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Sample records for 12-week randomized intervention-study

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

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

    2015-11-01

    Little is known about how the intensity of aerobic training influences appetite-regulating hormones in obese adolescents. Our goal was to assess the effect of low and high intensity aerobic trainings on food intake and appetite-regulating hormones in obese adolescents. Forty three obese adolescents (age: 13-18y, BMI: 34.48 ± 3.94 kg/m2) were randomized into high intensity training (HIT; n = 20) or low intensity training (LIT; n = 23) groups for 12 weeks. All participants also received the same nutritional, psychological and clinical counseling. Pre- and postintervention energy intake (EI) and circulating levels of insulin, leptin, peptide YY3-36 (PYY3-36) and ghrelin were measured. Adolescents in the HIT showed a reduction in total EI and an increase in PYY3-36 (p exercise training performed at ventilatory threshold 1 intensity, reduced EI and augmented PYY3-36 in obese adolescents, compared with LIT. The data suggest that HIT and LIT have differential effects in the regulation of appetite signals and subsequent EI in obese adolescents. PMID:26680421

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

    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...... patients declined to be enrolled in the exercise programme but completed the Cystic Fibrosis Questionnaire for Adolescents and Adults (CFQ-R 14+). Four patients did not want to participate at all. The 14 patients completing the exercise programme had a significantly increased VO(2max), but they showed no...

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

    Alessandra S. Braz; Liana Clébia S. Morais; Ana Patríca Paula; Margareth de F.F.M. Diniz; Reinaldo N. Almeida

    2013-01-01

    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. g...

  4. 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

    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

  5. 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.

    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.

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

    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.

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

    Vestman, Nelly Romani; Chen, Tsute; Lif Holgerson, Pernilla; Öhman, Carina; Johansson, Ingegerd

    2015-01-01

    BACKGROUND: Lactobacillus spp. potentially contribute to health by modulating bacterial biofilm formation, but their effects on the overall oral microbiota remain unclear. METHODS AND FINDINGS: 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/loze...

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

    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

  9. Evaluation of Immediate and 12-Week Effects of a Smartphone Sun-Safety Mobile Application: A Randomized Trial

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

    2015-01-01

    Importance Mobile apps on smart phones can communicate a large amount of personalized, real-time health information, including advice on skin cancer prevention, but their effectiveness may be affected by whether Americans can be convinced to use them. Objective A smart phone mobile application delivering real-time sun protection advice was evaluated for a second time in a randomized trial. Design The trial conducted in 2013 utilized a randomized pretest-posttest controlled design. Screening procedures and a 3-week run-in period were added to increase use of the mobile app. Also, follow-ups at 3- and 8-weeks after randomization were conducted to examine immediate and longer-term effects. Setting Data was collected from participants recruited nationwide through online promotions. Participants A volunteer sample of adults aged 18 or older who owned an Android or iPhone smart phones. Intervention The mobile application gave feedback on sun protection (i.e., sun safety practices and sunburn risk) and alerted users to apply/reapply sunscreen and get out of the sun. Also, it displayed the hourly UV Index and vitamin D production based on the forecast UV Index, time, and location. Main Outcomes and Measures Percent of days using sun protection and days and minutes outdoors in the midday sun and number of sunburns in the past 3 months were assesed. Results Treatment group participants used wide-brimmed hats more at 7-weeks than controls. Women who used Solar Cell reported using all sun protection combined more than men but men and older individuals used sunscreen and hats less. Conclusions and Relevance The mobile application appeared to weakly improve sun protection initially. Use of the mobile application was higher than in a previous trial and associated with greater sun protection especially by women. Strategies to increase use are needed if the mobile app is to be effective deployed to the general adult population. PMID:25629819

  10. 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

    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...

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

    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

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

    Ho Suleen S

    2012-08-01

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

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

    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...

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

    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...

  15. 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

    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

  16. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee

    Kneer, Werner; Rother, Matthias; Mazgareanu, Stefan; Seidel, Egbert J; ,

    2013-01-01

    Objective To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033) in comparison with a ketoprofen-free vehicle (TDT 064) for the treatment of osteoarthritis (OA) of the knee. Methods Patients with knee OA (N = 866) were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC®)...

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

    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

  18. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033 compared with the ketoprofen-free vehicle (TDT 064, in patients with osteoarthritis of the knee

    Kneer W

    2013-10-01

    Full Text Available Werner Kneer,1 Matthias Rother,2 Stefan Mazgareanu,3 Egbert J Seidel4 On behalf of the European IDEA-033 study group 1Orthopaedic Outpatient Centre, Stockach, Germany; 2IMR Partner GmbH, Graefelfing, Germany; 3Cardiorentis Ltd, Zug, Switzerland; 4Sophien- und Hufeland-Clinic, Weimar, Germany Objective: To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033 in comparison with a ketoprofen-free vehicle (TDT 064 for the treatment of osteoarthritis (OA of the knee. Methods: Patients with knee OA (N = 866 were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC® Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT-Osteoarthritis Research Society International (OARSI responder rates. Results: The WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%. The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283. Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064

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

    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. The......OBJECTIVES: The combination of high physical work demands and low physical capacity has been shown to increase the risk for cardiovascular disease and musculoskeletal disorders. The aim of this study was to assess the physical capacity of construction workers and evaluate the effect of individually...... participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. RESULTS: At baseline, participants had maximal oxygen consumption (VO (2max)) of 2.9 [standard deviation (SD) 0.7L/min] and body mass index (BMI...

  20. 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

    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

  1. 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

    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...

  2. 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

    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

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

    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...

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

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

    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 intervention......, 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...... OUTCOME: Change in physical activity from baseline to 12-and 36-month follow-up. RESULTS: In men, the high-intensity (group A) intervention had a beneficial effect at 12-month follow-up, whereas after 36 months both the high-intensity and the low-intensity (group B) intervention had a beneficial effect on...

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

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

    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 intervention......, 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...... OUTCOME: Change in physical activity from baseline to 12-and 36-month follow-up. RESULTS: In men, the high-intensity (group A)intervention had a beneficial effect at 12-month follow-up, whereas after 36 months both the high-intensity and the low-intensity (group B) intervention had a beneficial effect on...

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

    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.…

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

    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

  8. PS2-26: Recruitment Costs for a Multi-Center, Randomized Clinical Trial for a Behavioral Intervention Study

    Beaton, Sarah; Sperl-Hillen, JoAnn; Von Worley, Ann; Fernandes, Omar; Baumer, Dorothy; Davis, Herbert

    2010-01-01

    Background and Aims: The pace of recruitment impacts resources, planned study tasks, timelines, and ultimately, costs. The Journey for Control of Diabetes: the IDEA Study, a randomized trial conducted in two healthcare settings (Minnesota and New Mexico) utilized different recruitment methods at each site. This presentation compares these recruitment methods with respect to recruitment efficiency and costs.

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

    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…

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

    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

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

    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 (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH 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

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

    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.

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

    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

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

    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

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

    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

  16. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study

    Nielsen, Maria Mærsk; Sparre, Anita Belza; Stødkilde-Jørgensen, Hans;

    2012-01-01

    The consumption of sucrose-sweetened soft drinks (SSSDs) has been associated with obesity, the metabolic syndrome, and cardiovascular disorders in observational and short-term intervention studies. Too few long-term intervention studies in humans have examined the effects of soft drinks....

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

    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

  18. 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

    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.......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...

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

    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

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

    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

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

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

    2007-04-01

    Low glycaemic index (GI) diets may facilitate weight loss via behavioural and/or endocrine mechanisms. This study investigated whether the outcomes of the Weight Watchers POINTS Weight-Loss System could be improved by encouraging dieters to select low GI, high-carbohydrate foods. Ninety-six women (age 20-72 years; BMI 25-40 kg/m2) were recruited as they started the Weight Watchers POINTS programme for 12 weeks. Weekly classes were randomized so that seven (forty-five women) followed the regular programme while seven others (fifty-one women) followed a revised programme encouraging the selection of low GI foods. Anthropometric and biochemical parameters were measured before and after the 12-week diets. Participants rated hunger and desire to eat using visual analogue scales on 1 d per week, several times per d. Attrition was the same in both groups (32 v. 30 %), as well as many benefits (5 % weight loss, decreases in insulinaemia and blood lipids, waist and hip circumferences, blood pressure). Hunger and desire to eat were rated consistently lower in the low GI group over the 12-week diet. Group differences in subjective sensations were especially large in the afternoon. The 12-week weight management yielded many significant anthropometric and biochemical benefits that were not improved by encouraging dieters to select low GI foods. The subjective benefits (lower hunger and desire to eat) of the low GI diet may be a worthwhile contribution to the motivation of dieters that might affect adherence to the diet over the long term. PMID:17349094

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

    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...

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

    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...

  4. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

    Shih, Sophy TF; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O’Reilly, Sharleen; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. Methods/Design The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiven...

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

    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

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

    Zoran Milanovic; Goran Sporiš; Nebojša Trajkovic; Nic James; Krešimir Šamija

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slal...

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

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

    2008-01-01

    AIM: To evaluate the impact of promotion of exclusive breastfeeding on infant health in Guinea-Bissau, West Africa, where mortality rates are high, breastfeeding is widely practiced but exclusive breastfeeding is rare. METHOD: At the Bandim Health Project in Guinea Bissau, West Africa, a birth...... 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...

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

    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...

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

    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...

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

    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

  11. 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

    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......-intervention and 48 hours post-intervention. Symptomatic and asymptomatic participant groups were each randomized into two treatment sub-groups (superficial (SDN) and deep dry needling (DDN)) after baseline testing. At 48 hours post-intervention participants were asked whether delayed onset muscle soreness (DOMS) and...... or intervention (p=0.001). CONCLUSIONS: In selected female neck/shoulder pain sufferers, maximum voluntary contraction and rapid force generation of the upper Trapezius was not influenced by clinically relevant self-reported pain or the presence of diagnostically relevant MFTrPs. Dry needling, deep or superficial...

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

    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.

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

    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.

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

    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

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

    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. Effects of 12 weeks muscle hipetrophy training program in a young male athlete: stydy case

    Giacchi Legarra, Mikel

    2014-01-01

    PURPOSE: The main goals of the present study were: 1) to review some recommendations about how to increase lean body mass; 2) to analyse whether following scientific sources of current recommendations, visible changes can be shown or not in a participant (body composition, strength and blood analyses). METHODS: One male athlete completed 12 weeks of resistance training program and following a diet protocol. Some test were determined such as, strength 6RM, blood analyses, skindfold measurem...

  17. The Danish Alzheimer intervention study

    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

    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.

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

    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 (P<0.001) for the number of CD56+ cells per fiber (L: from 0.11 ± 0.02 to 0.13 ± 0.03; H: from 0.12 ± 0.03 to 0.15 ± 0.05, mean ± SD). The finding that 12 weeks of training skeletal muscle even with very light loads can induce an increase in the number of satellite...

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

    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

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

    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. Pentalogy of Cantrell accompanied by scoliosis and pes equinovarus deformity at 12 weeks gestation.

    Pekin, A Tazegül; Kerimoğlu, O Seçilmiş; Yilmaz, S A; Kebapcilar, A G; Bakbak, B Gencoğlu; Celik, C

    2015-01-01

    Cantrell's pentalogy (CP) is a rare syndrome characterized by defects in the lower sternum with ectopia cordis, anterior diaphragm defects, midline supraumbilical abdominal wall defects, defects in the diaphragmatic pericardium, and congenital heart disease. The authors report a 12-weeks gestation with multiple fetal anomalies suggesting the diagnosis of CP (a large thoraco-abdominal defect with herniating liver and bowel, heart deviated anteriorly with concomitant ventricular septal defect), and the 'S' shaped fetal spine due to increased lumbar lordosis and scoliosis with accompanying pes equinovarus deformity. Chorionic villus sampling was performed due to increased nuchal translucency (3.7 mm). The fetal karotype was found to be 47, XX,+21 (trisomy 21). In the literature, three scoliosis cases have been reported accompanying the CP along with multiple anomalies and one concomitant pes equinovarus deformity has been reported previously. PMID:26152022

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

    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.

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

    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.

  6. Sustained improvements in fitness and exercise tolerance in obese adolescents after a 12 week exercise intervention.

    Gow, Megan L; van Doorn, Nancy; Broderick, Carolyn R; Hardy, Louise L; Ho, Mandy; Baur, Louise A; Cowell, Chris T; Garnett, Sarah P

    2016-01-01

    A 12 week exercise program was evaluated for its effect on aerobic fitness, anaerobic threshold, physical activity and sedentary behavior levels in obese insulin resistant adolescents post intervention and at follow up. 111 obese insulin resistant 10-17 year olds were recruited to a 12 month lifestyle intervention, known as RESIST. From months 4 to 6, adolescents participated in supervised exercise sessions twice per week (45-60min/session). Aerobic fitness and anaerobic threshold were measured by gas analysis at baseline, 6 months (post intervention) and 12 months (follow up). Self-reported physical activity and sedentary behavior was measured using the CLASS questionnaire. At 6 months aerobic fitness and time to reach the anaerobic threshold had improved by 5.8% [95% CI: 0.8-11.3] and 19.7% [95% CI: 10.4-29.0], respectively compared with baseline. These improvements were maintained at 12 months. Compared to baseline, 6 month physical activity levels increased by 19min/day [95% CI: 5-33] and screen time decreased by 49min/day [95% CI: 23-74] but returned to baseline levels by 12 months. Improved fitness and anaerobic threshold can be sustained up to 6 months following completion of an exercise program possibly enhancing capacity to perform daily functional tasks. PMID:25959765

  7. Predictors of adherence to a 12-week exercise program among men treated for prostate cancer: ENGAGE study.

    Craike, Melinda; Gaskin, Cadeyrn J; Courneya, Kerry S; Fraser, Steve F; Salmon, Jo; Owen, Patrick J; Broadbent, Suzanne; Livingston, Patricia M

    2016-05-01

    Understanding the factors that influence adherence to exercise programs is necessary to develop effective interventions for people with cancer. We examined the predictors of adherence to a supervised exercise program for participants in the ENGAGE study - a cluster randomized controlled trial that assessed the efficacy of a clinician-referred 12-week exercise program among men treated for prostate cancer. Demographic, clinical, behavioral, and psychosocial data from 52 participants in the intervention group were collected at baseline through self-report and medical records. Adherence to the supervised exercise program was assessed through objective attendance records. Adherence to the supervised exercise program was 80.3%. In the univariate analyses, cancer-specific quality of life subscales (role functioning r = 0.37, P = 0.01; sexual activity r = 0.26, P = 0.06; fatigue r = -0.26, P = 0.06, and hormonal symptoms r = -0.31, P = 0.03) and education (d = -0.60, P = 0.011) were associated with adherence. In the subsequent multivariate analysis, role functioning (B = 0.309, P = 0.019) and hormonal symptoms (B = -0.483, P = 0.054) independently predicted adherence. Men who experienced more severe hormonal symptoms had lower levels of adherence to the exercise program. Those who experienced more positive perceptions of their ability to perform daily tasks and leisure activities had higher levels of adherence to the exercise program. Hormonal symptoms and role functioning need to be considered when conducting exercise programs for men who have been treated for prostate cancer. PMID:26872005

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

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

    2013-01-01

    The purpose of this study was to determine the effects of a 12 week conditioning programme involving speed, agility and quickness (SAQ) training and its effect on agility performance in young soccer players. Soccer players were randomly assigned to two groups: experimental group (EG; n = 66, body mass: 71.3 ± 5.9 kg; body height: 1.77 ± 0.07 m) and control group (CG; n = 66, body mass: 70.6 ± 4.9 kg; body height: 1.76 ± 0.06 m). Agility performance was assessed using field tests: Slalom; Slalom with ball; Sprint with 90° turns; Sprint with 90° turns with ball; Sprint with 180° turns; Sprint with backward and forward running; Sprint 4 x 5 m. Statistically significant improvements (p 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. Key pointsSAQ training appears to be an effective way of improving agility with and without the ball in young soccer playersSoccer coaches could use this training during pre-season and in-season trainingCompared with pre-training, there was a statistically significant improvement in all but one measure of agility, both with and without the ball after SAQ training. PMID:24149731

  9. 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.

    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 (Pantiaging. J Drugs Dermatol. 2016;15(6):750-758. PMID:27272084

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

    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

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

    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.

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

    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...

  13. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  14. 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

    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 ...

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

    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...

  16. Experiences of training-adherence in a 12 weeks home-based IMT program for individuals with COPD

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

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

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

    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 ...

  18. Quality assurance in non-interventional studies

    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

  19. Quality assurance in non-interventional studies.

    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

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

    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.

  1. The relation between anthropometric and physiological variables and bat velocity of high-school baseball players before and after 12 weeks of training.

    Szymanski, David J; Szymanski, Jessica M; Schade, Ryan L; Bradford, T Jason; McIntyre, Joseph S; DeRenne, Coop; Madsen, Nels H

    2010-11-01

    The purpose of this article was to investigate the relation between anthropometric and physiological variables to linear bat swing velocity (BV) of 2 groups of high-school baseball players before and after completing a 12-week periodized resistance exercise program. Participants were randomly assigned to 1 of 2 training groups using a stratified sampling technique. Group 1 (n = 24) and group 2 (n = 25) both performed a stepwise periodized resistance exercise program and took 100 swings a day, 3 d·wk-1, for 12 weeks with their normal game bat. Group 2 performed additional rotational and full-body medicine ball exercises 3 d·wk-1 for 12 weeks. Fourteen variables were measured or calculated before and after 12 weeks of training. Anthropometric and physiological variables tested were height, body mass, percent body fat, lean body mass (LBM), dominant torso rotational strength (DTRS) and nondominant torso rotational strength (NDTRS), sequential hip-torso-arm rotational strength measured by a medicine ball hitter's throw (MBHT), estimated 1 repetition maximum parallel squat (PS) and bench press (BP), vertical jump (VJ), estimated peak power, angular hip velocity (AHV), and angular shoulder velocity (ASV). The baseball-specific skill of linear BV was also measured. Statistical analysis indicated a significant moderately high positive relationship (p ≤ 0.05) between prelinear BV and pre-NDTRS for group 1, pre-LBM, DTRS, NDTRS, peak power, and ASV for group 2; moderate positive relationship between prelinear BV and preheight, LBM, DTRS, peak power, BP, PS, and ASV for group 1, preheight, body mass, MBHT, BP, and PS for group 2. Significantly high positive relationships were indicated between postlinear BV and post-NDTRS for group 1, post-DTRS and NDTRS for group 2; moderately high positive relationships between postlinear BV and post-LBM, DTRS, peak power, BP, and PS for group 1, postheight, LBM, VJ, peak power for group 2; moderate positive relationships between

  2. Good clinical practice in clinical interventional studies

    Pieterse, Herman; Diamant, Zuzana

    2014-01-01

    Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise ‘frequently asked questions’ format.While compliance to current rules and regulations is our mission, we also wish to play devil’s advocate attempting to translate the rules into sizeable chunks using a high dose of common sense.Keywords: clinical interventional studies; quality; safety; ...

