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Sample records for additional randomized controlled

  1. [Critical of the additive model of the randomized controlled trial].

    PubMed

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  2. Additive effects of neurofeedback on the treatment of ADHD: A randomized controlled study.

    PubMed

    Lee, Eun-Jeong; Jung, Chul-Ho

    2017-02-01

    Neurofeedback (NF) has been identified as a "possibly efficacious" treatment in current evidence-based reviews; therefore, more research is needed to determine its effects. The current study examined the potential additive effect of NF for children diagnosed with ADHD beginning a medication trial first. Thirty-six children (6-12 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to an NF with medication (NF condition) or a medication only condition. Children in the NF group attended 20 twice-weekly sessions. Outcome measures included individual cognitive performance scores (ADS, K-WISC-III), ADHD rating scores completed by their parents (ARS, CRS) and brainwave indices of left and right hemispheres before and after NF treatment. Significant additive treatment effect in any of the symptom variables was found and a reduction of theta waves in both the right and left hemispheres was recorded in NF condition participants. However our randomized controlled study could not demonstrate superior effects of combined NF on intelligent functioning compared to the medication treatment only. This study suggested any possible evidence of positive and additive treatment effects of NF on brainwaves and ADHD symptomatology.

  3. Statins Have No Additional Benefit for Pulmonary Hypertension: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Lin; Qu, Moying; Chen, Yao; Zhou, Yaxiong; Wan, Zhi

    2016-01-01

    Objectives We performed a meta-analysis to explore the effects of adding statins to standard treatment on adult patients of pulmonary hypertension (PH). Methods A systematic search up to December, 2015 of Medline, EMBASE, Cochrane Database of Systematic reviews and Cochrane Central Register of Controlled Trials was performed to identify randomized controlled trials with PH patients treated with statins. Results Five studies involving 425 patients were included into this meta-analysis. The results of our analysis showed that the statins can’t significantly increase 6-minute walking distance (6MWD, mean difference [MD] = -0.33 [CI: -18.25 to 17.59]), decrease the BORG dyspnea score (MD = -0.72 [CI: -2.28 to 0.85]), the clinical worsening risk (11% in statins vs. 10.1% in controls, Risk ratio = 1.06 [CI: 0.61, 1.83]), or the systolic pulmonary arterial pressure (SPAP) (MD = -0.72 [CI: -2.28 to 0.85]). Subgroup analysis for PH due to COPD or non-COPD also showed no significance. Conclusions Statins have no additional beneficial effect on standard therapy for PH, but the results from subgroup of PH due to COPD seem intriguing and further study with larger sample size and longer follow-up is suggested. PMID:27992469

  4. Addition of Dexamethasone and Buprenorphine to Bupivacaine Sciatic Nerve Block: A Randomized, Controlled Trial

    PubMed Central

    YaDeau, Jacques T.; Paroli, Leonardo; Fields, Kara G.; Kahn, Richard L.; LaSala, Vincent R.; Jules-Elysee, Kethy M.; Kim, David H.; Haskins, Stephen C.; Hedden, Jacob; Goon, Amanda; Roberts, Matthew M.; Levine, David S.

    2015-01-01

    Background and Objectives Sciatic nerve block provides analgesia after foot and ankle surgery, but block duration may be insufficient. We hypothesized that perineural dexamethasone and buprenorphine would reduce pain scores at 24 hours. Methods Ninety patients received ultrasound-guided sciatic (25 mL 0.25% bupivacaine) and adductor canal (10 mL 0.25% bupivacaine) blockade, with random assignment into 3 groups (30 patients per group): control blocks + intravenous dexamethasone (4 mg) (control); control blocks + intravenous buprenorphine (150 mcg) + intravenous dexamethasone (intravenous buprenorphine); nerve blocks containing buprenorphine + dexamethasone (perineural). Patients received mepivacaine neuraxial anesthesia and postoperative oxycodone / acetaminophen, meloxicam, pregabalin, and ondansetron. Patients and assessors were blinded to group assignment. The primary outcome was pain with movement at 24 hours. Results There was no difference in pain with movement at 24 hours (median score 0). However, the perineural group had longer block duration vs control (45.6 vs 30.0 hr). Perineural patients had lower scores for “worst pain” vs control (median 0 vs 2). Both intravenous buprenorphine and perineural groups were less likely to use opioids on the day after surgery, vs control (28.6%, 28.6%, 60.7%, respectively). Nausea after intravenous buprenorphine (but not perineural buprenorphine) was severe, frequent, and bothersome. Conclusions Pain scores were very low at 24 hours after surgery in the context of multimodal analgesia and were not improved by additives. However, perineural buprenorphine and dexamethasone prolonged block duration, reduced the worst pain experienced, and reduced opioid use. Intravenous buprenorphine caused troubling nausea and vomiting. Future research is needed to confirm and extend these observations. PMID:25974277

  5. Analysis of Time to Event Outcomes in Randomized Controlled Trials by Generalized Additive Models

    PubMed Central

    Argyropoulos, Christos; Unruh, Mark L.

    2015-01-01

    Background Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking. Methods By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM) can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated) and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population. Findings PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect) but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data. Conclusions By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial

  6. Sodium Bicarbonate Prevents Contrast-Induced Nephropathy in Addition to Theophylline: A Randomized Controlled Trial.

    PubMed

    Huber, Wolfgang; Huber, Toni; Baum, Stephan; Franzen, Michael; Schmidt, Christian; Stadlbauer, Thomas; Beitz, Analena; Schmid, Roland M; Schmid, Sebastian

    2016-05-01

    In this study, we investigated whether hydration with sodium bicarbonate is superior to hydration with saline in addition to theophylline (both groups) in the prophylaxis of contrast-induced nephropathy (CIN). It was a prospective, randomized, double-blinded study in a university hospital on 2 general intensive care units (63% of investigations) and normal wards.After approval of the local ethics committee and informed consent 152 patients with screening serum creatinine ≥1.1 mg/dL and/or at least 1 additional risk factor for CIN undergoing intravascular contrast media (CM) exposure were randomized to receive a total of 9 mL/kg bicarbonate 154 mmol/L (group B; n = 74) or saline 0.9% (group S; n = 78) hydration within 7 h in addition to intravenous application of 200 mg theophylline. Serum creatinine was determined immediately before, 24 and 48 h after CM exposure. As primary endpoint we investigated the incidence of CIN (increase of serum creatinine ≥0.5 mg/dL and/or ≥25% within 48 h of CM).Both groups were comparable regarding baseline characteristics. Incidence of CIN was significantly less frequent with bicarbonate compared to sodium hydration (1/74 [1.4%] vs 7/78 [9.0%]; P = 0.035). Time course of serum creatinine was more favorable in group B with decreases in serum creatinine after 24 h (-0.084 mg/dL [95% confidence interval: -0.035 to -0.133 mg/dL]; P = 0.008) and 48 h (-0.093 mg/dL (-0.025 to -0.161 mg/dL); P = 0.007) compared to baseline which were not observed in group S.In patients at increased risk of CIN receiving prophylactic theophylline, hydration with sodium bicarbonate reduces contrast-induced renal impairment compared to hydration with saline.

  7. Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial.

    PubMed

    Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathi; Gorelick, David A; Wu, Li-Tzy; Gottheil, Edward

    2009-04-01

    Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and long-term treatment of opioid dependence.

  8. The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial.

    PubMed

    Moustafa, Ibrahim M; Diab, Aliaa A

    2015-07-01

    The aim of this study was to investigate the immediate and long-term effects of a one-year multimodal program, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional (3D) postural measures. This randomized clinical trial with one-year follow-up was completed at the research laboratory of our university. A total of 120 (52 female) patients with fibromyalgia syndrome (FMS) and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multimodal program; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), whereas secondary outcomes included Pain Catastrophizing Scale (PCS), algometric score, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and 3D postural measures. Measures were assessed at three time intervals: baseline, 12 weeks, and 1 year after the 12-week follow-up. The general linear model with repeated measures indicated a significant group × time effect in favor of the experimental group on the measures of 3D postural parameters (P < .0005), FIQ (P < .0005), PCS (P < .0005), algometric score (F = P < .0005), PSQI (P < .0005), BAI (P < .0005), and BDI (P < .0005). The addition of the upper cervical manipulative therapy to a multimodal program is beneficial in treating patients with FMS.

  9. Website Use and Effects of Online Information About Tobacco Additives Among the Dutch General Population: A Randomized Controlled Trial

    PubMed Central

    Crutzen, Rik; Kienhuis, Anne S; Talhout, Reinskje; de Vries, Hein

    2017-01-01

    Background As a legal obligation, the Dutch government publishes online information about tobacco additives to make sure that it is publicly available. Little is known about the influence this website (”tabakinfo”) has on visitors and how the website is evaluated by them. Objective This study assesses how visitors use the website and its effect on their knowledge, risk perception, attitude, and smoking behavior. The study will also assess how the website is evaluated by visitors using a sample of the Dutch general population, including smokers and nonsmokers. Methods A randomized controlled trial was conducted, recruiting participants from an online panel. At baseline, participants (N=672) were asked to fill out an online questionnaire about tobacco additives. Next, participants were randomly allocated to either one of two experimental groups and invited to visit the website providing information about tobacco additives (either with or without a database containing product-specific information) or to a control group that had no access to the website. After 3 months, follow-up measurements took place. Results At follow-up (n=492), no statistically significant differences were found for knowledge, risk perception, attitude, or smoking behavior between the intervention and control groups. Website visits were positively related to younger participants (B=–0.07, 95% CI –0.12 to –0.01; t11=–2.43, P=.02) and having a low risk perception toward tobacco additives (B=–0.32, 95% CI –0.63 to –0.02; t11=–2.07, P=.04). In comparison, having a lower education (B=–0.67, 95% CI –1.14 to –0.17; t11=–2.65, P=.01) was a significant predictor for making less use of the website. Furthermore, the website was evaluated less positively by smokers compared to nonsmokers (t324=–3.55, P<.001), and males compared to females (t324=–2.21, P=.02). Conclusions The website did not change perceptions of tobacco additives or smoking behavior. Further research is

  10. Additional benefit of yoga to standard lifestyle modification on blood pressure in prehypertensive subjects: a randomized controlled study.

    PubMed

    Thiyagarajan, Ramkumar; Pal, Pravati; Pal, Gopal Krushna; Subramanian, Senthil Kumar; Trakroo, Madanmohan; Bobby, Zachariah; Das, Ashok Kumar

    2015-01-01

    High blood pressure (BP) is a known risk factor for cardiovascular disease morbidity. Considering the growing evidence of nonpharmacological interventions in the management of high BP, we designed a randomized, parallel active-controlled study on the effect of yoga and standard lifestyle modification (LSM) on BP and heart rate in individuals with prehypertension (systolic BP 120-139 mm Hg and/or diastolic BP 80-89 mm Hg). Volunteers (20-60 years) of both genders without any known cardiovascular disease were randomized into either LSM group (n = 92) or LSM+yoga group (n = 92). Before the intervention, age, waist circumference, physical activity, BP and fasting plasma glucose and lipids were comparable between the groups. After 12 weeks of intervention, we observed a significant reduction in the BP and heart rate in both the groups. Further, the reduction in systolic BP was significantly more in LSM+yoga group (6 mm Hg) as compared with LSM group (4 mm Hg). In addition, 13 prehypertensives became normotensives in LSM+yoga group and four in LSM group. The results indicate efficacy of nonpharmacological intervention and the additional benefit of yoga to standard LSM. Further research in this field may add to the level of evidence on the benefit of yoga, in the reduction of BP in high BP subjects, in the scientific literature.

  11. Smog control fuel additives

    SciTech Connect

    Lundby, W.

    1993-06-29

    A method is described of controlling, reducing or eliminating, ozone and related smog resulting from photochemical reactions between ozone and automotive or industrial gases comprising the addition of iodine or compounds of iodine to hydrocarbon-base fuels prior to or during combustion in an amount of about 1 part iodine per 240 to 10,000,000 parts fuel, by weight, to be accomplished by: (a) the addition of these inhibitors during or after the refining or manufacturing process of liquid fuels; (b) the production of these inhibitors for addition into fuel tanks, such as automotive or industrial tanks; or (c) the addition of these inhibitors into combustion chambers of equipment utilizing solid fuels for the purpose of reducing ozone.

  12. Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training.

    PubMed

    Warschburger, Petra; Kroeller, Katja; Haerting, Johannes; Unverzagt, Susanne; van Egmond-Fröhlich, Andreas

    2016-08-01

    Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects.

  13. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial.

    PubMed

    Added, Marco Aurélio Nemitalla; Costa, Leonardo Oliveira Pena; de Freitas, Diego Galace; Fukuda, Thiago Yukio; Monteiro, Renan Lima; Salomão, Evelyn Cassia; de Medeiros, Flávia Cordeiro; Costa, Lucíola da Cunha Menezes

    2016-07-01

    Study Design Randomized controlled trial. Background Many clinical practice guidelines endorse both manual therapy and exercise as effective treatment options for patients with low back pain. To optimize the effects of the treatments recommended by the guidelines, a new intervention known as Kinesio Taping is being widely used in these patients. Objectives To determine the effectiveness of Kinesio Taping in patients with chronic nonspecific low back pain when added to a physical therapy program consisting of exercise and manual therapy. Methods One hundred forty-eight patients with chronic nonspecific low back pain were randomly allocated to receive 10 (twice weekly) sessions of physical therapy, consisting of exercise and manual therapy, or the same treatment with the addition of Kinesio Taping applied to the lower back. The primary outcomes were pain intensity and disability (5 weeks after randomization) and the secondary outcomes were pain intensity, disability (3 months and 6 months after randomization), global perceived effect, and satisfaction with care (5 weeks after treatment). Data were collected by a blinded assessor. Results No between-group differences were observed in the primary outcomes of pain intensity (mean difference, -0.01 points; 95% confidence interval [CI]: -0.88, 0.85) or disability (mean difference, 1.14 points; 95% CI: -0.85, 3.13) at 5 weeks' follow-up. In addition, no between-group differences were observed for any of the other outcomes evaluated, except for disability 6 months after randomization (mean difference, 2.01 points; 95% CI: 0.03, 4.00) in favor of the control group. Conclusion Patients who received a physical therapy program consisting of exercise and manual therapy did not get additional benefit from the use of Kinesio Taping. Level of Evidence Therapy, level 1b. Prospectively registered May 28, 2013 at www.ClinicalTrials.gov (NCT01866332). J Orthop Sports Phys Ther 2016;46(7):506-513. Epub 6 Jun 2016. doi:10.2519/jospt.2016.6590.

  14. Does addition of `mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  15. Does addition of 'mud-pack and hot pool treatment' to patient education make a difference in fibromyalgia patients? A randomized controlled single blind study.

    PubMed

    Bağdatlı, Ali Osman; Donmez, Arif; Eröksüz, Rıza; Bahadır, Güler; Turan, Mustafa; Erdoğan, Nergis

    2015-12-01

    The aim of this randomized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia. Seventy women with fibromyalgia syndrome were randomly assigned to either balneotherapy with mud-pack and hot pool treatments (35) or control (35) groups. After randomization, five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses. All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme. The patients in balneotherapy group had heated pool treatment at 38 °C for 20 min a day, and mud-pack treatment afterwards on back region at 45 °C. Balneotherapy was applied on weekdays for 2 weeks. All patients continued to take their medical treatment. An investigator who was blinded to the intervention assessed all the patients before and after the treatment, at the first and the third months of follow-up. Outcome measures were FIQ, BDI and both patient's and physician's global assessments. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessments in terms of patient's and physician's global assessment, total FIQ score, and pain intensity, fatigue, non-refreshed awaking, stiffness, anxiety and depression subscales of FIQ. No significant difference was found between the groups in terms of BDI scores. It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone.

  16. Intra-Articular Corticosteroids in Addition to Exercise for Reducing Pain Sensitivity in Knee Osteoarthritis: Exploratory Outcome from a Randomized Controlled Trial

    PubMed Central

    Soriano-Maldonado, Alberto; Klokker, Louise; Bartholdy, Cecilie; Bandak, Elisabeth; Ellegaard, Karen; Bliddal, Henning; Henriksen, Marius

    2016-01-01

    Objective To assess the effects of one intra-articular corticosteroid injection two weeks prior to an exercise-based intervention program for reducing pain sensitivity in patients with knee osteoarthritis (OA). Design Randomized, masked, parallel, placebo-controlled trial involving 100 participants with clinical and radiographic knee OA that were randomized to one intra-articular injection on the knee with either 1 ml of 40 mg/ml methylprednisolone (corticosteroid) dissolved in 4 ml lidocaine (10 mg/ml) or 1 ml isotonic saline (placebo) mixed with 4 ml lidocaine (10 mg/ml). Two weeks after the injections all participants undertook a 12-week supervised exercise program. Main outcomes were changes from baseline in pressure-pain sensitivity (pressure-pain threshold [PPT] and temporal summation [TS]) assessed using cuff pressure algometry on the calf. These were exploratory outcomes from a randomized controlled trial. Results A total of 100 patients were randomized to receive either corticosteroid (n = 50) or placebo (n = 50); 45 and 44, respectively, completed the trial. Four participants had missing values for PPT and one for TS at baseline; thus modified intention-to-treat populations were analyzed. The mean group difference in changes from baseline at week 14 was 0.6 kPa (95% CI: -1.7 to 2.8; P = 0.626) for PPT and 384 mm×sec (95% CI: -2980 to 3750; P = 0.821) for TS. Conclusions These results suggest that adding intra-articular corticosteroid injection 2 weeks prior to an exercise program does not provide additional benefits compared to placebo in reducing pain sensitivity in patients with knee OA. Trial Registration EU clinical trials (EudraCT): 2012-002607-18 PMID:26871954

  17. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children

    PubMed Central

    García-Menor, Emilia; García-Marín, Fátima; Vecino-López, Raquel; Horcajo-Martínez, Gloria; de Ibarrondo Guerrica-Echevarría, María-José; Gómez-González, Pedro; Velasco-Ortega, Syra; Suárez-Almarza, Javier; Nieto-Magro, Concepción

    2016-01-01

    This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001). The duration of diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children. PMID:28229091

  18. Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

    PubMed Central

    Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

    2016-01-01

    Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

  19. Changes in acral blood flux under local application of ropivacaine and lidocaine with and without an adrenaline additive: a double-blind, randomized, placebo-controlled study.

    PubMed

    Häfner, Hans-Martin; Schmid, Ute; Moehrle, Matthias; Strölin, Anke; Breuninger, Helmut

    2008-01-01

    Vascular effects of local anesthetics are especially important in dermatological surgery. In particular, adequate perfusion must be ensured in order to offset surgical manipulations during surgical interventions at the acra. However, the use of adrenaline additives appears fraught with problems when anesthesia affects the terminal vascular system, particularly during interventions at the fingers, toes, penis, outer ears, and tip of the nose. We studied skin blood flux at the fingerpads via laser Doppler flowmetry over the course of 24 hours in a prospective, double-blind, randomized, placebo-controlled study with 20 vascularly healthy test persons following Oberst's-method anesthetic blocks. In each case, 6 ml ropivacaine (7.5 mg/ml) (A), lidocaine 1% without an additive (B), and lidocaine 1% with an adrenaline additive (1:200,000) (C) was used respectively as a verum. Isotonic saline solution was injected as a placebo (D). Measurements were carried out with the aid of a computer simultaneously at D II and D IV on both hands. Administration of (A) led to increased blood flux (+155.2%); of (B) initially to a decrease of 27%; of (C) to a reduction of 55% which was reversible after 40 minutes and of (D) to no change.(A) resulted in sustained vasodilatation which was still demonstrable after 24 h. (B) had notably less vasodilative effect, although comparison with (D) clearly showed that (B) is indeed vasodilative. (C) resulted in only a passing decrease in perfusion; this was no longer measurable when checked after 6 and 24 h. This transient inadequacy of blood flux also appeared after administration of (D). These tests show that adrenaline additive in local anesthesia does not decrease blood flow more than 55% for a period of 16 min. Following these results an adrenaline additive can be safely used for anesthetic blocks at the acra in healthy persons.

  20. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial

    PubMed Central

    Kumar, Ashish; Jha, Sanjeev K.; Mittal, Vibhu V.; Sharma, Praveen; Sharma, Barjesh C.; Sarin, Shiv K.

    2015-01-01

    Background Efficacy of endoscopic sclerotherapy in controlling acute variceal bleeding is significantly improved when vasoactive drug is added. Endoscopic variceal ligation (EVL) is superior to sclerotherapy. Whether efficacy of EVL will also improve with addition of somatostatin is not known. We compared EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding. Methods Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 h after start of therapy, or a 3 gm drop in Hb, or death. Results 61 patients were enrolled (EVL plus somatostatin group, n = 31 and EVL plus placebo group, n = 30). The baseline characteristics were similar. Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). The mortality was also similar in the two groups (3/31 [10%] vs. 3/30 [10%]; P = 1.000). Baseline HVPG ≥19 mm Hg and active bleeding at index endoscopy were independent predictors of treatment failure. Conclusions Addition of somatostatin infusion to EVL therapy does not offer any advantage in control of acute variceal bleeding or reducing mortality. The reason for this may be its failure to maintain sustained reduction in portal pressure for five days. Active bleeding at index endoscopy and high baseline HVPG should help choose early alternative treatment options. Trial registered with ClincalTrials.gov vide NCT01267669. PMID:26628838

  1. The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models. Results One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002). Conclusions When added to the currently recommended first-line care of acute

  2. Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Lahham, Aroub; McDonald, Christine F; Holland, Anne E

    2016-01-01

    Background Physical inactivity is associated with poor outcomes in COPD, and as a result, interventions to improve physical activity (PA) are a current research focus. However, many trials have been small and inconclusive. Objective The aim of this systematic review and meta-analysis was to study the effects of randomized controlled trials (RCTs) targeting PA in COPD. Methods Databases (Physiotherapy Evidence Database [PEDro], Embase, MEDLINE, CINAHL and the Cochrane Central Register for Controlled Trials) were searched using the following keywords: “COPD”, “intervention” and “physical activity” from inception to May 20, 2016; published RCTs that aimed to increase PA in individuals with COPD were included. The PEDro scale was used to rate study quality. Standardized mean differences (effect sizes, ESs) with 95% confidence intervals (CIs) were determined. Effects of included interventions were also measured according to the minimal important difference (MID) in daily steps for COPD (599 daily steps). Results A total of 37 RCTs with 4,314 participants (mean forced expiratory volume in one second (FEV1) % predicted 50.5 [SD=10.4]) were identified. Interventions including exercise training (ET; n=3 studies, 103 participants) significantly increased PA levels in COPD compared to standard care (ES [95% CI]; 0.84 [0.44–1.25]). The addition of activity counseling to pulmonary rehabilitation (PR; n=4 studies, 140 participants) showed important effects on PA levels compared to PR alone (0.47 [0.02–0.92]), achieving significant increases that exceeded the MID for daily steps in COPD (mean difference [95% CI], 1,452 daily steps [549–2,356]). Reporting of methodological quality was poor in most included RCTs. Conclusion Interventions that included ET and PA counseling during PR were effective strategies to improve PA in COPD. PMID:27994451

  3. Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

    PubMed Central

    2013-01-01

    Background Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient. Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma. Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. Methods/design The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later. The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment. In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed. The statistical analysis of the primary outcome will be performed

  4. Additive effects of nutritional supplementation, together with bisphosphonates, on bone mineral density after hip fracture: a 12-month randomized controlled study

    PubMed Central

    Flodin, Lena; Sääf, Maria; Cederholm, Tommy; Al-Ani, Amer N; Ackermann, Paul W; Samnegård, Eva; Dalen, Nils; Hedström, Margareta

    2014-01-01

    Background After a hip fracture, a catabolic state develops, with increased bone loss during the first year. The aim of this study was to evaluate the effects of postoperative treatment with calcium, vitamin D, and bisphosphonates (alone or together) with nutritional supplementation on total hip and total body bone mineral density (BMD). Methods Seventy-nine patients (56 women), with a mean age of 79 years (range, 61–96 years) and with a recent hip fracture, who were ambulatory before fracture and without severe cognitive impairment, were included. Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly) for 12 months (B; n=28), treatment with bisphosphonates along with nutritional supplementation (40 g protein, 600 kcal daily) for the first 6 months (BN; n=26), or to controls (C; n=25). All participants received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6, and 12 months. Marker of bone resorption C-terminal telopeptide of collagen I and 25-hydroxy vitamin D were analyzed in serum. Results Analysis of complete cases (70/79 at 6 months and 67/79 at 12 months) showed an increase in total hip BMD of 0.7% in the BN group, whereas the B and C groups lost 1.1% and 2.4% of BMD, respectively, between baseline and 6 months (P=0.071, between groups). There was no change in total body BMD between baseline and 12 months in the BN group, whereas the B group and C group both lost BMD, with C losing more than B (P=0.009). Intention-to-treat analysis was in concordance with the complete cases analyses. Conclusion Protein-and energy-rich supplementation in addition to calcium, vitamin D, and bisphosphonate therapy had additive effects on total body BMD and total hip BMD among elderly hip fracture patients. PMID:25045257

  5. Analysis of Additive Random Number Generators.

    DTIC Science & Technology

    1977-03-01

    linear congruential generators yn*\\* ayn+bmo,iPa- The simplest example of a sequence satisfying (1.1) with *> I is the Fibonacci sequence with p - 2...However, the Fibonacci sequence is not a suitable random number generator because successive triples are very poorly distributed in three...number generator should have small discrepancy. Definition 2.1 can be extended naturally to define discrepancy for sequences of points yn lying in

  6. Role of addition of dexamethasone to lignocaine 2% with adrenaline in dental nerve blocks for third molar surgery: A prospective randomized control trial

    PubMed Central

    Deo, Saroj Prasad

    2016-01-01

    Context: Dexamethasone has been frequently used in oral surgical procedure and accepted by oral and maxillofacial surgeon community worldwide. However, this is the first clinical trial that used dexamethasone as adjuvant with lignocaine in dental nerve block (DNB). Aims: The purpose of this double-blind, randomized control trial (RCT) was to compare the effect of dexamethasone with normal saline (NS) in a lignocaine DNB. Settings and Design: This prospective, double-blind, RCT was carried out after obtaining approval from the Institutional Ethical Committee. Subjects and Methods: In forty patients, the present placebo-controlled clinical trial was conducted; allocated randomly into two groups: study group (SG) or control group (CG). The single-dose submucosal dexamethasone or NS injection was administered immediately after 2% lignocaine with epinephrine 1:2,00,000 nerves block during mandibular third molar surgery (TMS). Visual analog scale score, number, and exact time nonsteroidal anti-inflammatory drugs were administered were used to measure postoperative analgesia in 2nd and 7th days. Statistical Analysis Used: All the data were entered into the Spreadsheet (Excel, Microsoft) and Chi-square test, Mann–Whitney U-test, Student's paired and unpaired t-test, and Fisher exact test were used. Results: This study found maximum duration of DNB in SG was 248.88 min and in CG was 175.44 min, whereas minimum duration in SG was 197 min and in CG was 140.78 min. Conclusions: Dexamethasone prolongs the action of lignocaine 2% in DNB for TMS. PMID:28299268

  7. Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Myocardial infarction causes irreversible loss of cardiomyocytes and may lead to loss of ventricular function, morbidity and mortality. Infarct size is a major prognostic factor and reduction of infarct size has therefore been an important objective of strategies to improve outcomes. In experimental studies, glucagon-like peptide 1 and exenatide, a long acting glucagon-like peptide 1 receptor agonist, a novel drug introduced for the treatment of type 2 diabetes, reduced infarct size after myocardial infarction by activating pro-survival pathways and by increasing metabolic efficiency. Methods The EXAMI trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate clinical outcome of exenatide infusion on top of standard treatment, in patients with an acute myocardial infarction, successfully treated with primary percutaneous coronary intervention. A total of 108 patients will be randomized to exenatide (5 μg bolus in 30 minutes followed by continuous infusion of 20 μg/24 h for 72 h) or placebo treatment. The primary end point of the study is myocardial infarct size (measured using magnetic resonance imaging with delayed enhancement at 4 months) as a percentage of the area at risk (measured using T2 weighted images at 3-7 days). Discussion If the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction. Trial registration ClinicalTrials.gov: NCT01254123 PMID:22067476

  8. Additive effect of elcatonin to risedronate for chronic back pain and quality of life in postmenopausal women with osteoporosis: a randomized controlled trial.

    PubMed

    Hongo, Michio; Miyakoshi, Naohisa; Kasukawa, Yuji; Ishikawa, Yoshinori; Shimada, Yoichi

    2015-07-01

    Calcitonin has been reported to reduce acute and chronic back pain in osteoporotic patients. The additive effect of calcitonin with a bisphosphonate on chronic back pain remains unclear. The purpose of this study was to evaluate the effect of combining elcatonin (eel calcitonin) with risedronate for patients with chronic back pain. Forty-five postmenopausal women diagnosed as having osteoporosis with chronic back pain persisting for more than 3 months, after excluding women with fresh vertebral fractures within the last 6 months, were randomly allocated to a risedronate group (risedronate alone, n = 22) and a combined group (risedronate and elcatonin, n = 23). The study period was 6 months. Pain was evaluated with a visual analogue scale (VAS) and the Roland-Morris questionnaire (RDQ). Back extensor strength, bone mineral density, and quality of life on the SF-36 and the Japanese osteoporosis quality of life score were also evaluated. Significant improvements were found in the combined group for VAS at final follow-up compared with baseline and 3 months, mental health status on the SF-36, and JOQOL domains for back pain and general health. The JOQOL domain for back pain improved significantly, but no change was found in the VAS or other domains in the risedronate group. Bone mineral density increased significantly in the two groups, but no significant difference was found between the groups. Back extensor strength did not change in both groups. In conclusion, the use of elcatonin in addition to risedronate for more than 3 months reduced chronic back pain. The additional therapy of risedronate with elcatonin may be a useful and practical choice for the treatment of osteoporosis with chronic back pain persisting more than 3 months.

  9. Addition of Ceftriaxone and Amikacin to a Ciprofloxacin plus Metronidazole Regimen for Preventing Infectious Complications of Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized Controlled Trial

    PubMed Central

    Izadpanahi, Mohammad-Hossein; Majidi, Seyed Mahmood; Khorrami, Mohammad-Hatef; Mohammadi-Sichani, Mehrdad

    2017-01-01

    Background. The objective of this study was to evaluate the efficacy of adding single doses of ceftriaxone and amikacin to a ciprofloxacin plus metronidazole regimen on the reduction of infectious complications following transrectal ultrasound-guided prostate biopsy (TRUS Bx). Materials and Methods. Four hundred and fifty patients who were candidates for TRUS Bx were divided into two groups of 225 each. The control group received ciprofloxacin 500 mg orally every 12 hours together with metronidazole 500 mg orally every 8 hours from the day prior to the procedure until the fifth postoperative day. In the second group, single doses of ceftriaxone 1 g by intravenous infusion and amikacin 5 mg/kg intramuscularly were administered 30–60 minutes before TRUS Bx in addition to the oral antimicrobials described for group 1. The incidence of infection was compared between the groups. Results. The incidence of infectious complications in the intervention group was significantly lower than that in the control group (4.6% versus 0.9%, p = 0.017). Conclusion. The addition of single doses of intramuscular amikacin and intravenously infused ceftriaxone to our prophylactic regimen of ciprofloxacin plus metronidazole resulted in a statistically significant reduction of infectious complications following TRUS Bx. PMID:28167960

  10. Addition of vitamin B12 to exercise training improves cycle ergometer endurance in advanced COPD patients: A randomized and controlled study.

    PubMed

    Paulin, Fernanda Viana; Zagatto, Alessandro Moura; Chiappa, Gaspar R; Müller, Paulo de Tarso

    2017-01-01

    Vitamin B12 is essential in the homocysteine, mitochondrial, muscle and hematopoietic metabolisms, and its effects on exercise tolerance and kinetics adjustments of oxygen consumption (V'O2p) in rest-to-exercise transition in COPD patients are unknown. This randomized, double-blind, controlled study aimed to verify a possible interaction between vitamin B12 supplementation and these outcomes. After recruiting 69 patients, 35 subjects with moderate-to-severe COPD were eligible and 32 patients concluded the study, divided into four groups (n = 8 for each group): 1. rehabilitation group; 2. rehabilitation plus B12 group; 3. B12 group; and 4. placebo group. The primary endpoint was cycle ergometry endurance before and after 8 weeks and the secondary endpoints were oxygen uptake kinetics parameters (time constant). The prevalence of vitamin B12 deficiency was high (34.4%) and there was a statistically significant interaction (p < 0.05), favoring a global effect of supplementation on exercise tolerance in the supplemented groups compared to the non-supplemented groups, even after adjusting for confounding variables (p < 0.05). The same was not found for the kinetics adjustment variables (τV'O2p and MRTV'O2p, p > 0.05 for both). Supplementation with vitamin B12 appears to lead to discrete positive effects on exercise tolerance in groups of subjects with more advanced COPD and further studies are needed to establish indications for long-term supplementation.

  11. The addition of STEPPS in the treatment of patients with bipolar disorder and comorbid borderline personality features: a protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Bipolar disorder (BD) and borderline personality disorder (BPD) both are severe and chronic psychiatric disorders. Both disorders have overlapping symptoms, and current research shows that the presence of a BPD has an adverse effect on the course of BD. The limited research available shows an unfavorable illness course, a worse prognosis and response to medication, longer treatment duration, more frequent psychiatric admissions, higher drop-out, increased risk of substance abuse, increased risk of suicide, and more impairment of social and occupational functioning. However, there is no research available on the effect of specific psychotherapeutic treatment for this patients. Methods/Design This paper presents the protocol of a RCT to investigate the presence of borderline personality features in patients treated for BD (study part 1) and the effectiveness of STEPPS (Systems Training for Emotional Predictability and Problem Solving) added to treatment as usual (TAU) for BD compared to TAU in patients with BD and comorbid borderline personality features (study part 2). STEPPS is a validated and effective intervention for BPD. The study population consists of patients treated for BD at specialized outpatient clinics for BD in the Netherlands. At first the prevalence of comorbid borderline personality features in outpatients with BD is investigated. Inclusion criteria for study part 2 is defined as having three or more of the DSM-IV-TR diagnostic criteria of BPD, including impulsivity and anger bursts. Primary outcomes will be the frequency and severity of manic and depressive recurrences as well as severity, course and burden of borderline personality features. Secondary outcomes will be quality of life, utilizing mental healthcare and psychopathologic symptoms not primarily related to BD or BPD. Assessment will be at baseline, at the end of the intervention, and at 12 and 18 months follow-up. Discussion This will be the first randomized controlled trial

  12. New ESP additive controls particulates

    SciTech Connect

    Durham, M.D.; Baldrey, K.E.; Bustard, C.J.; Martin, C.E.; Dharmarajan, N.N.

    1997-06-01

    This article reports that a conditioning agent enhanced precipitator performance after plant switched to low-sulfur coal. Firing low-sulfur coal at a power plant designed for medium- or high-sulfur coal will impact the downstream particulate control device. Since the performance of an electro-static precipitator (ESP) is a strong function of the sulfur content in the coal, switching to a low-sulfur coal will severely impact collection efficiency. Particle resistivity is the dominant parameter affecting the performance of an ESP. When the resistivity is too high, the ESP must be increased in size by a factor of two to three, resulting in proportionally increased capital and operating costs. Fly ash from low-sulfur coal is known to have a typical resistivity one or two orders of magnitude above that for ideal collection efficiency in a well-designed ESP. Therefore, when a utility burning a medium- or high-sulfur coal switches to a low-sulfur coal, the increase in particle resistivity resulting from the reduced SO{sub 3} concentration will lead to severe problems in the ESP. There have been many instances where utilities have switched from a high- to a low-sulfur coal, and the problems caused by the increased resistivity have had such a devastating effect on the performance of the ESP that emissions have increased by a factor of 10.

  13. The effect of addition of low dose fentanyl to epidural bupivacaine (0.5%) in patients undergoing elective caesarean section: A randomized, parallel group, double blind, placebo controlled study

    PubMed Central

    Parate, LH; Manjrekar, SP; Anandaswamy, TC; Manjunath, B

    2015-01-01

    Background: Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block. Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression. Aims: Our primary aim was to evaluate the analgesic effect of addition of 50 μg fentanyl to epidural 0.5% bupivacaine in patients undergoing elective caesarean section using visual analog scale. The secondary aim was to assess onset of analgesia, volume of drug required to achieve T6 level, grade and duration of motor block and Apgar score. Materials and Methods: In this prospective, randomized, double blind, placebo controlled study 64 patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of 32 each. The fentanyl group received 1ml of 50 μg fentanyl and the saline group received 1ml of normal saline mixed with 10ml of 0.5% bupivacaine for epidural anesthesia. VAS score, time to achieve T6 level, dose of bupivacaine, intraoperative analgesic consumption and duration of analgesia, grade and duration of motor block and any adverse maternal and neonatal effects were noted. Statistical Analysis: Data was analyzed using Students t test, chi-square test and Mann-Whitney U-test. The values of P < 0.05 were considered statistically significant. Results: Fentanyl improved the VAS score significantly (1.6 ± 1.32) compared to the saline group (3.77 ± 1.0, P < 0.0001). It also reduced the intraoperaitve analgesic supplementation compared to the saline group. (P = 0.031). The postoperative duration of analgesia was prolonged in the fentanyl group (275.80 ± 13.61 min) compared to the saline group (191.47 ± 12.16 min, P < 0.0001). The other characteristics of epidural block were unaltered. Conclusion: Addition of 50 μg fentanyl to epidural 0.5% bupivacaine significantly reduces the VAS score. It also reduces intra-operative analgesia supplementation and prolongs the duration

  14. Fuel compositions containing deposit control additives

    SciTech Connect

    Lilburn, J.E.

    1980-11-18

    Fuel compositions are provided which contain a deposit control additive. The deposit control additive is produced by reacting a hydrocarbylpoly(oxyalkylene) alcohol with excess phosgene and an excess amount of certain polyamines. The product comprises hydrocarbylpoly(oxyalkylene) ureylene carbamates.

  15. The Additive Effects of Choice and Control.

    ERIC Educational Resources Information Center

    Karbowski, Joseph; And Others

    In separate research studies, students who were given a choice of learning materials or who had control over aversive noise, demonstrated higher motivation and better task performance. To investigate the additive effects of choice and control on perception of control, 80 male and female college students participated in a 2 (choice vs. no-choice) X…

  16. Random attractors for the stochastic coupled fractional Ginzburg-Landau equation with additive noise

    SciTech Connect

    Shu, Ji E-mail: 530282863@qq.com; Li, Ping E-mail: 530282863@qq.com; Zhang, Jia; Liao, Ou

    2015-10-15

    This paper is concerned with the stochastic coupled fractional Ginzburg-Landau equation with additive noise. We first transform the stochastic coupled fractional Ginzburg-Landau equation into random equations whose solutions generate a random dynamical system. Then we prove the existence of random attractor for random dynamical system.

  17. Combined dispersant fluid loss control additives

    SciTech Connect

    Villa, J. L.; Zeiner, R. N.

    1985-12-31

    Water soluble polymer compositions containing polyacrylic acid and copolymer of itaconic acid and acrylamide are useful as combined dispersant and fluid loss control additives for aqueous drilling fluids, particularly fresh water, gypsum and seawater muds. An example is a polymer composition containing about 80% by weight polyacrylic acid and about 20% by weight copolymer of itaconic acid and acrylamide in its ammonium salt form.

  18. Additive and subtractive scrambling in optional randomized response modeling.

    PubMed

    Hussain, Zawar; Al-Sobhi, Mashail M; Al-Zahrani, Bander

    2014-01-01

    This article considers unbiased estimation of mean, variance and sensitivity level of a sensitive variable via scrambled response modeling. In particular, we focus on estimation of the mean. The idea of using additive and subtractive scrambling has been suggested under a recent scrambled response model. Whether it is estimation of mean, variance or sensitivity level, the proposed scheme of estimation is shown relatively more efficient than that recent model. As far as the estimation of mean is concerned, the proposed estimators perform relatively better than the estimators based on recent additive scrambling models. Relative efficiency comparisons are also made in order to highlight the performance of proposed estimators under suggested scrambling technique.

  19. Optimal Quantum Control Using Randomized Benchmarking

    NASA Astrophysics Data System (ADS)

    Kelly, J.; Barends, R.; Campbell, B.; Chen, Y.; Chen, Z.; Chiaro, B.; Dunsworth, A.; Fowler, A. G.; Hoi, I.-C.; Jeffrey, E.; Megrant, A.; Mutus, J.; Neill, C.; O'Malley, P. J. J.; Quintana, C.; Roushan, P.; Sank, D.; Vainsencher, A.; Wenner, J.; White, T. C.; Cleland, A. N.; Martinis, John M.

    2014-06-01

    We present a method for optimizing quantum control in experimental systems, using a subset of randomized benchmarking measurements to rapidly infer error. This is demonstrated to improve single- and two-qubit gates, minimize gate bleedthrough, where a gate mechanism can cause errors on subsequent gates, and identify control crosstalk in superconducting qubits. This method is able to correct parameters so that control errors no longer dominate and is suitable for automated and closed-loop optimization of experimental systems.

  20. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

    Mayo-Wilson, Evan; Grant, Sean; Montgomery, Paul

    2014-01-01

    Randomized controlled trials (RCTs) are increasingly used to evaluate programs and interventions in order to inform education policy and practice. High quality reports of these RCTs are needed for interested readers to understand the rigor of the study, the interventions tested, and the context in which the evaluation took place (Mayo-Wilson et…

  1. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    ERIC Educational Resources Information Center

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

    In this paper, we present a dataset consisting of data generated from 22 previously and currently running randomized controlled experiments inside the ASSISTments online learning platform. This dataset provides data mining opportunities for researchers to analyze ASSISTments data in a convenient format across multiple experiments at the same time.…

  2. Laboratory tests of sludge-control additives

    SciTech Connect

    Tatnall, R.E.

    1996-07-01

    Laboratory {open_quotes}jar{close_quotes} tests compared eleven different fuel oil and diesel fuel sludge-control additives. Factors studied included (1) ability to disperse and prevent buildup of sludge deposits on surfaces, (2) ability to protect steel from corrosion, (3) ability to inhibit growth and proliferation of bacteria, and (4) ability to disperse water. Results varied greatly, and it was found that many commercial products do not do what they claim. It is concluded that fuel retailers should not believe manufacturers` claims for their additive products, but rather should test such products themselves to be sure that the benefits of treatment are real. A simplified form of the procedure used here is proposed as one way for dealers to do such testing.

  3. Limited Effect of Rebamipide in Addition to Proton Pump Inhibitor (PPI) in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers: A Randomized Controlled Trial Comparing PPI Plus Rebamipide Combination Therapy with PPI Monotherapy

    PubMed Central

    Nakamura, Kazuhiko; Ihara, Eikichi; Akiho, Hirotada; Akahoshi, Kazuya; Harada, Naohiko; Ochiai, Toshiaki; Nakamura, Norimoto; Ogino, Haruei; Iwasa, Tsutomu; Aso, Akira; Iboshi, Yoichiro; Takayanagi, Ryoichi

    2016-01-01

    Background/Aims The ability of endoscopic submucosal dissection (ESD) to resect large early gastric cancers (EGCs) results in the need to treat large artificial gastric ulcers. This study assessed whether the combination therapy of rebamipide plus a proton pump inhibitor (PPI) offered benefits over PPI monotherapy. Methods In this prospective, randomized, multicenter, open-label, and comparative study, patients who had undergone ESD for EGC or gastric adenoma were randomized into groups receiving either rabeprazole monotherapy (10 mg/day, n=64) or a combination of rabeprazole plus rebamipide (300 mg/day, n=66). The Scar stage (S stage) ratio after treatment was compared, and factors independently associated with ulcer healing were identified by using multivariate analyses. Results The S stage rates at 4 and 8 weeks were similar in the two groups, even in the subgroups of patients with large amounts of tissue resected and regardless of CYP2C19 genotype. Independent factors for ulcer healing were circumferential location of the tumor and resected tissue size; the type of treatment did not affect ulcer healing. Conclusions Combination therapy with rebamipide and PPI had limited benefits compared with PPI monotherapy in the treatment of post-ESD gastric ulcer (UMIN Clinical Trials Registry, UMIN000007435). PMID:27282261

  4. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  5. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

    Rushton, Alan; Monck, Elizabeth; Leese, Morven; McCrone, Paul; Sharac, Jessica

    2010-10-01

    The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a "services as usual" group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference (p < 0.007) was found for "satisfaction with parenting" in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters' satisfaction with parenting in the intervention group compared to the routine service group.

  6. Sham Electroacupuncture Methods in Randomized Controlled Trials

    PubMed Central

    Chen, Zi-xian; Li, Yan; Zhang, Xiao-guang; Chen, Shuang; Yang, Wen-ting; Zheng, Xia-wei; Zheng, Guo-qing

    2017-01-01

    Sham electroacupuncture (EA) control is commonly used to evaluate the specific effects of EA in randomized-controlled trials (RCTs). However, establishing an inert and concealable sham EA control remains methodologically challenging. Here, we aimed to systematically investigate the sham EA methods. Eight electronic databases were searched from their inception to April 2015. Ten out of the 17 sham EA methods were identified from 94 RCTs involving 6134 participants according to three aspects: needle location, depth of needle insertion and electrical stimulation. The top three most frequently used types were sham EA type A, type L and type O ordinally. Only 24 out of the 94 trials reported credibility tests in six types of sham EA methods and the results were mainly as follows: sham EA type A (10/24), type B (5/24) and type Q (5/24). Compared with sham EA controls, EA therapy in 56.2% trials reported the specific effects, of which the highest positive rate was observed in type N (3/4), type F (5/7), type D (4/6) and type M (2/3). In conclusion, several sham EA types were identified as a promising candidate for further application in RCTs. Nonetheless, more evidence for inert and concealable sham EA control methods is needed. PMID:28106094

  7. Iron-control additives improve acidizing

    SciTech Connect

    Walker, M.; Dill, W. ); Besler, M. )

    1989-07-24

    Iron sulfide and sulfur precipitation in sour wells can be controlled with iron-sequestering agents and sulfide modifiers. Oil production has been routinely increased in sour wells where precipitation of iron sulfide and elemental sulfur has been brought under control. Production increases have been especially noteworthy on wells that had a history of rapid production decline after acid stimulation. Twenty-fold production increases have been recorded. Key to the production increase has been to increase permeability with: Iron chelating agents that control precipitation of iron sulfide. A sulfide modifier that reduces precipitation of solids in the presence of excessive amounts of hydrogen sulfide and prevents precipitation of elemental sulfur.

  8. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

    Fennis, W.M.; Kuijs, R.H.; Roeters, F.J.; Creugers, N.H.; Kreulen, C.M.

