evaluated in a controlled interventional study. METHODS: An interventional study including 2 acute psychiatric wards. In one ward nurses’ will receive pharmacological training and the other ward will function as a control...... of the interratervariability between the two professions. RESULTS: The hypothesis is that nurse-led medication reviews will reduce potential inappropriate prescribing and that training will increase nurses’ ability to identify and report potential inappropriate prescribing. It is assumed that this intervention, in addition...

  1. The ideal epidemiological intervention study model on chronic non-infectious diseases - the way forward?

    DEFF Research Database (Denmark)

    Jensen, Olaf Chresten

    to modify the specific risk factors for cardiovascular diseases, diabetes, hypertension, hyperlipidaemia and obesity. The objective here is to present the methodological gold standard for the intervention studies and to discuss how to improve the intervention studies and programs. Material and Methods....... Maritime health interventions programs should go together with the national and international (ILO-WHO) public health programs. References 1 Ebrahim S1, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G. Multiple risk factor interventions for primary prevention of coronary heart disease. Cochrane...

  2. Clinical correlates of weight loss and attrition during a 10-week dietary intervention study

    DEFF Research Database (Denmark)

    Handjieva-Darlenska, Teodora; Holst, Claus; Grau, Katrine;

    2012-01-01

    Objective: The aim of this study was to identify the pre-treatment subject characteristics and weight loss changes as determinants of weight loss and attrition during a 10-week dietary intervention study. Methods: A total of 771 obese subjects (BMI 35.6 kg/m(2)) of both genders were included from 8...... clinical centres in 7 European countries, who underwent a 10-week dietary intervention study comparing two hypo-energetic (-600 kcal/day) diets varying in fat content. Results: The multiple regression model showed that weight loss at week 10 was predicted by: 6.55 + 1.27 × early weight loss (kg) at week 1...

  3. Randomized Trial of a Lifestyle Program in Obese Infertile Women

    NARCIS (Netherlands)

    Mutsaerts, Meike A Q; van Oers, Anne M; Groen, Henk; Burggraaff, Jan M; Kuchenbecker, Walter K H; Perquin, Denise A M; Koks, Carolien A M; van Golde, Ron; Kaaijk, Eugenie M; Schierbeek, Jaap M; Oosterhuis, Gerrit J E; Broekmans, Frank J; Bemelmans, Wanda J E; Lambalk, Cornelis B; Verberg, Marieke F G; van der Veen, Fulco; Klijn, Nicole F; Mercelina, Patricia E A M; van Kasteren, Yvonne M; Nap, Annemiek W; Brinkhuis, Egbert A; Vogel, Niels E A; Mulder, Robert J A B; Gondrie, Ed T C M; de Bruin, Jan P; Sikkema, J Marko; de Greef, Mathieu H G; ter Bogt, Nancy C W; Land, Jolande A; Mol, Ben W J; Hoek, Annemieke

    2016-01-01

    BACKGROUND: Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS: We randomly assigned infertile women with a body-mass index (the weight in kilograms d

  4. Randomization tests

    CERN Document Server

    Edgington, Eugene

    2007-01-01

    Statistical Tests That Do Not Require Random Sampling Randomization Tests Numerical Examples Randomization Tests and Nonrandom Samples The Prevalence of Nonrandom Samples in Experiments The Irrelevance of Random Samples for the Typical Experiment Generalizing from Nonrandom Samples Intelligibility Respect for the Validity of Randomization Tests Versatility Practicality Precursors of Randomization Tests Other Applications of Permutation Tests Questions and Exercises Notes References Randomized Experiments Unique Benefits of Experiments Experimentation without Mani

  5. 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

  6. Effect of 12-week vanadate and magnesium co-administration on chosen haematological parameters as well as on some indices of iron and copper metabolism and biomarkers of oxidative stress in rats.

    Science.gov (United States)

    Scibior, Agnieszka; Adamczyk, Agnieszka; Gołębiowska, Dorota; Niedźwiecka, Irmina

    2012-09-01

    Changes in some blood parameters after 12-week administration of sodium metavanadate (SMV; 0.125mgV/ml) or/and magnesium sulphate (MS; 0.06mgMg/ml) in drinking water were studied in outbred male Wistar rats (16 rats/each group) to explore the probable mechanism(s) underlying SMV toxicity and check whether Mg at the level selected during SMV co-administration can protect, at least in part, from a possible deleterious action of SMV. Exposure to SMV alone and in combination with MS (a) led to a decrease in fluid and food intake and body weight gain; (b) predisposed the animals to the development of microcytic-hypochromic anaemia (with excessive liver and spleen Fe deposition, unaltered plasma Fe level and enhanced Zn concentration in the erythrocytes (RBCs) characterized by a reduced haematocrit (Ht) index and haemoglobin (Hb) level, unchanged erythrocyte and reticulocyte count, anisocytosis, lowered total iron binding capacity (TIBC) and elevated transferrin saturation (TS); (c) disturbed Cu homeostasis, but (d) did not influence the leukocyte count and the plasma total antioxidant status (TAS). We suggest that abnormal metabolism and accumulation of Fe as well as an altered Cu status and the RBC Zn level might lead to defective Fe utilization and be a factor promoting the development of Fe-utilization anaemia. The disturbances in the antioxidative capacity reported previously in rats' RBCs after SMV intoxication (Ścibior, Zaporowska, Environ. Toxicol. Pharmacol. 30 (2010) 153-161) may suggest that oxidative stress (OS) could also be, in part, involved in the mechanism responsible for the development of anaemia. The Mg dose ingested in combination with V under SMV-MS co-administration (a) was able to decrease, to some extent, the V concentration in the blood, (b) normalized the RBC Mg and Fe levels and (c) restored the values of some parameters of the Fe status near the control values. These results allow a supposition that a higher Mg dose consumed during SMV

  7. LA Sprouts Randomized Controlled Nutrition, Cooking and Gardening Program Reduces Obesity and Metabolic Risk in Latino Youth

    OpenAIRE

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

    2015-01-01

    Objective To assess the effects of a 12-week gardening, nutrition, and cooking intervention (“LA Sprouts”) on dietary intake, obesity parameters and metabolic disease risk among low-income, primarily Hispanic/Latino youth in Los Angeles. Methods Randomized control trial involving four elementary schools [2 schools randomized to intervention (172, 3rd–5th grade students); 2 schools randomized to control (147, 3rd–5th grade students)]. Classes were taught in 90-minute sessions once a week to ea...

  8. Efficacy of a Multicomponent Positive Psychology Self-Help Intervention: Study Protocol of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Schotanus-Dijkstra, Marijke; Drossaert, Constance H.C.; Pieterse, Marcel E.; Walburg, Jan A.; Bohlmeijer, Ernst T.

    2015-01-01

    Background: Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A

  9. Problems with trials and intervention studies on barrier creams and emollients at the workplace

    NARCIS (Netherlands)

    Coenraads, PJ; Diepgen, TL

    2003-01-01

    The potential effect of barrier creams or emollients in the prevention of work-related hand eczema has mostly been documented in a laboratory setting on experimentally damaged skin. Publications on real intervention studies of barrier creams or emollients in a workplace setting are scarce: only four

  10. Advanced Life Support in Obstetrics (ALSO) and postpartum hemorrhage: A prospective intervention study in Tanzania

    DEFF Research Database (Denmark)

    Sorensen, Bjarke Lund; Rasch, Vibeke; Massawe, Siriel;

    2011-01-01

    Objective. To evaluate the impact of Advanced Life Support in Obstetrics (ALSO) training on staff performance and the incidences of postpartum hemorrhage (PPH) at a regional hospital in Tanzania. Design. Prospective intervention study. Setting. A regional, referral hospital. Population. A total...

  11. Bullying and Students with Disabilities: A Systematic Literature Review of Intervention Studies

    Science.gov (United States)

    Houchins, David E.; Oakes, Wendy Peia; Johnson, Zachary G.

    2016-01-01

    Bullying is a serious issue affecting the psychological, social, and physical well-being of students. Although a substantial amount of bullying research has been conducted with general education students, there is a paucity of experimental prevention or intervention studies specifically focused on students with disabilities. The aim of this…

  12. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S;

    2011-01-01

    subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...

  13. Randomized Trial Comparing Two Treatment Strategies Using Prize-Based Reinforcement of Abstinence in Cocaine and Opiate Users

    Science.gov (United States)

    Preston, Kenzie L.; Ghitza, Udi E.; Schmittner, John P.; Schroeder, Jennifer R.; Epstein, David H.

    2008-01-01

    We compared two strategies of prize-based contingency management (CM) in methadone-maintained outpatients. Urine was tested thrice weekly for 5 weeks pre-CM, 12 weeks CM, and 8 weeks post-CM. Participants were randomly assigned to a cocaine contingency (four prize draws for each cocaine-negative urine, N = 29) or an opiate-cocaine contingency (one…

  14. Effective weight loss for overweight children: a meta-analysis of intervention studies.

    Science.gov (United States)

    Snethen, Julia A; Broome, Marion E; Cashin, Susan E

    2006-02-01

    Childhood overweight has increased in the United States. Success of weight-loss programs has been limited (Barlow, S.E., & Dietz, W.H. (1998). Obesity evaluation and treatment: Expert committee recomendations. Pediatrics, 102, e29.). The purpose of this investigation was to systematically examine the effectiveness of weight-loss interventions for children. For this meta-analysis, seven weight-loss intervention studies were coded and quality index scores calculated. The interventions had a significant positive effect on weight-loss average d = 0.95, with a 95% confidence interval of 0.79 to 1.11. Limited interventional studies with effective long-term maintenance of weight loss in children are available in the literature. However, there are effective methods for weight loss in children.

  15. Evaluation of the effectiveness of testicular cancer and testicular self-examination training for patient care personnel: intervention study.

    Science.gov (United States)

    Akar, Serife Zehra; Bebiş, Hatice

    2014-12-01

    Testicular cancer (TC) is the most common malignancy among men aged 15-35 years. Testicular self-examination (TSE) is an important tool for preventing late-stage TC diagnoses. This study aimed to assess health beliefs and knowledge related to TC and TSE and the effectiveness of TC and TSE training for patient care staff in a hospital. This was a prospective, randomized, controlled intervention study. The study included 96 patient care staff divided into two groups of 48 participants each: Group I, the interactive education group, and Group II, the pamphlet education group. The results demonstrated that TSE practice and TC knowledge significantly increased in both Group I and Group II. Significant differences were observed between the groups pre and post education. TSE and TC knowledge levels were higher for participants in Group I than those in Group II. There was a significant difference in the performance of TSEs between groups: the rates were 83.3% in Group I and 54.2% in Group II. Perceived confidence and perceived barriers increased significantly for both groups. Interactive education sessions should be used to train men at risk for TC to perform TSEs. PMID:25248831

  16. Who to target in sudden unexpected death in epilepsy prevention and how? Risk factors, biomarkers, and intervention study designs.

    Science.gov (United States)

    Tomson, Torbjörn; Surges, Rainer; Delamont, Robert; Haywood, Serena; Hesdorffer, Dale C

    2016-01-01

    The risk of dying suddenly and unexpectedly is increased 24- to 28-fold among young people with epilepsy compared to the general population, but the incidence of sudden unexpected death in epilepsy (SUDEP) varies markedly depending on the epilepsy population. This article first reviews risk factors and biomarkers for SUDEP with the overall aim of enabling identification of epilepsy populations with different risk levels as a background for a discussion of possible intervention strategies. The by far most important clinical risk factor is frequency of generalized tonic-clonic seizures (GTCS), but nocturnal seizures, early age at onset, and long duration of epilepsy have been identified as additional risk factors. Lack of antiepileptic drug (AED) treatment or, in the context of clinical trials, adjunctive placebo versus active treatment is associated with increased risks. Despite considerable research, reliable electrophysiologic (electrocardiography [ECG] or electroencephalography [EEG]) biomarkers of SUDEP risk remain to be established. This is an important limitation for prevention strategies and intervention studies. There is a lack of biomarkers for SUDEP, and until validated biomarkers are found, the endpoint of interventions to prevent SUDEP must be SUDEP itself. These interventions, be they pharmacologic, seizure-detection devices, or nocturnal supervision, require large numbers. Possible methods for assessing prevention measures include public health community interventions, self-management, and more traditional (and much more expensive) randomized clinical trials.

  17. Who to target in sudden unexpected death in epilepsy prevention and how? Risk factors, biomarkers, and intervention study designs.

    Science.gov (United States)

    Tomson, Torbjörn; Surges, Rainer; Delamont, Robert; Haywood, Serena; Hesdorffer, Dale C

    2016-01-01

    The risk of dying suddenly and unexpectedly is increased 24- to 28-fold among young people with epilepsy compared to the general population, but the incidence of sudden unexpected death in epilepsy (SUDEP) varies markedly depending on the epilepsy population. This article first reviews risk factors and biomarkers for SUDEP with the overall aim of enabling identification of epilepsy populations with different risk levels as a background for a discussion of possible intervention strategies. The by far most important clinical risk factor is frequency of generalized tonic-clonic seizures (GTCS), but nocturnal seizures, early age at onset, and long duration of epilepsy have been identified as additional risk factors. Lack of antiepileptic drug (AED) treatment or, in the context of clinical trials, adjunctive placebo versus active treatment is associated with increased risks. Despite considerable research, reliable electrophysiologic (electrocardiography [ECG] or electroencephalography [EEG]) biomarkers of SUDEP risk remain to be established. This is an important limitation for prevention strategies and intervention studies. There is a lack of biomarkers for SUDEP, and until validated biomarkers are found, the endpoint of interventions to prevent SUDEP must be SUDEP itself. These interventions, be they pharmacologic, seizure-detection devices, or nocturnal supervision, require large numbers. Possible methods for assessing prevention measures include public health community interventions, self-management, and more traditional (and much more expensive) randomized clinical trials. PMID:26749012

  18. A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists

    OpenAIRE

    Shamala Ayadurai; H. Laetitia Hattingh; Tee, Lisa B.G.; Siti Norlina Md Said

    2016-01-01

    Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT) on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, na...

  19. Towards good pharmacy practice in Hanoi : A multi-intervention study in private sector

    OpenAIRE

    Chuc, Nguyen Thi Kim

    2002-01-01

    This thesis describes the quality of private pharmacy practice and assesses the effects of an intervention package on knowledge and practice of private pharmacy staff in Hanoi, Vietnam. The study types used were a case study and a randomised controlled trial. In the case study, two private pharmacies were included. Interviews, observations and drug inventory were used for data collection. In the intervention study, 68 private pharmacies participated. A Simulated Client M...

  20. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    OpenAIRE

    Luca Regazzoni; Barbora de Courten; Davide Garzon; Alessandra Altomare; Cristina Marinello; Michaela Jakubova; Silvia Vallova; Patrik Krumpolec; Marina Carini; Jozef Ukropec; Barbara Ukropcova; Giancarlo Aldini

    2016-01-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, whi...

  1. Biological activity of Aronia melanocarpa antioxidants pre-screening in intervention study design

    OpenAIRE

    Konić-Ristić Aleksandra; Srdić-Rajić Tatjana; Kardum Nevena; Glibetić Marija

    2013-01-01

    Beneficial effects of black chokeberry fruits and juices in health promotion and prevention of chronic diseases shown both in epidemiological and dietary intervention studies are often connected with their antioxidant activity. The aim of this study was to investigate the total phenolics and anthocyanins content, chemical antioxidant activity (DPPH-assay), antioxidant protection in erythrocytes and anti-platelet activity in vitro of three different chokeberry products: commercial and fr...

  2. Deliberate self harm assessment by accident and emergency staff--an intervention study.

    OpenAIRE

    Crawford, M J; Turnbull, G; Wessely, S

    1998-01-01

    OBJECTIVE: To examine the impact of specific training for accident and emergency (A&E) staff on the quality of psychosocial assessment of deliberate self harm patients. METHODS: A non-randomised intervention study that compared the psychosocial assessment of deliberate self harm patients before and after a one hour teaching session for the A&E departments nursing and junior medical staff. Adequacy of psychosocial assessment was judged by examining A&E case notes. The records of the hospital's...

  3. Phenolic metabolites of anthocyanins following a dietary intervention study in post-menopausal women

    OpenAIRE

    de Ferrars, Rachel M; Cassidy, Aedín; Curtis, Peter; Kay, Colin D.

    2014-01-01

    Scope Numerous studies feeding anthocyanin-rich foods report limited bioavailability of the parent anthocyanins. The present study explores the identity and concentration of the phenolic metabolites of anthocyanins in humans. Methods and results Anthocyanin metabolites were quantified in samples collected from a previously conducted 12-wk elderberry intervention study in healthy post-menopausal women. Individual 1-, 2- and 3-h post-bolus urine samples and pooled plasma samples following acute...

  4. Can morbidity associated with untreated asthma in primary school children be reduced?: a controlled intervention study.

    OpenAIRE

    Hill, R.; Williams, J.; Britton, J.; Tattersfield, A

    1991-01-01

    OBJECTIVE--To determine whether an intervention programme based on existing school and community resources can reduce school absence and improve participation in games lessons and sport in children with unrecognised or undertreated asthma. DESIGN--Parallel group controlled intervention study. SETTING--102 primary schools in Nottingham: 49 were randomised to receive the intervention and 53 to be control schools. SUBJECTS--All children aged 5 to 10 years with parent reported absence from school...

  5. Return to work of breast cancer survivors: a systematic review of intervention studies

    Directory of Open Access Journals (Sweden)

    Frings-Dresen MHW

    2009-04-01

    Full Text Available Abstract Background Breast cancer management has improved dramatically in the past three decades and as a result, a population of working age women is breast cancer survivor. Interventions for breast cancer survivors have shown improvements in quality of life and in physical and psychological states. In contrast, efforts aimed at stimulating re-employment and return-to-work interventions for breast cancer survivors have not kept pace. The objective of this review was to study the effects and characteristics of intervention studies on breast cancer survivors in which the outcome was return to work. Methods The Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2006, Medline, Ovid, EMBASE and PsychInfo were systematically searched for studies conducted between 1970 to February 2007. Intervention studies for female breast cancer survivors that were focused on return to work were included. Results Our search strategy identified 5219 studies. Four studies out of 100 potentially relevant abstracts were selected and included 46–317 employed women who had had mastectomy, adjuvant therapy and rehabilitation, with the outcome return to work. The intervention programs focused on improvement of physical, psychological and social recovery. Although a substantial percentage (between 75% to 85% of patients included in these studies returned to work after rehabilitation, it is not clear whether this proportion would have been lower for patients without counseling or exercise, or any other interventions, as three out of four studies did not include a comparison group. Conclusion The most important finding of this review is the lack of methodologically sound intervention studies on breast cancer survivors with the outcome return to work. Using evidence from qualitative and observational studies on cancer and the good results of intervention studies on return to work programs and vocational rehabilitation, return to work interventions for breast

  6. Random Walks on Random Graphs

    Science.gov (United States)

    Cooper, Colin; Frieze, Alan

    The aim of this article is to discuss some of the notions and applications of random walks on finite graphs, especially as they apply to random graphs. In this section we give some basic definitions, in Section 2 we review applications of random walks in computer science, and in Section 3 we focus on walks in random graphs.

  7. Random duality

    Institute of Scientific and Technical Information of China (English)

    GUO TieXin; CHEN XinXiang

    2009-01-01

    The purpose of this paper is to provide a random duality theory for the further development of the theory of random conjugate spaces for random normed modules.First,the complicated stratification structure of a module over the algebra L(μ,K) frequently makes our investigations into random duality theory considerably different from the corresponding ones into classical duality theory,thus in this paper we have to first begin in overcoming several substantial obstacles to the study of stratification structure on random locally convex modules.Then,we give the representation theorem of weakly continuous canonical module homomorphisms,the theorem of existence of random Mackey structure,and the random bipolar theorem with respect to a regular random duality pair together with some important random compatible invariants.

  8. Random duality

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    The purpose of this paper is to provide a random duality theory for the further development of the theory of random conjugate spaces for random normed modules. First, the complicated stratification structure of a module over the algebra L(μ, K) frequently makes our investigations into random duality theory considerably difierent from the corresponding ones into classical duality theory, thus in this paper we have to first begin in overcoming several substantial obstacles to the study of stratification structure on random locally convex modules. Then, we give the representation theorem of weakly continuous canonical module homomorphisms, the theorem of existence of random Mackey structure, and the random bipolar theorem with respect to a regular random duality pair together with some important random compatible invariants.

  9. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  10. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    Science.gov (United States)

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  11. Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects with Metabolic Syndrome: a Double-blind Randomized Controlled Study

    OpenAIRE

    Park, Byoung-Jin; Lee, Yong-Jae; Lee, Hye-Ree; Jung, Dong-Hyuk; Na, Ha-Young; Kim, Hong-Bae; Shim, Jae-Yong

    2012-01-01

    Background This study investigated the effects of Korean red ginseng (KRG) supplementation on metabolic parameters, inflammatory markers, and arterial stiffness in subjects with metabolic syndrome. Methods We performed a randomized, double-blind, placebo-controlled, single-center study in 60 subjects who were not taking drugs that could affect metabolic and vascular functions. Subjects were randomized into either a KRG (4.5 g/d) group or a placebo group for a 12-week study. We collected anthr...

  12. Energy randomness

    OpenAIRE

    Miller, Joseph S.; Rute, Jason

    2015-01-01

    Energy randomness is a notion of partial randomness introduced by Diamondstone and Kjos-Hanssen to characterize the sequences that can be elements of a Martin-L\\"of random closed set (in the sense of Barmpalias, Brodhead, Cenzer, Dashti, and Weber). It has also been applied by Allen, Bienvenu, and Slaman to the characterization of the possible zero times of a Martin-L\\"of random Brownian motion. In this paper, we show that $X \\in 2^\\omega$ is $s$-energy random if and only if $\\sum_{n\\in\\omega...

  13. Objective and Subjective Responses to Low Relative Humidity in an Office Intervention Study

    DEFF Research Database (Denmark)

    Lagercrantz, Love Per; Wyon, David; Meyer, H. W.;

    2003-01-01

    The impact of dry indoor air on comfort and health in winter was investigated in a crossover intervention study in two floors of an office building in northern Sweden. The indoor air humidity (normally 10-20% RH) was raised to 23-24% RH, one floor at a time, using steam humidifiers. Questionnaires...... and objective (clinical) measurements were applied. The following effects of increased humidity were significant, though small: the air was evaluated as less dry (though still on the dry side of neutral), eyes smarted less (by 10% of full scale) eye irritation decreased (by 11%), symptoms of dry throat, mouth...

  14. Effects of Zymotic Grape Seed Meal on Digestive Physiology, Immune Organ Indices and Antioxidant Indices of Wulong Geese Aged from 5 to 12 Weeks%发酵葡萄籽粕对5~12周龄五龙鹅消化生理、免疫器官指数和抗氧化指标的影响

    Institute of Scientific and Technical Information of China (English)

    王宝维; 隋丽; 岳斌; 葛文华; 张名爱; 张开磊; 贾玉辉; 史雪萍

    2016-01-01

    Wulong geese aged from 5 to 12 weeks, to find the appropriate supplemental level of the zymotic grape seed meal and its feed effect.A to-tal of 288 five-week-old Wulong geese were randomly divided into 6 groups with 6 replicates per group and 8 geese per replicate ( half male and half female) .Geese in the control group ( groupⅠ) were fed a basal diet, and the others were fed the basal diet supplemented with 2%( groupⅡ) , 4%( groupⅢ) , 6%( groupⅣ) , 8%( groupⅤ) , 10%( groupⅥ) zymotic grape seed meal, respectively.The experiment lasted for 8 weeks. The results showed as follows:1) compared with the control group, the activities of amylase, trypsin, lipase in duodenum and jejunum in group Ⅴ were significantly increased (P0.05) .3) Compared with the control group, the intestinal villus height in groupⅣwas significantly increased (P0.05).Compared with the control group, the serum total antioxidant capacity in group Ⅴwas significantly increased ( P<0.01);the serum malonaldehyde content in groupⅣwas significant-ly decreased ( P<0.01 ) , the activities of total superoxide dismutase and glutathione peroxidase in serum in group Ⅴ were significantly increased ( P<0.01) .In conclusion, zymotic grape seed meal can improve diges-tive enzyme activity, optimize the structure of intestinal tissue, improve antioxidant function of Wulong geese aged from 5 to 12 weeks, and has no effect on immune organ index, and the dietary appropriate supplemental level is 6%to 8%.

  15. Níveis de cálcio e granulometrias do calcário para frangas de reposição no período de 3 a 12 semanas de idade Calcium levels and particle size of limestone for replacement pullets in the period from 3 to 12 weeks old

    Directory of Open Access Journals (Sweden)

    Adriano Geraldo

    2006-02-01

    four hundred Lohmann LSL replacement pullets were assigned to a complete randomized design with a 5 x 2 factorial (calcium levels and limestone particle size and five replicates of 28 and 18 birds/plot, respectively, for the periods from 3 to 7 and from 8 to 12 weeks old. The experimental diets contained: corn, soybean meal and wheat meal (wheat only at growing phase and were formulated to be isonitrogenous, isoenergetic and isophosphorus (monoammonium phosphorus. Diets were supplemented with minerals, vitamins and phytase (500 FTU/Kg and added with limestone in fine (DGM = 0.135 mm and gross (DGM=0.899 mm particle sizes to meet the levels of 0.60, 0.75, 0.90, 1.05 and 1.20% of dietary total calcium. The performance in the period from 3 to 12 weeks, morphometry of the digestive tract and contents of tibia ashes and minerals in animals slaughtered at 12th week old were evaluated. The feed intake increased linearly as the dietary calcium levels increased. No significant differences on weight gain, feed conversion, percentage of digestory tract and metatarsus length were noticed. Better tibia ash content were observed with 0.60% of calcium and a longer length of the small intestine in pullets fed diet with gross particle size of limestone. The diet with calcium level of 0.60% and gross particle size of limestone resulted in better esqueletic development, worse feed intake and larger length of small intestine.

  16. Randomized random walk on a random walk

    International Nuclear Information System (INIS)

    This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

  17. Positive effects of a healthy snack (fruit versus an unhealthy snack (chocolate/crisps on subjective reports of mental and physical health: A preliminary intervention study

    Directory of Open Access Journals (Sweden)

    Andrew Paul Smith

    2014-07-01

    Full Text Available Background/Aims: Recent research has shown associations between type of snack and wellbeing. These studies have been cross-sectional and the aim of the present research was to examine this topic using an intervention study.Methods: A between subjects intervention study was carried out. Volunteers (100students, mean age = 19.00 years; 27 male, 73 female completed online questionnaires measuring anxiety and depression; fatigue, somatic symptoms, cognitive difficulties and distress at baseline. They were then randomly assigned to one of two snacking conditions – chocolate/crisps or fruit. Volunteers consumed one snack item in the mid-afternoon each day for 10 days. At the end of the intervention the volunteers completed the questionnaires again.Results: Analyses of the baseline data confirmed that consumption of chocolate was associated with greater emotional eating and depression. Analyses of covariance, with the baseline data as covariates, were carried out on the post-intervention responses. The results showed that consumption of fruit was associated with lower anxiety, depression and emotional distress than consumption of crisps/chocolate. Similarly, scores for somatic symptoms, cognitive difficulties and fatigue were greater in the crisps/chocolate condition.Conclusions: These results extend findings from cross-sectional studies and give a clearer indication of causal effects of different types of snacks on wellbeing.

  18. The perceived quality of interprofessional teamwork in an intensive care unit: A single centre intervention study.

    Science.gov (United States)

    Van den Bulcke, Bo; Vyt, Andre; Vanheule, Stijn; Hoste, Eric; Decruyenaere, Johan; Benoit, Dominique

    2016-05-01

    This article describes a study that evaluated the quality of teamwork in a surgical intensive care unit and assessed whether teamwork could be improved significantly through a tailor-made intervention. The quality of teamwork prior to and after the intervention was assessed using the Interprofessional Practice and Education Quality Scales (IPEQS) using the PROSE online diagnostics and documenting system, which assesses three domains of teamwork: organisational factors, care processes, and team members' attitudes and beliefs. Furthermore, team members evaluated strengths and weaknesses of the teamwork through open-ended questions. Information gathered by means of the open questions was used to design a tailor-made 12-week intervention consisting of (1) optimising the existing weekly interdisciplinary meetings with collaborative decision-making and clear communication of goal-oriented actions, including the psychosocial aspects of care; and (2) organising and supporting the effective exchange of information over time between all professions involved. It was found that the intervention had a significant impact on organisational factors and care processes related to interprofessional teamwork for the total group and within all subgroups, despite baseline differences between the subgroups in interprofessional teamwork. In conclusion, teamwork, and more particularly the organisational aspects of interprofessional collaboration and processes of care, can be improved by a tailor-made intervention that takes into account the professional needs of healthcare workers. PMID:27152533

  19. The perceived quality of interprofessional teamwork in an intensive care unit: A single centre intervention study.

    Science.gov (United States)

    Van den Bulcke, Bo; Vyt, Andre; Vanheule, Stijn; Hoste, Eric; Decruyenaere, Johan; Benoit, Dominique

    2016-05-01

    This article describes a study that evaluated the quality of teamwork in a surgical intensive care unit and assessed whether teamwork could be improved significantly through a tailor-made intervention. The quality of teamwork prior to and after the intervention was assessed using the Interprofessional Practice and Education Quality Scales (IPEQS) using the PROSE online diagnostics and documenting system, which assesses three domains of teamwork: organisational factors, care processes, and team members' attitudes and beliefs. Furthermore, team members evaluated strengths and weaknesses of the teamwork through open-ended questions. Information gathered by means of the open questions was used to design a tailor-made 12-week intervention consisting of (1) optimising the existing weekly interdisciplinary meetings with collaborative decision-making and clear communication of goal-oriented actions, including the psychosocial aspects of care; and (2) organising and supporting the effective exchange of information over time between all professions involved. It was found that the intervention had a significant impact on organisational factors and care processes related to interprofessional teamwork for the total group and within all subgroups, despite baseline differences between the subgroups in interprofessional teamwork. In conclusion, teamwork, and more particularly the organisational aspects of interprofessional collaboration and processes of care, can be improved by a tailor-made intervention that takes into account the professional needs of healthcare workers.

  20. Improvement in Patient Performance of Skin Self-examinations After Intervention With Interactive Education and Telecommunication Reminders: A Randomized Controlled Study.

    Science.gov (United States)

    Aneja, Savina; Brimhall, Angela K; Kast, Douglas R; Aneja, Sanjay; Carlson, Diana; Cooper, Kevin D; Bordeaux, Jeremy S

    2012-11-01

    OBJECTIVE To determine if interactive computerized patient education, skin self-examination (SSE) tutorials, and telecommunication reminders could be combined to increase patient performance of SSEs, increase confidence in ability to identify melanoma, and influence individual melanoma risk perception. DESIGN A total of 132 adult participants from our dermatology clinics were enrolled in an interventional study and randomized to a control group or an intervention group. Survey data were collected from all participants on the day of enrollment and 3 months after enrollment. SETTING University Hospitals Case Medical Center outpatient dermatology clinics. PARTICIPANTS English speakers older than 18 years. INTERVENTIONS The intervention group (1) participated in a computer-assisted learning tutorial, (2) took part in a hands-on SSE tutorial, (3) received monthly telecommunication reminders to perform SSEs for 12 weeks, and (4) received a brochure on melanoma detection. The control group received only the brochure on melanoma detection. MAIN OUTCOME MEASURES Self-report of performance of SSEs. Melanoma risk perception and confidence in ability to identify melanoma were secondary considerations. Logistic regressions, controlling for race, age, sex, education, and family history of melanoma, were used to assess the effectiveness of the intervention. RESULTS At the 3-month follow-up, those in the intervention group were more likely to perform SSEs (odds ratio [OR], 2.36; P ≤ .05). In addition, those who participated in the intervention were more likely to report being confident in their ability to identify melanoma during an SSE (OR, 2.72; P ≤ .05). CONCLUSION Computer-assisted patient education used in conjunction with a hands-on SSE tutorial and telecommunication reminders can increase patient performance of SSEs and confidence in the ability to identify melanoma.

  1. Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies.

    Science.gov (United States)

    Farholm, Anders; Sørensen, Marit

    2016-06-01

    There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty-four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal-setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI. PMID:26916699

  2. Vitamin D and muscle strength throughout the life course: a review of epidemiological and intervention studies.

    Science.gov (United States)

    McCarthy, E K; Kiely, M

    2015-12-01

    The putative role of vitamin D in muscle function and strength throughout the life course is of interest because muscle strength is required for engagement in physical activity at all ages. As vitamin D deficiency is widely reported in the population, especially in countries at high latitude, the potential importance of vitamin D in muscle function throughout life, and the potential impacts on growth and development, participation in physical activity, and effects on skeletal and cardio-metabolic health, comprise an important topic for discussion. This review provides an overview of muscle function and summarises the role of the vitamin D receptor and the proposed molecular mechanisms of action of vitamin D in muscle cells. In addition, the review provides a comprehensive assessment of the clinical evidence surrounding the association between vitamin D and muscle strength. Among adults, particularly older adults, cross-sectional and cohort studies reported a positive association between vitamin D status and muscle strength. These associations have been largely confirmed by intervention studies. Limited research has been carried out in adolescents and children; two cross-sectional studies in adolescents have suggested an association between serum 25-hydroxyvitamin D concentrations and muscle strength. However, the two intervention studies in adolescents have yielded conflicting results. Other than a single observational study, data in young children are very limited and further investigation in under 12-year-olds is warranted.

  3. Motivation for physical activity and exercise in severe mental illness: A systematic review of intervention studies.

    Science.gov (United States)

    Farholm, Anders; Sørensen, Marit

    2016-06-01

    There has been increasing interest for research on motivation for physical activity (PA) and exercise among individuals with severe mental illness (SMI). The aim of this systematic review is to summarize findings from all intervention studies on PA or exercise that either include empirical data on motivational constructs or apply motivational techniques/theories in their intervention. Systematic searches of seven databases were conducted from database inception to February 2015. Studies were eligible if they: (i) included participants with SMI, (ii) had PA as part of the intervention, and (iii) reported empirical data on motivational constructs related to PA or incorporated motivational techniques/theory in their intervention. Of the 79 studies that met the inclusion criteria only one had motivation for PA as its main outcome. Nine additional interventions reported empirical data on motivational constructs. Altogether these studies yielded mixed results with respect to change in motivational constructs. Only one of those examined the association between motivation and PA, but found none. Sixty-four studies reported using motivational techniques/theory in their intervention. Motivational interviewing and goal-setting were the most popular techniques. Due to the exploratory nature of most of these studies, findings from intervention studies do not so far give very clear directions for motivational work with the patients. There is an urgent need for a more systematic theory based approach when developing strategies that target to increase engagement in PA among people with SMI.

