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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. The efficacy of social cognitive theory-based self-care intervention for rational antibiotic use: a randomized trial.

    Science.gov (United States)

    Mohebbi, Bahram; Tol, Azar; Sadeghi, Roya; Yaseri, Mehdi; Akbari Somar, Negar; Doyore Agide, Feleke

    2018-05-19

    Misuse of antibiotics can be described as a failure to complete treatment, skipping of the doses and reuse of leftover medicines and overuse of antibiotics. Health education interventions are expected to enhance awareness and general belief on rational antibiotics use. Therefore, the study aimed to determine the efficacy of social cognitive theory (SCT)-based self-care intervention for rational antibiotic use. This randomized trial was conducted in a sample of 260 adults. The study participants were randomly assigned as the intervention (n=130) and a control (n=130) groups. The intervention group received self-care educational intervention of four sessions lasting 45-60 min augmented with the text messages and the control groups attended usual education program in health centers. The study participants were invited to complete questionnaires at the baseline and end of the intervention. The data were analyzed using SPSS version 23.0. Chi-square (X2), independent t-test and covariance analysis were used for data analysis. Prational antibiotic use showed a significant difference in intervention group before and after six months (P0.05). The study suggested that tailored appropriate educational programs based on SCT constructs can reflect a positive impact on appropriate antibiotics use. Therefore, a tailored health promotion intervention should be provided to enhance the awareness and general beliefs of the target groups.

  3. 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 .

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

    International Nuclear Information System (INIS)

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

    2014-01-01

    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

  5. Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

    Science.gov (United States)

    Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

    2012-03-01

    This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

  6. 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

  7. Effectiveness of a theory-based intervention to increase colorectal cancer screening among Iranian health club members: a randomized trial.

    Science.gov (United States)

    Salimzadeh, Hamideh; Eftekhar, Hassan; Majdzadeh, Reza; Montazeri, Ali; Delavari, Alireza

    2014-10-01

    Colorectal cancer is the third most commonly diagnosed cancer and the fourth leading cause of death in the world. There are few published studies that have used theory-based interventions designed to increase colorectal cancer screening in community lay health organizations. The present study was guided by the theoretical concepts of the preventive health model. Twelve health clubs of a municipal district in Tehran were randomized to two study groups with equal ratio. The control group received usual services throughout the study while the intervention group also received a theory-based educational program on colorectal cancer screening plus a reminder call. Screening behavior, the main outcome, was assessed 4 months after randomization. A total of 360 members aged 50 and older from 12 health clubs completed a baseline survey. Participants in the intervention group reported increased knowledge of colorectal cancer and screening tests at 4 months follow-up (p's theory-based intervention significantly improved self-efficacy, perceived susceptibility, efficacy of screening, social support, and intention to be screened for colorectal cancer, from baseline to 4 months follow-up (p's theory-based intervention was found to have a significant effect on colorectal cancer screening use as measured by self-report. The findings could have implications for colorectal cancer screening program development and implementation in primary health care settings and through other community organizations.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

    Science.gov (United States)

    Wright, Julie A; Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

    2014-11-10

    Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405

  13. 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

  14. 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.

  15. Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Brody, Carinne; Tuot, Sovannary; Chhoun, Pheak; Swendenman, Dallas; Kaplan, Kathryn C; Yi, Siyan

    2018-04-19

    In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them

  16. 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...

  17. 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.

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

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  19. 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.

  20. Effectiveness of a theory-based mobile phone text message intervention for improving protective behaviors of pregnant women against air pollution: a randomized controlled trial.

    Science.gov (United States)

    Jasemzadeh, Mehrnoosh; Khafaie, Morteza Abdullatif; Jaafarzadeh, Nematallah; Araban, Marzieh

    2018-03-01

    Health impact of exposure to air pollution is a public health concern. The aim of this study was to investigate an extended parallel process model (EPPM)-based mobile phone text message intervention for improving protective behaviors against air pollution among pregnant women. In this randomized controlled trial (IRCT2016102810804N8), 130 pregnant women were randomly assigned into either experimental or control groups. A valid and reliable questionnaire was used to collect data. Experimental group received mobile phone intervention on a daily basis for 2 months. Control group received usual care, only. Data were analyzed using SPSS 15 applying t test, chi-square, and Wilcoxon and Mann-Whitney U test. Although before intervention, there were no significant differences between different structures of EPPM (P > 0.05), after intervention, there were statistically significant differences between perceived severity, response efficacy, self-efficacy, and protective behaviors between two groups (P mobile phone intervention could promote protective behaviors against air pollution among pregnant women. The present study might be used as a framework for evidence-based health promotion regarding air pollution risk communication and self-care behaviors. IRCT2016102810804N8.

  1. Policing behaviors, safe injection self-efficacy, and intervening on injection risks: Moderated mediation results from a randomized trial.

    Science.gov (United States)

    Pitpitan, Eileen V; Patterson, Thomas L; Abramovitz, Daniela; Vera, Alicia; Martinez, Gustavo; Staines, Hugo; Strathdee, Steffanie A

    2016-01-01

    We aim to use conditional or moderated mediation to simultaneously test how and for whom an injection risk intervention was efficacious at reducing receptive needle sharing among female sex workers who inject drugs (FSWs-IDUs) in Mexico. Secondary analysis of data from a randomized trial. A total of 300 FSW-IDUs participated in Mujer Mas Segura in Ciudad Juarez, Mexico, and were randomized to an interactive injection risk intervention or a didactic injection risk intervention. We measured safe injection self-efficacy as the hypothesized mediator and policing behaviors (being arrested and syringe confiscation) as hypothesized moderators. In total, 213 women provided complete data for the current analyses. Conditional (moderated) mediation showed that the intervention affected receptive needle sharing through safe injection self-efficacy among women who experienced syringe confiscation. On average, police syringe confiscation was associated with lower safe injection self-efficacy (p = .04). Among those who experienced syringe confiscation, those who received the interactive (vs. didactic) intervention reported higher self-efficacy, which in turn predicted lower receptive needle sharing (p = .04). Whereas syringe confiscation by the police negatively affected safe injection self-efficacy and ultimately injection risk behavior, our interactive intervention helped to "buffer" this negative impact of police behavior on risky injection practices. The theory-based, active skills building elements included in the interactive condition, which were absent from the didactic condition, helped participants' self-efficacy for safer injection in the face of syringe confiscation. (c) 2015 APA, all rights reserved).

  2. Sieve analysis in HIV-1 vaccine efficacy trials.

    Science.gov (United States)

    Edlefsen, Paul T; Gilbert, Peter B; Rolland, Morgane

    2013-09-01

    The genetic characterization of HIV-1 breakthrough infections in vaccine and placebo recipients offers new ways to assess vaccine efficacy trials. Statistical and sequence analysis methods provide opportunities to mine the mechanisms behind the effect of an HIV vaccine. The release of results from two HIV-1 vaccine efficacy trials, Step/HVTN-502 (HIV Vaccine Trials Network-502) and RV144, led to numerous studies in the last 5 years, including efforts to sequence HIV-1 breakthrough infections and compare viral characteristics between the vaccine and placebo groups. Novel genetic and statistical analysis methods uncovered features that distinguished founder viruses isolated from vaccinees from those isolated from placebo recipients, and identified HIV-1 genetic targets of vaccine-induced immune responses. Studies of HIV-1 breakthrough infections in vaccine efficacy trials can provide an independent confirmation to correlates of risk studies, as they take advantage of vaccine/placebo comparisons, whereas correlates of risk analyses are limited to vaccine recipients. Through the identification of viral determinants impacted by vaccine-mediated host immune responses, sieve analyses can shed light on potential mechanisms of vaccine protection.

  3. 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

    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......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....... 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....

  4. Dose Relations between Goal Setting, Theory-Based Correlates of Goal Setting and Increases in Physical Activity during a Workplace Trial

    Science.gov (United States)

    Dishman, Rod K.; Vandenberg, Robert J.; Motl, Robert W.; Wilson, Mark G.; DeJoy, David M.

    2010-01-01

    The effectiveness of an intervention depends on its dose and on moderators of dose, which usually are not studied. The purpose of the study is to determine whether goal setting and theory-based moderators of goal setting had dose relations with increases in goal-related physical activity during a successful workplace intervention. A…

  5. 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

  6. 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  virtual reality surgical simulation training of novices.

  7. A randomised control crossover trial of a theory based intervention to improve sun-safe and healthy behaviours in construction workers: study protocol.

    Science.gov (United States)

    Nioi, Amanda; Wendelboe-Nelson, Charlotte; Cowan, Sue; Cowie, Hilary; Rashid, Shahzad; Ritchie, Peter; Cherrie, Mark; Lansdown, Terry C; Cherrie, John W

    2018-02-15

    Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels. Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and

  8. 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.

  9. Traditional and new composite endpoints in heart failure clinical trials : facilitating comprehensive efficacy assessments and improving trial efficiency

    NARCIS (Netherlands)

    Anker, Stefan D. t; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J.; Ceconi, Claudio; Cowie, Martin R.; AdamCrisp,; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A.; Holcomb, Richard; Honarpour, Narimon; Jukema, J. Wouter; Kim, Albert M.; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A.; McMurray, John J.; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M. C.; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A.; Ruschitzka, Frank

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and

  10. Theory-Based Stakeholder Evaluation

    Science.gov (United States)

    Hansen, Morten Balle; Vedung, Evert

    2010-01-01

    This article introduces a new approach to program theory evaluation called theory-based stakeholder evaluation or the TSE model for short. Most theory-based approaches are program theory driven and some are stakeholder oriented as well. Practically, all of the latter fuse the program perceptions of the various stakeholder groups into one unitary…

  11. MR arthrography: pharmacology, efficacy and safety in clinical trials

    International Nuclear Information System (INIS)

    Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

    2003-01-01

    A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

  12. A social cognitive theory-based programme for eating patterns and sedentary activity among overweight adolescents in Makassar, South Sulawesi : a cluster randomised controlled trial.

    Science.gov (United States)

    Hidayanty, Healthy; Bardosono, Saptawati; Khusun, Helda; Damayanti, Rita; Kolopaking, Risatianti

    2016-12-01

    Social cognitive theory provides the opportunity for program development to enhance healthy personal behvioural characteristics. We devised study to employ social cognitive theory to reduce snacking habits and sedentary activity among overweight adolescents . Eight junior high schools in Makassar city were randomly assigned as intervention and control schools. A total of 238 overweight students aged 11-15 years (BMI z-score >=1 SD, according to a 2007 report from the WHO) were recruited. Adolescents from the intervention schools attended 12 weekly 75-min nutrition education group sessions, which focused on behavioural modification assisted by trained facilitators; furthermore, their parents received weekly nutrition education leaflets. Adolescents from the control schools, but not their parents, received leaflets on evidenced-based nutrition information. The BMI z-scores, waist circumference, snacking habits, sedentary activity, and the adolescents' self-efficacy data were assessed prior to and after 3 months of intervention. The outcomes were analysed on an intent-to-treat basis. Compared with the control group, the intervention group showed a higher reduction in BMI z-scores (-0.08; p<0.05) and waist circumference (-1.5; p<0.05) at 3 months. Significant between-group differences were also observed for decreased snacking habits, but not for sedentary activity. Additionally, the programme improved self-efficacy for reducing these behaviours. Mean compliance and satisfaction with the programme were 95% and 92%, respectively. These high reduction rates suggest that the programme is promising and may address the problem of overweightness in adolescents. Additional studies are required to develop the programme in community settings.

  13. 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

  14. 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

  15. A theory-based implementation program for alcohol screening and brief intervention (ASBI) in general practices: Planned development and study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    Abidi, L; Oenema, A; Candel, M J J M; van de Mheen, D

    2016-11-01

    Previous studies have shown that alcohol screening and brief intervention (ASBI) in general practices can lead to significant reductions in alcohol consumption among patients, yet ASBI is rarely implemented into routine clinical practice. The aim of this paper is to describe the development and evaluation of an ASBI implementation program aimed at increasing ASBI delivery rates of general practitioners (GPs) and decreasing patients' alcohol consumption. This study protocol describes the step-wise development and evaluation of an ASBI implementation program. A four-step method is used to identify relevant determinants of change and intervention components based on the Behaviour Change Wheel and the Theoretical Domains Framework. The program will be evaluated in general practices in The Netherlands in a two-arm cluster randomised controlled trial which investigates the effect of the program on GPs' ASBI delivery behaviour as well as on patients' alcohol consumption. Effective theory- and practice-based strategies to implement ASBI in general practices are highly needed. Using a stepwise method we described the development of a program consisting of an e-learning module, a tailored feedback module and environmental support and materials. We hypothesize that this program will result in an increase of GPs' ASBI delivery behaviour. Secondly, we expect an overall decrease in percentage of patients with excessive or problematic alcohol use and a higher proportion of patients from GPs receiving the ASBI implementation program decreasing their alcohol consumption, compared to patients from GPs in the control group. NTR5539. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

    Gorin, Amy A; Powers, Theodore A; Gettens, Katelyn; Cornelius, Talea; Koestner, Richard; Mobley, Amy R; Pescatello, Linda; Medina, Tania Huedo

    2017-09-29

    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. 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. This study addresses the fundamental importance of interpersonal

  18. Randomised controlled trial of the efficacy of misoprostol used as a ...

    African Journals Online (AJOL)

    Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Eric T M de Jonge, Rachel Jewkes, Jonathan Levin, Helen Rees ...

  19. 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.

  20. 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

  1. Do Published Data in Trials Assessing Cancer Drugs Reflect the Real Picture of Efficacy and Safety?

    Science.gov (United States)

    Lv, Jia-Wei; Chen, Yu-Pei; Zhou, Guan-Qun; Liu, Xu; Guo, Ying; Mao, Yan-Ping; Ma, Jun; Sun, Ying

    2017-11-01

    Background: The reporting quality of publications is of vital importance to ensure accurate evidence dissemination. This study aimed to compare the consistency of results reporting between the ClinicalTrials.gov results database and the respective matching publications. Methods: We identified 323 phase III/IV cancer drug trials with a randomized controlled design and searched PubMed for publications in a 50% random sample (n=160). Data were extracted independently from ClinicalTrials.gov and publications. A scoring system was applied to determine characteristics associated with reporting quality. Results: Of 117 reviewed trials with publications, result reporting was significantly more complete in ClinicalTrials.gov for efficacy measurement (92.3% vs 90.6%), serious adverse events (SAEs; 100% vs 43.6%), and other adverse events (OAEs; 100% vs 62.4%). For trials with both posted and published results for design information (n=117), efficacy measurements (n=98), SAEs (n=51), and OAEs (n=73), discrepancies were found in 16 (13.7%), 38 (38.8%), 26 (51.0%), and 54 (74.0%) trials, respectively. Overreporting of treatment effects (7 trials) and alteration of primary end points favoring statistically significant outcomes (11 trials) were the major discrepancies in efficacy reporting; incomplete (66 trials) and underreporting (20 trials) of SAEs were the predominant issues in benefit/risk reporting. Median quality score was 21 (range, 14-28). Trials that had parallel assignment, were phase IV, had primary funding by industry, were completed after 2009, and had earlier results posted possessed better reporting quality. Conclusions: Although most trials showed reasonable completeness and consistency, some discrepancies are prevalent and persistent, jeopardizing evidence-based decision-making. Our findings highlight the need to consult results systematically from both ClinicalTrials.gov and publications. Copyright © 2017 by the National Comprehensive Cancer Network.

  2. 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......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

  3. Should academic medical centers conduct clinical trials of the efficacy of intercessory prayer?

    Science.gov (United States)

    Halperin, E C

    2001-08-01

    Intercessory prayers for health or healing are requests to an object of worship for the preservation or restoration of health. There has been a recent proliferation of clinical trials that compare the health outcome of a group of prayed-for patients with that of controls, to test the efficacy of intercessory prayer. In this essay, the author defines the concept of intercessory prayer, contrasts it with other forms of prayer, and reviews the literature concerning clinical trials of its efficacy. The arguments put forward in favor of conducting such trials and those against are described and the reader is invited to consider their relative merits. The author concludes by discussing the potential power of faith in healing, reviewing the philosophical basis and pitfalls of clinical trials of intercessory prayer, and urging readers to weigh the arguments for and against such trials in academic medicine.

  4. Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial.

    Science.gov (United States)

    Champion, Jane Dimmitt; Collins, Jennifer L

    2012-02-01

    Ethnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women. To evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up. Controlled randomized trial with longitudinal follow-up. Southwestern United States, Metropolitan community-based clinic. Mexican-and-African American adolescent women aged 14-18 years with a history of abuse or sexually transmitted infection seeking sexual health care. Extensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models. 409 Mexican-(n=342) and African-(n=67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93

  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. 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

  7. A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

    Science.gov (United States)

    Neuzil, Kathleen M; Zaman, K; Victor, John C

    2014-08-11

    Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

  8. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    Full Text Available Abstract Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma, tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12. Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12 to determine subsequent fracture rates. Our co

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

    OpenAIRE

    Bradford, Andrew; Lees, Kennedy

    2000-01-01

    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....