    2014-01-01

    The objective of this randomized control trial was to compare the five-year clinical performance of direct and indirect resin composite restorations replacing cusps. In 157 patients, 176 restorations were made to restore maxillary premolars with Class II cavities and one missing cusp. Ninety-two direct and 84 indirect resin composite restorations were placed by two operators, following a strict protocol. Treatment technique and operator were assigned randomly. Follow-up period was at least 4.5 yrs. Survival rates were determined with time to reparable failure and complete failure as endpoints. Kaplan-Meier five-year survival rates were 86.6% (SE 0.27%) for reparable failure and 87.2% (SE 0.27%) for complete failure. Differences between survival rates of direct and indirect restorations [89.9% (SE 0.34%) vs. 83.2% (SE 0.42%) for reparable failure and 91.2% (SE 0.32%) vs. 83.2% (SE 0.42%) for complete failure] were not statistically significant (p = .23 for reparable failure; p = .15 for complete failure). Mode of failure was predominantly adhesive. The results suggest that direct and indirect techniques provide comparable results over the long term (trial registration number: ISRCTN29200848). PMID:24155264

  9. CONTROL ROD ALLOY CONTAINING NOBLE METAL ADDITIONS

    DOEpatents

    Anderson, W.K.; Ray, W.E.

    1960-05-01

    Silver-base alloys suitable for use in the fabrication of control rods for neutronic reactors are given. The alloy consists of from 0.5 wt.% to about 1.5 wt.% of a noble metal of platinum, ruthenium, rhodium, osmium, or palladium, up to 10 wt.% of cadmium, from 2 to 20 wt.% indium, the balance being silver.

  10. Microstructural Control of Additively Manufactured Metallic Materials

    NASA Astrophysics Data System (ADS)

    Collins, P. C.; Brice, D. A.; Samimi, P.; Ghamarian, I.; Fraser, H. L.

    2016-07-01

    In additively manufactured (AM) metallic materials, the fundamental interrelationships that exist between composition, processing, and microstructure govern these materials’ properties and potential improvements or reductions in performance. For example, by using AM, it is possible to achieve highly desirable microstructural features (e.g., highly refined precipitates) that could not otherwise be achieved by using conventional approaches. Simultaneously, opportunities exist to manage macro-level microstructural characteristics such as residual stress, porosity, and texture, the last of which might be desirable. To predictably realize optimal microstructures, it is necessary to establish a framework that integrates processing variables, alloy composition, and the resulting microstructure. Although such a framework is largely lacking for AM metallic materials, the basic scientific components of the framework exist in literature. This review considers these key components and presents them in a manner that highlights key interdependencies that would form an integrated framework to engineer microstructures using AM.

  11. Randomized controlled trials - a matter of design.

    PubMed

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

  12. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

    Yulmetyev, Renat M.; Yulmetyeva, Dinara; Gafarov, Fail M.

    2005-08-01

    We discuss the fundamental role that chaosity and randomness play in the determination of quality and efficiency of medical treatment. The statistical parameter of non-Markovity from non-equilibrium statistical physics of condensed matters is offered as a quantitative information measure of chaosity and randomness. The role of chaosity and randomness is determined by the phenomenological property, which includes quantitative informational measures of chaosity and randomness and pathology (disease) in a covariant form. Manifestations of the statistical informational behavior of chaosity and randomness are examined while analyzing the chaotic dynamics of RR intervals from human ECG's, the electric signals of a human muscle's tremor of legs in a normal state and at Parkinson disease, the electric potentials of the human brain core from EEG's during epileptic seizure and a human hand finger tremor in Parkinson's disease. The existence of the above stated informational measure allows to introduce the quantitative factor of the quality of treatment. The above-stated examples confirm the existence of new phenomenological property, which is important not only for the decision of medical problems, but also for the analysis of the wide range of problems of physics of complex systems of life and lifeless nature.

  13. Understanding and control of random lasing

    NASA Astrophysics Data System (ADS)

    Burin, Alexander L.; Cao, Hui; Ratner, Mark A.

    2003-10-01

    Random lasing attracts much attention because it helps to understand coherent phenomena in disordered media and can be used in optoelectronics due to easy preparation (no need in mirrors) and small size of random lasers down to few microns. Recently the remarkable progress in studying the material, geometry and external pumping dependences of laser properties and efficiency has been reached. Lasing emerges from the special random cavities of high quality formed within the active medium. They can be described as the decaying eigenoptical modes within the medium and the optical mode having the minimum decay rate is responsible for lasing. Numerical and analytical studies of the properties of these modes permit to interpret existing experiments and suggest the ways to optimize the performance of lasers.

  14. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

    Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs.

  15. Entropy and long-range memory in random symbolic additive Markov chains

    NASA Astrophysics Data System (ADS)

    Melnik, S. S.; Usatenko, O. V.

    2016-06-01

    The goal of this paper is to develop an estimate for the entropy of random symbolic sequences with elements belonging to a finite alphabet. As a plausible model, we use the high-order additive stationary ergodic Markov chain with long-range memory. Supposing that the correlations between random elements of the chain are weak, we express the conditional entropy of the sequence by means of the symbolic pair correlation function. We also examine an algorithm for estimating the conditional entropy of finite symbolic sequences. We show that the entropy contains two contributions, i.e., the correlation and the fluctuation. The obtained analytical results are used for numerical evaluation of the entropy of written English texts and DNA nucleotide sequences. The developed theory opens the way for constructing a more consistent and sophisticated approach to describe the systems with strong short-range and weak long-range memory.

  16. Multiple Shaker Random Vibration Control--An Update

    SciTech Connect

    Smallwood, D.O.

    1999-02-18

    The theory of the control of multiple shakers driving a single test item is reviewed. Several improvements that have been introduced since the original papers on the subject will be discussed. The improvements include: (1) specification of the control spectra; (2) the control of non-square systems (the number of shakers does not have to be equal to the number of control points); (3) the connection between sine testing, waveform control, and random control; (4) improvements in feedback control; (5) overlap-add versus time domain randomization; and (6) reproduction of non-Gaussian waveforms.

  17. Standardization for subgroup analysis in randomized controlled trials.

    PubMed

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

    Randomized controlled trials (RCTs) emphasize the average or overall effect of a treatment (ATE) on the primary endpoint. Even though the ATE provides the best summary of treatment efficacy, it is of critical importance to know whether the treatment is similarly efficacious in important, predefined subgroups. This is why the RCTs, in addition to the ATE, also present the results of subgroup analysis for preestablished subgroups. Typically, these are marginal subgroup analysis in the sense that treatment effects are estimated in mutually exclusive subgroups defined by only one baseline characteristic at a time (e.g., men versus women, young versus old). Forest plot is a popular graphical approach for displaying the results of subgroup analysis. These plots were originally used in meta-analysis for displaying the treatment effects from independent studies. Treatment effect estimates of different marginal subgroups are, however, not independent. Correlation between the subgrouping variables should be addressed for proper interpretation of forest plots, especially in large effectiveness trials where one of the goals is to address concerns about the generalizability of findings to various populations. Failure to account for the correlation between the subgrouping variables can result in misleading (confounded) interpretations of subgroup effects. Here we present an approach called standardization, a commonly used technique in epidemiology, that allows for valid comparison of subgroup effects depicted in a forest plot. We present simulations results and a subgroup analysis from parallel-group, placebo-controlled randomized trials of antibiotics for acute otitis media.

  18. Meaninglessness in terminally ill cancer patients: a randomized controlled study.

    PubMed

    Morita, Tatsuya; Murata, Hisayuki; Kishi, Emi; Miyashita, Mitsunori; Yamaguchi, Takuhiro; Uchitomi, Yosuke

    2009-04-01

    Although recent empirical studies reveal that fostering patients' perception of meaning in their lives is an essential task for palliative care clinicians, few studies have reported the effects of training programs for nurses specifically aimed at improving these skills. The primary aim of this randomized controlled trial was to determine the effects of an educational workshop focusing on patients' feelings of meaninglessness on nurses' confidence, self-reported practice, and attitudes toward caring for such patients, in addition to burnout and meaning of life. The study was designed as a single-institution, randomized controlled trial using a waiting list control. The intervention consisted of eight 180-minute training sessions over four months, including lectures and exercises using structured assessment. A total of 41 nurses were randomly allocated to three groups, which were separately trained, and all were evaluated four times at three-month intervals (before intervention, between each intervention, and after the last intervention). Assessments included validated Confidence and Self-Reported Practice scales, the Attitudes Toward Caring for Patients Feeling Meaningless Scale (including willingness to help, positive appraisal, and helplessness items), the Maslach Burnout Scale, job satisfaction, and the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). One participant withdrew from the study before the baseline evaluation, and the remaining 40 nurses completed the study. The nurses were all female and had a mean age of 31+/-6.4, and mean clinical experience of 8.9+/-5.5 years. There were no significant differences in background among the groups. The intervention effects were statistically significant on the Confidence Scale, the Self-Reported Practice Scale, and the willingness to help, positive appraisal, and helplessness subscales, in addition to the overall levels of burnout, emotional exhaustion, personal accomplishment, job satisfaction

  19. One of two rotodip feeders used to control addition of ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    One of two rotodip feeders used to control addition of alum solution into the water - Division Avenue Pumping Station & Filtration Plant, West 45th Street and Division Avenue, Cleveland, Cuyahoga County, OH

  20. Control of pyrite addition in coal liquefaction process

    DOEpatents

    Schmid, Bruce K.; Junkin, James E.

    1982-12-21

    Pyrite addition to a coal liquefaction process (22, 26) is controlled (118) in inverse proportion to the calcium content of the feed coal to maximize the C.sub.5 --900.degree. F. (482.degree. C.) liquid yield per unit weight of pyrite added (110). The pyrite addition is controlled in this manner so as to minimize the amount of pyrite used and thus reduce pyrite contribution to the slurry pumping load and disposal problems connected with pyrite produced slag.

  1. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    DTIC Science & Technology

    2016-03-01

    of Defense (DoD) Telemedicine and Advanced Technology Research Center (TATRC) funded randomized controlled trial of the Caring Letters intervention to...AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release

  2. An efficient voting algorithm for finding additive biclusters with random background.

    PubMed

    Xiao, Jing; Wang, Lusheng; Liu, Xiaowen; Jiang, Tao

    2008-12-01

    The biclustering problem has been extensively studied in many areas, including e-commerce, data mining, machine learning, pattern recognition, statistics, and, more recently, computational biology. Given an n x m matrix A (n >or= m), the main goal of biclustering is to identify a subset of rows (called objects) and a subset of columns (called properties) such that some objective function that specifies the quality of the found bicluster (formed by the subsets of rows and of columns of A) is optimized. The problem has been proved or conjectured to be NP-hard for various objective functions. In this article, we study a probabilistic model for the implanted additive bicluster problem, where each element in the n x m background matrix is a random integer from [0, L - 1] for some integer L, and a k x k implanted additive bicluster is obtained from an error-free additive bicluster by randomly changing each element to a number in [0, L - 1] with probability theta. We propose an O(n(2)m) time algorithm based on voting to solve the problem. We show that when k >or= Omega(square root of (n log n)), the voting algorithm can correctly find the implanted bicluster with probability at least 1 - (9/n(2)). We also implement our algorithm as a C++ program named VOTE. The implementation incorporates several ideas for estimating the size of an implanted bicluster, adjusting the threshold in voting, dealing with small biclusters, and dealing with overlapping implanted biclusters. Our experimental results on both simulated and real datasets show that VOTE can find biclusters with a high accuracy and speed.

  3. Active control of multi-dimensional random sound in ducts

    NASA Technical Reports Server (NTRS)

    Silcox, R. J.; Elliott, S. J.

    1990-01-01

    Previous work has demonstrated how active control may be applied to the control of random noise in ducts. These implementations, however, have been restricted to frequencies where only plane waves are propagating in the duct. In spite of this, the need for this technology at low frequencies has progressed to the point where commercial products that apply these concepts are currently available. Extending the frequency range of this technology requires the extension of current single channel controllers to multi-variate control systems as well as addressing the problems inherent in controlling higher order modes. The application of active control in the multi-dimensional propagation of random noise in waveguides is examined. An adaptive system is implemented using measured system frequency response functions. Experimental results are presented illustrating attained suppressions of 15 to 30 dB for random noise propagating in multiple modes.

  4. RANDOM ACCESS CONTROL OF ELECTROLUMINESCENT ELEMENTS.

    DTIC Science & Technology

    Cadmium selenide (CdSe) switches were devised to control the luminous emittance of electroluminescent cells in a solid-state display. The technique...purpose of this contract was to establish the feasibility of utilizing the hysteretic effect in cadmium selenide to provide switching and storage to an...array of electroluminescent cells by investigating the cadmium selenide material, by studying panel structure, and by investigating the addressing of

  5. Stochastic responses of a viscoelastic-impact system under additive and multiplicative random excitations

    NASA Astrophysics Data System (ADS)

    Zhao, Xiangrong; Xu, Wei; Yang, Yongge; Wang, Xiying

    2016-06-01

    This paper deals with the stochastic responses of a viscoelastic-impact system under additive and multiplicative random excitations. The viscoelastic force is replaced by a combination of stiffness and damping terms. The non-smooth transformation of the state variables is utilized to transform the original system to a new system without the impact term. The stochastic averaging method is applied to yield the stationary probability density functions. The validity of the analytical method is verified by comparing the analytical results with the numerical results. It is invaluable to note that the restitution coefficient, the viscoelastic parameters and the damping coefficients can induce the occurrence of stochastic P-bifurcation. Furthermore, the joint stationary probability density functions with three peaks are explored.

  6. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  7. Randomized controlled trial of Anticipatory and Preventive multidisciplinary Team Care

    PubMed Central

    Hogg, William; Lemelin, Jacques; Dahrouge, Simone; Liddy, Clare; Armstrong, Catherine Deri; Legault, Frances; Dalziel, Bill; Zhang, Wei

    2009-01-01

    ABSTRACT OBJECTIVE T o examine whether quality of care (QOC) improves when nurse practitioners and pharmacists work with family physicians in community practice and focus their work on patients who are 50 years of age and older and considered to be at risk of experiencing adverse health outcomes. DESIGN Randomized controlled trial. SETTING A family health network with 8 family physicians, 5 nurses, and 11 administrative personnel serving 10 000 patients in a rural area near Ottawa, Ont. PARTICIPANTS Patients 50 years of age and older at risk of experiencing adverse health outcomes (N = 241). INTERVENTIONS At-risk patients were randomly assigned to receive usual care from their family physicians or Anticipatory and Preventive Team Care (APTCare) from a collaborative team composed of their physicians, 1 of 3 nurse practitioners, and a pharmacist. MAIN OUTCOME MEASURES Quality of care for chronic disease management (CDM) for diabetes, coronary artery disease, congestive heart failure, and chronic obstructive pulmonary disease. RESULTS Controlling for baseline demographic characteristics, the APTCare approach improved CDM QOC by 9.2% (P < .001) compared with traditional care. The APTCare intervention also improved preventive care by 16.5% (P < .001). We did not observe significant differences in other secondary outcome measures (intermediate clinical outcomes, quality of life [Short-Form 36 and health-related quality of life scales], functional status [instrumental activities of daily living scale] and service usage). CONCLUSION Additional resources in the form of collaborative multidisciplinary care teams with intensive interventions in primary care can improve QOC for CDM in a population of older at-risk patients. The appropriateness of this intervention will depend on its cost-effectiveness. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT) PMID:20008582

  8. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

    A multi-input/output random vibration control algorithm was developed based on system identification concepts derived from random vibration spectral analysis theory. The unique features of the algorithm are: (1) the number of input excitors and the number of output control responses need not be identical; (2) the system inverse response matrix is obtained directly from the input/output spectral matrix; and (3) the system inverse response matrix is updated every control loop cycle to accommodate system amplitude nonlinearities. A laboratory demonstration case of two imputs with three outputs is presented to demonstrate the system capabilities.

  9. Affectionate Writing Reduces Total Cholesterol: Two Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Floyd, Kory; Mikkelson, Alan C.; Hesse, Colin; Pauley, Perry M.

    2007-01-01

    In two 5-week trials, healthy college students were randomly assigned either to experimental or control groups. Participants in the experimental groups wrote about their affection for significant friends, relatives, and/or romantic partners for 20 minutes on three separate occasions; on the same schedule, those in the control groups wrote about…

  10. Simulation of random wind fluctuations. [space shuttle ascent control

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

    A technique was developed for the simulation of random wind fluctuations for use in computer studies of the space shuttle ascent control. The simulated wind fluctuations were generated using the techniques of control theory that have statistical characteristics similar to the characteristics obtained from wind data at Kennedy Space Center.

  11. Substrate-controlled Michael additions of chiral ketones to enones.

    PubMed

    Fàbregas, Mireia; Gómez-Palomino, Alejandro; Pellicena, Miquel; Reina, Daniel F; Romea, Pedro; Urpí, Fèlix; Font-Bardia, Mercè

    2014-12-05

    Substrate-controlled Michael additions of the titanium(IV) enolate of lactate-derived ketone 1 to acyclic α,β-unsaturated ketones in the presence of a Lewis acid (TiCl4 or SnCl4) provide the corresponding 2,4-anti-4,5-anti dicarbonyl compounds in good yields and excellent diastereomeric ratios. Likely, the nucleophilic species involved in such additions are bimetallic enolates that may add to enones through cyclic transition states. Finally, further studies indicate that a structurally related β-benzyloxy chiral ketone can also participate in such stereocontrolled conjugate additions.

  12. Addition of parenteral cefoxitin to regimen of oral antibiotics for elective colorectal operations. A randomized prospective study.

    PubMed Central

    Schoetz, D J; Roberts, P L; Murray, J J; Coller, J A; Veidenheimer, M C

    1990-01-01

    The efficacy of cefoxitin, a perioperative parenteral antibiotic, combined with mechanical bowel preparation and oral antibiotics to prevent wound infections and other septic complications in patients undergoing elective colorectal operations, was examined in a prospective randomized study. All 197 patients who completed the study received mechanical bowel preparation and oral neomycin/erythromycin base. In addition a perioperative parenteral antibiotic was given in three divided doses to 101 patients. The other 96 patients received no parenteral antibiotics. The overall incidence of intra-abdominal septic complications was 7.3% (7 of 96) in the control group (no cefoxitin) and 5% (5 of 101) in the treatment group (cefoxitin). This difference was not statistically significant. The incidence of abdominal wound infection was 14.6% in the control group and 5% in the treatment group, a statistically significant difference (p = 0.02). The addition of perioperative parenteral cefoxitin greatly reduced the incidence of wound infections in patients undergoing elective colorectal operations who had been prepared with mechanical bowel cleansing and oral antimicrobial agents. PMID:2100983

  13. Improving Balance in Subacute Stroke Patients: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Goljar, Nika; Burger, Helena; Rudolf, Marko; Stanonik, Irena

    2010-01-01

    The aim of the study was to compare the efficacy of balance training in a balance trainer, a newly developed mechanical device for training balance, with conventional balance training in subacute stroke patients. This was a randomized controlled study. Fifty participants met the inclusion criteria and 39 finished the study. The participants were…

  14. Randomized Control Trials on the Dynamic Geometry Approach

    ERIC Educational Resources Information Center

    Jiang, Zhonghong; White, Alexander; Rosenwasser, Alana

    2011-01-01

    The project reported here is conducting repeated randomized control trials of an approach to high school geometry that utilizes Dynamic Geometry (DG) software to supplement ordinary instructional practices. It compares effects of that intervention with standard instruction that does not make use of computer drawing/exploration tools. The basic…

  15. A Systematic Review of Randomized Controlled Studies of Art Therapy

    ERIC Educational Resources Information Center

    Maujean, Annick; Pepping, Christopher A.; Kendall, Elizabeth

    2014-01-01

    This review article examines current knowledge about the efficacy of art therapy based on the findings of 8 randomized controlled trials (RCTs) conducted with adult populations from 2008-2013 that met a high standard of rigor. Of these studies, all but one reported beneficial effects of art therapy. Review findings suggest that art therapy may…

  16. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

    This study applies a randomized controlled trial to examine the effects of supplemental instruction using two online mathematics curricula--DreamBox and Reasoning Mind. It is an independent evaluation intended to generate unbiased results that will help inform the ongoing development of a charter school network's hybrid instructional model, which…

  17. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  18. Can the Randomized Controlled Trial Literature Generalize to Nonrandomized Patients?

    ERIC Educational Resources Information Center

    Stirman, Shannon Wiltsey; DeRubeis, Robert J.; Crits-Christoph, Paul; Rothman, Allison

    2005-01-01

    To determine the extent to which published randomized controlled trials (RCTs) of psychotherapy can be generalized to a sample of outpatients, the authors matched information obtained from charts of patients who had been screened out of RCTs to inclusion and exclusion criteria from published RCT studies. Most of the patients in the sample who had…

  19. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  20. Emission control devices, fuel additive, and fuel composition changes.

    PubMed Central

    Piver, W T

    1977-01-01

    Emission control devices are installed to meet the exhaust standards of the Clean Air Act for carbon monoxide and hydrocarbons, and it is necessary to know, from a public health point of view, how exhaust emissions may be affected by changes in fuel additives and fuel composition. Since these topics are concerned with developing technologies, the available literature on exhaust emission characteristics and the limited information on health effects, is reviewed. PMID:71235

  1. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    DTIC Science & Technology

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  2. Study of Randomness in AES Ciphertexts Produced by Randomly Generated S-Boxes and S-Boxes with Various Modulus and Additive Constant Polynomials

    NASA Astrophysics Data System (ADS)

    Das, Suman; Sadique Uz Zaman, J. K. M.; Ghosh, Ranjan

    2016-06-01

    In Advanced Encryption Standard (AES), the standard S-Box is conventionally generated by using a particular irreducible polynomial {11B} in GF(28) as the modulus and a particular additive constant polynomial {63} in GF(2), though it can be generated by many other polynomials. In this paper, it has been shown that it is possible to generate secured AES S-Boxes by using some other selected modulus and additive polynomials and also can be generated randomly, using a PRNG like BBS. A comparative study has been made on the randomness of corresponding AES ciphertexts generated, using these S-Boxes, by the NIST Test Suite coded for this paper. It has been found that besides using the standard one, other moduli and additive constants are also able to generate equally or better random ciphertexts; the same is true for random S-Boxes also. As these new types of S-Boxes are user-defined, hence unknown, they are able to prevent linear and differential cryptanalysis. Moreover, they act as additional key-inputs to AES, thus increasing the key-space.

  3. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

    This paper investigates networked control systems whose actuators communicate with the controller via a limited number of unreliable channels. The access to the channels is decided by a so-called group random access protocol, which is modelled as a binary Markov sequence. Data packet dropouts in the channels are modelled as independent Bernoulli processes. For such systems, a systematic characterisation for controller synthesis is established and stated in terms of the transition probabilities of the Markov protocol and the packet dropout probabilities. The results are illustrated via a numerical example.

  4. Extrinsic stain removal with a toothpowder: A randomized controlled trial

    PubMed Central

    Khan, Muhammad Khalil; Bokhari, Syed Akhtar Hussain; Haleem, Abdul; Kareem, Abdul; Khan, Ayyaz Ali; Hosein, Tasleem; Khan, Muhammad Usama

    2014-01-01

    Objectives The efficacy of a commercially available toothpowder was compared with toothpaste in removing extrinsic dental stains. Methods In this single-blind, randomized controlled trial, 77 volunteers were included from a residential professional college. All study subjects (control toothpaste users and test toothpowder users) plaque control measures. All study subjects were instructed to rinse with 5 ml 0.12% chlorhexidine mouthwash for 1 minute, twice and one cup of double tea bag solution three times daily for three weeks. Subjects were randomized into test (n=36) and control (n=36) groups. Toothpaste (control) and toothpowder (test) was used for two weeks to see the effects on removing stains on the labial surfaces of 12 anterior teeth. For measuring dental extrinsic stains Lobene Stain Index (SI) was used. Results The amount of stain following the use of toothpaste and toothpowder was more controlled with the experimental toothpowder. For all sites combined, there was evidence that the experimental toothpowder was significantly superior to toothpaste in reducing stain area (p<.001), stain intensity (p<.001) and composite/product (area × intensity) (p<.001). Conclusion Stain removing efficacy of toothpowder was significantly higher as compared with toothpaste. A toothpowder may be expected to be of benefit in controlling and removing extrinsic dental staining. PMID:25505862

  5. Review of Randomized Controlled Trials of Massage in Preterm Infants.

    PubMed

    Niemi, Anna-Kaisa

    2017-04-03

    Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  6. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

    Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors’ efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups—plausibly due to differences in the mechanisms of action. Antidepressants may not worsen

  7. [Randomized controlled trials terminated prematurely: beneficial therapy effects].

    PubMed

    Kluth, L A; Rink, M; Ahyai, S A; Fisch, M; Shariat, S F; Dahm, P

    2013-08-01

    Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.

  8. Randomized Algorithms for Systems and Control: Theory and Applications

    DTIC Science & Technology

    2008-05-01

    does not display a currently valid OMB control number . 1. REPORT DATE MAY 2008 2. REPORT TYPE 3. DATES COVERED 00-00-2008 to 00-00-2008 4...TITLE AND SUBTITLE Randomized Algorithms for Systems and Control: Theory and Applications 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT... NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) IEIIT-CNR

  9. A microfluidic abacus channel for controlling the addition of droplets.

    PubMed

    Um, Eujin; Park, Je-Kyun

    2009-01-21

    This paper reports the first use of the abacus-groove structure to handle droplets in a wide microchannel, with no external forces integrated to the system other than the pumps. Microfluidic abacus channels are demonstrated for the sequential addition of droplets at the desired location. A control channel which is analogous to biasing in electronics can also be used to precisely determine the number of added droplets, when all other experimental conditions are fixed including the size of the droplets and the frequency of droplet-generation. The device allows programmable and autonomous operations of complex two-phase microfluidics as well as new applications for the method of analysis and computations in lab-on-a-chip devices.

  10. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention.

  11. Randomly Sampled-Data Control Systems. Ph.D. Thesis

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

    The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

  12. Validation of Placebo in a Manual Therapy Randomized Controlled Trial.

    PubMed

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-07-06

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment ("yes" or "no") and how strongly they believed that active treatment was received (numeric rating scale 0-10). The outcome measures included the rate of successful blinding and the certitude of the participants' beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months.

  13. Validation of Placebo in a Manual Therapy Randomized Controlled Trial

    PubMed Central

    Chaibi, Aleksander; Šaltytė Benth, Jūratė; Bjørn Russell, Michael

    2015-01-01

    At present, no consensus exists among clinical and academic experts regarding an appropriate placebo for randomized controlled trials (RCTs) of spinal manipulative therapy (SMT). Therefore, we investigated whether it was possible to conduct a chiropractic manual-therapy RCT with placebo. Seventy migraineurs were randomized to a single-blinded placebo-controlled clinical trial that consisted of 12 treatment sessions over 3 months. The participants were randomized to chiropractic SMT or placebo (sham manipulation). After each session, the participants were surveyed on whether they thought they had undergone active treatment (“yes” or “no”) and how strongly they believed that active treatment was received (numeric rating scale 0–10). The outcome measures included the rate of successful blinding and the certitude of the participants’ beliefs in both treatment groups. At each treatment session, more than 80% of the participants believed that they had undergone active treatment, regardless of group allocation. The odds ratio for believing that active treatment was received was >10 for all treatment sessions in both groups (all p < 0.001). The blinding was maintained throughout the RCT. Our results strongly demonstrate that it is possible to conduct a single-blinded manual-therapy RCT with placebo and to maintain the blinding throughout 12 treatment sessions given over 3 months. PMID:26145718

  14. Control of Microthrix parvicella by aluminium salts addition.

    PubMed

    Durban, N; Juzan, L; Krier, J; Gillot, S

    2016-01-01

    Aluminium and iron chloride were added to a biological nutrient removal pilot plant (1,500 population equivalent) treating urban wastewater to investigate the control of Microthrix parvicella bulking and foaming by metallic salts. Monitoring plant performance over two 6-month periods showed a slight impact on the removal efficiencies. Addition of metallic salts (Me; aluminium or aluminium + iron) at a concentration of 41 mmol Me(kg MLSS·d) (MLSS: mixed liquor suspended solids) over 70 days allowed a stabilization of the diluted sludge volume index (DSVI), whereas higher dosages (94 mmol Me(kg MLSS·d) over 35 days or 137 mmol Me(kg MLSS·d) over 14 days induced a significant improvement of the settling conditions. Microscopic observations showed a compaction of biological aggregates with an embedding of filamentous bacteria into the flocs that is not specific to M. parvicella as bacteria from phylum Chloroflexi are embedded too. The quantitative polymerase chain reaction targeting M. parvicella further indicated a possible growth limitation in addition to the flocculation impact at the high dosages of metallic salts investigated. DSVI appeared to be correlated with the relative abundance of M. parvicella.

  15. Method for controlling a laser additive process using intrinsic illumination

    NASA Astrophysics Data System (ADS)

    Tait, Robert; Cai, Guoshuang; Azer, Magdi; Chen, Xiaobin; Liu, Yong; Harding, Kevin

    2015-05-01

    One form of additive manufacturing is to use a laser to generate a melt pool from powdered metal that is sprayed from a nozzle. The laser net-shape machining system builds the part a layer at a time by following a predetermined path. However, because the path may need to take many turns, maintaining a constant melt pool may not be easy. A straight section may require one speed and power while a sharp bend would over melt the metal at the same settings. This paper describes a process monitoring method that uses the intrinsic IR radiation from the melt pool along with a process model configured to establish target values for the parameters associated with the manufacture or repair. This model is based upon known properties of the metal being used as well as the properties of the laser beam. An adaptive control technique is then employed to control process parameters of the machining system based upon the real-time weld pool measurement. Since the system uses the heat radiant from the melt pool, other previously deposited metal does not confuse the system as only the melted material is seen by the camera.

  16. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  17. Biomimetic propulsion under random heaving conditions, using active pitch control

    NASA Astrophysics Data System (ADS)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

    Marine mammals travel long distances by utilizing and transforming wave energy to thrust through proper control of their caudal fin. On the other hand, manmade ships traveling in a wavy sea store large amounts of wave energy in the form of kinetic energy for heaving, pitching, rolling and other ship motions. A natural way to extract this energy and transform it to useful propulsive thrust is by using a biomimetic wing. The aim of this paper is to show how an actively pitched biomimetic wing could achieve this goal when it performs a random heaving motion. More specifically, we consider a biomimetic wing traveling with a given translational velocity in an infinitely extended fluid and performing a random heaving motion with a given energy spectrum which corresponds to a given sea state. A formula is invented by which the instantaneous pitch angle of the wing is determined using the heaving data of the current and past time steps. Simulations are then performed for a biomimetic wing at different heave energy spectra, using an indirect Source-Doublet 3-D-BEM, together with a time stepping algorithm capable to track the random motion of the wing. A nonlinear pressure type Kutta condition is applied at the trailing edge of the wing. With a mollifier-based filtering technique, the 3-D unsteady rollup pattern created by the random motion of the wing is calculated without any simplifying assumptions regarding its geometry. Calculated unsteady forces, moments and useful power, show that the proposed active pitch control always results in thrust producing motions, with significant propulsive power production and considerable beneficial stabilizing action to ship motions. Calculation of the power required to set the pitch angle prove it to be a very small percentage of the useful power and thus making the practical application of the device very tractable.

  18. Testimony Therapy With Ritual: A Pilot Randomized Controlled Trial.

    PubMed

    Esala, Jennifer J; Taing, Sopheap

    2017-02-01

    Testimony therapy can provide low-cost, brief, simple, and culturally adaptable psychosocial services in low-income countries (Agger, Raghuvanshi, Khan, Polatin, & Laursen, 2009). Nonetheless, there have been no well-controlled studies of testimony therapy. We report the analyses of a randomized controlled trial designed to assess the effectiveness of testimony therapy plus a culturally adapted ceremony in reducing mental health symptoms among Khmer Rouge torture survivors from across Cambodia. Using multilevel modeling, we compared symptoms of posttraumatic stress disorder, anxiety, and depression between a treatment (n = 45) and a control group (n = 43) at baseline, 3 months, and 6 months. We found that testimony therapy plus ceremony significantly reduced symptoms of posttraumatic stress disorder (d = 0.49), anxiety (d = 0.44), and depression (d = 0.53).

  19. Electrically controllable liquid crystal random lasers below the Fréedericksz transition threshold.

    PubMed

    Lee, Chia-Rong; Lin, Jia-De; Huang, Bo-Yuang; Lin, Shih-Hung; Mo, Ting-Shan; Huang, Shuan-Yu; Kuo, Chie-Tong; Yeh, Hui-Chen

    2011-01-31

    This investigation elucidates for the first time electrically controllable random lasers below the threshold voltage in dye-doped liquid crystal (DDLC) cells with and without adding an azo-dye. Experimental results show that the lasing intensities and the energy thresholds of the random lasers can be decreased and increased, respectively, by increasing the applied voltage below the Fréedericksz transition threshold. The below-threshold-electric-controllability of the random lasers is attributable to the effective decrease of the spatial fluctuation of the orientational order and thus of the dielectric tensor of LCs by increasing the electric-field-aligned order of LCs below the threshold, thereby increasing the diffusion constant and decreasing the scattering strength of the fluorescence photons in their recurrent multiple scattering. This can result in the decrease in the lasing intensity of the random lasers and the increase in their energy thresholds. Furthermore, the addition of an azo-dye in DDLC cell can induce the range of the working voltage below the threshold for the control of the random laser to reduce.

  20. Medication reconciliation at patient admission: a randomized controlled trial

    PubMed Central

    Mendes, Antonio E.; Lombardi, Natália F.; Andrzejevski, Vânia S.; Frandoloso, Gibran; Correr, Cassyano J.; Carvalho, Mauricio

    2015-01-01

    Objective: To measure length of hospital stay (LHS) in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620). The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety. PMID:27011775

  1. Randomized controlled trial design in rheumatoid arthritis: the past decade

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

    Much progress has occurred over the past decade in rheumatoid arthritis trial design. Recognized challenges have led to the establishment of a clear regulatory pathway to demonstrate efficacy of a new therapeutic. The use of pure placebo beyond 12 to 16 weeks has been demonstrated to be unethical and thus background therapy and/or early rescue has become regular practice. Goals of remission and 'treating to targets' may prove more relevant to identify real-world use of new and existing therapeutics. Identification of rare adverse events associated with new therapies has resulted in intensive safety evaluation during randomized controlled trials and emphasis on postmarketing surveillance and use of registries. PMID:19232061

  2. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2015-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. PMID:25456014

  3. Random transposon mutagenesis of the Saccharopolyspora erythraea genome reveals additional genes influencing erythromycin biosynthesis

    PubMed Central

    Fedashchin, Andrij; Cernota, William H.; Gonzalez, Melissa C.; Leach, Benjamin I.; Kwan, Noelle; Wesley, Roy K.; Weber, J. Mark

    2015-01-01

    A single cycle of strain improvement was performed in Saccharopolyspora erythraea mutB and 15 genotypes influencing erythromycin production were found. Genotypes generated by transposon mutagenesis appeared in the screen at a frequency of ∼3%. Mutations affecting central metabolism and regulatory genes were found, as well as hydrolases, peptidases, glycosyl transferases and unknown genes. Only one mutant retained high erythromycin production when scaled-up from micro-agar plug fermentations to shake flasks. This mutant had a knockout of the cwh1 gene (SACE_1598), encoding a cell-wall-associated hydrolase. The cwh1 knockout produced visible growth and morphological defects on solid medium. This study demonstrated that random transposon mutagenesis uncovers strain improvement-related genes potentially useful for strain engineering. PMID:26468041

  4. IS “RESCUE” THERAPY ETHICAL IN RANDOMIZED CONTROLLED TRIALS?

    PubMed Central

    Holubkov, Richard; Michael Dean, J.; Berger, John; Anand, K. J. S.; Carcillo, Joseph; Meert, Kathleen; Zimmerman, Jerry; Newth, Christopher; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

    2011-01-01

    Objective There is a commonly held belief that randomized, placebo-controlled trials in pediatric critical care should incorporate “rescue” therapy (open-label administration of active drug) when a child’s condition is deteriorating. The ethical, conceptual and analytic challenges related to “rescue” therapy in randomized trials can be misrepresented. Design Narrative review. Methods The ethical basis of “rescue” therapy, the equipoise concept, and intention-to-treat analysis are examined in the setting of a hypothetical randomized trial comparing corticosteroids versus placebo in pediatric septic shock. Findings The perceived need for “rescue” therapy may be partly motivated by the moral imperative to save a child’s life. However, allowing “rescue” therapy in a trial is misconceived and inconsistent with equipoise regarding the efficacy of the study drug. If “rescue” therapy is permitted, intention-to-treat analysis can only compare immediate versus delayed use of the study drug. When “rescue” therapy is beneficial, the observed treatment effect is substantially diminished from true effect of the study drug, leading to increased sample size and thereby placing more children at risk (18 “excess” placebo-arm deaths occur in our hypothetical example). Analysis of a trial incorporating “rescue” therapy cannot definitively assess overall efficacy of the agent, or distinguish beneficial or harmful treatment effects related to timing of drug use. Conclusions While a “rescue” therapy component in a randomized trial may be perceived as ethically desirable, inconsistency of “rescue” therapy with full equipoise may itself raise significant ethical concerns. Increased sample sizes expose more children to the risks of study participation, including death. Researchers should be aware that clinical trials designed with “rescue” therapy cannot definitively determine the beneficial or harmful effects of a treatment per se, and

  5. Efficacy of Yoga for Vasomotor Symptoms: A Randomized Controlled Trial

    PubMed Central

    Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2013-01-01

    Objective To determine the efficacy of yoga in alleviating VMS frequency and bother. Methods Three by two factorial design, randomized, controlled. Eligible women were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and were simultaneously randomized to double-blind comparison of omega-3 fatty acid (n=177) or placebo (n=178) capsules. Yoga intervention was twelve, weekly, 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Results Among 249 randomized women, 237 (95%) completed 12-week assessments. Mean baseline VMS frequency was 7.4/day (95% CI 6.6, 8.1) in the yoga group and 8.0/day (95% CI 7.3, 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n=237). There was no difference between intervention groups in change in VMS frequency from baseline to 6 and 12 weeks (mean difference (yoga – usual activity) from baseline −0.3 (95% CI −1.1, 0.5) at 6 weeks and −0.3 (95% CI −1.2, 0.6) at 12 weeks (p=0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga-usual activity] in change –Insomnia Severity Index, 1.3 [95% CI −2.5, −0.1][p=0.007]). Conclusion Among healthy women, 12 weeks of yoga class plus home practice compared with usual activity did not improve VMS frequency or bother, but reduced insomnia symptoms. PMID:24045673

  6. Barbed suture for gastrointestinal closure: a randomized control trial.

    PubMed

    Demyttenaere, Sebastian V; Nau, Peter; Henn, Matthew; Beck, Catherine; Zaruby, Jeffrey; Primavera, Michael; Kirsch, David; Miller, Jeffrey; Liu, James J; Bellizzi, Andrew; Melvin, W Scott

    2009-09-01

    In an effort to make laparoscopic suturing more efficient, the V-Loc advanced wound closure device (Covidien, Mansfield, MA) has been produced. This device is a self-anchoring barbed suture that obviates the need for knot tying. The goal of this initial feasibility study was to investigate the use of the barbed suture in gastrointestinal enterotomy closure. A randomized study of 12 pigs comparing enterotomy closure with barbed versus a nonbarbed suture of similar tensile strength was performed. To this end, 25 mm enterotomies were made in the stomach (1 control, 1 treatment), jejunum (2 controls, 2 treatments), and descending colon (1 control, 1 treatment). Animals were killed at 3, 7, and 14 days postoperatively (4 each group) and their gastrointestinal tracts harvested; 6 of the 8 enterotomies from each pig underwent burst strength testing. The remaining 2 were fixed in formalin and sent for histological examination. All 12 pigs survived until they were killed without any major complications. Enterotomy closure with barbed suture revealed adhesion scores, burst strength pressures, and histology scores that were similar to those for the control. Jejunal closures resulted in 6 failures at 7 days (3 control, 3 barbed) and 4 failures at 14 days (2 control, 2 barbed). The barbed suture significantly reduced suturing time in the stomach, jejunum, and colon. The V-Loc wound closure device appears to offer comparable gastrointestinal closure to 3-0 Maxon while being significantly faster. Further studies with V-Loc are required to assess its use in laparoscopic surgery.

  7. Exercise training in mitochondrial myopathy: a randomized controlled trial.

    PubMed

    Cejudo, Pilar; Bautista, Juan; Montemayor, Teodoro; Villagómez, Rafael; Jiménez, Luis; Ortega, Francisco; Campos, Yolanda; Sánchez, Hildegard; Arenas, Joaquín

    2005-09-01

    Patients with mitochondrial myopathies (MM) usually suffer from exercise intolerance due to their impaired oxidative capacity and physical deconditioning. We evaluated the effects of a 12-week supervised randomized rehabilitation program involving endurance training in patients with MM. Twenty MM patients were assigned to a training or control group. For three nonconsecutive days each week, patients combined cycle exercise at 70% of their peak work rate with three upper-body weight-lifting exercises performed at 50% of maximum capacity. Training increased maximal oxygen uptake (28.5%), work output (15.5%), and minute ventilation (40%), endurance performance (62%), walking distance in shuttle walking test (+95 m), and peripheral muscle strength (32%-62%), and improved Nottingham Health Profile scores (21.47%) and clinical symptoms. Control MM patients did not change from baseline. Results show that our exercise program is an adequate training strategy for patients with mitochondrial myopathy.

  8. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    PubMed Central

    Mendelsohn, Alan L.; Dreyer, Benard P.; Brockmeyer, Carolyn A.; Berkule-Silberman, Samantha B.; Huberman, Harris S.; Tomopoulos, Suzy

    2011-01-01

    Objectives To determine whether pediatric primary care–based programs to enhance parenting and early child development reduce media exposure and whether enhanced parenting mediates the effects. Design Randomized controlled trial. Setting Urban public hospital pediatric primary care clinic. Participants A total of 410 mother-newborn dyads enrolled after childbirth. Interventions Patients were randomly assigned to 1 of 2 interventions, the Video Interaction Project (VIP) and Building Blocks (BB) interventions, or to a control group. The VIP intervention comprised 1-on-1 sessions with a child development specialist who facilitated interactions in play and shared reading through review of videotapes made of the parent and child on primary care visit days; learning materials and parenting pamphlets were also provided. The BB intervention mailed parenting materials, including age-specific newsletters suggesting activities to facilitate interactions, learning materials, and parent-completed developmental questionnaires (Ages and Stages questionnaires). Outcome Measures Electronic media exposure in the home using a 24-hour recall diary. Results The mean (SD) exposure at 6 months was 146.5 (125.0) min/d. Exposure to VIP was associated with reduced total duration of media exposure compared with the BB and control groups (mean [SD] min/d for VIP, 131.6 [118.7]; BB, 151.2 [116.7]; control, 155.4 [138.7]; P=.009). Enhanced parent-child interactions were found to partially mediate relations between VIP and media exposure for families with a ninth grade or higher literacy level (Sobel statistic=2.49; P=.01). Conclusion Pediatric primary care may represent an important venue for addressing the public health problem of media exposure in young children at a population level. Trial Registration clinicaltrials.gov Identifier: NCT00212576 PMID:21199979

  9. Dynamic response analysis of closed-loop control system for random intelligent truss structure under random forces

    NASA Astrophysics Data System (ADS)

    Gao, Wei; Chen, Jianjun; Zhou, Yabin; Cui, Mingtao

    2004-07-01

    Considering the randomness of structural damping, physical parameters of structural materials, geometric dimensions of active bars and passive bars, applied loads and control forces simultaneously, the problems of dynamic response analysis of closed-loop control system based on probability for the random intelligent truss structures are studied in this paper. The computational expressions of numerical characteristics of structural dynamic response of closed-loop control system are derived by means of the mode superposition method. Through the engineering examples, the influences of the randomness of them on structural dynamic response are inspected and some significant conclusions are obtained.

  10. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

    PubMed

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study.

  11. A randomized controlled trial of financial incentives for weight loss

    PubMed Central

    Volpp, Kevin G.; John, Leslie K; Troxel, Andrea B; Norton, Laurie; Fassbender, Jennifer; Loewenstein, George

    2012-01-01

    Context Identifying effective strategies for treating obesity is both a clinical challenge and a public health priority due to the health consequences of obesity. Objective To determine whether common decision errors identified by behavioral economists such as prospect theory, loss aversion, and regret could be used to design an effective weight loss intervention. Design 3-arm randomized controlled trial in which participants were randomized to either usual care (weigh ins once a month) or one of two financial incentives arms. One incentive arm used deposit contracts in which participants put their own money at risk (matched 1:1 by the study) which they would lose if they failed to lose weight. The second used lottery-based incentives in which participants who met the weight loss target had each day a 1 in 5 chance of winning a small reward ($10) and a 1 in 100 chance of winning a large reward ($100). All participants were given a weight loss goal of 1 pound per week for 16 weeks, and results were analyzed using intention-to-treat analysis of variance models. Setting Philadelphia Veterans Affairs Medical Center. Patients 57 patients with BMIs between 30-40 aged between 30 and 70, with no contraindications for study participation. Main Outcome Measures Weight loss after 16 weeks. Results Participants in both incentive groups lost significantly more weight than participants in the control group (3.9 pounds); (Lottery = 13.1 lbs; p-value for lottery vs. control .014; deposit contract = 14.0 lbs, p-value vs. control .003). 47.4% of deposit contract participants and 52.6% of lottery arm participants met the 16-pound weight loss goal compared to 10.5% in the control group (p-value 0.014.). By the end of 7 months, substantial amounts of weight were regained; however, incentive participants weighed significantly less than they did at the study start whereas controls did not. Low lost to follow-up rates (7.0%) during the weight loss phase of the study suggest that both

  12. Diabetes Prevention in Hispanics: Report From a Randomized Controlled Trial

    PubMed Central

    Carosso, Elizabeth; Mariscal, Norma; Islas, Ilda; Ibarra, Genoveva; Holte, Sarah; Copeland, Wade; Linde, Sandra; Thompson, Beti

    2014-01-01

    Introduction Hispanics are at increased risk of developing type 2 diabetes. Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation. Methods We recruited Hispanic men and women (N = 320) who were residents of the Lower Yakima Valley, Washington, aged 18 years or older with hemoglobin A1c (HbA1c) levels higher than 6% to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012. The trial compared participants in the intervention arm, who received an immediate educational curriculum (n = 166), to participants in the control arm, who received a delayed educational curriculum (n = 154). The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes, diabetes treatment, and healthy dietary and physical activity behaviors. Participants were randomly assigned to the intervention and control arms, and analysts were blinded as to participant arm. We evaluated intervention effects on HbA1c levels; frequency (times per week) of fruit and vegetable consumption; and frequency (times per week) of mild, moderate, and strenuous leisure-time physical activity. At baseline, 3 months, and 6 months after randomization, participants completed a questionnaire and provided a blood sample. Analysts were blinded to intervention arm. Results The immediate intervention group (−0.64% [standard error (SE) 0.10]) showed a significant improvement in HbA1c scores (–37.5%, P = .04) compared with the delayed intervention group (–0.44%, P = .14). No significant changes were seen for dietary end points or changes in physical activity. We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group. Conclusion This home-based intervention delivered by CHWs was associated with a clinically and statistically

  13. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of

  14. Postoperative pain relief following hysterectomy: A randomized controlled trial

    PubMed Central

    Raghvendra, K. P.; Thapa, Deepak; Mitra, Sukanya; Ahuja, Vanita; Gombar, Satinder; Huria, Anju

    2016-01-01

    Background: Women experience moderate to severe postoperative pain following total abdominal hysterectomy (TAH). The transversus abdominis plane (TAP) block is a new modality for providing postoperative pain relief in these patients. Materials and Methods: The present study was a single center, prospective randomized trial. After the Institutional Ethics Committee approval and informed consent, patients were randomized to either epidural group: Epidural block placement + general anesthesia (GA) or TAP group: Single shot TAP block + GA. Patients in both the groups received standard general anesthetic technique and intravenous tramadol patient-controlled analgesia in the postoperative period. Patients were monitored for tramadol consumption, visual analog scale (VAS) both at rest and on coughing, hemodynamics, and side effects at 0, 2, 4, 6, 8, 12, and 24 h postoperatively. Results: The total consumption of tramadol in 24 h was greater in TAP group as compared to epidural group (68.8 [25.5] vs. 5.3 [11.6] mg, P < 0.001). The VAS scores at rest and on coughing were higher in TAP group as compared to the epidural group at 6, 8, 12, and 24 h postoperatively (P < 0.05). None of the patients in either group had any adverse effects. Conclusion: Epidural analgesia provided greater tramadol-sparing effect with superior analgesia postoperatively as compared to TAP block in patients up to 24 h following TAH. PMID:27499592

  15. Internet-enhanced management of fibromyalgia: a randomized controlled trial.

    PubMed

    Williams, David A; Kuper, David; Segar, Michelle; Mohan, Niveditha; Sheth, Manish; Clauw, Daniel J

    2010-12-01

    Both pharmacological and non-pharmacological interventions have demonstrated efficacy in the management of fibromyalgia (FM). Non-pharmacological interventions however are far less likely to be used in clinical settings, in part due to limited access. This manuscript presents the findings of a randomized controlled trail of an Internet-based exercise and behavioral self-management program for FM designed for use in the context of a routine clinical care. 118 individuals with FM were randomly assigned to either (a) standard care or (b) standard care plus access to a Web-Enhanced Behavioral Self-Management program (WEB-SM) grounded in cognitive and behavioral pain management principles. Individuals were assessed at baseline and again at 6 months for primary endpoints: reduction of pain and an improvement in physical functioning. Secondary outcomes included fatigue, sleep, anxiety and depressive symptoms, and a patient global impression of improvement. Individuals assigned to the WEB-SM condition reported significantly greater improvement in pain, physical functioning, and overall global improvement. Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period. A no-contact, Internet-based, self-management intervention demonstrated efficacy on key outcomes for FM. While not everyone is expected to benefit from this approach, this study demonstrated that non-pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes.

