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About 10,000 papers for “Randomized controlled trial”

randomized controlled trial

Biomed Central, Tanveer Nasr, Rukhsana Kausar · 2009

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background: The majority of patients with schizophrenia live with their relatives in Pakistan, thereby families experience a considerable burden. We aimed to study the impact of psychoeducation on the burden of schizophrenia on the family in a randomised controlled trial. Methods: A total of 108 patients with schizophrenia and their family members from the outpatient department of a teaching hospital in Lahore, Pakistan were randomised. Both groups received psychotropic drugs but one group received psychoeducation in addition. Family burden was assessed at the time of recruitment and at 6 months post intervention. Results: In all, 99 patients and their relatives completed the treatment. There was significant reduction in burden at post-intervention assessment in the psychoeducation group based on intention to treat analysis. Conclusion: Family psychoeducation can be an important intervention for patients with schizophrenia in Pakistan.

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Randomized Controlled Trial

Julia Naoumova, Jüri Kürol, Heidrun Kjellberg · 2016

Extraction of the deciduous canine as an interceptive treatment in children with palatally displaced canines. Part II: possible predictors of success and cut-off points for a spontaneous eruption

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Randomized Controlled Trial

Gestational Diabetes—a Double-blind, Toh Peng Yeow, Shueh Lin Lim et al. · 2016

Gestational DiabetesMellitus (GDM) and vitamin D deficiency are related to insulin resistance and impaired beta cell function, with heightened risk for future development of diabetes. We evaluated the impact of vitamin D supplementation onmarkers of glucosemetabolism and cardio metabolic risk in Asian women with former GDM and hypovitaminosis D. In this double blind, randomized controlled trial, 26 participants were randomized to receive either daily 4000 IU vitamin D3 or placebo capsules. 75g Oral Glucose Tolerance Test (OGTT) and bio-chemistry profiles were performed at baseline and 6 month visits. Mathematical models, using serial glucose, insulin and C peptide measurements fromOGTT, were employed to cal-culate insulin sensitivity and beta cell function. Thirty three (76%) women with former GDM screened had vitamin D level of <50 nmol/L at baseline. Supplementation, when compared with placebo, resulted in increased vitamin D level (+51.1 nmol/L vs 0.2 nmol/L, p<0.001) and increased fasting insulin (+20 % vs 18%, p = 0.034). The vitamin D group also demonstrated a 30 % improvement in disposition index and an absolute 0.2 % (2 mmol/mol) reduction in HbA1c. There was no clear change in insulin sensitivity or markers of cardio metabolic risk.

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randomized controlled trial

Caridad Pontes, Jordi Gratacós, Ferran Torres et al. · 2016

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with Discussion: The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical

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randomized controlled trial

Jessica Gokee-larose, Amy A Gorin, Rena R Wing · 2016

Objective: To determine the feasibility of recruiting and retaining young adults in a brief behavioral weight loss intervention tailored for this age group, and to assess the preliminary efficacy of an intervention that emphasizes daily self-weighing within the context of a self-regulation model. Methods: Forty young adults (29.1 ± 3.9 years, range 21–35, average BMI of 33.36 ± 3.4) were randomized to one of two brief behavioral weight loss interventions: behavioral self-regulation (BSR) or adapted standard behavioral treatment (SBT). Assessments were conducted at baseline, post-treatment (10 weeks), and follow-up (20 weeks). Intent to treat analyses were conducted using general linear modeling in SPSS version 14.0. Results: Participants in both groups attended an average of 8.7 out of 10 group meetings, and retention rates were 93 % and 88 % for post-treatment and follow-up assessments, respectively. Both groups achieved significant weight losses at post-treatment (BSR =-6.4 kg (4.0); SBT =-6.2 kg (4.5) and follow-up (BSR =-6.6 kg (5.5); SBT =-5.8 kg (5.2), p <.001; but the interaction of group × time was not statistically significant, p =.84. Across groups, there was a positive association between frequency of weighing at follow-up and overall weight change at follow-up (p =.01). Daily

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randomized controlled trial

Astrid Lehner, Martin Schecklmann, Peter M Kreuzer et al. · 2016

Comparing single-site with multisite rTMS for the treatment of chronic tinnitus – clinical effects and the treatment of chronic tinnitus. Furthermore, the comparison between tinnitus patients and healthy controls and

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randomized controlled trial

Intravenous Vitamin C Administration Reduces, Sang-yeon Suh, Woo Kyung Bae et al. · 2014

Background: Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods: We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results: The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004); fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p < 0.001, p < 0.001, respectively). When data analysis was refined by dividing each group into high-baseline and low-baseline subgroups, it was observed that fatigue was reduced in the lower baseline vitamin C level group after two hours and after one day (p = 0.004). The same did not hold for the higher baseline group (p = 0.206). Conclusion: Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration: The clinical trial registration of this trial is

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randomized controlled trial

Ronald M Lazar, Stephen K Williams, Girardin Jean-louis et al. · 2016

Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black hypertension are randomly assigned to one of two 12-month interventions: 1) HBPTM with wireless feedback to

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Randomized Controlled Trial

Salma Al-sibaie, Mohammad Y. Hajeer · 2016

Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial

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A randomized, controlled trial

Kim M. P, Van Bastelaar, François Pouwer et al. · 2013

OBJECTIVE—Comorbid depression is common in patients with type 1 and type 2 diabetes, adversely affecting quality of life, diabetes outcomes, and mortality. Depression can be effectively treated with cognitive behavior therapy (CBT). The Internet is a new and attractive method for delivering CBT intervention on a large scale at relatively low costs. This study evaluated the effectiveness of Web-based CBT for depression treatment in adults with type 1 or type 2 diabetes, with minimal guidance. RESEARCH DESIGN AND METHODS—A randomized controlled trial was conducted in the Netherlands in 255 adult diabetic patients with elevated depressive symptoms. Primary outcomes were depressive symptoms. Secondary outcomes were diabetes-specific emotional distress and glycemic control. Assessments were at baseline, after treatment, and at the 1-month follow-up. RESULTS—The Web-based CBT was effective in reducing depressive symptoms by intentionto-treat analyses (P=0.04, d = 0.29; clinical improvement 41 % vs. 24 % P, 0.001) and by perprotocol analyses (P, 0.001, d = 0.70; clinical improvement, 56 % vs. 24 % P, 0.001). The intervention reduced diabetes-specific emotional distress (P = 0.03) but had no beneficial effect

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Cluster randomized controlled trial

Forster, Anne, Young, John, Chapman, Katie et al. · London School of Economics and Political Science Research Online (London School of Economics and Political Science) · 2015

Background and Purpose—We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods—A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results—Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions—This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice.

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