  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

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

    2010-01-01

    We examined whether improvements in the performance and health profile of an intensive 12-week football intervention could be maintained with a reduced training frequency. Seventeen healthy untrained males completed the study. Ten subjects trained 2.4 times/week for 12 weeks and another 52 weeks ...

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

    Priya Selvaraj

    2012-01-01

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

  5. Differences in Maximum Upper and Lower Limb Strength in Older Adults After a 12 Week Intense Resistance Training Program

    Sousa, Nelson; Mendes, Romeu; Abrantes, Catarina; Sampaio, Jaime

    2011-01-01

    The purpose of this study was to identify differences in maximum strength after an intense strength training program, contrasting muscle groups from upper limbs versus lower limbs. The sample consisted of 10 healthy elderly males (age 73±6 years) with independent living. The training program lasted 12 weeks (3 × week, 50 to 80% of 1RM, 2–3 sets, 6 to 12 repetitions). Two muscle groups were analyzed: LOWER (sum of average values of three exercises for the lower limbs) and UPPER (sum of average...

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

    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...

  7. Changes in selected cardiorespiratory responses to exercise and in body composition following a 12-week aerobic dance programme.

    Williams, L D; Morton, A R

    1986-01-01

    Cardiorespiratory and body composition changes were evaluated in 25 sedentary females, aged 18 to 30 years, following 12 weeks of aerobic dance training (3 days a week, 45 min a session). Fifteen subjects, from the same population, comprised a control group: they maintained their normal activity and dietary habits over the course of the study. Analysis of variance of the values for selected cardiorespiratory responses revealed that the aerobic dance programme produced training effects in the experimental group. These training effects were indicated by significant improvements in O2 pulse, VE, heart rate and perceived exertion during submaximal exercise. Significant improvements were also noted in VO2 max, maximal O2 pulse, VE max, maximal heart rate and maximal running time on the treadmill. Additionally, increases in lean body mass and body density, together with decreases in percentage body fat and the sum of four skinfold thicknesses were found to be significant for the experimental group. No significant improvements in any of these variables were found for the control group. It was concluded that this 12-week aerobic dance programme was successful in promoting beneficial changes in cardiorespiratory fitness and body composition. PMID:3586112

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

    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

  9. The Effect of 12-Week Exercise with Omega-3 Supplement Consumption on Serum Level Changes of Adiponectin, Leptin, and Insulin in Girls

    F. Piroozan

    2015-07-01

    Full Text Available Introduction & Objective: Adiponectin and leptin are peptide hormones regulating the energy balance. Therefore, the present study aims to identify the possible mechanisms of the effect of omega-3 and aerobic exercise on the balance of these two hormones. Materials & Methods: 60 healthy young women with the average age of 23.4±1.8 and the average weight of 60.45±5.85 were randomly selected and divided into training, omega 3-training, omega-3 and control groups. A basketball training program was performed including specialized training 3 times a week for 90 minutes. During the 12 weeks of training, omega-3+exercise and omega -3 groups were fed a number of oral capsules of omega-3 every night. Blood samples were taken from the brachial vein. To analyze the data and determine the relationship, one way ANOVA and Tukey test and Pearson's correlation coefficient were used. Results: Significant differences in serum levels of adiponectin, leptin and insulin secretion in exercise, omega-3 and exercise+omega-3 groups were observed. However, there was a significant correlation between changes in serum levels of adiponectin, and leptin and insulin secretion was not observed in any of the groups. Conclusion: It seems that omega-3 fatty acid intake with exercise enhances fat metabolism and is helpful to regulate the secretion of adiponectin and leptin hormone.(Sci J Hamadan Univ Med Sci 2015; 22 (2: 129-136

  10. 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

    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.

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

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

    2013-01-01

    =38) or RW (N=34). Intestinal integrity was determined by measuring trans-epithelial resistance (TER) across a Caco-2 cell monolayer, following exposure to faecal water.Results:No significant differences in microbiota composition were observed between the two dietary groups; however, the whole...... 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......-grain intervention increased the relative abundance of Bifidobacterium compared to baseline, supporting a prebiotic effect of whole-grain wheat. Faecal water increased TER independent of dietary intervention, indicating that commensal bacteria produce metabolites that generally provide a positive effect on...

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

    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...... need for AMPK to control energy turnover during exercise. Thus, the remaining ¿3-associated AMPK activation by acute exercise after exercise training might be sufficient to maintain cellular energy balance....

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

    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.

  14. Quality assurance in non-interventional studies

    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...

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

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

    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

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

    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.

  18. 39-week toxicity and toxicokinetic study of ponezumab (PF-04360365) in cynomolgus monkeys with 12-week recovery period.

    Freeman, Gary B; Lin, John C; Pons, Jaume; Raha, Nancy M

    2012-01-01

    Ponezumab (PF-04360365) is a novel humanized IgG2Δa monoclonal antibody that binds to amyloid-β (Aβ). It is designed to have reduced immune effector function compared to other passive immunotherapies for Alzheimer's disease (AD). Toxicity was evaluated in cynomolgus monkeys treated intravenously with vehicle or 10, 30, or 100 mg/kg of ponezumab every 10th day for up to 39 weeks, and after a 12-week recovery phase. The Aβ peptide sequence of monkeys is identical to that of humans. No substantial difference in test article exposure between sexes was observed, and mean plasma Cmax and AUC0-n were approximately dose-proportional. Ponezumab was detectable approximately 9 weeks after cessation of dosing. All animals, except two males given 10 mg/kg, maintained exposure to test article. One of these males tested positive for anti-ponezumab antibodies. Ponezumab was detected in the cerebrospinal fluid (CSF) of animals given active treatment. The estimated CSF/plasma ponezumab concentration ratio was AUC basis, respectively, than human exposures at the highest dose (10 mg/kg) in a single-dose Phase I trial. These data suggest an acceptable safety profile for ponezumab as an immunotherapy for AD. PMID:22045481

  19. A 12-week after-school physical activity programme improves endothelial cell function in overweight and obese children: a randomised controlled study

    Park Jong-Hwan

    2012-07-01

    Full Text Available Abstract Background Endothelial dysfunction is associated with childhood obesity and is closely linked to the amount and function of endothelial progenitor cells. However, it remains unclear whether endothelial progenitor cells increase with after-school exercise in overweight and obese children. The purpose of this study was to investigate the effects of an after-school exercise programme on endothelial cell function in overweight and obese children. Methods A total of 29 overweight/obese children (12.2 ± 0.1 years were randomly divided into control (i.e. no after-school exercise, n = 14 and after-school exercise (n = 15 groups. The 12-week after-school exercise intervention consisted of 3 days of combined aerobic and resistance exercise per week. Each 80-minute exercise programme included 10 minutes of warm-up and 10 minutes of cool-down after school. CD34+ (a cell surface marker on hematopoietic stem cells, CD133+ (a cell surface marker on hematopoietic progenitor cells and CD34+/CD133+ (considered as endothelial progenitor cells were measured at baseline and after 12 weeks using flow cytometry. Results Increased percentages of CD34+, CD133+ and CD34+/CD133+ cells were observed in the after-school exercise group (p = 0.018; p = 0.001; p = 0.002, respectively compared with the control group. Carotid intima-media thickness decreased after 12 weeks in the after-school exercise group (p = 0.020 compared with the control group. Conclusions This study provides preliminary evidence that a combined after-school exercise programme may represent an effective intervention strategy for improving vascular repair and endothelial cell function, leading to improved cardiovascular health in overweight and obese children. Trial registration Current Controlled Trials ISRCTN19037201

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

    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

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

    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

  2. Trichloroethylene and trichloroethanol-induced formic aciduria and renal injury in male F-344 rats following 12 weeks exposure

    Trichloroethylene (TCE) is widely used as a cleaning and decreasing agent and has been shown to cause liver tumours in rodents and a small incidence of renal tubule tumours in male rats. The basis for the renal tubule injury is believed to be related to metabolism of TCE via glutathione conjugation to yield the cysteine conjugate that can be activated by the enzyme cysteine conjugate β-lyase in the kidney. More recently TCE and its major metabolite trichloroethanol (TCE-OH) have been shown to cause formic aciduria which can cause renal injury after chronic exposure in rats. In this study we have compared the renal toxicity of TCE and TCE-OH in rats to try and ascertain whether the glutathione pathway or formic aciduria can account for the toxicity. Male rats were given TCE (500 mg/kg/day) or TCE-OH at (100 mg/kg/day) for 12 weeks and the extent of renal injury measured at several time points using biomarkers of nephrotoxicity and prior to termination assessing renal tubule cell proliferation. The extent of formic aciduria was also determined at several time points, while renal pathology and plasma urea and creatinine were determined at the end of the study. TCE produced a very mild increase in biomarkers of renal injury, total protein, and glucose over the first two weeks of exposure and increased Kim-1 and NAG in urine after 1 and 5 weeks exposure, while TCE-OH did not produce a consistent increase in these biomarkers in urine. However, both chemicals produced a marked and sustained increase in the excretion of formic acid in urine to a very similar extent. The activity of methionine synthase in the liver of TCE and TCE-OH treated rats was inhibited by about 50% indicative of a block in folate synthesis. Both renal pathology and renal tubule cell proliferation were reduced after TCE and TCE-OH treatment compared to controls. Our findings do not clearly identify the pathway which is responsible for the renal toxicity of TCE but do provide some support for

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

    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.

  4. 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.

    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.

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

    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.

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

    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.

  7. Irisin and FNDC5: effects of 12-week strength training, and relations to muscle phenotype and body mass composition in untrained women

    Ellefsen, Stian; Vikmoen, Olav; Slettaløkken, Gunnar; Whist, Jon Elling; Nygård, Håvard; Hollan, Ivana; Rauk, Irene; Vegge, Geir; Strand, Tor A.; Raastad, Truls; Rønnestad, Bent

    2014-01-01

    Purpose: To investigate the effects of strength training on abundances of irisin-related biomarkers in skeletal muscle and blood of untrained young women, and their associations with body mass composition, muscle phenotype and levels of thyroid hormones. Methods: Eighteen untrained women performed 12 weeks of progressive whole-body heavy strength training, with measurement of strength, body composition, expression of irisin-related genes (FNDC5 and PGC1α) in two different skeletal muscles,...

  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

    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...

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

    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...

  10. A cross-cultural comparison of the development of the social smile: a longitudinal study of maternal and infant imitation in 6- and 12-week-old infants.

    Wörmann, Viktoriya; Holodynski, Manfred; Kärtner, Joscha; Keller, Heidi

    2012-06-01

    Social smiling is universally regarded as being an infant's first facial expression of pleasure. Underlying co-constructivist emotion theories are the assumptions that the emergence of social smiling is bound to experiences of face-to-face interactions with caregivers and the impact of two developmental mechanisms--maternal and infant imitation. We analyzed mother-infant interactions from two different socio-cultural contexts and hypothesized that cross-cultural differences in face-to-face interactions determine the occurrence of both of these mechanisms and of the frequency of social smiling by 12-week-old infants. Twenty mother-infant dyads from a socio-cultural community with many face-to-face interactions (German families, Münster) were compared with 24 mother-infant dyads from a socio-cultural community with few such interactions (rural Nso families, Cameroon) when the infants were aged 6 and 12 weeks. When infants were 6 weeks old, mothers and their infants from both cultural communities smiled at each other for similar (albeit very short) amounts of time and used imitated each other's smiling similarly rarely. In contrast, when infants were 12 weeks old, mothers and their infants from Münster smiled at and imitated each other more often than did Nso mothers and their infants. PMID:22721734

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

    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

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

    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 ...

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

    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...

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

    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.

  15. 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

    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...

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

    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

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

    Lee, Bo Ra; Ko, Yu Mi; Cho, Mi Hee; Yoon, Young Ran

    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 were asked on their dietary habit, bowel habit and stress measurement. After 12 weeks, reduction of BMI (kg/m2) 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

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

    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

  19. Using computers to teach listening skills: an intervention study

    Cain, T

    2010-01-01

    This report details an intervention study that I undertook with a group of students and their teacher in a Secondary school in England. 14-15 year old students were systematically taught several strategies for improving their listening skills, including using computers. Pre- and post- tests show a marked increase in scores. However, qualitative data show that students used haphazard approaches, rather than the systematic approach they were taught. This study suggests that intervention studies...

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

    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…

  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

    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. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12weeks.

    Martel, Céline; Labrie, Fernand; Archer, David F; Ke, Yuyong; Gonthier, Renaud; Simard, Jean-Nicolas; Lavoie, Lyne; Vaillancourt, Mario; Montesino, Marlene; Balser, John; Moyneur, Érick

    2016-05-01

    This study integrates all data obtained in women aged 40-80years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5mg) dehydroepiandrosterone (DHEA; prasterone) for 12weeks (n=723; ITT-S population) as compared with placebo (n=266; ITT-S population). To this end, serum steroid levels (DHEA, DHEA-sulfate (DHEA-S), androst-5-ene-3β, 17β-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17β-diol 17-glucuronide (3α-diol-17G)) were measured at Day 1 and Week 12 by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following validation performed according to the FDA guidelines [1-6]. In agreement with the mechanisms of intracrinology where DHEA is exclusively transformed intracellularly into active sex steroids which act and are inactivated locally before being released as glucuronided or sulfated metabolites for elimination by the kidneys and liver, all sex steroids remained well within normal postmenopausal values following administration of intravaginal DHEA. Serum estradiol, the most relevant sex steroid, was measured after 12weeks of treatment at 3.36pg/ml (cITT-S population) or 19% below the normal postmenopausal value of 4.17pg/ml. On the other hand, serum E1-S, the best recognized marker of global estrogenic activity, shows an average value of 209pg/ml at 12 weeks compared to 220pg/ml in normal postmenopausal women. Moreover, serum ADT-G, the main metabolite of androgens, also remains well within normal postmenopausal values. The present data shows that a low daily intravaginal dose (6.5mg) of DHEA (prasterone) which is efficacious on the symptoms and signs of VVA, permits to achieve the desired local efficacy without systemic exposure, in agreement with the stringent mechanisms of menopause established after 500 million years of

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

    Hove, K D; Brøns, C; Færch, K;

    2015-01-01

    helveticus on BP, glycaemic control and cardiovascular risk factors in T2D. DESIGN: A randomised, double-blinded, prospective, placebo-controlled study. METHODS: In one arm of a factorial study design, 41 patients with T2D were randomised to receive 300 ml milk fermented with L. helveticus (Cardi04 yogurt......) (n=23) or 300 ml artificially acidified milk (placebo yogurt) (n=18) for 12 weeks. BPs were measured over 24-h, and blood samples were collected in the fasting state and during a meal test before and after the intervention. RESULTS: Cardi04 yogurt did not reduce 24-h, daytime or nighttime systolic...... or diastolic BPs compared with placebo (P>0.05). Daytime and 24-h heart rate (HR) were significantly reduced in the group treated by Cardi04 yogurt compared with the placebo group (P

  4. Exercise-training intervention studies in competitive swimming.

    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

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

    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.

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

    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…

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

    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.

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

    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

  9. 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.

    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.

  10. 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

    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.

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

    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

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

    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.

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

    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

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

    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.

  15. Liquid versus gel handrub formulation: a prospective intervention study

    Traore, Ousmane; Hugonnet, Stephane; Lubbe, Jann; Griffiths, William; Pittet, Didier

    2007-01-01

    INTRODUCTION: Hand hygiene is one of the cornerstones of the prevention of health care-associated infection, but health care worker (HCW) compliance with good practices remains low. Alcohol-based handrub is the new standard for hand hygiene action worldwide and usually requires a system change for its successful introduction in routine care. Product acceptability by HCWs is a crucial step in this process. METHODS: We conducted a prospective intervention study to compare the impact on HCW comp...

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

    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...

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

    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

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

    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

  19. Development of opioid-induced constipation: post hoc analysis of data from a 12-week prospective, open-label, blinded-endpoint streamlined study in low-back pain patients treated with prolonged-release WHO step III opioids

    Ueberall MA

    2015-08-01

    vs OXY and MOR despite a significantly higher use of laxatives with the latter ones (P<0.001. The percentage of patients who maintained normal BFI scores despite opioid treatment was 54.5% (164/301 with OXN and was significantly superior to those seen with OXY (32.8% [98/300] (odds ratio [OR]: 2.47, 95% confidence interval [CI]: 1.77–3.44; P<0.001 or MOR (29.7% [89/300] (OR: 2.84, 95% CI: 2.03–3.97; P<0.001. Absolute BFI changes of ≥12mm 100 mm horizontal visual analog scale (VAS100 vs. baseline were seen for OXN in 41.4%, for OXY in 68.7%, and for MOR in 72.3%. Complete spontaneous bowel movements decreased at least by one per week in 10.3% with OXN vs 42.3% for OXY (OR: 6.39, 95% CI 4.13–9.89; P<0.001 and 42.0% for MOR (OR: 6.31, 95% CI: 4.08–9.76; P<0.001. Overall, 359 treatment emergent adverse events (78 [OXN], 134 [OXY], and 147 [MOR] in 204 patients (41 [OXN], 80 [OXY], and 83 [MOR] occurred, most affecting the gastrointestinal (49.3% and the nervous system (39.3%. Treatment contrasts between randomized vs nonrandomized patients were insignificant.Conclusion: In this post hoc analysis of data from a real-life 12-week study, OXN treatment was associated with a significantly lower risk of opioid-induced constipation, superior tolerability, and significantly better analgesic efficacy compared with OXY and MOR. Keywords: chronic pain, bowel function, quality of life

  20. Effects of feeding transgenic corn with mCry1Ac or maroACC gene to laying hens for 12 weeks on growth, egg quality and organ health.

