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Sample records for theory-based efficacy trial

  1. Efficacy of theory-based HIV behavioral prevention among rural-to-urban migrants in China: a randomized controlled trial.

    Science.gov (United States)

    Li, Xiaoming; Lin, Danhua; Wang, Bo; Du, Hongfei; Tam, Cheuk Chi; Stanton, Bonita

    2014-08-01

    Our objective was to evaluate the efficacy of a cultural adaptation of a social cognitive theory-based HIV behavioral prevention program among young rural-to-urban migrants in China. The intervention design and assessment were guided by the Protection Motivation Theory (PMT). The intervention was evaluated through a randomized controlled trial with 6-month and 12-month follow-ups. The primary behavioral outcome was the use of condoms. Other outcome measures include HIV knowledge, condom use knowledge, HIV-related perceptions (PMT constructs), and intention to use condom. The mixed-effects regression models for condom use with regular partners indicated that overall frequency of condom use, condom use in last three sexual acts and proper condom use increased over time for the participants but the increases were significantly greater among the intervention group than the control group at 6-month and 12-month follow-ups. The mixed-effects models for HIV-related perceptions indicated that extrinsic rewards, intrinsic rewards, and response costs decreased while vulnerability, severity, response efficacy, and self-efficacy increased over time for the intervention group. The increases in HIV knowledge, condom use knowledge, and intention to use condom were also significantly greater among the intervention group than the control group. The data in the current study suggested efficacy of a social cognitive theory-based behavioral intervention in increasing condom use among young migrants in China. The intervention also increased protective perceptions and decreased risk perception posited by the theory (i.e., PMT).

  2. Efficacy and Mediation of a Theory-Based Physical Activity Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial.

    Science.gov (United States)

    Zhang, Jingwen; Jemmott, John B; O'Leary, Ann; Stevens, Robin; Jemmott, Loretta Sweet; Icard, Larry D; Hsu, Janet; Rutledge, Scott E

    2017-02-01

    Few trials have tested physical-activity interventions among sexual minorities, including African American men who have sex with men (MSM). We examined the efficacy and mediation of the Being Responsible for Ourselves (BRO) physical-activity intervention among African American MSM. African American MSM were randomized to the physical-activity intervention consisting of three 90-min one-on-one sessions or an attention-matched control intervention and completed pre-intervention, immediately post-intervention, and 6- and 12-month post-intervention audio computer-based surveys. Of the 595 participants, 503 completed the 12-month follow-up. Generalized estimating equation models revealed that the intervention increased self-reported physical activity compared with the control intervention, adjusted for pre-intervention physical activity. Mediation analyses suggested that the intervention increased reasoned action approach variables, subjective norm and self-efficacy, increasing intention immediately post-intervention, which increased physical activity during the follow-up period. Interventions targeting reasoned action approach variables may contribute to efforts to increase African American MSM's physical activity. The trial was registered with the ClinicalTrials.gov Identifier NCT02561286 .

  3. Self-efficacy theory-based intervention in adolescents: a cluster randomized trial-focus on oral self-care practice and oral self-care skills.

    Science.gov (United States)

    Džiaugytė, Lina; Aleksejūnienė, Jolanta; Brukienė, Vilma; Pečiulienė, Vytaute

    2017-01-01

    The cluster randomized trial tested the efficacy of professional dental education for improving oral self-care skills (OSC-S) and oral self-care practice (OSC-P) in adolescents. All 15- to 16-year-old adolescents from four public schools were invited and 206 agreed to participate. Schools were randomly allocated to the intervention group and to the control group. Five sessions were given for the intervention group and one for the control group. The OSC-S and OSC-P outcomes were measured as % Oral Cleanliness Scores at the baseline, 6-month, and 12-month observations. OSC-S and OSC-P correlated significantly (Pearson's) at the baseline (r = 0.777, P oral healthcare interventions, a significant time × group effect was observed (repeated-measures anova, P Oral self-care skills and oral self-care practice scores were significantly correlated, (ii) self-efficacy theory-guided intervention was superior to the conventional dental instruction to improve oral self-care in adolescents, and (iii) varying levels of oral self-care improvement were observed among the intervention group adolescents. © 2016 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials.

    Science.gov (United States)

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-04-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.

  5. Randomised controlled trial of a brief theory-based intervention promoting breakfast consumption.

    Science.gov (United States)

    Kothe, Emily J; Mullan, Barbara A; Amaratunga, Rajith

    2011-02-01

    The present study sought to test the efficacy of a brief theory-based intervention to promote regular consumption of breakfast, and to expand previous results suggesting that the theory of planned behaviour (TPB) can be meaningfully applied to breakfast consumption. A four-armed randomised controlled trial was conducted. Participants (n=349) were allocated to receive either a (1) positively framed attitude intervention, (2) negatively framed attitude intervention, (3) Perceived Behavioural Control (PBC) intervention, or (4) control task. Attitude, subjective norm, PBC and behaviour were measured at baseline and 4-week follow-up. All three interventions employed persuasive communication and an implementation intention task. The intervention did not result in expected increases in breakfast consumption, or in changes in attitude, subjective norm or PBC. However, baseline attitude, subjective norm and PBC predicted 39.3% of baseline intention. Baseline intention in turn predicted 33% of breakfast consumption at 4 weeks. Change in breakfast consumption was predicted by change in attitude, subjective norm, and PBC between baseline and follow-up. Despite a lack of intervention effects, the TPB provided a good model of breakfast consumption over the four-week follow-up period. By expanding on previous work investigating breakfast consumption using the TPB, this study provides further support for the argument that that theory based interventions could result in meaningful increases in breakfast consumption. Copyright © 2010 Elsevier Ltd. All rights reserved.

  6. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults.

    Science.gov (United States)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-03-07

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants' attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults' sun-protective behaviour. Australian and New Zealand Trials Registry

  7. A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial.

    Science.gov (United States)

    Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny

    2011-01-21

    Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was

  8. The efficacy of a theory-based, participatory recycling intervention on a college campus.

    Science.gov (United States)

    Largo-Wight, Erin; Johnston, Dedee DeLongpre; Wight, Jeff

    2013-11-01

    Recycling solid waste is an important primary prevention focus to protect environmental resources and human health. Recycling reduces energy consumption and emissions and the need to harvest raw material, which protects air, water, and land. In the study described in this article, the authors conducted an eight week field study to test the efficacy of an intervention aimed to increase can and bottle recycling on a college campus. Recycling volume was assessed in three campus buildings (two treatments and one control) over eight weeks. The control building had standard outdoor-only recycling. The treatment buildings had standard outdoor recycling plus four weeks with the treatment indoor recycling. Total can and bottle recycling volume increased 65%-250% in the treatment buildings compared to the control building. Recycling significantly increased in both the classroom (t = -2.9, p administrative (t = -12.4, p education or additional promotion, resulted in significantly more recycling. Health promoters should prioritize efforts to make recycling easy and convenient.

  9. Theory-based Osteoporosis Prevention Education and Counseling Program for Women: A Randomized Controlled Trial.

    Science.gov (United States)

    Kalkım, Aslı; Dağhan, Şafak

    2017-06-01

    The purpose of this research was to investigate the effect of an osteoporosis prevention program based on the Health Belief Model for women between the ages of 30 years and 45 years at risk of osteoporosis. This study was conducted with randomized control group pretest, post-test and follow-up trial. Intervention group (n = 37) and control group (n = 36) participated in the research. Data were collected using a sociodemographic data questionnaire, the Osteoporosis Knowledge Test, the Osteoporosis Health Belief Scale, the Osteoporosis Self-efficacy Scale, a monitoring form for estimated dairy calcium intake, and a monitoring form for estimated weekly exercise. Intervention program was composed of a 4-week education program and a 24-week counseling program. Data were collected pretest, post-test 15 days after the end of the education program, follow-up 1 after 3 months, and follow-up 2 after 6 months. Mann Whitney U test, chi-square test, Friedman test, Bonferroni test, two means test and Wilcoxon signed-rank test were used for statistical analysis. After the education and counseling program, a significant increase was seen in comparison with the control group in the mean scores of the intervention group on the Osteoporosis Knowledge Test and its subscales (p Belief Scale and its subscales (p Belief Model-based osteoporosis prevention education and counseling program conducted by nurses. Copyright © 2017. Published by Elsevier B.V.

  10. Theory-based self-management educational interventions on patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhao, Fang-Fang; Suhonen, Riitta; Koskinen, Sanna; Leino-Kilpi, Helena

    2017-04-01

    To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes (T2DM) in randomized controlled trials. Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients. Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients. Systematic review with meta-analysis of randomized controlled trials following Cochrane methods. A literature search was carried out in the MEDLINE, EMBASE, CINAHL, PSYCINFO, and Web of Science databases (1980-April 2015). The risk of bias of these eligible studies was assessed independently by two authors using the Cochrane Collaboration's tool. The Publication bias of the main outcomes was examined. Statistical heterogeneity and random-effects model were used for meta-analysis. Twenty studies with 5802 participants met the inclusion criteria. The interventions in the studies were based on one or more theories which mostly belong to mid-range theories. The pooled main outcomes by random-effects model showed significant improvements in HbA1c, self-efficacy, and diabetes knowledge, but not in BMI. As for quality of life, no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded. No significant publication bias was found in the main outcomes. To get theory-based interventions to produce more effects, the role of patients should be more involved and stronger and the education team should be trained beyond the primary preparation for the self-management education program. © 2016 John Wiley & Sons Ltd.

  11. Pilot Trial of a Social Cognitive Theory-Based Physical Activity Intervention Delivered by Nonsupervised Technology in Persons With Multiple Sclerosis.

    Science.gov (United States)

    Suh, Yoojin; Motl, Robert W; Olsen, Connor; Joshi, Ina

    2015-07-01

    Physical inactivity is prevalent in people with multiple sclerosis (MS) and this highlights the importance of developing behavioral interventions for increasing physical activity (PA) in MS. This pilot trial examined the efficacy of a 6-week, behavioral intervention based on social cognitive theory (SCT) delivered by newsletters and phone calls for increasing PA in persons with MS who were physically inactive and had middle levels of self-efficacy. The sample included 68 persons with relapsing-remitting MS who were randomly assigned into intervention and control groups. The intervention group received SCT-based information by newsletters and phone calls, whereas the controls received information regarding topics such as stress management over 6 weeks. Participants completed self-report of PA and social cognitive variables. The intervention group had a significant increase in self-reported PA (d = 0.56, P = .02) over the 6 weeks, but the controls had a nonsignificant change (d = -0.13, P = .45). Goal setting was changed in the intervention group (d = 0.68, P ≤ .01) and identified as a significant mediator of change in self-reported PA. This study provides initial evidence for the benefit of a theory-based behavioral intervention for increasing PA in MS.

  12. Theory-based Osteoporosis Prevention Education and Counseling Program for Women: A Randomized Controlled Trial

    OpenAIRE

    Aslı Kalkım, RN, PhD; Şafak Dağhan, RN, PhD

    2017-01-01

    Purpose: The purpose of this research was to investigate the effect of an osteoporosis prevention program based on the Health Belief Model for women between the ages of 30 years and 45 years at risk of osteoporosis. Methods: This study was conducted with randomized control group pretest, post-test and follow-up trial. Intervention group (n = 37) and control group (n = 36) participated in the research. Data were collected using a sociodemographic data questionnaire, the Osteoporosis Knowled...

  13. A theory-based behavior-change intervention to reduce alcohol consumption in undergraduate students: trial protocol.

    Science.gov (United States)

    Hagger, Martin S; Wong, Ging Ging; Davey, Simon R

    2015-03-31

    Excessive alcohol consumption on single occasions among undergraduate students is a major health issue as research has shown this pattern of drinking to be related to maladaptive health and psychosocial outcomes. Brief, theory-based interventions targeting motivation and self-control as behavior-change techniques have been identified as effective means to reduce alcohol consumption, but few studies have examined the interactive effects of these components. The aim of the present study is to develop a brief theory-based intervention using motivational and self-control intervention techniques to reduce alcohol consumption in undergraduate students. The intervention will adopt a factorial design to test the main and interactive effects of the techniques on alcohol consumption. Using mental simulations and the strength model of self-control as the theoretical bases of the intervention, the study will adopt a fully randomized 2 (mental simulation: mental simulation vs. control irrelevant visualization exercise) × 2 (self-control training: challenging Stroop task vs. easy Stroop task) between-participants design. Non-abstinent undergraduate students aged 18 years or older will be eligible to participate in the study. Participants will complete an initial survey including self-reported alcohol consumption measures, measures of motivation and self- measures. Participants will be randomly allocated to receive either a mental simulation exercise presented in print format or a control irrelevant visualization exercise. Thereafter, participants will be randomly assigned to receive a challenging online self-control training exercise or an easy training exercise that has little self-control demand over the course of the next four weeks. Four weeks later participants will complete a follow-up alcohol consumption, motivation and self-control measures. This study will provide the first evidence for the individual and interactive effects of motivational and self-control training

  14. Theory to Practice: Self-Efficacy Related to Transfer of Learning as an Example of Theory-Based Instructional Design.

    Science.gov (United States)

    Carroll, Jan B.

    1993-01-01

    In social learning theory, perception of self-efficacy derives from accomplishments, vicarious experiences, verbal persuasion, and physiological states. Four corresponding instructional methods (practice, modeling, suggestion, climate setting) can be designed to ensure transfer of learning. (SK)

  15. Efficacy of psychological pain theory-based cognitive therapy in suicidal patients with major depressive disorder: A pilot study.

    Science.gov (United States)

    Zou, Yingmin; Li, Huanhuan; Shi, Chuan; Lin, Yixuan; Zhou, Hanyu; Zhang, Jiaqi

    2017-03-01

    The present study aimed to explore the effects of psychological pain theory-based cognitive therapy (PPTBCT) on suicide among depressed patients, compared with a control group who received usual psychological care (UPC). The sample consisted of 32 depressed patients and 32 healthy control subjects. All participants completed the Beck Scale for Suicide Ideation (BSI), Beck Depression Inventory, Three-Dimensional Psychological Pain Scale (TDPPS), and Problem Solving Inventory(PSI), and Automatic Thoughts Questionnaire (ATQ). All measures differed significantly between depressed patients and healthy controls. Then clinical participants were assigned randomly to the PPTBCT (n=19) and control (n=13) groups. During the 8-week intervention, scores related to depression, suicidal ideation, psychological pain, and automatic thoughts were decreased in both groups at the post-intervention and 4-week follow-up time points, compared with pre-intervention scores. BSI scores remained low at follow up and did not differ significantly from post-intervention scores in the PPTBCT group, but were significantly higher at follow up than at post-intervention in the control group. PPTBCT may effectively reduce suicide risk in patients with major depressive disorder, although the effects of its application need to be confirmed. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  16. A Causal Modelling Approach to the Development of Theory-Based Behaviour Change Programmes for Trial Evaluation

    Science.gov (United States)

    Hardeman, Wendy; Sutton, Stephen; Griffin, Simon; Johnston, Marie; White, Anthony; Wareham, Nicholas J.; Kinmonth, Ann Louise

    2005-01-01

    Theory-based intervention programmes to support health-related behaviour change aim to increase health impact and improve understanding of mechanisms of behaviour change. However, the science of intervention development remains at an early stage. We present a causal modelling approach to developing complex interventions for evaluation in…

  17. Mediation and moderation of an efficacious theory-based abstinence-only intervention for African American adolescents.

    Science.gov (United States)

    Zhang, Jingwen; Jemmott, John B; Jemmott, Loretta Sweet

    2015-12-01

    This secondary data analysis sought to determine what mediated reductions in self-reported sexual initiation over the 24-month postintervention period in early adolescents who received "Promoting Health among Teens," a theory-based, abstinence-only intervention (Jemmott, Jemmott, & Fong, 2010). African American Grade 6 and 7 students at inner-city public middle schools were randomized to 1 of 5 interventions grounded in social-cognitive theory and the theory of reasoned action: 8-hr abstinence-only targeting reduced sexual intercourse; 8-hr safer-sex-only targeting increased condom use; 8-hr and 12-hr comprehensive interventions targeting sexual intercourse and condom use; 8-hr control intervention targeting physical activity and diet. Primary outcome was self-report of vaginal intercourse by 24 months postintervention. Potential mediators, assessed immediately postintervention, were theory-of-reasoned-action variables, including behavioral beliefs about positive consequences of abstinence and negative consequences of sex, intention to have sex, normative beliefs about sex, and HIV and sexually transmitted infection (STI) knowledge. We tested single and serial mediation models using the product-of-coefficients approach. Of 509 students reporting never having vaginal intercourse at baseline (324 girls and 185 boys; mean age = 11.8 years, SD = 0.8), 500 or 98.2% were included in serial mediation analyses. Consistent with the theory of reasoned action, the abstinence-only intervention increased positive behavioral beliefs about abstinence, which reduced intention to have sex, which in turn reduced sexual initiation. Negative behavioral beliefs about sex, normative beliefs about sex, and HIV/STI knowledge were not mediators. Abstinence-only interventions should stress the gains to be realized from abstinence rather than the deleterious consequences of sexual involvement. (c) 2015 APA, all rights reserved).

  18. A theory-based online health behaviour intervention for new university students (U@Uni): results from a randomised controlled trial.

    Science.gov (United States)

    Epton, Tracy; Norman, Paul; Dadzie, Aba-Sah; Harris, Peter R; Webb, Thomas L; Sheeran, Paschal; Julious, Steven A; Ciravegna, Fabio; Brennan, Alan; Meier, Petra S; Naughton, Declan; Petroczi, Andrea; Kruger, Jen; Shah, Iltaf

    2014-06-05

    Too few young people engage in behaviours that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. This study sought to assess the efficacy and cost-effectiveness of a theory-based online health behaviour intervention (based on self-affirmation theory, the Theory of Planned Behaviour and implementation intentions) targeting these behaviours in new university students, in comparison to a measurement-only control. Two-weeks before starting university all incoming undergraduates at the University of Sheffield were invited to take part in a study of new students' health behaviour. A randomised controlled design, with a baseline questionnaire, and two follow-ups (1 and 6 months after starting university), was used to evaluate the intervention. Primary outcomes were measures of the four health behaviours targeted by the intervention at 6-month follow-up, i.e., portions of fruit and vegetables, metabolic equivalent of tasks (physical activity), units of alcohol, and smoking status. The study recruited 1,445 students (intervention n = 736, control n = 709, 58% female, Mean age = 18.9 years), of whom 1,107 completed at least one follow-up (23% attrition). The intervention had a statistically significant effect on one primary outcome, smoking status at 6-month follow-up, with fewer smokers in the intervention arm (8.7%) than in the control arm (13.0%; Odds ratio = 1.92, p = .010). There were no significant intervention effects on the other primary outcomes (physical activity, alcohol or fruit and vegetable consumption) at 6-month follow-up. The results of the RCT indicate that the online health behaviour intervention reduced smoking rates, but it had little effect on fruit and vegetable intake, physical activity or alcohol consumption, during the first six months at university. However, engagement with the intervention was low. Further research is needed before strong conclusions can be

  19. Field efficacy trials with sylvatic plague vaccine

    Science.gov (United States)

    Richgels, Katherine; Russell, Robin E.; Rocke, Tonie E.

    2017-01-01

    These data were collected as part of a field trial to test the efficacy of a sylvatic plague vaccine. Treatment and control sites were selected randomly from the available sites at each location. Site pairs were a minimum of 20 acres, (with a few exceptions). Prairie dog trapping took place a minimum of two weeks post-baiting and trapping procedures were approved by the NWHC Animal Care and Use Committee as well as individual states as required.

  20. A theory-based process evaluation alongside a randomised controlled trial of printed educational messages to increase primary care physicians' prescription of thiazide diuretics for hypertension [ISRCTN72772651].

    Science.gov (United States)

    Presseau, Justin; Grimshaw, Jeremy M; Tetroe, Jacqueline M; Eccles, Martin P; Francis, Jill J; Godin, Gaston; Graham, Ian D; Hux, Janet E; Johnston, Marie; Légaré, France; Lemyre, Louise; Robinson, Nicole; Zwarenstein, Merrick

    2016-09-13

    Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs. Theory-based process evaluations conducted alongside pragmatic randomised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change. The Ontario Printed Educational Materials (PEM) cluster trial was designed to increase family physicians' guideline-recommended prescription of thiazide diuretics. The trial found no intervention effect. Using the theory of planned behaviour (TPB), we hypothesised that changes in thiazide prescribing would be reflected in changes in intention, consistent with changes in attitude and subjective norm, with no change to their perceived behavioural control (PBC), and tested this alongside the RCT. We developed and sent TPB postal questionnaires to a random sub-sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs. We used analysis of covariance to test for group differences using a 2 × 3 factorial design. We content-analysed an open-ended question about perceived barriers to thiazide prescription. Using control group data, we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up. Four hundred twenty-six physicians completed pre- and post-intervention questionnaires. Baseline scores on measures of TPB constructs were high: intention mean = 5.9 out of 7 (SD = 1.4), attitude mean = 5.8 (SD = 1.1), subjective norm mean = 5.8 (SD = 1.1) and PBC mean = 6.2 (SD = 1.0). The arms did not significantly differ post-intervention on any of the theory-based constructs, suggesting a possible ceiling effect. Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific

  1. Effects of Theory-Based Behavioral Interventions on Physical Activity Among Overweight and Obese Female Cancer Survivors: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Rossi, Amerigo; Friel, Ciarán; Carter, Leeja; Garber, Carol Ewing

    2017-10-01

    To determine whether theory-based physical activity (PA) interventions for overweight and obese female cancer survivors lead to increased PA and improved health. This systematic review examined randomized controlled trials analyzing the impact of theory-based PA interventions on overweight and obese female cancer survivors through December 2016. Searches of 5 electronic databases revealed 10 articles that included 1351 participants who met the inclusion criteria. Participants were primarily non-Hispanic white (74%-100%) breast or endometrial cancer survivors. Intervention characteristics and PA assessment tools varied greatly. Adherence (68%-99%) and retention (79%-100%) were relatively high. Social cognitive theory was utilized as the theoretical construct in 9 of the 10 studies. Home-based interventions led to small improvements in PA (Cohen's d range = 0.25-0.31), whereas home-based plus center-based interventions led to moderate to large improvements (Cohen's d range = 0.45-1.02). Only three of the studies assessed psychosocial behavioral processes associated with PA, and the results were mixed. Health-related outcomes included improvements in aerobic fitness (Cohen's d = 0.32-1.1 in 5 studies), large absolute decreases in waist circumferences (>6 cm in 3 of 5 studies; Cohen's d = -0.31 to -1.02), and no change in inflammatory biomarkers (in 2 studies). Only one serious adverse event (pelvic stress fracture) was attributed to the interventions. Theory-based PA interventions are safe and feasible for overweight and obese female cancer survivors. Interventions that include a center-based component showed moderate to large effect sizes for PA. Future studies should evaluate behavioral variables and more health-related clinical outcomes.

  2. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kaner Eileen FS

    2008-11-01

    findings, thus offering an interpretation of the trial effects. This analytic approach demonstrates the potential of the TPB to explain trial effects in terms of different relationships between variables rather than differences in mean scores. This study illustrates the use of theory-based process evaluation to uncover processes underlying change in implementation trials.

  3. Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial.

    Science.gov (United States)

    Jemmott, John B; Jemmott, Loretta S; Ngwane, Zolani; Zhang, Jingwen; Heeren, G Anita; Icard, Larry D; O'Leary, Ann; Mtose, Xoliswa; Teitelman, Anne; Carty, Craig

    2014-07-01

    To determine whether a health-promotion intervention increases South African men's adherence to physical-activity guidelines. We utilized a cluster-randomized controlled trial design. Eligible clusters, residential neighborhoods near East London, South Africa, were matched in pairs. Within randomly selected pairs, neighborhoods were randomized to theory-based, culturally congruent health-promotion intervention encouraging physical activity or attention-matched HIV/STI risk-reduction control intervention. Men residing in the neighborhoods and reporting coitus in the previous 3 months were eligible. Primary outcome was self-reported individual-level adherence to physical-activity guidelines averaged over 6-month and 12-month post-intervention assessments. Data were collected in 2007-2010. Data collectors, but not facilitators or participants, were blind to group assignment. Primary outcome intention-to-treat analysis included 22 of 22 clusters and 537 of 572 men in the health-promotion intervention and 22 of 22 clusters and 569 of 609 men in the attention-control intervention. Model-estimated probability of meeting physical-activity guidelines was 51.0% in the health-promotion intervention and 44.7% in attention-matched control (OR=1.34; 95% CI, 1.09-1.63), adjusting for baseline prevalence and clustering from 44 neighborhoods. A theory-based culturally congruent intervention increased South African men's self-reported physical activity, a key contributor to deaths from non-communicable diseases in South Africa. ClinicalTrials.gov Identifier: NCT01490359. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Efficacy and effectiveness trials have different goals, use different tools, and generate different messages.

    Science.gov (United States)

    Porzsolt, Franz; Rocha, Natália Galito; Toledo-Arruda, Alessandra C; Thomaz, Tania G; Moraes, Cristiane; Bessa-Guerra, Thais R; Leão, Mauricio; Migowski, Arn; Araujo da Silva, André R; Weiss, Christel

    2015-01-01

    The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.

  5. A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): results from a repeat randomized controlled trial.

    Science.gov (United States)

    Cameron, David; Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L; Julious, Steven A; Brennan, Alan; Thomas, Chloe; Petroczi, Andrea; Naughton, Declan; Shah, Iltaf

    2015-12-07

    This paper reports the results of a repeat trial assessing the effectiveness of an online theory-based intervention to promote healthy lifestyle behaviours in new university students. The original trial found that the intervention reduced the number of smokers at 6-month follow-up compared with the control condition, but had non-significant effects on the other targeted health behaviours. However, the original trial suffered from low levels of engagement, which the repeat trial sought to rectify. Three weeks before staring university, all incoming undergraduate students at a large university in the UK were sent an email inviting them to participate in the study. After completing a baseline questionnaire, participants were randomly allocated to intervention or control conditions. The intervention consisted of a self-affirmation manipulation, health messages based on the theory of planned behaviour and implementation intention tasks. Participants were followed-up 1 and 6 months after starting university. The primary outcome measures were portions of fruit and vegetables consumed, physical activity levels, units of alcohol consumed and smoking status at 6-month follow-up. The study recruited 2,621 students (intervention n=1346, control n=1275), of whom 1495 completed at least one follow-up (intervention n=696, control n=799). Intention-to-treat analyses indicated that the intervention had a non-significant effect on the primary outcomes, although the effect of the intervention on fruit and vegetable intake was significant in the per-protocol analyses. Secondary analyses revealed that the intervention had significant effects on having smoked at university (self-report) and on a biochemical marker of alcohol use. Despite successfully increasing levels of engagement, the intervention did not have a significant effect on the primary outcome measures. The relatively weak effects of the intervention, found in both the original and repeat trials, may be due to the focus on

  6. Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians' diabetic retinopathy referrals [Trial registration number ISRCTN72772651].

    Science.gov (United States)

    Grimshaw, Jeremy M; Presseau, Justin; Tetroe, Jacqueline; Eccles, Martin P; Francis, Jill J; Godin, Gaston; Graham, Ian D; Hux, Janet E; Johnston, Marie; Légaré, France; Lemyre, Louise; Robinson, Nicole; Zwarenstein, Merrick

    2014-08-06

    Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy screening. We hypothesized that the PEMs would increase physicians' intention to refer patients for retinal screening by strengthening their attitude and subjective norm, but not their perceived behavioral control. Design: A theory based process evaluation alongside the Ontario Printed Educational Material (OPEM) cluster randomized trial. Postal surveys based on the Theory of Planned Behavior were sent to a random sample of trial participants two months before and six months after they received the intervention. Setting: Family physicians in Ontario, Canada. Participants: 1,512 family physicians (252 per intervention group) from the OPEM trial were invited to participate, and 31.3% (473/1512) responded at time one and time two. The final sample comprised 437 family physicians fully completing questionnaires at both time points. Main Outcome Measures: Primary: behavioral intention related to referring patient for retinopathy screening; secondary: attitude, subjective norm, perceived behavioral control. At baseline, family physicians reported positive intention, attitude, subjective norm, and perceived behavioral control to advise patients about retinopathy screening suggesting limited opportunities for improvement in these constructs. There were no significant differences on intention, attitude, subjective norm, and perceived behavioral control following the intervention. Respondents also reported additional physician- and patient-related factors perceived to influence whether patients received

  7. Efficacy versus effectiveness trials : informing guidelines for asthma management

    NARCIS (Netherlands)

    Price, David; Hillyer, Elizabeth V.; van der Molen, Thys

    Purpose of review Randomized controlled trials, known as efficacy trials and long considered the gold standard for evidence-based asthma guidelines, are designed to test whether interventions have a benefit for selective patient populations under ideal conditions. The goal of pragmatic trials and

  8. Explaining Physical Activity Maintenance After a Theory-Based Intervention Among Patients With Rheumatoid Arthritis: Process Evaluation of a Randomized Controlled Trial.

    Science.gov (United States)

    Knittle, Keegan; De Gucht, Véronique; Hurkmans, Emalie; Vlieland, Thea Vliet; Maes, Stan

    2016-02-01

    Regular physical activity (PA) benefits patients with rheumatoid arthritis (RA), particularly when maintained over time. Research in this area has largely focused on factors associated with initiating PA, while factors contributing to PA maintenance, particularly after lifestyle interventions, have received less attention. This study examined whether higher levels of autonomous motivation, self-efficacy for PA, and greater use of self-regulation skills mediated PA initiation and maintenance 6 months after a theory-based motivational interviewing and self-regulation coaching intervention. Seventy-eight individuals with RA were randomized to receive either a patient-education session (control group), or the patient-education session plus 1 motivational interview and 2 self-regulation coaching sessions (treatment group). Mediation analyses examined the effects of this intervention on PA initiation and maintenance through the intermediate variables autonomous motivation, self-efficacy for PA, and use of self-regulation skills. Analyses were controlled for age, sex, and previous levels of PA. The treatment group reported significantly higher autonomous motivation and greater use of self-regulation skills than controls at posttreatment. Increases in PA from baseline to posttreatment were not mediated by any intermediate variables. However, maintenance of PA from posttreatment to followup (6 months later) was mediated by greater autonomous motivation and use of self-regulation skills. Greater autonomous motivation and use of self-regulation skills predict maintenance of PA following a motivational interviewing and self-regulation coaching intervention. In promoting PA among patients with RA, supporting patient autonomy and teaching self-regulation skills, which focus attention on achieving PA goals, may improve long-term maintenance of PA. © 2016, American College of Rheumatology.

  9. The effect of implementing cognitive load theory-based design principles in virtual reality simulation training of surgical skills: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars

    2016-01-01

    Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation training...

  10. A randomised controlled trial of a theory-based intervention to improve sun protective behaviour in adolescents ('you can still be HOT in the shade': study protocol

    Directory of Open Access Journals (Sweden)

    Hawkes Anna L

    2012-01-01

    Full Text Available Abstract Background Most skin cancers are preventable by encouraging consistent use of sun protective behaviour. In Australia, adolescents have high levels of knowledge and awareness of the risks of skin cancer but exhibit significantly lower sun protection behaviours than adults. There is limited research aimed at understanding why people do or do not engage in sun protective behaviour, and an associated absence of theory-based interventions to improve sun safe behaviour. This paper presents the study protocol for a school-based intervention which aims to improve the sun safe behaviour of adolescents. Methods/design Approximately 400 adolescents (aged 12-17 years will be recruited through Queensland, Australia public and private schools and randomized to the intervention (n = 200 or 'wait-list' control group (n = 200. The intervention focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during three × one hour sessions over a three week period from a trained facilitator during class time. Data will be collected one week pre-intervention (Time 1, and at one week (Time 2 and four weeks (Time 3 post-intervention. Primary outcomes are intentions to sun protect and sun protection behaviour. Secondary outcomes include attitudes toward performing sun protective behaviours (i.e., attitudes, perceptions of normative support to sun protect (i.e., subjective norms, group norms, and image norms, and perceived control over performing sun protective behaviours (i.e., perceived behavioural control. Discussion The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of adolescents.

  11. Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial.

    Science.gov (United States)

    Wileman, Vari; Chilcot, Joseph; Armitage, Christopher J; Farrington, Ken; Wellsted, David M; Norton, Sam; Davenport, Andrew; Franklin, Gail; Da Silva Gane, Maria; Horne, Robert; Almond, Mike

    2016-01-01

    Haemodialysis patients are at risk of serious health complications; yet, treatment non-adherence remains high. Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory reduced resistance to health-risk information and improved fluid treatment adherence. In a cluster randomised controlled trial, 91 patients either self-affirmed or completed a matched control task before reading about the health-risks associated with inadequate fluid control. Patients' perceptions of the health-risk information, intention and self-efficacy to control fluid were assessed immediately after presentation of health-risk information. Interdialytic weight gain (IDWG), excess fluid removed during haemodialysis, is a clinical measure of fluid treatment adherence. IDWG data were collected up to 12 months post-intervention. Self-affirmed patients had significantly reduced IDWG levels over 12 months. However, contrary to predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, intention to control fluid or self-efficacy. A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce IDWG over a 12-month period, but the mechanism by which this apparent behaviour change occurred is uncertain. Further work is still required to identify mediators of the observed effects.

  12. The effect of implementing cognitive load theory-based design principles in virtual reality simulation training of surgical skills: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars

    2016-01-01

    . Increased cognitive load when part tasks needed to be integrated in the post-training procedures could be a possible explanation for this. Other instructional designs and methods are needed to lower the cognitive load and improve the performance in virtual reality surgical simulation training of novices.......Background Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation...... training of mastoidectomy. Methods Eighteen novice medical students received 1 h of self-directed virtual reality simulation training of the mastoidectomy procedure randomized for standard instructions (control) or cognitive load theory-based instructions with a worked example followed by a problem...

  13. First generation leishmaniasis vaccines: a review of field efficacy trials.

    Science.gov (United States)

    Noazin, Sassan; Modabber, Farrokh; Khamesipour, Ali; Smith, Peter G; Moulton, Lawrence H; Nasseri, Kiumarss; Sharifi, Iraj; Khalil, Eltahir A G; Bernal, Ivan Dario Velez; Antunes, Carlos M F; Kieny, Marie Paule; Tanner, Marcel

    2008-12-09

    First generation candidate vaccines against leishmaniasis, prepared using inactivated whole parasites as their main ingredient, were considered as promising because of their relative ease of production and low cost. These vaccines have been the subject of many investigations over several decades and are the only leishmaniasis vaccine candidates which have undergone phase 3 clinical trial evaluation. Although the studies demonstrated the safety of the vaccines and several studies showed reasonable immunogenicity and some indication of protection, an efficacious prophylactic vaccine is yet to be identified. Despite this overall failure, these trials contributed significantly to increasing knowledge on human leishmaniasis immunology. To provide a collective view, this review discusses the methods and findings of field efficacy trials of first generation leishmaniasis vaccine clinical trials conducted in the Old and New Worlds.

  14. Preparing for future efficacy trials of severe malaria vaccines.

    Science.gov (United States)

    Gonçalves, Bronner P; Prevots, D Rebecca; Kabyemela, Edward; Fried, Michal; Duffy, Patrick E

    2016-04-07

    Severe malaria is a major cause of mortality in children, but comprises only a small proportion of Plasmodium falciparum infections in naturally exposed populations. The evaluation of vaccines that prevent severe falciparum disease will require clinical trials whose primary efficacy endpoint will be severe malaria risk during follow-up. Here, we show that such trials are feasible with fewer than 1000 participants in areas with intense malaria transmission during the age interval when severe malaria incidence peaks. Published by Elsevier Ltd.

  15. Looking inside the black box: a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM to improve referral and prescribing practices in primary care in Ontario, Canada

    Directory of Open Access Journals (Sweden)

    Lemyre Louise

    2007-11-01

    Full Text Available Abstract Background Randomised controlled trials of implementation strategies tell us whether (or not an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths. This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB that incorporates these constructs. Methods/design We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial, in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use

  16. The effect of implementing cognitive load theory-based design principles in virtual reality simulation training of surgical skills: a randomized controlled trial.

    Science.gov (United States)

    Andersen, Steven Arild Wuyts; Mikkelsen, Peter Trier; Konge, Lars; Cayé-Thomasen, Per; Sørensen, Mads Sølvsten

    2016-01-01

    Cognitive overload can inhibit learning, and cognitive load theory-based instructional design principles can be used to optimize learning situations. This study aims to investigate the effect of implementing cognitive load theory-based design principles in virtual reality simulation training of mastoidectomy. Eighteen novice medical students received 1 h of self-directed virtual reality simulation training of the mastoidectomy procedure randomized for standard instructions (control) or cognitive load theory-based instructions with a worked example followed by a problem completion exercise (intervention). Participants then completed two post-training virtual procedures for assessment and comparison. Cognitive load during the post-training procedures was estimated by reaction time testing on an integrated secondary task. Final-product analysis by two blinded expert raters was used to assess the virtual mastoidectomy performances. Participants in the intervention group had a significantly increased cognitive load during the post-training procedures compared with the control group (52 vs. 41 %, p  = 0.02). This was also reflected in the final-product performance: the intervention group had a significantly lower final-product score than the control group (13.0 vs. 15.4, p  Increased cognitive load when part tasks needed to be integrated in the post-training procedures could be a possible explanation for this. Other instructional designs and methods are needed to lower the cognitive load and improve the performance in virtual reality surgical simulation training of novices.

  17. Efficacy trials of biomedical strategies to prevent HIV infection.

    Science.gov (United States)

    Kaldor, John M; Guy, Rebecca J; Wilson, David

    2008-07-01

    The aim of this article is to outline key challenges facing the conduct of efficacy trials for biomedical strategies to prevent HIV infection. The past 2-3 years have seen tumultuous development in this field. There have been disappointing findings in efficacy trials of vaginal microbicides, vaccines, the diaphragm and suppressive therapy for herpes, but a major breakthrough with the evidence that male circumcision prevents acquisition of infection. Meanwhile, clarity has started to emerge on a number of issues regarding trial conduct, including provision of standard of care, involvement of communities, and preparation for implementing effective interventions. HIV prevention practice must continue to rely on condom promotion and other established strategies while biomedical approaches continue to be assessed and their implementation strategies evolve.

  18. The relation between quality of clinical trials and acupuncture efficacy

    Directory of Open Access Journals (Sweden)

    David Gonçalves Nordon

    2013-06-01

    Full Text Available Introduction: Clinical trials of acupuncture not always have concordant results, mostly due to their great heterogeneity. Two indexes have been developed to analyze the quality of acupuncture trials. This study hypothesizes that, the more adequate the intervention and the control techniques, the more efficacious the acupuncture. Methods: Both indexes were applied to 27 randomized clinical trials comparing acupuncture to placebo. Results were compared by using the Mann-Whitney test. Results: Studies favorable to acupuncture had a intervention score’s median of 11.5; for the unfavorable ones, it was 7, p: 0.0017. Articles with and without statistically significant differences, though, had the same median for their scores in the control index: 6. Discussion: There is a positive relation between a better score for acupuncture technique and a statistically significant difference between acupuncture and interventional control. However, due to the little heterogeneity in the degree of physiological effect from each article, the control index had no statistical significance. Conclusion: This study established that, among acupuncture RCT controlled by placebo or sham of moderate physiological effect, the adequacy of the technique is more important than the adequacy of control in establishing a statistically significant difference between acupuncture and interventional control.

  19. Project TEAMS (Talking about Eating, Activity, and Mutual Support: a randomized controlled trial of a theory-based weight loss program for couples

    Directory of Open Access Journals (Sweden)

    Amy A. Gorin

    2017-09-01

    Full Text Available Abstract Background Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT, greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one’s spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Methods Project TEAMS (Talking about Eating, Activity, and Mutual Support is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other’s eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL or to 6 months of standard behavioral weight loss treatment (BWL. Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. Discussion This

  20. Theory-Based Interventions Combining Mental Simulation and Planning Techniques to Improve Physical Activity: Null Results from Two Randomized Controlled Trials.

    Science.gov (United States)

    Meslot, Carine; Gauchet, Aurélie; Allenet, Benoît; François, Olivier; Hagger, Martin S

    2016-01-01

    Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioral theories advocate the importance of both motivation and volition in interventions to change health behavior. Interventions adopting self-regulation strategies that foster motivational and volitional components may, therefore, have utility in promoting regular physical activity participation. We tested the efficacy of an intervention adopting motivational (mental simulation) and volitional (implementation intentions) components to promote a regular physical activity in two studies. Study 1 adopted a cluster randomized design in which participants (n = 92) were allocated to one of three conditions: mental simulation plus implementation intention, implementation intention only, or control. Study 2 adopted a 2 (mental simulation vs. no mental simulation) × 2 (implementation intention vs. no implementation intention) randomized controlled design in which fitness center attendees (n = 184) were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behavior was measured by self-report (Study 1) or fitness center attendance (Study 2) at 4- (Studies 1 and 2) and 19- (Study 2 only) week follow-up periods. Findings revealed no statistically significant main or interactive effects of the mental simulation and implementation intention conditions on physical activity outcomes in either study. Findings are in contrast to previous research which has found pervasive effects for both intervention strategies. Findings are discussed in light of study limitations including the relatively small sample sizes, particularly for Study 1, deviations in the operationalization of the intervention components from previous research and the lack of a prompt for a goal intention. Future research should focus on ensuring uniformity in the format of the

  1. Theory-based interventions combining mental simulation and planning techniques to improve physical activity: Null results from two randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Carine Meslot

    2016-11-01

    Full Text Available Interventions to assist individuals in initiating and maintaining regular participation in physical activity are not always effective. Psychological and behavioural theories advocate the importance of both motivation and volition in interventions to change health behaviour. Interventions adopting self-regulation strategies that foster motivational and volitional components may, therefore, have utility in promoting regular physical activity participation. We tested the efficacy of an intervention adopting motivational (mental simulation and volitional (implementation intentions components to promote a regular physical activity in two studies. Study 1 adopted a cluster randomised design students in which participants (n=92 were allocated to one of three conditions: mental simulation plus implementation intention, implementation intention only, or control. Study 2 adopted a 2 (mental simulation vs. no mental simulation x 2 (implementation intention vs. no implementation intention randomised controlled design in which fitness centre attendees (n=184 were randomly allocated one of four conditions: mental simulation only, implementation intention only, combined, or control. Physical activity behaviour was measured by self-report (Study 1 or fitness centre attendance (Study 2 at 4- (Studies 1 and 2 and 19- (Study 2 only week follow-up periods. Findings revealed no statistically significant main or interactive effects of the mental simulation and implementation intention conditions on physical activity outcomes in either study. Despite adopting protocols consistent with previous research, utilizing objective behavioural measures, and having sufficient statistical power, results provide evidence that, in contrast to previous findings, the motivational and volitional components are not effective in changing physical activity behaviour. Future research should focus on the format of the intervention components, test the effects of each component alone and

  2. Communication style and exercise compliance in physiotherapy (CONNECT. A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Lonsdale Chris

    2012-06-01

    they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded. We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. Discussion This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients’ adherence to rehabilitation recommendations. Trial Registration Current Controlled Trials ISRCTN63723433

  3. Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trial

    National Research Council Canada - National Science Library

    Shuaib, Ashfaq; Bornstein, Natan M; Diener, Hans-Christoph; Dillon, William; Fisher, Marc; Hammer, Maxim D; Molina, Carlos A; Rutledge, J Neal; Saver, Jeffrey L; Schellinger, Peter D; Shownkeen, Harish

    2011-01-01

    .... The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management...

  4. Resin infiltration of caries lesions: an efficacy randomized trial.

    Science.gov (United States)

    Paris, S; Hopfenmuller, W; Meyer-Lueckel, H

    2010-08-01

    Resin infiltration is an innovative approach to arrest progression of caries lesions. The aim of this randomized split-mouth placebo-controlled clinical trial was to assess whether resin infiltration of proximal lesions is more effective than non-operative measures alone with respect to the inhibition of caries progression. In 22 young adults, 29 pairs of interproximal lesions with radiological extension into the inner half of enamel or the outer third of dentin were randomly allocated to two treatment groups. In the test group, lesions were infiltrated (Icon, pre-product; DMG). A placebo treatment was performed in the control group. All participants received instructions for diet, flossing, and fluoridation. The primary outcome after 18 months was radiographic lesion progression (assessed by digital subtraction radiography). No unwanted effects could be observed. In the effect group, 2/27 lesions (7%) and in the control group 10/27 lesions (37%) showed progression (p = 0.021; McNemar). Infiltration of interproximal caries lesions is efficacious in reducing lesion progression.

  5. Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods.

    Science.gov (United States)

    Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

    2012-06-15

    received the communication skills training. Outcome assessors will also be blinded.We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients' adherence to rehabilitation recommendations.

  6. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial.

    Science.gov (United States)

    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

    2014-04-01

    This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 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 the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; 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 the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

  7. Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

    Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

  8. An open-label Optional Titration Trial to Evaluate the Efficacy ...

    African Journals Online (AJOL)

    An open-label Optional Titration Trial to Evaluate the Efficacy, Tolerability and Safety of Valsartan in Patients with Mild to Moderate Essential Hypertension Treated for 8 Weeks in the Lagos University Teaching Hospita.

  9. Efficacy trial of heat-inactivated hepatitis B vaccine (CLB) in male homosexuals in the Netherlands

    NARCIS (Netherlands)

    Coutinho, R. A.; Lelie, P. N.; Albrecht-van Lent, P.; Stoutjesdijk, L.; Huisman, J.; Kuipers, H.; Schut, L. J.; Reerink-Brongers, E. E.; Reesink, H. W.; van Aken, W. G.

    1983-01-01

    The efficacy of a heat-inactivated hepatitis B virus (HBV) vaccine, containing 3 micrograms-HBsAg, was studied among a group of 800 susceptible homosexual men. The trial was conducted randomized, placebo-controlled and double blind. At the trial end point (21.5 months) the attack-rate for all HBV

  10. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia...... sericata applied on ulcers with various aetiologies. Of these, seven studies had debridement and/or healing as an outcome variable. When evaluating maggots as debriding agents, the studies report MDT as being significantly more effective than hydrogel or a mixture of conventional therapy modalities...

  11. A Feasibility and Efficacy Randomized Controlled Trial of an Online Preventative Program for Childhood Obesity: Protocol for the EMPOWER Intervention.

    Science.gov (United States)

    Knowlden, Adam; Sharma, Manoj

    2012-06-21

    The home and family environment is a highly influential psychosocial antecedent of pediatric obesity. Implementation of conventional family- and home-based childhood obesity interventions is challenging for parents, often requiring them to attend multiple educational sessions. Attrition rates for traditional interventions are frequently high due to competing demands for parents' time. Under such constraints, an Internet-based intervention has the potential to modify determinants of childhood obesity while making judicious use of parents' time. Theory-based interventions offer many advantages over atheoretical interventions, including reduced intervention dosage, increased likelihood of behavioral change, and efficient resource allocation. Social cognitive theory (SCT) is a robust theoretical framework for addressing childhood obesity. SCT is a behavior change model rooted in reciprocal determinism, a causal paradigm that states that human functioning is the product of a dynamic interplay of behavioral, personal, and environmental factors. To evaluate the efficacy of the Enabling Mothers to Prevent Childhood Obesity Through Web-Based Education and Reciprocal Determinism (EMPOWER) program, an Internet-based, theory-driven intervention for preventing childhood overweight and obesity. The project goal is supported by two specific aims: (1) modification of four obesogenic protective factors related to childhood obesity (minutes engaged in physical activity, servings of fruits and vegetables consumed, servings of sugar-sweetened and sugar-free beverages consumed, and minutes engaged in screen time), and (2) reification of five maternal-mediated constructs of SCT (environment, expectations, emotional coping, self-control, and self-efficacy). We will recruit mothers with children ages 4 to 6 years from childcare centers and randomly assign them to either the theory-based (experimental) or knowledge-based (control) arm of the trial. Data for the intervention will be

  12. Lessons learnt from the first efficacy trial of a new infant tuberculosis vaccine since BCG.

    Science.gov (United States)

    Tameris, Michele; McShane, Helen; McClain, J Bruce; Landry, Bernard; Lockhart, Stephen; Luabeya, Angelique K K; Geldenhuys, Hennie; Shea, Jacqui; Hussey, Gregory; van der Merwe, Linda; de Kock, Marwou; Scriba, Thomas; Walker, Robert; Hanekom, Willem; Hatherill, Mark; Mahomed, Hassan

    2013-03-01

    New tuberculosis (TB) vaccines are being developed to combat the global epidemic. A phase IIb trial of a candidate vaccine, MVA85A, was conducted in a high burden setting in South Africa to evaluate proof-of-concept efficacy for prevention of TB in infants. To describe the study design and implementation lessons from an infant TB vaccine efficacy trial. This was a randomised, controlled, double-blind clinical trial comparing the safety and efficacy of MVA85A to Candin control administered to 4-6-month-old, BCG-vaccinated, HIV-negative infants at a rural site in South Africa. Infants were followed up for 15-39 months for incident TB disease based on pre-specified endpoints. 2797 infants were enrolled over 22 months. Factors adversely affecting recruitment and the solutions that were implemented are discussed. Slow case accrual led to six months extension of trial follow up. The clinical, regulatory and research environment for modern efficacy trials of new TB vaccines are substantially different to that when BCG vaccine was first evaluated in infants. Future infant TB vaccine trials will need to allocate sufficient resources and optimise operational efficiency. A stringent TB case definition is necessary to maximize specificity, and TB case accrual must be monitored closely. Copyright © 2013 Elsevier Ltd. All rights reserved.

  13. Brief Self-Efficacy Scales for use in Weight-Loss Trials: Preliminary Evidence of Validity

    Science.gov (United States)

    Wilson, Kathryn E.; Harden, Samantha M.; Almeida, Fabio A.; You, Wen; Hill, Jennie L.; Goessl, Cody; Estabrooks, Paul A.

    2015-01-01

    Self-efficacy is a commonly included cognitive variable in weight-loss trials, but there is little uniformity in its measurement. Weight-loss trials frequently focus on physical activity (PA) and eating behavior, as well as weight loss, but no survey is available that offers reliable measurement of self-efficacy as it relates to each of these targeted outcomes. The purpose of this study was to test the psychometric properties of brief, pragmatic self-efficacy scales specific to PA, healthful eating and weight-loss (4 items each). An adult sample (n=1790) from 28 worksites enrolled in a worksite weight-loss program completed the self-efficacy scale, as well as measures of PA, dietary fat intake, and weight, at baseline, 6-, and 12-months. The hypothesized factor structure was tested through confirmatory factor analysis, which supported the expected factor structure for three latent self-efficacy factors, specific to PA, healthful eating, and weight-loss. Measurement equivalence/invariance between relevant demographic groups, and over time was also supported. Parallel growth processes in self-efficacy factors and outcomes (PA, fat intake, and weight) support the predictive validity of score interpretations. Overall, this initial series of psychometric analyses supports the interpretation that scores on these scales reflect self-efficacy for PA, healthful eating, and weight-loss. The use of this instrument in large-scale weight-loss trials is encouraged. PMID:26619093

  14. randomised controlled trial of the efficacy of misoprostol used

    African Journals Online (AJOL)

    practice for cervical ripening in first-trimester abortions, but because of .... All women participating in the trial gave written informed consent. Design. Women were counselled and assessed by staff at the TOP unit and given a date for the procedure. On the day ... estimated placebo effect of 30% of women achieving sufficient.

  15. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two ...

  16. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial

    OpenAIRE

    Allegretti,Carlos E.; Sampaio, Roberta M.; Horliana, Anna C. R. T.; Armonia, Paschoal L.; Rocha,Rodney G.; Tortamano, Isabel Peixoto

    2016-01-01

    Abstract Inferior alveolar nerve block has a high failure rate in the treatment of mandibular posterior teeth with irreversible pulpitis. The aim of this study was to compare the anesthetic efficacy of 4% articaine, 2% lidocaine and 2% mepivacaine, all in combination with 1:100,000 epinephrine, in patients with irreversible pulpitis of permanent mandibular molars during a pulpectomy procedure. Sixty-six volunteers from the Emergency Center of the School of Dentistry, University of São Paulo, ...

  17. Open Label Trial of the Tolerability and Efficacy of Zonisamide in the Treatment of Alcohol Dependence

    OpenAIRE

    Knapp, Clifford M.; Sarid-Segal, Ofra; Richardson, Mark A.; Colaneri, Laurie Sickles; Afshar, Maryam; Devine, Eric; Streeter, Chris C.; Piechniczek-Buczek, Joanne; Ciraulo, Domenic A.

    2010-01-01

    Objectives: The objectives of this study are to assess the tolerability and efficacy of the anticonvulsant zonisamide in an open label trial of the treatment of alcohol dependence. Methods: In this trial, zonisamide (400-mg daily) was administered to alcohol-dependent subjects (ADS) (n = 16) over 13 weeks. The mean daily consumption of standard alcoholic drinks and performance on a verbal fluency task, the COWAT, and on a measure of attention and visuomotor speed, the DSMT were assessed, and ...

  18. Theory-based interventions for contraception.

    Science.gov (United States)

    Lopez, Laureen M; Grey, Thomas W; Chen, Mario; Tolley, Elizabeth E; Stockton, Laurie L

    2016-11-23

    The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base. To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use. To 1 November 2016, we searched for trials that tested a theory-based intervention for improving contraceptive use in PubMed, CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. For the initial review, we wrote to investigators to find other trials. Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use. We assessed titles and abstracts identified during the searches. One author extracted and entered the data into Review Manager; a second author verified accuracy. We examined studies for methodological quality.For unadjusted dichotomous outcomes, we calculated the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Cluster randomized trials used various methods of accounting for the clustering, such as multilevel modeling. Most reports did not provide information to calculate the effective sample size. Therefore, we presented the results as reported by the investigators. We did not conduct meta-analysis due to varied interventions and outcome measures. We included 10 new trials for a total of 25. Five were conducted outside the USA. Fifteen randomly assigned individuals and 10 randomized clusters. This section focuses on nine trials with high or

  19. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2008-01-01

    The transversus abdominis plane (TAP) block is an effective method of providing postoperative analgesia in patients undergoing midline abdominal wall incisions. We evaluated its analgesic efficacy over the first 48 postoperative hours after cesarean delivery performed through a Pfannensteil incision, in a randomized controlled, double-blind, clinical trial.

  20. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  1. Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

    NARCIS (Netherlands)

    Cheng, Y.Y.; Schouten, J.S.A.G.; Tahzib, N.G.; Wijdh, R.J.; Pels, E.; Cleynenbreugel, H. van; Eggink, C.A.; Rijneveld, W.J.; Nuijts, R.M.

    2009-01-01

    BACKGROUND: To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. METHODS: A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease

  2. Efficacy and Safety of Femtosecond Laser-Assisted Corneal Endothelial Keratoplasty : A Randomized Multicenter Clinical Trial

    NARCIS (Netherlands)

    Cheng, Yanny Y. Y.; Schouten, Jan S. A. G.; Tahzib, Nayyirih G.; Wijdh, Robert-Jan; Pels, Elisabeth; van Cleynenbreugel, Hugo; Eggink, Catharina A.; Rijneveld, Wilhelmina J.; Nuijts, Rudy M. M. A.

    2009-01-01

    Background. To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. Methods. A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease

  3. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  4. Efficacy of a Universal Parent Training Program (HOPE-20): Cluster Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Kwan, H. W.

    2017-01-01

    Objective: This study examined the efficacy of Hands-On Parent Empowerment-20 (HOPE-20) program. Methods: Eligible participants were parents residing in Hong Kong with target children aged 2 years attending nursery schools. Cluster randomized control trial was adopted, with 10 schools (110 participants) assigned to intervention group and 8 schools…

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

    Science.gov (United States)

    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…

  6. Theory-Based Evaluation: Reflections Ten Years On. Theory-Based Evaluation: Past, Present, and Future

    Science.gov (United States)

    Rogers, Patricia J.; Weiss, Carol H.

    2007-01-01

    This chapter begins with a brief introduction by Rogers, in which she highlights the continued salience of Carol Weiss's decade-old questions about theory-based evaluation. Theory-based evaluation has developed significantly since Carol Weiss's chapter was first published ten years ago. In 1997 Weiss pointed to theory-based evaluation being mostly…

  7. Self-efficacy as a predictor of weight change and behavior change in the PREMIER trial.

    Science.gov (United States)

    Wingo, Brooks C; Desmond, Renee A; Brantley, Phillip; Appel, Lawrence; Svetkey, Laura; Stevens, Victor J; Ard, Jamy D

    2013-01-01

    Determine whether self-efficacy independently predicted weight loss in a behavioral intervention and explore factors that influence the path between self-efficacy and weight change. Secondary analysis of the PREMIER trial, a randomized controlled trial testing effects of lifestyle interventions on blood pressure. Four academic medical centers. PREMIER recruited adults (n = 810) with pre-hypertension/stage 1 hypertension, not currently receiving medication. This analysis excluded participants in the control arm, resulting in n = 537. Participants were randomly assigned to 1 of 3 groups: advice only, established lifestyle recommendations, or established lifestyle recommendations plus Dietary Approaches to Stop Hypertension dietary pattern. Self-efficacy (dietary self-efficacy [DSE], exercise self-efficacy [ESE]), dietary intake, fitness. Pearson correlations, 1-way analysis of variance, mediation analyses. Despite an overall decrease in DSE/ESE, change in DSE/ESE significantly predicted weight change at 6 (β = -.21, P self-efficacy and adoption of behaviors that influence weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  8. Couple-focused human immunodeficiency virus prevention for young Latino parents: randomized clinical trial of efficacy and sustainability.

    Science.gov (United States)

    Koniak-Griffin, Deborah; Lesser, Janna; Takayanagi, Sumiko; Cumberland, William G

    2011-04-01

    To evaluate the efficacy and sustainability of a couple-focused human immunodeficiency virus (HIV) prevention intervention in reducing unprotected sex and increasing intent to use condoms and knowledge about AIDS. Randomized controlled trial. Urban community settings in Southern California. Primarily Latino couples (168 couples; 336 individuals) who were aged 14 to 25 years, English or Spanish speaking, and coparenting a child at least 3 months of age. A 12-hour theory-based, couple-focused HIV prevention program culturally tailored for young Latino parents, with emphasis on family protection, skill building, and issues related to gender and power. The 1½-hour control condition provided basic HIV-AIDS information. Primary outcome measures included self-report of condom use during the past 3 months; secondary, intent to use condoms and knowledge about AIDS. The HIV prevention intervention reduced the proportion of unprotected sex episodes (odds ratio, 0.87 per month from baseline to 6 months; 95% confidence interval [CI], 0.82-0.93) and increased intent to use condoms (slope increase, 0.20; 95% CI, 0.04-0.37) at the 6-month follow-up; however, these effects were not sustained at 12 months. Knowledge about AIDS was increased in both groups from baseline to 6 months (slope estimate, 0.57; 95% CI, 0.47-0.67) and was maintained in the intervention group only through 12 months. Female participants in both groups had higher intent to use condoms and knowledge about AIDS than male participants (P ≤ .01). The couple-focused HIV prevention intervention reduced risky sexual behaviors and improved intent to use condoms among young Latino parents at the 6-month evaluation. A maintenance program is needed to improve the sustainability of effects over time.