  10. Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial

    OpenAIRE

    Bradford, A.; Lees, K.

    2000-01-01

    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 rando...

  11. 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.

  12. 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…

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

    Science.gov (United States)

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

    2015-01-01

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

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

    African Journals Online (AJOL)

    An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...

  15. 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.

  16. The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

    NARCIS (Netherlands)

    Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

    1992-01-01

    Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

  17. 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…

  18. Evaluation of early efficacy endpoints for proof-of-concept trials.

    Science.gov (United States)

    Chen, Cong; Sun, Linda; Li, Chih-Lin

    2013-03-11

    A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.

  19. The mediating role of self-efficacy in the relationship between premotivational cognitions and engagement in multiple health behaviors: a theory-based cross-sectional study among township residents in South Africa.

    Science.gov (United States)

    Tshuma, Ndumiso; Muloongo, Keith; Nkwei, Emile S; Alaba, Olufunke A; Meera, Maheedhariah S; Mokgobi, Maboe G; Nyasulu, Peter S

    2017-01-01

    Noncommunicable diseases (NCDs) are one of the major global health challenges in developed countries and are rapidly increasing globally. Perception of self-efficacy is important for complex activities and long-term changes in health behavior. This study aimed to determine whether self-efficacy mediates the effect of individual beliefs (perceived severity, susceptibility, benefits and barriers) among informal settlement residents' health behavior in relation to the prevention and management of NCDs. A cross-sectional survey was conducted using a closed-ended questionnaire among informal settlement residents in Diepsloot, Johannesburg. The proposed model was tested using structural equation modeling (AMOS software). A total of 2,277 participants were interviewed during this survey, consisting of 1,236 (54.3%) females, with the majority of them aged between 20 and 29 years. All constructs in the questionnaire had a good reliability with a Cronbach's alpha of >0.7. Perceived benefits and perceived barriers were the strongest predictors of self-efficacy, with the highest beta values of 0.14 and 0.15, respectively. Once associated with perceived self-efficacy, the direct effect of perceived susceptibility and perceived benefits on health behavior was statistically nonsignificant ( P =0.0894 and P =0.2839, respectively). Perceived benefits and perceived susceptibility were totally mediated by self-efficacy. The indirect effects of perceived severity and perceived barriers (through self-efficacy) on health behavior were significant. Thus, perceived severity and perceived barriers were partially mediated by self-efficacy. Perceived susceptibility and perceived benefits did not affect health behavior unless associated with self-efficacy. In contrast, individual perception of the seriousness of NCDs and perceived barriers might still have a direct influence on health behavior even if the person does not feel able to prevent NCDs. However, this influence would be more

  20. 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.

  1. 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.

  2. 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.

    2013-01-01

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

  3. Review of key Belotero Balance safety and efficacy trials.

    Science.gov (United States)

    Lorenc, Z Paul; Fagien, Steven; Flynn, Timothy C; Waldorf, Heidi A

    2013-10-01

    Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

  4. Efficacy trial of Camouflage Syringe to reduce dental fear and anxiety.

    Science.gov (United States)

    Ujaoney, S; Mamtani, M; Thakre, T; Tote, J; Hazarey, V; Hazarey, P; Kulkarni, H

    2013-12-01

    Dental fear and anxiety in early childhood are widely prevalent and contribute to dental problems and behaviour in adulthood. Novel ways to reduce dental fear and anxiety in children are needed. Our aim was to conduct an efficacy trial of a novel Camouflage Syringe to reduce dental fear and anxiety in children. randomised controlled trial of efficacy of the Camouflage Syringe. We designed a Camouflage Syringe with a toy-like appearance that veils the conventional syringe to permit topical application and injection of local anaesthesia and ensure more involvement of the patient in the treatment process. We conducted a concurrent parallel, randomised controlled trial (NCT01398007) on the efficacy of this Camouflage Syringe to reduce the dental fear and anxiety in children seeking dental treatment who required the use of local anaesthesia. Using Venham's clinical rating scale, Venham's picture test, parental stress questionnaire and recall questionnaire, the efficacy of the Camouflage Syringe to reduce dental fear and anxiety ranged from 82% to 97% for various outcomes and from 60% to 100% for prevention of related adverse outcomes. For all outcomes, the number needed to treat was close to unity. Our results strongly favour the use of Camouflage Syringe to reduce dental fear and anxiety in children.

  5. 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

    2016-12-01

    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 self-care tools; and to examine the effects of a depression self-care coaching intervention on these two outcomes. Design/Study Setting. A secondary analysis of activation and self-efficacy data collected as part of a randomized trial to compare the effects of a telephone-based coached depression self-care intervention with a noncoached intervention. Activation (Patient Activation Measure) was measured at baseline and 6 months. Depression self-care self-efficacy was assessed at baseline, at 3 months, and at 6 months. In multivariable cross-sectional analyses (n = 215), activation and/or self-efficacy were associated with language, birthplace, better physical and mental health, individual exercise, specialist visits, and antidepressant nonuse. In longitudinal analyses (n = 158), an increase in activation was associated with increased medication adherence; an increase in self-efficacy was associated with use of cognitive self-care strategies and increases in social and solitary activities. There were significant improvements from baseline to 6 months in activation and self-efficacy scores both among coached and noncoached groups. The self-care coaching intervention did not affect 6-month activation or self-efficacy but was associated with quicker improvement in self-efficacy. Overall, the results for activation and self-efficacy were similar, although self-efficacy correlated more consistently than activation with depression-specific behaviors and was responsive to a depression self-care coaching intervention. © 2016 Society for Public Health Education.

  6. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  7. 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...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

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

    Science.gov (United States)

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

    2014-06-21

    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. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

  9. 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.

  10. Lithium carbonate in amyotrophic lateral sclerosis: lack of efficacy in a dose-finding trial.

    Science.gov (United States)

    Chiò, A; Borghero, G; Calvo, A; Capasso, M; Caponnetto, C; Corbo, M; Giannini, F; Logroscino, G; Mandrioli, J; Marcello, N; Mazzini, L; Moglia, C; Monsurrò, M R; Mora, G; Patti, F; Perini, M; Pietrini, V; Pisano, F; Pupillo, E; Sabatelli, M; Salvi, F; Silani, V; Simone, I L; Sorarù, G; Tola, M R; Volanti, P; Beghi, E

    2010-08-17

    A neuroprotective effect of lithium in amyotrophic lateral sclerosis (ALS) has been recently reported. We performed a multicenter trial with lithium carbonate to assess its tolerability, safety, and efficacy in patients with ALS, comparing 2 different target blood levels (0.4-0.8 mEq/L, therapeutic group [TG], vs 0.2-0.4 mEq/L, subtherapeutic group [STG]). The study was a multicenter, single-blind, randomized, dose-finding trial, conducted from May 2008 to November 2009 in 21 Italian ALS centers. The trial was registered with the public database of the Italian Agency for Drugs (http://oss-sper-clin.agenziafarmaco.it/) (EudraCT number 2008-001094-15). As of October 2009, a total of 171 patients had been enrolled, 87 randomized to the TG and 84 to the STG. The interim data analysis, performed per protocol, showed that 117 patients (68.4%) discontinued the study because of death/tracheotomy/severe disability, adverse events (AEs)/serious AEs (SAEs), or lack of efficacy. The Data Monitoring Committee recommended stopping the trial on November 2, 2009. Lithium was not well-tolerated in this cohort of patients with ALS, even at subtherapeutic doses. The 2 doses were equivalent in terms of survival/severe disability and functional data. The relatively high frequency of AEs/SAEs and the reduced tolerability of lithium raised serious doubts about its safety in ALS. The study provides Class II evidence that therapeutic (0.4-0.8 mEq/L) vs subtherapeutic (0.2-0.4 mEq/L) lithium carbonate did not differ in the primary outcome of efficacy (survival/loss of autonomy) in ALS. Both target levels led to dropouts in more than 30% of participants due to patient-perceived lack of efficacy and AEs.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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; pgroup. 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.

  16. 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.

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

    Science.gov (United States)

    Edlefsen, Paul T; Rolland, Morgane; Hertz, Tomer; Tovanabutra, Sodsai; Gartland, Andrew J; deCamp, Allan C; Magaret, Craig A; Ahmed, Hasan; Gottardo, Raphael; Juraska, Michal; McCoy, Connor; Larsen, Brendan B; Sanders-Buell, Eric; Carrico, Chris; Menis, Sergey; Kijak, Gustavo H; Bose, Meera; Arroyo, Miguel A; O'Connell, Robert J; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Kaewkungwal, Jaranit; Rerks-Ngarm, Supachai; Robb, Merlin L; Kirys, Tatsiana; Georgiev, Ivelin S; Kwong, Peter D; Scheffler, Konrad; Pond, Sergei L Kosakovsky; Carlson, Jonathan M; Michael, Nelson L; Schief, William R; Mullins, James I; Kim, Jerome H; Gilbert, Peter B

    2015-02-01

    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 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 efficacy trials for diverse pathogens.

  18. Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

    Science.gov (United States)

    Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

    2013-04-01

    To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

  19. Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial.

    Science.gov (United States)

    Bradford, Andrew; Lees, Kennedy

    2000-01-01

    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.

  20. The efficacy of virtual reality simulation training in laparoscopy: a systematic review of randomized trials.

    Science.gov (United States)

    Larsen, Christian Rifbjerg; Oestergaard, Jeanett; Ottesen, Bent S; Soerensen, Jette Led

    2012-09-01

    Virtual reality (VR) simulators for surgical training might possess the properties needed for basic training in laparoscopy. Evidence for training efficacy of VR has been investigated by research of varying quality over the past decade. To review randomized controlled trials regarding VR training efficacy compared with traditional or no training, with outcome measured as surgical performance in humans or animals. In June 2011 Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science and Google Scholar were searched using the following medical subject headings (MeSh) terms: Laparoscopy/standards, Computing methodologies, Programmed instruction, Surgical procedures, Operative, and the following free text terms: Virtual real* OR simulat* AND Laparoscop* OR train* Controlled trials. All randomized controlled trials investigating the effect of VR training in laparoscopy, with outcome measured as surgical performance. A total of 98 studies were screened, 26 selected and 12 included, with a total of 241 participants. Operation time was reduced by 17-50% by VR training, depending on simulator type and training principles. Proficiency-based training appeared superior to training based on fixed time or fixed numbers of repetition. Simulators offering training for complete operative procedures came out as more efficient than simulators offering only basic skills training. Skills in laparoscopic surgery can be increased by proficiency-based procedural VR simulator training. There is substantial evidence (grade IA - IIB) to support the use of VR simulators in laparoscopic training. © 2012 The Authors  Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

  1. 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

  2. [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.

  3. 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.

  4. Closing the antidepressant efficacy gap between clinical trials and real patient populations.

    Science.gov (United States)

    Wade, Alan G

    2006-01-01

    Overall, patient outcomes in the primary care of depression are seldom as good as those achieved in clinical trials - the "efficacy gap". Many factors contribute to this, including poor patient compliance, poor family and social support and negative media reporting of antidepressants. Indeed, negative media reporting has had far more impact on physicians' prescribing of antidepressants than have regulatory agencies, partly as a result of changing public attitudes. Negative media reports linking SSRIs to increased child suicide rates have also resulted in a decline in the prescribing of SSRIs to this age group, but with no concomitant increase in the prescribing of fluoxetine, the only antidepressant recommended for the treatment of children. There are also inadequacies in the guidelines available to primary care givers that might contribute to the efficacy gap. Guidelines can be too specific for clinical practice - especially where depression coexists with anxiety disorders - and too passive, resulting in delayed or inadequate intervention. Evidence suggests that many physicians prefer to be more proactive. In the recent AHEAD survey, physicians identified faster resolution of symptoms as the property most desirable for improving antidepressant therapy. There is recent evidence that structured long-term therapy and easily-implemented measurement-based care procedures can improve remission rates and help bridge the efficacy gap. If these can be allied with greater public/media understanding of depression and its treatment, along with improved guidelines, then significant progress can be anticipated in the management of mood disorders.

  5. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  6. 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.

  7. 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

  8. Within-person relationship between self-efficacy and performance across trials. Effect of task objective and task type.

    Science.gov (United States)

    Hepler, Teri J; Ritchie, Jason; Hill, Christopher R

    2017-07-05

    Self-efficacy has been shown to be a consistent, positive predictor of between-persons performance in sport. However, there have been equivocal results regarding the influence of self-efficacy on a person's performance over time. This study investigated the influence of self-efficacy on motor skill performance across trials with respect to two different task objectives and task types. Participants (N=84) performed 4 blocks of 10 trials of a dart throwing (closed skill) and a hitting (open skill) task under 2 different task objectives: competitive and goal-striving. For the goal-striving condition, success was defined as reaching a pre-determined performance level. The competitive condition involved competing against an opponent. Hierarchical linear modeling was used to examine the influence of past performance and self-efficacy on the within-person performance across multiple trials. Previous performance was negatively related with subsequent performance on all conditions. Self-efficacy was not a significant predictor of performance on any of the conditions. While task objective and task type did not moderate the efficacy-performance relationship in the current study, it is important to consider the role of other moderators in future research.

  9. Effect Size in Efficacy Trials of Women With Decreased Sexual Desire.

    Science.gov (United States)

    Pyke, Robert E; Clayton, Anita H

    2018-03-22

    Regarding hypoactive sexual desire disorder (HSDD) in women, some reviewers judge the effect size small for medications vs placebo, but substantial for cognitive behavior therapy (CBT) or mindfulness meditation training (MMT) vs wait list. However, we lack comparisons of the effect sizes for the active intervention itself, for the control treatment, and for the differential between the two. For efficacy trials of HSDD in women, compare effect sizes for medications (testosterone/testosterone transdermal system, flibanserin, and bremelanotide) and placebo vs effect sizes for psychotherapy and wait-list control. We conducted a literature search for mean changes and SD on main measures of sexual desire and associated distress in trials of medications, CBT, or MMT. Effect size was used as it measures the magnitude of the intervention without confounding by sample size. Cohen d was used to determine effect sizes. For medications, mean (SD) effect size was 1.0 (0.34); for CBT and MMT, 1.0 (0.36); for placebo, 0.55 (0.16); and for wait list, 0.05 (0.26). Recommendations of psychotherapy over medication for treatment of HSDD are premature and not supported by data on effect sizes. Active participation in treatment conveys considerable non-specific benefits. Caregivers should attend to biological and psychosocial elements, and patient preference, to optimize response. Few clinical trials of psychotherapies were substantial in size or utilized adequate control paradigms. Medications and psychotherapies had similar, large effect sizes. Effect size of placebo was moderate. Effect size of wait-list control was very small, about one quarter that of placebo. Thus, a substantial non-specific therapeutic effect is associated with receiving placebo plus active care and evaluation. The difference in effect size between placebo and wait-list controls distorts the value of the subtraction of effect of the control paradigms to estimate intervention effectiveness. Pyke RE, Clayton AH

  10. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials.

    Science.gov (United States)

    Levkovitz, Yeciel; Tedeschini, Enrico; Papakostas, George I

    2011-04-01

    The authors sought to determine the efficacy of antidepressants in dysthymic disorder and to compare antidepressant and placebo response rates between major depressive disorder (MDD) and dysthymic disorder. PubMed/MEDLINE databases were searched for double-blind, randomized, placebo-controlled trials of antidepressants used as monotherapy for treatment of MDD or dysthymic disorder. We defined antidepressants as those with a letter of approval by the US, Canadian, or European Union drug regulatory agencies for treatment of MDD or dysthymic disorder, which included the following: amitriptyline, nortriptyline, imipramine, desipramine, clomipramine, trimipramine, protriptyline, dothiepin, doxepin, lofepramine, amoxapine, maprotiline, amineptine, nomifensine, bupropion, phenelzine, tranylcypromine, isocarboxazid, moclobemide, brofaromine, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine, zimelidine, tianeptine, ritanserin, trazodone, nefazodone, agomelatine, venlafaxine, desvenlafaxine, duloxetine, milnacipran, reboxetine, mirtazapine, and mianserin. Eligible studies were identified by cross-referencing the search term placebo with each of the above-mentioned agents. The search was limited to articles published between January 1, 1980, and November 20, 2009 (inclusive). To expand our database, we also reviewed the reference lists of the identified studies. We selected randomized, double-blind, placebo-controlled trials of antidepressants for either MDD or dysthymic disorder according to preset criteria relating to comorbidities, patient age, drug formulation, study duration, diagnostic criteria, choice of assessment scales, and whether or not the study reported original data. Final selection of articles was determined by consensus among the authors. A total of 194 studies were found that were eligible for inclusion in our analysis. Of these, 177 focused on the treatment of MDD and 17 on the treatment of dysthymic disorder. We found that

  11. Optimal patient education for cancer pain: a systematic review and theory-based meta-analysis.

    Science.gov (United States)

    Marie, N; Luckett, T; Davidson, P M; Lovell, M; Lal, S

    2013-12-01

    Previous systematic reviews have found patient education to be moderately efficacious in decreasing the intensity of cancer pain, but variation in results warrants analysis aimed at identifying which strategies are optimal. A systematic review and meta-analysis was undertaken using a theory-based approach to classifying and comparing educational interventions for cancer pain. The reference lists of previous reviews and MEDLINE, PsycINFO, and CENTRAL were searched in May 2012. Studies had to be published in a peer-reviewed English language journal and compare the effect on cancer pain intensity of education with usual care. Meta-analyses used standardized effect sizes (ES) and a random effects model. Subgroup analyses compared intervention components categorized using the Michie et al. (Implement Sci 6:42, 2011) capability, opportunity, and motivation behavior (COM-B) model. Fifteen randomized controlled trials met the criteria. As expected, meta-analysis identified a small-moderate ES favoring education versus usual care (ES, 0.27 [-0.47, -0.07]; P = 0.007) with substantial heterogeneity (I² = 71 %). Subgroup analyses based on the taxonomy found that interventions using "enablement" were efficacious (ES, 0.35 [-0.63, -0.08]; P = 0.01), whereas those lacking this component were not (ES, 0.18 [-0.46, 0.10]; P = 0.20). However, the subgroup effect was nonsignificant (P = 0.39), and heterogeneity was not reduced. Factoring in the variable of individualized versus non-individualized influenced neither efficacy nor heterogeneity. The current meta-analysis follows a trend in using theory to understand the mechanisms of complex interventions. We suggest that future efforts focus on interventions that target patient self-efficacy. Authors are encouraged to report comprehensive details of interventions and methods to inform synthesis, replication, and refinement.