  4. Lessons for integrated household energy conservation policies from an intervention study in Singapore

    International Nuclear Information System (INIS)

    In preparation for a community energy conservation program in the southwest district of Singapore, a pilot intervention study was conducted between August and November 2008 to study the effectiveness of tailored information and feedback in promoting household conservation. A sample of 125 households was involved in the study, of which 63 were the control group. Both self-reported behavioral changes and actual energy reductions were measured and any Hawthorne effect was identified. It was found that self-reported behavioral changes were strongly correlated to the level of trust in the energy conservation information given, the need for ease in practicing the recommended conservation measures and feeling of satisfaction in executing the measures; these results differ from several past studies on energy interventions. 60.7% of those who reported behavioral changes actually reduced energy consumption. Reasons were found and discussed. Lessons from this intervention study can be applied to design integrated policies aimed at promoting energy conservation in households. - Highlights: ► Energy intervention was implemented on 125 households. ► Outreach instruments included stickers, pamphlets and counseling. ► Self-reported behavioral and actual reductions were recorded. ► Self-reported behavioral change was only correlated to trust of information given. ► It was also correlated to ease of actions and feeling of satisfaction from actions.

  5. Reporting of results of interventional studies by the information service of the National Institutes of Health

    Science.gov (United States)

    Shamliyan, Tatyana

    2010-01-01

    The Food and Drug Administration Amendments Act of 2007 mandated that sponsors of applicable studies must provide results within one year of study completion. We aimed to analyze the factors associated with reporting of results from interventional studies registered on ClinicalTrials.gov. On May 20, 2010, we retrieved 20 available fields from 57,233 closed studies on the website and identified 31,161 interventional studies that were required to post results. We compared the proportion of studies with results versus studies without results by age, gender, and disease status of participants, by interventions, sponsors, phase of clinical trials, and completion dates. The results of studies were reported for 4.7% of applicable studies, 8% of industry-sponsored studies, 7.5% of Phase II and 6.5% of Phase IV clinical trials, 4.9% of drug studies, and 0% of genetic studies. Withdrawn (n = 486) and suspended (n = 414) interventions did not provide results. The percentage of studies with results varied from 0% to 21% among different sponsors. The first studies with results were completed in 1992. The proportion of studies with results increased over time. Completion dates were not available for 7446 studies. The database does not have fields available to facilitate routine analysis of the rate of compliance with federal law for posting results. The analysis of accuracy of the protocols in relation to the results and publications is not possible without time-consuming evaluation of individual postings and individual publications. PMID:22291502

  6. Coffee Consumption and Oxidative Stress: A Review of Human Intervention Studies.

    Science.gov (United States)

    Martini, Daniela; Del Bo', Cristian; Tassotti, Michele; Riso, Patrizia; Del Rio, Daniele; Brighenti, Furio; Porrini, Marisa

    2016-01-01

    Research on the potential protective effects of coffee and its bioactives (caffeine, chlorogenic acids and diterpenes) against oxidative stress and related chronic disease risk has been increasing in the last years. The present review summarizes the main findings on the effect of coffee consumption on protection against lipid, protein and DNA damage, as well as on the modulation of antioxidant capacity and antioxidant enzymes in human studies. Twenty-six dietary intervention studies (involving acute and chronic coffee intake) have been considered. Overall, the results suggest that coffee consumption can increase glutathione levels and improve protection against DNA damage, especially following regular/repeated intake. On the contrary, the effects of coffee on plasma antioxidant capacity and antioxidant enzymes, as well as on protein and lipid damage, are unclear following both acute and chronic exposure. The high heterogeneity in terms of type of coffee, doses and duration of the studies, the lack of information on coffee and/or brew bioactive composition, as well as the choice of biomarkers and the methods used for their evaluation, may partially explain the variability observed among findings. More robust and well-controlled intervention studies are necessary for a thorough understanding of the effect of coffee on oxidative stress markers in humans. PMID:27483219

  7. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    Science.gov (United States)

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  8. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  9. Supervised strengthening exercises versus home-based movement exercises after arthroscopic acromioplasty : A randomized clinical trial

    OpenAIRE

    Holmgren, Theresa; Öberg, Birgitta; Sjöberg, Irene; Johansson, Kajsa

    2012-01-01

    Objective: To evaluate and compare the efficacy of 2 rehabilitation strategies after arthroscopic acromioplasty: supervised physical therapy focusing on strengthening exercises of the rotator cuff and scapula stabilizers (PT-group) vs home-based movement exercises (H-group). Design: A randomized, single-blinded, clinically controlled study. Patients: Thirty-six patients entered the study. Thirteen in the PT-group and 16 in the H-group fulfilled all the assessments. Methods: For 12 weeks follo...

  10. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    OpenAIRE

    Ana Luiza Soares Rodrigues; Beatriz Guitton Renaud Baptista de Oliveira; Débora Omena Futuro; Silvia Regina Secoli

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth wee...

  11. Web-based Intervention to Promote Physical Activity by Sedentary Older Adults: Randomized Controlled Trial

    OpenAIRE

    Irvine, A. Blair; Gelatt, Vicky A; John R. Seeley; Macfarlane, Pamela; Gau, Jeff M

    2013-01-01

    Background Physical activity (PA) for older adults has well-documented physical and cognitive benefits, but most seniors do not meet recommended guidelines for PA, and interventions are lacking. Objectives This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults over 55 years of age adopt and maintain an exercise regimen. Methods A total of 368 sedentary men and women (M=60.3; SD 4.9) were recruited, screened, and assessed online. They were randomize...

  12. Omega-3 Supplementation Lowers Inflammation and Anxiety in Medical Students: A Randomized Controlled Trial

    OpenAIRE

    Kiecolt-Glaser, Janice K.; Belury, Martha A.; Andridge, Rebecca; Malarkey, William B.; Glaser, Ronald

    2011-01-01

    Observational studies have linked lower omega-3 (n-3) polyunsaturated fatty acids (PUFAs) and higher omega-6 (n-6) PUFAs with inflammation and depression, but randomized controlled trial (RCT) data have been mixed. To determine whether n-3 decreases proinflammatory cytokine production and depressive and anxiety symptoms in healthy young adults, this parallel group, placebo-controlled, double-blind 12-week RCT compared n-3 supplementation with placebo. The participants, 68 medical students, pr...

  13. Parent Training for Young Children With Developmental Disabilities: Randomized Controlled Trial

    OpenAIRE

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group (n = 23) received usual care, including early childhood education and related services. Results suggest that this parent training intervention was su...

  14. A Randomized, Double-Blind, Placebo-Controlled Trial of Pregnenolone for Bipolar Depression

    OpenAIRE

    Brown, E. Sherwood; Park, John; Marx, Christine E.; Hynan, Linda S.; Gardner, Claire; Davila, Domingo; Nakamura, Alyson; Sunderajan, Prabha; Lo, Alexander; Holmes, Traci

    2014-01-01

    Depression in bipolar disorder (BPD) is challenging to treat. Therefore, additional medication options are needed. In the current report, the effect of the neurosteroid pregnenolone on depressive symptoms in BPD was examined. Adults (n=80) with BPD, depressed mood state, were randomized to pregnenolone (titrated to 500 mg/day) or placebo, as add-on therapy, for 12 weeks. Outcome measures included the 17-item Hamilton Rating Scale for Depression (HRSD), Inventory of Depressive Symptomatology—S...

  15. Flaxseed supplementation improved insulin resistance in obese glucose intolerant people: a randomized crossover design

    OpenAIRE

    Brunt Ardith; Rhee Yeong

    2011-01-01

    Abstract Background Obesity leads to an increase in inflammation and insulin resistance. This study determined antioxidant activity of flaxseed and its role in inflammation and insulin resistance in obese glucose intolerant people. Methods Using a randomized crossover design, nine obese glucose intolerant people consumed 40 g ground flaxseed or 40 g wheat bran daily for 12 weeks with a 4-week washout period. Plasma inflammation biomarkers (CRP, TNF-α, and IL-6), glucose, insulin, and thiobari...

  16. Random Matrices

    CERN Document Server

    Stephanov, M A; Wettig, T

    2005-01-01

    We review elementary properties of random matrices and discuss widely used mathematical methods for both hermitian and nonhermitian random matrix ensembles. Applications to a wide range of physics problems are summarized. This paper originally appeared as an article in the Wiley Encyclopedia of Electrical and Electronics Engineering.

  17. Development of immune organs and functioning in humans and test animals: Implications for immune intervention studies.

    Science.gov (United States)

    Kuper, C Frieke; van Bilsen, Jolanda; Cnossen, Hilde; Houben, Geert; Garthoff, Jossie; Wolterbeek, Andre

    2016-09-01

    A healthy immune status is mostly determined during early life stages and many immune-related diseases may find their origin in utero and the first years of life. Therefore, immune health optimization may be most effective during early life. This review is an inventory of immune organ maturation events in relation to developmental timeframes in minipig, rat, mouse and human. It is concluded that time windows of immune organ development in rodents can be translated to human, but minipig reflects the human timeframes better; however the lack of prenatal maternal-fetal immune interaction in minipig may cause less responsiveness to prenatal intervention. It is too early to conclude which immune parameters are most appropriate, because there are not enough comparative immune parameters. Filling these gaps will increase the predictability of results observed in experimental animals, and guide future intervention studies by assessing relevant parameters in the right corresponding developmental time frames. PMID:27282947

  18. Influence on working hours among shift workers and effects on sleep quality - An intervention study

    DEFF Research Database (Denmark)

    Garde, Anne Helene; Nabe-Nielsen, Kirsten; Aust, Birgit

    2011-01-01

    The aim of the present intervention study was to examine if increased influence on working hours among shift workers led to better sleep quality. 391 employees were categorized into groups based on the performed activities: High (self-rostering), moderate (education and/or policy for working hours......), and low intensity intervention (meetings and discussions) and reference. Sleep quality was assessed by Karolinska Sleep Questionnaire (KSQ) at baseline and follow-up (12 months). To elucidate the process of the intervention interviews were conducted. Influence on one's own working hours increased only...... in the high intensity group (p sleep quality were observed. Thus, sleep quality was not improved by increasing work time influence in the present group of Danish elder care workers. This was partly due to program failure (failed intervention), but may also be due...

  19. Involvement of informal caregivers in supporting patients with COPD: a review of intervention studies

    Directory of Open Access Journals (Sweden)

    Bryant J

    2016-07-01

    Full Text Available Jamie Bryant,1,2 Elise Mansfield,1,2 Allison W Boyes,1,2 Amy Waller,1,2 Rob Sanson-Fisher,1,2 Timothy Regan1,2 1Health Behaviour Research Group, Priority Research Centre for Health Behaviour, 2Hunter Medical Research Institute, University of Newcastle, Callaghan, NSW, Australia Abstract: Caregivers of individuals with COPD have a key role in maintaining patient adherence and optimizing patient function. However, no systematic review has examined how the caregiver role has been operationalized in interventions to improve outcomes of individuals with COPD or the quality or effectiveness of these interventions. The aims of this review were to 1 determine whether caregivers have been involved as part of interventions to improve outcomes of individuals with COPD; 2 determine the risk of bias within included intervention studies; and 3 examine the effectiveness of interventions that have involved caregivers in improving outcomes of individuals with COPD. The electronic databases of Medline, Embase, PsycINFO, and Cochrane Library were searched from January 2000 to November 2015. Experimental studies testing interventions that involved a caregiver to improve COPD patient outcomes were eligible. Nine studies involving caregivers met inclusion criteria. No studies reported any intervention components targeted solely at caregivers, with most instead including caregivers in dyadic or group education sessions about COPD delivered by health care professionals. The risk of bias identified in included studies was mixed. Seven of the nine studies were effective in improving a broad range of outcomes. These findings highlight that there is an urgent need for methodologically rigorous interventions to examine the effectiveness of strategies to assist caregivers to provide direct care, encourage adherence to health care provider recommendations, act as a health care advocate, and provide emotional and psychosocial support to individuals with COPD. Keywords: COPD

  20. Alcohol-based hand rub and ventilator-associated pneumonia after elective neurosurgery: An interventional study

    Directory of Open Access Journals (Sweden)

    P P Saramma

    2011-01-01

    Full Text Available Background: Interventional studies on the effect of alcohol-based hand rub on ventilator-associated pneumonia (VAP among neurosurgical patients are scarce. Aim: To observe the effect of alcohol-based hand rub on tracheobronchial colonization and VAP after elective neurosurgical procedures. Materials and Methods: An interventional study using a "before-after" design in a tertiary care center in Kerala. Two 9-month study periods were compared; between these periods, an infection control protocol incorporating an alcohol-based hand rub was implemented for a period of 3 months and continued thereafter. Consecutive patients who required mechanical ventilation after neurosurgery between January and September 2006 and 2007, respectively, were included. Outcome measures included VAP rate, tracheobronchial colonization rate, profile of microorganisms and patient survival. Results: A total of 352 patients were on mechanical ventilator for a varying period of 1-125 days. The patients in the control and intervention groups were similar with regard to sex, age and type of neurosurgery. Tracheobronchial colonization was seen in 86 (48.6% of 177 in the control group and 73 (41.7% of 175 among the intervention group (P = 0.195. The VAP rates in the control and intervention groups were 14.03 and 6.48 per 1000 ventilator days (P = 0.08. The predominant organisms causing VAP and tracheobronchial colonization were Klebsiella and Pseudomonas aeruginosa, respectively, in both groups. Patient survival rates were 87.6% (control and 92% (intervention. Conclusion: Clinical results indicated a better outcome, showing a reduction in tracheobronchial colonization rate and VAP rate, although this was not statistically significant.

  1. Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on Duration of antibiotic Therapy in suspected neonatal early-onset Sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study

    NARCIS (Netherlands)

    M. Stocker (Martin); W.C.J. Hop (Wim); A.M.C. van Rossum (Annemarie)

    2010-01-01

    textabstractBackground: Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with

  2. Do patients adhere to over-the-counter artemisinin combination therapy for malaria? evidence from an intervention study in Uganda

    Directory of Open Access Journals (Sweden)

    Cohen Jessica L

    2012-03-01

    Full Text Available Abstract Background Increasing affordability of artemisinin combination therapy (ACT in the African retail sector could be critical to expanding access to effective malaria treatment, but must be balanced by efforts to protect the efficacy of these drugs. Previous research estimates ACT adherence rates among public sector patients, but adherence among retail sector purchasers could differ substantially. This study aimed to estimate adherence rates to subsidized, over-the-counter ACT in rural Uganda. Methods An intervention study was conducted with four licensed drug shops in Eastern Uganda in December 2009. Artemether-lumefantrine (AL was made available for sale at a 95% subsidy over-the counter. Customers completed a brief survey at the time of purchase and then were randomly assigned to one of three study arms: no follow-up, follow-up after two days or follow-up after three days. Surveyors recorded the number of pills remaining through blister pack observation or through self-report if the pack was unavailable. The purpose of the three-day follow-up arm was to capture non-adherence in the sense of an incomplete treatment course ("under-dosing". The purpose of the two-day follow-up arm was to capture whether participants completed the full course too soon ("over-dosing". Results Of the 106 patients in the two-day follow-up sample, 14 (13.2% had finished the entire treatment course by the second day. Of the 152 patients in the three-day follow-up sample, 49 (32.2% were definitely non-adherent, three (2% were probably non-adherent and 100 (65.8% were probably adherent. Among the 52 who were non-adherent, 31 (59.6% had more than a full day of treatment remaining. Conclusions Overall, adherence to subsidized ACT purchased over-the-counter was found to be moderate. Further, a non-trivial fraction of those who complete treatment are taking the full course too quickly. Strategies to increase adherence in the retail sector are needed in the context of

  3. Impact of pedometer-based walking on menopausal women's sleep quality: a randomized controlled trial.

    Science.gov (United States)

    Tadayon, M; Abedi, P; Farshadbakht, F

    2016-08-01

    Objective Sleep disturbances are one of the most common psycho-physiological issues among postmenopausal women. This study was designed to evaluate the impact of walking with a pedometer on the sleep quality of postmenopausal Iranian women. Methods This randomized, controlled trial was conducted on 112 women who were randomly assigned to two groups. The women in the intervention group (n = 56) were asked to walk with a pedometer each day for 12 weeks and to increase their walking distance by 500 steps per week. A sociodemographic instrument and the Pittsburgh Sleep Quality Index were used to collect data. Sleep quality was measured at baseline, 4, 8, and 12 weeks after intervention. The control group (n = 56) did not receive any intervention. Results After 12 weeks, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction improved to a significantly greater extent in the intervention group than in the control group (p sleep quality score was significantly higher in the intervention group than in the control group (0.64 vs. 0.98, p = 0.001). Conclusion This study showed that walking with a pedometer is an easy and cost-effective way to improve the quality of sleep among postmenopausal women. Use of this method in public health centers is recommended. PMID:26757356

  4. Mass treatment against human taeniasis for the control of cysticercosis: a population-based intervention study.

    Science.gov (United States)

    Sarti, E; Schantz, P M; Avila, G; Ambrosio, J; Medina-Santillán, R; Flisser, A

    2000-01-01

    An intervention study with mass treatment against taeniasis to prevent neurocysticercosis due to Taenia solium in a rural community in Mexico was performed in 1991-96. Information and biological samples were obtained at the beginning of the study, at 6 months and at 42 months after mass treatment with praziquantel at a single dose of 5 mg/kg. Prevalence rates of taeniasis were measured by the detection of Taenia coproantigens and Taenia eggs in faeces; neurocysticercosis was suggested by clinical data and by serum antibodies in humans and also in swine. A reduction of 53% after 6 months and of 56% after 42 months for human taeniasis was seen after treatment. Late-onset general seizures decreased 70%. Anti-cysticercus antibodies in the human population were reduced by 75% after 42 months. Antibodies in pigs also showed a significant reduction of 55% after 6 months. In conclusion, an impact of mass chemotherapy against taeniasis to control cysticercosis in the short and long term was demonstrated. Praziquantel for tapeworm treatment should not be given at doses lower than 10 mg/kg. Late-onset convulsive crisis and specific antibodies are good indicators of neurocysticercosis and of exposure to the parasite, respectively.

  5. Burnout hazard in teachers results of a clinical-psychological intervention study

    Directory of Open Access Journals (Sweden)

    Wegner Ralf

    2011-12-01

    Full Text Available Abstract Background The study investigates whether established in-patient therapy for teachers with burnout results in long-acting success and whether gender gaps and differences between teachers of different school levels exist. According to our knowledge, our study is the most extensive inpatient intervention study on the burnout of a defined occupational group, i.e., teachers. Methods 200 teachers participated, 150 took part in a later performed katamnestic survey. The Maslach Burnout Inventory (MBI was used and work-related data were recorded. The days of incapacity for work and the percentage of teachers endangered by burnout decreased, which supports the long-term success of the treatment. Results Significant differences between males and females and between teacher levels were found. However, the differences between teacher levels only showed up before treatment. Because males only underwent treatment at a more severe stage, further efforts in persuading males to start therapy earlier are needed. Conclusions The proven and long-term success of the performed intervention could have greater effects if people, especially males, undergo treatment more frequently. Our results are based on selectively high proposition of teachers of advanced age. Thus it is possible that the long term effect of the intervention, particularly on retirement age, is greater when the intervention is started earlier. Regular burnout tests could help to identify risk cases among teachers at an early stage and to offer a therapeutic intervention.

  6. A carnosine intervention study in overweight human volunteers: bioavailability and reactive carbonyl species sequestering effect

    Science.gov (United States)

    Regazzoni, Luca; de Courten, Barbora; Garzon, Davide; Altomare, Alessandra; Marinello, Cristina; Jakubova, Michaela; Vallova, Silvia; Krumpolec, Patrik; Carini, Marina; Ukropec, Jozef; Ukropcova, Barbara; Aldini, Giancarlo

    2016-06-01

    Carnosine is a natural dipeptide able to react with reactive carbonyl species, which have been recently associated with the onset and progression of several human diseases. Herein, we report an intervention study in overweight individuals. Carnosine (2 g/day) was orally administered for twelve weeks in order to evaluate its bioavailability and metabolic fate. Two carnosine adducts were detected in the urine samples of all subjects. Such adducts are generated from a reaction with acrolein, which is one of the most toxic and reactive compounds among reactive carbonyl species. However, neither carnosine nor adducts have been detected in plasma. Urinary excretion of adducts and carnosine showed a positive correlation although a high variability of individual response to carnosine supplementation was observed. Interestingly, treated subjects showed a significant decrease in the percentage of excreted adducts in reduced form, accompanied by a significant increase of the urinary excretion of both carnosine and carnosine-acrolein adducts. Altogether, data suggest that acrolein is entrapped in vivo by carnosine although the response to its supplementation is possibly influenced by individual diversities in terms of carnosine dietary intake, metabolism and basal production of reactive carbonyl species.

  7. Biological activity of Aronia melanocarpa antioxidants pre-screening in intervention study design

    Directory of Open Access Journals (Sweden)

    Konić-Ristić Aleksandra

    2013-01-01

    Full Text Available Beneficial effects of black chokeberry fruits and juices in health promotion and prevention of chronic diseases shown both in epidemiological and dietary intervention studies are often connected with their antioxidant activity. The aim of this study was to investigate the total phenolics and anthocyanins content, chemical antioxidant activity (DPPH-assay, antioxidant protection in erythrocytes and anti-platelet activity in vitro of three different chokeberry products: commercial and fresh pure chokeberry juice and crude lyophilized water-ethanol extract of chokeberry fruits, as a part of their pre-clinical evaluation. Obtained results indicated the differences in chemical composition and antioxidant activity of investigated products. Cellular effects, including both in vitro anti-platelet and antioxidant effects, were not directly correlated with the chemical antioxidant activity and results obtained in vitro for anti-platelet effects just partially consistent with the results obtained in vivo, in a pilot intervention trial. In conclusion, chemical analyses and in vitro experiments on foods and their bioactives are a valuable pre-screening tool for the evaluation of their biological activity. However, extrapolation of the obtained results to the in vivo settings is often limited and influenced by the bioavailability and metabolism of native dietary compounds or interactions with different molecules within the human body. [Projekat Ministarstva nauke Republike Srbije, br. III41030

  8. Workplace restructurings in intervention studies – a challenge for design, analysis and interpretation

    Directory of Open Access Journals (Sweden)

    Poulsen Kjeld

    2008-06-01

    Full Text Available Abstract Background Interventions in occupational health often target worksites rather than individuals. The objective of this paper is to describe the (lack of stability in units of analysis in occupational health and safety intervention projects directed toward worksites. Methods A case study approach is used to describe naturally occurring organizational changes in four, large, Nordic intervention projects that ran 3–5 years, covered 3–52 worksites, cost 0.25 mill–2.2 mill €, and involved 3–7 researchers. Results In all four cases, high rates of closing, merging, moving, downsizing or restructuring was observed, and in all four cases at least one company/worksite experienced two or more re-organizations during the project period. If individual worksites remained, ownership or (for publicly owned administrative or legal base often shifted. Forthcoming closure led employees and managers to seek employment at other worksites participating in the studies. Key employees involved in the intervention process often changed. Conclusion Major changes were the rule rather than the exception. Frequent fundamental changes at worksites need to be taken into account when planning intervention studies and raises serious questions concerning design, analyses and interpretation of results. The frequent changes may also have deleterious implications for the potential effectiveness of many real life interventions directed toward worksites. We urge researchers and editors to prioritize this subject in order to improve the quality of future intervention research and preventive action.

  9. A Narrative Review of Diabetes Intervention Studies to Explore Diabetes Care Opportunities for Pharmacists

    Directory of Open Access Journals (Sweden)

    Shamala Ayadurai

    2016-01-01

    Full Text Available Background. We conducted a review of current diabetes intervention studies in type 2 diabetes and identified opportunities for pharmacists to deliver quality diabetes care. Methods. A search on randomised controlled trials (RCT on diabetes management by healthcare professionals including pharmacists published between 2010 and 2015 was conducted. Results and Discussion. Diabetes management includes multifactorial intervention which includes seven factors as outlined in diabetes guidelines, namely, glycaemic, cholesterol and blood pressure control, medication, lifestyle, education, and cardiovascular risk factors. Most studies do not provide evidence that the intervention methods used included all seven factors with exception of three RCT which indicated HbA1c (glycated hemoglobin reduction range of 0.5% to 1.8%. The varied HbA1C reduction suggests a lack of standardised and consistent approach to diabetes care. Furthermore, the duration of most studies was from one month to two years; therefore long term outcomes could not be established. Conclusion. Although pharmacists’ contribution towards improving clinical outcomes of diabetes patients was well documented, the methods used to deliver structured, consistent evidence-based care were not clearly stipulated. Therefore, approaches to achieving long term continuity of care are uncertain. An intervention strategy that encompass all seven evidence-based factors will be useful.

  10. Intervention studies for improving global health and health care: An important arena for epidemiologists

    Directory of Open Access Journals (Sweden)

    Gunnar Kvåle

    2009-10-01

    Full Text Available Marginalised populations in many low- and middle-income countries experience an increasing burden of disease, in sub-Saharan Africa to a large extent due to faltering health systems and serious HIV epidemics. Also other poverty related diseases (PRDs are prevalent, especially respiratory and diarrhoeal diseases in children, malnutrition, maternal and perinatal health problems, tuberculosis and malaria. Daily, nearly 30,000 children under the age of 5 die, most from preventable causes, and 8,000 people die from HIV infections. In spite of the availability of powerful preventive and therapeutic tools for combating these PRDs, their implementation, especially in terms of equitable delivery, leaves much to be desired. The research community must address this tragic gap between knowledge and implementation. Epidemiologists have a very important role to play in conducting studies on diseases that account for the largest share of the global disease burden. A shift of focus of epidemiologic research towards intervention studies addressing health problems of major public health importance for disadvantaged population groups is needed. There is a need to generate an evidence-base for interventions that can be implemented on a large scale; this can result in increased funding of health promotion programs as well as enable rational prioritization and integration between different health interventions. This will require close and synergetic teamwork between epidemiologists and other professions across disciplines and sectors. In this way epidemiologists can contribute significantly to improve health and optimise health care delivery for marginalized populations.

  11. Clinical diagnostic and intervention studies of children with semantic-pragmatic language disorder.

    Science.gov (United States)

    Adams, C

    2001-01-01

    The diagnosis of semantic-pragmatic language disorder (SPLD) has been the subject of a number of research studies over the last two decades. Classification and diagnostic debates, while illuminating, have done little to develop tools to improve services to these children. In this paper, two children whose communication difficulties are suggestive of an SPLD diagnosis but who have differing profiles are studied. Using existing models of psycholinguistics and pragmatics to guide assessment and intervention, the diversity of language and social communicative behaviours that are covered by the label SPLD are exemplified. Consideration is given to whether the term SPLD is appropriate for both children or whether Bishop's revision of the diagnosis to 'pragmatic language impairment' might be more useful. Methods of intervention and evaluation for semantic and pragmatic deficits in these two cases are described. It is argued that existing tools can enable accurate explanation and modelling of the communication of children with SPLD and that there is a role for intervention studies in helping to refine those tools, to improve therapies and to understand the nature of the condition more fully. PMID:11491481

  12. Development of luciferase tagged brain tumour models in mice for chemotherapy intervention studies.

    Science.gov (United States)

    Kemper, E M; Leenders, W; Küsters, B; Lyons, S; Buckle, T; Heerschap, A; Boogerd, W; Beijnen, J H; van Tellingen, O

    2006-12-01

    The blood-brain barrier (BBB) is considered one of the major causes for the low efficacy of cytotoxic compounds against primary brain tumours. The aim of this study was to develop intracranial tumour models in mice featuring intact or locally disrupted BBB properties, which can be used in testing chemotherapy against brain tumours. These tumours were established by intracranial injection of suspensions of different tumour cell lines. All cell lines had been transfected with luciferase to allow non-invasive imaging of tumour development using a super-cooled CCD-camera. Following their implantation, tumours developed which displayed the infiltrative, invasive or expansive growth patterns that are also found in primary brain cancer or brain metastases. Contrast-enhanced magnetic resonance imaging showed that the Mel57, K1735Br2 and RG-2 lesions grow without disruption of the BBB, whereas the BBB was leaky in the U87MG and VEGF-A-transfected Mel57 lesions. This was confirmed by immunohistochemistry. Bioluminescence measurements allowed the visualisation of tumour burden already within 4 days after injection of the tumour cells. The applicability of our models for performing efficacy studies was demonstrated in an experiment using temozolomide as study drug. In conclusion, we have developed experimental brain tumour models with partly disrupted, or completely intact BBB properties. In vivo imaging by luciferase allows convenient follow-up of tumour growth and these models will be useful for chemotherapeutic intervention studies.

  13. The healthy building intervention study: Objectives, methods and results of selected environmental measurements

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, W.J.; Faulkner, D.; Sullivan, D. [and others

    1998-02-17

    To test proposed methods for reducing SBS symptoms and to learn about the causes of these symptoms, a double-blind controlled intervention study was designed and implemented. This study utilized two different interventions designed to reduce occupants` exposures to airborne particles: (1) high efficiency filters in the building`s HVAC systems; and (2) thorough cleaning of carpeted floors and fabric-covered chairs with an unusually powerful vacuum cleaner. The study population was the workers on the second and fourth floors of a large office building with mechanical ventilation, air conditioning, and sealed windows. Interventions were implemented on one floor while the occupants on the other floor served as a control group. For the enhanced-filtration intervention, a multiple crossover design was used (a crossover is a repeat of the experiment with the former experimental group as the control group and vice versa). Demographic and health symptom data were collected via an initial questionnaire on the first study week and health symptom data were obtained each week, for eight additional weeks, via weekly questionnaires. A large number of indoor environmental parameters were measured during the study including air temperatures and humidities, carbon dioxide concentrations, particle concentrations, concentrations of several airborne bioaerosols, and concentrations of several microbiologic compounds within the dust sampled from floors and chairs. This report describes the study methods and summarizes the results of selected environmental measurements.

  14. Child development surveillance: intervention study with nurses of the Family Health Strategy1

    Science.gov (United States)

    Reichert, Altamira Pereira da Silva; Collet, Neusa; Eickmann, Sophie Helena; Lima, Marília de Carvalho

    2015-01-01

    Objective: to evaluate the effectiveness of an educational action in child development surveillance performed by nurses working in primary health care. Methods: interventional study with a before-and-after type of design, carried out with 45 nurses and 450 mothers of children under 2 years of age. Initially, it was evaluated the practices and knowledge of nurses on child development surveillance and the mothers were interviewed about these practices. Subsequently, workshops were carried out with nurses and four months later, the knowledge of nurses and the maternal information were reevaluated. Results: after intervention there was significant increase in the frequency of the following aspects: from 73% to 100%, in relation to the practice of nurses of asking the opinion of mothers about their children's development; from 42% to 91%, regarding the use of the systematized instrument of evaluation; from 91% to 100% with respect to guidance to mothers on how to stimulate child development. Conclusions: the intervention contributed to the increase of knowledge of nurses and implementation of child development surveillance, showing the importance of this initiative to improve the quality of child health care. PMID:26487147

  15. Child development surveillance: intervention study with nurses of the Family Health Strategy

    Directory of Open Access Journals (Sweden)

    Altamira Pereira da Silva Reichert

    2015-10-01

    Full Text Available Objective: to evaluate the effectiveness of an educational action in child development surveillance performed by nurses working in primary health care.Methods: interventional study with a before-and-after type of design, carried out with 45 nurses and 450 mothers of children under 2 years of age. Initially, it was evaluated the practices and knowledge of nurses on child development surveillance and the mothers were interviewed about these practices. Subsequently, workshops were carried out with nurses and four months later, the knowledge of nurses and the maternal information were reevaluated.Results: after intervention there was significant increase in the frequency of the following aspects: from 73% to 100%, in relation to the practice of nurses of asking the opinion of mothers about their children's development; from 42% to 91%, regarding the use of the systematized instrument of evaluation; from 91% to 100% with respect to guidance to mothers on how to stimulate child development.Conclusions: the intervention contributed to the increase of knowledge of nurses and implementation of child development surveillance, showing the importance of this initiative to improve the quality of child health care.

  16. Random magnetism

    International Nuclear Information System (INIS)

    The 'ingredients' which control a phase transition in well defined systems as well as in random ones (e.q. random magnetic systems) are listed and discussed within a somehow unifying perspective. Among these 'ingredients' the couplings and elements responsible for the cooperative phenomenon, the topological connectivity as well as possible topological incompatibilities, the influence of new degrees of freedom, the order parameter dimensionality, the ground state degeneracy and finally the 'quanticity' of the system are found. The general trends, though illustrated in magnetic systems, essentially hold for all phase transitions, and give a basis for connection of this area with Field theory, Theory of dynamical systems, etc. (Author)

  17. School-based humanistic counseling for psychological distress in young people: pilot randomized controlled trial.

    Science.gov (United States)

    McArthur, Katherine; Cooper, Mick; Berdondini, Lucia

    2013-01-01

    School-based humanistic counseling (SBHC) is a widely delivered intervention for psychological distress in young people, particularly in the UK. This study piloted a set of procedures for evaluating SBHC and obtaining indications of effect. Psychologically distressed young people (aged 13-16) were randomized to either 12 weeks of SBHC or a waiting list control. The primary outcome was psychological distress at the 12-week endpoint, as measured by the Young Person's CORE. Those allocated to counseling (n=16) showed significantly greater reductions in psychological distress than participants in the control group (n=17), with an effect size (ES) (g) of 1.14 on the primary outcome and a mean ES across all four outcome measures of 0.73 at endpoint. The findings indicate that SBHC may be an effective means of reducing psychological distress in young people.

  18. Calcipotriol versus coal tar: a prospective randomized study in stable plaque psoriasis

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, V.; Kaur, I.; Kumar, B. [Postgraduate Institute of Medicinal Education & Research, Chandigarh (India)

    2003-10-01

    Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

  19. Random dynamics

    International Nuclear Information System (INIS)

    The goal of random dynamics is the derivation of the laws of Nature as we know them (standard model) from inessential assumptions. The inessential assumptions made here are expressed as sets of general models at extremely high energies: gauge glass and spacetime foam. Both sets of models lead tentatively to the standard model. (orig.)