    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

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

    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

  2. Effectiveness of a Physical Activity Intervention for Head Start Preschoolers: A Randomized Intervention Study

    Bellows, Laura L.; Davies, Patricia L.; ANDERSON, JENNIFER; Kennedy, Catherine

    2013-01-01

    OBJECTIVES. The level of children’s motor skill proficiency may be an important determinant of their physical activity behaviors. This study assessed the efficacy of an intervention on gross motor skill performance, physical activity, and weight status of preschoolers.

  3. Paediatric Early Warning Score - A multi-center randomized controlled intervention study

    Jensen, Claus Sixtus; Aagaard, Hanne; Olesen, Hanne Vebert; Kirkegaard, Hans

    group interview. Development and implementation of PEWS is expected to contribute to reduce the number of children developing acute critical illness, number of admissions to intensive care. PEWS is also expected to contribute to increase professional skills and competences in health professionals. It is...

  4. The Effect of 12-Week Exercise with Omega-3 Supplement Consumption on Serum Level Changes of Adiponectin, Leptin, and Insulin in Girls

    F. Piroozan; f Daryanoosh; H. Jafari; m Sherafati Moghadam

    2015-01-01

    Introduction & Objective: Adiponectin and leptin are peptide hormones regulating the energy balance. Therefore, the present study aims to identify the possible mechanisms of the effect of omega-3 and aerobic exercise on the balance of these two hormones. Materials & Methods: 60 healthy young women with the average age of 23.4±1.8 and the average weight of 60.45±5.85 were randomly selected and divided into training, omega 3-training, omega-3 and control groups. A basketball training program wa...

  5. Whole Grain Compared with Refined Wheat Decreases the Percentage of Body Fat Following a 12-Week, Energy-Restricted Dietary Intervention in Postmenopausal Women

    Kristensen, Mette; Toubro, Søren; Jensen, Morten Georg;

    2012-01-01

    intervention diets. Body weight decreased significantly from baseline in both the RW (–2.7 ± 1.9 kg) and WW (–3.6 ± 3.2 kg) groups, but the decreases did not differ between the groups (P = 0.11). The reduction in body fat percentage was greater in the WW group (–3.0%) than in the RW group (–2.1%) (P = 0.......04). Serum total and LDL cholesterol increased by approximately 5% (P <0.01) in the RW group but did not change in the WW group; hence, the changes differed between the groups (P = 0.02). In conclusion, consumption of whole-grain products resulted in a greater reduction in the percentage fat mass, whereas...... whole-grain wheat (WW) for 12 wk on body weight and composition after a 2-wk run-in period of consumption of RW-containing food intake. In this open-label randomized trial, 79 overweight or obese postmenopausal women were randomized to an energy-restricted diet (deficit of approximately 1250 kJ/d) with...

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

    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.

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

    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.

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

    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

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

    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

  10. 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

    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

  11. Omega-3 Fatty Acid Supplementation for 12 Weeks Increases Resting and Exercise Metabolic Rate in Healthy Community-Dwelling Older Females.

    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.

  12. 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

    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...

  13. 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

    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...

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

    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

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

    Jensen, Olaf Chresten

    Introduction Intervention studies in public- and occupational health on chronic non-infectious diseases have been increasingly used. Also in the maritime health area, intervention studies have been done and some are on the way. The intervention methods are most often counselling or education...

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

    Lanzini, Pietro; Thøgersen, John

    2014-01-01

    environmentally relevant behaviours and after a six weeks intervention period where they were requested to keep track of their purchases by means of a shopping diary they answered a second survey with the same content as the first. This allowed us to analyse the change in self-reported pro- environmental......-environmental 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......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...

  17. Dietary Antioxidants and Melanoma: Evidence from Cohort and Intervention Studies.

    Miura, Kyoko; Green, Adèle C

    2015-01-01

    Melanoma is the most serious form of skin cancer affecting mostly people of Caucasian origin and is associated with high exposure to solar ultraviolet (UV) radiation. Antioxidants in the diet are thought to prevent UV-induced DNA damage and oxidative stress and laboratory-based studies have shown that high antioxidant intakes inhibit melanoma development. Corresponding epidemiological evidence is inconsistent, however. We therefore reviewed results from prospective observational studies and randomized controlled trials (RCTs) to clarify whether consumption of antioxidant vitamin C, E (tocopherol), and A (retinol), carotenoids and selenium, as food, supplements, or both, or high fruit and vegetable intake, reduce the incidence of cutaneous melanoma. A total of 9 studies (2 cohort, 1 nested case-control, 6 RCTs) were included. Neither antioxidant nutrients, individually or combined, nor fruit and vegetable intake showed any strong and significant associations with melanoma, though the number of relevant studies was limited and several had methodological shortcomings. In particular, melanoma was not a primary disease outcome in any of the RCTs and therefore, none adequately accounted for potential confounding by sun exposure. In conclusion, available evidence is currently inadequate to assess possible beneficial effects of antioxidant intake on melanoma risk. PMID:26147450

  18. Quality of life after self-management cancer rehabilitation: A randomized controlled trial comparing physical and cognitive-behavioral training versus physical training

    Korstjens, Irene; May, Anne; van Weert, Ellen; Mesters, Ilse; Tan, Frans; Ros, Wynand; Hoekstra-Weebers, Josette; van der Schans, Cees; Borne, Bart

    2008-01-01

    textabstractObjective: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitivebehavioral training (once weekly) with those of a 12-week group-based physical training (twice weekly). In addition, both interventions were compared with no intervention. Methods: Participants (all cancer types, medical treatment co...

  19. Randomized controlled trial of traditional Chinese medicine (acupuncture and Tuina) in cerebral palsy: Part 1 - Any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group?

    Wu, Y; Zou, LP; Han, TL; Zheng, H.; Caspi, O; Wong, V; Su, Y.; Shen, KL

    2008-01-01

    Objective: The objective of this study was to observe for any change in baseline seizure frequency with acupuncture in children with cerebral palsy. Methods: A randomized controlled study was conducted: Group I consisted of integrated acupuncture, tuina, and rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks; and Group II consisted of rehabilitation (physiotherapy, occupational therapy, and hydrotherapy) for 12 weeks. After a washout period of 4 weeks, Group I...

  20. Taking a Low Glycemic Index Multi-Nutrient Supplement as Breakfast Improves Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial

    Di Li

    2014-12-01

    Full Text Available 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.

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

    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

  2. Dietary arginine and linear growth: the Copenhagen School Child Intervention Study.

    van Vught, Anneke J A H; Dagnelie, Pieter C; Arts, Ilja C W; Froberg, Karsten; Andersen, Lars B; El-Naaman, Bianca; Bugge, Anna; Nielsen, Birgit M; Heitman, Berit L

    2013-03-28

    The amino acid arginine is a well-known growth hormone (GH) stimulator and GH is an important modulator of linear growth. The aim of the present study was to investigate the effect of dietary arginine on growth velocity in children between 7 and 13 years of age. Data from the Copenhagen School Child Intervention Study during 2001-2 (baseline), and at 3-year and 7-year follow-up, were used. Arginine intake was estimated via a 7 d precoded food diary at baseline and 3-year follow-up. Data were analysed in a multilevel structure in which children were embedded within schools. Random intercept and slopes were defined to estimate the association between arginine intake and growth velocity, including the following covariates: sex; age; baseline height; energy intake; puberty stage at 7-year follow-up and intervention/control group. The association between arginine intake and growth velocity was significant for the third and fourth quintile of arginine intake (2.5-2.8 and 2.8-3.2 g/d, respectively) compared with the first quintile ( < 2.2 g/d) (P for trend = 0.04). Protein intake (excluding arginine) was significantly associated with growth velocity; however, the association was weaker than the association between arginine intake and growth velocity (P for trend = 0.14). The results of the present study suggest a dose-dependent physiological role of habitual protein intake, and specifically arginine intake, on linear growth in normally growing children. However, since the study was designed in healthy children, we cannot firmly conclude whether arginine supplementation represents a relevant clinical strategy. Further research is needed to investigate whether dietary arginine may represent a nutritional strategy potentially advantageous for the prevention and treatment of short stature. PMID:23046689

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

    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...

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

    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…

  5. Supervised Home Training of Dialogue Skills in Chronic Aphasia: A Randomized Parallel Group Study

    Nobis-Bosch, Ruth; Springer, Luise; Radermacher, Irmgard; Huber, Walter

    2011-01-01

    Purpose: The aim of this study was to prove the efficacy of supervised self-training for individuals with aphasia. Linguistic and communicative performance in structured dialogues represented the main study parameters. Method: In a cross-over design for randomized matched pairs, 18 individuals with chronic aphasia were examined during 12 weeks of…

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

    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…

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

    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…

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

    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…

  9. 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)

    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.

  10. A preliminary, randomized trial of aerobic exercise for alcohol dependence

    Brown, Richard A.; Abrantes, Ana M.; Minami, Haruka; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John M.; Strong, David R.; Dubreuil, Mary Ella; Gordon, Alan A.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory L.

    2014-01-01

    Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relative untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n = 25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Further...

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

    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

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

    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

  13. 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

    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.

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

    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...

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

    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 of...

  16. Experimental Intervention Studies on Word Problem Solving and Math Disabilities: A Selective Analysis of the Literature

    Zheng, Xinhua; Flynn, Lindsay J.; Swanson, H. Lee

    2013-01-01

    This article provides a quantitative synthesis of the published literature on word problem solving intervention studies for children with math disabilities (MD). Seven group and eight single-subject design studies met inclusion criteria. Mean effect sizes ("ES"s) for solution accuracy for group design studies were 0.95 (SE = 0.19) for children…

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

    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

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

    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

  19. Randomization tests

    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

  20. 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

    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

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

    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…

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

    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

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

    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

  4. Alcohol Use and Stress in University Freshmen - A Comparative Intervention Study of Two Universities

    Andersson, Claes

    2009-01-01

    Starting university is associated with major academic, personal and social opportunities. For many people, university entrance is also associated with increased stress and alcohol consumption. At the start of the autumn term 2002, all students entering educational programmes at two comparable middle-sized Swedish universities were invited to participate in a comparative intervention study. This included both primary and secondary interventions targeting hazardous drinking and stress. The over...

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

    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...

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

    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...

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

    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

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

    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...

  9. Deconstructing Supermarket Interventions as a Mechanism for Improving Diet: Lessons from the Seacroft Intervention Study

    Rudkin, Simon

    2015-01-01

    Supermarkets, with vast product ranges and relatively low prices, are an established solution to problems of availability of healthy foodstuffs in areas of limited retail access. However, where they may indeed raise consumption of desirable goods they also open up new opportunities to buy less healthful items for less, a situation which potentially undermines their ability to improve diet. Using under-reported diary data from the Seacroft Intervention Study in the United Kingdom takes this pa...

  10. Educating the clinical trainer: professional gain for the trainee? A controlled intervention study in general practice

    Jochemsen-van der Leeuw, H.G.A. Ria; van Dijk, Nynke; de Jong, Wilfried; Wieringa-de Waard, Margreet

    2014-01-01

    The aim of this study was to establish whether a ‘teach-the-trainer’ course leads to improvements in, firstly, the knowledge and attitude of clinical trainers and their trainees, and, secondly, the role model behaviour of the clinical trainers. A controlled intervention study was performed with GP trainers and GP trainees from four training institutes in the Netherlands. Clinical trainers in the two intervention institutes received two 3-h training sessions on weight management, focusing on k...

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

    Ayşegül Şükran Öz

    2013-01-01

    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 fo...

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

    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...

  13. The Efficacy of Teaching hand Hygiene to Medical students: An Interventional Study

    Rita Rezaee; Mina Danaei; Mehrdad Askarian

    2014-01-01

    Hand hygiene is one of the most important measures to prevent and reduce the incidence of hospital-associated infections. The main objective of this study was to determine the effect of an educational program on medical students’ knowledge, attitude and compliance with hand hygiene at Shiraz University of Medical Sciences. All medical students who had passed physiopathology courses were selected to participate in this interventional study. A baseline self-reported questionnaire was distribute...

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

    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...

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

    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...

  16. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis

    Pariser, David; Schenkel, Brad; Carter, Chureen; Farahi, Kamyar; Brown, T Michelle; Charles N. Ellis; ,

    2015-01-01

    Abstract Background: Moderate to severe plaque psoriasis (with or without psoriatic arthritis) places significant burden on patients’ lives. Objective: Explore and document patients’ experiences of living with psoriasis, including symptoms, treatments, impact on daily lives and patient-reported functioning. Methods: In a US-based, non-interventional study, narrative interviews were conducted at baseline and again within 16 weeks. In interviews, patients with moderate to severe psoriasis indic...

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

    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...

  18. Random Walks on Random Graphs

    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.

  19. Random duality

    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.

  20. Random duality

    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.

  1. Retreatment With Varenicline for Smoking Cessation in Smokers Who Have Previously Taken Varenicline: A Randomized, Placebo-Controlled Trial

    Gonzales, D.; Hajek, P; Pliamm, L; Nackaerts, K; Tseng, L-J; McRae, T. D.; Treadow, J

    2014-01-01

    The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥10 cigarettes/day) with ≥1 prior quit attempt (≥2 weeks) using varenicline and no quit attempts in ≤3 months; they were randomly assigned (1:1) to 12 weeks' varen...

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

    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...

  3. 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

    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.

  4. An intervention study of oral cancer and precancer in rural Indian populations: a preliminary report

    1982-01-01

    A large-scale epidemiological study of oral cancer and precancer was initiated in 1966 in several regions of India. Phase 1 of the study consisted of a cross-section survey to determine the prevalence of cancer and precancerous lesions, while phase 2 was a 10-year follow-up survey to determine the incidence and natural history of oral precancer. Following these preliminary investigations, an intervention study was started to try to persuade subjects to give up tobacco, and to measure the subs...

  5. Workplace restructurings in intervention studies - a challenge for design, analysis and interpretation

    Olsen, Ole; Albertsen, Karen; Nielsen, Martin;

    2008-01-01

    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...

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

    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

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

    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

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

    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.

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

    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

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

    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

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

    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…

  12. Energy randomness

    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. Randomized random walk on a random walk

    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)

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

    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...

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

    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...

  16. The effect of antenatal exercise on women’s experience of labor: A randomized controlled trial

    Austad, Åshild; Forså, Marianne Inngjerdingen

    2013-01-01

    Objective: To assess whether following a standardized exercise program during pregnancy affects women’s experience of labor.Methods: 855 healthy pregnant women were randomized to an intervention or a control group. The intervention group followed a 12 weeks standardized exercise program between gestational weeks 20 and 36. The program included aerobic and strengthening exercises of moderate to high-intensity. The control group followed standard antenatal care. At inclusion and three months po...

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

    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...

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

    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...

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

    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...

  20. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients

    Lee, Eun Hee; Park, Ji-Eun; Choi, Young-Ju; Huh, Kap-Bum; Kim, Wha-Young

    2008-01-01

    Spirulina is a microscopic and filamentous cyanobacterium that contains essential amino acids, essential fatty acids, vitamins, minerals and anti-oxidative components. The purpose of this study was to examine effects of spirulina intervention in Korean patients with type 2 diabetes. The subjects were 37 type 2 diabetic patients who visited a diabetic clinic in Seoul and randomly assigned into spirulina (8 g/day) or control group. During the intervention period of 12 weeks, subjects were asked...

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

    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...

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

    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...

  3. Can life coaching improve health outcomes? - A systematic review of intervention studies

    Ammentorp, Jette; Uhrenfeldt, Lisbeth; Angel, Flemming;

    2013-01-01

    between health coaching and life coaching. In this review, we will only focus on the latter method and on that basis assess the health related outcomes of life coaching. METHODS Intervention studies using quantitative or qualitative methods to evaluate the outcome of the life coach interventions were...... limited number of solid studies, this review can only present tendencies for patient outcomes and a preliminary description of an effective life coaching intervention. The coaching method used in these studies aims to improve self-efficacy and self-empowerment. This may explain why the studies including......BACKGROUND In recent years, coaching has received special attention as a method to improve healthy lifestyle behaviours. The fact that coaching has found its way into healthcare and may provide new ways of engaging the patients and making them accountable for their health, justifies the need for an...

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

    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 <0.001). No effects of interventions on 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...

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

    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

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

    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

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

    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.

  8. 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

    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

  9. Clinical improvement after 6 weeks of eccentric exercise in patients with mid-portion Achilles tendinopathy - a randomized trial with 1-year follow-up.

    Roos, Ewa; Engström, Mikael; Lagerquist, Annika; Söderberg, Bengt

    2004-01-01

    Achilles tendinopathy is common and treatment with eccentric exercises seems promising. We designed a prospective randomized clinical trial to test the hypothesis that eccentric calf muscle exercises reduce pain and improve function in patients with Achilles tendinopathy. Forty-four patients were recruited from primary care (mean age: 45 years; 23 women; 65% active in sports) and randomized to three treatment groups for 12 weeks: eccentric exercises, a night splint or a combination of both tr...

  10. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial

    Cella, D; Ivanescu, C; Holmstrom, S.; Bui, C. N.; Spalding, J.; Fizazi, K.

    2014-01-01

    Background To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. Patients and methods Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study tre...

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

    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

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

    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

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

    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.

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

    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.

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

    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

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

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

    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, 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. PMID:27247949

  17. Educating the clinical trainer: professional gain for the trainee? A controlled intervention study in general practice.

    Jochemsen-van der Leeuw, H G A Ria; van Dijk, Nynke; de Jong, Wilfried; Wieringa-de Waard, Margreet

    2014-12-01

    The aim of this study was to establish whether a 'teach-the-trainer' course leads to improvements in, firstly, the knowledge and attitude of clinical trainers and their trainees, and, secondly, the role model behaviour of the clinical trainers. A controlled intervention study was performed with GP trainers and GP trainees from four training institutes in the Netherlands. Clinical trainers in the two intervention institutes received two 3-h training sessions on weight management, focusing on knowledge and attitudes towards obesity, and on conveying the correct professional competency as a positive role model for trainees. This was measured using questionnaires on knowledge, attitude, and role model behaviour (the role model apperception tool; RoMAT). GP trainers showed an increase in knowledge and several characteristics could be identified as being related to positive role model behaviour. A small correlation was found between the trainer's score on the RoMAT and the attitude of the trainee. A teach-the-trainer course in which knowledge, attitudes, and role modelling are integrated proved to be a first step toward improving the knowledge of clinical trainers, but did not result in a measurably better professional outcome for the trainee, maybe due to a more objective level of assessment. PMID:25338922

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

    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

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

    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.