  12. Randomized controlled clinical trial on the efficacy of fosfomycin trometamol for uncomplicated gonococcal urethritis in men.

    Science.gov (United States)

    Yuan, Z; He, C; Yan, S; Ke, Y; Tang, W

    2016-06-01

    We assessed the efficacy of fosfomycin trometamol in treating uncomplicated gonococcal urethritis in men. We conducted an open randomized controlled trial in 152 consecutive men with any main complaints suggestive of uncomplicated gonococcal urethritis in Dujiangyan Medical Center between 1 September 2013 and 31 August 2015. In total, 126 patients completed all aspects of this study. Sixty were provided therapy with fosfomycin trometamol 3 g orally on days 1, 3 and 5 in the intervention group; the other 61 were provided ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally simultaneously as a single dose in the control group. The primary outcomes involved clinical and microbiologic cure on days 7 and 14 after receipt of all the study medications. At the day 7 follow-up visit, all the 121 participants had complete resolution of clinical symptoms and signs. In addition, five patients (two in the intervention group and three in the control group) discontinued intervention because of unsuccessful treatment. After receipt of all the study medications, these five patients still had urethral purulent discharge and were switched to other unknown treatment regimens by other doctors. The bacterial smears and cultures of urethral or urine specimens in the 121 patients who completed all aspects of the study were negative on a test-of-cure visit. In the per-protocol analysis, both clinical and microbiologic cure were experienced by 96.8% (60/62 patients) in the intervention group and 95.3% (61/64 patients) in the control group. There were no recurrences at the day 14 test-of-cure visit. This trial indicates that fosfomycin trometamol exhibits excellent efficacy for treatment of uncomplicated gonococcal urethritis in men. Serious adverse effects are rare. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  13. 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

  14. The efficacy of trimetazidine on stable angina pectoris: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Peng, Song; Zhao, Min; Wan, Jing; Fang, Qi; Fang, Dong; Li, Kaiyong

    2014-12-20

    This meta-analysis aimed to evaluate the efficacy of trimetazidine in combination with other anti-anginal drugs versus other anti-anginal drugs in the treatment of stable angina pectoris (SAP). Randomized controlled trials (RCTs) published in English and Chinese were retrieved from computerized databases: Embase, PubMed, and CNKI. Primary outcomes consist of clinical parameters (numbers of weekly angina attacks and nitroglycerin use) and ergometric parameters (time to 1mm ST-segment depression, and total work (in Mets) and exercise duration (in seconds) at peak exercise) in stable angina pectoris treated by trimetazidine or not. The quality of studies was evaluated using Jadad score. Data analysis of 13 studies was performed using Stata 12.0 software. Results showed that treatment of trimetazidine and other anti-anginal drugs was associated with a smaller weekly mean number of angina attacks (WMD=-0.95, 95%CI: -1.30 to -0.61, Z=5.39, Pangina pectoris. Sensitivity analysis was performed. Sub-group analysis showed that treatment duration was not a significant moderator and patients treated within 8 weeks and above 12 weeks had no difference in the outcomes addressed in this meta-analysis. No publish bias was detected. This meta-analysis confirms the efficacy of trimetazidine in the treatment of stable angina pectoris, in comparison with conventional antianginal agents, regardless of treatment duration. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. 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

  16. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial.

    Science.gov (United States)

    Papas, A S; Vollmer, W M; Gullion, C M; Bader, J; Laws, R; Fellows, J; Hollis, J F; Maupomé, G; Singh, M L; Snyder, J; Blanchard, P

    2012-02-01

    The Prevention of Adult Caries Study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983 adults (aged 18-80 yrs) at high risk for developing caries (20 or more intact teeth and 2 or more lesions at screening) to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v) dental coating (CHX). We excluded participants for whom the study treatment was contraindicated or whose health might affect outcomes or ability to complete the study. Participants were randomly assigned to receive either the CHX coating (n = 490) or a placebo control (n = 493). Coatings were applied weekly for 4 weeks and a fifth time 6 months later. The primary outcome (total net D(1-2)FS increment) was the sum of weighted counts of changes in tooth surface status over 13 months. We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol analyses. Analysis of 3 protocol-specified secondary outcomes produced similar findings. This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for the prevention of new caries (Clinicaltrials.gov registration number NCT00357877).

  17. 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.

  18. 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.

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

    Science.gov (United States)

    Ghoncheh, Rezvan; Gould, Madelyn S; Twisk, Jos Wr; Kerkhof, Ad Jfm; Koot, Hans M

    2016-01-29

    Face-to-face gatekeeper training can be an effective strategy in the enhancement of gatekeepers' knowledge and self-efficacy in adolescent suicide prevention. However, barriers related to access (eg, time, resources) may hamper participation in face-to-face training sessions. The transition to a Web-based setting could address obstacles associated with face-to-face gatekeeper training. Although Web-based suicide prevention training targeting adolescents exists, so far no randomized controlled trials (RCTs) have been conducted to investigate their efficacy. This RCT study investigated the efficacy of a Web-based adolescent suicide prevention program entitled Mental Health Online, which aimed to improve the knowledge and self-confidence of gatekeepers working with adolescents (12-20 years old). The program consisted of 8 short e-learning modules each capturing an important aspect of the process of early recognition, guidance, and referral of suicidal adolescents, alongside additional information on the topic of (adolescent) suicide prevention. A total of 190 gatekeepers (ages 21 to 62 years) participated in this study and were randomized to either the experimental group or waitlist control group. The intervention was not masked. Participants from both groups completed 3 Web-based assessments (pretest, posttest, and 3-month follow-up). The outcome measures of this study were actual knowledge, and participants' ratings of perceived knowledge and perceived self-confidence using questionnaires developed specifically for this study. The actual knowledge, perceived knowledge, and perceived self-confidence of gatekeepers in the experimental group improved significantly compared to those in the waitlist control group at posttest, and the effects remained significant at 3-month follow-up. The overall effect sizes were 0.76, 1.20, and 1.02, respectively, across assessments. The findings of this study indicate that Web-based suicide prevention e-learning modules can be an

  20. Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Yasmina Nasstasia

    2018-03-01

    Conclusion: This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.

  1. 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

  2. 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,

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. SieveSifter: a web-based tool for visualizing the sieve analyses of HIV-1 vaccine efficacy trials.

    Science.gov (United States)

    Fiore-Gartland, Andrew; Kullman, Nicholas; deCamp, Allan C; Clenaghan, Graham; Yang, Wayne; Magaret, Craig A; Edlefsen, Paul T; Gilbert, Peter B

    2017-08-01

    Analysis of HIV-1 virions from participants infected in a randomized controlled preventive HIV-1 vaccine efficacy trial can help elucidate mechanisms of partial protection. By comparing the genetic sequence of viruses from vaccine and placebo recipients to the sequence of the vaccine itself, a technique called 'sieve analysis', one can identify functional specificities of vaccine-induced immune responses. We have created an interactive web-based visualization and data access tool for exploring the results of sieve analyses performed on four major preventive HIV-1 vaccine efficacy trials: (i) the HIV Vaccine Trial Network (HVTN) 502/Step trial, (ii) the RV144/Thai trial, (iii) the HVTN 503/Phambili trial and (iv) the HVTN 505 trial. The tool acts simultaneously as a platform for rapid reinterpretation of sieve effects and as a portal for organizing and sharing the viral sequence data. Access to these valuable datasets also enables the development of novel methodology for future sieve analyses. Visualization: http://sieve.fredhutch.org/viz . Source code: https://github.com/nkullman/SIEVE . Data API: http://sieve.fredhutch.org/data . agartlan@fredhutch.org. © The Author(s) 2017. Published by Oxford University Press.

  9. Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

    Science.gov (United States)

    James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

    2016-08-01

    Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study.

    Science.gov (United States)

    Kitchener, H; Swart, A M C; Qian, Q; Amos, C; Parmar, M K B

    2009-01-10

    Hysterectomy and bilateral salpingo-oophorectomy (BSO) is the standard surgery for stage I endometrial cancer. Systematic pelvic lymphadenectomy has been used to establish whether there is extra-uterine disease and as a therapeutic procedure; however, randomised trials need to be done to assess therapeutic efficacy. The ASTEC surgical trial investigated whether pelvic lymphadenectomy could improve survival of women with endometrial cancer. From 85 centres in four countries, 1408 women with histologically proven endometrial carcinoma thought preoperatively to be confined to the corpus were randomly allocated by a minimisation method to standard surgery (hysterectomy and BSO, peritoneal washings, and palpation of para-aortic nodes; n=704) or standard surgery plus lymphadenectomy (n=704). The primary outcome measure was overall survival. To control for postsurgical treatment, women with early-stage disease at intermediate or high risk of recurrence were randomised (independent of lymph-node status) into the ASTEC radiotherapy trial. Analysis was by intention to treat. This study is registered, number ISRCTN 16571884. After a median follow-up of 37 months (IQR 24-58), 191 women (88 standard surgery group, 103 lymphadenectomy group) had died, with a hazard ratio (HR) of 1.16 (95% CI 0.87-1.54; p=0.31) in favour of standard surgery and an absolute difference in 5-year overall survival of 1% (95% CI -4 to 6). 251 women died or had recurrent disease (107 standard surgery group, 144 lymphadenectomy group), with an HR of 1.35 (1.06-1.73; p=0.017) in favour of standard surgery and an absolute difference in 5-year recurrence-free survival of 6% (1-12). With adjustment for baseline characteristics and pathology details, the HR for overall survival was 1.04 (0.74-1.45; p=0.83) and for recurrence-free survival was 1.25 (0.93-1.66; p=0.14). Our results show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early

  11. 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

  12. Recruitment for 'A pilot study of randomized controlled trial to evaluate the efficacy of lung cancer screening by thoracic CT'

    International Nuclear Information System (INIS)

    Sagawa, Motoyasu; Tanaka, Makoto; Mizukami, Satoru

    2011-01-01

    The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)

  13. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

    Science.gov (United States)

    Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

    2016-08-24

    Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

  14. Efficacy of handrubbing with alcohol based solution versus standard handwashing with antiseptic soap: randomised clinical trial

    Science.gov (United States)

    Girou, Emmanuelle; Loyeau, Sabrina; Legrand, Patrick; Oppein, Françoise; Brun-Buisson, Christian

    2002-01-01

    Objective To compare the efficacy of handrubbing with an alcohol based solution versus conventional handwashing with antiseptic soap in reducing hand contamination during routine patient care. Design Randomised controlled trial during daily nursing sessions of 2 to 3 hours. Setting Three intensive care units in a French university hospital. Participants 23 healthcare workers. Interventions Handrubbing with alcohol based solution (n=12) or handwashing with antiseptic soap (n=11) when hand hygiene was indicated before and after patient care. Imprints taken of fingertips and palm of dominant hand before and after hand hygiene procedure. Bacterial counts quantified blindly. Main outcome measures Bacterial reduction of hand contamination. Results With handrubbing the median percentage reduction in bacterial contamination was significantly higher than with handwashing (83% v 58%, P=0.012), with a median difference in the percentage reduction of 26% (95% confidence interval 8% to 44%). The median duration of hand hygiene was 30 seconds in each group. Conclusions During routine patient care handrubbing with an alcohol based solution is significantly more efficient in reducing hand contamination than handwashing with antiseptic soap. What is already known on this topicTo improve compliance with hand hygiene during patient care, handrubbing with an alcohol based solution has been proposed as a substitute for handwashing because of its rapid action and accessibilityExperimental studies show that handrubbing is at least as effective as medicated soap in reducing artificial contamination of handsMany healthcare workers still have reservations regarding its efficacy and are reluctant to use this techniqueWhat this study addsWhen used in routine practice, handrubbing with an alcohol based solution after contact with patients achieved a greater reduction in bacterial contamination of hands than conventional handwashing with medicated soap PMID:12183307

  15. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  17. Web-Based Aftercare for Women With Bulimia Nervosa Following Inpatient Treatment: Randomized Controlled Efficacy Trial.

    Science.gov (United States)

    Jacobi, Corinna; Beintner, Ina; Fittig, Eike; Trockel, Mickey; Braks, Karsten; Schade-Brittinger, Carmen; Dempfle, Astrid

    2017-09-22

    Relapse rates in bulimia nervosa (BN) are high even after successful treatment, but patients often hesitate to take up further treatment. An easily accessible program might help maintain treatment gains. Encouraged by the effects of Web-based eating disorder prevention programs, we developed a manualized, Web-based aftercare program (IN@) for women with BN following inpatient treatment. The objective of this study was to determine the efficacy of the web-based guided, 9-month, cognitive-behavioral aftercare program IN@ for women with BN following inpatient treatment. We conducted a randomized controlled efficacy trial in 253 women with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, fourth edition) BN and compared the results of IN@ with treatment as usual (TAU). Assessments were carried out at hospital admission (T0), hospital discharge/baseline (T1), postintervention (T2; 9 months after baseline), 9-month follow-up (T3; 18 months after baseline). The primary outcome, abstinence from binge eating and compensatory behaviors during the 2 months preceding T2, was analyzed by intention to treat, using logistic regression analyses. Frequencies of binge eating and vomiting episodes, and episodes of all compensatory behaviors were analyzed using mixed effects models. At T2, data from 167 women were available. There were no significant differences in abstinence rates between the TAU group (n=24, 18.9%) and the IN@ group (n=27, 21.4%; odds ratio, OR=1.29; P=.44). The frequency of vomiting episodes in the IN@ group was significantly (46%) lower than in the TAU group (P=.003). Moderator analyses revealed that both at T2 and T3, women of the intervention group who still reported binge eating and compensatory behaviors after inpatient treatment benefited from IN@, whereas women who were already abstinent after the inpatient treatment did not (P=.004; P=.002). Additional treatment utilization was high in both groups between baseline and follow-up. Overall, data

  18. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial

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    Ai May Tan

    2016-08-01

    Full Text Available Abstract Background Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. Methods A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each. Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day and physical activity level (duration: minutes/week, measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Results Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005 and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005. Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005 and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005

  19. 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

  20. The efficacy of N-acetylcysteine as an adjunctive treatment in bipolar depression: an open label trial.

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    Berk, Michael; Dean, Olivia; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa S; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Allwang, Christine; Cobb, Heidi; Bush, Ashley I; Schapkaitz, Ian; Dodd, Seetal; Malhi, Gin S

    2011-12-01

    Evidence is accumulating to support the presence of redox dysregulation in a number of psychiatric disorders, including bipolar disorder. This dysregulation may be amenable to therapeutic intervention. Glutathione is the predominant non-enzymatic intracellular free radical scavenger in the brain, and the most generic of all endogenous antioxidants in terms of action. N-acetylcysteine (NAC) is a glutathione precursor that effectively replenishes brain glutathione. Given the failure of almost all modern trials of antidepressants in bipolar disorder to demonstrate efficacy, and the limited efficacy of mood stabilisers in the depressive phase of the disorder, this is a major unmet need. This study reports data on the treatment of 149 individuals with moderate depression during the 2 month open label phase of a randomised placebo controlled clinical trial of the efficacy of 1g BID of NAC that examined the use of NAC as a maintenance treatment for bipolar disorder. In this trial, the estimated mean baseline Bipolar Depression Rating Scale (BDRS) score was 19.7 (SE=0.8), and the mean BDRS score at the end of the 8 week open label treatment phase was 11.1 (SE=0.8). This reduction was statistically significant (pdepression scores with NAC treatment. Large placebo controlled trials of acute bipolar depression are warranted. Copyright © 2011 Elsevier B.V. All rights reserved.