  20. Randomized metarounding

    Energy Technology Data Exchange (ETDEWEB)

    CARR,ROBERT D.; VEMPALA,SANTOSH

    2000-01-25

    The authors present a new technique for the design of approximation algorithms that can be viewed as a generalization of randomized rounding. They derive new or improved approximation guarantees for a class of generalized congestion problems such as multicast congestion, multiple TSP etc. Their main mathematical tool is a structural decomposition theorem related to the integrality gap of a relaxation.

  1. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J.C.; Ibrahim, S.R.; Brincker, Rune

    Abstraet Thispaper demansirates how to use the Random Decrement (RD) technique for identification o flinear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a...

  2. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J. C.; Ibrahim, S. R.; Brincker, Rune

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  3. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J. C.; Ibrahim, R.; Brincker, Rune

    1998-01-01

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  4. Safety and Efficacy of Memantine in Children with Autism: Randomized, Placebo-Controlled Study and Open-Label Extension.

    OpenAIRE

    Aman, MG; Findling, RL; Hardan, AY; Hendren, RL; Melmed, RD; Kehinde-Nelson, O; Hsu, HA; Trugman, JM; Palmer, RH; Graham, SM; Gage, AT; Perhach, JL; Katz, E.

    2016-01-01

    Abnormal glutamatergic neurotransmission is implicated in the pathophysiology of autism spectrum disorder (ASD). In this study, the safety, tolerability, and efficacy of the glutamatergic N-methyl-d-aspartate (NMDA) receptor antagonist memantine (once-daily extended-release [ER]) were investigated in children with autism in a randomized, placebo-controlled, 12 week trial and a 48 week open-label extension.A total of 121 children 6-12 years of age with Diagnostic and Statistical Manual of Ment...

  5. Randomized Trial of a Literacy-Sensitive, Culturally Tailored Diabetes Self-Management Intervention for Low-Income Latinos

    OpenAIRE

    Rosal, Milagros C.; Ockene, Ira S; Restrepo, Angela; White, Mary Jo; Borg, Amy; Olendzki, Barbara; Scavron, Jeffrey; Candib, Lucy; Welch, Garry; Reed, George

    2011-01-01

    OBJECTIVE To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-mana...

  6. Baclofen for maintenance treatment of opioid dependence: A randomized double-blind placebo-controlled clinical trial [ISRCTN32121581

    OpenAIRE

    Ahmadi-Abhari Seyed Ali; Radgoodarzi Reza; Assadi Seyed Mohammad

    2003-01-01

    Abstract Background Results of preclinical studies suggest that the GABAB receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence. Methods A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day) or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. S...

  7. Onset of bronchodilation with fluticasone/formoterol combination versus fluticasone/salmeterol in an open-label, randomized study

    OpenAIRE

    Aalbers, René; Brusselle, Guy; McIver, Tammy; Grothe, Birgit; Bodzenta-Lukaszyk, Anna

    2012-01-01

    Introduction: The inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting beta2-agonist, formoterol fumarate (formoterol), have been combined in a single aerosol inhaler (fluticasone/formoterol). In a randomized, open-label study, fluticasone/formoterol showed similar efficacy to fluticasone/salmeterol after 12 weeks of treatment. This post-hoc analysis compared the onset of bronchodilation with the two treatments. Methods: Adults with mild-to-moderatesevere persi...

  8. Identification of biomarkers for intake of protein from meat, dairy products and grains : a controlled dietary intervention study

    NARCIS (Netherlands)

    Altorf-van der Kuil, Wieke; Brink, Elizabeth J.; Boetje, Martine; Siebelink, Els; Bijlsma, Sabina; Engberink, Marielle F.; van 't Veer, Pieter; Tome, Daniel; Bakker, Stephan J. L.; van Baak, Marleen A.; Geleijnse, Johanna M.

    2013-01-01

    In the present controlled, randomised, multiple cross-over dietary intervention study, we aimed to identify potential biomarkers for dietary protein from dairy products, meat and grain, which could be useful to estimate intake of these protein types in epidemiological studies. After 9 d run-in, thir

  9. Identification of biomarkers for intake of protein from meat, dairy products and grains: A controlled dietary intervention study

    NARCIS (Netherlands)

    Altorf-van der Kuil, W.; Brink, E.J.; Boetje, M.; Siebelink, E.; Bijlsma, S.; Engberink, M.F.; Veer, P.V.'.; Tomé, D.; Bakker, S.J.L.; Baak, M.A. van; Geleijnse, J.M.

    2013-01-01

    In the present controlled, randomised, multiple cross-over dietary intervention study, we aimed to identify potential biomarkers for dietary protein from dairy products, meat and grain, which could be useful to estimate intake of these protein types in epidemiological studies. After 9 d run-in, thir

  10. Identification of biomarkers for intake of protein from meat, dairy products and grains: a controlled dietary intervention study

    NARCIS (Netherlands)

    Altorf-van der Kuil, W.; Brink, E.J.; Boetje, M.; Siebelink, E.; Bijlsma, S.; Engberink, M.F.; Tome, D.; Bakker, S.J.; Baak, van M.A.; Geleijnse, J.M.; Veer, van 't P.

    2013-01-01

    In the present controlled, randomised, multiple cross-over dietary intervention study, we aimed to identify potential biomarkers for dietary protein from dairy products, meat and grain, which could be useful to estimate intake of these protein types in epidemiological studies. After 9 d run-in, thir

  11. Policy assessment and policy development for physical activity promotion: results of an exploratory intervention study in 15 European Nations

    NARCIS (Netherlands)

    Rütten, A.; Abu-Omar, K.; Gelius, P.; Dinan-Young, S.; Frändin, K.; Hopman-Rock, M.; Young, A.

    2012-01-01

    Background. Purpose of the study was to test a theoretical model to assess and develop policies for the promotion of physical activity among older people as part of an international intervention study. Methods 248 semi-standardized interviews with policy-makers were conducted in 15 European nations.

  12. Comparative evaluation of serum antioxidant levels in periodontally diseased patients: An interventional study

    Directory of Open Access Journals (Sweden)

    Biju Thomas

    2014-01-01

    Full Text Available Background: Periodontal disease is an immune-inflammatory disease characterized by connective tissue breakdown, loss of attachment and alveolar bone resorption. In normal physiology, there is a dynamic equilibrium between reactive oxygen species activity and antioxidant defense capacity and when that equilibrium shifts in favor of reactive oxygen species, oxidative stress results. Oxidative stress is thought to play a causative role in the pathogenesis of periodontal diseases. Catalase (CAT protects cells from hydrogen peroxide generated within them. Even though, CAT is not essential for some cell types under normal conditions, it plays an important role countering the effects of oxidative stress on the cell. Aim: This study was designed to estimate and compare the CAT and total antioxidant capacity (TAOC levels in the serum of periodontitis, gingivitis, and healthy individuals before and after nonsurgical periodontal therapy. Materials and Methods: This study was conducted in the Department of Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore. The study was designed as a single blinded interventional study comprising of 75 subjects, inclusive of both sexes and divided into three groups of 25 patients each. Patients were categorized into chronic periodontitis, gingivitis and healthy. The severity of inflammation was assessed by using gingival index and pocket probing depth. Biochemical analysis was done to estimate the TAOC and CAT levels before and after nonsurgical periodontal therapy. Results obtained were then statistically analyzed using ANOVA test and paired t-test. Results: The results showed a higher level of serum TAOC and CAT in the healthy group compared with the other groups. The difference was found to be statistically significant (P < 0.0001. The posttreatment levels of TAOC were statistically higher than the pretreatment levels in periodontitis group.

  13. Brain imaging and human nutrition: which measures to use in intervention studies?

    Science.gov (United States)

    Sizonenko, Stéphane V; Babiloni, Claudio; de Bruin, Eveline A; Isaacs, Elizabeth B; Jönsson, Lena S; Kennedy, David O; Latulippe, Marie E; Mohajeri, M Hasan; Moreines, Judith; Pietrini, Pietro; Walhovd, Kristine B; Winwood, Robert J; Sijben, John W

    2013-08-01

    The present review describes brain imaging technologies that can be used to assess the effects of nutritional interventions in human subjects. Specifically, we summarise the biological relevance of their outcome measures, practical use and feasibility, and recommended use in short- and long-term nutritional studies. The brain imaging technologies described consist of MRI, including diffusion tensor imaging, magnetic resonance spectroscopy and functional MRI, as well as electroencephalography/magnetoencephalography, near-IR spectroscopy, positron emission tomography and single-photon emission computerised tomography. In nutritional interventions and across the lifespan, brain imaging can detect macro- and microstructural, functional, electrophysiological and metabolic changes linked to broader functional outcomes, such as cognition. Imaging markers can be considered as specific for one or several brain processes and as surrogate instrumental endpoints that may provide sensitive measures of short- and long-term effects. For the majority of imaging measures, little information is available regarding their correlation with functional endpoints in healthy subjects; therefore, imaging markers generally cannot replace clinical endpoints that reflect the overall capacity of the brain to behaviourally respond to specific situations and stimuli. The principal added value of brain imaging measures for human nutritional intervention studies is their ability to provide unique in vivo information on the working mechanism of an intervention in hypothesis-driven research. Selection of brain imaging techniques and target markers within a given technique should mainly depend on the hypothesis regarding the mechanism of action of the intervention, level (structural, metabolic or functional) and anticipated timescale of the intervention's effects, target population, availability and costs of the techniques.

  14. Comparative evaluation of serum superoxide dismutase and glutathione levels in periodontally diseased patients: An interventional study

    Directory of Open Access Journals (Sweden)

    Thomas Biju

    2014-01-01

    Full Text Available Background: Periodontal disease is an immune-inflammatory disease characterized by connective tissue breakdown, loss of attachment, and alveolar bone resorption. Under normal physiological conditions, a dynamic equilibrium is maintained between the reactive oxygen species (ROS and antioxidant defense capacity. Oxidative stress occurs when this equilibrium shifts in favor of ROS. Oxidative stress is thought to play a causative role in the pathogenesis of periodontal diseases. Aim: The present study was designed to estimate and compare the superoxide dismutase (SOD and glutathione (GSH levels in the serum of periodontitis, gingivitis, and healthy individuals before and after nonsurgical periodontal therapy. Materials and Methods: The present study was conducted in the Department of Periodontics, A. B. Shetty Memorial Institute of Dental Sciences, Deralakatte, Mangalore. The study was designed as a single blinded interventional study comprising 75 subjects, inclusive of both sexes and divided into three groups of 25 patients each. Patients were categorized into chronic periodontitis, gingivitis, and healthy. The severity of inflammation was assessed using gingival index and pocket probing depth. Biochemical analysis was done to estimate the SOD and GSH levels before and after nonsurgical periodontal therapy. Results obtained were then statistically analyzed using ANOVA test and paired t-test. Results: The results showed a higher level of serum SOD and GSH in the healthy group compared to the other groups. The difference was found to be statistically significant (P < 0.0001. The post-treatment levels of SOD were statistically higher than the pre-treatment levels in periodontitis and gingivitis group.

  15. A pilot home-based early intervention study to improve the mathematical skills of young children

    Directory of Open Access Journals (Sweden)

    Ayşegül Şükran Öz

    2013-12-01

    Full Text Available Children who come from low socioeconomic backgrounds and children with learning disabilities are found to be at risk for future failure in mathematics. Even though the mathematics scores increases over time the achievement gap remains between the various ethnic and socioeconomic groups. One way to prevent this failure is to identify the students who are at risk and provide them with effective early intervention. This study reports the results of a pilot early mathematics intervention study focusing on two Turkish families in the US. In this single-subject research, a multiple probe technique was used in order to examine the impact of the SRA DLM Math Pre-K CD-ROM in combination with parent scaffolding on young children’s number sense skills. Two parent-child dyads participated in this study. Two semi-structured interviews were conducted with the parents before and after the intervention. The child participants received 3 Mathematical Curriculum Based Measure (CBM every week to monitor their progress. Building Blocks Assessment was used to identify whether children were able to generalize the number sense skills developed during work sessions in different settings. This measure was administered both before and after the intervention.This study demonstrated that children’s and parents’ use of a software program where they work collaboratively at home resulted in increased number sense skills. These results were interpreted in the context of socio-cultural theory. The parents displayed different strategies during the mathematics work sessions, reflecting their own feelings about mathematics and technology.

  16. Variation in effect of intervention studies in research on sickness absence

    Directory of Open Access Journals (Sweden)

    Soegaard H

    2012-04-01

    Full Text Available Hans Joergen SoegaardResearch Unit West, Centre for Psychiatric Research, Aarhus University Hospital, RisskovBackground: Intervention studies in sickness absence research demonstrate a low effect and ambiguous results in reducing sickness absence and improving work status. The aim of this study was to determine if the effect of interventions is related to type of intervention, target population, inclusion criteria used, and impact of the scientific quality of the studies.Methods: Based on a structured review of 57 studies, short-term, medium-term, and long-term effects were analyzed with regard to the type of intervention, target population, inclusion criteria, and scientific quality of the studies.Results: The overall result was that the effect rate was low, ie, about 20% for short-term effect (up to 6 months and medium-term effect (6–12 months, and 40% for long-term effect (≥12 months. Interventions using stress reduction were most effective with regard to short-term and medium-term effects, whereas collaborative care was most effective for long-term effects. The effects were related to the inclusion criteria and, to a minor degree, to the scientific quality of the studies.Conclusion: In the field of sickness absence research, more attention should be paid to the interrelationship between the types of interventions, target populations, and inclusion criteria for the studies. Larger studies of high methodological quality are needed. Steps should be taken to standardize outcome measures.Keywords: nonparticipation, sickness absence, return to work, controlled trial, review

  17. Preservice Teachers' Beliefs and Attitude about Teaching and Learning Mathematics through Music: An Intervention Study

    Science.gov (United States)

    An, Song A.; Ma, Tingting; Capraro, Mary Margaret

    2011-01-01

    This article presents exploratory research investigating the integration of music and a mathematics lesson as an intervention to promote preservice teachers' attitude and confidence and to extend their beliefs toward teaching mathematics integrated with music. Thirty students were randomly selected from 64 preservice teachers in a southern…

  18. Self-Regulation, Motivation and Teaching Styles in Physical Education Classes: An Intervention Study

    Science.gov (United States)

    Chatzipanteli, Athanasia; Digelidis, Nikolaos; Papaioannou, Athanasios G.

    2015-01-01

    The aim of the study was to investigate the influence of student-activated teaching styles through a specific intervention program on students' self-regulation, lesson satisfaction, and motivation. Six hundred and one 7th grade students (318 boys and 283 girls), aged 13 years were randomly assigned to an experimental group and a comparison group.…

  19. Peer Acceptance and the Development of Emotional and Behavioural Problems: Results from a Preventive Intervention Study

    Science.gov (United States)

    Menting, Barbara; Koot, Hans; van Lier, Pol

    2015-01-01

    Difficulties in peer acceptance during elementary school have been associated with emotional and behavioural problems. This study used a randomized controlled intervention design to test whether improvements in peer acceptance mediated reduced rates of emotional and behavioural problems in intervention compared to control-group children. A total…

  20. Male and Female Pathways to Psychopathology: Findings from a Preventive Intervention Study

    NARCIS (Netherlands)

    P. Vuijk

    2006-01-01

    textabstractThe objective of the present study was to extent the knowledge on the pathways to male and female psychopathology from childhood into early adolescence. In Chapter 1, the background of the Good Behavior Game (GBG) study was presented. The GBG study is a randomized controlled intervent

  1. Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy – Results from the randomized DAHANCA 25B trial

    International Nuclear Information System (INIS)

    Purpose: The critical weight loss observed in head and neck squamous cell carcinoma (HNSCC) patients following radiotherapy is mainly due to loss of lean body mass. This is associated with decreases in muscle strength, functional performance and Quality of Life (QoL). The present study investigated the effect of progressive resistance training (PRT) on lean body mass, muscle strength and functional performance in HNSCC patients following radiotherapy. Patients and methods: Following radiotherapy HNSCC patients were randomized into two groups: Early Exercise (EE, n = 20) initiated 12 weeks of PRT followed by 12 weeks of self-chosen physical activity. Delayed Exercise (DE, n = 21) initiated 12 weeks of self-chosen physical activity followed by 12 weeks of PRT. Lean body mass, muscle strength, functional performance and QoL were evaluated at baseline and after week 12 and 24. Results: In the first 12 weeks lean body mass increased by 4.3% in EE after PRT and in the last 12 weeks by 4.2% in DE after PRT. These increases were significantly larger than the changes after self-chosen physical activity (p ⩽ 0.005). Regardless of PRT start-up time, the odds ratio of increasing lean body mass by more than 4% after PRT was 6.26 (p < 0.05). PRT significantly increased muscle strength, whereas functional performance increased significantly more than after self-chosen physical activity only after delayed onset of PRT. Overall QoL improved significantly more in EE than DE from baseline to week 12. Conclusion: PRT effectively increased lean body mass and muscle strength in HNSCC patients following radiotherapy, irrespectively of early or delayed start-up

  2. RANDOM LASSO.

    Science.gov (United States)

    Wang, Sijian; Nan, Bin; Rosset, Saharon; Zhu, Ji

    2011-03-01

    We propose a computationally intensive method, the random lasso method, for variable selection in linear models. The method consists of two major steps. In step 1, the lasso method is applied to many bootstrap samples, each using a set of randomly selected covariates. A measure of importance is yielded from this step for each covariate. In step 2, a similar procedure to the first step is implemented with the exception that for each bootstrap sample, a subset of covariates is randomly selected with unequal selection probabilities determined by the covariates' importance. Adaptive lasso may be used in the second step with weights determined by the importance measures. The final set of covariates and their coefficients are determined by averaging bootstrap results obtained from step 2. The proposed method alleviates some of the limitations of lasso, elastic-net and related methods noted especially in the context of microarray data analysis: it tends to remove highly correlated variables altogether or select them all, and maintains maximal flexibility in estimating their coefficients, particularly with different signs; the number of selected variables is no longer limited by the sample size; and the resulting prediction accuracy is competitive or superior compared to the alternatives. We illustrate the proposed method by extensive simulation studies. The proposed method is also applied to a Glioblastoma microarray data analysis. PMID:22997542

  3. Fractional randomness

    Science.gov (United States)

    Tapiero, Charles S.; Vallois, Pierre

    2016-11-01

    The premise of this paper is that a fractional probability distribution is based on fractional operators and the fractional (Hurst) index used that alters the classical setting of random variables. For example, a random variable defined by its density function might not have a fractional density function defined in its conventional sense. Practically, it implies that a distribution's granularity defined by a fractional kernel may have properties that differ due to the fractional index used and the fractional calculus applied to define it. The purpose of this paper is to consider an application of fractional calculus to define the fractional density function of a random variable. In addition, we provide and prove a number of results, defining the functional forms of these distributions as well as their existence. In particular, we define fractional probability distributions for increasing and decreasing functions that are right continuous. Examples are used to motivate the usefulness of a statistical approach to fractional calculus and its application to economic and financial problems. In conclusion, this paper is a preliminary attempt to construct statistical fractional models. Due to the breadth and the extent of such problems, this paper may be considered as an initial attempt to do so.

  4. 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

    .0003) compared with placebo. Improvement in glycemic control was evident after 1 week. Body weight decreased by 1.2 kg in the 0.45-mg liraglutide group (P = 0.0184) compared with placebo. The proinsulin-to-insulin ratio decreased in the 0.75-mg liraglutide group (-0.18; P = 0.0244) compared with placebo...

  5. The Importance of Risk and Subgroup Analysis of Nonparticipants in a Geriatric Intervention Study

    DEFF Research Database (Denmark)

    Rosted, Elizabeth; Poulsen, Ingrid; Hendriksen, Carsten;

    2016-01-01

    on a randomized controlled trial.  Setting: University hospital in the Capital Region of Denmark.  Participants: Patients ≥70 years discharged home after a short Emergency Department stay. 399 were requested to participate; 271 consented, whereas 128 refused.  Results: Refusers were more likely to be readmitted...... () or die (). The largest subgroup of refusers described as “too ill” had the highest risk of readmission (OR = 3.00, 95% CI = 1.61–5.47, ) and of mortality within six months (OR = 3.50, 95% CI = 1.64–7.49, ). However, this seems not to have affected the results of our randomized study.  Conclusion: We...

  6. Impact of Simulation and Clinical Experience on Self-efficacy in Nursing Students: Intervention Study.

    Science.gov (United States)

    Kimhi, Einat; Reishtein, Judith L; Cohen, Miri; Friger, Michael; Hurvitz, Nancy; Avraham, Rinat

    2016-01-01

    This study compared the effect of simulation and clinical experience timing on self-confidence/self-efficacy for the nursing process. Using a randomized, double-crossover design, self-efficacy was measured 3 times. Although self-efficacy was significantly higher at time 1 for students who had clinical experience, there was no difference between the groups at the end of the course (time 2). Thus, simulation increased self-confidence/self-efficacy equivalently if placed either before or after clinical experience.

  7. Non-pharmacological intervention study of hypercholesterolemia among middle-aged people

    OpenAIRE

    Okayama, Akira; Chiba, Nagako; Ueshima, Hirotsugu

    2004-01-01

    Middle-aged people with a serum total cholesterol of more than 220 mg/dl at the latest health examination (n=197) at a chemical company were invited to join a health education program for 6 months. Participants meeting inclusion criteria were randomly assigned to an intervention (n=96) and a control group (n=92). Periodical interviews and blood tests were performed every 2 months for both groups. The intervention group was educated by health professionals in the factories through programs dev...

  8. Curative and health enhancement effects of aquatic exercise: evidence based on interventional studies

    OpenAIRE

    Honda T.; Kamioka H

    2012-01-01

    Takuya Honda1, Hiroharu Kamioka21Research Fellow of the Japanese Society for the Promotion of Science, 2Laboratory of Physical and Health Education, Faculty of Regional Environment Science, Tokyo University of Agriculture, Tokyo, JapanBackground: The purpose of this study was to report on the health benefits and curative effects of aquatic exercise.Methods: We adopted the results of high-grade study designs (ie, randomized controlled trials and nonrandomized controlled trials), for which ther...

  9. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-06-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  10. Sexual Behaviour of Rural College Youth in Maharashtra,India: An Intervention Study

    Institute of Scientific and Technical Information of China (English)

    Mohan Ghule; Balaiah Donta

    2008-01-01

    Objective To promote healthy sexual behaviour among rural college youth. Methods The intervention study consisted a sample of 1 500(800 male and 700 female) in baseline and 1 953 (1 022 male and 931 female) college going students in post intervention,in the age groups 15—24 years from 8 colleges in Thane district of Maharashtra.The interventions included dissemination of IEC(Information,Education and Communication),counselling in colleges and provision of health care services at rural health centers in the experimental area.Male and female teachers and peer leaders were trained to provide IEC.Chi-square test was carried out to find out the association between contributing factors and sexual behaviour. Results Post intervention results showed that overall any sexual experience (coital/non—coital) increased by 2.6%and 1.0%among male students and 4.6% and 0.8% among female students in control and experimental groups respectively which suggests that in the control area physical closeness and sexual relationship has increased between sexes.A significant improvement was noted in the usage of condom during their sexual intercourse in experimental group.The provision of IEC in college settings,peer leader training and orientation to teachers helped students and teachers to initiate a dialogue on reproductive health issues.Intervention programs helped college youth to develop the skills,make informed decisions about engaging in sexual intercourse and using contraceptives in a social context that sometimes encourages risky sexual behaviour.The study found that peer interaction was exposure to erotic material;habits and working status among boys and peer interaction and place of study among girls were closely associated with their coital and non—coital sex experience.Conclusion A scientifically developed,need based and demand driven reproductive health service package for male and female students in colleges can help them to develop their knowledge

  11. Experimental gingivitis induces systemic inflammatory markers in young healthy individuals: a single-subject interventional study.

    Directory of Open Access Journals (Sweden)

    Jörg Eberhard

    Full Text Available OBJECTIVES: We here investigated whether experimental gingivitis enhances systemic markers of inflammation which are also known as surrogate markers of atherosclerotic plaque development. BACKGROUND: Gingivitis is a low-level oral infection induced by bacterial deposits with a high prevalence within Western populations. A potential link between the more severe oral disease periodontitis and cardiovascular disease has already been shown. METHODS: 37 non-smoking young volunteers with no inflammatory disease or any cardiovascular risk factors participated in this single-subject interventional study with an intra-individual control. Intentionally experimental oral inflammation was induced by the interruption of oral hygiene for 21 days, followed by a 21-days resolving phase after reinitiation of oral hygiene. Primary outcome measures at baseline, day 21 and 42 were concentrations of hsCRP, IL-6, and MCP-1, as well as adhesion capacity and oxLDL uptake of isolated blood monocytes. RESULTS: The partial cessation of oral hygiene procedures was followed by the significant increase of gingival bleeding (34.0%, P<0.0001. This local inflammation was associated with a systemic increase in hsCRP (0.24 mg/L, P = 0.038, IL-6 (12.52 ng/L, P = 0.0002 and MCP-1 (9.10 ng/l, P = 0.124 in peripheral blood samples between baseline and day 21, which decreased at day 42. Monocytes showed an enhanced adherence to endothelial cells and increased foam cell formation after oxLDL uptake (P<0.050 at day 21 of gingivitis. CONCLUSIONS: Bacterial-induced gingival low-level inflammation induced a systemic increase in inflammatory markers. Dental hygiene almost completely reversed this experimental inflammatory process, suggesting that appropriate dental prophylaxis may also limit systemic markers of inflammation in subjects with natural gingivitis. International Clinical Trials Register Platform of the World Health Organization, registry number: DRKS00003366, URL

  12. Complementary health approach to quality of life in menopausal women: a community-based interventional study

    Directory of Open Access Journals (Sweden)

    Jayabharathi B

    2014-11-01

    Full Text Available Baskaran Jayabharathi, Arulappan Judie SRM College of Nursing, SRM University, Kattankulathur, Kancheepuram District, Tamil Nadu, India Background: Menopause is the stage when the menstrual period permanently stops, and is a part of every woman’s life. It usually occurs between the ages of 40 and 60 years, and is associated with hormonal, physical, and psychological changes. Estrogen and progesterone levels play the biggest part in menopause. In this stage, the ovaries make less estrogen and progesterone. When the body produces less of these hormones, the parts of the body that depend on estrogen to keep them healthy will react and this often causes discomfort for women. This study tested the impact of a complementary health approach to quality of life in menopausal women. Methods: A community-based interventional study was conducted in selected areas in Kattankulathur Block, Kanchipuram District, Tamil Nadu, India. A simple random sampling technique was used to select menopausal women for the study. Of 260 menopausal women identified, 130 were allocated to a study group and 130 to a control group. The study group underwent yoga training for 1.5 hours per day on 5 consecutive days. After the 5-day intensive yoga training program, the menopausal women practiced yoga daily at home for 35–40 minutes a day. Along with daily yoga practice, they underwent group yoga practice for 2 days a week under the supervision of one of the investigators until 18 weeks. The yoga training program consisted of Yogasanas, Pranayama (breathing exercises, and meditation. The standardized World Health Organization QoL BREF scale was used to assess the women’s quality of life. We distributed an instruction manual on steps of selected yoga practice for the women’s self-reference at home after the 5 days of continuous yoga practice. A yoga practice diary was used to confirm regular performance of yoga. The women in the control group did not participate in the yoga

  13. Random tensors

    CERN Document Server

    Gurau, Razvan

    2017-01-01

    Written by the creator of the modern theory of random tensors, this book is the first self-contained introductory text to this rapidly developing theory. Starting from notions familiar to the average researcher or PhD student in mathematical or theoretical physics, the book presents in detail the theory and its applications to physics. The recent detections of the Higgs boson at the LHC and gravitational waves at LIGO mark new milestones in Physics confirming long standing predictions of Quantum Field Theory and General Relativity. These two experimental results only reinforce today the need to find an underlying common framework of the two: the elusive theory of Quantum Gravity. Over the past thirty years, several alternatives have been proposed as theories of Quantum Gravity, chief among them String Theory. While these theories are yet to be tested experimentally, key lessons have already been learned. Whatever the theory of Quantum Gravity may be, it must incorporate random geometry in one form or another....

  14. Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

    Science.gov (United States)

    Ruppert, Thorsten; Hahn, Michael; Hundt, Ferdinand

    2012-01-01

    In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.

  15. A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease

    Directory of Open Access Journals (Sweden)

    Ho Chiang-Hong

    2011-02-01

    Full Text Available Abstract Background Hyperphosphatemia in patients with chronic kidney disease (CKD contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. Methods In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR 2 and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH levels. Results At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04. The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p p Conclusions In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. Trial Registration www.clinicaltrials.gov NCT00211978.

  16. Carnosine treatment for gulf war illness: a randomized controlled trial.

    Science.gov (United States)

    Baraniuk, James Nicholas; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib; Timbol, Christian

    2013-05-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (B-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  17. An Intervention Study of Reproductive Tract Infections among Married Women of Reproductive Age in Shanghai

    Institute of Scientific and Technical Information of China (English)

    Zong-min JIANG; Yu-yan LI; Jun-qing WU; Wen-ying LI; Zeng-yu WEN; Er-sheng GAO; Xiao-ping ZHOU; Ben-cheng ZHOU

    2007-01-01

    Objective To evaluate the impacts of reproductive tract infections (RTIs) intervention on RTIs-related knowledge, attitudes, practices and prevalence of married women at reproductive age.Methods Four sub-districts from Xuhui district, Shanghai were selected by multistage cluster random sampling and residence committees were randomly assigned to either an intervention group or a control one. RTIs intervention was implemented in intervention group, while routine family planning program was conducted in control group.Results Compared with control group, intervention group have improved the following targets: the increment of RTI knowledge score was higher than that in control group (OR=9.22, 95%CI: 7.01-12.14); the increment score of individual health behaviors (6.31)was higher than that in control group (4.50) (OR=1.60, 95%CI: 1.21-2.10); the increase of condom use frequency in intervention group was higher than that in control group (4.12% vs 0.69%) (OR=1.84, 95%CI: 1.31 -2.57); the decreased RTIs rate was higher than that in control group (7.45% vs 0.96%) (OR=0.68, 95%CI: 0.49-0.95).Conclusion It is an effective way to conduct community-based intervention to increase women's RTIs knowledge, improve RTIs-related attitudes, promote good individual health behaviors, so as to decrease RTIs prevalence.

  18. The effects of fantastical pretend-play on the development of executive functions: An intervention study.

    Science.gov (United States)

    Thibodeau, Rachel B; Gilpin, Ansley T; Brown, Melissa M; Meyer, Brooke A

    2016-05-01

    Although recent correlational studies have found a relationship between fantasy orientation (FO; i.e., a child's propensity to play in a fantastical realm) and higher order cognitive skills called executive functions (EFs), no work has addressed the causality and directionality of this relationship. The current study experimentally examined the directionality of the observed relationship between FO and EF development in preschool-aged children through an innovative play intervention employing a randomized controlled design. A sample of 110 children between the ages of 3 and 5years were randomly assigned to one of three conditions: fantastical pretend-play intervention, non-imaginative play intervention, or business-as-usual control. Results revealed that children who participated in a 5-week fantastical pretend-play intervention showed improvements in EFs, whereas children in the other two conditions did not. Within the fantastical pretend-play condition, children who were highly engaged in the play and those who were highly fantastical demonstrated the greatest gains in EFs. These data provide evidence for the equifinal relationship between fantasy-oriented play and EF development, such that engaging in fantasy-oriented play may be one of many ways to directly enhance EF development. PMID:26835841

  19. Healthcare professionals and managers' participation in developing an intervention: A pre-intervention study in the elderly care context

    Directory of Open Access Journals (Sweden)

    Bergman Howard

    2009-04-01

    Full Text Available Abstract Background In order to increase the chances of success in new interventions in healthcare, it is generally recommended to tailor the intervention to the target setting and the target professionals. Nonetheless, pre-intervention studies are rarely conducted or are very limited in scope. Moreover, little is known about how to integrate the results of a pre-intervention study into an intervention. As part of a project to develop an intervention aimed at improving care for the elderly in France, a pre-intervention study was conducted to systematically gather data on the current practices, issues, and expectations of healthcare professionals and managers in order to determine the defining features of a successful intervention. Methods A qualitative study was carried out from 2004 to 2006 using a grounded theory approach and involving a purposeful sample of 56 healthcare professionals and managers in Paris, France. Four sources of evidence were used: interviews, focus groups, observation, and documentation. Results The stepwise approach comprised three phases, and each provided specific results. In the first step of the pre-intervention study, we gathered data on practices, perceived issues, and expectations of healthcare professionals and managers. The second step involved holding focus groups in order to define the characteristics of a tailor-made intervention. The third step allowed validation of the findings. Using this approach, we were able to design and develop an intervention in elderly care that met the professionals' and managers' expectations. Conclusion This article reports on an in-depth pre-intervention study that led to the design and development of an intervention in partnership with local healthcare professionals and managers. The stepwise approach represents an innovative strategy for developing tailored interventions, particularly in complex domains such as chronic care. It highlights the usefulness of seeking out the

  20. Random functions and turbulence

    CERN Document Server

    Panchev, S

    1971-01-01

    International Series of Monographs in Natural Philosophy, Volume 32: Random Functions and Turbulence focuses on the use of random functions as mathematical methods. The manuscript first offers information on the elements of the theory of random functions. Topics include determination of statistical moments by characteristic functions; functional transformations of random variables; multidimensional random variables with spherical symmetry; and random variables and distribution functions. The book then discusses random processes and random fields, including stationarity and ergodicity of random

  1. 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

  2. The nurse clinician as research participant recruiter: experience from a longitudinal intervention study.

    Science.gov (United States)

    Morrison-Beedy, D; Aronowitz, T; Dyne, J; Mkandawire, L; Murphy, C; Martin, J

    2001-01-01

    One of the most critical phases involved in carrying out a research project is participant recruitment. Recruitment into clinical trials and health programs is a primary public health challenge, particularly among adolescents. Special skills and abilities are needed to successfully recruit participants from this developmental age group. This paper describes the similarities found between the recruitment process developed for a randomized controlled trial with adolescents and the steps of the nursing process, and demonstrates that knowledge of the nursing process can assist in successfully recruiting individuals for a research study. Even without research training, clinical nurses can play a significant role in research studies because of their skills and experiences with the nursing process. Thus, nurse scientists and clinicians can work together successfully to conduct research studies and health projects that involve challenging recruitment efforts. PMID:16052902

  3. Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: a randomized controlled trial.