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

    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.

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

    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.

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

    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.

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

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

    Zhao Peng

    2002-05-01

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

  5. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY)

    Sulkowski, Mark; Hezode, Christophe; Gerstoft, Jan;

    2015-01-01

    BACKGROUND: Both hepatitis C virus (HCV) mono-infected and HIV/HCV co-infected patients are in need of safe, effective, all-oral HCV regimens. In a phase 2 study we aimed to assess the efficacy and safety of grazoprevir (MK-5172; HCV NS3/4A protease inhibitor) and two doses of elbasvir (MK-8742...... (100 mg) plus elbasvir (50 mg) with or without ribavirin (arms B1-3) and HIV/HCV co-infected patients to 12 weeks of therapy with or without ribavirin. The primary endpoint was the proportion of patients achieving HCV RNA less than 25 IU/mL 12 weeks after end of treatment (SVR12). Randomisation was by...... (7/188, 4%) and was associated with emergence of resistance-associated variants to one or both drugs. The safety profile of grazoprevir plus elbasvir with or without ribavirin was similar in mono-infected and co-infected patients. No patient discontinued due to an adverse event or laboratory...

  6. A randomized study to establish the effects of spirulina in type 2 diabetes mellitus patients.

    Lee, Eun Hee; Park, Ji-Eun; Choi, Young-Ju; Huh, Kap-Bum; Kim, Wha-Young

    2008-01-01

    Spirulina is a microscopic and filamentous cyanobacterium that contains essential amino acids, essential fatty acids, vitamins, minerals and anti-oxidative components. The purpose of this study was to examine effects of spirulina intervention in Korean patients with type 2 diabetes. The subjects were 37 type 2 diabetic patients who visited a diabetic clinic in Seoul and randomly assigned into spirulina (8 g/day) or control group. During the intervention period of 12 weeks, subjects were asked to keep usual diet and prohibited to take any functional foods or dietary supplements. Spirulina supplementation for 12 weeks did not affect anthropometric parameters, however, lowered plasma triglycerides level significantly (pdiabetes. The results suggest that spirulina is a promising agent as a functional food for diabetes management. PMID:20016733

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

    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.

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

    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

    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

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

    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...

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

    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...

  13. Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes

    Courneya Kerry S; Plotnikoff Ronald C; Liebreich Tanis; Boulé Normand

    2009-01-01

    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...

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

    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...

  15. Effectiveness of Tai Chi on Physical and Psychological Health of College Students: Results of a Randomized Controlled Trial

    Zheng, Guohua; Lan, Xiulu; Li, Moyi; Ling, Kun; Lin, Hui; Chen, Lidian; Tao, Jing; Li, Junzhe; Zheng, Xin; Chen, Bai; Fang, Qianying

    2015-01-01

    Objective To investigate the effectiveness and safety of Tai Chi Chuan (TCC) on physical and psychological health of college students. Methods Two hundred six college students were recruited and randomly allocated to a control group or a TCC exercise group in an equal ratio. Participants in the control group were instructed to maintain their original activity level and those in the TCC exercise group received 12 weeks of TCC exercise training based on their original activity level. Physical a...

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

    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...

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

    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.

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

    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.

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

    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

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

    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.

  1. Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul F; Haghfelt, Torben; Hartvigsen, Jan

    2012-01-01

    ) 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...... chiropractic treatment at 4 weeks regarding the primary outcome of self-perceived change in chest pain and at 12 weeks with respect to the primary outcome of numeric change in pain intensity. CONCLUSIONS: To the best of our knowledge, this is the first randomized trial assessing chiropractic treatment vs...

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

    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…

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

    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.…

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

    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

  5. Comprehension Strategy Instruction during Parent-Child Shared Reading: An Intervention Study

    Roberts, Kathryn L.

    2013-01-01

    This study examined the effectiveness of a series of workshops and at-home activities designed to teach parents to integrate comprehension strategy instruction into read-alouds with their pre-kindergarten-aged children. Twenty parent-child dyads were randomly assigned to condition and parents in the experimental (workshop) condition were taught to…

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

    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

  7. Random magnetism

    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)

  8. Random matrices

    Eynard, Bertrand; Ribault, Sylvain

    2015-01-01

    We provide a self-contained introduction to random matrices. While some applications are mentioned, our main emphasis is on three different approaches to random matrix models: the Coulomb gas method and its interpretation in terms of algebraic geometry, loop equations and their solution using topological recursion, orthogonal polynomials and their relation with integrable systems. Each approach provides its own definition of the spectral curve, a geometric object which encodes all the properties of a model. We also introduce the two peripheral subjects of counting polygonal surfaces, and computing angular integrals.

  9. Random Decrement

    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...

  10. Random Decrement

    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...

  11. Random Decrement

    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...

  12. Random dynamics

    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.)

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

    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...

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

    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...

  15. Random Vibrations

    Messaro. Semma; Harrison, Phillip

    2010-01-01

    Ares I Zonal Random vibration environments due to acoustic impingement and combustion processes are develop for liftoff, ascent and reentry. Random Vibration test criteria for Ares I Upper Stage pyrotechnic components are developed by enveloping the applicable zonal environments where each component is located. Random vibration tests will be conducted to assure that these components will survive and function appropriately after exposure to the expected vibration environments. Methodology: Random Vibration test criteria for Ares I Upper Stage pyrotechnic components were desired that would envelope all the applicable environments where each component was located. Applicable Ares I Vehicle drawings and design information needed to be assessed to determine the location(s) for each component on the Ares I Upper Stage. Design and test criteria needed to be developed by plotting and enveloping the applicable environments using Microsoft Excel Spreadsheet Software and documenting them in a report Using Microsoft Word Processing Software. Conclusion: Random vibration liftoff, ascent, and green run design & test criteria for the Upper Stage Pyrotechnic Components were developed by using Microsoft Excel to envelope zonal environments applicable to each component. Results were transferred from Excel into a report using Microsoft Word. After the report is reviewed and edited by my mentor it will be submitted for publication as an attachment to a memorandum. Pyrotechnic component designers will extract criteria from my report for incorporation into the design and test specifications for components. Eventually the hardware will be tested to the environments I developed to assure that the components will survive and function appropriately after exposure to the expected vibration environments.

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

    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

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

    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

  18. A Facility Specialist Model for Improving Retention of Nursing Home Staff: Results from a Randomized, Controlled Study

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles, Jr.; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-01-01

    Purpose: This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. Design and Methods: We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and…

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

    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.

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

    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

  1. Implementation of a low-budget, lifestyle-improvement method in an ordinary primary healthcare setting: a stepwise intervention study

    Blomstrand, Ann; Ariai, Nashmil; Baar, Ann-Christine; Finbom-Forsgren, Britt-Marie; Thorn, Jörgen; Björkelund, Cecilia

    2012-01-01

    Objective To evaluate, in an ordinary primary healthcare setting, the effects of a screening questionnaire and a self-administered health profile dealing with special reference to the involvement of motivated individuals in need of lifestyle changes. Design Intervention study in a naturalistic context, using a screening questionnaire offered to consecutive patients, followed by a self-administered health profile and a health dialogue. Setting Hisingen primary healthcare area (130 033 inhabita...

  2. Effects of a One Year Intensive Multidisciplinary Rehabilitation Program for Patients with Huntington’s Disease: a Prospective Intervention Study

    Piira, Anu; van Walsem, Marleen R.; Mikalsen, Geir; Nilsen, Kjell Haavik; Knutsen, Synnove; Frich, Jan C.

    2013-01-01

    Objective: To assess the effects of an intensive, multidisciplinary rehabilitation program for patients with early to mid-stage Huntington’s disease. Design: A prospective intervention study. Setting: Two Norwegian inpatient rehabilitation centers. Subjects: 37 patients, with early- to midstage Huntington’s disease Interventions: A one year rehabilitation program, consisting of three admissions of three weeks each, and a five-day evaluation stay approximately 3 months after the last rehabilit...

  3. RANDOM LASSO.

    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

  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

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

    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

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

    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.

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

    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

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

    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

  9. Effect of Lepidium meyenii Walp. on Semen Parameters and Serum Hormone Levels in Healthy Adult Men: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

    Melnikovova, Ingrid; Fait, Tomas; Kolarova, Michaela; Fernandez, Eloy C.; Milella, Luigi

    2015-01-01

    Background/Aims. Products of Lepidium meyenii Walp. (maca) are touted worldwide as an alimentary supplement to enhance fertility and restore hormonal balance. Enhancing properties of maca on semen parameters in animals were previously reported by various authors, but we present to the best of our knowledge the first double-blind, randomized, placebo-controlled pilot trial in men. The aim of this study was to evaluate the effects of maca on semen parameters and serum hormone levels in healthy adult men. Methods. A group of 20 volunteers aged 20–40 years was supplied by milled hypocotyl of maca or placebo (1.75 g/day) for 12 weeks. Negative controls of semen were compared to the samples after 6 and 12 weeks of maca administration; negative blood controls were compared to the samples after 12 weeks of treatment. Results. Sperm concentration and motility showed rising trends compared to placebo even though levels of hormones did not change significantly after 12 weeks of trial. Conclusion. Our results indicate that maca possesses fertility enhancing properties in men. As long as men prefer to use alimentary supplement to enhance fertility rather than prescribed medication or any medical intervention, it is worth continuing to assess its possible benefits. PMID:26421049

  10. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger.

    Céline Langendorf

    2014-09-01

    Full Text Available BACKGROUND: Finding the most appropriate strategy for the prevention of moderate acute malnutrition (MAM and severe acute malnutrition (SAM in young children is essential in countries like Niger with annual "hunger gaps." Options for large-scale prevention include distribution of supplementary foods, such as fortified-blended foods or lipid-based nutrient supplements (LNSs with or without household support (cash or food transfer. To date, there has been no direct controlled comparison between these strategies leading to debate concerning their effectiveness. We compared the effectiveness of seven preventive strategies-including distribution of nutritious supplementary foods, with or without additional household support (family food ration or cash transfer, and cash transfer only-on the incidence of SAM and MAM among children aged 6-23 months over a 5-month period, partly overlapping the hunger gap, in Maradi region, Niger. We hypothesized that distributions of supplementary foods would more effectively reduce the incidence of acute malnutrition than distributions of household support by cash transfer. METHODS AND FINDINGS: We conducted a prospective intervention study in 48 rural villages located within 15 km of a health center supported by Forum Santé Niger (FORSANI/Médecins Sans Frontières in Madarounfa. Seven groups of villages (five to 11 villages were allocated to different strategies of monthly distributions targeting households including at least one child measuring 60 cm-80 cm (at any time during the study period whatever their nutritional status: three groups received high-quantity LNS (HQ-LNS or medium-quantity LNS (MQ-LNS or Super Cereal Plus (SC+ with cash (€38/month [US$52/month]; one group received SC+ and family food ration; two groups received HQ-LNS or SC+ only; one group received cash only (€43/month [US$59/month]. Children 60 cm-80 cm of participating households were assessed at each monthly distribution from August to

  11. A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia

    Tandon, Rajiv; Cucchiaro, Josephine; Phillips, Debra; Hernandez, David; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony

    2016-01-01

    Objective: To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia. Method: Adults experiencing an acute exacerbation of schizophrenia initially received 12–24 weeks of open-label treatment with lurasidone (40–80 mg/d, flexibly dosed). Patients who maintained clinical stability for ⩾12 weeks were randomized in double-blind fashion to placebo or lurasidone (40–80 mg/d, flexibly dosed) for an additional 28-week treatment period. The primary efficacy endpoint was t...

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

    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...

  13. A Multicenter, Randomized, Open-Labeled, Parallel Group Trial of Sildenafil in Alcohol-Associated Erectile Dysfunction: The Impact on Psychosocial Outcomes

    Alexander Grinshpoon; Ira Radomislensky; Lev Averbuch; Alexander M. Ponizovsky

    2009-01-01

    To examine the effect of sildenafil on erectile dysfunction (ED) and psychosocial outcomes in alcohol-dependent (AD) men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg) as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF) and a battery of self-report questionnaires. IIEF scores and psy...

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

    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

  15. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women.

    Choi, JiWon; Lee, Ji Hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2016-05-01

    Introduction Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Methods Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. Results On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. Discussion It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707. PMID:26649879

  16. The Impact of Different Degrees of Feedback on Physical Activity Levels: A 4-Week Intervention Study

    Karen Van Hoye

    2015-06-01

    Full Text Available Assessing levels of physical activity (PA and providing feedback about these levels might have an effect on participant’s PA behavior. This study discusses the effect of different levels of feedback—from minimal to use of a feedback display and coach—on PA over a 4-week intervention period. PA was measured at baseline, during and immediately after the intervention. Participants (n = 227 were randomly assigned to a Minimal Intervention Group (MIG-no feedback, Pedometer Group (PG-feedback on steps taken, Display Group (DG-feedback on steps, minutes of moderate to vigorous physical activity and energy expenditure or Coaching Group (CoachG-same as DG with need-supportive coaching. Two-way ANCOVA showed no significant Group × Time interaction effect for the different PA variables between the MIG and PG. Also no differences emerged between PG and DG. As hypothesized, CoachG had higher PA values throughout the intervention compared with DG. Self-monitoring using a pedometer resulted in more steps compared with a no-feedback condition at the start of the intervention. However, adding individualized coaching seems necessary to increase the PA level until the end of the intervention.

  17. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study.

    Lane, Andrew M; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J; Friesen, Andrew P; Beedie, Christopher J; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times-practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

  18. Brief Online Training Enhances Competitive Performance: Findings of the BBC Lab UK Psychological Skills Intervention Study

    Lane, Andrew M.; Totterdell, Peter; MacDonald, Ian; Devonport, Tracey J.; Friesen, Andrew P.; Beedie, Christopher J.; Stanley, Damian; Nevill, Alan

    2016-01-01

    In conjunction with BBC Lab UK, the present study developed 12 brief psychological skill interventions for online delivery. A protocol was designed that captured data via self-report measures, used video recordings to deliver interventions, involved a competitive concentration task against an individually matched computer opponent, and provided feedback on the effects of the interventions. Three psychological skills were used; imagery, self-talk, and if-then planning, with each skill directed to one of four different foci: outcome goal, process goal, instruction, or arousal-control. This resulted in 12 different intervention participant groups (randomly assigned) with a 13th group acting as a control. Participants (n = 44,742) completed a competitive task four times—practice, baseline, following an intervention, and again after repeating the intervention. Results revealed performance improved following practice with incremental effects for imagery-outcome, imagery-process, and self-talk-outcome and self-talk-process over the control group, with the same interventions increasing the intensity of effort invested, arousal and pleasant emotion. Arousal-control interventions associated with pleasant emotions, low arousal, and low effort invested in performance. Instructional interventions were not effective. Results offer support for the utility of online interventions in teaching psychological skills and suggest brief interventions that focus on increasing motivation, increased arousal, effort invested, and pleasant emotions were the most effective. PMID:27065904

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

    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

  20. 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

    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

  1. The associations between regional gray matter structural changes and changes of cognitive performance in control groups of intervention studies

    Hikaru Takeuchi

    2015-12-01

    Full Text Available In intervention studies of cognitive training, the challenging cognitive tests, which were used as outcome measures, are generally completed in more than a few hours. Here, utilizing the control groups’ data from three 1-week intervention studies in which young healthy adult subjects underwent a wide range of cognitive tests and T1-weighted magnetic resonance imaging (MRI before and after the intervention period, we investigated how regional gray matter (GM density (rGMD of the subjects changed through voxel-based morphometry (VBM. Statistically significant increases in rGMD were observed in the anatomical cluster that mainly spread around the bilateral dorsal anterior cingulate cortex (dACC and the right superior frontal gyrus (rSFG. Moreover, mean rGMD within this cluster changes were significantly and positively correlated with performance changes in the Stroop task, and tended to positively correlate with performance changes in a divergent thinking task. Affected regions are considered to be associated with performance monitoring (dACC and manipulation of the maintained information including generating associations (rSFG, and both are relevant to the cognitive functions measured in the cognitive tests. Thus, the results suggest that even in the groups of the typical “control group” in intervention studies including those of the passive one, experimental or non-experimental factors can result in an increase in the regional GM structure and form the association between such neural changes and improvements related to these cognitive tests. These results suggest caution toward the experimental study designs without control groups.

  2. Calcium Dobesilate in Symptomatic Treatment of Hemorrhoidal Disease: An Interventional Study

    Hiteshkumar D Patel

    2013-02-01

    Full Text Available Introduction: Hemorrhoidaldisease is one of the commonest ailments that affects mankind and is currently believed to be caused by distal displacement and structural distortion of anal cushions, which are physiologic structuresA randomized, double blind, controlled study was conducted to investigate the efficacy of oral and local calcium dobesilate therapy in treating acute attacks of internal hemorrhoids. Methods: fiftynine (59adult patients with first or second-degree internal hemorrhoids were treated with calcium dobesilate for six weeks, while 56 patients received only a high fiber diet to serve as control. Both symptoms and anoscopic inflammation were scored on a scale from 0 to 2 before and six weeks after treatment. Results: Asuccess rateof 83.05% percent with cessation of bleeding plus lack of severe anitis anoscopically at 6 weeks were achieved with calcium dobesilate. Thepretreatmentsymptoms score of 2 were fell significantly to 0.390.16 and the pretreatment anitis score of 1.730.12 fell to 0.590.17 at 6 weeks (p=0.0002 for both comparisons. The symptoms and anoscopic inflammation score obtained with calcium dobesilate therapy were also significantly better than those with diet only. (P=0.0016 and p=0.0014,respectively. Conclusions: oral as well as local calcium dobesilate treatment supplemented with diet and bowel habits discipline provides an effective, fast, and safe symptomatic relief from acute symptoms of Hemorrhoidal disease. This symptomatic relief is associated with significant improvement in anoscopically observed inflammation. [Natl J of Med Res 2013; 3(1.000: 42-44

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

    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

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

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

    2015-01-01

    Introduction  Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA) is a fatty acid that isproduced in many cells in the body, and it is thought to potentiate endocannabinoids. PEA is suggested to reduce pain and inflammation but....... 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...