  16. Randomized controlled trials in environmental health research: ethical issues.

    PubMed

    Resnik, David B

    2008-01-01

    Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many ethical challenges, ranging from obtaining informed consent to minimizing risks to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.

  17. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  18. Ameliorating children's reading-comprehension difficulties: a randomized controlled trial.

    PubMed

    Clarke, Paula J; Snowling, Margaret J; Truelove, Emma; Hulme, Charles

    2010-08-01

    Children with specific reading-comprehension difficulties can read accurately, but they have poor comprehension. In a randomized controlled trial, we examined the efficacy of three interventions designed to improve such children's reading comprehension: text-comprehension (TC) training, oral-language (OL) training, and TC and OL training combined (COM). Children were assessed preintervention, midintervention, postintervention, and at an 11-month follow-up. All intervention groups made significant improvements in reading comprehension relative to an untreated control group. Although these gains were maintained at follow-up in the TC and COM groups, the OL group made greater gains than the other groups did between the end of the intervention and follow-up. The OL and COM groups also demonstrated significant improvements in expressive vocabulary compared with the control group, and this was a mediator of the improved reading comprehension of the OL and COM groups. We conclude that specific reading-comprehension difficulties reflect (at least partly) underlying oral-language weaknesses that can be effectively ameliorated by suitable teaching.

  19. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  20. A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection.

    PubMed

    Davey, Richard T; Dodd, Lori; Proschan, Michael A; Neaton, James; Neuhaus Nordwall, Jacquie; Koopmeiners, Joseph S; Beigel, John; Tierney, John; Lane, H Clifford; Fauci, Anthony S; Massaquoi, Moses B F; Sahr, Foday; Malvy, Denis

    2016-10-13

    Background Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). Methods Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day). Patients were stratified according to baseline PCR cycle-threshold value for the virus (≤22 vs. >22) and country of enrollment. Oral favipiravir was part of the current standard of care in Guinea. The primary end point was mortality at 28 days. Results A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30%. Death occurred in 13 of 35 patients (37%) who received the current standard of care alone and in 8 of 36 patients (22%) who received the current standard of care plus ZMapp. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2%, falling short of the prespecified threshold of 97.5%. Frequentist analyses yielded similar results (absolute difference in mortality with ZMapp, -15 percentage points; 95% confidence interval, -36 to 7). Baseline viral load was strongly predictive of both mortality and duration of hospitalization in all age groups. Conclusions In this randomized, controlled trial of a putative therapeutic agent for EVD, although the estimated effect of ZMapp appeared to be beneficial, the result did not meet the prespecified

  1. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  2. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    PubMed Central

    2012-01-01

    Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes). However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-)environment interactions to obtain more insight into a) moderating effects of polymorphisms on the link between parenting and child behavior, and b) behavioral mechanisms that underlie these gene-(gene-)environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training). In a screening, families with children aged 4–8 who show mild to (sub)clinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest), after 6 months (i.e., posttest), and after 10 months (i.e., follow-up). Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-)environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s) received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and will manifest

  3. Side effects can enhance treatment response through expectancy effects: an experimental analgesic randomized controlled trial.

    PubMed

    Berna, Chantal; Kirsch, Irving; Zion, Sean R; Lee, Yvonne C; Jensen, Karin B; Sadler, Pamela; Kaptchuk, Ted J; Edwards, Robert R

    2017-02-04

    In randomized controlled trials, medication side effects may lead to beliefs that one is receiving the active intervention and enhance active treatment responses, thereby increasing drug-placebo differences. We tested these hypotheses with an experimental double-blind randomized controlled trial of a nonsteroidal anti-inflammatory drug with and without the addition of atropine to induce side effects. One hundred healthy volunteers were told they would be randomized to either combined analgesics that might produce dry mouth or inert placebos. In reality, they were randomized double blind, double-dummy to 1 of the 4 conditions: (1) 100 mg diclofenac + 1.2 mg atropine, (2) placebo + 1.2 mg atropine, (3) 100 mg diclofenac + placebo, or (4) placebo + placebo, and tested with heat-induced pain. Groups did not differ significantly in demographics, temperature producing moderate pain, state anxiety, or depression. Analgesia was observed in all groups; there was a significant interaction between diclofenac and atropine, without main effects. Diclofenac alone was not better than double-placebo. The addition of atropine increased pain relief more than 3-fold among participants given diclofenac (d = 0.77), but did not enhance the response to placebo (d = 0.09). A chain of mediation analysis demonstrated that the addition of atropine increased dry mouth symptoms, which increased beliefs that one had received the active medication, which, in turn, increased analgesia. In addition to this indirect effect of atropine on analgesia (via dry mouth and beliefs), analyses suggest that among those who received diclofenac, atropine directly increased analgesia. This possible synergistic effect between diclofenac and atropine might warrant future research.

  4. Building social resilience in soldiers: A double dissociative randomized controlled study.

    PubMed

    Cacioppo, John T; Adler, Amy B; Lester, Paul B; McGurk, Dennis; Thomas, Jeffrey L; Chen, Hsi-Yuan; Cacioppo, Stephanie

    2015-07-01

    Can social resilience be trained? We report results of a double-dissociative randomized controlled study in which 48 Army platoons were randomly assigned to social resilience training (intervention condition) or cultural awareness training (active control group). The same surveys were administered to all platoons at baseline and after the completion of training to determine the short-term training effects, generalization effects beyond training, and possible adverse effects. Multilevel modeling analyses indicated that social resilience, compared with cultural awareness, training produced small but significant improvements in social cognition (e.g., increased empathy, perspective taking, & military hardiness) and decreased loneliness, but no evidence was found for social resilience training to generalize beyond these training foci nor to have adverse effects. Moreover, as predicted, cultural awareness, compared with social resilience, training produced increases in knowledge about and decreases in prejudice toward Afghans. Additional research is warranted to determine the long-term durability, safety, and generalizability of social resilience training.

  5. Additives and method for controlling clathrate hydrates in fluid systems

    DOEpatents

    Sloan, Jr., Earle Dendy; Christiansen, Richard Lee; Lederhos, Joseph P.; Long, Jin Ping; Panchalingam, Vaithilingam; Du, Yahe; Sum, Amadeu Kun Wan

    1997-01-01

    Discussed is a process for preventing clathrate hydrate masses from detrimentally impeding the possible flow of a fluid susceptible to clathrate hydrate formation. The process is particularly useful in the natural gas and petroleum production, transportation and processing industry where gas hydrate formation can cause serious problems. Additives preferably contain one or more five member, six member and/or seven member cyclic chemical groupings. Additives include polymers having lactam rings. Additives can also contain polyelectrolytes that are believed to improve conformance of polymer additives through steric hinderance and/or charge repulsion. Also, polymers having an amide on which a C.sub.1 -C.sub.4 group is attached to the nitrogen and/or the carbonyl carbon of the amide may be used alone, or in combination with ring-containing polymers for enhanced effectiveness. Polymers having at least some repeating units representative of polymerizing at least one of an oxazoline, an N-substituted acrylamide and an N-vinyl alkyl amide are preferred.

  6. Additives and method for controlling clathrate hydrates in fluid systems

    DOEpatents

    Sloan, E.D. Jr.; Christiansen, R.L.; Lederhos, J.P.; Long, J.P.; Panchalingam, V.; Du, Y.; Sum, A.K.W.

    1997-06-17

    Discussed is a process for preventing clathrate hydrate masses from detrimentally impeding the possible flow of a fluid susceptible to clathrate hydrate formation. The process is particularly useful in the natural gas and petroleum production, transportation and processing industry where gas hydrate formation can cause serious problems. Additives preferably contain one or more five member, six member and/or seven member cyclic chemical groupings. Additives include polymers having lactam rings. Additives can also contain polyelectrolytes that are believed to improve conformance of polymer additives through steric hindrance and/or charge repulsion. Also, polymers having an amide on which a C{sub 1}-C{sub 4} group is attached to the nitrogen and/or the carbonyl carbon of the amide may be used alone, or in combination with ring-containing polymers for enhanced effectiveness. Polymers having at least some repeating units representative of polymerizing at least one of an oxazoline, an N-substituted acrylamide and an N-vinyl alkyl amide are preferred.

  7. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    PubMed

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P<0.001) during cognitive tasks. Among controls, high-frequency power was unchanged (P=0.29), and RR interval decreased (P=0.03). Neither intervention altered spontaneous baroreflex sensitivity (P>0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  8. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    PubMed Central

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  9. Prevention of pathological gambling: a randomized controlled trial.

    PubMed

    Doiron, Jason P; Nicki, Richard M

    2007-01-01

    Although the gambling industry is expanding rapidly throughout North America and around the world, there are only a few empirically evaluated programs aimed at the prevention of pathological gambling (PG). The purpose of this study was to measure the effectiveness of a new prevention program aimed at PG. The Stop & Think! program was designed to teach at-risk video lottery terminal (VLT) gamblers cognitive restructuring and problem-solving skills that may help to prevent the development of PG. These skills were taught through a variety of methods - including an automated educational presentation, video and text vignettes, audio training tapes, and skill rehearsal. The program was evaluated using a randomized, 2-group experimental design with a wait-list control group and pre-, post-, and follow-up measures. Results indicated that, compared with the control group, the experimental group was less at risk for developing a gambling problem after the program. The experimental group endorsed fewer gambling-related cognitive distortions, engaged in less VLT gambling, and had lower scores on a measure of PG. The results of this study provide the basis for the implementation of the Stop & Think! program in the province of Prince Edward Island, Canada, and perhaps other jurisdictions too.

  10. Microstructure-controllable Laser Additive Manufacturing Process for Metal Products

    NASA Astrophysics Data System (ADS)

    Huang, Wei-Chin; Chuang, Chuan-Sheng; Lin, Ching-Chih; Wu, Chih-Hsien; Lin, De-Yau; Liu, Sung-Ho; Tseng, Wen-Peng; Horng, Ji-Bin

    Controlling the cooling rate of alloy during solidification is the most commonly used method for varying the material microstructure. However, the cooling rate of selective laser melting (SLM) production is constrained by the optimal parameter settings for a dense product. This study proposes a method for forming metal products via the SLM process with electromagnetic vibrations. The electromagnetic vibrations change the solidification process for a given set of SLM parameters, allowing the microstructure to be varied via magnetic flux density. This proposed method can be used for creating microstructure-controllable bio-implant products with complex shapes.

  11. Rural providers' access to online resources: a randomized controlled trial

    PubMed Central

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  12. Fluid loss control additives for oil well cementing compositions

    SciTech Connect

    Crema, S.C.; Kucera, C.H.

    1992-03-03

    This patent describes a cementing composition useful in cementing oil, gas and water wells. It comprises hydraulic cement; and a fluid loss additive in an amount effective to reduce fluid loss, the fluid loss additive comprised of a copolymer of acrylamide monomer and vinyl formamide monomer and derivatives thereof in a weight percent ratio of from about 95:5 to 5:95, the copolymer having a molecular weight range of from about 10,000 to 3,000,000, the acrylamide monomer being selected from the group consisting of acrylamide, methacrylamide, N,N-dimethyl(meth)acrylamide, dialkylaminoalkyl(meth) acrylamide and mixtures thereof, the vinyl formamide monomer being selected from the group consisting of vinyl formamide, its hydrolysis products and derivatives thereof.

  13. Fouling control in seawater by on-line acid addition

    SciTech Connect

    Salvago, G.; Taccani, G.; Polimeni, R.; Fumagalli, G.; Picenoni, D.

    1996-11-01

    An experimental plant was set up containing once-through test lines supplied with seawater. The pH level of the seawater was maintained at 6.3 by the acids addition. Heat exchange monitoring equipment and channels exposing different metal specimens were installed on each of the lines. Observation by microscope and EDS analyses were carried out both on the specimen surfaces and on the cross section of the fouling after fracturing in liquid N{sub 2}. The results obtained show that: fouling must not be confused with its effects or simply with its biological components; acidifying seawater can prevent the resistance to heat exchange from increasing without impeding its biological activity. Observation by microscope of the fouling cross sections showed that in untreated seawater the foulings on stainless steel were composed of a continuous compact layer, covered by disorderly clusters. These compact layers were found to contain high quantities of corrosion products of the metals. Elements typical of corrosion products of ferrous materials (Fe, Mn) were also found on Pt, copper alloys and plastic materials. The addition of HCl or H{sub 2}SO{sub 4} to the seawater, to bring it to pH 6.3, reduces the amount of fouling adhering to the surfaces, prevents the development of the continuous layer containing iron and prevents significant increases in heat exchange resistance. The addition of CO{sub 2} can encourage the development of incoherent fibrous material with high Si content and low Fe content which is of little impediment to heat exchange. The addition of lactic acid can encourage both the abnormal development of biomass and the formation of several, separate, layers on stainless steel surfaces.

  14. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    PubMed Central

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

  15. Direct laser additive fabrication system with image feedback control

    DOEpatents

    Griffith, Michelle L.; Hofmeister, William H.; Knorovsky, Gerald A.; MacCallum, Danny O.; Schlienger, M. Eric; Smugeresky, John E.

    2002-01-01

    A closed-loop, feedback-controlled direct laser fabrication system is disclosed. The feedback refers to the actual growth conditions obtained by real-time analysis of thermal radiation images. The resulting system can fabricate components with severalfold improvement in dimensional tolerances and surface finish.

  16. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    ERIC Educational Resources Information Center

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  17. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    PubMed

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  18. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial

    PubMed Central

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research. PMID:27703964

  19. A Randomized Controlled Study of Neurofeedback for Chronic PTSD

    PubMed Central

    van der Kolk, Bessel A.; Hodgdon, Hilary; Gapen, Mark; Musicaro, Regina; Suvak, Michael K.; Hamlin, Ed; Spinazzola, Joseph

    2016-01-01

    Introduction Brain/Computer Interaction (BCI) devices are designed to alter neural signals and, thereby, mental activity. This study was a randomized, waitlist (TAU) controlled trial of a BCI, EEG neurofeedback training (NF), in patients with chronic PTSD to explore the capacity of NF to reduce PTSD symptoms and increase affect regulation capacities. Study Design 52 individuals with chronic PTSD were randomized to either NF (n = 28) or waitlist (WL) (n = 24). They completed four evaluations, at baseline (T1), after week 6 (T2), at post-treatment (T3), and at one month follow up (T4). Assessment measures were:1. Traumatic Events Screening Inventory (T1); 2. the Clinician Administered PTSD Scale (CAPS; T1, T3, T4); 3. the Davidson Trauma Scale (DTS; T1-T4) and 4. the Inventory of Altered Self-Capacities (IASC; T1-T4). NF training occurred two times per week for 12 weeks and involved a sequential placement with T4 as the active site, P4 as the reference site. Results Participants had experienced an average of 9.29 (SD = 2.90) different traumatic events. Post-treatment a significantly smaller proportion of NF (6/22, 27.3%) met criteria for PTSD than the WL condition (15/22, 68.2%), χ2 (n = 44, df = 1) = 7.38, p = .007. There was a significant treatment condition x time interaction (b = -10.45, t = -5.10, p< .001). Measures of tension reduction activities, affect dysregulation, and affect instability exhibited a significant Time x Condition interaction. The effect sizes of NF (d = -2.33 within, d = - 1.71 between groups) are comparable to those reported for the most effective evidence based treatments for PTSD. Discussion Compared with the control group NF produced significant PTSD symptom improvement in individuals with chronic PTSD, as well as in affect regulation capacities. NF deserves further investigation for its potential to ameliorate PTSD and to improve affect regulation, and to clarify its mechanisms of action. PMID:27992435

  20. Placebo Effects and the Common Cold: A Randomized Controlled Trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

    2011-01-01

    PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group

  1. Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control

    PubMed Central

    Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

    2014-01-01

    Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part’s porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented. PMID:26601041

  2. Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control.

    PubMed

    Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

    2014-01-01

    Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part's porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented.

  3. Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial

    PubMed Central

    2014-01-01

    Background Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. Methods/Design The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). Discussion This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low

  4. Deposit control additives and fuel compositions containing the same

    SciTech Connect

    Abramo, G.P.; Avery, N.L.; Trewella, J.C.

    1992-02-18

    This patent describes a fuel composition comprising a major amount of a fuel and an additive which imparts intake valve deposit inhibiting properties to the fuel. It comprises a polyisobutenyl succinimide which is the reaction product of a polyisobutenyl succinic anhydride and a polyalkylene polyamine; a polymer of isobutylene; an ester which is an adipate, phthalate, isophthalate, terephthalate and trimellitate of iso-octanol, iso-nonanol, iso-decanol, or iso-tridecanol or mixture thereof, polyol ester of neopentyl glycol, pentaerythritol or trimethylol-propane with corresponding monocarboxylic acid, oligomer and polymer ester of dicarboxylic acid, polyol and monoalcohol; and a polyether which is a polymer or copolymer of ethylene oxide, propylene oxide, butylene oxide, pentene oxide, hexene oxide, octene oxide, decene oxide or isomer thereof.

  5. Part height control of laser metal additive manufacturing process

    NASA Astrophysics Data System (ADS)

    Pan, Yu-Herng

    Laser Metal Deposition (LMD) has been used to not only make but also repair damaged parts in a layer-by-layer fashion. Parts made in this manner may produce less waste than those made through conventional machining processes. However, a common issue of LMD involves controlling the deposition's layer thickness. Accuracy is important, and as it increases, both the time required to produce the part and the material wasted during the material removal process (e.g., milling, lathe) decrease. The deposition rate is affected by multiple parameters, such as the powder feed rate, laser input power, axis feed rate, material type, and part design, the values of each of which may change during the LMD process. Using a mathematical model to build a generic equation that predicts the deposition's layer thickness is difficult due to these complex parameters. In this thesis, we propose a simple method that utilizes a single device. This device uses a pyrometer to monitor the current build height, thereby allowing the layer thickness to be controlled during the LMD process. This method also helps the LMD system to build parts even with complex parameters and to increase material efficiency.

  6. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

    PubMed

    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

  7. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  8. Randomized controlled trials to assess therapies for multiple sclerosis.

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

    MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

  9. Randomized controlled trials – a matter of design

    PubMed Central

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial. PMID:27354804

  10. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    PubMed

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes.

  11. Validation of a MIMO Random Control Tool Using the CUBE™

    NASA Astrophysics Data System (ADS)

    Carrella, Alex; Janssens, Joris; Debille, Jan; Faignet, Eddy; Peetrs, Bart

    2012-07-01

    Environmental testing is an important engineering discipline which aims at simulating the effect of the environmnet on a given structure, item or system. A particular environment is the vibratory one. From development to qualification, engineering systems subject to harsh dynamic environments have to be tested in order to ensure their capability to withstand vibrations. To this end, there exist a wealth of test stadards which impose strict pass/fail criteria. However, these methods are rather dated and the testing community is constantly striving to update the standards to account for new technologies and ever more stringent requirements. Currently, the standard specify to carry out vibration tests along one axis at the time, that is using a Single-Input-Single-Ouput (SISO) or a Single-Input- Multiple-Ouput (SIMO) approach. However, there are a number of significant advanteges in using a Multiple- Input-Multiple-Ouput (MIMO) apporach. In this paper are presented the results of an experimental campaign aimed at assessing the capabilty of the new MIMO Random control developed at LMS.

  12. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes

    PubMed Central

    Cook, Andrea J.; Wellman, Robert D.; Cherkin, Daniel C.; Kahn, Janet R.; Sherman, Karen J.

    2015-01-01

    Background Context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments. Purpose To determine the optimal dose of massage for neck pain. Study Design/Setting Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage. Patient Sample 179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011. Outcome Measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only

  13. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    PubMed Central

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  14. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial

    PubMed Central

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer’s disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. Methods and findings This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Conclusions Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  15. Modifying Media Content for Preschool Children: A Randomized Controlled Trial

    PubMed Central

    Garrison, Michelle M.; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P.; Zhou, Chuan; Liekweg, Kimberly

    2013-01-01

    BACKGROUND: Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. METHODS: We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. RESULTS: At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78–3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06–1.30]) and the social competence subscale (1.04 [95% CI: 0.34–1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: −0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60–11.37]). CONCLUSIONS: An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior. PMID:23420911

  16. Roles of additives and surface control in slurry atomization

    SciTech Connect

    Tsai, S.C.

    1992-01-01

    This project studies the rheology and airblast atomization of micronized coal slurries. Its major objectives are (1) to promote further understanding of the mechanisms and the roles of additives in airblast atomization of coal water slurry (CWS), and (2) to investigate the impacts of coal particle surface properties and interparticle forces on CWS rheology. We have found that the flow behavior index (n) of a suspension (or slurry) is determined by the relative importance of the interparticle van der Waals attraction and the interparticle electrostatic repulsion. The interparticle attraction, measured by the Hamaker constant scaled to the thermal energy at 25[degrees]C (A/kT), causes particle aggregation, which breaks down at high shear rates, and thus leads to slurry pseudoplastic behavior (n< 1). At a constant particle volume fraction and surface charge density (qualitatively measured by the zeta potential in deionized water), n decreases linearly as A/kT increases. The relative viscosity of the pseudoplastic suspension with respect to that of the suspending liquid is found to be independent of particle density and correlate well with the particle Peclet number which equals the particle diffusional relaxation time multiplied by shear rate. Specifically, the relative viscosities of the pseudoplastic glycerol/water coal slurry and the ethylene glycol/glycerol sand slurry, at same volume fractions as well as similar particle size distributions and liquid viscosities, as functions of the particle Peclet number fall along the same line.

  17. Hierarchical random additive process and logarithmic scaling of generalized high order, two-point correlations in turbulent boundary layer flow

    NASA Astrophysics Data System (ADS)

    Yang, X. I. A.; Marusic, I.; Meneveau, C.

    2016-06-01

    Townsend [Townsend, The Structure of Turbulent Shear Flow (Cambridge University Press, Cambridge, UK, 1976)] hypothesized that the logarithmic region in high-Reynolds-number wall-bounded flows consists of space-filling, self-similar attached eddies. Invoking this hypothesis, we express streamwise velocity fluctuations in the inertial layer in high-Reynolds-number wall-bounded flows as a hierarchical random additive process (HRAP): uz+=∑i=1Nzai . Here u is the streamwise velocity fluctuation, + indicates normalization in wall units, z is the wall normal distance, and ai's are independently, identically distributed random additives, each of which is associated with an attached eddy in the wall-attached hierarchy. The number of random additives is Nz˜ln(δ /z ) where δ is the boundary layer thickness and ln is natural log. Due to its simplified structure, such a process leads to predictions of the scaling behaviors for various turbulence statistics in the logarithmic layer. Besides reproducing known logarithmic scaling of moments, structure functions, and correlation function [" close="]3/2 uz(x ) uz(x +r ) >, new logarithmic laws in two-point statistics such as uz4(x ) > 1 /2, 1/3, etc. can be derived using the HRAP formalism. Supporting empirical evidence for the logarithmic scaling in such statistics is found from the Melbourne High Reynolds Number Boundary Layer Wind Tunnel measurements. We also show that, at high Reynolds numbers, the above mentioned new logarithmic laws can be derived by assuming the arrival of an attached eddy at a generic point in the flow field to be a Poisson process [Woodcock and Marusic, Phys. Fluids 27, 015104 (2015), 10.1063/1.4905301]. Taken together, the results provide new evidence supporting the essential ingredients of the attached eddy hypothesis to describe streamwise velocity fluctuations of large, momentum transporting eddies in wall-bounded turbulence, while

  18. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  19. A Chinese Mind-Body Exercise Improves Self-Control of Children with Autism: A Randomized Controlled Trial

    PubMed Central

    Chan, Agnes S.; Sze, Sophia L.; Siu, Nicolson Y.; Lau, Eliza M.; Cheung, Mei-chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants’ self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants’ brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org. PMID:23874533

  20. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial.

    PubMed

    Chan, Agnes S; Sze, Sophia L; Siu, Nicolson Y; Lau, Eliza M; Cheung, Mei-Chun

    2013-01-01

    Self-control problems commonly manifest as temper outbursts and repetitive/rigid/impulsive behaviors, in children with autism spectrum disorders (ASD), which often contributes to learning difficulties and caregiver burden. The present study aims to compare the effect of a traditional Chinese Chan-based mind-body exercise, Nei Yang Gong, with that of the conventional Progressive Muscle Relaxation (PMR) technique in enhancing the self-control of children with ASD. Forty-six age- and IQ-matched ASD children were randomly assigned to receive group training in Nei Yang Gong (experimental group) or PMR (control group) twice per week for four weeks. The participants' self-control was measured by three neuropsychological tests and parental rating on standardized questionnaires, and the underlying neural mechanism was assessed by the participants' brain EEG activity during an inhibitory-control task before and after intervention. The results show that the experimental group demonstrated significantly greater improvement in self-control than the control group, which concurs with the parental reports of reduced autistic symptoms and increased control of temper and behaviors. In addition, the experimental group showed enhanced EEG activity in the anterior cingulate cortex, a region that mediates self-control, whereas the PMR group did not. The present findings support the potential application of Chinese Chan-based mind-body exercises as a form of neuropsychological rehabilitation for patients with self-control problems. Chinese Clinical Trial Registry; Registration No.: ChiCTR-TRC-12002561; URL: www.chictr.org.

  1. Pretravel Health Advice Among Australians Returning From Bali, Indonesia: A Randomized Controlled Trial Protocol

    PubMed Central

    Gibbs, Robyn A; Heyworth, Jane S; Giele, Carolien; Firth, Martin J; Effler, Paul V

    2016-01-01

    Background The effect of pretravel health advice (PTHA) on travel-related illness rates is poorly understood, and to date there are no published randomized controlled trials evaluating the impact of PTHA outcomes. Objective This study aims to determine the effect of an online PTHA intervention on travel-related illness rates in Western Australians visiting Bali, Indonesia. Methods Western Australian travelers to Bali will be recruited online before departure and will be randomly allocated to an intervention or control group by computer algorithm. The intervention in this study is a short animated video, with accompanying text, containing PTHA relevant to Bali. An online posttravel survey will be administered to all participants within two weeks of their return from Bali. The primary outcome is the difference in self-reported travel-related illness rates between control and intervention groups. Secondary outcomes include the difference in risk prevention behaviors and health risk knowledge between the control and intervention groups. Further secondary outcomes include whether individuals in the control group who sought external PTHA differ from those who did not with respect to risk prevention behaviors, health risk knowledge, and health risk perception, as well as the rate of self-reported travel-related illness. Results The study began recruitment in September 2016 and will conclude in September 2017. Data analysis will take place in late 2017, with results disseminated via peer-reviewed journals in early 2018. Conclusions This will be the first randomized controlled trial to examine the effect of a novel PTHA intervention upon travel-related illness. In addition, this study builds upon the limited existing data on the effectiveness of PTHA on travel-related illness. ClinicalTrial Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12615001230549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369567 (Archived by WebCite at http

  2. Generating and controlling homogeneous air turbulence using random jet arrays

    NASA Astrophysics Data System (ADS)

    Carter, Douglas; Petersen, Alec; Amili, Omid; Coletti, Filippo

    2016-12-01

    The use of random jet arrays, already employed in water tank facilities to generate zero-mean-flow homogeneous turbulence, is extended to air as a working fluid. A novel facility is introduced that uses two facing arrays of individually controlled jets (256 in total) to force steady homogeneous turbulence with negligible mean flow, shear, and strain. Quasi-synthetic jet pumps are created by expanding pressurized air through small straight nozzles and are actuated by fast-response low-voltage solenoid valves. Velocity fields, two-point correlations, energy spectra, and second-order structure functions are obtained from 2D PIV and are used to characterize the turbulence from the integral-to-the Kolmogorov scales. Several metrics are defined to quantify how well zero-mean-flow homogeneous turbulence is approximated for a wide range of forcing and geometric parameters. With increasing jet firing time duration, both the velocity fluctuations and the integral length scales are augmented and therefore the Reynolds number is increased. We reach a Taylor-microscale Reynolds number of 470, a large-scale Reynolds number of 74,000, and an integral-to-Kolmogorov length scale ratio of 680. The volume of the present homogeneous turbulence, the largest reported to date in a zero-mean-flow facility, is much larger than the integral length scale, allowing for the natural development of the energy cascade. The turbulence is found to be anisotropic irrespective of the distance between the jet arrays. Fine grids placed in front of the jets are effective at modulating the turbulence, reducing both velocity fluctuations and integral scales. Varying the jet-to-jet spacing within each array has no effect on the integral length scale, suggesting that this is dictated by the length scale of the jets.

  3. Mortality in the randomized, controlled lung intergroup trial of isotretinoin.

    PubMed

    Lee, J Jack; Feng, Lei; Reshef, Daniel S; Sabichi, Anita L; Williams, Brendell; Rinsurongkawong, Waree; Wistuba, Ignacio I; Lotan, Reuben; Lippman, Scott M

    2010-06-01

    In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial. We report the overall and cause (cancer, cardiovascular disease, or other)-specific mortality associated with long-term isotretinoin after an extended median follow-up of 6.2 years that included the capture of cause-of-death data from 428 deceased patients. Overall mortality was 36.7% in each of the two trial arms, about two thirds related to cancer and one third to other or unknown causes. Overall and cancer deaths increased in current smokers in the isotretinoin arm during the treatment and the extended follow-up period. No mortality end point increased among never smokers and former smokers taking isotretinoin, and cancer deaths decreased marginally in this combined subgroup. Isotretinoin also increased deaths from cardiovascular disease in current smokers. The present analysis supports the safety of protracted isotretinoin use in the combined group of never smokers and former smokers, which has important public health implications, for example, for treating acne in young people. The increased mortality in current smokers in this study is further evidence of the multifaceted danger of active smoking. The overall indications of this study have public health implications for treating acne in young people and other uses of retinoids in smokers.

  4. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  5. A Randomized Controlled Design Investigating the Effects of Classroom-Based Physical Activity on Children's Fluid Intelligence and Achievement

    ERIC Educational Resources Information Center

    Fedewa, Alicia L.; Ahn, Soyeon; Erwin, Heather; Davis, Matthew C.

    2015-01-01

    Existing literature shows promising effects of physical activity on children's cognitive outcomes. This study assessed via a randomized, controlled design whether additional curricular physical activity during the school day resulted in gains for children's fluid intelligence and standardized achievement outcomes. Participants were children…

  6. Effects of random whole-body vibration on postural control in Parkinson's disease.

    PubMed

    Turbanski, Stephan; Haas, Christian T; Schmidtbleicher, Dietmar; Friedrich, Antje; Duisberg, Petra

    2005-01-01

    We investigated spontaneous effects of random whole-body vibration (rWBV) on postural control in Parkinsonian subjects. Effects were examined in biomechanical tests from a total of 52 patients divided equally into one experimental and one control group. Postural control was tested pre- and post-treatment in two standardized conditions (narrow standing and tandem standing). The intervention was based on rWBV (ŷ: 3 mm, f: 6 Hz 1 Hz/sec) consisting of 5 series lasting 60 seconds each. The main findings from this study were that (1) rWBV can improve postural stability in Parkinson's disease (PD) spontaneously (2) these effects depend on the test condition. Based on the results of this study, rWBV can be regarded as an additional device in physical therapy in PD.

  7. Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

    PubMed Central

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-01-01

    Background & objectives: Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 200 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results: Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001) compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions: Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group. PMID:24820831

  8. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    PubMed Central

    2009-01-01

    Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette), susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline). Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465 PMID:20025727

  9. Effects of Resistance Exercise Applied Early After Coronary Artery Bypass Grafting: a Randomized Controlled Trial

    PubMed Central

    Ximenes, Nayana Nazaré Pessoa Sousa; Borges, Daniel Lago; Lima, Reijane Oliveira; Silva, Mayara Gabrielle Barbosa e; da Silva, Luan Nascimento; Costa, Marina de Albuquerque Gonçalves; Baldez, Thiago Eduardo Pereira; Nina, Vinícius José da Silva

    2015-01-01

    OBJECTIVE To evaluate the effects of resistance exercise applied early after coronary artery bypass grafting. METHODS It is a randomized controlled trial with 34 patients undergoing coronary artery bypass grafting between August 2013 and May 2014. Patients were randomized into two groups by simple draw: a control group (n=17), who received conventional physical therapy and an intervention group (n=17), who received, additionally, resistance exercise. Pulmonary function and functional capacity were evaluated in preoperative period and hospital discharge by spirometry and the six-minute walk test. For statistical analysis, we used the following tests: Shapiro-Wilk, Mann-Whitney, Student's t and Fisher's exact. Variables with P<0.05 were considered significant. RESULTS Groups were homogeneous in terms of demographic, clinical and surgical variables. Resistance exercise exerted no effect on pulmonary function of intervention group compared to control group. However, intervention group maintained functional capacity at hospital discharge measured by percentage of predict distance in 6MWT (54.122.7% vs. 52.515.5%, P=0.42), while control group had a significant decrease (59.211.1% vs. 50.69.9%, P<0.016). CONCLUSION Our results indicate that resistance exercise, applied early, may promote maintenance of functional capacity on coronary artery bypass grafting patients, having no impact on pulmonary function when compared to conventional physical therapy. PMID:26934401

  10. Short-term treatment of a resilient appliance in TMD pain patients: a randomized controlled trial.

    PubMed

    Nilsson, H; Limchaichana, N; Nilner, M; Ekberg, E C

    2009-08-01

    To investigate the short-term efficacy of a resilient appliance in patients with temporomandibular disorders (TMD) suffering from pain, a randomized, controlled trial was performed in 80 recruited TMD pain patients. They were randomly allocated to one of two groups: treatment with a resilient appliance or treatment with a hard, palatal, non-occluding appliance. The primary treatment outcome measure was judged positive when patients' TMD pain at worst, according to the Visual Analog Scale (VAS), decreased by at least 30%. One additional treatment outcome was reduction of characteristic pain intensity. Number needed to treat was measured on the basis of primary treatment outcome at 10 weeks. At baseline, patient characteristics and TMD pain did not differ between the groups. There were no significant differences between groups regarding a 30% reduction in VAS-reported TMD pain at worst at 10 weeks' follow-up; 61% in the treatment group and 46% in the control group. After 6 and 10 weeks of treatment, CPI decreased in both groups. Number needed to treat was 9.1 for both the resilient and the control appliance therapy during 10 weeks. There was no statistically significant difference between the resilient appliance and the non-occluding control appliance in reducing TMD pain from a short-term perspective.

  11. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    PubMed Central

    Tan, Jing-Yu; Suen, Lorna K. P.; Wang, Tao; Molassiotis, Alexander

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from inception to July 3, 2014. Meanwhile, eight Chinese journals on complementary and alternative medicine were manually searched to locate eligible articles. In addition, eligible studies listed in the reference lists of the included papers and other related systematic reviews on acupressure were also screened to further search any potentially eligible trials. Methodological quality of the included studies was evaluated using the risk of bias assessment tool developed by the Cochrane Back Review Group. Descriptive analysis was adopted to summarize the therapeutic outcomes. Results Sixty-six studies with 7265 participants were included. Methodological quality of the included trials was generally satisfactory. Six types of sham acupressure approaches were identified and “non-acupoint” stimulation was the most frequently utilized sham point while an acupressure device was the most commonly used approach for administering sham treatments. Acupressure therapy was a beneficial approach in managing a variety of health problems and the therapeutic effect was found to be more effective in the true acupressure groups than that in the sham comparative groups. No clear association could be identified between different sham acupressure modalities and the reported treatment outcomes. Conclusions A great diversity of sham acupressure controls have been used in clinical practice and research. A solid conclusion whether different sham alternatives are related to different treatment outcomes

  12. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  13. Costing and cost analysis in randomized controlled trials: caveat emptor.

    PubMed

    Polsky, Daniel; Glick, Henry

    2009-01-01

    This article provides an overview of the central issues regarding cost valuation and analysis for a decision maker's evaluation of costing performed within randomized controlled trials (RCTs). Costing involves specific choices for valuation and analysis that involve trade-offs. Understanding these choices and their implications is necessary for proper evaluation of how costs are valued and analyzed within an RCT and cannot be assessed through a checklist of adherence to general principles. Resource costing, the most common method of costing, involves measuring medical service use in study case report forms and translating this use into a cost by multiplying the number of units of each medical service by price weights for those services. A choice must be made as to how detailed the measurement of resources will be. Micro-costing improves the specificity of the cost estimate, but it is often impractical to precisely measure resources at this level and the price weights for these micro-units may not be available. Gross-costing may be more practical, and price weights are often easier to find and are more reliable, but important resource differences between treatment groups may be lost in the bundling of resources. Price weights can either be nationally determined or centre specific, but the appropriate price weight will depend on perspective, convenience, completeness and accuracy. Identifying the resource types and the appropriate price weights for these resources are the essential elements to an accurate valuation of costs. Once medical services are valued, the resulting individual patient cost estimates must be analysed. The difference in the mean cost between treatment groups is the important summary statistic for cost-effectiveness analysis from both the budgetary and the social perspectives. The statistical challenges with cost data typically stem from its skewed distribution and the resulting possibility that the sample mean may be inefficient and possibly

  14. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  15. Psychophysiological effects of stress management in patients with atopic dermatitis: a randomized controlled trial.

    PubMed

    Schut, Christina; Weik, Ulrike; Tews, Natalia; Gieler, Uwe; Deinzer, Renate; Kupfer, Jörg

    2013-01-01

    Atopic dermatitis leads to, and can be triggered by, stress. Psychological interventions have been shown to have positive effects on skin status, itch and scratching behaviour. However, it has not been analysed whether stress management leads to a change in physiological stress level and psychophysiological stress reaction under acute stress in this patient group. In this study 28 patients with atopic dermatitis were randomized to an experimental group (cognitive behavioural stress management) or a control group. The endocrine stress level and skin status were measured before and after the stress management programme. A public-speaking paradigm was used to induce acute stress. The study revealed that the experimental group had a tentatively reduced cortisol awakening response after the stress management programme. In addition, the experimental group remained calmer and showed lower salivary cortisol levels under acute stress. Thus, stress management might be a useful addition to standard treatment in patients with atopic dermatitis.

  16. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2013-10-01

    and Therapy, 47, 902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing ( EMDR ): Basic principles...Hopper, E. K., Korn, D. L., & Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine...Josef Ruzek, Ph.D. CONTRACTING ORGANIZATION: Palo Alto Institute for Research and Education Palo Alto, CA 94304 REPORT

  17. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2013-10-01

    and Therapy, 47, 902-909. Shapiro, F. (2001). Eye movement desensitization and reprocessing ( EMDR ): Basic principles, protocols, and procedures...Simpson, W. B. (2007). A randomized clinical trial of eye movement desensitization and reprocessing ( EMDR ), fluoxetine, and pill placebo in the...21702 DISTRIBUTION STATEMENT: Approved for Public Release; Distribution Unlimited The views, opinions

  18. Computer Control of a Random Access Slide Projector.

    ERIC Educational Resources Information Center

    Barker, Philip G.

    1982-01-01

    A description of a simple interface to enable the interconnection of a random access slide projector and a microcomputer is provided, as well as summaries of the role of slide images as a means of implementing graphic communication and the new activity in graphics as an area of information processing. The microcomputer interface is then detailed,…

  19. Building Kindergartners' Number Sense: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small-group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to 1 of 3 groups (n = 44 in each…

  20. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  1. The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

  2. Meta-Analysis of Randomized, Controlled Treatment Trials for Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Watson, Hunna J.; Rees, Clare S.

    2008-01-01

    Objective: To conduct a meta-analysis on randomized, controlled treatment trials of pediatric obsessive-compulsive disorder (OCD). Method: Studies were included if they employed randomized, controlled methodology and treated young people (19 years or under) with OCD. A comprehensive literature search identified 13 RCTs containing 10…

  3. A Randomized Controlled Study of the Virginia Student Threat Assessment Guidelines in Kindergarten through Grade 12

    ERIC Educational Resources Information Center

    Cornell, Dewey G.; Allen, Korrie; Fan, Xitao

    2012-01-01

    This randomized controlled study examined disciplinary outcomes for 201 students who made threats of violence at school. The students attended 40 schools randomly assigned to use the Virginia Student Threat Assessment Guidelines or follow a business-as-usual disciplinary approach in a control group. Logistic regression analyses found, after…

  4. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  5. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    ERIC Educational Resources Information Center

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  6. Key Items to Get Right When Conducting a Randomized Controlled Trial in Education

    ERIC Educational Resources Information Center

    Coalition for Evidence-Based Policy, 2005

    2005-01-01

    This is a checklist of key items to get right when conducting a randomized controlled trial to evaluate an educational program or practice ("intervention"). It is intended as a practical resource for researchers and sponsors of research, describing items that are often critical to the success of a randomized controlled trial. A significant…

  7. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    ERIC Educational Resources Information Center

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  8. Text Message Reminders Increase Appointment Adherence in a Pediatric Clinic: A Randomized Controlled Trial

    PubMed Central

    Mistry, Nila; Boneh, Jordana; Li, Hong; Lazebnik, Rina

    2016-01-01

    Background. High no-show rates can burden clinic productivity and affect patient care. Although multiple studies have shown that text messages improve appointment adherence, very little research has focused on low-income and predominantly African American populations in resident clinic settings. Objectives. To determine whether incorporating a text message reminder reduces the no-show rate at an urban, pediatric resident clinic. Methods. A randomized controlled trial was conducted at a tertiary level ambulatory pediatric practice between August 2014 and February 2015. Following a demographic survey, 170 patients were enrolled. Patients were randomized into control or intervention groups. All patients received the standard voice message appointment reminder, but the intervention group additionally received a text message reminder. The primary outcome was no-show rate. Results. 95.3% of the participants were African American, and the overall no-show rate was 30.8%. No-show rate was significantly lower in the intervention group (23.5%) than the control group (38.1%) representing a difference of 14.6% (p = 0.04). No demographic factors were found to alter the association between no-show rate and text message intervention. Conclusions. Text message reminders effectively improve show rates at a resident pediatric practice with high no-show rates, representing a promising approach to improving appointment adherence. PMID:28127311

  9. Can Inner Peace be Improved by Mindfulness Training: A Randomized Controlled Trial.

    PubMed

    Liu, Xinghua; Xu, Wei; Wang, Yuzheng; Williams, J Mark G; Geng, Yan; Zhang, Qian; Liu, Xin

    2015-08-01

    This article reports a randomized controlled trial to investigate whether mindfulness training can successfully improve inner peace in participants with no known mental disorder. Fifty-seven participants were randomized to either mindfulness training (n = 29) or wait-list control (n = 28). The experience sampling method was used to measure the fleeting momentary experience of inner peace in participants. In addition, we used an experimental approach to assessing ability to focus attention: the Meditation Breath Attention Score, as well as the self-report Five-Facet Mindfulness Questionnaire (FFMQ). Compared with the wait-list control group, mindfulness training led to an increase in scores of inner peace, Meditation Breath Attention Score and FFMQ, using analysis of repeated measures analysis of variance. Change in inner peace was not, however, mediated by changes in self-rated mindfulness (FFMQ) nor by increased attentional focus. The findings provide first evidence suggesting that using mindfulness training improves the participants' inner peace. The focus here was on the immediate effects and future studies need to use follow-up.

  10. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153.

  11. Protective effect of tartary buckwheat on renal function in type 2 diabetics: a randomized controlled trial

    PubMed Central

    Qiu, Ju; Li, Zaigui; Qin, Yuchang; Yue, Yanfen; Liu, Yanping

    2016-01-01

    Tartary buckwheat (TB) has been reported to be associated with a decreased risk of type 2 diabetes mellitus (T2DM), and T2DM has had a major impact on the development of diabetic kidney disease (DKD). Thus, the hypothesis that a daily intake of TB will improve DKD risk factors, including urinary albumin to creatinine ratio (UACR), urea nitrogen (UN), serum creatinine, and uric acid was tested. In a parallel, randomized, open-label controlled trial, 104 T2DM patients were randomly assigned to a diet control group (systematic diet plans and intensive nutritional education) or a TB intervention group (daily replacement of a portion of staple foods with TB foods). Blood samples and dietary information were collected at baseline and the end of the 4-week study. The primary outcomes were that TB significantly decreased the rela tive changes in UACR (2.43–2.35, logarithmic transformed mg/g creatinine) and UN (5.12–4.91 mmol/L) in the TB intervention group vs the diet control group at 4 weeks (P<0.05), without obvious effect on blood glucose during the 4-week study. In addition, subgroup analyses based on different DKD stages also showed a significant reduction in UACR and UN for the T2DM patients with normoalbuminuria and microalbuminuria (P<0.05). These results support the hypothesis that TB as a replacement of staple food probably alleviates renal dysfunction in T2DM patients. PMID:27920542

  12. Modification of Appetite by Bread Consumption: A Systematic Review of Randomized Controlled Trials.

    PubMed

    Gonzalez-Anton, Carolina; Artacho, Reyes; Ruiz-Lopez, Maria D; Gil, Angel; Mesa, Maria D

    2015-10-19

    The inclusion of different ingredients or the use of different baking technologies may modify the satiety response to bread, and aid in the control of food intake. The aim of this study was to perform a systematic search of randomized clinical trials on the effect of bread consumption on appetite ratings in humans. The search equation was ("Bread"[MeSH]) AND ("Satiation"[MeSH] OR "Satiety response"[MeSH]), and the filter 'clinical trials'. As a result of this procedure, 37 publications were selected. The satiety response was considered as the primary outcome. The studies were classified as follows: breads differing in their flour composition, breads differing in ingredients other than flours, breads with added organic acids or breads made using different baking technologies. Additionally, we have revised the data related to the influence of bread on glycemic index, insulinemic index and postprandial gastrointestinal hormones responses. The inclusion of appropriate ingredients such as fiber, proteins, legumes, seaweeds and acids into breads and the use of specific technologies may result in the development of healthier breads that increase satiety and satiation, which may aid in the control of weight gain and benefit postprandial glycemia. However, more well-designed randomized control trials are required to reach final conclusions.