  9. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Allegretti, Carlos E; Sampaio, Roberta M; Horliana, Anna C R T; Armonia, Paschoal L; Rocha, Rodney G; Tortamano, Isabel Peixoto

    2016-01-01

    Inferior alveolar nerve block has a high failure rate in the treatment of mandibular posterior teeth with irreversible pulpitis. The aim of this study was to compare the anesthetic efficacy of 4% articaine, 2% lidocaine and 2% mepivacaine, all in combination with 1:100,000 epinephrine, in patients with irreversible pulpitis of permanent mandibular molars during a pulpectomy procedure. Sixty-six volunteers from the Emergency Center of the School of Dentistry, University of São Paulo, randomly received 3.6 mL of local anesthetic as a conventional inferior alveolar nerve block (IANB). The subjective signal of lip numbness, pulpal anesthesia and absence of pain during the pulpectomy procedure were evaluated respectively, by questioning the patient, stimulation using an electric pulp tester and a verbal analogue scale. All patients reported the subjective signal of lip numbness. Regarding pulpal anesthesia success as measured with the pulp tester, the success rate was respectively 68.2% for mepivacaine, 63.6% for articaine and 63.6% for lidocaine. Regarding patients who reported no pain or mild pain during the pulpectomy, the success rate was, respectively 72.7% for mepivacaine, 63.6% for articaine and 54.5% for lidocaine. These differences were not statistically significant. Neither of the solutions resulted in 100% anesthetic success in patients with irreversible pulpitis of mandibular molars.

  10. Efficacy of cryotherapy for the treatment of cutaneous leishmaniasis: meta-analyses of clinical trials.

    Science.gov (United States)

    López-Carvajal, Liliana; Cardona-Arias, Jaiberth Antonio; Zapata-Cardona, María Isabel; Sánchez-Giraldo, Vanesa; Vélez, Iván Darío

    2016-07-26

    Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials. A meta-analysis based on a search of nine databases with eight strategies was conducted. Inclusion and exclusion criteria were applied, the methodological quality of each article was evaluated, and the reproducibility of the study selection and information extraction from each clinical trial was assured. The per lesion and per patient efficacy was calculated, and a meta-analysis of relative risks with the random effects model and the Dersimonian and Laird's, Begg, and Egger tests, along with a sensitivity analysis, were performed. A meta-regression based on the methodological quality of the trials included was also performed. Eight studies were included in which respective per lesion efficacies of 67.3 % and 67.7 % were reported for cryotherapy and pentavalent antimonials. In 271 patients treated with cryotherapy and in 199 with pentavalent antimonials, respective per protocol and intent to treat efficacies of 63.6 % and 54.2 % were found in the first group, and per protocol and intent to treat efficacies of 74.7 % and 68.3 % were found in the second group. The relative risk for the comparison of efficacy in the two groups was 0.73 (0.42-1.29). The results of the sensitivity analysis and the meta-regression analysis of relative risks were statistically equal to the overall results. This investigation provides evidence in favor of the use of cryotherapy given that its efficacy is similar to that of pentavalent antimonials.

  11. Deconstructing the measure of vaccine efficacy against disease irrespective of HPV in HPV vaccine clinical trials.

    Science.gov (United States)

    Bautista, Oliver M; Luxembourg, Alain

    2016-03-01

    Human papillomavirus (HPV) vaccines were licensed by demonstrating prevention of anogenital disease caused by specific HPV types in clinical studies. Measuring the impact of HPV vaccination on the overall burden of anogenital disease (irrespective of HPV) is an important public health question which is ideally addressed in post-licensure epidemiological studies. Attempts were made to use clinical trial data for that purpose. However, the interpretation of vaccine efficacy on the endpoint of disease irrespective of HPV is not widely understood. We used the 9-valent HPV vaccine clinical program as a case study to determine the value of measuring vaccine efficacy in such endpoint. This assessment was rigorously performed by heuristic reasoning and through probability calculations. The measure of vaccine efficacy in the irrespective of HPV endpoint is driven simultaneously in opposite directions by the high estimate of prophylactic efficacy and a numerically negative estimate of risk reduction that is also a reflection of high prophylactic efficacy and no cross-protection. The vaccine efficacy estimate in the irrespective of HPV endpoint is ambiguous and difficult to interpret. Comparing this estimate across different HPV vaccine studies requires an understanding of the contributions of vaccine HPV type efficacy and the incidence of disease not related to vaccine HPV types for each study. Without such understanding, comparing studies and drawing conclusions from such comparison are highly misleading. Approaches are proposed to divide this endpoint in components that are easier to interpret. Copyright © 2016. Published by Elsevier Inc.

  12. Days with severe symptoms: an additional efficacy endpoint in immunotherapy trials.

    Science.gov (United States)

    Durham, S R; Birk, A O; Andersen, J S

    2011-01-01

    In immunotherapy trials, primary and secondary endpoints often focus on average symptom and medication scores during the pollen season or on days with low symptoms and low medication use. Thus, there is a need for endpoints describing the treatment effect on the most troublesome days in the pollen season. A possible additional efficacy endpoint, days with severe symptoms during the pollen season, was investigated using data from a multicentre, double-blind, randomized, placebo-controlled trial of the SQ-standardized grass allergy immunotherapy tablet (AIT) (Grazax, Phleum pratense, 75,000 SQ-T/2,800 BAU, ALK, Hørsholm, Denmark). The trial included 634 subjects (N(Grass AIT) = 316; N(Placebo) = 318) with grass pollen-induced rhinoconjunctivitis. Six different definitions of a day with severe symptoms were suggested. The number of days with severe symptoms was analysed and odds ratios were calculated. The number and percentage of days with severe symptoms differed between definitions, but overall the analysis of days with severe symptoms showed consistent results (odds ratios: 2.0-3.4) for the different definitions. All definitions showed a reduced risk of having days with severe symptoms in the grass AIT group when compared to the placebo group. Days with severe symptoms during the pollen season is a relevant additional efficacy endpoint, which can be used in immunotherapy trials to support the clinical interpretation of commonly used efficacy endpoints. © 2010 John Wiley & Sons A/S.

  13. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Directory of Open Access Journals (Sweden)

    Oliveira Fabíola A

    2008-09-01

    Full Text Available Abstract Background Infestation with the human head louse (Pediculus humanus capitis occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92% concentration of the silicone oil dimeticone (identical in composition to NYDA®, as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5% and permethrin 66.7% (95% CI: 54.6% – 77.3%; p Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system, development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709.

  14. EFFICACY OF HYOSCINE BUTYLBROMIDE IN TREATMENT OF IRRITABLE BOWEL SYNDROME IN CHILDREN: PLACEBO-CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    K.V. Arifullina

    2008-01-01

    Full Text Available The activity of hyoscine butylbromide (buscopan was evaluated in a placebobcontrolled trial, on pediatric patients with algid type of irritable bowel syndrome. Hyoscine butylbromide favored to the increase of quality of life in pediatric patients, alleviation of clinical symptoms of disease, reliable decrease of malonic dialdehyde and increase of antioxidant activity of blood plasma significantly superior to placebo. Clinical efficacy of hyoscine butylbromide accompanies to its good tolerance and safety.Key words: children, irritable bowel syndrome, hyoscine butylbromide, placebo controlled trial.

  15. Assessing the interest to participate in a dengue vaccine efficacy trial among residents of Puerto Rico.

    Science.gov (United States)

    Pérez-Guerra, Carmen L; Rodríguez-Acosta, Rosa L; Soto-Gómez, Eunice; Zielinski-Gutierrez, Emily; Peña-Orellana, Marisol; Santiago, Luis M; Rivera, Reinaldo; Cruz, R Rhode; Ramírez, Viani; Tomashek, Kay M; Dayan, Gustavo

    2012-07-01

    Dengue, endemic in Puerto Rico, is a major public health problem. Vaccines are thought the best means to prevent dengue because vector control alone has been largely ineffective. We implemented qualitative studies in 2006 and 2010 to determine the acceptability of conducting placebo-controlled dengue vaccine efficacy trials in Puerto Rican children. Key informant interviews and focus groups with parents and children were conducted in municipalities with high dengue incidence. We used structured open-ended questions to determine motivators and attitudes regarding vaccine trial participation. Knowledge about dengue risk and prevention, and knowledge, attitudes, and beliefs regarding vaccines and vaccine trials were assessed. Using grounded theory, we conducted content analysis and established categories and sub-categories of participant responses. All participants were knowledgeable about dengue prevention and perceived children as most affected age groups. Participants were aware of vaccines benefits and they thought a vaccine could prevent dengue. However, most would not allow their children to participate in a placebo-controlled vaccine trial. Barriers included lack of trust in new vaccines and vaccine trial procedures; fear of developing dengue or side effects from the vaccine and lack of information about candidate dengue vaccines. Participants thought information, including results of previous trials might overcome barriers to participation. Motivators for participation were altruism, protection from dengue, free medical attention, and compensation for transportation and participation. Parents would consider children participation if accurate vaccine trial information is provided.

  16. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial

    OpenAIRE

    Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

    2014-01-01

    Background Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. Methods/design In this multicenter randomiz...

  17. Efficacy of a powered wheelchair simulator for school aged children: A randomised controlled trial.

    OpenAIRE

    Linden, Mark A; Whyatt, Caroline; Craig, Cathy; Kerr, Claire

    2013-01-01

    Purpose: To determine the efficacy of a custom made wheelchair simulation in training children to use a powered wheelchair (PWC). Design: Randomised controlled trial employing the 4C/ID-model of learning. Twenty-eight typically developing children (13M, 15F; mean age 6 years, SD 6 months) were assessed on their operation of a PWC using a functional evaluation rating scale. Participants were randomly assigned to intervention (8x 30minute training sessions using a joystick operated wheelchair s...

  18. Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial

    OpenAIRE

    Carlos Flores-González, J.; Matamala-Morillo, Miguel A; Patricia Rodríguez-Campoy; Juan J Pérez-Guerrero; Belén Serrano-Moyano; Paloma Comino-Vazquez; Encarnación Palma-Zambrano; Rocio Bulo-Concellón; Vanessa Santos-Sánchez; Lechuga-Sancho, Alfonso M.

    2015-01-01

    Background and Aims There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline. Patients and Methods We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hy...

  19. Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods

    National Research Council Canada - National Science Library

    Lonsdale, Chris; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Murray, Aileen; Hurley, Deirdre A

    2012-01-01

    ...., adherence to physiotherapists' recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists' autonomy-supportive communication on low back pain patients' adherence to physical activity...

  20. The use of randomisation-based efficacy estimators in non-inferiority trials.

    Science.gov (United States)

    Gillespie, David; Farewell, Daniel; Barrett-Lee, Peter; Casbard, Angela; Hawthorne, Anthony Barney; Hurt, Chris; Murray, Nick; Probert, Chris; Stenson, Rachel; Hood, Kerenza

    2017-03-09

    In a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However, PP analysis relies on the often implausible assumption of no confounders. Randomisation-based efficacy estimators (RBEEs) allow for treatment non-adherence while maintaining a comparison of randomised groups. Fischer et al. have developed an approach for estimating RBEEs in randomised trials with two active treatments, a common feature of NI trials. The aim of this paper was to demonstrate the use of RBEEs in NI trials using this approach, and to appraise the feasibility of these estimators as the primary analysis in NI trials. Two NI trials were used. One comparing two different dosing regimens for the maintenance of remission in people with ulcerative colitis (CODA), and the other comparing an orally administered treatment to an intravenously administered treatment in preventing skeletal-related events in patients with bone metastases from breast cancer (ZICE). Variables that predicted adherence in each of the trial arms, and were also independent of outcome, were sought in each of the studies. Structural mean models (SMMs) were fitted that conditioned on these variables, and the point estimates and confidence intervals compared to that found in the corresponding ITT and PP analyses. In the CODA study, no variables were found that differentially predicted treatment adherence while remaining independent of outcome. The SMM, using standard methodology, moved the point estimate closer to 0 (no difference between arms) compared to the ITT and PP analyses, but the confidence interval was still within the NI margin, indicating that the conclusions drawn would remain the same. In the ZICE study, cognitive functioning as measured by the corresponding domain of the QLQ-C30, and use of chemotherapy at baseline were both differentially associated with adherence while

  1. Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design

    National Research Council Canada - National Science Library

    Hinman, Rana S; McCrory, Paul; Pirotta, Marie; Relf, Ian; Crossley, Kay M; Reddy, Prasuna; Forbes, Andrew; Harris, Anthony; Metcalf, Ben R; Kyriakides, Mary; Novy, Kitty; Bennell, Kim L

    2012-01-01

    .... This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain...

  2. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy : efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  3. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L. F.; Lindeboom, J.; Kasteleijn-Nolst Trenité, D. G.; Heimans, J. J.; Snoek, F. J.; Touw, D. J.; Adèr, H. J.; van Alphen, H. A.

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  4. Effects of an osteoporosis prevention training program on physical activity-related stages of change and self-efficacy among university students, Shiraz, Iran: a Randomized Clinical Trial.

    Science.gov (United States)

    Kaveh, Mohammad Hossien; Golij, Monire; Nazari, Mahin; Mazloom, Zohreh; Rezaeian Zadeh, Abbas

    2014-10-01

    Osteoporosis is a major problem in today's world, being characterized by decreased bone mass and bone change. Due to deficiency of theory-based studies in young population, especially in students, there are significant knowledge gaps of effective planning. Thepresent study was performed in response to this need. The present study investigated the effect of an empowerment program on physical activity related stages of change and self-efficacyin preventing osteoporosis among university students. In this randomized controlled trial (IRCT: IRCT201212016261N2), 152 female students of Shiraz University of Medical Sciences were selected through multi-stages cluster sampling and were randomly assigned to an experimental (n=76) and a control (n=76) group.The pre-and post-intervention data were collected using the Stages of Exercise Change Questionnaire (SECQ) of Marcos with Cronbach's alpha reliability of 0.89 and also the self-efficacy scale with a Cronbach's alpha reliability of 0.88 and Test-Retest Correlation Coefficient of 0.80. The educational intervention for the experimental group took place through problem-based learning method, small group discussion, and training manuals. In addition, training CDs and brochures were given to the subjects and short SMSs were sent to them. The data were analyzed throughSPSS, version 14, usingMann-Whitney test, Chi-square test, Wilcoxon and regression tests. Pre-intervention findings showed that participants had behavioral constructs below the expected levels. The results showed that the experimental group received significant statisticalincrease after the intervention in stage of change. Before the intervention, the mean scores of stages of changes in the experimental groups was 2.28±0.86 but this rose to 3±0.84 in the first post-test and 3.22±0.84 in the second post-test. The control group showed a significant increase in stage of change without intervention (pre-test 2.04±0.82, first post-test 2.18±0.87 and second post

  5. Positive psychotherapy for depression and self-efficacy in undergraduate nursing students: A randomized, controlled trial.

    Science.gov (United States)

    Guo, Yu-Fang; Zhang, Xia; Plummer, Virginia; Lam, Louisa; Cross, Wendy; Zhang, Jing-Ping

    2017-08-01

    Nursing students across the globe experience depressive symptoms, and many interventions have been used to alleviate their depression. However, few interventions focus on students' personal strengths and advantages. The aim of the present study was to explore the effects of an 8-week group positive psychotherapy (PPT) programme on depression and self-efficacy in full-time undergraduate nursing students. A randomized, controlled trial was conducted for 76 nursing students (34 in the experimental group, 42 in the control group). The Beck Depression Inventory-II and the General Self-Efficacy Scale were used to collect data prior to, immediately after PPT, 3 months', and 6 months' post-PPT. Repeated-measures analysis of variance indicated that the intervention significantly alleviated depression and improved self-efficacy (each P self-efficacy. We recommend that PPT is effective in alleviating depression and improving self-efficacy in undergraduate nursing students. Academic mental health nurses should appreciate the value of PPT and consider incorporating it in psychological support methods in order to facilitate nursing students' mental health. © 2016 Australian College of Mental Health Nurses Inc.

  6. Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ricke, Jens, E-mail: jens.ricke@med.ovgu.de; Jürgens, Julian H. W., E-mail: julian.juergens@med.ovgu.de [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Deschamps, Frederic; Tselikas, Lambros [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France); Uhde, Katja; Kosiek, Ortrud [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Baere, Thierry De [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France)

    2015-04-15

    PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

  7. The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial.

    Science.gov (United States)

    Thomsen, Tanja; Aadahl, Mette; Beyer, Nina; Hetland, Merete Lund; Løppenthin, Katrine; Midtgaard, Julie; Christensen, Robin; Østergaard, Mikkel; Jennum, Poul Jørgen; Esbensen, Bente Appel

    2017-09-01

    The aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA). In this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist-hip ratio. 75 patients were allocated to each group. Mean reduction in daily sitting time was -1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference -2.20 (95% CI -2.72 to -1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention. An individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels. NCT01969604; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

    Science.gov (United States)

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-12-01

    Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  9. [Can we assess the efficacy of psychotherapies in a clinical trial?

    Science.gov (United States)

    Correard, N; Consoloni, J-L; Belzeaux, R; Fakra, E; Adida, M; Azorin, J-M

    2016-12-01

    Extensive evidence demonstrates that psychotherapy can be an efficacious and effective health care service for a wide range of mental health and health conditions. Recently, an important distinction between efficacy research and effectiveness research has been made within research focused on the outcome of psychotherapy. Data from both efficacy and effectiveness studies are fundamental to a complete understanding of the potential impact of a psychotherapy and the way to carry successful psychotherapeutics interventions to routine clinical practice. Efficacy studies, using randomized controlled trials, maximize the internal validity of a study by the use of design features, such as random assignment to a psychotherapeutic intervention and control conditions, training of therapists to a specified level of competence in providing the treatment, and ensuring that all participants have the condition that the treatment was designed to address. The randomized controlled trials allowed to objectify the efficacy of the psychotherapies in multiple pathological contexts, as we will see with the example of bipolar disorders. On the other hand, effectiveness studies strive to maximize external validity (while maintaining an adequate level of internal validity) by locating the study within clinical service sites that provide ongoing health services, using clinicians who are routinely providing psychological services and patients who have been referred to the clinical settings. These studies do not allow understanding changes and psychotherapeutic processes in real practice. A solution might be found in using pragmatic case studies in a systematic manner to constitute ecologically valid samples and measure change and psychotherapeutic processes during clinically significant periods of time. © L’Encéphale, Paris, 2016.

  10. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Xie Cheng-long

    2013-01-01

    Full Text Available Abstract Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well

  11. Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial

    NARCIS (Netherlands)

    Coutinho, R. A.; Lelie, N.; Albrecht-van Lent, P.; Reerink-Brongers, E. E.; Stoutjesdijk, L.; Dees, P.; Nivard, J.; Huisman, J.; Reesink, H. W.

    1983-01-01

    The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B

  12. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials

    NARCIS (Netherlands)

    Koes, B. W.; Scholten, R. J.; Mens, J. M.; Bouter, L. M.

    1997-01-01

    To assess the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) for low back pain. Computer aided search of published randomised clinical trials and assessment of the methods of the studies. 26 randomised clinical trials evaluating NSAIDs for low back pain were identified. Score for quality

  13. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Hung, Shao Kang; Perry, Rachel; Ernst, Edzard

    2011-02-15

    To critically assess the current evidence from randomized clinical trials (RCTs) for or against the effectiveness or efficacy of Rhodiola rosea. Systematic literature searches were performed in six electronic databases: AMED (1985-July 2009), CINAHL (1982-July 2009), The Cochrane Library (search in July 2009), EMBASE (1974-July 2009), MEDLINE (1950-July 2009) and Web of Science (searched in July 2009). No language restrictions were imposed. Reference lists of all retrieved articles were searched, and experts and manufacturers were contacted for unpublished RCT. RCTs testing the efficacy or effectiveness of mono-preparations of R. rosea as sole treatment administered orally against a control intervention in any human individual suffering from any condition or healthy human volunteers were included. Studies were selected, data extracted, and quality assessed by two independent reviewers. Eleven RCTs met the inclusion criteria; all were placebo-controlled. Six trials investigated the effects of R. rosea on physical performance, four on mental performance, and two in patients diagnosed with mental health condition. The methodological quality of most trials was moderate or good. Only few mild adverse events were reported. R. rosea may have beneficial effects on physical performance, mental performance, and certain mental health conditions. There is, however, a lack of independent replications of the single different studies. Five of the 10 RCTs reached more than three points on the Jadad score (i.e., good quality). More research seems warranted. Copyright © 2010 Elsevier GmbH. All rights reserved.

  14. Neural Mobilization: A Systematic Review of Randomized Controlled Trials with an Analysis of Therapeutic Efficacy

    Science.gov (United States)

    Ellis, Richard F.; Hing, Wayne A.

    2008-01-01

    Neural mobilization is a treatment modality used in relation to pathologies of the nervous system. It has been suggested that neural mobilization is an effective treatment modality, although support of this suggestion is primarily anecdotal. The purpose of this paper was to provide a systematic review of the literature pertaining to the therapeutic efficacy of neural mobilization. A search to identify randomized controlled trials investigating neural mobilization was conducted using the key words neural mobilisation/mobilization, nerve mobilisation/mobilization, neural manipulative physical therapy, physical therapy, neural/nerve glide, nerve glide exercises, nerve/neural treatment, nerve/neural stretching, neurodynamics, and nerve/neural physiotherapy. The titles and abstracts of the papers identified were reviewed to select papers specifically detailing neural mobilization as a treatment modality. The PEDro scale, a systematic tool used to critique RCTs and grade methodological quality, was used to assess these trials. Methodological assessment allowed an analysis of research investigating therapeutic efficacy of neural mobilization. Ten randomized clinical trials (discussed in 11 retrieved articles) were identified that discussed the therapeutic effect of neural mobilization. This review highlights the lack in quantity and quality of the available research. Qualitative analysis of these studies revealed that there is only limited evidence to support the use of neural mobilization. Future research needs to re-examine the application of neural mobilization with use of more homogeneous study designs and pathologies; in addition, it should standardize the neural mobilization interventions used in the study. PMID:19119380

  15. Field trial on comparative efficacy of four fasciolicides against natural liver fluke infection in cattle.

    Science.gov (United States)

    Elitok, Bülent; Elitok, Ozgül Mukaddes; Kabu, Mustafa

    2006-02-18

    A controlled trial was conducted to evaluate the current efficacy of albendazole (ABZ), rafoxanide (RFX), triclabendazole (TRC) or clorsulon (CLS) against Fasciola hepatica in naturally infected cattle. This trial was conducted in Turkey during the spring, the time of year when liver fluke infection is endemic. Fifty crossbred cattle were selected for inclusion in the trial based on finding eggs of F. hepatica in the feces. The cattle were weighed and randomly allotted into five groups of 10 cattle and treatments were as follows: Group 1 served as non-treated control (CONT), Group 2 was treated orally with ABZ at 12 mg/kg, Group 3 was treated orally with RFX at 10 mg/kg, Group 4 received TRC orally at 12 mg/kg and Group 5 received CLS administered subcutaneously (s.c.) at 2 mg/kg. On day 0 (inclusion day), individual fecal samples were collected on days 0 (inclusion day), 7, 14, 28 and 56, after treatment. The drug efficacy was assessed as a percentage of the egg or fluke reduction and body weight gain relative to the untreated control. The results in the study showed a mean reduction of egg counts by 66.7%, 68.2%, 78% and 84.2% in Groups 2-5, respectively. In conclusion, our results indicate that CLS is a highly effective compound for the treatment of F. hepatica in cattle under these field conditions.

  16. Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.

    Directory of Open Access Journals (Sweden)

    Jaiberth Antonio Cardona-Arias

    Full Text Available The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power.To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis.A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot and analytical methods (DerSimonian-Laird, Begg and Egger. Random-effects forest plots were constructed, and a cumulative meta-analysis was performed.Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI = 69.6-76.7%, and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%. Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15, showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs.Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome.

  17. Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.

    Science.gov (United States)

    Cardona-Arias, Jaiberth Antonio; Vélez, Iván Darío; López-Carvajal, Liliana

    2015-01-01

    The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power. To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis. A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot) and analytical methods (DerSimonian-Laird, Begg and Egger). Random-effects forest plots were constructed, and a cumulative meta-analysis was performed. Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI) = 69.6-76.7%), and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%). Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15), showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs. Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome.

  18. Efficacy of Thermotherapy to Treat Cutaneous Leishmaniasis: A Meta-Analysis of Controlled Clinical Trials

    Science.gov (United States)

    2015-01-01

    Introduction The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power. Objective To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis. Methods A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot) and analytical methods (DerSimonian-Laird, Begg and Egger). Random-effects forest plots were constructed, and a cumulative meta-analysis was performed. Results Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI) = 69.6-76.7%), and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%). Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15), showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs. Conclusion Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome. PMID:26009885

  19. Influenza vaccine efficacy in young children attending childcare: A randomised controlled trial.

    Science.gov (United States)

    Li-Kim-Moy, Jean P; Yin, Jiehui K; Heron, Leon; Leask, Julie; Lambert, Stephen B; Nissen, Michael; Sloots, Theo; Booy, Robert

    2017-01-01

    Influenza causes a substantial burden in young children. Vaccine efficacy (VE) data are limited in this age group. We examined trivalent influenza vaccine (TIV) efficacy and safety in young children attending childcare. A double-blind, randomised controlled trial in children aged 6 to vaccine. Efficacy was evaluated against polymerase chain reaction-confirmed influenza using parent-collected nose/throat swabs during influenza-like-illness. Safety outcomes were assessed during 6 months of follow-up. Fifty-seven children were allocated to influenza vaccine and 67 to control; all completed the study. The influenza attack rate was 1.8 vs 13.4% in the TIV and control groups, respectively; VE 87% (95%CI: 0-98%). For children aged 24 to vaccine appeared efficacious in the subgroup of children aged 24 to vaccinate again. Influenza vaccination in a childcare setting could be valuable and a larger confirmatory study would be helpful. © 2016 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

  20. Effect of guided relaxation and imagery on falls self-efficacy: a randomized controlled trial.

    Science.gov (United States)

    Kim, Bang Hyun; Newton, Roberta A; Sachs, Michael L; Glutting, Joseph J; Glanz, Karen

    2012-06-01

    To examine the effects of guided relaxation and imagery (GRI) on improvement in falls self-efficacy in older adults who report having a fear of falling. Randomized, controlled trial with allocation to GRI or guided relaxation with music of choice. General community. Ninety-one men and women aged 60 to 92. Participants were randomized to listen to a GRI audio compact disk (intervention group) or a guided relaxation audio compact disk and music of choice (control group) twice a week for 6 weeks for 10 minutes per session. Primary outcome measure was the Short Falls Efficacy Scale-International (FES-I). Secondary outcome measures were the Leisure Time Exercise Questionnaire (LTEQ) and the Timed Up and Go (TUG) mobility test. GRI participants reported greater improvements on the Short FES-I (P = .002) and LTEQ (P = .001) scores and shorter time on the TUG (P = .002) than the guided relaxation and music-of-choice group. GRI was more effective at increasing falls self-efficacy and self-reported leisure time exercise and reducing times on a simple mobility test than was guided relaxation with music of choice. GRI is an effective, simple, low-cost tool for older adults to improve falls self-efficacy and leisure time exercise behaviors. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

  1. Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dörr Jan

    2012-02-01

    of the efficacy of high-dose vitamin D supplementation in MS patients. The study design presented here fulfills the criteria of a high-quality clinical phase II trial in MS. Trial Registration ClinicalTrials.gov Identifier: NCT01440062

  2. Shock efficacy of single and dual coil electrodes-new insights from the NORDIC ICD Trial

    DEFF Research Database (Denmark)

    Bänsch, Dietmar; Bonnemeier, Hendrik; Brandt, Johan

    2017-01-01

    efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation. Methods and results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined...... before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT...

  3. A Bayesian adaptive Phase I-II clinical trial for evaluating efficacy and toxicity with delayed outcomes.

    Science.gov (United States)

    Koopmeiners, Joseph S; Modiano, Jaime

    2014-02-01

    In traditional Phase-I oncology trials, the safety of a new chemotherapeutic agent is tested in a dose escalation study to identify the maximum tolerated dose, which is defined as the highest dose with acceptable toxicity. An alternate approach is to jointly model toxicity and efficacy and allow dose finding to be directed by a prespecified trade-off between efficacy and toxicity. With this goal in mind, several designs have been proposed to jointly model toxicity and efficacy in a Phase I-II dose escalation study. A factor limiting the use of these designs is that toxicity and efficacy must be observed in a timely manner. One approach to overcoming this problem is to model toxicity and efficacy as time-to-event outcomes. This would allow new subjects to be enrolled before full information is available for previous subjects while incorporating partial information when adaptively assigning new subjects to a dose level. We propose a Phase I-II dose escalation study for evaluating toxicity and efficacy with delayed outcomes by jointly modeling toxicity and efficacy as time-to-event outcomes. We apply our proposed design to a Phase I-II clinical trial of a novel targeted toxin for canine hemangiosarcoma. Our simulation results show that our design identifies the optimal dose at a similar rate to dose finding that treats toxicity and efficacy as binary outcomes, but with substantial savings in study duration. Our proposed design has acceptable operating characteristics and dramatically reduces the trial duration compared to a design that considers toxicity and efficacy as binary outcomes, but comes at the cost of enrolling additional subjects when all dose levels are unacceptable. We developed a novel Phase I-II design that accounts for delayed outcomes by modeling toxicity and efficacy as time-to-event outcomes. Our design has similar operating characteristics to efficacy/toxicity trade-off designs that consider efficacy and toxicity as binary outcomes, but with a

  4. Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.

    Science.gov (United States)

    Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K

    2014-01-01

    We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  5. Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

    Directory of Open Access Journals (Sweden)

    Rajalakshmi Lakshman

    2014-01-01

    Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  6. [Efficacy of dolutegravir in treatment-experienced patients: the SAILING and VIKING trials].

    Science.gov (United States)

    Moreno, Santiago; Berenguer, Juan

    2015-03-01

    Dolutegravir is an HIV integrase inhibitor with a high genetic barrier to resistance and is active against raltegravir- and/or elvitegravir-resistant strains. The clinical development of dolutegravir for HIV infection rescue therapy is based on 3 clinical trials. In the SAILING trial, dolutegravir (5 mg once daily) in combination with 2 other antiretroviral agents was well tolerated and showed greater virological effect than raltegravir (400 mg twice daily) in the treatment of integrase inhibitor-naïve adults with virological failure infected with HIV strains with at least two-class drug resistance. The VIKING studies were designed to evaluate the efficacy of dolutegravir as rescue therapy in treatment-experienced patients infected with HIV strains with resistance mutations to raltegravir and/or elvitegravir. VIKING-1-2 was a dose-ranging phase IIb trial. VIKING-3 was a phase III trial in which dolutegravir (50 mg twice daily) formed part of an optimized regimen and proved safe and effective in this difficult-to-treat group of patients. Dolutegravir is the integrase inhibitor of choice for rescue therapy in multiresistant HIV infection, both in integrase inhibitor-naïve patients and in those previously treated with raltegravir or elvitegravir. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  7. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial

    Directory of Open Access Journals (Sweden)

    Fanaian Mahnaz

    2010-02-01

    Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients

  8. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    Directory of Open Access Journals (Sweden)

    Mohammad Dehghani Firoozabadi

    2014-01-01

    Full Text Available Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients and conventional treatment group (30 patients. An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months. Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6 and 32.6 (±12.7 years, respectively (P = 0.45. After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80, frequency of migraine attacks (P = 0.63 and duration of attacks per hours (P = 0.48 were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001. Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  9. application of decision theory based criteria

    African Journals Online (AJOL)

    2012-11-03

    Nov 3, 2012 ... In this paper, the reliability of the struc- ture is predicted using decision theory based criteria as a tool. The net probability of failure of the structure after assessment was 1.4898E-3 which exceeded the target value of probability of failure of 3.931E -6 for slabs, 4.78E-7 for beams in flexure, 1.591E-4 for beams ...

  10. Mediating Mechanisms of Theory-Based Psychosocial Determinants on Behavioral Changes in a Middle School Obesity Risk Reduction Curriculum Intervention, Choice, Control, and Change.

    Science.gov (United States)

    Gray, Heewon Lee; Contento, Isobel R; Koch, Pamela A; Noia, Jennifer Di

    2016-10-01

    A limited number of school-based intervention studies have explored mediating mechanisms of theory-based psychosocial variables on obesity risk behavior changes. The current study investigated how theory-based psychosocial determinants mediated changes in energy balance-related behaviors (EBRBs) among urban youth. A secondary analysis study was conducted using data from a cluster randomized controlled trial. Data from students at 10 middle schools in New York City (n = 1136) were used. The intervention, Choice, Control, and Change curriculum, was based on social cognitive and self-determination theories. Theory-based psychosocial determinants (goal intention, cognitive outcome expectations, affective outcome expectations, self-efficacy, perceived barriers, and autonomous motivation) and EBRBs were measured with self-report questionnaires. Mediation mechanisms were examined using structural equation modeling, Results: Mediating mechanisms for daily sugar-sweetened beverage (SSB) consumption and purposeful stair climbing were identified. Models with best fit indices (root mean square error of approximation = 0.039/0.045, normed fit index = 0.916/0.882; comparative fit index = 0.945/0.932; Tucker-Lewis index = 0.896/0.882, respectively) suggested that goal intention and reduced perceived barriers were significant proximal mediators for reducing SSB consumption among both boys and girls or increasing physical activity by stair climbing among boys. Cognitive outcome expectations, affective outcome expectations, self-efficacy, and autonomous motivation indirectly mediated behavioral changes through goal intention or perceived barriers (p behavioral outcome variances. Theory-based psychosocial determinants targeted in Choice, Control, and Change in fact mediated behavior changes in middle school students. Strategies targeting these mediators might benefit future success of behavioral interventions. Further studies are needed to determine other

  11. Design and analysis of Bayesian adaptive crossover trials for evaluating contact lens safety and efficacy.

    Science.gov (United States)

    Zhang, Quan; Toubouti, Youssef; Carlin, Bradley P

    2017-06-01

    A crossover study, also referred to as a crossover trial, is a form of longitudinal study. Subjects are randomly assigned to different arms of the study and receive different treatments sequentially. While there are many frequentist methods to analyze data from a crossover study, random effects models for longitudinal data are perhaps most naturally modeled within a Bayesian framework. In this article, we introduce a Bayesian adaptive approach to crossover studies for both efficacy and safety endpoints using Gibbs sampling. Using simulation, we find our approach can detect a true difference between two treatments with a specific false-positive rate that we can readily control via the standard equal-tail posterior credible interval. We then illustrate our Bayesian approaches using real data from Johnson & Johnson Vision Care, Inc. contact lens studies. We then design a variety of Bayesian adaptive predictive probability crossover studies for single and multiple continuous efficacy endpoints, indicate their extension to binary safety endpoints, and investigate their frequentist operating characteristics via simulation. The Bayesian adaptive approach emerges as a crossover trials tool that is useful yet surprisingly overlooked to date, particularly in contact lens development.

  12. Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.

    Science.gov (United States)

    Kim, Kyu Han; Choi, Tae Hyun; Choi, Yunhee; Park, Young Woon; Hong, Ki Yong; Kim, Dong Young; Choe, Yun Seon; Lee, Hyunjung; Cheon, Jung-Eun; Park, Jung-Bin; Park, Kyung Duk; Kang, Hyoung Jin; Shin, Hee Young; Jeong, Jae Hoon

    2017-06-01

    There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH). To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH. This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH. The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d). The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs. A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes. Our trial demonstrated that

  13. Adherence-adjusted estimates of benefits and harms from treatment with amoxicillin for LRTI : Secondary analysis of a 12-country randomised placebocontrolled trial using randomisationbased efficacy estimators

    NARCIS (Netherlands)

    Gillespie, David; Hood, Kerenza; Farewell, Daniel; Butler, Christopher C.; Verheij, Theo; Goossens, Herman; Stuart, Beth; Mullee, Mark; Little, Paul

    2015-01-01

    Objectives: Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection (LRTI) in primary care and demonstrate the use of randomisationbased efficacy estimators. Design: Secondary analysis of a two-arm individuallyrandomised placebo-controlled trial. Setting:

  14. Move more for life: the protocol for a randomised efficacy trial of a tailored-print physical activity intervention for post-treatment breast cancer survivors.

    Science.gov (United States)

    Short, Camille E; James, Erica L; Girgis, Afaf; McElduff, Patrick; Plotnikoff, Ronald C

    2012-05-08

    Due to early detection and advances in treatment, the number of women surviving breast cancer is increasing. Whilst there are many positive aspects of improved survival, breast cancer survival is associated with many long-term health and psychosocial sequelae. Engaging in regular physical activity post-diagnosis can reduce this burden. Despite this evidence, the majority of breast cancer survivors do not engage in regular physical activity. The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way. This article describes the protocol for the Move More for Life Study, which aims to assess the relative efficacy of two promising theory-based, print interventions designed to promote regular physical activity amongst breast cancer survivors. Breast cancer survivors were recruited from across Australia. Participants will be randomised into one of three groups: (1) A tailored-print intervention group, (2) a targeted-print intervention group, or (3) a standard recommendation control group. Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period. Participants in the targeted-print group will receive a previously developed physical activity guidebook designed specifically for breast cancer survivors immediately after baseline. Participants in the standard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults. All participants will be assessed at baseline, and at 4 and 10 months post-baseline. Intervention efficacy for changing the primary outcomes (mins/wk aerobic physical activity; sessions/exercises per week resistance physical activity) and secondary outcomes (steps per day, health-related quality life, compliance with physical activity guidelines, fatigue) will be assessed. Mediation and moderation analyses will also be conducted. Given the growing number

  15. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Schmitt, J; Rosumeck, S; Thomaschewski, G; Sporbeck, B; Haufe, E; Nast, A

    2014-02-01

    Dermatologists may choose from various conventional and biological systemic agents to treat patients with moderate-to-severe psoriasis. We set out to analyse systematically the efficacy and tolerability of approved treatments for moderate-to-severe psoriasis. We undertook a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the efficacy of systemic treatment approved for moderate-to-severe psoriasis. Efficacy was assessed as the proportion of participants with 75% improvement in Psoriasis Area and Severity Index at primary efficacy measurement (week 8-16). Safety was summarized as rates of adverse events and withdrawals. Direct and indirect comparative efficacy was assessed by random effects meta-analysis of risk differences (RDs). In total, 48 eligible RCTs totalling 16 696 patients (11 178 randomized to biologics, 1888 to conventional treatments) were identified. In placebo-controlled trials, infliximab was the most efficacious [RD 76%, 95% confidence interval (CI) 73-79%]. Adalimumab (RD 61%, 95% CI 56-67%), and ustekinumab 45 mg (RD 63%, 95% CI 59-66%) and 90 mg (RD 67%, 95% CI 60-74%) each had similar efficacy. These biologics are more effective than etanercept and all conventional treatments. Head-to-head trials indicate the superiority of adalimumab and infliximab over methotrexate (MTX), the superiority of ustekinumab over etanercept, the nonsignificant superiority of ciclosporin over MTX, and the dose-dependent efficacy of etanercept and ustekinumab. Fumaric acid is as efficacious as MTX. Safety of treatments could not be pooled due to a lack of standardization in reporting across trials. In conclusion, the qualitative and quantitative evidence is much stronger for biological interventions than for conventional treatments. © 2013 British Association of Dermatologists.

  16. Effect of a self-determination theory-based communication skills training program on physiotherapists' psychological support for their patients with chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Murray, Aileen; Hall, Amanda M; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Taylor, Ian M; Jackson, Ben; Matthews, James; Hurley, Deirdre A; Lonsdale, Chris

    2015-05-01

    To examine the effects of communication skills training on physiotherapists' supportive behavior during clinical practice. Randomized trial. Hospital outpatient physiotherapy clinics. Physiotherapists (N=24) and patients (N=24) with chronic low back pain. Two hospital clinics were randomly assigned to the intervention arm. Physiotherapists (n=12) received 8 hours of communication skills training focused on supporting patients' psychological needs. Physiotherapists (n=12) from 2 other hospital clinics formed a waitlist control arm. Verbal communication between each physiotherapist and a patient was recorded on an audiotape, and independent, blinded raters used the Health Care Climate Questionnaire to assess physiotherapists' needs-supportive behavior (primary outcome). Independent raters' Health Care Climate Questionnaire scores favored the intervention arm (Cohen's d=2.27; PCommunication style and exercise compliance in physiotherapy training were found to provide greater support for patients' needs in a single assessed session. Long-term maintenance of this needs-supportive behavior should be examined. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  17. Efficacy and safety of curcumin in major depressive disorder: a randomized controlled trial.

    Science.gov (United States)

    Sanmukhani, Jayesh; Satodia, Vimal; Trivedi, Jaladhi; Patel, Tejas; Tiwari, Deepak; Panchal, Bharat; Goel, Ajay; Tripathi, Chandra Bhanu

    2014-04-01

    Curcumin, an active ingredient of Curcuma longa Linn (Zingiberaceae), has shown potential antidepressant-like activity in animal studies. The objectives of this trial were to compare the efficacy and safety of curcumin with fluoxetine in patients with major depressive disorder (MDD). Herein, 60 patients diagnosed with MDD were randomized in a 1:1:1 ratio for six weeks observer-masked treatment with fluoxetine (20 mg) and curcumin (1000 mg) individually or their combination. The primary efficacy variable was response rates according to Hamilton Depression Rating Scale, 17-item version (HAM-D17 ). The secondary efficacy variable was the mean change in HAM-D17 score after six weeks. We observed that curcumin was well tolerated by all the patients. The proportion of responders as measured by the HAM-D17 scale was higher in the combination group (77.8%) than in the fluoxetine (64.7%) and the curcumin (62.5%) groups; however, these data were not statistically significant (P = 0.58). Interestingly, the mean change in HAM-D17 score at the end of six weeks was comparable in all three groups (P = 0.77). This study provides first clinical evidence that curcumin may be used as an effective and safe modality for treatment in patients with MDD without concurrent suicidal ideation or other psychotic disorders. . Copyright © 2013 John Wiley & Sons, Ltd.

  18. Safety and efficacy of rivastigmine in children with Down syndrome: A double blind placebo controlled trial.

    Science.gov (United States)

    Spiridigliozzi, Gail A; Hart, Sarah J; Heller, James H; Schneider, Heather E; Baker, Jane Ann; Weadon, Cathleen; Capone, George T; Kishnani, Priya S

    2016-06-01

    Individuals with Down syndrome (DS) have decreased cholinergic function and an uneven profile of cognitive abilities, with more pronounced deficits in learning, memory, and expressive language. Cholinesterase inhibitors may improve cognitive function in adults and adolescents with DS, but studies in children with DS have been limited. This study aimed to: (i) investigate the safety and efficacy of rivastigmine treatment; (ii) build upon our open-label studies in children with DS in a double-blind, placebo-controlled clinical trial; and (iii) investigate specific cognitive domains that may respond to rivastigmine treatment. We conducted a 20-week double-blind, placebo-controlled trial to investigate the safety and efficacy of rivastigmine in 22 children and adolescents with DS aged 10-17 years. Safety measures included reports of adverse events, laboratory parameters, and electrocardiograms. Efficacy measures included parental assessments of adaptive behavior and executive function, and direct measures of language and memory. No group differences were found on safety measures and 22 of 24 participants that passed study screening completed the study. The results did not demonstrate evidence for significant improvement in aspects of cognition, language, or overall function in the children receiving rivastigmine. Our results suggest that rivastigmine is safe and well-tolerated for children and adolescents with DS, but may not be effective for improving performance on the selected measures in this study. However, larger samples and/or alternate measures could possibly reveal improvements in cognitive function with rivastigmine treatment. Further research is needed to define a battery of cognitive measures that is sensitive to treatment effects in DS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  19. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Science.gov (United States)

    Heukelbach, Jorg; Pilger, Daniel; Oliveira, Fabíola A; Khakban, Adak; Ariza, Liana; Feldmeier, Hermann

    2008-01-01

    Background Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group. Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709. PMID:18783606

  20. Effects of a social cognitive theory-based hip fracture prevention web site for older adults.

    Science.gov (United States)

    Nahm, Eun-Shim; Barker, Bausell; Resnick, Barbara; Covington, Barbara; Magaziner, Jay; Brennan, Patricia Flatley

    2010-01-01

    The purposes of this study were to develop a Social Cognitive Theory-based, structured Hip Fracture Prevention Web site for older adults and conduct a preliminary evaluation of its effectiveness. The Theory-based, structured Hip Fracture Prevention Web site is composed of learning modules and a moderated discussion board. A total of 245 older adults recruited from two Web sites and a newspaper advertisement were randomized into the Theory-based, structured Hip Fracture Prevention Web site and the conventional Web sites groups. Outcomes included (1) knowledge (hip fractures and osteoporosis), (2) self-efficacy and outcome expectations, and (3) calcium intake and exercise and were assessed at baseline, end of treatment (2 weeks), and follow-up (3 months). Both groups showed significant improvement in most outcomes. For calcium intake, only the Theory-based, structured Hip Fracture Prevention Web site group showed improvement. None of the group and time interactions were significant. The Theory-based, structured Hip Fracture Prevention Web site group, however, was more satisfied with the intervention. The discussion board usage was significantly correlated with outcome gains. Despite several limitations, the findings showed some preliminary effectiveness of Web-based health interventions for older adults and the use of a Theory-based, structured Hip Fracture Prevention Web site as a sustainable Web structure for online health behavior change interventions.

  1. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial.

    Science.gov (United States)

    Leiter, Lawrence A; Teoh, Hwee; Braunwald, Eugene; Mosenzon, Ofri; Cahn, Avivit; Kumar, K M Prasanna; Smahelova, Alena; Hirshberg, Boaz; Stahre, Christina; Frederich, Robert; Bonnici, Francois; Scirica, Benjamin M; Bhatt, Deepak L; Raz, Itamar

    2015-06-01

    To examine the safety and cardiovascular (CV) effects of saxagliptin in the predefined elderly (≥65 years) and very elderly (≥75 years) subpopulations of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial. Individuals ≥40 years (n = 16,492; elderly, n = 8,561; very elderly, n = 2,330) with HbA1c ≥6.5% (47.5 mmol/mol) and ≤12.0% (107.7 mmol/mol) were randomized (1:1) to saxagliptin (5 or 2.5 mg daily) or placebo in a double-blind trial for a median follow-up of 2.1 years. The hazard ratio (HR) for the comparison of saxagliptin versus placebo for the primary end point (composite of CV mortality, myocardial infarction, or ischemic stroke) was 0.92 for elderly patients vs. 1.15 for patients TIMI 53 trial supports the overall CV safety of saxagliptin in a robust number of elderly and very elderly participants, although the risk of heart failure hospitalization was increased irrespective of age category. AEs and serious AEs as well as glycemic efficacy of saxagliptin in elderly patients are similar to those found in younger patients. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  2. A Double Blind Clinical Trial on the Efficacy of Honey Drop in Vernal Keratoconjunctivitis

    Directory of Open Access Journals (Sweden)

    Ali Salehi

    2014-01-01

    Full Text Available Purpose. This trial was designed to evaluate the efficacy and safety of topical honey eye drops in patients with diagnosed VKC. Methods. This clinical trial was conducted on 60 patients with diagnosed VKC. The patients were selected and randomly allocated between two groups of 30. Patients in two groups received honey eye drop (60% in artificial tear or placebo, other than cromolyn and fluorometholone 1% eye drops, to be used topically in each eye, four times per day. The patients were examined with slit lamp and torch at baseline and the follow-up visits on the 1st, 3rd, and 6th months of the study for redness, limbal papillae, and intraocular pressure. Results. Out of 60 patients who completed the study, 19 patients (31.7% were female. There was significant increase in eye pressure and reduction in redness as well as limbal papillae, following the consumption of the honey drop in honey group compared to placebo control group (P<0.05. At the end of trial, one patient in honey group and 7 ones in placebo group had limbal papillae (P<0.05. Conclusion. Topical honey eye drops, when used along with Cromolyn and Fluorometholone eye drops, might be beneficial for the treatment of VKC.

  3. A double blind clinical trial on the efficacy of honey drop in vernal keratoconjunctivitis.

    Science.gov (United States)

    Salehi, Ali; Jabarzare, Solmaz; Neurmohamadi, Mohammadreza; Kheiri, Soleiman; Rafieian-Kopaei, Mahmoud

    2014-01-01

    Purpose. This trial was designed to evaluate the efficacy and safety of topical honey eye drops in patients with diagnosed VKC. Methods. This clinical trial was conducted on 60 patients with diagnosed VKC. The patients were selected and randomly allocated between two groups of 30. Patients in two groups received honey eye drop (60% in artificial tear) or placebo, other than cromolyn and fluorometholone 1% eye drops, to be used topically in each eye, four times per day. The patients were examined with slit lamp and torch at baseline and the follow-up visits on the 1st, 3rd, and 6th months of the study for redness, limbal papillae, and intraocular pressure. Results. Out of 60 patients who completed the study, 19 patients (31.7%) were female. There was significant increase in eye pressure and reduction in redness as well as limbal papillae, following the consumption of the honey drop in honey group compared to placebo control group (P < 0.05). At the end of trial, one patient in honey group and 7 ones in placebo group had limbal papillae (P < 0.05). Conclusion. Topical honey eye drops, when used along with Cromolyn and Fluorometholone eye drops, might be beneficial for the treatment of VKC.

  4. A review of clinical trials assessing the efficacy and safety of newer antiarrhythmic drugs in atrial fibrillation.

    Science.gov (United States)

    Naccarelli, Gerald V; Wolbrette, Deborah L; Bhatta, Luna; Khan, Mazhar; Hynes, John; Samii, Soraya; Luck, Jerry

    2003-10-01

    Clinical trials assessing the efficacy of anti- arrhythmic drugs for terminating atrial fibrillation have demonstrated that rate control drugs have little to no added efficacy compared to placebo; however, spontaneous conversion of recent-onset atrial fibrillation is common. Antiarrhythmic drugs such as oral dofetilide, oral bolus-flecainide and propafenone and intravenous ibutilide all have a role in terminating atrial fibrillation. Active comparator trials have demonstrated that amiodarone is more efficacious in maintaining sinus rhythm than propafenone and sotalol. Multiple trials have demonstrated the safety of amiodarone, sotalol, dofetilide and azimilide in a post-myocardial infarction population and amiodarone and dofetilide in a congestive heart failure population. Newer antiarrhythmic agents, some with novel mechanisms of action, will add to the pharmacologic armamentarium in treating atrial fibrillation.

  5. Feasibility of Training Physical Therapists to Deliver the Theory-Based Self-Management of Osteoarthritis and Low Back Pain Through Activity and Skills (SOLAS) Intervention Within a Trial.

    Science.gov (United States)

    Keogh, Alison; Matthews, James; Segurado, Ricardo; Hurley, Deirdre A

    2017-10-23

    Provider training programs are frequently under evaluated leading to ambiguity surrounding effective intervention components. To assess the effectiveness of a training program in guiding physical therapists to deliver the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) group education and exercise intervention (ISRCTN49875385) using a communication style underpinned by self-determination theory (SDT). Assessment of the intervention arm training program using quantitative methods. Thirteen physical therapists were trained using mixed methods to deliver the SOLAS intervention. Training was evaluated using the Kirkpatrick model: (1) Reaction- physical therapists' satisfaction with training, (2) Learning -therapists' confidence in and knowledge of the SDT-based communication strategies and intervention content and their skills in applying the strategies during training), and (3) Behavior -8 therapists were audio-recorded delivering all 6 SOLAS intervention classes (n = 48), and 2 raters independently coded 50% of recordings (n = 24) using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behavior Scale (CCBS), and an intervention-specific measure. Reaction : Physical therapists reacted well to training (median [IRQ]; min-max = 4.7; [0.5]; 3.7-5.0). Learning : Therapists' confidence in the SDT-based communication strategies and knowledge of some intervention content components significantly improved. Behavior: Therapists delivered the intervention in a needs-supportive manner (median HCCQ = 5.3 [1.4]; 3.9-6.0; median CCBS = 6.6 ([0.5]; 6.1-6.8; median intervention specific measure = 4.0 [1.2]; 3.2-4.9). However, "goal-setting" was delivered below acceptable levels by all therapists (median 2.9 [0.9]; 2.0-4.0). The intervention group only was assessed as part of the process evaluation of the feasibility trial. Training effectively guided physical therapists to be needs-supportive during delivery of the SOLAS

  6. Theory-based explanation as intervention.

    Science.gov (United States)

    Weisman, Kara; Markman, Ellen M

    2017-10-01

    Cogent explanations are an indispensable means of providing new information and an essential component of effective education. Beyond this, we argue that there is tremendous untapped potential in using explanations to motivate behavior change. In this article we focus on health interventions. We review four case studies that used carefully tailored explanations to address gaps and misconceptions in people's intuitive theories, providing participants with a conceptual framework for understanding how and why some recommended behavior is an effective way of achieving a health goal. These case studies targeted a variety of health-promoting behaviors: (1) children washing their hands to prevent viral epidemics; (2) parents vaccinating their children to stem the resurgence of infectious diseases; (3) adults completing the full course of an antibiotic prescription to reduce antibiotic resistance; and (4) children eating a variety of healthy foods to improve unhealthy diets. Simply telling people to engage in these behaviors has been largely ineffective-if anything, concern about these issues is mounting. But in each case, teaching participants coherent explanatory frameworks for understanding health recommendations has shown great promise, with such theory-based explanations outperforming state-of-the-art interventions from national health authorities. We contrast theory-based explanations both with simply listing facts, information, and advice and with providing a full-blown educational curriculum, and argue for providing the minimum amount of information required to understand the causal link between a target behavior and a health outcome. We argue that such theory-based explanations lend people the motivation and confidence to act on their new understanding.

  7. Comparision Of The Efficacy Of Nebulized L-Epinephrine, Salbutamoland Normal Saline In Acute Bronchiolitis: A Randomized Clinical Trial

    OpenAIRE

    H. Mussavi; M. Karamiyar; S. Salari Lak; J. Khashabi

    2005-01-01

    Background:Acute bronchiolitis is the most common form of lower respiratory tract infection in infancy.There are numerous contradictory reports regarding the efficacy of nebulized bronchodilators in the management of infants with acute bronchiolitis. This study was designed to compare the efficacy of nebulized epinephrine with salbutamol for treatment of the disease.Methods:In a randomized clinical trial, 72 infants with moderately severe bronchiolitis were enrolled in three equal groups. Thr...

  8. Theory-Based Evaluation Meets Ambiguity

    DEFF Research Database (Denmark)

    Dahler-Larsen, Peter

    2017-01-01

    ambiguity as a fruitful perspective that helps TBE face current challenges. Literatures in organization theory and political theory are consulted in order to cultivate the concept of ambiguity. Janus variables (which work in two ways) and other ambiguous aspects of program theories are classified......As theory-based evaluation (TBE) engages in situations where multiple stakeholders help develop complex program theory about dynamic phenomena in politically contested settings, it becomes difficult to develop and use program theory without ambiguity. The purpose of this article is to explore...

  9. Comprehensive sieve analysis of breakthrough HIV-1 sequences in the RV144 vaccine efficacy trial.

    Directory of Open Access Journals (Sweden)

    Paul T Edlefsen

    2015-02-01

    Full Text Available The RV144 clinical trial showed the partial efficacy of a vaccine regimen with an estimated vaccine efficacy (VE of 31% for protecting low-risk Thai volunteers against acquisition of HIV-1. The impact of vaccine-induced immune responses can be investigated through sieve analysis of HIV-1 breakthrough infections (infected vaccine and placebo recipients. A V1/V2-targeted comparison of the genomes of HIV-1 breakthrough viruses identified two V2 amino acid sites that differed between the vaccine and placebo groups. Here we extended the V1/V2 analysis to the entire HIV-1 genome using an array of methods based on individual sites, k-mers and genes/proteins. We identified 56 amino acid sites or "signatures" and 119 k-mers that differed between the vaccine and placebo groups. Of those, 19 sites and 38 k-mers were located in the regions comprising the RV144 vaccine (Env-gp120, Gag, and Pro. The nine signature sites in Env-gp120 were significantly enriched for known antibody-associated sites (p = 0.0021. In particular, site 317 in the third variable loop (V3 overlapped with a hotspot of antibody recognition, and sites 369 and 424 were linked to CD4 binding site neutralization. The identified signature sites significantly covaried with other sites across the genome (mean = 32.1 more than did non-signature sites (mean = 0.9 (p < 0.0001, suggesting functional and/or structural relevance of the signature sites. Since signature sites were not preferentially restricted to the vaccine immunogens and because most of the associations were insignificant following correction for multiple testing, we predict that few of the genetic differences are strongly linked to the RV144 vaccine-induced immune pressure. In addition to presenting results of the first complete-genome analysis of the breakthrough infections in the RV144 trial, this work describes a set of statistical methods and tools applicable to analysis of breakthrough infection genomes in general vaccine

  10. Efficacy of 3 commonly used hearing aid circuits: A crossover trial. NIDCD/VA Hearing Aid Clinical Trial Group.

    Science.gov (United States)

    Larson, V D; Williams, D W; Henderson, W G; Luethke, L E; Beck, L B; Noffsinger, D; Wilson, R H; Dobie, R A; Haskell, G B; Bratt, G W; Shanks, J E; Stelmachowicz, P; Studebaker, G A; Boysen, A E; Donahue, A; Canalis, R; Fausti, S A; Rappaport, B Z

    2000-10-11

    Numerous studies have demonstrated that hearing aids provide significant benefit for a wide range of sensorineural hearing loss, but no carefully controlled, multicenter clinical trials comparing hearing aid efficacy have been conducted. To compare the benefits provided to patients with sensorineural hearing loss by 3 commonly used hearing aid circuits. Double-blind, 3-period, 3-treatment crossover trial conducted from May 1996 to February 1998. Eight audiology laboratories at Department of Veterans Affairs medical centers across the United States. A sample of 360 patients with bilateral sensorineural hearing loss (mean age, 67.2 years; 57% male; 78.6% white). Patients were randomly assigned to 1 of 6 sequences of linear peak clipper (PC), compression limiter (CL), and wide dynamic range compressor (WDRC) hearing aid circuits. All patients wore each of the 3 hearing aids, which were installed in identical casements, for 3 months. Results of tests of speech recognition, sound quality, and subjective hearing aid benefit, administered at baseline and after each 3-month intervention with and without a hearing aid. At the end of the experiment, patients ranked the 3 hearing aid circuits. Each circuit markedly improved speech recognition, with greater improvement observed for soft and conversationally loud speech (all 52-dB and 62-dB conditions, Phearing aid circuits more frequently (41.6%) than the WDRC (29.8%) and the PC (28.6%) (P =.001 for CL vs both WDRC and PC). Each circuit provided significant benefit in quiet and noisy listening situations. The CL and WDRC circuits appeared to provide superior benefits compared with the PC, although the differences between them were much less than the differences between the aided vs unaided conditions. JAMA. 2000;284:1806-1813.