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

    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...

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

    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.

  7. Adolescent Diet and Subsequent Serum Hormones, Breast Density and Bone Mineral Density in Young Women: Results of the Dietary Intervention Study in Children (DISC) Follow-Up Study

    Dorgan, Joanne F.; Liu, Lea; Klifa, Catherine; Hylton, Nola; Shepherd, John A.; Stanczyk, Frank Z.; Snetselaar, Linda G.; Van Horn, Linda; Stevens, Victor J.; Robson, Alan; Kwiterovich, Peter O.; Lasser, Norman L.; Himes, John H.; Gabriel, Kelley Pettee; Kriska, Andrea; Ruder, Elizabeth H.; Fang, Carolyn Y.; Barton, Bruce A.

    2010-01-01

    Background Adolescent diet is hypothesized to influence breast cancer risk. We evaluated the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults. Methods A follow-up study was conducted of 230 girls who participated in the Dietary Intervention Study in Children (DISC), in which healthy, prepubertal 8-10 year olds were randomly assigned to usual care or to a behavioral intervention that promoted a reduced fat diet. Participants were 25-29 years old at follow-up visits. All tests of statistical significance are two-sided. Results In analyses that did not take account of diet at the time of the follow-up visit, the only statistically significant treatment group difference was higher bone mineral content (BMC) in intervention group participants compared to usual care group participants; their mean BMCs were 2,444g and 2,377g, respectively. After adjustment for current diet, the intervention group also had statistically significantly higher bone mineral density and luteal phase serum estradiol concentrations. Serum progesterone concentrations and breast density did not differ by treatment group in unadjusted or adjusted analyses. Conclusion Results do not support the hypothesis that consumption of a lower fat diet during adolescence reduces breast cancer risk via effects on subsequent serum estradiol and progesterone levels, breast density or BMD. Impact Additional research is needed to clarify the association of adolescent diet with breast cancer risk and to determine if the results reported here are specific to the DISC intervention or more broadly applicable. PMID:20501774

  8. Trials and tribulations of conducting interventional studies in urban slums of a developing country: Experiences from Kolkata, India.

    Mahapatra, Tanmay; Mahapatra, Sanchita; Pal, Debottam; Saha, Jayanta; Lopez, AnnaLena; Ali, Mohammad; Bannerjee, Barnali; Manna, Byomkesh; Sur, Dipika; Bhattacharya, Sujit; Kanungo, Suman

    2016-01-01

    Experimental studies involving human subjects provide most internally valid evidences in epidemiological research due to their robust methodology. While conducting population-based interventional studies, to achieve external validity, inclusion of information from vulnerable groups like urban slum-dwellers of the developing world, in the epidemiological estimates is of paramount importance. The challenges faced while conducting 2 consecutive large-scale, community-based vaccine trials in urban slums of Kolkata, India are presented in this article. Interventions in these communities often get constrained by issues pertaining to human rights and benefits, socio-cultural factors, political environment, methodological shortcomings in addition to the challenges in ensuring community participation. While conducting these trials although we intermittently faced obstacles, by virtue of having a long term and robust surveillance system and developing a trusted relationship between the researchers, community leaders and residents we were able to come up with a commendable community participation which culminated into the success of the interventions. Bridging the gap between research and field operations by incorporating knowledge gathered from interventional studies and making strategies to improve health conditions of these informal settlers is a major unfulfilled agenda. We believe the lessons learnt during our research will help researchers while developing efficient interventions in similar setting. PMID:26224251

  9. Representativeness of participants in a lifestyle intervention study in obese pregnant women - the difference between study participants and non-participants

    Gesche, Joanna; Renault, Kristina; Nørgaard, Kirsten;

    2014-01-01

    OBJECTIVE: To examine the representativeness of participants attending a lifestyle intervention study addressing obese pregnant women. METHODS: Retrospective comparison of baseline data, attendance to oral glucose tolerance test (OGTT) during pregnancy, and pregnancy outcome in eligible women...

  10. A Novel Minimally Invasive Technique to Create a Rabbit VX2 Lung Tumor Model for Nano-Sized Image Contrast and Interventional Studies

    Anayama, Takashi; Nakajima, Takahiro; Dunne, Michael; Zheng, Jinzi; Allen, Christine; Driscoll, Brandon; Vines, Douglass; Keshavjee, Shaf; Jaffray, David; Yasufuku, Kazuhiro

    2013-01-01

    Background The rabbit VX2 lung cancer model is a large animal model useful for preclinical lung cancer imaging and interventional studies. However, previously reported models had issues in terms of invasiveness of tumor inoculation, control of tumor aggressiveness and incidence of complications. Purpose We aimed to develop a minimally invasive rabbit VX2 lung cancer model suitable for imaging and transbronchial interventional studies. Methods New Zealand white rabbits and VX2 tumors were used...

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

    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

  12. Topics in random walks in random environment

    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)

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

    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

  14. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV.

    Wu, Evan S; Rothbard, Aileen; Holtgrave, David R; Blank, Michael B

    2016-05-01

    Persons with serious mental illnesses are at increased risk for contracting and transmitting HIV and often have poor adherence to medication regimens. Determining the economic feasibility of different HIV adherence interventions among individuals with HIV and serious mental illness is important for program planners who must make resource allocation decisions. The goal of this study was to provide a methodology to estimate potential cost savings from an HIV medication adherence intervention program for a new study population, using data from prior published studies. The novelty of this approach is the way CD4 count data was used as a biological marker to estimate costs averted by greater adherence to anti-retroviral treatment. Our approach is meant to be used in other adherence intervention studies requiring cost modeling. PMID:25535041

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

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

    2015-01-01

    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......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...... 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 of...

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

    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, and......) 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...

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

    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

  18. Resistance training in the early postoperative phase reduces hospitalization and leads to muscle hypertrophy in elderly hip surgery patients--a controlled, randomized study

    Suetta, Charlotte; Magnusson, S Peter; Rosted, Anna;

    2004-01-01

    OBJECTIVES: To better understand how immobilization and surgery affect muscle size and function in the elderly and to identify effective training regimes. DESIGN: A prospective randomized, controlled study. SETTING: Bispebjerg University Hospital, Copenhagen, Denmark. PARTICIPANTS: Thirty...... resistance training of the operated side (3/wk x 12 weeks). MEASUREMENTS: Hospital length of stay (LOS), quadriceps muscle cross-sectional area (CSA), isokinetic muscle strength, and functional performance. Patients were tested presurgery and 5 and 12 weeks postsurgery. RESULTS: Mean+/-standard error LOS was...... shorter for the resistance training group (10.0+/-2.4 days, P<.05) than for the standard rehabilitation group (16.0+/-7.2 days). Resistance training, but not electrical stimulation or standard rehabilitation, resulted in increased CSA (12%, P<.05) and muscle strength (22-28%, P<.05). Functional muscle...

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

    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...

  20. 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

    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...

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

    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

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

    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

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

    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...

  4. Pars plana vitrectomy versus three intravitreal injections of bevacizumab for nontractional diabetic macular edema. A prospective, randomized comparative study

    Seemant Raizada; Jamal Al Kandari; Fahad Al Diab; Khalid Al Sabah; Niranjan Kumar,; Sebastian Mathew

    2015-01-01

    Background: The aim of this study was to compare the effectiveness of pars plana vitrectomy (PPV) and removal of the internal limiting membrane (ILM) with three, monthly, intravitreal bevacizumab (IVB) injections for refractory diabetic macular edema. Materials and Methods: This was a prospective, randomized, comparative, interventional study. Forty-four patients were enrolled and randomized in two groups. Twenty-two eyes enrolled in Group I received three IVB injections at monthly interval. ...

  5. Completely random signed measures

    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....

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

    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.

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

    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

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

    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

  9. Randomized LU Decomposition

    Shabat, Gil; Shmueli, Yaniv; Aizenbud, Yariv; Averbuch, Amir

    2013-01-01

    We present a fast randomized algorithm that computes a low rank LU decomposition. Our algorithm uses random projections type techniques to efficiently compute a low rank approximation of large matrices. The randomized LU algorithm can be parallelized and further accelerated by using sparse random matrices in its projection step. Several different error bounds are proven for the algorithm approximations. To prove these bounds, recent results from random matrix theory related to subgaussian mat...

  10. Comparing MTI randomization procedures to blocked randomization.

    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

  11. Vitamin D and Calcium supplementation prevents severe falls in elderly community dwelling residents: a pragmatic population-based 3-year intervention study

    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...

  12. Promoting the Social and Communicative Behavior of Young Children with Autism Spectrum Disorders: A Review of Parent-Implemented Intervention Studies

    Meadan, Hedda; Ostrosky, Michaelene M.; Zaghlawan, Hasan Y.; Yu, SeonYeong

    2009-01-01

    The purpose of this article is to critically review the literature on parent-implemented interventions aimed at promoting and enhancing the social and communicative behavior of young children with autism spectrum disorders. Twelve parent-implemented intervention studies that were conducted, at least in part, in home environments and were published…

  13. 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

    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

  14. 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

    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

  15. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars;

    2013-01-01

    treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured 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...

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

    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

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

    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

  18. Substantial reduction of inappropriate tablet splitting with computerised decision support: a prospective intervention study assessing potential benefit and harm

    Quinzler Renate

    2009-06-01

    Full Text Available Abstract Background Currently ambulatory patients break one in four tablets before ingestion. Roughly 10% of them are not suitable for splitting because they lack score lines or because enteric or modified release coating is destroyed impairing safety and effectiveness of the medication. We assessed impact and safety of computerised decision support on the inappropriate prescription of split tablets. Methods We performed a prospective intervention study in a 1680-bed university hospital. Over a 15-week period we evaluated all electronically composed medication regimens and determined the fraction of tablets and capsules that demanded inappropriate splitting. In a subsequent intervention phase of 15 weeks duration for 10553 oral drugs divisibility characteristics were indicated in the system. In addition, an alert was generated and displayed during the prescription process whenever the entered dosage regimen demanded inappropriate splitting (splitting of capsules, unscored tablets, or scored tablets unsuitable for the intended fragmentation. Results During the baseline period 12.5% of all drugs required splitting and 2.7% of all drugs (257/9545 required inappropriate splitting. During the intervention period the frequency of inappropriate splitting was significantly reduced (1.4% of all drugs (146/10486; p = 0.0008. In response to half of the alerts (69/136 physicians adjusted the medication regimen. In the other half (67/136 no corrections were made although a switch to more suitable drugs (scored tablets, tablets with lower strength, liquid formulation was possible in 82% (55/67. Conclusion This study revealed that computerised decision support can immediately reduce the frequency of inappropriate splitting without introducing new safety hazards.

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

    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

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

    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…

  1. Random walks on combs

    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.

  2. Matricially free random variables

    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.

  3. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

    2012-01-01

    Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of t...

  4. On Gaussian random supergravity

    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

  5. Quantum Random Number Generators

    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...

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

    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

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

    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.

  8. Outpatient vs. home-based pulmonary rehabilitation in COPD: a randomized controlled trial

    Mendes de Oliveira Júlio C

    2010-12-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD is a common cause of morbidity and mortality affecting a large number of individuals in both developed and developing countries and it represents a significant financial burden for patients, families and society. Pulmonary rehabilitation (PR is a multidisciplinary program that integrates components of exercise training, education, nutritional support, psychological support and self-care, resulting in an improvement in dyspnea, fatigue and quality of life. Despite its proven effectiveness and the strong scientific recommendations for its routine use in the care of COPD, PR is generally underutilized and strategies for increasing access to PR are needed. Home-based self-monitored pulmonary rehabilitation is an alternative to outpatient rehabilitation. In the present study, patients with mild, moderate and severe COPD submitted to either an outpatient or at-home PR program for 12 weeks were analyzed. Methods Patients who fulfilled the inclusion criteria were randomized into three distinct groups: an outpatient group who performed all activities at the clinic, a home-based group who performed the activities at home and a control group. PR consisted of a combination of aerobic exercises and strengthening of upper and lower limbs 3 times a week for 12 weeks. Results There was a significant difference in the distance covered on the six-minute walk test (p Conclusion A home-based self-monitoring pulmonary rehabilitation program is as effective as outpatient pulmonary rehabilitation and is a valid alternative for the management of patients with COPD.

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

    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...

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

    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...

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

    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

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

    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. PMID:26764156

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

    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.

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

    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

  15. Evaluation of a crataegus-based multiherb formula for dyslipidemia: a randomized, double-blind, placebo-controlled clinical trial.

    Hu, Miao; 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

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

    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 as...

  17. Kangaroo mother care for infantile colic: a randomized clinical trial

    Reza Saeidi

    2010-03-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 st1":*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Infantile colic has been defined as episodes of excessive and persistent crying without known medical cause. Kangaroo mother care is a new method for baby care with several advantages. A universally available and biologically sound method of care for all newborns, with three components: skin-to-skin contact, exclusive breastfeeding, support to the mother-infant dyad. This study designed for evaluating Kangaroo mother care on infantile colic.  "n"nMethods: This study was a randomized controlled trial. From 1th may 2008 to 1 may 2009 a total of 70 children, aged 3-12 weeks with persistent colic symptoms were studied. The children were referred to Sheikh clinic, Mashhad, Iran, because of excessive crying. Normal mother-infant pairs were recruited at 3 to 12 weeks of age after obtaining baseline for two days. Subjects divided randomly to kangaroo care or conventional care group and mothers in both groups filled diary for seven days. "n"nResults: In the beginning of the study, the infants in kangaroo care group had 3.5 hr/d crying and after the intervention, it decreased to 1.7 hr/d, the difference were significant (p<0.05. But there were no difference in feeding duration between

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

    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.

  19. Blocked randomization with randomly selected block sizes.

    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

  20. Blocked Randomization with Randomly Selected Block Sizes

    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.

  1. Development and Field-Testing of a Study Protocol, including a Web-Based Occupant Survey Tool, for Use in Intervention Studies of Indoor Environmental Quality

    Mendell, Mark

    2009-01-01

    We developed and pilot-tested an overall protocol for intervention studies to evaluate the effects of indoor environmental changes in office buildings on the health symptoms and comfort of occupants. The protocol includes a web-based survey to assess the occupant's responses, as well as specific features of study design and analysis. The pilot study, carried out on two similar floors in a single building, compared two types of ventilation system filter media. With support from the building's ...

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

    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...

  3. On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study

    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...

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

    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.

  5. Interaction of Fatty Acid Genotype and Diet on Changes in Colonic Fatty Acids in a Mediterranean Diet Intervention Study

    Porenta, Shannon R.; Ko, Yi-An; Gruber, Stephen B.; Mukherjee, Bhramar; Baylin, Ana; Raskin, Leonid; Ren, Jianwei; Djuric, Zora

    2013-01-01

    A Mediterranean diet increases intakes of n-3 and n-9 fatty acids and lowers intake of n-6 fatty acids. This can impact colon cancer risk since n-6 fatty acids are metabolized to pro-inflammatory eicosanoids. The purpose of this study was to evaluate interactions of polymorphisms in the fatty acid desaturase genes, FADS1 and FADS2, and changes in diet on fatty acid concentrations in serum and colon. A total of 108 individuals at increased risk of colon cancer were randomized to either a Medit...

  6. Random walks, random fields, and disordered systems

    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...

  7. Methylation patterns in sentinel genes in peripheral blood cells of heavy smokers: Influence of cruciferous vegetables in an intervention study.

    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

  8. Predictors of remission in depression to individual and combined treatments (PReDICT: study protocol for a randomized controlled trial

    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

  9. Influence of general self-efficacy as a mediator in Taiji-induced stress reduction : results from a randomized controlled trial

    Nedeljkovic, Marko; Wepfer, Viviane; Ausfeld-Hafter, Brigitte; Wirtz, Petra H.; Streitberger, Konrad M.

    2013-01-01

    Aim of the studyIn this study we examined the effects of Taiji on perceived stress and general self-efficacy (GSE), and investigated the mediating role of a Taiji-induced GSE increase on Taiji-related reduction of perceived stress.Materials and methods70 healthy participants were randomly allocated either to the Taiji intervention group or the waiting list control group. The intervention lasted for 12 weeks comprising two Taiji classes per week. Before, shortly after, and two months after the...

  10. Misuse of randomization

    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....../150) of the studies were imbalanced at the 0.05 level of probability for the two treatments and 13.3% (20/150) imbalanced at the 0.01 level in the randomization. It is suggested that there may exist misunderstanding of the concept and the misuse of randomization based on the review....

  11. Random mapping statistics

    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...

  12. Randomization and Dynamic Consistency

    Jürgen Eichberger; Simon Grant; David Kelsey

    2014-01-01

    Raiffa (1961) has suggested that ambiguity aversion will cause a strict preference for randomization. We show that dynamic consistency implies that individuals will be indifferent to ex ante randomizations. On the other hand, it is possible for a dynamically-consistent ambiguity averse preference relation to exhibit a strict preference for some ex post randomizations. We argue that our analysis throws some light on the recent debate about paradoxes for the smooth model of ambiguity. We show t...

  13. The Randomized Dependence Coefficient

    Lopez-Paz, David; Hennig, Philipp; Schölkopf, Bernhard

    2013-01-01

    We introduce the Randomized Dependence Coefficient (RDC), a measure of non-linear dependence between random variables of arbitrary dimension based on the Hirschfeld-Gebelein-R\\'enyi Maximum Correlation Coefficient. RDC is defined in terms of correlation of random non-linear copula projections; it is invariant with respect to marginal distribution transformations, has low computational cost and is easy to implement: just five lines of R code, included at the end of the paper.

  14. Random fractal dendrites

    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...

  15. Random Maxout Features

    Mroueh, Youssef; Rennie, Steven; Goel, Vaibhava

    2015-01-01

    In this paper, we propose and study random maxout features, which are constructed by first projecting the input data onto sets of randomly generated vectors with Gaussian elements, and then outputing the maximum projection value for each set. We show that the resulting random feature map, when used in conjunction with linear models, allows for the locally linear estimation of the function of interest in classification tasks, and for the locally linear embedding of points when used for dimensi...

  16. Random Sampling with Removal

    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...

  17. On Random Rough Sets

    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.