  13. Impact of online patient reminders to improve asthma care: A randomized controlled trial

    PubMed Central

    Pool, Andrew C.; Kraschnewski, Jennifer L.; Poger, Jennifer M.; Smyth, Joshua; Stuckey, Heather L.; Craig, Timothy J.; Lehman, Erik B.; Yang, Chengwu; Sciamanna, Christopher N.

    2017-01-01

    Importance Asthma is one of the most burdensome chronic illnesses in the US. Despite widespread dissemination of evidence-based guidelines, more than half of the adults with asthma have uncontrolled symptoms. Objective To examine the efficacy of an online tool designed to improve asthma control. Design 12-month single blind randomized controlled trial of the online tool (Intervention condition, IC) versus an active control tool (CC). Setting Patients enrolled in an insurance plan. Participants Participants were 408 adults (21–60 years of age) with persistent asthma. Intervention At least once each month and before provider visits, participants in the IC answered questions online about their asthma symptoms, asthma medications and asthma care received from providers, such as an asthma management plan. The tool then provided tailored feedback to remind patients 1) to ask health care providers specific questions that may improve asthma control (e.g., additional controller medications) and 2) to consistently perform specific self-care behaviors (e.g., proper inhaler technique). Participants in the CC received similar questions and feedback, yet focused instead on preventive services unrelated to asthma control (e.g., cancer screening). Main outcome measures The main outcome measure was asthma control, as assessed by the 5-question Asthma Control Test (ACT). Secondary outcomes included quality of life, medication use and healthcare utilization (e.g., emergency department visits). Results After 12 months, 323 participants completed follow-up measures (79.2%). Participants in the IC reported a greater mean improvement in the ACT score than participants in the CC (2.3 vs. 1.2; p = 0.02) and 9 of 11 individual asthma control survey items showed non-significant improvements favoring the IC. No differences were observed in medication adherence, number of asthma controller medications or health care utilization. Conclusion and relevance Simple and brief online patient

  14. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    DTIC Science & Technology

    2013-10-01

    AD_________________ Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure...SUBTITLE A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans 5a. CONTRACT NUMBER...will: 1) evaluate effects of Transcendental Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician

  15. Behavioral effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    PubMed

    Bink, Marleen; van Nieuwenhuizen, Chijs; Popma, Arne; Bongers, Ilja L; van Boxtel, Geert J M

    2015-09-01

    Neurofeedback has been proposed as a potentially effective intervention for reducing Attention Deficit Hyperactivity Disorder (ADHD) symptoms. However, it remains unclear whether neurofeedback is of additional value to treatment as usual (TAU) for adolescents with clinical ADHD symptoms. Using a multicenter parallel-randomized controlled trial design, adolescents with ADHD symptoms were randomized to receive either a combination of TAU and neurofeedback (NFB + TAU, n = 45) or TAU-only (n = 26). Randomization was computer generated and stratified for age group (ages 12 through 16, 16 through 20, 20 through 24). Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Primary behavioral outcome measures included the ADHD-rating scale, Youth Self Report, and Child Behavior Checklist all assessed pre- and post-intervention. Behavioral problems decreased equally for both groups with medium to large effect sizes, range of partial η2 = 0.08-0.31, p < 0.05. Hence, the combination of NFB + TAU was not more effective than TAU-only on the behavioral outcome measures. In addition, reported adverse effects were similar for both groups. On behavioral outcome measures, the combination of neurofeedback and TAU was as effective as TAU-only for adolescents with ADHD symptoms. Considering the absence of additional behavioral effects in the current study, in combination with the limited knowledge of specific treatment effects, it is questionable whether theta/SMR neurofeedback for adolescents with ADHD and comorbid disorders in clinical practice should be used. Further research is warranted to investigate possible working mechanisms and (long-term) specific treatment effects of neurofeedback.

  16. Spirulina did not ameliorate idiopathic chronic fatigue in four N-of-1 randomized controlled trials.

    PubMed

    Baicus, Cristian; Baicus, Anda

    2007-06-01

    Idiopathic chronic fatigue is an exclusion diagnosis established when no chronic disease is found. Spirulina platensis is an alga with a rich content of proteins, vitamins, minerals and amino acids and is considered as a bioactive additive with multiple effects, among them being effects against fatigue. However, despite the worldwide utilization of Spirulina, there are only a few quality studies with it and none concerning fatigue. The N-of-1 randomized trials are made on one patient, and by this kind of study the efficacy of a treatment on that particular patient can be assessed. A series of four N-of-1 double-blind, randomized trials were performed on four physicians who complained of chronic fatigue. Each patient was his own control and received three pairs of treatments comprising 4 weeks of spirulina and 4 weeks of placebo. Spirulina platensis was administered in a dose of 3 g/day. For each pair, the order of treatments was randomized. Outcome measures were severity of fatigue measured on a 10-point scale. The scores of fatigue were not significantly different between spirulina and placebo. Spirulina administered in a dose of 3 g/day did not ameliorate fatigue more than the placebo in any of the four subjects, and possibly it has no effect on chronic fatigue.

  17. Additional Targeted Biopsy in Clinically Suspected Prostate Cancer: Prospective Randomized Comparison between Contrast-Enhanced Ultrasound and Sonoelastography Guidance.

    PubMed

    Koh, Jieun; Jung, Dae Chul; Oh, Young Taik; Yoo, Moon Gyu; Noh, Songmi; Han, Kyung Hwa; Rha, Koon-Ho; Choi, Young Deuk; Hong, Sung Joon

    2015-11-01

    Our aim was to improve the detection of prostate cancer by evaluating whether contrast-enhanced ultrasound (CEUS) or sonoelastography (SE) is more helpful in guiding targeted biopsy (TB) performed before systematic biopsy (SB). A total of 52 patients suspected of having prostate cancer were prospectively included and randomly assigned to either the CEUS or SE group. Different, independent radiologists performed TB and twelve-core SB. Within each group, cancer detection rates based on core number were compared between SB and TB. We evaluated the effect of TB on core-based cancer detection rates between the CEUS and SE groups. Cancer detection was higher in overall TB cores 16.4% (28/171) than SB cores 11.4% (71/624) in both groups. In the SE group, TB cores revealed higher cancer detection than did SB cores from 4.49% (14/312) to 12.86% (9/70) (p = 0.01). Compared with CEUS, SE may improve detection rates when considering additional TB guidance methods.

  18. Bifidobacterium lactis in Treatment of Children with Acute Diarrhea. A Randomized Double Blind Controlled Trial

    PubMed Central

    El-Soud, Neveen Helmy Abou; Said, Reem Nabil; Mosallam, Dalia Sayed; Barakat, Nahla Abdel Moniem; Sabry, Mohamed Ahmed

    2015-01-01

    BACKGROUND: Probiotics are becoming increasingly popular treatment for children diarrhea. Although there are several probiotic strains potentially useful, researches were often limited to certain strains. AIM: To test Bifidobacterium lactis on morbidity of acute diarrhea in children less than 2 years. SUBJECTS AND METHODS: A randomized double-blind controlled clinical trial was conducted in 50 children (1 - 23 months) admitted with acute diarrhea to the Pediatric Hospital, Cairo University and were randomly assigned to receive in addition to usual treatment of diarrhea according to WHO guidelines; one of two treatments either milk formula non-supplemented (n = 25) or supplemented (n = 25) with Bifidobacterium lactis 14.5 × 106 CFU/100 ml daily for one week. Primary outcomes were frequency and duration of diarrhea and hospital stay. Secondary outcomes were duration of fever and vomiting episodes. Safety and tolerance were also recorded. RESULTS: On admission, patients’ characteristics of both groups (50 cases) were similar. For children who received the probiotics for one week; mean duration of diarrhoea was shorter than in controls (3.12 ± 0.92 vs. 4.10 ± 0.94 days) (P = 0.02), number of motions per day was less than in controls (3.96 ± 0.62 vs. 4.46 ± 0.85) (P = 0.04) and discharge from hospital <2 days was more frequent than in controls (72% vs. 44%) (P = 0.048). There was no effect on fever (P = 0.63) or vomiting (P = 0.54). CONCLUSION: Bifidobacterium lactis probiotics in supplemented milk formula decreased significantly frequency, duration of diarrhea, and hospital stay than usual treatment alone in children with acute diarrhea. Additional researches on other uncommon local probiotic species should be encouraged. PMID:27275258

  19. Effect of diclofenac suppository on pain control during flexible cystoscopy-A randomized controlled trial

    PubMed Central

    Nadeem, Mehwash; Ather, M Hammad

    2016-01-01

    TRIAL DESIGN: To compare the difference in pain score during flexible cystoscopy between patients undergoing the procedure with plain lubricating gel  only and plain gel with diclofenac suppository in a randomized control trial. METHODS:  A total of 60 male patients with an indication of flexible cystoscopy were enrolled in a prospective, randomized controlled study. Patients were randomized in two groups. In group “A”, patients received diclofenac suppository one hour prior to the procedure while group “B” did not receive diclofenac suppository. Both groups received 10 ml of intra-urethral  plain gel for lubrication during flexible cystoscopy. Pain score was recorded immediately after the procedure using the visual analogue scale (VAS). Pre- and post-procedure pulse rate and systolic blood pressure was also recorded. Statistical analyses were performed using chi-square test and student t-test. Regression analysis was performed to address the confounding variables. RESULTS: Both groups were comparable for variables including age, duration of procedure, level of operating surgeon and indication of procedure. Most common indication for flexible cystoscopy was removal of double J stent. There was a statistically significant difference in the mean pain score between two groups ( p = 0.012).  The difference in post-procedure mean pulse rate in the two groups was statistically significant ( p= 0.01) however there was no difference observed in mean post procedure systolic blood pressure. Regression analysis showed that none of the confounding variables were significantly affecting pain perception. CONCLUSIONS: Intra rectal diclofenac suppository is simple and effective pre-emptive analgesia. We recommend its routine use during flexible cystoscopy for better pain control.

  20. Escitalopram versus paroxetine controlled release in major depressive disorder: a randomized trial

    PubMed Central

    Kishi, Taro; Matsuda, Yuki; Matsunaga, Shinji; Moriwaki, Masatsugu; Otake, Yoichiro; Akamatsu, Kaku; Okochi, Tomo; Hirano, Shigeki; Funahashi, Toshihiko; Okuda, Momoko; Tabuse, Hideaki; Fujita, Kiyoshi; Iwata, Nakao

    2017-01-01

    Objective There are no direct comparisons between escitalopram and paroxetine controlled release in patients with major depressive disorder (MDD). Methods We conducted a 24-week, rater-masked, randomized trial of escitalopram (5–20 mg/day) versus paroxetine controlled release (12.5–50 mg/day) in patients with MDD (UMIN000011191). Patients with the diagnosis of moderate-to-severe MDD (a 17-item Hamilton Rating Scale for Depression [HAMD-17], with total score at baseline being ≥20) were recruited to participate in a parallel, randomized, controlled trial. The primary outcome for efficacy was an improvement in the 21-item HAMD (HAMD-21) total score at 24 weeks. The secondary outcomes were the response, remission, and discontinuation rates and the incidence of individual adverse events. Results A total of 88 patients with MDD (males, 61.4%; mean age, 40.8±13.4 years) were recruited. The discontinuation rate was 58.0% (escitalopram, 55.8%; paroxetine controlled release, 60.0%). Both escitalopram and paroxetine controlled-release treatment groups exhibited significant reduction in the HAMD-21 total score at 2, 4, 8, 12, and 24 weeks from the baseline. However, there were no significant differences in the HAMD-21 total score, response rate, remission rate, and discontinuation rate at any time point between the groups. In addition, there were no significant differences in the incidence of any individual adverse events (eg, nausea, vomiting, and somnolence) between the treatment groups. Conclusion Our results suggest that escitalopram and paroxetine controlled release had similar efficacy and safety profiles in patients with MDD. One of the primary limitations of this study is the small sample size. PMID:28123299

  1. The debate: a case for randomized controls in invasive aspergillosis.

    PubMed

    Bennett, John E

    2006-09-01

    Randomized trials in invasive aspergillosis have evolved over the past decade. Definitions of disease now include specifics of the underlying disease and how this affects interpretation of certain tests, including high resolution computed tomography and smears or cultures of sputum and bronchoalveolar lavage. Study hypotheses have changed from underpowered superiority trials to adequately powered noninferiority trials. Consensus building between Europe and North America has allowed trials to be conducted with the same protocol in both regions, thereby increasing study enrollment. In aggregate, the following outcomes can be drawn from randomized trials: (i) Liposomal amphotericin B is possibly superior to conventional amphotericin B at 14 days and less toxic. Whether the dose of liposomal amphotericin is 1 or 4 mg/kg daily is not as important as other factors in determining outcome of possible aspergillosis; (ii) amphotericin B colloidal dispersion is less nephrotoxic but has more acute infusion-related reactions than conventional amphotericin B; (iii) starting treatment with voriconazole is superior to starting with conventional amphotericin B. In an era of increasing cost containment, it will be the randomized trials that provide the clinician with the information needed to avoid inappropriate use of expensive drugs and drug combinations.

  2. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    PubMed Central

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking

  3. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    PubMed Central

    2012-01-01

    Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost effectiveness of remifentanil as

  4. Robotic Compared With Laparoscopic Sacrocolpopexy: A Randomized Controlled Trial

    PubMed Central

    Anger, Jennifer T.; Mueller, Elizabeth R.; Tarnay, Christopher; Smith, Bridget; Stroupe, Kevin; Rosenman, Amy; Brubaker, Linda; Bresee, Catherine; Kenton, Kimberly

    2014-01-01

    Objective: Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy. Methods: Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared surgical costs (including costs for robot, initial hospitalization) and re-hospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events. Results: We randomized 78 women [mean age 59 years]: laparoscopic (n=38), robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 vs. $11,573, p < 0.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 vs. $12,170, p < 0.001). When we excluded costs of robot purchase and maintenance, we did not detect a statistical difference in initial day of surgery costs of robotic vs. laparoscopic ($12,586 vs. $11,573; p = 0.160) or hospital costs over 6 weeks ($13,867 vs. $12,170; p = 0.060). The robotic group had longer operating room times (202.8 min vs. 178.4 min, p = 0.030) and higher pain scores 1-week after surgery (3.5 ± 2.1 vs. 2.6 ± 2.2; p = 0.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events. Conclusion: Costs of robotic sacrocolpopexy are higher than laparoscopic, while short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. PMID:24463657

  5. Controlled-release phentermine/topiramate in severely obese adults: a randomized controlled trial (EQUIP).

    PubMed

    Allison, David B; Gadde, Kishore M; Garvey, William Timothy; Peterson, Craig A; Schwiers, Michael L; Najarian, Thomas; Tam, Peter Y; Troupin, Barbara; Day, Wesley W

    2012-02-01

    A 56-week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled-release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m(2)) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced-energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks (P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks (P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose-dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.

  6. Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic.

    PubMed

    Schmidt, Norman B; Raines, Amanda M; Allan, Nicholas P; Zvolensky, Michael J

    2016-02-01

    Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers.

  7. Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic

    PubMed Central

    Schmidt, Norman B.; Raines, Amanda M.; Allan, Nicholas P.; Zvolensky, Michael J.

    2016-01-01

    Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. PMID:26752327

  8. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  9. A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

    DTIC Science & Technology

    2014-10-01

    Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and...COVERED 30 Sep 2013 - 29 Sep 2014 4. TITLE AND SUBTITLE A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education... Meditation (TM) vs. Prolonged Exposure (PE) and PTSD health education control (EC), using the Clinician Administered PTSD Scale (CAPS) (primary

  10. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study.

    PubMed

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients' engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed.

  11. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    PubMed Central

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

  12. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention

    PubMed Central

    Bomyea, Jessica; Stein, Murray B.; Lang, Ariel J.

    2015-01-01

    Post-traumatic stress disorder (PTSD) is a chronic and debilitating condition characterized by persistent intrusive memories. Although effective treatments exist for PTSD, there is a need for development of alternative treatments. Diminished ability to control proactive interference may contribute to re-experiencing symptoms and may be a novel intervention target. The present study tested an intervention designed to modify proactive interference control. Forty-two women with PTSD were randomly assigned to a computerized cognitive training or a control condition. The impact of these programs on cognitive performance and symptoms was assessed. PTSD re-experiencing symptoms and interference control performance improved significantly more for individuals in the training group relative to those in the control group. Other PTSD and general distress symptoms improved equally over time in both groups. Cognitive training of this type may hold promise as a novel intervention for reducing PTSD symptoms, although the mechanism of action and implications for models of PTSD requires future study. PMID:26114901

  13. Effect of Probiotics on Blood Lipid Concentrations: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Cho, Young Ae; Kim, Jeongseon

    2015-10-01

    Previous clinical studies have reported mixed results regarding the effect of probiotics on lipid metabolism. Therefore, we conducted a meta-analysis of randomized controlled trials to quantify the direction and magnitude of the potential effect of probiotics on blood lipid concentrations.Eligible studies were randomized, placebo-controlled trials whose interventions were probiotic products containing live bacteria. The studies reported net changes in lipid profiles (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides) and their associated standard deviations (or the data to calculate them). The probiotic products did not contain prebiotics or other active ingredients, and the full article was accessible in English.The pooled mean net change in lipid profiles and 95% confidence intervals (95% CIs) were calculated. Q statistics and I were calculated to examine heterogeneity. Potential sources of heterogeneity were investigated via subgroup and sensitivity analyses, and publication biases were estimated.A total of 30 randomized controlled trials with 1624 participants (828 in intervention groups and 796 in placebo groups) were included in this analysis. Subjects treated with probiotics demonstrated reduced total cholesterol and LDL cholesterol compared to control subjects by 7.8 mg/dL (95% CI: -10.4, -5.2) and 7.3 mg/dL (95% CI: -10.1, -4.4), respectively. There was no significant effect of probiotics on HDL cholesterol or triglycerides. The effect of probiotics on total cholesterol and LDL cholesterol depended on a variety of factors. The significant effects were greater for higher baseline total cholesterol levels, longer treatment durations, and certain probiotic strains. In addition, these associations seem stronger in studies supported by probiotics companies.The studies included in this meta-analysis showed significant heterogeneity as indicated by the Q statistics and I. In addition, industry sponsorship may affect study findings

  14. Randomized controlled trials in central vascular access devices: A scoping review

    PubMed Central

    Keogh, Samantha; Rickard, Claire M.

    2017-01-01

    Background Randomized controlled trials evaluate the effectiveness of interventions for central venous access devices, however, high complication rates remain. Scoping reviews map the available evidence and demonstrate evidence deficiencies to focus ongoing research priorities. Method A scoping review (January 2006–December 2015) of randomized controlled trials evaluating the effectiveness of interventions to improve central venous access device outcomes; including peripherally inserted central catheters, non-tunneled, tunneled and totally implanted venous access catheters. MeSH terms were used to undertake a systematic search with data extracted by two independent researchers, using a standardized data extraction form. Results In total, 178 trials were included (78 non-tunneled [44%]; 40 peripherally inserted central catheters [22%]; 20 totally implanted [11%]; 12 tunneled [6%]; 6 non-specified [3%]; and 22 combined device trials [12%]). There were 119 trials (68%) involving adult participants only, with 18 (9%) pediatric and 20 (11%) neonatal trials. Insertion-related themes existed in 38% of trials (67 RCTs), 35 RCTs (20%) related to post-insertion patency, with fewer trials on infection prevention (15 RCTs, 8%), education (14RCTs, 8%), and dressing and securement (12 RCTs, 7%). There were 46 different study outcomes reported, with the most common being infection outcomes (161 outcomes; 37%), with divergent definitions used for catheter-related bloodstream and other infections. Conclusion More high quality randomized trials across central venous access device management are necessary, especially in dressing and securement and patency. These can be encouraged by having more studies with multidisciplinary team involvement and consumer engagement. Additionally, there were extensive gaps within population sub-groups, particularly in tunneled devices, and in pediatrics and neonates. Finally, outcome definitions need to be unified for results to be meaningful and

  15. Preventive Gabapentin versus Pregabalin to Decrease Postoperative Pain after Lumbar Microdiscectomy: A Randomized Controlled Trial

    PubMed Central

    Qadeer, Mohsin; Waqas, Muhammad; Rashid, Muhammad Jawad; Enam, Syed Ather; Sharif, Salman

    2017-01-01

    Study Design Randomized controlled trial. Purpose The purpose of this study was to compare pregabalin and gabapentin for mean postoperative visual analog score (VAS) for pain in patients undergoing single-level lumbar microdiscectomy for intervertebral disc prolapse at a tertiary care hospital. Overview of Literature Pregabalin has a superior pharmacokinetic profile and analgesic effect at lower doses than gabapentin; however, analgesic efficacy must be established during the perioperative period after lumbar spine surgery. Methods This randomized controlled trial was carried out at our institute from February to October 2011 on 78 patients, with 39 participants in each study group. Patients undergoing lumbar microdiscectomy were randomized to group A (gabapentin) or group B (pregabalin) and started on trial medicines one week before surgery. The VAS for pain was recorded at 24 hours and one week postoperatively. Results Both groups had similar baseline variables, with mean ages of 42 and 39 years in groups A and B, respectively, and a majority of male patients in each group. The mean VAS values for pain at 24 hours for gabapentin vs. pregabalin were comparable (1.97±0.84 vs. 1.6±0.87, respectively; p=0.087) as were the results at one week after surgery (0.27±0.45 vs. 0.3±0.46, respectively; p=0.79). None of the patients required additional analgesia postoperatively. After adjusting for age and sex, the VAS value for group B patients was 0.028 points lower than for group A patients, but this difference was not statistically significant (p=0.817, R2=0.018). Conclusions Pregabalin is equivalent to gabapentin for the relief of postoperative pain at a lower dose in patients undergoing lumbar microdiscectomy. Therefore, other factors, such as dose, frequency, cost, pharmacokinetics, and side effects of these medicines, should be taken into account whenever it is prescribed. PMID:28243376

  16. Safety data from randomized controlled trials: applying models for recurrent events.

    PubMed

    Hengelbrock, Johannes; Gillhaus, Johanna; Kloss, Sebastian; Leverkus, Friedhelm

    2016-07-01

    Simple descriptive listings and inference statistics based on 2×2 tables are still the most common way of summarizing and reporting adverse events data from randomized controlled trials, although these methods do not account for differences in observation times between treatment groups. Using standard methods from survival analysis such as the Cox model or Kaplan-Meier estimates would overcome this problem but limit the analysis to the first safety-related event of each subject. As an alternative, we discuss two models for recurrent events data-the Andersen-Gill and Prentice-Williams-Peterson model-regarding their applicability to safety data from randomized controlled trials. We argue that these models can be used to estimate two different quantities: a direct treatment effect on the risk of an event (Prentice-Williams-Peterson) and a total treatment effect as sum of the direct effect and the treatment's indirect effect via the event history (Anderson-Gill). Using simulated data, we illustrate the difference between these treatment effects and analyze the performance of both models in different scenarios. Because both models are limited to the analysis of cause-specific hazards if competing risks are present, we suggest to incorporate estimates of the mean frequency of events in the analysis to additionally allow the comparison of treatment effects on absolute event probabilities. We demonstrate the application of both models and the mean frequency function to safety endpoints with an illustrative analysis of data from a randomized phase-III study. Copyright © 2016 John Wiley & Sons, Ltd.

  17. A Randomized Controlled Trial of Brief Interventions for Body Dissatisfaction

    ERIC Educational Resources Information Center

    Wade, Tracey; George, Wing Man; Atkinson, Melissa

    2009-01-01

    The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction…

  18. Control problem for diffusion-type random fields

    SciTech Connect

    Knopov, P.S.; Derieva, E.N.

    1995-09-01

    Sufficient existence conditions are given for optimal control in a system described by a stochastic differential equations. These conditions are derived by Girsanov`s method of transformation of measures. Existence of {epsilon}-optimal controls is proved and a method of their construction is described.

  19. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  20. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    PubMed

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  1. Randomized controlled trial of sealed in-office bleaching effectiveness.

    PubMed

    Santana, Mário Artur Pereira; Nahsan, Flávia Pardo Salata; Oliveira, Alaíde Hermínia de Aguiar; Loguércio, Alessandro Dourado; Faria-e-Silva, André Luis

    2014-01-01

    Regardless of the high success rate, patients commonly report the occurrence of tooth sensitivity during the in-office bleaching procedures. Recently, it has been demonstrated that using a customized tray (called sealed in-office bleaching technique) reduces peroxide penetration. The aim of this randomized clinical study was to evaluate tooth sensitivity and bleaching efficacy of sealed bleaching, in comparison with a conventional in-office technique. Twenty patients were randomized allocated in two groups in which 35% hydrogen peroxide gel was used in a single 45-min application. For the sealed technique, a customized bleaching tray was fabricated and carefully positioned over the bleaching agent during the session. The color was recorded at a baseline, 7 and 28 days after the bleaching session, using Vita Easy Shade spectrophotometer. Tooth sensitivity was recorded during (20 and 40 min) and immediately after the treatment using a visual analogue scale. The bleaching efficacy was evaluated by repeated-measures ANOVA, while the absolute risk of tooth sensitivity and its intensity were evaluated by Fisher's exact and Mann-Whitney tests, respectively (α=0.05). No significant difference on bleaching efficacy was observed between the conventional (7.4 and 8.1 ΔE) and sealed techniques (7.8 and 8.3 ΔE) at both evaluation periods. No significant difference was observed regarding the absolute risk of tooth sensitivity (p=0.15). Sealed technique showed a significant decrease of sensitivity intensity after 40 min (p=0.03). Sealed bleaching technique was able to reduce the sensitivity intensity during the bleaching procedure, without jeopardizing the bleaching efficacy.

  2. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial

    PubMed Central

    Spillane, Nichea S.; Day, Anne M.; Cioe, Patricia A.; Parks, Acacia; Leventhal, Adam M.; Brown, Richard A.

    2015-01-01

    Objective: Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). Method: Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. Results: Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). Conclusion: This trial suggests substantial promise for incorporating PPT into smoking cessation treatment. PMID:25646352

  3. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

  4. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    ERIC Educational Resources Information Center

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  5. The Late Pretest Problem in Randomized Control Trials of Education Interventions

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2010-01-01

    Pretest-posttest experimental designs often are used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data often are collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  6. The Late Pretest Problem in Randomized Control Trials of Education Interventions. NCEE 2009-4033

    ERIC Educational Resources Information Center

    Schochet, Peter Z.

    2008-01-01

    Pretest-posttest experimental designs are often used in randomized control trials (RCTs) in the education field to improve the precision of the estimated treatment effects. For logistic reasons, however, pretest data are often collected after random assignment, so that including them in the analysis could bias the posttest impact estimates. Thus,…

  7. Efficacy of Parent-Child Interaction Therapy with Chinese ADHD Children: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Ng, Gene S. H.; Choi, S. Y.

    2017-01-01

    Purpose: This study aimed to evaluate the efficacy of Parent-Child Interaction Therapy (PCIT) in Chinese children with attention-deficit/hyperactivity disorder (ADHD) or ADHD features. Methods: This study adopted a randomized controlled trial design without blinding. Participants were randomized into either the intervention group (n = 32) and…

  8. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  9. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  10. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  11. Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

    2016-01-01

    This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

  12. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  13. Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

    ERIC Educational Resources Information Center

    Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

    2015-01-01

    Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

  14. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  15. Preventing Relapse/Recurrence in Recurrent Depression With Cognitive Therapy: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bockting, Claudi L. H.; Schene, Aart H.; Spinhoven, Philip; Koeter, Maarten W. J.; Wouters, Luuk F.; Huyser, Jochanan; Kamphuis, Jan H.

    2005-01-01

    This article reports on the outcome of a randomized controlled trial of cognitive group therapy (CT) to prevent relapse/recurrence in a group of high-risk patients diagnosed with recurrent depression. Recurrently depressed patients (N = 187) currently in remission following various types of treatment were randomized to treatment as usual,…

  16. Retracted: Postoperative pain after irrigation with Vibringe versus a conventional needle: a randomized controlled trial.

    PubMed

    Bilgili, D; Yilmaz, S; Dumani, A; Yoldas, O

    2016-08-01

    The following article from International Endodontic Journal, 'Postoperative pain after irrigation with Vibringe versus a conventional needle: a randomized controlled trial' by D. Bilgili, S. Yilmaz, A. Dumani & O. Yoldas, published online on 29 February 2016 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the authors, the Journal Editor in Chief, Prof. Paul Dummer, and John Wiley & Sons Ltd. The retraction has been agreed because the corresponding author did not contact the first author who carried out the work before alterations to the article were made prior to submission. This damages the integrity of the work and there are additional concerns over the number of patients and the accuracy of the results and conclusions.

  17. Randomized controlled trial of the focus parent training for toddlers with autism: 1-year outcome.

    PubMed

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-12-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five toddlers with autism spectrum disorder (65 autism, 10 PDD-NOS, mean age = 34.4 months, SD = 6.2) were enrolled. Analyses were conducted on a final sample of 67 children (lost to follow-up = 8). No significant intervention effects were found for any of the primary (language), secondary (global clinical improvement), or mediating (child engagement, early precursors of social communication, or parental skills) outcome variables, suggesting that the 'Focus parent training' was not of additional value to the more general care-as-usual.

  18. Melatonin for sleep disorders and cognition in dementia: a meta-analysis of randomized controlled trials.

    PubMed

    Xu, Jing; Wang, Li-Ling; Dammer, Eric B; Li, Chun-Bo; Xu, Gang; Chen, Sheng-Di; Wang, Gang

    2015-08-01

    The current review aims to examine melatonin therapy for both sleep disturbances and cognitive function in dementia. We searched all randomized controlled trials published in Medline, Embase, the Cochrane Library, China National Knowledge Infrastructure, the Cochrane Dementia and Cognitive Improvement Group’s Specialized Register, and Clinical Trials.gov. The grading of recommendations assessment, development and evaluation framework was used to assess the quality of evidence. Seven studies were included (n = 520). Treated participants showed prolonged total sleep time (TST) by 24.36 minutes (P = .02). Sleep efficacy (SE) was marginally improved (P = .07). This effect was stronger under a longer intervention period lasting more than 4 weeks (P = .02). Conversely, cognitive function did not change significantly. Additionally, there was no report of severe adverse events. Given the current studies, we conclude that melatonin therapy may be effective in improving SE and prolonging TST in patients with dementia; however, there is no evidence that this improvement impacts cognitive function.

  19. Just-in-Time Information Improved Decision-Making in Primary Care: A Randomized Controlled Trial

    PubMed Central

    McGowan, Jessie; Hogg, William; Campbell, Craig; Rowan, Margo

    2008-01-01

    Background The “Just-in-time Information” (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction. Methods and Finding A randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued. Conclusions In this study, providing timely information to clinical questions had a highly positive impact on decision

  20. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

    PubMed Central

    Ratanasiripong, Paul; Ratanasiripong, Nop; Kathalae, Duangrat

    2012-01-01

    Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession. PMID:22811932

  1. Patient agenda setting in respiratory outpatients: A randomized controlled trial.

    PubMed

    Early, Frances; Everden, Angharad Jt; O'Brien, Cathy M; Fagan, Petrea L; Fuld, Jonathan P

    2015-11-01

    Soliciting a patient's agenda (the reason for their visit, concerns and expectations) is fundamental to health care but if not done effectively outcomes can be adversely affected. Forms to help patients consider important issues prior to a consultation have been tested with mixed results. We hypothesized that using an agenda form would impact the extent to which patients felt their doctor discussed the issues that were important to them. Patients were randomized to receive an agenda form to complete whilst waiting or usual care. The primary outcome measure was the proportion of patients agreeing with the statement 'My doctor discussed the issues that were important to me' rated on a four-point scale. Secondary outcomes included other experience and satisfaction measures, consultation duration and patient confidence. There was no significant effect of agenda form use on primary or secondary outcomes. Post hoc exploratory analyses suggested possible differential effects for new compared to follow-up patients. There was no overall benefit from the form and a risk of detrimental impact on patient experience for some patients. There is a need for greater understanding of what works for whom in supporting patients to get the most from their consultation.

  2. Electroacupuncture for Functional Constipation: A Multicenter, Randomized, Control Trial

    PubMed Central

    Zheng, Cuihong; Ding, Pei; Tian, Man; Wang, Ying; Dong, Haoxu; Zhang, Mingmin; Wang, Wei; Xu, Shabei; Xie, Minjie

    2017-01-01

    Background and Aim. To investigate the efficacy and safety of electroacupuncture (EA) with different current intensities for functional constipation (FC) and to assess whether the effects of EA with different current intensities are superior to the mosapride. Methods. Patients with FC were randomly divided into low current intensity group (LCI), high current intensity group (HCI), and mosapride group (MC). The primary outcome was three or more spontaneous bowel movements (SBMs) per week and an increase of one or more SBMs from baseline during at least 3 of the 4 weeks. Results. The primary outcome was reached by 53.45%, 66.15%, and 52.24% of the patients who received LCI, HCI, and mosapride, respectively. EA can significantly improve the weekly SBMs and stool consistency and reduce straining severity (p < 0.0001, all). HCI improved the quality of life better than mosapride (p < 0.05) and reduced the proportion of severe constipation more than LCI and mosapride (p < 0.05, both). Conclusions. EA is effective and safe at both current intensities for FC; therapeutic effects of LCI and HCI are not superior to mosapride. EA is superior to mosapride in improving patients' life quality and satisfaction level of treatment; EA has fewer adverse events than mosapride. PMID:28250788

  3. 77 FR 26789 - Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... From the Federal Register Online via the Government Publishing Office ] INTERNATIONAL TRADE COMMISSION Certain Semiconductor Chips Having Synchronous Dynamic Random Access Memory Controllers and Products Containing Same; Determination Rescinding the Exclusion Order and Cease and Desist Orders...

  4. Behavior Therapy for Pediatric Trichotillomania: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Franklin, Martin E.; Edson, Aubrey L.; Ledley, Deborah A.; Cahill, Shawn P.

    2011-01-01

    Objective: To examine the efficacy and durability of a behavioral therapy (BT) protocol for pediatric TTM compared with a minimal attention control (MAC) condition. It was hypothesized that the BT condition would be superior to MAC at the end of acute treatment, and would also demonstrate durability of gains through the maintenance treatment…

  5. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    PubMed Central

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  6. Removal of extrinsic stain using a tartar control whitening dentifrice: a randomized clinical trial.

    PubMed

    Gerlach, R W; White, D J

    2001-01-01

    A nine-week, double blind clinical trial was conducted to evaluate the effectiveness of a novel tartar control whitening dentifrice with a silica-based abrasive system on induced dental stain. The study model involved three weeks of stain induction followed by six weeks of unsupervised brushing to assess efficacy. To induce stain, 222 healthy adult volunteers received a dental prophylaxis, and then began a limited brushing regimen supplemented by three-times daily rinsing with tea and once daily rinsing with 15 ml of 0.12% chlorhexidine. This regimen was suspended, and 187 subjects with tooth stain were entered into a six-week clinical trial where they were randomized to either a silica-based tartar control whitening dentifrice or a marketed regular dentifrice control, balancing for stain levels and smoking status. At baseline, three and six weeks, stain area and stain intensity were measured on the 8 anterior teeth using the Lobene Index. After six weeks' use, composite Lobene means were 35% lower for the whitening dentifrice compared to the regular control. In addition to the overall reductions, there were statistically significant reductions in stain area (p < 0.015) and stain intensity (p < 0.01) at both three and six weeks. The tartar control whitening dentifrice was effective in removing stain on the gingival margins and elsewhere on the body of the tooth. Safety profiles for the two test dentifrices were generally similar. After three and six weeks' use, the tartar control whitening dentifrice reduced chlorhexidine and tea stain compared to the marketed control.

  7. Randomized controlled trial: Moxibustion and acupuncture for the treatment of Crohn’s disease

    PubMed Central

    Bao, Chun-Hui; Zhao, Ji-Meng; Liu, Hui-Rong; Lu, Yuan; Zhu, Yi-Fang; Shi, Yin; Weng, Zhi-Jun; Feng, Hui; Guan, Xin; Li, Jing; Chen, Wei-Feng; Wu, Lu-Yi; Jin, Xiao-Ming; Dou, Chuan-Zi; Wu, Huan-Gan

    2014-01-01

    AIM: To evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active Crohn’s disease (CD). METHODS: Ninety-two patients were equally and randomly divided into the treatment group and received herb-partitioned moxibustion combined with acupuncture, and the control group received wheat bran-partitioned moxibustion combined with superficial acupuncture. The patients received three treatment sessions per week for 12 wk and were followed up for 24 wk. The main outcome was evaluated using the CD Activity Index (CDAI) score, and the secondary outcomes were evaluated using laboratory indicators such as hemoglobin (HGB), C-reactive protein (CRP), erythrocyte sedimentation rate, quality-of-life, endoscopic ratings, and intestinal histology scores. RESULTS: The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared with those measured before treatment. However, the degree of improvement in the treatment group was significantly greater than that of the control group. The improvement in symptoms in patients of the treatment group was sustained at follow-up, whereas that of the control group was not. The overall efficacy of the treatment was significantly greater than that of the control. Both groups demonstrated significant improvements in quality-of-life ratings after treatment, but the improvement was significantly greater in the treatment group than in the control group. In addition, the patients in the treatment group showed significantly increased HGB and significantly decreased CRP levels and histopathological scores at the end of treatment, whereas the control group did not exhibit significant changes. CONCLUSION: Moxibustion with acupuncture provided significant therapeutic benefits in patients with active CD beyond the placebo effect and is therefore an effective and safe treatment for active CD. PMID:25152604

  8. Effect of acupressure on pain in Iranian leukemia patients: A randomized controlled trial study.

    PubMed

    Sharif Nia, Hamid; Pahlevan Sharif, Saeed; Yaghoobzadeh, Ameneh; Yeoh, Ken Kyid; Goudarzian, Amir Hossein; Soleimani, Mohammad Ali; Jamali, Saman

    2017-04-01

    Nonpharmacological methods of pain relief such as acupressure are becoming increasingly popular worldwide. Practitioners often claim that such methods are highly effective and less invasive than analgesic drugs, but available empirical evidence is largely inconclusive. This study aimed to test the hypothesis that, postacupressure intervention, the amount of pain experienced by sampled leukemia patients, who received acupressure in addition to standard care, will reduce substantially compared to patients who received only routine treatment. This controlled trial was undertaken with hospitalized leukemia patients between February and June 2015. Our primary sample consisted of 100 participants who were randomly allocated to 2 groups. One (intervention) group underwent 12 acupressure sessions in addition to standard treatment while the control group received no intervention apart from being given the standard treatment for leukemia. The visual analogue scale was used to measure the levels of pain experienced. No significant differences were found between the 2 groups across 12 interventions. However, each group reported significantly different pain level changes before and after each intervention, suggested that the acupressure method was effective in reducing pain in the short term. Nurses are able to apply this complementary therapy alongside other procedures to manage these patients' pain. It is recommended that further studies be conducted to better understand the specific conditions under which acupressure can provide effective pain relief.

  9. A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis.

    PubMed

    McCann, Terence V; Lubman, Dan I; Cotton, Sue M; Murphy, Brendan; Crisp, Kingsley; Catania, Lisa; Marck, Claudia; Gleeson, John F M

    2013-11-01

    Caring for young people with first-episode psychosis (FEP) is challenging and can adversely affect carer well-being, with limited evidence-based support materials available. We aimed to examine whether completion of a self-directed problem-solving bibliotherapy among carers of young people with FEP led to a better experience of caring, less distress and expressed emotion, and better general health than carers who only received treatment as usual (TAU). A randomized controlled trial was conducted across two early-intervention psychosis services in Melbourne, Australia. A total of 124 carers were randomized to problem-solving bibliotherapy intervention (PSBI) or TAU and assessed at baseline, 6-week and 16-week follow-up. Intent-to-treat analyses were carried out and indicated that recipients of PSBI had a more favorable experience of caring than those receiving TAU, and these effects were sustained at both follow-up time points. Across the other measures, both groups demonstrated improvements by week 16, although the PBSI group tended to improve earlier. The PSBI group experienced a greater reduction in negative emotional evaluations of the need to provide additional support to young people with FEP than the TAU group by week 6, while the level of psychological distress decreased at a greater rate from baseline to 6 weeks in the PSBI compared with the TAU group. These findings support the use of problem-solving bibliotherapy for first-time carers, particularly as a cost-effective adjunct to TAU.

  10. Pharmacopuncture in Korea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Park, Jimin; Lee, Hyangsook; Shin, Byung-Cheul; Lee, Myeong Soo; Kim, Boryang; Kim, Jong-In

    2016-01-01

    Background. Pharmacopuncture is a new form of acupuncture combining acupuncture with herbal medicine, and it has been used under various conditions in Korea. The aim of this study is to establish clinical evidence for the safety and efficacy of pharmacopuncture in Korea. Methods. We searched 9 databases and two relevant journals up to December 2014 using keywords, such as pharmacopuncture. All randomized, controlled trials evaluating pharmacopuncture under any conditions in Korea were considered. Results. Twenty-nine studies involving 1,211 participants were included. A meta-analysis of two studies on obesity showed that 5 to 8 weeks of pharmacopuncture reduced weight, waist circumference, and body mass index (BMI) more than normal saline injections. In the 5 studies of musculoskeletal conditions, 7 to 30 days of pharmacopuncture had additional effects on the reduction of pain intensity, and this benefit was maintained by limiting analyses to studies with a low risk of bias for randomization and/or allocation concealment. Conclusions. This systematic review suggests the potential of pharmacopuncture for obesity and musculoskeletal diseases. However, it is difficult to recommend pharmacopuncture as an evidence-based treatment because of methodological flaws and small sample sizes of the included studies. Further well-designed trials are needed to draw a definitive conclusion. PMID:26881003

  11. Random coil negative control reproduces the discrepancy between scattering and FRET measurements of denatured protein dimensions

    PubMed Central

    Watkins, Herschel M.; Simon, Anna J.; Sosnick, Tobin R.; Lipman, Everett A.; Hjelm, Rex P.; Plaxco, Kevin W.

    2015-01-01

    Small-angle scattering studies generally indicate that the dimensions of unfolded single-domain proteins are independent (to within experimental uncertainty of a few percent) of denaturant concentration. In contrast, single-molecule FRET (smFRET) studies invariably suggest that protein unfolded states contract significantly as the denaturant concentration falls from high (∼6 M) to low (∼1 M). Here, we explore this discrepancy by using PEG to perform a hitherto absent negative control. This uncharged, highly hydrophilic polymer has been shown by multiple independent techniques to behave as a random coil in water, suggesting that it is unlikely to expand further on the addition of denaturant. Consistent with this observation, small-angle neutron scattering indicates that the dimensions of PEG are not significantly altered by the presence of either guanidine hydrochloride or urea. smFRET measurements on a PEG construct modified with the most commonly used FRET dye pair, however, produce denaturant-dependent changes in transfer efficiency similar to those seen for a number of unfolded proteins. Given the vastly different chemistries of PEG and unfolded proteins and the significant evidence that dye-free PEG is well-described as a denaturant-independent random coil, this similarity raises questions regarding the interpretation of smFRET data in terms of the hydrogen bond- or hydrophobically driven contraction of the unfolded state at low denaturant. PMID:25964362

  12. Pharmacopuncture in Korea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Park, Jimin; Lee, Hyangsook; Shin, Byung-Cheul; Lee, Myeong Soo; Kim, Boryang; Kim, Jong-In

    2016-01-01

    Background. Pharmacopuncture is a new form of acupuncture combining acupuncture with herbal medicine, and it has been used under various conditions in Korea. The aim of this study is to establish clinical evidence for the safety and efficacy of pharmacopuncture in Korea. Methods. We searched 9 databases and two relevant journals up to December 2014 using keywords, such as pharmacopuncture. All randomized, controlled trials evaluating pharmacopuncture under any conditions in Korea were considered. Results. Twenty-nine studies involving 1,211 participants were included. A meta-analysis of two studies on obesity showed that 5 to 8 weeks of pharmacopuncture reduced weight, waist circumference, and body mass index (BMI) more than normal saline injections. In the 5 studies of musculoskeletal conditions, 7 to 30 days of pharmacopuncture had additional effects on the reduction of pain intensity, and this benefit was maintained by limiting analyses to studies with a low risk of bias for randomization and/or allocation concealment. Conclusions. This systematic review suggests the potential of pharmacopuncture for obesity and musculoskeletal diseases. However, it is difficult to recommend pharmacopuncture as an evidence-based treatment because of methodological flaws and small sample sizes of the included studies. Further well-designed trials are needed to draw a definitive conclusion.

  13. Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

    PubMed Central

    King, Summer; Green, Heather Joy

    2015-01-01

    Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

  14. Comparing Adrenaline with Tranexamic Acid to Control Acute Endobronchial Bleeding: A Randomized Controlled Trial

    PubMed Central

    Fekri, Mitra Samareh; Hashemi-Bajgani, Seyed Mehdy; Shafahi, Ahmad; Zarshenas, Rozita

    2017-01-01

    Background: Hemoptysis occurs due to either pulmonary diseases or bronchoscopy interventions. The aim of the present study was to compare the efficacy of the endobronchial instillation of adrenaline with that of tranexamic acid. Methods: Fifty patients were randomly selected as 2 double-blinded sample groups (n=25). In these patients, bleeding could not be controlled with cold saline lavage during bronchoscopy and they, therefore, required prescription of another medicine. Adrenaline (1 mg) in one group and tranexamic acid (500 mg) in the other group were diluted in 20 mL of normal saline and instilled through the bronchoscope. This technique was repeated 3 times at 90-second intervals, if necessary. In the case of persistent bleeding, 90 seconds after the last dose, a second medicine was given for bleeding control. Observation of clot through the bronchoscope meant that the bleeding had stopped. The efficacy of tranexamic acid and adrenaline was evaluated and then compared using the Mann–Whitney test. Results: The time of bleeding control had no significant difference between tranexamic acid and adrenaline (P=0.908). Another analysis was done to evaluate bleeding control with a second medicine; the results showed that 1 (4%) patient in the tranexamic acid and 8 (32%) in the adrenaline group needed the second medicine and there was no significant difference between the 2 groups (P=0.609). Conclusion: Our results suggested that tranexamic acid by endobronchial instillation was as efficient as adrenaline in controlling hemoptysis and required less frequent use of a second medicine. Trial Registration Number: IRCT2014120220188 PMID:28360438

  15. Spacer-controlled emission of randomly oriented fluorophores enhanced with surface plasmon-polaritons.

    PubMed

    Akimov, Yu; Sun, S

    2017-03-29

    In surface plasmon-polariton enhanced fluorescence, the use of spacers is simply understood to control the distance between the fluorescence dyes and metals to avoid quenching. However, the presence of a spacer layer over the metallic surface not only manipulates the quantum yield, but also affects the surface plasmon-polariton resonance, which in turn modifies the florescence excitation rate as well as the far-field radiation pattern of the emission. This study presents a systematic investigation on the spacer-controlled emission of randomly oriented emitters in the Kretschmann configuration, with the full leverage of the coupled transfer matrix, reciprocity and plane-wave decomposition methods. It demonstrates that the introduction of a spacer between the metal film and fluorescence dyes decreases the excitation rate. Furthermore, the excitation rate decreases more for spacers with a higher refractive index due to the reduction of the effective power that goes into the resonance excitation. Combining the excitation rate with the quantum yield and photon-collection efficiency, the detected fluorescence enhancement from either the medium side or substrate side is determined and optimized for the spacer thickness and material. It was found that the highest enhancement of a randomly oriented fluorophore's emission was generally achieved in detection from the substrate side with a low refractive index spacer (e.g. Teflon and SiO2). In addition, the substrate-side measurements were thought to benefit from highly directional radiation and a more stable enhancement compared to the medium-side measurements. Our results clearly reveal physical insights into the spacer-controlled emission and provide concrete guidance in the design and measurement of fluorescence-based sensing and imaging systems.