    Science.gov (United States)

    Oh, Eui Geum; Yoo, Jae Yong; Lee, Jung Eun; Hyun, Sa Saeng; Ko, Il Sun; Chu, Sang Hui

    2014-08-01

    In this randomized controlled trial, we examined the effects of a 3-month therapeutic lifestyle modification (TLM) intervention on knowledge, self-efficacy, and health behaviors related to bone health in postmenopausal women in rural Korea. Forty-one women ages 45 or older were randomly assigned to either the intervention (n = 21) or control (n = 20) group. The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium-vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis.

  4. Tai Chi for Lower Urinary Tract Symptoms and Quality of Life in Elderly Patients with Benign Prostate Hypertrophy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Seil Jung

    2012-01-01

    Full Text Available Tai chi exercise has been recommended as suitable for the improvement of health in the elderly. The purpose of this study was to investigate the effects of tai chi on lower urinary tract symptoms (LUTSs, quality of life (QoL, and sex hormone levels in patients with benign prostate hypertrophy (BPH. The elderly patients with BPH were randomized to receive tai chi or usual care. Fifty-six participants were randomized into either the tai chi group (n=28 or the control group (n=28. After 12 weeks of treatment, the tai chi group showed significant improvement in LUTS and QoL. There was a significant effect of tai chi on testosterone but no significant effect on insulin or glucose. No serious adverse events were observed during the study period. In conclusion, our results suggest that 12 weeks of tai chi may improve LUTS and QoL in elderly patients with BPH.

  5. Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.

    Science.gov (United States)

    Groessl, Erik J; Schmalzl, Laura; Maiya, Meghan; Liu, Lin; Goodman, Debora; Chang, Douglas G; Wetherell, Julie L; Bormann, Jill E; Atkinson, J Hamp; Baxi, Sunita

    2016-05-01

    Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2× weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans. PMID:27103548

  6. Low Level Laser Therapy And Exercise Therapy In Treatment Of Chronic Low Back Pain: A Double-Blind Randomized Clinical Trial

    OpenAIRE

    Mehrdad R; Esmaeili Javid G; Hasan Zadeh H; Sotoodeh Manesh A; Ghasemi M

    2005-01-01

    Background: This study was designed to compare low-level laser therapy (LLLT) + exercise therapy with LLLT alone and exercise therapy alone, and to determine whether laser therapy is a useful treatment modality for chronic low back pain (LBP). Materials and Methods: This study was a double-blind placebo-controlled randomized clinical trial. Patients with chronic LBP for at least 12 weeks were included. Visual analogue scale (VAS), Modified Oswestry Disability Questionnaire (MODQ), Schober tes...

  7. Skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and upper Trapezius myofascial trigger points - a randomized intervention study

    DEFF Research Database (Denmark)

    Myburgh, Corrie; Hartvigsen, Jan; Aagaard, Per;

    2012-01-01

    ABSTRACT: BACKGROUND: In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study explored muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes...

  8. Reducing smoking reduces suicidality among individuals with psychosis: Complementary outcomes from a Healthy Lifestyles intervention study.

    Science.gov (United States)

    Sankaranarayanan, Anoop; Clark, Vanessa; Baker, Amanda; Palazzi, Kerrin; Lewin, Terry J; Richmond, Robyn; Kay-Lambkin, Frances J; Filia, Sacha; Castle, David; Williams, Jill M

    2016-09-30

    This study sought to explore the impact of smoking reduction on suicidality (suicide ideation and behaviour) among people with a psychotic disorder (n=235) who participated in a randomized trial of a healthy lifestyle intervention trial. Suicidality, measured by item -4 of the Brief Psychiatric Rating Scale (BPRS) was the main variable of interest. Measures were collected by research assistants blind to treatment allocation at baseline, at 15 weeks (mid-intervention) and 12 months after baseline. Mediation analysis, adjusted for confounders, was used to determine the relationship between smoking reduction and suicidality and to explore whether this was mediated through depression. At 12 months, smoking reduction was found to be significantly associated with suicidality change; an association was also seen between smoking reduction and depression and depression and suicidality. After adjusting for depression, the association between smoking reduction and suicidality was attenuated but remained statistically significant; the proportion of the total effect that was mediated through depression was 30%. There was no significant association between suicidality and treatment group (vs. controls) over time. Our study suggests that smoking interventions may have benefits over and above those for improved physical health, by reducing suicidal ideation in people with psychosis. PMID:27450743

  9. Curative and health enhancement effects of aquatic exercise: evidence based on interventional studies

    Directory of Open Access Journals (Sweden)

    Honda T

    2012-03-01

    Full Text Available Takuya Honda1, Hiroharu Kamioka21Research Fellow of the Japanese Society for the Promotion of Science, 2Laboratory of Physical and Health Education, Faculty of Regional Environment Science, Tokyo University of Agriculture, Tokyo, JapanBackground: The purpose of this study was to report on the health benefits and curative effects of aquatic exercise.Methods: We adopted the results of high-grade study designs (ie, randomized controlled trials and nonrandomized controlled trials, for which there were many studies on aquatic exercise. Aquatic exercise, in this study, means walking in all directions, stretching, and various exercises and conditioning performed with the feet grounded on the floor of a swimming pool. We excluded swimming. We decided to treat aquatic exercise, underwater exercise, hydrotherapy, and pool exercise as all having the same meaning.Results: Aquatic exercise had significant effects on pain relief and related outcome measurements for locomotor diseases.Conclusion: Patients may become more active, and improve their quality of life, as a result of aquatic exercise.Keywords: aquatic exercise, health enhancement, evidence

  10. Random fixed points and random differential inclusions

    Directory of Open Access Journals (Sweden)

    Nikolaos S. Papageorgiou

    1988-01-01

    Full Text Available In this paper, first, we study random best approximations to random sets, using fixed point techniques, obtaining this way stochastic analogues of earlier deterministic results by Browder-Petryshyn, KyFan and Reich. Then we prove two fixed point theorems for random multifunctions with stochastic domain that satisfy certain tangential conditions. Finally we consider a random differential inclusion with upper semicontinuous orientor field and establish the existence of random solutions.

  11. Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede;

    2015-01-01

    . Methods  A randomized, double-blind, placebo-controlled parallel multicenter study. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric...... is 55.3 (±9.5) years and average time since injury is 8.8 (±8.9)years. Causes of injury are 31% transport, 27% fall, 21% non-traumatic SCI, 14% other traumatic cause and 7% sports injuries. No major side effectshave been reported. Further results will be presented at the meeting...

  12. Discrepancy between self- and proxy-rated pain in Alzheimer's disease: results from the danish Alzheimer intervention study

    DEFF Research Database (Denmark)

    Jensen-Dahm, C.; Vogel, A.; Waldorff, F.B.;

    2012-01-01

    OBJECTIVES: To investigate the prevalence of self- and proxy-reported pain in a cohort with Alzheimer's disease (AD) and to identify characteristics of individuals with AD reporting pain. DESIGN: Data were collected at the baseline visit of the Danish Alzheimer Intervention Study. SETTING......: Community. PARTICIPANTS: Three hundred twenty-one community-living individuals with AD (MMSE >/= 20) and their primary caregivers. MEASUREMENTS: Pain was assessed as part of the EuroQol EQ-5D (caregiver- and self-rated). The Cornell Scale for Depression in Dementia, Quality of Life in Alzheimer's Disease...

  13. Self-rated health in patients with mild Alzheimer's disease: baseline data from the Danish Alzheimer Intervention Study

    DEFF Research Database (Denmark)

    Waldorff, Frans Boch; Nielsen, Anni B S; Waldemar, Gunhild

    2010-01-01

    , but the validity and the influence on other factors on SRH among cognitively impaired persons remain unknown. This study reports how patients with mild Alzheimer's disease (AD) report SRH and which factors influence SRH. The study was based on baseline data from 321 home living patients with mild AD who...... participated in the Danish Alzheimer Intervention Study (DAISY). Analysis using the generalized estimating equation (GEE) models revealed that good/excellent SRH among patients with mild AD were associated with longer education, lack of other chronic conditions, higher scores of quality of life (QOL), lower...

  14. Effects of physical activity on health status in older adults. II. Intervention studies.

    Science.gov (United States)

    Buchner, D M; Beresford, S A; Larson, E B; LaCroix, A Z; Wagner, E H

    1992-01-01

    This review has focused on a specific part of the relationship of exercise to health. The overall evidence supporting the health benefits of exercise is substantial and has been critically reviewed recently (18, 94). Thus, the United States Preventive Services Task Force recommends that all adults exercise regularly (94). The conclusions summarized below regarding older adults do not affect this basic recommendation. There is solid evidence that exercise can improve measures of fitness in older adults, particularly strength and aerobic capacity. These exercise effects occur in chronically ill adults, as well as in healthy adults. Because physical fitness is a determinant of functional status, it is logical to ask whether exercise can prevent or improve impairments in functional status in older adults. The evidence that exercise improves functional status is promising, but inconclusive. Problems with existing studies include a lack of randomized controlled trials, a lack of evidence that effects of exercise can be sustained over long periods of time, inadequate statistical power, and failure to target physically unfit individuals. Existing studies suggest that exercise may produce improvements in gait and balance. Arthritis patients may experience long-term functional status benefits from exercise, including improved mobility and decreased pain symptoms. Nonrandomized trials suggest exercise promotes bone mineral density and thereby decreases fracture risk. Recent studies have generally concluded that short-term exercise does not improve cognitive function. Yet the limited statistical power of these studies does not preclude what may be a modest, but functionally meaningful, effect of exercise on cognition. Future research, beyond correcting methodologic deficiencies in existing studies, should systematically study how functional status effects of exercise vary with the type, intensity, and duration of exercise. It should address issues in recruiting functionally

  15. Effects of sodium and potassium supplementation on endothelial function: a fully controlled dietary intervention study.

    Science.gov (United States)

    Gijsbers, Lieke; Dower, James I; Schalkwijk, Casper G; Kusters, Yvo H A M; Bakker, Stephan J L; Hollman, Peter C H; Geleijnse, Johanna M

    2015-11-14

    High Na and low K intakes have adverse effects on blood pressure, which increases the risk for CVD. The role of endothelial dysfunction and inflammation in this pathophysiological process is not yet clear. In a randomised placebo-controlled cross-over study in untreated (pre)hypertensives, we examined the effects of Na and K supplementation on endothelial function and inflammation. During the study period, subjects were provided with a diet that contained 2·4 g/d of Na and 2·3 g/d of K for a 10 460 kJ (2500 kcal) intake. After 1-week run-in, subjects received capsules with supplemental Na (3·0 g/d), supplemental K (2·8 g/d) or placebo, for 4 weeks each, in random order. After each intervention, circulating biomarkers of endothelial function and inflammation were measured. Brachial artery flow-mediated dilation (FMD) and skin microvascular vasomotion were assessed in sub-groups of twenty-two to twenty-four subjects. Of thirty-seven randomised subjects, thirty-six completed the study. Following Na supplementation, serum endothelin-1 was increased by 0·24 pg/ml (95 % CI 0·03, 0·45), but no change was seen in other endothelial or inflammatory biomarkers. FMD and microvascular vasomotion were unaffected by Na supplementation. K supplementation reduced IL-8 levels by 0·28 pg/ml (95 % CI 0·03, 0·53), without affecting other circulating biomarkers. FMD was 1·16 % (95% CI 0·37, 1·96) higher after K supplementation than after placebo. Microvascular vasomotion was unaffected. In conclusion, a 4-week increase in Na intake increased endothelin-1, but had no effect on other endothelial or inflammatory markers. Increased K intake had a beneficial effect on FMD and possibly IL-8, without affecting other circulating endothelial or inflammatory biomarkers.

  16. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

    OpenAIRE

    Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.

    2011-01-01

    OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...

  17. Topics in random walks in random environment

    International Nuclear Information System (INIS)

    Over the last twenty-five years random motions in random media have been intensively investigated and some new general methods and paradigms have by now emerged. Random walks in random environment constitute one of the canonical models of the field. However in dimension bigger than one they are still poorly understood and many of the basic issues remain to this day unresolved. The present series of lectures attempt to give an account of the progresses which have been made over the last few years, especially in the study of multi-dimensional random walks in random environment with ballistic behavior. (author)

  18. The Comparison of Learning Radiographic Extraoral Anatomic Landmarks through Lecture and blended method(Computer-Assisted teaching and Lecture:An interventional Study

    Directory of Open Access Journals (Sweden)

    T ahmine Razi

    2013-05-01

    Full Text Available Introduction: One of the main problems in learning extraoral radiographic anatomic indexes is the long interval between presentation of radiology and human anatomy courses, resulting in forgetting anatomic regions. Therefore, radiographic indexes are formed as complete abstract and transient images in students’ minds; as a result, their learning and retention decrease. The aim of this study was to compare lecture with combination of computer-assisted learning and lecture of extra-oral radiographic landmarks among dental students. Methods: This interventional study was carried out in 2009 on 51 dental students of Tabriz University of Medical Sciences. Students were randomly allocated into two groups. The first group was taught through a teaching method which involved lectures in the classroom. In the second group, a CD was given to the students. The teaching was accomplished through presentation using skull. Six months after finishing the teaching, both groups took a similar test for evaluation of long term learning. The data was analyzed by SPSS 16 using U Mann-Whitney test. Results: There was no significant differences in the mean scores between the two groups in the first exam after teaching (P=0.13, yet it was significant in the second exam (regarding retention (P=0.006, and average of non-traditional teaching method group (20.89±10.23 was higher than that of lecture group (13.48±6.39. Conclusion: Based on the results, non-traditional technique of teaching was not more effective than the lecture in short-term learning but in longterm learning, non-traditional technique was more effective than the lecture.

  19. Effects of low-fat dairy consumption on markers of low-grade systemic inflammation and endothelial function in overweight and obese subjects: an intervention study.

    Science.gov (United States)

    van Meijl, Leonie E C; Mensink, Ronald P

    2010-11-01

    Although increased concentrations of plasma inflammatory markers are not one of the criteria to diagnose the metabolic syndrome, low-grade systemic inflammation is receiving large attention as a metabolic syndrome component and cardiovascular risk factor. As several epidemiological studies have suggested a negative relationship between low-fat dairy consumption and the metabolic syndrome, we decided to investigate the effects of low-fat dairy consumption on inflammatory markers and adhesion molecules in overweight and obese subjects in an intervention study. Thirty-five healthy subjects (BMI>27 kg/m²) consumed, in a random order, low-fat dairy products (500 ml low-fat milk and 150 g low-fat yogurt) or carbohydrate-rich control products (600 ml fruit juice and three fruit biscuits) daily for 8 weeks. Plasma concentrations of TNF-α were decreased by 0.16 (SD 0.50) pg/ml (P = 0.070), and soluble TNF-α receptor-1 (s-TNFR-1) was increased by 110.0 (SD 338.4) pg/ml (P = 0.062) after the low-fat dairy period than after the control period. s-TNFR-2 was increased by 227.0 (SD 449.0) pg/ml (P = 0.020) by the dairy intervention. As a result, the TNF-α index, defined as the TNF-α:s-TNFR-2 ratio, was decreased by 0.000053 (SD 0.00012) (P = 0.015) after the dairy diet consumption. Low-fat dairy consumption had no effect on IL-6, monocyte chemoattractant protein-1, intracellular adhesion molecule-1 and vascular cell adhesion molecule-1 concentrations. The present results indicate that in overweight and obese subjects, low-fat dairy consumption for 8 weeks may increase concentrations of s-TNFR compared with carbohydrate-rich product consumption, but that it has no effects on other markers of chronic inflammation and endothelial function.

  20. Tai Chi for treating knee osteoarthritis: Designing a long-term follow up randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rones Ramel

    2008-07-01

    Full Text Available Abstract Background Knee Osteoarthritis (KOA is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. Methods/Design Forty eligible patients, age > 55 yr, BMI ≤ 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi or attention control (wellness education and stretching. The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks. Discussion In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence

  1. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial.

    Science.gov (United States)

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m² and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p fat oxidation during submaximal aerobic exercise, p fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  2. Autonomy among physically frail older people in nursing home settings: a study protocol for an intervention study

    Directory of Open Access Journals (Sweden)

    Andresen Mette

    2008-12-01

    Full Text Available Abstract Background Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings themselves perceive autonomy in daily life. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on residents' own wishes for daily activities. Methods and design A total of 9 nursing homes and 55 participants aged 65 years or older were included in the study. All the participants were restricted in performing at least one P-ADL activity unassisted and had a Mini Mental State Examination-score above 16. Perceived autonomy was measured at baseline, after 12 weeks and after 24 weeks by The Autonomy Sub-dimension in the Measure of Actualisation of Potential test. Programmes were based on participants' individual assessment of their most important daily activities. Staff at all nursing homes who usually organize physical training, social or creative activities carried out individually tailored programmes using their usual methods and equipment. Participants in each nursing home were divided by lot into either a control group or an intervention group. The control groups received their usual care and treatment. Discussion This study is designed to assess the status of perceived autonomy at baseline and to provide information about the effectiveness of individually tailored programmes according to perceptions of autonomy registered in institutionalised physically frail older people. This will add knowledge to assist response to present and future challenges in relation to health promotion initiatives for this group. Trial registration number NCT00783055

  3. Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.

    Science.gov (United States)

    Sterling, Michele; Vicenzino, Bill; Souvlis, Tina; Connelly, Luke B

    2015-04-01

    This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise. PMID:25790454

  4. The Effect of Green Tea Ingestion and Interval Sprinting Exercise on the Body Composition of Overweight Males: A Randomized Trial

    Science.gov (United States)

    Gahreman, Daniel; Heydari, Mehrdad; Boutcher, Yati; Freund, Judith; Boutcher, Stephen

    2016-01-01

    The combined effect of green tea ingestion and interval sprinting exercise on body and abdominal fat of overweight males was investigated. Participants were randomly assigned into control (C), green tea (GT), interval sprinting exercise (ISE), and green tea and ISE (GT + ISE) groups. The GT, GT + ISE, and C groups consumed three GT capsules daily. The ISE and GT + ISE groups completed 36 ISE sessions over 12 weeks. Forty eight overweight males with a mean BMI of 28.5 ± 0.92 kg/m2 and age of 26 ± 0.7 years acted as participants. There was a significant reduction in total and abdominal fat mass for the ISE and GT + ISE groups, p < 0.05, however, total and abdominal fat mass did not significantly change in the GT and C groups. There was a significant increase in total lean mass, p < 0.05, after the intervention for the ISE and GT + ISE groups only. There was a significant increase in fat oxidation during submaximal aerobic exercise, p < 0.05, after the intervention for the ISE, GT + ISE, and GT groups with no change for the C group. Following the 12-week intervention the ISE and GT + ISE groups, compared to C, recorded a significantly greater decrease in body and abdominal fat, and a significant increase in total lean mass. Ingestion of green tea by itself, however, did not result in a significant decrease in body or abdominal fat, but increased fat utilization during submaximal exercise. The combination of 12 weeks of GT ingestion and ISE did not result in greater total and abdominal fat reduction compared to 12 weeks of ISE alone. PMID:27548216

  5. Improving the diet of employees at blue-collar worksites: results from the "Food at work" intervention study

    DEFF Research Database (Denmark)

    Lassen, Anne Dahl; Thorsen, Anne Vibeke; Sommer, Helle Mølgaard;

    2011-01-01

    Objective. To examine the impact of a 6-month participatory and empowerment-based intervention study on employees' dietary habits and on changes in the canteen nutrition environment. Design. Worksites were stratified by company type and by the presence or absence of an in-house canteen......) changes in employees' dietary habits derived from 4 d pre-coded food diaries of a group of employees at the worksites (paired-data structure); and (ii) the canteen nutrition environment as identified by aggregating chemical nutritional analysis of individual canteen lunches (different participants...... at baseline and at endpoint). Setting. Eight blue-collar worksites (five of these with canteens). Subject. Employees. Results. In the intervention group (n 102), several significant positive nutritional effects were observed among employees, including a median daily decrease in intake of fat (—2.2% E, P = 0...

  6. Prediction of fruit and vegetable intake from biomarkers using individual participant data of diet-controlled intervention studies

    DEFF Research Database (Denmark)

    Souverein, Olga W; de Vries, Jeanne H M; Freese, Riitta;

    2015-01-01

    Fruit and vegetable consumption produces changes in several biomarkers in blood. The present study aimed to examine the dose-response curve between fruit and vegetable consumption and carotenoid (α-carotene, β-carotene, β-cryptoxanthin, lycopene, lutein and zeaxanthin), folate and vitamin C...... concentrations. Furthermore, a prediction model of fruit and vegetable intake based on these biomarkers and subject characteristics (i.e. age, sex, BMI and smoking status) was established. Data from twelve diet-controlled intervention studies were obtained to develop a prediction model for fruit and vegetable...... intake (including and excluding fruit and vegetable juices). The study population in the present individual participant data meta-analysis consisted of 526 men and women. Carotenoid, folate and vitamin C concentrations showed a positive relationship with fruit and vegetable intake. Measures...

  7. Efficacy of ‘Itrifal Saghir’, a combination of three medicinal plants in the treatment of obesity; A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kamali Seyed Hamid

    2012-09-01

    Full Text Available Abstract Background Herbal combination of Itrifal Saghir (triphala has been widely used in traditional medicine. And brings health benefits such as antioxidant effect and scavenger of hydroxyl radicals and nitric oxide radicals activity and substantiated in traditional medicine a anti-obesity. Material and method In this study we aimed to assess the efficacy of this herbal medicinal on reduction of weight and body mass index (BMI of simple obese subjects in comparison with placebo. Obese subjects aged between 16 and 60 years were selected for 12-week, double-blind, randomized, placebo-controlled trial using a parallel design. Subjects were randomly assigned to take 5 grams of either the Itrifal Saghir (n = 31 or placebo (n = 31, 2 times daily for 12 weeks. Measures of body weight, BMI, waist circumference (WC, hip circumference (HC, were assessed at baseline and once every four weeks during the 12 week treatment period. The safety was evaluated by means of measuring the liver and kidney function. Homeostasis model of insulin resistance (HOMA-IR was calculated as [fasting insulin (μU/mL × fasting glucose (mmol/L/22.5]. Results Compared to placebo group, in treatment group the mean difference of effective weight loss was 4.82Kg (CI95% 3.52 - 6.11, ρ  Conclusions Itrifal Saghir appears to produce a positive effect on weight loss in obese subjects.

  8. The Effect of Eicosapentaenoic Acid Supplementation on Depression Remission: a Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Karamati

    2011-12-01

    Full Text Available Introduction: There is some evidence that omega-3 fatty acids are associated with depression. The aim of this study was to compare the effects of eicosapentaenoic acid(EPA and placebo on mild to moderate depression. Methods: This double-blind randomized clinical trial was conducted on 54 outpatients with mild to moderate depression. Patients were randomly assigned to two groups: receiving EPA supplement or placebo. EPA and placebo groups received two identical capsules per day for 12 weeks. Each capsule contained 500 mg EPA or coconut oil. Hamilton Rating Scale for Depression(HRSD was used to determine the severity of depression at baseline, sixth and twelfth weeks after intervention. Results: Forty two patients(77.8% completed the 12-week intervention. A statistically significant difference was observed in mean scores of HRSD between EPA and placebo groups at the end of the study (P=0.001. Mean scores of HRSD decreased over time in both groups so that the analysis of variance for repeated measurements showed a statistically significant time effect(F=50.55, df=1.32, P<0.0001. Also, a statistically significant treatment effect of EPA compared to placebo was observed over time (treatment*time interaction, F=12.67, df=1.32, P=0.0001. Conclusion: The results of this study showed the efficacy of EPA in treatment of depression, so its use is recommended as an add-on to antidepressant medications in treatment of mild to moderate depression.

  9. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    DEFF Research Database (Denmark)

    Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina;

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized and...... exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors...

  10. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study

    OpenAIRE

    McAulay Kirsten; Dymek Andrzej; Bodzenta-Lukaszyk Anna; Mansikka Heikki

    2011-01-01

    Abstract Background The inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) and the long-acting β2-agonist (LABA) formoterol fumarate (formoterol) are being made available as a combination product (fluticasone/formoterol, flutiform®) in a single aerosol inhaler. This 12-week, open-label, randomized, active-controlled, parallel-group, multicentre, phase 3 study compared the efficacy and safety of fluticasone/formoterol with the commercially available combination product fluticaso...

  11. Effect of trans-fatty acid intake on insulin sensitivity and intramuscular lipids - a randomized trial in overweight postmenopausal women

    DEFF Research Database (Denmark)

    Bendsen, Nathalie Tommerup; Haugaard, Steen; Larsen, Thomas Meinert;

    2011-01-01

    lipid deposition in abdominally obese women. In a double-blind, parallel dietary intervention study, 52 healthy but overweight postmenopausal women were randomized to receive either partially hydrogenated soybean oil (15 g/d TFA) or a control oil (mainly oleic and palmitic acid) for 16 weeks. Three...

  12. Completely random signed measures

    DEFF Research Database (Denmark)

    Hellmund, Gunnar

    Completely random signed measures are defined, characterized and related to Lévy random measures and Lévy bases.......Completely random signed measures are defined, characterized and related to Lévy random measures and Lévy bases....

  13. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    OpenAIRE

    Smith Lisa; Pisinger Charlotta; Lau Cathrine; Ovesen Lars; Ladelund Steen; Kristoffersen Lis; Toft Ulla; Borch-Johnsen Knut; Jørgensen Torben

    2008-01-01

    Abstract Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; grou...

  14. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial

    OpenAIRE

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-01-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static st...

  15. What's the effect of the implementation of general practitioner cooperatives on caseload? Prospective intervention study on primary and secondary care

    Directory of Open Access Journals (Sweden)

    Geudens Leo

    2010-07-01

    Full Text Available Abstract Background Out-of-hours care in the primary care setting is rapidly changing and evolving towards general practitioner 'cooperatives' (GPC. GPCs already exist in the Netherlands, the United Kingdom and Scandinavia, all countries with strong general practice, including gatekeepers' role. This intervention study reports the use and caseload of out-of-hours care before and after implementation of a GPC in a well subscribed region in a country with an open access health care system and no gatekeepers' role for general practice. Methods We used a prospective before/after interventional study design. The intervention was the implementation of a GPC. Results One year after the implementation of a GPC, the number of patient contacts in the intervention region significantly increased at the GPC (OR: 1.645; 95% CI: 1.439-1.880, while there were no significant changes in patient contacts at the Emergency Department (ED or in other regions where a simultaneous registration was performed. Although home visits decreased in all general practitioner registrations, the difference was more pronounced in the intervention region (intervention region: OR: 0.515; 95% CI: 0.411-0.646, other regions: OR: 0.743; 95% CI: 0.608-0.908. At the ED we observed a decrease in the number of trauma cases (OR: 0.789; 95% CI: 0.648-0.960 and of patients who came to hospital by ambulance (OR: 0.687; 95% CI: 0.565-0.836. Conclusions One year after its implementation more people seek help at the GPC, while the number of contacts at the ED remains the same. The most prominent changes in caseload are found in the trauma cases. Establishing a GPC in an open health care system, might redirect some patients with particular medical problems to primary care. This could lead to a lowering of costs or a more cost-effective out of hours care, but further research should focus on effective usage to divert patient flows and on quality and outcome of care.

  16. An exploratory intervention study suggests clinical benefits of training in chronic stroke to be paralleled by changes in brain activity using repeated fMRI

    Directory of Open Access Journals (Sweden)

    Landsmann B

    2016-01-01

    Full Text Available Barbara Landsmann,1,2 Daniela Pinter,2 Eva Pirker,1,2 Gerald Pichler,3 Walter Schippinger,3 Elisabeth M Weiss,1 Gabriel Mathie,2 Thomas Gattringer,2 Franz Fazekas,2 Christian Enzinger2,4 1Institute of Psychology, University of Graz, Graz, Austria; 2Department of Neurology, Medical University of Graz, Graz, Austria; 3Albert Schweitzer Clinic Graz, Graz, Austria; 4Division of Neuroradiology, Department of Radiology, Medical University of Graz, Graz, Austria Purpose: Previous studies demonstrated changes in sensorimotor network activation over time after stroke that have been interpreted as partly compensatory. Locomotor and balance trainings may improve both mobility and cognition even in chronic stroke and thereby impact on cerebral activation patterns. We here aimed at testing these assumptions in an exploratory study to inform subsequent larger intervention studies. Patients and methods: Eight patients (73.3±4.4 years with a chronic lacunar stroke (mean interval 3.7 years after the acute event with a range from 2 to 4 years and residual leg paresis leading to gait disturbance received a guided 5-week training focusing on mobility, endurance, and coordination. Before and afterward, they underwent clinical, neuropsychological, and gait assessments and brain MRI at 3 T including a functional ankle movement paradigm. Sixteen healthy controls (HCs; 68.8±5.4 years followed the same protocol without intervention. Results: After training, patients had improved in mobility, memory, and delayed recall of memory. While cerebral activations in HC remained completely unaltered, patients showed increased activations in the right precentral gyrus, the right and left superior frontal gyri, and the right frontal lobe, with bipedal ankle movements after training. Conclusion: In this exploratory study of chronic stroke, we found not only significant effects of physical training on mobility but also distinct aspects of cognition already with a small number of

  17. Aconselhamento em alimentação infantil: um estudo de intervenção Infant and young child feeding counseling: an intervention study

    Directory of Open Access Journals (Sweden)

    Katia Cristina Bassichetto

    2008-02-01

    Full Text Available OBJETIVO: Avaliar a efetividade do Curso Integrado de Aconselhamento em Alimentação Infantil na transformação de conhecimentos, atitudes e práticas de pediatras e nutricionistas da rede municipal de saúde de São Paulo. MÉTODOS: Estudo de intervenção randomizado com 29 profissionais no grupo intervenção e 27 no grupo controle. Entrevistadores previamente capacitados coletaram dados dos profissionais nas unidades de saúde antes da intervenção e 2 meses após. Utilizaram-se três instrumentos para avaliar o perfil do profissional, seus conhecimentos e um roteiro de observação clínica. Para análise, utilizaram-se o teste de Kruskal-Wallis para amostras independentes e o método de Tukey. RESULTADOS: Quanto ao conhecimento, observou-se melhora no grupo intervenção (p OBJECTIVE: To evaluate the effectiveness of an integrated infant and young child feeding counseling course for transforming the knowledge, attitudes and practices of pediatricians and nutritionists working for the municipal health system of São Paulo, Brazil. METHODS: A randomized intervention study enrolling 29 professionals in the intervention group and 27 in the control group. Interviewers were trained in advance to collect data on the professionals working at health centers, before and 2 months after the intervention. Three research instruments were used, the first was to assess the profile of each professional, the second assessed their knowledge and the third was a clinical observation protocol. Analysis was performed using the Kruskal-Wallis test for independent samples and the Tukey method. RESULTS: The results for the knowledge questionnaire showed improvements in the intervention group (p < 0.001 for the whole questionnaire and for questions on breastfeeding (p = 0.004; HIV and infant and young child feeding (p = 0.049; complementary feeding (p = 0.012; and counseling in infant and young child feeding (p = 0.004. In terms of performance, it was observed

  18. Comparing MTI randomization procedures to blocked randomization.

    Science.gov (United States)

    Berger, Vance W; Bejleri, Klejda; Agnor, Rebecca

    2016-02-28

    Randomization is one of the cornerstones of the randomized clinical trial, and there is no shortage of methods one can use to randomize patients to treatment groups. When deciding which one to use, researchers must bear in mind that not all randomization procedures are equally adept at achieving the objective of randomization, namely, balanced treatment groups. One threat is chronological bias, and permuted blocks randomization does such a good job at controlling chronological bias that it has become the standard randomization procedure in clinical trials. But permuted blocks randomization is especially vulnerable to selection bias, so as a result, the maximum tolerated imbalance (MTI) procedures were proposed as better alternatives. In comparing the procedures, we have somewhat of a false controversy, in that actual practice goes uniformly one way (permuted blocks), whereas scientific arguments go uniformly the other way (MTI procedures). There is no argument in the literature to suggest that the permuted block design is better than or even as good as the MTI procedures, but this dearth is matched by an equivalent one regarding actual trials using the MTI procedures. So the 'controversy', if we are to call it that, pits misguided precedent against sound advice that tends to be ignored in practice. We shall review the issues to determine scientifically which of the procedures is better and, therefore, should be used. PMID:26337607

  19. Settings for Physical Activity – Developing a Site-specific Physical Activity Behavior Model based on Multi-level Intervention Studies

    DEFF Research Database (Denmark)

    Troelsen, Jens; Klinker, Charlotte Demant; Breum, Lars;

    activity (PA). The potential is shown by the fact that there has been a dramatic increase in application of ecological models in research and practice. One proposed core principle is that an ecological model is most powerful if the model is behavior-specific. However, based on multi-level interventions......-study is a comprehensive intervention in 7 local school districts (N=1,348). 2) The When Cities Move Children-study is investigating the effects of urban refurbishment on adolescents’ movement patterns (N=653) and 3) The Valuable Detours for PA-project is a intervention study in 9 municipalities measuring the effect...