  11. Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial.

    Science.gov (United States)

    Ludwig, Martin; Enzenhofer, Elisabeth; Schneider, Sven; Rauch, Margit; Bodenteich, Angelika; Neumann, Kurt; Prieschl-Grassauer, Eva; Grassauer, Andreas; Lion, Thomas; Mueller, Christian A

    2013-11-13

    The common cold is the most widespread viral infection in humans. Iota-carrageenan has previously shown antiviral effectiveness against cold viruses in clinical trials. This study investigated the efficacy of a carrageenan-containing nasal spray on the duration of the common cold and nasal fluid viral load in adult patients. In a randomized, double-blind, placebo-controlled trial, 211 patients suffering from early symptoms of the common cold were treated for seven days. Application was performed three times daily with either a carrageenan-supplemented nasal spray or saline solution as placebo with an overall observation period of 21 days. The primary endpoint was the duration of disease defined as the time until the last day with symptoms followed by all other days in the study period without symptoms. During the study, but prior unblinding, the definition of disease duration was adapted from the original protocol that defines disease duration as the time period of symptoms followed by 48 hours without symptoms. In patients showing a laboratory-confirmed cold virus infection and adherence to the protocol, alleviation of symptoms was 2.1 days faster in the carrageenan group in comparison to placebo (p = 0.037). The primary endpoint that had been prespecified but was changed before unblinding was not met. Viral titers in nasal fluids showed a significantly greater decrease in carrageenan patients in the intention-to-treat population (p = 0.024) and in the per protocol population (p = 0.018) between days 1 and 3/4. In adults with common cold virus infections, direct local administration of carrageenan with nasal sprays reduced the duration of cold symptoms. A significant reduction of viral load in the nasal wash fluids of patients confirmed similar findings from earlier trials in children and adults. Current Controlled Trials ISRCTN80148028.

  12. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials.

    Science.gov (United States)

    Burke, Brian L; Arkowitz, Hal; Menchola, Marisa

    2003-10-01

    A meta-analysis was conducted on controlled clinical trials investigating adaptations of motivational interviewing (AMIs), a promising approach to treating problem behaviors. AMIs were equivalent to other active treatments and yielded moderate effects (from .25 to .57) compared with no treatment and/or placebo for problems involving alcohol, drugs, and diet and exercise. Results did not support the efficacy of AMIs for smoking or HIV-risk behaviors. AMIs showed clinical impact, with 51% improvement rates, a 56% reduction in client drinking, and moderate effect sizes on social impact measures (d=0.47). Potential moderators (comparative dose, AMI format, and problem area) were identified using both homogeneity analyses and exploratory multiple regression. Results are compared with other review results and suggestions for future research are offered.

  13. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  14. Efficacy of a self-forgiveness workbook: a randomized controlled trial with interpersonal offenders.

    Science.gov (United States)

    Griffin, Brandon J; Worthington, Everett L; Lavelock, Caroline R; Greer, Chelsea L; Lin, Yin; Davis, Don E; Hook, Joshua N

    2015-04-01

    The present study tested the efficacy of a 6-hr self-directed workbook intervention designed to increase self-forgiveness and reduce self-condemnation among perpetrators of interpersonal offenses. University students (N = 204) were randomly assigned to either an immediate treatment or wait-list control condition, and assessments were administered on 3 occasions. Treatment led to increases in self-forgiveness and decreases in self-condemnation. Stronger treatment effects were associated with (a) lower levels of dispositional self-forgivingness, (b) higher levels of transgression severity, and (c) higher dose of treatment. In summary, the workbook appeared to facilitate self-forgiveness among perpetrators of interpersonal wrongdoing, though replication trials are needed to build from these preliminary findings. (c) 2015 APA, all rights reserved).

  15. Comparative efficacy of aloe vera mouthwash and chlorhexidine on periodontal health: A randomized controlled trial.

    Science.gov (United States)

    Vangipuram, Swathi; Jha, Abhishek; Bhashyam, Mamtha

    2016-10-01

    With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Thirty days randomized controlled trial was conducted among 390 dental students. The students were randomized into two intervention groups namely Aloe Vera (AV) chlorhexidine group (CHX) and one control (placebo) group. Plaque index and gingival index was recorded for each participant at baseline, 15 days and 30 days. The findings were than statistically analyzed, ANOVA and Post Hoc test were used. There was significant reduction (pAloe Vera (AV) and chlorhexidine group. Post hoc test showed significant difference (paloe Vera and placebo and chlorhexidine and placebo group. No significant difference (pAloe vera, chlorhexidine, dental plaque, gingivitis.

  16. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand

  17. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  18. Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

    Science.gov (United States)

    Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

    2015-11-01

    Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

  19. Efficacy of straight versus angled interdental brushes on interproximal tooth cleaning: a randomized controlled trial.

    Science.gov (United States)

    Jordan, R A; Hong, H M; Lucaciu, A; Zimmer, S

    2014-05-01

    To investigate interproximal biofilm reduction with an angled interdental brush as compared to a straight interdental brush (standard control) in a clinical, single-centre, single-blind, controlled, parallel-group trial. Recruitment and examinations of the subjects were performed at the Witten/Herdecke University School of Dental Medicine. 128 volunteers, aged 20-65 years, were recruited and stratified according to sex and age. Two groups with 64 subjects each used either straight (standard control) or angled (test group) handgripped interdental toothbrushes of the same bristle stiffness. After a 12-day home-care habituation period, participants received a professional tooth cleaning followed by a 48-h plaque regrowth period. At the intervention appointment, plaque was recorded with a fluorescent revelator and soft tissue damage was noted (T0 ). Interdental brushing was performed by the participant for 2 min, and clinical parameters were recorded again (T1 ). The primary efficacy end point was the difference in modified Proximal Plaque Index (mPPI) after brushing compared to baseline. Secondary efficacy end points were mPPI differences in subgroups (anterior vs. posterior teeth; vestibular vs. oral tooth surfaces). Safety end point was the Danser gingival abrasion index (DI). mPPI showed lower scores after brushing within all (sub)groups (P brushing efficacy (ΔT0  - T1 ) in subjects using straight interdental brushes was significantly higher as compared to angled interdental brushes (P brushes were significantly more effective in posterior teeth, when used from vestibular and from oral tooth surfaces (P teeth and concerning soft tissue damage. Straight interdental brushes may better remove plaque interproximally when compared to angled interdental brushes. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. PrEP Adherence Patterns Strongly Affect Individual HIV Risk and Observed Efficacy in Randomized Clinical Trials.

    Science.gov (United States)

    Dimitrov, Dobromir T; Mâsse, Benoît R; Donnell, Deborah

    2016-08-01

    Randomized controlled trials (RCTs) suggest that the efficacy of tenofovir-based preexposure prophylaxis (PrEP) strongly depends on the consistency of PrEP use. We explore how the patterns of pill taking and waning of PrEP protection may affect PrEP efficacy for HIV prevention. A 2-arm RCT was simulated by mathematical models assuming that the prescribed daily doses were skipped periodically, randomly, or in large blocks. Risk-driven adherence, in which PrEP was taken when sex was expected, was also investigated. Three temporal PrEP protection profiles were explored: long (5 days), intermediate (3 days), and short (24 hours). Modeling results were compared to the efficacy observed in completed RCTs. The expected PrEP efficacy was 60% with periodic, 50% with random, and 34% with block adherence when PrEP had a long protection profile and pills were taken only 50% of the days. Risk-driven pill taking resulted in 29% and 37% daily pills taken and efficacy of 43% and 51%, respectively, for long protection. High PrEP efficacy comparable with that observed in Partners PrEP and Centers for Disease Control and Prevention Botswana trials was simulated under long protection, high overall adherence, and limited block pill taking; the moderate efficacy observed in iPrEx and Bangkok trials was comparable with the 50% adherence scenarios under random pill taking and long protection. Pill-taking patterns may have a substantial impact on the protection provided by PrEP even when the same numbers of pills are taken. When PrEP retains protection for longer than a day, pill-taking patterns can explain a broad range of efficacies observed in PrEP RCTs.

  1. Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial

    Science.gov (United States)

    Comino-Vazquez, Paloma; Palma-Zambrano, Encarnación; Bulo-Concellón, Rocio; Santos-Sánchez, Vanessa

    2015-01-01

    Background and Aims There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline. Patients and Methods We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay. Results A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011). Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively). Conclusions In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before. Trial Registration EudraCT 2009-016042-57 PMID:26575036

  2. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial.

    Science.gov (United States)

    do Prado, Juliana Miyuki; Kurebayashi, Leonice Fumiko Sato; da Silva, Maria Júlia Paes

    2012-01-01

    This study is a randomized single-blind trial, which aimed to evaluate the efficacy of true auriculotherapy and placebo auriculotherapy in reducing the stress levels of mid-level Nursing students of the School of Nursing of the Beneficência Portuguesa Hospital. Seventy-one students with average, high and very high scores, according to Vasconcellos' List of Stress Symptoms, were divided into three groups: Control (25), Auriculotherapy (24), and Placebo/Sham (22). They were evaluated at the baseline, 8th and 12th sessions and at the follow-up (15 days) and received Shen Men and Brainstem points (Auriculotherapy Group) and Wrist and Outer Ear points (Placebo/Sham Group). The analysis of variance (ANOVA) showed statistically significant differences between the Control/Auriculotherapy groups from the 8th session, which was maintained in the third and fourth evaluations (p=0.000) and between the Control/Placebo groups (pauriculotherapy obtained better responses (45.39%) than the placebo (34.18%) in the reduction of the stress, but further studies are recommended for the re-evaluation of the sham points for stress. ClinicalTrials.gov Identifier: NCT01420848.

  3. Efficacy of hydrotherapy in fibromyalgia syndrome--a meta-analysis of randomized controlled clinical trials.

    Science.gov (United States)

    Langhorst, Jost; Musial, Frauke; Klose, Petra; Häuser, Winfried

    2009-09-01

    To systematically review the efficacy of hydrotherapy in FM syndrome (FMS). We screened MEDLINE, PsychInfo, EMBASE, CAMBASE and CENTRAL (through December 2008) and the reference sections of original studies and systematic reviews on hydrotherapy in FMS. Randomized controlled trials (RCTs) on the treatment of FMS with hydrotherapy (spa-, balneo- and thalassotherapy, hydrotherapy and packing and compresses) were analysed. Methodological quality was assessed by the van Tulder score. Effects were summarized using standardized mean differences (SMDs). Ten out of 13 RCTs with 446 subjects, with a median sample size of 41 (range 24-80) and a median treatment time of 240 (range 200-300) min, were included into the meta-analysis. Only three studies had a moderate quality score. There was moderate evidence for reduction of pain (SMD -0.78; 95% CI -1.42, -0.13; P hydrotherapy has short-term beneficial effects on pain and HRQOL in FMS patients. There is a risk to over-estimate the effects of hydrotherapy due to methodological weaknesses of the studies and to small trials included in meta-analysis.

  4. Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES trial [ISRCTN19943732

    Directory of Open Access Journals (Sweden)

    Lees Kennedy

    2000-12-01

    Full Text Available Abstract The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4 funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up. By randomizing 2700 patients, the study will have 84% power to detect a 5.5% absolute reduction in the primary end-point. By April 2000, 86 centres were participating, with representation in Canada, USA, Europe, South America, Singapore and Australia. So far, 1206 patients have been randomised, of whom 37% were treated within 6 h. Overall 3-month mortality was 20% and the primary outcome event rate was 43%. The study is ongoing and centres worldwide are encouraged to participate.

  5. EFFICACY OF CITALOPRAM IN TREATMENT OF PATHOLOGICAL SKIN PICKING, A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    M Arbabi

    2008-11-01

    Full Text Available "nVarious studies suggest that selective serotonin reuptake inhibitors (SSRIs may be useful in treating pathological skin picking (PSP. This study sought to assess effectiveness of citalopram in comparison with placebo in treating PSP. Forty five individuals with PSP were recruited in a four-week, randomized clinical trial of citalopram (20 mg/day in comparison with placebo. Study measures assessing skin picking severity, mental health status, obsessive compulsive disorder and quality of life were given at baseline, weeks 2 and 4. PSP severity, general health status, obsession-compulsion severity and quality of life level were similar between two groups at baseline (P > 0.05. Treatment analyses revealed significant improvements in quality of life, general health status and obsession-compulsion severity in citalopram group compared to placebo group (P < 0.05. Mean PSP severity reduction in citalopram group was more than placebo group but this difference was not significant. Citalopram can improve general health status and quality of life in individuals with PSP but its effect on skin picking behavior doesn't differ significantly with placebo. Other trials with longer time are needed to determine the exact efficacy of citalopram on PSP

  6. Clinical trials of interventional oncology-moving from efficacy to outcomes.

    Science.gov (United States)

    Franklin, James M; Gebski, Val; Poston, Graeme J; Sharma, Ricky A

    2015-02-01

    Interventional oncology is a rapidly growing sub-speciality that aims to develop new disease-modifying treatment options beyond conventional surgical and oncological therapies in several disease settings. The evidence for interventional oncology success is dominated by single-arm studies reporting technical success or clinical efficacy. These studies have successfully resulted in the development of new techniques, but are not sufficient to change clinical practice uniformly across health-care systems. This Review discusses why clinical investigators must incorporate measures of cost-effectiveness and patient-reported outcomes into large-scale studies currently being designed to provide robust evidence for changing clinical practice. In particular, interventional oncology trials could be designed to show that certain treatments may be as effective as the current standard of care, but with significantly less morbidity and with better outcomes for patients with cancer. Innovative trial design and awareness of the challenges from interventional studies in other fields of medicine and surgery are also discussed to demonstrate how this new speciality can make progress. Registry-based models are emerging as an alternative means of deriving cohort data and can be used in parallel with local or national commissioning of new services.

  7. Move more for life: the protocol for a randomised efficacy trial of a tailored-print physical activity intervention for post-treatment breast cancer survivors

    Directory of Open Access Journals (Sweden)

    Short Camille E

    2012-05-01

    Full Text Available Abstract Background Due to early detection and advances in treatment, the number of women surviving breast cancer is increasing. Whilst there are many positive aspects of improved survival, breast cancer survival is associated with many long-term health and psychosocial sequelae. Engaging in regular physical activity post-diagnosis can reduce this burden. Despite this evidence, the majority of breast cancer survivors do not engage in regular physical activity. The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way. This article describes the protocol for the Move More for Life Study, which aims to assess the relative efficacy of two promising theory-based, print interventions designed to promote regular physical activity amongst breast cancer survivors. Method and design Breast cancer survivors were recruited from across Australia. Participants will be randomised into one of three groups: (1 A tailored-print intervention group, (2 a targeted-print intervention group, or (3 a standard recommendation control group. Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period. Participants in the targeted-print group will receive a previously developed physical activity guidebook designed specifically for breast cancer survivors immediately after baseline. Participants in the standard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults. All participants will be assessed at baseline, and at 4 and 10 months post-baseline. Intervention efficacy for changing the primary outcomes (mins/wk aerobic physical activity; sessions/exercises per week resistance physical activity and secondary outcomes (steps per day, health-related quality life, compliance with physical activity guidelines, fatigue will be assessed. Mediation and moderation

  8. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children.

    Science.gov (United States)

    Galetti, Valeria; Kujinga, Prosper; Mitchikpè, Comlan Evariste S; Zeder, Christophe; Tay, Fabian; Tossou, Félicien; Hounhouigan, Joseph D; Zimmermann, Michael B; Moretti, Diego

    2015-11-01

    Zinc deficiency and contaminated water are major contributors to diarrhea in developing countries. Food fortification with zinc has not shown clear benefits, possibly because of low zinc absorption from inhibitory food matrices. We used a novel point-of-use water ultrafiltration device configured with glass zinc plates to produce zinc-fortified, potable water. The objective was to determine zinc bioavailability from filtered water and the efficacy of zinc-fortified water in improving zinc status. In a crossover balanced study, we measured fractional zinc absorption (FAZ) from the zinc-fortified water in 18 healthy Swiss adults using zinc stable isotopes and compared it with zinc-fortified maize porridge. We conducted a 20-wk double-blind randomized controlled trial (RCT) in 277 Beninese school children from rural settings who were randomly assigned to receive a daily portion of zinc-fortified filtered water delivering 2.8 mg Zn (Zn+filter), nonfortified filtered water (Filter), or nonfortified nonfiltered water (Pump) from the local improved supply, acting as the control group. The main outcome was plasma zinc concentration (PZn), and the 3 groups were compared by using mixed-effects models. Secondary outcomes were prevalence of zinc deficiency, diarrhea prevalence, and growth. Geometric mean (-SD, +SD) FAZ was 7-fold higher from fortified water (65.9%; 42.2, 102.4) than from fortified maize (9.1%; 6.0, 13.7; P water fortified with a low dose of highly bioavailable zinc is an effective intervention in children from rural African settings. Large community-based trials are needed to assess the effectiveness of zinc-fortified filtered water on diarrhea and growth. These trials were registered at clinicaltrials.gov as NCT01636583 and NCT01790321. © 2015 American Society for Nutrition.

  9. Initial severity and efficacy of risperidone in autism: Results from the RUPP trial.

    Science.gov (United States)

    Levine, S Z; Kodesh, A; Goldberg, Y; Reichenberg, A; Furukawa, T A; Kolevzon, A; Leucht, S

    2016-02-01

    Risperidone is a common psychopharmacological treatment for irritability in autism spectrum disorder (ASD). It is not well-established how effective risperidone is across the initial symptom severity range. This study aims to examine the influence of baseline severity on the efficacy of risperidone in the treatment of ASD. Participants were from the NIMH funded RUPP multisite, randomized, double-blind trial that compared risperidone to placebo to treat autistic disorder with severe tantrums, aggression, or self-injury. Participants were aged 5 to 17, and randomly assigned to risperidone (n=49) or placebo (n=52). Baseline and change scores were computed with the Aberrant Behavior Checklist (ABC) parent assessed scales with irritability as the primary outcome, as well as the clinician assessed ABC Irritability subscale, and Clinical Global Impression Scale. The relationship between baseline severity and change scores for the risperdone and placebo groups was examined with eight competing three-level mixed-effects models for repeated measure models. Significant (Prisperidone and placebo were observed from moderate to very severe baseline severity on irritability and lethargy. Initial severity values over approximately 30 had a strong effect on symptom change [irritability: effect size (ES)=1.9, number needed to treat (NNT)=2, lethargy ES=0.9, NNT=5]. Parents may expect benefits of risperidone on irritability and lethargy with moderate to severe symptoms of ASD. Registry name: ClinicalTrials.gov, trial identifier: NCT00005014, URL: http://www.clinicaltrials.gov/ct2/show/NCT00005014?term=NCT00005014&rank=1, registered on March 31, 2000. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  10. Magnitude of efficacy measurements in grass allergy immunotherapy trials is highly dependent on pollen exposure.

    Science.gov (United States)

    Durham, S R; Nelson, H S; Nolte, H; Bernstein, D I; Creticos, P S; Li, Z; Andersen, J S

    2014-05-01

    The objective was to evaluate the association between grass pollen exposure, allergy symptoms and impact on measured treatment effect after grass sublingual immunotherapy (SLIT)-tablet treatment. The association between grass pollen counts and total combined rhinoconjunctivitis symptom and medication score (TCS) was based on a post hoc analysis of data collected over six trials and seven grass pollen seasons across North America and Europe, including 2363 subjects treated with grass SLIT-tablet or placebo. Daily pollen counts were obtained from centralized pollen databases. The effect of treatment on the relationship between the TCS and pollen counts was investigated, and the relative difference between grass SLIT-tablet and placebo as a function of average grass pollen counts was modelled by linear regression. The magnitude of treatment effect based on TCS was greater with higher pollen exposure (P pollen exposure during the first period of the season, with predicted reduction in TCS = 12% + 0.35% × pollen count (slope significantly different from 0, P = 0.003; R(2)  = 0.66). Corresponding correlations to the entire grass pollen season and to the peak season were equally good, whereas there was a poor correlation between difference in measured efficacy and pollen exposure during the last part of the season. In seasonal allergy trials with grass SLIT-tablet, the observed treatment effect is highly dependent on pollen exposure with the magnitude being greater with higher pollen exposure. This is an important relationship to consider when interpreting individual clinical trial results. © 2014 The Authors. Allergy Published by John Wiley & Sons Ltd.

  11. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Rationale, Design, and Methods.

    Science.gov (United States)

    Humphrey, Jean H; Jones, Andrew D; Manges, Amee; Mangwadu, Goldberg; Maluccio, John A; Mbuya, Mduduzi N N; Moulton, Lawrence H; Ntozini, Robert; Prendergast, Andrew J; Stoltzfus, Rebecca J; Tielsch, James M

    2015-12-15

    Child stunting and anemia are intractable public health problems in developing countries and have profound short- and long-term consequences. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial is motivated by the premise that environmental enteric dysfunction (EED) is a major underlying cause of both stunting and anemia, that chronic inflammation is the central characteristic of EED mediating these adverse effects, and that EED is primarily caused by high fecal ingestion due to living in conditions of poor water, sanitation, and hygiene (WASH). SHINE is a proof-of-concept, 2 × 2 factorial, cluster-randomized, community-based trial in 2 rural districts of Zimbabwe that will test the independent and combined effects of protecting babies from fecal ingestion (factor 1, operationalized through a WASH intervention) and optimizing nutritional adequacy of infant diet (factor 2, operationalized through an infant and young child feeding [IYCF] intervention) on length and hemoglobin at 18 months of age. Within SHINE we will measure 2 causal pathways. The program impact pathway comprises the series of processes and behaviors linking implementation of the interventions with the 2 child health primary outcomes; it will be modeled using measures of fidelity of intervention delivery and household uptake of promoted behaviors and practices. We will also measure a range of household and individual characteristics, social interactions, and maternal capabilities for childcare, which we hypothesize will explain heterogeneity along these pathways. The biomedical pathway comprises the infant biologic responses to the WASH and IYCF interventions that ultimately result in attained stature and hemoglobin concentration at 18 months of age; it will be elucidated by measuring biomarkers of intestinal structure and function (inflammation, regeneration, absorption, and permeability); microbial translocation; systemic inflammation; and hormonal determinants of growth and anemia

  12. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate) : a phase 2, randomised, controlled trial

    NARCIS (Netherlands)

    Khanna, Dinesh; Denton, Christopher P.; Jahreis, Angelika; van Laar, Jacob M.; Frech, Tracy M.; Anderson, Marina E.; Baron, Murray; Chung, Lorinda; Fierlbeck, Gerhard; Lakshminarayanan, Santhanam; Allanore, Yannick; Pope, Janet E.; Riemekasten, Gabriela; Steen, Virginia; Müller-Ladner, Ulf; Lafyatis, Robert; Stifano, Giuseppina; Spotswood, Helen; Chen-Harris, Haiyin; Dziadek, Sebastian; Morimoto, Alyssa; Sornasse, Thierry; Siegel, Jeffrey; Furst, Daniel E.

    2016-01-01

    Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind,

  13. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial

    NARCIS (Netherlands)

    Ebert, D.D.; Lehr, D.; BoB, L.; Riper, H.; Cuijpers, P.; Andersson, G.; Thiart, H.; Heber, E.; Berking, M.

    2014-01-01

    Objective The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of internet-based problem-solving training (iPST) for employees in the educational sector (teachers) with depressive symptoms. The results of training were compared to those of a waitlist control

  14. Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlled trial

    NARCIS (Netherlands)

    Desmyter, J.; Colaert, J.; de Groote, G.; Reynders, M.; Reerink-Brongers, E. E.; Lelie, P. N.; Dees, P. J.; Reesink, H. W.

    1983-01-01

    The efficacy of a heat-inactivated hepatitis B vaccine, 3 micrograms of surface antigen (HBsAg), given at 0, 1, 2, and 5 months, was evaluated in 401 haemodialysis patients in 18 centres by a placebo-controlled, double-blind, randomised trial. The attack-rate of hepatitis B virus (HBV) infections in

  15. Short-term efficacy of nicotine replacement therapy for smoking cessation in adolescents : A randomized controlled trial

    NARCIS (Netherlands)

    Scherphof, Charlotte S.|info:eu-repo/dai/nl/341769797; van den Eijnden, Regina J. J. M.|info:eu-repo/dai/nl/17399394X; Engels, Rutger C. M. E.; Vollebergh, Wilma A. M.|info:eu-repo/dai/nl/090632893

    The aim of this randomized, double-blind placebo-controlled clinical trial is to test the efficacy and safety of nicotine replacement therapy (NRT) in promoting end-of-treatment abstinence among adolescents and whether this relation is moderated by medication compliance. Participants (N = 257, age:

  16. Short-term efficacy of nicotine replacement therapy for smoking cessation in adolescents: A randomized controlled trial

    NARCIS (Netherlands)

    Scherphof, C.S.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.; Vollebergh, W.A.M.

    2014-01-01

    The aim of this randomized, double-blind placebo-controlled clinical trial is to test the efficacy and safety of nicotine replacement therapy (NRT) in promoting end-of-treatment abstinence among adolescents and whether this relation is moderated by medication compliance. Participants (N = 257, age:

  17. Sleep-related safety behaviors and dysfunctional beliefs mediate the efficacy of online CBT for insomnia: a randomized controlled trial

    NARCIS (Netherlands)

    Lancee, J.; Eisma, M.C.; van Straten, A.; Kamphuis, J.H.

    2015-01-01

    Several trials have demonstrated the efficacy of online cognitive behavioral therapy (CBT) for insomnia. However, few studies have examined putative mechanisms of change based on the cognitive model of insomnia. Identification of modifiable mechanisms by which the treatment works may guide efforts

  18. The efficacy of resiliency training programs: a systematic review and meta-analysis of randomized trials.

    Directory of Open Access Journals (Sweden)

    Aaron L Leppin

    Full Text Available Poor mental health places a burden on individuals and populations. Resilient persons are able to adapt to life's challenges and maintain high quality of life and function. Finding effective strategies to bolster resilience in individuals and populations is of interest to many stakeholders.To synthesize the evidence for resiliency training programs in improving mental health and capacity in 1 diverse adult populations and 2 persons with chronic diseases.Electronic databases, clinical trial registries, and bibliographies. We also contacted study authors and field experts.Randomized trials assessing the efficacy of any program intended to enhance resilience in adults and published after 1990. No restrictions were made based on outcome measured or comparator used.Reviewers worked independently and in duplicate to extract study characteristics and data. These were confirmed with authors. We conducted a random effects meta-analysis on available data and tested for interaction in planned subgroups.The standardized mean difference (SMD effect of resiliency training programs on 1 resilience/hardiness, 2 quality of life/well-being, 3 self-efficacy/activation, 4 depression, 5 stress, and 6 anxiety.We found 25 small trials at moderate to high risk of bias. Interventions varied in format and theoretical approach. Random effects meta-analysis showed a moderate effect of generalized stress-directed programs on enhancing resilience [pooled SMD 0.37 (95% CI 0.18, 0.57 p = .0002; I2 = 41%] within 3 months of follow up. Improvement in other outcomes was favorable to the interventions and reached statistical significance after removing two studies at high risk of bias. Trauma-induced stress-directed programs significantly improved stress [-0.53 (-1.04, -0.03 p = .03; I2 = 73%] and depression [-0.51 (-0.92, -0.10 p = .04; I2 = 61%].We found evidence warranting low confidence that resiliency training programs have a small to moderate effect at

  19. Efficacy and safety of collagenase clostridium histolyticum for Dupuytren disease nodules: a randomized controlled trial.

    Science.gov (United States)

    Costas, Bronier; Coleman, Stephen; Kaufman, Greg; James, Robert; Cohen, Brian; Gaston, R Glenn

    2017-08-30

    To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules. In this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end. In the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (-80.1%, P = 0.0002) and CCH 0.60 mg (-78.2%, P = 0.0003), but not CCH 0.25 mg (-58.3%, P = 0.079), versus placebo (-42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were "very satisfied" or "quite satisfied" with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment. In patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture. ClinicalTrials.gov identifier: NCT

  20. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia.

    Science.gov (United States)

    Grant, Paul M; Huh, Gloria A; Perivoliotis, Dimitri; Stolar, Neal M; Beck, Aaron T

    2012-02-01

    Low-functioning patients with chronic schizophrenia have high direct treatment costs and indirect costs incurred due to lost employment and productivity and have a low quality of life; antipsychotic medications and psychosocial interventions have shown limited efficacy to promote improved functional outcomes. To determine the efficacy of an 18-month recovery-oriented cognitive therapy program to improve psychosocial functioning and negative symptoms (avolition-apathy, anhedonia-asociality) in low-functioning patients with schizophrenia. Design, Setting, and A single-center, 18-month, randomized, single-blind, parallel group trial enrolled 60 low-functioning, neurocognitively impaired patients with schizophrenia (mean age, 38.4 years; 33.3% female; 65.0% African American). Cognitive therapy plus standard treatment vs standard treatment alone. The primary outcome measure was the Global Assessment Scale score at 18 months after randomization. The secondary outcomes were scores on the Scale for the Assessment of Negative Symptoms and the Scale for the Assessment of Positive Symptoms at 18 months after randomization. Patients treated with cognitive therapy showed a clinically significant mean improvement in global functioning from baseline to 18 months that was greater than the improvement seen with standard treatment (within-group Cohen d, 1.36 vs 0.06, respectively; adjusted mean [SE], 58.3 [3.30] vs 47.9 [3.60], respectively; P = .03; between-group d = 0.56). Patients receiving cognitive therapy as compared with those receiving standard treatment also showed a greater mean reduction in avolition-apathy (adjusted mean [SE], 1.66 [0.31] vs 2.81 [0.34], respectively; P = .01; between-group d = -0.66) and positive symptoms (hallucinations, delusions, disorganization) (adjusted mean [SE], 9.4 [3.3] vs 18.2 [3.8], respectively; P = .04; between-group d = -0.46) at 18 months. Age was controlled in the analyses, and there were no meaningful group differences in

  1. Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial.

    Science.gov (United States)

    Dawson, Liza; Garner, Sam; Anude, Chuka; Ndebele, Paul; Karuna, Shelly; Holt, Renee; Broder, Gail; Handibode, Jessica; Hammer, Scott M; Sobieszczyk, Magdalena E

    2015-08-01

    The field of HIV prevention research has recently experienced some mixed results in efficacy trials of pre-exposure prophylaxis, vaginal microbicides, and HIV vaccines. While there have been positive trial results in some studies, in the near term, no single method will be sufficient to quell the epidemic. Improved HIV prevention methods, choices among methods, and coverage for all at-risk populations will be needed. The emergence of partially effective prevention methods that are not uniformly available raises complex ethical and scientific questions regarding the design of ongoing prevention trials. We present here an ethical analysis regarding inclusion of pre-exposure prophylaxis in an ongoing phase IIb vaccine efficacy trial, HVTN 505. This is the first large vaccine efficacy trial to address the issue of pre-exposure prophylaxis, and the decisions made by the protocol team were informed by extensive stakeholder consultations. The key ethical concerns are analyzed here, and the process of stakeholder engagement and decision-making described. This discussion and analysis will be useful as current and future research teams grapple with ethical and scientific study design questions emerging with the rapidly expanding evidence base for HIV prevention. © The Author(s) 2015.

  2. Iterative development of Vegethon: a theory-based mobile app intervention to increase vegetable consumption.

    Science.gov (United States)

    Mummah, Sarah A; King, Abby C; Gardner, Christopher D; Sutton, Stephen

    2016-08-08

    ). Vegethon is a theory-based, user-informed mobile intervention that was systematically developed using the IDEAS framework. Vegethon targets increased vegetable consumption among overweight adults and is currently being evaluated in a randomized controlled efficacy trial. Clinical Trials.gov: NCT01826591.

  3. A theory-based online health behavior intervention for new university students: study protocol

    Directory of Open Access Journals (Sweden)

    Epton Tracy

    2013-02-01

    Full Text Available Abstract Background Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Methods/design Potential participants (all undergraduates about to enter the University of Sheffield will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking. Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy as well as socio-demographic variables, health status, Body Mass Index (BMI, health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. Discussion The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote

  4. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.

    Science.gov (United States)

    Pavel, Marianne; Gross, David J; Benavent, Marta; Perros, Petros; Srirajaskanthan, Raj; Warner, Richard R P; Kulke, Matthew H; Anthony, Lowell B; Kunz, Pamela L; Hörsch, Dieter; Weickert, Martin O; Lapuerta, Pablo; Jiang, Wenjun; Kassler-Taub, Kenneth; Wason, Suman; Fleming, Rosanna; Fleming, Douglas; Garcia-Carbonero, Rocio

    2018-03-01

    Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients ( N  = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. Through week 12, TEAEs were generally mild to moderate in severity; 5 (placebo), 1 (telotristat ethyl 250 mg) and 3 (telotristat ethyl 500 mg) patients experienced serious events, and the rate of TEAEs in the OLE was comparable. At week 12, significant reductions in u5-HIAA from baseline were observed, with Hodges-Lehmann estimators of median treatment differences from placebo of -54.0% (95% confidence limits, -85.0%, -25.1%, P  < 0.001) and -89.7% (95% confidence limits, -113.1%, -63.9%, P  < 0.001) for telotristat ethyl 250 mg and 500 mg. These results support the safety and efficacy of telotristat ethyl when added to SSAs in patients with CS diarrhea (ClinicalTrials.gov identifier: Nbib2063659). © 2018 The authors.

  5. [Efficacy of cervical fixed-point traction manipulation for cervical spondylotic radiculopathy: a randomized controlled trial].

    Science.gov (United States)

    Jiang, Chong-Bo; Wang, Jun; Zheng, Zhi-Xin; Hou, Jing-Shan; Ma, Ling; Sun, Tong

    2012-01-01

    Cervical spondylotic radiculopathy is a commonly encountered and frequently occurring disease. Traditional Chinese osteopathic manipulations may have better therapeutic efficacy than that of other methods in treating patients with cervical spondylotic radiculopathy. To evaluate the clinical therapeutic effects of cervical fixed-point traction manipulation in treating patients with cervical spondylotic radiculopathy. A prospective, randomized controlled trial was adopted. Eighty-four patients with cervical spondylotic radiculopathy were randomly divided into treatment group (n=42) and control group (n=42). All patients were enrolled from the outpatient service of Department of Rehabilitation of Chinese PLA General Hospital of China. Patients received oral and written information about clinical procedures before giving their written informed consent. The patients were treated with cervical fixed-point traction manipulation (treatment group) or cervical computer traction (control group). Cervical fixed-point traction was performed once every other day for a total of seven treatment periods and cervical computer traction was performed 30 min, once per day for 14 d. Before and after treatment, visual analogue scale (VAS) score and temperature of upper limb skin (normal limb and abnormal limb) detected by infrared thermal imaging system were contrastively analyzed. Five patients were lost to follow-up, one patient in the treatment group and four patients in the control group. There were significant differences in VAS score and temperature difference between the normal and abnormal upper limbs of infrared thermal imaging in the treatment group (t=28.652, Pmanipulation has better efficacy than cervical computer traction in treating patients with cervical spondylotic radiculopathy.

  6. Efficacy of Cinnarizine and Sodium Valproate in migraine prophylaxis: a clinical trial

    Directory of Open Access Journals (Sweden)

    M. Togha

    2006-07-01

    Full Text Available Background: Calcium-antagonists (CA are heterogeneous group of drugs with different efficacy in migraine prophylaxis. Several studies have firmly demonstrated flunarizine (FLU, and verapamil as the proven calcium-antagonists for migraine prophylaxis. Cinnarizine (CIN, is another CA with less complications and less antihistaminic action. There is very few studies to show the effect of this drug on migraine. The current study evaluates the efficacy and safety of cinnarizine on migraine in comparison to sodium valproate, an acceptable drug in migraine prophylaxis. Methods: The current study is a randomized double blind clinical trial on 133 participants with intractable migraine headache to evaluate the positive effect of cinnarizine in comparison to sodium valproate. The data was collected and analized by SPSS software. Results: The mean age of cases was 34.3±10 years in Cinnarizine group and 33.4±11 in Sodium Valproate users. The headache frequency decreased to about 50% and its severity to about 30% in both groups. Although the effect of Cinnarizine was started earlier than sodium valproate , there was no significant difference between two groups of cases in improvement of headache attacks. Statistically significant difference was noted in drug’s complication led to discontinuation of treatment, 5.2% in Cinnarizine users in respect to 14% in valproate group. Conclusion: The patients who received Cinnarizine, similar to the patients on sodium valprote showed significant improvement in headache attacks, frequency, duration and severity. Cinnarizine such as sodium valproate is an effective drug in migraine prophylaxis even in intractable headache, but with lesser severe complication.

  7. Safety and efficacy of denosumab in children with osteogenesis imperfect--a first prospective trial.

    Science.gov (United States)

    Hoyer-Kuhn, H; Franklin, J; Allo, G; Kron, M; Netzer, C; Eysel, P; Hero, B; Schoenau, E; Semler, O

    2016-03-01

    Osteogenesis imperfecta (OI) is a rare hereditary disease leading to bone fragility. Denosumab as a RANK ligand antibody inhibiting osteoclast maturation has been approved for osteoporosis treatment in adults. Aim of this study was a 48-week, open-label, pilot study of the safety and efficacy of denosumab in 10 children with OI. Ten patients (age range: 5.0-11.0 years; at least two years of prior bisphosphonate treatment) with genetically confirmed OI were studied. Denosumab was administered subcutaneously every 12 weeks with 1 mg/kg body weight. Primary endpoint was change of areal bone mineral density (aBMD) using dual energy x-ray absorptiometry of the lumbar spine after 48 weeks. Safety was assessed by bone metabolism markers and adverse event reporting. Mean relative change of lumbar aBMD was +19 % (95%-CI: 7-31%). Lumbar spine aBMD Z-Scores increased from -2.23±2.03 (mean±SD) to -1.27±2.37 (p=0.0006). Mobility did not change (GMFM-88 +2.72±4.62% (p=0.16); one-minute walking test +11.00±15.82 m (p=0.15). No severe side effects occurred. On average, there was a significant increase in lumbar spine aBMD percent change after 48 weeks of denosumab. There was no change in mobility parameters and no serious adverse events. Further trials are necessary to assess long-term side effects and efficacy.

  8. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

    Science.gov (United States)

    Cowie, Martin R; Filippatos, Gerasimos S; Alonso Garcia, Maria de Los Angeles; Anker, Stefan D; Baczynska, Anna; Bloomfield, Daniel M; Borentain, Maria; Bruins Slot, Karsten; Cronin, Maureen; Doevendans, Pieter A; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R; Malik, Fady I; McMurray, John J V; Metra, Marco; Figueroa Perez, Santiago; Pfeffer, Marc A; Pocock, Stuart J; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M C; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

    2017-06-01

    Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  9. A randomized trial of telemedicine efficacy and safety for nonacute headaches.

    Science.gov (United States)

    Müller, Kai I; Alstadhaug, Karl B; Bekkelund, Svein I

    2017-07-11

    To evaluate long-term treatment efficacy and safety of one-time telemedicine consultations for nonacute headaches. We randomized, allocated, and consulted nonacute headache patients via telemedicine (n = 200) or in a traditional manner (n = 202) in a noninferiority trial. Efficacy endpoints, assessed by questionnaires at 3 and 12 months, included change from baseline in Headache Impact Test-6 (HIT-6) (primary endpoint) and pain intensity (visual analogue scale [VAS]) (secondary endpoint). The primary safety endpoint, assessed via patient records, was presence of secondary headache within 12 months after consultation. We found no differences between telemedicine and traditional consultations in HIT-6 (p = 0.84) or VAS (p = 0.64) over 3 periods. The absolute difference in HIT-6 from baseline was 0.3 (95% confidence interval [CI] -1.26 to 1.82, p = 0.72) at 3 months and 0.2 (95% CI -1.98 to 1.58, p = 0.83) at 12 months. The absolute change in VAS was 0.4 (95% CI -0.93 to 0.22, p = 0.23) after 3 months and 0.3 (95% CI -0.94 to 0.29, p = 0.30) at 12 months. We found one secondary headache in each group at 12 months. The estimated number of consultations needed to miss one secondary headache with the use of telemedicine was 20,200. Telemedicine consultation for nonacute headache is as efficient and safe as a traditional consultation. NCT02270177. This study provides Class III evidence that a one-time telemedicine consultation for nonacute headache is noninferior to a one-time traditional consultation regarding long-term treatment outcome and safety. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  10. Treg depletion inhibits efficacy of cancer immunotherapy: implications for clinical trials.

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    James F Curtin

    2008-04-01

    Full Text Available Regulatory T lymphocytes (Treg infiltrate human glioblastoma (GBM; are involved in tumor progression and correlate with tumor grade. Transient elimination of Tregs using CD25 depleting antibodies (PC61 has been found to mediate GBM regression in preclinical models of brain tumors. Clinical trials that combine Treg depletion with tumor vaccination are underway to determine whether transient Treg depletion can enhance anti-tumor immune responses and improve long term survival in cancer patients.Using a syngeneic intracrabial glioblastoma (GBM mouse model we show that systemic depletion of Tregs 15 days after tumor implantation using PC61 resulted in a decrease in Tregs present in tumors, draining lymph nodes and spleen and improved long-term survival (50% of mice survived >150 days. No improvement in survival was observed when Tregs were depleted 24 days after tumor implantation, suggesting that tumor burden is an important factor for determining efficacy of Treg depletion in clinical trials. In a T cell dependent model of brain tumor regression elicited by intratumoral delivery of adenoviral vectors (Ad expressing Fms-like Tyrosine Kinase 3 ligand (Flt3L and Herpes Simplex Type 1-Thymidine Kinase (TK with ganciclovir (GCV, we demonstrate that administration of PC61 24 days after tumor implantation (7 days after treatment inhibited T cell dependent tumor regression and long term survival. Further, depletion with PC61 completely inhibited clonal expansion of tumor antigen-specific T lymphocytes in response to the treatment.Our data demonstrate for the first time, that although Treg depletion inhibits the progression/eliminates GBM tumors, its efficacy is dependent on tumor burden. We conclude that this approach will be useful in a setting of minimal residual disease. Further, we also demonstrate that Treg depletion, using PC61 in combination with immunotherapy, inhibits clonal expansion of tumor antigen-specific T cells, suggesting that new, more

  11. Efficacy and safety of acupuncture treatment on primary insomnia: a randomized controlled trial.

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    Yin, Xuan; Gou, Minghui; Xu, Jian; Dong, Bo; Yin, Ping; Masquelin, Fernand; Wu, Junyi; Lao, Lixing; Xu, Shifen

    2017-09-01

    The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primary insomnia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventy-two patients with primary insomnia were randomly assigned into two groups - the acupuncture group, who received acupuncture treatment, and the control group, who received sham acupuncture treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Compared with pretreatment baseline, patients in both groups had varying degrees of improvements in their sleep conditions. Paired t-test showed that there was a significant difference in all indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks post-treatment (F = 11.3, p = 0.001), four weeks post-treatment (F = 33.6, p acupuncture treatment group after the two-week and four-week follow-ups. Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients' sleep quality and improving their psychological health. Chinese Clinical Trial Registry: Chi CTR-TRC-14004859. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  12. A randomized controlled trial on therapeutic efficacy and safety of No. 1 Decoction for common cold

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    Xiao-rong HUO

    2012-12-01

    Full Text Available Objective  To assess therapeutic efficacy and safety of No. 1 Decoction for common cold in patients. Methods  A randomized controlled trial was conducted to study 225 male military officers and soldiers who were suffering from common cold, while 6 of them who showed positive results in the colloidal gold immunochromatography assay (GICA for detecting Flu A/ B or LP were excluded. The remaining 219 patients were randomly allocated either to receive No. 1 Decoction (study group, n=111 or Ganmao Qingre Keli (control group, n=108 for 3 days. Grading quantization form for symptoms of common cold were filled for all patients. Clinical response rate, significant response rate and complete cure rate were analyzed. Adverse events were also observed and recorded. Results  In this trial, 2 patients in test group and 1 in study group were lost in follow-up, 13 cases with incomplete data were excluded (5 in study group, 8 in control group. 219 patients were included in FAS set and SS set, and data of 203 cases were observed in the PP set. In FAS set, the study group had a higher clinical recovery rate and effective rate than the control group (14.41% vs12.96%, P=0.755; 72.97% vs64.81%, P=0.192, and had a lower significant effective rate than control group (36.94% vs43.52%, P=0.321. The 95% confidence interval for the difference between the effective rates of study group and control group was (–4.06%-20.38%, Δ=–10%, suggesting No.1 Decoction might be as effective as Ganmao Qingre Keli. The results of PP set were similar to that of FAS set. Conclusion  No. 1 Decoction is a safe and effective drug for common cold.

  13. Efficacy and safety of telavancin in clinical trials: a systematic review and meta-analysis.

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    Konstantinos A Polyzos

    Full Text Available INTRODUCTION: The epidemiology and antibiotic resistance of Staphylococcus aureus have evolved, underscoring the need for novel antibiotics, particularly against methicillin-resistant S. aureus (MRSA. Telavancin is a bactericidal lipoglycopeptide with potent activity against Gram-positive pathogens. OBJECTIVE: To systematically review and synthesize the available evidence from randomized controlled trials (RCTs evaluating telavancin in the treatment of patients with infections due to Gram-positive organisms with the methodology of meta-analysis. RESULTS: Six RCTs comparing telavancin with vancomycin were included; 4 (2229 patients referred to complicated skin and soft tissue infections (cSSTIs and 2 (1503 patients to hospital-acquired pneumonia (HAP. Regarding cSSTIs, telavancin and vancomycin showed comparable efficacy in clinically evaluable patients (odds ratio [OR] =1.10 [95% confidence intervals: 0.82-1.48]. Among patients with MRSA infection, telavancin showed higher eradication rates (OR=1.71 [1.08-2.70] and a trend towards better clinical response (OR=1.55 [0.93-2.58]. Regarding HAP, telavancin was non-inferior to vancomycin in terms of clinical response in two Phase III RCTs; mortality rates for the pooled trials were comparable with telavancin (20% and vancomycin (18.6%. Pooled data from cSSTIs and HAP studies on telavancin 10 mg/kg indicated higher rates of serum creatinine increases (OR=2.22 [1.38-3.57], serious adverse events (OR=1.53 [1.05-2.24], and adverse event-related withdrawals (OR=1.49 [1.14-1.95] among telavancin recipients. CONCLUSION: Telavancin might be an alternative to vancomycin in cases of difficult-to-treat MRSA infections. The potent antistaphylococcal activity of telavancin should be weighted against the potential for nephrotoxicity.

  14. Efficacy of different strategies to treat anemia in children: a randomized clinical trial

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    García Olga P

    2010-09-01

    Full Text Available Abstract Background Anemia continues to be a major public health problem among children in many regions of the world, and it is still not clear which strategy to treat it is most effective. Objective To evaluate the efficacy and children's acceptance of several recognized strategies to treat anemia. Methods Non-breastfed children (n = 577, 6 to 43 mo of age, were screened for the trial; 267 were anemic (hemoglobin Results All treatments significantly increased Hb and total iron concentration; ferritin did not change significantly. Groups MMS, IS and IFS increased Hb (g/dL [1.50 (95%CI: 1.17, 1.83, 1.48 [(1.18, 1.78 and 1.57 (1.26, 1.88, respectively] and total iron ((μg/dL [0.15 (0.01, 0.29, 0.19 (0.06, 0.31 and 0.12(-0.01, 0.25, respectively] significantly more than FCF [0.92 (0.64, 1.20] but not to FW group [0.14 (0.04, 0.24]. The prevalence of anemia was reduced to a greater extent in the MMS and IFS groups (72% and 69%, respectively than in the FCF group (45% (p Conclusion The three supplements IS, ISF and MMS increased Hb more than the FCF; the supplements that contained micronutrients (IFS and MMS were more effective for reducing the prevalence of anemia. In general, fortified foods were better accepted by the study participants than supplements. ClinicalTrial.gov Identifier NCT00822380

  15. Efficacy and safety of bevacizumab for the treatment of advanced hepatocellular carcinoma: a systematic review of phase II trials.

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    Ping Fang

    Full Text Available BACKGROUND: Hepatocellular carcinoma (HCC is a common cancer associated with a poor prognosis. Bevacizumab is a monoclonal antibody that binds vascular endothelial growth factor, a mediator of tumor angiogenesis. Bevacizumab is currently under investigation as treatment for HCC. We performed a systematic review of the efficacy and safety of bevacizumab for the treatment of advanced HCC. METHODS: PubMed, the Cochrane Library, and Google Scholar were searched using the terms "bevacizumab AND hepatocellular carcinoma AND (advanced OR unresectable". Phase II trials of bevacizumab for the treatment of advanced HCC were included. Outcomes of interest included progression-free and overall survival (PFS and OS, tumor response, and toxicities. RESULTS: A total of 26 records were identified. Of these, 18 were excluded. Hence, eight trials involving 300 patients were included. Bevacizumab was given as monotherapy (n = 1 trial or in combination with erlotinib (n = 4 trials, capecitabine (n = 1 trial, capecitabine+oxaliplatin (n = 1 trial, or gemcitabine+oxaliplatin (n = 1 trial. Most trials (five of eight reported median PFS and OS between 5.3 months and 9.0 months and 5.9 and 13.7 months, respectively. The disease control rate was consistent in five of eight trials, ranging from 51.1% to 76.9%. The response and partial response rates ranged from 0 to 23.7%, but were around 20% in four trials. Only one patient had a complete response. Frequently reported Grade 3/4 toxicities were increased aspartate transaminase/alanine transaminase (13%, fatigue (12%, hypertension (10%, diarrhea (8%, and neutropenia (5%. Thirty patients experienced gastrointestinal bleeding (grade 1/2 = 18, grade 3/4 = 12, typically due to esophageal varices. CONCLUSIONS: Bevacizumab shows promise as an effective and tolerable treatment for advanced HCC. The reported efficacy of bevacizumab appears to compare favorably with that of sorafenib, the only currently

  16. The Effects of Triggers’ Modifying on Adolescent Self-Efficacy with Asthma: A Randomized Controlled Clinical Trial

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    Leila Valizadeh

    2014-06-01

    Full Text Available Introduction: The management of asthma during adolescence has specific challenges and is likely influenced, to some extent, by the patient's belief in their ability to affect change, their self-efficacy. Bolstering self-efficacy could potentially improve an adolescent’s ability to self-manage their asthma. The aim of this study was to examine the effects of a triggers’ educational-modifying intervention on self-efficacy among adolescents diagnosed with asthma living in Iran. Methods: Sixty adolescents, aged 12 to 18 years, diagnosed with asthma participated in this randomized clinical trial. Participants randomly assigned to the control group received standard care while those assigned to the experimental group participated in a 5 week, nurse led, triggers modifying educational intervention in specialized clinics of lung in Tabriz, Iran. The self-efficacy scale developed by Bursh et al., was used for data collection. Results: The level of self- efficacy in two groups before intervention was not statistically significant, while the post intervention measures were statistically significant. Intervention was effective in improving adolescents’ self-efficacy. Conclusion: Since this type of intervention has the potential to improve Self- efficacy in adolescents with asthma, it is suggested that adolescence directly education about asthma triggers along with modulating triggers will be of value and parent‐centered could be diminished. The need for such interventions emphasizes in clinic and outpatient clinics.

  17. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial.

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    Sturkenboom, Ingrid H W M; Graff, Maud J L; Hendriks, Jan C M; Veenhuizen, Yvonne; Munneke, Marten; Bloem, Bastiaan R; Nijhuis-van der Sanden, Maria W

    2014-06-01

    There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson's disease. We did a multicentre, assessor-masked, randomised controlled clinical trial in ten hospitals in nine Dutch regional networks of specialised health-care professionals (ParkinsonNet), with assessment at 3 months and 6 months. Patients with Parkinson's disease with self-reported difficulties in daily activities were included, along with their primary caregivers. Patients were randomly assigned (2:1) to the intervention or control group by a computer-generated minimisation algorithm. The intervention consisted of 10 weeks of home-based occupational therapy according to national practice guidelines; control individuals received usual care with no occupational therapy. The primary outcome was self-perceived performance in daily activities at 3 months, assessed with the Canadian Occupational Performance Measure (score 1-10). Data were analysed using linear mixed models for repeated measures (intention-to-treat principle). Assessors monitored safety by asking patients about any unusual health events during the preceding 3 months. This trial is registered with ClinicalTrials.gov, NCT01336127. Between April 14, 2011, and Nov 2, 2012, 191 patients were randomly assigned to the intervention group (n=124) or the control group (n=67). 117 (94%) of 124 patients in the intervention group and 63 (94%) of 67 in the control group had a participating caregiver. At baseline, the median score on the Canadian Occupational Performance Measure was 4·3 (IQR 3·5-5·0) in the intervention group and 4·4 (3·8-5·0) in the control group. At 3 months, these scores were 5·8 (5·0-6·4) and 4·6 (4·6-6·6), respectively. The adjusted mean difference in score between groups at 3 months was in favour of the intervention group (1·2; 95% CI 0·8-1·6

  18. The efficacy of aspirin and dipyridamole on the patency of arteriovenous fistulae and grafts; Review of the randomized control trials

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    Hasan Ravari

    2014-07-01

    Full Text Available Vascular access failure is known as a principal cause of morbidity of end stage renal disease (ESRD patients. The major reason for vascular access failure is the neointimal hyperplasia which leads to venous thrombosis and stenosis. The efficacy of different pharmacological therapies has been studied in increasing the vascular access patency duration or decreasing the thrombosis of arteriovenous grafts or fistulas. In the current review, we reviewed the results obtained in different randomized control trials considering the efficacy of pharmacotherapy on the thrombosis rate and duration of vascular access grafts patency in HD patients.

  19. Efficacy of Adjunctive Single Session Counseling for Medically Unexplained Symptoms: A Randomized Controlled Trial

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    Menon, Vikas; Shanmuganathan, Balasubramanian; Thamizh, Jaiganesh Selvapandian; Arun, Anand Babu; Sarkar, Siddharth

    2017-01-01

    Context: Medically unexplained symptoms (MUS) are often poorly responsive to standard treatments. Aim: The aim of the study is to assess short-term efficacy of adjunctive single session cognitive behavior therapy (CBT)-based counseling for patients with MUS. Setting and Design: Randomized controlled trial at a psychosomatic clinic of a tertiary care hospital. Materials and Methods: Patients with MUS were randomized to receive either the single session counseling (intervention group) (n = 41) or control group which received treatment as usual (n = 35). The counseling intervention focused on three areas – cognitive reattribution, shifting focus, and guided muscular relaxation and lasted around 30 min. The two groups were assessed at baseline and after 1 month for change in outcome measures. Statistical Analysis Used: Repeated measures analysis of variance. P value was adjusted for multiple comparisons using Bonferroni correction and set at <0.01 for significance. Results: Both groups did not differ on change in the primary outcome measure: Patient Health Questionnaire – 15 scores (P = 0.055). However, at follow-up, the intervention group showed statistically greater reduction in the number of workdays lost (P = 0.005). Trend level changes were noted for depressive symptom reduction only in the intervention group (P = 0.022). Conclusions: One session CBT-based therapy demonstrates potentially important benefits over standard care among Indian patients with MUS. Further testing in larger samples with longer follow-up periods is therefore recommended. PMID:29200561

  20. Efficacy of Upper Extremity Robotic Therapy in Subacute Poststroke Hemiplegia: An Exploratory Randomized Trial.

    Science.gov (United States)

    Takahashi, Kayoko; Domen, Kazuhisa; Sakamoto, Tomosaburo; Toshima, Masahiko; Otaka, Yohei; Seto, Makiko; Irie, Katsumi; Haga, Bin; Takebayashi, Takashi; Hachisuka, Kenji

    2016-05-01

    Our aim was to study the efficacy of robotic therapy as an adjuvant to standard therapy during poststroke rehabilitation. Prospective, open, blinded end point, randomized, multicenter exploratory clinical trial in Japan of 60 individuals with mild to moderate hemiplegia 4 to 8 weeks post stroke randomized to receive standard therapy plus 40 minutes of either robotic or self-guided therapy for 6 weeks (7 days/week). Upper extremity impairment before and after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Motor Activity Log. Robotic therapy significantly improved Fugl-Meyer assessment flexor synergy (2.1±2.7 versus -0.1±2.4; P<0.01) and proximal upper extremity (4.8±5.0 versus 1.9±5.5; P<0.05) compared with self-guided therapy. No significant changes in Wolf Motor Function Test or Motor Activity Log were observed. Robotic therapy also significantly improved Fugl-Meyer assessment proximal upper extremity among low-functioning patients (baseline Fugl-Meyer assessment score <30) and among patients with Wolf Motor Function Test ≥120 at baseline compared with self-guided therapy (P<0.05 for both). Robotic therapy as an adjuvant to standard rehabilitation may improve upper extremity recovery in moderately impaired poststroke patients. Results of this exploratory study should be interpreted with caution. URL: http://www.umin.ac.jp/. Unique identifier: UMIN000001619. © 2016 American Heart Association, Inc.

  1. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

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    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  2. Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

    Science.gov (United States)

    Cheng, Yanny Y Y; Schouten, Jan S A G; Tahzib, Nayyirih G; Wijdh, Robert-Jan; Pels, Elisabeth; van Cleynenbreugel, Hugo; Eggink, Catharina A; Rijneveld, Wilhelmina J; Nuijts, Rudy M M A

    2009-12-15

    To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease were randomized to FLEK or PK. Clinical outcomes (astigmatism and visual acuity) and incidence of postoperative complications were compared between the two groups. At 12 months, the percentage of eyes with a refractive astigmatism less than or equal to 3 diopters was higher in the FLEK group in comparison with the PK group (86.2% vs. 51.3%, P=0.004). The mean postoperative best corrected visual acuity was 20/70+/-2 lines in the FLEK group and 20/44+/-2 lines in the PK group (Pastigmatism and results in an absence of wound healing related problems in patients with endothelial disease. However, visual acuity is lower as compared with conventional PK, and the high level of endothelial cell loss warrants a modification of the insertion technique of the endothelial graft.