  16. Effects of Coriandrum sativum Syrup on Migraine: A Randomized, Triple-Blind, Placebo-Controlled Trial

    PubMed Central

    Delavar Kasmaei, Hosein; Ghorbanifar, Zahra; Zayeri, Farid; Minaei, Bagher; Kamali, Seyed Hamid; Rezaeizadeh, Hossein; Amin, Gholamreza; Ghobadi, Ali; Mirzaei, Zohreh

    2016-01-01

    Background: Migraine is one of the most common and debilitating neurological problems. Although numerous preventive drugs are used to treat migraine, their complications are unavoidable. Application of herbal medicine, especially well-known medicinal plants, to treatment of chronic diseases, like migraine, could be effective. Coriandrum sativum L. (C. sativum) fruit is one of the most commonly prescribed herbs in Persian medicine, which has been used to treat headache. Objectives: This study was designed to evaluate the effects of C. sativum syrup on duration, severity and frequency of migraine. Patients and Methods: A total of 68 migraineurs, who had the eligibility criteria, according to international headache society diagnostic criteria, were randomly assigned to intervention group (n = 34) or control group (n = 34). In addition to 500 mg of sodium valproate per day, in intervention group, they received 15 mL of Coriander fruit syrup and 15 mL of placebo syrup, in control group, three times a day, during a month. The subjects were followed for clinical efficacy at weeks 1, 2, 3 and 4. The number of migraine attacks per week, as well as the duration and severity of attacks, were evaluated. Results: Of 68 patients randomized, 66 were included in analysis. The generalized estimating equations analysis showed that the Coriander fruit syrup decreased duration, severity and frequency of migraine, in the intervention group (P < 0.001). To be more precise, the mean migraine duration, severity and frequency, in the intervention group, were 5.7 hours, 3.65 units and about 50% less than control group, respectively. Conclusions: Results of this study showed that C. sativum fruit is efficient in reduction of the duration and frequency of migraine attacks and in diminishing pain degree. PMID:26889386

  17. Wavelength control of random polymer fiber laser based on adaptive disorder.

    PubMed

    Hu, Zhijia; Gao, Pengfei; Xie, Kang; Liang, Yunyun; Jiang, Haiming

    2014-12-15

    We demonstrate the realization of two different kinds of random polymer optical fiber lasers to control the random lasing wavelength by changing the disorder of polymer optical fibers (POFs). One is a long-range disorder POF based on copolymer refractive-index inhomogeneity, and the other is a short-range disorder POF based on polyhedral oligomeric silsesquioxanes scattering. By end pumped both disorder POFs, the coherent random lasing for both is observed. Meanwhile, the random lasing wavelength of the short-range disorder POF because of a small scattering mean-free path has been found to be blue shifted with respect to the long-range disorder POF, which will give a way to control the random lasing wavelength.

  18. Model predictive control for tracking randomly varying references

    NASA Astrophysics Data System (ADS)

    Falugi, Paola

    2015-04-01

    This paper proposes a model predictive control scheme for tracking a-priori unknown references varying in a wide range and analyses its performance. It is usual to assume that the reference eventually converges to a constant in which case convergence to zero of the tracking error can be established. In this note we remove this simplifying assumption and characterise the set to which the tracking error converges and the associated region of convergence.

  19. Surface segregation of fluorinated moieties on random copolymer films controlled by random-coil conformation of polymer chains in solution.

    PubMed

    Xue, Dongwu; Wang, Xinping; Ni, Huagang; Zhang, Wei; Xue, Gi

    2009-02-17

    The relationship between solution properties, film-forming methods, and the solid surface structures of random copolymers composed of butyl methacrylate and dodecafluorheptyl methylacrylate (DFHMA) was investigated by contact angle measurements, X-ray photoelectron spectroscopy, sum frequency generation vibrational spectroscopy, and surface tension measurements. The results, based on thermodynamic considerations, demonstrated that the random copolymer chain conformation at the solution/air interface greatly affected the surface structure of the resulting film, thereby determining the surface segregation of fluorinated moieties on films obtained by various film-forming techniques. When the fluorinated monomer content of the copolymer solution was low, entropic forces dominated the interfacial structure, with the perfluoroalkyl groups unable to migrate to the solution/air interface and thus becoming buried in a random-coil chain conformation. When employing this copolymer solution for film preparation by spin-coating, the copolymer chains in solution were likely extended due to centrifugal forces, thereby weakening the entropy effect of the polymer chains. Consequently, this resulted in the segregation of the fluorinated moieties on the film surface. For the films prepared by casting, the perfluoroalkyl groups were, similar to those in solution, incapable of segregating at the film surface and were thus buried in the random-coil chains. When the copolymers contained a high content of DFHMA, the migration of perfluoroalkyl groups at the solution/air interface was controlled by enthalpic forces, and the perfluoroalkyl groups segregated at the surface of the film regardless of the film-forming technique. The aim of the present work was to obtain an enhanced understanding of the formation mechanism of the chemical structure on the surface of the polymer film, while demonstrating that film-forming methods may be used in practice to promote the segregation of fluorinated

  20. Sham Control Methods Used in Ear-Acupuncture/Ear-Acupressure Randomized Controlled Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Yang, Angela Weihong; Zhang, Anthony Lin; May, Brian H.

    2014-01-01

    Abstract Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL®) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo ear-acupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were “high risk” in terms of participants blinding, and 45 RCTs were “high risk” in terms of personnel blinding. Meta-analysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review. PMID:24138333

  1. Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

    PubMed

    Schmidt, Jennifer; Martin, Alexandra

    2015-12-01

    Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p < .01; r > .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

  2. A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

    PubMed

    Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

    2017-02-01

    Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

  3. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial.

    PubMed

    Dalal, Krishna; Maran, V Bharathi; Pandey, Ravindra M; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.

  4. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    PubMed Central

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet. Method. Subjects (N = 58) with diagnosed diabetic neuropathy were randomly distributed into reflexology and control groups in which both group patients were treated with ongoing pharmacological drugs. Reflexology group patients were additionally treated holistically with the hypothesis that this therapy would bring homeostasis among body organ functions. This was a caregiver-based study with a follow-up period of 6 months. The outcome measures were pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities. The skin features leading to the detection of the abnormal functional states of body parts were also recorded and analyzed. Results. Reflexology group showed more improvements in all outcome measures than those of control subjects with statistical significance. Conclusion. This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy. PMID:24527055

  5. Temperature-Controlled Continuous Cold Flow Device after Total Knee Arthroplasty: A Randomized Controlled Trial Study.

    PubMed

    Ruffilli, Alberto; Castagnini, Francesco; Traina, Francesco; Corneti, Isabella; Fenga, Domenico; Giannini, Sandro; Faldini, Cesare

    2016-11-30

    Total knee arthroplasty (TKA) is a widely accepted and successful procedure for end-stage arthritis. Nevertheless, fast-track may be compromised by many factors, such as pain, edema, and blood loss. Cryotherapy has been advocated as a safe and effective strategy to improve the postoperative results, acting on pain, edema, and blood loss. This study is a prospective randomized controlled study, involving 50 patients after primary TKA. A power analysis was performed preoperatively. Twenty-four patients were addressed to a postoperative treatment with a continuous cold flow device (Hilotherm, Hilotherm GmbH, Germany). Twenty-six patients represented the control group, treated with crushed ice packs. All the patients shared the same analgesic strategy and the same rehabilitation protocol. Pain, analgesic consumption, active knee range of motion, drain output, transfusion requirement, and total blood loss were evaluated at different follow-ups (postoperative first, third, and seventh days). The two groups were homogenous for preoperative and intraoperative features. The groups showed no statistically significant differences in all the evaluated parameters. A modest reduction of knee volume was evident after 7 days from surgery (trend). No differences in blood loss were noticed. Continuous cold flow device in the acute postoperative setting after TKA did not show superiority in reducing edema, pain, and blood loss, compared with traditional icing regimen. Thus, due to the costs, it should be reserved to selected cases.

  6. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study.

    PubMed

    De Vito, Andrea; Agnoletti, Vanni; Berrettini, Stefano; Piraccini, Emanuele; Criscuolo, Armando; Corso, Ruggero; Campanini, Aldo; Gambale, Giorgio; Vicini, Claudio

    2011-03-01

    Understanding the sites of pharyngeal collapse is mandatory for surgical treatment decision-making in obstructive sleep-apnea-hypopnea syndrome patients. Drug-induced sleep endoscopy (DISE) allows for the direct observation of the upper airway during sedative-induced sleep. In order to re-create snoring and apnea patterns related to a spontaneous sleep situation, the authors used a target-controlled infusion (TCI) sleep endoscopy (DISE-TCI), comparing this technique to conventional DISE, in which sedation was reached by a manual bolus injection. The authors conducted a prospective, randomized, unicenter study. The apneic event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plans of DISE-TCI technique. From January 2009 to June 2009, 40 OSAHS patients were included in the study and randomized allocated in two groups: the bolus injection conventional DISE group and the DISE-TCI group. We recorded the complete apnea event at the oropharynx and hypopharynx levels in 4 patients of the conventional DISE group (20%) and in 17 patients of the DISE-TCI group (85%) (P < 0.0001). Two patients needed oxygen in the conventional DISE group because of severe desaturation that resulted from the first bolus of propofol (1 mg/kg) (P = 0.4872 ns). We recorded the instability of the sedation plan in 13 patients from the conventional DISE group (65%) and 1 patient from the DISE-TCI group (5%) (P = 0.0001). Our results suggest that the DISE-TCI technique should be the first choice in performing sleep endoscopy because of its increased accuracy, stability and safety.

  7. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  8. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Patients with bipolar disorder experience sleep disturbance, even in euthymic phases. Changes in sleep pattern are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for primary insomnia, but there are no published results on the effects of CBT-I in patients with bipolar disorder. In this randomized controlled trial, we wish to compare CBT-I and treatment as usual with treatment as usual alone to determine its effect in improving quality of sleep, stabilizing minor mood variations and preventing new mood episodes in euthymic patients with bipolar disorder and comorbid insomnia. Methods Patients with euthymic bipolar I or II disorder and insomnia, as verified by the Structured Clinical Interview for DSM Disorders (SCID-1) assessment, will be included. The patients enter a three-week run-in phase in which they complete a sleep diary and a mood diary, are monitored for seven consecutive days with an actigraph and on two of these nights with polysomnography in addition before randomization to an eight-week treatment trial. Treatment as usual consists of pharmacological and supportive psychosocial treatment. In this trial, CBT-I will consist of sleep restriction, psychoeducation about sleep, stabilization of the circadian rhythm, and challenging and correcting sleep state misperception, in three to eight sessions. Discussion This trial could document a new treatment for insomnia in bipolar disorder with possible effects on sleep and on stability of mood. In addition, more precise information can be obtained about the character of sleep disturbance in bipolar disorder. Trial registration ClinicalTrials.gov: NCT01704352. PMID:24433249

  9. Distributed reservation control protocols for random access broadcasting channels

    NASA Astrophysics Data System (ADS)

    Greene, E. P.; Ephremides, A.

    1981-05-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  10. Distributed reservation control protocols for random access broadcasting channels

    NASA Technical Reports Server (NTRS)

    Greene, E. P.; Ephremides, A.

    1981-01-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  11. Worksite intervention effects on sleep quality: a randomized controlled trial.

    PubMed

    Atlantis, Evan; Chow, Chin-Moi; Kirby, Adrienne; Singh, Maria A Fiatarone

    2006-10-01

    Employees with sleep disturbance are at increased risk of disease. Exercise is believed to be effective for improving sleep quality, but few studies have been conducted. This study investigated the effects of a 24-week worksite exercise/behavioral intervention on self-rated sleep quality, via the Pittsburgh Sleep Quality Index (PSQI), in 73 employees. Greater post-test improvements in the PSQI (-2.0 +/- 2.6 vs. -1.3 +/- 2.7 points, p = .006, and -16 +/- 61 vs. -1 +/- 76%, p = .02) were found in treatment versus controls, and in women versus men (by -2.7 points [-5.0 to -0.3 points, p = .03], and by -72% [-142 to -2%, p = .04]). Similar results were found in the shift worker subgroup. Changes in sleep scores were not significantly related to baseline characteristics, changes in psychological health or quality-of-life scores, or level of exercise compliance.

  12. Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial

    PubMed Central

    Mao, Jun J.; Bowman, Marjorie A.; Xie, Sharon X.; Bruner, Deborah; DeMichele, Angela; Farrar, John T.

    2015-01-01

    Purpose Hot flashes are a common and debilitating symptom among survivors of breast cancer. This study aimed at evaluating the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo and nocebo effects. Patients and Methods We conducted a randomized controlled trial involving 120 survivors of breast cancer experiencing bothersome hot flashes twice per day or greater. Participants were randomly assigned to receive 8 weeks of EA or GP once per day with validated placebo controls (sham acupuncture [SA] or placebo pills [PPs]). The primary end point was change in the hot flash composite score (HFCS) between SA and PP at week 8, with secondary end points including group comparisons and additional evaluation at week 24 for durability of treatment effects. Results By week 8, SA produced significantly greater reduction in HFCS than did PP (−2.39; 95% CI, −4.60 to −0.17). Among all treatment groups, the mean reduction in HFCS was greatest in the EA group, followed by SA, GP, and PP (−7.4 v −5.9 v −5.2 v −3.4; P = < .001). The pill groups had more treatment-related adverse events than did the acupuncture groups: GP (39.3%), PP (20.0%), EA (16.7%), and SA (3.1%), with P = .005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (−8.5 v −6.1 v −4.6 v −2.8; P = .002). Conclusion Acupuncture produced larger placebo and smaller nocebo effects than did pills for the treatment of hot flashes. EA may be more effective than GP, with fewer adverse effects for managing hot flashes among breast cancer survivors; however, these preliminary findings need to be confirmed in larger randomized controlled trials with long-term follow-up. PMID:26304905

  13. The Effect of Probiotic Yogurt on Constipation in Pregnant Women: A Randomized Controlled Clinical Trial

    PubMed Central

    Mirghafourvand, Mojgan; Homayouni Rad, Aziz; Mohammad Alizadeh Charandabi, Sakineh; Fardiazar, Zahra; Shokri, Kolsoum

    2016-01-01

    Background Probiotics can alter the colonic microbiota and might improve bowel function. Objectives The aim of this study was to evaluate the effect of the consumption of yogurt, enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 (CFU) on the symptoms of constipated pregnant women. Materials and Methods This triple-blind randomized controlled trial was conducted on 60 constipated pregnant women who were diagnosed by the ROME III criteria in Tabriz, Iran from December 2014 to July 2015. Participants were randomly put into two groups including the treatment and the control group through block randomization. The treatment group received 300 g of yogurt enriched with Bifidobacterium and Lactobacillus 4.8 × 1010 colony forming units (CFU) (n = 30) while the control group received conventional yogurt (n = 30) for 4 weeks. The defecation frequency, stool consistency, straining during defecation, sensation of anorectal obstruction, sensation of incomplete evacuation and manual manoeuvres to facilitate defecation were primary outcomes while the amount of defecation, stool colure, and quality of life were secondary outcomes. Results The frequency of defecation was increased from 2.1 (0.8) at baseline to 8.3 (4.4) in the probiotic yogurt group vs. 2.3 (0.7) at baseline to 8.1 (4.3) in the conventional yogurt group at the end of 4th week. These results were based on the repeated measure ANOVA test and there was no statistically significant difference between the two groups (mean difference: 0.1; Confidence Interval 95%: -1.4 to 1.7; P = 0.872). Constipation symptoms including straining, anorectal obstruction, manipulation to facilitate defecation, consistency of stool and color of stool were improved significantly (P < 0.05) in both groups. In addition, the amount of defecation was significantly increased in both groups (P < 0.05), while incomplete evacuation was significantly reduced in the treatment group (P = 0.01). There was no statistically significant

  14. Strengths and limitations of industry vs. academic randomized controlled trials.

    PubMed

    Laterre, P-F; François, B

    2015-10-01

    Clinical research has evolved substantially over the last two decades, but industry-sponsored research is still substantially superior to academic research in preparing, organizing and monitoring studies. Academics have to realize that conducting clinical research has become a real job with professionalism requirements. The primary objectives of research and development clearly differ between industry and academics. In the first case, new drug development is expected to generate profit, whereas in the latter case, research is aimed at understanding mechanisms of disease, promoting evidence-based medicine, and improving public health and care. However, a large number of clinical studies do not achieve their goals, and the reasons for failure may also differ between sponsored and academic studies. Industry and academics should develop better constructive partnerships and learn from each other. Academics should guide industry in study design and in investigator site selection, and academics should benefit from industry's expertise in improving monitoring and reporting processes. Finally, the existing database from former studies should be opened and shared with academics, to enable the exploration of additional scientific questions and the generation of new hypotheses. The two types of research should not be opposed, but should take the form of a constructive collaboration, increasing the chances of reaching each individual goal.

  15. Proper use of sludge-control additives in residential heating oil systems

    SciTech Connect

    Tatnall, R.E.

    1995-04-01

    Discussed are various aspects of heating oil `sludge`: How it forms, typical problems it causes, how sludge-control additives work, what should be expected of them, and what happens in a contaminated system when such additives are used. Test results from laboratory and field experiments demonstrate that performance of commercially available additives varies greatly. The concept of `end-of-the-line` treatment is described and compared with bulk fuel treatment. A procedure is described whereby a retailer can test additives himself, and thus determine just what those additives will or will not do for his business. Finally, the economics of an effective treatment program are outlined.

  16. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  17. The next step in translational research: lessons learned from the first preclinical randomized controlled trial.

    PubMed

    Llovera, Gemma; Liesz, Arthur

    2016-10-01

    For years, low reproducibility of preclinical trials and poor translation of promising preclinical therapies to the clinic have posed major challenges to translational research in most biomedical fields. To overcome the limitations that stand between experimental and clinical research, international consortia have attempted to establish standardized guidelines for study design and for reporting the resulting data. In addition, multicenter preclinical randomized controlled trials (pRCTs) have been proposed as a suitable tool for 'bridging the gap' between experimental research and clinical trials. We recently reported the design and results of the first such pRCT in which we confirmed the feasibility of using a coordinated approach with standardized protocols in collaboration with independent multinational research centers. However, despite its successes, this first pRCT also had several difficulties, particularly with respect to following the protocols established in the study design and analyzing the data. Here, we review our experiences performing the study, and we analyze and discuss the lessons learned from performing the first pRCT. Moreover, we provide suggestions regarding how obstacles can be overcome to improve the performance and outcome of future pRCT studies. Translational research is hampered by low reproducibility of preclinical studies and countless failed clinical trials. International consortia have proposed preclinical multicenter trials as an intermediate step to overcome this 'translational roadblock'. We have recently performed the first such preclinical randomized controlled trial (pRCT) by adopting key elements of clinical study design to preclinical research. In this review, we discuss the lessons learned from this trial and provide suggestions how to optimize future pRCTs. This article is part of the 60th Anniversary special issue.

  18. The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial

    PubMed Central

    Sheidaei, Ali; Abadi, Alireza; Zayeri, Farid; Nahidi, Fatemeh; Gazerani, Nafiseh; Mansouri, Anita

    2016-01-01

    Background: Infantile colic, cry-fuss and sleep problems are transient in the initial months of life, but they contribute to maternal depression, parenting stress and family mental health problems. In this randomized clinical trial, we aimed to explore the efficacy of massage therapy compared to rocking in reducing infantile colic symptoms including duration and number of cries, sleep duration and severity of infant colic. Methods: This was a single blind RCT study with a one-week follow-up. One hundred colicky infants aged younger than 12 weeks old were randomly assigned into massage and rocking groups. Infants in the massage group received a massage for 15-20 minutes once during a day and once at night before sleeping for a week. In the control group, mothers rocked their infants gently for 5-25 minutes when the symptoms of colic appeared. Parents recorded the details of the colic symptoms in a diary every day. A GEE approach was applied to explore the effect of the intervention. Results: Efficiency of massage therapy was significantly higher than rocking. At the end of the study, the mean number of daily cries was 4.26±1.40 in the massage and 6.9±2.14 the rocking groups (p<0.01). The mean of the severity score was 1.39±0.19 less in the massage group (p<0.01). Moreover, the mean differences of massage and rocking groups were -0.82±0.20 hour (p<0.01) and 0.72±0.35 (p= 0.04) in the duration of cries and duration of sleep, respectively. Conclusion: Massaging significantly improved colic symptoms during a one-week intervention for all outcomes. In addition, significant differences were found between the intervention and control groups in favor of massaging. Therefore, massage therapy is more effective than rocking for treating infant colic symptoms. PMID:27453882

  19. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  20. Prebiotic supplementation improves appetite control in children with overweight and obesity: a randomized controlled trial.

    PubMed

    Hume, Megan P; Nicolucci, Alissa C; Reimer, Raylene A

    2017-02-22

    Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk. Objective measures of appetite included energy intake at an ad libitum breakfast buffet, 3-d food records, and fasting satiety hormone concentrations. Subjective appetite ratings were obtained from visual analog scales before and after the breakfast. Children's Eating Behavior Questionnaires were also completed by caregivers.Results: Compared with placebo, prebiotic intake resulted in significantly higher feelings of fullness (P = 0.04) and lower prospective food consumption (P = 0.03) at the breakfast buffet at 16 wk compared with baseline. Compared with placebo, prebiotic supplementation significantly reduced energy intake at the week 16 breakfast buffet in 11- and 12-y-olds (P = 0.04) but not in 7- to 10-y-olds. Fasting adiponectin (P = 0.04) and ghrelin (P = 0.03) increased at 16 wk with the prebiotic compared with placebo. In intent-to-treat analysis, there was a trend for prebiotic supplementation to reduce BMI z score to a greater extent than placebo (-3.4%; P = 0.09) and a significant -3.8% reduction in per-protocol analysis (P = 0.043).Conclusions: Independent of other lifestyle changes, prebiotic supplementation in children with overweight and obesity improved subjective appetite ratings. This translated into reduced energy intake in a breakfast buffet in older but not in younger children. This simple dietary change has the potential to help with appetite regulation in children with obesity. This trial was registered at

  1. Arthroscopy or ultrasound in undergraduate anatomy education: a randomized cross-over controlled trial

    PubMed Central

    2012-01-01

    Background The exponential growth of image-based diagnostic and minimally invasive interventions requires a detailed three-dimensional anatomical knowledge and increases the demand towards the undergraduate anatomical curriculum. This randomized controlled trial investigates whether musculoskeletal ultrasound (MSUS) or arthroscopic methods can increase the anatomical knowledge uptake. Methods Second-year medical students were randomly allocated to three groups. In addition to the compulsory dissection course, the ultrasound group (MSUS) was taught by eight, didactically and professionally trained, experienced student-teachers and the arthroscopy group (ASK) was taught by eight experienced physicians. The control group (CON) acquired the anatomical knowledge only via the dissection course. Exposure (MSUS and ASK) took place in two separate lessons (75 minutes each, shoulder and knee joint) and introduced standard scan planes using a 10-MHz ultrasound system as well as arthroscopy tutorials at a simulator combined with video tutorials. The theoretical anatomic learning outcomes were tested using a multiple-choice questionnaire (MCQ), and after cross-over an objective structured clinical examination (OSCE). Differences in student’s perceptions were evaluated using Likert scale-based items. Results The ASK-group (n = 70, age 23.4 (20–36) yrs.) performed moderately better in the anatomical MC exam in comparison to the MSUS-group (n = 84, age 24.2 (20–53) yrs.) and the CON-group (n = 88, 22.8 (20–33) yrs.; p = 0.019). After an additional arthroscopy teaching 1% of students failed the MC exam, in contrast to 10% in the MSUS- or CON-group, respectively. The benefit of the ASK module was limited to the shoulder area (p < 0.001). The final examination (OSCE) showed no significant differences between any of the groups with good overall performances. In the evaluation, the students certified the arthroscopic tutorial a greater advantage concerning anatomical skills

  2. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse

  3. Data withdrawal in randomized controlled trials: Defining the problem and proposing solutions: a commentary.

    PubMed

    Ye, Chenglin; Giangregorio, Lora; Holbrook, Anne; Pullenayegum, Eleanor; Goldsmith, Charlie H; Thabane, Lehana

    2011-05-01

    It is not uncommon for a participant to withdraw from a randomized controlled trial (RCT). The withdrawal of a participant results in missing data and the potential for withdrawal bias. Data withdrawal, or a request from a participant to withdraw all of their previously collected data from a study, is particularly problematic because it leaves little opportunity to characterize or statistically address those that have withdrawn to minimize withdrawal bias. The aim of this commentary is to (1) provide a synthesis of available information on the ethical and methodological issues related to data withdrawal in RCTs and (2) provide some suggestions on how to minimize the impact of data withdrawal during the execution or analysis phases of an RCT. We searched PubMed, EMBASE and JSTOR for published articles on data withdrawal. In addition, we used internet sources as an additional tool to identify content on data withdrawal from research ethics guidelines, legislation, research ethics boards, funding agencies, professional organizations and researchers. We did not find any definitive guidelines for dealing with data withdrawal. We propose recommendations for minimizing the occurrence of data withdrawal, including explicit and clear descriptions in consent forms of how data will be handled after participant withdrawal. We also suggest using imputation techniques to deal with the missing data during analysis. The current commentary can be used to minimize the impact of data withdrawal in RCTs.

  4. A randomized controlled trial of a multi-dose bystander intervention program using peer education theater.

    PubMed

    McMahon, Sarah; Winter, Samantha C; Palmer, Jane E; Postmus, Judy L; Peterson, N Andrew; Zucker, Sharon; Koenick, RuthAnne

    2015-08-01

    This article reports findings from a longitudinal, experimental evaluation of a peer education theater program, Students Challenging Realities and Educating Against Myths (SCREAM) Theater. This study examines the impact of SCREAM Theater on a range of bystander-related outcomes (i.e. bystander intentions, bystander efficacy, perception of friend norms and bystander behaviors) in situations involving sexual violence and whether there was a differential impact of the program by participant sex. First-year college students completed three waves of surveys (pretest, first post-test and second post-test). All participants received one dose of the intervention during summer orientation after the pretest. After the first post-test, participants were randomly assigned to receive two additional doses, or to a control condition, in which they received no additional doses. Students in both one- and three-dose groups reported a number of positive increases. Overall, an intent-to-treat analysis (n = 1390) indicated three doses of the intervention during the first semester of college resulted in better outcomes than the one-time intervention during summer orientation alone. Although both male and female students' scores increased during the study period, female students consistently scored higher than male students on each outcome. The findings suggest that peer education theater holds promise for bystander intervention education on college campuses.

  5. High-dose inhaled corticosteroids or addition of theophylline in patients with poorly controlled asthma?

    PubMed

    Celis, Pilar; Rada, Gabriel

    2015-08-19

    There are several management strategies for patients with poorly controlled asthma despite usual treatment. Increasing doses of inhaled corticosteroids or adding theophylline are among the therapeutic alternatives. However, the latter is associated with important adverse effects. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified only one systematic review including four pertinent randomized controlled trials. We combined the evidence using meta-analysis and generated a summary of findings following the GRADE approach. We concluded it is not clear whether theophylline or high-dose inhaled corticosteroids constitute a better alternative for symptomatic control or reduction in exacerbations in poorly controlled asthmatic patients because the certainty of the evidence is very low.

  6. Effects of a Worksite Weight-Control Programme in Obese Male Workers: A Randomized Controlled Crossover Trial

    ERIC Educational Resources Information Center

    Iriyama, Yae; Murayama, Nobuko

    2014-01-01

    Objective: We conducted a randomized controlled crossover trial to evaluate the effects of a new worksite weight-control programme designed for men with or at risk of obesity using a combination of nutrition education and nutrition environmental interventions. Subjects and methods: Male workers with or at risk of obesity were recruited for this…

  7. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  8. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  9. Strength and Agility Training in Adolescents with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lin, Hsiu-Ching; Wuang, Yee-Pay

    2012-01-01

    The purpose of this study was to investigate the effects of a proposed strength and agility training program of adolescents with Down syndrome. Ninety-two adolescents were recruited and evenly randomized to two intervention groups (exercise group vs. control group). The mean age for the exercise and the control group was 10.6 plus or minus 3.2 and…

  10. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  11. A Randomized Controlled Trial of Hanen's "More than Words" in Toddlers with Early Autism Symptoms

    ERIC Educational Resources Information Center

    Carter, Alice S.; Messinger, Daniel S.; Stone, Wendy L.; Celimli, Seniz; Nahmias, Allison S.; Yoder, Paul

    2011-01-01

    Background: This randomized controlled trial compared Hanen's "More than Words" (HMTW), a parent-implemented intervention, to a "business as usual" control group. Methods: Sixty-two children (51 boys and 11 girls; M age = 20 months; SD = 2.6) who met criteria for autism spectrum disorders (ASD) and their parents participated in the study. The HMTW…

  12. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    ERIC Educational Resources Information Center

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  13. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    PubMed

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  14. Local Infiltration Analgesia reduces pain and hospital stay after primary TKA: randomized controlled double blind trial.

    PubMed

    Vaishya, Raju; Wani, Ajaz Majeed; Vijay, Vipul

    2015-12-01

    Postoperative analgesia following Total Knee Arthroplasty (TKA) with the use of parenteral opioids or epidural analgesia can be associated with important side effects. Good perioperative analgesia facilitates faster rehabilitation, improves patient satisfaction, and may reduce the hospital stay. We investigated the analgesic effect of a locally injected mixture of drugs, in a double blinded RCT in 80 primary TKA. They were randomized either to receive a periarticular mixture of drugs containing bupivacaine, ketorolac, morphine, and adrenalline or to receive normal saline. Visual analog scores (VAS) for pain (at rest and during activity) and for patient satisfaction and range of motion were recorded postoperatively. The patients who had received the periarticular injection used significantly less the Patient Controlled Analgesia (PCA) after the surgery as compared to the control group. In addition, they had lower VAS for pain during rest and activity and higher visual analog scores for patient satisfaction 72 hours postoperatively. No major complication related to the drugs was observed. Intraoperative periarticular injection with multimodal drugs following TKA can significantly reduce the postoperative pain and hence the requirements for PCA and hospital stay, with no apparent risks.

  15. Efficacy and safety of topiramate on weight loss: a meta-analysis of randomized controlled trials.

    PubMed

    Kramer, C K; Leitão, C B; Pinto, L C; Canani, L H; Azevedo, M J; Gross, J L

    2011-05-01

    Topiramate was associated with weight loss in clinical trials. We summarize the evidence on the efficacy and safety of topiramate in the treatment of overweight/obesity. The databases Medline, Embase, and Cochrane were searched. Randomized controlled studies with at least 16 weeks of duration that report the effect of topiramate on weight loss and adverse events were eligible for inclusion. Ten studies were included (3320 individuals). Patients treated with topiramate lost an average of 5.34 kg (95% confidence interval [95%CI]-6.12 to -4.56) of additional weight as compared with placebo. According to meta-regression analysis, treatment duration and dosage were associated with the efficacy of topiramate treatment. Evaluating trials using topiramate 96-200 mg day(-1) , the weight loss was higher in trials with >28 weeks of duration (-6.58 kg [95%CI -7.48 to -5.68]) than in trials with ≤28 weeks (-4.11 kg [95%CI -4.92 to -3.30]). Data of 6620 individuals were available for adverse events evaluation and those more frequently observed were paraesthesia, taste impairment and psychomotor disturbances. The odds ratio for adverse events leading to topiramate withdrawal was 1.94 (95%CI 1.64-2.29) compared with the control group. In conclusion, topiramate might be a useful adjunctive therapeutic tool in the treatment of obesity as long as proper warnings about side effects are considered.

  16. Evaluation of a preventive intervention for child anxiety in two randomized attention-control school trials.

    PubMed

    Miller, Lynn D; Laye-Gindhu, Aviva; Liu, Yan; March, John S; Thordarson, Dana S; Garland, E Jane

    2011-05-01

    The present research examined the effectiveness of a cognitive-behavioral therapy (CBT) based intervention program, FRIENDS, for children from grades 4 to 6, using random assignment at the school-level and an attention-control design in two longitudinal studies. The first study targeted children with anxiety symptoms (N=191, mean age=10.1) as screened with self, parent, and teacher-reports; the second study took a universal approach with full classrooms of children participating (N=253, mean age=9.8). The results showed no intervention effect in both studies, with children's anxiety symptoms decreasing over time regardless of whether they were in the story-reading (attention control) or FRIENDS condition. The findings also indicated that girls reported a higher level of anxiety than boys and children in higher grades reported lower anxiety relative to younger children in both studies. In addition, similar patterns were found using a subgroup of children with high-anxiety symptoms from both studies.

  17. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension

    PubMed Central

    Galiè, Nazzareno; Manes, Alessandra; Negro, Luca; Palazzini, Massimiliano; Bacchi-Reggiani, Maria Letizia; Branzi, Angelo

    2009-01-01

    Aims There is no cure for pulmonary arterial hypertension, but current approved treatment options include prostanoids, endothelin-receptor antagonists, and phosphodiesterase type-5 inhibitors. The effect on survival of these compounds has not been appropriately assessed in individual trials because of small sample size and short duration. We performed a meta-analysis of all randomized controlled trials with drugs published in this condition. Methods and results Trials were searched in the Medline database from January 1990 to October 2008. The primary analysis included only studies with a placebo comparator arm, the sensitivity analysis also included studies comparing two active treatment arms. The main outcome measure was all-cause mortality. Twenty-one trials were included in the primary analysis (3140 patients) and two additional studies (59 patients) were included in the sensitivity analysis. Average duration of the trials was 14.3 weeks. All-cause mortality rate in the control group was 3.8%. Active treatments were associated with a reduction in mortality of 43% (RR 0.57; 95% CI 0.35–0.92; P = 0.023); the sensitivity analysis confirmed a reduction in mortality of 38% (RR 0.62; 95% CI 0.39–1.00; P = 0.048). Conclusion The results of this meta-analysis suggest an improvement of survival in the patients treated with the targeted therapies approved for pulmonary arterial hypertension. PMID:19155250

  18. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    PubMed Central

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min

    2017-01-01

    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  19. Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods

    PubMed Central

    Zhang, Shiyuan; Paul, James; Nantha-Aree, Manyat; Buckley, Norman; Shahzad, Uswa; Cheng, Ji; DeBeer, Justin; Winemaker, Mitchell; Wismer, David; Punthakee, Dinshaw; Avram, Victoria; Thabane, Lehana

    2015-01-01

    Background Postoperative pain management in total joint replacement surgery remains ineffective in up to 50% of patients and has an overwhelming impact in terms of patient well-being and health care burden. We present here an empirical analysis of two randomized controlled trials assessing whether addition of gabapentin to a multimodal perioperative analgesia regimen can reduce morphine consumption or improve analgesia for patients following total joint arthroplasty (the MOBILE trials). Methods Morphine consumption, measured for four time periods in patients undergoing total hip or total knee arthroplasty, was analyzed using a linear mixed-effects model to provide a longitudinal estimate of the treatment effect. Repeated-measures analysis of variance and generalized estimating equations were used in a sensitivity analysis to compare the robustness of the methods. Results There was no statistically significant difference in morphine consumption between the treatment group and a control group (mean effect size estimate 1.0, 95% confidence interval −4.7, 6.7, P=0.73). The results remained robust across different longitudinal methods. Conclusion The results of the current reanalysis of morphine consumption align with those of the MOBILE trials. Gabapentin did not significantly reduce morphine consumption in patients undergoing major replacement surgeries. The results remain consistent across longitudinal methods. More work in the area of postoperative pain is required to provide adequate management for this patient population. PMID:25709496

  20. [Randomized controlled trials for the prevention and treatment of glucocorticoid-induced osteoporosis].

    PubMed

    Suzuki, Yasuo

    2006-11-01

    The effectiveness of drug therapy for the prevention or treatment of glucocorticoid-induced osteoporosis has been reported. Especially, the beneficial effects of bisphosphonates (etidoronate, alendronate, and risedronate) to prevent bone loss and fractures have been confirmed by the large-scale, multicenter, double-blind, randomized controlled trials in terms of both primary and secondary prevention. This article reviews the results of recent randomized prospective trials using bisphosphonates in glucocorticoid-induced osteoporosis.

  1. Army Corps of Engineers: Additional Steps Needed for Review and Revision of Water Control Manuals

    DTIC Science & Technology

    2016-07-01

    ARMY CORPS OF ENGINEERS Additional Steps Needed for Review and Revision of Water Control Manuals Report to...Revision of Water Control Manuals What GAO Found According to U.S. Army Corps of Engineers (Corps) officials, the agency conducts ongoing, informal...reviews of selected water control manuals and has revised some of them, but the extent of the reviews and revisions is unclear because they are not

  2. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. Objective This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Methods Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant’s experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. Results In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More

  3. Long-term effects of daily postprandial physical activity on blood glucose: a randomized controlled trial.

    PubMed

    Nygaard, Håvard; Grindaker, Eirik; Rønnestad, Bent Ronny; Holmboe-Ottesen, Gerd; Høstmark, Arne Torbjørn

    2017-01-03

    Previous studies have shown that a bout of moderate or light postprandial physical activity effectively blunts the postprandial increase in blood glucose. The objective of this study was to test whether regular light postprandial physical activity can improve glycemia in persons with hyperglycemia or with a high risk of hyperglycemia. We randomized 56 participants to an intervention or a control group. They were diagnosed as hyperglycemic, not using antidiabetics, or were categorized as high-risk individuals for type 2 diabetes. The intervention group was instructed to undertake a minimum 30 min of daily light physical activity, starting a maximum of 30 min after a meal in addition to their usual physical activity for 12 weeks. The control group maintained their usual lifestyle. Blood samples were taken pre- and post-test. Forty participants completed the study and are included in the results. The self-reported increase in daily physical activity from before to within the study period was higher in the intervention group compared with control (41 ± 25 vs. 2 ± 16 min, p < 0.001). Activity diaries and accelerometer recordings supported this observation. The activity in the intervention group started earlier after the last meal compared with control (30 ± 13 vs. 100 ± 57 min, p = 0.001). There were no within- or between-group differences in any glycemic variable from pre- to post-test. In conclusion, the present study does not seem to support the notion that regular light postprandial physical activity improves blood glucose in the long term in persons with hyperglycemia or with high risk of hyperglycemia.

  4. Impact of multiplex PCR on antimicrobial treatment in febrile neutropenia: a randomized controlled study.

    PubMed

    Idelevich, Evgeny A; Silling, Gerda; Niederbracht, Yvonne; Penner, Hanna; Sauerland, Maria Cristina; Tafelski, Sascha; Nachtigall, Irit; Berdel, Wolfgang E; Peters, Georg; Becker, Karsten

    2015-10-01

    Multiplex PCR (mPCR) directly from blood has been suggested as a promising method for rapid identification of pathogens causing sepsis. This study aimed to investigate whether mPCR has any impact on antimicrobial treatment. Hematological patients with febrile neutropenia were randomized into two groups. In the study group, mPCR was performed as an addition to standard diagnostics, and PCR finding was immediately communicated to the clinicians, thus being available for decision making. In the control group, clinicians were not aware of PCR result. PCR samples were collected simultaneously with clinically indicated blood culture specimens from peripheral vein and/or central venous catheter at fever onset and once again if fever persisted up to 72 h. Overall, 74 patients of the study group and 76 patients of the control group were enrolled and 253 samples collected. Therapy was changed to targeted antimicrobial therapy (AMT) in 12 patients (16.2%) in the study group and in 12 patients (15.8%) in the control group. For patients with changes, the median time to change to the targeted AMT was 21.4 h in the study group and 47.5 h in the control group (p = 0.018). In the study group, 57.1% (8/14) of changes to targeted AMT was due to PCR finding. PCR led to AMT change in 9.5% (7/74) of study group patients, i.e., in 33.3% (7/21) of patients who had positive PCR finding. There were no significant differences in patient outcomes (secondary endpoints). In conclusion, PCR method accelerates change to the targeted AMT in febrile neutropenic patients.

  5. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial

    PubMed Central

    Hardy, Joseph L.; Nelson, Rolf A.; Thomason, Moriah E.; Sternberg, Daniel A.; Katovich, Kiefer; Farzin, Faraz; Scanlon, Michael

    2015-01-01

    Background A variety of studies have demonstrated gains in cognitive ability following cognitive training interventions. However, other studies have not shown such gains, and questions remain regarding the efficacy of specific cognitive training interventions. Cognitive training research often involves programs made up of just one or a few exercises, targeting limited and specific cognitive endpoints. In addition, cognitive training studies typically involve small samples that may be insufficient for reliable measurement of change. Other studies have utilized training periods that were too short to generate reliable gains in cognitive performance. Methods The present study evaluated an online cognitive training program comprised of 49 exercises targeting a variety of cognitive capacities. The cognitive training program was compared to an active control condition in which participants completed crossword puzzles. All participants were recruited, trained, and tested online (N = 4,715 fully evaluable participants). Participants in both groups were instructed to complete one approximately 15-minute session at least 5 days per week for 10 weeks. Results Participants randomly assigned to the treatment group improved significantly more on the primary outcome measure, an aggregate measure of neuropsychological performance, than did the active control group (Cohen’s d effect size = 0.255; 95% confidence interval = [0.198, 0.312]). Treatment participants showed greater improvements than controls on speed of processing, short-term memory, working memory, problem solving, and fluid reasoning assessments. Participants in the treatment group also showed greater improvements on self-reported measures of cognitive functioning, particularly on those items related to concentration compared to the control group (Cohen’s d = 0.249; 95% confidence interval = [0.191, 0.306]). Conclusion Taken together, these results indicate that a varied training program composed of a number of

  6. Ritodrine in Oral Maintenance of Tocolysis after Active Preterm Labor: Randomized Controlled Trial

    PubMed Central

    Matijević, Ratko; Grgić, Ozren; Vasilj, Oliver

    2006-01-01

    Aim To assess the efficacy of oral ritodrine in the form of sustained-release capsules for maintenance of uterine quiescence after successful treatment of threatened preterm labor. Methods We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n = 62) or no treatment (control group, n = 58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects. Results There was no difference in the frequency of recurrent episodes of threatened preterm labor requiring another course of intravenous treatment between the study (8/62) and control (6/58) group of women (P = 0.879). No differences were found between the study and control groups in any of the predefined secondary outcome measures, ie, delivery before 37 weeks (13/62 vs 7/58, respectively; P = 0.288), delivery before 34 weeks (3/62 vs 1/58, respectively; P = 0.682) and birth weight (3037 ± 573 g vs 3223 ± 423 g, respectively, P = 0.862). There were more reported maternal side effects in the study group than in control group (47/62 vs 23/58, respectively; P<0.001). Conclusions Additional maintenance ritodrine therapy was unnecessary in women with singleton pregnancy who had an episode of threatened preterm labor successfully treated with intravenous tocolytic therapy. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT00290173 PMID:16489694

  7. Visual Rehabilitation in Chronic Cerebral Blindness: A Randomized Controlled Crossover Study

    PubMed Central

    Elshout, Joris A.; van Asten, Freekje; Hoyng, Carel B.; Bergsma, Douwe P.; van den Berg, Albert V.

    2016-01-01

    The treatment of patients suffering from cerebral blindness following stroke is a topic of much recent interest. Several types of treatment are under investigation, such as substitution with prisms and compensation training of saccades. A third approach, aimed at vision restitution is controversial, as a proper controlled study design is missing. In the current study, 27 chronic stroke patients with homonymous visual field defects were trained at home with a visual training device. We used a discrimination task for two types of stimuli: a static point stimulus and a new optic flow-discontinuity stimulus. Using a randomized controlled crossover design, each patient received two successive training rounds, one with high contrast stimuli in their affected hemifield (test) and one round with low-contrast stimuli in their intact hemifield (control). Goldmann and Humphrey perimetry were performed at the start of the study and following each training round. In addition, reading performance was measured. Goldmann perimetry revealed a statistically significant reduction of the visual field defect after the test training, but not after the control training or after no intervention. For both training rounds combined, Humphrey perimetry revealed that the effect of a directed training (sensitivity change in trained hemifield) exceeded that of an undirected training (sensitivity change in untrained hemifield). The interaction between trained and tested hemifield was just above the threshold of significance (p = 0.058). Interestingly, reduction of the field defect assessed by Goldmann perimetry increases with the difference between defect size as measured by Humphrey and Goldmann perimetry prior to training. Moreover, improvement of visual sensitivity measured by Humphrey perimetry increases with the fraction of non-responsive elements (i.e., more relative field loss) in Humphrey perimetry prior to training. Reading speed revealed a significant improvement after training. Our

  8. Puerarin and betahistine treatment of vertebrobasilar ischemia vertigo: A meta-analysis of randomized controlled trials.

    PubMed

    Chen, Yan-Yan; Chen, Wen; Zhang, Qing; Li, Hui; Zhang, Ye-Wen; Kang, Qian; Lan, Y I; Wu, Qing

    2016-03-01

    The present meta-analysis aimed to evaluate the effectiveness and safety of puerarin co-treatment with betahistine in treating vertebrobasilar ischemia (VBI) vertigo. A total of 6 medical databases were searched, identifying randomized controlled trials (RCTs) of VBI vertigo performed until August 2014 that investigated a combined treatment of puerarin with betahistine or with other conventional drugs. The quality of the literature was evaluated using the Cochrane Collaboration's tool for assessing risk of bias, and Rev Man 5.0 software was used for statistical analysis and evaluation. The present study included 7 RCTs, involving a total of 664 subjects, and revealed a statistically significant increase in efficacy between the control and the experimental group (odds ratio [OR], 4.99; 95% confidence interval [CI], 3.05 to 8.15). The average blood flow velocity within the vertebrobasilar arteries increased following treatment with puerarin and betahistine compared with that of the control groups (OR, 7.59; 95% CI, 6.19 to 9.00); however, no difference was detected between these groups in the average flow velocity within the left vertebral artery (OR, 6.17; 95% CI, 5.22 to 7.13). The frequency of adverse reactions in the experimental group was lower (OR, 0.75; 95% CI, 0.32 to 1.77) compared with the control group. Combined puerarin and betahistine regimens were more effective in treating VBI vertigo compared with other, conventional drugs; effectively alleviating the associated symptoms, including dizziness and increased average blood flow velocity within the vertebrobasilar arteries, without causing an increased number of serious side effects. However, the efficacy and safety of puerarin and betahistine use in treating VBI vertigo requires additional investigation.