  1. The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial.

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    Inoue, Takuya; Takagi, Hironori; Owada, Yuki; Watanabe, Yuzuru; Yamaura, Takumi; Fukuhara, Mitsuro; Muto, Satoshi; Okabe, Naoyuki; Matsumura, Yuki; Hasegawa, Takeo; Osugi, Jun; Hoshino, Mika; Higuchi, Mitsunori; Shio, Yutaka; Yokouchi, Hiroshi; Kanazawa, Kenya; Ohbuchi, Katsuya; Fukushima, Takahisa; Munakata, Mitsuru; Suzuki, Hiroyuki

    2017-10-18

    Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement. This placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017. This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer. Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

  2. 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

    2018-02-01

    Provider training programs are frequently underevaluated, leading to ambiguity surrounding effective intervention components. The purpose of this study was 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). This was an 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: Physical 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

  3. 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

  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 and safety of adjunctive topiramate for schizophrenia: a meta-analysis of randomized controlled trials.

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    Zheng, W; Xiang, Y-T; Xiang, Y-Q; Li, X-B; Ungvari, G S; Chiu, H F K; Correll, C U

    2016-11-01

    To systematically examine the randomized controlled trial (RCT) evidence regarding efficacy and tolerability of topiramate cotreatment with antipsychotics in schizophrenia-spectrum disorders. Random-effects meta-analysis of RCTs of topiramate cotreatment with antipsychotics vs. placebo/ongoing antipsychotic treatment in schizophrenia-spectrum disorders. Standardized or weighted mean difference (SMD/WMD), risk ratio (RR) ±95% confidence intervals (CIs), and number needed to harm (NNH) were calculated. Across 16 RCTs (n = 934, duration = 11.8 ± 5.6 weeks), topiramate outperformed the comparator regarding change/endpoint of total (SMD: -0.58, 95% CI: -0.82, -0.35, P weight loss was greater in prevention/co-initiation vs. intervention/augmentation RCTs (-4.11 kg, 95% CI: -6.70, -1.52 vs. -1.41 kg, 95% CI: -2.23, -0.59, P schizophrenia-spectrum disorders. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    Science.gov (United States)

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

  7. Efficacy of succimer chelation of mercury at background exposures in toddlers: a randomized trial

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    Cao, Yang; Chen, Aimin; Jones, Robert L.; Radcliffe, Jerilynn; Dietrich, Kim N.; Caldwell, Kathleen L.; Peddada, Shyamal; Rogan, Walter J.

    2011-01-01

    Objective To examine whether succimer, a mercaptan compound known to reduce blood lead concentration in children, reduces blood mercury concentration. Study Design We used samples from a randomized clinical trial of succimer chelation for lead-exposed children. We measured mercury in pre-treatment samples from 767 children. We also measured mercury in blood samples drawn 1 week after treatment began (N=768) and in a 20% random sample of the children who received the maximum 3 courses of treatment (N=67). A bootstrap-based isotonic regression method was used to compare the trend over time in the difference between the adjusted mean mercury concentrations in the succimer group and the placebo group. Results The adjusted mean organic mercury concentration in the succimer group relative to the placebo group fell from 99% at baseline to 82% after three courses of treatment (p for trend = 0.048), but this resulted from the prevention of the age-related increase in the succimer group. Conclusion Succimer chelation for low level organic mercury exposure in children has limited efficacy. PMID:20889164

  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. A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury.

    Science.gov (United States)

    Wade, Shari L; Walz, Nicolay C; Carey, JoAnne; McMullen, Kendra M; Cass, Jennifer; Mark, Erin; Yeates, Keith Owen

    2012-11-01

    To examine the results of a randomized clinical trial (RCT) of Teen Online Problem Solving (TOPS), an online problem solving therapy model, in increasing problem-solving skills and decreasing depressive symptoms and global distress for caregivers of adolescents with traumatic brain injury (TBI). Families of adolescents aged 11-18 who sustained a moderate to severe TBI between 3 and 19 months earlier were recruited from hospital trauma registries. Participants were assigned to receive a web-based, problem-solving intervention (TOPS, n = 20), or access to online resources pertaining to TBI (Internet Resource Comparison; IRC; n = 21). Parent report of problem solving skills, depressive symptoms, global distress, utilization, and satisfaction were assessed pre- and posttreatment. Groups were compared on follow-up scores after controlling for pretreatment levels. Family income was examined as a potential moderator of treatment efficacy. Improvement in problem solving was examined as a mediator of reductions in depression and distress. Forty-one participants provided consent and completed baseline assessments, with follow-up assessments completed on 35 participants (16 TOPS and 19 IRC). Parents in both groups reported a high level of satisfaction with both interventions. Improvements in problem solving skills and depression were moderated by family income, with caregivers of lower income in TOPS reporting greater improvements. Increases in problem solving partially mediated reductions in global distress. Findings suggest that TOPS may be effective in improving problem solving skills and reducing depressive symptoms for certain subsets of caregivers in families of adolescents with TBI.

  10. Alpha lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial

    Science.gov (United States)

    Palacios-Sánchez, Begoña; Cerero-Lapiedra, Rocío; Llamas-Martínez, Silvia; Esparza-Gómez, Germán

    2015-01-01

    Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment. 27.6% of the placebo group also demonstrated some reduction in BMS symptoms. Conclusions Long-term evolution and the intensity of symptoms are variables that reduce the probability of improvement with ALA treatment. Key words: Burning mouth syndrome, neuropathy, alpha lipoic acid. PMID:26034927

  11. 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.

  12. Evidence for efficacy of acute treatment of episodic tension-type headache: methodological critique of randomised trials for oral treatments.

    Science.gov (United States)

    Moore, R Andrew; Derry, Sheena; Wiffen, Philip J; Straube, Sebastian; Bendtsen, Lars

    2014-11-01

    The International Headache Society (IHS) provides guidance on the conduct of trials for acute treatment of episodic tension-type headache (TTH), a common disorder with considerable disability. Electronic and other searches identified randomised, double-blind trials of oral drugs treating episodic TTH with moderate or severe pain at baseline, or that tested drugs at first pain onset. The aims were to review methods, quality, and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain-free after 2 hours), and to assess efficacy by meta-analysis. We identified 58 reports: 55 from previous reviews and searches, 2 unpublished reports, and 1 clinical trial report with results. We included 40 reports of 55 randomised trials involving 12,143 patients. Reporting quality was generally good, with potential risk of bias from incomplete outcome reporting and small size; the 23 largest trials involved 82% of patients. Few trials reported IHS outcomes. The number needed to treat values for being pain-free at 2 hours compared with placebo were 8.7 (95% confidence interval [CI] 6.2 to 15) for paracetamol 1000 mg, 8.9 (95% CI 5.9 to 18) for ibuprofen 400mg, and 9.8 (95% CI 5.1 to 146) for ketoprofen 25mg. Lower (better) number needed to treat values were calculated for outcomes of mild or no pain at 2 hours, and patient global assessment. These were similar to values for these drugs in migraine. No other drugs had evaluable results for these patient-centred outcomes. There was no evidence that any one outcome was better than others. The evidence available for treatment efficacy is small in comparison to the size of the clinical problem. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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

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    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.

  14. 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

  15. 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 pAtomoxetine was superior to placebo on the domains of both inattention [-0.42; 95% CI -0.49, -0.35; overall effect pAtomoxetine was significantly more efficacious (pAtomoxetine is efficacious in treating adult ADHD compared to placebo, though the efficacy is significantly superior for inattention than hyperactivity/impulsivity. Copyright © 2016. Published by Elsevier B.V.

  16. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

    Science.gov (United States)

    Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

    2017-12-22

    The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

  17. 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

  18. Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

    Science.gov (United States)

    Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

    2018-03-05

    The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

  19. 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; Newton, Katherine M.; Sherman, Sheryl; Sammel, Mary D.; La Croix, Andrea Z.

    2011-01-01

    Context Concerns for the risks of hormone therapy have resulted in its decline and a demand for non-hormonal treatments with demonstrated efficacy for hot flashes. Objective Determine the efficacy and tolerability of 10–20 mg/day escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity and bother of menopausal hot flashes. Design, Setting and Patients Randomized, double-blind, placebo-controlled, parallel arm trial for 8 weeks in a sample stratified by race (African American n=95; white n=102) and conducted at 4 MsFlash network sites between July 2009 and June 2010. Of 205 women randomized, 194 (95%) completed week 8 (intervention endpoint), and 183 completed post-treatment follow-up. Main Outcome Measures Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries. Secondary outcomes were hot flash "bother" recorded on daily diaries and clinical improvement (hot flash frequency >=50% decrease from baseline). Results Hot flash frequency was 9.78/day (SD 5.60) at baseline. At week 8, reduction in hot flash frequency was greater in the escitalopram group versus placebo (−4.60, SD 4.28 and −3.20, SD 4.76, respectively, P=0.004). Fifty-five percent of the escitalopram group (versus 36% of the placebo group) reported >=50% decreases in hot flash frequency (P=0.009). Differences in decreases in the severity and bother of hot flashes were significant (P=0.003 and P=0.013, respectively), paralleling the decreases in hot flash frequency. Three weeks after treatment ended, hot flash frequency increased in the escitalopram group to the level of the placebo group, which remained stable in the follow-up interval (P=0.020). Overall discontinuation due to side effects was 4% (7 drug, 2 placebo). Conclusion Escitalopram 10–20 mg/day provides non-hormonal off-label treatment for menopausal hot flashes that is effective and well-tolerated in healthy women. PMID:21245182

  20. 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.

  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 a biomechanically-based yoga exercise program in knee osteoarthritis: A randomized controlled trial.

    Science.gov (United States)

    Kuntz, Alexander B; Chopp-Hurley, Jaclyn N; Brenneman, Elora C; Karampatos, Sarah; Wiebenga, Emily G; Adachi, Jonathan D; Noseworthy, Michael D; Maly, Monica R

    2018-01-01

    demonstrated improvements in mobility. No improvement in any outcome was present in NE. The biomechanically-based yoga exercise program produced clinically meaningful improvements in pain, self-reported physical function and mobility in women with clinical knee OA compared to no exercise. While not statistically significant, improvements in these outcomes were larger than those elicited from the traditional exercise-based program. Though this may suggest that the yoga program may be more efficacious for knee OA, future research studying a larger sample is required. ClinicalTrials.gov (NCT02370667).

  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 metformin in pregnant obese women: a randomised controlled trial.

    Science.gov (United States)

    Chiswick, Carolyn A; Reynolds, Rebecca M; Denison, Fiona C; Whyte, Sonia A; Drake, Amanda J; Newby, David E; Walker, Brian R; Forbes, Shareen; Murray, Gordon D; Quenby, Siobhan; Wray, Susan; Norman, Jane E

    2015-01-14

    Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications. The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m(2)) pregnant women from 16 weeks' gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks' gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks' gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK. The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals. ISRCTN51279843. Published by the BMJ Publishing Group Limited. For

  5. Theory-Based Evaluation Meets Ambiguity

    DEFF Research Database (Denmark)

    Dahler-Larsen, Peter

    2017-01-01

    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...... 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...... and exemplified. Stances towards ambiguity are considered, as are concrete steps that TBE evaluators can take to identify and deal with ambiguity in TBE....

  6. 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

  7. Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial.

    Science.gov (United States)

    van Emmerik, Arnold A P; Berings, Fieke; Lancee, Jaap

    2018-01-01

    Although several hundreds of apps are available that (cl)aim to promote mindfulness, only a few methodologically sound studies have evaluated the efficacy of these apps. This randomized waiting-list controlled trial therefore tested the hypothesis that one such app (the VGZ Mindfulness Coach ) can achieve immediate and long-term improvements of mindfulness, quality of life, general psychiatric symptoms, and self-actualization. One hundred ninety-one experimental participants received the VGZ Mindfulness Coach, which offers 40 mindfulness exercises and background information about mindfulness without any form of therapeutic guidance. Compared to 186 control participants, they reported large (Cohen's d  = 0.77) and statistically significant increases of mindfulness after 8 weeks and small-to-medium increases of the Observing, Describing, Acting with awareness, Nonjudging, and Nonreactivity mindfulness facets as measured with the Five Facet Mindfulness Questionnaire (Cohen's d  = 0.66, 0.26, 0.49, 0.34, and 0.43, respectively). Also, there were large decreases of general psychiatric symptoms (GHQ-12; Cohen's d  = -0.68) and moderate increases of psychological, social, and environmental quality of life (WHOQOL-BREF; Cohen's d  = 0.38, 0.38, and 0.36, respectively). Except for social quality of life, these gains were maintained for at least 3 months. We conclude that it is possible to achieve durable positive effects on mindfulness, general psychiatric symptoms, and several aspects of quality of life at low costs with smartphone apps for mindfulness such as the VGZ Mindfulness Coach.

  8. Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

    Science.gov (United States)

    Kreutzer, Jeffrey S; Marwitz, Jennifer H; Sima, Adam P; Mills, Ana; Hsu, Nancy H; Lukow, Herman R

    2018-05-24

    Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

  9. 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.

  10. 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.

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

    International Nuclear Information System (INIS)

    Avilés, Agustin; Neri, Natividad; Fernández, Raúl; Huerta-Guzmán, Judith; Nambo, María J.

    2012-01-01

    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.

  12. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial.

    Science.gov (United States)

    Shaheen, Nicholas J; Denison, Hans; Björck, Karin; Karlsson, Maria; Silberg, Debra G

    2013-09-01

    Lesogaberan (AZD3355) is a novel γ-aminobutyric acid B-type receptor agonist designed to treat gastro-oesophageal reflux disease (GERD) by inhibiting transient lower oesophageal sphincter relaxations. A randomised, double-blind, placebo-controlled, multi-centre phase IIb study was performed to assess the efficacy and safety of lesogaberan as an add-on to proton pump inhibitor (PPI) therapy in patients with GERD who are partially responsive to PPI therapy (ClinicalTrials.gov reference: NCT01005251). In total, 661 patients were randomised to receive 4 weeks of placebo or 60, 120, 180 or 240 mg of lesogaberan twice daily, in addition to ongoing PPI therapy. Symptoms were measured using the Reflux Symptom Questionnaire electronic Diary. Response to treatment was defined as having an average of ≥ 3 additional days per week of not more than mild GERD symptoms during treatment compared with baseline. In the primary analysis, 20.9%, 25.6%, 23.5% and 26.2% of patients responded to the 60, 120, 180 and 240 mg twice daily lesogaberan doses, respectively, and 17.9% responded to placebo. The response to the 240 mg twice daily dose was statistically significantly greater than the response to placebo using a one-sided test at the predefined significance level of p < 0.1. However, the absolute increases in the proportions of patients who responded to lesogaberan compared with placebo were low. Lesogaberan was generally well tolerated, although six patients receiving lesogaberan developed reversible elevated alanine transaminase levels. In patients with GERD symptoms partially responsive to PPI therapy, lesogaberan was only marginally superior to placebo in achieving an improvement in symptoms.

  13. Efficacy of dry extract of ivy leaves in children with bronchial asthma--a review of randomized controlled trials.

    Science.gov (United States)

    Hofmann, D; Hecker, M; Völp, A

    2003-03-01

    To investigate if extracts from dried ivy leaves (Hedera helix L.) are effective in the treatment of chronic airway obstruction in children suffering from bronchial asthma. Systematic review of trials documented in the literature with re-analysis of original data. 5 randomized controlled trials investigating the efficacy of ivy leaf extract preparations in chronic bronchitis, 3 of which were conducted in children and met our selection criteria. One compared ivy leaf extract cough drops to placebo, one compared suppositories to drops and one tested syrup against drops. Body-plethysmographic and spirometric measures. Drops were significantly superior to placebo in reducing airway resistance (primary outcome measure; p = 0.04 two-sided) and descriptively superior in all other 'objective' measures. For syrup and suppositories, at least 54%, resp. 35% of the effect against placebo were preserved. The trials included in this review indicate that ivy leaf extract preparations have effects with respect to an improvement of respiratory functions of children with chronic bronchial asthma, but more far-reaching conclusions can hardly be drawn because of a meagre database, including the fact that only one primary trial included a placebo control. Further research, particularly into the long-term efficacy of the herbal extract, is needed.