  20. Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Guoyan Yang

    Full Text Available BACKGROUND: Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease. METHODS: We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249. RESULTS: 20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A. CONCLUSIONS: Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the

  1. A eficácia do milnaciprano em pacientes ambulatoriais com transtorno depressivo maior não respondedores ao tratamento com ISRSs: um estudo aberto de 12 semanas Efficacy of milnacipran in outpatients experiencing major depression non respondent to SSRIs: a 12-week open study

    Directory of Open Access Journals (Sweden)

    Marcelo P. Fleck

    2010-01-01

    Full Text Available CONTEXTO: O objetivo deste estudo é avaliar a eficácia do milnaciprano em pacientes ambulatoriais com depressão maior grave que não respondem em tempo e em dosagem adequados à terapia com ISRSs. MÉTODOS: Um estudo aberto multicêntrico com a duração de 12 semanas foi elaborado para avaliar a eficácia do milnaciprano após falha em um experimento com ISRS. Remissão completa (HAMD-17 50%, CGI e avaliação da qualidade de vida (WHOQOL-Bref. RESULTADOS: O escore HAMD-17 médio da amostra foi de 27 (7,2. As taxas de remissão com o milnaciprano foram de 17,5%, e as de resposta, 61,3%. Na linha de base, 70,9% dos pacientes foram classificados como gravemente sintomáticos. Ao final do tratamento, 48,1% dos pacientes foram classificados como normais assintomáticos ou sintomáticos limítrofes e 20,2% eram moderadamente sintomáticos. Além disso, os quatro domínios do WHOQOL-Bref, um instrumento genérico de mensuração de qualidade de vida, apresentou diferenças clínicas e estatísticas: CONCLUSÃO: Nossos resultados sugerem que o milnaciprano é uma possível opção para pacientes que não respondem a ISRSs. Uma vez que não há evidências na literatura de um antidepressivo que seja a melhor opção quando um ISRS falha, o uso do milnaciprano deveria ser considerado em casos de pacientes com depressão severa.BACKGROUND: The objective of this study is to evaluate the efficacy of milnacipran in outpatients experiencing severe MDD non-respondent to adequate time and dosing of SSRI therapy. METHODS: A 12 week multi-centric study open study was designed to evaluate the efficacy of milnacipran after a SRRI trial failure. Complete remission (HAMD-17 50%, CGI and quality of life measure (WHOQOL-Bref. RESULTS: The mean HAMD-17 score of the sample was 27 (7.2. The remission rates for minalcipran were 17.5% and response 61.3%. At baseline, 70.9% of the patients were markedly or severely ill. At treatment end, 48.1% of the patients were normal

  2. Experimental Study on the Astragalus Impact on Athletes' IgA, IgG, IgM after Increasing Load in 12 Weeks%黄芪对12周递增负荷后运动员IgA、IgG、IgM影响的实验研究

    Institute of Scientific and Technical Information of China (English)

    谭惠仪; 苏晴

    2015-01-01

    By using incremental load exercise,through the experimental study,12 weeks. The results showed that: compared with ordinary college students, athletes before taking astragalus single agent, there was a significant difference in IgA 90W and 150W,60W and 120W does not exist significant differences between IgG and IgM;there is significant difference in 150w. Athletes taking astragalus single agent,compared with single dose of astragalus of ordinary college students, IgA and IgG have a significant difference in the 60W, 90W,120W and four grade 150W,IgM there were significant differences in the 90W,120W and 150W three levels. Compared with the unexposed members,members of IgA and IgG treatment there were significant differences in the 120 and two grades of 150W, IgM, the difference was significant only in 150W. From the results we can draw the following conclusions: in the increasing load, immune globulin content increased gradually with the increase of training athletes,even will produce a certain inhibition on the immune function of the organism,and with the increase of exercise load,the degree of immune suppression is growing,and the athletes in the sports in the process of continuous taking astragalus agents effectively alleviate exercise-induced immunosuppression,so take a single dose of astragalus for significant role in improving the immune function of athletes.%为采用逐级递增负荷运动,通过12周的实验研究发现,与普通大学生相比较,运动员在未服用黄芪单剂的情况下,IgA在90W和150W存在显著性差异,60W和120w不存在显著性差异;IgG和IgM仅在150w存在显著性差异。运动员服用黄芪单剂之后,与服用黄芪单剂的普通大学生相比较,IgA和IgG在60W、90W、120W和150W四个等级上都存在显著性差异,IgM在90W、120W和150W三个等级上都存在显著性差异。与未服药队员相比较,服药队员IgA和IgG在120W和150W两个等级上都存

  3. Fractional Nonablative 1540 nm Laser Resurfacing for Thermal Burn Scars: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Haedersdal, M.; Moreau, K.E.R.; Beyer, D.M.;

    2009-01-01

    Background and Objective: Burn scars cause permanent and disfiguring problems for many patients and limited treatments are available. Nonablative fractional lasers induce a wound healing response, which may lead to remodeling of burn sear texture. This randomized trial evaluates efficacy...... and adverse effects of 1540 nm fractional laser versus untreated control for burn scars. Materials and Methods: Seventeen adult patients with burn scars of 1 year or older and Fitzpatrick skin types I-III were included in the study. Side-by-side test areas were randomized to (i) three monthly 1540 nm.......0015; 12 weeks: 4 (2-5), P = 0.0007). Patients were satisfied with treatments (week 12: 7 (4-8.5)) and 8/17 patients evaluated burn scars to be moderately or significantly improved. Skin redness increased transiently from laser treatments. No significant differences were found in skin pigmentation...

  4. Ma-Pi 2 macrobiotic diet and type 2 diabetes mellitus: pooled analysis of short-term intervention studies.

    Science.gov (United States)

    Porrata-Maury, C; Hernández-Triana, M; Ruiz-Álvarez, V; Díaz-Sánchez, M E; Fallucca, F; Bin, W; Baba-Abubakari, B; Pianesi, M

    2014-03-01

    The macrobiotic, Ma-Pi 2 diet (12% protein, 18% fat and 70% carbohydrate), has shown benefit in adults with type 2 diabetes mellitus (T2DM). This pooled analysis aims to confirm results from four, 21-day intervention studies with the Ma-Pi 2 diet, carried out in Cuba, China, Ghana and Italy. Baseline and end of study biochemical, body composition and blood pressure data, were compared using multivariate statistical methods and assessment of the Cohen effect size (d). Results showed that all measured indicators demonstrated significant changes (p diet was Italy (1.96), China (1.79), Cuba (1.38) and Ghana (0.98). The magnitude of the individual effect on each variable by country, and the global effect by country, was independent of the sample size (p > 0.05). Similarly, glycemia and glycemic profiles in all four studies were independent of the sample size (p = 0.237). The Ma-Pi diet 2 significantly reduced glycemia, serum lipids, uremia and cardiovascular risk in adults with T2DM. These results suggest that the Ma-Pi 2 diet could be a valid alternative treatment for patients with T2DM and point to the need for further clinical studies. Mechanisms related to its benefits as a functional diet are discussed.

  5. Policy assessment and policy development for physical activity promotion: results of an exploratory intervention study in 15 European Nations

    Directory of Open Access Journals (Sweden)

    Rütten Alfred

    2012-04-01

    Full Text Available Abstract Background Purpose of the study was to test a theoretical model to assess and develop policies for the promotion of physical activity among older people as part of an international intervention study. Methods 248 semi-standardized interviews with policy-makers were conducted in 15 European nations. The questionnaire assessed policy-makers' perceptions of organizational goals, resources, obligations, as well as organizational, political and public opportunities in the area of physical activity promotion among older people. In order to develop policies, workshops with policy-makers were conducted. Workshop outputs and outcomes were assessed for four nations nine months after the workshops. Results Policy assessment: Results of the policy assessment were diverse across nations and policy sectors. For example, organizational goals regarding actions for physical activity promotion were perceived as being most favorably by the sports sector. Organizational obligations for the development of such policies were perceived as being most favorably by the health sector. Policy development: The workshops resulted in different outputs: a national intersectoral action plan (United Kingdom, a national alliance (Sweden, an integrated policy (the Netherlands, and a continuing dialogue (Germany. Conclusions Theory-driven policy assessment and policy-maker workshops might be an important means of scientific engagement in policy development for health promotion.

  6. Dosage Optimization for Letrozole Treatment in Clomiphene-Resistant Patients with Polycystic Ovary Syndrome: A Prospective Interventional Study

    Directory of Open Access Journals (Sweden)

    Elham Rahmani

    2012-01-01

    Full Text Available Objective. Dose adjustment for induction of ovulation is one of the most important problem. Methods. In a prospective interventional study, 44 clomiphene-resistant infertile patients (113 cycles were selected from the Abolfazl Infertility Clinic of Bushehr University of Medical Sciences. Letrozole was given orally in a dose of 2.5 mg, 5 mg, and 7.5 mg, respectively. If the patient displayed no response, the dosage was increased. Results. In this patients ovulation occurred in 50 cycles (44.24%, clinical pregnancy rate according to number of cycles was 23.89% (27 of 113 cycles and according to the number of patients was 61.36% (27 of 44 patients. In the 2.5, 5, and 7.5 groups, follicles occurred in 22.9%, 42.1%, and 85.18% of cycles, and pregnancy rate was 14.58%, 28.94% and, 33.33%, respectively. Conclusions. It is better to administer Letrozole at a lower dosage to prevent complications and increase the dose based on sonographic results antral follicular count, anti-Müllerian hormone, LH/FSH, and estradiol.

  7. Improving Cognitive Function from Children to Old Age: A Systematic Review of Recent Smart Ageing Intervention Studies

    Directory of Open Access Journals (Sweden)

    Rui Nouchi

    2014-01-01

    Full Text Available Background. Cognitive functions are important for daily life at any age. One purpose of Smart Ageing is to investigate how to improve cognitive functions. This systematic review evaluates beneficial effects of the intervention on cognitive functions. Method. We conducted a systematic review of intervention studies of improvements of cognitive functions published or in press before December 2013. Because of the heterogeneity of the intervention programs, a systematic and critical review of the interventions and outcomes was conducted instead of a meta-analysis. Results. We identified nine completed and published studies, which were divided into four categories: cognitive training using video game, cognitive training using PC, cognitive training using paper and pencil, and exercise training. Review results showed that various intervention programs can improve cognitive functions such as executive functions, working memory, episodic memory, processing speed, and general cognitive ability/IQ. Conclusions. The systematic review demonstrated that some intervention programs can be effective for improving various aspects of cognitive functioning at any age. Some limitations to this review include its small sample size and heterogeneity of programs and cognitive function measures, in addition to unresolved issues such as transfer of everyday skills and effectiveness for nonhealthy people.

  8. Impact of vehicular strike on particulate matter air quality: results from a natural intervention study in Kathmandu valley.

    Science.gov (United States)

    Fransen, Michelle; Pérodin, Joanne; Hada, Jayjeev; He, Xin; Sapkota, Amir

    2013-04-01

    In this natural intervention study, we evaluated the impact of vehicular shutdown during bandhas (general strikes) and meteorological parameters on ambient PM10 concentrations (particulate matter of aerodynamic diameter 10 μm or less) in the Kathmandu Valley, Nepal. Publicly available PM10 data (January 2003-February 2008) collected at six monitoring stations were combined with meteorological and bandh data. Linear mixed effects regression models were used to examine the effects of bandhas on PM10 concentrations. Lower PM10 concentrations were observed during the monsoon season compared to the winter, across all monitoring stations, with the largest reduction observed for the urban high traffic area (mean ± standard deviation: 290 ± 71 vs 143 ± 36 μg/m(3)). In the high traffic area, there was 36 μg/m(3) decrease in PM10 concentration during the bandh period compared to 2 days preceding the bandh, adjusting for season, rainfall, temperature, and windspeed. The improvements in air quality were short lived: PM10 concentration in the urban high traffic area increased by an average of 26 μg/m(3) within the first 2 days after the bandh. Our results suggest that controlling vehicular traffic can have an immediate impact in improving particulate matter air quality even among the most polluted cities in the world. PMID:23433338

  9. Random walks on combs

    CERN Document Server

    Durhuus, B; Wheater, J; Durhuus, Bergfinnur; Jonsson, Thordur; Wheater, John

    2006-01-01

    We develop techniques to obtain rigorous bounds on the behaviour of random walks on combs. Using these bounds we calculate exactly the spectral dimension of random combs with infinite teeth at random positions or teeth with random but finite length. We also calculate exactly the spectral dimension of some fixed non-translationally invariant combs. We relate the spectral dimension to the critical exponent of the mass of the two-point function for random walks on random combs, and compute mean displacements as a function of walk duration. We prove that the mean first passage time is generally infinite for combs with anomalous spectral dimension.

  10. Matricially free random variables

    CERN Document Server

    Lenczewski, Romuald

    2008-01-01

    We show that the operatorial framework developed by Voiculescu for free random variables can be extended to arrays of random variables whose multiplication imitates matricial multiplication. The associated notion of independence, called matricial freeness, can be viewed as a generalization of both freeness and monotone independence. At the same time, the sums of matricially free random variables, called random pseudomatrices, are closely related to Gaussian random matrices. The main results presented in this paper concern the standard and tracial central limit theorems for random pseudomatrices and the corresponding limit distributions which can be viewed as matricial generalizations of semicirle laws.

  11. On Gaussian random supergravity

    International Nuclear Information System (INIS)

    We study the distribution of metastable vacua and the likelihood of slow roll inflation in high dimensional random landscapes. We consider two examples of landscapes: a Gaussian random potential and an effective supergravity potential defined via a Gaussian random superpotential and a trivial Kähler potential. To examine these landscapes we introduce a random matrix model that describes the correlations between various derivatives and we propose an efficient algorithm that allows for a numerical study of high dimensional random fields. Using these novel tools, we find that the vast majority of metastable critical points in N dimensional random supergravities are either approximately supersymmetric with |F|≪Msusy or supersymmetric. Such approximately supersymmetric points are dynamical attractors in the landscape and the probability that a randomly chosen critical point is metastable scales as log (P)∝−N. We argue that random supergravities lead to potentially interesting inflationary dynamics

  12. Quantum Random Number Generators

    OpenAIRE

    Herrero-Collantes, Miguel; Garcia-Escartin, Juan Carlos

    2016-01-01

    Random numbers are a fundamental resource in science and engineering with important applications in simulation and cryptography. The inherent randomness at the core of quantum mechanics makes quantum systems a perfect source of entropy. Quantum random number generation is one of the most mature quantum technologies with many alternative generation methods. We discuss the different technologies in quantum random number generation from the early devices based on radioactive decay to the multipl...

  13. Impact of accessible sexual and reproductive health care on poor and underserved adolescents in Managua, Nicaragua: a quasi-experimental intervention study.

    NARCIS (Netherlands)

    Meuwissen, L.E.; Gorter, A.C.; Knottnerus, A.J.A.

    2006-01-01

    BACKGROUND: The objective of this study was to evaluate a competitive voucher program intended to make sexual and reproductive health care (SRHC) accessible to adolescents from disadvantaged areas of Managua. METHODS: A quasi-experimental intervention study was performed in which 28,711 vouchers tha

  14. The effect of alcohol consumption on insulin sensitivity and glycemic status: a systematic review and meta-analysis of intervention studies

    NARCIS (Netherlands)

    Schrieks, I.C.; Heil, A.L.; Hendriks, H.F.; Mukamal, K.J.; Beulens, J.W.

    2015-01-01

    OBJECTIVE: Moderate alcohol consumption is associated with a reduced risk of type 2 diabetes. This reduced risk might be explained by improved insulin sensitivity or improved glycemic status, but results of intervention studies on this relation are inconsistent. The purpose of this study was to cond

  15. Reducing indoor air pollution with a randomised intervention design - a presentation of the Stove Intervention Study in the Guatemalan Highlands

    Directory of Open Access Journals (Sweden)

    Tone Smith-Sivertsen m.fl

    2009-10-01

    Full Text Available Indoor air pollution from the burning of solid fuels (like wood and coal in simple stoves is a global problem especially affecting people living in poor rural areas of the world. When typically burnt on open fires, the resulting indoor pollution levels may be orders of magnitude higher than levels recommended by international guidelines. The most important health effects seem to be acute lower respiratory infections (ALRI in children and chronic obstructive pulmonary disease in women. So far, health risks from solid fuel use have only been studied with observational designs, often with poor assessment of exposures. Hence there is good reason to conduct a well-designed randomised intervention study.                                          In this randomised study, conducted in a poor rural community in Guatemala, indoor exposure burden in the intervention group is reduced by replacing open fires with new chimney stoves burning the same wood fuels. Participating households (n=534 all started the project with a child less than four months or a pregnant woman, and are being followed until the child reaches 18 months. At the end of follow-up, the control households receive their new stove. The main health outcome investigated is the incidence of ALRI in infants. Also, respiratory and cardiovascular health in women is studied. Preparations are also being made to study asthma/atopy in the children as they grow older. This study will define the relationship between exposure and disease more completely, quantify the impacts of reducing indoor air pollution and document the potential for prevention of ill-health that new stoves give. It is the first randomised controlled trial ever performed on health effects from combustion pollutants in normal populations.

  16. A Intervention Study to Improve HBsAg Testing and Preventive Practices for Hepatitis B in an Obstetrics Hospital

    Directory of Open Access Journals (Sweden)

    Ibrahim Koruk

    2011-06-01

    Full Text Available Objectives: This study was conducted to determine the effectiveness of a multicomponent intervention in Sanliurfa Gynecology and Obstetrics Hospital (SGOH, which is designed to overcome the obstacles encountered in the application of HBsAg testing to all delivering women, the administration of hepatitis B vaccine and Hepatitis B Immunglobulin(HBIG to newborns of HBsAg positive pregnant women. Methods: This is an intervention study, conducted between December 15, 2007 and December 30, 2008. Intervention procedure is composed of four methods; namely, motivation of all parties through academic leadership, implementation of workshops to determine the obstacles, provision of administrative commitment, and training of healthcare personnel. Results: In 2007, a total of 18,709 deliveries were realized in SGOH; HBsAg testing was performed in only 16.5% of the pregnant women and 0.8% of these women were found to be HBsAg positive. It was determined that HBIG was administered to 28.2% of newborns of HBsAg positive mothers and hepatitis B vaccine was given to 71.4% (n=13349 of all newborns. After the intervention, the increase in HBsAg test application status, HBsAg positivity, HIBG administration and hepatitis B vaccination was 6.0, 5.8, 2.0 and 1.2 fold, respectively (P<0.05. Conclusions: In order to reduce the incidence of hepatitis B and maintain patient safety in newborns, HBsAg testing should be included in routine pregnancy screening programs and this approach should be supported by legal arrangements and systematic continuous training activities. [TAF Prev Med Bull 2011; 10(3.000: 287-292

  17. Impact of aesthetic restorative treatment on anterior teeth with fluorosis among residents of an endemic area in Brazil: intervention study

    Science.gov (United States)

    2014-01-01

    Background Endemic dental fluorosis has already been described in some regions of the world. The aim of this study was to evaluate the functional and psychosocial impact of direct aesthetic restorative treatments in endemic fluorosis patients in the northern state of Minas Gerais, Brazil. Was a quasi-experimental intervention study. Methods The reference population consisted of individuals between 9 and 27 years of age that were served by a project intended to recover the smiles of patients with severe fluorosis. The questionnaires were administered on two occasions, 24 months apart (before and after dental treatment). Initially, descriptive analyses were conducted. Prevalence and severity, as well as the extent of the functional and psychosocial impact of oral disorders were estimated based on the Oral Health Impact Profile instrument (OHIP-14). Comparisons between baseline and follow-up and between treatment techniques were carried out using the McNemar, Wilcoxon, and Mann–Whitney tests. Results The study involved 53 individuals, with a mean age of 15.9 years, treated with microabrasion, dental composite, or a combination of both techniques. The treatments performed proved to be competent for reducing the functional and psychosocial impact of oral disorders as measured by the OHIP-14, pointing to the possibility of establishing protocols to be used in programs aimed at restoring the aesthetics and functionality of the anterior teeth in large populations. Conclusions After performing the direct aesthetic restorative treatments in patients with endemic fluorosis, a significant improvement was observed in the prevalence and severity, as well as the extent of the functional and psychosocial impact of oral disorders. PMID:24886223

  18. CRISTOPH – A cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice

    Directory of Open Access Journals (Sweden)

    Wegscheider Karl

    2008-06-01

    Full Text Available Abstract Background Recent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR, rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs. Methods/design A prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease, defined as 10-year-mortality ≥ 5% employing the European SCORE formula. Secondary outcome measures include the intervention's effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above, 2. low CVR (SCORE Discussion To our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk. Trial registration ISRCTN44478543

  19. Documenting the experiences of health workers expected to implement guidelines during an intervention study in Kenyan hospitals

    Directory of Open Access Journals (Sweden)

    Warira Ann

    2009-07-01

    Full Text Available Abstract Background Although considerable efforts are directed at developing international guidelines to improve clinical management in low-income settings they appear to influence practice rarely. This study aimed to explore barriers to guideline implementation in the early phase of an intervention study in four district hospitals in Kenya. Methods We developed a simple interview guide based on a simple characterisation of the intervention informed by review of major theories on barriers to uptake of guidelines. In-depth interviews, non-participatory observation, and informal discussions were then used to explore perceived barriers to guideline introduction and general improvements in paediatric and newborn care. Data were collected four to five months after in-service training in the hospitals. Data were transcribed, themes explored, and revised in two rounds of coding and analysis using NVivo 7 software, subjected to a layered analysis, reviewed, and revised after discussion with four hospital staff who acted as within-hospital facilitators. Results A total of 29 health workers were interviewed. Ten major themes preventing guideline uptake were identified: incomplete training coverage; inadequacies in local standard setting and leadership; lack of recognition and appreciation of good work; poor communication and teamwork; organizational constraints and limited resources; counterproductive health worker norms; absence of perceived benefits linked to adoption of new practices; difficulties accepting change; lack of motivation; and conflicting attitudes and beliefs. Conclusion While the barriers identified are broadly similar in theme to those reported from high-income settings, their specific nature often differs. For example, at an institutional level there is an almost complete lack of systems to introduce or reinforce guidelines, poor teamwork across different cadres of health worker, and failure to confront poor practice. At an individual

  20. Black Raspberry Extract Increased Circulating Endothelial Progenitor Cells and Improved Arterial Stiffness in Patients with Metabolic Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Jeong, Han Saem; Kim, Sohyeon; Hong, Soon Jun; Choi, Seung Cheol; Choi, Ji-Hyun; Kim, Jong-Ho; Park, Chi-Yeon; Cho, Jae Young; Lee, Tae-Bum; Kwon, Ji-Wung; Joo, Hyung Joon; Park, Jae Hyoung; Yu, Cheol Woong; Lim, Do-Sun

    2016-04-01

    Administration of black raspberry (Rubus occidentalis) is known to improve vascular endothelial function in patients at a high risk for cardiovascular (CV) disease. We investigated short-term effects of black raspberry on circulating endothelial progenitor cells (EPCs) and arterial stiffness in patients with metabolic syndrome. Patients with metabolic syndrome (n = 51) were prospectively randomized into the black raspberry group (n = 26, 750 mg/day) and placebo group (n = 25) during the 12-week follow-up. Central blood pressure, augmentation index, and EPCs, such as CD34/KDR(+), CD34/CD117(+), and CD34/CD133(+), were measured at baseline and at 12-week follow-up. Radial augmentation indexes were significantly decreased in the black raspberry group compared to the placebo group (-5% ± 10% vs. 3% ± 14%, P raspberry group compared to the placebo group (19 ± 109/μL vs. -28 ± 57/μL, P raspberry group compared to the placebo group (-0.5 ± 1.4 pg/mL vs. -0.1 ± 1.1 pg/mL, P raspberry group. The use of black raspberry significantly lowered the augmentation index and increased circulating EPCs, thereby improving CV risks in patients with metabolic syndrome during the 12-week follow-up.

  1. The Role of Friends' Disruptive Behavior in the Development of Children's Tobacco Experimentation: Results from a Preventive Intervention Study

    Science.gov (United States)

    van Lier, Pol A. C.; Huizink, Anja; Vuijk, Patricia

    2011-01-01

    Having friends who engage in disruptive behavior in childhood may be a risk factor for childhood tobacco experimentation. This study tested the role of friends' disruptive behavior as a mediator of the effects of a classroom based intervention on children's tobacco experimentation. 433 Children (52% males) were randomly assigned to the Good…

  2. 奥氮平换用齐拉西酮治疗精神分裂症的安全性和有效性研究%Switching from olanzapine to ziprasidone: a 12-Week, open-label, multicenter study evaluating the effectiveness and safety of ziprasidone in patients with schizophrenia.

    Institute of Scientific and Technical Information of China (English)

    段艳平; 司天梅; 苏允爱; 党卫民; 邓红; 陈红辉; 刘铁榜; 陶明

    2013-01-01

    Objective To evaluate the effectiveness and safety of switching to ziprasidone from olanzapine because of inadequate response or intolerance. Methods A total of 100 patients with first-episode or non-refractory schizophrenia (diagnosed according with the criteria of DSM-IV) who had no response to olanzapine or showed poor tolerance to alanzapine were enrolled in a 12-week, open-label, flexible-dose ziprasidone trial. All patients were assessed with Positive and Negative Syndrome Scale (PANSS) , Calgary Depression Scale (CDSS) , global impression scale (CGI) and Social Functions ( SF-12) at baseline and the end of 2nd, 4th, 8th, 12th week to evaluate the efficacy. Extrapyramidal Side Effects Scale (SAS) , laboratory examination and electrocardiogram examination were performed to evaluate the safety at baseline and the end of the 4th, 8th week of the treatment. Results A total of 86 patients completed the trial. Scores of PANSS, CDSS, CGI and SF-12 all decreased significantly with the advance of the treatment (P <0. 001). 61 complete records of adverse reactions were collected. The most common adverse reaction was extrapyramidal effect (32 cases, 36. 07%). The prevalence of relatively rare adverse reactions was 16. 39% (10 cases) , which consisted of agitation (2 cases) , nausea (1 case) , constipation (1 case) , insomnia (1 case) , dizziness (1 case) , headache (1 case) , anxiety (1 case) , dry mouth ( 1 case) and tachycardia ( 1 case). There were no significant changes in fasting glucose, HbAlc, triglyceride, total cholesterol, prolactin, QTc interval, heart rate at different observation time-points with the advance of the treatment. Conclusion Ziprasidone can improve the clinical symptoms effectively in patients who had no response to olanzapine or showed poor tolerance to alanzapine. Ziprasidone has less adverse reactions and has little effect on metabolism.%目的 观察不能耐受奥氮平治疗或经奥氮平治疗无效的精神分裂症

  3. Fractional Carbon Dioxide Laser for Keratosis Pilaris: A Single-Blind, Randomized, Comparative Study

    Directory of Open Access Journals (Sweden)

    Vasanop Vachiramon

    2016-01-01

    Full Text Available Objective. Keratosis pilaris (KP is a common condition which can frequently be cosmetically disturbing. Topical treatments can be used with limited efficacy. The objective of this study is to evaluate the effectiveness and safety of fractional carbon dioxide (CO2 laser for the treatment of KP. Patients and Methods. A prospective, randomized, single-blinded, intraindividual comparative study was conducted on adult patients with KP. A single session of fractional CO2 laser was performed to one side of arm whereas the contralateral side served as control. Patients were scheduled for follow-up at 4 and 12 weeks after treatment. Clinical improvement was graded subjectively by blinded dermatologists. Patients rated treatment satisfaction at the end of the study. Results. Twenty patients completed the study. All patients stated that the laser treatment improved KP lesions. At 12-week follow-up, 30% of lesions on the laser-treated side had moderate to good improvement according to physicians’ global assessment (p=0.02. Keratotic papules and hyperpigmentation appeared to respond better than the erythematous component. Four patients with Fitzpatrick skin type V developed transient pigmentary alteration. Conclusions. Fractional CO2 laser treatment may be offered to patients with KP. Dark-skinned patients should be treated with special caution.

  4. Fixed combination of cinnarizine and dimenhydrinate versus betahistine dimesylate in the treatment of Ménière's disease: a randomized, double-blind, parallel group clinical study.

    Science.gov (United States)

    Novotný, Miroslav; Kostrica, Rom

    2002-01-01

    In a randomized, double-blind clinical study, we evaluated the efficacy and tolerability of the fixed combination of cinnarizine, 20 mg, and dimenhydrinate, 40 mg (Arlevert [ARL]) in comparison to betahistine dimesylate (12 mg) in 82 patients suffering from Ménière's disease for at least 3 months and showing the characteristic triad of symptoms (paroxysmal vertigo attacks, cochlear hearing loss, and tinnitus). The treatment (one tablet three times daily) extended to 12 weeks, with control visits at 1, 3, 6, and 12 weeks after drug intake. The study demonstrated for both the fixed-combination ARL and for betahistine a highly efficient reduction of vertigo symptoms in the course of the 12 weeks of treatment; however, no statistically significant difference between the two treatment groups could be established. Similar results were found for tinnitus (approximately 60% reduction) and for the associated vegetative symptoms (almost complete disappearance). Vestibulospinal reactions, recorded by means of craniocorpography, also improved distinctly, with a statistically significant superiority of ARL versus betahistine (p < .042) for the parameter of lateral sway (Unterberger's test). The caloric tests (electronystagmography) showed only minor changes for both treatment groups in the course of the study. A statistically significant improvement of hearing function of the affected ear (p = .042) was found for the combination preparation after 12 weeks of treatment. The tolerability was judged by the vast majority of patients (97.5%) in both groups to be very good. Only one patient (betahistine group) reported a nonserious adverse event, and two betahistine patients did not complete the study. In conclusion, the combination preparation proved to be a highly efficient and safe treatment option for Ménière's disease and may be used both in the management of acute episodes and in long-term treatment. Efficacy and safety were found to be similar to the widely used standard

  5. Blocked Randomization with Randomly Selected Block Sizes

    Directory of Open Access Journals (Sweden)

    Jimmy Efird

    2010-12-01

    Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  6. Blocked randomization with randomly selected block sizes.

    Science.gov (United States)

    Efird, Jimmy

    2011-01-01

    When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes. PMID:21318011

  7. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  8. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial

    OpenAIRE

    Xu Guifa; Ma Jun; Shang Xianwen; Xu Haiquan; Duan Yifan; Hao Linan; Fang Hongyun; Liu Ailing; Zhang Qian; Hu Xiaoqi; Li Yanping; Du Lin; Li Ying; Guo Hongwei; Li Tingyu

    2010-01-01

    Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objecti...

  9. Reducing Emergency Medical Service Use in Patients with Chronic Psychotic Disorders: Results from the FAST Intervention Study

    OpenAIRE

    Mausbach, Brent T.; Cardenas, Veronica; McKibbin, Christine L.; Jeste, Dilip V.; Patterson, Thomas L

    2007-01-01

    Patients with schizophrenia have disproportionately high rates of emergency medical service use, likely contributing to the high cost this illness places on society. The aim of this study was to examine the impact of a theory-based, behavioral intervention on immediate and long-term use of emergency medical services. Older patients with schizophrenia (N=240) were randomized to receive either a behavioral, skills-building intervention known as Functional Adaptation and Skills Training (FAST) o...

  10. Poor Sleep Quality in Patients after Coronary Artery Bypass Graft Surgery: An Intervention Study Using the PRECEDE-PROCEED Model

    OpenAIRE

    Soheila Ranjbaran; Tahereh Dehdari; Khosro Sadeghniiat- Haghighi; Mahmood Mahmoodi-Majdabadi

    2015-01-01

    Background: Poor sleep quality (SQ) is common among patients after coronary artery bypass graft surgery (CABG). This study attempted to determine the status of SQ following an intervention based on the PRECEDE-PROCEED model in patients with poor SQ after CABG.Methods: This study was a randomized clinical trial. The study sample, including 100 patients referred to the Cardiac Rehabilitation Clinic of Tehran Heart Center, was assigned either to the intervention (recipient of exercise and lifest...

  11. Random walks, random fields, and disordered systems

    CERN Document Server

    Černý, Jiří; Kotecký, Roman

    2015-01-01

    Focusing on the mathematics that lies at the intersection of probability theory, statistical physics, combinatorics and computer science, this volume collects together lecture notes on recent developments in the area. The common ground of these subjects is perhaps best described by the three terms in the title: Random Walks, Random Fields and Disordered Systems. The specific topics covered include a study of Branching Brownian Motion from the perspective of disordered (spin-glass) systems, a detailed analysis of weakly self-avoiding random walks in four spatial dimensions via methods of field theory and the renormalization group, a study of phase transitions in disordered discrete structures using a rigorous version of the cavity method, a survey of recent work on interacting polymers in the ballisticity regime and, finally, a treatise on two-dimensional loop-soup models and their connection to conformally invariant systems and the Gaussian Free Field. The notes are aimed at early graduate students with a mod...

  12. Recruiting and retaining GPs and patients in intervention studies: the DEPS-GP project as a case study

    Directory of Open Access Journals (Sweden)

    Lautenschlager Nicola T

    2007-09-01

    Full Text Available Abstract Background Recruiting and retaining GPs for research can prove difficult, and may result in sub-optimal patient participation where GPs are required to recruit patients. Low participation rates may affect the validity of research. This paper describes a multi-faceted approach to maximise participation of GPs and their patients in intervention studies, using an Australian randomised controlled trial of a depression/suicidality management intervention as a case study. The paper aims to outline experiences that may be of interest to others considering engaging GPs and/or their patients in primary care studies. Methods A case study approach is used to describe strategies for: (a recruiting GPs; (b encouraging GPs to recruit patients to complete a postal questionnaire; and (c encouraging GPs to recruit patients as part of a practice audit. Participant retention strategies are discussed in light of reasons for withdrawal. Results The strategies described, led to the recruitment of a higher than expected number of GPs (n = 772. Three hundred and eighty three GPs (49.6% followed through with the intent to participate by sending out a total of 77,820 postal questionnaires, 22,251 (28.6% of which were returned. Three hundred and three GPs (37.0% participated in the practice audit, which aimed to recruit 20 patients per participating GP (i.e., a total of 6,060 older adults. In total, 5,143 patients (84.9% were represented in the audit. Conclusion Inexpensive methods were chosen to identify and recruit GPs; these relied on an existing database, minor promotion and a letter of invitation. Anecdotally, participating GPs agreed to be involved because they had an interest in the topic, believed the study would not impinge too greatly on their time, and appreciated the professional recognition afforded by the Continuing Professional Development (CPD points associated with study participation. The study team established a strong rapport with GPs and

  13. Effects of Triage Education on Knowledge, Practice and Qualitative Index of Emergency Room Staff: A Quasi-Interventional Study

    Directory of Open Access Journals (Sweden)

    Najaf Zare

    2013-04-01

    Full Text Available Objective: To determine the effects of triage education based on emergency severity index (ESI on promoting the knowledge and performance of nurses and qualitative indices of emergency department.Methods: This study was a quasi-interventional study being performed in Vali Asr Hospital of Fasa University of Medical Sciences during 2012. For this purpose, 50 members of staff including nurses and technicians of emergency medicine in the Emergency department with the inclusion criteria for participation were selected. Data collection instruments included a questionnaire consisting of two parts, (personal characteristics, and knowledge and the performance assessment checklist was prepared. Content validity was used to determine the validity. The test-retest method and quder-Richardson 20 were applied to determine the reliability of the questionnaire. Interobserver reliability and the correlation between the two observers and imaging modalities were measured to determine the reliability of the performance checklist. The questionnaires and checklist were completed by the participants before, 2 days and 6 weeks after completion of the training. Workshop in two 9-hour sessions was provided which consisted of lectures, questions and answers.Results: The triage scores were 10.7±3.1, 17.8± 1.6 and 16.1±2.3 before, 2 days and 6 weeks after training, respectively. Triage performance score increased from 48.9 ± 9.9 before training to 59.8 ± 7.6, two days after training and to 59.7 ± 8.1 six weeks later (p=0.001. In addition to triage training of the nurses the emergency department qualitative indices were impressively upgraded. Other results showed that there was no significant correlation between individual characteristics and personal knowledge of triage score 6-week after training (r=0.018, p=0.126. However, significant positive correlation was found between nursing work experience, work experience in emergency ward and type of employment and

  14. Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

    Science.gov (United States)

    Dehghan, Mohammad; Akbari, Negin; Alborzi, Nazila; Sadani, Somayeh; Keshtkar, Abas A

    2010-08-01

    This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

  15. Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Monica Köhn

    2013-01-01

    Full Text Available An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53±12 years were included. General stress level (measured using Perceived Stress Scale (PSS, burnout (Shirom-Melamed Burnout Questionnaire (SMBQ, anxiety and depression (Hospital Anxiety and Depression Scale (HADS, insomnia severity (Insomnia Severity Index (ISI, pain (visual analogue scale (VAS, and overall health status (Euro Quality of Life VAS (EQ-VAS were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P<0.000, anxiety (P<0.019, and overall health status (P<0.018 compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

  16. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial

    Science.gov (United States)

    2016-01-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  17. 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.