  9. Puerarin and betahistine treatment of vertebrobasilar ischemia vertigo: A meta-analysis of randomized controlled trials

    PubMed Central

    CHEN, YAN-YAN; CHEN, WEN; ZHANG, QING; LI, HUI; ZHANG, YE-WEN; KANG, QIAN; LAN, YI; WU, QING

    2016-01-01

    The present meta-analysis aimed to evaluate the effectiveness and safety of puerarin co-treatment with betahistine in treating vertebrobasilar ischemia (VBI) vertigo. A total of 6 medical databases were searched, identifying randomized controlled trials (RCTs) of VBI vertigo performed until August 2014 that investigated a combined treatment of puerarin with betahistine or with other conventional drugs. The quality of the literature was evaluated using the Cochrane Collaboration's tool for assessing risk of bias, and Rev Man 5.0 software was used for statistical analysis and evaluation. The present study included 7 RCTs, involving a total of 664 subjects, and revealed a statistically significant increase in efficacy between the control and the experimental group (odds ratio [OR], 4.99; 95% confidence interval [CI], 3.05 to 8.15). The average blood flow velocity within the vertebrobasilar arteries increased following treatment with puerarin and betahistine compared with that of the control groups (OR, 7.59; 95% CI, 6.19 to 9.00); however, no difference was detected between these groups in the average flow velocity within the left vertebral artery (OR, 6.17; 95% CI, 5.22 to 7.13). The frequency of adverse reactions in the experimental group was lower (OR, 0.75; 95% CI, 0.32 to 1.77) compared with the control group. Combined puerarin and betahistine regimens were more effective in treating VBI vertigo compared with other, conventional drugs; effectively alleviating the associated symptoms, including dizziness and increased average blood flow velocity within the vertebrobasilar arteries, without causing an increased number of serious side effects. However, the efficacy and safety of puerarin and betahistine use in treating VBI vertigo requires additional investigation. PMID:26998036

  10. Change in Pulmonary Function after Incentive Spirometer Exercise in Children with Spastic Cerebral Palsy: A Randomized Controlled Study

    PubMed Central

    Choi, Ja Young; Rha, Dong-wook

    2016-01-01

    Purpose The aim of this study was to investigate the effect of incentive spirometer exercise (ISE) on pulmonary function and maximal phonation time (MPT) in children with spastic cerebral palsy (CP). Materials and Methods Fifty children with CP were randomly assigned to two groups: the experimental group and the control group. Both groups underwent comprehensive rehabilitation therapy. The experimental group underwent additional ISE. The forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC ratio, peak expiratory flow (PEF), and MPT were assessed as outcome measures before and after 4 weeks of training. Results There were significant improvements in FVC, FEV1, PEF, and MPT in the experimental group, but not in the control group. In addition, the improvements in FVC, FEV1, and MPT were significantly greater in the experimental group than in the control group. Conclusion The results of this randomized controlled study support the use of ISE for enhancing pulmonary function and breath control for speech production in children with CP. PMID:26996580

  11. Vitamin D3 Supplementation and Childhood Diarrhea: A Randomized Controlled Trial

    PubMed Central

    Maroof, Zabihullah; Chandramohan, Daniel; Bruce, Jane; Mughal, M. Zulf; Bhutta, Zulfiqar; Walraven, Gijs; Masher, Mohammad I.; Ensink, Jeroen H.J.; Manaseki-Holland, Semira

    2013-01-01

    OBJECTIVE: To investigate the effect of vitamin D3 supplementation on the incidence and risk for first and recurrent diarrheal illnesses among children in Kabul, Afghanistan. METHODS: This double-blind placebo-controlled trial randomized 3046 high-risk 1- to 11-month-old infants to receive 6 quarterly doses of oral vitamin D3 (cholecalciferol 100 000 IU) or placebo in inner city Kabul. Data on diarrheal episodes (≥3 loose/liquid stools in 24 hours) was gathered through active and passive surveillance over 18 months of follow-up. Time to first diarrheal illness was analyzed by using Kaplan-Meier plots. Incidence rates and hazard ratios (HRs) were calculated by using recurrent event Poisson regression models. RESULTS: No significant difference existed in survival time to first diarrheal illness (log rank P = .55). The incidences of diarrheal episodes were 3.43 (95% confidence interval [CI], 3.28–3.59) and 3.59 per child-year (95% CI, 3.44–3.76) in the placebo and intervention arms, respectively. Vitamin D3 supplementation was found to have no effect on the risk for recurrent diarrheal disease in either intention-to-treat (HR, 1.05; 95% CI, 0.98–1.17; P = .15) or per protocol (HR, 1.05; 95% CI, 0.98–1.12; P = .14) analyses. The lack of preventive benefit remained when the randomized population was stratified by age groups, nutritional status, and seasons. CONCLUSIONS: Quarterly supplementation with vitamin D3 conferred no reduction on time to first illness or on the risk for recurrent diarrheal disease in this study. Similar supplementation to comparable populations is not recommended. Additional research in alternative settings may be helpful in elucidating the role of vitamin D3 supplementation for prevention of diarrheal diseases. PMID:24019420

  12. Treatment with Sildenafil Improves Insulin Sensitivity in Prediabetes: A Randomized, Controlled Trial

    PubMed Central

    Ramirez, Claudia E.; Nian, Hui; Yu, Chang; Gamboa, Jorge L.; Luther, James M.; Shibao, Cyndya A.

    2015-01-01

    Context: Sildenafil increases insulin sensitivity in mice. In humans, phosphodiesterase 5 inhibition improves disposition index, but the mechanism of this effect has not been elucidated and may depend on duration. In addition, increasing cyclic GMP without increasing nitric oxide could have beneficial effects on fibrinolytic balance. Objective: The objective was to test the hypothesis that chronic phosphodiesterase 5 inhibition with sildenafil improves insulin sensitivity and secretion without diminishing fibrinolytic function. Design: This was a randomized, double-blind, placebo-controlled study. Setting: This trial was conducted at Vanderbilt Clinical Research Center. Participants: Participants included overweight individuals with prediabetes. Interventions: Subjects were randomized to treatment with sildenafil 25 mg three times a day or matching placebo for 3 months. Subjects underwent a hyperglycemic clamp prior to and at the end of treatment. Main Outcome Measures: The primary outcomes of the study were insulin sensitivity and glucose-stimulated insulin secretion. Result: Twenty-one subjects completed each treatment arm. After 3 months, the insulin sensitivity index was significantly greater in the sildenafil group compared to the placebo group by 1.84 mg/kg/min per μU/mL*100 (95% confidence interval, 0.01 to 3.67 mg/kg/min per μU/mL*100; P = .049), after adjusting for baseline insulin sensitivity index and body mass index. In contrast, there was no effect of 3-month treatment with sildenafil on acute- or late-phase glucose-stimulated insulin secretion (P > .30). Sildenafil decreased plasminogen activator inhibitor-1 (P = .01), without altering tissue-plasminogen activator. In contrast to placebo, sildenafil also decreased the urine albumin-to-creatinine ratio from 12.67 ± 14.67 to 6.84 ± 4.86 μg/mg Cr. This effect persisted 3 months after sildenafil discontinuation. Conclusions: Three-month phosphodiesterase 5 inhibition enhances insulin sensitivity and

  13. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial.

    PubMed

    Hunger, Christina; Bornhäuser, Annette; Link, Leoni; Schweitzer, Jochen; Weinhold, Jan

    2014-06-01

    This study examined the efficacy of family constellation seminars (FCSs) on individuals' experience in their personal social systems, especially the experience of belonging, autonomy, accord, and confidence. We conducted a single-blind, stratified and balanced, randomized controlled trial. Participants were 208 adults (M = 48 years, SD = 10, 79% women) who were randomly allocated either to the intervention group (3-day FCSs; 64 active participants, 40 observing participants) or to the wait-list group (64 active participants, 40 observing participants). Change was measured short-term (2-week and 4-month follow-up) using the Experience In Social Systems Questionnaire, personal domain (EXIS.pers). EXIS.pers is a new outcome measure being applied for the first time in evaluation research. In addition, we used interpersonal scales derived from established measures (Outcome Questionnaire, OQ-45; Tool for the Evaluation of the Psychotherapeutic Progress, FEP). The average person in the intervention group showed improved experience in personal social systems, as compared with approximately 73% of the wait-list group after 2 weeks (total score: Cohen's d = .61, p = .000) and 69% of the wait-list group after 4 months (total score: d = .53, p = .000). The results were confirmed in per-protocol analyses (n = 191) by the results of the EXIS.pers dimensions (Belonging, Autonomy, Accord, and Confidence) and the interpersonal scales derived from the OQ-45 and FEP. No adverse events were reported. This RCT provides first evidence that FCSs tend to positively influence participants' experience in their social systems.

  14. Open-label placebo treatment in chronic low back pain: a randomized controlled trial

    PubMed Central

    Carvalho, Cláudia; Caetano, Joaquim Machado; Cunha, Lidia; Rebouta, Paula; Kaptchuk, Ted J.; Kirsch, Irving

    2016-01-01

    Abstract This randomized controlled trial was performed to investigate whether placebo effects in chronic low back pain could be harnessed ethically by adding open-label placebo (OLP) treatment to treatment as usual (TAU) for 3 weeks. Pain severity was assessed on three 0- to 10-point Numeric Rating Scales, scoring maximum pain, minimum pain, and usual pain, and a composite, primary outcome, total pain score. Our other primary outcome was back-related dysfunction, assessed on the Roland–Morris Disability Questionnaire. In an exploratory follow-up, participants on TAU received placebo pills for 3 additional weeks. We randomized 97 adults reporting persistent low back pain for more than 3 months' duration and diagnosed by a board-certified pain specialist. Eighty-three adults completed the trial. Compared to TAU, OLP elicited greater pain reduction on each of the three 0- to 10-point Numeric Rating Scales and on the 0- to 10-point composite pain scale (P < 0.001), with moderate to large effect sizes. Pain reduction on the composite Numeric Rating Scales was 1.5 (95% confidence interval: 1.0-2.0) in the OLP group and 0.2 (−0.3 to 0.8) in the TAU group. Open-label placebo treatment also reduced disability compared to TAU (P < 0.001), with a large effect size. Improvement in disability scores was 2.9 (1.7-4.0) in the OLP group and 0.0 (−1.1 to 1.2) in the TAU group. After being switched to OLP, the TAU group showed significant reductions in both pain (1.5, 0.8-2.3) and disability (3.4, 2.2-4.5). Our findings suggest that OLP pills presented in a positive context may be helpful in chronic low back pain. PMID:27755279

  15. Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial

    PubMed Central

    Younge, John O.; Wery, Machteld F.; Gotink, Rinske A.; Utens, Elisabeth M. W. J.; Michels, Michelle; Rizopoulos, Dimitris; van Rossum, Elisabeth F. C.

    2015-01-01

    Background Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease. Methods The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male) with heart disease in a 2:1 ratio (n = 215 versus n = 109) to a 12-week online mindfulness training in addition to usual care (UC) compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP), subjective health status (SF-36), perceived stress (PSS), psychological well-being (HADS), social support (PSSS12) and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention). Linear mixed models were used to evaluate differences between groups on the repeated outcome measures. Results Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050). There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033). No significant differences were seen on other outcomes. Conclusions Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease. Trial Registration Dutch Trial Register 3453 PMID:26641099

  16. Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

    PubMed

    Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

    2017-03-22

    Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms.

  17. Electroacupuncture versus Diclofenac in symptomatic treatment of Osteoarthritis of the knee: a randomized controlled trial

    PubMed Central

    Sangdee, Chaichan; Teekachunhatean, Supanimit; Sananpanich, Kanit; Sugandhavesa, Nantawit; Chiewchantanakit, Siripong; Pojchamarnwiputh, Suwalee; Jayasvasti, Subhachai

    2002-01-01

    Background The purpose of this study was to compare the efficacy of electroacupuncture (EA), diclofenac and their combination in symptomatic treatment of osteoarthritis (OA) of the knee. Methods This study was a randomized, single-blind, placebo controlled trial. The 193 out-patients with OA of the knee were randomized into four groups: placebo, diclofenac, EA and combined (diclofenac plus EA). Paracetamol tablets were prescribed as a rescue analgesic during the study. The patients were evaluated after a run-in period of one week (week 0) and again at the end of the study (week 4). The clinical assessments included the amount of paracetamol taken/week, visual analog scale (VAS), Western Ontario and McMaster Universities (WOMAC) OA Index, Lequesne's functional index, 50 feet-walk time, and the orthopedist's and patient's opinion of change. Results One hundred and eighty six patients completed the study. The improvement of symptoms (reduction in mean changes) in most outcome parameters was greatest in the EA group. The proportions of responders and patients with an overall opinion of "much better" were also greatest in the EA group. The improvement in VAS was significantly different between the EA and placebo group as well as the EA and diclofenac group. The improvement in Lequesne's functional index also differed significantly between the EA and placebo group. In addition, there was a significant improvement in WOMAC pain index between the combined and placebo group. Conclusion EA is significantly more effective than placebo and diclofenac in the symptomatic treatment of OA of the knee in some circumstances. However, the combination of EA and diclofenac treatment was no more effective than EA treatment alone. PMID:11914160

  18. Zonisamide for Weight Reduction in Obese Adults A 1-Year Randomized Controlled Trial

    PubMed Central

    Gadde, Kishore M.; Kopping, Mariko F.; Wagner, H. Ryan; Yonish, Gretchen M.; Allison, David B.; Bray, George A.

    2013-01-01

    SUMMARY Background Obese individuals who have failed to achieve adequate weight loss with lifestyle changes have limited non-surgical therapeutic options. We evaluated the efficacy and tolerability of zonisamide, an antiepileptic drug, for enhancing weight loss in obese patients receiving diet and lifestyle guidance. Methods This was a 1-year randomized, double-blind, placebo-controlled trial conducted between January 2006 and September 2011 at Duke University Medical Center. Patients were 225 obese (mean [SD] body mass index 37.6 [4.9]) women (134 [59.6%]) and men (91 [40.4%]) without diabetes. Interventions were daily dosing with placebo (n=74), zonisamide 200 mg (n=76), orzonisamide 400 mg (n=75), in addition to diet and lifestyle counseling by a dietitian for 1 year. Primary outcome was change in body weight at 1-year. Results Of the 225 randomized patients, 218 (97%) provided 1-year follow-up assessments. Change(least-squares mean) in body weight was -4.0 kg (−3.7%; 95% CI, −5.8 kg to −2.3 kg) for placebo, −4.4 kg (−3.9%; −6.1 to −2.6, P=.79vs placebo) for zonisamide 200 mg, and −7.3 kg (−6.8%; −9.0 to −5.6, P=.009vs placebo) for zonisamide 400 mg. In the categorical analysis,23 (31%) on placebo, 26 (34%; P=.71) on zonisamide 200 mg, and 41 (55%; P=.007) onzonisamide 400 mg achieved ≥5% weight loss; for ≥10% weight loss, the corresponding numbers were 6 (8%), 17 (22%; P=.022), and 24 (32%; P=.001). Gastrointestinal, nervous system and psychiatric adverse events occurred at a higher incidence with zonisamide than with placebo. Conclusion Zonisamide 400 mg/d moderately enhanced weight loss achieved with diet and lifestyle counseling, but had a high incidence of adverse events. PMID:23147455

  19. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks

  20. Heart rate variability biofeedback in patients with alcohol dependence: a randomized controlled study

    PubMed Central

    Penzlin, Ana Isabel; Siepmann, Timo; Illigens, Ben Min-Woo; Weidner, Kerstin; Siepmann, Martin

    2015-01-01

    Background and objective In patients with alcohol dependence, ethyl-toxic damage of vasomotor and cardiac autonomic nerve fibers leads to autonomic imbalance with neurovascular and cardiac dysfunction, the latter resulting in reduced heart rate variability (HRV). Autonomic imbalance is linked to increased craving and cardiovascular mortality. In this study, we sought to assess the effects of HRV biofeedback training on HRV, vasomotor function, craving, and anxiety. Methods We conducted a randomized controlled study in 48 patients (14 females, ages 25–59 years) undergoing inpatient rehabilitation treatment. In the treatment group, patients (n=24) attended six sessions of HRV biofeedback over 2 weeks in addition to standard rehabilitative care, whereas, in the control group, subjects received standard care only. Psychometric testing for craving (Obsessive Compulsive Drinking Scale), anxiety (Symptom Checklist-90-Revised), HRV assessment using coefficient of variation of R-R intervals (CVNN) analysis, and vasomotor function assessment using laser Doppler flowmetry were performed at baseline, immediately after completion of treatment or control period, and 3 and 6 weeks afterward (follow-ups 1 and 2). Results Psychometric testing showed decreased craving in the biofeedback group immediately postintervention (OCDS scores: 8.6±7.9 post-biofeedback versus 13.7±11.0 baseline [mean ± standard deviation], P<0.05), whereas craving was unchanged at this time point in the control group. Anxiety was reduced at follow-ups 1 and 2 post-biofeedback, but was unchanged in the control group (P<0.05). Following biofeedback, CVNN tended to be increased (10.3%±2.8% post-biofeedback, 10.1%±3.5% follow-up 1, 10.1%±2.9% follow-up 2 versus 9.7%±3.6% baseline; P=not significant). There was no such trend in the control group. Vasomotor function assessed using the mean duration to 50% vasoconstriction of cutaneous vessels after deep inspiration was improved following biofeedback

  1. Digital servo control of random sound test excitation. [in reverberant acoustic chamber

    NASA Technical Reports Server (NTRS)

    Nakich, R. B. (Inventor)

    1974-01-01

    A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

  2. Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers: A Randomized Controlled Trial

    PubMed Central

    Gould, Madelyn S; Twisk, Jos WR; Kerkhof, Ad JFM; Koot, Hans M

    2016-01-01

    Background Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers’ knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. Objective This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. Methods A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants’ ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. Results The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. Conclusions The findings of this study indicate that Web

  3. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study

    PubMed Central

    Roshdy, Eman; Rajaratnam, Veera; Maitra, Sarbani; Sabry, Mohamed; Allah, Abdou S Ait; Al-Hendy, Ayman

    2013-01-01

    Background Uterine fibroids (UFs, also known as leiomyoma) affect 70% of reproductive-age women. Imposing a major burden on health-related quality-of-life (HRQL) of premenopausal women, UF is a public health concern. There are no effective medicinal treatment options currently available for women with symptomatic UF. Objectives To evaluate the efficacy and safety of green tea extract (epigallocatechin gallate [EGCG]) on UF burden and quality of life in women with symptomatic UF, in a double-blinded, placebo-controlled randomized clinical trial. Methods A total of 39 reproductive-age women (age 18–50 years, day 3 serum follicle-stimulating hormone <10 \\U/mL) with symptomatic UF were recruited for this study. All subjects had at least one fibroid lesion 2 cm3 or larger, as confirmed by transvaginal ultrasonography. The subjects were randomized to oral daily treatment with either 800 mg of green tea extract (45% EGCG) or placebo (800 mg of brown rice) for 4 months, and UF volumes were measured at the end, also by transvaginal ultrasonography. The fibroid-specific symptom severity and HRQL of these UF patients were scored at each monthly visit, using the symptom severity and quality-of-life questionnaires. Student’s t-test was used to evaluate statistical significance of treatment effect between the two groups. Results Of the final 39 women recruited for the study, 33 were compliant and completed all five visits of the study. In the placebo group (n = 11), fibroid volume increased (24.3%) over the study period; however, patients randomized to green tea extract (n = 22, 800 mg/day) treatment showed significant reduction (32.6%, P = 0.0001) in total UF volume. In addition, EGCG treatment significantly reduced fibroid-specific symptom severity (32.4%, P = 0.0001) and induced significant improvement in HRQL (18.53%, P = 0.01) compared to the placebo group. Anemia also significantly improved by 0.7 g/dL (P = 0.02) in the EGCG treatment group, while average blood loss

  4. Effects of a Randomized Controlled Trial to Increase Repeat Mammography Screening in Iranian Women

    PubMed Central

    Taymoori, Parvaneh; Molina, Yamile; Roshani, Daem

    2014-01-01

    Background Although mammography use has increased in developed countries, regular screening in developing countries including Iran remains low. Multiple frameworks, including the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), have been used to understand screening practices among Iranians. The HBM includes intrapersonal constructs such as perceptions of breast cancer and mammography. The TPB includes interpersonal and environmental constructs, such as perceived control and subjective norms. Objectives The current study had 2 objectives: (1) to examine changes in the HBM and TPB constructs and repeat mammography screening in women receiving either intervention and women in the control group and (2) to compare changes in the HBM and TPB constructs and repeat mammography screening across the 2 interventions. Methods One hundred eight-four women from 3 randomly selected health centers in Sanandaj, Iran, participated. Eligibility criteria were being 50 years or older, having received a mammogram in the past 2 to 3 years, and no intention to obtain a mammogram within the next year. Results The TPB and HBM participants exhibited greater changes in the HBM and TPB constructs and were more likely to have a mammogram relative to control participants. The TPB and HBM participants exhibited comparable changes in constructs and repeat mammography. Conclusion Findings suggest both interventions equally improved mammography screening. Additional studies are furthermore warranted to address nonadherent Iranian women’s needs in line with these conceptual models. Implications for Practice Use of the HBM and TPB constructs in clinical practice may be helpful to promote continued screening among this population. PMID:25122130

  5. Relaxation Training and Written Emotional Disclosure for Tension or Migraine Headaches: A Randomized, Controlled Trial

    PubMed Central

    D’Souza, Pamela J.; Lumley, Mark A.; Kraft, Christina A.; Dooley, John A.

    2010-01-01

    Background and Purpose Behavioral medicine interventions that directly reduce arousal and negative emotions, such as relaxation training (RT), are conceptually different from interventions that temporarily increase negative emotions, such as written emotional disclosure (WED), but no studies have directly compared their efficacy. We compared the effects of RT and WED on people with tension or migraine headaches. Methods College students with either tension (n = 51) or migraine (n = 90) headaches were randomized to 1 of 3 groups: RT, WED, or a neutral writing control condition; 4 sessions were held over 2 weeks. Mood was measured before and after each session, and outcomes (headache frequency, severity, disability, and general physical symptoms) were assessed at baseline and at 1-month and 3-month follow-ups. Results As expected, RT led to an immediate increase in calmness, whereas WED led to an immediate increase in negative mood, for both headache samples. Intent-to-treat analyses showed that for the tension headache sample, RT led to improved headache frequency and disability compared to both WED and the control group, but WED had no effect. For migraine headaches, RT improved pain severity relative to the control group, but WED again had no effect. Conclusions A brief RT protocol was effective for tension headaches, but WED had no effect on health status for either tension or migraine headaches. Modifications to WED, such as targeting people with unresolved stress, providing guidance to enhance the potency of the writing, or including additional at-home writing and exposure exercises, may improve its efficacy for people with headaches and other health problems. PMID:18696172

  6. Rehabilitating Walking Speed Poststroke With Treadmill-Based Interventions: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Charalambous, Charalambos C.; Bonilha, Heather Shaw; Kautz, Steven A.; Gregory, Chris M.; Bowden, Mark G.

    2015-01-01

    Background In the past several years, several randomized controlled trials (RCTs) have been reported regarding the efficacy of treadmill-based walking-specific rehabilitation programs, either individually (TT) or combined with body weight support (BWSTT), over control group therapies poststroke. No clear consensus exists as to whether treadmill-based interventions are superior in rehabilitating walking speed (WS) poststroke. Objective To review published RCTs examining TT and BWSTT poststroke and describe the effects on improving and retaining WS. Methods A systematic literature search in computerized databases was conducted to identify RCTs whose methodological quality was assessed with PEDro. Pre- and post-WS, change in WS, functional outcomes, and follow-up speed were extracted and calculated from each study. Additionally, statistical results of each study were examined, and the intragroup and intergroup effect sizes (ESintra and ESinter, respectively) were calculated. Results All studies (8 TT; 7 BWSTT) met the inclusion criteria, and their methodological quality was generally good, with a mean PEDro score 6.9/10. Of the 15 studies, 8 studies (4 TT; 4 BWSTT) reported intragroup significant increases of WS, whereas only 4 (4 TT) found superiority of treadmill interventions. Nine studies demonstrated large ESintra (4 TT; 5 BWSTT), yet only 3 showed large ESinter (1 TT; 2 BWSTT). Four studies (2 TT and 2 BWSTT) reported retention of gains in WS, regardless of intervention. Conclusions Treadmill-based interventions poststroke may increase and retain WS, but their universal superiority to other control group therapies has failed to be established. PMID:23764885

  7. Is early postoperative administration of pregabalin beneficial for patients with lung cancer?—randomized control trial

    PubMed Central

    Sakai, Tetsuya; Sato, Shuntaro; Yamasaki, Naoya; Tsuchiya, Tomoshi; Matsumoto, Keitaro; Kamohara, Ryotaro; Hatachi, Go; Doi, Ryoichiro; Nagayasu, Takeshi

    2016-01-01

    Background Post-thoracotomy pain is an obstacle for lung-cancer patients even after introduction of less invasive surgical procedures. The aim of this prospective study was to evaluate if early postoperative administration of pregabalin is beneficial for patients with non-small cell lung cancer (NSCLC). Methods We conducted a randomized open control trial. Patients with NSCLC were allocated randomly to epidural and nonsteroidal anti-inflammatory drug (NSAID) use for analgesia (control group) or pregabalin use (pregabalin group). Primary endpoint was the frequency of additional administration of a NSAID. Secondary endpoints were intensity of ongoing pain, frequency of neuropathic pain, and pain catastrophizing. Results Seventy-two patients were registered and allocated. Thirty-four cases in the control group and 33 in the pregabalin group were assessed. Age, sex, body mass index (BMI), type of surgical procedure, type of lymph-node dissection, operation time, bleeding, duration of chest-tube insertion, and postoperative hospital stay between the two groups was not significantly different. Frequency of additional NSAID use between the control group (2±4 suppositories) and pregabalin group (2±3 suppositories) was not significantly different (P=0.62). Numeric Rating Scale (NRS) for the intensity of ongoing pain, frequency of neuropathic pain, and Pain Catastrophizing Scale (PCS) between each group were not significantly different at any time until 3 months after surgery. Conclusions Early postoperative administration of pregabalin is not beneficial for patients with NSCLC. PMID:28149551

  8. Antagonistic control of a dual-input mammalian gene switch by food additives

    PubMed Central

    Xie, Mingqi; Ye, Haifeng; Hamri, Ghislaine Charpin-El; Fussenegger, Martin

    2014-01-01

    Synthetic biology has significantly advanced the design of mammalian trigger-inducible transgene-control devices that are able to programme complex cellular behaviour. Fruit-based benzoate derivatives licensed as food additives, such as flavours (e.g. vanillate) and preservatives (e.g. benzoate), are a particularly attractive class of trigger compounds for orthogonal mammalian transgene control devices because of their innocuousness, physiological compatibility and simple oral administration. Capitalizing on the genetic componentry of the soil bacterium Comamonas testosteroni, which has evolved to catabolize a variety of aromatic compounds, we have designed different mammalian gene expression systems that could be induced and repressed by the food additives benzoate and vanillate. When implanting designer cells engineered for gene switch-driven expression of the human placental secreted alkaline phosphatase (SEAP) into mice, blood SEAP levels of treated animals directly correlated with a benzoate-enriched drinking programme. Additionally, the benzoate-/vanillate-responsive device was compatible with other transgene control systems and could be assembled into higher-order control networks providing expression dynamics reminiscent of a lap-timing stopwatch. Designer gene switches using licensed food additives as trigger compounds to achieve antagonistic dual-input expression profiles and provide novel control topologies and regulation dynamics may advance future gene- and cell-based therapies. PMID:25030908

  9. Antagonistic control of a dual-input mammalian gene switch by food additives.

    PubMed

    Xie, Mingqi; Ye, Haifeng; Hamri, Ghislaine Charpin-El; Fussenegger, Martin

    2014-08-01

    Synthetic biology has significantly advanced the design of mammalian trigger-inducible transgene-control devices that are able to programme complex cellular behaviour. Fruit-based benzoate derivatives licensed as food additives, such as flavours (e.g. vanillate) and preservatives (e.g. benzoate), are a particularly attractive class of trigger compounds for orthogonal mammalian transgene control devices because of their innocuousness, physiological compatibility and simple oral administration. Capitalizing on the genetic componentry of the soil bacterium Comamonas testosteroni, which has evolved to catabolize a variety of aromatic compounds, we have designed different mammalian gene expression systems that could be induced and repressed by the food additives benzoate and vanillate. When implanting designer cells engineered for gene switch-driven expression of the human placental secreted alkaline phosphatase (SEAP) into mice, blood SEAP levels of treated animals directly correlated with a benzoate-enriched drinking programme. Additionally, the benzoate-/vanillate-responsive device was compatible with other transgene control systems and could be assembled into higher-order control networks providing expression dynamics reminiscent of a lap-timing stopwatch. Designer gene switches using licensed food additives as trigger compounds to achieve antagonistic dual-input expression profiles and provide novel control topologies and regulation dynamics may advance future gene- and cell-based therapies.

  10. Use of Kampo Diagnosis in Randomized Controlled Trials of Kampo Products in Japan: A Systematic Review

    PubMed Central

    Motoo, Yoshiharu; Arai, Ichiro; Tsutani, Kiichiro

    2014-01-01

    Background The Committee for Evidence-based Medicine (EBM) of the Japan Society for Oriental Medicine started compiling Evidence Reports of Kampo Treatment (EKAT) in 2007. EKAT is a compilation of structured abstracts of randomized controlled trials (RCTs), along with comments by a third party reviewer. As of 31 December, 2012, there were 378 RCTs of Kampo medicines in Japan. The primary research question of this study is “How frequently is Kampo diagnosis used in RCTs of Kampo medicines?” The secondary research question is “When is Kampo diagnosis used in RCTs?” Materials and Methods The structured abstract (SA) of each RCT article was reviewed to examine how Kampo diagnosis was used in RCTs, especially how Kampo diagnosis was used in the randomization process. Results Kampo diagnosis was used before randomization in 27 RCTs (7.1%), after randomization in 31 RCTs (8.2%), and not used in 320 RCTs (84.7%). Before randomization, Kampo diagnosis was used as a criterion for inclusion in 10 RCTs, criterion for exclusion in 9 RCTs, and criteria for both inclusion and exclusion in 2 RCTs. Kampo formulas were determined according to Kampo diagnosis in 7 RCTs. After randomization, subgroup analyses according to Kampo diagnosis were done in 27 RCTs, and grade of disease severity at Kampo diagnosis was used for analysis as an endpoint in 4 RCTs. Conclusions Kampo diagnosis was used before randomization only in approximately 15% of RCTs, and the number of RCT articles using Kampo diagnosis after randomization was almost the same as that before randomization. Further studies to determine the good RCTs conforming to CONSORT requirements and good systematic reviews conforming to PRISMA requirements are needed to clarify the significance of Kampo diagnosis. PMID:25119187

  11. Improving diet, activity and wellness in adults at risk of diabetes: randomized controlled trial

    PubMed Central

    Block, G; Azar, K M J; Romanelli, R J; Block, T J; Palaniappan, L P; Dolginsky, M; Block, C H

    2016-01-01

    Objective: The purpose of this analysis is to examine the effect of an algorithm-driven online diabetes prevention program on changes in eating habits, physical activity and wellness/productivity factors. Methods: The intervention, Alive-PD, used small-step individually tailored goal setting and other features to promote changes in diet and physical activity. A 6-month randomized controlled trial was conducted among patients from a healthcare delivery system who had confirmed prediabetes (n =339). Change in weight and glycemic markers were measured in the clinic. Changes in physical activity, diet and wellness/productivity factors were self-reported. Mean age was 55 (s.d. 8.9) years, mean body mass index was 31 (s.d. 4.4) kg m−2, 68% were white and 69% were male. Results: The intervention group increased fruit/vegetable consumption by 3.71 (95% confidence interval (CI) 2.73, 4.70) times per week (effect size 0.62), and decreased refined carbohydrates by 3.77 (95% CI 3.10, 4.44) times per week both significantly (P<0.001) greater changes than in the control group. The intervention group also reported a significantly greater increase in physical activity than in the control group, effect size 0.49, P<0.001. In addition, the intervention group reported a significant increase in self-rated health, in confidence in ability to make dietary changes and in ability to accomplish tasks, and a decrease in fatigue, compared with the control group. These changes paralleled the significant treatment effects on glycemic markers and weight. Conclusions: In addition to promoting improvements in weight and glycemic markers, the Alive-PD program appears to improve eating habits and physical activity, behaviors important not just for diabetes prevention but for those with diagnosed diabetes or obesity. The improvements in wellness/productivity may derive from the diet and activity improvements, and from the satisfaction and self-efficacy of achieving goals. PMID:27643726

  12. A Web-Based Health Promotion Program for Older Workers: Randomized Controlled Trial

    PubMed Central

    Hersch, Rebekah K; Schlossberg, Dana; Leaf, Samantha L

    2015-01-01

    Background Recent evidence supports the efficacy of programs that promote improvements in the health practices of workers 50 years and older who are at higher risk for chronic diseases than younger workers are. Internet-based programs that promote healthy practices have also shown promise and, therefore, should be especially appropriate for workers aged 50 years and older. Objective The purpose of the research was to evaluate the effectiveness of HealthyPast50, a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers 50 years and older. Methods The randomized controlled trial was conducted across multiple US offices of a large global information technology company. The sample included 278 employees aged 50 to 68 who were recruited online and randomly assigned to the Web-based HealthyPast50 program or to a wait-list control condition. Self-report measures of diet, physical activity, stress, and tobacco use were collected online before and 3 months after the program group was given access to the program. Use data included number of log-ins and number of pages accessed. The primary analysis was multiple linear regression, following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo (MCMC) approach for nonmonotone missing data. Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models. Additional analyses were conducted on complete (nonimputed) cases, excluding program participants who used the program for less than 30 minutes. Results Retention rates were good for both groups: 80.4% (111/138) for the program group and 94.3% (132/140) for the control group. Program group participants spent a mean of 102.26 minutes in the program (SD 148.32), logged in a mean of 4.33 times (SD 4.28), and viewed a mean of 11.04 pages (SD 20.08). In the analysis of the imputed dataset, the program group performed

  13. Hypercaloric enteral nutrition in Amyotrophic Lateral Sclerosis: a randomized double-blind placebo-controlled trial

    PubMed Central

    Wills, Anne-Marie; Hubbard, Jane; Macklin, Eric A.; Glass, Jonathan; Tandan, Rup; Simpson, Ericka P; Brooks, Benjamin; Gelinas, Deborah; Mitsumoto, Hiroshi; Mozaffar, Tahseen; Hanes, Gregory P.; Ladha, Shafeeq S.; Heiman-Patterson, Terry; Katz, Jonathan; Lou, Jau-Shin; Mahoney, Katy; Grasso, Daniela; Lawson, Robert; Yu, Hong; Cudkowicz, Merit

    2014-01-01

    Background Amyotrophic Lateral Sclerosis (ALS) is a rapidly fatal neurodegenerative disease with few therapeutic options. Mild obesity is associated with greater survival in ALS patients and calorie-dense diets increase survival in an ALS mouse model. We therefore hypothesized that hypercaloric diets might lead to weight gain and slow ALS disease progression. Methods In this double-blind, placebo-controlled, multi-center clinical trial, we enrolled adults with ALS without a history of diabetes, significant liver or cardiovascular disease, who were already receiving percutaneous enteral nutrition. We randomly assigned participants to one of three dietary interventions: replacement calories using an isocaloric diet (controls) vs. a high-carbohydrate hypercaloric diet (HC/HC), vs. a high-fat hypercaloric diet (HF/HC). Participants received the intervention diets for four months and were followed for five months. The primary outcomes were safety and tolerability. Secondary outcomes included measures of disease progression, survival, and metabolism. This trial is registered with Clinicaltrials.gov, number NCT00983983. Findings A total of 24 participants were enrolled of whom 20 initiated study diet (six control, eight HC/HC, six HF/HC). Baseline demographics were similar among the three study arms. The HC/HC diet was better tolerated with fewer serious adverse events than the control diet (zero vs. nine, p<0·001) and fewer dose discontinuations due to adverse events (0% vs. 50%). There were no deaths in the HC/HC arm vs. three deaths (43%) in the control arm (logrank p = 0·03). The HF/HC arm was not statistically different from the controls in adverse events, tolerability, deaths or disease progression. Interpretation Our results suggest that hypercaloric enteral nutrition is safe and tolerable in ALS and support the study of nutritional interventions at earlier stages of the disease. Funding The Muscular Dystrophy Association with additional support from the National

  14. Oxytocin and Autism Spectrum Disorders: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Ooi, Yoon Phaik; Weng, Shih-Jen; Kossowsky, Joe; Gerger, Heike; Sung, Min

    2017-01-01

    Aim: Oxytocin presents an exciting potential to target the core symptoms of autism spectrum disorder (ASD) pharmacologically in an easily administered, cost-effective form with possibly minimal adverse effects. But, there are still major gaps in this area of research. This paper reviewed randomized controlled trials (RCTs) examining the effects of oxytocin administration on social cognition and restricted, repetitive behaviors in individuals with an ASD. Method: Electronic literature searches were conducted from PsycINFO, PubMed, Web of Knowledge, and EMBASE for RCTs published through June 2015. Results: 12 RCTs were included in this review. 7 out of the 11 studies that examined social cognition reported improvements. Additionally, one out of the 4 studies on restricted, repetitive behaviors, reported improvements following oxytocin administration. However, results from our meta-analyses suggest that oxytocin has no significant effect on these 2 domains. Conclusion: Previous evidence revealed mixed findings about the effects of oxytocin on ASD. Given the limited number of RCTs, our summary of findings on the effectiveness of oxytocin on ASD should still be considered tentative.

  15. Randomized controlled trials in pediatric complementary and alternative medicine: Where can they be found?

    PubMed Central

    Sampson, Margaret; Campbell, Kaitryn; Ajiferuke, Isola; Moher, David

    2003-01-01

    Background The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM). Methods Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews. Results We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs. Conclusions Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection. PMID:12589711

  16. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials.

    PubMed

    Black, David S; Slavich, George M

    2016-06-01

    Mindfulness meditation represents a mental training framework for cultivating the state of mindful awareness in daily life. Recently, there has been a surge of interest in how mindfulness meditation improves human health and well-being. Although studies have shown that mindfulness meditation can improve self-reported measures of disease symptomatology, the effect that mindfulness meditation has on biological mechanisms underlying human aging and disease is less clear. To address this issue, we conducted the first comprehensive review of randomized controlled trials examining the effects of mindfulness meditation on immune system parameters, with a specific focus on five outcomes: (1) circulating and stimulated inflammatory proteins, (2) cellular transcription factors and gene expression, (3) immune cell count, (4) immune cell aging, and (5) antibody response. This analysis revealed substantial heterogeneity across studies with respect to patient population, study design, and assay procedures. The findings suggest possible effects of mindfulness meditation on specific markers of inflammation, cell-mediated immunity, and biological aging, but these results are tentative and require further replication. On the basis of this analysis, we describe the limitations of existing work and suggest possible avenues for future research. Mindfulness meditation may be salutogenic for immune system dynamics, but additional work is needed to examine these effects.

  17. The effect of occupational therapy in patients with chronic obstructive pulmonary disease: A randomized controlled trial.

    PubMed

    Martinsen, Unni; Bentzen, Hege; Holter, Morag Kelly; Nilsen, Tove; Skullerud, Hallvard; Mowinckel, Petter; Kjeken, Ingvild

    2017-03-01

    Aim The main aim of this study was to evaluate the effect of individualized occupational therapy in patients with chronic obstructive pulmonary disease (COPD). Additionally, the authors wanted to explore the occupational problems experienced in daily life by individuals with COPD. Methods A total of 52 patients were randomly assigned to the intervention group (occupational therapy) or control group (treatment as usual). The primary outcome was assessed using the Canadian Occupational Performance Measure (COPM), and participants were assessed at baseline and after four and 12 months. Results There were no treatment effects on occupational performance or satisfaction with performance, as measured by the COPM. However, we found a significant effect in favour of the intervention group at exertion when performing an individually chosen activity, and in the activity dimension of St George's Respiratory Questionnaire. A total of 595 occupational problems were reported, most frequently within mobility, active recreation, and household management. Conclusions The results show that, compared with the usual care, individualized occupational therapy did not improve occupational performance or satisfaction with performance. Small but significant changes in activity performance in favour of the intervention group were found in some of the secondary outcomes.

  18. Dexamethasone as An Additive to Bupivacaine in Fascia Lliaca Compartment Block: A Prospective, Randomized and Double Blind Study

    PubMed Central

    Kumar N, Suresh; N, Kiran; Sebastian, Don; Gowda RM, Punith

    2014-01-01

    Background: Patients with fracture femur experience severe pain on movement during positioning for spinal anaesthesia. Fascia Iliaca Compartment Block (FICB) has been used effectively for providing analgesia during positioning of the patient for spinal anaesthesia. Aim: To test the hypothesis that, adding dexamethasone would significantly prolong the duration of Bupivacaine in FICB. Materials and Methods: Sixty patients aged 18 to 80 years posted for ORIF (Open Reduction and Internal Fixation) of fracture femur were included to receive FICB. This was a prospective, randomized, double blind study done at tertiary medical college hospital. Thirty patients received 38ml of 0.25 % bupivacaine with 2ml saline and another 30 patients received 38ml of 0.25 % bupivacaine with 2ml dexamethasone (8mg). Thirty minutes after FICB, patient satisfaction during positioning for spinal anesthesia was recorded. In the post-operative period, duration of analgesia and the total doses of rescue analgesics were recorded in both the groups. Results: Patients who received Bupivacaine with dexamethasone had significant prolongation of analgesia and required fewer doses of rescue analgesics as compared to patients who received Bupivacaine alone for FICB. However, the onset of analgesia, VAS scores and patient satisfaction during positioning for spinal anaesthesia were similar in both groups. Conclusion: Our study shows that adding Dexamethasone (8mg) to Bupivacaine for FICB significantly prolonged the duration of block and decreased the requirement of rescue analgesics as compared to patients who received Bupivacaine alone. FICB is relatively easy and safe to perform. In our study we did not encounter any complication while doing the procedures and also by adding dexamethasone. PMID:25302209

  19. Effect of Aerobic Exercise on Cognition, Academic Achievement, and Psychosocial Function in Children: A Systematic Review of Randomized Control Trials

    PubMed Central

    Lees, Caitlin

    2013-01-01

    Introduction Although the effects of aerobic physical activity (APA) on children’s physical health is well characterized, the effect of aerobic physical activity on cognition, academic achievement, and psychosocial function has not yet been established. This systematic review provides an overview of research elucidating the relationship between aerobic physical activity and children’s cognition, academic achievement, and psychosocial function. Methods A systematic review of English articles was performed in April 2013 using MEDLINE, Cochrane, PsycINFO, SPORTDiscus, and EMBASE. Additional studies were identified through back-searching bibliographies. Only randomized control trials with an intervention of aerobic physical activity in children younger than 19 years that measured psychological, behavioral, cognitive, or academic outcomes were included. Results We found 8 relevant randomized control trials that met our inclusion criteria and extracted relevant data and evaluated the methodologic quality of the studies. Of the 8 studies identified, 2 studies were crossover randomized control trials studying the effects of acute aerobic physical activity on cognitive performance. Six studies were parallel-group randomized control studies, of which only 2 had a follow-up period of longer than 6 months. All studies showed that APA had a generally positive impact on children’s cognition and psychosocial function. However, this relationship was found to be minimal in many studies and in some measures, no significant improvement was seen at all. There was no documentation of APA having any negative impact on children’s cognition and psychosocial health, even in cases where school curriculum time was reassigned from classroom teaching to aerobic physical activity. Conclusion APA is positively associated with cognition, academic achievement, behavior, and psychosocial functioning outcomes. More rigorous trials with adequate sample sizes assessing the impact of APA on

  20. Covered versus bare stents for transjugular intrahepatic portosystemic shunt: an updated meta-analysis of randomized controlled trials

    PubMed Central

    Qi, Xingshun; Tian, Yulong; Zhang, Wei; Yang, Zhiping; Guo, Xiaozhong

    2016-01-01

    Background: Transjugular intrahepatic portosystemic shunt (TIPS) is a standard treatment option for the management of portal hypertension in liver cirrhosis. Since the introduction of covered stents, shunt patency has been greatly improved. However, it remains uncertain about whether covered stents could improve survival. A meta-analysis of randomized controlled trials has been performed to compare the outcomes of covered versus bare stents for TIPS. Methods: PubMed, EMBASE, and Cochrane Library databases were searched to identify the relevant randomized controlled trials. Overall survival, shunt patency, and hepatic encephalopathy were the major endpoints. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was calculated. Cochrane risk of bias tool was employed. Results: Overall, 119 papers were identified. Among them, four randomized controlled trials were eligible. Viatorr covered stents alone, Fluency covered stents alone, and Viatorr plus Fluency covered stents were employed in one, two, and one randomized controlled trials, respectively. Risk of bias was relatively low. Meta-analyses demonstrated that the covered-stents group had significantly higher probabilities of overall survival (HR = 0.67, 95% CI = 0.50–0.90, p = 0.008) and shunt patency (HR = 0.42, 95% CI = 0.29–0.62, p < 0.0001) than the bare-stents group. Additionally, the covered-stents group might have a lower risk of hepatic encephalopathy than the bare-stents group (HR = 0.70, 95% CI = 0.49–1.00, p = 0.05). The heterogeneity among studies was not statistically significant in the meta-analyses. Conclusions: Compared with bare stents, covered stents for TIPS may improve the overall survival. In the era of covered stents, the indications for TIPS may be further expanded. PMID:28286557

  1. Traditional Chinese Medications for Knee Osteoarthritis Pain: A Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Chen, Bo; Zhan, Hongsheng; Marszalek, Jolanta; Chung, Mei; Lin, Xun; Zhang, Min; Pang, Jian; Wang, Chenchen

    2016-01-01

    Traditional Chinese medication (TCM) has analgesic and anti-inflammatory effects in patients with knee osteoarthritis (OA). We conducted the first systematic review of the best quantitative and qualitative evidence currently available in order to evaluate the effectiveness of TCM in relieving pain in knee OA. A comprehensive literature search was conducted using three English and four Chinese biomedical databases from their inception through March 1, 2015. We included randomized controlled trials of TCM for knee OA with intervention durations of at least two weeks. The effects of TCM on pain and other clinical symptoms were measured with the visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total effectiveness rate, which was used to assess overall pain, physical performance and wellness, was also measured. Two researchers independently extracted data on study design, population characteristics, duration, intervention, outcomes, risk of bias, and primary results. We performed a random-effects meta-analysis when appropriate. We also explored factors that could explain the heterogeneity by conducting subgroup and meta-regression analyses. Twenty-three studies, totaling 2362 subjects, met the eligibility criteria. Treatments were formulated with an average of 8 Chinese herbs and were prescribed based on the traditional Chinese diagnostic method of syndrome differentiation. The mean treatment duration was seven weeks, with oral administration occurring one to three times a day. Compared with non-steroidal anti-inflammatory drugs and intra-articular hyaluronate injections, 18 of the studies showed significantly improved VAS pain scores (Mean Difference [MD] [Formula: see text] 0.56; 95% confidence interval [CI], 0.18 to 0.94; [Formula: see text]), six of the studies showed significantly improved WOMAC pain subscale scores (MD [Formula: see text] 2.23; 95% CI, 0.56 to 3.91; [Formula: see text]), and 16 of the trials

  2. Torsional Control of Stereoselectivities in Electrophilic Additions and Cycloadditions to Alkenes

    PubMed Central

    Wang, Hao; Houk, K. N.