  14. Estimating efficacy in the presence of non-ignorable non-trial interventions in the Helsinki Psychotherapy Study.

    Science.gov (United States)

    Härkänen, Tommi; Arjas, Elja; Laaksonen, Maarit A; Lindfors, Olavi; Haukka, Jari; Knekt, Paul

    2016-04-01

    In a randomised clinical trial with a longitudinal outcome, analyses of the efficacy of the study treatments may be complicated by both non-trial interventions, which have not been administered by the researcher, and sparsely measured outcome values. The delay between the change in outcome and the starting of the non-trial intervention may be much shorter than the time intervals between the actual measurements. We propose a model that accounts for the possible dynamic interdependence between the longitudinal outcome and time-to-event data. The model is based on discretising time into short intervals. This results in a missing data problem, which we tackle using Bayesian inference and data augmentation. The method is based on the assumption that decisions to initiate non-trial interventions are not confounded by unobservable factors. The Helsinki Psychotherapy Study data are used as an illustration. Different psychotherapies were compared, and possible episodes of psychotropic medication were viewed as non-trial interventions. Simulation studies suggest that our method provides reasonable estimates of the effects of both the study treatment and the non-trial intervention also showing some robustness against possible latent background factors. An application of marginal structural modelling, however, appeared to underestimate the differences between the treatments. © The Author(s) 2013.

  15. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial

    International Nuclear Information System (INIS)

    McNeely, Margaret L.; Campbell, Kristin L.; Webster, Marc; Kuusk, Urve; Tracey, Karen; Mackey, John

    2016-01-01

    Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated with reduced quality of life. More recent observational data suggest that the addition of night-time compression to day-time use of a compression garment results in better long-term control of arm lymphedema. The primary objectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression on arm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensive reduction treatment for their lymphedema. The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 women with breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1: Day-time compression garment alone or Group 2: Day-time compression garment + night-time compression bandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. The duration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baseline to week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire: Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. All measurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24. The use of night-time compression as a self-management strategy for chronic breast cancer related lymphedema is seen as an innovative approach to improve long-term control over the condition. This trial aims to advance the knowledge on self-management strategies for lymphedema

  16. 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

  17. 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

  18. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

    Science.gov (United States)

    Grangé, Gilles; Jacob, Nelly; Tanguy, Marie-Laure

    2014-01-01

    Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day). Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France. Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group. Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support. Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis. Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self

  19. 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

  20. 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

  1. Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

    2015-06-01

    To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

  2. 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.

  3. Virological confirmation of suspected dengue in a Phase 2 Latin American vaccine trial: Implications for vaccine efficacy evaluation

    Directory of Open Access Journals (Sweden)

    Mark Boaz

    2014-01-01

    Full Text Available The CYD tetravalent dengue vaccine candidate is being evaluated for protective efficacy against symptomatic dengue in Phase 3 efficacy trials. The laboratory test algorithm to confirm dengue cases was evaluated prior to Phase 3 trials. During a Phase 2 trial in Latin America a dengue epidemic occurred in the study countries. A total of 72 suspected dengue cases were reported and assessed: virological confirmation comprised qRT-PCR methods and a commercial ELISA kit for NS1 protein (Bio-Rad. The qRT-PCR included a screening assay targeting a conserved dengue region of the 3′-UTR (dengue screen assay followed by 4 individual serotype assays targeting the conserved dengue NS5 genomic region (WT dengue qRT-PCR assays. The NS1 and WT dengue qRT-PCR were endpoint assays for protocol virological confirmation (PVC. Of the 72 suspected cases, 14 were PVC. However, a unique pattern of dengue qRT-PCR results were observed in 5 suspected cases from Honduras: the dengue screen qRT-PCR assay was positive but WT dengue qRT-PCR and NS1 Ag ELISA were negative. To investigate these observations, additional molecular methods were applied: a SYBR® Green-based RT-PCR assay, sequencing assays directed at the genome regions covered by the WT dengue qRT-PCR, and a modified commercial dengue RT-PCR test (Simplexa™ Dengue, Focus Diagnostics. The exploratory data confirmed these additional cases as dengue and indicated the serotype 2 WT dengue qRT-PCR assay was unable to detect a circulating Latin American strain (DENV-2/NI/BID-V608/2006 due to a sequence variation in the isolate. The Simplexa Dengue RT-PCR test was able to detect and serotype dengue. Based on these findings an updated molecular test algorithm for the virological confirmation of dengue cases was developed and implemented in the Phase 3 efficacy trials.

  4. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Coombes, Brooke K; Bisset, Leanne; Vicenzino, Bill

    2010-11-20

    Few evidence-based treatment guidelines for tendinopathy exist. We undertook a systematic review of randomised trials to establish clinical efficacy and risk of adverse events for treatment by injection. We searched eight databases without language, publication, or date restrictions. We included randomised trials assessing efficacy of one or more peritendinous injections with placebo or non-surgical interventions for tendinopathy, scoring more than 50% on the modified physiotherapy evidence database scale. We undertook meta-analyses with a random-effects model, and estimated relative risk and standardised mean differences (SMDs). The primary outcome of clinical efficacy was protocol-defined pain score in the short term (4 weeks, range 0-12), intermediate term (26 weeks, 13-26), or long term (52 weeks, ≥52). Adverse events were also reported. 3824 trials were identified and 41 met inclusion criteria, providing data for 2672 participants. We showed consistent findings between many high-quality randomised controlled trials that corticosteroid injections reduced pain in the short term compared with other interventions, but this effect was reversed at intermediate and long terms. For example, in pooled analysis of treatment for lateral epicondylalgia, corticosteroid injection had a large effect (defined as SMD>0·8) on reduction of pain compared with no intervention in the short term (SMD 1·44, 95% CI 1·17-1·71, ptendon rupture). By comparison with placebo, reductions in pain were reported after injections of sodium hyaluronate (short [3·91, 3·54-4·28, peffective than was eccentric exercise. Despite the effectiveness of corticosteroid injections in the short term, non-corticosteroid injections might be of benefit for long-term treatment of lateral epicondylalgia. However, response to injection should not be generalised because of variation in effect between sites of tendinopathy. None. Copyright © 2010 Elsevier Ltd. All rights reserved.

  5. 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.

  6. 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 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.

  7. Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Lancee, Jaap; Eisma, Maarten C; van Straten, Annemieke; Kamphuis, Jan 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 to further improve the efficacy of insomnia treatment. The current study therefore has two aims: (1) to replicate the finding that online CBT is effective for insomnia and (2) to test putative mechanism of change (i.e., safety behaviors and dysfunctional beliefs). Accordingly, we conducted a randomized controlled trial in which individuals with insomnia were randomized to either online CBT for insomnia (n = 36) or a waiting-list control group (n = 27). Baseline and posttest assessments included questionnaires assessing insomnia severity, safety behaviors, dysfunctional beliefs, anxiety and depression, and a sleep diary. Three- and six-month assessments were administered to the CBT group only. Results show moderate to large statistically significant effects of the online treatment compared to the waiting list on insomnia severity, sleep measures, sleep safety behaviors, and dysfunctional beliefs. Furthermore, dysfunctional beliefs and safety behaviors mediated the effects of treatment on insomnia severity and sleep efficiency. Together, these findings corroborate the efficacy of online CBT for insomnia, and suggest that these effects were produced by changing maladaptive beliefs, as well as safety behaviors. Treatment protocols for insomnia may specifically be enhanced by more focused attention on the comprehensive fading of sleep safety behaviors, for instance through behavioral experiments.

  8. Efficacy of a grapefruit extract on head lice: a clinical trial.

    Science.gov (United States)

    Abdel-Ghaffar, Fathy; Semmler, Margit; Al-Rasheid, Khaled; Klimpel, Sven; Mehlhorn, Heinz

    2010-01-01

    Twenty children aging 2-9 years old--four boys with short hair and 16 girls with long hair--were included in a clinical test on the efficacy of a product against head lice (Pediculus humanus capitis). Their hair were exposed to Licatack, which is a recently developed new anti-louse medicinal product containing extracts of grapefruits besides high quality shampoo components. Prior to this field trial, the product Licatack was tested dermatologically to be skin safe receiving the grade "very good". The children's mothers combed the kids prior to the start of the test in order to confirm that they were all lice-infested. The obtained lice were used for in vitro tests. All children were heavily infested. After combing and preservation of the living lice, the hair was wet with tap water. Then, 50 ml of the Licatack shampoo was placed onto the top of each child's head. Then, the mothers distributed the rather fluid product all over the hair thoroughly from their base at the skin until the free end. During this process, a type of massage, the product became foamy and it was easily recognized where the product covered the hair, thus, avoiding untreated spots. The hair of half of the treated children were washed with tap water after 10 min of exposition; while in the other half of the children, the exposition period was prolonged to 20 min before washing. When combing the kids with a metal louse comb after the washing, the lice were found immobile and they did not recover during the following observation period of 4 h. Only two lice from the group with an exposition time of only 10 min showed some slight leg movements after they had been combed off, but they died within the next 2 h. Thus, this new anti-louse medicinal product has a very quick and efficient activity besides its advantages of being non-inflammable, skin safe, and nice smelling. None of the kids claimed any burning at the skin or other side effects, although the skin showed, prior to treatment, lots of scars

  9. 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 (Pparaffin group (Pparaffin group were significantly higher than the control group at 12 weeks (PParaffin bath therapy 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

  10. Efficacy of the I-SOCIAL intervention for loneliness in old age: Lessons from a randomized controlled trial.

    Science.gov (United States)

    Cohen-Mansfield, Jiska; Hazan, Haim; Lerman, Yaffa; Shalom, Vera; Birkenfeld, Shlomo; Cohen, Rinat

    2018-04-01

    Loneliness is common among older persons and is associated with adverse health and wellbeing outcomes. We investigated a theory-based intervention that addresses barriers to social contacts and aims at increasing social self-efficacy. Individuals that met pre-assessment criteria of cognitive function, physical health, and loneliness levels were randomly assigned either to the I-SOCIAL intervention that combined both individual and group sessions to address individuals' unique social challenges, or to the control group. Assessment was administered at baseline, after the completion of the intervention, and after a 3-month follow-up period. The intervention group showed significant decline in loneliness level compared to the control group, both after the intervention and after the follow-up period. This innovative combination of analysis of personal barriers, support provided by the counselors, group activities, and individualized suggestions for social activities in the participant's neighborhood, may account for the success of the intervention in decreasing participants' loneliness levels. Copyright © 2018 Elsevier Ltd. All rights reserved.

  11. 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; 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

  12. Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

    Science.gov (United States)

    Zeng, Yuxiao; Zhang, Xuecheng; Zhou, Jing; Wang, Xinwei; Jiao, Ruimin; Liu, Zhishun

    2018-05-01

    To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

  13. Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

    Science.gov (United States)

    Genovese, Mark C; Pacheco-Tena, César; Covarrubias, Arturo; Leon, Gustavo; Mysler, Eduardo; Keiserman, Mauro; Valente, Robert M; Nash, Peter; Simon-Campos, J Abraham; Box, Jane; Legerton, Clarence W; Nasonov, Evgeny; Durez, Patrick; Elegbe, Ayanbola; Wong, Robert; Li, Xiaohui; Banerjee, Subhashis; Alten, Rieke

    2018-04-15

    To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96-8.58), infection 38.60 (36.24-41.12), serious infection 1.68 (1.35-2.07), malignancies 1.09 (0.84-1.42), and autoimmune disorders 1.33 (1.05-1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX.

  14. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Dong, Hongli; Pi, Fuhua; Ding, Zan; Chen, Wei; Pang, Shaojie; Dong, Wenya; Zhang, Qingying

    2015-01-01

    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.

  15. 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

  16. 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.

  17. Efficacy and Safety of Nitazoxanide, Albendazole, and Nitazoxanide-Albendazole against Trichuris trichiura Infection: A Randomized Controlled Trial

    Science.gov (United States)

    Speich, Benjamin; Ame, Shaali M.; Ali, Said M.; Alles, Rainer; Hattendorf, Jan; Utzinger, Jürg; Albonico, Marco; Keiser, Jennifer

    2012-01-01

    Background The currently used anthelmintic drugs, in single oral application, have low efficacy against Trichuris trichiura infection, and hence novel anthelmintic drugs are needed. Nitazoxanide has been suggested as potential drug candidate. Methodology The efficacy and safety of a single oral dose of nitazoxanide (1,000 mg), or albendazole (400 mg), and a nitazoxanide-albendazole combination (1,000 mg–400 mg), with each drug administered separately on two consecutive days, were assessed in a double-blind, randomized, placebo-controlled trial in two schools on Pemba, Tanzania. Cure and egg reduction rates were calculated by per-protocol analysis and by available case analysis. Adverse events were assessed and graded before treatment and four times after treatment. Principal Findings Complete data for the per-protocol analysis were available from 533 T. trichiura-positive children. Cure rates against T. trichiura were low regardless of the treatment (nitazoxanide-albendazole, 16.0%; albendazole, 14.5%; and nitazoxanide, 6.6%). Egg reduction rates were 54.9% for the nitazoxanide-albendazole combination, 45.6% for single albendazole, and 13.4% for single nitazoxanide. Similar cure and egg reduction rates were calculated using the available case analysis. Children receiving nitazoxanide had significantly more adverse events compared to placebo recipients. Most of the adverse events were mild and had resolved within 24 hours posttreatment. Conclusions/Significance Nitazoxanide shows no effect on T. trichiura infection. The low efficacy of albendazole against T. trichiura in the current setting characterized by high anthelmintic drug pressure is confirmed. There is a pressing need to develop new anthelmintics against trichuriasis. Trial Registration Controlled-Trials.com ISRCTN08336605 PMID:22679525

  18. Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

    Science.gov (United States)

    Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

    2012-04-27

    An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

  19. Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial.

    Science.gov (United States)

    Misawa, Sonoko; Kuwabara, Satoshi; Sato, Yasunori; Yamaguchi, Nobuko; Nagashima, Kengo; Katayama, Kanako; Sekiguchi, Yukari; Iwai, Yuta; Amino, Hiroshi; Suichi, Tomoki; Yokota, Takanori; Nishida, Yoichiro; Kanouchi, Tadashi; Kohara, Nobuo; Kawamoto, Michi; Ishii, Junko; Kuwahara, Motoi; Suzuki, Hidekazu; Hirata, Koichi; Kokubun, Norito; Masuda, Ray; Kaneko, Juntaro; Yabe, Ichiro; Sasaki, Hidenao; Kaida, Ken-Ichi; Takazaki, Hiroshi; Suzuki, Norihiro; Suzuki, Shigeaki; Nodera, Hiroyuki; Matsui, Naoko; Tsuji, Shoji; Koike, Haruki; Yamasaki, Ryo; Kusunoki, Susumu

    2018-06-01

    Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein C5, in patients with severe Guillain-Barré syndrome. This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3-5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via a computer-generated process and web response system with minimisation for functional grade and age. The study had a parallel non-comparative single-arm outcome measure. The primary outcomes were efficacy (the proportion of patients with restored ability to walk independently [functional grade ≤2] at week 4) in the eculizumab group and safety in the full analysis set. For the efficacy endpoint, we predefined a response rate threshold of the lower 90% CI boundary exceeding 50%. This trial is registered with ClinicalTrials.gov, number, NCT02493725. Between Aug 10, 2015, and April 21, 2016, 34 patients were assigned to receive either eculizumab (n=23) or placebo (n=11). At week 4, the proportion of the patients able to walk independently (functional grade ≤2) was 61% (90% CI 42-78; n=14) in the eculizumab group, and 45% (20-73; n=5) in the placebo group. Adverse events occurred in all 34 patients. Three patients had serious adverse events: two in the eculizumab group (anaphylaxis in one patient and intracranial haemorrhage and abscess in another patient) and one in the placebo group (depression

  20. 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

    2010-01-01

    Full Text Available 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.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.This novel application of a penalized Cox model for adjustment of a trial estimate of treatment efficacy incorporates evidence-based estimates for other therapies, preserves comparisons between the

  1. 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; pcultural and geographic differences. Further rigorous RCTs from around the world are warranted to confirm the effect and safety of auriculotherapy for constipation.

  2. Network meta-analysis of randomized trials in multiple myeloma: efficacy and safety in relapsed/refractory patients.

    Science.gov (United States)

    Botta, Cirino; Ciliberto, Domenico; Rossi, Marco; Staropoli, Nicoletta; Cucè, Maria; Galeano, Teresa; Tagliaferri, Pierosandro; Tassone, Pierfrancesco

    2017-02-28

    Despite major therapeutic advancements, multiple myeloma (MM) is still incurable and relapsed/refractory multiple myeloma (RRMM) remains a challenge; the rational choice of the most appropriate regimen in this setting is currently undefined. We performed a systematic review and 2 standard pairwise meta-analyses to evaluate the efficacy of regimens that have been directly compared with bortezomib or immunomodulatory imide drugs (IMiDs) in head-to-head clinical trials and a network meta-analysis (NMA) to determine the relevance of each regimen on the basis of all the available direct and indirect evidence. Sixteen trials were included in the pairwise meta-analyses, and 18 trials were included in the NMA. Pairwise meta-analyses showed that a 3-drug regimen (bortezomib- or IMiD-based) was superior to a 2-drug regimen in progression-free-survival (PFS) and overall response rate (ORR). NMA showed that an IMiD backbone associated with anti-MM monoclonal antibodies (mAbs) (preferably) or proteasome inhibitors had the highest probability of being the most effective regimen with the lowest toxicity. The combination of daratumumab, lenalidomide, and dexamethasone ranked as the first regimen in terms of activity, efficacy, and tolerability according to the average value between surface under the cumulative ranking curve of PFS, overall survival, ORR, complete response rate, and safety. This is the first NMA comparing all currently available regimens evaluated in published randomized trials for the treatment of RRMM, but our results need to be interpreted taking into account differences in their patient populations. Our analysis suggests that IMiDs plus new anti-MM mAb-containing regimens are the most active therapeutic option in RRMM.