  3. Efficacy of a powered wheelchair simulator for school aged children: a randomized controlled trial.

    Science.gov (United States)

    Linden, Mark A; Whyatt, Caroline; Craig, Cathy; Kerr, Claire

    2013-11-01

    To determine the efficacy of a custom-made wheelchair simulation in training children to use a powered wheelchair (PWC). Randomized controlled trial employing the 4C/ID-model of learning. Twenty-eight typically developing children (13M, 15F; mean age 6 years, SD 6 months) were assessed on their operation of a PWC using a functional evaluation rating scale. Participants were randomly assigned to intervention (8 × 30-minute training sessions using a joystick operated wheelchair simulation) or control conditions (no task), and were reassessed on their PWC use after the intervention phase. Additional data from the simulation on completion times, errors, and total scores were recorded for the intervention group. Analysis of variance showed a main effect of time, with planned comparisons revealing a statistically significant change in PWC use for the intervention (p = .022) but not the control condition. Although the intervention group showed greater improvement than the controls, this did not reach statistical significance. Multiple regression analyses showed that gender was predictive of pretest (p = .005) functional ability. A simulated wheelchair task appears to be effective in helping children learn to operate a PWC. Greater attention should be given to female learners who underperformed when compared with their male counterparts. This low-cost intervention could be easily used at home to reduce PWC training times in children with motor disorders. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  4. Efficacy of a triclosan formula in controlling early subgingival biofilm formation: a randomized trial

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    Ernesto ANDRADE

    2015-01-01

    Full Text Available The aim of this study was to determine the efficacy of rinses with slurries of a dentifrice containing triclosan (TCS, as compared with rinses with slurries from a control dentifrice, in controlling early subgingival biofilm formation. A double-blind, randomized and cross-over clinical trial was designed, and 26 dental students were included. In the first period, participants were randomized to rinse with a TCS slurry or a control slurry, in a 12 h interval, and to refrain from mechanical cleaning. A Plaque Free Zone Index was assessed at 24 h, 48 h, 72 h and 96 h. After a washout period of 10 days, the second experimental period was conducted, following the same protocol as the first period, except that the slurry groups were switched. Use of the TCS slurry resulted in a significantly higher percentage of plaque-free surfaces, both at 24 h and at 72 h (p < 0.01. In the of 48-72 h interval, the triclosan slurry showed a lower percentage of sites converted to a score of 2 (38.1% for the testversus 40% for the control product, p = 0.015. In conclusion, rinsing with slurries of dentifrice containing TCS retards the down growth of bacterial biofilms from the supra- to the subgingival environment.

  5. Efficacy of acupunture in patients with chronic neck pain--a randomised, sham controlled trial.

    Science.gov (United States)

    Sahin, Nilay; Ozcan, Emel; Sezen, Kasim; Karatas, Omer; Issever, Halim

    2010-01-01

    The aim of this study was to compare the efficacy of electroacupuncture and sham acupuncture in the treatment of patients with chronic neck pain. 31 patients with chronic neck pain were included in a randomised, controlled trial. Electric stimulation was given for 30 minutes at low frequency (1-4Hz), pulse width of 200 micros, interrupted wave form. Of the 29 patients who completed the therapy, 13 were assigned to conventional acupuncture and 16 to sham acupuncture groups, receiving 3 sessions a week for a total of 10 sessions, each lasting for 30 minutes. Patients were evaluated before and after therapy and 3 months later by Visual Analogue Scale (VAS) and the bodily pain subscale of the Short Form Health Survey-36 scale. The treating physician was different from the evaluating physician who, like the patient, was blinded. VAS scores in both groups significantly reduced after therapy and at 3 months post-therapy, but the difference between groups was not significant. In respect of bodily pain, there was a significant improvement in the acupuncture group after therapy (P<0.01). Stimulation of conventional acupuncture points was not generally superior to needling ofnonspecific points on the neck, and both treatments were associated with improvement of symptoms. Needles inserted into the neck are likely to be an inappropriate sham control for acupuncture.

  6. Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial.

    Science.gov (United States)

    Flores-González, J Carlos; Matamala-Morillo, Miguel A; Rodríguez-Campoy, Patricia; Pérez-Guerrero, Juan J; Serrano-Moyano, Belén; Comino-Vazquez, Paloma; Palma-Zambrano, Encarnación; Bulo-Concellón, Rocio; Santos-Sánchez, Vanessa; Lechuga-Sancho, Alfonso M

    2015-01-01

    There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline. We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay. A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011). Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively). In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before. EudraCT 2009-016042-57.

  7. Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial.

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    J Carlos Flores-González

    Full Text Available There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline.We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay.A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011. Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively.In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before.EudraCT 2009-016042-57.

  8. Efficacy of ultrasound-guided transversus abdominis plane block in laparoscopic hysterectomy. Clinical trial.

    Science.gov (United States)

    Guardabassi, D S; Lupi, S; Agejas, R; Allub, J M; García-Fornari, G

    2017-05-01

    Transversus abdominis plane block is a regional anaesthesia technique that has proven to be effective for postoperative pain reduction in different abdominal surgical procedures. This study evaluated its efficacy on post laparoscopic hysterectomy pain intensity and analgesic consumption. Randomized controlled trial which included 40 patients scheduled for laparoscopic hysterectomy, enrolled in 2 groups: transversus abdominis plane block+systemic analgesia (Group 1; n=20), versus systemic analgesia (Group 2; n=20). Opioid consumption within the first 24 postoperative hours, pain intensity scores at 60min, 2, 8 and 24h after surgery, adverse events related to systemic analgesia and time to hospital discharge were evaluated and registered. We found no differences between both groups in opioid consumption (10mg vs. 7mg; P=.2) and pain scores (NVS) within the first 24 postoperative hours, at 60min (3 vs. 5; P=.65), 120min (0 vs. 2; P=.15), 8 and 24h (0 vs. 0; P>.50) for the last 2 points in time analysed. Adverse events related to medication and time to hospital discharge showed similar results. Adding a transversus abdominis plane block technique to opioid PCA does not seem to improve postoperative pain management in laparoscopic hysterectomy. Patient preparation time and costs could be incremented and complications (although rare) related to the technique could appear. Copyright © 2017 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model.

    Science.gov (United States)

    Diakite, Ibrahim; Mooring, Eric Q; Velásquez, Gustavo E; Murray, Megan B

    2016-08-01

    During the 2014 Ebola virus disease (EVD) outbreak, policy-makers were confronted with difficult decisions on how best to test the efficacy of EVD vaccines. On one hand, many were reluctant to withhold a vaccine that might prevent a fatal disease from study participants randomized to a control arm. On the other, regulatory bodies called for rigorous placebo-controlled trials to permit direct measurement of vaccine efficacy prior to approval of the products. A stepped-wedge cluster study (SWCT) was proposed as an alternative to a more traditional randomized controlled vaccine trial to address these concerns. Here, we propose novel "ordered stepped-wedge cluster trial" (OSWCT) designs to further mitigate tradeoffs between ethical concerns, logistics, and statistical rigor. We constructed a spatially structured mathematical model of the EVD outbreak in Sierra Leone. We used the output of this model to simulate and compare a series of stepped-wedge cluster vaccine studies. Our model reproduced the observed order of first case occurrence within districts of Sierra Leone. Depending on the infection risk within the trial population and the trial start dates, the statistical power to detect a vaccine efficacy of 90% varied from 14% to 32% for standard SWCT, and from 67% to 91% for OSWCTs for an alpha error of 5%. The model's projection of first case occurrence was robust to changes in disease natural history parameters. Ordering clusters in a step-wedge trial based on the cluster's underlying risk of infection as predicted by a spatial model can increase the statistical power of a SWCT. In the event of another hemorrhagic fever outbreak, implementation of our proposed OSWCT designs could improve statistical power when a step-wedge study is desirable based on either ethical concerns or logistical constraints.

  10. Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model.

    Directory of Open Access Journals (Sweden)

    Ibrahim Diakite

    2016-08-01

    Full Text Available During the 2014 Ebola virus disease (EVD outbreak, policy-makers were confronted with difficult decisions on how best to test the efficacy of EVD vaccines. On one hand, many were reluctant to withhold a vaccine that might prevent a fatal disease from study participants randomized to a control arm. On the other, regulatory bodies called for rigorous placebo-controlled trials to permit direct measurement of vaccine efficacy prior to approval of the products. A stepped-wedge cluster study (SWCT was proposed as an alternative to a more traditional randomized controlled vaccine trial to address these concerns. Here, we propose novel "ordered stepped-wedge cluster trial" (OSWCT designs to further mitigate tradeoffs between ethical concerns, logistics, and statistical rigor.We constructed a spatially structured mathematical model of the EVD outbreak in Sierra Leone. We used the output of this model to simulate and compare a series of stepped-wedge cluster vaccine studies. Our model reproduced the observed order of first case occurrence within districts of Sierra Leone. Depending on the infection risk within the trial population and the trial start dates, the statistical power to detect a vaccine efficacy of 90% varied from 14% to 32% for standard SWCT, and from 67% to 91% for OSWCTs for an alpha error of 5%. The model's projection of first case occurrence was robust to changes in disease natural history parameters.Ordering clusters in a step-wedge trial based on the cluster's underlying risk of infection as predicted by a spatial model can increase the statistical power of a SWCT. In the event of another hemorrhagic fever outbreak, implementation of our proposed OSWCT designs could improve statistical power when a step-wedge study is desirable based on either ethical concerns or logistical constraints.

  11. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

    Science.gov (United States)

    Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

    2017-01-01

    Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration

  12. Prospects for subunit vaccines: Technology advances resulting in efficacious antigens requires matching advances in early clinical trial investment.

    Science.gov (United States)

    McClean, Siobhán

    2016-12-01

    With the continued march of antimicrobial resistance, a renewed impetus for better vaccines has been heralded. Identification of potent subunit vaccines has been greatly facilitated by recent developments in reverse vaccinology and proteomics strategies. There are a range of antimicrobial resistant bacterial pathogens that could be targeted by potent vaccine antigens identified within the coming years. However, cost is a significant hurdle in progressing lead antigen candidates to clinical trials. In order for novel vaccine technologies to realize their clinical potential, there is a requirement to improve investment and incentives to expedite the development of vaccines that are apparently efficacious in preclinical trials.

  13. [Controlled trials on the efficacy of occupational therapy with elderly. Part II: Evidence for prioritized diseases and disabilities].

    Science.gov (United States)

    Voigt-Radloff, S; Schochat, T; Heiss, H W

    2004-12-01

    To identify the evidence for the efficacy of occupational therapy on prioritized diseases and disabilities of the elderly. Reviews, meta-analyses and clinical trials with control group design regarding "occupational therapy" were identified by an electronic search of pubmed and reviewed based on the CONSORT-Statement. The study results were summarised in regard to diseases and commented considering further literature. A total of 31 studies were identified: 10 on stroke, 6 on dementia, 5 on prevention of falls, growing loneliness or inactivity, 4 on need of nursing care, and 6 on other diseases or disabilities. There is evidence for a positive efficacy of occupational therapy on the level of several controlled trials or reviews. Especially in Germany, further research specific to occupational therapy is needed in the fields of depression, diabetes mellitus and nursing care in the community.

  14. Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials.

    Science.gov (United States)

    Gilbert, Peter B; Juraska, Michal; deCamp, Allan C; Karuna, Shelly; Edupuganti, Srilatha; Mgodi, Nyaradzo; Donnell, Deborah J; Bentley, Carter; Sista, Nirupama; Andrew, Philip; Isaacs, Abby; Huang, Yunda; Zhang, Lily; Capparelli, Edmund; Kochar, Nidhi; Wang, Jing; Eshleman, Susan H; Mayer, Kenneth H; Magaret, Craig A; Hural, John; Kublin, James G; Gray, Glenda; Montefiori, David C; Gomez, Margarita M; Burns, David N; McElrath, Julie; Ledgerwood, Julie; Graham, Barney S; Mascola, John R; Cohen, Myron; Corey, Lawrence

    2017-01-01

    Anti-HIV-1 broadly neutralizing antibodies (bnAbs) have been developed as potential agents for prevention of HIV-1 infection. The HIV Vaccine Trials Network and the HIV Prevention Trials Network are conducting the Antibody Mediated Prevention (AMP) trials to assess whether, and how, intravenous infusion of the anti-CD4 binding site bnAb, VRC01, prevents HIV-1 infection. These are the first test-of-concept studies to assess HIV-1 bnAb prevention efficacy in humans. The AMP trials are two parallel phase 2b HIV-1 prevention efficacy trials conducted in two cohorts: 2700 HIV-uninfected men and transgender persons who have sex with men in the United States, Peru, Brazil, and Switzerland; and 1500 HIV-uninfected sexually active women in seven countries in sub-Saharan Africa. Participants are randomized 1:1:1 to receive an intravenous infusion of 10 mg/kg VRC01, 30 mg/kg VRC01, or a control preparation every 8 weeks for a total of 10 infusions. Each trial is designed (1) to assess overall prevention efficacy (PE) pooled over the two VRC01 dose groups vs. control and (2) to assess VRC01 dose and laboratory markers as correlates of protection (CoPs) against overall and genotype- and phenotype-specific infection. Each AMP trial is designed to have 90% power to detect PE > 0% if PE is ≥ 60%. The AMP trials are also designed to identify VRC01 properties (i.e., concentration and effector functions) that correlate with protection and to provide insight into mechanistic CoPs. CoPs are assessed using data from breakthrough HIV-1 infections, including genetic sequences and sensitivities to VRC01-mediated neutralization and Fc effector functions. The AMP trials test whether VRC01 can prevent HIV-1 infection in two study populations. If affirmative, they will provide information for estimating the optimal dosage of VRC01 (or subsequent derivatives) and identify threshold levels of neutralization and Fc effector functions associated with high-level protection, setting a benchmark

  15. Randomized comparative trial of efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children

    OpenAIRE

    Falgun Indravadan Vyas; Devang Ashwinkumar Rana; Patel, Piyush M.; Varsha Jitendra Patel; Bhavsar, Rekha H.

    2014-01-01

    Objective: Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children. Materials and Methods: This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, al...

  16. Alcohol brief intervention for hospitalized veterans with hazardous drinking: protocol for a 3-arm randomized controlled efficacy trial

    OpenAIRE

    Broyles, Lauren M.; Wieland, Melissa E; Confer, Andrea L; DiNardo, Monica M; Kraemer, Kevin L; Hanusa, Barbara H.; Youk, Ada O.; GORDON, ADAM J; Sevick, Mary Ann

    2015-01-01

    Background Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trial...

  17. Survival time outcomes in randomized, controlled trials and meta-analyses: the parallel universes of efficacy and cost-effectiveness.

    Science.gov (United States)

    Guyot, Patricia; Welton, Nicky J; Ouwens, Mario J N M; Ades, A E

    2011-01-01

    Many regulatory agencies require that manufacturers establish both efficacy and cost-effectiveness. The statistical analysis of the randomized, controlled trial (RCT) outcomes should be the same for both purposes. The question addressed by this article is the following: for survival outcomes, what is the relationship between the statistical analyses used to support inference and the statistical model used to support decision making based on cost-effectiveness analysis (CEA)? We performed a review of CEAs alongside trials and CEAs based on a synthesis of RCT results, which were submitted to the National Institute for Health and Clinical Excellence (NICE) Technology Appraisal program and included survival outcomes. We recorded the summary statistics and the statistical models used in both efficacy and cost-effectiveness analyses as well as procedures for model diagnosis and selection. In no case was the statistical model for efficacy and CEA the same. For efficacy, relative risks or Cox regression was used. For CEA, the common practice was to fit a parametric model to the control arm, then to apply the hazard ratio from the efficacy analysis to predict the treatment arm. The proportional hazards assumption was seldom checked; the choice of model was seldom based on formal criteria, and uncertainty in model choice was seldom addressed and never propagated through the model. Both inference and decisions based on CEAs should be based on the same statistical model. This article shows that for survival outcomes, this is not the case. In the interests of transparency, trial protocols should specify a common procedure for model choice for both purposes. Further, the sufficient statistics and the life tables for each arm should be reported to improve transparency and to facilitate secondary analyses of results of RCTs. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  18. Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial.

    Science.gov (United States)

    Freeman, Ellen W; Guthrie, Katherine A; Caan, Bette; Sternfeld, Barbara; Cohen, Lee S; Joffe, Hadine; Carpenter, Janet S; Anderson, Garnet L; Larson, Joseph C; Ensrud, Kristine E; Reed, Susan D; Newton, Katherine M; Sherman, Sheryl; Sammel, Mary D; LaCroix, Andrea Z

    2011-01-19

    Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes. To determine the efficacy and tolerability of 10 to 20 mg/d escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity, and bother of menopausal hot flashes. A multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 205 women (95 African American; 102 white; 8 other) between July 2009 and June 2010. Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks. Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8. Secondary outcomes were hot flash bother, recorded on daily diaries, and clinical improvement (defined as hot flash frequency ≥50% decrease from baseline). Mean (SD) daily hot flash frequency was 9.78 (5.60) at baseline. In a modified intent-to-treat analysis that included all randomized participants who provided hot flash diary data, the mean difference in hot flash frequency reduction was 1.41 (95% CI, 0.13-2.69) fewer hot flashes per day at week 8 among women taking escitalopram (P hot flashes per day in the escitalopram and placebo groups, respectively. Fifty-five percent of women in the escitalopram group vs 36% in the placebo group reported a decrease of at least 50% in hot flash frequency (P = .009) at the 8-week follow-up. Reductions in hot flash severity scores were significantly greater in the escitalopram group (-0.52; 95% CI, -0.64 to -0.40 vs -0.30; 95% CI, -0.42 to -0.17 for placebo; P women in the escitalopram group reported a mean 1.59 (95% CI, 0.55-2.63; P = .02) more hot flashes per day than women in the placebo group. Among healthy women, the use of escitalopram (10-20 mg/d) compared with placebo resulted in fewer and less severe menopausal hot

  19. Efficacy of aliskiren supplementation for heart failure : A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Luo, Y; Chen, Q

    2018-02-22

    Aliskiren might be beneficial for heart failure. However, the results of various studies are controversial. We conducted a systematic review and meta-analysis to explore the efficacy of aliskiren supplementation for heart failure. PubMed, Embase, Web of Science, EBSCO, and the Cochrane Library databases were systematically searched. Randomized controlled trials (RCTs) assessing the efficacy of aliskiren for heart failure were included. Two investigators independently searched for articles, extracted data, and assessed the quality of included studies. The meta-analysis was performed using the random-effect model. Five RCTs comprising 1973 patients were included in the meta-analysis. Compared with control interventions in heart failure, aliskiren supplementation was found to significantly reduce NT-proBNP levels (standardized mean difference [SMD] = -0.12; 95% CI = -0.21 to -0.03 pg/ml; p = 0.008) and plasma renin activity (SMD = -0.66; 95% CI = -0.89 to -0.44 ng/ml.h; p < 0.00001) while increasing plasma renin concentration (SMD = 0.52; 95% CI = 0.30-0.75 ng/l; p < 0.00001); however, it demonstrated no significant influence on BNP levels (SMD = -0.08; 95% CI = -0.31-0.15 pg/ml; p = 0.49), mortality (RR = 0.97; 95% CI = 0.79-1.20; p = 0.79), aldosterone levels (SMD = -0.09; 95% CI = -0.32-0.14 pmol/l; p = 0.44), adverse events (RR = 3.03; 95% CI = 0.18-49.51; p = 0.44), and serious adverse events (RR = 1.34; 95% CI = 0.54-3.33; p = 0.53). Aliskiren supplementation was found to significantly decrease NT-proBNP levels and plasma renin activity and to improve plasma renin concentration in the setting of heart failure.

  20. A cluster-randomised controlled trial to test the efficacy of facemasks in preventing respiratory viral infection among Hajj pilgrims.

    Science.gov (United States)

    Wang, Mandy; Barasheed, Osamah; Rashid, Harunor; Booy, Robert; El Bashir, Haitham; Haworth, Elizabeth; Ridda, Iman; Holmes, Edward C; Dwyer, Dominic E; Nguyen-Van-Tam, Jonathan; Memish, Ziad A; Heron, Leon

    2015-06-01

    Cost-effective interventions are needed to control the transmission of viral respiratory tract infections (RTIs) in mass gatherings. Facemasks are a promising preventive measure, however, previous studies on the efficacy of facemasks have been inconclusive. This study proposes a large-scale facemask trial during the Hajj pilgrimage in Saudi Arabia and presents this protocol to illustrate its feasibility and to promote both collaboration with other research groups and additional relevant studies. A cluster-randomised controlled trial is being conducted to test the efficacy of standard facemasks in preventing symptomatic and proven viral RTIs among pilgrims during the Hajj season in Mina, Mecca, Saudi Arabia. The trial will compare the 'supervised use of facemasks' versus 'standard measures' among pilgrims over several Hajj seasons. Cluster-randomisation will be done by accommodation tents with a 1:1 ratio. For the intervention tents, free facemasks will be provided to be worn consistently for 7days. Data on flu-like symptoms and mask use will be recorded in diaries. Nasal samples will be collected from symptomatic recruits and tested for nucleic acid of respiratory viruses. Data obtained from questionnaires, diaries and laboratory tests will be analysed to examine whether mask use significantly reduces the frequency of laboratory-confirmed respiratory viral infection and syndromic RTI as primary outcomes. This trial will provide valuable evidence on the efficacy of standard facemask use in preventing viral respiratory tract infections at mass gatherings. This study is registered at the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12613001018707 (http://www.anzctr.org.au). Copyright © 2014 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

  1. Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Danfeng Zhang

    2017-01-01

    Full Text Available Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios and mean differences were pooled with fixed-effects model or random-effects model. Seven studies were identified, involving 1779 patients with AIS. The summary results failed to demonstrate significant superiority of cerebrolysin in the assessment of efficacy outcomes of mRS and BI. Similarly, administration of cerebrolysin had neutral effects on safety outcomes compared with placebo, including mortality and SAE. However, the number of included studies was small, especially in the analysis of efficacy outcomes, which might cause publication bias and inaccurate between-studies variance in the meta-analysis. Conclusively, although it seemed to be safe, routine use of cerebrolysin to improve the long-term rehabilitation after stroke could not be supported by available evidence.

  2. Efficacy of different strategies to treat anemia in children: a randomized clinical trial

    Science.gov (United States)

    2010-01-01

    Background Anemia continues to be a major public health problem among children in many regions of the world, and it is still not clear which strategy to treat it is most effective. Objective To evaluate the efficacy and children's acceptance of several recognized strategies to treat anemia. Methods Non-breastfed children (n = 577), 6 to 43 mo of age, were screened for the trial; 267 were anemic (hemoglobin acid supplement (IFS), a multiple micronutrient supplement (MMS), a micronutrient-fortified complementary food as porridge powder (FCF), or zinc+iron+ascorbic acid fortified water (FW). The iron content of each daily dose was 20, 12.5, 10, 10 and 6.7 mg respectively. Hemoglobin (Hb), ferritin, total iron, weight and height were measured at baseline and after 4 months of treatment. Morbidity, treatment acceptability and adherence were recorded during the intervention. Results All treatments significantly increased Hb and total iron concentration; ferritin did not change significantly. Groups MMS, IS and IFS increased Hb (g/dL) [1.50 (95%CI: 1.17, 1.83), 1.48 [(1.18, 1.78) and 1.57 (1.26, 1.88), respectively] and total iron ((μg/dL) [0.15 (0.01, 0.29), 0.19 (0.06, 0.31) and 0.12(-0.01, 0.25), respectively] significantly more than FCF [0.92 (0.64, 1.20)] but not to FW group [0.14 (0.04, 0.24)]. The prevalence of anemia was reduced to a greater extent in the MMS and IFS groups (72% and 69%, respectively) than in the FCF group (45%) (p children, than IFS, FCF and FW. Conclusion The three supplements IS, ISF and MMS increased Hb more than the FCF; the supplements that contained micronutrients (IFS and MMS) were more effective for reducing the prevalence of anemia. In general, fortified foods were better accepted by the study participants than supplements. ClinicalTrial.gov Identifier NCT00822380 PMID:20863398

  3. Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

    Science.gov (United States)

    Siewe, Jan; Bredow, Jan; Oppermann, Johannes; Koy, Timmo; Delank, Stefan; Knoell, Peter; Eysel, Peer; Sobottke, Rolf; Zarghooni, Kourosh; Röllinghoff, Marc

    2014-09-05

    of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. NCT01852526.

  4. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Román Miguel

    2013-02-01

    Full Text Available Abstract Background Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients’ quality of life. Methods This study aimed to assess the efficacy of a 3-month Pulmonary Rehabilitation (PR program with a further 9 months of maintenance (RHBM group compared with both PR for 3 months without further maintenance (RHB group and usual care in improving the quality of life of patients with moderate COPD. We conducted a parallel-group, randomized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups. Health outcomes were quality of life, exercise capacity, pulmonary function and exacerbations. Results We found statistically and clinically significant differences in the three groups at 3 months in the emotion dimension (0.53; 95%CI0.06-1.01 in the usual care group, (0.72; 95%CI0.26-1.18 the RHB group (0.87; 95%CI 0.44-1.30 and the RHBM group as well as in fatigue (0.47; 95%CI 0.17-0.78 in the RHBM group. After 1 year, these differences favored the long-term rehabilitation group in the domains of fatigue (0.56; 95%CI 0.22-0.91, mastery (0.79; 95%CI 0.03-1.55 and emotion (0.75; 95%CI 0.17-1.33. Between-group analysis only showed statistically and clinically significant differences between the RHB group and control group in the dyspnea dimension (0.79 95%CI 0.05-1.52. No differences were found for exacerbations, pulmonary function or exercise capacity. Conclusions We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL, exercise tolerance, pulmonary function or exacerbation after a one-year, community based rehabilitation program. However, long-term improvements in the emotional, fatigue and mastery dimensions (within intervention groups were identified. Trial registration ISRCTN94514482

  5. Attentional and affective consequences of technology supported mindfulness training: a randomised, active control, efficacy trial.

    Science.gov (United States)

    Bhayee, Sheffy; Tomaszewski, Patricia; Lee, Daniel H; Moffat, Graeme; Pino, Lou; Moreno, Sylvain; Farb, Norman A S

    2016-11-29

    Mindfulness training (MT) programs represent an approach to attention training with well-validated mental health benefits. However, research supporting MT efficacy is based predominantly on weekly-meeting, facilitator-led, group-intervention formats. It is unknown whether participants might benefit from neurofeedback-assisted, technology-supported MT (N-tsMT), in which meditation is delivered individually, without the need for a facilitator, travel to a training site, or the presence of a supportive group environment. Mirroring the validation of group MT interventions, the first step in addressing this question requires identifying whether N-tsMT promotes measurable benefits. Here, we report on an initial investigation of a commercial N-tsMT system. In a randomized, active control trial, community-dwelling healthy adult participants carried out 6 weeks of daily practice, receiving either N-tsMT (n = 13), or a control condition of daily online math training (n = 13). Training effects were assessed on target measures of attention and well-being. Participants also completed daily post-training surveys assessing effects on mood, body awareness, calm, effort, and stress. Analysis revealed training effects specific to N-tsMT, with attentional improvements in overall reaction time on a Stroop task, and well-being improvements via reduced somatic symptoms on the Brief Symptom Inventory. Attention and well-being improvements were correlated, and effects were greatest for the most neurotic participants. However, secondary, exploratory measures of attention and well-being did not show training-specific effects. N-tsMT was associated with greater body awareness and calm, and initially greater effort that later converged with effort in the control condition. Preliminary findings indicate that N-tsMT promotes modest benefits for attention and subjective well-being in a healthy community sample relative to an active control condition. However, the findings would benefit

  6. Efficacy of Vitamin and Antioxidant Supplements in Prevention of Esophageal Cancer: Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Myung, Seung-Kwon; Yang, Hyo Jin

    2013-06-01

    Observational epidemiological studies have shown that higher intakes of vitamins or antioxidants were inversely associated with the risk of esophageal cancer. However, randomized controlled trials (RCTs) have reported no preventive efficacy of vitamin or antioxidant supplements on esophageal cancer. This meta-analysis aimed to investigate the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer as reported by RCTs. We searched PubMed, EMBASE, and the Cochrane Library in May 2013. Two authors independently reviewed and selected eligible articles based on predetermined selection criteria. Of 171 articles searched from three databases and relevant bibliographies, 10 RCTs were included in the final analyses. In a fixed-effect meta-analysis of 10 trials, there was no efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer (relative risk [RR], 1.04; 95% confidence interval [CI], 0.86-1.25; I(2)=0.0%). Also, subgroup meta-analyses showed that vitamin and antioxidant supplements had no preventive efficacy on esophageal cancer both in the high risk (RR, 1.04; 95% CI, 0.85-1.28; n=4) and non-high risk (RR, 1.01; 95% CI, 0.65-1.56; n=6) groups for esophageal cancer. Further, subgroup meta-analyses revealed no preventive efficacy on esophageal cancer by type of methodological quality and type of vitamin and antioxidant supplements. Unlike observational epidemiological studies, this meta-analysis of RCTs suggests that there is no clinical evidence to support the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer.

  7. A theory-based online health behavior intervention for new university students: study protocol.

    Science.gov (United States)

    Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L; Ciravegna, Fabio; Brennan, Alan; Meier, Petra; Julious, Steven A; Naughton, Declan; Petroczi, Andrea; Dadzie, Aba-Sah; Kruger, Jen

    2013-02-05

    Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Potential participants (all undergraduates about to enter the University of Sheffield) will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni) or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions) to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking). Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy) as well as socio-demographic variables, health status, Body Mass Index (BMI), health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote healthy behaviors among new undergraduates. Current Controlled

  8. Efficacy of Omega-3 Treatment for Vasomotor Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Cohen, Lee S.; Joffe, Hadine; Guthrie, Katherine A.; Ensrud, Kristine E.; Freeman, Marlene; Carpenter, Janet S.; Learman, Lee A.; Newton, Katherine M.; Reed, Susan D.; Manson, JoAnn E.; Sternfeld, Barbara; Caan, Bette; Freeman, Ellen W.; LaCroix, Andrea Z.; Tinker, Lesley F.; LaForce, Cathryn Booth; Larson, Joseph C.; Anderson, Garnet L.

    2013-01-01

    Objective To determine the efficacy and tolerability of omega-3 fatty acids in reducing VMS frequency and bother in peri- and postmenopausal women. Methods Three-by-two factorial, randomized, controlled 12-week trial. Eligible women were randomized to double-blind comparison of omega-3s (n=177) or placebo (n=178) capsules, and simultaneously to yoga (n=107), aerobic exercise (n=106), or their usual physical activity (n=142). Participants received 12 weeks of omega-3 dosage at a dose of 1.8 grams daily. Each capsule contained ethyl eicosapentaenoic acid (EPA; 425 mg) and docosahexaenoic acid (DHA; 100 mg) and other omega-3s (90mg). Primary outcomes were VMS frequency and bother. Secondary outcomes included sleep quality (Pittsburg Sleep Quality Index), insomnia symptoms (Insomnia Severity Index), depressive symptoms (Physician's Health Questionnaire-8), and anxiety (Generalized Anxiety Disorder-7). Results The mean baseline frequency of VMS/day was 7.6 (95% confidence interval [CI] 7.0, 8.2). After 12 weeks, reduction in VMS frequency for omega-3 (−2.5, 95% CI −3.0, −1.9) did not differ significantly from that in placebo (−2.7, 95% CI −3.3, −2.2), with a relative difference of 0.3 fewer hot flashes per day (95% CI −0.5, 1.0, p=0.28). Changes in VMS bother at 12 weeks were also similar between groups, with no relative difference on a 4-point scale (95% CI −0.1, 0.2, p=0.36). Omega-3s compared with placebo showed no improvement in self-reported sleep or mood (p>0.09 for all comparisons). Conclusion Among healthy peri- and postmenopausal sedentary women, 12 weeks of omega-3 treatment compared with placebo did not improve VMS frequency, VMS bother, sleep, or mood compared to placebo. PMID:23982113

  9. Efficacy of omega-3 for vasomotor symptoms treatment: a randomized controlled trial.

    Science.gov (United States)

    Cohen, Lee S; Joffe, Hadine; Guthrie, Katherine A; Ensrud, Kristine E; Freeman, Marlene; Carpenter, Janet S; Learman, Lee A; Newton, Katherine M; Reed, Susan D; Manson, Joann E; Sternfeld, Barbara; Caan, Bette; Freeman, Ellen W; LaCroix, Andrea Z; Tinker, Lesley F; Booth-Laforce, Cathryn; Larson, Joseph C; Anderson, Garnet L

    2014-04-01

    This study aims to determine the efficacy and tolerability of omega-3 fatty acids in reducing vasomotor symptoms (VMS) frequency and bother in perimenopausal and postmenopausal women. This study was a 12-week, three-by-two factorial, randomized controlled trial. Eligible women were randomized to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules, and simultaneously to yoga (n = 107), aerobic exercise (n = 106), or their usual physical activity (n = 142). Participants received 1.8 g of omega-3 daily for 12 weeks. Each capsule contained ethyl eicosapentaenoic acid (425 mg), docosahexaenoic acid (100 mg), and other omega-3s (90 mg). Primary outcomes were VMS frequency and bother. Secondary outcomes included sleep quality (Pittsburgh Sleep Quality Index), insomnia symptoms (Insomnia Severity Index), depressive symptoms (Physician's Health Questionnaire-8), and anxiety (Generalized Anxiety Disorder-7). The mean baseline frequency of VMS per day was 7.6 (95% CI, 7.0 to 8.2). After 12 weeks, the reduction in VMS frequency with omega-3 (-2.5; 95% CI, -3.0 to -1.9) did not differ significantly from that with placebo (-2.7; 95% CI, -3.3 to -2.2), with a relative difference of 0.3 fewer hot flashes per day (95% CI, -0.5 to 1.0; P = 0.28). Changes in VMS bother at 12 weeks were also similar between groups, with no relative difference on a four-point scale (95% CI, -0.1 to 0.2; P = 0.36). Omega-3s compared with placebo showed no improvement in self-reported sleep or mood (P > 0.09 for all comparisons). Among healthy, sedentary perimenopausal and postmenopausal women, a 12-week treatment with omega-3 does not improve VMS frequency, VMS bother, sleep, or mood compared with placebo.

  10. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Aviles, Agustin, E-mail: agustin.aviles@imss.gob.mx [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)

    2012-07-15

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  11. Efficacy of salbutamol and ipratropium bromide in the management of acute bronchiolitis--a clinical trial.

    Science.gov (United States)

    Karadag, Bulent; Ceran, Omer; Guven, Gulsah; Dursun, Esengul; Ipek, Ilke Ozahi; Karakoc, Fazilet; Ersu, Refika Hamutcu; Bozaykut, Abdulkadir; Inan, Savas; Dagli, Elif

    2008-01-01

    A wide range of drugs are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. To investigate the efficacy of ipratropium bromide and salbutamol in the treatment of patients with moderate-severe bronchiolitis. Sixty-nine infants with moderate-severe bronchiolitis hospitalized at their first episode of wheezing or crepitations in the chest were enrolled in a prospective, double-blind, placebo-controlled trial. Patients were randomly assigned to receive nebulized salbutamol, ipratropium bromide or placebo. Main outcome measures were changes in oxygen saturation rates and clinical scores and duration of hospitalization. In the bronchodilator groups, clinical scores were better compared to the placebo group at 30 min (8.4 +/- 1.3 vs. 7.5 +/- 0.8, p < 0.05). Bronchodilator groups had also significantly lower clinical scores (7.3 +/- 1.2 vs. 5.9 +/- 1.1, p < 0.0001, and 5.3 +/- 1.4 vs. 4.5 +/- 1.6, p = 0.006, respectively) and higher oxygen saturation rates compared to the placebo group at 8 and 24 h (89.6 +/- 2.4 vs. 94.3 +/- 4.4, and 92.2 +/- 2.6 vs. 95.9 +/-4.4, respectively, p < 0.0001). Improvement rates and duration of hospitalization were not statistically different among groups. Clinical scores and oxygen saturation levels improved more rapidly in the bronchodilator groups than in the placebo group up to 24 h, but these drugs did not have a sufficient effect to change the natural course of the disease. Copyright 2007 S. Karger AG, Basel.

  12. Acceptability, efficacy and safety of two treatment protocols for dental fluorosis: a randomized clinical trial.

    Science.gov (United States)

    Castro, Kaline Silva; Ferreira, Ana Cláudia de Araújo; Duarte, Rosângela Marques; Sampaio, Fábio Correia; Meireles, Sônia Saeger

    2014-08-01

    This parallel randomized clinical trial evaluated the efficacy of two treatments for removing fluorosis stains. Seventy individuals living in an area endemic for fluorosis, with at least four maxillary anterior teeth presenting fluorosis with a Thylstrup and Fejerskov index from 1 to 7, were randomized into two treatment groups (n=35): GI - enamel microabrasion or GII - microabrasion associated with at-home bleaching. Microabrasion was performed using 37% phosphoric acid and pumice and, at-home tooth bleaching was performed with 10% carbamide peroxide. Areas of enamel opacities were recorded by digital camera at baseline and 1-month (1M) after treatment. Two blinded examiners evaluated the reduction in the area (mm(2)) of opacity using software. Two visual analogue scales were used: one for recording tooth sensitivity and/or gingival irritation ranging from 1 (none) to 5 (severe) and the other to evaluate participant satisfaction with the treatment used ranging from 1 (no improvement) to 7 (exceptional improvement). 1M after treatment, both groups showed a significant reduction in the area of enamel opacity (p=0.0001) and there was no difference between groups (p=0.1). Most of the participants from both treatment groups reported no or mild tooth sensitivity and gingival irritation (p>0.05). Participants reported that they were happy with the improvement in dental appearance, however, individuals from GII reported that they were happier than those from GI (p=0.004). Both treatment protocols were effective in reducing fluoride stains, however, when home bleaching was associated to enamel microabrasion, patients reported a major satisfaction with dental appearance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

    Science.gov (United States)

    Palos, Claudia Cristina; Maturana, Ana P; Ghersel, Frederico R; Fernandes, Cesar E; Oliveira, Emerson

    2018-01-01

    The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications. This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings. Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement. The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

  14. Simvastatin reduces vaso-occlusive pain in sickle cell anaemia: a pilot efficacy trial.

    Science.gov (United States)

    Hoppe, Carolyn; Jacob, Eufemia; Styles, Lori; Kuypers, Frans; Larkin, Sandra; Vichinsky, Elliott

    2017-05-01

    Sickle cell anaemia (SCA) is a progressive vascular disease characterized by episodic vaso-occlusive pain. Despite the broad impact of inflammation on acute and chronic clinical manifestations of SCA, no directed anti-inflammatory therapies currently exist. Statins are cholesterol-lowering agents shown to confer protection from vascular injury by suppressing inflammation. We previously documented a reduction in soluble biomarkers of inflammation in patients with sickle cell disease treated with simvastatin. To determine the potential clinical efficacy of simvastatin, we treated 19 SCA patients with single daily dose simvastatin for 3 months and assessed changes from baseline in the frequency and intensity of diary-reported pain and levels of circulating nitric oxide metabolites (NOx), high sensitivity C-reactive protein (hs-CRP), vascular cell adhesion molecule 1 (VCAM-1), intercellular adhesion molecule 1 (ICAM-1), ICAM-3, E-selectin, and vascular endothelial growth factor (VEGF). Treatment with simvastatin resulted in a significant reduction in the frequency of pain (P = 0·0003), oral analgesic use (P = 0·003) and circulating hs-CRP (P = 0·003), soluble (s)E-selectin (P = 0·01), sICAM-1 (P = 0·02), sICAM-3 (P = 0·02) and sVEGF (P = 0·01). Simvastatin had no effect on pain intensity or levels of NOx, sP-selectin and sVCAM-1. The observed reductions in pain rate and markers of inflammation were greatest in subjects receiving hydroxycarbamide (HC), suggesting a synergistic effect of simvastatin. These results provide preliminary clinical data to support a larger trial of simvastatin in SCA. © 2017 John Wiley & Sons Ltd.

  15. The efficacy and tolerability of mirabegron in a non-trial clinical setting.

    Science.gov (United States)

    Balachandran, Aswini; Duckett, Jonathan

    2016-05-01

    Mirabegron is the first β3-adrenoceptor selective agonist approved for the treatment of OAB. Many randomised controlled trials report outcomes that are difficult to interpret in usual clinical practice. The aim of our study is to evaluate the efficacy and tolerability of mirabegron as treatment option for OAB in an unselected patient population in daily clinical practice and to identify if any patient characteristics predicted patients response to therapy. A prospective consecutive cohort of patients was studied between February 2013 and July 2014. Patients were prescribed Mirabegron 50mg once daily for 6 weeks. They were assessed at the initial appointment and at 6 weeks using validated questionnaires. The primary outcome measure was defined using the Patient Global Impression of Improvement Scale (PGI-I). 317 women were prescribed mirabegron and 244 (77%) completed 6 weeks of drug therapy. Of those completing the course, 27 (11%) described themselves as "very much better" and a further 56 (23%) much better. There was significant symptom improvement based on the ICIQ-FLUTS long form scores from 19.7 to 16.2 (p<0.001) and urinary distress inventory from 68.6 to 61.3 (p<0.005). Twenty-three (8.6%) patients discontinued mirabegron prematurely due to side-effects. Thirty one (10%) did not attend follow up and 19 (6%) decided against taking the medication and did not use their prescription. Mirabegron is a treatment option for patients with overactive bladder. Treatment benefits are modest but the discontinuation rate for side effects are low. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  16. Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial.

    Science.gov (United States)

    Raghav, Kumar; Van Wijk, A J; Abdullah, Fawzia; Islam, Md Nurul; Bernatchez, Marc; De Jongh, Ad

    2016-02-27

    Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET. This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis. This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia. ISRCTN25824611 , Date of registration: 26 October 2015.

  17. Efficacy and Safety of Donepezil in Chinese Patients with Severe Alzheimer's Disease: A Randomized Controlled Trial.

    Science.gov (United States)

    Jia, Jianping; Wei, Cuibai; Jia, Longfei; Tang, Yi; Liang, Junhua; Zhou, Aihong; Li, Fangyu; Shi, Lu; Doody, Rachelle S

    2017-01-01

    Donepezil has been used worldwide for the treatment of severe Alzheimer's disease (AD). Whether it is also appropriate for severe AD in Chinese patients remains unknown. To determine whether donepezil is effective and tolerable for Chinese patients with severe AD. The present study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study conducted at 38 investigational hospitals in China. Patients with severe AD were enrolled in this trial. Patients were randomly assigned in a 1:1 ratio to receive either donepezil or placebo (5 mg for 6 weeks and10 mg for the remaining 18 weeks). The efficacy for donepezil were evaluated by the SIB, the Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-plus) and the MMSE. Safety parameters were monitored throughout. A total of 313 patients included the donepezil (n = 157) and the placebo groups (n = 156). Donepezil group improved more in SIB scores (least squares [LS] mean difference: 4.8, 95% CI 1.56 to 8.08, p = 0.004) and CIBIC-plus scores (drug-placebo difference: -0.4, 95% CI -0.66 to 0.03, p = 0.04) than placebo groups at Week 24. The MMSE scores between drug and placebo groups did not differ significantly. Twenty-nine patients with serious adverse events (SAEs) were reported in donepezil (n = 11) and placebo groups (n = 18) (p = 0.08). Most SAEs were not considered drug-related. Donepezil for 24 weeks was more effective than placebo and showed good safety and tolerability in Chinese patients with severe AD. This study supports utility of the drug in severe stages of AD in the Chinese population.

  18. Randomized controlled trial on mouth rinse and flossing efficacy on interproximal gingivitis and dental plaque.

    Science.gov (United States)

    Luís, H S; Luís, L S; Bernardo, M; Santos, Nr Dos

    2017-08-22

    The objective of this study was to compare the efficacy of an essential oils mouth rinse and dental floss on dental plaque accumulation and gingivitis in interproximal areas. With informed consent, a parallel randomized controlled clinical trial was developed with 60 third-year dental hygiene students, randomly divided into two non-blind groups of 30 individuals each. For a period of 2 weeks, one group used an essential oils mouth rinse, according to manufacturer's instructions, and the other group flossed twice a day. Both groups received a toothbrush and fluoridated toothpaste for home dental hygiene care. A baseline dental hygiene appointment consisted of tooth scaling, prophylaxis and collection of the study data, using the Lobene modified gingival index; Saxton & Ouderaa gingival bleeding index and the Quigley & Hein modified by Turesky dental plaque index. At baseline, there was no significant difference between the groups for interproximal gingival inflammation (P = .214), gingival bleeding (P = .829) and dental plaque accumulation (P = .860). After 2 weeks of treatment, no significant differences were found between the essential oils mouth rinse and dental flossing for reduction of interproximal gingival inflammation (P = .938) and bleeding (P = .307). Essential oils mouth rinse showed to be significantly better than dental flossing in reducing interproximal dental plaque accumulation (P = .006). The use of an essential oils mouth rinse may be advised, as a complement, for patients unable to floss effectively, as it is more effective in reducing interproximal dental plaque accumulation than dental floss. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Dilek, Banu; Gözüm, Mehtap; Şahin, Ebru; Baydar, Meltem; Ergör, Gül; El, Ozlem; Bircan, Çigdem; Gülbahar, Selmin

    2013-04-01

    To evaluate the efficacy of paraffin bath therapy on pain, function, and muscle strength in patients with hand osteoarthritis. Prospective single-blinded randomized controlled trial. Department of physical medicine and rehabilitation in a university hospital. Patients with bilateral hand osteoarthritis (N=56). Patients were randomized into 2 groups with a random number table by using block randomization with 4 patients in a block. Group 1 (n=29) had paraffin bath therapy (5 times per week, for 3-week duration) for both hands. Group 2 (n=27) was the control group. All patients were informed about joint-protection techniques, and paracetamol intake was recorded. The primary outcome measures were pain (at last 48h) at rest and during activities of daily living (ADL), assessed with a visual analog scale (0-10cm) at 12 weeks. The secondary outcome measures were the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and the Dreiser Functional Index (DFI), used for subjective functional evaluation, loss of range of motion (ROM), grip and pinch strength, painful and tender joint counts, and paracetamol intake. A researcher blind to group allocation recorded the measures for both hands at baseline, 3 weeks, and 12 weeks at the hospital setting. At baseline, there were no significant differences between groups in any of the parameters (P>.05). After treatment, the paraffin group exhibited significant improvement in pain at rest and during ADL, ROM of the right hand, and pain and stiffness dimensions of the AUSCAN (P.05). The control group showed a significant deterioration in right hand grip and bilateral lateral pinch and right chuck pinch strength (Ptherapy seemed to be effective both in reducing pain and tenderness and maintaining muscle strength in hand osteoarthritis. It may be regarded as a beneficial short-term therapy option, which is effective for a 12-week period. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All

  20. Efficacy of three different pulpotomy agents in primary molars: a randomized control trial.

    Science.gov (United States)

    Rajasekharan, S; Martens, L C; Vandenbulcke, J; Jacquet, W; Bottenberg, P; Cauwels, R G E C

    2017-03-01

    To compare the clinical and radiographic efficacy of Biodentine™ , ProRoot® White Mineral Trioxide Aggregate (WMTA) and Tempophore™ as pulpotomy medicaments in the treatment of carious primary molars. A parallel-design, randomized controlled trial was developed. Patients above 3 years of age with carious primary teeth with vital pulps without spontaneous pain or history of swelling were included. Fifty-eight patients (82 teeth) with a mean age of 4.79 ± 1.23 years were included. The teeth were randomized, blinded and allocated to one of the three groups (Biodentine™ , ProRoot® WMTA or Tempophore™ ) for pulpotomy treatment. All teeth were followed up clinically and radiographically (after 6, 12 and 18 months) by two blinded calibrated investigators. A generalized estimating equation (GEE), Wald chi-square test and an intention-to-treat analysis (ITT) with 'last carried forward' approach were performed using Statistical Package for Social Sciences v 21.0 (IBM Corp., Armonk, NK, USA). Forty-six patients and 69 teeth were available for follow-up after 18 months. Clinical success (radiographic success in parenthesis) was 95.24% (94.4%), 100% (90.9%) and 95.65% (82.4%) in the Biodentine™ , ProRoot® WMTA and Tempophore™ groups, respectively, but the difference was not significant. Pulp canal obliteration was significantly different amongst the experimental groups as the Biodentine™ group exhibited significantly more pulp canal obliteration when compared to the ProRoot® WMTA group at 6 months (P = 0.008) and 18 months (P = 0.003). After 18-month follow-up, there was no significant difference between Biodentine™ in comparison with ProRoot® WMTA or Tempophore™ . © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  1. Efficacy of pulmonary rehabilitation in patients with moderate chronic obstructive pulmonary disease: a randomized controlled trial.

    Science.gov (United States)

    Román, Miguel; Larraz, Concepción; Gómez, Amalia; Ripoll, Joana; Mir, Isabel; Miranda, Eduardo Z; Macho, Ana; Thomas, Vicenç; Esteva, Magdalena

    2013-02-11

    Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients' quality of life. This study aimed to assess the efficacy of a 3-month Pulmonary Rehabilitation (PR) program with a further 9 months of maintenance (RHBM group) compared with both PR for 3 months without further maintenance (RHB group) and usual care in improving the quality of life of patients with moderate COPD.We conducted a parallel-group, randomized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups. Health outcomes were quality of life, exercise capacity, pulmonary function and exacerbations. We found statistically and clinically significant differences in the three groups at 3 months in the emotion dimension (0.53; 95%CI0.06-1.01) in the usual care group, (0.72; 95%CI0.26-1.18) the RHB group (0.87; 95%CI 0.44-1.30) and the RHBM group as well as in fatigue (0.47; 95%CI 0.17-0.78) in the RHBM group. After 1 year, these differences favored the long-term rehabilitation group in the domains of fatigue (0.56; 95%CI 0.22-0.91), mastery (0.79; 95%CI 0.03-1.55) and emotion (0.75; 95%CI 0.17-1.33). Between-group analysis only showed statistically and clinically significant differences between the RHB group and control group in the dyspnea dimension (0.79 95%CI 0.05-1.52). No differences were found for exacerbations, pulmonary function or exercise capacity. We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL, exercise tolerance, pulmonary function or exacerbation after a one-year, community based rehabilitation program. However, long-term improvements in the emotional, fatigue and mastery dimensions (within intervention groups) were identified. ISRCTN94514482.

  2. Efficacy of a multifaceted podiatry intervention to improve balance and prevent falls in older people: study protocol for a randomised trial

    National Research Council Canada - National Science Library

    Spink, Martin J; Menz, Hylton B; Lord, Stephen R

    2008-01-01

    ... decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people...

  3. Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Forbes Andrew

    2010-10-01

    Full Text Available Abstract Background Hip osteoarthritis (OA is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function. Methods The trial will be conducted at the University of Melbourne Centre for Health, Exercise and Sports Medicine. 128 participants with hip pain greater or equal to 40/100 on visual analogue scale (VAS and evidence of OA on x-ray will be recruited. Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region. The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice. The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel. The participants and the study assessor will be blinded to the treatment allocation. Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC immediately after the 12 week intervention. Participants will also be followed up at 36 weeks post baseline. Conclusions The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice. The findings from this randomised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA. Trial Registration Australian New Zealand Clinical Trials Registry reference: ACTRN12610000439044

  4. Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol

    Science.gov (United States)

    2010-01-01

    Background Hip osteoarthritis (OA) is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function. Methods The trial will be conducted at the University of Melbourne Centre for Health, Exercise and Sports Medicine. 128 participants with hip pain greater or equal to 40/100 on visual analogue scale (VAS) and evidence of OA on x-ray will be recruited. Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region. The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice. The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel. The participants and the study assessor will be blinded to the treatment allocation. Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) immediately after the 12 week intervention. Participants will also be followed up at 36 weeks post baseline. Conclusions The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice. The findings from this randomised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA. Trial Registration Australian New Zealand Clinical Trials Registry reference: ACTRN12610000439044 PMID:20946621

  5. Efficacy of antipsychotic drugs against hostility in the European First-Episode Schizophrenia Trial (EUFEST)

    NARCIS (Netherlands)

    Volavka, Jan; Czobor, Pal; Derks, Eske M.; Bitter, Istvan; Libiger, Jan; Kahn, René S.; Fleischhacker, W. Wolfgang; Kahn, R. S.; Fleischhacker, W. W.; Boter, H.; Keet, I. P. M.; Brugman, C.; Davidson, M.; Dollfus, S.; Gaebel, W.; Galderisi, S.; Gheorghe, M.; Gonen, I.; Grobbee, D. E.; Hranov, L. G.; Hummer, M.; Libiger, J.; Králové, Hradec; Lindefors, N.; López-Ibor, J. J.; Nijssen, K.; Peuskens, J.; Prelipceanu, D.; Riecher-Rössler, A.; Rybakowski, J. K.; Sedvall, G.; von Wilmsdorff, M.

    2011-01-01

    To compare the effects of haloperidol, amisulpride, olanzapine, quetiapine, and ziprasidone on hostility in first-episode schizophrenia, schizoaffective disorder, or schizophreniform disorder. We used the data acquired in the European First-Episode Schizophrenia Trial, an open, randomized trial

  6. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Directory of Open Access Journals (Sweden)

    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  7. A Theory Based Introductory Programming Course

    DEFF Research Database (Denmark)

    Hansen, Michael Reichhardt; Kristensen, Jens Thyge; Rischel, Hans

    1999-01-01

    This paper presents an introductory programming course designed to teach programming as an intellectual activity. The course emphasizes understandable concepts which can be useful in designing programs, while the oddities of today's technology are considered of secondary importance. An important...... goal is to fight the trial-and-error approach to programming which is a result of the students battles with horribly designed and documented systems and languages prior to their studies at university. Instead, the authors strive for giving the students a good experience of programming as a systematic...

  8. Reducing Sexual Risk Behaviors and Alcohol Use among HIV-Positive Men Who Have Sex with Men: A Randomized Clinical Trial

    Science.gov (United States)

    Velasquez, Mary M.; von Sternberg, Kirk; Johnson, David H.; Green, Charles; Carbonari, Joseph P.; Parsons, Jeffrey T.

    2009-01-01

    This randomized clinical trial (N = 253) evaluated the efficacy of a theory-based intervention designed to reduce both alcohol use and incidence of unprotected sexual behaviors among HIV-positive men who have sex with men with alcohol use disorders. An integrated, manualized intervention, using both individual counseling and peer group…

  9. Capture-recapture method for estimating misclassification errors: application to the measurement of vaccine efficacy in randomized controlled trials.

    Science.gov (United States)

    Simondon, F; Khodja, H

    1999-02-01

    The measure of efficacy is optimally performed by randomized controlled trials. However, low specificity of the judgement criteria is known to bias toward lower estimation, while low sensitivity increases the required sample size. A common technique for ensuring good specificity without a drop in sensitivity is to use several diagnostic tests in parallel, with each of them being specific. This approach is similar to the more general situation of case-counting from multiple data sources, and this paper explores the application of the capture-recapture method for the analysis of the estimates of efficacy. An illustration of this application is derived from a study on the efficacy of pertussis vaccines where the outcome was based on > or =21 days of cough confirmed by at least one of three criteria performed independently for each subject: bacteriology, serology, or epidemiological link. Log-linear methods were applied to these data considered as three sources of information. The best model considered the three simple effects and an interaction term between bacteriology and epidemiological linkage. Among the 801 children experiencing > or =21 days of cough, it was estimated that 93 cases were missed, leading to a corrected total of 413 confirmed cases. The relative vaccine efficacy estimated from the same model was 1.50 (95% confidence interval: 1.24-1.82), similar to the crude estimate of 1.59 and confirming better protection afforded by one of the two vaccines. This method allows supporting analysis to interpret primary estimates of vaccine efficacy.

  10. Efficacy and safety of acupuncture therapy for nerve deafness: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jiang, Yuebo; Shi, Xian; Tang, Yan

    2015-01-01

    Acupuncture is one of the important parts of therapeutic methods in traditional Chinese medicine, and has been widely used for the treatment of nerve deafness in recent years. The current study was to evaluate the efficacy and safety of acupuncture therapy for nerve deafness compared with conventional medicine therapy. PubMed, the Chinese National Knowledge Infrastructure Database, the Chinese Science and Technology Periodical Database, the Chinese Biomedical Database, the Wanfang Database were searched for articles published to identify randomized controlled trials evaluating efficacy and side effects between acupuncture and conventional medicine therapies up to 2013/06. A total of 12 studies, including 527 patients assessed the efficacy and safety of acupuncture therapy for nerve deafness. Overall, the efficacy of acupuncture was significantly better than that of the conventional western medication (RR: 1.54, 95% CI: 1.36-1.74) or traditional Chinese medicines (RR: 1.51, 95% CI: 1.24-1.84), and the efficacy of acupuncture in combination with conventional western medication or traditional Chinese medicine was better than that of the conventional western medication alone (RR: 1.51, 95% CI: 1.29-1.77) or traditional Chinese medicine alone (RR: 1.59, 95% CI: 1.30-1.95). Based on the comparison of number of deafness patients who were completely cured, the efficacy of acupuncture in combination with traditional Chinese medicines was better than that of traditional Chinese medicine alone (RR: 4.62, 95% CI: 1.38-15.47). Acupuncture therapy can significantly improve the hearing of patients with nerve deafness, and the efficacy of acupuncture in combination with medication is superior to medication alone.

  11. The HEART mobile phone trial: The partial mediating effects of self-efficacy on physical activity among cardiac patients

    Directory of Open Access Journals (Sweden)

    Ralph eMaddison

    2014-05-01

    Full Text Available Background: The ubiquitous use of mobile phones provides an ideal opportunity to deliver interventions to increase physical activity levels. Understanding potential mediators of such interventions is needed to increase their effectiveness. A recent randomized controlled trial of a mobile phone and Internet (mHealth intervention was conducted in New Zealand to determine the effectiveness on exercise capacity and physical activity levels in addition to current cardiac rehabilitation (CR services for people (n=171 with ischaemic heart disease (IHD. Significant intervention effect was observed for self-reported leisure time physical activity and walking, but not peak oxygen uptake (PVO2 at 24 weeks. There was also significant improvement in self-efficacy.Objective: To evaluate the mediating effect of self-efficacy on physical activity levels in an mHealth delivered exercise CR programme. Methods: Treatment evaluations were performed on the principle of intention to treat (ITT. Adjusted regression analyses were conducted to evaluate the main treatment effect on leisure time physical activity and walking at 24 weeks, with and without change in self-efficacy as the mediator of interest. Results: Change in self-efficacy at 24 weeks significantly mediated the treatment effect on leisure time physical activity by 13%, but only partially mediated the effect on walking by 4% at 24 weeks. Conclusion: An mHealth intervention involving text messaging and Internet support had a positive treatment effect on leisure time physical activity and walking at 24 weeks, and this effect was likely mediated through changes in self-efficacy. Future trials should examine other potential mediators related to this type of intervention.

  12. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial.

    Science.gov (United States)

    Silverstein, Michael; Diaz-Linhart, Yaminette; Cabral, Howard; Beardslee, William; Hegel, Mark; Haile, Winta; Sander, Jenna; Patts, Gregory; Feinberg, Emily

    2017-08-01

    Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy. To determine the efficacy of a depression prevention strategy embedded in Head Start. This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016. Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119). Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders. Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants

  13. Results of a curtailed randomized controlled trial, evaluating the efficacy and safety of azimilide in patients with implantable cardioverter-defibrillators: The SHIELD-2 trial.