  18. 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

  19. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    Science.gov (United States)

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  20. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Hedelund, Lene; Moreau, Karen Estell R; Beyer, Ditte M;

    2010-01-01

    The efficacy of nonablative fractional laser resurfacing of acne scars has been described in case reports and uncontrolled trials. The present study is the first randomized controlled trial in this field. The aim of this study was to examine the efficacy and adverse effects of 1,540-nm nonablative...... fractional laser treatment of acne scars. Ten patients with acne scars were included. Two intraindividual areas of similar size and appearance within contralateral anatomical regions were randomized to (1) 3-monthly laser treatments with a StarLux 1,540-nm fractional handpiece, and (2) no treatment. Blinded...... appeared more even and smooth than untreated control areas (4.5, 2-6.5, versus 6.5, 4.5-8, P=0.0156, at 4 weeks; 4.5, 2.5-6.5, versus 6.5, 4.5-8, at 12 weeks; P=0.0313). Patients were satisfied with the treatment (5.5, 1-7, after 12 weeks) and five of the ten patients evaluated their acne scars...

  1. Random mapping statistics

    OpenAIRE

    Flajolet, Philippe; Odlyzko, Andrew M.

    1989-01-01

    Random mappings from a finite set into itself are either a heuristic or an exact model for a variety of applications in random number generation, computational number theory, cryptography, and the analysis of algorithms at large. This paper introduces a general framework in which the analysis of about twenty characteristic parameters of random mappings is carried out. These parameters are studied systematically through the use of generating functions and singularity analysis. In particular, a...

  2. Random Sampling with Removal

    OpenAIRE

    Gärtner, Bernd; Lengler, Johannes; Szedlak, May

    2015-01-01

    Random sampling is a classical tool in constrained optimization. Under favorable conditions, the optimal solution subject to a small subset of randomly chosen constraints violates only a small subset of the remaining constraints. Here we study the following variant that we call random sampling with removal: suppose that after sampling the subset, we remove a fixed number of constraints from the sample, according to an arbitrary rule. Is it still true that the optimal solution of the reduced s...

  3. Random fractal dendrites

    OpenAIRE

    Croydon, David (David Alexander); Hambly, Ben M.; Dr. Ben Hambly

    2006-01-01

    Dendrites are tree-like topological spaces, and in this thesis, the physical characteristics of various random fractal versions of this type of set are investigated. This work will contribute to the development of analysis on fractals, an area which has grown considerably over the last twenty years. First, a collection of random self-similar dendrites is constructed, and their Hausdorff dimension is calculated. Previous results determining this quantity for random self-simi...

  4. Aerobic endurance training versus relaxation training in patients with migraine (ARMIG: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Totzeck Andreas

    2012-04-01

    Full Text Available Abstract Background Migraine is one of the most frequent headache diseases and impairs patients’ quality of life. Up to now, many randomized studies reported efficacy of prophylactic therapy with medications such as beta-blockers or anti-epileptic drugs. Non-medical treatment, like aerobic endurance training, is considered to be an encouraging alternative in migraine prophylaxis. However, there is still a lack of prospective, high-quality randomized trials. We therefore designed a randomized controlled trial to evaluate the efficacy of aerobic endurance training versus relaxation training in patients with migraine (ARMIG. Methods This is a single-center, open-label, prospective, randomized trial. Sixty participants with migraine are randomly allocated to either endurance training or a relaxation group. After baseline headache diary documentation over at least 4 weeks, participants in the exercise group will start moderate aerobic endurance training under a sport therapist’s supervision at least 3 times a week over a 12-week period. The second group will perform Jacobson’s progressive muscle relaxation training guided by a trained relaxation therapist, also at least 3 times a week over a 12-week period. Both study arms will train in groups of up to 10 participants. More frequent individual training is possible. The follow-up period will be 12 weeks after the training period. The general state of health, possible state of anxiety or depression, impairments due to the headache disorder, pain-related disabilities, the headache-specific locus of control, and the motor fitness status are measured with standardized questionnaires. Discussion The study design is adequate to generate meaningful results. The trial will be helpful in gaining important data on exercise training for non-medical migraine prophylaxis. Trial registration The trial is registered at ClinicalTrials.gov: NCT01407861.

  5. Vitamin D₃supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Andrew P Steenhoff

    Full Text Available Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃ in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D.Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.Sixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D ≥32 ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL, CD4%, anti-retroviral therapy (ART regime, and height-adjusted (HAZ, weight-adjusted (WAZ and Body Mass Index (BMIZ Z scores.Subjects were 50% male, age (mean±SD 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4 in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001 and 68% and 90% had 25D ≥32 ng/ml, respectively (p = 0.02. Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04. HAZ and CD4% increased and VL decreased in the 7000 IU/d group (p<0.04. Younger (5-13y and older (30-50y subjects had greater Δ25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p≤0.001. Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03.In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.ClinicalTrials.gov NCT02189902.

  6. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    Science.gov (United States)

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  7. Misuse of randomization

    DEFF Research Database (Denmark)

    Liu, Jianping; Kjaergard, Lise Lotte; Gluud, Christian

    2002-01-01

    The quality of randomization of Chinese randomized trials on herbal medicines for hepatitis B was assessed. Search strategy and inclusion criteria were based on the published protocol. One hundred and seventy-six randomized clinical trials (RCTs) involving 20,452 patients with chronic hepatitis B...... virus (HBV) infection were identified that tested Chinese medicinal herbs. They were published in 49 Chinese journals. Only 10% (18/176) of the studies reported the method by which they randomized patients. Only two reported allocation concealment and were considered as adequate. Twenty percent (30...

  8. On Random Rough Sets

    Institute of Scientific and Technical Information of China (English)

    Weizhi Wu

    2006-01-01

    In this paper,the concept of a random rough set which includes the mechanisms of numeric and non-numeric aspects of uncertain knowledge is introduced. It is proved that for any belief structure and its inducing belief and plausibility measures there exists a random approximation space such that the associated lower and upper probabilities are respectively the given belief and plausibility measures, and vice versa. And for a random approximation space generated from a totally random set, its inducing lower and upper probabilities are respectively a pair of necessity and possibility measures.

  9. Medical students’ education on organ donation and its evaluation during six consecutive years: results of a voluntary, anonymous educational intervention study

    OpenAIRE

    Radunz, Sonia; Benkö, Tamás; Stern, Sabrina; Saner, Fuat H.; Paul, Andreas; Kaiser, Gernot M

    2015-01-01

    Background One of the main reasons for organ shortage is insufficient education on organ donation. Knowledgeable medical students could share the information with friends and families resulting in a positive attitude to organ donation of the general public. Methods During six consecutive years (2009 to 2014), we conducted a voluntary, anonymous educational intervention study on organ donation among fourth year medical students in the course of the main surgery lecture at the University of Ess...

  10. On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study

    OpenAIRE

    Klopotowska, J.E.; Kuiper, R; Kan, van, J.; Pont, de, A.C.J.; Dijkgraaf, M.G.; Lie-A-Huen, L.; Vroom, M.B.; Smorenburg, S.M.

    2010-01-01

    Introduction Patients admitted to an intensive care unit (ICU) are at high risk for prescribing errors and related adverse drug events (ADEs). An effective intervention to decrease this risk, based on studies conducted mainly in North America, is on-ward participation of a clinical pharmacist in an ICU team. As the Dutch Healthcare System is organized differently and the on-ward role of hospital pharmacists in Dutch ICU teams is not well established, we conducted an intervention study to inve...

  11. Vitamin D and Calcium supplementation prevents severe falls in elderly community dwelling residents: a pragmatic population-based 3-year intervention study

    DEFF Research Database (Denmark)

    Larsen, Erik Roj; Mosekilde, Leif; Foldspang, Anders

    2005-01-01

    Background and aims: We evaluated the effect of two programs for the prevention of falls leading to acute hospital admission in a population of elderly community-dwelling Danish residents. Methods: This was a factorial, pragmatic, intervention study. We included 9605 community-dwelling city...... in severe falls (RR 0.88; 95% CI 0.79-0.98; pelderly females in a northern European region known to be deficient in vitamin D....

  12. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dunlop Boadie W

    2012-07-01

    Full Text Available Abstract Background Limited controlled data exist to guide treatment choices for clinicians caring for patients with major depressive disorder (MDD. Although many putative predictors of treatment response have been reported, most were identified through retrospective analyses of existing datasets and very few have been replicated in a manner that can impact clinical practice. One major confound in previous studies examining predictors of treatment response is the patient’s treatment history, which may affect both the predictor of interest and treatment outcomes. Moreover, prior treatment history provides an important source of selection bias, thereby limiting generalizability. Consequently, we initiated a randomized clinical trial designed to identify factors that moderate response to three treatments for MDD among patients never treated previously for the condition. Methods/design Treatment-naïve adults aged 18 to 65 years with moderate-to-severe, non-psychotic MDD are randomized equally to one of three 12-week treatment arms: (1 cognitive behavior therapy (CBT, 16 sessions; (2 duloxetine (30–60 mg/d; or (3 escitalopram (10–20 mg/d. Prior to randomization, patients undergo multiple assessments, including resting state functional magnetic resonance imaging (fMRI, immune markers, DNA and gene expression products, and dexamethasone-corticotropin-releasing hormone (Dex/CRH testing. Prior to or shortly after randomization, patients also complete a comprehensive personality assessment. Repeat assessment of the biological measures (fMRI, immune markers, and gene expression products occurs at an early time-point in treatment, and upon completion of 12-week treatment, when a second Dex/CRH test is also conducted. Patients remitting by the end of this acute treatment phase are then eligible to enter a 21-month follow-up phase, with quarterly visits to monitor for recurrence. Non-remitters are offered augmentation treatment for a second 12

  13. Methylation patterns in sentinel genes in peripheral blood cells of heavy smokers: Influence of cruciferous vegetables in an intervention study.

    Science.gov (United States)

    Scoccianti, Chiara; Ricceri, Fulvio; Ferrari, Pietro; Cuenin, Cyrille; Sacerdote, Carlotta; Polidoro, Silvia; Jenab, Mazda; Hainaut, Pierre; Vineis, Paolo; Herceg, Zdenko

    2011-09-01

    Changes in DNA methylation patterns are a hallmark of tobacco-induced carcinogenesis. We have conducted a randomized 4-week intervention trial to investigate the effects of three dietary regimens to modify DNA methylation patterns in peripheral white blood cells of heavy smokers. A group of 88 smokers were randomly assigned to and distributed among three diets, including (1) normal isocaloric diet (balanced in fruits and vegetables), according to international guidelines; (2) a diet enriched in flavonoids and isothiocyanates (particularly cruciferous vegetables); (3) a regimen consisting of diet 1 supplemented with flavonoids (green tea and soy products). Methylation patterns were analyzed by pyrosequencing in LINE1 (Long Interspersed DNA Elements), RASSF1A, ARF and CDKN2a (tumor suppressor genes), MLH1 (mismatch DNA repair) and MTHFR (folate metabolism). Three distinct patterns of methylation were observed. In LINE1, methylation showed a small but reproducible increase with all three regimens. MTHFR was constitutively methylated with no significant modulation by diets. The four other loci showed low basal levels of methylation with no substantial change after intervention. These data suggest that the isocaloric diet may stabilize global epigenetic (LINE1 DNA methylation) patterns in peripheral white blood cells but does not provide evidence for methylation changes in specific genes associated with this short-term dietary intervention. PMID:21822058

  14. Asymptotics of Random Contractions

    CERN Document Server

    Hashorva, Enkelejd; Tang, Qihe

    2010-01-01

    In this paper we discuss the asymptotic behaviour of random contractions $X=RS$, where $R$, with distribution function $F$, is a positive random variable independent of $S\\in (0,1)$. Random contractions appear naturally in insurance and finance. Our principal contribution is the derivation of the tail asymptotics of $X$ assuming that $F$ is in the max-domain of attraction of an extreme value distribution and the distribution function of $S$ satisfies a regular variation property. We apply our result to derive the asymptotics of the probability of ruin for a particular discrete-time risk model. Further we quantify in our asymptotic setting the effect of the random scaling on the Conditional Tail Expectations, risk aggregation, and derive the joint asymptotic distribution of linear combinations of random contractions.

  15. Randomness: quantum versus classical

    CERN Document Server

    Khrennikov, Andrei

    2015-01-01

    Recent tremendous development of quantum information theory led to a number of quantum technological projects, e.g., quantum random generators. This development stimulates a new wave of interest in quantum foundations. One of the most intriguing problems of quantum foundations is elaboration of a consistent and commonly accepted interpretation of quantum state. Closely related problem is clarification of the notion of quantum randomness and its interrelation with classical randomness. In this short review we shall discuss basics of classical theory of randomness (which by itself is very complex and characterized by diversity of approaches) and compare it with irreducible quantum randomness. The second part of this review is devoted to the information interpretation of quantum mechanics (QM) in the spirit of Zeilinger and Brukner (and QBism of Fuchs et al.) and physics in general (e.g., Wheeler's "it from bit") as well as digital philosophy of Chaitin (with historical coupling to ideas of Leibnitz). Finally, w...

  16. Random bistochastic matrices

    Energy Technology Data Exchange (ETDEWEB)

    Cappellini, Valerio [' Mark Kac' Complex Systems Research Centre, Uniwersytet Jagiellonski, ul. Reymonta 4, 30-059 Krakow (Poland); Sommers, Hans-Juergen [Fachbereich Physik, Universitaet Duisburg-Essen, Campus Duisburg, 47048 Duisburg (Germany); Bruzda, Wojciech; Zyczkowski, Karol [Instytut Fizyki im. Smoluchowskiego, Uniwersytet Jagiellonski, ul. Reymonta 4, 30-059 Krakow (Poland)], E-mail: valerio@ictp.it, E-mail: h.j.sommers@uni-due.de, E-mail: w.bruzda@uj.edu.pl, E-mail: karol@cft.edu.pl

    2009-09-11

    Ensembles of random stochastic and bistochastic matrices are investigated. While all columns of a random stochastic matrix can be chosen independently, the rows and columns of a bistochastic matrix have to be correlated. We evaluate the probability measure induced into the Birkhoff polytope of bistochastic matrices by applying the Sinkhorn algorithm to a given ensemble of random stochastic matrices. For matrices of order N = 2 we derive explicit formulae for the probability distributions induced by random stochastic matrices with columns distributed according to the Dirichlet distribution. For arbitrary N we construct an initial ensemble of stochastic matrices which allows one to generate random bistochastic matrices according to a distribution locally flat at the center of the Birkhoff polytope. The value of the probability density at this point enables us to obtain an estimation of the volume of the Birkhoff polytope, consistent with recent asymptotic results.

  17. Random Bistochastic Matrices

    CERN Document Server

    Cappellini, V; Bruzda, W; Zyczkowski, K

    2009-01-01

    Ensembles of random stochastic and bistochastic matrices are investigated. While all columns of a random stochastic matrix can be chosen independently, the rows and columns of a bistochastic matrix have to be correlated. We evaluate the probability measure induced into the Birkhoff polytope of bistochastic matrices by applying the Sinkhorn algorithm to a given ensemble of random stochastic matrices. For matrices of order N=2 we derive explicit formulae for the probability distributions induced by random stochastic matrices with columns distributed according to the Dirichlet distribution. For arbitrary $N$ we construct an initial ensemble of stochastic matrices which allows one to generate random bistochastic matrices according to a distribution locally flat at the center of the Birkhoff polytope. The value of the probability density at this point enables us to obtain an estimation of the volume of the Birkhoff polytope, consistent with recent asymptotic results.

  18. Quantum random number generator

    Energy Technology Data Exchange (ETDEWEB)

    Pooser, Raphael C.

    2016-05-10

    A quantum random number generator (QRNG) and a photon generator for a QRNG are provided. The photon generator may be operated in a spontaneous mode below a lasing threshold to emit photons. Photons emitted from the photon generator may have at least one random characteristic, which may be monitored by the QRNG to generate a random number. In one embodiment, the photon generator may include a photon emitter and an amplifier coupled to the photon emitter. The amplifier may enable the photon generator to be used in the QRNG without introducing significant bias in the random number and may enable multiplexing of multiple random numbers. The amplifier may also desensitize the photon generator to fluctuations in power supplied thereto while operating in the spontaneous mode. In one embodiment, the photon emitter and amplifier may be a tapered diode amplifier.

  19. A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension

    Science.gov (United States)

    Chogtu, Bharti; Kuriachan, Sanitha; Magazine, Rahul; Shetty, K. Ranjan; Kamath, Asha; George, Manu Mathew; Tripathy, Amruta; Kumar, D. Mahesh

    2016-01-01

    Objectives: Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. Materials and Methods: It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. Results: In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. Conclusion: Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established. PMID:27721534

  20. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    DEFF Research Database (Denmark)

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars;

    2013-01-01

    , strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO2 max test...... and supervised counseling and exercise program.Methods/design: This paper presents the study protocol: Patient Activation through Counseling and Exercise -- Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction...... chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70 - 80%) on an ergometer cycle...

  1. Effects of sertindole on cognition in clozapine-treated schizophrenia patients - a double-blinded, randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Nielsen, R E; Levander, S; Nielsen, Jimmi

    Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Objective:  To assess the cognitive effects of sertindole augmentation in clozapine-treated patients diagnosed with schizophrenia. Cognition is secondary outcome of the trial....... Method:  A 12-week, double-blinded, randomized, placebo-controlled, augmentation study of patients treated with clozapine. Participants were randomized 1:1 to receive 16 mg of sertindole or placebo as adjunctive treatment to clozapine. Results:  Participants displayed substantial cognitive deficits...... changes in cognitive test performance, and found no significant correlations. Conclusion:  The clozapine-treated patients displayed marked cognitive deficits at baseline. Adding sertindole did not improve or worsen cognitive functioning, which is in line with previous negative studies of the effect...

  2. Random attractors for asymptotically upper semicompact multivalue random semiflows

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    The present paper studied the dynamics of some multivalued random semiflow. The corresponding concept of random attractor for this case was introduced to study asymptotic behavior. The existence of random attractor of multivalued random semiflow was proved under the assumption of pullback asymptotically upper semicompact, and this random attractor is random compact and invariant. Furthermore, if the system has ergodicity, then this random attractor is the limit set of a deterministic bounded set.

  3. Effects of exercises on knee cartilage volume in young healthy adults: a randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Lu Liangyu; Wang Yubin

    2014-01-01

    Background Acute effects of physical exercise on the deformational behavior of knee articular cartilage and changes in cartilage volume are definite.However,conclusive effects of different exercises on the loss of articular cartilage volume have not been proved.In this parallel-group randomized controlled trial,we tested whether 12 weeks of swimming,powerstriding,cycling,and running exercises would decrease the cartilage volume significantly and whether there would be a difference in the loss of cartilage volume after different types of exercises.Methods From October 2012 to January 2013 we evaluated 120 healthy volunteer students in Biomechanics Laboratory of Tongji University.Body mass index (BMI),right lower limb strength,and right knee cartilage magnetic resonance imaging (MRI) were obtained before exercise.MRI were conducted in East Hospital.The study was approved by Tongji University Ethical Committee,all subjects were randomly assigned to the running,powerstriding,cycling,swimming,and control groups by a drawing of lots.Each group contained 24 samples.At the end of 12 weeks of regular exercises,the same measurement procedures were applied.Cartilage volume was calculated with OSIRIS software based on the quantitative-MRI.Pre-and post-exercise comparisons were carried out using paired t-tests and one-way analysis of variance (ANOVA) was used to compare differences of cartilage volume loss between groups with Student-Newman-Keuls procedure for multiple comparisons.Results Running,cycling,and swimming groups resulted in a significant decrease in BMI.The quadriceps peak torque increased significantly in the swimming and cycling groups.Total cartilage volume significantly decreased in the running and cycling groups after 12 weeks of training,without any significant change in the nonimpact swimming,low-impact powerstriding,and control groups.Loss of total cartilage volume in the running and cycling groups were 2.21% (3.03) and 1.50% (0.42).Conclusions Twelve

  4. Cellulite and extracorporeal Shockwave therapy (CelluShock-2009 - a Randomized Trial

    Directory of Open Access Journals (Sweden)

    Joest Beatrice

    2010-10-01

    strength exercise training. Follow-up: 12 weeks. Blinding was achieved for all participants enrolled in the trial, the photograph taking the digital images for the primary outcome measure, the two assessors of the outcome measures, all additional health care providers and for the analyst from the biometrical department. Only one researcher (BJ was aware of the group assignment performing the randomisation and the extracorporeal shock wave therapy. Discussion This randomised-controlled trial will provide much needed evidence on the clinical effectiveness of focused extracorporal shock wave therapy as an adjunct to gluteal strength training in females suffering cellulite. ClinicalTrials.gov identifier NCT00947414

  5. Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Satabdi Pande

    2014-01-01

    Full Text Available Objectives: Benign prostatic hyperplasia (BPH is the most common cause of lower urinary tract symptoms in elderly men. Selective alfa 1 -adrenergic antagonists are now first-line drugs in the medical management of BPH. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa 1 -blocker silodosin versus the established drug tamsulosin in symptomatic BPH. Materials and Methods: Ambulatory male BPH patients, aged above 50 years, were recruited on the basis of International Prostate Symptom Score (IPSS. Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12-week. Primary outcome measure was reduction in IPSS. Proportion of subjects who achieved IPSS <8, change in prostate size as assessed by ultrasonography and changes in peak urine flow rate and allied uroflowmetry parameters, were secondary effectiveness variables. Treatment emergent adverse events were recorded. Results: Data of 53 subjects - 26 on silodosin and 27 on tamsulosin were analyzed. Final IPSS at 12-week was significantly less than baseline for both groups. However, groups remained comparable in terms of IPSS at all visits. There was a significant impact on sexual function (assessed by IPSS sexual function score in silodosin arm compared with tamsulosin. Prostate size and uroflowmetry parameters did not change. Both treatments were well-tolerated. Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin. Conclusions: Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men. However, retrograde ejaculation may be troublesome for sexually active patients.

  6. Congruence Couple Therapy for Pathological Gambling: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Bonnie K; Awosoga, Olu

    2015-09-01

    A multi-site pilot randomized controlled trial of Congruence Couple Therapy (CCT) for problem gambling was conducted in Ontario and Alberta, Canada from 2009 to 2011. The purpose was to assess the feasibility of a full trial and to identify methodological modifications to enhance future trials. The sample (N = 30; 15 couples) consisted of 66% male gamblers and 34% female. Mean age of sample was 49.1 years. Baseline mean DSM-IV gambling score was 8.7/10. Retention of the treatment couples was 89% at 2-month follow-up. Retention of control couples was 78%. A randomized controlled design compared the status of couples in treatment condition to control condition. Treatment couples received 12-week CCT while control couples received three brief check-ins over 12 weeks. No significant difference was found between treatment and control group at baseline on all measures. At (1) week 12 post-treatment, and (2) week 20 follow-up, significant treatment effects were found for gambling symptoms (p = 0.008; p = 0.041), mental distress (p = 0.001; p = 0.035), and family systems function (p = 0.023; p = 0.054) between treatment and control group. Within group changes for treatment couples over time were significant for mental distress (p = 0.000), dyadic adjustment (p = 0.002), and family systems function (p = 0.000). On similar measures, control group showed non-significant improvement. Future methodological changes, advantages and disadvantages of multi-site partnerships with community treatment agencies are discussed. Of interest is that control participants showed unintended improvement. CCT as a treatment was favourably accepted by counselors, problem gamblers and their spouses. Positive outcome trends ranging from small to large effect size on key measures indicate that a full-scaled trial will require approximately 140 couples and is an investment worth pursuing.

  7. Random Fiber Laser

    CERN Document Server

    de Matos, Christiano J S; Brito-Silva, Antônio M; Gámez, M A Martinez; Gomes, Anderson S L; de Araújo, Cid B

    2007-01-01

    We investigate the effects of two dimensional confinement on the lasing properties of a classical random laser system operating in the incoherent feedback (diffusive) regime. A suspension of 250nm rutile (TiO2) particles in a Rhodamine 6G solution was inserted into the hollow core of a photonic crystal fiber (PCF) generating the first random fiber laser and a novel quasi-one-dimensional RL geometry. Comparison with similar systems in bulk format shows that the random fiber laser presents an efficiency that is at least two orders of magnitude higher.

  8. Invitation to random tensors

    CERN Document Server

    Gurau, Razvan

    2016-01-01

    Preface to the SIGMA special issue "Tensor Models, Formalism and Applications." The SIGMA special issue "Tensor Models, Formalism and Applications" is a collection of eight excellent, up to date reviews \\cite{Ryan:2016sundry,Bonzom:2016dwy,Rivasseau:2016zco,Carrozza:2016vsq,Krajewski:2016svb,Rivasseau:2016rgt,Tanasa:2015uhr,Gielen:2016dss} on random tensor models. The reviews combine pedagogical introductions meant for a general audience with presentations of the most recent developments in the field. This preface aims to give a condensed panoramic overview of random tensors as the natural generalization of random matrices to higher dimensions.

  9. Quantum random access memory

    OpenAIRE

    Giovannetti, Vittorio; Lloyd, Seth; Maccone, Lorenzo

    2007-01-01

    A random access memory (RAM) uses n bits to randomly address N=2^n distinct memory cells. A quantum random access memory (qRAM) uses n qubits to address any quantum superposition of N memory cells. We present an architecture that exponentially reduces the requirements for a memory call: O(log N) switches need be thrown instead of the N used in conventional (classical or quantum) RAM designs. This yields a more robust qRAM algorithm, as it in general requires entanglement among exponentially l...

  10. Random Fiber Laser

    OpenAIRE

    Christiano J. S. de Matos; Menezes, Leonardo de S.; Brito-Silva, Antônio M.; Gámez, M. A. Martinez; Gomes, Anderson S. L.; de Araújo, Cid B.

    2007-01-01

    We investigate the effects of two dimensional confinement on the lasing properties of a classical random laser system operating in the incoherent feedback (diffusive) regime. A suspension of 250nm rutile (TiO2) particles in a Rhodamine 6G solution was inserted into the hollow core of a photonic crystal fiber (PCF) generating the first random fiber laser and a novel quasi-one-dimensional RL geometry. Comparison with similar systems in bulk format shows that the random fiber laser presents an e...

  11. A random walk with a branching system in random environments

    Institute of Scientific and Technical Information of China (English)

    Ying-qiu LI; Xu LI; Quan-sheng LIU

    2007-01-01

    We consider a branching random walk in random environments, where the particles are reproduced as a branching process with a random environment (in time), and move independently as a random walk on Z with a random environment (in locations). We obtain the asymptotic properties on the position of the rightmost particle at time n, revealing a phase transition phenomenon of the system.

  12. Random maintenance policies

    CERN Document Server

    Nakagawa, Toshio

    2014-01-01

    Exploring random maintenance models, this book provides an introduction to the implementation of random maintenance, and it is one of the first books to be written on this subject.  It aims to help readers learn new techniques for applying random policies to actual reliability models, and it provides new theoretical analyses of various models including classical replacement, preventive maintenance and inspection policies. These policies are applied to scheduling problems, backup policies of database systems, maintenance policies of cumulative damage models, and reliability of random redundant systems. Reliability theory is a major concern for engineers and managers, and in light of Japan’s recent earthquake, the reliability of large-scale systems has increased in importance. This also highlights the need for a new notion of maintenance and reliability theory, and how this can practically be applied to systems. Providing an essential guide for engineers and managers specializing in reliability maintenance a...

  13. Spiders in random environment

    CERN Document Server

    Gallesco, Christophe; Popov, Serguei; Vachkovskaia, Marina

    2010-01-01

    A spider consists of several, say $N$, particles. Particles can jump independently according to a random walk if the movement does not violate some given restriction rules. If the movement violates a rule it is not carried out. We consider random walk in random environment (RWRE) on $\\Z$ as underlying random walk. We suppose the environment $\\omega=(\\omega_x)_{x \\in \\Z}$ to be elliptic, with positive drift and nestling, so that there exists a unique positive constant $\\kappa$ such that $\\E[((1-\\omega_0)/\\omega_0)^{\\kappa}]=1$. The restriction rules are kept very general; we only assume transitivity and irreducibility of the spider. The main result is that the speed of a spider is positive if $\\kappa/N>1$ and null if $\\kappa/N<1$. In particular, if $\\kappa/N <1$ a spider has null speed but the speed of a (single) RWRE is positive.

  14. Tunable random packings

    International Nuclear Information System (INIS)

    We present an experimental protocol that allows one to tune the packing fraction η of a random pile of ferromagnetic spheres from a value close to the lower limit of random loose packing ηRLP≅0.56 to the upper limit of random close packing ηRCP≅0.64. This broad range of packing fraction values is obtained under normal gravity in air, by adjusting a magnetic cohesion between the grains during the formation of the pile. Attractive and repulsive magnetic interactions are found to affect stongly the internal structure and the stability of sphere packing. After the formation of the pile, the induced cohesion is decreased continuously along a linear decreasing ramp. The controlled collapse of the pile is found to generate various and reproducible values of the random packing fraction η

  15. Random unistochastic matrices

    OpenAIRE

    Zyczkowski, K.; Slomczynski, W.; Kus, M.; Sommers, H. -J.

    2001-01-01

    An ensemble of random unistochastic (orthostochastic) matrices is defined by taking squared moduli of elements of random unitary (orthogonal) matrices distributed according to the Haar measure on U(N) (or O(N), respectively). An ensemble of symmetric unistochastic matrices is obtained with use of unitary symmetric matrices pertaining to the circular orthogonal ensemble. We study the distribution of complex eigenvalues of bistochastic, unistochastic and ortostochastic matrices in the complex p...

  16. Randomized Aperture Imaging

    CERN Document Server

    Peng, Xiaopeng; Swartzlander, Grover A

    2016-01-01

    Speckled images of a binary broad band light source (600-670 nm), generated by randomized reflections or transmissions, were used to reconstruct a binary image by use of multi-frame blind deconvolution algorithms. Craft store glitter was used as reflective elements. Another experiment used perforated foil. Also reported here are numerical models that afforded controlled tip-tilt and piston aberrations. These results suggest the potential importance of a poorly figured, randomly varying segmented imaging system.

  17. Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Bohnen Arthur M

    2010-01-01

    Full Text Available Abstract Background Osteoarthritis is the most frequent chronic joint disease which causes pain and disability of especially hip and knee. According to international guidelines and the Dutch general practitioners guidelines for non-traumatic knee symptoms, acetaminophen should be the pain medication of first choice for osteoarthritis. However, of all prescribed pain medication in general practice, 90% consists of non-steroidal anti-inflammatory drugs compared to 10% of acetaminophen. Because general practitioners may lack evidence showing a similar efficacy of acetaminophen and non-steroidal anti-inflammatory drugs, we present the design of a randomized open-label trial to investigate the efficacy of a non-steroidal anti-inflammatory drug (diclofenac compared with acetaminophen in new consulters with knee osteoarthritis in general practice. Methods/Design Patients aged 45 years or older consulting their general practitioner with non-traumatic knee pain, meeting the clinical American College of Rheumatology criteria, and with a pain severity score of 2 or higher (on a 0-10 scale, will be randomly allocated to either diclofenac (maximum daily dose of 150 mg or acetaminophen (maximum daily dose of 3000 mg for 2 weeks and, if required, an additional 1-2 weeks, with a total follow-up period of 12 weeks. The primary outcomes are knee pain measured with a daily diary, and pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS at baseline, and at 3, 6, 9, and 12-weeks follow-up. Secondary outcomes are patients' perceived recovery, quality of life, medical, patient, and productivity costs, compliance to therapy, co-interventions, and adverse reactions. Discussion The successful completion of this trial would lead to a better understanding of which medication should be used in the treatment of primary care patients with mild knee osteoarthritis. Trial registration Dutch trial registry NTR1485.

  18. Can Word Puzzles be Tailored to Improve Different Dimensions of Verbal Fluency? A Report of an Intervention Study.

    Science.gov (United States)

    Murphy, Mike; Spillane, Katie; Cully, James; Navarro-Pardo, Esperanza; Moret-Tatay, Carmen

    2016-08-17

    Verbal fluency is commonly used as a proxy measure of executive functioning, as it involves cognitive flexibility, working memory, and inhibitory control. Previous research has demonstrated that crosswords can be a useful means of improving verbal fluency, results consistent with the cognitive reserve hypothesis; the form of verbal fluency affected has, however, differed across studies. The present study sought to assess the extent to which it was possible to target phonemic (PVF) and semantic verbal fluency (SVF) separately through word puzzles designed to focus on semantic/thematic and structural clues respectively. Fifty-three university students were randomly assigned to one of three groups: semantic/thematic, structural, or a daily diary control group. They were assessed on PVF and SVF at baseline, and immediately following a four-week intervention. Age, sex, and depression scores were controlled for. A 2 × 3 mixed ANCOVA showed that the structural group improved significantly more in PVF during the intervention period than did the semantic/thematic or control groups, with the improvement linked to improved switching performance. The effect size was large. No significant difference in improvement in SVF emerged, although the effect size was moderate. The findings support the notion that it is possible to improve specific forms of verbal fluency through tailored brief word-puzzle interventions. PMID:27224052

  19. DOES FATHER INVOLVEMENT INFLUENCE THE AFFECT, LANGUAGE ACQUISITION, SOCIAL ENGAGEMENT AND BEHAVIOR IN YOUNG AUTISTIC CHILDREN? AN EARLY INTERVENTION STUDY

    Directory of Open Access Journals (Sweden)

    Preeti Tabitha LOUIS

    2015-11-01

    Full Text Available The present study adopts a randomized experimental design to evaluate the impact of a father-mediated therapy to improve the play skills, affect, language, social skills and behavior among 30 clinically diagnosed autistic children at the age of 3-5 years. Standardized inventories such as, The Play Based Observation (PBO, The Griffiths Mental Developmental Scales (GMDS, The Vineland Social Maturity Scale (VSMS and the Rendel Shorts Questionnaire were administered pre and post intervention. A special program that involved fathers in the caregiving and nurturing processes of these children was designed and implemented for 6 months after which the children were reassessed. Prior to the intervention, deficits in play skills and developmental delays across expressive and receptive language were observed Scores on the Vineland Social Maturity Scale and the Rendel Shorts revealed behavioral markers. Post intervention, we noticed significant differences in the play, language acquisition, social engagement and behavior in the treatment group in comparison to the control group. The results suggested that father-mediated therapeutic involvement significantly has proven to positively foster development in young autistic children and this is an important implication for practitioners in developing early intervention programs.