  18. Effects of sertindole on cognition in clozapine-treated schizophrenia patients - a double-blinded, randomized, placebo-controlled trial

    Nielsen, R E; Levander, S; Nielsen, Jimmi

    . 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...... Syndrome (PANSS) subscales, Global Assessment of Functioning subscale (GAF-F) and Clinical Global Impression (CGI) with 20 neurocognitive indices was conducted, but no significant correlations were found. Second, we tested change from baseline to endpoint for the PANSS, GAF-F, and CGI, vs. the concomitant...... 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 on...

  19. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (pGGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management. PMID:26983396

  20. Effects of exercises on knee cartilage volume in young healthy adults: a randomized controlled trial

    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

  1. Cellulite and extracorporeal Shockwave therapy (CelluShock-2009 - a Randomized Trial

    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

  2. Random surfaces and strings

    The theory of strings is the theory of random surfaces. I review the present attempts to regularize the world sheet of the string by triangulation. The corresponding statistical theory of triangulated random surfaces has a surprising rich structure, but the connection to conventional string theory seems non-trivial. (orig.)

  3. On fairness and randomness

    Jaeger, Manfred

    2009-01-01

    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...

  4. Hashing, Randomness and Dictionaries

    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...

  5. Random and vector measures

    Rao, M M

    2011-01-01

    The book is devoted to the structural analysis of vector and random (or both) valued countably additive measures, and used for integral representations of random fields. The spaces can be Banach or Frechet types. Several stationary aspects and related processes are analyzed whilst numerous new results are included and many research avenues are opened up.

  6. Randomness: quantum versus classical

    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...

  7. Quantum random number generator

    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.

  8. Prospective, double blind, randomized, controlled trial of simvastatin in human fracture healing.

    Patil, Sanjeev; Holt, Graeme; Raby, Nigel; McLellan, Alastair R; Smith, Karen; O'Kane, Sarah; Beastall, Graham; Crossan, James F

    2009-03-01

    Although statins are widely prescribed as cholesterol-lowering drugs, a number of studies suggest that these compounds may have anabolic effects on bone. Our aim was to assess whether simvastatin affects the rate of fracture healing in humans. A prospective, double-blind, randomized controlled trial was performed. Individuals who had sustained an undisplaced, extra-articular fracture of the distal radial metaphysis were recruited from a trauma clinic. Patients were randomized to receive simvastatin 20 mg once daily or a placebo. Regular clinical and radiological follow-up was undertaken for a 12 week period. Dual-energy X-ray absorptiometry assessment of bone mineral density was conducted at 2 and 12 weeks postinjury. Biochemical markers of bone turnover were assayed during the study period. Time to fracture union was defined as the time to cortical bridging in four cortices on plain radiographs. In addition, the rate of trabecular union was assessed. Eighty patients were recruited, of which 62 completed the study (31 in each group). Study cohorts were matched for age and gender. For patients receiving simvastatin therapy, the mean time to fracture union was 71.6 days (SD 22.2 days, SEM 3.8 days). This compared to 71.3 days (SD 21.3, SEM 4.1 days) for the control cohort (p = 0.6481). There was no significant difference between bone mineral density or bone biochemical markers between groups (p > 0.05). Despite promising results from in vivo and in vitro animal studies, simvastatin at a treatment dose of 20 mg once daily does not affect the rate of fracture healing in humans. PMID:18853428

  9. Random attractors for asymptotically upper semicompact multivalue random semiflows

    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.

  10. DOES FATHER INVOLVEMENT INFLUENCE THE AFFECT, LANGUAGE ACQUISITION, SOCIAL ENGAGEMENT AND BEHAVIOR IN YOUNG AUTISTIC CHILDREN? AN EARLY INTERVENTION STUDY

    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.

  11. Can Word Puzzles be Tailored to Improve Different Dimensions of Verbal Fluency? A Report of an Intervention Study.

    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

  12. Comparative evaluation of diode laser versus argon laser photocoagulation in patients with central serous retinopathy: A pilot, randomized controlled trial [ISRCTN84128484

    Venkatesh Pradeep

    2004-10-01

    Full Text Available Abstract Background To evaluate the efficacy of diode laser photocoagulation in patients with central serous retinopathy (CSR and to compare it with the effects of argon green laser. Methods Thirty patients with type 1 unilateral CSR were enrolled and evaluated on parameters like best corrected visual acuity (BCVA, direct and indirect ophthalmoscopy, amsler grid for recording scotoma and metamorphopsia, contrast sensitivity using Cambridge low contrast gratings and fluorescein angiography to determine the site of leakage. Patients were randomly assigned into 2 groups according to the statistical random table using sequence generation. In Group 1 (n = 15, diode laser (810 nm photocoagulation was performed at the site of leakage while in Group 2 (n = 15, eyes were treated with argon green laser (514 nm using the same laser parameters. Patients were followed up at 4, 8 and 12 weeks after laser. Results The mean BCVA in group 1 improved from a pre-laser decimal value of 0.29 ± 0.14 to 0.84 ± 0.23 at 4 weeks and 1.06 ± 0.09 at 12 weeks following laser. In group 2, the same improved from 0.32 ± 0.16 to 0.67 ± 0.18 at 4 weeks and 0.98 ± 0.14 at 12 weeks following laser. The improvement in BCVA was significantly better in group 1 (p Conclusion Diode laser may be a better alternative to argon green laser whenever laser treatment becomes indicated in patients with central serous retinopathy in terms of faster visual rehabilitation and better contrast sensitivity. In addition, diode laser also has the well-recognized ergonomic and economic advantages.

  13. Effectiveness of diclofenac versus acetaminophen in primary care patients with knee osteoarthritis: [NTR1485], DIPA-Trial: design of a randomized clinical trial

    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.

  14. 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.

    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

  15. A random walk with a branching system in random environments

    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.

  16. Psychological consequences of screening for cardiovascular risk factors in an un-selected general population: results from the Inter99 randomised intervention study

    Løkkegaard, Thomas; Andersen, John Sahl; Badsberg, Jens Henrik; Jørgensen, Torben; Pisinger, Charlotta Holm

    Background: Concerns that general health checks, including screening for risk factors to ischemic heart disease (IHD), have negative psychological consequences seem widely unfounded; however, previous studies are only based on self-reports from participants. Aim: To investigate if risk factor...... psychological status did not influence the psychological impact of screening. Conclusions: This large, randomised intervention study supports that screening for risk factors to IHD does not increase mental distress, not even in the mentally or socioeconomically most vulnerable persons. This study included the...

  17. Suicide prevention for youth - a mental health awareness program: lessons learned from the Saving and Empowering Young Lives in Europe (SEYLE) intervention study

    Wasserman Camilla; Hoven Christina W; Wasserman Danuta; Carli Vladimir; Sarchiapone Marco; Al-Halabí Susana; Apter Alan; Balazs Judit; Bobes Julio; Cosman Doina; Farkas Luca; Feldman Dana; Fischer Gloria; Graber Nadja; Haring Christian

    2012-01-01

    Abstract Background The Awareness program was designed as a part of the EU-funded Saving and Empowering Young Lives in Europe (SEYLE) intervention study to promote mental health of adolescents in 11 European countries by helping them to develop problem-solving skills and encouraging them to self-recognize the need for help as well as how to help peers in need. Methods For this descriptive study all coordinators of the SEYLE Awareness program answered an open-ended evaluation questionnaire at ...

  18. Rationale and design of a randomized controlled trial examining the effect of classroom-based physical activity on math achievement

    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...

  19. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    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...

  20. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    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...

  1. Effect of Fish Oil Supplementation on Fasting Vascular Endothelial Function in Humans: A Meta-Analysis of Randomized Controlled Trials

    Xin, Wei; Wei, Wei; Li, Xiaoying

    2012-01-01

    Background Effect of fish oil supplementation on flow-mediated dilation, an index of endothelial function in humans, remains controversial. We performed a meta-analysis to determine whether fish oil supplementation could improve endothelial function. Methods Human intervention studies were identified by systematic searches of Medline, Embase, Cochrane's library and references of related reviews and studies. A random-effect model was applied to estimate the pooled results. Meta-regression and ...

  2. Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial

    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

    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. Random Fiber Laser

    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...

  5. Random Fiber Laser

    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.

  6. Effects of Pistachio Nut Supplementation on Blood Glucose in Patients with Type 2 Diabetes: A Randomized Crossover Trial

    Parham, Mahmoud; Heidari, Saeide; Khorramirad, Ashraf; Hozoori, Mohammad; Hosseinzadeh, Fatemeh; Bakhtyari, Lida; Vafaeimanesh, Jamshid

    2014-01-01

    BACKGROUND: Diabetes is a chronic, potentially debilitating, and often fatal disease. Dietary strategies to reduce postprandial glycemia are important in the prevention and treatment of diabetes. Nuts are rich in mono- and polyunsaturated fatty acids, which may reduce hyperglycemia and improve metabolism. OBJECTIVES: To evaluate the effectiveness of pistachio nut supplementation on glycemic and inflammatory measures in patients with type 2 diabetes. METHODS: In this double-blind, randomized, placebo-controlled, crossover trial, 48 diabetic patients were equally assigned to groups A and B. Patients in group A received a snack of 25 g pistachio nuts twice a day for 12 weeks and group B received a control meal without nuts. After 12 weeks of intervention, the patients had an 8-week washout. Then the groups were displaced, and group B received the same amount of pistachios for 12 weeks. RESULTS: With respect to the total change in variables over both phases, there was a marked decrease in HbA1c (-0.4%) and fasting blood glucose (FBG) concentrations (-16 mg/dl) in the pistachio group compared with the control group (p ≤ 0.001 for both). There was no overall significant change in BMI, blood pressure, HOMA-IR, and C-reactive protein (CRP) concentrations. Analysis of the two phases separately showed a decrease in FBG by 14 mg/dl and in HbA1c by 0.45% in the treatment group (A) after 12 weeks, while no significant differences were seen in group B (control group). In the second phase, FBG decreased from 151.36 ± 39.22 to 137.28 ± 28.65 mg/dl (-14 mg/dl) and HbA1c decreased from 7.42 ± 0.97 to 7.15 ± 0.68 mg/dl (-0.28%, p = 0.013 and p = 0.033, respectively) in the pistachio group (B). Pistachio consumption reduced systolic blood pressure (p = 0.007), BMI (p = 0.011), and CRP (p = 0.002) in patients from the treatment groups, but not insulin resistance. CONCLUSIONS: Dietary consumption of pistachio nuts as a snack has beneficial effects on glycemic control, blood

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

    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.

  8. Interaction of fatty acid genotype and diet on changes in colonic fatty acids in a Mediterranean diet intervention study.

    Porenta, Shannon R; Ko, Yi-An; Gruber, Stephen B; Mukherjee, Bhramar; Baylin, Ana; Ren, Jianwei; Djuric, Zora

    2013-11-01

    A Mediterranean diet increases intakes of n-3 and n-9 fatty acids and lowers intake of n-6 fatty acids. This can impact colon cancer risk as n-6 fatty acids are metabolized to proinflammatory eicosanoids. The purpose of this study was to evaluate interactions of polymorphisms in the fatty acid desaturase (FADS) genes, FADS1 and FADS2, and changes in diet on fatty acid concentrations in serum and colon. A total of 108 individuals at increased risk of colon cancer were randomized to either a Mediterranean or a Healthy Eating diet. Fatty acids were measured in both serum and colonic mucosa at baseline and after six months. Each individual was genotyped for four single-nucleotide polymorphisms in the FADS gene cluster. Linear regression was used to evaluate the effects of diet, genotype, and the diet by genotype interaction on fatty acid concentrations in serum and colon. Genetic variation in the FADS genes was strongly associated with baseline serum arachidonic acid (n-6) but serum eicosapentaenoic acid (n-3) and colonic fatty acid concentrations were not significantly associated with genotype. After intervention, there was a significant diet by genotype interaction for arachidonic acid concentrations in colon. Subjects who had all major alleles for FADS1/2 and were following a Mediterranean diet had 16% lower arachidonic acid concentrations in the colon after six months of intervention than subjects following the Healthy Eating diet. These results indicate that FADS genotype could modify the effects of changes in dietary fat intakes on arachidonic acid concentrations in the colon. PMID:24022589

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

    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

  10. Ginger Supplementation in Nonalcoholic Fatty Liver Disease: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

    Rahimlou

    2016-01-01

    Full Text Available Background Nonalcoholic fatty liver disease (NAFLD is one of the most common chronic liver diseases worldwide. The pathogenesis of this disease is closely associated with obesity and insulin resistance. Ginger can have hypolipidemic and antioxidant effects, and act as an insulinsensitizer. Objectives The aim of this study was to evaluate the effects of ginger supplementation in NAFLD management. Patients and Methods In a randomized, double-blind, placebo-controlled clinical trial, 44 patients with NAFLD were assigned to take either two grams per day of a ginger supplement or the identical placebo, for 12 weeks. In both groups, patients were advised to follow a modified diet and physical activity program. The metabolic parameters and indicators of liver damage were measured at study baseline and after the 12 week intervention. Results Ginger supplementation resulted in a significant reduction in alanine aminotransferase, γ-glutamyl transferase, inflammatory cytokines, as well as the insulin resistance index and hepatic steatosis grade in comparison to the placebo. We did not find any significant effect of taking ginger supplements on hepatic fibrosis and aspartate aminotransferase. Conclusions Twelve weeks of two grams of ginger supplementation showed beneficial effects on some NAFLD characteristics. Further studies are recommended to assess the long-term supplementation effects.

  11. Tunable random packings

    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

  12. Drawing a random number

    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...... is to generate highly uniform multidimensional draws, which are highly relevant for todays traffic models. This paper shows among others combined shuffling and scrambling seems needless, that scrambling gives the lowest correlation and that there are detectable differences between random numbers...

  13. Random access photonic metamaterials

    Cencillo-Abad, P.; Ou, J.Y.; Valente, J.; Plum, E.; Zheludev, N.I.

    2015-01-01

    We demonstrate the first addressable reconfigurable photonic metamaterials thus enabling control over optical material properties with simultaneous spatial and temporal resolution. Potential applications of random access metadevices include active focusing, beam steering, dynamic transformation optics and video holography.

  14. Random maintenance policies

    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...

  15. Spiders in random environment

    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.

  16. Randomized Aperture Imaging

    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. Ensembles on Random Patches

    Louppe, Gilles; Geurts, Pierre

    2012-01-01

    In this paper, we consider supervised learning under the assumption that the available memory is small compared to the dataset size. This general framework is relevant in the context of big data, distributed databases and embedded systems. We investigate a very simple, yet effective, ensemble framework that builds each individual model of the ensemble from a random patch of data obtained by drawing random subsets of both instances and features from the whole dataset. We carry out an extensive...

  18. A new delirium phenotype with rapid high amplitude onset and nearly as rapid reversal: Central Coast Australia Delirium Intervention Study

    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

  19. Assessment of natural variation of iron and zinc isotope ratios during an iron intervention study in lactating women of Bangladesh

    groups during supplementation period, taking the diets on two random days. (author)

  20. 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

    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

  1. Soccer vs. running training effects in young adult men: which programme is more effective in improvement of body composition? Randomized controlled trial.

    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

  2. Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial

    Hayley L. Loftus

    2015-11-01

    Full Text Available Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15 or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI, waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C was significantly increased (p = 0.01 in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

  3. Duration of luteal support (DOLS with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial

    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

  4. Effects of free leucine supplementation and resistance training on muscle strength and functional status in older adults: a randomized controlled trial

    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

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

    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 adve......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...... fractional laser treatments and (ii) no treatment. Blinded on-site response evaluations were performed 4 and 12 weeks after final treatment. Primary endpoints were change in skin texture (0-10 categorical scale), pain and adverse effects. Secondary endpoints were change in skin color and patient satisfaction...

  6. Random errors revisited

    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....

  7. Coded Random Access

    Paolini, Enrico; Stefanovic, Cedomir; Liva, Gianluigi;

    2015-01-01

    The rise of machine-to-machine communications has rekindled the interest in random access protocols as a support for a massive number of uncoordinatedly transmitting devices. The legacy ALOHA approach is developed under a collision model, where slots containing collided packets are considered 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......, in which the structure of the access protocol can be mapped to a structure of an erasure-correcting code defined on graph. This opens the possibility to use coding theory and tools for designing efficient random access protocols, offering markedly better performance than ALOHA. Several instances of...

  8. Random copying in space

    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.

  9. Reconstructing random media

    We formulate a procedure to reconstruct the structure of general random heterogeneous media from limited morphological information by extending the methodology of Rintoul and Torquato [J. Colloid Interface Sci. 186, 467 (1997)] developed for dispersions. The procedure has the advantages that it is simple to implement and generally applicable to multidimensional, multiphase, and anisotropic structures. Furthermore, an extremely useful feature is that it can incorporate any type and number of correlation functions in order to provide as much morphological information as is necessary for accurate reconstruction. We consider a variety of one- and two-dimensional reconstructions, including periodic and random arrays of rods, various distribution of disks, Debye random media, and a Fontainebleau sandstone sample. We also use our algorithm to construct heterogeneous media from specified hypothetical correlation functions, including an exponentially damped, oscillating function as well as physically unrealizable ones. copyright 1998 The American Physical Society

  10. Graphene random laser

    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.

  11. RANDOM SINGULAR INTEGRAL OF RANDOM PROCESS WITH SECOND ORDER MOMENT

    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.

  12. Random quantum operations

    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.

  13. Random unistochastic matrices

    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.

  14. Intermittency and random matrices

    Sokoloff, Dmitry; Illarionov, E. A.

    2015-08-01

    A spectacular phenomenon of intermittency, i.e. a progressive growth of higher statistical moments of a physical field excited by an instability in a random medium, attracted the attention of Zeldovich in the last years of his life. At that time, the mathematical aspects underlying the physical description of this phenomenon were still under development and relations between various findings in the field remained obscure. Contemporary results from the theory of the product of independent random matrices (the Furstenberg theory) allowed the elaboration of the phenomenon of intermittency in a systematic way. We consider applications of the Furstenberg theory to some problems in cosmology and dynamo theory.

  15. Free Completely Random Measures

    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.