    Science.gov (United States)

    Robinson, Victoria M; Bharucha, David B; Mahaffey, Kenneth W; Dorian, Paul; Kowey, Peter R

    2017-03-01

    Frequent hospital attendances in patients with implantable cardioverter-defibrillators (ICDs) result in significant morbidity and health care costs. Current drugs to reduce ICD shocks and hospital visits have limited efficacy and considerable toxicity. We evaluated the efficacy and safety of azimilide, a novel oral class III antiarrhythmic, for use in ICD patients. A total of 240 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial to evaluate the effect of oral azimilide 75 mg daily in ICD patients with previously documented ventricular tachycardia or ventricular fibrillation, and a left ventricular ejection fraction ≤40%. The primary outcome metric was the adjudicated time-to-first unplanned cardiovascular (CV) hospitalization, or CV emergency department (ED) visit, or CV death. The trial was prematurely discontinued due to withdrawal of study sponsorship. Azimilide demonstrated numerical but statistically nonsignificant reductions in the primary composite outcome (odds ratio [OR] 0.79, 95% CI 0.44-1.44), unplanned CV hospitalizations (OR 0.75, 95% CI 0.41-1.38), ED visits (OR 0.68, 95% CI 0.35-1.31), and all-cause shocks (OR 0.58, 95% CI 0.32-1.05). The incidence of adverse events was lower in the azimilide group. Neutropenia was not observed (absolute neutrophil count <1000 μ/L), and there was one possible torsade de pointes case that led to a successful ICD discharge. The SHIELD-2 trial was statistically underpowered due to early trial termination and did not meet its primary objective. Despite this limitation, azimilide showed promise as a safe and effective drug in reducing all-cause shocks, unplanned hospitalizations, and ED visits in ICD patients. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  14. The efficacy of heparinization in prolonging patency of arterial and central venous catheters in children: A randomized double-blind trial

    NARCIS (Netherlands)

    de Neef, M.; Heijboer, H.; van Woensel, J. B. M.; de Haan, R. J.

    2002-01-01

    This study evaluates the efficacy of heparinization in prolonging patency of arterial and central venous catheters in children. A randomized double-blind trial in a tertiary 10-bed pediatric intensive care unit was used to evaluate 300 children (age older than 4 weeks, younger than 18 years). Trial

  15. Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: an open, randomized, prospective, multicenter, parallel-group trial

    DEFF Research Database (Denmark)

    Fischer, Lars; Seiler, Christoph M; Broelsch, Christoph E

    2011-01-01

    BACKGROUND: The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection. METHODS: This trial was designed as an international, multicenter, randomized, controlled...

  16. A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain

    DEFF Research Database (Denmark)

    Kress, H.G.; Laage, D. Von der; Hoerauf, K.H.

    2008-01-01

    to be pharmacokinetically bioequivalent to the marked fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter trial...

  17. Efficacy and Safety Assessment of the Addition of Bevacizumab to Adjuvant Therapy Agents in Cancer Patients : A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Ahmadizar, Fariba; Onland-Moret, N Charlotte|info:eu-repo/dai/nl/26504362X; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H

    2015-01-01

    AIM: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. METHODS & DESIGN/ RESULTS: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials

  18. Efficacy and safety assessment of the addition of bevacizumab to adjuvant therapy agents in cancer patients: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Ahmadizar, Fariba|info:eu-repo/dai/nl/369491440; Onland-Moret, N. Charlotte; De Boer, Anthonius|info:eu-repo/dai/nl/075097346; Liu, Geoffrey; Maitland-Van Der Zee, Anke H.|info:eu-repo/dai/nl/255164688

    2015-01-01

    Aim: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/Results: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials

  19. Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial.

    Science.gov (United States)

    Alam, Murad; Han, Sandra; Pongprutthipan, Marisa; Disphanurat, Wareeporn; Kakar, Rohit; Nodzenski, Michael; Pace, Natalie; Kim, Natalie; Yoo, Simon; Veledar, Emir; Poon, Emily; West, Dennis P

    2014-08-01

    Neocollagenesis can be achieved using a dermal rolling needle device, thereby reducing the appearance of acne scars. To determine the efficacy of a needling device for treatment of acne scars. We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. The study took place from November 30, 2009, through July 27, 2010. Twenty healthy adults (age range, 20-65 years) with acne scars on both sides of the face were enrolled. Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects. For each participant, one side of the face was randomized for needling. Three needling treatments were performed at 2-week intervals. Two blinded dermatologists separately rated participants' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system. Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months (mean difference, 3.4; 95% CI, 0.2-6.5; P = .03) and nominally but not significantly lower compared with baseline at 3 months (mean difference, 2.4; 95% CI, -0.01 to 4.8; P = .052). In the control group, mean scar scores did not vary significantly from baseline at 3 months (mean difference, 1.0; 95% CI, -1.4 to 3.4; P = .96) and at 6 months (mean difference, 0.4; 95% CI, -2.3 to 3.5; P > .99). The needling procedure was not particularly painful, with a mean pain rating of 1.08 of 10. Participants perceived a 41% mean improvement in overall scar appearance on the treated side. No adverse events were reported. After 3 needling treatments, there was improvement in the appearance of acne scars over time compared with the control group, with minimal pain reported. clinicaltrials.gov Identifier: NCT00974870.

  20. Efficacy and Safety of Spironolactone in Acute Heart Failure: The ATHENA-HF Randomized Clinical Trial.

    Science.gov (United States)

    Butler, Javed; Anstrom, Kevin J; Felker, G Michael; Givertz, Michael M; Kalogeropoulos, Andreas P; Konstam, Marvin A; Mann, Douglas L; Margulies, Kenneth B; McNulty, Steven E; Mentz, Robert J; Redfield, Margaret M; Tang, W H Wilson; Whellan, David J; Shah, Monica; Desvigne-Nickens, Patrice; Hernandez, Adrian F; Braunwald, Eugene

    2017-09-01

    Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists administered at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. To assess the effect of high-dose spironolactone and usual care on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels compared with usual care alone. This double-blind and placebo (or low-dose)-controlled randomized clinical trial was conducted in 22 US acute care hospitals among patients with AHF who were previously receiving no or low-dose (12.5 mg or 25 mg daily) spironolactone and had NT-proBNP levels of 1000 pg/mL or more or B-type natriuretic peptide levels of 250 pg/mL or more, regardless of ejection fraction. High-dose spironolactone (100 mg) vs placebo or 25 mg spironolactone (usual care) daily for 96 hours. The primary end point was the change in NT-proBNP levels from baseline to 96 hours. Secondary end points included the clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety end points included hyperkalemia and changes in renal function. A total of 360 patients were randomized, of whom the median age was 65 years, 129 (36%) were women, 200 (55.5%) were white, 151 (42%) were black, 8 (2%) were Hispanic or Latino, 9 (2.5%) were of other race/ethnicity, and the median left ventricular ejection fraction was 34%. Baseline median (interquartile range) NT-proBNP levels were 4601 (2697-9596) pg/mL among the group treated with high-dose spironolactone and 3753 (1968-7633) pg/mL among the group who received usual care. There was no significant difference in the log NT-proBNP reduction between the 2 groups (-0.55 [95% CI, -0.92 to -0.18] with high-dose spironolactone and -0.49 [95% CI, -0.98 to -0.14] with usual care, P = .57). None of the secondary end point or day-30 all-cause mortality or heart failure hospitalization rate differed

  1. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial.

    Science.gov (United States)

    Katz, Molly; DeRogatis, Leonard R; Ackerman, Ronald; Hedges, Parke; Lesko, Lynna; Garcia, Miguel; Sand, Michael

    2013-07-01

    Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. The aim of this study was to assess the efficacy and safety of the 5-HT1A agonist/5-HT2A antagonist flibanserin in premenopausal women with HSDD. This was a randomized, placebo-controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks. Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and FSDS-R Item 13 score. Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS-R Item 13 score of -1.0 (0.1) vs. -0.7 (0.1) and mean (SE) FSDS-R total score of -9.4 (0.6) vs. -6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo. In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS-R total score) and distress associated with low sexual desire (FSDS-R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks. © 2013 International Society for Sexual Medicine.

  2. Efficacy of Acupuncture for Bell's Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Pingping Li

    Full Text Available Acupuncture has emerged as an alternative therapy for Bell's palsy in both adults and children. However, the use of acupuncture is controversial. We conducted a systematic review and meta-analysis to assess the efficacy of acupuncture for Bell's palsy. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, irrespective of any language restrictions. Randomized controlled trials comparing acupuncture with other therapies for Bell's palsy in adults or children were included. Fourteen randomized controlled trials involving 1541 individuals were included in this meta-analysis. Significant association was observed in acupuncture with a higher effective response rate for Bell's palsy (relative risk, 1.14; 95% confidence interval, 1.04-1.25; P = 0.005 but there was a heterogeneity among the studies (I2 = 87%. An assessment of the included studies revealed a high risk of bias in methodological quality. An evaluation of the incidence of complications was not available, owing to incomplete data. Acupuncture seems to be an effective therapy for Bell's palsy, but there was insufficient evidence to support the efficacy and safety of acupuncture. However, the results should be interpreted cautiously, because of the poor quality and heterogeneity of the included studies.

  3. A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials.

    Directory of Open Access Journals (Sweden)

    John Simes

    Full Text Available BACKGROUND: When rates of uptake of other drugs differ between treatment arms in long-term trials, the true benefit or harm of the treatment may be underestimated. Methods to allow for such contamination have often been limited by failing to preserve the randomization comparisons. In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD study, patients were randomized to fenofibrate or placebo, but during the trial many started additional drugs, particularly statins, more so in the placebo group. The effects of fenofibrate estimated by intention-to-treat were likely to have been attenuated. We aimed to quantify this effect and to develop a method for use in other long-term trials. METHODOLOGY/PRINCIPAL FINDINGS: We applied efficacies of statins and other cardiovascular drugs from meta-analyses of randomized trials to adjust the effect of fenofibrate in a penalized Cox model. We assumed that future cardiovascular disease events were reduced by an average of 24% by statins, and 20% by a first other major cardiovascular drug. We applied these estimates to each patient who took these drugs for the period they were on them. We also adjusted the analysis by the rate of discontinuing fenofibrate. Among 4,900 placebo patients, average statin use was 16% over five years. Among 4,895 assigned fenofibrate, statin use was 8% and nonuse of fenofibrate was 10%. In placebo patients, use of cardiovascular drugs was 1% to 3% higher. Before adjustment, fenofibrate was associated with an 11% reduction in coronary events (coronary heart disease death or myocardial infarction (P = 0.16 and an 11% reduction in cardiovascular disease events (P = 0.04. After adjustment, the effects of fenofibrate on coronary events and cardiovascular disease events were 16% (P = 0.06 and 15% (P = 0.008, respectively. CONCLUSIONS/SIGNIFICANCE: This novel application of a penalized Cox model for adjustment of a trial estimate of treatment efficacy incorporates evidence

  4. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol

    Directory of Open Access Journals (Sweden)

    Murray Mary Ann

    2008-04-01

    Full Text Available Abstract Background Most people prefer home palliation but die in an institution. Some experience decisional conflict when weighing options regarding place of care. Clinicians can identify patients' decisional needs and provide decision support, yet generally lack skills and confidence in doing so. This study aims to determine whether the quality of clinicians' decision support can be improved with a brief, theory-based, skills-building intervention. Theory The Ottawa Decision Support Framework (ODSF guides an evidence based, practical approach to assist clinicians in providing high-quality decision support. The ODSF proposes that decisional needs [personal uncertainty, knowledge, values clarity, support, personal characteristics] strongly influence the quality of decisions patients make. Clinicians can improve decision quality by providing decision support to address decisional needs [clarify decisional needs, provide facts and probabilities, clarify values, support/guide deliberation, monitor/facilitate progress]. Methods/Design The efficacy of a brief education intervention will be assessed in a two-phase study. In phase one a focused needs assessment will be conducted with key informants. Phase two is a randomized control trial where clinicians will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, knowledge transfer best practices and the ODSF, comprises an online tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach. Participants will be assessed: a at baseline (quality of decision support; b after the tutorial (knowledge; and c four weeks after the other interventions (quality of decision support, intention to incorporate decision support into practice and perceived usefulness of intervention components. Between group differences in the primary outcome (quality of decision support scores will be analyzed

  5. Observational attachment theory-based parenting measures predict children's attachment narratives independently from social learning theory-based measures.

    Science.gov (United States)

    Matias, Carla; O'Connor, Thomas G; Futh, Annabel; Scott, Stephen

    2014-01-01

    Conceptually and methodologically distinct models exist for assessing quality of parent-child relationships, but few studies contrast competing models or assess their overlap in predicting developmental outcomes. Using observational methodology, the current study examined the distinctiveness of attachment theory-based and social learning theory-based measures of parenting in predicting two key measures of child adjustment: security of attachment narratives and social acceptance in peer nominations. A total of 113 5-6-year-old children from ethnically diverse families participated. Parent-child relationships were rated using standard paradigms. Measures derived from attachment theory included sensitive responding and mutuality; measures derived from social learning theory included positive attending, directives, and criticism. Child outcomes were independently-rated attachment narrative representations and peer nominations. Results indicated that Attachment theory-based and Social Learning theory-based measures were modestly correlated; nonetheless, parent-child mutuality predicted secure child attachment narratives independently of social learning theory-based measures; in contrast, criticism predicted peer-nominated fighting independently of attachment theory-based measures. In young children, there is some evidence that attachment theory-based measures may be particularly predictive of attachment narratives; however, no single model of measuring parent-child relationships is likely to best predict multiple developmental outcomes. Assessment in research and applied settings may benefit from integration of different theoretical and methodological paradigms.

  6. The efficacy of atomoxetine in treating adult attention deficit hyperactivity disorder (ADHD): A meta-analysis of controlled trials.

    Science.gov (United States)

    Ravishankar, Vinutha; Chowdappa, Suresh Vedaveni; Benegal, Vivek; Muralidharan, Kesavan

    2016-12-01

    Atomoxetine, a non-stimulant, is FDA approved drug used in the management of adult ADHD. Since the presentation of adult ADHD is different from the childhood onset condition, there is an urgent need to study the efficacy of atomoxetine on the different symptom domains of adult ADHD. To study the efficacy of atomoxetine in treating adult ADHD compared to placebo, we performed a Medline search for English language publications of Randomized Controlled Trials (RCTs) comparing atomoxetine to placebo for adult ADHD using the keywords "adult ADHD", "atomoxetine" and "placebo". A total of 41 RCTs were returned of which we included 13 relevant RCTs reporting data on 1824 patients with adult ADHD in the analysis. Standardized mean difference between atomoxetine and placebo for the mean baseline-to-endpoint change in total ADHD scores, impulsivity/hyperactivity and inattention scores was calculated, with a 95% confidence limit. Atomoxetine had superior efficacy than placebo on overall adult ADHD scores [-0.45; 95% CI -0.54, -0.35; overall effect padult ADHD compared to placebo, though the efficacy is significantly superior for inattention than hyperactivity/impulsivity. Copyright © 2016. Published by Elsevier B.V.

  7. Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials.

    Science.gov (United States)

    Bartels, E M; Folmer, V N; Bliddal, H; Altman, R D; Juhl, C; Tarp, S; Zhang, W; Christensen, R

    2015-01-01

    The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing oral ginger treatment with placebo in OA patients aged >18 years. Outcomes were reduction in pain and reduction in disability. Harm was assessed as withdrawals due to adverse events. The efficacy effect size was estimated using Hedges' standardized mean difference (SMD), and safety by risk ratio (RR). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). Out of 122 retrieved references, 117 were discarded, leaving five trials (593 patients) for meta-analyses. The majority reported relevant randomization procedures and blinding, but an inadequate intention-to-treat (ITT) analysis. Following ginger intake, a statistically significant pain reduction SMD = -0.30 ([95% CI: [(-0.50, -0.09)], P = 0.005]) with a low degree of inconsistency among trials (I(2) = 27%), and a statistically significant reduction in disability SMD = -0.22 ([95% CI: ([-0.39, -0.04)]; P = 0.01; I(2) = 0%]) were seen, both in favor of ginger. Patients given ginger were more than twice as likely to discontinue treatment compared to placebo ([RR = 2.33; 95% CI: (1.04, 5.22)]; P = 0.04; I(2) = 0%]). Ginger was modestly efficacious and reasonably safe for treatment of OA. We judged the evidence to be of moderate quality, based on the small number of participants and inadequate ITT populations. Prospero: CRD42011001777. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  8. Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data from the Phase 3 REFINE Trials.

    Science.gov (United States)

    Dayan, Steven H; Schlessinger, Joel; Beer, Kenneth; Donofrio, Lisa M; Jones, Derek H; Humphrey, Shannon; Carruthers, Jean; Lizzul, Paul F; Gross, Todd M; Beddingfield, Frederick C; Somogyi, Christine

    2018-02-01

    ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. To evaluate the efficacy and safety of ATX-101 by treatment session. This post-hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated subjects achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or subject assessment. Furthermore, 19.1% of ATX-101-treated subjects (vs 3.9% of placebo-treated subjects) received fewer than 6 treatment sessions owing to subject satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated subjects achieved an improvement in SMF within 2 to 4 treatment sessions.

  9. Efficacy and safety of bupivacaine versus lidocaine in dental treatments: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Su, Naichuan; Wang, Hang; Zhang, Shu; Liao, Shuang; Yang, Shuying; Huang, Yi

    2014-02-01

    The objective of this study was to assess the efficacy and safety of bupivacaine compared with lidocaine in local anaesthesia in dental treatment. Medline, Cochrane Central Register of Controlled Trials, EMBASE, Chinese BioMedical Literature Database, China National Knowledge Infrastructure, and the World Health Organisation (WHO) International Clinical Trials Registry Platform were searched electronically. Relevant journals and references of studies included were hand-searched for randomised controlled trials comparing bupivacaine with lidocaine in terms of efficacy and safety. Sixteen studies were included, of which nine had low, six had moderate and one had high risk of bias. In comparison with 2% lidocaine plus 1:100,000 adrenaline, 0.5% bupivacaine plus 1:200,000 adrenaline showed a higher success rate in inflamed pulp (P = 0.03) but a lower success rate in vital pulp (P analgesics (P < 0.00001), a longer onset times of pulpal anaesthesia and a longer duration of pulpal anaesthesia (P < 0.00001). In comparison with 2% lidocaine plus 1:80,000 adrenaline, 0.75% bupivacaine plus 1:200,000 adrenaline had same level of success rate (P = 0.29), and was better in postoperative pain control (P = 0.001) while 0.75% levobupivacaine had same level of postoperative pain control (P = 0.16); 0.5% levobupivacaine had higher success rate (P = 0.04) and was better in postoperative pain control (P = 0.001) than 2% lidocaine. There was no statistically significance in adverse events between two groups. Given the efficacy and safety, the bupivacaine group is better than the lidocaine group in dental operations that take a relatively long time, especially in endodontic treatments or where there is a need for postoperative pain management. © 2013 FDI World Dental Federation.

  10. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Science.gov (United States)

    2010-01-01

    Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years) improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a universal parenting interventions

  11. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    Directory of Open Access Journals (Sweden)

    Burke Kylie

    2010-08-01

    Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

  12. Effect of Motivational Interviewing on Weight Efficacy Lifestyle among Women with Overweight and Obesity: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kamal Mirkarimi

    2017-03-01

    Full Text Available Obesity and overweight have become increasingly a major public health problem across the world. This study aimed at exploring the effects of motivational interviewing on weight efficacy lifestyle among women with obesity and overweight. A single-blind randomized clinical trial study was conducted on 100 overweight and obese women who attended a nutrition clinic. The samples were selected based on the clinical records and assigned into two groups, namely motivational interviewing arm (50 samples and nutrition education arm (50 samples. Data were collected using a standard validated questionnaire entitled “weight efficacy lifestyle”. The intervention was designed according to five motivation sessions and four nutrition education programs, such that the participants of the nutrition education arm were also provided with the nutrition pamphlets related to weight control. Data were finally analyzed using the SPSS statistical software by performing the independent t-test, chi-square, LSD and repeated measures ANOVA tests. P<0.05 were considered statistically significant. The mean age of women was 39.9±9.1 and 36.3±8.9 years in the control and motivational interviewing arms, respectively. Compared with the control group, the score of the motivational interviewing group was statistically significant in terms of weight efficacy lifestyle P=0.0001 and all subscales including social pressure (P=0.0001, physical discomfort (P=0.005, food accessibility (P=0.0001, positive and entertainment activities (P=0.0001, as well as negative emotions (P=0.003. Motivational interviewing appeared to be effective in increasing weight efficacy lifestyle among women with overweight and obesity. Trial Registration Number: IRCT2014051817736N1

  13. Assessing vaccine efficacy for the prevention of acute otitis media by pneumococcal vaccination in children: a methodological overview of statistical practice in randomized controlled clinical trials.

    Science.gov (United States)

    Jahn-Eimermacher, Antje; du Prel, Jean-Baptist; Schmitt, Heinz-Josef

    2007-08-14

    Acute otitis media (AOM) is the most common bacterial infectious disease among children. Vaccination is proposed to prevent otitis and several clinical trials were performed to assess the efficacy of pneumococcal vaccines. The way vaccine efficacy is analysed varies among trials. However, the clinical meaning of an estimate of vaccine effect and its statistical test depends on the applied statistical method. We aim to bring the meaning and validity of statistical trial results to the attention of researchers. We consider all methodological approaches for analysing vaccine efficacy applied in pneumococcal vaccination trials included in a recent Cochrane Review. We demonstrate how different methods address different scientific questions on the effect of vaccination, how they can complement each other and why some methods can produce misleading results.

  14. Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial.

    Directory of Open Access Journals (Sweden)

    Gustavo Adolfo Sierra Romero

    2017-06-01

    Full Text Available There is insufficient evidence to support visceral leishmaniasis (VL treatment recommendations in Brazil and an urgent need to improve current treatments. Drug combinations may be an option.A multicenter, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of (i amphotericin B deoxycholate (AmphoB (1 mg/kg/day for 14 days, (ii liposomal amphotericin B (LAMB (3 mg/kg/day for 7 days and (iii a combination of LAMB (10 mg/kg single dose plus meglumine antimoniate (MA (20 mg Sb+5/kg/day for 10 days, compared to (iv standard treatment with MA (20 mg Sb+5/kg/day for 20 days. Patients, aged 6 months to 50 years, with confirmed VL and without HIV infection were enrolled in the study. Primary efficacy endpoint was clinical cure at 6 months. A planned efficacy and safety interim analysis led to trial interruption.378 patients were randomized to the four treatment arms: MA (n = 112, AmphoB (n = 45, LAMB (n = 109, or LAMB plus MA (n = 112. A high toxicity of AmphoB prompted an unplanned interim safety analysis and this treatment arm was dropped. Per intention-to-treat protocol final analyses of the remaining 332 patients show cure rates at 6 months of 77.5% for MA, 87.2% for LAMB, and 83.9% for LAMB plus MA, without statistically significant differences between the experimental arms and comparator (LAMB: 9.7%; CI95% -0.28 to 19.68, p = 0.06; LAMB plus MA: 6.4%; CI95% -3.93 to 16.73; p = 0.222. LAMB monotherapy was safer than MA regarding frequency of treatment-related adverse events (AE (p = 0.045, proportion of patients presenting at least one severe AE (p = 0.029, and the proportion of AEs resulting in definitive treatment discontinuation (p = 0.003.Due to lower toxicity and acceptable efficacy, LAMB would be a more suitable first line treatment for VL than standard treatment. ClinicalTrials.gov identification number: NCT01310738.ClinicalTrials.gov NCT01310738.

  15. Partial aortic occlusion for cerebral perfusion augmentation: safety and efficacy of NeuroFlo in Acute Ischemic Stroke trial.

    Science.gov (United States)

    Shuaib, Ashfaq; Bornstein, Natan M; Diener, Hans-Christoph; Dillon, William; Fisher, Marc; Hammer, Maxim D; Molina, Carlos A; Rutledge, J Neal; Saver, Jeffrey L; Schellinger, Peter D; Shownkeen, Harish

    2011-06-01

    Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours. The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis. Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81-1.67; P=0.407). The primary safety end point did not show a difference in serious adverse events (P=0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control (P=0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31-8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99-3.30), or older than age 70 years (OR, 2.02; CI, 1.02-4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4% = 17/230; 14.4% = 37/257). The trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation. URL: http://clinicaltrials.gov. Unique identifier: NCT00119717.

  16. Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials.

    Science.gov (United States)

    Leonard, N R; Banfield, A; Riedel, M; Ritchie, A S; Mildvan, D; Arredondo, G; Cleland, C M; Gwadz, M V

    2013-08-01

    AIDS clinical trials (ACTs) are critical to the development of new treatments for HIV infection. However, people of color living with HIV/AIDS are involved in ACTs at disproportionally low rates, with African-Americans experiencing the greatest under-representation. In this article, we describe the core elements and key characteristics of a highly efficacious multi-component peer-driven intervention (PDI) designed to increase rates of screening for and enrollment into ACTs among African-American and Latino/Hispanic individuals, by addressing the main complex, multi-level barriers they experience to ACTs. We discuss the process of developing the intervention, the theoretical models guiding its delivery format and content, and provide an overview of the intervention's components. We then use brief case studies to illustrate a number of key issues that may arise during intervention implementation. Finally, we describe lessons learned and provide recommendations for the PDI's uptake in clinical and clinical trials settings.

  17. The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial

    Science.gov (United States)

    Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T

    2016-01-01

    Background Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. Objective To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. Setting School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14–18 years in school rugby programmes over the 2015–2016 school winter term. Methods A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Outcome measures Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. Trial registration number ISRTCNN13422001. PMID:27900148

  18. Long-term efficacy and safety of carotid artery stenting versus endarterectomy: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Yang; Yang, Jing-Jing; Zhu, Su-Hui; Xu, Biao; Wang, Lian

    2017-01-01

    Many recent trials have investigated the long-term efficacy and safety of endarterectomy versus stenting in treating patients with carotid artery stenosis. We aimed to determine the long-term comparative efficacy and safety of both procedures by pooling this evidence in a meta-analysis. We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published until May 6, 2016. Randomized controlled trials, which reported outcomes of interest with a median follow-up of at least 4-year, were included. Eight trials involving 7005 patients and 41824 patient-years of follow-up were included. In terms of the periprocedural outcomes, stenting was associated with a lower risk of myocardial infarction (OR: 0.51; 95% CI: 0.33 to 0.80; P = 0.003) but a higher risk of death or stroke (the composite endpoint, OR: 1.76; 95% CI: 1.38 to 2.25; P endarterectomy (OR: 1.09; 95% CI: 0.95 to 1.26; P = 0.21) and restenosis (OR: 1.48 (95% CI: 0.93 to 2.35; P = 0.10). No evidence of significant heterogeneity was found in any of the analyses. Carotid endarterectomy was found to be superior to stenting for short- and long-term outcomes, although endarterectomy was associated with a higher risk of periprocedural myocardial infarction. Carotid endarterectomy should be offered as the first choice for carotid stenosis at present, however, more evidence is needed because rapid progress in concurrent devices and medical treatments is being made.

  19. A comparison of safety and efficacy of cytotoxic versus molecularly targeted drugs in pediatric phase I solid tumor oncology trials.

    Science.gov (United States)

    Dorris, Kathleen; Liu, Chunyan; Li, Dandan; Hummel, Trent R; Wang, Xia; Perentesis, John; Kim, Mi-Ok; Fouladi, Maryam

    2017-03-01

    Prior reviews of phase I pediatric oncology trials involving primarily cytotoxic agents have reported objective response rates (ORRs) and toxic death rates of 7.9-9.6% and 0.5%, respectively. These data may not reflect safety and efficacy in phase I trials of molecularly targeted (targeted) drugs. A systematic review of pediatric phase I solid tumor trials published in 1990-2013 was performed. The published reports were evaluated for patient characteristics, toxicity information, and response numbers. A total of 143 phase I pediatric clinical trials enrolling 3,896 children involving 53 targeted and 48 cytotoxic drugs were identified. A meta-analysis demonstrated that the ORR is 2.1-fold higher with cytotoxic drugs (0.066 vs. 0.031 per subject; P = 0.007). By contrast, the pooled estimate of the stable disease rate (SDR) is similar for cytotoxic and targeted drugs (0.2 vs. 0.23 per subject; P = 0.27).  The pooled estimate of the dose-limiting toxicity rate is 1.8-fold larger with cytotoxic drugs (0.24 vs. 0.13 per subject; P = 0.0003). The hematologic grade 3-4 (G3/4) toxicity rate is 3.6-fold larger with cytotoxic drugs (0.43 vs. 0.12 per treatment course; P = 0.0001); however, the nonhematologic G3/4 toxicities and toxic deaths occur at similar rates for cytotoxic and targeted drugs. In phase I pediatric solid tumor trials, ORRs were significantly higher for cytotoxic versus targeted agents. SDRs were similar in targeted and cytotoxic drug trials. Patients treated with cytotoxic agents were more likely to experience hematologic G3/4 toxicities than those patients receiving targeted drugs. © 2016 Wiley Periodicals, Inc.

  20. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mowinckel Petter

    2010-10-01

    Full Text Available Abstract Background Surgery for type II SLAP (superior labral anterior posterior lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months and long-term (2 years efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy for alleviating pain and improving function for type II SLAP lesions. Methods/Design A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version and the Western Ontario Instability Index (WOSI at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ, the generic EuroQol (EQ-5 D and EQ-VAS, return to work and previous sports activity, complications, and the number of reoperations. Discussion The results of this trial will be of international importance and the results will be translatable into clinical practice. Trial Registration [ClinicalTrials.gov NCT00586742

  1. Efficacy of occupational therapy for patients with Parkinson's disease: a randomised controlled trial

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Graff, M.J.; Hendriks, J.C.M.; Veenhuizen, Y.; Munneke, M.; Bloem, B.R.; Nijhuis-Van der Sanden, M.W.

    2014-01-01

    BACKGROUND: There is insufficient evidence to support use of occupational therapy interventions for patients with Parkinson's disease. We aimed to assess the efficacy of occupational therapy in improving daily activities of patients with Parkinson's disease. METHODS: We did a multicentre,

  2. Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine.

    Science.gov (United States)

    Delrieu, Isabelle; Leboulleux, Didier; Ivinson, Karen; Gessner, Bradford D

    2015-03-24

    Vaccines interrupting Plasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens (SSM-VIMT) are currently under development to reduce malaria transmission. An international group of malaria experts was established to evaluate the feasibility and optimal design of a Phase III cluster randomized trial (CRT) that could support regulatory review and approval of an SSM-VIMT. The consensus design is a CRT with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. Trials should be conducted first in areas of moderate transmission, where SSM-VIMT impact should be greatest. Sample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Profermin is Efficacious in Patients with Active Ulcerative Colitis—A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Krag, Aleksander; Munkholm, Pia; Israelsen, Hans

    2013-01-01

    Profermin is developed for the dietary management of ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v. The aim of this study was to assess the clinical efficacy of Profermin.......Profermin is developed for the dietary management of ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v. The aim of this study was to assess the clinical efficacy of Profermin....

  4. Effects of birth ball exercise on pain and self-efficacy during childbirth: a randomised controlled trial in Taiwan.

    Science.gov (United States)

    Gau, Meei-Ling; Chang, Ching-Yi; Tian, Shu-Hui; Lin, Kuan-Chia

    2011-12-01

    To examine the effectiveness of a birth ball exercise programme during childbirth by measuring childbirth self-efficacy and childbirth pain. In addition, it tested the mediating effects of childbirth self-efficacy on the relationship between the birth ball exercise programme and childbirth pain. Randomised controlled trial. The study was conducted from December 2008 to November 2009, at two birth units, one at a regional hospital and one at a medical centre, with 600 and 1022 annual births, respectively. One hundred and eighty-eight expectant mothers were recruited (recruitment rate: 47%) and were allocated by block randomisation into the two arms of the study, but only 48 intervention and 39 control group participants completing the trial. The birth ball exercise programme consisted of a 26-page booklet and a 19-minute videotape, with periodic follow-ups during prenatal checks. All members of the experimental group were asked to practise the exercises and positions at home for at least 20 minutes three times a week for a period of 6-8 weeks. Each woman in the experimental group was given a birth ball for use during labour and encouraged every hour to choose the most comfortable positions, movements, and exercises. Both the experimental and control groups received standard nursing and midwifery care from hospital staff nurses in all aspects of pregnancy and childbirth. When cervical dilations were four centimetres and eight centimetres, the women completed demographic and obstetrics information, the Childbirth Self-efficacy Inventory (CBSEI), and the short form of the McGill Pain Questionnaire (SF-MPQ). Our study revealed that birth ball exercises provided statistically significant improvements in childbirth self-efficacy and pain. Specifically, self-efficacy had a 30-40% mediating effect on relationships between birth ball exercises and childbirth pain. Mothers in the experimental group had shorter first-stage labour duration, less epidural analgesia, and fewer

  5. Efficacy of test of memory malingering Trial 1, Trial 2, the Retention Trial, and the Albany Consistency Index in a criterion group forensic neuropsychological sample.

    Science.gov (United States)

    Schroeder, R W; Buddin, W H; Hargrave, D D; VonDran, E J; Campbell, E B; Brockman, C J; Heinrichs, R J; Baade, L E

    2013-02-01

    The Test of Memory Malingering is one of the most popular and heavily researched validity tests available for use in neuropsychological evaluations. Recent research has suggested, however, that the original indices and cutoffs may require modifications to increase sensitivity rates. Some of these modifications lack cross-validation and no study has examined all indices in a single sample. This study compares Trial 1, Trial 2, the Retention Trial, and the newly created Albany Consistency Index in a criterion group forensic neuropsychological sample. Findings lend support for the newly created indices and cutoff scores. Implications and cautionary statements are provided and discussed.

  6. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial.

    Science.gov (United States)

    Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

    2017-02-24

    A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. NCT02841683; Pre-results. Published by the BMJ Publishing Group Limited. For

  7. Comparative Efficacy of Insecticides on Bactrocera tryoni and Zeugodacus cucumis (Diptera: Tephritidae) in Laboratory and Semifield Trials in Fruiting Vegetables.

    Science.gov (United States)

    Senior, L J; Missenden, B P; Wright, C

    2017-08-01

    In-field management of Bactrocera tryoni (Froggatt) and Zeugodacus cucumis (French) (Diptera: Tephritidae) in fruiting vegetable crops has relied almost exclusively on organophosphate cover sprays. Laboratory and semifield trials were performed to compare a number of alternative insecticides for efficacy against these species. A novel semifield method was used whereby the insecticides were applied to crops as cover sprays under field conditions, and treated plants bearing fruit were transferred to large cages and exposed to fruit flies. Efficacy was assessed in terms of numbers of pupae developing from treated fruit. A laboratory cage method was also used to assess effects on adult mortality and comparative effects of 1- and 3-d-aged residues. The neonicotinoids clothianidin and thiacloprid were very effective against B. tryoni and Z. cucumis. Clothianidin was the only insecticide other than dimethoate to affect adult mortality. The synthetic pyrethroid alpha-cypermethrin was also very effective, particularly in semifield trials, although higher incidence of aphid and whitefly infestation was observed in this treatment compared to others. Cyantraniliprole was effective against B. tryoni, but less effective against Z. cucumis. Imidacloprid, bifenthrin, spinetoram, and abamectin were all relatively less effective, although all demonstrated a suppressive effect. © Commonwealth of Australia, Department of Agriculture and Fisheries, 2017.

  8. Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zwerenz Rüdiger

    2012-12-01

    Full Text Available Abstract Background There is a lack of psychotherapeutic trials of treatments of comorbid depression in cancer patients. Our study determines the efficacy of a manualized short-term psychodynamic psychotherapy and predictors of outcome by personality and quality of the therapeutic relationship. Methods/design Eligible breast cancer patients with comorbid depression are assigned to short-term psychodynamic psychotherapy (up to 20 + 5 sessions or to treatment as usual (augmented by recommendation for counseling center and physician information. We plan to recruit a total of 180 patients (90 per arm in two centers. Assessments are conducted pretreatment, after 6 (treatment termination and 12 months (follow-up. The primary outcome measures are reduction of the depression score in the Hospital Anxiety and Depression Scale and remission of depression as assessed by means of the Structured Clinical Interview for DSM IV Disorders by independent, blinded assessors at treatment termination. Secondary outcomes refer to quality of life. Discussion We investigate the efficacy of short-term psychodynamic psychotherapy in acute care and we aim to identify predictors for acceptance and success of treatment. Trial registration ISRCTN96793588

  9. Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy: study protocol for a randomised trial

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2009-10-01

    Full Text Available Abstract Background Achilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy. Methods One hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam or an experimental group (customised foot orthoses made from semi-rigid polypropylene. Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire

  10. Study protocol of the SACURA trial: a randomized phase III trial of efficacy and safety of UFT as adjuvant chemotherapy for stage II colon cancer

    Directory of Open Access Journals (Sweden)

    Ishiguro Megumi

    2012-07-01

    Full Text Available Abstract Background Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy, but the usefulness of adjuvant chemotherapy for stage II colon cancer remains controversial. The major Western guidelines recommend adjuvant chemotherapy for “high-risk stage II” cancer, but this is not clearly defined and the efficacy has not been confirmed. Methods/design SACURA trial is a multicenter randomized phase III study which aims to evaluate the superiority of 1-year adjuvant treatment with UFT to observation without any adjuvant treatment after surgery for stage II colon cancer in a large population, and to identify “high-risk factors of recurrence/death” in stage II colon cancer and predictors of efficacy and adverse events of the chemotherapy. Patients aged between 20 and 80 years with curatively resected stage II colon cancer are randomly assigned to a observation group or UFT adjuvant therapy group (UFT at 500–600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by 2-day rest. This 1-week treatment cycle is repeated for 1 year. The patients are followed up for 5 years until recurrence or death. Treatment delivery and adverse events are entered into a web-based case report form system every 3 months. The target sample size is 2,000 patients. The primary endpoint is disease-free survival, and the secondary endpoints are overall survival, recurrence-free survival, and incidence and severity of adverse events. In an additional translational study, the mRNA expression of 5-FU-related enzymes, microsatellite instability and chromosomal instability, and histopathological factors including tumor budding are assessed to evaluate correlation with recurrences, survivals and adverse events. Discussion A total of 2,024 patients were enrolled from October 2006 to July 2010. The results of this study will provide important information that help to improve the

  11. Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh.

    Science.gov (United States)

    Rolfes, Melissa A; Goswami, Doli; Sharmeen, Amina Tahia; Yeasmin, Sultana; Parvin, Nasrin; Nahar, Kamrun; Rahman, Mustafizur; Barends, Marion; Ahmed, Dilruba; Rahman, Mohammed Ziaur; Bresee, Joseph; Luby, Stephen; Moulton, Lawrence H; Santosham, Mathuram; Fry, Alicia M; Brooks, W Abdullah

    2017-12-15

    Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged Children aged 6-23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010-March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1-(rate ratio of illness) × 100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955. Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex. Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries. Published by Elsevier Ltd.

  12. Efficacy of an improved absorbent pad on incontinence-associated dermatitis in older women: cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sugama Junko

    2012-05-01

    Full Text Available Abstract Background Most older adults with urinary incontinence use absorbent pads. Because of exposure to moisture and chemical irritating substances in urine, the perineal skin region is always at risk for development of incontinence-associated dermatitis (IAD. The aim of this study was to examine the efficacy of an improved absorbent pad against IAD. Methods A cluster randomized controlled design was used to compare the efficacy of two absorbent pads. Female inpatients aged ≥65 years who had IAD and used an absorbent pad or diaper all day were enrolled. Healing rate of IAD and variables of skin barrier function such as skin pH and skin moisture were compared between the usual absorbent pad group (n = 30 and the test absorbent pad group (n = 30. Results Thirteen patients (43.3% from the test absorbent pad group and 4 patients (13.3% from the usual absorbent pad group recovered completely from IAD. Moreover, the test absorbent pad group healed significantly faster than the usual absorbent pad group (p = 0.009. On the other hand, there were no significant differences between the two groups in skin barrier function. Conclusion The test absorbent pad for older adults with urinary incontinence might be more efficacious against IAD than usual absorbent pad. Trial registration UMIN-CTR: UMIN000006188

  13. The Impact of the Project K Youth Development Program on Self-Efficacy: A Randomized Controlled Trial.

    Science.gov (United States)

    Deane, Kelsey L; Harré, Niki; Moore, Julie; Courtney, Matthew G R

    2017-03-01

    A key issue for youth development programs is whether the learning they provide is transferred to participants' daily lives. It is also important that they are effective for the diverse range of participants they attract. This study used a randomized controlled trial design to measure the impact of Project K, a New Zealand-based youth development program, on academic and social self-efficacy. Project K combines a 3-week wilderness adventure, a 10 day community service component, and 1 year of mentoring to promote positive growth in 14-15 year olds with low self-efficacy. At baseline, the evaluation included 600 Project K (46 % female) and 577 Control participants (48 % female) and revealed that Project K was effective in improving both social and academic self-efficacy from pre- to post-program with effects being sustained 1 year later. Parents' perceptions of changes in the participants' interpersonal skills supported these findings. Differential program effects were found across participant subgroups, particularly 1 year after program completion. The implications of these differences are discussed.

  14. Efficacy and safety of ticagrelor in patients with acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jing, Yunyan; Ni, Bin; Zhou, Donglai; Zhang, Xingwei; Liu, Shanxin

    2017-09-25

    Acute coronary syndrome (ACS) is a dangerous and urgent clinical pattern of coronary artery disease. Aspirin and adenosine diphosphate P2Y12 receptor antagonists are the standard dual anti-platelet therapy for patients with ACS. Ticagrelor is a new oral antagonist of the adenosine diphosphate P2Y12 receptor. Randomized controlled trials (RCTs) have evaluated the efficacy and safety of ticagrelor compared to clopidogrel or prasugrel in patients with ACS, obtaining conflicting results. Thus, we conducted a meta-analysis of these RCTs to determine the efficacy and safety of ticagrelor in patients with ACS. Results of the meta-analysis indicate that ticagrelor decreased the risk of major adverse cardiovascular events (MACE) and all-cause death, but increased the risk of bleeding events. In Asiatic patients, analysis indicates that ticagrelor did not decrease the risk of MACE and all-cause death, while increasing the risk of bleeding events. Together, this meta-analysis suggests that ticagrelor was more effective, but less safe than clopidogrel and prasugrel in patients with ACS. Subgroup analysis indicates that ticagrelor was not more effective, although less safe than clopidogrel in Asiatic patients, thus more evidence is needed to further evaluate the efficacy and safety of ticagrelor in Asiatic patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  15. Physical activity, self-esteem, and self-efficacy relationships in older adults: a randomized controlled trial.

    Science.gov (United States)

    McAuley, E; Blissmer, B; Katula, J; Duncan, T E; Mihalko, S L

    2000-01-01

    A randomized controlled trial examined the growth and form of multidimensional self-esteem over a 12-month period (6-month exercise intervention and 6-month follow-up) in 174 older adults engaged in either a walking or stretching/toning program. The extent to which changes in physical fitness parameters and physical self-efficacy were related to changes in perceptions of attractive body, strength, physical conditioning, and physical self-worth was also determined. Latent growth curve analyses showed a curvilinear pattern of growth in esteem with significant increases at all levels of self-esteem upon completion of the intervention followed by significant declines at 6 months postintervention in both groups. Frequency of activity and changes in physical fitness, body fat, and self-efficacy were related to improvements in esteem perceptions relative to attractive body, strength, and physical condition. Model fitting procedures suggested that the best fit of the data was to a model in which the influence of changes in efficacy and physical parameters on physical self-worth were mediated by perceptions of attractive body and physical condition.

  16. Safety and efficacy of tibolone and menopausal transition: a randomized, double-blind placebo-controlled trial.

    Science.gov (United States)

    Morais-Socorro, Maria; Cavalcanti, Maciel Alvaro; Martins, Rand; Neto Francisco, Paulo; Rezende, Adriana; Azevedo, George; Almeida, Maria

    2012-06-01

    To evaluate the efficacy, safety and tolerability of Tibolone use during the menopausal transition (MT). Sixty-five healthy women aged 40-55 years (48.5 ± 3.5 years) were recruited for a randomized, double-blind controlled trial. Thirty participants were recruited to receive oral Tibolone 2.5 mg/day - Tibolone Group (TG), and 35 participants were assigned to the Placebo Group (PG), which received one capsule of lactose/day. Both groups were treated for 12 consecutive weeks. The Blatt-Kupperman Menopausal Index (KMI) and the Greene Climacteric Scale (GCS) were used. The glycaemic and lipid profiles, biochemical measures of hepatic function and endometrial thickness were measured for safety. A daily registry of complaints related to the treatment was maintained, and anthropometric measures were obtained to assess tolerability. A total of 57 women completed the study. After 12 weeks of Tibolone use, the total score and percentage of the KMI and GCS were significantly decreased compared to baseline, which reflected the efficacy of the treatment of climacteric symptoms. The improvement in blood biochemistry, endometrial atrophy and maintenance of the anthropometrical measures reflected the safety of Tibolone use. The absence of serious side effects demonstrated good tolerability for Tibolone use. The results showed good efficacy, tolerability and safety of Tibolone use during the MT.

  17. Efficacy of Acupuncture in Children with Nocturnal Enuresis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Zheng-tao Lv

    2015-01-01

    Full Text Available Background. Nocturnal enuresis (NE is recognized as a widespread health problem in young children and adolescents. Clinical researches about acupuncture therapy for nocturnal enuresis are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This study aims to assess the effectiveness of acupuncture therapy for nocturnal enuresis. Materials and Methods. A comprehensive literature search of 8 databases was performed up to June 2014; randomized controlled trials which compared acupuncture therapy and placebo treatment or pharmacological therapy were identified. A meta-analysis was conducted. Results. This review included 21 RCTs and a total of 1590 subjects. The overall methodological qualities were low. The results of meta-analysis showed that acupuncture therapy was more effective for clinical efficacy when compared with placebo or pharmacological treatment. Adverse events associated with acupuncture therapy were not documented. Conclusion. Based on the findings of this study, we cautiously suggest that acupuncture therapy could improve the clinical efficacy. However, the beneficial effect of acupuncture might be overstated due to low methodological qualities. Rigorous high quality RCTs are urgently needed.

  18. Field trial on the efficacy of an experimental fasciolicide compared with some commercial compounds in naturally infected cattle.

    Science.gov (United States)

    Vera Montenegro, Y; Ibarra Velarde, F; Quiroz Romero, H; Hernández Campos, A; Castillo, R

    2003-09-01

    The efficacy of 5-chloro-2-methylthio-6-(1-napthyloxy)-1H-benzimidazole was evaluated with three commercial fasciolicides in terms of the percentage of egg reduction in cattle. Fifty Swiss cows were selected for inclusion in the trial based on finding eggs of Fasciola hepatica in their feces. On day 0, they were blocked in five groups (G) of ten animals each according to fecal egg counts. G1 received compound alpha at 12 mg/kg p.o.; G2 triclabendazole at 12 mg/kg p.o.; G3.closantel at 3.5 mg/kg s.c.; G4 clorsulon at 2.0 mg/kg s.c. G5 animals served as untreated controls. Fecal analysis was performed on days 0, 7, 14, 21, 28, 60 and 90. Efficacy was measured on days 14 and 21. In addition, the extension and intensity effects were determined on day 60. The percentage efficacy for groups 1-4 was 98.1, 98.7, 98.2 and 97.9 on day 14 and 98.5, 97.9, 97.7 and 97.9 on day 21, respectively. No statistical differences were observed between treated groups.

  19. Efficacy of Alcohol Interventions for First-Year College Students: A Meta-Analytic Review of Randomized Controlled Trials

    Science.gov (United States)

    Scott-Sheldon, Lori A. J.; Carey, Kate B.; Elliott, Jennifer C.; Garey, Lorra; Carey, Michael P.

    2014-01-01

    Objective Alcohol use established during the first-year of college can result in adverse consequences during the college years and beyond. This meta-analysis evaluates the efficacy of interventions to prevent alcohol misuse by first-year college students. Methods Prevention studies were included if the study reported an individual- or group-level intervention using a randomized controlled trial, targeted first-year college students, and assessed alcohol use. Forty-one studies with 62 separate interventions (N = 24,294; 57% women; 77% White) were included. Independent raters coded sample, design, methodological features, and intervention content. Weighted mean effect sizes, using fixed- and random-effects models, were calculated. Potential moderators, determined a priori, were examined to explain variability in effect sizes. Results Relative to controls, students receiving an intervention reported lower quantity and frequency of drinking and fewer problems (d+s = 0.07 – 0.14). These results were more pronounced when the interventions were compared to an assessment-only control group (d+s = 0.11 – 0.19). Intervention content (e.g., personalized feedback) moderated the efficacy of the intervention. Conclusions Behavioral interventions for first-year college students reduce alcohol consumption and alcohol-related problems. Interventions that include personalized feedback, moderation strategies, expectancy challenge, identification of risky situations, and goal setting optimize efficacy. Strategies to prevent alcohol misuse among first-year students are recommended. PMID:24447002

  20. Efficacy of alcohol interventions for first-year college students: a meta-analytic review of randomized controlled trials.

    Science.gov (United States)

    Scott-Sheldon, Lori A J; Carey, Kate B; Elliott, Jennifer C; Garey, Lorra; Carey, Michael P

    2014-04-01

    Alcohol use established during the first-year of college can result in adverse consequences during the college years and beyond. In this meta-analysis, we evaluated the efficacy of interventions to prevent alcohol misuse by first-year college students. Studies were included if the study reported an individual- or group-level intervention using a randomized controlled trial, targeted 1st-year college students, and assessed alcohol use. Forty-one studies with 62 separate interventions (N = 24,294; 57% women; 77% White) were included. Independent raters coded sample, design, methodological features, and intervention content. Weighted mean effect sizes, using fixed- and random-effects models, were calculated. Potential moderators, determined a priori, were examined to explain variability in effect sizes. Relative to controls, students receiving an intervention reported lower quantity and frequency of drinking and fewer problems (d(+)s = 0.07-0.14). These results were more pronounced when the interventions were compared with an assessment-only control group (d(+)s = 0.11-0.19). Intervention content (e.g., personalized feedback) moderated the efficacy of the intervention. Behavioral interventions for 1st-year college students reduce alcohol consumption and alcohol-related problems. Interventions that include personalized feedback, moderation strategies, expectancy challenge, identification of risky situations, and goal-setting optimize efficacy. Strategies to prevent alcohol misuse among first-year students are recommended.

  1. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.

    Science.gov (United States)

    Lai, Agnes Y K; Fong, Daniel Y T; Lam, Jamie C M; Weaver, Terri E; Ip, Mary S M

    2014-09-01

    Poor adherence to CPAP treatment in OSA adversely affects the effectiveness of this therapy. This randomized controlled trial (RCT) examined the efficacy of a brief motivational enhancement education program in improving adherence to CPAP treatment in subjects with OSA. Subjects with newly diagnosed OSA were recruited into this RCT. The control group received usual advice on the importance of CPAP therapy and its care. The intervention group received usual care plus a brief motivational enhancement education program directed at enhancing the subjects' knowledge, motivation, and self-efficacy to use CPAP through the use of a 25-min video, a 20-min patient-centered interview, and a 10-min telephone follow-up. Self-reported daytime sleepiness adherence-related cognitions and quality of life were assessed at 1 month and 3 months. CPAP usage data were downloaded at the completion of this 3-month study. One hundred subjects with OSA (mean ± SD, age 52 ± 10 years; Epworth Sleepiness Scales [ESS], 9 ± 5; median [interquartile range] apnea-hypopnea index, 29 [20, 53] events/h) prescribed CPAP treatment were recruited. The intervention group had better CPAP use (higher daily CPAP usage by 2 h/d [Cohen d = 1.33, P CPAP for ≥ 70% of days with ≥ 4 h/d [P motivational enhancement education in addition to usual care were more likely to show better adherence to CPAP treatment, with greater improvements in treatment self-efficacy and daytime sleepiness. ClinicalTrials.gov; No.: NCT01173406; URL: www.clinicaltrials.gov.

  2. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    OBJECTIVES: To compare the efficacy and safety of indinavir 800 mg three times a day, ritonavir 600 mg twice a day, and a combination of ritonavir 400 mg twice a day and saquinavir 400 mg twice a day, when administered with two nucleoside analogues. DESIGN: A randomized, open-labelled, controlled...... is generally safe, and has superior short-term antiviral efficacy compared with indinavir and ritonavir also combined with two nucleoside analogues in antiretroviral drug-naive patients. Further follow-up is needed to determine the durability of the viral response....

  3. Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

    Directory of Open Access Journals (Sweden)

    Kalpana P. Padala

    2017-01-01

    Full Text Available Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7 years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9 compared to the control group (0.5; 95% CI, −0.3–1.3 at 8 weeks (average intergroup difference (95% CI, 5.5 (4.3–6.7, p < 0.001 after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045.

  4. The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial.

    Science.gov (United States)

    Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T; Trewartha, G

    2016-01-01

    Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14-18 years in school rugby programmes over the 2015-2016 school winter term. A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. ISRTCNN13422001.

  5. Efficacy and safety of long-chain polyunsaturated fatty acid supplementation of infant-formula milk: a randomised trial.

    Science.gov (United States)

    Lucas, A; Stafford, M; Morley, R; Abbott, R; Stephenson, T; MacFadyen, U; Elias-Jones, A; Clements, H

    1999-12-04

    We tested whether addition of n-3 and n-6 long-chain polyunsaturated fatty acids (LCPUFA) to infant-formula milk during the first 6 months promotes long-term cognitive and motor development, without adverse consequences. We did a double-blind, randomised, controlled, efficacy and safety trial of formula with and without LCPUFAs, with an additional breastfed reference group, in four hospitals in two cities in the UK. The participants were 447 healthy full-term babies. 309 were fed formula (155 without LCPUFAs) and 138 were breastfed for at least 6 weeks. The main outcome measures were: Bayley Mental and Psychomotor Development Indices (MDI, PDI) at 18 months (primary efficacy outcome) and Knobloch, Passamanick, and Sherrards test at 9 months (secondary outcome). Principal safety outcomes were: infection, atopy, growth, and gastrointestinal tolerance. Babies fed formula with and without LCPUFA did not differ in cognitive or motor development, growth, infection, atopy or tolerance. The mean (95% CI) MDI was 0.5 (-2.7 to 3.8) units and the PDI 0.6 (-1.8 to 3.0) units higher in the supplementation group. Formula-fed infants had similar developmental scores to the breastfed reference group after adjustment for higher social class and maternal education in the latter. There was no evidence of a beneficial or adverse effect on cognitive and motor development or growth up to 18 months. Although no significant differences in safety outcomes were observed, we suggest such data should be collected in future LCPUFA trials. Our trial does not provide support for addition of LCPUFA to standard infant formula but we are now doing further follow-up of this cohort.

  6. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lev-Tov Hadar

    2013-01-01

    Full Text Available Abstract Background Diabetic foot ulcers (DFUs represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively. The extracellular matrix (ECM in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair. To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. Methods/Design To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts and SOC plus Oasis® (ECM devoid of living cells in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. Discussion If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test

  7. Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Metse, Alexandra P; Bowman, Jenny A; Wye, Paula; Stockings, Emily; Adams, Maree; Clancy, Richard; Terry, Margarett; Wolfenden, Luke; Freund, Megan; Allan, John; Prochaska, Judith J; Wiggers, John

    2014-07-05

    Smoking rates, and associated negative health outcomes, are disproportionately high among people with mental illness compared to the general population. Smoke-free policies within mental health hospitals can positively impact on patients' motivation and self-efficacy to address their smoking. However, without post-discharge support, preadmission smoking behaviours typically resume. This protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence. Eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of New South Wales, Australia. After completing a baseline interview, participants will be randomly allocated to receive either: 'Supported Care', a multimodal smoking cessation intervention; or 'Normal Care', consisting of existing hospital care only. The 'Supported Care' intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital, and, following discharge, 16 weeks of motivational telephone-based counselling, 12 weeks of free nicotine replacement therapy, and a referral to the Quitline. Data will be collected at 1, 6 and 12 months post-discharge via computer-assisted telephone interview. The primary outcomes are abstinence from smoking (7-day point prevalence and prolonged cessation), and secondary outcomes comprise daily cigarette consumption, nicotine dependence, quit attempts, and readiness to change smoking behaviour. If shown to be effective, the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities. Australian New Zealand Clinical Trials Registry ANZTCN: ACTRN12612001042831

  8. Efficacy of a physiotherapy rehabilitation program for individuals undergoing arthroscopic management of femoroacetabular impingement – the FAIR trial: a randomised controlled trial protocol

    Science.gov (United States)

    2014-01-01

    Background Femoroacetabular impingement is a common cause of hip/groin symptoms and impaired functional performance in younger sporting populations and results from morphological abnormalities of the hip in which the proximal femur abuts against the acetabular rim. Many people with symptomatic femoroacetabular impingement undergo arthroscopic hip surgery to correct the bony abnormalities. While many case series over the past decade have reported favourable surgical outcomes, it is not known whether formal rehabilitation is needed as part of the management of patients undergoing this surgical procedure. This randomised controlled trial will investigate the efficacy of a progressive physiotherapist-supervised rehabilitation program (Takla-O’Donnell Protocol) in improving health-related quality of life, physical function and symptoms in individuals undergoing arthroscopic management of femoroacetabular impingement. Methods/design 100 people aged 16–35 years undergoing hip arthroscopy for symptomatic femoroacetabular impingement will be recruited from surgical practices in Melbourne, Australia and randomly allocated to either a physiotherapy or control group. Both groups will receive written information and one standardised post-operative physiotherapy visit whilst in hospital as per usual care. Those in the physiotherapy group will also receive seven individual 30-minute physiotherapy sessions, including one pre-operative visit (within 2 weeks of surgery) and six post-operative visits at fortnightly intervals (commencing two weeks after surgery). The physiotherapy intervention will incorporate education and advice, manual techniques and prescription of a progressive rehabilitation program including home, aquatic and gym exercises. The control group will not receive additional physiotherapy management. Measurements will be taken at baseline (2 weeks pre-operatively) and at 14 and 24 weeks post-surgery. Primary outcomes are the International Hip Outcome Tool and

  9. The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF

    Directory of Open Access Journals (Sweden)

    Birkenmaier Christof

    2010-09-01

    Full Text Available Abstract Background Because of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy. Methods/Design Multicentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs. Discussion This trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the

  10. Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: a phase II randomized controlled trial.

    Science.gov (United States)

    Julião, Miguel; Oliveira, Fátima; Nunes, Baltazar; Vaz Carneiro, António; Barbosa, António

    2014-06-01

    Dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness. To determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit. A nonblinded phase II randomized controlled trial of 80 patients who were randomly assigned to one of two groups: intervention group (dignity therapy+standard palliative care [SPC]) or control group (SPC alone). The main outcomes were depression and anxiety scores, as measured with the Hospital Anxiety and Depression Scale, and assessed at baseline (T1), day 4 (T2), day 15 (T3), and day 30 (T4) of follow-up. This study is registered with www.controlled-trials.com/ISRCTN34354086. Of the final 80 participants, 41 were randomly assigned to SPC and 39 to dignity therapy. Baseline characteristics were similar between the two groups. Dignity therapy was associated with a decrease in depression scores (median, 95% confidence interval [CI]: -4.00, -6.00 to -2.00, pdepression and anxiety symptoms in end-of-life care. The therapeutic benefit of dignity therapy was sustained over a 30-day period. Having established its efficacy, future trials of dignity therapy may now begin, comparing it with other psychotherapeutic approaches within the context of terminal illness.