  3. 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

  4. Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial

    Science.gov (United States)

    Piotrowska, Hania E G; Yousuf, Ahmed; Kanellakis, Nikolaos I; Kagithala, Gayathri; Mohammed, Seid; Clifton, Lei; Corcoran, John P; Russell, Nicky; Dobson, Melissa; Miller, Robert F; Rahman, Najib M

    2017-01-01

    Introduction Malignant pleural effusion (MPE) is common and currently in UK there are an estimated 50 000 new cases of MPE per year. Talc pleurodesis remains one of the most popular methods for fluid control. The value of thoracic ultrasound (TUS) imaging, before and after pleurodesis, in improving the quality and efficacy of care for patients with MPE remains unknown. Additionally, biomarkers of successful pleurodesis including measurement of pleural fluid proteins have not been validated in prospective studies. The SIMPLE trial is an appropriately powered, multicentre, randomised controlled trial designed to assess ’by the patient bedside' use of TUS imaging and pleural fluid analysis in improving management of MPE. Methods and analysis 262 participants with a confirmed MPE requiring intervention will be recruited from hospitals in UK and The Netherlands. Participants will be randomised (1:1) to undergo either chest drain insertion followed by instillation of sterile talc, or medical thoracoscopy and simultaneous poudrage. The allocated procedure will be done while the patient is hospitalised, and within 3 days of randomisation. Following hospital discharge, participants will be followed up at 1, 3 and 12 months. The primary outcome measure is the length of hospital stay during initial hospitalisation. Ethics and dissemination The trial has received ethical approval from the South Central-Oxford C Research Ethics Committee (Reference number 15/SC/0600). The Trial Steering Committee includes an independent chair and members, and a patient representative. The trial results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN: 16441661. PMID:29225889

  5. 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

  6. 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....

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

    OpenAIRE

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

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet....

  8. Evidence-based recommendations for analgesic efficacy to treat pain of endodontic origin: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Aminoshariae, Anita; Kulild, James C; Donaldson, Mark; Hersh, Elliot V

    2016-10-01

    The purpose of this investigation was to identify evidence-based clinical trials to aid dental clinicians in establishing the efficacy for recommending or prescribing analgesics for pain of endodontic origin. The authors prepared and registered a protocol on PROSPERO and conducted electronic searches in MEDLINE, Scopus, the Cochrane Library, and ClinicalTrials.gov. In addition, the authors manually searched the bibliographies of all relevant articles, the gray literature, and textbooks for randomized controlled trials. Two authors selected the relevant articles independently. There were no disagreements between the authors. The authors analyzed 27 randomized, placebo-controlled trials. The authors divided the studies into 2 groups: preoperative and postoperative analgesic treatments. There was moderate evidence to support the use of steroids for patients with symptomatic irreversible pulpitis. Also, there was moderate evidence to support nonsteroidal anti-inflammatory drugs (NSAIDs) preoperatively or postoperatively to control pain of endodontic origin. When NSAIDs were not effective, a combination of NSAIDs with acetaminophen, tramadol, or an opioid appeared beneficial. NSAIDs should be considered as the drugs of choice to alleviate or minimize pain of endodontic origin if there are no contraindications for the patient to ingest an NSAID. In situations in which NSAIDs alone are not effective, the combination of an NSAID with acetaminophen or a centrally acting drug is recommended. Steroids appear effective in irreversible pulpitis. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  9. 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

  10. Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial.

    Science.gov (United States)

    Saleem, Mohammed D; Negus, Deborah; Feldman, Steven R

    2018-02-01

    Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative formulations have gained popularity due to their ease of application, improved adherence and efficacy. To evaluate the efficacy of topical desoximetasone 0.25% spray formulation in extensive psoriasis. This multicenter, double-blinded, randomized trial compared twice daily topical 0.25% desoximetasone spray to placebo in subjects ≥18 with moderate to severe plaque psoriasis. Primary outcome of the study was the proportion of subjects in each group that achieved clinical success (Physician Global Assessment [PGA] of 0 or 1) and/or treatment success at (target lesion score of 0 or 1) day 28. One-hundred-and-twenty subjects were enrolled. At baseline, 75.0% and 73.3% of the treatment and placebo group had at least moderate PGA, respectively. Clinical success in the intended-to treat and placebo group was 30% and 5% (p = .0003), respectively; treatment success was 39% and 7% (p psoriasis treatments limits the ability to compare the results to other treatments. Topical desoximetasone spray provides rapid control of moderate to severe psoriasis lesions and may be considered for patients awaiting approval of biologicals. Clinical Trial was registered at clinicaltrial.gov: NCT01206387.

  11. Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

    Science.gov (United States)

    Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

    2016-04-01

    Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. 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

  13. Patients or volunteers? The impact of motivation for trial participation on the efficacy of patient decision Aids: a secondary analysis of a Cochrane systematic review.

    Science.gov (United States)

    Brown, James G; Joyce, Kerry E; Stacey, Dawn; Thomson, Richard G

    2015-05-01

    Efficacy of patient decision aids (PtDAs) may be influenced by trial participants' identity either as patients seeking to benefit personally from involvement or as volunteers supporting the research effort. To determine if study characteristics indicative of participants' trial identity might influence PtDA efficacy. We undertook exploratory subgroup meta-analysis of the 2011 Cochrane review of PtDAs, including trials that compared PtDA with usual care for treatment decisions. We extracted data on whether participants initiated the care pathway, setting, practitioner interactions, and 6 outcome variables (knowledge, risk perception, decisional conflict, feeling informed, feeling clear about values, and participation). The main subgroup analysis categorized trials as "volunteerism" or "patienthood" on the basis of whether participants initiated the care pathway. A supplementary subgroup analysis categorized trials on the basis of whether any volunteerism factors were present (participants had not initiated the care pathway, had attended a research setting, or had a face-to-face interaction with a researcher). Twenty-nine trials were included. Compared with volunteerism trials, pooled effect sizes were higher in patienthood trials (where participants initiated the care pathway) for knowledge, decisional conflict, feeling informed, feeling clear, and participation. The subgroup difference was statistically significant for knowledge only (P = 0.03). When trials were compared on the basis of whether volunteerism factors were present, knowledge was significantly greater in patienthood trials (P < 0.001), but there was otherwise no consistent pattern of differences in effects across outcomes. There is a tendency toward greater PtDA efficacy in trials in which participants initiate the pathway of care. Knowledge acquisition appears to be greater in trials where participants are predominantly patients rather than volunteers. © The Author(s) 2015.

  14. Short‐term efficacy of Epley's manoeuvre: a double‐blind randomised trial

    Science.gov (United States)

    von Brevern, M; Seelig, T; Radtke, A; Tiel‐Wilck, K; Neuhauser, H; Lempert, T

    2006-01-01

    Background Benign paroxysmal positional vertigo of the posterior canal (PC‐BPPV) is a common vestibular disorder and can be easily treated with Epley's manoeuvre. Thus far, the short‐term efficacy of Epley's manoeuvre for treatment of PC‐BPPV is unknown. Objectives To evaluate the efficacy of Epley's manoeuvre for treatment of PC‐BPPV 24 h after applying the manoeuvre. Methods The short‐term efficacy of Epley's manoeuvre was compared with a sham procedure in 66 patients with PC‐BPPV by using a double‐blind randomised study design. Results 24 h after treatment, 28 of 35 (80%) patients in the Epley's manoeuvre group had neither vertigo nor nystagmus on positional testing compared with 3 of 31 (10%) patients in the sham group (p<0.001). Conclusion Epley's manoeuvre is shown to resolve PC‐BPPV both effectively and rapidly. PMID:16549410

  15. 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

  16. 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.

  17. Efficacy and Safety of Artemether in the Treatment of Chronic Fascioliasis in Egypt: Exploratory Phase-2 Trials

    Science.gov (United States)

    Keiser, Jennifer; Sayed, Hanan; El-Ghanam, Maged; Sabry, Hoda; Anani, Saad; El-Wakeel, Aly; Hatz, Christoph; Utzinger, Jürg; el-Din, Sayed Seif; El-Maadawy, Walaa; Botros, Sanaa

    2011-01-01

    Background Fascioliasis is an emerging zoonotic disease of considerable veterinary and public health importance. Triclabendazole is the only available drug for treatment. Laboratory studies have documented promising fasciocidal properties of the artemisinins (e.g., artemether). Methodology We carried out two exploratory phase-2 trials to assess the efficacy and safety of oral artemether administered at (i) 6×80 mg over 3 consecutive days, and (ii) 3×200 mg within 24 h in 36 Fasciola-infected individuals in Egypt. Efficacy was determined by cure rate (CR) and egg reduction rate (ERR) based on multiple Kato-Katz thick smears before and after drug administration. Patients who remained Fasciola-positive following artemether dosing were treated with single 10 mg/kg oral triclabendazole. In case of treatment failure, triclabendazole was re-administered at 20 mg/kg in two divided doses. Principal Findings CRs achieved with 6×80 mg and 3×200 mg artemether were 35% and 6%, respectively. The corresponding ERRs were 63% and nil, respectively. Artemether was well tolerated. A high efficacy was observed with triclabendazole administered at 10 mg/kg (16 patients; CR: 67%, ERR: 94%) and 20 mg/kg (4 patients; CR: 75%, ERR: 96%). Conclusions/Significance Artemether, administered at malaria treatment regimens, shows no or only little effect against fascioliasis, and hence does not represent an alternative to triclabendazole. The role of artemether and other artemisinin derivatives as partner drug in combination chemotherapy remains to be elucidated. PMID:21909440

  18. Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Shimonovich, Shachar; Gigi, Roy; Shapira, Amir; Sarig-Meth, Tal; Nadav, Danielle; Rozenek, Mattan; West, Debra; Halpern, Pinchas

    2016-11-09

    Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

  19. Clinical Efficacy of Jump Training Augmented With Body Weight Support After ACL Reconstruction: A Randomized Controlled Trial.

    Science.gov (United States)

    Elias, Audrey R C; Harris, Kari J; LaStayo, Paul C; Mizner, Ryan L

    2018-06-01

    Limited knee flexion and increased muscle co-contraction during jump landing are believed to diminish outcomes after anterior cruciate ligament (ACL) reconstruction. The efficacy of jump training to improve patients' mechanical and neuromuscular deficits is understudied. Jump training will improve functional, mechanical, and neuromuscular outcomes and higher repetition training augmented by body weight support will result in better retention of gains. Randomized controlled trial; Level of evidence, 1. Thirty athletes (18 months after surgery) were screened, and 19 with mechanical deficits and limited clinical outcomes were enrolled in the trial. Testing included the International Knee Documentation Committee (IKDC) questionnaire, leg landing mechanics via motion analysis, knee joint effusion using a stroke test, and a surface electromyography-generated co-contraction index during a single-legged landing. Participants were randomly assigned to 1 of 2 groups: jump training with normal body weight (JTBW) and high-repetition jump training with body weight support (JTBWS). Knee effusion grading throughout training was used to assess joint tolerance. Changes in outcomes over time were analyzed with mixed-effects modeling. Immediate outcomes were compared with retention testing at 8 weeks after training by use of 2-way analyses of variance with effects of time and group. Significant effects of time were found during the training phase for all outcome measures, but no effects of group or sex were found. IKDC score (pooled; mean ± SD) increased from 76 ± 12 to 87 ± 8 ( P Jump training mitigated some risk factors for second injury and osteoarthritis in patients after ACL reconstruction. Training made lasting improvements in physical function measures as well as mechanical and neuromuscular coordination deficits. Higher repetitions used with body weight support did not improve retention but substantially reduced risk for effusion. Jump training is an efficacious

  20. 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

  1. 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.

  2. Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

    Science.gov (United States)

    Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

    2016-02-01

    Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

  3. A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol.

    Science.gov (United States)

    Slater, Rebeccah; Hartley, Caroline; Moultrie, Fiona; Adams, Eleri; Juszczak, Ed; Rogers, Richard; Norman, Jane E; Patel, Chetan; Stanbury, Kayleigh; Hoskin, Amy; Green, Gabrielle

    2016-11-15

    Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants. A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. 
156 infants between 34 and 42 weeks' gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 μg/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration. The primary outcome will be the Premature Infant Pain Profile-revised (PIPP-R) score 30 seconds after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an Accepted Protocol Summary by The Lancet .

  4. 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)…

  5. Efficacy of strategy training in left hemisphere stroke patients with apraxia : A randomised clinical trial

    NARCIS (Netherlands)

    Donkervoort, M; Dekker, J; Stehmann-Saris, FC; Deelman, B. G.

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. A total of 113 left hemisphere stroke patients with apraxia were randomly assigned to two treatment groups; (1) strategy training integrated

  6. 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

  7. Efficacy of strategy training in left hemisphere stroke patients with apraxia: a randomised clinical trial.

    NARCIS (Netherlands)

    Donkervoort, M.; Dekker, J.; Stehmann-Saris, F.C.; Deelman, B.G.

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. A total of 113 left hemisphere stroke patients with apraxia were randomly assigned to two treatment groups; (1) strategy training integrated

  8. Efficacy of strategy training in left hemisphere stroke patients with apraxia: a randomized clinical trial.

    NARCIS (Netherlands)

    Dekker, J.; Donkervoort, M.; Stehman, F.C.; Deelman, B.G.

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. 113 Left hemisphere assigned to two treatment groups: i) strategy training integrated into usual occupational therapy and ii) usual

  9. 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…

  10. 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

  11. Efficacy trial of three pour-on acaricides on external parasites of ...

    African Journals Online (AJOL)

    External parasites cause adverse effects on livestock production globally. In a study to determine the efficacy of three acaricides, fifteen pastoralist herds were randomly selected. Each herd had a group with eight cattle and three other groups with four. All animals were screened for external parasites pre-acaricide ...

  12. 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.

  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 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.

  15. 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

  16. A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

    Science.gov (United States)

    Wiley, Henry E; Thompson, Darby J S; Bailey, Clare; Chew, Emily Y; Cukras, Catherine A; Jaffe, Glenn J; Lee, Richard W J; Loken, Erin K; Meyerle, Catherine B; Wong, Wai; Ferris, Frederick L

    2016-04-01

    To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design. Randomized, double-masked, 36-week, 3-period crossover clinical trial. Fifty-six subjects with DME involving the center of the macula in one or both eyes. Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model. Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and 6.6 letters for ranibizumab (difference, 1.3 letters; P = 0.039). Estimated change in optical coherence tomography (OCT) central subfield mean thickness (CSMT) was -89 μm for bevacizumab and -137 μm for ranibizumab (difference, 48 μm; P < 0.001). Incorporating cumulative treatment benefit, the model yielded a predicted 36-week (9-month) average improvement in visual acuity of 7.1 letters (95% confidence interval [CI], 5.0-9.2) for bevacizumab and 8.4 letters (95% CI, 6.3-10.5) for ranibizumab, and a change in OCT CSMT of -128 μm (95% CI, -155 to -100) for bevacizumab and -176 μm (95% CI, -202 to -149) for ranibizumab. There was no significant treatment-by-period interaction (i.e., treatment difference was constant in all 3 periods), nor was there a significant differential carryover effect from one period to the next. This trial demonstrated a statistically significant but small relative clinical benefit of ranibizumab compared with bevacizumab for treatment of DME, using a markedly reduced sample size relative to a full comparative efficacy study. The effects on visual acuity and central retinal thickness for the 2 drugs are consistent with those reported at 1 year for the concurrent parallel-group trial by the Diabetic Retinopathy Clinical Research Network testing bevacizumab

  17. 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

    2014-08-01

    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. 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. 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). No significant differences in adverse

  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. Efficacy of a medical food in mild Alzheimer's disease: a randomized, controlled trial

    NARCIS (Netherlands)

    Scheltens, P.; Kamphuis, P.J.G.H.; 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-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a

  20. Patient safety and efficacy as measured by clinical trials and regulatory policy.

    Science.gov (United States)

    Harvey, B E; Alpert, S

    1997-01-01

    Virtual Reality and other technological innovations in medicine provide new challenges to the regulatory framework of the premarket review process for medical devices. By reinventing the government-academia-industry partnership, clinical trial data necessary for a medical device to enter the market can be more efficiently obtained.