  20. [Assistance for customers with sexually transmitted diseases at pharmacies in the Federal District, Brazil: an intervention study].

    Science.gov (United States)

    Naves, Janeth de Oliveira Silva; Castro, Lia Lusitana Cardozo de; Melo, Gislane Ferreira de; Giavoni, Adriana; Merchán-Hamann, Edgar

    2008-03-01

    A quantitative survey was conducted to analyze the type of assistance provided by pharmacy employees for cases of STDs. Simulated customer visits and interviews were conducted in 70 pharmacies in Brasilia and Taguatinga, Brazil, randomly assigned to two groups, one of which participated in educational activities on STDs. There were 411 simulated client visits to the pharmacies, with the following results: recommendation to seek medical care in 30% of cases, while in 70% of cases the pharmacy employees themselves recommended some drug treatment (although only 16.4% admitted to such practice). None of these suggested treatments was appropriate, based on the syndromic approach. Recommendations for prevention and treatment of partners were rare. Pharmacists recommended consulting a physician more frequently than attendants, and the latter recommended medicines more frequently than the former. Pharmacy workers had only superficial knowledge of STDs. After an educational intervention, none of the indicators showed a significant improvement in either group. The observations point to the need for regulation and intervention to publicize educational practices for the control of diseases like STDs and for the rational use of medicines in pharmacies.

  1. Regular consumption of Fiit-ns, a polyphenol extract from fruit and vegetables frequently consumed within the Mediterranean diet, improves metabolic ageing of obese volunteers: a randomized, double-blind, parallel trial.

    Science.gov (United States)

    Cases, Julien; Romain, Cindy; Dallas, Constantin; Gerbi, Alain; Cloarec, Maurice

    2015-02-01

    Epidemiological studies suggest that metabolic ageing process of overweight and obese populations is associated with an increased risk of developing non-communicable diseases (NCDs). Inflammation, hyper-glycaemia, dyslipidemia and oxidative stress have been associated with early stages of NCDs development whereas cohort surveys have demonstrated health benefits of dietary polyphenols from various dietary sources to reverse such progress. Obese volunteers were included in a double-blind, randomized, parallel pilot trial where they received daily for a 12-week period 900 mg of a polyphenol-rich treatment extracted from fruit and vegetables frequently consumed within the Mediterranean diet. 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 general satisfaction considerably ameliorated. These data suggest that over a 12-week period, the synergistic action of bioactives within the treatment improves metabolic ageing process and quality of life in obese volunteers. PMID:25358490

  2. Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial

    OpenAIRE

    Schmidt, K.; Thiel, P; Mueller, F.; Schmuecker, K.; Worrack, S.; Mehlhorn, J; Engel, C.; Brenk-Franz, K.; Kausche, S; Jakobi, U.; Bindara-Klippel, A.; Schneider, N; Freytag, A.; Davydow, D.; Wensing, M

    2014-01-01

    BACKGROUND Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors. METHODS/DESIGN In a two-armed randomized multicenter interventional study, patients after sepsi...

  3. The effect of health and nutrition education intervention on women's postpartum beliefs and practices: a randomized controlled trial

    OpenAIRE

    Yao Ping; Liu Liegang; Sun Xiufa; Mao Limei; Liu Nian; Chen Banghua

    2009-01-01

    Abstract Background 'Sitting month' is the Chinese tradition for postpartum customs. Available studies indicate that some of the traditional postpartum practices are potentially harmful for women's health. However, no intervention study aiming at postpartum practices has been performed. In this paper we evaluated the effect of a health and nutrition education intervention, which focused on improving postpartum dietary quality and optimal health behaviors. Methods The study design was a random...

  4. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    OpenAIRE

    Have, Mona; Nielsen, Jacob Have; Gejl, Anne Kær; Thomsen Ernst, Martin; Fredens, Kjeld; Støckel, Jan Toftegaard; Wedderkopp, Niels; Domazet, Sidsel Louise; Gudex, Claire; Grøntved, Anders; Kristensen, Peter Lund

    2016-01-01

    Background Integration of physical activity (PA) into the classroom may be an effective way of promoting the learning and academic achievement of children at elementary school. This paper describes the research design and methodology of an intervention study examining the effect of classroom-based PA on mathematical achievement, creativity, executive function, body mass index and aerobic fitness. Methods The study was designed as a school-based cluster-randomized controlled trial targeting sc...

  5. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    OpenAIRE

    Ritzwoller Debra P; Barrera Manuel; Strycker Lisa A; Glasgow Russell E; Toobert Deborah J; Weidner Gerdi

    2007-01-01

    Abstract Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279) with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP), a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eat...

  6. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    OpenAIRE

    Toobert, Deborah J.; Glasgow, Russell E.; Strycker, Lisa A.; Barrera, Manuel; Ritzwoller, Debra P; Weidner, Gerdi

    2007-01-01

    Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279) with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP), a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, phys...

  7. Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Courneya Kerry S

    2009-03-01

    Full Text Available Abstract Background - This pilot study evaluated the feasibility (recruitment, retention, adherence and satisfaction and preliminary efficacy of a 12-week website and email-linked counselling intervention on physical activity behaviour change in individuals with type 2 diabetes. Methods - A total of 49 individuals with type 2 diabetes (59% female, average age 54.1 years were randomized to the Diabetes NetPLAY intervention or control condition. The intervention condition received information grounded in the Social Cognitive Theory (SCT, personalized weekly emails, an on-line logbook and message board. Key outcomes included physical activity behaviour and related cognition changes. The control condition was provided links to the Canadian Diabetes Association's Clinical Practice Guidelines for Physical Activity and Canada's Guide to Physical Activity. Results - Intervention participants indicated high levels of satisfaction for this mode of delivery and study results demonstrated the feasibility of web-based mediums for the delivery of physical activity information in this population. The intervention group demonstrated a significant improvement in total vigorous and moderate minutes of physical activity (p = 0.05 compared to the control group over the 12-week study. Among the SCT variables, behavioural capacity, showed a significant increase (p Conclusion - Web-based interventions for individuals with type 2 diabetes are feasible and show promise for improving positive physical activity outcomes.

  8. Effects of Pilates on muscle strength, postural balance and quality of life of older adults: a randomized, controlled, clinical trial.

    Science.gov (United States)

    Campos de Oliveira, Laís; Gonçalves de Oliveira, Raphael; Pires-Oliveira, Deise Aparecida de Almeida

    2015-03-01

    [Purpose] The aim of the present study was to determine the effects of Pilates on lower leg strength, postural balance and the health-related quality of life (HRQoL) of older adults. [Subjects and Methods] Thirty-two older adults were randomly allocated either to the experimental group (EG, n = 16; mean age, 63.62 ± 1.02 years), which performed two sessions of Pilates per week for 12 weeks, or to the control group (CG, n = 16; mean age, 64.21 ± 0.80), which performed two sessions of static stretching per week for 12 weeks. The following evaluations were performed before and after the interventions: isokinetic torque of knee extensors and flexors at 300°/s, the Timed Up and Go (TUG) test, the Berg Balance Scale, and the Health Survey assessment (SF-36). [Results] In the intra-group analysis, the EG demonstrated significant improvement in all variables. In the inter-group analysis, the EG demonstrated significant improvement in most variables. [Conclusion] Pilates exercises led to significant improvement in isokinetic torque of the knee extensors and flexors, postural balance and aspects of the health-related quality of life of older adults. PMID:25931749

  9. Poor Sleep Quality in Patients after Coronary Artery Bypass Graft Surgery: An Intervention Study Using the PRECEDE-PROCEED Model

    Directory of Open Access Journals (Sweden)

    Soheila Ranjbaran

    2015-10-01

    Full Text Available Background: Poor sleep quality (SQ is common among patients after coronary artery bypass graft surgery (CABG. This study attempted to determine the status of SQ following an intervention based on the PRECEDE-PROCEED model in patients with poor SQ after CABG.Methods: This study was a randomized clinical trial. The study sample, including 100 patients referred to the Cardiac Rehabilitation Clinic of Tehran Heart Center, was assigned either to the intervention (recipient of exercise and lifestyle training plus designed intervention based on the PRECEDE-PROCEED model or to the control group (recipient of exercise and lifestyle training. Eight training sessions over 8 weeks were conducted for the intervention group. Predisposing, enabling, and reinforcing factors as well as social support and SQ were measured in the intervention group before and one month after the intervention and compared to those in the control group at the same time points.Results: The mean age of the patients in the intervention (24% women and control (24% women groups was 59.3 ± 7.3 and 59.5 ± 9.3 years, respectively. The results showed that the mean scores of SQ (p value < 0.001, knowledge (p value < 0.001, beliefs (p value < 0.001, sleep self-efficacy (p value < 0.001, enabling factors (p value < 0.001, reinforcing factors (p value < 0.001, and social support (p value < 0.001 were significantly different between the intervention and control groups after the intervention.Conclusion: Adding an intervention based on the PRECEDE-PROCEED model to the cardiac rehabilitation program may further improve the SQ of patients.

  10. Generating random density matrices

    CERN Document Server

    Zyczkowski, Karol; Nechita, Ion; Collins, Benoit

    2010-01-01

    We study various methods to generate ensembles of quantum density matrices of a fixed size N and analyze the corresponding probability distributions P(x), where x denotes the rescaled eigenvalue, x=N\\lambda. Taking a random pure state of a two-partite system and performing the partial trace over one subsystem one obtains a mixed state represented by a Wishart--like matrix W=GG^{\\dagger}, distributed according to the induced measure and characterized asymptotically, as N -> \\infty, by the Marchenko-Pastur distribution. Superposition of k random maximally entangled states leads to another family of explicitly derived distributions, describing singular values of the sum of k independent random unitaries. Taking a larger system composed of 2s particles, constructing $s$ random bi-partite states, performing the measurement into a product of s-1 maximally entangled states and performing the partial trace over the remaining subsystem we arrive at a random state characterized by the Fuss-Catalan distribution of order...

  11. A new delirium phenotype with rapid high amplitude onset and nearly as rapid reversal: Central Coast Australia Delirium Intervention Study

    Directory of Open Access Journals (Sweden)

    Regal PJ

    2015-02-01

    Full Text Available Paul J RegalGeriatric Medicine, University of Newcastle, Callaghan, AustraliaBackground: Traditional models for delirium based on the Diagnostic and Statistical Manual for Mental Disorders and its 1990 offspring, the Confusion Assessment Method (CAM, were not designed to distinguish behavioral and psychological symptoms of dementia from rapid cognitive decline. We examined a new diagnostic criterion for delirium plus exclusion of behavioral and psychological symptoms of dementia and recent inattention with a 25% decline in digit span forward (DSF.Methods: This was a prospective, randomized controlled trial comparing management of prevalent delirium in general medical with that in geriatric medical wards in a 370-bed hospital north of Sydney. Inclusion criteria were age ≥65 years and prevalent delirium in the emergency department based on: CAM; proof that CAM elements were not better explained by behavioral and psychological symptoms of dementia; proof of recent inattention on DSF; evidence of cognitive decline not due to sedatives or antipsychotics in the emergency department. Measurements included the Instrumental Activities of Daily Living (IADL, 22-item, Selective IADL (8-item, Mini-Mental State Examination, DSF daily, Delirium Index daily, and Apathy Evaluation Scale. Pre-delirium scores from past cognitive tests and best scores were imputed after admission. Relative change (RC was calculated as absolute change/test range and RC/MPC ratio was calculated as RC after admission/maximal possible change.Results: A total of 130 subjects were recruited but 14 with subsyndromal delirium were excluded, leaving 116 subjects (mean age 83.6 years. Forty-eight percent had prior dementia. RC from pre-delirium to admission was 42% for the Mini-Mental State Examination, 41% for Selective IADL, 34% for 5-DSF, 54% for 6-DSF, and 37% for the Apathy Evaluation Scale. Improvements after admission (RC and RC/MPC ratios were 32%/98% for 5-DSF, 54%/82% for 6-DSF

  12. Graphene random laser

    CERN Document Server

    Marini, Andrea

    2015-01-01

    Manipulating and controlling the optical energy flow inside random media is a research frontier of photonics and the basis of novel laser designs. In particular, light amplification in randomly dispersed active inclusions under external pumping has been extensively investigated, although it still lacks external tunability, reproducibility, and control over the beam spatial pattern, thus hindering its application in practical devices. Here we show that a graphene random metamaterial provides the means to overcome these limitations through its extraordinarily-low threshold for saturable absorption. The nonlinear properties of nano-graphene combined with an optically pumped gain medium allow us to controllably tune the system from chaotic to stable single-mode lasing. Our results hold great potential for the development of single-mode cavity-free lasers with engineered beam patterns in disordered media.

  13. Drawing a random number

    DEFF Research Database (Denmark)

    Wanscher, Jørgen Bundgaard; Sørensen, Majken Vildrik

    2006-01-01

    Random numbers are used for a great variety of applications in almost any field of computer and economic sciences today. Examples ranges from stock market forecasting in economics, through stochastic traffic modelling in operations research to photon and ray tracing in graphics. The construction...... of a model or a solution method requires certain characteristics of the random numbers used. This is usually a distribution classification, which the sequence of random numbers must fulfill; of these some are very hard to fulfill and others are next to impossible. Today mathematics allows us to transform...... distributions into others with most of the required characteristics. In essence, a uniform sequence which is transformed into a new sequence with the required distribution. The subject of this article is to consider the well known highly uniform Halton sequence and modifications to it. The intent is to generate...

  14. Random copying in space

    CERN Document Server

    Blythe, Richard A

    2011-01-01

    Random copying is a simple model for population dynamics in the absence of selection, and has been applied to both biological and cultural evolution. In this work, we investigate the effect that spatial structure has on the dynamics. We focus in particular on how a measure of the diversity in the population changes over time. We show that even when the vast majority of a population's history may be well-described by a spatially-unstructured model, spatial structure may nevertheless affect the expected level of diversity seen at a local scale. We demonstrate this phenomenon explicitly by examining the random copying process on small-world networks, and use our results to comment on the use of simple random-copying models in an empirical context.

  15. Random errors revisited

    DEFF Research Database (Denmark)

    Jacobsen, Finn

    2000-01-01

    It is well known that the random errors of sound intensity estimates can be much larger than the theoretical minimum value determined by the BT-product, in particular under reverberant conditions and when there are several sources present. More than ten years ago it was shown that one can predict...... the random errors of estimates of the sound intensity in, say, one-third octave bands from the power and cross power spectra of the signals from an intensity probe determined with a dual channel FFT analyser. This is not very practical, though. In this paper it is demonstrated that one can predict the...... random errors from the power and cross power spectra determined with the same spectral resolution as the sound intensity itself....

  16. Random hypergraphs and algorithmics

    CERN Document Server

    Andriamampianina, Tsiriniaina

    2008-01-01

    Hypergraphs are structures that can be decomposed or described; in other words they are recursively countable. Here, we get exact and asymptotic enumeration results on hypergraphs by mean of exponential generating functions. The number of hypergraph component is bounded, as a generalisation of Wright inequalities for graphs: the proof is a combinatorial understanding of the structure by inclusion exclusion. Asymptotic results are obtained, thanks to generating functions proofs are at the end very easy to read, through complex analysis by saddle point method. By this way, we characterized: - the components with a given number of vertices and of hyperedges by the expected size of a random hypermatching in these structures. - the random hypergraphs (evolving hyperedge by hyperedge) according to the expected number of hyperedges when the first cycle appears in the evolving structure. This work is an open road to further works on random hypergraphs such as threshold phenomenon, tools used here seem to be sufficien...

  17. Free Completely Random Measures

    CERN Document Server

    Collet, Francesca

    2011-01-01

    Free probability is a noncommutative probability theory introduced by Voiculescu where the concept of independence of classical probability is replaced by the concept of freeness. An important connection between free and classical infinitely divisibility was established by Bercovici and Pata (1999) in form of a bijection, mapping the class of classical infinitely divisible laws into the class of free infinitely divisible laws. A particular class of infinitely divisible laws are the completely random measures introduced by Kingman (1967). In this paper, a free analogous of completely random measures is introduced and, a free Poisson process characterization is provided as well as a representation through a free cumulant transform. Furthermore, some examples are displayed.

  18. Random quantum operations

    Energy Technology Data Exchange (ETDEWEB)

    Bruzda, Wojciech [Mark Kac Complex Systems Research Centre, Institute of Physics, Jagiellonian University, ul. Reymonta 4, 30-059 Krakow (Poland)], E-mail: wojtek@gorce.if.uj.edu.pl; Cappellini, Valerio [Mark Kac Complex Systems Research Centre, Institute of Physics, Jagiellonian University, ul. Reymonta 4, 30-059 Krakow (Poland); Sommers, Hans-Juergen [Fachbereich Physik, Universitaet Duisburg-Essen, Campus Duisburg, 47048 Duisburg (Germany); Zyczkowski, Karol [Mark Kac Complex Systems Research Centre, Institute of Physics, Jagiellonian University, ul. Reymonta 4, 30-059 Krakow (Poland); Centrum Fizyki Teoretycznej, Polska Akademia Nauk, Al. Lotnikow 32/44, 02-668 Warszawa (Poland)

    2009-01-12

    We define a natural ensemble of trace preserving, completely positive quantum maps and present algorithms to generate them at random. Spectral properties of the superoperator {phi} associated with a given quantum map are investigated and a quantum analogue of the Frobenius-Perron theorem is proved. We derive a general formula for the density of eigenvalues of {phi} and show the connection with the Ginibre ensemble of real non-symmetric random matrices. Numerical investigations of the spectral gap imply that a generic state of the system iterated several times by a fixed generic map converges exponentially to an invariant state.

  19. Random unistochastic matrices

    Energy Technology Data Exchange (ETDEWEB)

    Zyczkowski, Karol [Centrum Fizyki Teoretycznej, Polska Akademia Nauk, Al. Lotnikow 32/44, 02-668 Warsaw (Poland); Kus, Marek [Centrum Fizyki Teoretycznej, Polska Akademia Nauk, Al. Lotnikow 32/44, 02-668 Warsaw (Poland); Slomczynski, Wojciech [Instytut Matematyki, Uniwersytet Jagiellonski, ul. Reymonta 4, 30-059 Cracow (Poland); Sommers, Hans-Juergen [Fachbereich 7 Physik, Universitaet Essen, 45117 Essen (Germany)

    2003-03-28

    An ensemble of random unistochastic (orthostochastic) matrices is defined by taking squared moduli of elements of random unitary (orthogonal) matrices distributed according to the Haar measure on U(N) (or O(N)). An ensemble of symmetric unistochastic matrices is obtained with use of unitary symmetric matrices pertaining to the circular orthogonal ensemble. We study the distribution of complex eigenvalues of bistochastic, unistochastic and orthostochastic matrices in the complex plane. We compute averages (entropy, traces) over the ensembles of unistochastic matrices and present inequalities concerning the entropies of products of bistochastic matrices.

  20. Delayed Random Relays

    CERN Document Server

    Ohira, Toru

    2016-01-01

    We present here a system with collection of random walks relaying a signal in one dimension with a presence of a delay. We are interested in the time for a signal to travel from one end (start) to the other end (finish) of the lined group of random walkers. It is found that there is an optimal number of walkers for the signal to travel fastest if the delay is present. We discuss implications of this model and associated behaviors to physical and biological systems.

  1. The Effect of Ginger (Zingiber Officinale Powder Supplement on Pain in Patients with Knee Osteoarthritis: a Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    A Nadjarzadeh

    2013-01-01

    Full Text Available Introduction: There is limited evidence that ginger (Zingiber Officinale powder consumption is effective to relieve the pain and inflammation due to special phytichemicals. The aim of this study was to investigate the effect of ginger powder supplementation in pain improvement in patients with knee osteoarthritis. Methods: This double-blind randomized clinical trial was conducted on 120 outpatients with knee osteoarthritis of moderate pain. Patients were randomly assigned to two groups: receiving ginger powder supplement and placebo. Ginger and placebo groups received two identical capsules per day for 12 weeks. Each capsule contained 500 mg ginger powder or starch. Pain severity was measured by VAS (Visual Analog Scale at first and after 3 months. A responder was defined as a reduction in pain of > 1.5 cm on a visual analog scale (VAS. Results: Before intervention, there was no significant difference between the two groups in severity of pain. However, after ginger supplementation, pain score decreased in ginger group. After 12 weeks, Pain reduction was more significant in ginger group than placebo. Response to intervention was 88% and 14% in ginger and placebo groups, respectively. There was statistically significant difference between both groups in response to intervention (p<0.001. Conclusion: The results of this study showed that ginger powder supplementation was effective in reducing pain in patients with knee osteoarthritis, therefore it is recommended as a safe supplement for these patients

  2. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong.

    Science.gov (United States)

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275). PMID:27199864

  3. Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

    Science.gov (United States)

    Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

    2016-10-01

    The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (Pyoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits. PMID:26791478

  4. Soccer vs. running training effects in young adult men: which programme is more effective in improvement of body composition? Randomized controlled trial.

    Science.gov (United States)

    Milanović, Z; Pantelić, S; Kostić, R; Trajković, N; Sporiš, G

    2015-11-01

    The aims of this study were: 1) To determine the effects of a 12-week recreational soccer training programme and continuous endurance running on body composition of young adult men and 2) to determine which of these two programmes was more effective concerning body composition. Sixty-four participants completed the randomized controlled trial and were randomly assigned to one of three groups: a soccer training group (SOC; n=20), a running group (RUN; n=21) or a control group performing no physical training (CON; n=23). Training programmes for SOC and RUN lasted 12-week with 3 training sessions per week. Soccer sessions consisted of 60 min ordinary five-a-side, six-a-side or seven-a-side matches on a 30-45 m wide and 45-60 m long plastic grass pitch. Running sessions consisted of 60 min of continuous moderate intensity running at the same average heart rate as in SOC (~80% HRmax). All participants, regardless of group assignment, were tested for each of the following dependent variables: body weight, body height, body mass index, percent body fat, body fat mass, fat-free mass and total body water. In the SOC and RUN groups there was a significant decrease (p RUN groups compared to CON. To conclude, recreational soccer training provides at least the same changes in body composition parameters as continuous running in young adult men when the training intensity is well matched. PMID:26681832

  5. The Impact of Vitamin D Supplementation on Post-Partum Glucose Tolerance and Insulin Resistance in Gestational Diabetes: A Randomized Controlled Trial

    Science.gov (United States)

    Valizadeh, Majid; Piri, Zahra; Mohammadian, Farnaz; Kamali, Koorosh; Amir Moghadami, Hamid Reza

    2016-01-01

    Background Hypovitaminosis D has been associated with the development of gestational diabetes mellitus (GDM) in many observational studies. Objectives We report the first study of the impact of prenatal vitamin D supplementation on postpartum dysglycemia in GDM patients in a randomized clinical trial. Patients and Methods Women with GDM at 12 - 32 weeks of gestation were assigned randomly to either the intervention group (in which serum 25-hydroxy vitamin D [25OHD] levels were measured immediately, n = 48) or the control group (in which the serum was stored and assayed at 6 - 12 weeks post-partum, n = 48). Participants with initial serum 25OHD resistance (HOMA-IR), HbA1C, and 25 OHD at 6 - 12 weeks after delivery. Results The mean ± SD of serum 25OHD in the intervention group raised dramatically from 14.6 ± 6.3 to 32.4 ± 14.4 ng/mL, whereas no significant change occurred in the control group (from 17.7 ± 6.1 to 19.3 ± 9.6 ng/mL, P resistance at short term follow-up after delivery.

  6. RANDOM SINGULAR INTEGRAL OF RANDOM PROCESS WITH SECOND ORDER MOMENT

    Institute of Scientific and Technical Information of China (English)

    Wang Chuanrong

    2005-01-01

    This paper discussses the random singular integral of random process with second order moment, establishes the concepts of the random singular integral and proves that it's a linear bounded operator of space Hα(L)(m, s). Then Plemelj formula and some other properties for random singular integral are proved.

  7. Coded Random Access

    DEFF Research Database (Denmark)

    Paolini, Enrico; Stefanovic, Cedomir; Liva, Gianluigi;

    2015-01-01

    as waste. However, if the common receiver (e.g., base station) is capable to store the collision slots and use them in a transmission recovery process based on successive interference cancellation, the design space for access protocols is radically expanded. We present the paradigm of coded random access...

  8. Randomness Of Amoeba Movements

    Science.gov (United States)

    Hashiguchi, S.; Khadijah, Siti; Kuwajima, T.; Ohki, M.; Tacano, M.; Sikula, J.

    2005-11-01

    Movements of amoebas were automatically traced using the difference between two successive frames of the microscopic movie. It was observed that the movements were almost random in that the directions and the magnitudes of the successive two steps are not correlated, and that the distance from the origin was proportional to the square root of the step number.

  9. Photographic dataset: random peppercorns

    CERN Document Server

    Helenius, Teemu

    2016-01-01

    This is a photographic dataset collected for testing image processing algorithms. The idea is to have sets of different but statistically similar images. In this work the images show randomly distributed peppercorns. The dataset is made available at www.fips.fi/photographic_dataset.php .

  10. Asymmetric Carrier Random PWM

    DEFF Research Database (Denmark)

    Mathe, Laszlo; Lungeanu, Florin; Rasmussen, Peter Omand;

    2010-01-01

    This paper presents a new fixed carrier frequency random PWM method, where a new type of carrier wave is proposed for modulation. Based on the measurements, it is shown that the spread effect of the discrete components from the motor current spectra is very effective independent of the modulation...

  11. Testing for Subcellular Randomness

    CERN Document Server

    Okunoye, Babatunde O

    2008-01-01

    Statistical tests were conducted on 1,000 numbers generated from the genome of Bacteriophage T4, obtained from GenBank with accession number AF158101.The numbers passed the non-parametric, distribution-free tests.Deoxyribonucleic acid was discovered to be a random number generator, existent in nature.

  12. Duration of luteal support (DOLS with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gazvani Rafet

    2012-07-01

    Full Text Available Abstract Background Luteal support with progesterone is necessary for successful implantation of the embryo following egg collection and embryo transfer in an in-vitro fertilization (IVF cycle. Progesterone has been used for as little as 2 weeks and for as long as 12 weeks of gestation. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation. Design The trial is a prospective, randomized, double-blind, placebo-controlled trial to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Following 2 weeks standard treatment and a positive biochemical pregnancy test, this randomized control trial will allocate women to a supplementary 8 weeks treatment with vaginal progesterone or 8 weeks placebo. Further studies would be required to investigate whether additional supplementation with progesterone is beneficial in early pregnancy. Discussion Currently at the Hewitt Centre, approximately 32.5% of women have a positive biochemical pregnancy test 2 weeks after embryo transfer. It is this population that is eligible for trial entry and randomization. Once the patient has confirmed a positive urinary pregnancy test they will be invited to join the trial. Once the consent form has been completed by the patient a trial prescription sheet will be sent to pharmacy with a stated collection time. The patient can then be randomized and the drugs dispensed according to pharmacy protocol. A blood sample will then be drawn for measurement of baseline hormone levels (progesterone, estradiol, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A, Activin A, Inhibin A and Inhibin B. The primary outcome measure is the proportion of all randomized women that continue successfully to a viable pregnancy (at least one fetus with fetal heart rate >100 beats/minute on transabdominal/transvaginal ultrasound at 10 weeks post embryo

  13. Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Trabal J

    2015-04-01

    Full Text Available Joan Trabal,1 Maria Forga,1 Pere Leyes,1 Ferran Torres,2,3 Jordi Rubio,4 Esther Prieto,5 Andreu Farran-Codina6 1Department of Endocrinology and Nutrition, Hospital Clínic Universitari de Barcelona, Barcelona, Catalonia, Spain; 2Biostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic Universitari de Barcelona, Barcelona, Catalonia, Spain; 3Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain; 4Residencia Ballesol Almogavers, Grupo Ballesol, Barcelona, Catalonia, Spain; 5Centre de Rehabilitacio, Fundació Amiba, Badalona, Catalonia, Spain; 6Department of Nutrition and Food Science, Faculty of Pharmacy, Universitat de Barcelona, Barcelona, Catalonia, Spain Objective: To assess the effect of free leucine supplementation combined with resistance training versus resistance training only on muscle strength and functional status in older adults.Methods: This was a randomized, double-blind, placebo-controlled, parallel study with two intervention groups. Thirty older adults were randomly assigned to receive either 10 g leucine/day (leucine group [LG], n=15 or a placebo (control group [CG], n=15, plus resistance training over a 12-week period. Maximal overcoming isometric leg strength, functional status, nutritional status, body composition, health-related quality of life, depression, and dietary intake were assessed at 4 and 12 weeks. Missing data at 12 weeks were handled using mixed models for repeated measurements for data imputation.Results: Twenty-four subjects completed the 4-week assessment and eleven completed the 12-week intervention. Clinically significant gains were found in isometric leg strength at both assessment time points. Analysis of the effect size also showed how participants in LG outperformed those in CG for chair stands and the timed up and go test. No significant changes were observed for the rest of the outcomes.Conclusion: Our combined analysis showed moderate

  14. Treatment of Accommodative Dysfunction in Children: Results from an Random Clinical Trial

    Science.gov (United States)

    Scheiman, Mitchell; Cotter, Susan; Kulp, Marjean Taylor; Mitchell, G. Lynn; Cooper, Jeffrey; Gallaway, Michael; Hopkins, Kristine B.; Bartuccio, Mary; Chung, Ida

    2011-01-01

    Purpose To report the effectiveness of various forms of vision therapy/orthoptics in improving accommodative amplitude and facility in children with symptomatic convergence insufficiency (CI) and co-existing accommodative dysfunction. Methods In a randomized clinical trial, 221 children 9 to 17 years with symptomatic CI were assigned to one of four treatments. Of the enrolled children, 164 (74%) had accommodative dysfunction; 63 (29%) had a decreased amplitude of accommodation with respect to age, 43 (19%) had decreased accommodative facility, and 58 (26%) had both. Analysis of variance models were used to compare mean accommodative amplitude and accommodative facility for each treatment group after 4, 8, and 12 weeks of treatment. Results After 12 weeks of treatment, the increases in amplitude of accommodation [office-based vergence/accommodative therapy with home reinforcement group (OBVAT) 9.9D, home-based computer vergence/accommodative therapy group (HBCVAT+) 6.7D, home-based pencil push-up therapy group (HBPP) 5.8D] were significantly greater than in the office-based placebo therapy group (2.2D) (p-values ≤ 0.010). Significant increases in accommodative facility were found in all groups (OBVAT: 9cpm, HBCVAT+: 7cpm, HBPP: 5cpm, OBPT: 5.5cpm); only the improvement in the OBVAT group was significantly greater than that found in the OBPT group (p = 0.016). One year after completion of therapy, reoccurrence of decreased accommodative amplitude was present in only 12.5% and accommodative facility in only 11%. Conclusions Vision therapy/orthoptics is effective in improving accommodative amplitude and accommodative facility in school-age children with symptomatic CI and accommodative dysfunction. PMID:21873922

  15. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Stegenga Boudewijn

    2011-01-01

    Full Text Available Abstract Background Shoulder pain is a common musculoskeletal problem that is often chronic or recurrent. Myofascial trigger points (MTrPs cause shoulder pain and are prevalent in patients with shoulder pain. However, few studies have focused on MTrP therapy. The aim of this study was to assess the effectiveness of multimodal treatment of MTrPs in patients with chronic shoulder pain. Methods A single-assessor, blinded, randomized, controlled trial was conducted. The intervention group received comprehensive treatment once weekly consisting of manual compression of the MTrPs, manual stretching of the muscles and intermittent cold application with stretching. Patients were instructed to perform muscle-stretching and relaxation exercises at home and received ergonomic recommendations and advice to assume and maintain good posture. The control group remained on the waiting list for 3 months. The Disabilities of Arm, Shoulder and Hand (DASH questionnaire score (primary outcome, Visual Analogue Scale for Pain (VAS-P, Global Perceived Effect (GPE scale and the number of muscles with MTrPs were assessed at 6 and 12 weeks in the intervention group and compared with those of a control group. Results Compared with the control group, the intervention group showed significant improvement (P Conclusions The results of this study show that 12-week comprehensive treatment of MTrPs in shoulder muscles reduces the number of muscles with active MTrPs and is effective in reducing symptoms and improving shoulder function in patients with chronic shoulder pain. Trial registration number ISRCTN: ISRCTN75722066

  16. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kuskowski Michael A

    2008-02-01

    Full Text Available Abstract Background This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee. Methods Subjects (n = 70 with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a Glucosamine sulfate (1500 mg/d; (b Aquamin (2400 mg/d; (c Combined treatment composed of Glucosamine sulfate (1500 mg/d plus Aquamin (2400 mg/d and (d Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD. Laboratory based blood tests were used as safety measures. Results Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA; however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA. Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7% and 56 feet (+3.5% extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups. Conclusion This small preliminary study suggested that a multi mineral supplement (Aquamin may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and

  17. Evaluation of a commercial web-based weight loss and weight loss maintenance program in overweight and obese adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Neve Melinda

    2010-11-01

    Full Text Available Abstract Background Obesity rates in adults continue to rise and effective treatment programs with a broad reach are urgently required. This paper describes the study protocol for a web-based randomized controlled trial (RCT of a commercially available program for overweight and obese adult males and females. The aim of this RCT was to determine and compare the efficacy of two web-based interventions for weight loss and maintenance of lost weight. Methods/Design Overweight and obese adult males and females were stratified by gender and BMI and randomly assigned to one of three groups for 12-weeks: waitlist control, or basic or enhanced online weight-loss. Control participants were re-randomized to the two weight loss groups at the end of the 12-week period. The basic and enhanced group participants had an option to continue or repeat the 12-week program. If the weight loss goal was achieved at the end of 12, otherwise on completion of 24 weeks of weight loss, participants were re-randomized to one of two online maintenance programs (maintenance basic or maintenance enhanced, until 18 months from commencing the weight loss program. Assessments took place at baseline, three, six, and 18 months after commencing the initial weight loss intervention with control participants repeating the initial assessment after three month of waiting. The primary outcome is body mass index (BMI. Other outcomes include weight, waist circumference, blood pressure, plasma markers of cardiovascular disease risk, dietary intake, eating behaviours, physical activity and quality of life. Both the weight loss and maintenance of lost weight programs were based on social cognitive theory with participants advised to set goals, self-monitor weight, dietary intake and physical activity levels. The enhanced weight loss and maintenance programs provided additional personalized, system-generated feedback on progress and use of the program. Details of the methodological aspects of

  18. Obesity-Related Metabolomic Analysis of Human Subjects in Black Soybean Peptide Intervention Study by Ultraperformance Liquid Chromatography and Quadrupole-Time-of-Flight Mass Spectrometry

    Directory of Open Access Journals (Sweden)

    Min Jung Kim

    2013-01-01

    Full Text Available The present study aimed to identify key metabolites related to weight reduction in humans by studying the metabolic profiles of sera obtained from 34 participants who underwent dietary intervention with black soybean peptides (BSP for 12 weeks. This research is a sequel to our previous work in which the effects of BSP on BMI and blood composition of lipid were investigated. Sera of the study were subjected to ultra performance liquid chromatography and quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS, and the data were analyzed using partial least-squares discriminate analysis (PLS-DA score plots. Body mass index and percent body fat of the test group were reduced. Levels of betaine, benzoic acid, pyroglutamic acid, pipecolic acid, N-phenylacetamide, uric acid, l-aspartyl-l-phenylalanine, and lysophosphatidyl cholines (lysoPCs (C18:1, C18:2, C20:1, and C20:4 showed significant increases. Levels of l-proline, valine, l-leucine/isoleucine, hypoxanthine, glutamine, l-methionine, phenylpyruvic acid, several carnitine derivatives, and lysoPCs (C14:0, PC16:0, C15:0, C16:0, C17:1, C18:0, and C22:0 were significantly decreased. In particular, lysoPC 16:0 with a VIP value of 12.02 is esteemed to be the most important metabolite for evaluating the differences between the 2 serum samples. Our result confirmed weight-lowering effects of BSP, accompanied by favorable changes in metabolites in the subjects’ blood. Therefore, this research enables us to better understand obesity and increases the predictability of the obesity-related risk by studying metabolites present in the blood.