  11. Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

    Directory of Open Access Journals (Sweden)

    Marta Sacchetti

    2015-01-01

    Full Text Available Aims. Several treatments have been proposed to slow down progression of Retinitis pigmentosa (RP, a hereditary retinal degenerative condition leading to severe visual impairment. The aim of this study is to systematically review data from randomized clinical trials (RCTs evaluating safety and efficacy of medical interventions for the treatment of RP. Methods. Randomized clinical trials on medical treatments for syndromic and nonsyndromic RP published up to December 2014 were included in the review. Visual acuity, visual field, electroretinogram, and adverse events were used as outcome measures. Results. The 19 RCTs included in this systematic review included trials on hyperbaric oxygen delivery, topical brimonidine tartrate, vitamins, docosahexaenoic acid, gangliosides, lutein, oral nilvadipine, ciliary neurotrophic factor, and valproic acid. All treatments proved safe but did not show significant benefit on visual function. Long term supplementation with vitamin A showed a significantly slower decline rate in electroretinogram amplitude. Conclusions. Although all medical treatments for RP appear safe, evidence emerging from RCTs is limited since they do not present comparable results suitable for quantitative statistical analysis. The limited number of RCTs, the poor clinical results, and the heterogeneity among studies negatively influence the strength of recommendations for the long term management of RP patients.

  12. A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children.

    Science.gov (United States)

    Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2012-01-01

    Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Sixty-six infants with DD (aged Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Although improvement in the severity of DD was observed in both treatment groups (P Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications. The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

  13. Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Xuan Yin

    2016-01-01

    Full Text Available Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression. Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture, control A group (superficial acupuncture at sham points, and control B group (sham acupuncture. All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI. The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD, and Self-Rating Depression Scale (SDS. All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS. Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up. Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21 and is registered with ChiCTR-IIR-16008058.

  14. [Efficacy comparison of menopausal irritability between acupuncture and medication: a randomized controlled trial].

    Science.gov (United States)

    Kou, Suo-Tang

    2014-05-01

    To observe the differences in the clinical efficacy on menopausal irritability between acupuncture and medication. Sixty cases of menopausal irritability were randomized into an acupuncture group (31 cases) and a medication group (29 cases). In the acupuncture group, the warming needling manipulation was applied at the key acupoints such as Hegu (LI 4) and Taichong (LR 3), once a day, 10 treatments made one session. Totally, 2 sessions were required. In the medication group, 2.5 mg diazepam tablets were prescribed, three times a day, for 23 days totally. The clinical efficacy, the modified Kupperman score and self-rated health measurement scale (SRHMS) were compared before and after treatment in the two groups. RESULTS The total effective rate was 87. 1% (27/31) in the acupuncture group and 82.8% (24/29) in the medication group. The difference in the clinical efficacy was not significant between the two groups (P > 0.05). The modified Kupperman score and SRHMS score were both reduced obviously after treatment in the two groups, indicating the significant difference (all P acupuncture group was more obvious than those in the medication group (Kupperman: 15.23 +/- 6.19 vs 18.45 +/- 5.37; SRHMS: 116.29 +/- 38.24 vs 140.34 +/- 42.15, both P acupuncture and medication are effective in the treatment of menopausal irritability, but the efficacy of warming needling manipulation is better than that of diazepam tablets.

  15. Efficacy of meaning-centered group psychotherapy for cancer survivors : a randomized controlled trial

    NARCIS (Netherlands)

    van der Spek, N; Vos, J; van Uden-Kraan, C F; Breitbart, W.; Cuijpers, P; Holtmaat, K; Witte, B I; Tollenaar, R.A.E.M.; Verdonck-de Leeuw, I M

    BACKGROUND: The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors (MCGP-CS) to improve personal meaning, compared with supportive group psychotherapy (SGP) and care as usual (CAU). METHOD: A total of 170 cancer survivors were randomly assigned

  16. Efficacy of Creative Clay Work for Reducing Negative Mood: A Randomized Controlled Trial

    Science.gov (United States)

    Kimport, Elizabeth R.; Robbins, Steven J.

    2012-01-01

    Clay work has long been used in art therapy to achieve therapeutic goals. However, little empirical evidence exists to document the efficacy of such work. The present study randomly assigned 102 adult participants to one of four conditions following induction of a negative mood: (a) handling clay with instructions to create a pinch pot, (b)…

  17. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention

    Science.gov (United States)

    McCusker, Jane; Lambert, Sylvie D.; Cole, Martin G.; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E.; Belzile, Eric

    2016-01-01

    Objectives: In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of…

  18. Efficacy of a trauma-focused treatment approach for dental phobia: a randomized clinical trial

    NARCIS (Netherlands)

    Doering, S.; Ohlmeier, M.C.; de Jongh, A.; Hofmann, A.; Bisping, V.

    2013-01-01

    It has been hypothesized that treatment specifically focused on resolving memories of negative dental events might be efficacious for the alleviation of anxiety in patients with dental phobia. Thirty-one medication-free patients who met the Diagnostic and Statistical Manual of Mental Disorders

  19. Safety and efficacy of anticoagulation for secondary stroke prevention in atrial fibrillation patients: The AMADEUS trial

    NARCIS (Netherlands)

    Lane, D.A.; Kamphuisen, P.W.; Minini, P.; Buller, H.R.; Lip, G.Y.H.

    2010-01-01

    ackground: Patients with atrial fibrillation (AF) and previous ischemic stroke are at high risk of recurrent stroke, but are also perceived to be at increased bleeding risk while treated with anticoagulants. Methods: Post-hoc analyses examined the efficacy and safety of anticoagulation of 4576 AF

  20. In-vitro Acaricidal efficacy evaluation trial of Ixodid ticks at Borana ...

    African Journals Online (AJOL)

    cattle. These ticks were placed individually in different plastic flasks prelabeled with time, date, place of collection and code number. Afterwards the ticks were transported to Yabello Regional Veterinary Laboratory within 24 hours of collection for the in-vitro acaricidal efficacy evaluation using modified adult immersion test ...

  1. Efficacy of Adolescent Suicide Prevention E-Learning Modules for Gatekeepers : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Ghoncheh, Rezvan; 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

  2. Efficacy of Web-Based Personalized Normative Feedback: A Two-Year Randomized Controlled Trial

    Science.gov (United States)

    Neighbors, Clayton; Lewis, Melissa A.; Atkins, David C.; Jensen, Megan M.; Walter, Theresa; Fossos, Nicole; Lee, Christine M.; Larimer, Mary E.

    2010-01-01

    Objective: Web-based brief alcohol interventions have the potential to reach a large number of individuals at low cost; however, few controlled evaluations have been conducted to date. The present study was designed to evaluate the efficacy of gender-specific versus gender-nonspecific personalized normative feedback (PNF) with single versus…

  3. Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS,S/AS01 malaria vaccine in African children

    Directory of Open Access Journals (Sweden)

    Lievens Marc

    2011-08-01

    Full Text Available Abstract Background There has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials. Methods The present paper describes, for a pivotal phase III efficacy of the RTS, S/AS01 malaria vaccine, the methods of the statistical analysis and the rationale for their selection. The methods used to estimate efficacy of the primary course of vaccination, and of a booster dose, in preventing clinical episodes of uncomplicated and severe malaria, and to determine the duration of protection, are described. The interpretation of various measures of efficacy in terms of the potential public health impact of the vaccine is discussed. Conclusions The methodology selected to analyse the clinical trial must be scientifically sound, acceptable to regulatory authorities and meaningful to those responsible for malaria control and public health policy. Trial registration Clinicaltrials.gov NCT00866619

  4. Safety and efficacy of treatment with asfotase alfa in patients with hypophosphatasia: Results from a Japanese clinical trial.

    Science.gov (United States)

    Kitaoka, Taichi; Tajima, Toshihiro; Nagasaki, Keisuke; Kikuchi, Toru; Yamamoto, Katsusuke; Michigami, Toshimi; Okada, Satoshi; Fujiwara, Ikuma; Kokaji, Masayuki; Mochizuki, Hiroshi; Ogata, Tsutomu; Tatebayashi, Koji; Watanabe, Atsushi; Yatsuga, Shuichi; Kubota, Takuo; Ozono, Keiichi

    2017-07-01

    Hypophosphatasia (HPP) is a rare skeletal disease characterized by hypomineralization and low alkaline phosphatase activity. Asfotase alfa (AA) has been recently developed to treat HPP complications. This study evaluated its safety and efficacy in Japan. Open-label, multicentre, prospective trial. Patients were enrolled in 11 hospitals from June 2014 to July 2015. Thirteen patients (9 females, 4 males) ages 0 days to 34 years at baseline were enrolled and treated with AA (2 mg/kg three times weekly subcutaneously in all but one patient). All had ALPL gene mutations. HPP forms were perinatal (n=6), infantile (n=5), childhood (n=1) and adult (n=1). Safety determined from adverse events (AEs) and laboratory data was the primary outcome measure. Efficacy was assessed as a secondary outcome measure from overall survival, respiratory status, rickets severity and gross motor development. Injection site reactions were the most frequent AEs. Serious AEs possibly related to treatment were convulsion and hypocalcaemia observed in a patient with the perinatal form. In addition, hypercalcaemia and/or hyperphosphatemia was observed in three patients with the infantile form and a low-calcium and/or low-phosphate formula was given to these patients. With respect to efficacy, all patients survived and the radiographic findings, developmental milestones and respiratory function improved. Asfotase alfa therapy improved skeletal, respiratory and physical symptoms with a few serious AEs in patients with HPP. Our results add support to the safety and efficacy of AA therapy for HPP patients. © 2017 John Wiley & Sons Ltd.

  5. A randomized controlled trial on Stroke telerehabilitation: The effects on falls self-efficacy and satisfaction with care.

    Science.gov (United States)

    Chumbler, Neale R; Li, Xinli; Quigley, Patricia; Morey, Miriam C; Rose, Dorian; Griffiths, Patricia; Sanford, Jon; Hoenig, Helen

    2015-04-01

    We determined the effect of a multifaceted stroke telerehabilitation (STeleR) intervention on falls-related self-efficacy and satisfaction with care. We conducted a prospective, randomized, multisite, single-blinded trial in 52 veterans from three Veterans Affairs Medical Centers. Participants who experienced a stroke in the past 24 months were randomized to the STeleR intervention or usual care. Participants in the intervention arm were administered an exit interview to gather specific patient satisfaction data three months after their final outcome measure. The STeleR intervention consisted of three home visits, five telephone calls, and an in-home messaging device provided over three months to instruct patients in functionally based exercises and adaptive strategies. The outcome measures included Falls Efficacy Scale to measure fall-related self-efficacy and a Stroke-Specific Patient Satisfaction with Care (SSPSC) scale, a measure separated into two subscales (satisfaction with home care and satisfaction with hospital care) was employed to measure the participants' satisfaction. At six months, compared with the usual care group, the STeleR group showed statistically significant improvements in one of the two SSPSC scales (satisfaction with hospital care, p = .029) and approached significance in the second SSPSC scale (satisfaction with home care, p = .077). There were no improvements in fall-related self-efficacy. Core concepts identified were: (a) beneficial impact of the trained assistant; (b) exercises helpful; (c) home use of technology. The STeleR intervention improved satisfaction with care, especially as it relates to care following their experience from the hospital. With the limited resources available for in-home rehabilitation for stroke survivors, STeleR (and especially its exercise components) can be a useful complement to traditional post-stroke rehabilitation. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  6. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Hongli Dong

    Full Text Available Supplementation with B vitamins for stroke prevention has been evaluated over the years, but which combination of B vitamins is optimal for stroke prevention is unclear. We performed a network meta-analysis to assess the impact of different combinations of B vitamins on risk of stroke.A total of 17 trials (86 393 patients comparing 7 treatment strategies and placebo were included. A network meta-analysis combined all available direct and indirect treatment comparisons to evaluate the efficacy of B vitamin supplementation for all interventions.B vitamin supplementation was associated with reduced risk of stroke and cerebral hemorrhage. The risk of stroke was lower with folic acid plus vitamin B6 as compared with folic acid plus vitamin B12 and was lower with folic acid plus vitamin B6 plus vitamin B12 as compared with placebo or folic acid plus vitamin B12. The treatments ranked in order of efficacy for stroke, from higher to lower, were folic acid plus vitamin B6 > folic acid > folic acid plus vitamin B6 plus vitamin B12 > vitamin B6 plus vitamin B12 > niacin > vitamin B6 > placebo > folic acid plus vitamin B12.B vitamin supplementation was associated with reduced risk of stroke; different B vitamins and their combined treatments had different efficacy on stroke prevention. Folic acid plus vitamin B6 might be the optimal therapy for stroke prevention. Folic acid and vitamin B6 were both valuable for stroke prevention. The efficacy of vitamin B12 remains to be studied.

  7. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke.

    Science.gov (United States)

    Bruno, Askiel; Durkalski, Valerie L; Hall, Christiana E; Juneja, Rattan; Barsan, William G; Janis, Scott; Meurer, William J; Fansler, Amy; Johnston, Karen C

    2014-02-01

    Patients with acute ischemic stroke and hyperglycemia have worse outcomes than those without hyperglycemia. Intensive glucose control during acute stroke is feasible and can be accomplished safely but has not been fully assessed for efficacy. The Stroke Hyperglycemia Insulin Network Effort trial aims to determine the safety and efficacy of standard vs. intensive glucose control with insulin in hyperglycemic acute ischemic stroke patients. This is a randomized, blinded, multicenter, phase III trial of approximately 1400 hyperglycemic patients who receive either standard sliding scale subcutaneous insulin (blood glucose range 80-179 mg/dL, 4·44-9·93 mmol/L) or continuous intravenous insulin (target blood glucose 80-130 mg/dL, 4·44-7·21 mmol/L) for up to 72 h, starting within 12 h of stroke symptom onset. The acute treatment phase is single blind (for the patients), but the final outcome assessment is double blind. The study is powered to detect a 7% absolute difference in favorable outcome at 90 days. The primary outcome is a baseline severity adjusted 90-day modified Rankin Scale score, defined as 0, 0-1, or 0-2, if the baseline National Institutes of Health Stroke Scale score is 3-7, 8-14, or 15-22, respectively. The primary safety outcome is the rate of severe hypoglycemia (hyperglycemia. It will determine the potential benefits and risks of intensive glucose control during acute stroke. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  8. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    Science.gov (United States)

    Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-01-01

    Background The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with

  9. A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain

    DEFF Research Database (Denmark)

    Kress, Hans G; Von der Laage, Dorothea; Hoerauf, Klaus H

    2008-01-01

    to be pharmacokinetically bioequivalent to the marketed fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter...... trial, in which 220 patients were randomized to receive either the fentanyl patch or standard opioid treatment for 30 days. The primary efficacy variable, pain intensity (PI) on a 0-10-point numerical rating scale, was recorded once daily. The primary endpoint was the relative area under the curve of PI...

  10. Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial

    Science.gov (United States)

    Garcia, Hector H; Gonzales, Isidro; Lescano, Andres G; Bustos, Javier A; Zimic, Mirko; Escalante, Diego; Saavedra, Herbert; Gavidia, Martin; Rodriguez, Lourdes; Najar, Enrique; Umeres, Hugo; Pretell, E Javier

    2014-01-01

    Summary Background Neurocysticercosis causes a substantial burden of seizure disorders worldwide. Treatment with either praziquantel or albendazole has suboptimum efficacy. We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures. We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations. Methods In this double-blind, placebo-controlled, phase 3 trial, patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole (15 mg/kg per day) plus praziquantel (50 mg/kg per day), standard albendazole (15 mg/kg per day), or increased dose albendazole (22·5 mg/kg per day). Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug. Patients and investigators were masked to group assignment. The primary outcome was complete cyst resolution on 6-month MRI. Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group. Analysis excluded patients lost to follow-up before the 6-month MRI. This trial is registered with ClinicalTrials.gov, number NCT00441285. Findings Between March 3, 2010 and Nov 14, 2011, 124 patients were randomly assigned to study groups (41 to receive combined albendazole plus praziquantel [39 analysed], 43 standard albendazole [41 analysed], and 40 increased albendazole [38 analysed]). 25 (64%) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 (37%) of 41 patients in the standard albendazole group (rate ratio [RR] 1·75, 95% CI 1·10–2·79, p=0·014). 20 (53%) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 (37%) of 41 patients in the standard albendazole group (RR 1·44, 95% CI 0·87–2·38, p=0·151

  11. Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy: study protocol for a randomised trial.

    Science.gov (United States)

    Munteanu, Shannon E; Landorf, Karl B; Menz, Hylton B; Cook, Jill L; Pizzari, Tania; Scott, Lisa A

    2009-10-24

    Achilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy. One hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at

  12. Declining efficacy in controlled trials of antidepressants: effects of placebo dropout

    NARCIS (Netherlands)

    Schalkwijk, S.J.; Undurraga, J.; Tondo, L.; Baldessarini, R.J.

    2014-01-01

    Drug-placebo differences (effect-sizes) in controlled trials of antidepressants for major depressive episodes have declined for several decades, in association with selectively increasing clinical improvement associated with placebo-treatment. As these trends require adequate explanation, we tested

  13. Efficacy Trial of the Second Step Early Learning (SSEL) Curriculum: Preliminary Outcomes

    Science.gov (United States)

    Upshur, Carole C.; Heyman, Miriam; Wenz-Gross, Melodie

    2017-01-01

    A classroom randomized trial (n = 31 classrooms) was conducted using the Second Step Early Learning (SSEL) curriculum compared to usual curricula. Head Start and community preschool classrooms enrolling low income children were randomly assigned to deliver SSEL (n = 16) or usual curricula (n = 15). Data are reported for four year olds…

  14. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    DEFF Research Database (Denmark)

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

    2014-01-01

    Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews b...

  15. Efficacy of Skin Stretching for Burn Scar Excision: A Multicenter Randomized Controlled Trial

    NARCIS (Netherlands)

    Verhaegen, P.D.H.M.; van Trier, A.J.M.; Jongen, S.J.M.; Vlig, M.; Nieuwenhuis, M.K.; Middelkoop, E.; van Zuijlen, P.P.M.

    2011-01-01

    Background: Burn survivors are frequently faced with disfiguring scars. Various techniques exist to improve scar appearance, such as laser treatment and dermabrasion. Next to that, surgical reconstruction, such as scar excision is an option. This randomized controlled trial investigates whether a

  16. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    Science.gov (United States)

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  17. Dissonance and Healthy Weight Eating Disorder Prevention Programs: A Randomized Efficacy Trial

    Science.gov (United States)

    Stice, Eric; Shaw, Heather; Burton, Emily; Wade, Emily

    2006-01-01

    In this trial, adolescent girls with body dissatisfaction (N = 481, M age = 17 years) were randomized to an eating disorder prevention program involving dissonance-inducing activities that reduce thin-ideal internalization, a prevention program promoting healthy weight management, an expressive writing control condition, or an assessment-only…

  18. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial.

    NARCIS (Netherlands)

    Scheltens, P.; Kamphuis, P.J.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Wurtman, R.J.; Wilkinson, D.; Twisk, J.W.R.; Kurz, A.

    2010-01-01

    OBJECTIVE: To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). METHODS: A total of 225 drug-naive AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

  19. Trial efficacy vs real world effectiveness in first line treatment of multiple myeloma

    NARCIS (Netherlands)

    Liwing, J.; Heeg, B.M.; Karstorp, S.; Postma, M.; Silvennoinen, R.; Putkonen, M.; Anttila, P.; Remes, K.; Abildgaard, N.; Waage, A.; Nahi, H.

    2015-01-01

    Background: Large randomized clinical trials (RCT) are the foundation of the registration of newly developed drugs. A potential problem with RCTs is that the inclusion/exclusion criteria will make the population different from the actual population treated in real life. Hence, it is important to

  20. Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial

    DEFF Research Database (Denmark)

    Pagsberg, Anne Katrine; Jeppesen, Pia; Klauber, Dea Gowers

    2014-01-01

    BACKGROUND: The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus...... aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. METHODS/DESIGN: The TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients...... about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable...

  1. Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials.

    Science.gov (United States)

    Holland, Edward J; Whitley, Walter O; Sall, Kenneth; Lane, Stephen S; Raychaudhuri, Aparna; Zhang, Steven Y; Shojaei, Amir

    2016-07-22

    Report efficacy findings from three clinical trials (one phase 2 and two phase 3 [OPUS-1, OPUS-2]) of lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease (DED). Three 84-day, randomized, double-masked, placebo-controlled trials. Adults (≥18 years) with DED were randomized (1:1) to lifitegrast 5.0% or matching placebo. Changes from baseline to day 84 in signs and symptoms of DED were analyzed. Phase 2, pre-specified endpoint: inferior corneal staining score (ICSS; 0-4); OPUS-1, coprimary endpoints: ICSS and visual-related function subscale (0-4 scale); OPUS-2, coprimary endpoints: ICSS and eye dryness score (EDS, VAS; 0-100). Fifty-eight participants were randomized to lifitegrast 5.0% and 58 to placebo in the phase 2 trial; 293 to lifitegrast and 295 to placebo in OPUS-1; 358 to lifitegrast and 360 to placebo in OPUS-2. In participants with mild-to-moderate baseline DED symptomatology, lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05-0.65; p = 0.0209) and OPUS-1 (effect, 0.24; 95% CI, 0.10-0.38; p = 0.0007). Among more symptomatic participants (baseline EDS ≥40, recent artificial tear use), lifitegrast improved EDS versus placebo in a post hoc analysis of OPUS-1 (effect, 13.34; 95% CI, 2.35-24.33; nominal p = 0.0178) and in OPUS-2 (effect, 12.61; 95% CI, 8.51-16.70; p lifitegrast improved ICSS in participants with mild-to-moderate baseline symptomatology in two studies, and EDS in participants with moderate-to-severe baseline symptomatology in two studies. Based on the overall findings from these trials, lifitegrast shows promise as a new treatment option for signs and symptoms of DED.

  2. Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.

    Science.gov (United States)

    Winhusen, Theresa; Brady, Kathleen T; Stitzer, Maxine; Woody, George; Lindblad, Robert; Kropp, Frankie; Brigham, Gregory; Liu, David; Sparenborg, Steven; Sharma, Gaurav; Vanveldhuisen, Paul; Adinoff, Bryon; Somoza, Eugene

    2012-09-01

    Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Maas Josina C

    2012-03-01

    Full Text Available Abstract Background Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP. Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. Methods A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching. Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i ankle and knee flexion during gait and ii gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. Discussion This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Trial Registration Number

  4. Efficacy of N-Acetylcysteine Augmentation on Obsessive Compulsive Disorder: A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ahmad Ghanizadeh

    2017-04-01

    Full Text Available Objective: Glutamate is considered a target for treating obsessive-compulsive disorder (OCD. The efficacy and safety of the nutritional supplement of N-Acetylcysteine (NAC as an adjuvant to serotonin reuptake inhibitor (SSRI for treating children and adolescents with OCD has never been examined.Methods: This was a 10-week randomized double-blind placebo-controlled clinical trial with 34 OCD outpatients. The patients received citalopram plus NAC or placebo. Yale-Brown Obsessive-Compulsive Scale (YBOCS and Pediatric Quality of Life Inventory (PedsQL™ were used. Adverse effects were monitored.Results: YBOCS score was not different between the two groups at baseline, but the score was different between the two groups at the end of this trial (P<0.02. The YBOCS score of NAC group significantly decreased from 21.0(8.2 to 11.3(5.7 during this study. However, no statistically significant decrease of YBOCS was found in the placebo group. The Cohen’s d effect size was 0.83.The mean change of score of resistance/control to obsessions in the NAC and placebo groups was 1.8(2.3 and 0.8(2.1, respectively (P = 0.2. However, the mean score of change for resistance/control to compulsion in the NAC and placebo groups was 2.3(1.8 and 0.9(2.3, respectively. Cohen’s d effect size was 0.42.The score of three domains of quality of life significantly decreased in N-Acetylcysteine group during this trial. However, no statistically significant decrease was detected in the placebo group. No serious adverse effect was found in the two groups.Conclusion: This trial suggests that NAC adds to the effect of citalopram in improving resistance/control to compulsions in OCD children and adolescents. In addition, it is well tolerated.

  5. Efficacy of coenzyme Q10 in patients with cardiac failure: a meta-analysis of clinical trials.

    Science.gov (United States)

    Lei, Li; Liu, Yan

    2017-07-24

    The therapeutic efficacy of coenzyme Q10 on patients with cardiac failure remains controversial. We pooled previous clinical studies to re-evaluate the efficacy of coenzyme Q10 in patients with cardiac failure. We searched PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for controlled trials. The endpoints were death, left heart ejection fraction, exercise capacity, and New York Heart Association (NYHA) cardiac function classification after treatment. The pooled risk ratios (RRs) and standardized mean difference (SMD) were used to assess the efficacy of coenzyme Q10. A total of 14 RCTs with 2149 patients met the inclusion criteria and were included in the analysis. Coenzyme Q10 decreased the mortality compared with placebo (RR = 0.69; 95% CI = 0.50-0.95; P = 0.02; I 2  = 0%). A greater improvement in exercise capacity was established in patients who used coenzyme Q10 than in those who used placebo (SMD = 0.62; 95% CI = 0.02-0.30; P = 0.04; I 2  = 54%). No significant difference was observed in the endpoints of left heart ejection fraction between patients who received coenzyme Q10 and the patients in whom placebo was administered (SMD = 0.62; 95% CI = 0.02-1.12; P = 0.04; I 2  = 75%). The two types of treatment resulted in obtaining similar NYHA classification results (SMD = -0.70; 95% CI = -1.92-0.51; P = 0.26; I 2  = 89%). Patients with heart failure who used coenzyme Q10 had lower mortality and a higher exercise capacity improvement than the placebo-treated patients with heart failure. No significant differences between the efficacy of the administration of coenzyme Q10 and placebo in the endpoints of left heart ejection fraction and NYHA classification were observed.

  6. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

    OpenAIRE

    Romy Lauche; Julia Spitzer; Barbara Schwahn; Thomas Ostermann; Kathrin Bernardy; Holger Cramer; Gustav Dobos; Jost Langhorst

    2016-01-01

    This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain se...

  7. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.

    Science.gov (United States)

    Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-11-22

    The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait

  8. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials.

    Science.gov (United States)

    Jacobson, Ira M; Lawitz, Eric; Gane, Edward J; Willems, Bernard E; Ruane, Peter J; Nahass, Ronald G; Borgia, Sergio M; Shafran, Stephen D; Workowski, Kimberly A; Pearlman, Brian; Hyland, Robert H; Stamm, Luisa M; Svarovskaia, Evguenia; Dvory-Sobol, Hadas; Zhu, Yanni; Subramanian, G Mani; Brainard, Diana M; McHutchison, John G; Bräu, Norbert; Berg, Thomas; Agarwal, Kosh; Bhandari, Bal Raj; Davis, Mitchell; Feld, Jordan J; Dore, Gregory J; Stedman, Catherine A M; Thompson, Alexander J; Asselah, Tarik; Roberts, Stuart K; Foster, Graham R

    2017-07-01

    Patients with chronic hepatitis C virus (HCV) infection have high rates of sustained virologic response (SVR) after 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor velpatasvir. We assessed the efficacy of 8 weeks of treatment with sofosbuvir and velpatasvir plus the pangenotypic NS3/4A protease inhibitor voxilaprevir (sofosbuvir-velpatasvir-voxilaprevir). In 2 phase 3, open-label trials, patients with HCV infection who had not been treated previously with a direct-acting antiviral agent were assigned randomly to groups given sofosbuvir-velpatasvir-voxilaprevir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks. POLARIS-2, which enrolled patients infected with all HCV genotypes with or without cirrhosis, except patients with genotype 3 and cirrhosis, was designed to test the noninferiority of 8 weeks of sofosbuvir-velpatasvir-voxilaprevir to 12 weeks of sofosbuvir-velpatasvir using a noninferiority margin of 5%. POLARIS-3, which enrolled patients infected with HCV genotype 3 who had cirrhosis, compared rates of SVR in both groups with a performance goal of 83%. In POLARIS-2, 95% (95% confidence interval [CI], 93%-97%) of patients had an SVR to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir; this did not meet the criterion to establish noninferiority to 12 weeks of sofosbuvir-velpatasvir, which produced an SVR in 98% of patients (95% CI, 96%-99%; difference in the stratum-adjusted Mantel-Haenszel proportions of -3.2%; 95% CI, -6.0% to -0.4%). The difference in the efficacy was owing primarily to a lower rate of SVR (92%) among patients with HCV genotype 1a infection receiving 8 weeks of sofosbuvir-velpatasvir-voxilaprevir. In POLARIS-3, 96% of patients (95% CI, 91%-99%) achieved an SVR in both treatment groups, which was significantly superior to the performance goal. Overall, the most common adverse events were headache, fatigue, diarrhea, and nausea; diarrhea and nausea were reported more frequently by

  9. A phase 2b randomized, controlled trial of the efficacy of the GMZ2 malaria vaccine in African children

    DEFF Research Database (Denmark)

    Sirima, Sodiomon B; Mordmüller, Benjamin; Milligan, Paul

    2016-01-01

    randomized to receive three injections of either 100μg GMZ2 adjuvanted with aluminum hydroxide or a control vaccine (rabies) four weeks apart and were followed up for six months to measure the incidence of malaria defined as fever or history of fever and a parasite density ⩾5000/μL. RESULTS: A cohort of 1849...... in the rabies vaccine group and 14 in the GMZ2 group), VE 27% (95% CI -44%, 63%). CONCLUSIONS: GMZ2 is the first blood-stage malaria vaccine to be evaluated in a large multicenter trial. GMZ2 was well tolerated and immunogenic, and reduced the incidence of malaria, but efficacy would need to be substantially...

  10. Efficacy and Acceptability of Psychotherapy for Anxious Young Children: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Zhang, Hanping; Zhang, Yuqing; Yang, Lining; Yuan, Shuai; Zhou, Xinyu; Pu, Juncai; Liu, Lanxiang; Jiang, Xiaofeng; Xie, Peng

    2017-10-23

    We aimed to provide an overview of psychotherapy in young anxious children (mean age, ProQuest Dissertations, were searched. Randomized controlled trials that compared psychotherapies with control conditions were included. Efficacy (score change on an anxiety rating scale and rate of being freed from anxiety) and acceptability (discontinuations due to any event) were evaluated. Six of the total seven studies included in our study adopted cognitive behavioral therapy (CBT), with only one adopting behavior therapy (BT). Psychotherapy effectively reduced anxiety symptoms (standardized mean difference = -0.83; 95% confidence interval [CI], -1.08 to -0.57), and its rate of freeing patients from anxiety was high (risk ratio [RR] = 0.30; 95% CI, 0.19 to 0.47). No remarkable difference for acceptability was found between the two therapy types (RR = 0.54; 95% CI, 0.25 to 1.18). Psychotherapy, both CBT and BT, benefits young anxious children.

  11. Efficacy of Art Therapy in Individuals With Personality Disorders Cluster B/C: A Randomized Controlled Trial.

    Science.gov (United States)

    Haeyen, Suzanne; van Hooren, Susan; van der Veld, William; Hutschemaekers, Giel

    2017-09-19

    Multidisciplinary treatment programs for patients with personality disorders (PDs) often include art therapy, but the efficacy of this intervention has hardly been evaluated. The objective of this study is to evaluate the effects of an art therapy intervention on psychological functioning of patients with a PD. In this randomized controlled trial, 57 adult participants diagnosed with a PD cluster B/C (SCID-II) were randomly assigned to either weekly group art therapy (1.5 hours, 10 weeks) or a waiting list group. Outcome measures OQ45, AAQ-II, and SMI were assessed at baseline, at post-test (10 weeks after baseline), and at follow-up (5 weeks after post-test). The results show that art therapy is an effective treatment for PD patients because it not only reduces PD pathology and maladaptive modes but it also helps patients to develop adaptive, positive modes that indicate better mental health and self-regulation.

  12. Efficacy of 'Tailored Physical Activity' in reducing sickness absence among health care workers: design of a randomised controlled trial.

    Science.gov (United States)

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2013-10-02

    Health care workers have high physical work demands, involving patient handling and manual work tasks. A strategy for prevention of work-related musculoskeletal disorders can enhance the physical capacity of the health care worker. The aim of this study is to evaluate the efficacy of 'Tailored Physical Activity' for health care workers in the Sonderborg Municipality. This protocol describes the design of a randomised controlled trial to assess the efficacy of 'Tailored Physical Activity' versus a reference group for health care workers in the Sonderborg Municipality. Inclusion criteria to be fulfilled: health care workers with daily work that includes manual work and with the experience of work-related musculoskeletal pain in the back or upper body.All participants will receive 'Health Guidance', a (90-minute) individualised dialogue focusing on improving life style, based on assessments of risk behaviour, on motivation for change and on personal resources. In addition, the experimental groups will receive 'Tailored Physical Activity' (three 50-minute sessions per week over 10 weeks). The reference group will receive only 'Health Guidance'.The primary outcome measure is the participants' self-reported sickness absence during the last three months due to musculoskeletal troubles, measured 3 and 12 months after baseline.In addition, secondary outcomes include anthropometric measurements, functional capacity and self-reported number of sick days, musculoskeletal symptoms, self-reported health, work ability, work productivity, physical capacity, kinesiophobia and physical functional status. The results from this study will contribute to the knowledge about evidence-based interventions for prevention of sickness absence among health care workers. ClinicalTrials.gov: NCT01543984.

  13. Efficacy of Cellular Therapy for Diabetic Foot Ulcer: A Meta-Analysis of Randomized Controlled Clinical Trials.

    Science.gov (United States)

    Zhang, Ye; Deng, Hong; Tang, Zhouping

    2017-12-01

    Diabetes mellitus is a widely spread chronic disease with growing incidence worldwide, and diabetic foot ulcer is one of the most serious complications of diabetes. Cellular therapy has shown promise in the management of diabetic foot ulcer in many preclinical experiments and clinical researches. Here, we performed a meta-analysis to evaluate the efficacy and safety of cellular therapy in the management of diabetic foot ulcer. We systematically searched PubMed, MEDLINE, EMBASE, and Cochrane Library databases from inception to May 2017 for randomized controlled trials assessing the efficacy of cellular therapy in diabetic foot ulcer, and a meta-analysis was conducted. A total of 6 randomized controlled clinical trials involving 241 individuals were included in this meta-analysis. The results suggested that cellular therapy could help accelerating the healing of diabetic foot ulcer, presented as higher ankle-brachial index (mean difference = 0.17, 95% confidence interval [CI] = 0.11 to 0.23), higher transcutaneous oxygen pressure (standardized mean difference [SMD] = 1.43; 95% CI, 1.09- to 1.78), higher ulcer healing rate (relative risk [RR] = 1.78; 95% CI, 1.41 to 2.25), higher amputation-free survival (RR = 1.25; 95% CI, 1.11 to 1.40), and lower scale of pain (SMD = -1.69; 95% CI, -2.05 to -1.33). Furthermore, cellular therapy seemed to be safe, with no serious complications and low risk of short-term slight complications. Cellular therapy could accelerate the rate of diabetic foot ulcer healing and may be more efficient than standard therapy for diabetic foot treatment.

  14. Efficacy of hypnosis/guided imagery in fibromyalgia syndrome - a systematic review and meta-analysis of controlled trials

    Science.gov (United States)

    2011-01-01

    Background Recent systematic reviews on psychological therapies of fibromyalgia syndrome (FMS) did not consider hypnosis/guided imagery (H/GI). Therefore we performed a systematic review with meta-analysis of the efficacy of H/GI in FMS. Methods We screened http://ClinicalTrials.gov, Cochrane Library, MEDLINE, PsycINFO and SCOPUS (through December 2010). (Quasi-) randomized controlled trials (CTs) comparing H/GI with controls were analyzed. Outcomes were pain, sleep, fatigue, depressed mood and health-related quality of life (HRQOL). Effects were summarized using standardized mean differences (SMD). Results Six CTs with 239 subjects with a median of 9 (range 7-12) H/GI-sessions were analysed. The median number of patients in the H/GI groups was 20 (range 8-26). Three studies performed follow-ups. H/GI reduced pain compared to controls at final treatment (SMD -1.17 [95% CI -2.21, -0.13]; p = 0.03). H/GI did not reduce limitations of HRQOL at final treatment (SMD -0.90 [95% CI -2.55, 0.76]; p = 0.29) compared to controls. Effect sizes on fatigue, sleep and depressed mood at final treatment and follow-up and on pain and HRQOL at follow-up were not calculated because of limited data available. The significant effect on pain at final treatment was associated with low methodological and low treatment quality. Conclusion Further studies with better treatment quality and adequate methodological quality assessing all key domains of FMS are necessary to clarify the efficacy of H/GI in FMS. PMID:21676255

  15. Efficacy of Chinese eye exercises on reducing accommodative lag in school-aged children: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Shi-Ming Li

    Full Text Available To evaluate the efficacy of Chinese eye exercises on reducing accommodative lag in children by a randomized, double-blinded controlled trial.A total of 190 children aged 10 to 14 years with emmetropia to moderate myopia were included. They were randomly allocated to three groups: standard Chinese eye exercises group (trained for eye exercises by doctors of traditional Chinese medicine; sham point eye exercises group (instructed to massage on non-acupoints; and eyes closed group (asked to close their eyes without massage. Primary outcome was change in accommodative lag immediately after intervention. Secondary outcomes included changes in corrected near and distant visual acuity, and visual discomfort score.Children in the standard Chinese eye exercises group had significantly greater alleviation of accommodative lag (-0.10 D than those in sham point eye exercises group (-0.03 D and eyes closed group (0.07 D (P = 0.04. The proportion of children with alleviation of accommodative lag was significantly higher in the standard Chinese eye exercises group (54.0% than in the sham point eye exercises group (32.8% and the eyes closed group (34.9% (P = 0.03. No significant differences were found in secondary outcomes.Chinese eye exercises as performed daily in primary and middle schools in China have statistically but probably clinically insignificant effect in reducing accommodative lag of school-aged children in the short-term. Considering the higher amounts of near work load of Chinese children, the efficacy of eye exercises may be insufficient in preventing myopia progression in the long-term.ClinicalTrials.gov NCT01756287.

  16. Magnitude of efficacy measurements in grass allergy immunotherapy trials is highly dependent on pollen exposure

    OpenAIRE

    Durham, S R; Nelson, H. S.; Nolte, H.; Bernstein, D I; Creticos, P S; Li, Z; Andersen, J. S.

    2014-01-01

    Background The objective was to evaluate the association between grass pollen exposure, allergy symptoms and impact on measured treatment effect after grass sublingual immunotherapy (SLIT)-tablet treatment. Methods The association between grass pollen counts and total combined rhinoconjunctivitis symptom and medication score (TCS) was based on a post hoc analysis of data collected over six trials and seven grass pollen seasons across North America and Europe, including 2363 subjects treated w...

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

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract 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

  18. How Can Theory-Based Evaluation Make Greater Headway?

    Science.gov (United States)

    Weiss, Carol H.

    1997-01-01

    Explores the problems of theory-based evaluation, describes the nature of potential benefits, and suggests that the benefits are significant enough to warrant continued effort to overcome the obstacles and advance its use. Many of the problems are related to inadequate theories about pathways to desired program outcomes. (SLD)

  19. Theory-Based Lexicographical Methods in a Functional Perspective

    DEFF Research Database (Denmark)

    Tarp, Sven

    2014-01-01

    This contribution provides an overview of some of the methods used in relation to the function theory. It starts with a definition of the concept of method and the relation existing between theory and method. It establishes an initial distinction between artisanal and theory-based methods...

  20. Continuing Bonds in Bereavement: An Attachment Theory Based Perspective

    Science.gov (United States)

    Field, Nigel P.; Gao, Beryl; Paderna, Lisa

    2005-01-01

    An attachment theory based perspective on the continuing bond to the deceased (CB) is proposed. The value of attachment theory in specifying the normative course of CB expression and in identifying adaptive versus maladaptive variants of CB expression based on their deviation from this normative course is outlined. The role of individual…

  1. Towards a Theory-Based Framework for Assessing the ...

    African Journals Online (AJOL)

    2015:17). The theory-based framework attempts to capture ESD's complexity in terms of the underlying pedagogy and change processes. We argue that this framework can provide support and anchor teacher education institutions wishing to mainstream ESD in their local context. The necessary data were gathered as part ...

  2. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial.

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    Chris Fox

    Full Text Available Agitation in Alzheimer's disease (AD is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary hypothesis, memantine is superior to placebo for clinically significant agitation, in patients with moderate-to-severe AD.We recruited 153 participants with AD and clinically significant agitation from care-homes or hospitals for a double-blind randomised-controlled trial and 149 people started the trial of memantine versus placebo. The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory (CMAI. Secondary outcomes were: 12 weeks CMAI; 6 and 12 weeks Neuropsychiatric symptoms (NPI, Clinical Global Impression Change (CGI-C, Standardised Mini Mental State Examination, Severe Impairment Battery. Using a mixed effects model we found no significant differences in the primary outcome, 6 weeks CMAI, between memantine and placebo (memantine lower -3.0; -8.3 to 2.2, p = 0.26; or 12 weeks CMAI; or CGI-C or adverse events at 6 or 12 weeks. NPI mean difference favoured memantine at weeks 6 (-6.9; -12.2 to -1.6; p = 0.012 and 12 (-9.6; -15.0 to -4.3 p = 0.0005. Memantine was significantly better than placebo for cognition. The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD.Memantine did not improve significant agitation in people with in moderate-to-severe AD. Future studies are urgently needed to test other pharmacological candidates in this group and memantine for neuropsychiatric symptoms.ClinicalTrials.gov NCT00371059.International Standard Randomised Controlled Trial 24953404.

  3. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

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    Higurashi Takuma

    2012-03-01

    Full Text Available Abstract Background Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF. ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. Discussion This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with

  4. Cognitive bibliotherapy for mild depressive symptomatology: randomized clinical trial of efficacy and mechanisms of change.

    Science.gov (United States)

    Moldovan, Ramona; Cobeanu, Oana; David, Daniel

    2013-01-01

    It has been increasingly recognized that subthreshold depression is associated with considerable personal, social and economic costs. However, there is no accepted definition or clear-cut treatment for subthreshold depression. Cognitive bibliotherapy is a promising approach, but further research is necessary in order to assess its clinical efficacy and key mechanisms of change. This study aimed to investigate the efficacy of bibliotherapy for subthreshold depression and test whether maladaptive cognitions mediate the effects of bibliotherapy on depressive symptoms. A total of 96 young adults with subthreshold depression were randomized in one of the following treatment conditions: immediate treatment, delayed treatment, placebo and no treatment. The main outcome was represented by depressive symptoms assessed before, during and immediately after the treatment, as well as at 3-month follow-up. Automatic thoughts, dysfunctional attitudes and irrational beliefs were also assessed throughout the study, and we investigated their involvement as mediators of bibliotherapy effects on depressive symptoms. The results indicated that cognitive bibliotherapy resulted in statistically and clinically significant changes both in depressive symptoms and cognitions, which were maintained at follow-up. In contrast, placebo was only associated with a temporary decrease in depressive symptoms, without significant cognitive changes. No changes in symptoms or cognitions were found in the delayed treatment and no treatment groups. We also found that automatic thoughts significantly mediated the effect of bibliotherapy on depressive symptoms. This study provided compelling evidence for the efficacy of cognitive bibliotherapy in subthreshold depression and showed that changes in automatic thoughts mediated the effect of bibliotherapy on depressive symptoms. Cognitive bibliotherapy is an effective treatment of subthreshold depression. Changing automatic thoughts is important, as they

  5. Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial.

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    Berking, Matthias; Ebert, David; Cuijpers, Pim; Hofmann, Stefan G

    2013-01-01

    Deficits in emotion regulation skills are possible factors maintaining major depressive disorder (MDD). Therefore, the aim of the study was to test whether integrating a systematic emotion regulation training (ERT) enhances the efficacy of routine inpatient cognitive behavioral therapy (CBT) for MDD. In a prospective randomized controlled trial, 432 inpatients meeting criteria for MDD were assigned to receive either routine CBT or CBT enriched with an intense emotion regulation skills training (CBT-ERT). Participants in the CBT-ERT condition demonstrated a significantly greater reduction in depression (response rates - CBT: 75.5%, CBT-ERT: 84.9%; remission rates - CBT: 51.1%, CBT-ERT: 65.1%). Moreover, CBT-ERT participants demonstrated a significantly greater reduction of negative affect, as well as a greater increase of well-being and emotion regulation skills particularly relevant for mental health. Integrating strategies that target emotion regulation skills improves the efficacy of CBT for MDD. Copyright © 2013 S. Karger AG, Basel.

  6. Comparision Of The Efficacy Of Nebulized L-Epinephrine, Salbutamoland Normal Saline In Acute Bronchiolitis: A Randomized Clinical Trial

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    H. Mussavi

    2005-08-01

    Full Text Available Background:Acute bronchiolitis is the most common form of lower respiratory tract infection in infancy.There are numerous contradictory reports regarding the efficacy of nebulized bronchodilators in the management of infants with acute bronchiolitis. This study was designed to compare the efficacy of nebulized epinephrine with salbutamol for treatment of the disease.Methods:In a randomized clinical trial, 72 infants with moderately severe bronchiolitis were enrolled in three equal groups. Three doses of epinephrine, salbutamol, and normal saline as a placebo nebulized with oxygen were given at 20 minute intervals. Oxygen saturation, respiratory rate and distress were recorded before intervention and I0 minutes after each dose of the drugs. Results: At the end of the study, pre- and post-treatment mean oxygen saturation values, clinical scores and respiratory rates showed significant differences between the epinephrine and salbutamol groups in comparison with the placebo group. The results were more significant in the epinephrine group than other groups. After the treatment course 66%, 50%, and 25% of patients in epinephrine, salbutamol, and placebo groups respectively showed significant improvement at a degree that they could be sent home. No serious side effects were observed.Conclusion: Both nebulized epinephrine and salbutamol improved oxygenation and decreased respiratory distress better than normal saline. L-epinephrim was more effective in relieving respiratory distress and improving oxygen saturation as well as the need for hospitalization than nebulized salbutamol.

  7. Efficacy and safety of sublingual immunotherapy for allergic rhinitis in pediatric patients: A meta-analysis of randomized controlled trials.

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    Feng, Bohai; Wu, Jueting; Chen, Bobei; Xiang, Haijie; Chen, Ruru; Li, Bangliang; Chen, Si

    2017-01-01

    Allergic rhinitis (AR) has become a global health problem that constantly affects a large part of the general population, especially children. Sublingual allergen immunotherapy (SLIT) has been used extensively for pediatric AR, although its efficacy and safety are often questioned. In this meta-analysis of randomized controlled trials (RCT), we evaluated the use of SLIT for pediatric AR. A number of medical literature data bases were searched through January 2016 to identify RCTs that examined the use of SLIT for pediatric AR and that assessed clinical outcomes related to efficacy. Descriptive and quantitative information was abstracted. Standardized mean differences (SMD) were calculated by using fixed- and random-effects models. Subgroup analyses were performed. Heterogeneity was assessed by using the I2 metric. A network meta-analysis was used to estimate SMDs between two SLIT protocols for pediatric seasonal AR. All data were extracted from publications or received from the authors. Twenty-six studies were eligible for inclusion in the meta-analysis of rhinitis or rhinoconjunctivitis symptom scores, and 19 studies were eligible for the meta-analysis of medication scores. Descriptive and quantitative data were extracted. SLIT differed significantly from placebo in terms of symptom scores (SMD -0.55 [95% confidence interval {CI}, -0.86 to -0.25]; p = 0.0003, I2 = 90%) and medication scores (SMD -0.67 [95% CI, -0.96 to -0.38]; p pediatric patients. Moreover, the safety of SLIT needs to be confirmed in RCTs with larger samples.

  8. A randomized controlled clinical trial to assess the efficacy of Nasya in reducing the signs and symptoms of cervical spondylosis.

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    Radhika, C; Kumar, G Vinod; Mihirjan, K

    2012-01-01

    This work was designed to assess the efficacy of Nasya in reducing the signs and symptoms of cervical spondylosis. The patients attending the O. P. D of Department of Kaya Chikitsa and Panchakarma, Government Ayurveda College Hospital, Thiruvananthapuram were enrolled and subjected to the treatment schedule. Total duration of treatment was 21days. The schedule for the first 14 days was similar in both the groups. It included Rooksha Sveda for 7days followed by Patra Pottali Sveda for 7days. During this period, 90 ml Gandharvahastadi Kashaya twice and Guggulu Tiktaka Kashaya once were given internally. After this, in the Nasya group Nasya was done for 7days with Dhanwantaram Tailam (21times Aavartita), MriduPaka in Madhyama Matra (8Bindu). Along with this Guggulu Tiktaka Kashaya was given thrice. In the control group, Guggulu Tiktaka kashaya alone was given thrice daily. Assessments were done with regard to pain, tenderness, radiation of pain, numbness, range of movements and hand grip strength. These were done before treatment, before nasya, after treatment and after 1month follow-up. The statistical hypothesis was tested using paired 't' test and 'Z' test for proportion. The trial proved that conventional management along with Nasya was more efficacious than conventional management alone in reducing the signs and symptoms of cervical spondylosis.

  9. The efficacy and safety of Crataegus extract WS 1442 in patients with heart failure: the SPICE trial.

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    Holubarsch, Christian J F; Colucci, Wilson S; Meinertz, Thomas; Gaus, Wilhelm; Tendera, Michal

    2008-12-01

    Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed. To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS 1442 in patients with congestive heart failure. In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF or =25%, WS 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups. In this study, WS 1442 had no significant effect on the primary endpoint. WS 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.

  10. The efficacy, safety and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; a randomized trial.

    Science.gov (United States)

    Babaeinejad, S H; Fouladi, R F

    2013-09-01

    Topical treatments, such as adapalene and benzoyl peroxide (BPO), are popular in mild-to-moderate acne vulgaris. This study aimed to compare the efficacy, safety and tolerability of adapalene and BPO in mild acne vulgaris. In this single-center, randomized, double-blind, clinical trial, 60 patients with mild acne vulgaris received either topical adapalene 0.1% gel or topical BPO 2.5% gel on their face once daily for two months. The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients' overall satisfaction (tolerability) were compared after 3 months of follow-up. In both groups the mean number of noninflammatory, inflammatory and total lesions decreased significantly from baseline (10.77±5.54, 9.73±5.09, and 20.50±7.54, respectively in adapalene group; 11.50±5.92, 8.43±5.45, and 19.93±9.01, respectively in BPO group) to the third month (1.70±1.68, 0.33±0.66, and 0.50±0.78, respectively in adapalene group; 4.23±4.14, 0.33±0.71, and 4.13±4.44, respectively in BPO group; Pacne vulgaris, with a marginal tendency toward the former.

  11. The efficacy, safety, and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris: a randomized trial.

    Science.gov (United States)

    Babaeinejad, S H; Fouladi, R F

    2013-07-01

    Topical treatments, such as adapalene and benzoyl peroxide (BPO), are popular in mild-to-moderate acne vulgaris. This study aimed to compare the efficacy, safety and tolerability of adapalene and BPO in mild acne vulgaris. In this single-center, randomized, double-blind, clinical trial, 60 patients with mild acne vulgaris received either topical adapalene 0.1% gel or topical BPO 2.5% gel on their face once daily for two months. The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients' overall satisfaction (tolerability) were compared after 3 months of follow-up. In both groups the mean number of noninflammatory, inflammatory and total lesions decreased significantly from baseline (10.77±5.54, 9.73±5.09, and 20.50±7.54, respectively in adapalene group; 11.50±5.92, 8.43±5.45, and 19.93±9.01, respectively in BPO group) to the third month (1.70±1.68, 0.33±0.66, and 0.50±0.78, respectively in adapalene group; 4.23±4.14, 0.33±0.71, and 4.13±4.44, respectively in BPO group; Pacne vulgaris, with a marginal tendency toward the former.

  12. Efficacy and Effectiveness of Exercise on Tender Points in Adults with Fibromyalgia: A Meta-Analysis of Randomized Controlled Trials

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    George A. Kelley

    2011-01-01

    Full Text Available Fibromyalgia is a major public health problem affecting an estimated 200 to 400 million people worldwide. The purpose of this study was to use the meta-analytic approach to determine the efficacy and effectiveness of randomized controlled exercise intervention trials (aerobic, strength training, or both on tender points (TPs in adults with fibromyalgia. Using random effects models and 95% confidence intervals (CI, a statistically significant reduction in TPs was observed based on per-protocol analyses (8 studies representing 322 participants but not intention-to-treat analyses (5 studies representing 338 participants (per-protocol, , −0.68, 95% CI, −1.16, −0.20; intention-to-treat, , −0.24, 95% CI, −0.62, 0.15. Changes were equivalent to relative reductions of 10.9% and 6.9%, respectively, for per-protocol and intention-to-treat analyses. It was concluded that exercise is efficacious for reducing TPs in women with FM. However, a need exists for additional well-designed and reported studies on this topic.

  13. Efficacy of Tailored Exercise Therapy on Physical Functioning in Patients With Knee Osteoarthritis and Comorbidity: A Randomized Controlled Trial.

    Science.gov (United States)

    de Rooij, Mariëtte; van der Leeden, Marike; Cheung, John; van der Esch, Martin; Häkkinen, Arja; Haverkamp, Daniël; Roorda, Leo D; Twisk, Jos; Vollebregt, Joke; Lems, Willem F; Dekker, Joost

    2017-06-01

    To evaluate the efficacy on physical functioning and safety of tailored exercise therapy in patients with knee osteoarthritis (OA) and comorbidities. In a randomized controlled trial, 126 participants were included with a clinical diagnosis of knee OA and at least 1 of the following target comorbidities: coronary disease, heart failure, type 2 diabetes mellitus, chronic obstructive pulmonary disease, or obesity (body mass index ≥30 kg/m(2) ), with severity score ≥2 on the Cumulative Illness Rating Scale. The intervention group received a 20-week, individualized, comorbidity-adapted exercise program consisting of aerobic and strength training and training of daily activities. The control group received their current medical care for knee OA and were placed on a waiting list for exercise therapy. Primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index, subscale physical functioning (WOMAC-pf), and the 6-minute walk test (6MWT). Measurements were performed at baseline, after 20 weeks (directly posttreatment), and at 3 months posttreatment. Statistically significant physical functioning differences over time were found between the intervention and control group (WOMAC: B = -7.43 [95% confidence interval (95% CI) -9.99, -4.87], P exercise therapy is efficacious in improving physical functioning and safe in patients with knee OA and severe comorbidities. © 2016, American College of Rheumatology.

  14. A prospective randomised trial to compare the efficacy of povidone-iodine 10% and chlorhexidine 2% for skin disinfection

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    Atul P Kulkarni

    2013-01-01

    Full Text Available Context: Infectious complications of invasive procedures affect patient outcomes adversely. Choice of antiseptic solution at the time of insertion is one of the major factors affecting their incidence. Aims: This study was undertaken to compare efficacy of chlorhexidine 2% and povidone iodine 10% for skin disinfection prior to placement of epidural and central venous catheters (CVCs. Settings and Design: A prospective randomised trial in the operating rooms of a tertiary referral cancer centre. Methods: Sixty consecutive adult patients undergoing elective oncosurgery requiring placement of epidural and CVCs were enrolled. Paired skin swabs were collected before and after application of the antiseptic solution. The samples were incubated in McConkey′s media and blood agar at 35°C for up to 24 h. Any bacterial growth was graded as: 50 colonies as heavy growth. Data on demographics and antibiotic prophylaxis and costs was collected for all patients. Statistical Analysis: Student′s t-test and Mann-Whitney tests were used to analyse data, P>0.05 was considered significant. Results: Demographics and antibiotic prophylaxis use was similar in both groups. Before application of antiseptic solution, a variety of micro-organisms were grown from most patients with growth ranging from none-heavy. No organism was grown after application of either antiseptic solution from any patient. Conclusions: We found no differences between 2% chlorhexidine and 10% povidone-iodine for skin disinfection in regard to costs, efficacy or side-effects.

  15. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial.

    Science.gov (United States)

    Irwin, Michael R; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Breen, Elizabeth C; Witarama, Tuff; Yokomizo, Megumi; Lavretsky, Helen; Carroll, Judith E; Motivala, Sarosh J; Bootzin, Richard; Nicassio, Perry

    2014-09-01

    To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Randomized controlled, comparative efficacy trial. Los Angeles community. 123 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07-0.97] P Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. © 2014 Associated Professional Sleep Societies, LLC.

  16. Drospirenone-only oral contraceptive: results from a multicenter noncomparative trial of efficacy, safety and tolerability.

    Science.gov (United States)

    Archer, David F; Ahrendt, Hans-Joachim; Drouin, Dominique

    2015-11-01

    This study was performed to assess the contraceptive efficacy of the drospirenone (DRSP)-only pill and to provide information regarding its safety and cycle-control profile. This prospective, multicenter, noncomparative study was conducted at 41 European sites in healthy women at risk of pregnancy, aged 18 to 45 years. The study medication was DRSP 4.0mg daily for 24 days followed by a placebo for 4 days (DRSP 4 mg 24/4, Exeltis, Spain) for thirteen 28-day treatment cycles. The primary efficacy endpoint was the overall Pearl Index (PI). Bleeding patterns, changes in vital signs and changes in laboratory values were also analyzed. A total of 713 participants with 7638 DRSP treatment cycles were analyzed. The overall PI was 0.51 (95% confidence interval, 0.1053-1.4922). The proportion of participants with any bleeding decreased from 72.7% in Cycle 1 to 40% in Cycle 6 and 32.1% in Cycle 13. Unscheduled bleeding decreased from 49.1% in Cycle 1 to 27.8% in Cycle 6 and to 22.8% in Cycle 13. Prolonged bleeding was reported by 6.5% during Cycles 2 to 4 decreasing to 4.2% during Cycles 11 to 13. There were no reports of deep vein thrombosis, pulmonary embolism or hyperkalemia. No relevant changes were observed for laboratory parameters, body weight, body mass index, blood pressure or heart rate. Study drug acceptability was considered as "excellent/good" by over 82% of subjects. This new DRSP-only oral contraceptive provides clinical contraceptive efficacy similar to that of the currently marketed Combination estrogen plus progestin Oral Contraceptive, with a good safety profile, and favorable cycle control. A novel 4-mg DRSP-only pill taken daily for 24 days followed by a placebo for 4 days demonstrated contraceptive efficacy similar to that of currently marketed Combination estrogen plus progestin Oral Contraceptive, with a good safety profile, and favorable cycle control. Copyright © 2015. Published by Elsevier Inc.