    2013-01-01

    Torsional effects control the π-facial stereoselectivities of a variety of synthetically important organic reactions. This review surveys theoretical calculations that have led to the understanding of the influence of the torsional effects on several types of stereoselective organic reactions, especially electrophilic additions and cycloadditions to alkenes. PMID:24409340

  3. Chill water additive controls transfer of Salmonella and Campylobacter by improved chlorine efficacy

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In earlier work, we showed that a proprietary additive (T-128) maintains chlorine activity in the presence of organic material such as broiler parts. T-128 improves the efficacy of chlorine to control transfer of Campylobacter and Salmonella from inoculated wings to un-inoculated wings during immer...

  4. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  5. Lower extremity power training in elderly subjects with moderate mobility limitations: A randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Fifty-seven community-dwelling older adults were randomized to either high-velocity high-power training (POW), slow-velocity progressive resistance training (STR) or a control group of lower extremity stretching (CON). Training was performed three times per week for 12 weeks and subjects completed t...

  6. Service Learning in Medical and Nursing Training: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, A. Y. M.; Chan, S. S. C.; Kwan, C. W.; Cheung, M. K. T.; Leung, S. S. K.; Fong, D. Y. T.

    2012-01-01

    The purpose of this study was to explore the long term effect of a service learning project on medical and nursing students' knowledge in aging and their attitudes toward older adults. A total of 124 students were recruited and then randomized to intervention group (IG) and control group (CG). A pre-and-post-intervention design measured students'…

  7. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  8. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  9. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    ERIC Educational Resources Information Center

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  10. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    ERIC Educational Resources Information Center

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  11. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  12. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  13. An Empirical Comparison of Randomized Control Trials and Regression Discontinuity Estimations

    ERIC Educational Resources Information Center

    Barrera-Osorio, Felipe; Filmer, Deon; McIntyre, Joe

    2014-01-01

    Randomized controlled trials (RCTs) and regression discontinuity (RD) studies both provide estimates of causal effects. A major difference between the two is that RD only estimates local average treatment effects (LATE) near the cutoff point of the forcing variable. This has been cited as a drawback to RD designs (Cook & Wong, 2008).…

  14. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    ERIC Educational Resources Information Center

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  15. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  16. Scaling Academic Planning in Community College: A Randomized Controlled Trial. REL 2017-204

    ERIC Educational Resources Information Center

    Visher, Mary G.; Mayer, Alexander K.; Johns, Michael; Rudd, Timothy; Levine, Andrew; Rauner, Mary

    2016-01-01

    Community college students often lack an academic plan to guide their choices of coursework to achieve their educational goals, in part because counseling departments typically lack the capacity to advise students at scale. This randomized controlled trial tests the impact of guaranteed access to one of two alternative counseling sessions (group…

  17. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  18. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial

    DTIC Science & Technology

    2013-10-01

    Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Henry W. Mahncke, Ph.D. CONTRACTING ORGANIZATION: Brain Plasticity, Inc...WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Brain Plasticity Inc. AND ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT...TERMS traumatic brain injury, tbi, concussion, persistent post-concussive symptoms, cognition, cognitive function, cognitive rehabilitation

  19. Plasticity-Based Adaptive Cognitive Remediation (PACR) for OIF/OEF Veterans: A Randomized Controlled Trial

    DTIC Science & Technology

    2012-10-01

    Veterans: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Henry W. Mahncke, Ph.D. CONTRACTING ORGANIZATION: Brain Plasticity...7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Brain Plasticity Inc., San Francisco, CA 94105 ES) 8. PERFORMING ORGANIZATION REPORT...SUBJECT TERMS traumatic brain injury, tbi, concussion, persistent post-concussive symptoms, cognition, cognitive function, cognitive rehabilitation

  20. Computer-Assisted Learning in Elementary Reading: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Shannon, Lisa Cassidy; Styers, Mary Koenig; Wilkerson, Stephanie Baird; Peery, Elizabeth

    2015-01-01

    This study evaluated the efficacy of Accelerated Reader, a computer-based learning program, at improving student reading. Accelerated Reader is a progress-monitoring, assessment, and practice tool that supports classroom instruction and guides independent reading. Researchers used a randomized controlled trial to evaluate the program with 344…

  1. Ice Hockey Players Using a Weighted Implement when Training on the Ice: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Stark, Timothy W.; Tvoric, Bojan; Walker, Bruce; Noonan, Dom; Sibla, Janeene

    2009-01-01

    The purpose of this study was to investigate the potential for improving hockey players' performance using a weighted implement on the ice. Forty-eight players were tested using a grip strength dynamometer. They also were assessed on their abilities to stick-handle. The participants were randomly placed into a control or research group. The…

  2. Determinants of glycemic control in youth with type 2 diabetes at randomization in the TODAY study

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The purpose of this study was to investigate insulin sensitivity and secretion indices and determinants of glycemic control in youth with recent-onset type 2 diabetes (T2DM) at randomization in the TODAY study, the largest study of youth with T2DM to date. We examined estimates of insulin sensitivit...

  3. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  4. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  5. Randomized Controlled Trial of Transdermal Secretin on Behavior of Children with Autism

    ERIC Educational Resources Information Center

    Ratliff-Schaub, Karen; Carey, Tracy; Reeves, Gretchen; Rogers, Mary

    2005-01-01

    Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in…

  6. Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Goodkind, Jessica R.; Amer, Suha; Christian, Charlisa; Hess, Julia Meredith; Bybee, Deborah; Isakson, Brian L.; Baca, Brandon; Ndayisenga, Martin; Greene, R. Neil; Shantzek, Cece

    2017-01-01

    Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants' intervention experiences, and their…

  7. Randomized controlled trials of antibiotics for neonatal infections: a systematic review

    PubMed Central

    Kaguelidou, Florentia; Turner, Mark A; Choonara, Imti; van Anker, John; Manzoni, Paolo; Alberti, Corinne; Langhendries, Jean-Paul; Jacqz-Aigrain, Evelyne

    2013-01-01

    Aims Antibiotics are a key resource for the management of infectious diseases in neonatology and their evaluation is particularly challenging. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials on antibiotics in neonatal infections. Methods We performed a systematic search of PubMed, Embase and the Cochrane Library from January 1995 to March 2010. Bibliographies of relevant articles were also hand-searched. We included all randomized controlled trials that involved neonates and evaluated the use of an antibiotic agent in the context of a neonatal infectious disease. Methodological quality was evaluated using the Jadad scale and the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality. Results A total of 35 randomized controlled trials were evaluated. The majority were conducted in a single hospital institution, without funding. Median sample size was 63 (34–103) participants. The most frequently evaluated antibiotic was gentamicin. Respectively, 18 (51%) and 17 (49%) trials evaluated the therapeutic or prophylactic use of antibiotics in various neonatal infections. Overall, the methodological quality was poor and did not improve over the years. Risk of bias was high in 66% of the trials. Conclusions Design and reporting of randomized controlled trials of antibacterial agents in neonates should be improved. Nevertheless, the necessity of implementing such trials when antibacterial efficacy has already been established in other age groups may be questioned and different methods of evaluation should be further developed. PMID:23488627

  8. Learning What Works in ITS from Non-Traditional Randomized Controlled Trial Data

    ERIC Educational Resources Information Center

    Pardos, Zachary A.; Dailey, Matthew D.; Heffernan, Neil T.

    2011-01-01

    The well established, gold standard approach to finding out what works in education research is to run a randomized controlled trial (RCT) using a standard pre-test and post-test design. RCTs have been used in the intelligent tutoring community for decades to determine which questions and tutorial feedback work best. Practically speaking, however,…

  9. Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

    ERIC Educational Resources Information Center

    Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

    2010-01-01

    Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

  10. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    ERIC Educational Resources Information Center

    Fuchs, Lynn S.; Malone, Amelia S.; Schumacher, Robin F.; Namkung, Jessica; Wang, Amber

    2016-01-01

    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

  11. A Randomized Placebo-Controlled Trial of a School-Based Depression Prevention Program.

    ERIC Educational Resources Information Center

    Merry, Sally; McDowell, Heather; Wild, Chris J.; Bir, Julliet; Cunliffe, Rachel

    2004-01-01

    Objective: To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program. Method: Three hundred ninety-two students age 13 to 15 from two schools were randomized to intervention (RAP-Kiwi) and placebo programs run by teachers. RAP-Kiwi was an 11-session manual-based program derived from…

  12. Installing the Communities that Care Prevention System: Implementation Progress and Fidelity in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Quinby, Rose K.; Hanson, Koren; Brooke-Weiss, Blair; Arthur, Michael W.; Hawkins, J. David; Fagan, Abigail A.

    2008-01-01

    This article describes the degree to which high fidelity implementation of the Communities That Care (CTC) prevention operating system was reached during the first 18 months of intervention in 12 communities in the Community Youth Development Study, a 5-year group randomized controlled trial designed to test the efficacy of the CTC system. CTC…

  13. Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

    ERIC Educational Resources Information Center

    Braam, W.; Didden, R.; Smits, M.; Curfs, L.

    2008-01-01

    Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

  14. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  15. Training Anxious Children to Disengage Attention from Threat: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bar-Haim, Yair; Morag, Inbar; Glickman, Shlomit

    2011-01-01

    Background: Threat-related attention biases have been implicated in the etiology and maintenance of anxiety disorders. As a result, attention bias modification (ABM) protocols have been employed as treatments for anxious adults. However, they have yet to emerge for children. A randomized, double-blind placebo-controlled trial was conducted to…

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

    ERIC Educational Resources Information Center

    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…

  17. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Young, Helen E.; Falco, Ruth A.; Hanita, Makoto

    2016-01-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement…

  18. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  19. Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

    ERIC Educational Resources Information Center

    Eisenkopf, Gerald; Sulser, Pascal A.

    2016-01-01

    The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

  20. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  1. Covariate Adjustment Strategy Increases Power in the Randomized Controlled Trial With Discrete-Time Survival Endpoints

    ERIC Educational Resources Information Center

    Safarkhani, Maryam; Moerbeek, Mirjam

    2013-01-01

    In a randomized controlled trial, a decision needs to be made about the total number of subjects for adequate statistical power. One way to increase the power of a trial is by including a predictive covariate in the model. In this article, the effects of various covariate adjustment strategies on increasing the power is studied for discrete-time…

  2. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    ERIC Educational Resources Information Center

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  3. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  4. Management of Hypertension in Private Practice: A Randomized Controlled Trial in Continuing Medical Education.

    ERIC Educational Resources Information Center

    Gullion, David S.; And Others

    1988-01-01

    A randomized control trial was used to evaluate a physician education program designed to improve physician management of patients' hypertension, hypertension-related behaviors, and diastolic blood pressure. It was suggested that more intensive continuing medical education programs are needed to improve physician performance and patient outcome.…

  5. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  6. Searching for Control: Priming Randomness Increases the Evaluation of Ritual Efficacy

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, André L.

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual…

  7. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  8. Theory of Mind Training in Children with Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Begeer, Sander; Gevers, Carolien; Clifford, Pamela; Verhoeve, Manja; Kat, Kirstin; Hoddenbach, Elske; Boer, Frits

    2011-01-01

    Many children with Autism Spectrum Disorders (ASD) participate in social skills or Theory of Mind (ToM) treatments. However, few studies have shown evidence for their effectiveness. The current study used a randomized controlled design to test the effectiveness of a 16-week ToM treatment in 8-13 year old children with ASD and normal IQs (n = 40).…

  9. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  10. Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

    2007-01-01

    The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

  11. Methodology for conduct of epidemiologic surveys and randomized controlled trials of diabetic polyneuropathy.

    PubMed

    Dyck, Peter James

    2014-01-01

    This chapter outlines: (1) the reasons why epidemiologic surveys and randomized controlled clinical trials (RCTs) of diabetic polyneuropathy (DPN) are difficult and expensive, and often poorly done, (2) primary and secondary neuropathy end points, (3) single versus composite neuropathic end points, (4) adequate reference values from study of population representative cohorts, and (5) the issue of clinical proficiency.

  12. Evaluation of Parent and Child Enhancement (PACE) Program: Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Lo, Cyrus

    2017-01-01

    Objective: This study examined the efficacy of the Parent and Child Enhancement (PACE) program on child learning, child behavior problems, and parental stress, using randomized controlled trial design, in social services centers. Methods: Eligibility criteria were (1) children aged 2 years at program commencement, (2) low-income, new immigrant, or…

  13. A Randomized Controlled Trial of a Behavioral Economic Supplement to Brief Motivational Interventions for College Drinking

    ERIC Educational Resources Information Center

    Murphy, James G.; Dennhardt, Ashley A.; Skidmore, Jessica R.; Borsari, Brian; Barnett, Nancy P.; Colby, Suzanne M.; Martens, Matthew P.

    2012-01-01

    Objective: Behavioral economic theory suggests that a reduction in substance use is most likely when there is an increase in rewarding substance-free activities. The goal of this randomized controlled clinical trial was to evaluate the incremental efficacy of a novel behavioral economic supplement (Substance-Free Activity Session [SFAS]) to a…

  14. Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Amir, Nader; Beard, Courtney; Taylor, Charles T.; Klumpp, Heide; Elias, Jason; Burns, Michelle; Chen, Xi

    2009-01-01

    The authors conducted a randomized, double-blind placebo-controlled trial to examine the efficacy of an attention training procedure in reducing symptoms of social anxiety in 44 individuals diagnosed with generalized social phobia (GSP). Attention training comprised a probe detection task in which pictures of faces with either a threatening or…

  15. Randomized Controlled Non-Inferiority Trial of a Telehealth Treatment for Chronic Stuttering: The Camperdown Program

    ERIC Educational Resources Information Center

    Carey, Brenda; O'Brian, Sue; Onslow, Mark; Block, Susan; Jones, Mark; Packman, Ann

    2010-01-01

    Background: Although there are treatments that can alleviate stuttering in adults for clinically significant periods, in Australia there are barriers to the accessibility and availability of best-practice treatment. Aims: This parallel group, non-inferiority randomized controlled trial with multiple blinded outcome assessments investigated whether…

  16. Benefits and Harms of Sick Leave: Lack of Randomized, Controlled Trials

    ERIC Educational Resources Information Center

    Axelsson, Inge; Marnetoft, Sven-Uno

    2010-01-01

    The aim of this study was to try to identify those randomized controlled trials that compare sick leave with no sick leave or a different duration or degree of sick leave. A comprehensive, systematic, electronic search of Clinical Evidence, the Cochrane Library and PubMed, and a manual search of the Campbell Library and a journal supplement was…

  17. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    ERIC Educational Resources Information Center

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  18. Involving Parents in Paired Reading with Preschoolers: Results from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lam, Shui-fong; Chow-Yeung, Kamfung; Wong, Bernard P. H.; Lau, Kwok Kiu; Tse, Shuk In

    2013-01-01

    A paired reading program was implemented for 195 Hong Kong preschoolers (mean age = 4.7 years) and their parents from families with a wide range of family income. The preschoolers were randomly assigned to experimental or waitlist control groups. The parents in the experimental group received 12 sessions of school-based training on paired reading…

  19. Targeting Children's Behavior Problems in Preschool Classrooms: A Cluster-Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Raver, C. Cybele; Jones, Stephanie M.; Li-Grining, Christine; Zhai, Fuhua; Metzger, Molly W.; Solomon, Bonnie

    2009-01-01

    The present study evaluated the efficacy of a multicomponent, classroom-based intervention in reducing preschoolers' behavior problems. The Chicago School Readiness Project model was implemented in 35 Head Start classrooms using a clustered-randomized controlled trial design. Results indicate significant treatment effects (ds = 0.53-0.89) for…

  20. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  1. Fluoxetine, Smoking, and History of Major Depression: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; McChargue, Dennis; Cook, Jessica Werth; Bailey, Katherine; Crayton, John; Hedeker, Donald

    2007-01-01

    The study was a randomized placebo-controlled trial testing whether fluoxetine selectively enhances cessation for smokers with a history of depression. Euthymic smokers with (H+, n = 109) or without (H-, n = 138) a history of major depression received 60 mg fluoxetine or placebo plus group behavioral quit-smoking treatment for 12 weeks. Fluoxetine…

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

    ERIC Educational Resources Information Center

    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…

  3. Thinking outside the Randomized Controlled Trials Experimental Box: Strategies for Enhancing Credibility and Social Justice

    ERIC Educational Resources Information Center

    Hesse-Biber, Sharlene

    2013-01-01

    Some evaluators employ randomized controlled trials (RCTs) as the gold standard of evidence-based practice (EBP). Critics of RCT designs argue that RCTs do not include the complexity of program participants' experiences or clinical expertise, and couple this with criticisms that it is difficult to transfer RCT findings from the laboratory to…

  4. Working Memory Training in Young Children with ADHD: A Randomized Placebo-Controlled Trial

    ERIC Educational Resources Information Center

    Dongen-Boomsma, Martine; Vollebregt, Madelon A.; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: Until now, working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD; for young children with ADHD, no studies are available. To this end, a triple-blind, randomized, placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training…

  5. Search Control Algorithm Based on Random Step Size Hill-Climbing Method for Adaptive PMD Compensation

    NASA Astrophysics Data System (ADS)

    Tanizawa, Ken; Hirose, Akira

    Adaptive polarization mode dispersion (PMD) compensation is required for the speed-up and advancement of the present optical communications. The combination of a tunable PMD compensator and its adaptive control method achieves adaptive PMD compensation. In this paper, we report an effective search control algorithm for the feedback control of the PMD compensator. The algorithm is based on the hill-climbing method. However, the step size changes randomly to prevent the convergence from being trapped at a local maximum or a flat, unlike the conventional hill-climbing method. The randomness depends on the Gaussian probability density functions. We conducted transmission simulations at 160Gb/s and the results show that the proposed method provides more optimal compensator control than the conventional hill-climbing method.

  6. A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance.

    PubMed

    Leahey, Tricia M; Fava, Joseph L; Seiden, Andrew; Fernandes, Denise; Doyle, Caroline; Kent, Kimberly; La Rue, Molly; Mitchell, Marc; Wing, Rena R

    2016-11-01

    Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the "costs" of adhering to weight management behaviors may outweigh the "benefits." This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013 to 2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial.

  7. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials.

    PubMed

    Brown, Andrew W; Li, Peng; Bohan Brown, Michelle M; Kaiser, Kathryn A; Keith, Scott W; Oakes, J Michael; Allison, David B

    2015-08-01

    Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples.

  8. Tuning of an optimal fuzzy PID controller with stochastic algorithms for networked control systems with random time delay.

    PubMed

    Pan, Indranil; Das, Saptarshi; Gupta, Amitava

    2011-01-01

    An optimal PID and an optimal fuzzy PID have been tuned by minimizing the Integral of Time multiplied Absolute Error (ITAE) and squared controller output for a networked control system (NCS). The tuning is attempted for a higher order and a time delay system using two stochastic algorithms viz. the Genetic Algorithm (GA) and two variants of Particle Swarm Optimization (PSO) and the closed loop performances are compared. The paper shows that random variation in network delay can be handled efficiently with fuzzy logic based PID controllers over conventional PID controllers.

  9. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial

    PubMed Central

    Toppin, Patrick J; Reid, Marvin; Plummer, Joseph M; Roberts, Patrick O; Harding-Goldson, Hyacinth; McFarlane, Michael E

    2017-01-01

    Background Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard. Objective To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty. Methods This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status. Results To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017. Conclusions This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines. Trial registration Clinicaltrials.gov NCT02444260; https

  10. Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses

    PubMed Central

    Wallach, Joshua D; Sullivan, Patrick G; Trepanowski, John F; Steyerberg, Ewout W

    2016-01-01

    Objective To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses. Design Meta-epidemiological study. Data sources Cochrane Database of Systematic Reviews (CDSR) and PubMed. Eligibility criteria for study selection Reviews published in the CDSR with sex-treatment subgroup analyses in the forest plots, using data from randomized controlled trials. Data extraction Information on the study design and sex subgroup data were extracted from reviews and forest plots that met inclusion criteria. For each statistically significant sex-treatment interaction, the potential for biological plausibility and clinical significance was considered. Results Among the 41 reviews with relevant data, there were 109 separate treatment-outcome analyses (“topics”). Among the 109 topics, eight (7%) had a statistically significant sex-treatment interaction. The 109 topics included 311 randomized controlled trials (162 with both sexes, 46 with males only, 103 with females only). Of the 162 individual randomized controlled trials that included both sexes, 15 (9%) had a statistically significant sex-treatment interaction. Of four topics where the first published randomized controlled trial had a statistically significant sex-treatment interaction, no meta-analyses that included other randomized controlled trials retained the statistical significance and no meta-analyses showed statistical significance when data from the first published randomized controlled trial were excluded. Of the eight statistically significant sex-treatment interactions from the overall analyses, only three were discussed by the CDSR reviewers for a potential impact on different clinical management for males compared with females. None of these topics had a sex-treatment interaction that influenced treatment recommendations in recent guidelines. UpToDate, an online physician-authored clinical

  11. Using random proportional pulse feedback of system variables to control chaos and hyperchaos

    NASA Astrophysics Data System (ADS)

    Luo, Xiao-shu; Wang, Bing-hong; Jiang, Feng; Gao, Yuan

    2001-01-01

    A method that allows one to control chaotic and hyperchaotic systems by a random proportional pulse feedback of system variables is proposed. This method is illustrated with the Rossler chaotic and the complex Lorenz-Harken hyperchaotic systems and a better control result is obtained. The advantage of this method is that just one perturbed system variable is enough to obtain a stabilized periodic orbit.

  12. Doula support during first trimester surgical abortion: A randomized controlled trial

    PubMed Central

    Chor, Julie; Hill, Brandon; Martins, Summer; Mistretta, Stephanie; Patel, Ashlesha; Gilliam, Melissa

    2014-01-01

    Objectives To evaluate the impact of doula support on first trimester abortion care. Study Design Women were randomized to receive doula support or routine care during first trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100-mm visual analog scale. The study had statistical power to detect 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support. Results Two hundred and fourteen women completed the study: 106 received doula support, 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6mm [±26.3mm] vs. 43.6mm [±25.9mm], p=0.18) or procedure completion (68.2mm [±28.0mm] vs. 70.6mm [±23.5mm], p=0.52). Procedure duration (3.39min [±2.83min] vs. 3.18min [±2.36min], p=0.55) and patient satisfaction (75.2mm [±28.6mm] vs. 74.6mm [±27.4mm], p=0.89) did not differ between doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls (p<0.01). Conclusions Although doula support did not have a measurable effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support, therefore, may address patient psychosocial needs. PMID:24983679

  13. Morphology-Controlled High-Efficiency Small Molecule Organic Solar Cells without Additive Solvent Treatment

    PubMed Central

    Kim, Il Ku; Jo, Jun Hyung; Yun, Jung-Ho

    2016-01-01

    This paper focuses on nano-morphology-controlled small-molecule organic solar cells without solvent treatment for high power-conversion efficiencies (PCEs). The maximum high PCE reaches up to 7.22% with a bulk-heterojunction (BHJ) thickness of 320 nm. This high efficiency was obtained by eliminating solvent additives such as 1,8-diiodooctane (DIO) to find an alternative way to control the domain sizes in the BHJ layer. Furthermore, the generalized transfer matrix method (GTMM) analysis has been applied to confirm the effects of applying a different thickness of BHJs for organic solar cells from 100 to 320 nm, respectively. Finally, the study showed an alternative way to achieve high PCE organic solar cells without additive solvent treatments to control the morphology of the bulk-heterojunction.

  14. Protective Efficacy of Plasmodium vivax Radiation-Attenuated Sporozoites in Colombian Volunteers: A Randomized Controlled Trial

    PubMed Central

    Arévalo-Herrera, Myriam; Vásquez-Jiménez, Juan M.; Lopez-Perez, Mary; Vallejo, Andrés F.; Amado-Garavito, Andrés B.; Céspedes, Nora; Castellanos, Angélica; Molina, Karen; Trejos, Johanna; Oñate, José; Epstein, Judith E.; Richie, Thomas L.; Herrera, Sócrates

    2016-01-01

    Background Immunizing human volunteers by mosquito bite with radiation-attenuated Plasmodium falciparum sporozoites (RAS) results in high-level protection against infection. Only two volunteers have been similarly immunized with P. vivax (Pv) RAS, and both were protected. A phase 2 controlled clinical trial was conducted to assess the safety and protective efficacy of PvRAS immunization. Methodology/Principal Findings A randomized, single-blinded trial was conducted. Duffy positive (Fy+; Pv susceptible) individuals were enrolled: 14 received bites from irradiated (150 ± 10 cGy) Pv-infected Anopheles mosquitoes (RAS) and 7 from non-irradiated non-infected mosquitoes (Ctl). An additional group of seven Fy- (Pv refractory) volunteers was immunized with bites from non-irradiated Pv-infected mosquitoes. A total of seven immunizations were carried out at mean intervals of nine weeks. Eight weeks after last immunization, a controlled human malaria infection (CHMI) with non-irradiated Pv-infected mosquitoes was performed. Nineteen volunteers completed seven immunizations (12 RAS, 2 Ctl, and 5 Fy-) and received a CHMI. Five of 12 (42%) RAS volunteers were protected (receiving a median of 434 infective bites) compared with 0/2 Ctl. None of the Fy- volunteers developed infection by the seventh immunization or after CHMI. All non-protected volunteers developed symptoms 8–13 days after CHMI with a mean pre-patent period of 12.8 days. No serious adverse events related to the immunizations were observed. Specific IgG1 anti-PvCS response was associated with protection. Conclusion Immunization with PvRAS was safe, immunogenic, and induced sterile immunity in 42% of the Fy+ volunteers. Moreover, Fy- volunteers were refractory to Pv malaria. Trial registration Identifier: NCT01082341. PMID:27760143

  15. Preventive Antibacterial Therapy in Acute Ischemic Stroke: A Randomized Controlled Trial

    PubMed Central

    Klehmet, Juliane; Rogge, Witold; Drenckhahn, Christoph; Göhler, Jos; Bereswill, Stefan; Göbel, Ulf; Wernecke, Klaus Dieter; Wolf, Tilo; Arnold, Guy; Halle, Elke; Volk, Hans-Dieter; Dirnagl, Ulrich; Meisel, Andreas

    2008-01-01

    Background Pneumonia is a major risk factor of death after acute stroke. In a mouse model, preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections, it also reduces mortality, and improves neurological outcome significantly. In this study we investigate whether this approach is effective in stroke patients. Methods Preventive ANtibacterial THERapy in acute Ischemic Stroke (PANTHERIS) is a randomized, double-blind, placebo-controlled trial in 80 patients with severe, non-lacunar, ischemic stroke (NIHSS>11) in the middle cerebral artery (MCA) territory. Patients received either intravenous moxifloxacin (400 mg daily) or placebo for 5 days starting within 36 hours after stroke onset. Primary endpoint was infection within 11 days. Secondary endpoints included neurological outcome, survival, development of stroke-induced immunodepression, and induction of bacterial resistance. Findings On intention-to treat analysis (79 patients), the infection rate at day 11 in the moxifloxacin treated group was 15.4% compared to 32.5% in the placebo treated group (p = 0.114). On per protocol analysis (n = 66), moxifloxacin significantly reduced infection rate from 41.9% to 17.1% (p = 0.032). Stroke associated infections were associated with a lower survival rate. In this study, neurological outcome and survival were not significantly influenced by treatment with moxifloxacin. Frequency of fluoroquinolone resistance in both treatment groups did not differ. On logistic regression analysis, treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression (a marker for immunodepression) at day 1 after stroke onset was independently and highly predictive for post-stroke infections. Interpretation PANTHERIS suggests that preventive administration of moxifloxacin is superior in reducing infections after severe non-lacunar ischemic stroke compared to placebo. In addition, the results emphasize the

  16. The Effects of Self-Massage on Osteoarthritis of the Knee: a Randomized, Controlled Trial

    PubMed Central

    Atkins, Dorothea V.; Eichler, David A.

    2013-01-01

    Introduction Recent research has provided a rationale for the efficacy and use of massage therapy in the management of knee osteoarthritis (OA) symptoms. Additionally, research has also implicated the role of the quadriceps muscles in the genesis of knee OA. Although both areas of research have demonstrated strong evidence that the muscles and massage therapy may affect knee OA symptoms, self-massage applied on the quadriceps muscle has received no attention. Methods Conducted at the Lourdes Wellness Center in Collingswood, NJ, the study investigated the outcomes of a self-massage intervention applied to the quadriceps muscle on reported pain, stiffness, physical function, and knee range of motion in adults with diagnosed knee OA. Forty adults with diagnosed knee OA were randomly assigned to either an intervention (n = 21) or a wait list control (n = 19) group. The participants applied a narrated 20-minute self-massage therapy twice weekly during ten supervised and three unsupervised intervention sessions. The control group had four supervised assessments with no intervention. Outcome measures were the Western Ontario and McMaster’s Osteoarthritis Index (WOMAC) and assessment of knee range of motion. Results Between-groups analyses of WOMAC pain, stiffness, function subscales, and total WOMAC scores indicated significant difference between groups (p < .05), n = 36). No significant differences were seen in range of motion. Conclusions The study demonstrated that participants who have OA of the knee benefit from the self-massage intervention therapy. Further studies are needed to clarify the long-term effects of self-massage on the progression and symptoms of knee OA. PMID:23482239

  17. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities.

    PubMed

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R; Platt, Robert; Toh, Sengwee

    2015-11-05

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up time, small sample size, highly selected population, high cost, and ethical restrictions. In this paper, we discuss the challenges and opportunities of incorporating both RCTs and non-randomized comparative cohort studies into network meta-analysis for assessing the safety and effectiveness of medical treatments. Non-randomized studies with inadequate control of biases such as confounding may threaten the validity of the entire network meta-analysis. Therefore, identification and inclusion of non-randomized studies must balance their strengths with their limitations. Inclusion of both RCTs and non-randomized studies in network meta-analysis will likely increase in the future due to the growing need to assess multiple treatments simultaneously, the availability of higher quality non-randomized data and more valid methods, and the increased use of progressive licensing and product listing agreements requiring collection of data over the life cycle of medical products. Inappropriate inclusion of non-randomized studies could perpetuate the biases that are unknown, unmeasured, or uncontrolled. However, thoughtful integration of randomized and non-randomized studies may offer opportunities to provide more timely, comprehensive, and generalizable evidence about the comparative safety and effectiveness of medical treatments.

  18. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent Versus Sequential Intervention.

    ERIC Educational Resources Information Center

    Spring, Bonnie; Pagoto, Sherry; Pingitore, Regina; Doran, Neal; Schneider, Kristin; Hedeker, Don

    2004-01-01

    The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

  19. A Randomized Controlled Trial of Cognitive-Behavioral Therapy for Generalized Anxiety Disorder with Integrated Techniques from Emotion-Focused and Interpersonal Therapies

    ERIC Educational Resources Information Center

    Newman, Michelle G.; Castonguay, Louis G.; Borkovec, Thomas D.; Fisher, Aaron J.; Boswell, James F.; Szkodny, Lauren E.; Nordberg, Samuel S.

    2011-01-01

    Objective: Recent models suggest that generalized anxiety disorder (GAD) symptoms may be maintained by emotional processing avoidance and interpersonal problems. Method: This is the first randomized controlled trial to test directly whether cognitive-behavioral therapy (CBT) could be augmented with the addition of a module targeting interpersonal…

  20. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial.

    PubMed

    Springer, Bryan D; Beaver, Walter B; Griffin, William L; Mason, J Bohannon; Odum, Susan M

    2015-09-01

    We conducted a randomized controlled trial to compare efficacy of an occlusive antimicrobial barrier dressing and a standard surgical dressing in patients who underwent primary total joint arthroplasty. Two hundred sixty-two patients were randomized to receive either an occlusive dressing or a standard dressing. Wounds were closed in identical fashion. Outcomes included wound complications, dressing changes, and patient satisfaction. With use of occlusive dressing (vs standard dressing), wound complications (including skin blistering) were significantly (P = 0.15) reduced; there were significantly (P < .0001) fewer dressing changes; and patient satisfaction was significantly (P < .0001) higher. Use of occlusive dressings can reduce wound complications and promote wound healing after total joint arthroplasty.

  1. Double threshold behavior in a resonance-controlled ZnO random laser

    NASA Astrophysics Data System (ADS)

    Niyuki, Ryo; Fujiwara, Hideki; Nakamura, Toshihiro; Ishikawa, Yoshie; Koshizaki, Naoto; Tsuji, Takeshi; Sasaki, Keiji

    2017-03-01

    We observed unusual lasing characteristics, such as double thresholds and blue-shift of lasing peak, in a resonance-controlled ZnO random laser. From the analysis of lasing threshold carrier density, we found that the lasing at 1st and 2nd thresholds possibly arises from different mechanisms; the lasing at 1st threshold involves exciton recombination, whereas the lasing at 2nd threshold is caused by electron-hole plasma recombination, which is the typical origin of conventional random lasers. These phenomena are very similar to the transition from polariton lasing to photon lasing observed in a well-defined cavity laser.

  2. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials.

    PubMed

    Suresh, S; Schaldenbrand, K; Wallis, B; De Oliveira, G S

    2014-09-01

    Summary The development of analgesic interventions in paediatric surgical patients is often limited by the inherent difficulties of conducting large randomized clinical trials to test interventions in those patients. Regional anaesthesia is a valid strategy to improve postoperative pain in the adult surgical population, but the effects of regional anaesthesia on postoperative pain outcomes in paediatric patients are currently not well defined. The main objective of the current review was to systematically evaluate the use of regional anaesthesia techniques to minimize postoperative pain in paediatric patients. A systematic search was performed to identify randomized controlled trials that evaluated the effects of the regional anaesthesia techniques on postoperative pain outcomes in paediatric surgical patients' procedures. Seventy-three studies on 5125 paediatric patients were evaluated. Only few surgical procedures had more than one small randomized controlled trial favouring the use of regional anaesthesia to minimize postoperative pain (ophthalmological surgery, cleft lip repair, inguinal hernia, and urological procedures). Additional evidence is required to support the use of specific regional anaesthesia techniques to improve postoperative pain for several surgical procedures (craniectomy, adenotonsillectomy, appendectomy, cardiac surgery, umbilical hernia repair, upper and lower extremity) in paediatric patients. Currently, only a very limited number of regional anaesthesia techniques have demonstrated significant improvement on postoperative pain outcomes for a restricted number of surgical procedures. More studies are needed in order to establish regional anaesthesia as a valid strategy to improve analgesia in the paediatric surgical population.

  3. Evaluating an Organizational-Level Occupational Health Intervention in a Combined Regression Discontinuity and Randomized Control Design.

    PubMed

    Sørensen, By Ole H

    2016-10-01

    Organizational-level occupational health interventions have great potential to improve employees' health and well-being. However, they often compare unfavourably to individual-level interventions. This calls for improving methods for designing, implementing and evaluating organizational interventions. This paper presents and discusses the regression discontinuity design because, like the randomized control trial, it is a strong summative experimental design, but it typically fits organizational-level interventions better. The paper explores advantages and disadvantages of a regression discontinuity design with an embedded randomized control trial. It provides an example from an intervention study focusing on reducing sickness absence in 196 preschools. The paper demonstrates that such a design fits the organizational context, because it allows management to focus on organizations or workgroups with the most salient problems. In addition, organizations may accept an embedded randomized design because the organizations or groups with most salient needs receive obligatory treatment as part of the regression discontinuity design. Copyright © 2016 John Wiley & Sons, Ltd.

  4. CCA addition to tRNA: implications for tRNA quality control.

    PubMed

    Hou, Ya-Ming

    2010-04-01

    The CCA sequence is conserved at the 3' end of all mature tRNA molecules to function as the site of amino acid attachment. This sequence is acquired and maintained by stepwise nucleotide addition by the ubiquitous CCA enzyme, which is an unusual RNA polymerase that does not use a nucleic acid template for nucleotide addition. Crystal structural work has divided CCA enzymes into two structurally distinct classes, which differ in the mechanism of template-independent nucleotide selection. Recent kinetic work of the class II E. coli CCA enzyme has demonstrated a rapid and uniform rate constant for the chemistry of nucleotide addition at each step of CCA synthesis, although the enzyme uses different determinants to control the rate of each step. Importantly, the kinetic work reveals that, at each step of CCA synthesis, E. coli CCA enzyme has an innate ability to discriminate against tRNA backbone damage. This discrimination suggests the possibility of a previously unrecognized quality control mechanism that would prevent damaged tRNA from CCA maturation and from entering the ribosome machinery of protein synthesis. This quality control is relevant to cellular stress conditions that damage tRNA backbone and predicts a role of CCA addition in stress response.

  5. Robustness of connectionist swimming controllers against random variation in neural connections.

    PubMed

    Or, Jimmy

    2007-06-01

    The ability to achieve high swimming speed and efficiency is very important to both the real lamprey and its robotic implementation. In previous studies, we used evolutionary algorithms to evolve biologically plausible connectionist swimming controllers for a simulated lamprey. This letter investigates the robustness and optimality of the best-evolved controllers as well as the biological controller hand-crafted by Ekeberg. Comparing cases of random variation in intrasegmental or intersegmental weights against each controller allows estimates of robustness to be made. We conduct experiments on the controllers' robustness at the excitation level, which corresponds to either the maximum swimming speed or efficiency by randomly varying the segmental connection weights and on some occasions also the intersegmental couplings, through varying noise ranges. Interestingly, although the swimming performance (in terms of maximum speed and efficiency) of the Ekeberg biological controller is not as good as that of the artificially evolved controllers, it is relatively robust against noise in the neural networks. This suggests that the natural evolutions have evolved a swimming controller that is good enough to survive in the real world. Our findings could inspire neurobiologists to conduct real physiological experiments to gain a better understanding on how neural connectivity affects behavior. The results can also be applied to control an artificial lamprey in simulation and possibly also a robotic one.

  6. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  7. A Simple and Inexpensive Device for Slow, Controlled Addition of a Solution to a Reaction Mixture

    NASA Astrophysics Data System (ADS)

    Osvath, Peter

    1995-07-01

    A number of reactions require the slow and controlled addition of a solution containing one reagent to another. Attempting to control the flow rate over a number of hours using a conventional constant pressure addition funnel is a frustrating exercise; commercially available constant volume addition funnels are expensive and must be adjusted by trial and error each time a reaction is carried out. The use of an (expensive) peristaltic pump or syringe pump overcomes these problems but can introduce other complications. We have recently had occasion to carry out the synthesis of thioether macrocycles and cages requiring the slow and controlled addition of DMF solutions of (offensively odoriferous) thiols or (air-sensitive) thiolates to a reactant solution under nitrogen(1), Although the use of a syringe pump was called for, there are obvious difficulties associated with purging the solution and assembling such an apparatus under nitrogen, and we report a simple and inexpensive solution. A Male Luer Lock tip (recovered from a broken syringe) was sweated onto the flattened tip of a pressure-equalizing addition funnel and a syringe needle was attached. Judicious selection of needle length, bore size, and reactant volume can be used to control the addition time simply and reproducibly. With a 250-mL funnel, the flow rate changes by <25% from the beginning to the end of the addition. (In fact, a reduction in the rate of addition may even be advantageous as the reaction proceeds, the reagent in the receiving flask is consumed, its concentration drops, and the rate of reaction will decrease). A piece of fine Teflon tubing of appropriate length attached to the needle can be used to reduce the flow rate even further, but this is only necessary for very slow rates of addition. For example, the time of addition of 200 mL, of an ethanolic solution could be varied from approximately 5 minutes (150mm/17 gauge) to approximately 5 h (200mm/22 gauge), and once the addition time for a

  8. Modular Skeletal Evolution in Sticklebacks Is Controlled by Additive and Clustered Quantitative Trait Loci

    PubMed Central

    Miller, Craig T.; Glazer, Andrew M.; Summers, Brian R.; Blackman, Benjamin K.; Norman, Andrew R.; Shapiro, Michael D.; Cole, Bonnie L.; Peichel, Catherine L.; Schluter, Dolph; Kingsley, David M.

    2014-01-01

    Understanding the genetic architecture of evolutionary change remains a long-standing goal in biology. In vertebrates, skeletal evolution has contributed greatly to adaptation in body form and function in response to changing ecological variables like diet and predation. Here we use genome-wide linkage mapping in threespine stickleback fish to investigate the genetic architecture of evolved changes in many armor and trophic traits. We identify >100 quantitative trait loci (QTL) controlling the pattern of serially repeating skeletal elements, including gill rakers, teeth, branchial bones, jaws, median fin spines, and vertebrae. We use this large collection of QTL to address long-standing questions about the anatomical specificity, genetic dominance, and genomic clustering of loci controlling skeletal differences in evolving populations. We find that most QTL (76%) that influence serially repeating skeletal elements have anatomically regional effects. In addition, most QTL (71%) have at least partially additive effects, regardless of whether the QTL controls evolved loss or gain of skeletal elements. Finally, many QTL with high LOD scores cluster on chromosomes 4, 20, and 21. These results identify a modular system that can control highly specific aspects of skeletal form. Because of the general additivity and genomic clustering of major QTL, concerted changes in both protective armor and trophic traits may occur when sticklebacks inherit either marine or freshwater alleles at linked or possible “supergene” regions of the stickleback genome. Further study of these regions will help identify the molecular basis of both modular and coordinated changes in the vertebrate skeleton. PMID:24652999

  9. Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Nonclinician Sleep Coaches: Randomized Controlled Trial

    PubMed Central

    Alessi, Cathy; Martin, Jennifer L.; Fiorentino, Lavinia; Fung, Constance H.; Dzierzewski, Joseph M.; Rodriguez Tapia, Juan C.; Song, Yeonsu; Josephson, Karen; Jouldjian, Stella; Mitchell, Michael N.

    2017-01-01

    OBJECTIVES To test a new cognitive behavioral therapy for insomnia (CBT-I) program designed for use by nonclinicians. DESIGN Randomized controlled trial. SETTING Department of Veterans Affairs healthcare system. PARTICIPANTS Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). INTERVENTION Nonclinician “sleep coaches” delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. MEASUREMENTS Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency (SOL-D), wake after sleep onset (WASO-D), total wake time (TWT-D), and sleep efficiency (SE-D); Pittsburgh Sleep Quality Index (PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index (ISI), depressive symptoms (Patient Health Questionnaire-9 (PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 (SF-12v2)). RESULTS Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. CONCLUSION Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia

  10. A randomized controlled trial of solcoseryl and duoderm in chronic sickle-cell ulcers.

    PubMed

    La Grenade, L; Thomas, P W; Serjeant, G R

    1993-09-01

    A randomized controlled trial of Solcoseryl, DuoDerm and conventional conservative therapy with Eusol has been performed in 32 patients with homozygous sickle-cell (SS) disease. After 12 weeks' baseline observation, patients were randomized to one of three therapies and monitored for a further 12 weeks. Of 44 ulcerated legs, 20 received control treatment, 12 Solcoseryl and 12 DuoDerm. DuoDerm was generally unacceptable, and two-thirds of the patients defaulted from this treatment. Solcoseryl increased ulcer healing compared to the controls but the difference was not significant. Solcoseryl was well tolerated and may have a role in the treatment of chronic leg ulcers of sickle-cell disease.

  11. Stochastic sampled-data control for synchronization of complex dynamical networks with control packet loss and additive time-varying delays.

    PubMed

    Rakkiyappan, R; Sakthivel, N; Cao, Jinde

    2015-06-01

    This study examines the exponential synchronization of complex dynamical networks with control packet loss and additive time-varying delays. Additionally, sampled-data controller with time-varying sampling period is considered and is assumed to switch between m different values in a random way with given probability. Then, a novel Lyapunov-Krasovskii functional (LKF) with triple integral terms is constructed and by using Jensen's inequality and reciprocally convex approach, sufficient conditions under which the dynamical network is exponentially mean-square stable are derived. When applying Jensen's inequality to partition double integral terms in the derivation of linear matrix inequality (LMI) conditions, a new kind of linear combination of positive functions weighted by the inverses of squared convex parameters appears. In order to handle such a combination, an effective method is introduced by extending the lower bound lemma. To design the sampled-data controller, the synchronization error system is represented as a switched system. Based on the derived LMI conditions and average dwell-time method, sufficient conditions for the synchronization of switched error system are derived in terms of LMIs. Finally, numerical example is employed to show the effectiveness of the proposed methods.

  12. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  13. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    PubMed Central

    2014-01-01

    Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically

  14. Effect of Citalopram on Agitation in Alzheimer's Disease – The CitAD Randomized Controlled Trial

    PubMed Central

    Porsteinsson, Anton P.; Drye, Lea T.; Pollock, Bruce G.; Devanand, D.P.; Frangakis, Constantine; Ismail, Zahinoor; Marano, Christopher; Meinert, Curtis L.; Mintzer, Jacobo E.; Munro, Cynthia A.; Pelton, Gregory; Rabins, Peter V.; Rosenberg, Paul B.; Schneider, Lon S.; Shade, David M.; Weintraub, Daniel; Yesavage, Jerome; Lyketsos, Constantine G.

    2014-01-01

    Importance Agitation is common, persistent, and associated with adverse consequences for patients with Alzheimer's disease (AD). Pharmacological treatment options, including antipsychotics are not satisfactory. Objective The primary objective was to evaluate the efficacy of citalopram for agitation in patients with AD. Key secondary objectives examined effects of citalopram on function, caregiver distress, safety, cognitive safety, and tolerability. Design, Setting and Participants The Citalopram for Agitation in Alzheimer's Disease Study (CitAD) was a multicenter, randomized, placebo-controlled, double-blind, parallel group trial that enrolled 186 patients with probable AD and clinically significant agitation from eight academic centers in the US and Canada from August 2009 to January 2013. Interventions Participants (n=186) were randomized to receive a psychosocial intervention plus either citalopram (n=94) or placebo (n=92) for 9 weeks. Dose began at 10 mg/d with planned titration to 30 mg/d over 3 weeks based on response and tolerability. Main Outcomes and Measures Primary outcome measures were the Neurobehavioral Rating Scale, agitation subscale (NBRS-A) and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) Other outcomes were the Cohen-Mansfield Agitation Inventory (CMAI), Neuropsychiatric Inventory (NPI), activities of daily living (ADLs), caregiver distress, cognitive safety (MMSE), and adverse events. Results Participants on citalopram showed significant improvement compared to placebo on both primary outcome measures. NBRS-A estimated treatment difference at week 9 (citalopram minus placebo) was −0.93 [95% CI: −1.80 to −0.06], p = 0.036. mADCS-CGIC results showed 40% of citalopram participants having moderate or marked improvement from baseline compared to 26% on placebo, with estimated treatment effect (odds ratio of being at or better than a given CGIC category) of 2.13 [95% CI 1.23 to 3.69], p = 0

  15. Early Sitting in Ischemic Stroke Patients (SEVEL): A Randomized Controlled Trial

    PubMed Central

    Herisson, Fanny; Godard, Sophie; Volteau, Christelle; Le Blanc, Emilie; Guillon, Benoit; Gaudron, Marie

    2016-01-01

    Background Extended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients. Objective As early mobilization has been shown to be feasible and safe, we tested the hypothesis that early sitting could be beneficial to stroke patient outcome. Methods This prospective multicenter study tested two sitting procedures at the acute phase of ischemic stroke, in a randomized controlled fashion (clinicaltrials.org registration number NCT01573299). Patients were eligible if they were above 18 years of age and showed no sign of massive infarction or any contra-indication for sitting. In the early-sitting group, patients were seated out of bed at the earliest possible time but no later than one calendar day after stroke onset, whereas the progressively-sitting group was first seated out of bed on the third calendar day after stroke onset. Primary outcome measure was the proportion of patients with a modified Rankin score [0–2] at 3 months post stroke. Secondary outcome measures were a.) prevalence of medical complications, b.) length of hospital stay, and c.) tolerance to the procedure. Results One hundred sixty seven patients were included in the study, of which 29 were excluded after randomization. Data from 138 patients, 63 in the early-sitting group and 75 in the progressively-sitting group were analyzed. There was no difference regarding outcome of people with stroke, with a proportion of Rankin [0–2] score at 3 months of 76.2% and 77.3% of patients in the early- and progressive-sitting groups, respectively (p = 0.52). There was also no difference between groups for secondary outcome measures, and the procedure was well tolerated in both arms. Conclusion Due to a slow enrollment, fewer patients than anticipated were available for analysis. As a result, we can only detect beneficial/detrimental effects of +/- 15% of the early sitting procedure on stroke

  16. Randomized Placebo-Controlled D-Cycloserine with Cognitive Behavior Therapy for Pediatric Posttraumatic Stress

    PubMed Central

    Weems, Carl F.