  16. Lectures on random evolution

    Pinsky, Mark A

    1991-01-01

    Random evolution denotes a class of stochastic processes which evolve according to a rule which varies in time according to jumps. This is in contrast to diffusion processes, which assume that the rule changes continuously with time. Random evolutions provide a very flexible language, having the advantage that they permit direct numerical simulation-which is not possible for a diffusion process. Furthermore, they allow connections with hyperbolic partial differential equations and the kinetic theory of gases, which is impossible within the domain of diffusion proceses. They also posses great g

  17. Treatment of Accommodative Dysfunction in Children: Results from an Random Clinical Trial

    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

  18. Treatment of myofascial trigger points in patients with chronic shoulder pain: a randomized, controlled trial

    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

  19. "The effect of a template when constructing individual syllabuses in nursing education – an evaluation of student perspective in a mixed methods intervention study"

    Vilstrup, Dorte Lindstrøm; Udsen, Helle; Prip, Anne

    2014-01-01

    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...... potential to translate the curriculum-based learning objectives into practical studies and, thereby, improve the gap between theory and practice. The importance of clinical teachers’ effect on the way students work becomes evident. The use of templates and structured tools in a pedagogical context is...... debatable but should receive more attention in the future. Key words Individual syllabus, Theory/practice gap, Templates for learning, Tools for learning, Translation of learning objectives...

  20. Fitness consultations in routine care of patients with type 2 diabetes in general practice: an 18-month non-randomised intervention study

    Lohmann, H.; Siersma, V.; Olivarius, Niels de Fine

    2010-01-01

    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 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...

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

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

    a Danish context, it must be considered that ecological models also should be site-specific to capture local and cultural aspects related to PA. Methods: Three major multi-level intervention studies are carried out in Denmark with the objective to promote PA in 17 local communities. 1) The SPACE...... studies clarifies different local and cultural aspects with specific effect on PA behavior. This finding is closely related to the fact that the new outdoor PA facilities in the 17 local communities have different size, composition and are targeted to different subgroups with different organizational...... setup to support the use of the facilities. Despite the conceptual and contextual differences PA behavior is also affected by cultural and social values related to the specific site which not alone can be explained by intrapersonal, interpersonal or organizational factors. Discussion: The Ecological...

  2. Random intersection graph process

    Bloznelis, Mindaugas; Karonski, Michal

    2013-01-01

    We introduce a random intersection graph process aimed at modeling sparse evolving affiliation networks that admit tunable (power law) degree distribution and assortativity and clustering coefficients. We show the asymptotic degree distribution and provide explicit asymptotic formulas for assortativity and clustering coefficients.

  3. Random Boolean Networks

    Drossel, Barbara

    2007-01-01

    This review explains in a self-contained way the properties of random Boolean networks and their attractors, with a special focus on critical networks. Using small example networks, analytical calculations, phenomenological arguments, and problems to solve, the basic concepts are introduced and important results concerning phase diagrams, numbers of relevant nodes and attractor properties are derived.

  4. Asymmetric Carrier Random PWM

    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...

  5. Randomized Filtering Algorithms

    Katriel, Irit; Van Hentenryck, Pascal

    2008-01-01

    Filtering every global constraint of a CPS to are consistency at every search step can be costly and solvers often compromise on either the level of consistency or the frequency at which are consistency is enforced. In this paper we propose two randomized filtering schemes for dense instances...

  6. Randomized clinical trial

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam;

    2015-01-01

    : The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...

  7. Photographic dataset: random peppercorns

    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 .

  8. Testing for Subcellular Randomness

    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.

  9. Generating "Random" Integers

    Griffiths, Martin

    2011-01-01

    One of the author's undergraduate students recently asked him whether it was possible to generate a random positive integer. After some thought, the author realised that there were plenty of interesting mathematical ideas inherent in her question. So much so in fact, that the author decided to organise a workshop, open both to undergraduates and…

  10. Single-case and small-n experimental designs a practical guide to randomization tests

    Todman, John B

    2014-01-01

    This book is a practical guide to help researchers draw valid causal inferences from small-scale clinical intervention studies. It should be of interest to teachers of, and students in, courses with an experimental clinical component, as well as clinical researchers. Inferential statistics used in the analysis of group data are frequently invalid for use with data from single-case experimental designs. Even non-parametric rank tests provide, at best, approximate solutions for only some single-case (and small-n ) designs. Randomization (Exact) tests, on the other hand, can provide valid statis

  11. Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

    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...

  12. Saffron supplements modulate serum pro-oxidant-antioxidant balance in patients with metabolic syndrome: A randomized, placebo-controlled clinical trial

    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.

  13. A randomized controlled trial of the efficacy and safety of CCX282-B, an orally-administered blocker of chemokine receptor CCR9, for patients with Crohn's disease

    Keshav, Satish; Va?ásek, Tomáš; Niv, Yaron;

    2013-01-01

    CCX282-B, also called vercirnon, is a specific, orally-administered chemokine receptor CCR9 antagonist that regulates migration and activation of inflammatory cells in the intestine. This randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of CCX282-B in 436...... patients with Crohn's disease. Crohn's Disease Activity Index (CDAI) scores were 250-450 and C-reactive protein >7.5 mg/L at study entry. In addition to stable concomitant Crohn's medication (85% of subjects), subjects received placebo or CCX282-B (250 mg once daily, 250 mg twice daily, or 500 mg once...... daily) for 12 weeks. They then received 250 mg CCX282-B twice daily, open-label, through week 16. Subjects who had a clinical response (a ≥ 70 point drop in CDAI) at week 16 were randomly assigned to groups given placebo or CCX282-B (250 mg, twice daily) for 36 weeks. Primary endpoints were clinical...

  14. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    Mansikkamäki Kirsi

    2010-08-01

    Full Text Available Abstract Background Annual prevalence of gestational diabetes mellitus (GDM is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g, age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost

  15. Effectiveness of intramuscular corticosteroid injection versus placebo injection in patients with hip osteoarthritis: design of a randomized double-blinded controlled trial

    Dorleijn Desirée MJ

    2011-12-01

    Full Text Available Abstract Background Recent international guidelines recommend intra-articular corticosteroid injections for patients with hip osteoarthritis who have moderate to severe pain and do not respond satisfactorily to oral analgesic/anti-inflammatory agents. Of the five available randomized controlled trials, four showed positive effects with respect to pain reduction. However, intra-articular injection in the hip is complex because the joint is adjacent to important neurovascular structures and cannot be palpated. Therefore fluoroscopic or ultrasound guidance is needed. The systemic effect of corticosteroids has been studied in patients with impingement shoulder pain. Gluteal corticosteroid injection was almost as effective as ultrasound-guided subacromial corticosteroid injection. Such a clinically relevant effect of a systemic corticosteroid injection offers a less complex alternative for treatment of patients with hip osteoarthritis not responsive to oral pain medication. Methods/Design This is a double-blinded, randomized controlled trial. A total of 135 patients (aged > 40 years with hip osteoarthritis and persistent pain despite oral analgesics visiting a general practitioner or orthopaedic surgeon will be included. They will be randomized to a gluteal intramuscular corticosteroid injection or a gluteal intramuscular placebo (saline injection. The randomization will be stratified for setting (general practitioner and outpatient clinics of department of orthopaedics. Treatment effect will be evaluated by questionnaires at 2, 4, 6, and 12 weeks follow-up and a physical examination at 12 weeks. Primary outcome is severity of hip pain reported by the patients at 2-week follow-up. Statistical analyses will be based on the intention-to-treat principle. Discussion This study will evaluate the effectiveness of an intramuscular corticosteroid injection on pain in patients with hip osteoarthritis. Patient recruitment has started. Trial Registration This

  16. Effects of pomegranate juice consumption on inflammatory markers in patients with type 2 diabetes: A randomized, placebo-controlled trial

    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.

  17. Random very loose packings.

    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

  18. Decorating random quadrangulations

    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

  19. Decorating random quadrangulations

    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.

  20. a randomized, controlled trial

    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...

  1. Beyond Random Assignment

    Eva Lantos Rezmovic; Thomas J. Cook; L. Douglas Dobson

    1981-01-01

    This article draws on the experience gained from conducting a true experiment in the criminal justice field to discuss practical problems in maintaining the integrity of evaluation studies. Issues revolving around budgeting, randomization, data collectors, interview payments, and evaluation of black box treatments are addressed. While these nontechnical aspects of evaluation can significantly affect the validity and meaningfulness of research results, they are rarely discussed in research rep...

  2. Randomly Wired Multistage Networks

    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.

  3. Random Conformal Weldings

    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 $\\kappa<4$.

  4. Quenched moderate deviations principle for random walk in random environment

    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.

  5. Effect of industrially produced trans fat on markers of systemic inflammation: evidence from a randomized trial in women

    Bendsen, Nathalie T.; Stender, Steen; Szecsi, Pal B.;

    2011-01-01

    Consumption of industrially produced trans fatty acids (IP-TFA) has been positively associated with systemic markers of low-grade inflammation and endothelial dysfunction in cross-sectional studies, but results from intervention studies are inconclusive. Therefore, we conducted a 16 week double......-blind parallel intervention study with the objective to examine the effect of IP-TFA intake on biomarkers of inflammation, oxidative stress, and endothelial dysfunction. Fifty-two healthy overweight postmenopausal women (49 completers) were randomly assigned to receive either partially hydrogenated soybean oil...... (15.7 g/day IP-TFA) or control oil without IP-TFA. After 16 weeks, IP-TFA intake increased baseline-adjusted serum tumor necrosis factor (TNF) α by 12% [95% confidence interval (CI): 5–20; P = 0.002] more in the IP-TFA group compared with controls. Plasma soluble TNF receptors 1 and 2 were also...

  6. Evaluation of the Effects of Pinus koraiensis Needle Extracts on Serum Lipid and Oxidative Stress in Adults with Borderline Dyslipidemia: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

    Kim, Hyerang; Choue, Ryowon

    2016-01-01

    Background. Dyslipidemia has been well-known as a common metabolic disorder contributing to cardiovascular disease. The aim of this study was to evaluate the effect of the Pinus koraiensis needle extracts (PKE) on the blood cholesterol and oxidative stress. Method. We conducted a 12-week randomized, double-blinded controlled trial to examine the effect of PKE on blood lipid profiles in adults with borderline dyslipidemia. Thirty-three eligible persons were recruited and randomly assigned into PKE (n = 20) and placebo groups (n = 13). Serum lipids including total cholesterol, low-density lipoprotein- (LDL-) cholesterol, high-density lipoprotein- (HDL-) cholesterol, very low-density lipoprotein- (VLDL-) cholesterol, and triglyceride were measured before and after trial. Serum insulin, glucose, and antioxidant indicators were also analyzed before and after trial and anthropometry and blood pressure were measured every 4 weeks. Results. After 12 weeks, PKE statically significant decreases in systolic blood pressure (p < 0.05) and waist circumference (p < 0.05) were observed. Also, VLDL-cholesterol significantly decreased (from 24.4 ± 10.0 mg/dL at baseline to 18.4 ± 4.1 mg/dL after 12 weeks) (p < 0.05) and superoxide dismutase (SOD) increased (6.12 ± 0.41 U/mL to 9.06 ± 0.62 U/mL) (p < 0.01) in PKE group. However, after adjustment with WC, VLDL-cholesterol was not significant between groups (p = 0.095) and while SOD remained significant between groups (p = 0.013). Conclusion. The results show that PKE was effective in improving the superoxide dismutase in the individuals with borderline dyslipidemia.

  7. An open label prospective randomized trial to compare the efficacy of coal tar-salicylic acid ointment versus calcipotriol/betamethasone dipropionate ointment in the treatment of limited chronic plaque psoriasis

    Sujay Khandpur

    2014-01-01

    Full Text Available Background: Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis. Aims and Objectives: A prospective randomized open label controlled trial to compare the efficacy and safety of topical application of coal tar-salicylic acid ointment with calcipotriol/betamethasone dipropionate ointment applied once at night for 12 weeks for the treatment of limited chronic plaque psoriasis. Materials and Methods: A total of 62 patients of limited chronic plaque psoriasis (body surface area <10% were randomized into two treatment groups: Group A received topical application of 6% coal tar with 3% salicylic acid ointment and Group B received calcipotriol/betamethasone dipropionate, once at night for 12 weeks. Results were assessed based on psoriasis area severity index (PASI scores and patient global assessment (PGA at each visit. Results: Mean PASI was significantly lower at week 2 (P = 0.01 and week 4 follow-up (P = 0.05 and the mean reduction in PASI was significantly higher at week 2 (P = 0.02 with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively. There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks. Conclusion: Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.

  8. Random Response of Linear Viscoelastic Systems under Random Excitation

    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.

  9. Planning of activities in the Laguna Verde Central planning at 12 weeks

    The universe of works that are carried out in a nuclear facility to maintain effective the structures, systems and components require of a continuous analysis, in the order of the maintenance frequencies that can be of the preventive, predictive or corrective type. Each component is associated to reserve parts, readiness of systems, in fulfillment to the operation technical specifications, to the environment of the one work; each component requires of a planning level, where it is distinguished with clarity when they are executed, in the operation stage, stop or recharge. This work has as end to show like the activities are planned during the operation, using planning methods to twelve weeks, where the reach of the task is conceptualized, operative requirements, of reserve parts, of the work environment analysis, of those radiological conditions, of the authorizations for their execution, the same execution and the evaluation post work like a technique to maintain in continuous improvement the tasks of the maintenance of the Units of the Power station. A motor valve to be worked in its internals requires access to the work point, it requires bill of the system, electric disconnection, maneuvers to disassemble actuators and retirement of thermal isolation if it applies, reserve parts of the caps joints, control mechanisms, personal, tools, radiological control. The success of the continuous operation of a power station is in the planning quality, the attention of each one of the details to assure that the components, structures and components stay effective to make their function when they are demanded. The planning task requires of experience and knowledge of each some of the components, the task of planning of activities and its execution is multidisciplinary This work has that purpose, to show the planning tools in the Laguna Verde Nuclear Power station, under the concept of twelve weeks. (Author)

  10. Effects of a 12-Week Resistance Exercise Program on Physical Self-Perceptions in College Students

    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…

  11. A 12-Week Exercise Therapy Program in Middle-Aged Patients With Degenerative Meniscus Tears

    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, the...... specific program is significantly better than other interventions. LEVEL OF EVIDENCE: Therapy, level 4. J Orthop Sports Phys Ther, Epub 5 September 2012. doi:10.2519/jospt.2012.4165....

  12. 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)

    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...... 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...

  13. 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

    Qu, Chunfeng; Chen, Taoyang; Fan, Chunsun; Zhan, Qimin; Wang, Yuting; Lu, Jianhua; Lu, Ling-ling; Ni, Zhengping; Huang, Fei; Yao, Hongyu; Zhu, Jian; Fan, Jian; Zhu, Yuanrong; Wu, Zhiyuan; Liu, Guoting

    2014-01-01

    Editors' Summary Background Hepatitis B is a life-threatening liver infection caused by the hepatitis B virus (HBV). HBV, which is transmitted through contact with the blood or other bodily fluids of an infected person, can cause both acute (short-term) and chronic (long-term) liver infections. Acute infections rarely cause any symptoms and more than 90% of adults who become infected with HBV (usually through sexual intercourse with an infected partner or through the use of contaminated needl...

  14. ON THE RANGE OF RANDOM WALKS IN RANDOM ENVIRONMENT

    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.

  15. Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

    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…

  16. Design and methods of a social network isolation study for reducing respiratory infection transmission: The eX-FLU cluster randomized trial

    Aiello, Allison E.; Simanek, Amanda M.; Marisa C Eisenberg; Alison R. Walsh; Brian Davis; Erik Volz; Caroline Cheng; Rainey, Jeanette J.; Amra Uzicanin; Hongjiang Gao; Nathaniel Osgood; Dylan Knowles; Kevin Stanley; Kara Tarter; Monto, Arnold S.

    2016-01-01

    Background: Social networks are increasingly recognized as important points of intervention, yet relatively few intervention studies of respiratory infection transmission have utilized a network design. Here we describe the design, methods, and social network structure of a randomized intervention for isolating respiratory infection cases in a university setting over a 10-week period. Methodology/principal findings: 590 students in six residence halls enrolled in the eX-FLU study during a ...

  17. The GRONORUN study: is a graded training program for novice runners effective in preventing running related injuries? Design of a Randomized Controlled Trial

    Pepping Gert-Jan; Lemmink Koen APM; Bredeweg Steef W; Buist Ida; Zwerver Johannes; van Mechelen Willem; Diercks Ron L

    2007-01-01

    Abstract Background Running is a popular form of recreational exercise. Beside the positive effects of running on health and fitness, the risk of a running related injury has to be considered. The incidence of injuries in runners is high and varies from 30–79%. However, few intervention studies on prevention of running related injuries have been performed and none of these studies involved novice runners. Methods GRONORUN (Groningen Novice Running) is a two armed randomized controlled trial, ...

  18. Cross-sectional investigation and intervention study of cardiopulmonary resuscitation knowledge and technique in officers and soldiers%部队官兵心肺复苏急救能力的现况调查及干预研究

    赵京生; 袁跃彬; 姚玉川; 肖雪青

    2013-01-01

    Objective: To investigate and promote the cardiopulmonary resuscitation ( CPR) skill in officers and soldiers. Methods; A total of 2 200 military personnels from 20 troops of navy, army, air force were surveyed, then learning CPR technique through multimedia and demonstration. Six months later, 600 officers and soldiers from 6 troops among the above 20 troops were randomly surveyed again. Results; Before intervention study, their CPR knowledge was deficient, and their CPR skill was unqualified. The score in navy group was significantly higher than that in army group and air force group (P <0. 01). All their scores were significantly promoted after intervention (P<0.01). Conclusion; The CPR skills of officers and soldiers were unqualified before training, indicating that it is necessary to learn the CRP technique for the potential high - tech war in the future.%目的:全面了解并提高我军官兵的心肺复苏(CPR)急救能力.方法:全军范围内抽样2 200名官兵,来源于海陆空三军,现场填写调查表考核,现场多媒体教学,现场CPR技能演示,半年后随机抽查上述单位官兵600名进行复查.结果:示教前官兵CPR知识缺乏,操作不够熟练,海军战士成绩优于空军和陆军(P<0.01).示教后官兵的CPR理论和技能成绩明显提高(P<0.01).结论:官兵CPR知识和技能与实际要求存在较大的差距,努力提高军队CPR技能,为潜在的高科技战争做好准备有重要的现实意义.