  19. Exponential random graph models

    CERN Document Server

    Fronczak, Agata

    2012-01-01

    Nowadays, exponential random graphs (ERGs) are among the most widely-studied network models. Different analytical and numerical techniques for ERG have been developed that resulted in the well-established theory with true predictive power. An excellent basic discussion of exponential random graphs addressed to social science students and researchers is given in [Anderson et al., 1999][Robins et al., 2007]. This essay is intentionally designed to be more theoretical in comparison with the well-known primers just mentioned. Given the interdisciplinary character of the new emerging science of complex networks, the essay aims to give a contribution upon which network scientists and practitioners, who represent different research areas, could build a common area of understanding.

  20. Hashing, Randomness and Dictionaries

    DEFF Research Database (Denmark)

    Pagh, Rasmus

    time and memory space. To some extent we also consider lower bounds, i.e., we attempt to show limitations on how efficient algorithms are possible. A central theme in the thesis is randomness. Randomized algorithms play an important role, in particular through the key technique of hashing. Additionally...... algorithms community. We work (almost) exclusively with a model, a mathematical object that is meant to capture essential aspects of a real computer. The main model considered here (and in most of the literature on dictionaries) is a unit cost RAM with a word size that allows a set element to be stored...... in one word. We consider several variants of the dictionary problem, as well as some related problems. The problems are studied mainly from an upper bound perspective, i.e., we try to come up with algorithms that are as efficient as possible with respect to various computing resources, mainly computation...

  1. Random very loose packings.

    Science.gov (United States)

    Ciamarra, Massimo Pica; Coniglio, Antonio

    2008-09-19

    We measure the number Omega(phi) of mechanically stable states of volume fraction phi of a granular assembly under gravity. The granular entropy S(phi)=logOmega(phi) vanishes both at high density, at phi approximately equal to phi_rcp, and a low density, at phi approximately equal to phi_rvlp, where phi_rvlp is a new lower bound we call random very loose pack. phi_rlp is the volume fraction where the entropy is maximal. These findings allow for a clear explanation of compaction experiments and provide the first first-principle definition of the random loose volume fraction. In the context of the statistical mechanics approach to static granular materials, states with phi

  2. On fairness and randomness

    DEFF Research Database (Denmark)

    Jaeger, Manfred

    2009-01-01

    We investigate the relation between the behavior of non-deterministic systems under fairness constraints, and the behavior of probabilistic systems. To this end, first a framework based on computable stopping strategies is developed that provides a common foundation for describing both fair...... and probabilistic behavior. On the basis of stopping strategies it is then shown that fair behavior corresponds in a precise sense to random behavior in the sense of Martin-Löf's definition of randomness. We view probabilistic systems as concrete implementations of more abstract non-deterministic systems. Under...... this perspective the question is investigated what probabilistic properties are needed in such an implementation to guarantee (with probability one) certain required fairness properties in the behavior of the probabilistic system. Generalizing earlier concepts of ε -bounded transition probabilities, we introduce...

  3. Random Raman lasing

    CERN Document Server

    Hokr, Brett H; Mason, John D; Beier, Hope T; Rockwll, Benjamin A; Thomas, Robert J; Noojin, Gary D; Petrov, Georgi I; Golovan, Leonid A; Yakovlev, Vladislav V

    2013-01-01

    Propagation of light in a highly scattering medium is among the most fascinating optical effect that everyone experiences on an everyday basis and possesses a number of fundamental problems which have yet to be solved. Conventional wisdom suggests that non-linear effects do not play a significant role because the diffusive nature of scattering acts to spread the intensity, dramatically weakening these effects. We demonstrate the first experimental evidence of lasing on a Raman transition in a bulk three-dimensional random media. From a practical standpoint, Raman transitions allow for spectroscopic analysis of the chemical makeup of the sample. A random Raman laser could serve as a bright Raman source allowing for remote, chemically specific, identification of powders and aerosols. Fundamentally, the first demonstration of this new light source opens up an entire new field of study into non-linear light propagation in turbid media, with the most notable application related to non-invasive biomedical imaging.

  4. Decorating random quadrangulations

    International Nuclear Information System (INIS)

    On various regular lattices (simple cubic, body centred cubic, etc) decorating an edge with an Ising spin coupled by bonds of strength L to the original vertex spins and competing with a direct anti-ferromagnetic bond of strength αL can give rise to three transition temperatures for suitable α. The system passes through ferromagnetic, paramagnetic, anti-ferromagnetic and paramagnetic phases respectively as the temperature is increased. For the square lattice on the other hand, multiple decoration is required to see this effect. We note here that a single decoration suffices for the Ising model on planar random quadrangulations (coupled to 2D quantum gravity). Other random bipartite lattices such as the Penrose tiling are more akin to the regular square lattice and require multiple decoration to have any affect. (author). Letter-to-the-editor

  5. Decorating random quadrangulations

    Energy Technology Data Exchange (ETDEWEB)

    Johnston, Desmond A. [Department of Mathematics, Heriot-Watt University, Riccarton, Edinburgh (United Kingdom); Malmini, Ranasinghe P.K.C. [Department of Mathematics, University of Sri Jayewardenepura, Gangodawila (Sri Lanka)

    2002-02-22

    On various regular lattices (simple cubic, body centred cubic, etc) decorating an edge with an Ising spin coupled by bonds of strength L to the original vertex spins and competing with a direct anti-ferromagnetic bond of strength {alpha}L can give rise to three transition temperatures for suitable {alpha}. The system passes through ferromagnetic, paramagnetic, anti-ferromagnetic and paramagnetic phases respectively as the temperature is increased. For the square lattice on the other hand, multiple decoration is required to see this effect. We note here that a single decoration suffices for the Ising model on planar random quadrangulations (coupled to 2D quantum gravity). Other random bipartite lattices such as the Penrose tiling are more akin to the regular square lattice and require multiple decoration to have any affect. (author). Letter-to-the-editor.

  6. On Complex Random Variables

    Directory of Open Access Journals (Sweden)

    Anwer Khurshid

    2012-07-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE In this paper, it is shown that a complex multivariate random variable  is a complex multivariate normal random variable of dimensionality if and only if all nondegenerate complex linear combinations of  have a complex univariate normal distribution. The characteristic function of  has been derived, and simpler forms of some theorems have been given using this characterization theorem without assuming that the variance-covariance matrix of the vector  is Hermitian positive definite. Marginal distributions of  have been given. In addition, a complex multivariate t-distribution has been defined and the density derived. A characterization of the complex multivariate t-distribution is given. A few possible uses of this distribution have been suggested.

  7. "The effect of a template when constructing individual syllabuses in nursing education – an evaluation of student perspective in a mixed methods intervention study"

    DEFF Research Database (Denmark)

    Vilstrup, Dorte Lindstrøm; Udsen, Helle; Prip, Anne

    2014-01-01

    -intervention questionnaires and a student focus group interview. Results: By using a template, the students’ understanding of the purpose, their perception of the value and their sense of ownership of the individual syllabus are improved. The same results are not seen for the clinical teachers. The results point to the fact...... of the individual syllabus in a clinical setting. Design: A mixed methods intervention study involving first year nursing students and clinical teachers. The intervention consisted of: 1) design of a template and a precise description, 2) testing of the template and description in the form of baseline and post...... that there is potential for improving cooperation between clinical teachers and students concerning the tool. The majority of the clinical teachers, however, did find that the template improved the quality of the individual syllabus. Conclusion: A template has the potential to translate the curriculum-based learning...

  8. Fitness consultations in routine care of patients with type 2 diabetes in general practice: an 18-month non-randomised intervention study

    DEFF Research Database (Denmark)

    Lohmann, H.; Siersma, V.; Olivarius, Niels de Fine

    2010-01-01

    with an arm curl test and a chair stand test. The results were used in a subsequent motivational interview conducted by one of the GPs. Patients were encouraged to engage in lifestyle exercise and simple home-based self-managed exercise programmes. Data were analysed with mixed models. RESULTS: At end...... of motivational interviewing combined with fitness tests in the type 2 diabetes care programme was followed by a change in cardio-respiratory fitness expressed by VO2max, muscle strength of upper and lower extremities, haemoglobin A1c (HbA1c) and HDL-cholesterol. METHODS: Uncontrolled 18-month intervention study...... with follow-up and effect assessment every 3 months in a primary care unit in Denmark with six general practitioners (GPs). Of 354 eligible patients with type 2 diabetes, 127 (35.9%) were included. Maximum work capacity was tested on a cycle ergometer and converted to VO2max. Muscle strength was measured...

  9. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  10. Randomly Wired Multistage Networks

    OpenAIRE

    Maggs, Bruce M.

    1993-01-01

    Randomly wired multistage networks have recently been shown to outperform traditional multistage networks in three respects. First, they have fast deterministic packet-switching and circuit-switching algorithms for routing permutations. Second, they are nonblocking, and there are on-line algorithms for establishing new connections in them, even if many requests for connections are made simultaneously. Finally, and perhaps most importantly, they are highly fault tolerant.

  11. Random Conformal Weldings

    CERN Document Server

    Astala, K; Kupiainen, A; Saksman, E

    2009-01-01

    We construct a conformally invariant random family of closed curves in the plane by welding of random homeomorphisms of the unit circle. The homeomorphism is constructed using the exponential of $\\beta X$ where $X$ is the restriction of the two dimensional free field on the circle and the parameter $\\beta$ is in the "high temperature" regime $\\beta<\\sqrt 2$. The welding problem is solved by studying a non-uniformly elliptic Beltrami equation with a random complex dilatation. For the existence a method of Lehto is used. This requires sharp probabilistic estimates to control conformal moduli of annuli and they are proven by decomposing the free field as a sum of independent fixed scale fields and controlling the correlations of the complex dilation restricted to dyadic cells of various scales. For uniqueness we invoke a result by Jones and Smirnov on conformal removability of H\\"older curves. We conjecture that our curves are locally related to SLE$(\\kappa)$ for $\\kappa<4$.

  12. Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

    DEFF Research Database (Denmark)

    Marckmann, Peter; Agerskov, Hanne; Thineshkumar, Sasikala;

    2012-01-01

    BackgroundHypovitaminosis D is common in chronic kidney disease (CKD). Effects of 25-hydroxyvitamin D replenishment in CKD are not well described.MethodsAn 8-week randomized, placebo-controlled, double-blind parallel intervention study was conducted in haemodialysis (HD) and non-HD CKD patients...... biomarkers related to cardiovascular disease (plasma D-dimer, plasma fibrinogen, plasma von Willebrand factor antigen and activity, plasma interleukin 6, plasma C-reactive protein, blood pressure, aortic augmentation index, aortic pulse wave velocity and 24-h urinary protein loss). Objective and subjective...

  13. A Randomized Controlled Trial to Assess Pain and Magnetic Resonance Imaging-Based (MRI-Based) Structural Spine Changes in Low Back Pain Patients After Yoga Practice.

    Science.gov (United States)

    Telles, Shirley; Bhardwaj, Abhishek K; Gupta, Ram K; Sharma, Sachin K; Monro, Robin; Balkrishna, Acharya

    2016-01-01

    BACKGROUND The present study aimed at determining whether 12 weeks of yoga practice in patients with chronic LBP and MRI-based degenerative changes would result in differences in: (i) self-reported pain, anxiety, and spinal flexibility; and (ii) the structure of the discs or vertebrae. MATERIAL AND METHODS Sixty-two persons with MRI-proven degenerative intervertebral discs (group mean ±S.D., 36.2±6.4 years; 30 females) were randomly assigned to yoga and control groups. However, testing was conducted on only 40 subjects, so only their data are included in this study. The assessments were: self-reported pain, state anxiety, spinal flexibility, and MRI of the lumbosacral spine, performed using a 1.5 Tesla system with a spinal surface column. The yoga group was taught light exercises, physical postures, breathing techniques, and yoga relaxation techniques for 1 hour daily for 3 months. No intervention was given to the control group except for routine medical care. A repeated-measures analysis of variance (ANOVA) with post hoc analyses (which was Bonferroni-adjusted) was used. The Ethics Committee of Patanjali Research Foundation had approved the study which had been registered in the Clinical Trials Registry of India (CTRI/2012/11/003094). RESULTS The yoga group showed a significant reduction in self-reported pain and state anxiety in a before/after comparison at 12 weeks. A few patients in both groups showed changes in the discs and vertebrae at post-intervention assessment. CONCLUSIONS Within 12 weeks, yoga practice reduced pain and state anxiety but did not alter MRI-proven changes in the intervertebral discs and in the vertebrae. PMID:27619104

  14. A Randomized Controlled Trial to Assess Pain and Magnetic Resonance Imaging-Based (MRI-Based) Structural Spine Changes in Low Back Pain Patients After Yoga Practice

    Science.gov (United States)

    Telles, Shirley; Bhardwaj, Abhishek K.; Gupta, Ram K.; Sharma, Sachin K.; Monro, Robin; Balkrishna, Acharya

    2016-01-01

    Background The present study aimed at determining whether 12 weeks of yoga practice in patients with chronic LBP and MRI-based degenerative changes would result in differences in: (i) self-reported pain, anxiety, and spinal flexibility; and (ii) the structure of the discs or vertebrae. Material/Methods Sixty-two persons with MRI-proven degenerative intervertebral discs (group mean ±S.D., 36.2±6.4 years; 30 females) were randomly assigned to yoga and control groups. However, testing was conducted on only 40 subjects, so only their data are included in this study. The assessments were: self-reported pain, state anxiety, spinal flexibility, and MRI of the lumbosacral spine, performed using a 1.5 Tesla system with a spinal surface column. The yoga group was taught light exercises, physical postures, breathing techniques, and yoga relaxation techniques for 1 hour daily for 3 months. No intervention was given to the control group except for routine medical care. A repeated-measures analysis of variance (ANOVA) with post hoc analyses (which was Bonferroni-adjusted) was used. The Ethics Committee of Patanjali Research Foundation had approved the study which had been registered in the Clinical Trials Registry of India (CTRI/2012/11/003094). Results The yoga group showed a significant reduction in self-reported pain and state anxiety in a before/after comparison at 12 weeks. A few patients in both groups showed changes in the discs and vertebrae at post-intervention assessment. Conclusions Within 12 weeks, yoga practice reduced pain and state anxiety but did not alter MRI-proven changes in the intervertebral discs and in the vertebrae.

  15. Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome

    DEFF Research Database (Denmark)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner;

    2012-01-01

    OBJECTIVE: The musculoskeletal system is a common but often overlooked cause of chest pain. The purpose of the present study is to evaluate the relative effectiveness of 2 treatment approaches for acute musculoskeletal chest pain: (1) chiropractic treatment that included spinal manipulation and (2......) self-management as an example of minimal intervention. METHODS: In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were...... included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical...

  16. Saffron supplements modulate serum pro-oxidant-antioxidant balance in patients with metabolic syndrome: A randomized, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Tayyebeh Kermani

    2015-08-01

    Full Text Available Objectives: We have investigated the effect of a saffron supplement, given at a dose of 100 mg/kg, on prooxidant-antioxidant balance (PAB in individuals with metabolic syndrome. Materials and Methods: A randomized, placebo-controlled trial design was used in 75 subjects with metabolic syndrome who were randomly allocated to one of two study groups: (1 the case group received 100mg/kg saffron and (2 the placebo control group received placebo for 12 weeks. The serum PAB assay was applied to all subjects before (week 0 and after (weeks 6 and 12 the intervention. Results: There was a significant (p=0.035 reduction in serum PAB between week 0 to week 6 and also from week 0 to week 12.  Conclusion: Saffron supplements can modulate serum PAB in subjects with metabolic syndrome, implying an improvement in some aspects of oxidative stress or antioxidant protection.

  17. Randomized crossover study comparing the phosphate-binding efficacy of calcium ketoglutarate versus calcium carbonate in patients on chronic hemodialysis

    DEFF Research Database (Denmark)

    Bro, S; Rasmussen, R A; Handberg, J;

    1998-01-01

    into the study. Calculations based on median doses after 12 weeks showed that the cost of the therapy in Denmark was 10 times higher for calcium ketoglutarate compared with calcium carbonate (US$6.00/d v US$0.65/d). Calcium ketoglutarate may be an effective and safe alternative to treatment with aluminum......The objective of the study was to evaluate the phosphate-binding efficacy, side effects, and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis. The study design used was a randomized, crossover open trial, and the main...... outcome measurements were plasma ionized calcium levels, plasma phosphate levels, plasma intact parathyroid hormone (PTH) levels, requirements for supplemental aluminum-aminoacetate therapy, patient tolerance, and cost of therapy. Nineteen patients on chronic hemodialysis were treated with a dialysate...

  18. Prospective randomized comparison of oxybutynin, functional electrostimulation, and pelvic floor training for treatment of detrusor overactivity in women.

    Science.gov (United States)

    Arruda, Raquel M; Castro, Rodrigo A; Sousa, Gabriela C; Sartori, Marair G F; Baracat, Edmund C; Girão, Manoel J B C

    2008-08-01

    The purpose of this study is to compare the effectiveness of oxybutynin, functional electrostimulation (FES), and pelvic floor training (PFT) for treatment of women with detrusor overactivity. Sixty-four subjects were randomized to oxybutynin (n=22), FES (n=21), or PFT (n=21). Women were evaluated before and after completion of 12 weeks of treatment by subjective response, voiding diary, and urodynamic test. There was subjective symptomatic improvement in 77% of the women treated with oxybutynin, 52% with FES, and 76% with PFT. Urgency resolved in 64% of women treated with oxybutynin, 52% with FES, and in 57% with PFT. Urodynamic evaluation was normal in 36% treated with oxybutynin, 57% with FES, and 52% with PFT. Maximum detrusor involuntary contraction pressure decreased in all groups (p<0.05). All treatments were equally effective. Subjective reduction of urge-incontinence episodes was associated with symptomatic improvement.

  19. Remote treatment of bulimia nervosa and binge eating disorder: a randomized trial of Internet-assisted cognitive behavioural therapy.

    Science.gov (United States)

    Ljotsson, B; Lundin, C; Mitsell, K; Carlbring, P; Ramklint, M; Ghaderi, A

    2007-04-01

    The present study investigated the efficacy of self-help based on cognitive behaviour therapy in combination with Internet support in the treatment of bulimia nervosa and binge eating disorder. After confirming the diagnosis with an in-person interview, 73 patients were randomly allocated to treatment or a waiting list control group. Treated individuals showed marked improvement after 12 weeks of self-help compared to the control group on both primary and secondary outcome measures. Intent-to-treat analyses revealed that 37% (46% among completers) had no binge eating or purging at the end of the treatment and a considerable number of patients achieved clinically significant improvement on most of the other measures as well. The results were maintained at the 6-month follow-up, and provide evidence to support the continued use and development of self-help programmes.

  20. 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...

  1. Efficacy of Radiotherapy for Painful Bone Metastases During the Last 12 Weeks of Life

    NARCIS (Netherlands)

    Meeuse, Jan J.; van der Linden, Yvette M.; van Tienhoven, Geertjan; Gans, Rijk O. B.; Leer, Jan Willem H.; Reyners, An K. L.

    2010-01-01

    BACKGROUND: Radiotherapy is an effective treatment for painful bone metastases. Whether this applies also in patients with limited survival remains to be investigated. This study analyzed the effect of radiotherapy for painful bone metastases in patients with a survival

  2. Maintenance of behaviour change after a 12-week mHealth lifestyle programme for young adults.

    Directory of Open Access Journals (Sweden)

    Margaret Allman-Farinelli

    2015-09-01

    Conclusions: Young adulthood is a period of rapid weight gain but this group are hard to reach for health promotion. Despite the relatively low intensity of the TXT2BFiT programme, behaviours were maintained during the six months following the intervention. mHealth shows promise to deliver intervention with wide reach and low cost.

  3. A 12-Week Exercise Therapy Program in Middle-Aged Patients With Degenerative Meniscus Tears

    DEFF Research Database (Denmark)

    Stensrud, Silje; Roos, Ewa M.; Risberg, May Arna

    2012-01-01

    , progression, tolerance, and potential benefit from an exercise therapy program in these patients who have not had surgery. This study describes a progressive exercise therapy program aiming at improving neuromuscular function and muscle strength in middle-aged patients with degenerative meniscus tears...... global rating of change scale, isokinetic knee muscle strength tests, and 3 lower extremity performance tests. Post intervention there were clinically meaningful changes (greater than 10 points) in 16 of 20 patients on the KOOS knee related quality of life, 19 of 20 patients rated themselves as "a lot...... better" or "better" on the global rating of change scale, all patients had increased quadriceps muscle strength, and the majority of patients improved on the lower extremity performance tests. At 1 year post-intervention, the majority of patients had sustained the improvements and none of the patients...

  4. Effects of a 12-Week Resistance Exercise Program on Physical Self-Perceptions in College Students

    Science.gov (United States)

    Moore, Justin B.; Mitchell, Nathanael G.; Bibeau, Wendy S.; Bartholomew, John B.

    2011-01-01

    There is an increase in literature suggesting exercise can promote positive changes in physical self-perceptions that can manifest as an increase in global self-esteem. In the present study, we assessed self-esteem using the hierarchical framework of the Exercise and Self-Esteem Model (EXSEM) along with cognitive facets at the subdomain level…

  5. Quenched moderate deviations principle for random walk in random environment

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    We derive a quenched moderate deviations principle for the one-dimensional nearest random walk in random environment,where the environment is assumed to be stationary and ergodic.The approach is based on hitting time decomposition.

  6. Random Response of Linear Viscoelastic Systems under Random Excitation

    Institute of Scientific and Technical Information of China (English)

    张天舒; 方同

    2001-01-01

    A method of analyzing random response of linear viscoelastic systems under random excitation has been presented. The covariance matrices of random responses of a single-degree-freedom linear viscoelastic system subjected to stationary white noise and filtered white noise excitations have been obtained in closed form. For illustration, a numerical example has been included. It is observed that viscoelasticity has damping effect on the mean square random responses of the system, the higher is viscoelastic behavior, the higher the damping effect.

  7. Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Golbon Sohrab

    2014-01-01

    Full Text Available Background: Diabetes causes the increased concentration of circulatory cytokines as a result of inflammation. Considering that pomegranate juice (PJ is known to have antioxidant and anti-inflammatory properties, the purpose of this study was to determine the effects of PJ consumption on markers of inflammation in patients with type 2 diabetes (T2D. Materials and Methods: In a randomized, double-blind clinical trial study, 50 patients with T2D (40-65 years old were randomly assigned to one of two groups. Participants in each group received either 250 mL/day PJ or a control beverage for 12 weeks. Biochemical markers including fasting plasma glucose (FPG, insulin and inflammatory markers were assayed on the baseline and follow-up blood samples. Results: In all, 44 patients in two groups were included in the analysis: PJ (n = 22 and placebo (n = 22. After 12 weeks of intervention, in the PJ group, there were 32% and 30% significant decreases in plasma C-reactive protein (hs-CRP and Interlukin-6, respectively (P < 0.05. The mean ± SD plasma interlukin-6 (7.1 ± 5.6 vs. 11.9 ± 14.4 mg/L and hs-CRP (1791 ± 1657 and 1953 ± 1561 ng/mL concentrations in the PJ group were significantly lower than the placebo group after intervention (P < 0.05. Conclusion: PJ consumption by patients with T2D does not affect FPG or the insulin resistance index (HOMA-IR, whereas it does reduce Interlukin-6 and hs-CRP concentrations in plasma. Therefore, PJ consumption may have an anti-inflammatory effect in patients with T2D.

  8. Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

    Science.gov (United States)

    Wagler, Amy; Wagler, Ron

    2014-01-01

    Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

  9. ON THE RANGE OF RANDOM WALKS IN RANDOM ENVIRONMENT

    Institute of Scientific and Technical Information of China (English)

    ZHOUXIANYIN

    1995-01-01

    The range of roaldom walk on Zd in symmetric random environment is investigated. As results, it is proved that the strong law of large numbers for the range of random walk oil Zd in some random environments holds if d > 3, and a weak law of large numbers holds for d = 1.

  10. Random Cell Identifiers Assignment

    Directory of Open Access Journals (Sweden)

    Robert Bestak

    2012-01-01

    Full Text Available Despite integration of advanced functions that enable Femto Access Points (FAPs to be deployed in a plug-and-play manner, the femtocell concept still cause several opened issues to be resolved. One of them represents an assignment of Physical Cell Identifiers (PCIs to FAPs. This paper analyses a random based assignment algorithm in LTE systems operating in diverse femtocell scenarios. The performance of the algorithm is evaluated by comparing the number of confusions for various femtocell densities, PCI ranges and knowledge of vicinity. Simulation results show that better knowledge of vicinity can significantly reduce the number of confusions events.

  11. Random Web Crawls

    OpenAIRE

    Bennouas, Toufik; de Montgolfier, Fabien

    2007-01-01

    International audience This paper proposes a random Web crawl model. A Web crawl is a (biased and partial) image of the Web. This paper deals with the hyperlink structure, i.e. a Web crawl is a graph, whose vertices are the pages and whose edges are the hypertextual links. Of course a Web crawl has a very special structure; we recall some known results about it. We then propose a model generating similar structures. Our model simply simulates a crawling, i.e. builds and crawls the graph at...

  12. Optimized random chemistry

    OpenAIRE

    Buzas, Jeffrey S.; Warrington, Gregory S.

    2013-01-01

    The random chemistry algorithm of Kauffman can be used to determine an unknown subset S of a fixed set V. The algorithm proceeds by zeroing in on S through a succession of nested subsets V=V_0,V_1,...,V_m=S. In Kauffman's original algorithm, the size of each V_i is chosen to be half the size of V_{i-1}. In this paper we determine the optimal sequence of sizes so as to minimize the expected run time of the algorithm.

  13. Can randomization be informative?

    Science.gov (United States)

    Pereira, Carlos A. B.; Campos, Thiago F.; Silva, Gustavo M.; Wechsler, Sergio

    2012-10-01

    In this paper the Pair of Siblings Paradox introduced by Pereira [1] is extended by considering more than two children and more than one child observed for gender. We follow the same lines of Wechsler et al. [2] that generalizes the three prisoners' dilemma, introduced by Gardner [3]. This paper's conjecture is that the Pair of Siblings and the Three Prisoners dilemma are dual paradoxes. Looking at possible likelihoods, the sure (randomized) selection for the former is non informative (informative), the opposite that holds for the latter. This situation is maintained for generalizations. Non informative likelihood here means that prior and posterior are equal.

  14. A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomized Danish Alzheimer Intervention Study (DAISY)

    DEFF Research Database (Denmark)

    Phung, K.T.T.; Waldorff, F.B.; Buss, D.V.;

    2013-01-01

    OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial....... SETTING: Primary care and memory clinics in five Danish districts. PARTICIPANTS: 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads). INTERVENTIONS: Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control...... of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer...

  15. Random numbers from vacuum fluctuations

    Science.gov (United States)

    Shi, Yicheng; Chng, Brenda; Kurtsiefer, Christian

    2016-07-01

    We implement a quantum random number generator based on a balanced homodyne measurement of vacuum fluctuations of the electromagnetic field. The digitized signal is directly processed with a fast randomness extraction scheme based on a linear feedback shift register. The random bit stream is continuously read in a computer at a rate of about 480 Mbit/s and passes an extended test suite for random numbers.

  16. Random recursive trees and the elephant random walk

    Science.gov (United States)

    Kürsten, Rüdiger

    2016-03-01

    One class of random walks with infinite memory, so-called elephant random walks, are simple models describing anomalous diffusion. We present a surprising connection between these models and bond percolation on random recursive trees. We use a coupling between the two models to translate results from elephant random walks to the percolation process. We calculate, besides other quantities, exact expressions for the first and the second moment of the root cluster size and of the number of nodes in child clusters of the first generation. We further introduce another model, the skew elephant random walk, and calculate the first and second moment of this process.

  17. Precise Asymptotics for Random Matrices and Random Growth Models

    Institute of Scientific and Technical Information of China (English)

    Zhong Gen SU

    2008-01-01

    The author considers the largest eigenvalues of random matrices from Gaussian unitary ensemble and Laguerre unitary ensemble, and the rightmost charge in certain random growth models.We obtain some precise asymptotics results, which are in a sense similar to the precise asymptotics for sums of independent random variables in the context of the law of large numbers and complete convergence. Our proofs depend heavily upon the upper and lower tail estimates for random matrices and random growth models. The Tracy-Widom distribution plays a central role as well.

  18. Random-walk enzymes

    Science.gov (United States)

    Mak, Chi H.; Pham, Phuong; Afif, Samir A.; Goodman, Myron F.

    2015-09-01

    Enzymes that rely on random walk to search for substrate targets in a heterogeneously dispersed medium can leave behind complex spatial profiles of their catalyzed conversions. The catalytic signatures of these random-walk enzymes are the result of two coupled stochastic processes: scanning and catalysis. Here we develop analytical models to understand the conversion profiles produced by these enzymes, comparing an intrusive model, in which scanning and catalysis are tightly coupled, against a loosely coupled passive model. Diagrammatic theory and path-integral solutions of these models revealed clearly distinct predictions. Comparison to experimental data from catalyzed deaminations deposited on single-stranded DNA by the enzyme activation-induced deoxycytidine deaminase (AID) demonstrates that catalysis and diffusion are strongly intertwined, where the chemical conversions give rise to new stochastic trajectories that were absent if the substrate DNA was homogeneous. The C →U deamination profiles in both analytical predictions and experiments exhibit a strong contextual dependence, where the conversion rate of each target site is strongly contingent on the identities of other surrounding targets, with the intrusive model showing an excellent fit to the data. These methods can be applied to deduce sequence-dependent catalytic signatures of other DNA modification enzymes, with potential applications to cancer, gene regulation, and epigenetics.

  19. Random rectangular Graphs

    CERN Document Server

    Estrada, Ernesto

    2015-01-01

    A generalization of the random geometric graph (RGG) model is proposed by considering a set of points uniformly and independently distributed on a rectangle of unit area instead of on a unit square \\left[0,1\\right]^{2}. The topological properties, such as connectivity, average degree, average path length and clustering, of the random rectangular graphs (RRGs) generated by this model are then studied as a function of the rectangle sides lengths a and b=1/a, and the radius r used to connect the nodes. When a=1 we recover the RGG, and when a\\rightarrow\\infty the very elongated rectangle generated resembles a one-dimensional RGG. We provided computational and analytical evidence that the topological properties of the RRG differ significantly from those of the RGG. The connectivity of the RRG depends not only on the number of nodes as in the case of the RGG, but also on the side length of the rectangle. As the rectangle is more elongated the critical radius for connectivity increases following first a power-law an...

  20. Random-walk enzymes.

    Science.gov (United States)

    Mak, Chi H; Pham, Phuong; Afif, Samir A; Goodman, Myron F

    2015-09-01

    Enzymes that rely on random walk to search for substrate targets in a heterogeneously dispersed medium can leave behind complex spatial profiles of their catalyzed conversions. The catalytic signatures of these random-walk enzymes are the result of two coupled stochastic processes: scanning and catalysis. Here we develop analytical models to understand the conversion profiles produced by these enzymes, comparing an intrusive model, in which scanning and catalysis are tightly coupled, against a loosely coupled passive model. Diagrammatic theory and path-integral solutions of these models revealed clearly distinct predictions. Comparison to experimental data from catalyzed deaminations deposited on single-stranded DNA by the enzyme activation-induced deoxycytidine deaminase (AID) demonstrates that catalysis and diffusion are strongly intertwined, where the chemical conversions give rise to new stochastic trajectories that were absent if the substrate DNA was homogeneous. The C→U deamination profiles in both analytical predictions and experiments exhibit a strong contextual dependence, where the conversion rate of each target site is strongly contingent on the identities of other surrounding targets, with the intrusive model showing an excellent fit to the data. These methods can be applied to deduce sequence-dependent catalytic signatures of other DNA modification enzymes, with potential applications to cancer, gene regulation, and epigenetics.