  17. Fasting versus gradual initiation of the ketogenic diet: a prospective, randomized clinical trial of efficacy.

    Science.gov (United States)

    Bergqvist, A G Christina; Schall, Joan I; Gallagher, Paul R; Cnaan, Avital; Stallings, Virginia A

    2005-11-01

    The ketogenic diet (KD) is a 90% fat diet that is an effective treatment for intractable epilepsy. Rapid initiation of the KD requires hospital admission because of the complexity of the protocol and frequent mild and moderate adverse events. The purpose of the study was to compare the efficacy of a gradual KD initiation with the standard KD initiation preceded by a 24- to 48-h fast. Children ages 1 to 14 years with intractable epilepsy were randomized to a fasting initiation (FAST-KD) or gradual initiation (GRAD-KD). Baseline seizure activity was recorded daily for 28 days before admission and continued for the 3-month duration of the study. Effectiveness was measured in two ways: (a) the proportion of subjects with >50% reduction in target seizure type from baseline to 3-month evaluation, and (b) percentage reduction in the frequency of the target seizure type from baseline to 3-month evaluation. Blood glucose was assessed q4 to 6h, and weights, electrolytes, hydration status, vomiting, acid balance, need for interventions (citric acid and sodium citrates (Bicitra) and IV fluids) were assessed daily. Fisher's exact tests were used to examine the association between protocol and occurrence of adverse events, and longitudinal mixed-effects models were used to look for trends in tolerability data over time. Forty-eight subjects, 24 in each arm, were randomized. In the FAST-KD protocol, 58% of the children had >50% reduction in the target seizure type at 3 months, and 21% were seizure free. In the GRAD-KD protocol, 67% had a >50% reduction at 3 months, and 21% were seizure free. The two protocols were equivalent in efficacy (p = 0.033). At 3 months, the FAST-KD median percentage seizure reduction rate was 78% (ranging from 100% reduction to 73% increase in seizures per week) and was 94% (ranging from 100% reduction to 161% increase in seizures per week) for the GRAD-KD protocol. By using a logarithmic transformed percentage reduction rate and an equivalence limit

  18. Integrative group-based cognitive rehabilitation efficacy in multiple sclerosis: a randomized clinical trial.

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    Rilo, Oiane; Peña, Javier; Ojeda, Natalia; Rodríguez-Antigüedad, Alfredo; Mendibe-Bilbao, Mar; Gómez-Gastiasoro, Ainara; DeLuca, John; Chiaravalloti, Nancy; Ibarretxe-Bilbao, Naroa

    2018-01-01

    This study aimed to determine the efficacy of the integrative group-based cognitive rehabilitation programme, REHACOP, on improving cognitive functions in multiple sclerosis (MS). Fourty-two MS patients were randomized to the treatment programme REHACOP (n = 21) or waiting list control condition (n = 21). The REHACOP group received cognitive rehabilitation in group format for three months focused on attention, processing speed, learning and memory, language, executive functioning, and social cognition. Patients completed a neuropsychological assessment at baseline and follow-up, which included tests of attention, processing speed, working memory, verbal memory, verbal fluency, and executive functioning. Repeated measures multivariate analysis of covariance (MANCOVA) was used to determine the efficacy of the cognitive rehabilitation programme. Group × Time interactions revealed significant improvements in the REHACOP group as compared with the control group for processing speed (p = 0.011, np2 = 0.16), working memory (p = 0.014, np2 = 0.15), verbal memory (p = 0.025, np2 = 0.13), and executive functioning (p = 0.024, np2 = 0.13), showing medium-large effect sizes. Patients receiving REHACOP showed improvements in several cognitive domains. This preliminary study thus provides evidence supporting the efficacy of this integrative group-based cognitive rehabilitation intervention in MS. Future research should confirm these findings, examine the impact of the treatment on everyday life functioning and explore the presence of brain changes associated with cognitive rehabilitation. Implications for rehabilitation This study provides initial evidence for integrative group-based cognitive rehabilitation efficacy in MS patients through the implementation of the REHACOP cognitive rehabilitation programme. Patients received cognitive rehabilitation for three months (3 one-hour-sessions per week) focused on training attention

  19. Analgesic efficacy of diazepam and placebo in patients with temporomandibular disorders: A double blind randomized clinical trial

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    G V Pramod

    2011-01-01

    Full Text Available Aim: The aim of the study was to evaluate and compare the analgesic efficacy of placebo and diazepam in patients with temporomandibular disorder. Materials and Methods: Thirty-five patients were recruited with a diagnosis of temporomandibular disorder based on standard clinical diagnostic criteria for temporomandibular disorder. The patients were put in to one of the two groups: placebo or diazepam at random. The average pain intensity was recorded with visual analog scale (VAS at pretreatment, at weekly interval till the completion of a three-week trial and at post-treatment visit on the eighth week from baseline. The secondary outcome measures were changes in masticatory muscle tenderness, viz. massater muscle, lateral pterygoid muscle, medial pterygoid muscle and temporalis muscle and changes in mouth opening. Statistical Analysis: Intra-group comparison for analgesic efficacy and mouth opening was carried out by Wilcoxon′s signed ranked test. Inter-group comparison for analgesic efficacy was also carried out using Mann-Whitney′s test. Results: A statistically significant (P<0.01 decrease in temporomandibular disorder pain in the placebo group (65% and statistically highly significant (P<0.001 decrease in the diazepam group (72% were observed on VAS after three weeks of treatment. The inter-group comparison demonstrated no statistically significant difference between the groups. Conclusion: This study suggests that the placebo can give near similar results as diazepam can. So the role of placebo should also be considered as one of the important management strategies. In the short term, reduction in the masticatory muscle tenderness and significant improvement in the mouth opening in both the groups were observed.

  20. A phase 2b randomized, controlled trial of the efficacy of the GMZ2 malaria vaccine in African children.

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    Sirima, Sodiomon B; Mordmüller, Benjamin; Milligan, Paul; Ngoa, Ulysse Ateba; Kironde, Fred; Atuguba, Frank; Tiono, Alfred B; Issifou, Saadou; Kaddumukasa, Mark; Bangre, Oscar; Flach, Clare; Christiansen, Michael; Bang, Peter; Chilengi, Roma; Jepsen, Søren; Kremsner, Peter G; Theisen, Michael

    2016-08-31

    GMZ2 is a recombinant protein malaria vaccine, comprising two blood-stage antigens of Plasmodium falciparum, glutamate-rich protein and merozoite surface protein 3. We assessed efficacy of GMZ2 in children in Burkina Faso, Gabon, Ghana and Uganda. Children 12-60months old were randomized to receive three injections of either 100μg GMZ2 adjuvanted with aluminum hydroxide or a control vaccine (rabies) four weeks apart and were followed up for six months to measure the incidence of malaria defined as fever or history of fever and a parasite density ⩾5000/μL. A cohort of 1849 children were randomized, 1735 received three doses of vaccine (868 GMZ2, 867 control-vaccine). There were 641 malaria episodes in the GMZ2/Alum group and 720 in the control group. In the ATP analysis, vaccine efficacy (VE), adjusted for age and site was 14% (95% confidence interval [CI]: 3.6%, 23%, p-value=0.009). In the ITT analysis, age-adjusted VE was 11.3% (95% CI 2.5%, 19%, p-value=0.013). VE was higher in older children. In GMZ2-vaccinated children, the incidence of malaria decreased with increasing vaccine-induced anti-GMZ2 IgG concentration. There were 32 cases of severe malaria (18 in the rabies vaccine group and 14 in the GMZ2 group), VE 27% (95% CI -44%, 63%). GMZ2 is the first blood-stage malaria vaccine to be evaluated in a large multicenter trial. GMZ2 was well tolerated and immunogenic, and reduced the incidence of malaria, but efficacy would need to be substantially improved, using a more immunogenic formulation, for the vaccine to have a public health role. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Efficacy of a Process Improvement Intervention on Inmate Awareness of HIV Services: A Multi-Site Trial.

    Science.gov (United States)

    Swan, Holly; Hiller, Matthew L; Albizu-García, Carmen E; Pich, Michele; Patterson, Yvonne; O'Connell, Daniel J

    2015-06-01

    The prevalence of HIV among U.S. inmates is much greater than in the general population, creating public health concerns and cost issues for the criminal justice system. The HIV Services and Treatment Implementation in Corrections protocol of the NIDA funded Criminal Justice Drug Abuse Treatment Studies cooperative tested the efficacy of an organizational process improvement strategy on improving HIV services in correctional facilities. For this paper, we analyzed efficacy of this strategy on improving inmate awareness and perceptions of HIV services. The study used a multi-site (n=28) clustered randomized trial approach. Facilities randomized to the experimental condition used a coach-driven local change team approach to improve HIV services at their facility. Facilities in the control condition were given a directive to improve HIV services on their own. Surveys about awareness and perceptions of HIV services were administered anonymously to inmates who were incarcerated in study facilities at baseline (n=1253) and follow-up (n=1048). A series of one-way ANOVAs were run to test whether there were differences between inmates in the experimental and control facilities at baseline and follow-up. Differences were observed at baseline, with the experimental group having significantly lower scores than the control group on key variables. But, at post-test, following the intervention, these differences were no longer significant. Taken in context of the findings from the main study, these results suggest that the change team approach to improving HIV services in correctional facilities is efficacious for improving inmates' awareness and perceptions of HIV services.

  2. Efficacy of 1.23% APF gel applications on incipient carious lesions: a double-blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Maria Laura Menezes Bonow

    2013-06-01

    Full Text Available The aim of this double-blind randomized clinical trial was to evaluate the efficacy of 1.23% APF gel application on the arrest of active incipient carious lesions in children. Sixty 7- to 12-year-old children, with active incipient lesions were included in the study. Children were divided randomly into 2 groups: 1.23% APF gel and placebo gel applications. Each group received 8 weekly applications of treatment. The lesions were re-evaluated at the 4th and 8th appointments. Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions. Groups showed similar results (PR = 1.67; CI 95% 0.69–3.98. The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline (PR = 2.67; CI 95% 1.19–6.03, but not with sugar intake (PR = 1.06; CI 95% 0.56–2.86 and previous exposure to fluoride dentifrice (PR = 1.26; CI 95% 0.49–2.29. The trial demonstrates the equivalence of the treatments. The use of the APF gel showed no additional benefits in this sample of children exposed to fluoridated water and dentifrice. The professional dental plaque removal in both groups may also account for the resulting equivalence of the treatments.

  3. Efficacy of auriculotherapy for constipation in adults: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yang, Li-Hua; Duan, Pei-Bei; Du, Shi-Zheng; Sun, Jin-Fang; Mei, Si-Juan; Wang, Xiao-Qing; Zhang, Yuan-Yuan

    2014-08-01

    To assess the clinical evidence of auriculotherapy for constipation treatment and to identify the efficacy of groups using Semen vaccariae or magnetic pellets as taped objects in managing constipation. Databases were searched, including five English-language databases (the Cochrane Library, PubMed, Embase, CINAHL, and AMED) and four Chinese medical databases. Only randomized controlled trials were included in the review process. Critical appraisal was conducted using the Cochrane risk of bias tool. Seventeen randomized, controlled trials (RCTs) met the inclusion criteria, of which 2 had low risk of bias. The primary outcome measures were the improvement rate and total effective rate. A meta-analysis of 15 RCTs showed a moderate, significant effect of auriculotherapy in managing constipation compared with controls (relative risk [RR], 2.06; 95% confidence interval [CI], 1.52- 2.79; pauriculotherapy in relieving constipation (RR, 1.28; 95% CI, 1.13-1.44; pauriculotherapy, a relatively safe strategy, is probably beneficial in managing constipation. However, most of the eligible RCTs had a high risk of bias, and all were conducted in China. No definitive conclusion can be made because of cultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

  4. Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial

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    Cherubino Di Lorenzo

    2018-02-01

    Full Text Available IntroductionDrug-resistant cluster headache (CH is still an open clinical challenge. Recently, our group observed the clinical efficacy of a ketogenic diet (KD, usually adopted to treat drug-resistant epilepsies, on migraine.AimHere, we aim to detect the effect of KD in a group of drug-resistant chronic CH (CCH patients.Materials and methodsEighteen drug-resistant CCH patients underwent a 12-week KD (Modified Atkins Diet, MAD, and the clinical response was evaluated in terms of response (≥50% attack reduction.ResultsOf the 18 CCH patients, 15 were considered responders to the diet (11 experienced a full resolution of headache, and 4 had a headache reduction of at least 50% in terms of mean monthly number of attacks during the diet. The mean monthly number of attacks for each patient at the baseline was 108.71 (SD = 81.71; at the end of the third month of diet, it was reduced to 31.44 (SD = 84.61.ConclusionWe observed for the first time that a 3-month ketogenesis ameliorates clinical features of CCH.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NCT03244735.

  5. Evaluation of efficacy of skin cleansing with chlorhexidine in prevention of neonatal nosocomial sepsis - a randomized controlled trial.

    Science.gov (United States)

    Gupta, Basudev; Vaswani, Narain Das; Sharma, Deepak; Chaudhary, Uma; Lekhwani, Seema

    2016-01-01

    The aim of this study was to evaluate the efficacy of skin cleansing with chlorhexidine (CHD) in the prevention of neonatal nosocomial sepsis - a randomized controlled trial. This study design was a randomized controlled trial carried out in a tertiary care center of north India. About 140 eligible neonates were randomly allocated to either the subject area group (wiped with CHD solution till day seven of life) or the control group (wiped with lukewarm water). The primary outcome studied was to determine the decrease in the incidence of neonatal nosocomial sepsis (blood culture proven) in the intervention group. Out of 140 enrolled neonates, 70 were allocated to each group. The ratio of positive blood culture among the CHD group was 3.57%, while the ratio of positive blood culture among the control group was 6.85%. There was trending towards a reduction in blood culture proven sepsis in the intervention group, although the remainder was not statistically significant. A similar decreasing trend was observed in rates of skin colonization, duration of hospital stay, and duration of antibiotic treatment. CHD skin cleansing decreases the incidence of blood culture sepsis and could be an easy and cheap intervention for reducing the neonatal sepsis in countries where the neonatal mortality rate is high because of sepsis.

  6. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial.

    Science.gov (United States)

    Montserrat-Bosch, Marta; Figueiredo, Rui; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-07-01

    To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries.

  7. Efficacy of an educational material on second primary cancer screening practice for cancer survivors: a randomized controlled trial.

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    Dong Wook Shin

    Full Text Available Cancer surivors have limited knowledge about second primary cancer (SPC screening and suboptimal rates of completion of screening practices for SPC. Our objective was to test the efficacy of an educational material on the knowledge, attitudes, and screening practices for SPC among cancer survivors.Randomized, controlled trial among 326 cancer survivors from 6 oncology care outpatient clinics in Korea. Patients were randomized to an intervention or an attention control group. The intervention was a photo-novel, culturally tailored to increase knowledge about SPC screening. Knowledge and attitudes regarding SPC screening were assessed two weeks after the intervention, and screening practices were assessed after one year.At two weeks post-intervention, the average knowledge score was significantly higher in the intervention compared to the control group (0.81 vs. 0.75, P<0.01, with no significant difference in their attitude scores (2.64 vs. 2.57, P = 0.18. After 1 year of follow-up, the completion rate of all appropriate cancer screening was 47.2% in both intervention and control groups.While the educational material was effective for increasing knowledge of SPC screening, it did not promote cancer screening practice among cancer survivors. More effective interventions are needed to increase SPC screening rates in this population.ClinicalTrial.gov NCT00948337.

  8. Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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    Li-Hua Yang

    2017-01-01

    Full Text Available Objectives. To identify the efficacy of auricular acupressure on pain and disability for chronic LBP by systematic review. Methods. A search of randomized controlled trials was conducted in four English medical electronic databases and three Chinese databases. Two reviewers independently retrieved related studies, assessed the methodological quality, and extracted data with a standardized data form. Meta-analyses were performed using all time-points meta-analysis. Results. A total of 7 trials met the inclusion criteria, of which 4 had the low risk of bias. The findings of this study showed that, for the immediate effect, auricular acupressure had large, significant effects in improving pain within 12 weeks. As for the follow-up effect, the pooled estimates also showed promising effect at 4-week follow-up after 4-week intervention (standardized mean difference = −1.13, 95% CI (-1.70, -0.56, P<0.001. But, for the disability level, the therapeutic effect was not significant (mean difference = −1.99, 95% CI (-4.93, 0.95, P=0.18. No serious adverse effects were recorded. Conclusions. The encouraging evidence of this study indicates that it is recommended to provide auricular acupressure to patients with chronic low back pain. However, a more accurate estimate of the effect will require further rigorously designed large-scale RCTs on chronic LBP for improving pain and disability.

  9. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial

    Science.gov (United States)

    Montserrat-Bosch, Marta; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-01-01

    Objectives: To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). Study Design: A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. Results: A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Conclusions: Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries. Key words:Dental anesthesia, inferior alveolar nerve block, lidocaine, third molar, intravascular injection. PMID:24608204

  10. Clinical efficacy of herbal coded formulation ocucure for the improvement of presbyopia: a randomized comparative clinical trial.

    Science.gov (United States)

    Khan, Muhammad Muslim; Usmanghani, Khan; Nazar, Halima; Asif, Hafiz Muhammad

    2014-03-01

    A progressively diminishing capacity of eye to visualize for close proximity increasing by age is known as presbyopia which is usually resulted due to loss of elasticity of crystalline lens. A clinical trial was conducted to evaluate the efficacy of coded herbal formulation "ocucure" (Test drug) for the treatment of presbyopia comparing with leutivit (Placebo). One hundred and eleven patients suffering from presbyopia from both groups (Males: 63, mean age: 34±14 and females: 48, mean age: 33±13 year, range: 20-60) were enrolled in the trial and divided in to two groups according to treatment regimens. Ocucure (Test drug) 500mg two tablets and leutivit (Placebo) 250mg tablets twice daily were prescribed for 6-8 weeks. Presbyopia was improved in 17 patients (28.81%) out of 59 patients by the use of ocucure (Test drug), and in 6 patients (11.53%) out of 52 by the use of leutivit (Control drug). Furthermore, there was a significant improvement in presbyopic associated clinical features as compared to leutivit. It is concluded that ocucure possesses a therapeutic value for the improvement of presbyopia and its associated symptoms as compared to leutivit.

  11. Efficacy of two soft-bristle toothbrushes in plaque removal: a randomized controlled trial

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    Cassiano Kuchenbecker ROSING

    Full Text Available Abstract The aim of this study was to compare the efficacy in supragingival plaque removal of two soft-bristle toothbrushes. Seventy volunteers were allocated randomly to the Colgate Slim Soft or Curaprox CS5460 toothbrush grourps. At baseline appointment, volunteers underwent plaque examination using the Rustogi Modification of the Navy Plaque Index. Under supervision, they then brushed their teeth for 1minute with their assigned toothbrushes and the plaque examination was repeated. Volunteers performed daily oral hygiene with their assigned toothbrush and a regular dentifrice provided by the researchers for 7 days. The baseline experimental procedures were then repeated. Separate analyses of variance were performed for the whole-mouth, interproximal, and gumline plaque scores (p < 0.05. No difference in baseline pre-brushing scores was found between groups. After a single toothbrushing, the mean plaque score was significantly reduced in both groups (p < 0.05, with greater reduction of whole-mouth and interproximal plaque scores observed in the SlimSoft group compared with the Curaprox group (p < 0.05. After 7 days, the SlimSoft group showed greater reduction of the whole-mouth and interproximal plaque scores compared with the Curaprox group (p < 0.05. In conclusion, the SlimSoft toothbrush presented greater efficacy in supragingival plaque removal than did the Curaprox CS5460 toothbrush, as reflected by whole-mouth and interproximal plaque scores.

  12. Efficacy and preference of manual toothbrushes: a randomised, single blind, controlled trial.

    Science.gov (United States)

    Nieri, Michele; Giani, Monica; Pagliaro, Umberto; Picciullo, Alessia; Franceschi, Debora; Rotundo, Roberto

    2013-01-01

    Toothbrushes are manufactured in different designs but it is unclear whether these differences may lead to improvement in the removal of bacterial plaque or make the toothbrushes more appealing to users. The aim of this study is to compare the efficacy of 11 toothbrushes in terms of plaque removal and their acceptance by patients. Eleven toothbrushes were randomly assigned to one of the 12 sectors of the mouth of 48 patients. Each patient underwent one plaque recording before and after toothbrushing. Eleven sectors of the mouth were brushed by 11 different toothbrushes, while one sector was used as a control (no toothbrushing). Two questionnaires were also administered to investigate the aesthetic and comfort preference by each participant. All 11 toothbrushes resulted in effective plaque reduction with respect to the control sector (P Colgate Massager showed the highest score for aesthetic preference by the patients when compared with Butler 311 and Gum Super Tip 463 (P = 0.0148). Oral-B Indicator 35 exhibited the highest score in terms of comfort felt by the patients compared to Colgate Omni and Gum Technique 493 (P = 0.0095). All of the tested toothbrushes, even though different with respect to shape and scope of function, demonstrated efficacious plaque removal.

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

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    Krishna Dalal

    2014-01-01

    Full Text Available 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.

  14. Percentage of subjects with no heavy drinking days: evaluation as an efficacy endpoint for alcohol clinical trials.

    Science.gov (United States)

    Falk, Daniel; Wang, Xin Qun; Liu, Lei; Fertig, Joanne; Mattson, Margaret; Ryan, Megan; Johnson, Bankole; Stout, Robert; Litten, Raye Z

    2010-12-01

    Percent subjects with no heavy drinking days (PSNHDDs), an efficacy end point recommended by the Food and Drug Administration, considers abstinent individuals or those engaging in low-risk drinking behavior as successful responders to treatment. As PSNHDD has been used infrequently in previous alcohol clinical trials, we evaluated the utility and validity of the PSNHDD outcome measure in 2 large alcohol clinical trials. Data sets from 2 alcohol trials, COMBINE and a multisite topiramate trial, were used to analyze PSNHDDs and other traditional end points for the topiramate, naltrexone, acamprosate, and placebo groups. Effect sizes of PSNHDDs were determined for each month of active treatment and by varying grace periods-early periods in the trial where outcome is not considered in the analysis-and were compared with that of other traditional outcome measures. Long-term outcomes were compared for groups that had no heavy drinking days versus those that had heavy drinking days during active treatment. PSNHDD effect sizes were significant for both topiramate (0.34 and 0.25 at months 2 and 3, respectively) and naltrexone (0.24 and 0.26 at months 3 and 4, respectively). Given a 2-month grace period for naltrexone, the effect size of PSNHDDs was comparable to the effect sizes using traditional outcome measures. With a 1-month grace period for topiramate, it was greater than the majority of traditional outcome measures. Little is gained by allowing up to 1, 2, or 3 heavy drinking days as an end point. Subjects with no HDDs during treatment fared better than those with some HDDs on drinking outcomes and alcohol-related consequences during a 1-year follow-up. PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets

  15. Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ebenfeld, Lara; Kleine Stegemann, Stefan; Lehr, Dirk; Ebert, David Daniel; Jazaieri, Hooria; van Ballegooijen, Wouter; Funk, Burkhardt; Riper, Heleen; Berking, Matthias

    2014-11-04

    Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks. A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol. To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research

  16. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Owoeye, Oluwatoyosi B A; Akinbo, Sunday R A; Tella, Bosede A; Olawale, Olajide A

    2014-05-01

    The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years) in the Premier League division were block-randomised into either an intervention (INT) or a control (CON) group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25%) of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 - 0.86; p = 0.006)] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 - 0.82; p = 0.004)]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players. Key pointsThe FIFA 11+ has only been tested in randomised controlled trials conducted on female youth football players; this study

  17. Efficacy of gemfibrozil in the primary prevention of atrial fibrillation in a large randomized controlled trial.

    Science.gov (United States)

    Adabag, A Selcuk; Mithani, Salima; Al Aloul, Basel; Collins, Dorothea; Bertog, Stefan; Bloomfield, Hanna E

    2009-05-01

    Peroxisome proliferator-activated receptor alpha (PPARalpha) activators reduce inflammation and oxidative stress. Inflammation plays an important role in the initiation and maintenance of atrial fibrillation (AF). It has been suggested that PPARalpha activators may have antiarrhythmic properties, but no clinical data exist. The objective of this study was to investigate whether the PPARalpha activator gemfibrozil prevents or delays the development of AF in patients with coronary heart disease. We retrospectively analyzed the electrocardiograms (ECGs) performed in the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial, a multicenter, randomized, double-blinded, secondary prevention trial of gemfibrozil and matching placebo. The ECGs were performed annually or biannually and when clinically indicated. Participants who were in AF on baseline ECG were excluded from the present analysis. Relative risk for AF was calculated from Cox regression with death as a competing risk factor. A total of 12,605 ECGs from 2,130 participants were interpreted (5.9 +/- 2.1 ECGs per participant, range 2-20). At baseline, the gemfibrozil (n = 1,070) and placebo (n = 1,060) groups were well matched. Mean age was 64.1 +/- 7.1 years. Over 4.4 +/- 1.5 years of follow-up, 123 (5.8%) participants developed new AF. There was no difference in AF incidence between the gemfibrozil and placebo groups (64/1,070 vs 59/1,060, respectively; P = .33). In Cox regression, the risk of AF was similar between the 2 study groups (hazard ratio 1.04, 95% CI 0.73-1.49, P = .82). In this post hoc analysis of a multicenter, double-blinded, randomized controlled trial, the PPARalpha activator gemfibrozil did not reduce the 4-year incidence of AF among men with coronary heart disease.

  18. Safety and efficacy of lorcaserin: a combined analysis of the BLOOM and BLOSSOM trials.

    Science.gov (United States)

    Aronne, Louis; Shanahan, William; Fain, Randi; Glicklich, Alan; Soliman, William; Li, Yuhan; Smith, Steven

    2014-10-01

    Lorcaserin, a novel selective 5-HT2C receptor agonist, is approved by the US Food and Drug Administration (FDA) for weight management in combination with lifestyle modification for adults with obesity and adults with overweight and ≥ 1 weight-related comorbid condition. The safety and effectiveness of lorcaserin in adult patients without type 2 diabetes mellitus was established based on 2 phase III clinical trials of similar design: Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) and Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM). This report presents a prespecified analysis of pooled data from these trials. Co-primary end points in this analysis include the proportion of patients with a reduction in baseline body weight of ≥ 5% and ≥ 10%, and a change in weight from baseline. Key secondary end points include changes from baseline values in lipid parameters, quality-of-life measures, glycemic indicators, and vital signs. At week 52, more than twice as many lorcaserin-treated patients achieved a weight loss of ≥ 5% compared with placebo (lorcaserin, 47.1%; placebo, 22.6%), and lorcaserin-treated patients lost significantly more body weight (lorcaserin, -5.8%; placebo, -2.5%). A significantly greater proportion of lorcaserin-treated patients achieved a weight loss of ≥ 10% (lorcaserin, 22.4%; placebo, 8.7%). There were statistically significant improvements in lipid parameters, glycemic indicators, quality-of-life measures, and vital signs in the lorcaserin group compared with placebo. The most common adverse events associated with lorcaserin treatment were headache, upper respiratory tract infection, and nasopharyngitis. Lorcaserin-treated patients had a rate of FDA-defined valvulopathy similar to placebo. This pooled analysis of the phase III BLOOM and BLOSSOM trials shows that lorcaserin 10 mg twice daily, in combination with diet and exercise, is safe and tolerable, and is

  19. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial.

    NARCIS (Netherlands)

    Aalderen, J.R. van; Donders, A.R.T.; Giommi, F.; Spinhoven, P.; Barendregt, H.P.; Speckens, A.E.M.

    2012-01-01

    BACKGROUND: The aim of this study is to examine the efficacy of mindfulness-based cognitive therapy (MBCT) in addition to treatment as usual (TAU) for recurrent depressive patients with and without a current depressive episode. METHOD: A randomized, controlled trial comparing MBCT+TAU (n=102) with

  20. The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single-blinded multicentre randomised controlled trial

    NARCIS (Netherlands)

    Bus, Sicco A.; van Netten, Jaap J.; Kottink, Anke Ir; Manning, Erik A.; Spraul, Maximilian; Woittiez, Arend-Jan; van Baal, Jeff G.

    2018-01-01

    Non-removable offloading is the 'gold standard' treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common 'standard of care'. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60

  1. The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

    Science.gov (United States)

    Kroeze, Willemieke; Oenema, Anke; Campbell, Marci; Brug, Johannes

    2008-01-01

    Objective: To test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction. Design: A 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam.…

  2. One-Year Efficacy Testing of Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) Randomized Control Trial

    Science.gov (United States)

    Knowlden, Adam; Sharma, Manoj

    2016-01-01

    Background: The purpose of this study was to evaluate the efficacy of the Enabling Mothers to Prevent Pediatric Obesity through Web-Based Education and Reciprocal Determinism (EMPOWER) intervention at 1-year, postintervention follow-up. Method: A mixed between-within subjects design was used to evaluate the trial. Independent variables included a…

  3. Safety and Efficacy of Gliclazide as Treatment for Type 2 Diabetes : A Systematic Review and Meta-Analysis of Randomized Trials

    NARCIS (Netherlands)

    Landman, Gijs W D; de Bock, Geertruide H; van Hateren, Kornelis J J; van Dijk, Peter R; Groenier, Klaas H; Gans, Rijk O B; Houweling, Sebastiaan T; Bilo, Henk J G; Kleefstra, Nanne

    2014-01-01

    Objective and Design: Gliclazide has been associated with a low risk of hypoglycemic episodes and beneficial long-term cardiovascular safety in observational cohorts. The aim of this study was to assess in a systematic review and meta-analysis of randomized controlled trials the safety and efficacy

  4. Similar efficacy and safety of initial COBRA-light and COBRA therapy in rheumatoid arthritis: 4-year results from the COBRA-light trial

    NARCIS (Netherlands)

    Konijn, Nicole P. C.; van Tuyl, Lilian H. D.; Boers, Maarten; den Uyl, Debby; ter Wee, Marieke M.; van der Wijden, Lindsey K. M.; Bultink, Irene E. M.; Kerstens, Pit J. S. M.; Voskuyl, Alexandre E.; van Schaardenburg, Dirkjan; Nurmohamed, Michael T.; Lems, Willem F.

    2017-01-01

    To assess the efficacy and safety of initial COBRA-light vs COBRA therapy in RA patients after a 4-year follow-up period. In the COBRA-light trial, 162 consecutive patients with recent-onset RA were randomized to either COBRA-light (prednisolone and MTX) or COBRA therapy (prednisolone, MTX and SSZ)

  5. Efficacy of a Cream Containing Ceramides and Magnesium in the Treatment of Mild to Moderate Atopic Dermatitis: A Randomized, Double-blind, Emollient- and Hydrocortisone-controlled Trial

    NARCIS (Netherlands)

    Koppes, Sjors A.; Charles, Frank; Lammers, Laureen; Frings-Dresen, Monique; Kezic, Sanja; Rustemeyer, Thomas

    2016-01-01

    The aim of this randomized controlled trial was to assess the efficacy of a cream containing ceramides and magnesium (Cer-Mg) in the treatment of mild to moderate atopic dermatitis and to compare it with hydrocortisone and a commonly used emollient (unguentum leniens; cold cream). A total of 100

  6. Long-term analysis of the efficacy and tolerability of sorafenib in advanced radio-iodine refractory differentiated thyroid carcinoma: final results of a phase II trial

    NARCIS (Netherlands)

    Schneider, T.C.; Abdulrahman, R.M.; Corssmit, E.P.; Morreau, H.; Smit, J.W.A.; Kapiteijn, E.

    2012-01-01

    OBJECTIVE: We conducted a prospective phase II clinical trial to determine the efficacy of sorafenib in patients with advanced radio-iodine refractory differentiated thyroid cancer. In this article, the long-term results are presented. PATIENTS AND METHODS: Thirty-one patients with progressive

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...

  8. Randomized double-blind controlled Phase I/IIa trial to assess the efficacy of malaria vaccine PfCS102 to protect against challenge with P. falciparum.

    NARCIS (Netherlands)

    Genton, B.; D'Acremont, V.; Lurati-Ruiz, F.; Verhage, D.F.; Audran, R.; Hermsen, C.C.; Wolters, L.; Reymond, C.; Spertini, F.; Sauerwein, R.W.

    2010-01-01

    The aim of this Phase I/IIa double-blind controlled trial was to test the efficacy of the sporozoite-based malaria vaccine PfCS 282-383 (PfCS102) to protect against Plasmodium falciparum parasitaemia. 16 volunteers were randomized to receive twice 30 mug of PfCS102 formulated in Montanide ISA 720 or

  9. A cluster randomised controlled trial on the efficacy of client-centred occupational therapy in multiple sclerosis: good process, poor outcome

    NARCIS (Netherlands)

    Eijssen, I.C.J.M.; Steultjens, M.P.M.; de Groot, V.; Steultjens, E.M.J.; Knol, D.L.; Polman, C.H.; Dekker, J.

    2013-01-01

    Purpose: To assess the efficacy of client-centred occupational therapy (OT) according to a client-centred process framework, as compared to usual care OT, in patients with multiple sclerosis (MS). Method: A multicentre cluster randomised controlled trial with the institution (i.e. hospital or

  10. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Johannsen, Maja; O Connor, Maja; OToole, Mia Skytte

    2016-01-01

    PURPOSE: To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. METHODS: A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3...

  11. Efficacy of Cognitive Behavioral Therapy for insomnia in adolescents: A randomized controlled trial with internet therapy, group therapy and a waiting list condition

    NARCIS (Netherlands)

    de Bruin, E.J.; Bögels, S.M.; Oort, F.J.; Meijer, A.M.

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment

  12. Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial.

    NARCIS (Netherlands)

    Smulders, E.; Weerdesteijn, V.G.M.; Groen, B.E.; Duysens, J.E.J.; Eijsbouts, A.; Laan, R.F.J.M.; Lankveld, W.G.J.M. van

    2010-01-01

    OBJECTIVE: To evaluate the efficacy of the Nijmegen Falls Prevention Program (NFPP) for persons with osteoporosis and a fall history in a randomized controlled trial. Persons with osteoporosis are at risk for fall-related fractures because of decreased bone strength. A decrease in the number of

  13. Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design

    Directory of Open Access Journals (Sweden)

    Hinman Rana S

    2012-09-01

    Full Text Available Abstract Background Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain. Methods/Design Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group and received no acupuncture treatment. The other three were treatment groups: i laser acupuncture, ii sham laser or, iii needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8–12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS and self-reported physical function measured by the Western Ontario and McMaster (WOMAC Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale and physical function (NRS. Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12

  14. Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial.

    Directory of Open Access Journals (Sweden)

    Leonore Lovis

    Full Text Available BACKGROUND: Schistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ is the drug of choice for morbidity control but few dose comparisons have been made. METHODOLOGY: Ninety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz before and 28-30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45 or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45. Adverse events were assessed at 3 and 24 hours posttreatment. PRINCIPAL FINDINGS: Baseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI: 56.6-88.5% and 80.8% (95% CI: 60.6-93.4% for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60. O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4-84.4% and 96.6% (95% CI: not defined, respectively (P = 0.009. Egg reduction rates (ERRs against O. viverrini were very high for both doses (>99%, but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1% and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment. Adverse events were common (96%, mainly mild with no significant differences between the two treatment groups. CONCLUSIONS/SIGNIFICANCE: Cure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses. TRIAL REGISTRATION: Controlled-Trials

  15. Efficacy and safety of puerarin injection in curing acute ischemic stroke: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zheng, Qing-Hua; Li, Xiao-Li; Mei, Zhi-Gang; Xiong, Li; Mei, Qing-Xian; Wang, Jin-Feng; Tan, Ling-Jing; Yang, Song-Bai; Feng, Zhi-Tao

    2017-01-01

    Previous studies indicated that the puerarin injection has been widely employed in China for the treatment of acute ischemic stroke. We aim to evaluate the efficacy and safety of the puerarin injection for the treatment of acute ischemic stroke. A systematic literature search was performed in PUBMED, EMBASE, SPRINGER LINK, Scopus, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Journals Database, Wanfang database and the China Biological Medicine database before November 2016, randomized controlled clinical trials (RCTs) of puerarin injection treating acute ischemic stroke were included. In addition, we searched reference lists of relevant retrieved articles. Two authors extracted data independently. The effective rate, the neurologic deficit score, the blood rheology indexes, and fibrinogen were assessed and analyzed by the Review Manager 5.3 software. The continuous variables were expressed as MD with 95% CI and dichotomous data used RR or ORs. Adverse reactions related to the puerarin injection were also examined. Thirty-five RCTs with a total of 3224 participants were identified in the meta-analysis. The combined results of 32 trials indicated that the puerarin injection was better than control drugs at the clinical effective rate (RR 1.22, 95% CI 1.17 to 1.28, P < 0.001) and 16 studies showed the neurological deficit was significantly improved (MD -3.69, 95% CI -4.67 to -2.71, P < 0.001); the hemorheology index and fibrinogen were much lower with the puerarin injection when compared with western conventional medicines (WCM) or other control drugs (the whole blood viscosity: MD -0.89, 95% CI -1.37 to -0.41, P < 0.001; the HCT: MD -0.04, 95% CI -0.06 to -0.02, P < 0.001; the fibrinogen: MD -0.64, 95% CI -0.96 to -0.31, P < 0.001). Eleven trials reported that the adverse reactions related to the puerarin injection included facial flushing, dizziness, vomiting, nausea, and other mild gastrointestinal discomfort and

  16. Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Szakacs, Zoltan; Dauvilliers, Yves; Mikhaylov, Vladimir; Poverennova, Irina; Krylov, Sergei; Jankovic, Slavko; Sonka, Karel; Lehert, Philippe; Lecomte, Isabelle; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

    2017-03-01

    Histaminergic neurons are crucial to maintain wakefulness, but their role in cataplexy is unknown. We assessed the safety and efficacy of pitolisant, a histamine H3 receptor inverse agonist, for treatment of cataplexy in patients with narcolepsy. For this randomised, double-blind, placebo-controlled trial we recruited patients with narcolepsy from 16 sleep centres in nine countries (Bulgaria, Czech Republic, Hungary, Macedonia, Poland, Russia, Serbia, Turkey, and Ukraine). Patients were eligible if they were aged 18 years or older, diagnosed with narcolepsy with cataplexy according to version two of the International Classification of Sleep Disorders criteria, experienced at least three cataplexies per week, and had excessive daytime sleepiness (defined as an Epworth Sleepiness Scale score ≥12). We used a computer-generated sequence via an interactive web response system to randomly assign patients to receive either pitolisant or placebo once per day (1:1 ratio). Randomisation was done in blocks of four. Participants and investigators were masked to treatment allocation. Treatment lasted for 7 weeks: 3 weeks of flexible dosing decided by investigators according to efficacy and tolerance (5 mg, 10 mg, or 20 mg oral pitolisant), followed by 4 weeks of stable dosing (5 mg, 10 mg, 20 mg, or 40 mg). The primary endpoint was the change in the average number of cataplexy attacks per week as recorded in patient diaries (weekly cataplexy rate [WCR]) between the 2 weeks of baseline and the 4 weeks of stable dosing period. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01800045. The trial was done between April 19, 2013, and Jan 28, 2015. We screened 117 patients, 106 of whom were randomly assigned to treatment (54 to pitolisant and 52 to placebo) and, after dropout, 54 patients from the pitolisant group and 51 from the placebo group were included in the intention-to-treat analysis. The WCR during the stable dosing period

  17. Efficacy of a Text Message-Based Smoking Cessation Intervention for Young People: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Schaub, Michael P; Venzin, Vigeli; Meyer, Christian; John, Ulrich

    2013-01-01

    Background Smoking prevalence remains high, particularly among adolescents and young adults with lower educational levels, posing a serious public health problem. There is limited evidence of effective smoking cessation interventions in this population. Objective To test the efficacy of an individually tailored, fully automated text messaging (short message service, SMS)–based intervention for smoking cessation in young people. Methods A 2-arm cluster randomized controlled trial, using school class as the randomization unit, was conducted to test the efficacy of the SMS text messaging intervention compared to an assessment-only control group. Students who smoked were proactively recruited via online screening in vocational school classes. Text messages, tailored to demographic and smoking-related variables, were sent to the participants of the intervention group at least 3 times per week over a period of 3 months. A follow-up assessment was performed 6 months after study inclusion. The primary outcome measure was 7-day smoking abstinence. Secondary outcomes were 4-week smoking abstinence, cigarette consumption, stage of change, and attempts to quit smoking. We used regression models controlling for baseline differences between the study groups to test the efficacy of the intervention. Both complete-case analyses (CCA) and intention-to-treat analyses (ITT) were performed. Subgroup analyses were conducted for occasional and daily smokers. Results A total of 2638 students in 178 vocational school classes in Switzerland participated in the online screening. Overall, 1012 persons met the inclusion criteria for study participation, and 755 persons (74.6%) participated in the study (intervention: n=372; control: n=383). Of the 372 program participants, 9 (2.4%) unsubscribed from the program during the intervention period. Six-month follow-up data were obtained for 559 study participants (74.0%). The 7-day smoking abstinence rate at follow-up was 12.5% in the

  18. Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome - a double blind randomized controlled trial - TAK-MetS trial.

    Science.gov (United States)

    Amin, F; Islam, N; Anila, Nfn; Gilani, A H

    2015-04-01

    To compare the clinical efficacy of Black seeds and Turmeric alone and its co-administration in lower doses among patients with metabolic syndrome (MetS). Double-blind-randomized-controlled trial. Hijrat colony, Karachi, Pakistan. Apparently healthy males (n=250), who screened positive for MetS, were randomized to either Black seeds (1.5g/day), Turmeric (2.4g/day), its combination (900mg Black seeds and 1.5g Turmeric/day) or placebo for 8 weeks. body-mass-index (BMI), body-fat-percent (BF%), waist-circumference (WC), hip-circumference (HC), blood pressure (BP), lipid-profile (cholesterol, HDL-cholesterol, LDL-cholesterol and TG), fasting blood glucose (FBG) and c-reactive protein (CRP). At 4 weeks, compared to baseline, Black seed and Turmeric alone showed improvement in BMI, WC and BF%. Combination improved all parameters except HDL-cholesterol with lower FBG and LDL-cholesterol as compared to placebo. At 8 weeks, compared to placebo, Black seeds reduced lipids and FBG, while Turmeric reduced LDL-cholesterol and CRP. Interestingly, combination group with 60% dose of the individual herbs showed an improvement in all parameters from baseline. When compared to placebo, it reduced BF%, FBG, cholesterol, TG, LDL-cholesterol, CRP and raised HDL-cholesterol. Turmeric and Black seeds showed improvement in all parameters of metabolic syndrome, when co-administered at 60% of doses of individual herbs with enhanced efficacy and negligible adverse-effects. The combination of Black seeds and Turmeric can therefore, be recommended with lifestyle modification as a starting point for patients with MetS to halt its future complications and progression. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. The efficacy of auriculotherapy for smoking cessation: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Fritz, Deborah J; Carney, Robert M; Steinmeyer, Brian; Ditson, Gary; Hill, Nina; Zee-Cheng, Joyce

    2013-01-01

    Quitting smoking remains a challenge for almost one-third of the military veteran population. Alternatives to pharmacological therapies such as acupuncture, acupressure, and electrical stimulation have received minimal attention in research but have been widely reported to be popular and safe interventions for smoking cessation. This randomized, double-blind, placebo-controlled clinical trial of 125 veterans was conducted to determine whether aural electrical stimulation (auriculotherapy) once a week for 5 consecutive weeks is associated with a higher rate of smoking abstinence are than observed with sham stimulation. Auriculotherapy was found to be safe and largely free from significant side effects. However, there was no difference in the rate of smoking cessation between those participants who received true auriculotherapy and those who received sham auriculotherapy. The auriculotherapy group achieved a rate of 20.9% abstinence versus 17.9% for the placebo arm after 6 weeks. The results of this randomized, controlled clinical trial do not support the use of auriculotherapy to assist with smoking cessation. It is possible that a longer treatment duration, more frequent sessions, or other modifications of the intervention protocol used in this study may result in a different outcome. However, based on the results of this study, there is no evidence that auriculotherapy is superior to placebo when offered once a week for 5 weeks, as described in previous uncontrolled studies.

  20. Efficacy of docosahexaenoic acid-choline-vitamin E in paediatric NASH: a randomized controlled clinical trial.

    Science.gov (United States)

    Zöhrer, Evelyn; Alisi, Anna; Jahnel, Jörg; Mosca, Antonella; Della Corte, Claudia; Crudele, Annalisa; Fauler, Günter; Nobili, Valerio

    2017-09-01

    Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease, is one of the most common hepatic diseases in children. We conducted a randomized controlled clinical trial on children with biopsy-proven NASH based on a combinatorial nutritional approach compared with placebo. Participants were assigned to lifestyle modification plus placebo or lifestyle modification plus a mix containing docosahexaenoic acid, choline, and vitamin E (DHA-CHO-VE). Forty children and adolescents participated in the entire trial. The primary outcome was the improvement of liver hyperechogenicity. Secondary outcomes included alterations of alanine aminotransferase (ALT) and other metabolic parameters. Furthermore, changes of serum bile acids (BA) and plasma fibroblast growth factor 19 (FGF19) levels were evaluated as inverse biomarkers of disease severity. At the end of the study, we observed a significant decrease in severe steatosis in the treatment group (50% to 5%, p = 0.001). Furthermore, although the anthropometric and biochemical measurements in the placebo and DHA-CHO-VE groups were comparable at baseline, at the end of the study ALT and fasting glucose levels improved only in the treatment group. Finally, we found that BA levels were not influenced whereas FGF19 levels were significantly increased by DHA-CHO-VE. The results suggest that a combination of DHA, VE, and CHO could improve steatosis and reduce ALT and glucose levels in children with NASH. However, further studies are needed to assess the impact of a DHA and VE combination on repair of liver damage in paediatric NASH.

  1. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial.

    Science.gov (United States)

    Kurebayashi, Leonice Fumiko Sato; Silva, Maria Júlia Paes da

    2014-01-01

    this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff. a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58), Group with protocol (58), Group with no protocol (59). They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days). in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (pauriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835.

  2. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Leonice Fumiko Sato Kurebayashi

    2014-06-01

    Full Text Available OBJECTIVE: this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff.METHOD: a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58, Group with protocol (58, Group with no protocol (59. They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days.RESULTS: in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (p<0.05 with greater size of effect indices (Cohen for the No protocol group. The Yang Liver 1 and 2, Kidney, Brain Stem and Shen Men were the points most used.CONCLUSION: individualized auriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835

  3. Cardioversion Efficacy Using Pulsed Biphasic or Biphasic Truncated Exponential Waveforms: A Randomized Clinical Trial.

    Science.gov (United States)

    Schmidt, Anders S; Lauridsen, Kasper G; Adelborg, Kasper; Torp, Peter; Bach, Leif F; Jepsen, Simon M; Hornung, Nete; Deakin, Charles D; Rickers, Hans; Løfgren, Bo

    2017-03-08

    Several different defibrillators are currently used for cardioversion and defibrillation of cardiac arrhythmias. The efficacy of a novel pulsed biphasic (PB) waveform has not been compared to other biphasic waveforms. Accordingly, this study aims to compare the efficacy and safety of PB shocks with biphasic truncated exponential (BTE) shocks in patients undergoing cardioversion of atrial fibrillation or -flutter. This prospective, randomized study included patients admitted for elective direct current cardioversion. Patients were randomized to receive cardioversion using either PB or BTE shocks. We used escalating shocks until sinus rhythm was obtained or to a maximum of 4 shocks. Patients randomized to PB shocks received 90, 120, 150, and 200 J and patients randomized to BTE shocks received 100, 150, 200, and 250 J, as recommended by the manufacturers. In total, 69 patients (51%) received PB shocks and 65 patients (49%) BTE shocks. Successful cardioversion, defined as sinus rhythm 4 hours after cardioversion, was achieved in 43 patients (62%) using PB shocks and in 56 patients (86%) using BTE shocks; ratio 1.4 (95% CI 1.1-1.7) (P=0.002). There was no difference in safety (ie, myocardial injury judged by changes in high-sensitive troponin I levels; ratio 1.1) (95% CI 1.0-1.3), P=0.15. The study was terminated prematurely because of an adverse event. Cardioversion using a BTE waveform was more effective when compared with a PB waveform. There was no difference in safety between the 2 waveforms, as judged by changes in troponin I levels. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02317029. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  4. The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2015-08-01

    Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

  5. Sixty Years of Placebo-Controlled Antipsychotic Drug Trials in Acute Schizophrenia: Systematic Review, Bayesian Meta-Analysis, and Meta-Regression of Efficacy Predictors.

    Science.gov (United States)

    Leucht, Stefan; Leucht, Claudia; Huhn, Maximilian; Chaimani, Anna; Mavridis, Dimitris; Helfer, Bartosz; Samara, Myrto; Rabaioli, Matteo; Bächer, Susanne; Cipriani, Andrea; Geddes, John R; Salanti, Georgia; Davis, John M

    2017-10-01

    Antipsychotic drug efficacy may have decreased over recent decades. The authors present a meta-analysis of all placebo-controlled trials in patients with acute exacerbations of schizophrenia, and they investigate which trial characteristics have changed over the years and which are moderators of drug-placebo efficacy differences. The search included multiple electronic databases. The outcomes were overall efficacy (primary outcome); responder and dropout rates; positive, negative, and depressive symptoms; quality of life; functioning; and major side effects. Potential moderators of efficacy were analyzed by meta-regression. The analysis included 167 double-blind randomized controlled trials with 28,102 mainly chronic participants. The standardized mean difference (SMD) for overall efficacy was 0.47 (95% credible interval 0.42, 0.51), but accounting for small-trial effects and publication bias reduced the SMD to 0.38. At least a "minimal" response occurred in 51% of the antipsychotic group versus 30% in the placebo group, and 23% versus 14% had a "good" response. Positive symptoms (SMD 0.45) improved more than negative symptoms (SMD 0.35) and depression (SMD 0.27). Quality of life (SMD 0.35) and functioning (SMD 0.34) improved even in the short term. Antipsychotics differed substantially in side effects. Of the response predictors analyzed, 16 trial characteristics changed over the decades. However, in a multivariable meta-regression, only industry sponsorship and increasing placebo response were significant moderators of effect sizes. Drug response remained stable over time. Approximately twice as many patients improved with antipsychotics as with placebo, but only a minority experienced a good response. Effect sizes were reduced by industry sponsorship and increasing placebo response, not decreasing drug response. Drug development may benefit from smaller samples but better-selected patients.

  6. The efficacy of systemic therapy for internalizing and other disorders of childhood and adolescence: a systematic review of 38 randomized trials.

    Science.gov (United States)

    Retzlaff, Ruediger; von Sydow, Kirsten; Beher, Stefan; Haun, Markus W; Schweitzer, Jochen

    2013-12-01

    Systemic therapy (ST) is one of the most widely applied psychotherapeutic approaches in the treatment of children and adolescents, yet few systematic reviews exist on the efficacy of ST with this age group. Parallel to a similar study on adults, a systematic review was performed to analyze the efficacy of ST in the treatment of children and adolescents. All randomized or matched controlled trials (RCT) evaluating ST in any setting with child and adolescent index patients were identified by database searches and cross-references, as well as in existing meta-analyses and reviews. Inclusion criteria were: index patient diagnosed with a DSM-IV or ICD-10 listed psychological disorder, or suffering from other clinically relevant conditions, and trial published by December 2011. Studies were analyzed according to their sample, research methodology, interventions applied, and results at end-of-treatment and at follow-up. This article presents findings for internalizing and mixed disorders. Thirty-eight trials were identified, with 33 showing ST to be efficacious for the treatment of internalizing disorders (including mood disorders, eating disorders, and psychological factors in somatic illness). There is some evidence for ST being also efficacious in mixed disorders, anxiety disorders, Asperger disorder, and in cases of child neglect. Results were stable across follow-up periods of up to 5 years. Trials on the efficacy of ST for externalizing disorders are presented in a second article. There is a sound evidence base for the efficacy of ST as a treatment for internalizing disorders of child and adolescent patients. © FPI, Inc.

  7. Evaluation of a theory-based intervention aimed at reducing intention to use restrictive dietary behaviors among adolescent female athletes

    OpenAIRE

    Laramée, Catherine; Drapeau, Vicky; Valois, Pierre; Goulet, Claude; Jacob, Raphaëlle; Provencher, Véronique; Lamarche, Benoît

    2017-01-01

    Objective: To evaluate the effectiveness of a theory-based intervention to reduce the intention to use restrictive dietary behaviors for losing weight among adolescent female athletes involved in aesthetic sports. Design: Cluster randomized controlled trial. Setting: Aesthetic sport teams of adolescent (age 12-17) female athletes. Participants: Two teams (n=37 athletes) in the intervention group and 3 teams (n=33) in the comparison group. Interventions: The 2 groups received nu...

  8. Combination therapy containing ritonavir plus saquinavir has superior short-term antiretroviral efficacy: a randomized trial

    DEFF Research Database (Denmark)

    Kirk, O; Katzenstein, T L; Gerstoft, J

    1999-01-01

    trial. Two hundred and eighty-four patients started randomized treatment. The primary end-point was the proportion of patients with HIV RNA of 200 copies/ml or less (Roche Amplicor) and HIV RNA of 20 copies/ml or less (Roche ultradirect assay) at 6 months. Analysis was performed as intent......-to-treat, and missing values were accounted for as failures. RESULTS: As of 1 May 1998, 269 patients should have completed 24 weeks of treatment. The proportion of patients with HIV RNA of 200 copies/ml or less was 71% (indinavir), 67% (ritonavir), and 82% (ritonavir + saquinavir), P = 0.07. In antiretroviral drug......-naive patients (n = 119), the corresponding figures were 63, 57, and 89% (P RNA of 200 copies/ml or less (P = 0.90). The same pattern was observed in the ultradirect analysis. All three regimens were generally safe...

  9. Efficacy of dioctahedral smectite in acute watery diarrhea in Indian children: a randomized clinical trial.

    Science.gov (United States)

    Mujawar, Quais Mohammad; Naganoor, Ravi; Ali, Mir Dilshad; Malagi, Naushad; Thobbi, Achyut Narayan

    2012-02-01

    To determine the effects and safety of dioctahedral smectite (DS) on the duration of acute watery diarrhea in children. A Randomized, open labeled, clinical controlled trial in a tertiary care hospital outpatient department (OPD) and emergency department. Participants were one hundred and seventeen children without any chronic illness between 2 and 5 years presenting to OPD, having acute watery diarrhea for diarrhea in children aged 2-5 years. There were no adverse effects on the use of DS. DS was acceptable to the children, and its administration was not accompanied with any side effects. DS reduces the duration of diarrhea in Indian children and prevents a prolonged course, and therefore, may consistently reduce the costs in treatment of acute watery diarrhea.

  10. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders.

    Science.gov (United States)

    Humaidan, P; Chin, W; Rogoff, D; D'Hooghe, T; Longobardi, S; Hubbard, J; Schertz, J

    2017-03-01

    How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH (follitropin alfa plus lutropin alfa; r-hFSH/r-hLH) compare with that of r-hFSH monotherapy for controlled ovarian stimulation (COS) in patients with poor ovarian response (POR)? The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable. Although meta-analyses of clinical trials have suggested some beneficial effect on reproductive outcomes with r-hLH supplementation in patients with POR, the definitions of POR were heterogeneous and limit the comparability across studies. Phase III, single-blind, active-comparator, randomized, parallel-group clinical trial. Patients were followed for a single ART cycle. A total of 939 women were randomized (1:1) to receive either r-hFSH/r-hLH or r-hFSH. Randomization, stratified by study site and participant age, was conducted via an interactive voice response system. Women classified as having POR, based on criteria incorporating the ESHRE Bologna criteria, were down-regulated with a long GnRH agonist protocol and following successful down-regulation were randomized (1:1) to COS with r-hFSH/r-hLH or r-hFSH alone. The primary efficacy endpoint was the number of oocytes retrieved following COS. Safety endpoints included the incidence of adverse events, including ovarian hyperstimulation syndrome (OHSS). Post hoc analyses investigated safety outcomes and correlations between live birth and baseline characteristics (age and number of oocytes retrieved in previous ART treatment cycles or serum anti-Müllerian hormone (AMH)). The significance of the treatment effect was tested by generalized linear models (Poisson regression for counts and logistic regression for binary endpoints) adjusting for age and country. Of 949 subjects achieving down-regulation, 939 were randomized to r-hFSH/r-hLH (n = 477) or r-hFSH (n = 462) and received

  11. Does participation in an HIV vaccine efficacy trial affect risk behaviour in South Africa?

    Science.gov (United States)

    Gray, G E; Metch, B; Churchyard, G; Mlisana, K; Nchabeleng, M; Allen, M; Moodie, Z; Kublin, J; Bekker, L-G

    2013-04-12

    Increased sexual risk behaviour in participants enrolled in HIV prevention trials has been a concern. The HVTN 503/Phambili study, a phase 2B study of the Merck Ad-5 multiclade HIV vaccine in South Africa, suspended enrollment and vaccinations following the results of the Step study. Participants were notified of their treatment allocation and continue to be followed. We investigated changes in risk behaviour over time and assessed the impact of study unblinding. 801 participants were enrolled. Risk behaviours were assessed with an interviewer-administered questionnaire at 6-month intervals. We assessed change from enrolment to the first 6-month assessment pre-unblinding and between enrolment and at least 6 months post-unblinding on all participants with comparable data. A one-time unblinding risk perception questionnaire was administered post-unblinding. A decrease in participants reporting unprotected sex was observed in both measured time periods for men and women, with no differences by treatment arm. At 6 months (pre-unblinding), 29.6% of men and 35.8% of women reported changing from unprotected to protected sex (p<0.0001 for each). Men (22%) were more likely than women (14%) to report behaviour change after unblinding (p=0.009). Post-enrolment, 142 (45%) of 313 previously uncircumcised men underwent medical circumcision. 663 participants completed the unblinding questionnaire. More vaccine (24.6%) as compared to placebo recipients (12.0%) agreed that they were more likely to get HIV than most people (p<0.0001), and attributed this to receiving the vaccine. We did not find evidence of risk compensation during this clinical trial. Some risk behaviour reductions including male circumcision were noted irrespective of treatment allocation. Copyright © 2013. Published by Elsevier Ltd.

  12. Efficacy and tolerability of biologic and nonbiologic systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Schmitt, J; Zhang, Z; Wozel, G; Meurer, M; Kirch, W

    2008-09-01

    The comparative efficacy and tolerability of conventional and biologic treatments for moderate-to-severe plaque psoriasis are unknown. To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) reporting efficacy of systemic treatments approved for moderate-to-severe psoriasis by means of the Psoriasis Area and Severity Index (PASI). We identified relevant articles by systematic electronic searches (Cochrane Library, Medline, Embase, Scopus). Efficacy was defined as proportion of participants with >or= 75% decrease in PASI (PASI-75) at primary efficacy measurement (week 8-16). PASI-75 response rates of double-blind placebo-controlled trials were summarized as risk differences (RDs) and pooled using random effects models. Tolerability was assessed from rates of withdrawals and adverse events. Twenty-four RCTs totalling 9384 patients were analysed qualitatively. Sixteen double-blind placebo-controlled trials were eligible for meta-analysis. Infliximab was significantly superior to all other interventions [RD 77%, 95% confidence interval (CI) 72-81%]. Adalimumab (RD 64%, 95% CI 61-68%) was superior to ciclosporin (RD 33%, 95% CI 13-52%), efalizumab (RD 24%, 95% CI 19-30%), etanercept 50 mg twice weekly (RD 44%, 95% CI 40-48%) and etanercept 25 mg twice weekly (RD 30%, 95% CI 25-35%). Efalizumab was significantly less efficacious than fumaric acid esters (RD 48%, 95% CI 32-64%). Rates of withdrawals due to adverse events were highest for methotrexate and fumaric acid esters. The efficacy of systemic agents approved for moderate-to-severe psoriasis differs considerably both within and between biologics and nonbiologics. Infliximab is most efficacious, followed by adalimumab. Patients receiving infliximab have an excess chance of 77% over placebo to achieve PASI-75 response. Published evidence questions regulatory guidelines that recommend biologics as second-line therapy for moderate-to-severe plaque psoriasis.