  19. Dietary predictors of the insulin-like growth factor system in adolescent females: results from the Dietary Intervention Study in Children (DISC)123

    Gardiner, Joseph C; Dorgan, Joanne F; Rosen, Cliff J; Velie, Ellen M

    2010-01-01

    Background: The insulin-like growth factor (IGF) system is associated with the adult diet and chronic disease. Childhood diet may influence chronic disease through its effect on the IGF system; however, there is limited information describing the dietary predictors of the IGF system in adolescents. Objective: We examined associations between dietary food intake [fat, protein (animal and vegetable), carbohydrate, lactose, dietary fiber, calcium, zinc, and sodium] and serum IGF-I, IGF binding protein 1 (IGFBP-1), IGF binding protein 3 (IGFBP-3), and the IGF-I:IGFBP-3 molar ratio in adolescent females. Design: One hundred fifty-nine adolescent females in the Dietary Intervention Study in Children (age range: 14–18 y; 0.2–6.3 y postmenarche) were included. The dietary intake was assessed via three 24-h dietary recalls. IGF-related biomarkers were determined by using radioimmunoassays. Associations between dietary intakes and biomarkers were assessed with Pearson's correlations and multivariable linear regression. Dietary intakes and biomarkers were logarithmically transformed; thus, β coefficients represented percentages. Results: In analyses adjusted for energy, age, and time since menarche, significant correlations (P < 0.05) were as follows: IGF-I with total protein, lactose, calcium, and sodium; IGFBP-3 with total fat (inverse), lactose, fiber, and calcium; IGF-I/IGFBP-3 with lactose and calcium; and IGFBP-1 with vegetable protein. In multivariable analyses, significant predictors of IGF-I were energy (β = 0.14, P < 0.05) and calcium (β = 0.14, P < 0.01), the significant predictor of IGFBP-3 was calcium (β = 0.07, P < 0.05), and significant predictors of IGFBP-1 were vegetable protein (β = 0.49, P < 0.05) and body mass index–for-age percentile (β = −0.01, P < 0.001). Conclusion: This study provides evidence that dietary intake affects IGF-related biomarkers—particularly elevated calcium with IGF-I and IGFBP-3 and elevated vegetable protein with

  20. Response to Statin Therapy in Obstructive Sleep Apnea Syndrome: A Multicenter Randomized Controlled Trial

    Marie Joyeux-Faure

    2014-01-01

    Full Text Available Rationale. Accumulated evidence implicates sympathetic activation as inducing oxidative stress and systemic inflammation, which in turn lead to hypertension, endothelial dysfunction, and atherosclerosis in obstructive sleep apnea (OSA. Statins through their pleiotropic properties may modify inflammation, lipid profile, and cardiovascular outcomes in OSA. Methods. This multicenter, randomized, double-blind study compared the effects of atorvastatin 40 mg/day versus placebo over 12 weeks on endothelial function (the primary endpoint measured by peripheral arterial tone (PAT. Secondary endpoints included office blood pressure (BP, early carotid atherosclerosis, arterial stiffness measured by pulse wave velocity (PWV, and metabolic parameters. Results. 51 severe OSA patients were randomized. Key demographics for the study population were age 54 ± 11 years, 21.6% female, and BMI 28.5 ± 4.5 kg/m2. In intention to treat analysis, mean PAT difference between atorvastatin and placebo groups was 0.008 (−0.29; 0.28, P=0.979. Total and LDL cholesterol significantly improved with atorvastatin. Systolic BP significantly decreased with atorvastatin (mean difference: −6.34 mmHg (−12.68; −0.01, P=0.050 whereas carotid atherosclerosis and PWV were unchanged compared to the placebo group. Conclusion. In OSA patients, 3 months of atorvastatin neither improved endothelial function nor reduced early signs of atherosclerosis although it lowered blood pressure and improved lipid profile. This trial is registered with NCT00669695.

  1. A randomized controlled trial of attention bias modification training for socially anxious adolescents.

    Fitzgerald, Amanda; Rawdon, Caroline; Dooley, Barbara

    2016-09-01

    The current study aimed to examine the efficacy of attention bias modification (ABM) training to reduce social anxiety in a community-based sample of adolescents 15-18 years. The study used a single-blind, parallel group, randomized controlled trial design (Clinical Trials ID: NCT02270671). Participants were screened in second-level schools using a social anxiety questionnaire. 130 participants scoring ≥24 on the Social Phobia and Anxiety Inventory for Children (SPAI-C) were randomized to the ABM training (n = 66)/placebo (n = 64) group, 120 of which completed pre-, post-, and 12-week follow-up data collection including threat bias, anxiety, and depression measures. The ABM intervention included 4 weekly training sessions using a dot-probe task designed to reduce attention bias to threatening stimuli. ABM training did not alter the primary outcomes of attention bias to threat or social anxiety symptoms raising questions about the efficacy of ABM as an intervention for adolescents. PMID:27379745

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

    A R Pradeep

    2012-01-01

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

  3. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults.

    Chapman, Sandra B; Aslan, Sina; Spence, Jeffrey S; Keebler, Molly W; DeFina, Laura F; Didehbani, Nyaz; Perez, Alison M; Lu, Hanzhang; D'Esposito, Mark

    2016-01-01

    Insidious declines in normal aging are well-established. Emerging evidence suggests that non-pharmacological interventions, specifically cognitive and physical training, may counter diminishing age-related cognitive and brain functions. This randomized trial compared effects of two training protocols: cognitive training (CT) vs. physical training (PT) on cognition and brain function in adults 56-75 years. Sedentary participants (N = 36) were randomized to either CT or PT group for 3 h/week over 12 weeks. They were assessed at baseline-, mid-, and post-training using neurocognitive, MRI, and physiological measures. The CT group improved on executive function whereas PT group's memory was enhanced. Uniquely deploying cerebral blood flow (CBF) and cerebral vascular reactivity (CVR) MRI, the CT cohort showed increased CBF within the prefrontal and middle/posterior cingulate cortex (PCC) without change to CVR compared to PT group. Improvements in complex abstraction were positively associated with increased resting CBF in dorsal anterior cingulate cortex (dACC). Exercisers with higher CBF in hippocampi bilaterally showed better immediate memory. The preliminary evidence indicates that increased cognitive and physical activity improves brain health in distinct ways. Reasoning training enhanced frontal networks shown to be integral to top-down cognitive control and brain resilience. Evidence of increased resting CBF without changes to CVR implicates increased neural health rather than improved vascular response. Exercise did not improve cerebrovascular response, although CBF increased in hippocampi of those with memory gains. Distinct benefits incentivize testing effectiveness of combined protocols to strengthen brain health. PMID:27462210

  4. Distinct Brain and Behavioral Benefits from Cognitive vs. Physical Training: A Randomized Trial in Aging Adults

    Chapman, Sandra B.; Aslan, Sina; Spence, Jeffrey S.; Keebler, Molly W.; DeFina, Laura F.; Didehbani, Nyaz; Perez, Alison M.; Lu, Hanzhang; D'Esposito, Mark

    2016-01-01

    Insidious declines in normal aging are well-established. Emerging evidence suggests that non-pharmacological interventions, specifically cognitive and physical training, may counter diminishing age-related cognitive and brain functions. This randomized trial compared effects of two training protocols: cognitive training (CT) vs. physical training (PT) on cognition and brain function in adults 56–75 years. Sedentary participants (N = 36) were randomized to either CT or PT group for 3 h/week over 12 weeks. They were assessed at baseline-, mid-, and post-training using neurocognitive, MRI, and physiological measures. The CT group improved on executive function whereas PT group's memory was enhanced. Uniquely deploying cerebral blood flow (CBF) and cerebral vascular reactivity (CVR) MRI, the CT cohort showed increased CBF within the prefrontal and middle/posterior cingulate cortex (PCC) without change to CVR compared to PT group. Improvements in complex abstraction were positively associated with increased resting CBF in dorsal anterior cingulate cortex (dACC). Exercisers with higher CBF in hippocampi bilaterally showed better immediate memory. The preliminary evidence indicates that increased cognitive and physical activity improves brain health in distinct ways. Reasoning training enhanced frontal networks shown to be integral to top-down cognitive control and brain resilience. Evidence of increased resting CBF without changes to CVR implicates increased neural health rather than improved vascular response. Exercise did not improve cerebrovascular response, although CBF increased in hippocampi of those with memory gains. Distinct benefits incentivize testing effectiveness of combined protocols to strengthen brain health. PMID:27462210

  5. Consistency of Online Random Forests

    Denil, Misha; Matheson, David; De Freitas, Nando

    2013-01-01

    As a testament to their success, the theory of random forests has long been outpaced by their application in practice. In this paper, we take a step towards narrowing this gap by providing a consistency result for online random forests.

  6. Random recursive trees and the elephant random walk

    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.

  7. Precise Asymptotics for Random Matrices and Random Growth Models

    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.

  8. Effects of aerobic dance training on blood pressure in individuals with uncontrolled hypertension on two antihypertensive drugs: a randomized clinical trial.

    Maruf, Fatai Adesina; Akinpelu, Aderonke Omobonike; Salako, Babatunde Lawal; Akinyemi, Joshua Odunayo

    2016-04-01

    There is a dearth of reports on possible additive blood pressure (BP)-reducing effect of aerobic exercise on antihypertensive drug in humans. This study investigated the additive BP-reducing effect of aerobic exercise on BP in individuals with uncontrolled hypertension. In this 12-week double-blind study, 120 new-diagnosed individuals with mild-to-moderate hypertension were randomized to receive coamilozide + 5/10 mg of amlodipine + aerobic dance or coamilozide + 5/10 mg of amlodipine alone. Forty-five and 43 participants in exercise and control groups, respectively, completed the 12-week intervention. Addition of aerobic exercise to antihypertensive drug therapy significantly reduced systolic BP (7.1 mm Hg [95% confidence interval: 5.0, 9.3]; P dance and antihypertensive drugs reduces number of antihypertensive drugs needed to achieve BP control and enhances BP control in individuals with hypertension on two antihypertensive drugs. PMID:26948962

  9. The effect of calcium and vitamin D3 supplementation on the healing of the proximal humerus fracture: a randomized placebo-controlled study

    Doetsch, A M; Faber, J; Lynnerup, N;

    2004-01-01

    The purpose of this study was to (1) quantify the healing process of the human osteoporotic proximal humerus fracture (PHF) expressed in terms of callus formation over the fracture region using BMD scanning, and (2) quantify the impact of medical intervention with vitamin D3 and calcium on the...... scan, WHO criteria), and not taking any drugs related to bone formation, including calcium or vitamin D supplementation, were randomly assigned to either oral 800 IU vitamin D3 plus 1 g calcium or placebo, in a double-blind prospective study. We measured biochemical, radiographic, and bone mineral...... improved from 2.8% immediately after fracture occurrence to 1.7% at 12 weeks (P = 0.003) approaching the 1.2% levels observed over the healthy shoulder. BMD was similar in the two groups at baseline (active 0.534 g/cm2 vs. placebo 0.518 g/cm2), and both increased over the 12-week observation period, with...

  10. Optimized random chemistry

    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.

  11. Random walk loop soup

    Lawler, Gregory F.; Ferreras, José A. Trujillo

    2004-01-01

    The Brownian loop soup introduced in Lawler and Werner (2004) is a Poissonian realization from a sigma-finite measure on unrooted loops. This measure satisfies both conformal invariance and a restriction property. In this paper, we define a random walk loop soup and show that it converges to the Brownian loop soup. In fact, we give a strong approximation result making use of the strong approximation result of Koml\\'os, Major, and Tusn\\'ady. To make the paper self-contained, we include a proof...

  12. Random Web Crawls

    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...

  13. Derandomizing from random strings

    Buhrman, H.; Fortnow, L.; Koucký, Michal; Loff, B.

    Los Alamitos : IEEE Computer Society 2010, 2010, s. 58-63. ISBN 978-0-7695-4060-3. [25th Annual IEEE Conference on Computational Complexity, CCC 2010. Cambridge (US), 09.06.2010-12.06.2010] R&D Projects: GA ČR GAP202/10/0854; GA AV ČR IAA100190902; GA MŠk(CZ) 1M0545 Institutional research plan: CEZ:AV0Z10190503 Keywords : Kolmogorov random strings * reducibility * complexity classes Subject RIV: BA - General Mathematics http://ieeexplore.ieee.org/xpl/articleDetails.jsp?arnumber=5497897

  14. Strong Decomposition of Random Variables

    Hoffmann-Jørgensen, Jørgen; Kagan, Abram M.; Pitt, Loren D.;

    2007-01-01

    A random variable X is stongly decomposable if X=Y+Z where Y=Φ(X) and Z=X-Φ(X) are independent non-degenerated random variables (called the components). It is shown that at least one of the components is singular, and we derive a necessary and sufficient condition for strong decomposability of a...... discrete random variable....

  15. Random Numbers and Quantum Computers

    McCartney, Mark; Glass, David

    2002-01-01

    The topic of random numbers is investigated in such a way as to illustrate links between mathematics, physics and computer science. First, the generation of random numbers by a classical computer using the linear congruential generator and logistic map is considered. It is noted that these procedures yield only pseudo-random numbers since…

  16. Investigating the Randomness of Numbers

    Pendleton, Kenn L.

    2009-01-01

    The use of random numbers is pervasive in today's world. Random numbers have practical applications in such far-flung arenas as computer simulations, cryptography, gambling, the legal system, statistical sampling, and even the war on terrorism. Evaluating the randomness of extremely large samples is a complex, intricate process. However, the…

  17. Improving temperature monitoring in the vaccine cold chain at the periphery: an intervention study using a 30-day electronic refrigerator temperature logger (Fridge-tag).

    Kartoğlu, Umit; Nelaj, Erida; Maire, Denis

    2010-05-28

    This intervention study was conducted in Albania to establish the superiority of the Fridge-tag (30-day electronic refrigerator temperature logger) against thermometers. Intervention sites used Fridge-tag and a modified temperature control record sheet, while control sites continued with their routine operation with thermometers. All refrigerators in both groups were equipped with downloadable electronic data loggers to record temperatures for reference. Focus group sessions were conducted with involved staff to discuss temperature monitoring, Fridge-tag use and its user-friendliness. Significant discrepancies were observed between thermometer readings and the electronic data loggers in control sites, while all alarms from Fridge-tag were confirmed in the intervention group. Thermometers are not sufficient to monitor temperatures in refrigerators since they miss the great majority of low and high alarms. Fridge-tag has proven to be an effective tool in providing health workers with the information they need to take the necessary actions when there are refrigerator temperature variations. PMID:20398615

  18. An e-learning reproductive health module to support improved student learning and interaction: a prospective interventional study at a medical school in Egypt

    Abdelhai Rehab

    2012-03-01

    Full Text Available Abstract Background The Public Health (PH course at the medical college of Cairo University is based on traditional lectures. Large enrollment limits students' discussions and interactions with instructors. Aim Evaluate students' learning outcomes as measured by improved knowledge acquisition and opinions of redesigning the Reproductive Health (RH section of the PH course into e-learning and assessing e-course utilization. Methods This prospective interventional study started with development of an e-learning course covering the RH section, with visual and interactive emphasis, to satisfy students' diverse learning styles. Two student groups participated in this study. The first group received traditional lecturing, while the second volunteered to enroll in the e-learning course, taking online course quizzes. Both groups answered knowledge and course evaluation questionnaires and were invited to group discussions. Additionally, the first group answered another questionnaire about reasons for non-participation. Results Students participating in the e-learning course showed significantly better results, than those receiving traditional tutoring. Students who originally shunned the e-course expressed eagerness to access the course before the end of the academic year. Overall, students using the redesigned e-course reported better learning experiences. Conclusions An online course with interactivities and interaction, can overcome many educational drawbacks of large enrolment classes, enhance student's learning and complement pit-falls of large enrollment traditional tutoring.

  19. Youth and young adult physical activity and body composition of young adult women: findings from the dietary intervention study in children.

    Hodge, Melissa G; Hovinga, Mary; Shepherd, John A; Egleston, Brian; Gabriel, Kelley; Van Horn, Linda; Robson, Alan; Snetselaar, Linda; Stevens, Victor K; Jung, Seungyoun; Dorgan, Joanne

    2015-02-01

    This study prospectively investigates associations between youth moderate-to-vigorous-intensity physical activity (MVPA) and body composition in young adult women using data from the Dietary Intervention Study in Children (DISC) and the DISC06 Follow-Up Study. MVPA was assessed by questionnaire on 5 occasions between the ages 8 and 18 years and at age 25-29 years in 215 DISC female participants. Using whole body dual-energy x-ray absorptiometry (DXA), overall adiposity and body fat distribution were assessed at age 25-29 years by percent body fat (%fat) and android-to-gynoid (A:G) fat ratio, respectively. Linear mixed effects models and generalized linear latent and mixed models were used to assess associations of youth MVPA with both outcomes. Young adult MVPA, adjusted for other young adult characteristics, was significantly inversely associated with young adult %fat (%fat decreased from 37.4% in the lowest MVPA quartile to 32.8% in the highest (p-trend = 0.02)). Adjusted for youth and young adult characteristics including young adult MVPA, youth MVPA also was significantly inversely associated with young adult %fat (β=-0.40 per 10 MET-hrs/wk, p = .02) . No significant associations between MVPA and A:G fat ratio were observed. Results suggest that youth and young adult MVPA are important independent predictors of adiposity in young women. PMID:25387239

  20. Suicide prevention for youth - a mental health awareness program: lessons learned from the Saving and Empowering Young Lives in Europe (SEYLE intervention study

    Wasserman Camilla

    2012-09-01

    Full Text Available Abstract Background The Awareness program was designed as a part of the EU-funded Saving and Empowering Young Lives in Europe (SEYLE intervention study to promote mental health of adolescents in 11 European countries by helping them to develop problem-solving skills and encouraging them to self-recognize the need for help as well as how to help peers in need. Methods For this descriptive study all coordinators of the SEYLE Awareness program answered an open-ended evaluation questionnaire at the end of the project implementation. Their answers were synthesized and analyzed and are presented here. Results The results show that the program cultivated peer understanding and support. Adolescents not only learned about mental health by participating in the Awareness program, but the majority of them also greatly enjoyed the experience. Conclusions Recommendations for enhancing the successes of mental health awareness programs are presented. Help and cooperation from schools, teachers, local politicians and other stakeholders will lead to more efficacious future programs.