  1. 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

  2. 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

  3. Trial-based psychotherapy and the efficacy of trial-based thought record in changing unhelpful core beliefs and reducing self-criticism.

    Science.gov (United States)

    de Oliveira, Irismar Reis; Hemmany, Curt; Powell, Vania B; Bonfim, Thaís D; Duran, Erica P; Novais, Nilma; Velasquez, Michella; Di Sarno, Elaine; Alves, Gledson L; Cesnik, Joici A

    2012-03-01

    The best prevention against relapse results when patients are taught to restructure negative core beliefs (CBs). Efficacy of the trial-based thought record (TBTR) in decreasing the credit given by patients to negative CBs and corresponding emotions was evaluated. Patients (n = 166) were submitted to a simulation of a legal trial to assess their adherence to negative CBs and corresponding emotions after each cognitive therapy technique incorporated by TBTR. Significant reductions existed in percent values after the first and second defense attorney pleas, as well as after jury's verdict and initial preparation for the appeal (p < 0.001), relative to the investigation phase. Significant differences also emerged between the defense attorney's first and second pleas and between the defense attorney's second plea and jury's verdict, as well as preparation for the appeal (p < 0.001). There was no significant difference between percentages presented by patients submitted to TBTR used in the empty chair format relative to the conventional format. Similarly, there was no difference between outcomes, regardless of therapists' level of exposure to TBTR. TBTR may help patients reduce attachment to negative CBs and corresponding emotions. Outcomes were significantly favorable regardless of the format use and therapists' level of exposure to TBTR.

  4. 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...

  5. 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.

  6. 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

  7. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial

    OpenAIRE

    Hazarey, Vinay K; Sakrikar, Aditee R; Ganvir, Sindhu M

    2015-01-01

    Introduction: Oral submucous fibrosis (OSF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin′′ are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Materials and Methods: Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group fro...

  8. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

    OpenAIRE

    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 se...

  9. 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

  10. 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...

  11. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial.

    Science.gov (United States)

    Chignon-Sicard, Bérengère; Georgiou, Charalambos A; Fontas, Eric; David, Sylvain; Dumas, Pierre; Ihrai, Tarik; Lebreton, Elisabeth

    2012-12-01

    Application of platelet concentrates to wounds could speed healing. Leukocyte- and platelet-rich fibrin, a relatively recent development, stands out from the other preparations. This prospective, randomized, controlled clinical trial studied the rate of healing of postoperative hand wounds after a single application of leukocyte- and platelet-rich fibrin. Eligible patients were healthy individuals older than 18 years who had been scheduled for elective McCash (open palm) surgery for Dupuytren disease at the Plastic and Hand Surgery Department of Nice's University Hospital between August of 2007 and February of 2010. The control group received the reference care of petroleum jelly mesh (Vaselitulle), and test patients had leukocyte- and platelet-rich fibrin applied. The primary endpoint was healing delay measured in postoperative days. Secondary endpoints included pain, bleeding, and wound exudate. The trial was carried out as a single-blind trial. Among the 68 randomized patients, 33 patients in the leukocyte- and platelet-rich fibrin group and 31 in the Vaselitulle group were analyzed. Primary endpoint analysis showed a median healing delay of 24 days (interquartile range, 18 to 28 days) for the fibrin group and 29 days (interquartile range, 26 to 35 days) for the Vaselitulle group (p = 0.014, log-rank test). Postoperative pain assessment, bleeding, and exudate were always lower for the fibrin group, but not significantly so. The authors trial demonstrates that a single leukocyte- and platelet-rich fibrin application on fresh postoperative hand wounds shows a median improvement of 5 days in comparison with the standard treatment. Therapeutic, II.

  12. 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

  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 targeted therapy for advanced renal cell carcinoma: A systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chao Wei

    Full Text Available ABSTRACT We conducted a systematic review and meta-analysis of the literature on the efficacy of the targeted therapies in the treatment of advanced RCC and, via an indirect comparison, to provide an optimal treatment among these agents. A systematic search of Medline, Scopus, Cochrane Library and Clinical Trials unpublished was performed up to Jan 1, 2015 to identify eligible randomized trials. Outcomes of interest assessing a targeted agent included progression free survival (PFS, overall survival (OS and objective response rate (ORR. Thirty eligible randomized controlled studies, total twentyfourth trails (5110 cases and 4626 controls were identified. Compared with placebo and IFN-α, single vascular epithelial growth factor (receptor tyrosine kinase inhibitor and mammalian target of rapamycin agent (VEGF(r-TKI & mTOR inhibitor were associated with improved PFS, improved OS and higher ORR, respectively. Comparing sorafenib combination vs sorafenib, there was no significant difference with regard to PFS and OS, but with a higher ORR. Comparing single or combination VEGF(r-TKI & mTOR inhibitor vs BEV + IFN-α, there was no significant difference with regard to PFS, OS, or ORR. Our network ITC meta-analysis also indicated a superior PFS of axitinib and everolimus compared to sorafenib. Our data suggest that targeted therapy with VEGF(r-TKI & mTOR inhibitor is associated with superior efficacy for treating advanced RCC with improved PFS, OS and higher ORR compared to placebo and IFN-α. In summary, here we give a comprehensive overview of current targeted therapies of advanced RCC that may provide evidence for the adequate targeted therapy selecting.

  15. 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......, intellectual activity where the solution of a programming problem can be described in an understandable way. The approach is illustrated by an example which is a commented solution of a problem posed to the students in the course....

  16. The efficacy of Protected Mealtimes in hospitalised patients: a stepped wedge cluster randomised controlled trial.

    Science.gov (United States)

    Porter, Judi; Haines, Terry P; Truby, Helen

    2017-02-07

    Protected Mealtimes is an intervention developed to address the problem of malnutrition in hospitalised patients through increasing positive interruptions (such as feeding assistance) whilst minimising unnecessary interruptions (including ward rounds and diagnostic procedures) during mealtimes. This clinical trial aimed to measure the effect of implementing Protected Mealtimes on the energy and protein intake of patients admitted to the subacute setting. A prospective, stepped wedge cluster randomised controlled trial was undertaken across three hospital sites at one health network in Melbourne, Australia. All patients, except those receiving end-of-life care or not receiving oral nutrition, admitted to these wards during the study period participated. The intervention was guided by the British Hospital Caterers Association reference policy on Protected Mealtimes and by principles of implementation science. Primary outcome measures were daily energy and protein intake. The study was powered to determine whether the intervention closed the daily energy deficit between estimated intake and energy requirements measured as 1900 kJ/day in the pilot study for this trial. There were 149 unique participants, including 38 who crossed over from the control to intervention period as the Protected Mealtimes intervention was implemented. In total, 416 observations of 24-hour food intake were obtained. Energy intake was not significantly different between the intervention ([mean ± SD] 6479 ± 2486 kJ/day) and control (6532 ± 2328 kJ/day) conditions (p = 0.88). Daily protein intake was also not significantly different between the intervention (68.6 ± 26.0 g/day) and control (67.0 ± 25.2 g/day) conditions (p = 0.86). The differences between estimated energy/protein requirements and estimated energy/protein intakes were also limited between groups. The adjusted analysis yielded significant findings for energy deficit: (coefficient [robust 95% CI], p

  17. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    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

  18. Self-efficacy and embodiment associated with Alexander Technique lessons or with acupuncture sessions: A longitudinal qualitative sub-study within the ATLAS trial.

    Science.gov (United States)

    Wenham, Aniela; Atkin, Karl; Woodman, Julia; Ballard, Kathleen; MacPherson, Hugh

    2018-05-01

    A large randomised controlled trial found that the provision of either Alexander Technique lessons or acupuncture, for those with chronic neck pain, resulted in significantly increased self-efficacy when compared with usual care alone. In turn, enhanced self-efficacy was associated with significant reductions in neck pain at 6 and 12 months. In this analysis we explore the perspectives of participants within the trial, with the aim of gaining a better understanding of how these interventions had an impact. We used a longitudinal qualitative approach; in-depth interviews, informed by a topic guide, were conducted with a sample of the trial population. Participants were interviewed twice: at around six months (n = 30) and twelve months (n = 26) after trial entry. Analysis was guided by the principles of grounded theory, and key themes were developed. Five key themes emerged: pre-trial experiences of biomedical treatment against which subsequent interventions were compared; emergence of tangible benefits from the interventions; factors that contributed to the observed benefits, notably growing self-care and self-efficacy; a developing sense of embodiment as an integral part of the transformative process; and contribution of these factors to sustaining benefits over the longer term. In-depth interviews revealed a rich array of experiences. They gave insight into the positive impact of the interventions on development of self-care, self-efficacy and embodiment. These findings complement the quantitative trial data, providing a more nuanced understanding of the factors that underpin the previously quantified improvement in self-efficacy and its association with longer-term reductions in pain. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

    OpenAIRE

    AMMARI, Michelle Mikhael; MOLITERNO, Luiz Flávio Martins; HIRATA JÚNIOR, Raphael; SÉLLOS, Mariana Canano; SOVIERO, Vera Mendes; COUTINHO FILHO, Wagner Pereira

    2014-01-01

    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 thr...

  20. Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart

    2015-01-01

    This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

  1. 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 insomnia was associated with lower levels of CRP (P insomnia remission. PSG measures did not change. 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.

  2. Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Geng, Hua; Wang, Chengzhong

    2017-01-01

    To assess the efficacy and safety of oxcarbazepine (OXC) in the treatment of children with epilepsy. 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. 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 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.

  3. Efficacy and Effectiveness of Exercise on Tender Points in Adults with Fibromyalgia: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    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.

  4. Efficacy of aprepitant for prevention of postoperative nausea and vomiting. Systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Berrío Valencia, Marta Inés

    2014-10-01

    Full Text Available Objective: To evaluate the efficacy of aprepitant compared with other antiemetics for the prevention of postoperative nausea and vomiting in adults who underwent general anesthesia. Methods: Systematic review of randomized clinical trials with meta-analysis, that evaluated the efficacy of aprepitant in comparatison with other antiemetics for the prevention of postoperative nausea and vomiting, antiemetic rescue and adverse effects. The search was done in The Cochrane Library, EBSCO, EMBASE, LILACS, OVID, PubMed, SciELO, ScienceDirect, Scopus and Google Scholar. Heterogeneity was defined with the Cochran Q and I2 statistic, the model fixed and random effects were used, the Mantel-Haenszel for relative risk of each outcome and its respective confidence interval 95% were used. Results: There was significant difference in favor of aprepitant for the prevention of vomiting at 24 (RR 0.52; 95% CI: 0.38-0.7 and at 48 hours (RR 0.51; 95% CI: 0.39 to 0.67 but not for nausea at 24 hours (RR 1.16; 95% CI: 0.85-1.6. Conclusions: Aprepitant prevents postoperative vomiting, but not nausea, at 24 and 48 hours.

  5. The Tolerability and Efficacy of Oral Isotonic Solution versus Plain Water in Dengue Patients: A Randomized Clinical Trial.

    Science.gov (United States)

    Nainggolan, Leonard; Bardosono, Saptawati; Ibrahim Ilyas, Ermita I

    2018-01-01

    Plasma leakage plays an important role in dengue infection, and this condition can lead to hemoconcentration, hypovolemia, and shock. Fluid replacement is the main treatment for dengue. There is a lack of evidence to support certain oral fluid therapy as a treatment for dengue patients. The objective of this study is to evaluate tolerability and efficacy of oral isotonic solution (OIS) compared to plain water as a fluid replacement in dengue patients. A randomized, clinical trial with single-blinded groups was conducted to compare tolerability and efficacy of OIS and plain water in dengue patients. We evaluated gastrointestinal disturbances (nausea, vomiting, and bloating), body temperature, mean arterial pressure (MAP), fluid balance, hematocrit, Na + , and K + levels. Data were analyzed with SPSS 20.0, and figures were made with GraphPad Prism version 5.01. Twenty four subjects were included and divided equally into two groups. Our results showed that there are no significant differences but indicate several noteworthy trends. The intervention group (OIS) experienced less nausea, less vomiting, had positive fluid balance and higher MAP, and became afebrile faster compared to the control group (plain water). Although not statistically significant, this study shows the trend that OIS is well-tolerated and effective for dengue patients compared to plain water.

  6. Efficacy of an Ice Popsicle on Thirst Management in the Immediate Postoperative Period: A Randomized Clinical Trial.

    Science.gov (United States)

    Conchon, Marilia Ferrari; Fonseca, Ligia Fahl

    2018-04-01

    Perioperative thirst is an intense discomfort with high incidence in the immediate postoperative period, but nonetheless, it is highly neglected in clinical practice. The purpose of this study was to evaluate the efficacy of an ice popsicle compared with water at room temperature for thirst relief in the immediate postoperative period in terms of variation in the intensity of the initial compared with the final thirst and the satiety reached after an hour of evaluation and intervention. A parallel randomized clinical trial was used. A total of 208 patients in the immediate postoperative period were assessed for 1 hour, every 15 minutes. Thirst intensity was assessed initially and subsequently; interventions were performed according to the group: (1) control group, 10 mL of water at room temperature; and (2) experimental group, 10-mL ice popsicle. The ice popsicle was 37.8% (P popsicle has greater efficacy than water at room temperature for thirst management in the immediate postoperative period. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

  7. Efficacy of an adapted HIV and sexually transmitted infection prevention intervention for incarcerated women: a randomized controlled trial.

    Science.gov (United States)

    Fogel, Catherine I; Crandell, Jamie L; Neevel, A M; Parker, Sharon D; Carry, Monique; White, Becky L; Fasula, Amy M; Herbst, Jeffrey H; Gelaude, Deborah J

    2015-04-01

    We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection (STI) behavioral intervention (Providing Opportunities for Women's Empowerment, Risk-Reduction, and Relationships, or POWER) among incarcerated women. We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011. Intervention participants attended 8 POWER sessions; control participants received a single standard-of-care STI prevention session. We followed up at 3 and 6 months after release. We examined intervention efficacy with mixed-effects models. POWER participants reported fewer male sexual partners than did control participants at 3 months, although this finding did not reach statistical significance; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner. POWER participants also reported significantly fewer condom barriers, and greater HIV knowledge, health-protective communication, and tangible social support. The intervention had no significant effects on incident STIs. POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities.

  8. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial.

    Science.gov (United States)

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-02-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22-68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission: 32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. © 2015 World Psychiatric Association.

  9. Comparison of efficacy and safety of topiramate with gabapentin in migraine prophylaxis: randomized open label control trial

    International Nuclear Information System (INIS)

    Zain, S.; Khan, M.; Alam, R.; Zafar, I.; Ahmed, S.

    2013-01-01

    Objective: To compare the efficacy and safety of topiramate with gabapentin in the prophylaxis of migraine patients. Methods: A 12-week randomised open label control trial was conducted at the Department of Pharmacology and Therapeutics, Basic Medical Sciences Institute, Jinnah Postgraduate Medical Centre (JPMC), Karachi from January to March 2011 involving 80 outpatients who had a history of migraine. The sample was divided into two equal groups. Primary efficacy measure was changed into mean monthly migraine frequency. Secondary efficacy measure included reduction in severity and average duration of an attack. Chi square test and paired t-test were used to analyse the data through SPSS 15. Result: Reduction in mean monthly migraine frequency (10.67+-4.25 to 1.82+-2.02) in the topiramate group was significantly greater compared with (11.97+-4.452 to 2.73+-2.59) that in the gabapentin group (p<0.001). Reduction in severity from 6.60+-2.122 to 1.03+-0.92 in the topiramate group was also significantly greater compared with 6.93+-1.90 to 1.18+-1.01 in the gabapentin group (p<0.001). Reduction in the average duration of attacks from 25.77+-22.32 hours to 1.0 1.06 hours in the topiramate group was significantly greater compared with 22.20+-20.72 to 1.08+-1.40 hours in the gabapentin group (p<0.001). Weight loss and numbness were common adverse effects in the topiramate group. Dizziness, weight gain and somnolence were reported in the gabapentin group. Conclusion: Gabapentin appeared well tolerated in 30(75%) patients compared to topiramate in 23(57.5%) patients. Both drugs were equally effective in migraine prophylaxis. (author)

  10. Enhancing the efficacy of computerized feedback interventions for college alcohol misuse: An exploratory randomized trial.