  13. Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial

    Directory of Open Access Journals (Sweden)

    Catley Delwyn

    2012-06-01

    autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation. Discussion This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline. Trial registration ClinicalTrials.gov NCT01188018

  14. Managing for resilience: an information theory-based ...

    Science.gov (United States)

    Ecosystems are complex and multivariate; hence, methods to assess the dynamics of ecosystems should have the capacity to evaluate multiple indicators simultaneously. Most research on identifying leading indicators of regime shifts has focused on univariate methods and simple models which have limited utility when evaluating real ecosystems, particularly because drivers are often unknown. We discuss some common univariate and multivariate approaches for detecting critical transitions in ecosystems and demonstrate their capabilities via case studies. Synthesis and applications. We illustrate the utility of an information theory-based index for assessing ecosystem dynamics. Trends in this index also provide a sentinel of both abrupt and gradual transitions in ecosystems. In response to the need to identify leading indicators of regime shifts in ecosystems, our research compares traditional indicators and Fisher information, an information theory based method, by examining four case study systems. Results demonstrate the utility of methods and offers great promise for quantifying and managing for resilience.

  15. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses.

    Science.gov (United States)

    Chinea Martinez, Angel R; Correale, Jorge; Coyle, Patricia K; Meng, Xiangyi; Tenenbaum, Nadia

    2014-10-01

    The disease characteristics of multiple sclerosis (MS) appear to differ between Hispanic and Caucasian patients, with Hispanic patients having a younger age at onset, and a higher prevalence of optic nerve and spinal cord involvement. Fingolimod, the first-in-class oral sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS, has been shown to significantly reduce annualized relapse rates (ARRs), lesion-based magnetic resonance imaging (MRI) activity, confirmed disability, and brain volume loss, compared with placebo or intramuscular interferon beta-1a (IFNβ-1a IM) in randomized, double-blind, controlled clinical studies. Here, the efficacy and safety profile of fingolimod in Hispanic patients was compared to that observed in the overall study populations. This was a post hoc analysis of relapses and safety data for Hispanic patients with relapsing-remitting MS (RRMS) randomized to receive daily fingolimod 0.5 mg, weekly IFNβ-1a IM (30 mg) or placebo, in the phase 3, controlled FREEDOMS, FREEDOMS II, and TRANSFORMS fingolimod studies. The ARR was estimated for each treatment group; only relapses that were confirmed by an independent examining neurologist were included in these analyses. Safety assessments included the incidence of adverse events and serious adverse events. Eligible Hispanic patients aged 18-55 years (n=181) had been treated as follows: fingolimod 0.5 mg (n=89), IFNβ-1a IM (n=65), and placebo (n=27). Hispanic patients treated with fingolimod for up to 2 years had lower ARRs (ARR: 0.22, 95% confidence interval [CI]: 0.14-0.35) than those receiving placebo (ARR: 0.46, 95% CI: 0.24-0.88) or IFNβ-1a IM (ARR: 0.34, 95% CI: 0.18-0.63), with relative reductions of 52% and 35%, respectively. A transient decrease in heart rate that started to attenuate 6 h after fingolimod administration was observed, consistent with the well-characterized pharmacologic effect following fingolimod treatment initiation. No cases of

  16. Randomised controlled trial of school-based humanistic counselling for emotional distress in young people: Feasibility study and preliminary indications of efficacy

    Science.gov (United States)

    2010-01-01

    Aims The purpose of this study was to test the feasibility of a randomised controlled trial comparing six weeks of humanistic school-based counselling versus waiting list in the reduction of emotional distress in young people, and to obtain initial indications of efficacy. Methods Following a screening procedure, young people (13 - 15 years old) who experienced emotional distress were randomised to either humanistic counselling or waiting list in this multi-site study. Outcomes were assessed using a range of self-report mental health measures, with the emotional symptoms subscale of the Strengths and Difficulties Questionnaire (SDQ) acting as the primary outcome indicator. Results Recruitment procedures were successful, with 32 young people consenting to participate in the trial and 27 completing endpoint measures. Trial procedures were acceptable to all involved in the research. No significant differences were found between the counselling and waiting list groups in reductions in levels of emotional symptoms (Hedges' g = 0.03), but clients allocated to counselling showed significantly greater improvement in prosocial behaviour (g = 0.89) with an average effect size (g) across the nine outcome measures of 0.25. Participants with higher levels of depressive symptoms showed significantly greater change. Conclusion This study suggested that a randomised controlled trial of counselling in schools is acceptable and feasible, although initial indications of efficacy are mixed. Trial registration Current Controlled Trials ISRCTN68290510. PMID:20412578

  17. Randomized control trial investigating the efficacy of a computer-based intolerance of uncertainty intervention.

    Science.gov (United States)

    Oglesby, Mary E; Allan, Nicholas P; Schmidt, Norman B

    2017-08-01

    Intolerance of uncertainty (IU) is an important transdiagnostic variable within various anxiety and mood disorders. Theory suggests that individuals high in IU interpret ambiguous information in a more threatening manner. A parallel line of research has shown that interpretive biases can be modified through cognitive training and previous research aimed at modifying negative interpretations through Cognitive Bias Modification (CBM-I) has yielded promising results. Despite these findings, no research to date has examined the efficacy of an IU-focused CBM-I paradigm. The current study investigated the impact of a brief IU-focused CBM-I on reductions in IU. Participants selected for a high IU interpretation bias (IU-IB) were randomly assigned to an active (IU CBM-I) or control CBM-I condition. Results indicated that our active IU CBM-I was associated with significant changes in IU-IB from pre-to-post intervention as well as with significant reductions in IU at post-intervention and month-one follow-up. Findings also found that the IU CBM-I led to reductions in IU self-report via the hypothesized mechanism. This study is the first to provide evidence that a CBM-I focused on IU is effective in reducing IU-IB and IU across time and suggest that IU CBM-I paradigms may be a novel prevention/intervention treatment for anxiety. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. [Efficacy comparison of different points combination in the treatment of menopausal insomnia: a randomized controlled trial].

    Science.gov (United States)

    Yang, Song-Bai; Mei, Zhi-Gang; Cai, San-Jin; Lei, Hua-Ping; Sun, Cheng-Hong; Chen, Ling; Zhou, Chuang

    2014-01-01

    To compare the efficacy of different points combination in the treatment of menopausal insomnia. Ninety-six cases of menopausal insomnia were randomized into 3 groups, Xinshu (BL 15), Shenshu (BL 23), Sishencong (EX-HN 1), Shenmen (HT 7), Sanyinjiao (SP 6) were chosen in the restore interaction between the heart and the kidney group (group A, 32 cases); Zhaohai (KI 6), Jiaoxin (KI 8), Shenmai (BL 62), Pucan (BL 61) were chosen in the acupuncturing qiao mai group (group B, 32 cases); auricular Shenmen (TF4) and sensitive spot at the distribution area of auricular vagus nervus were chosen in the ear acupuncture group (group C, 32 cases). Six days made one session and the treatments were finished after 4 courses. The polysomnography (PSG) and Pittsburgh sleep quality index (PSQI) were employed before and after treatment to evaluate the alleviation of insomnia. The parameters of the sleep latency (SL), rapid wave sleep latency (RL) and sleep efficiency (SE) were significantly improved in the three groups, and the differences were statistically significant (P acupuncture has a better curative effect than the restore interaction between the heart and the kidney group and acupuncturing qiao mai group, it is worth of being promoted.

  19. Different bismuth-based therapies for eradicating Helicobacter pylori: Randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Gokcan, Hale; Oztas, Erkin; Onal, Ibrahim Koral

    2016-02-01

    Bismuth salts are used for treating dyspepsia, and they exert antibacterial effects on Helicobacter pylori. This study aimed to compare the efficacy and safety of three bismuth-containing combination regimens for H. pylori eradication in a Turkish population. In this single-center study, 149 patients, who were diagnosed with H. pylori infection with urea breath test and histopathological examination, were randomized to receive the following therapies for 14 days: (1) bismuth-containing clarithromycin-based triple therapy (CBS-LAC), (2) bismuth-containing levofloxacin-based triple therapy (CBS-LAL), and (3) bismuth-containing quadruple therapy (BCQT). Eradication rates were evaluated six weeks after the treatment by performing intention to treat (ITT) and per protocol (PP) analyses. In addition, data on side effect profiles and patient compliance were collected. PP and ITT analyses showed that eradication rates were 86% and 81.1%, respectively, with BCQT; 68.3% and 66.7%, respectively, with CBS-LAL therapy; and 65.3% and 59.3%, respectively, with CBS-LAC therapy. Eradication rates obtained using PP and ITT analyses were statistically significant for all the regimens. Addition of bismuth to standard triple and levofloxacin-based regimen did not show an acceptable increase in eradication rates. Therefore, BCQT may be preferred for the first-line treatment of H. pylori infection. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  20. Efficacy of a health-promotion intervention for college students: a randomized controlled trial.

    Science.gov (United States)

    Ulla Díez, Sara M; Fortis, Adriana Pérez; Franco, Soledad Franco

    2012-01-01

    Diabetes is a leading cause of death in Mexico. Research has shown that encouraging healthy behaviors, especially among younger people, is an effective way to reduce chronic illnesses such as diabetes and the related morbidity and mortality from these diseases. The aim of this study was to test the efficacy of a brief health-promotion intervention in encouraging a health-promoting lifestyle in university students. A 2-group randomized controlled experimental design was used. Seventy-three freshman Mexican students (31 in the experimental group and 42 in the control group) participated in the study. The experimental group attended a7-session program, with a duration of 2 hours per session. Lifestyle was measured using the Health-Promoting Lifestyle Profile-II questionnaire. Repeated-measures and factorial analysis of variance were computed. There was a significant main effect of the intervention in all dependent health profile variables, F(2, 138) = 3.46-14.45, p stress management, F(2, 138) = 8.71, p Students attending the intervention presented a healthier lifestyle than did students in the control group. These results offer interesting experimental evidence to establish guidelines for the design of healthier universities.

  1. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

    Directory of Open Access Journals (Sweden)

    Tarun Kumar

    2016-01-01

    Full Text Available The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal, colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. Aim and Objectives: To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. Materials and Methods: A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis. The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. Results: All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Conclusion: Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions.

  2. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial.

    Science.gov (United States)

    Kumar, Tarun; Arora, Neha; Puri, Gagan; Aravinda, Konidena; Dixit, Avani; Jatti, Deepa

    2016-01-01

    The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal), colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis). The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions.

  3. Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Michelle Mikhael AMMARI

    2014-08-01

    Full Text Available The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie® versus the manual method (excavators in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into three different groups: Papacárie® (n = 25, Carisolv™ (n = 27 and Manual (n = 22. Samples of carious and sound dentine were collected with sterile excavators before and after caries removal in the three groups. The dentine samples were transferred to glass tubes containing a 1mL thioglycollate medium used as a carrier and enriched for microbiological detection of mutans streptococci and Lactobacillus spp, after incubation for 6h at room temperature. The minimum detection value for colony forming units (CFU was 3.3 x 102 CFU/ml, and the results were converted into scores from 0 to 4. A significant difference was observed in relation to the microbiological scores before and after caries removal for all methods (Wilcoxon test; p < 0.001. The use of chemomechanical methods for caries removal did not improve the reduction of cariogenic microorganisms in dentine caries lesions, in comparison with manual excavation.

  4. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial.

    Science.gov (United States)

    Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

    2016-11-17

    This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference -12.4; 95% CI: -18.9; -5.9, p cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time.

  5. Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials.

    Science.gov (United States)

    Meininger, Vincent; Bensimon, Gilbert; Bradley, Walter R; Brooks, Benjamin; Douillet, Patrice; Eisen, Andrew A; Lacomblez, Lucette; Leigh, P Nigel; Robberecht, Wim

    2004-06-01

    Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal motor neuron disease. We carried out two randomized, double-blind, placebo-controlled, multi-centre, multi-national studies with xaliproden (a drug with neurotrophic effect) to assess drug efficacy and safety at two doses. Patients with clinically probable or definite ALS of more than 6 months and less than 5 years duration were randomly assigned to placebo, 1 mg or 2 mg xaliproden orally once daily as monotherapy in Study 1 (n=867); or to the same regimen with addition of riluzole 50 mg bid background therapy in Study 2 (n=1210 patients). The two primary endpoints were defined as: 1. Time to death, tracheostomy, or permanent assisted ventilation (DTP), and 2. Time to vital capacity (VC)side effects were largely associated with the serotonergic properties of xaliproden. An effect of xaliproden on functional parameters, especially VC, was noted. Although this effect did not reach statistical significance, xaliproden had a small effect on clinically noteworthy aspects of disease progression in ALS.

  6. Efficacy of dental floss impregnated with chlorhexidine on reduction of supragingival biofilm: a randomized controlled trial.

    Science.gov (United States)

    Muniz, F W M G; Sena, K S; de Oliveira, C C; Veríssimo, D M; Carvalho, R S; Martins, R S

    2015-05-01

    The use of a toothbrush has a limited ability to control the dental biofilm in interproximal areas. Therefore, specialized devices, such as dental floss, may be useful for these specific areas. This study aimed to investigate the efficacy of dental floss impregnated with 5% chlorhexidine gluconate on the reduction of the supragingival biofilm. This research was parallel, single-blind, controlled and randomized, and contained a sample of thirty dental students from the Faculty of Pharmacy, Dentistry and Nursing of the Federal University of Ceará, Brazil, who were divided equally into three groups. The negative control group (NC) did not utilize any kind of interproximal cleaning; the positive control group (PC) used waxed floss without impregnation twice a day; and the test group (T) used the same dental floss, which was impregnated with 5% chlorhexidine gluconate, twice a day. For all groups, this study lasted for 15 days. The presence of a biofilm was evaluated on four surfaces (mesiobuccal, distobuccal, mesiolingual and distolingual) by the Quigley-Hein Index, resulting in four scores for each tooth. Group T had the lowest plaque scores, showing a significant difference compared to group NC (P dental floss impregnated with 5% chlorhexidine gluconate resulted in additional reductions in the supragingival biofilm relative to the results achieved with conventional waxed floss on the anterior teeth of a well-motivated and well-instructed population. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

    Science.gov (United States)

    Kumar, Tarun; Arora, Neha; Puri, Gagan; Aravinda, Konidena; Dixit, Avani; Jatti, Deepa

    2016-01-01

    The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal), colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. Aim and Objectives: To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. Materials and Methods: A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis). The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. Results: All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Conclusion: Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions. PMID:27041901

  8. Efficacy of intravitreal ocriplasmin for treatment of vitreomacular adhesion: subgroup analyses from two randomized trials.

    Science.gov (United States)

    Haller, Julia A; Stalmans, Peter; Benz, Matthew S; Gandorfer, Arnd; Pakola, Stephen J; Girach, Aniz; Kampik, Anselm; Jaffe, Glenn J; Toth, Cynthia A

    2015-01-01

    To evaluate the efficacy of a single intravitreal injection of ocriplasmin 125 μg across relevant subpopulations of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT), including when associated with macular hole. Two multicenter, randomized, placebo-controlled, double-masked, 6-month studies. A total of 652 randomized patients (464 receiving ocriplasmin; 188 receiving placebo). A single intravitreal injection of ocriplasmin 125 μg or placebo in the study eye. Prespecified subgroup analyses were conducted to evaluate the effects on the proportion of patients with nonsurgical resolution of focal VMA at day 28, nonsurgical full-thickness macular hole (FTMH) closure at month 6, and categoric improvement in best-corrected visual acuity (BCVA) at month 6. Resolution of VMA at day 28 was achieved more often in younger patients (Treatment differences in favor of ocriplasmin were generally observed across each subgroup of subpopulations studied. Subgroup analyses confirmed the positive effect of ocriplasmin across relevant subpopulations. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  9. Psychodynamic psychotherapy versus cognitive behavior therapy for social anxiety disorder: an efficacy and partial effectiveness trial.

    Science.gov (United States)

    Bögels, Susan M; Wijts, Paul; Oort, Frans J; Sallaerts, Steph J M

    2014-05-01

    Comparing the overall and differential effects of psychodynamic psychotherapy (PDT) versus cognitive behavior therapy (CBT) for social anxiety disorder (SAD). Patients with a primary SAD (N = 47) were randomly assigned to PDT (N = 22) or CBT (N = 27). Both PDT and CBT consisted of up to 36 sessions (average PDT 31.4 and CBT 19.8 sessions). Assessments took place at waitlist: pretest, after 12 and 24 weeks for those who received longer treatment: posttest, 3-month and 1-year follow-up. Changes in the main outcome measure self-reported social anxiety composite, as well as in other psychopathology, social skills, negative social beliefs, public self-consciousness, defense mechanisms, personal goals, independent rater's judgments of SAD and general improvement, and approach behavior during an objective test, were analyzed using multilevel analysis. No improvement occurred during waitlist. Treatments were highly efficacious, with large within-subject effect sizes for social anxiety, but no differences between PDT and CBT on general and treatment-specific measures occurred. Remission rates were over 50% and similar for PDT and CBT. Personality disorders did not influence the effects of PDT or CBT. PDT and CBT are both effective approaches for SAD. Further research is needed on the cost-effectiveness of PDT versus CBT, on different lengths PDT, and on patient preferences and their relationship to outcome of PDT versus CBT. © 2014 Wiley Periodicals, Inc.

  10. The Efficacy of a Walking Intervention Using Social Media to Increase Physical Activity: A Randomized Trial.

    Science.gov (United States)

    Rote, Aubrianne E; Klos, Lori A; Brondino, Michael J; Harley, Amy E; Swartz, Ann M

    2015-06-16

    Facebook may be a useful tool to provide a social support group to encourage increases in physical activity. This study examines the efficacy of a Facebook social support group to increase steps/day in young women. Female college freshmen (N = 63) were randomized to one of two 8-week interventions: a Facebook Social Support Group (n = 32) or a Standard Walking Intervention (n = 31). Participants in both groups received weekly step goals and tracked steps/day with a pedometer. Women in the Facebook Social Support Group were also enrolled in a Facebook group and asked to post information about their steps/day and provide feedback to one another. Women in both intervention arms significantly increased steps/day pre- to postintervention (F(8,425) = 94.43, P Social Support Group increased steps/day significantly more (F(1,138) = 11.34, P social support group to increase physical activity in young women. Women in the Facebook Social Support Group increased walking by approximately 1.5 miles/day more than women in the Standard Walking Intervention which, if maintained, could have a profound impact on their future health.

  11. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

    Science.gov (United States)

    Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

    2016-01-01

    This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference −12.4; 95% CI: −18.9; −5.9, p effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time. PMID:27853272

  12. Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial

    Science.gov (United States)

    Duval, Xavier; van der Werf, Sylvie; Blanchon, Thierry; Mosnier, Anne; Bouscambert-Duchamp, Maude; Tibi, Annick; Enouf, Vincent; Charlois-Ou, Cécile; Vincent, Corine; Andreoletti, Laurent; Tubach, Florence; Lina, Bruno; Mentré, France; Leport, Catherine

    2010-01-01

    Background Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo. Methods and Findings We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008–2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ), oseltamivir plus inhaled placebo (O), or zanamivir plus oral placebo (Z). Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT)-PCR below 200 copies genome equivalent (cgeq)/µl at day 2 (primary outcome), and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned) were included (OZ, n = 192; O, n = 176; Z, n = 173), 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n = 157), O (n = 141), and Z (n = 149) arms had RT-PCR<200 cgeq/µl (−13.0%, 95% confidence interval [CI] −23.1 to −2.9, p = 0.025; +12.3%, 95% CI 2.39–22.2, p = 0.028 for OZ/O and OZ/Z comparisons). Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log10 cgeq/µl (p = 0.060, p = 0.016 for OZ/O and OZ/Z). Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0–4.0, p = 0.018; +0.0, 95% CI −3.0 to 3.0, p = 0.960 for OZ/O and OZ/Z). Four severe adverse events were observed. Nausea

  13. Attention and interpretation bias modification treatment for social anxiety disorder: A randomized clinical trial of efficacy and synergy.

    Science.gov (United States)

    Naim, Reut; Kivity, Yogev; Bar-Haim, Yair; Huppert, Jonathan D

    2017-10-24

    Attention bias modification treatment (ABMT) and cognitive bias modification of interpretation (CBM-I) both have demonstrated efficacy in alleviating social anxiety, but how they compare with each other, their combination, and with a combined control condition has not been studied. We examined their relative and combined efficacy compared to control conditions in a randomized controlled trial (RCT). Ninety-five adults diagnosed with social anxiety disorder (SAD), were randomly allocated to 4 groups: ABMT + CBM-I control (hereafter ABMT; n = 23), CBM-I + ABMT control (hereafter CBM-I; n = 24), combined ABMT + CBM-I (n = 23), and combined control (n = 25). Treatment included eight sessions over four weeks. Clinician-rated and self-reported measures of social anxiety symptoms, functional impairment, and threat-related attention and interpretive biases were evaluated at baseline, post-treatment, and 3-month follow-up. ABMT yielded greater symptom reduction as measured by both clinician-ratings (Cohen's ds = 0.57-0.70) and self-reports (ds = 0.70-0.85) compared with the CBM-I, the combined ABMT + CBM-I, and the combined control conditions. Neither of the other conditions demonstrated superior symptom change compared to the control condition. No group differences were found for functioning or cognitive biases measures. Limitations mainly include the mix of active and control treatments applied across the different groups. Therefore, the net effect of each of the treatments by itself could not be clearly tested. Results suggest superiority of ABMT compared to CBM-I and their combination in terms of symptom reduction. Possible interpretations and methodological issues underlying the observed findings are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Efficacy and tolerability of vilazodone for major depressive disorder: evidence from phase III/IV randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Shi LG

    2016-11-01

    Full Text Available Ligen Shi,1,2 Jingyi Wang,1 Shenbin Xu,2 Yunrong Lu1 1Department of Psychiatry, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu, 2Department of Neurosurgery, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People’s Republic of China Abstract: Vilazodone is a new molecule approved for major depressive disorder (MDD. This report focuses on the efficacy and tolerability of vilazodone for MDD. MEDLINE, EMBASE, and Cochrane Library were searched. A total of 1,930 patients from four trials were included. A significant improvement in the Montgomery–Asberg Depression Rating Scale (MADRS total score was seen as early as week 2 (P<0.01 in vilazodone-treated patients. The results showed a higher rate of MADRS response with vilazodone compared with placebo (P<0.001. There were also greater improvements in the Hamilton Rating Scale for Anxiety as well as the Clinical Global Impressions (severity of illness and improvement of illness scores from baseline in vilazodone-treated patients compared to placebo patients (P<0.001. Discontinuation rates due to adverse events were higher with vilazodone than placebo (P=0.0002. The most common adverse events of vilazodone were vomiting, nausea, diarrhea, insomnia, somnolence, dizziness, and dry mouth (P<0.05. Treatment-related effects on sexual function were mild compared to placebo in men (P=0.03. In conclusion, 40 mg/day of vilazodone had a rapid onset of response and showed good improvement in anxiety symptoms as well as good tolerability during short-term treatment (8–10 weeks for MDD. Further studies should focus on the efficacy and tolerability of vilazodone over a longer duration and should utilize active comparators. Keywords: vilazodone, major depressive disorder, sexual dysfunction, anxiety

  15. Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Geng H

    2017-03-01

    Full Text Available Hua Geng, Chengzhong Wang Department of Pediatrics, Maternal and Child Health Hospital of Yancheng, Yancheng City, People’s Republic of China Background: To assess the efficacy and safety of oxcarbazepine (OXC in the treatment of children with epilepsy.Methods: Randomized controlled trials (RCTs published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China, and Chinese National Knowledge Infrastructure (China database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR with 95% confidence intervals (95% CIs was calculated using fixed-effects or random-effects model.Results: Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo, OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P=0.366 and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P=0.310; for 50%–75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P=0.301; for <50% reduction: RR =0.79, 95% CI: 0.56, 1.12; P=0.179. Moreover, patients treated with OXC had a comparable incidence of adverse events compared with those treated with other antiepileptic drugs (RR =1.01, 95% CI: 0.92, 1.11; P=0.760.Conclusion: OXC showed similar effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings. Keywords: epilepsy, children, oxcarbazepine, meta-analysis

  16. Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: a randomized controlled trial.

    Science.gov (United States)

    Prado, Judith; Daza, Raúl; Chumbes, Oscar; Loayza, Iván; Huicho, Luis

    2006-05-04

    Dipyrone is a widely used over-the-counter antipyretic in Latin America, and elsewhere among Latin immigrants. Despite limited evidence, physicians often prescribe oral ibuprofen or intramuscular dipyrone as the most effective antipyretics. Our aim was to compare the antipyretic efficacy and tolerability of a single dose of oral ibuprofen, oral dipyrone or intramuscular dipyrone in febrile children. Randomized, single-blind clinical trial, at San Bartolomé Mother-Child National Teaching Hospital, Lima, Peru. Children from six months to six years old with fever (rectal temperature: 38.3 to 39.8 degrees C) in the emergency ward between February and June 2003 were eligible. Seventy-five children were randomly assigned to receive a single dose of oral ibuprofen (10 mg/kg), oral dipyrone (15 mg/kg) or intramuscular dipyrone (15 mg/kg). The primary outcome was mean temperature reduction after 30, 45, 60, 90 and 120 minutes. Secondary outcomes were fever-associated symptoms and clinical adverse events. Fever decreased by about 0.5 degrees C after 45 minutes and by about 1.0 degrees C after 120 minutes in all three groups. Mean temperatures were similar for the three groups at all times. There was a significant decrease in fever-associated symptoms for all groups. Six patients (four receiving oral dipyrone and two receiving ibuprofen) were withdrawn because of vomiting within 20 minutes after first dose of study medication. One patient assigned to oral ibuprofen presented transient urticaria. Antipyretic efficacy and tolerability were similar for oral ibuprofen, oral dipyrone and intramuscular dipyrone. Oral antipyretics seem more appropriate for feverish children.

  17. Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Judith Prado

    Full Text Available CONTEXT AND OBJECTIVE: Dipyrone is a widely used over-the-counter antipyretic in Latin America, and elsewhere among Latin immigrants. Despite limited evidence, physicians often prescribe oral ibuprofen or intramuscular dipyrone as the most effective antipyretics. Our aim was to compare the antipyretic efficacy and tolerability of a single dose of oral ibuprofen, oral dipyrone or intramuscular dipyrone in febrile children. DESIGN AND SETTING: Randomized, single-blind clinical trial, at San Bartolomé Mother-Child National Teaching Hospital, Lima, Peru. METHODS: Children from six months to six years old with fever (rectal temperature: 38.3 to 39.8° C in the emergency ward between February and June 2003 were eligible. Seventy-five children were randomly assigned to receive a single dose of oral ibuprofen (10 mg/kg, oral dipyrone (15 mg/kg or intramuscular dipyrone (15 mg/kg. The primary outcome was mean temperature reduction after 30, 45, 60, 90 and 120 minutes. Secondary outcomes were fever-associated symptoms and clinical adverse events. RESULTS: Fever decreased by about 0.5° C after 45 minutes and by about 1.0° C after 120 minutes in all three groups. Mean temperatures were similar for the three groups at all times. There was a significant decrease in fever-associated symptoms for all groups. Six patients (four receiving oral dipyrone and two receiving ibuprofen were withdrawn because of vomiting within 20 minutes after first dose of study medication. One patient assigned to oral ibuprofen presented transient urticaria. CONCLUSIONS: Antipyretic efficacy and tolerability were similar for oral ibuprofen, oral dipyrone and intramuscular dipyrone. Oral antipyretics seem more appropriate for feverish children.

  18. Efficacy of Sublingual Immunotherapy for House Dust Mite-Induced Allergic Rhinitis: A Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Feng, Bohai; Xiang, Haijie; Jin, Haiyong; Gao, Jinjian; Huang, Saiyu; Shi, Yunbin; Chen, Ruru

    2017-01-01

    Purpose Allergic rhinitis (AR) has become a global issue for a large part of the general population. Sublingual immunotherapy (SLIT) has been used extensively to treat persistent allergic rhinitis (PAR). Although systematic reviews have confirmed the effectiveness of SLIT for the treatment of AR, a considerable number of studies using extracts of house dust mites (HDMs) for immunotherapy found no consensus on basic treatment parameters and questioned the efficacy of SLIT. Methods In this study, we evaluated SLIT for PAR by a meta-analysis of randomized controlled trials (RCTs). Medline, Embase, and Cochrane Library database searches were performed for RCTs on the treatment of PAR by SLIT that assessed clinical outcomes related to efficacy through May 2016. Descriptive and quantitative information was abstracted. An analysis was performed with standardized mean differences (SMDs) under a fixed or random effects model. Subgroup analyses were performed. Heterogeneity was assessed using the I2 metric. Results In total, 25 studies were eligible for inclusion in the meta-analysis for symptom scores and 15 studies for medication scores. SLIT was significantly different from the controls for symptom scores (SMD=1.23; 95% confidence interval [CI]=1.74 to 0.73; P<0.001). For medication scores, significant differences for SLIT were also observed versus the controls (SMD=-1.39; 95% CI=-1.90 to -0.88; P<0.001). Conclusions Our meta-analysis indicates that SLIT provided significant symptom relief and reduced the need for medications in PAR. In this study, significant evidence was obtained despite heterogeneity with regard to the use of mite extract. Specifically, the mite extract used was provided by the patients with PAR. Furthermore, to confirm both the objective outcomes and the effective doses of HDM allergen extracts, experimental data should be obtained from large high-quality population-based studies. PMID:28293928

  19. Everolimus safety and efficacy for renal angiomyolipomas associated with tuberous sclerosis complex: a Spanish expanded access trial.

    Science.gov (United States)

    Robles, Nicolás Roberto; Peces, Ramón; Gómez-Ferrer, Álvaro; Villacampa, Felipe; Álvarez-Ossorio, Jose Luis; Pérez-Segura, Pedro; Morote, Juan; Herrera-Imbroda, Bernardo; Nieto, Javier; Carballido, Joaquín; Anido, Urbano; Valero, Marian; Meseguer, Cristina; Torra, Roser

    2016-09-26

    Renal angiomyolipomas (AML) are usual manifestations of tuberous sclerosis complex (TSC) that may cause aneurism-related haemorrhages and renal impairment. Everolimus has emerged as an alternative to surgery/embolization. We provide further insight into everolimus safety and efficacy for TSC-related AML. This was a Spanish expanded access trial including patients aged ≥18 years with TSC-related AML. They received 10 mg everolimus once daily until AML progression, unacceptable toxicity, death/withdrawal, commercialisation for TSC-related AML, or 1 year after first patient enrolment. The primary outcome was dose-limiting safety according to grade 3/4 adverse events, serious adverse events, or adverse events leading to treatment modification. Secondary outcomes included overall safety and efficacy. Nineteen patients were enrolled and received everolimus for a median of 6.6 (5.3-10.9) months. Eleven (57.9 %) remained on 10 mg/day throughout the study and eight (42.1 %) required treatment modifications due to adverse events; none permanently discontinued treatment. Adverse events were overall grade 1/2 and most frequently included aphthous stomatitis/mucosal inflammation, hypercholesterolaemia/hypertriglyceridaemia, urinary tract infection, hypertension, dermatitis acneiform, and insomnia. Four (21.1 %) patients experienced grade 3 adverse events, none was grade 4, and only one (5.3 %) was serious (pneumonia). AML volume was reduced ≥30 % in 11 (57.9 %) patients and ≥50 % in 9 (47.4 %); none progressed. Right and left kidney sizes decreased in 16 and 14 patients, respectively. These findings support the benefit of everolimus for renal AML due to a manageable safety profile accompanied by reduced AML and kidney volumes. EudraCT number 2012-005397-63 ; date of registration 22 Nov 2012.

  20. Comparison of the efficacy of two anesthetic techniques of mandibular primary first molar: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Davood Ghasemi Tudeshchoie

    2013-01-01

    Full Text Available Background: The most common technique to anesthetize mandibular primary teeth is inferior alveolar (I.A nerve block injection which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable. The aim of this study was a comparison of the efficacy of two anesthetic techniques of mandibular primary first molar. Materials and Methods: In this randomized crossover clinical trial, 40 children with ages ranged from 5 years to 8 years whose mandibular primary first molars were eligible for pulpotomy, were selected and divided randomly into two groups. The right and left mandibular first molars of group A were anesthetized with infiltration and I. A nerve block techniques in the first and second sessions respectively. The left and right mandibular first molars of group B were anesthetized with I.A nerve block and infiltration techniques in the first and second sessions respectively. The severity of pain were measured and recorded according to sound-eye-motor scale by a certain person. Data was analyzed using Wilcoxon Signed Rank and Mann-Whitney U tests (P < 0.05. Results: The severity of pain was lower in infiltration technique versus I.A nerve block. There were no significant differences between the severities of pain on pulpal exposure of two techniques. Conclusion: It seems that infiltration technique is more favorable to anesthetize the mandibular primary first molar compared to I.A nerve block.

  1. A randomized trial of the efficacy and safety of quilizumab in adults with inadequately controlled allergic asthma.

    Science.gov (United States)

    Harris, Jeffrey M; Maciuca, Romeo; Bradley, Mary S; Cabanski, Christopher R; Scheerens, Heleen; Lim, Jeremy; Cai, Fang; Kishnani, Mona; Liao, X Charlene; Samineni, Divya; Zhu, Rui; Cochran, Colette; Soong, Weily; Diaz, Joseph D; Perin, Patrick; Tsukayama, Miguel; Dimov, Dimo; Agache, Ioana; Kelsen, Steven G

    2016-03-18

    Quilizumab, a humanized IgG1 monoclonal antibody, targets the M1-prime segment of membrane-expressed IgE, leading to depletion of IgE-switched and memory B cells. In patients with mild asthma, quilizumab reduced serum IgE and attenuated the early and late asthmatic reaction following whole lung allergen challenge. This study evaluated the efficacy and safety of quilizumab in adults with allergic asthma, inadequately controlled despite high-dose inhaled corticosteroids (ICS) and a second controller. Five hundred seventy-eight patients were randomized to monthly or quarterly dosing regimens of subcutaneous quilizumab or placebo for 36 weeks, with a 48-week safety follow-up. Quilizumab was evaluated for effects on the rate of asthma exacerbations, lung function, patient symptoms, serum IgE, and pharmacokinetics. Exploratory analyses were conducted on biomarker subgroups (periostin, blood eosinophils, serum IgE, and exhaled nitric oxide). Quilizumab was well tolerated and reduced serum total and allergen-specific IgE by 30-40 %, but had no impact on asthma exacerbations, lung function, or patient-reported symptom measures. At Week 36, the 300 mg monthly quilizumab group showed a 19.6 % reduction (p = 0.38) in the asthma exacerbation rate relative to placebo, but this was neither statistically nor clinically significant. Biomarker subgroups did not reveal meaningful efficacy benefits following quilizumab treatment. Quilizumab had an acceptable safety profile and reduced serum IgE. However, targeting the IgE pathway via depletion of IgE-switched and memory B cells was not sufficient for a clinically meaningful benefit for adults with allergic asthma uncontrolled by standard therapy. ClinicalTrials.gov NCT01582503.

  2. Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial.

    Science.gov (United States)

    Schwameis, Michael; Kündig, Thomas; Huber, Gustave; von Bidder, Luzi; Meinel, Lorenz; Weisser, Roland; Aberer, Elisabeth; Härter, Georg; Weinke, Thomas; Jelinek, Tomas; Fätkenheuer, Gerd; Wollina, Uwe; Burchard, Gerd-Dieter; Aschoff, Roland; Nischik, Ruth; Sattler, Gerhard; Popp, Georg; Lotte, Wolfgang; Wiechert, Dirk; Eder, Gerald; Maus, Olga; Staubach-Renz, Petra; Gräfe, Andrea; Geigenberger, Veronika; Naudts, Ingomar; Sebastian, Michael; Reider, Norbert; Weber, Ridwan; Heckmann, Marc; Reisinger, Emil C; Klein, Georg; Wantzen, Johannes; Jilma, Bernd

    2017-03-01

    Lyme borreliosis develops in 1-5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. We assessed its efficacy in human beings. In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by study site, were accessed in study centres via an interactive voice-response system, by pharmacists not involved in the study. The primary outcome was the number of treatment failures, defined as erythema migrans, seroconversion, or both, in participants who were seronegative at baseline, had no further tick bites during the study, and had serology results available at 8 weeks (intention-to-treat [ITT] population). This study is registered with EudraCT, number 2011-000117-39. Between July 7, 2011, and Dec 3, 2012, 1371 participants were randomly assigned to treatment, of whom 995 were included in the ITT population. The trial was stopped early because an improvement in the primary endpoint in the group receiving azithromycin was not reached. At 8 weeks, 11 (2%) of 505 in the azithromycin group and 11 (2%) of 490 in the placebo group had treatment failure (odds ratio 0·97, 95% CI 0·42-2·26, p=0·47). Topical azithromycin was well tolerated. Similar numbers of patients had adverse events in the two groups (175 [26%] of 505 vs 177 [26%] of 490, p=0·87), and most adverse events were mild. Topical azithromycin was well tolerated and had a good safety profile. Inclusion of asymptomatic seroconversion into the primary efficacy analysis led to no prevention effect with topical azithromycin. Adequately powered

  3. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION

    Directory of Open Access Journals (Sweden)

    Vidrine Damon J

    2012-08-01

    Full Text Available Abstract Background Despite a significant decrease in smoking prevalence over the past ten years, cigarette smoking still represents the leading cause of preventable morbidity and mortality in the United States. Moreover, smoking prevalence is significantly higher among those with low levels of education and those living at, or below, the poverty level. These groups tend to be confronted with significant barriers to utilizing more traditional smoking cessation intervention approaches. The purpose of the study, Project ACTION (Adult smoking Cessation Treatment through Innovative Outreach to Neighborhoods, is to utilize a mobile clinic model, a network of community sites (i.e., community centers and churches and an interactive mobile messaging system to reach and deliver smoking cessation treatment to underserved, low-income communities. Methods/Design We are using a group-randomized design, with the community site as the sampling unit, to compare the efficacy of three smoking cessation interventions: 1 Standard Care - brief advice to quit smoking, nicotine replacement therapy (NRT, and self-help materials; 2 Enhanced Care - standard care components plus a cell phone-delivered text/graphical messaging component; and 3 Intensive Care - enhanced care components plus a series of 11 cell phone-delivered proactive counseling sessions. An economic evaluation will also be performed to evaluate the relative cost effectiveness of the three treatment approaches. We will recruit 756 participants (252 participants in each of the 3 intervention groups. At the time of randomization, participants complete a baseline assessment, consisting of smoking history, socio-demographic, and psychosocial variables. Monthly cell phone assessments are conducted for 6 months-post enrollment, and a final 12-month follow-up is conducted at the original neighborhood site of enrollment. We will perform mixed-model logistic regression to compare the efficacy of the three smoking

  4. Efficacy of Oral Risperidone, Haloperidol, or Placebo for Symptoms of Delirium Among Patients in Palliative Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Agar, Meera R; Lawlor, Peter G; Quinn, Stephen; Draper, Brian; Caplan, Gideon A; Rowett, Debra; Sanderson, Christine; Hardy, Janet; Le, Brian; Eckermann, Simon; McCaffrey, Nicola; Devilee, Linda; Fazekas, Belinda; Hill, Mark; Currow, David C

    2017-01-01

    Antipsychotics are widely used for distressing symptoms of delirium, but efficacy has not been established in placebo-controlled trials in palliative care. To determine efficacy of risperidone or haloperidol relative to placebo in relieving target symptoms of delirium associated with distress among patients receiving palliative care. A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services between August 13, 2008, and April 2, 2014, among participants with life-limiting illness, delirium, and a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more. Age-adjusted titrated doses of oral risperidone, haloperidol, or placebo solution were administered every 12 hours for 72 hours, based on symptoms of delirium. Patients also received supportive care, individualized treatment of delirium precipitants, and subcutaneous midazolam hydrochloride as required for severe distress or safety. Improvement in mean group difference of delirium symptom score (severity range, 0-6) between baseline and day 3. Five a priori secondary outcomes: delirium severity, midazolam use, extrapyramidal effects, sedation, and survival. Two hundred forty-seven participants (mean [SD] age, 74.9 [9.8] years; 85 women [34.4%]; 218 with cancer [88.3%]) were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo). In the primary intention-to-treat analysis, participants in the risperidone arm had delirium symptom scores that were significantly higher than those among participants in the placebo arm (on average 0.48 Units higher; 95% CI, 0.09-0.86; P = .02) at study end. Similarly, for those in the haloperidol arm, delirium symptom scores were on average 0.24 Units higher (95% CI, 0.06-0.42; P = .009) than in the placebo arm. Compared with placebo, patients in both

  5. Efficacy of memory training in healthy community-dwelling older people: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pérez, Anna; Roqué, Marta; Domènech, Sara; Monteserín, Rosa; Soriano, Núria; Blancafort, Xavier; Bosom, Maria; Vidal, Cristina; Petit, Montse; Hortal, Núria; Gil, Carles; Espelt, Albert; López, Maria José

    2015-10-01

    There is limited evidence on the efficacy and social utility of cognitive training. To address this, we have designed a randomized controlled trial to assess the effectiveness of memory training workshops for healthy older people in terms of their short- and long-term impact on cognitive function, health-related quality of life, and functionality. A randomized controlled trial will be performed in health care centers in Barcelona (Spain) through comparison of a group of individuals participating in memory training workshops (experimental group) with another group with similar characteristics not participating in the workshops (control group). The intervention will consist of twelve 90-minute group sessions imparted once a week by a psychologist specialized in memory training. The groups will each comprise approximately 15 people, for a total number of 230 patients involved in the study. Each session has its own objectives, materials and activities. The content of the intervention is based on memory training from different perspectives, including cognitive and emotional aspects and social and individual skills. Data will be collected at baseline, at 3-4 months and at 6 months. To assess the efficacy of the intervention on cognitive function, health-related quality of life and functionality, a statistical analysis will be performed by fitting a repeated-measures mixed effects model for each main outcome: Self-perceived memory, measured by a Subjective Self-reported Memory Score (from 0 to 10) and by the Memory Failures in Everyday life questionnaire (MFE); Everyday memory, measured using the Rivermead Behavioural Memory Test-3 (RBMT-3) and Executive control abilities, measured in terms of visual-perceptual ability, working memory and task-switching ability with the Trail Making Test (TMT) and with the digit span scale of the Wechsler Adult Intelligence Scale III (WAIS III). The results of this study will be highly useful for social and public health policies related

  6. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial.

    Science.gov (United States)

    Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Montesano, Adrián; Dada, Gloria; Compañ, Victoria; Aguilera, Mari; Salla, Marta; Soldevilla, Joan Miquel; Trujillo, Adriana; Paz, Clara; Botella, Lluís; Corbella, Sergi; Saúl-Gutiérrez, Luis Angel; Cañete, José; Gasol, Miquel; Ibarra, Montserrat; Medeiros-Ferreira, Leticia; Soriano, José; Ribeiro, Eugénia; Caspar, Franz; Winter, David

    2013-05-17

    Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments, most of the cases evolve with only partial remission, relapse and recurrence.Cognitive models have contributed significantly to the understanding of unipolar depression and its psychological treatment. However, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence. Our research group has been working on the notion of cognitive conflict viewed as personal dilemmas according to personal construct theory. We use a novel method for identifying those conflicts using the repertory grid technique (RGT). Preliminary results with depressive patients show that about 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused on the resolution of these internal conflicts. This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will enhance the efficacy of cognitive behavioral therapy (CBT) for depression. A therapy manual for a dilemma-focused intervention will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: combined group CBT (eight, 2-hour weekly sessions) plus individual dilemma-focused therapy (eight, 1-hour weekly sessions) and CBT alone (eight, 2-hour group weekly sessions plus eight, 1-hour individual weekly sessions). Participants are patients aged over 18 years

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

    Science.gov (United States)

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

    2015-08-20

    Positive psychology interventions have been found to enhance well-being and decrease clinical symptomatology. However, it is still unknown how flourishing can also be increased. Although multicomponent interventions seem to be necessary for this purpose, different formats can be used. A cost-effective approach could be a positive psychology-based self-help book with tailored email support to reach large target groups and to prevent dropout. This study will evaluate the efficacy of a comprehensive multicomponent self-help intervention with or without email support on well-being and flourishing, and will seek to determine the working mechanisms underlying the intervention. In this 3-armed, parallel, randomized controlled trial, 396 participants with low or moderate levels of well-being and without clinical symptomatology will be randomly assigned to (1) a self-help book condition with weekly email support, (2) a self-help book condition without email support but with a weekly information email, or (3) a waiting list control condition. Online measurements will be assessed at baseline, at post-test (3 months after baseline), and at 6 and 12 months after baseline. The primary outcomes are well-being and flourishing (ie, high levels of well-being). Secondary outcomes are the well-being components included in the intervention: positive emotion, use of strengths, optimism, self-compassion, resilience, and positive relations. Other measures include depressive and anxiety symptoms, personality traits, direct medical and non-medical costs, life-events, and client satisfaction. This study will add knowledge to the efficacy and cost-effectiveness of a multicomponent positive psychology intervention. We will also explore who can benefit most from this intervention. If the intervention is found to be effective, our results will be especially relevant for public mental health services, governments, and primary care. The Netherlands Trial Register NTR4297; http

  8. The efficacy of azithromycin in pityriasis rosea: A randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Deepika Pandhi

    2014-01-01

    Full Text Available Background: Macrolides are prescribed in the treatment of pityriasis rosea despite conflicting results of the limited number of studies evaluating their role in its treatment. Aim: A randomized double-blind placebo-controlled trial was conducted to evaluate the effect of azithromycin on the clinical course of pityriasis rosea. Methods: Seventy patients of pityriasis rosea were given either azithromycin (n = 35 or placebo (n = 35 and were followed-up at 2, 4 and 6 weeks. Pruritus was assessed in both groups using the visual analogue scale (VAS . Change in the pityriasis rosea severity score (PRSS and in the VAS were recorded as outcome measures and were compared statistically. Results: The decrease in PRSS from baseline through 2, 4 and 6 weeks within both treatment (P < 0.001 and placebo (P < 0.001 arms was found to be statistically significant; however, this change was not significantly different in the two groups (P = 0.179. Similarly, the decrease in VAS was found to be statistically significant within both groups (P < 0.001; however, the change was comparable between the two groups (P < 0.937. Analysis by Fisher′s exact test did not find a significant difference between the two groups for PRSS and VAS. Conclusion: Azithromycin is not effective in pityriasis rosea and the use of macrolides for this disease should not be encouraged in clinical practice.

  9. The efficacy of a plasma arc light in orthodontic bonding: a randomized controlled clinical trial.

    Science.gov (United States)

    Russell, Joanne S; Littlewood, Simon J; Blance, Andrew; Mitchell, Laura

    2008-09-01

    To evaluate the clinical performance of a plasma arc light (Ortho LITE, 3M Unitek, Monrovia, CA, USA) against a conventional tungsten-quartz halogen curing light (Visilux 2, 3M Unitek, Monrovia, CA, USA) for direct orthodontic bonding. A single centre prospective randomized controlled clinical trial. The Orthodontic Department at St Luke's Hospital, Bradford, UK. Forty-three consecutive patients requiring fixed appliances from the orthodontic waiting list. A split mouth technique was adopted; with quadrants randomly assigned to either the plasma arc light or the conventional halogen curing light and bonded directly with APC pre-adjusted edgewise brackets (3M Unitek, Monrovia, CA, USA). Bracket failures. Time taken to bond-up the appliances, patient sensitivity or discomfort during curing and time to replace failed brackets were investigated. No statistically significant difference in bracket failure rates over the full course of treatment was found between the plasma arc light (6.7%; 95% CI 4.5-10.0) and the halogen curing light (9.5%; 95% CI 6.8-13.1). There was no statistically significant difference in bracket survival times. The bond-up times were typically reduced by 204 seconds per patient with the plasma arc light. There were no differences in patient reported sensitivity or discomfort or rebond times. The plasma arc light is a viable clinical alternative to the conventional halogen curing light with benefits for both the clinician and patient due to reduced bonding times.

  10. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial.

    Science.gov (United States)

    Saelens, Brian E; Grow, H Mollie; Stark, Lori J; Seeley, Randy J; Roehrig, Helmut

    2011-04-01

    To examine whether differentially targeting physical activity within the context of pilot family-based pediatric weight control treatment results in differential change in abdominal fat, particularly visceral fat. Twenty-nine overweight children (>85(th) body mass index [BMI] percentile) and at least one participating parent were randomly assigned to one of two family-based behavioral weight management conditions that either targeted 1) primarily dietary change (STANDARD; n = 15) or 2) dietary plus physical activity change (ADDED; n = 14). Differences at post-treatment in overall child weight status (e.g., BMI), whole-body composition (measured by dual x-ray absorptiometry), and abdominal fat (measured by waist circumference and magnetic resonance imaging) were assessed using intent-to-treat analyses, as were post-treatment parent BMI and waist circumference. Child and parent physical activity and dietary behavior changes were also evaluated. Results. At post-treatment, overall child weight status, whole-body composition, and child dietary measures did not differ by condition. Children in the ADDED condition tended to have higher physical activity and lower visceral abdominal fat at post-treatment relative to children in the STANDARD condition. Increasing physical activity may be important to optimize reductions in abdominal fat, especially visceral fat, among overweight children provided with family-based behavioral weight management treatment. ClinicalTrials.gov identifier: NCT00359957.

  11. "Comparing efficacy and costs of four facial fillers in HIV-associated lipodystrophy: a clinical trial."

    Science.gov (United States)

    Vallejo, Alfonso; Garcia-Ruano, Angela A; Pinilla, Carmen; Castellano, Michele; Deleyto, Esther; Perez-Cano, Rosa

    2017-11-08

    The objective was to evaluate and compare safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to Human Immunodeficiency Virus (HIV). We conducted a clinical trial including 147 patients suffering from HIV-induced lipoatrophy treated with Sculptra® (poly-L-lactic acid), Radiesse® (calcium hydroxylapatite), Aquamid® (polyacrylamide) or autologous fat. Objective and subjective changes were evaluated during a 24-monthfollow-up. Number of sessions, total injected volume and overall costs of treatment were also analyzed. A comparative cost-effectiveness analysis of the treatment options was performed. Objective improvement in facial lipoatrophy, assessed by the surgeon in terms of changes from baseline using the published classification of Fontdevila, was reported in 53% of the cases. Patient self-evaluation showed a general improvement after the use of facial fillers. Patients referred to be satisfied with the treatment and with the reduced impact of lipodystrophy on their quality of life. Despite the non-significant differences observed in number of sessions and volume, autologous fat showed significantly lower costs than all synthetic fillers (p<0.05). Surgical treatment of HIV-associated facial lipoatrophy using dermal fillers is a safe and effective procedure that improves the aesthetic appearance and the quality of life of patients. Permanent fillers and autologous fat achieve the most consistent results over time, being lipofilling the most cost-effective procedure.

  12. The analgesic efficacy of oxycodone hydrochloride versus fentanyl during outpatient artificial abortion operation: A randomized trial.

    Science.gov (United States)

    Xie, Kangjie; Zhang, Wen; Fang, Wumei; Lian, Yanhong; Lin, Sufeng; Fang, Jun

    2017-06-01

    Problems like body movement, respiratory depression, and complained of pain are still common phenomenon in outpatient artificial abortion general anesthesia. Oxycodone hydrochloride is a semisynthetic opioid and has a good therapeutic effect on visceral pain. We hypothesize that oxycodone hydrochloride would be superior to fentanyl in outpatient artificial abortion surgery. In this clinical trial 149 American Society of Anesthesiologists (ASA) I or II female outpatients scheduled for elective artificial abortion surgeries under general anesthesia were randomly divided into 3 groups: oxycodone hydrochloride 0.06 mg/kg group (group A), oxycodone hydrochloride 0.08 mg/kg group (group B), and control group fentanyl 2 ug/kg (group C). The primary outcome was level body movement and respiratory depression during the surgery, the second outcome included the visual analogue scale (VAS) score 30 minutes after waking. A total of 120 participants completed the study, n = 40 in each group. There was no significant difference in patients' age, body mass index (BMI), preoperative heart rate, mean arterial blood pressure, consumption dose of propofol, intraoperative body movement type and times, and duration of surgery among the 3 groups (P > .05). Comparing the incidence of intraoperative respiratory depression and SPO2 fentanyl, but the incidence of intraoperative respiratory depression and hypoxemia is significantly lower than fentanyl.

  13. Anti-aging and filling efficacy of six types hyaluronic acid based dermo-cosmetic treatment: double blind, randomized clinical trial of efficacy and safety

    Science.gov (United States)

    Nobile, Vincenzo; Buonocore, Daniela; Michelotti, Angela; Marzatico, Fulvio

    2014-01-01

    Background Human skin aging is a multifactorial and complex biological process affecting the different skin constituents. Even if the skin aging mechanism is not yet fully unravelled is evident that epidermis loses the principal molecule responsible for binding and retaining water molecules, resulting in loss of skin moisture and accounting for some of the most striking alterations of the aged skin. Objectives This Study investigated the cosmetic filling efficacy of Fillerina® in decreasing the skin aging signs and in improving facial volume deficiencies. Methods A placebo-controlled, double-blind, randomized clinical trial was carried out on 40 healthy female subjects showing mild to moderate clinical signs of skin aging. The effect of the treatment on skin surface and on face volumes was assessed both in the short-term (3 h after a single product application) and in the long-term (7, 14, and 30 days after continuative daily use). Results Three hours after a single application and after 7, 14, and 30 days of treatment the lips volume was increased by 8.5%, 11.3%, 12.8%, and 14.2%. After 7, 14, and 30 days: (1) skin sagging of the face contours was decreased by −0.443 ± 0.286, −1.124 ± 0.511, and −1.326 ± 0.649 mm, respectively; (2) skin sagging of the cheekbones contours was decreased by −0.989 ± 0.585, −2.500 ± 0.929, and −2.517 ± 0.927 mm, respectively; (3) cheekbones volume was increased by 0.875 ± 0.519, 2.186 ± 0.781, and 2.275 ± 0.725 mm, respectively; (4) wrinkle volume was decreased by −11.3%, −18.4%, and −26.3%, respectively; and (5) wrinkle depth was decreased by −8.4%, −14.5%, and −21.8% respectively. Conclusion This study demonstrated the positive filling effect of Fillerina® in decreasing the clinical signs of skin aging and in improving the face volumes. PMID:25399620

  14. Efficacy and Safety of Adding Ezetimibe to Statin Therapy Among Women and Men: Insight From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial).

    Science.gov (United States)

    Kato, Eri Toda; Cannon, Christopher P; Blazing, Michael A; Bohula, Erin; Guneri, Sema; White, Jennifer A; Murphy, Sabina A; Park, Jeong-Gun; Braunwald, Eugene; Giugliano, Robert P

    2017-11-18

    IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) showed that adding the nonstatin ezetimibe to statin therapy further reduced cardiovascular events in patients after an acute coronary syndrome. In a prespecified analysis, we explore results stratified by sex. In IMPROVE-IT, patients with acute coronary syndrome and low-density lipoprotein cholesterol of 50 to 125 mg/dL were randomized to placebo/simvastatin 40 mg or ezetimibe/simvastatin 10/40 mg. They were followed up for a median of 6 years for the primary composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, coronary revascularization ≥30 days, and stroke. Among 18 144 patients in IMPROVE-IT, 4416 (24%) were women. At 12 months, the addition of ezetimibe to simvastatin significantly reduced low-density lipoprotein cholesterol from baseline compared with simvastatin monotherapy in men and women equally (absolute reduction, 16.7 mg/dL in men and 16.4 mg/dL in women). Women receiving ezetimibe/simvastatin had a 12% risk reduction over those receiving placebo/simvastatin for the primary composite end point (hazard ratio, 0.88; 95% confidence interval, 0.79-0.99) compared with a 5% reduction for men (hazard ratio, 0.95; 95% confidence interval, 0.90-1.01; P=0.26 for interaction). When the total number of primary events was considered, women had an 18% reduction with the addition of ezetimibe (relative risk, 95% confidence interval, 0.81; 0.71-0.94) and men had a 6% reduction (relative risk, 0.94; 95% confidence interval, 0.87-1.02; P=0.08 for interaction). The addition of ezetimibe did not increase the rates of safety events in either women or men. IMPROVE-IT demonstrated that the benefit of adding ezetimibe to statin is present in both women and men, with a good safety profile supporting the use of intensive, combination, lipid-lowering therapy to optimize cardiovascular outcomes. URL: http://www.clinicaltrials.gov. Unique

  15. Genomic predictors of chemotherapy efficacy in advanced or recurrent gastric cancer in the GC0301/TOP002 phase III clinical trial.

    Science.gov (United States)

    Das, Kakoli; Taguri, Masataka; Imamura, Hiroshi; Sugimoto, Naotoshi; Nishikawa, Kazuhiro; Yoshida, Kazuhiro; Tan, Patrick; Tsuburaya, Akira

    2018-01-01

    Recent gastric cancer clinical trials have aimed to establish the efficacy of combination therapy over monotherapy, however, the role for genomic biomarkers in these trials has remained largely unexplored. Here, using the NanoString expression platform, we analyzed 105 gastric tumors from a randomized phase III Japanese clinical trial (GC0301/TOP002) testing the efficacy of irinotecan plus S-1(IRI-S) versus S-1 therapy. We found that previously established proliferative subtype signatures, were associated with older patients (>65 years) and liver metastasis while mesenchymal subtype signatures were associated with younger patients (≤65 years) and peritoneal metastasis. Genes associated with tumor microenvironment (CD4, CD14, ADAMTS1, CCL5, CXCL12, CCL19), therapeutic implications (DPYD) and oncogenic signaling (Wnt5A, PTRF) were significantly associated with patient age, histology, tumor status, measurable lesions and metastasis. We identified Wnt5A downregulation as a candidate predictor of improved progression free survival (>8 weeks) in S-1 but not in IRI-S treatment. Although statistical significance was not achieved, mesenchymal subtype showed a trend for treatment interaction with IRI-S for efficacy. These findings highlight promising genomic markers that could be useful predictors of chemotherapy