    2014-01-01

    Abstract Objective: Research on D-cycloserine (DCS), a partial N-methyl-d-aspartic acid (NMDA) agonist, has suggested that it may enhance exposure-based therapies for anxiety disorders. Results with DCS in adult posttraumatic stress disorder (PTSD) have been conflicting; however, no data have been reported on children with PTSD. Although many individuals with PTSD respond to exposure-based cognitive behavioral therapy (CBT), there are subgroups of individuals who are nonresponders, and many responders still have substantial residual symptoms. This randomized, triple-blind, placebo-controlled study tested DCS as an adjunct to CBT to improve and speed treatment response for PTSD in youth. Methods: Seven to 18 year-old youth with exposure to trauma and PTSD were offered a 12 session, manualized CBT treatment. Those who remained in treatment at the fifth session were randomly allocated (n=57) to either CBT and DCS or CBT and placebo. Results: Youth in the CBT and DCS group had significant reductions in symptoms, but these reductions were not greater than those in the CBT and placebo group. There was a trend toward DCS speeding PTSD symptom recovery during the exposure-based sessions, and evidence that the CBT and DCS group better maintained stability of gains on inattention ratings from posttreatment to the 3 month follow-up. Conclusions: This initial study of CBT and DCS to treat pediatric PTSD provided suggestive and preliminary evidence for more rapid symptom recovery and beneficial effects on attention, but did not show an overall greater effect for reducing PTSD symptoms. It appears that augmentation with DCS represents unique challenges in PTSD. Because PTSD involves complex, life-threatening trauma memories, as opposed to the imagined dreadful outcomes of other anxiety disorders, the use of DCS may require greater attention to how its use is coupled with exposure-based techniques. DCS may have inadvertently enhanced reconsolidation of trauma memories rather than

  17. Randomized, placebo-controlled trial of flax oil in pediatric bipolar disorder

    PubMed Central

    Gracious, Barbara L; Chirieac, Madalina C; Costescu, Stefan; Finucane, Teresa L; Youngstrom, Eric A; Hibbeln, Joseph R

    2010-01-01

    Objectives This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid α-linolenic acid (α-LNA), safely reduced symptom severity in youth with bipolar disorder. Methods Children and adolescents aged 6-17 years with symptomatic bipolar I or bipolar II disorder (n = 51), manic, hypomanic, mixed, or depressed, were randomized to either flax oil capsules containing 550 mg α-LNA per 1 gram or an olive oil placebo adjunctively or as monotherapy. Doses were titrated to 12 capsules per day as tolerated over 16 weeks. Primary outcomes included changes in the Young Mania Rating Scale, Child Depression Rating Scale-Revised, and Clinical Global Impressions-Bipolar ratings using Kaplan-Meier survival analyses. Results There were no significant differences in primary outcome measures when compared by treatment assignment. However, clinician-rated Global Symptom Severity was negatively correlated with final serum omega-3 fatty acid compositions: % α-LNA (r = −0.45, p < 0.007), % eicosapentaenoic acid (EPA) (r = −0.47, p < 0.005), and positively correlated with final arachidonic acid (AA) (r = 0.36, p < 0.05) and docosapentaenoic acid (DPA) n-6 (r = 0.48, p < 0.004). The mean duration of treatment for α-LNA was 11.8 weeks versus 8 weeks for placebo; however, the longer treatment duration for α-LNA was not significant after controlling for baseline variables. Subjects discontinued the study for continued depressive symptoms. Conclusions Studies of essential fatty acid supplementation are feasible and well tolerated in the pediatric population. Although flax oil may decrease severity of illness in children and adolescents with bipolar disorder who have meaningful increases in serum EPA percent levels and/or decreased AA and DPA n-6 levels, individual variations in conversion of α-LNA to EPA and docosahexaenoic acid as well as dosing burden favor the use of fish oil both for clinical trials and clinical practice. Additionally

  18. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    PubMed Central

    Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P

  19. Short-course eflornithine in Gambian trypanosomiasis: a multicentre randomized controlled trial.

    PubMed Central

    Pépin, J.; Khonde, N.; Maiso, F.; Doua, F.; Jaffar, S.; Ngampo, S.; Mpia, B.; Mbulamberi, D.; Kuzoe, F.

    2000-01-01

    OBJECTIVE: A randomized controlled trial was conducted to determine whether 7 days of intravenous eflornithine (100 mg/kg every 6 h) was as effective as the standard 14-day regimen in the treatment of late-stage Trypanosoma brucei gambiense trypanosomiasis. METHODS: A total of 321 patients (274 new cases, 47 relapsing cases) were randomized at four participating centres in Congo, Côte d'Ivoire, the Democratic Republic of the Congo, and Uganda to one of these treatment regimens and followed up for 2 years. RESULTS: Six patients died during treatment, one of whom was on the 7-day regimen, whereas the other five had been on the 14-day regimen (P = 0.2). The response to eflornithine differed markedly between Uganda and other countries. Among new cases in Uganda, the 2-year probability of cure was 73% on the 14-day course compared with 62% on the 7-day regimen (hazard ratio (HR) for treatment failure, 7-day versus 14-day regimen: 1.45, 95% CI: 0.7, 3.1, P = 0.3). Among new cases in Côte d'Ivoire, Congo, and the Democratic Republic of the Congo combined, the 2-year probability of cure was 97% on the 14-day course compared with 86.5% on the 7-day regimen (HR for treatment failure, 7-day vs 14-day: 6.72, 95% confidence interval (CI): 1.5, 31.0, P = 0.003). Among relapsing cases in all four countries, the 2-year probability of cure was 94% with 7 days and 100% with 14 days of treatment. Factors associated with a higher risk of treatment failure were: a positive lymph node aspirate (HR 4.1; 95% CI: 1.8-9.4), a cerebrospinal fluid (CSF) white cell count > or = 100/mm3 (HR 3.5; 95% CI: 1.1-10.9), being treated in Uganda (HR 2.9; 95% CI: 1.4-5.9), and CSF trypanosomes (HR 1.9; 95% CI: 0.9-4.1). Being stuporous on admission was associated with a lower risk of treatment failure (HR 0.18; 95% CI: 0.02-1.4) as was increasing age (HR 0.977; 95% CI: 0.95-1.0, for each additional year of age). DISCUSSION: The 7-day course of eflornithine is an effective treatment of relapsing cases

  20. Efficacy of Leflunomide, Telmisartan, and Clopidogrel for Immunoglobulin A Nephropathy: A Randomized Controlled Trial

    PubMed Central

    Wu, Jie; Duan, Shu-Wei; Sun, Xue-Feng; Li, Wen-Ge; Wang, Ya-Ping; Liu, Wen-Hu; Zhang, Jian-Rong; Lun, Li-De; Li, Xue-Mei; Zhou, Chun-Hua; Li, Ji-Jun; Liu, Shu-Wen; Xie, Yuan-Sheng; Cai, Guang-Yan; Ma, Lu; Huang, Wen; Wu, Hua; Jia, Qiang; Chen, Xiang-Mei

    2016-01-01

    Background: The efficacy and safety of telmisartan combined with clopidogrel, leflunomide, or both drugs for immunoglobulin A nephropathy (IgAN) are unclear. This study was designed to evaluate the efficacy and safety of telmisartan combined with clopidogrel, leflunomide, or both drugs for IgAN. Methods: It is a multicenter, prospective, double-dummy randomized controlled trial. Primary IgAN patients were recruited in 13 renal units across Beijing, China, from July 2010 to June 2012. After a 4-week telmisartan (80 mg/d) wash-in, 400 patients continuing on 80 mg/d telmisartan were randomly assigned to additionally receive placebo (Group A), 50 mg/d clopidogrel (Group B), 20 mg/d leflunomide (Group C), or 50 mg/d clopidogrel and 20 mg/d leflunomide (Group D). The 24-week intervention was completed by 360 patients. The primary endpoint was change in 24-h proteinuria at 24 weeks. A linear mixed-effect model was used to analyze the changes at 4, 12, and 24 weeks. Generalized estimating equations were used to evaluate changes in hematuria grade. This trial was registered at the Chinese Clinical Trial Registry. Results: The effects of telmisartan combined with leflunomide on changes in proteinuria (0.36 [95% confidence interval (CI) 0.18–0.55] g/d, P < 0.001), in serum uric acid (76.96 [95% CI 57.44–96.49] μmol/L, P < 0.001), in serum creatinine (9.49 [95% CI 6.54–12.44] μmol/L, P < 0.001), and in estimated glomerular filtration rate (−6.72 [95% CI −9.46 to −3.98] ml∙min−1∙1.73 m−2, P < 0.001) were statistically significant, whereas they were not statistically significant on changes in systolic and diastolic blood pressure and weight (P > 0.05). Telmisartan combined with clopidogrel had no statistical effect on any outcome, and there was no interaction between the interventions. No obvious adverse reactions were observed. Conclusions: Telmisartan combined with leflunomide, not clopidogrel, is safe and effective for decreasing proteinuria in certain

  1. Controlling quality of ferroalloys and alloying additives in the manufacture of nickel alloys for nuclear applications

    SciTech Connect

    Stryker, R.S.

    1981-01-01

    Nickel alloys supplied to the nuclear industry must meet strict requirements for quality and traceability of constituents. Ensuring that end products meet those requirements involves careful control of the raw materials used in melting the alloys. Especially important is an effective system of quality control for purchasing and consuming ferroalloys and alloying additives. Development and operation of such a system requires (1) adequate specifications, (2) good relations with suppliers, (3) an approved-suppliers list, (4) formal receiving inspection, and (5) backup surveillance during processing.

  2. Controlling crystalline structure of ZnS nanocrystals only by tuning sulfur precursor addition rate.

    PubMed

    Bi, Chong; Pan, Liqing; Xu, Mei; Xiao, John Q

    2010-12-01

    Unlike previous studies that emphasize the important role of thermodynamics or surface energy on the structure stabilization of ZnS nanocrystals, we successfully controlled the crystalline structure of ZnS nanocrystals simply by tuning sulfur precursor addition rate under exactly the same other conditions. We observed the structure of as prepared ZnS nanocrystals was evolved from wurtzite into zinc blende with increasing the addition rate of sulfur precursor. The method may extend to engineer other nanomaterials with desired physicochemical properties by controlling crystalline structure. On the other hand, it also makes a new approach to understand the crucial factors that determine the growth mechanism and the crystal structure of nanomaterials in theory.

  3. Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials ‐ a case study in dentistry

    PubMed Central

    Ferreira, Christiane Alves; Loureiro, Carlos Alfredo Salles; Saconato, Humberto; Atallah, Alvaro

    2011-01-01

    OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open‐access journals and performed a page‐by‐page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall‐tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials. PMID:21484055

  4. Intensification of Antiretroviral Therapy through Addition of Enfuvirtide in Naive HIV-1-Infected Patients with Severe Immunosuppression Does Not Improve Immunological Response: Results of a Randomized Multicenter Trial (ANRS 130 Apollo)

    PubMed Central

    Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

    2013-01-01

    We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm3 or stage B/C disease with CD4 counts of <200/mm3. Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥200/mm3 at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm3, and the median HIV-1 RNA load was 5.4 log10 copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥200/mm3 at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression. PMID:23165467

  5. Intensification of antiretroviral therapy through addition of enfuvirtide in naive HIV-1-infected patients with severe immunosuppression does not improve immunological response: results of a randomized multicenter trial (ANRS 130 Apollo).

    PubMed

    Joly, Véronique; Fagard, Catherine; Grondin, Carine; Descamps, Diane; Yazdanpanah, Yazdan; Charpentier, Charlotte; Colin de Verdiere, Nathalie; Tabuteau, Sophie; Raffi, François; Cabie, André; Chene, Geneviève; Yeni, Patrick

    2013-02-01

    We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of <100/mm(3) or stage B/C disease with CD4 counts of <200/mm(3). Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥ 200/mm(3) at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm(3), and the median HIV-1 RNA load was 5.4 log(10) copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥ 200/mm(3) at week 24 were 34% and 38% in the ENF and control arms, respectively (P = 0.53). The proportions of patients with HIV-1 RNA loads of <50 copies/ml were 74% and 58% at week 24 in the ENF and control arms, respectively (P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up (P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.

  6. Use of antibacterial sutures for skin closure in controlling surgical site infections: a systematic review of published randomized, controlled trials

    PubMed Central

    Sajid, Muhammad S.; Craciunas, L.; Sains, P.; Singh, K.K.; Baig, M.K.

    2013-01-01

    Objective: The objective of this article is to systematically analyse the randomized, controlled trials that compare the use of antibacterial sutures (ABS) for skin closure in controlling surgical site infections. Methods: Randomized, controlled trials on surgical patients comparing the use of ABS for skin closure in controlling the surgical site infections were analysed systematically using RevMan® and combined outcomes were expressed as odds ratios (OR) and standardized mean differences (SMD). Results: Seven randomized, controlled trials evaluating 1631 patients were retrieved from electronic databases. There were 760 patients in the ABS group and 871 patients in the simple suture group. There was moderate heterogeneity among trials (Tau2 = 0.12; chi2 = 8.40, df = 6 [P < 0.01]; I2 = 29%). Therefore in the random-effects model, the use of ABS for skin closure in surgical patients was associated with a reduced risk of developing surgical site infections (OR, 0.16; 95% CI, 0.37, 0.99; z = 2.02; P < 0.04) and postoperative complications (OR, 0.56; 95% CI, 0.32, 0.98 z = 2.04; P = 0.04). The durations of operation and lengths of hospital stay were similar following the use of ABS and SS for skin closure in patients undergoing various surgical procedures. Conclusion: Use of ABS for skin closure in surgical patients is effective in reducing the risk of surgical site infection and postoperative complications. ABS is comparable with SS in terms of length of hospital stay and duration of operation. PMID:24759666

  7. Early enteral nutrition therapy in congenital cardiac repair postoperatively: A randomized, controlled pilot study

    PubMed Central

    Sahu, Manoj Kumar; Singal, Anuradha; Menon, Ramesh; Singh, Sarvesh Pal; Mohan, Alka; Manral, Mala; Singh, Divya; Devagouru, V.; Talwar, Sachin; Choudhary, Shiv Kumar

    2016-01-01

    Background and Objectives: Adequate nutritional supplementation in infants with cardiac malformations after surgical repair is a challenge. Critically ill infants in the early postoperative period are in a catabolic stress. The mismatch between estimated energy requirement (EER) and the intake in the postoperative period is multifactorial, predisposing them to complications such as immune deficiency, more infection, and growth failure. This study aimed to assess the feasibility and efficacy of enriched breast milk feed on postoperative recovery and growth of infants after open heart surgery. Methodology: Fifty infants <6 months of age were prospectively randomized in the trial for enteral nutrition (EN) postoperatively from day 1 to 10, after obtaining the Institute Ethics Committee's approval. They were equally divided into two groups on the basis of the feed they received: Control group was fed with expressed breast milk (EBM; 0.65 kcal/ml) and intervention group was fed with EBM + energy supplementation/fortification with human milk fortifier (7.5 kcal/2 g)/Simyl medium-chain triglyceride oil (7.8 kcal/ml). Energy need for each infant was calculated as per EER at 90 kcal/kg/day, as the target requirement. The intra- and post-operative variables such as cardiopulmonary bypass and aortic cross-clamp times, ventilation duration, Intensive Care Unit (ICU), and hospital length of stay and mortality were recorded. Anthropometric and hematological parameters and infection control data were recorded in a predesigned pro forma. Data were analyzed using Stata 14.1 software. Results: The duration of mechanical ventilation, length of ICU stay (LOIS), length of hospital stay (LOHS), infection rate, and mortality rate were lower in the intervention group compared to the control group although none of the differences were statistically significant. Infants in control group needed mechanical ventilation for about a day more (i.e., 153.6 ± 149.0 h vs. 123.2 ± 107.0 h; P = 0

  8. Low-boiling-point solvent additives can also enable morphological control in polymer solar cells

    SciTech Connect

    Mahadevapuram, Rakesh C.; Carr, John A.; Chen, Yuqing; Bose, Sayantan; Nalwa, Kanwar S.; Petrich, Jacob W.; Chaudhary, Sumit

    2013-11-02

    Processing organic photovoltaic (OPV) blend solutions with high-boiling-point solvent additives has recently been used for morphological control in bulk-heterojunction OPV cells. Here we show that even low-boiling-point solvents can be effective additives. When P3HT:PCBM OPV cells were processed with a low-boiling-point solvent tetrahydrafuran as an additive in parent solvent o-dichlorobenzene, charge extraction increased leading to fill factors as high as 69.5%, without low work-function cathodes, electrode buffer layers or thermal treatment. This was attributed to PCBM demixing from P3HT domains and better vertical phase separation, as indicated by photoluminescence lifetimes, hole mobilities, and shunt leakage currents. Dependence on solvent parameters and applicability beyond P3HT system was also investigated. (C) 2013 Elsevier B.V. All rights reserved.

  9. Endoscopic versus microscopic transsphenoidal surgery in the treatment of pituitary tumors: systematic review and meta-analysis of randomized and non-randomized controlled trials.

    PubMed

    Bastos, Rodrigo V S; Silva, Carla Maria D M; Tagliarini, Jose Vicente; Zanini, Marco Antonio; Romero, Flavio R; Boguszewski, Cesar Luiz; Nunes, Vania Dos Santos

    2016-10-01

    We conducted a systematic review and meta-analysis of randomized and non-randomized controlled trials that compared pure endoscopic with microscopic transsphenoidal surgery (TSS) in the resection of pituitary tumors. Embase, PubMed, Lilacs, and Central Cochrane were used as our data sources. The outcomes were total tumor resection, achievement of biochemical control of functioning adenomas, hospital stay and surgery complications. The randomized trials were analyzed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Two randomized and three prospective controlled non-randomized studies were included. Two studies, including 68 patients, evaluated total tumor resection and the meta-analysis did not show differences between the groups [RR: 1.45 (95% CI: 0.87, 2.44)]. Three studies involving 65 patients analyzed the achievement of biochemical control and no statistical difference was found [RR: 0.94 (95% CI: 0.7, 1.26)]. All five studies compared the frequency of postoperative complications between intervention and control group and meta-analysis favored for a low rate of postoperative complications in the endoscopic TSS group [(RR: 0.37 (95% CI: 0.16, 0.83)]. Due to the low evidence level and low number of observations, the results of our meta-analysis should not be viewed as a final proof of inferiority or superiority of one approach in relation to the other. More data including higher numbers of observations are needed.

  10. A systematic review of randomized controlled trials on sterilization methods of extracted human teeth

    PubMed Central

    Western, J. Sylvia; Dicksit, Daniel Devaprakash

    2016-01-01

    Aim of this Study: The aim was to evaluate the efficiency of different sterilization methods on extracted human teeth (EHT) by a systematic review of in vitro randomized controlled trials. Methodology: An extensive electronic database literature search concerning the sterilization of EHT was conducted. The search terms used were “human teeth, sterilization, disinfection, randomized controlled trials, and infection control.” Randomized controlled trials which aim at comparing the efficiency of different methods of sterilization of EHT were all included in this systematic review. Results: Out of 1618 articles obtained, eight articles were selected for this systematic review. The sterilization methods reviewed were autoclaving, 10% formalin, 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C. Data were extracted from the selected individual studies and their findings were summarized. Conclusion: Autoclaving and 10% formalin can be considered as 100% efficient and reliable methods. While the use of 5.25% sodium hypochlorite, 3% hydrogen peroxide, 2% glutaraldehyde, 0.1% thymol, and boiling to 100°C was inefficient and unreliable methods of sterilization of EHT. PMID:27563183

  11. Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

    PubMed

    Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-08-06

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications.

  12. Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

    PubMed Central

    Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

    2015-01-01

    Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

  13. Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial

    PubMed Central

    Mohammed, Shama; Glennerster, Rachel; Khan, Aamir J.

    2016-01-01

    Importance The rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes. Objective To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. Design We conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day. Setting Public and private sector tuberculosis clinics in Karachi, Pakistan. Participants Newly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group. Main Outcome The primary outcome was clinically recorded treatment success based upon intention-to-treat. Results We found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment. Conclusion In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. Trial Registration The trial was registered with ClinicalTrials.gov, NCT

  14. Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

    PubMed Central

    Yektatalab, Shahrzad; Alipour, Abdolrasool; Edraki, Mitra; Tavakoli, Pouran

    2016-01-01

    Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01), verbal (P=0.02) and physical (P=0.01) aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09) and impulsive anger (P=0.08) subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers. Trial Registration Number: IRCT2014042617436N1 PMID:26793733

  15. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  16. On the repeated measures designs and sample sizes for randomized controlled trials.

    PubMed

    Tango, Toshiro

    2016-04-01

    For the analysis of longitudinal or repeated measures data, generalized linear mixed-effects models provide a flexible and powerful tool to deal with heterogeneity among subject response profiles. However, the typical statistical design adopted in usual randomized controlled trials is an analysis of covariance type analysis using a pre-defined pair of "pre-post" data, in which pre-(baseline) data are used as a covariate for adjustment together with other covariates. Then, the major design issue is to calculate the sample size or the number of subjects allocated to each treatment group. In this paper, we propose a new repeated measures design and sample size calculations combined with generalized linear mixed-effects models that depend not only on the number of subjects but on the number of repeated measures before and after randomization per subject used for the analysis. The main advantages of the proposed design combined with the generalized linear mixed-effects models are (1) it can easily handle missing data by applying the likelihood-based ignorable analyses under the missing at random assumption and (2) it may lead to a reduction in sample size, compared with the simple pre-post design. The proposed designs and the sample size calculations are illustrated with real data arising from randomized controlled trials.

  17. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

    PubMed

    Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

    2017-04-01

    The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record

  18. An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial

    PubMed Central

    Smith-Ray, Renae L; Dzewaltowski, David A; Glasgow, Russell E; Lee, Rebecca E; Thomas, Deborah SK; Xu, Stanley; Estabrooks, Paul A

    2015-01-01

    Background Physical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action. Objective Our aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT). Methods This study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a “5 As”-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome. Results Sedentary participants (n=452; 34.7% participation rate) without

  19. CR-Calculus and adaptive array theory applied to MIMO random vibration control tests

    NASA Astrophysics Data System (ADS)

    Musella, U.; Manzato, S.; Peeters, B.; Guillaume, P.

    2016-09-01

    Performing Multiple-Input Multiple-Output (MIMO) tests to reproduce the vibration environment in a user-defined number of control points of a unit under test is necessary in applications where a realistic environment replication has to be achieved. MIMO tests require vibration control strategies to calculate the required drive signal vector that gives an acceptable replication of the target. This target is a (complex) vector with magnitude and phase information at the control points for MIMO Sine Control tests while in MIMO Random Control tests, in the most general case, the target is a complete spectral density matrix. The idea behind this work is to tailor a MIMO random vibration control approach that can be generalized to other MIMO tests, e.g. MIMO Sine and MIMO Time Waveform Replication. In this work the approach is to use gradient-based procedures over the complex space, applying the so called CR-Calculus and the adaptive array theory. With this approach it is possible to better control the process performances allowing the step-by-step Jacobian Matrix update. The theoretical bases behind the work are followed by an application of the developed method to a two-exciter two-axis system and by performance comparisons with standard methods.

  20. Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Hauser, Goran; Salkic, Nermin; Vukelic, Karina; JajacKnez, Alenka; Stimac, Davor

    2015-05-01

    The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.

  1. A randomized, double-blind, placebo-controlled trial of pridopidine in Huntington's disease.

    PubMed

    2013-09-01

    We examined the effects of 3 dosages of pridopidine, a dopamine-stabilizing compound, on motor function and other features of Huntington's disease, with additional evaluation of its safety and tolerability. This was a randomized, double-blind, placebo-controlled trial in outpatient neurology clinics at 27 sites in the United States and Canada. Two hundred twenty-seven subjects enrolled from October 24, 2009, to May 10, 2010. The intervention was pridopidine, either 20 (n=56), 45 (n=55), or 90 (n=58) mg daily for 12 weeks or matching placebo (n=58). The primary outcome measure was the change from baseline to week 12 in the Modified Motor Score, a subset of the Unified Huntington's Disease Rating Scale Total Motor Score. Measures of safety and tolerability included adverse events and trial completion on the assigned dosage. After 12 weeks, the treatment effect (relative to placebo, where negative values indicate improvement) of pridopidine 90 mg/day on the Modified Motor Score was -1.2 points (95% confidence interval [CI], -2.5 to 0.1 points; P = .08). The effect on the Total Motor Score was -2.8 points (95% CI, -5.4 to -0.1 points; nominal P = .04). No significant effects were seen in secondary outcome measures with any of the active dosages. Pridopidine was generally well tolerated. Although the primary analysis did not demonstrate a statistically significant treatment effect, the overall results suggest that pridopidine may improve motor function in Huntington's disease. The 90 mg/day dosage appears worthy of further study. Pridopidine was well tolerated.

  2. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial

    PubMed Central

    Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; McLoughlin, Karen Sax; Ramelson, Harley; Schneider, Louise; Bates, David W

    2012-01-01

    Background Accurate clinical problem lists are critical for patient care, clinical decision support, population reporting, quality improvement, and research. However, problem lists are often incomplete or out of date. Objective To determine whether a clinical alerting system, which uses inference rules to notify providers of undocumented problems, improves problem list documentation. Study Design and Methods Inference rules for 17 conditions were constructed and an electronic health record-based intervention was evaluated to improve problem documentation. A cluster randomized trial was conducted of 11 participating clinics affiliated with a large academic medical center, totaling 28 primary care clinical areas, with 14 receiving the intervention and 14 as controls. The intervention was a clinical alert directed to the provider that suggested adding a problem to the electronic problem list based on inference rules. The primary outcome measure was acceptance of the alert. The number of study problems added in each arm as a pre-specified secondary outcome was also assessed. Data were collected during 6-month pre-intervention (11/2009–5/2010) and intervention (5/2010–11/2010) periods. Results 17 043 alerts were presented, of which 41.1% were accepted. In the intervention arm, providers documented significantly more study problems (adjusted OR=3.4, p<0.001), with an absolute difference of 6277 additional problems. In the intervention group, 70.4% of all study problems were added via the problem list alerts. Significant increases in problem notation were observed for 13 of 17 conditions. Conclusion Problem inference alerts significantly increase notation of important patient problems in primary care, which in turn has the potential to facilitate quality improvement. Trial Registration ClinicalTrials.gov: NCT01105923. PMID:22215056

  3. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    PubMed

    Huang, Ruixue; Wang, Ke; Hu, Jianan

    2016-08-06

    It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder) = -0.30, 95% CI (-0.51--0.09), p = 0.005) in the subjects. Probiotics had an effect on both the healthy population (MD = -0.25, 95% CI (-0.47--0.03), p = 0.03) and patients with major depressive disorder (MDD) (MD = -0.73, 95% CI (-1.37--0.09), p = 0.03). Probiotics had an effect on the population aged under 60 (MD = -0.43, 95% CI (-0.72--0.13), p = 0.005), while it had no effect on people aged over 65 (MD = -0.18, 95% CI (-0.47-0.11), p = 0.22). This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression.

  4. A multicenter randomized controlled trial of intravenous magnesium for sickle cell pain crisis in children.

    PubMed

    Brousseau, David C; Scott, J Paul; Badaki-Makun, Oluwakemi; Darbari, Deepika S; Chumpitazi, Corrie E; Airewele, Gladstone E; Ellison, Angela M; Smith-Whitley, Kim; Mahajan, Prashant; Sarnaik, Sharada A; Casper, T Charles; Cook, Lawrence J; Dean, J Michael; Leonard, Julie; Hulbert, Monica L; Powell, Elizabeth C; Liem, Robert I; Hickey, Robert; Krishnamurti, Lakshmanan; Hillery, Cheryl A; Nimmer, Mark; Panepinto, Julie A

    2015-10-01

    Magnesium, a vasodilator, anti-inflammatory, and pain reliever, could alter the pathophysiology of sickle cell pain crises. We hypothesized that intravenous magnesium would shorten length of stay, decrease opioid use, and improve health-related quality of life (HRQL) for pediatric patients hospitalized with sickle cell pain crises. The Magnesium for Children in Crisis (MAGiC) study was a randomized, double-blind, placebo-controlled trial of intravenous magnesium vs normal saline placebo conducted at 8 sites within the Pediatric Emergency Care Applied Research Network (PECARN). Children 4 to 21 years old with hemoglobin SS or Sβ(0) thalassemia requiring hospitalization for pain were eligible. Children received 40 mg/kg of magnesium or placebo every 8 hours for up to 6 doses plus standard therapy. The primary outcome was length of stay in hours from the time of first study drug infusion, compared using a Van Elteren test. Secondary outcomes included opioid use and HRQL. Of 208 children enrolled, 204 received the study drug (101 magnesium, 103 placebo). Between-group demographics and prerandomization treatment were similar. The median interquartile range (IQR) length of stay was 56.0 (27.0-109.0) hours for magnesium vs 47.0 (24.0-99.0) hours for placebo (P = .24). Magnesium patients received 1.46 mg/kg morphine equivalents vs 1.28 mg/kg for placebo (P = .12). Changes in HRQL before discharge and 1 week after discharge were similar (P > .05 for all comparisons). The addition of intravenous magnesium did not shorten length of stay, reduce opioid use, or improve quality of life in children hospitalized for sickle cell pain crisis. This trial was registered at www.clinicaltrials.gov as #NCT01197417.

  5. Interpersonal Problems Predict Differential Response to Cognitive Versus Behavioral Treatment in a Randomized Controlled Trial

    PubMed Central

    Newman, Michelle G.; Jacobson, Nicholas C.; Erickson, Thane M.; Fisher, Aaron J.

    2016-01-01

    Objective We examined dimensional interpersonal problems as moderators of cognitive behavioral therapy (CBT) versus its components (cognitive therapy [CT] and behavioral therapy [BT]). We predicted that people with generalized anxiety disorder (GAD) whose interpersonal problems reflected more dominance and intrusiveness would respond best to a relaxation-based BT compared to CT or CBT, based on studies showing that people with personality features associated with a need for autonomy respond best to treatments that are more experiential, concrete, and self-directed compared to therapies involving abstract analysis of one’s problems (e.g., containing CT). Method This was a secondary analysis of Borkovec, Newman, Pincus, and Lytle (2002). Forty-seven participants with principal diagnoses of GAD were assigned randomly to combined CBT (n = 16), CT (n = 15), or BT (n = 16). Results As predicted, compared to participants with less intrusiveness, those with dimensionally more intrusiveness responded with greater GAD symptom reduction to BT than to CBT at posttreatment and greater change to BT than to CT or CBT across all follow-up points. Similarly, those with more dominance responded better to BT compared to CT and CBT at all follow-up points. Additionally, being overly nurturant at baseline was associated with GAD symptoms at baseline, post, and all follow-up time-points regardless of therapy condition. Conclusions Generally anxious individuals with domineering and intrusive problems associated with higher need for control may respond better to experiential behavioral interventions than to cognitive interventions, which may be perceived as a direct challenge of their perceptions. PMID:28077221

  6. Effect of jumping interval training on neuromuscular and physiological parameters: a randomized controlled study.

    PubMed

    Ache-Dias, Jonathan; Dellagrana, Rodolfo A; Teixeira, Anderson S; Dal Pupo, Juliano; Moro, Antônio R P

    2016-01-01

    This study analyzed the effect of 4 weeks of jumping interval training (JIT), included in endurance training, on neuromuscular and physiological parameters. Eighteen recreational runners, randomized in control and experimental groups, performed 40 min of running at 70% of velocity at peak oxygen uptake, for 3 times per week. Additionally, the experimental group performed the JIT twice per week, which consisted of 4 to 6 bouts of continuous vertical jumps (30 s) with 5-min intervals. Three days before and after the training period, the countermovement (CMJ) and continuous jump (CJ30), isokinetic and isometric evaluation of knee extensors/flexors, progressive maximal exercise, and submaximal constant-load exercise were performed. The JIT provoked improvement in neuromuscular performance, indicated by (i) increased jump height (4.7%; effect size (ES) = 0.99) and power output (≈ 3.7%; ES ≈ 0.82) of CMJ and rate of torque development of knee extensors in isometric contraction (29.5%; ES = 1.02); (ii) anaerobic power and capacity, represented by the mean of jump height (7.4%; ES = 0.8), and peak power output (PPO) (5.6%; ES = 0.73) of the first jumps of CJ30 and the mean of jump height (10.2%, ES = 1.04) and PPO (9.5%, ES = 1.1), considering all jumps of CJ30; and (iii) aerobic power and capacity, represented by peak oxygen uptake (9.1%, ES = 1.28), velocity at peak oxygen uptake (2.7%, ES = 1.11), and velocity corresponding to the onset of blood lactate accumulation (9.7%, ES = 1.23). These results suggest that the JIT included in traditional endurance training induces moderate to large effects on neuromuscular and physiological parameters.

  7. Confronting Fear Using Exposure and Response Prevention for Anorexia Nervosa: A Randomized Controlled Pilot Study

    PubMed Central

    Steinglass, Joanna E; Albano, Anne Marie; Simpson, H Blair; Wang, Yuanjia; Zou, Jingjing; Attia, Evelyn; Walsh, B. Timothy

    2014-01-01

    Objective Anorexia nervosa (AN) is a severe illness with high rates of relapse. Exposure and Response Prevention for AN (AN-EXRP) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety. The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration, at a pivotal moment when treatment goals shift toward relapse prevention. Method A randomized controlled trial was conducted to compare AN-EXRP with a comparison condition, Cognitive Remediation Therapy (CRT). Hospitalized patients with AN (n=32) who had achieved weight restoration to a BMI > 18.5 kg/m2 received 12 sessions of either AN-EXRP or CRT. Outcome was assessed by change in caloric intake in an objective assessment of eating behavior. Results The average test meal caloric intake of participants who received AN-EXRP increased from 352±263 kcal at baseline to 401±215 kcal post-treatment, while that of participants who received CRT decreased from 501±232 kcal at baseline to 424±221 kcal post-treatment (t(28)=2.5, p=0.02). Improvement in intake was significantly associated with improvement in eating-related anxiety (Spearman’s ρ=0.40, p=0.03). Conclusions These data demonstrate that AN-EXRP, compared to a credible comparison intervention, is associated with better caloric intake in a laboratory meal over time in AN. Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinically significant change. PMID:24488838

  8. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    PubMed

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C

    2010-02-01

    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  9. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Huang, Ruixue; Wang, Ke; Hu, Jianan

    2016-01-01

    It has been reported that gut probiotics play a major role in the bidirectional communication between the gut and the brain. Probiotics may be essential to people with depression, which remains a global health challenge, as depression is a metabolic brain disorder. However, the efficacy of probiotics for depression is controversial. This study aimed to systematically review the existing evidence on the effect of probiotics-based interventions on depression. Randomized, controlled trials, identified through screening multiple databases and grey literature, were included in the meta-analysis. The meta-analysis was performed using Review Manager 5.3 software using a fixed-effects model. The meta-analysis showed that probiotics significantly decreased the depression scale score (MD (depressive disorder) = −0.30, 95% CI (−0.51–−0.09), p = 0.005) in the subjects. Probiotics had an effect on both the healthy population (MD = −0.25, 95% CI (−0.47–−0.03), p = 0.03) and patients with major depressive disorder (MDD) (MD = −0.73, 95% CI (−1.37–−0.09), p = 0.03). Probiotics had an effect on the population aged under 60 (MD = −0.43, 95% CI (−0.72–−0.13), p = 0.005), while it had no effect on people aged over 65 (MD = −0.18, 95% CI (−0.47–0.11), p = 0.22). This is the first systematic review and meta-analysis with the goal of determining the effect of probiotics on depression. We found that probiotics were associated with a significant reduction in depression, underscoring the need for additional research on this potential preventive strategy for depression. PMID:27509521

  10. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    PubMed Central

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  11. Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial

    PubMed Central

    Irvine, A Blair; Russell, Holly; Manocchia, Michael; Mino, David E; Cox Glassen, Terri; Morgan, Rebecca; Gau, Jeff M; Ary, Dennis V

    2015-01-01

    Background Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines. Objective This study evaluated the efficacy of a mobile-Web intervention called “FitBack” to help users implement self-tailored strategies to manage and prevent NLBP occurrences. Methods A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments. Results Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on

  12. Speed synchronization control for integrated automotive motor-transmission powertrain system with random delays

    NASA Astrophysics Data System (ADS)

    Zhu, Xiaoyuan; Zhang, Hui; Fang, Zongde

    2015-12-01

    This paper presents a robust speed synchronization controller design for an integrated motor-transmission powertrain system in which the driving motor and multi-gearbox are directly coupled. As the controller area network (CAN) is commonly used in the vehicle powertrain system, the possible network-induced random delays in both feedback and forward channel are considered and modeled by using two Markov chains in the controller design process. For the application perspective, the control law adopted here is a generalized proportional-integral (PI) control. By employing the system-augmentation technique, a delay-free stochastic closed-loop system is obtained and the generalized PI controller design problem is converted to a static output feedback (SOF) controller design problem. Since there are external disturbances involved in the closed-loop system, the energy-to-peak performance is considered to guarantee the robustness of the controller. And the controlled output is chosen as the speed synchronization error. To further improve the transient response of the closed-loop system, the pole placement is also employed in the energy-to-peak performance based speed synchronization control. The mode-dependent control gains are obtained by using an iterative linear matrix inequality (LMI) algorithm. Simulation results show the effectiveness of the proposed control approach.

  13. PID Controller Design Based on Global Optimization Technique with Additional Constraints

    NASA Astrophysics Data System (ADS)

    Ozana, Stepan; Docekal, Tomas

    2016-05-01

    This paper deals with design of PID controller with the use of methods of global optimization implemented in Matlab environment and Optimization Toolbox. It is based on minimization of a chosen integral criterion with respect to additional requirements on control quality such as overshoot, phase margin and limits for manipulated value. The objective function also respects user-defined weigh coefficients for its particular terms for a different penalization of individual requirements that often clash each other such as for example overshoot and phase margin. The described solution is designated for continuous linear time-invariant static systems up to 4th order and thus efficient for the most of real control processes in practice.

  14. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

    PubMed

    Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

    2016-08-03

    The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, <2 years recent running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period.

  15. Controlling dispersion forces between small particles with artificially created random light fields.

    PubMed

    Brügger, Georges; Froufe-Pérez, Luis S; Scheffold, Frank; José Sáenz, Juan

    2015-06-22

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with optical tweezers as well as to induce significant optical binding forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir-Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as a gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light-induced interactions open a path towards the control of translationally invariant interactions with tuneable strength and range in colloidal systems.

  16. Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study.

    PubMed

    Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

    2015-09-01

    The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.

  17. Prayer and healing: A medical and scientific perspective on randomized controlled trials

    PubMed Central

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect on outcomes, to worsen outcomes and to have retrospective healing effects. For a multitude of reasons, research on the healing effects of prayer is riddled with assumptions, challenges and contradictions that make the subject a scientific and religious minefield. We believe that the research has led nowhere, and that future research, if any, will forever be constrained by the scientific limitations that we outline. PMID:20048448

  18. Controlling dispersion forces between small particles with artificially created random light fields

    PubMed Central

    Brügger, Georges; Froufe-Pérez, Luis S.; Scheffold, Frank; José Sáenz, Juan

    2015-01-01

    Appropriate combinations of laser beams can be used to trap and manipulate small particles with optical tweezers as well as to induce significant optical binding forces between particles. These interaction forces are usually strongly anisotropic depending on the interference landscape of the external fields. This is in contrast with the familiar isotropic, translationally invariant, van der Waals and, in general, Casimir–Lifshitz interactions between neutral bodies arising from random electromagnetic waves generated by equilibrium quantum and thermal fluctuations. Here we show, both theoretically and experimentally, that dispersion forces between small colloidal particles can also be induced and controlled using artificially created fluctuating light fields. Using optical tweezers as a gauge, we present experimental evidence for the predicted isotropic attractive interactions between dielectric microspheres induced by laser-generated, random light fields. These light-induced interactions open a path towards the control of translationally invariant interactions with tuneable strength and range in colloidal systems. PMID:26096622

  19. Can Modifications to the Bedroom Environment Improve the Sleep of New Parents? Two Randomized Controlled Trials

    PubMed Central

    Gay, Caryl L.

    2011-01-01

    Postpartum sleep disruption is common among new parents. In this randomized controlled trial we evaluated a modified sleep hygiene intervention for new parents (infant proximity, noise masking, and dim lighting) in anticipation of night-time infant care. Two samples of new mothers (n = 118 and 122) were randomized to the experimental intervention or attention control, and sleep was assessed in late pregnancy and first 3 months postpartum using actigraphy and the General Sleep Disturbance Scale. The sleep hygiene strategies evaluated did not benefit the more socioeconomically advantaged women or their partners in Sample 1, but did improve postpartum sleep among the less advantaged women of Sample 2. Simple changes to the bedroom environment can improve sleep for new mothers with few resources. PMID:21243655

  20. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials.

    PubMed

    Lee, Kathryn A; Gay, Caryl L

    2011-02-01

    Postpartum sleep disruption is common among new parents. In this randomized controlled trial we evaluated a modified sleep hygiene intervention for new parents (infant proximity, noise masking, and dim lighting) in anticipation of night-time infant care. Two samples of new mothers (n = 118 and 122) were randomized to the experimental intervention or attention control, and sleep was assessed in late pregnancy and first 3 months postpartum using actigraphy and the General Sleep Disturbance Scale. The sleep hygiene strategies evaluated did not benefit the more socioeconomically advantaged women or their partners in Sample 1, but did improve postpartum sleep among the less advantaged women of Sample 2. Simple changes to the bedroom environment can improve sleep for new mothers with few resources.

  1. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  2. Feasibility, safety, and compliance in a randomized controlled trial of physical therapy for Parkinson's disease.

    PubMed

    McGinley, Jennifer L; Martin, Clarissa; Huxham, Frances E; Menz, Hylton B; Danoudis, Mary; Murphy, Anna T; Watts, Jennifer J; Iansek, Robert; Morris, Meg E

    2012-01-01

    Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD) (n = 210) were randomized into three groups: (1) progressive strength training (PST); (2) movement strategy training (MST); or (3) control ("life skills"). PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance >80%) did not differ between groups (P = .435). Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.

  3. Mindfulness training for loneliness among Chinese college students: A pilot randomized controlled trial.

    PubMed

    Zhang, Na; Fan, Fu-Min; Huang, Si-Yuan; Rodriguez, Marcus A

    2016-10-05

    Loneliness has been found to predict a wide range of physical and mental health problems. It is suggested that China's One-Child Policy places young Chinese people at a particularly high risk for loneliness. Although loneliness is most prevalent in late adolescence and early adulthood, interventions have primarily targeted children or older adults with limited success. The current study examines a pilot randomized controlled trial of a mindfulness training program among Chinese college students. Participants with elevated loneliness (N = 50, ages 17-25) were randomized into either an 8-week mindfulness training or a control group. Self-reported measures of loneliness and mindfulness were administered at baseline and posttest. The training group also completed a program evaluation form and a 3-month follow-up assessment. Results provided preliminary evidence indicating that the intervention was feasible and effective at reducing loneliness among Chinese college students. Limitations and future directions were discussed.

  4. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  5. The influence of additions of Al and Si on the lattice stability of fcc and hcp Fe-Mn random alloys.

    PubMed

    Gebhardt, T; Music, D; Ekholm, M; Abrikosov, I A; Vitos, L; Dick, A; Hickel, T; Neugebauer, J; Schneider, J M

    2011-06-22

    We have studied the influence of additions of Al and Si on the lattice stability of face-centred-cubic (fcc) versus hexagonal-closed-packed (hcp) Fe-Mn random alloys, considering the influence of magnetism below and above the fcc Néel temperature. Employing two different ab initio approaches with respect to basis sets and treatment of magnetic and chemical disorder, we are able to quantify the predictive power of the ab initio methods. We find that the addition of Al strongly stabilizes the fcc lattice independent of the regarded magnetic states. For Si a much stronger dependence on magnetism is observed. Compared to Al, almost no volume change is observed as Si is added to Fe-Mn, indicating that the electronic contributions are responsible for stabilization/destabilization of the fcc phase.

  6. Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

    PubMed

    Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

    2014-05-01

    Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work.

  7. Pragmatic consideration of recent randomized, placebo-controlled clinical trials for treatment of fibromyalgia.

    PubMed

    Holman, Andrew J

    2008-12-01

    A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

  8. A systematic mapping review of Randomized Controlled Trials (RCTs) in care homes

    PubMed Central

    2012-01-01

    Background A thorough understanding of the literature generated from research in care homes is required to support evidence-based commissioning and delivery of healthcare. So far this research has not been compiled or described. We set out to describe the extent of the evidence base derived from randomized controlled trials conducted in care homes. Methods A systematic mapping review was conducted of the randomized controlled trials (RCTs) conducted in care homes. Medline was searched for “Nursing Home”, “Residential Facilities” and “Homes for the Aged”; CINAHL for “nursing homes”, “residential facilities” and “skilled nursing facilities”; AMED for “Nursing homes”, “Long term care”, “Residential facilities” and “Randomized controlled trial”; and BNI for “Nursing Homes”, “Residential Care” and “Long-term care”. Articles were classified against a keywording strategy describing: year and country of publication; randomization, stratification and blinding methodology; target of intervention; intervention and control treatments; number of subjects and/or clusters; outcome measures; and results. Results 3226 abstracts were identified and 291 articles reviewed in full. Most were recent (median age 6 years) and from the United States. A wide range of targets and interventions were identified. Studies were mostly functional (44 behaviour, 20 prescribing and 20 malnutrition studies) rather than disease-based. Over a quarter focussed on mental health. Conclusions This study is the first to collate data from all RCTs conducted in care homes and represents an important resource for those providing and commissioning healthcare for this sector. The evidence-base is rapidly developing. Several areas - influenza, falls, mobility, fractures, osteoporosis – are appropriate for systematic review. For other topics, researchers need to focus on outcome measures that can be compared and collated. PMID:22731652

  9. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    PubMed

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active contr