    Science.gov (United States)

    Miller, Mary Beth; Leavens, Eleanor L; Meier, Ellen; Lombardi, Nathaniel; Leffingwell, Thad R

    2016-02-01

    Personalized feedback interventions (PFIs) have been associated with decreased alcohol consumption and related problems among college students; however, the necessary and sufficient components responsible for efficacy remain unclear. The present study investigated the relative efficacy of 3 computerized PFIs with differing content, the content-specific mechanisms of change within PFIs, and the moderating roles of comparison orientation and baseline risk in intervention outcomes. College students (N = 212) reporting alcohol use in a typical week completed an assessment prior to randomization (norms PFI, enhanced PFI, choice PFI, assessment only) and 1 month postintervention. Participants who received a PFI reported greater decreases in alcohol use, peak blood alcohol concentration (BAC), related problems, and perceptions of typical students' drinking than those in the control group. Neither tendency to compare oneself with others nor baseline risk moderated outcomes. PFIs influenced weekly alcohol use indirectly through changes in descriptive normative perceptions and alcohol-related consequences indirectly through changes in peak BAC. Computerized PFIs are more effective than assessment alone in decreasing alcohol use and related problems among college students. Normative comparisons may be sufficient to elicit behavior change, and inclusion of select additional components may not yield significant improvements in outcomes. However, the consistent benefit of including feedback on physical and monetary costs of drinking and moderation strategies, although nonsignificant, may warrant the negligible increase in time and money required to provide such information electronically. Computerized PFIs seem to be an ideal first step to the prevention and treatment of college alcohol misuse. (c) 2016 APA, all rights reserved).

  11. Efficacy and safety of topical Trikatu preparation in, relieving mosquito bite reactions: a randomized controlled trial.

    Science.gov (United States)

    Maenthaisong, Ratree; Chaiyakunapruk, Nathorn; Tiyaboonchai, Waree; Tawatsin, Apiwat; Rojanawiwat, Archawin; Thavara, Usavadee

    2014-02-01

    Trikatu is composed of dried fruits of Piper nigrum L and Piper retrofractum Vahl, and dried rhizomes of Zingiber officinale R. Although this preparation has been used to relieve pruritis, pain, and inflammation for a long time, there is no clinical evidence to confirm its efficacy and safety. Therefore, we performed a double-blind, within person-randomized controlled study of 30 healthy volunteers to determine efficacy and safety of topical Trikatu on mosquito bite reactions. All subjects were bitten by Aedes aegypti laboratory mosquitoes on their forearms and they were randomly assigned arms to apply either Trikatu or reference product on the mosquito bite papule. The main outcome was the difference of papule size reduction at 30 min, measured by a caliper, between the Trikatu and reference arms. Pruritis, redness, pain, and patient satisfaction were assessed at 15, 30, 60, 180, and 360 min as secondary outcomes. There were no significant differences between treatment and reference arms on any outcome at any time of measurement. Trikatu did not show additional effects for relieving mosquito bite reaction as compared with the reference product containing camphor, menthol, and eucalyptus. For further study, it is very important to consider a proper selection of subjects, comparator product, and concentration of extract when Trikatu preparation is investigated. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference.

    Science.gov (United States)

    Black, Jed; Pillar, Giora; Hedner, Jan; Polo, Olli; Berkani, Ouali; Mangialaio, Sara; Hmissi, Abdel; Zammit, Gary; Hajak, Goran

    2017-08-01

    The orally active dual OX 1 R and OX 2 R antagonist, almorexant, targets the orexin system for the treatment of primary insomnia. This clinical trial assessed the effect of almorexant on sleep maintenance and other sleep endpoints, and its safety and tolerability in adults. Prospective, randomized, double-blind, placebo-controlled, active referenced trial in male and female adults aged 18-64 years with chronic, primary insomnia. Patients were randomized 1:1:1:1 to receive placebo, almorexant 100 mg, almorexant 200 mg, or zolpidem 10 mg (active reference) for 16 days. Primary efficacy assessments were objective (polysomnography-measured) and subjective (patient-recorded) wake time after sleep onset (WASO). Further sleep variables were also evaluated. From 709 randomized patients, 707 (mean age 45.4 years; 61.7% female) received treatment and 663 (93.8%) completed the study. A significant decrease versus placebo in median objective WASO was observed with almorexant 200 mg at the start and end of randomized treatment (-26.8 min and -19.5 min, respectively; both p system in insomnia disorder. CLINICALTRIALS. NCT00608985. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. 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.

  16. Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    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.

  17. A behavioral Bayes method to determine the sample size of a clinical trial considering efficacy and safety.

    Science.gov (United States)

    Kikuchi, Takashi; Gittins, John

    2009-08-15

    It is necessary for the calculation of sample size to achieve the best balance between the cost of a clinical trial and the possible benefits from a new treatment. Gittins and Pezeshk developed an innovative (behavioral Bayes) approach, which assumes that the number of users is an increasing function of the difference in performance between the new treatment and the standard treatment. The better a new treatment, the more the number of patients who want to switch to it. The optimal sample size is calculated in this framework. This BeBay approach takes account of three decision-makers, a pharmaceutical company, the health authority and medical advisers. Kikuchi, Pezeshk and Gittins generalized this approach by introducing a logistic benefit function, and by extending to the more usual unpaired case, and with unknown variance. The expected net benefit in this model is based on the efficacy of the new drug but does not take account of the incidence of adverse reactions. The present paper extends the model to include the costs of treating adverse reactions and focuses on societal cost-effectiveness as the criterion for determining sample size. The main application is likely to be to phase III clinical trials, for which the primary outcome is to compare the costs and benefits of a new drug with a standard drug in relation to national health-care. Copyright 2009 John Wiley & Sons, Ltd.

  18. 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.

  19. 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.

  20. Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial

    Directory of Open Access Journals (Sweden)

    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.

  1. 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.

    2014-01-01

    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 points The FIFA 11+ has only been tested in randomised controlled trials conducted on female youth football players; this

  2. 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.

  3. Efficacy of physiotherapy management of knee joint osteoarthritis: a randomised, double blind, placebo controlled trial

    Science.gov (United States)

    Bennell, K; Hinman, R; Metcalf, B; Buchbinder, R; McConnell, J; McColl, G; Green, S; Crossley, K

    2005-01-01

    Objective: To determine whether a multimodal physiotherapy programme including taping, exercises, and massage is effective for knee osteoarthritis, and if benefits can be maintained with self management. Methods: Randomised, double blind, placebo controlled trial; 140 community volunteers with knee osteoarthritis participated and 119 completed the trial. Physiotherapy and placebo interventions were applied by 10 physiotherapists in private practices for 12 weeks. Physiotherapy included exercise, massage, taping, and mobilisation, followed by 12 weeks of self management. Placebo was sham ultrasound and light application of a non-therapeutic gel, followed by no treatment. Primary outcomes were pain measured by visual analogue scale and patient global change. Secondary measures included WOMAC, knee pain scale, SF-36, assessment of quality of life index, quadriceps strength, and balance test. Results: Using an intention to treat analysis, physiotherapy and placebo groups showed similar pain reductions at 12 weeks: –2.2 cm (95% CI, –2.6 to –1.7) and –2.0 cm (–2.5 to –1.5), respectively. At 24 weeks, pain remained reduced from baseline in both groups: –2.1 (–2.6 to –1.6) and –1.6 (–2.2 to –1.0), respectively. Global improvement was reported by 70% of physiotherapy participants (51/73) at 12 weeks and by 59% (43/73) at 24 weeks. Similarly, global improvement was reported by 72% of placebo participants (48/67) at 12 weeks and by 49% (33/67) at 24 weeks (all p>0.05). Conclusions: The physiotherapy programme tested in this trial was no more effective than regular contact with a therapist at reducing pain and disability. PMID:15897310

  4. Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

    Science.gov (United States)

    Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

    2018-02-01

    Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

  5. [Clinical trials in dermatology. Evaluation of the tolerability and efficacy of a topical anti-acne].

    Science.gov (United States)

    Verschoore, M; Poncet, M; Schaefer, H; Revuz, J; De Prost, Y; Guillaume, J C; Ortonne, J P; Czernielewski, J

    1991-01-01

    Acne is a frequent dermatologic disease of the teenagers. Methodology of antiacne preparations clinical trials has evolved recently, leading to better comprehension of acne treatment on acne lesions. The main rules for good clinical evaluation of acne treatments are: an objective counting of each individual lesions on a defined area (face, back), a global acne assessment, a therapy duration from 1 to 3 months or more, a skin safety evaluation for erythema, desquamation, dryness, itching, burning and oiliness with a 0 to 3 scoring system.

  6. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    International Nuclear Information System (INIS)

    Higurashi, Takuma; Fujisawa, Nobutaka; Uchiyama, Shiori; Ezuka, Akiko; Nagase, Hajime; Kessoku, Takaomi; Matsuhashi, Nobuyuki; Yamanaka, Shoji; Inayama, Yoshiaki; Morita, Satoshi; Nakajima, Atsushi; Takahashi, Hirokazu; Endo, Hiroki; Hosono, Kunihiro; Yamada, Eiji; Ohkubo, Hidenori; Sakai, Eiji; Uchiyama, Takashi; Hata, Yasuo

    2012-01-01

    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. 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. 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 type 2 diabetes taking under treatment with metformin have been

  7. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial.

    Science.gov (United States)

    Maas, Josina C; Dallmeijer, Annet J; Huijing, Peter A; Brunstrom-Hernandez, Janice E; van Kampen, Petra J; Jaspers, Richard T; Becher, Jules G

    2012-03-26

    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. 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. 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. Nederlands Trial Register NTR2091.

  8. Efficacy of Probiotic Escherichia coli Nissle 1917 in Patients with Irritable Bowel Syndrome: a Double Blind Placebocontrolled Randomized Trial

    Directory of Open Access Journals (Sweden)

    Amir H Faghihi

    2015-07-01

    Full Text Available Aim: to evaluate potential improvement effect for probiotic E. coliNissle 1917 in the management of refractory IBS in an Iranian population. Methods: a double blind placebo controlled approach as been used in the current clinical trial. 139 confirmed IBS patients were included into the study, and were given probiotic E.coli Nissle 1917 for 6 weeks. 11 items Birmingham IBS Symptom Questionnairehas been used for evaluation of changes in the symptoms every 2 weeks. Results: sixty eight subjects (49% were males. Mean±SD age of the participants was 38±13.3 years. 49(35.3% of the patients were diarrhea-predominant. The total scores showed no significant difference between the intervention vs. control group(-6.7±6.8 vs. -6.7±6.5, respectively; p=0.95; neither did any of the questionnaire items any significant alterations in the two groups. After stratification of patients based on their IBS type, diarrhea-predominant patients showed a positive response to the probiotic improving their sleep (p=0.05&0.03 at weeks 2&6, respectively. Patients with constipation-predominant IBS showed no response to the probiotic; while patients with diarrhea-constipation mixed IBS showed unfavorable response to the probiotic in the need for strain to pass a motion compared to the placebo (p=0.03&0.02 at weeks 4&6, respectively. Conclusion: probiotic therapy with E.coliNissle 1917 was not able to induce significant improvement in the symptoms of patients with non-categorized IBS. Nevertheless, when IBS patients were recategorized to subgroups according to their main symptoms, evaluation of the efficacy of the probiotic on some individual items in the symptom list reached the significance level. Prospective clinical trials are recommended to confirm our findings. Key words: probiotic Escherichia Coli Nissle 1917, irritable bowel syndrome, double blind randomized controlled trial.

  9. The efficacy of laser therapy for musculoskeletal and skin disorders : A criteria-based meta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Beckerman, H.; De Bie, R. A.; Bouter, L. M.; De Cuyper, H. J.; Oostendorp, R. A.B.

    1992-01-01

    The efficacy of laser therapy for musculoskeletal and skin disorders has been assessed on the basis of the results of 36 randomized clinical trials (RCTs) involving 1,704 patients. For this purpose, a criteria-based meta- analysis that took into account the methodological quality of the individual

  10. 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…

  11. 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

  12. A randomised clinical trial on the efficacy of oxytetracycline dose through water medication of nursery pigs on diarrhoea, faecal shedding of Lawsonia intracellularis and average daily weight gain

    DEFF Research Database (Denmark)

    Larsen, Inge-Lise; Hjulsager, Charlotte Kristiane; Holm, Anders

    2016-01-01

    the efficacy of three oral dosage regimens (5, 10 and 20mg/kg body weight) of oxytetracycline (OTC) in drinking water over a five-day period on diarrhoea, faecal shedding of LI and average daily weight gain (ADG). A randomised clinical trial was carried out in four Danish pig herds. In total, 539 animals from...

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

    DEFF Research Database (Denmark)

    Keshav, Satish; Vaňásek, Tomáš; Niv, Yaron

    2013-01-01

    CCX282-B, also called vercirnon, is a specific, orally-administered chemokine receptor CCR9 antagonist that regulates migration and activation of inflammatory cells in the intestine. This randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of CCX282-B in 436...

  14. 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

  15. 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...

  16. 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

  17. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background 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. Design 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). Method Participants are

  18. 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

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

    Science.gov (United States)

    Drossaert, Constance HC; Pieterse, Marcel E; Walburg, Jan A; Bohlmeijer, Ernst T

    2015-01-01

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

  20. Efficacy and safety of empagliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Devi, R; Mali, Ghanshyam; Chakraborty, Indrani; Unnikrishnan, Mazhuvancherry Kesavan; Abdulsalim, Suhaj

    2017-04-01

    The prevalence of diabetes has increased in the recent decades and optimum glycemic control is required to reduce morbidity and mortality. We meta-analyzed randomized controlled trials in order to assess the efficacy and safety of empagliflozin compared to placebo in type 2 diabetes mellitus patients. We included double-blind, placebo controlled trials of empagliflozin that evaluated glycemic efficacy and safety (10 mg or 25 mg) either as monotherapy or as add-on to existing diabetes pharmacotherapy. The results demonstrated significant improvements in HbA1c (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) and FPG (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) with empagliflozin monotherapy (n = 609) compared to placebo. Significant improvements in HbA1c [SMD -1.582%, 95% CI -2.164 to -1.000, for 10 mg (n = 1079) and -1.668%, 95% CI -2.260 to -1.077, for 25 mg (n = 1070)] and FPG [SMD -0.865 mmol/L, 95 % CI -1.309 to -0.420, for 10 mg (n = 854) and -0.996 mmol/L, 95% CI -1.456 to -0.536, for 25 mg (n = 854)] were also observed in empagliflozin add-on therapy trials. Reductions in blood pressure and body weight were also seen in both monotherapy and add-on therapy. Empagliflozin was associated with increased risk of hypoglycemia, genital and urinary tract infections (OR 1.043, 2.814, 1.119 respectively). This meta-analysis shows empagliflozin is safe and effective for the treatment of T2DM along with existing diabetes pharmacotherapy.

  1. Efficacy of Hippotherapy Versus Pharmacotherapy in Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.

    Science.gov (United States)

    Oh, Yunhye; Joung, Yoo-Sook; Jang, Byongsu; Yoo, Jae Hyun; Song, Jihye; Kim, Jiwon; Kim, Kiho; Kim, Seonwoo; Lee, Jiyoung; Shin, Hye-Yeon; Kwon, Jeong-Yi; Kim, Yun-Hee; Jeong, Bumseok

    2018-04-11

    Pharmacotherapy among children with attention-deficit/hyperactivity disorder (ADHD) is effective, but many patients suffer from secondary psychiatric problems even after improvement of ADHD core symptoms. Hippotherapy have been used as adjunct treatment options for physical and psychosocial rehabilitation as well as to ameliorate core symptoms. The aim of this study was to investigate the effects of Hippotherapy versus pharmacotherapy for children with ADHD. Thirty-four participants with ADHD were randomly assigned at a 1:1 ratio to either 24 sessions of a twice-weekly hippotherapy or pharmacotherapy. To assess therapeutic effects, the ADHD Rating Scale (ARS) was used pretreatment and posttreatment as the primary outcome measure. Secondary outcomes included the Child Behavior Checklist (CBCL), Self-Esteem Scale (SES), Pediatric Quality of Life Inventory (PedsQL) child and parent report version, Developmental Coordination Disorder Questionnaire (DCDQ), Clinical Global Impressions-Severity (CGI-S), and quantitative electroencephalography. Both groups showed marked improvements in ADHD symptoms, CGI-S. No significant differences between groups were detected regarding treatment outcome except thought problem subscales of CBCL. Twelve weeks of hippotherapy improved attention, impulsivity/hyperactivity, and quality of life. This trial is promising, but further studies are required to evaluate the long-term clinical effectiveness of hippotherapy. The study is registered with ClinicalTrials.gov, number NCT 02482649.

  2. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial.

    Science.gov (United States)

    Scheltens, Philip; Kamphuis, Patrick J G H; Verhey, Frans R J; Olde Rikkert, Marcel G M; Wurtman, Richard J; Wilkinson, David; Twisk, Jos W R; Kurz, Alexander

    2010-01-01

    To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD). A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale-revised, and the 13-item modified Alzheimer's Disease Assessment Scale-cognitive subscale at week 12. At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P = .021). Modified Alzheimer's Disease Assessment Scale-cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer's disease Co-operative Study-Activities of Daily Living, Quality of Life in Alzheimer's Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated. Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials. 2010 The Alzheimer's Association. All rights reserved.

  3. The efficacy of imagery rescripting (IR) for social phobia: a randomized controlled trial.

    Science.gov (United States)

    Lee, Seung Won; Kwon, Jung-Hye

    2013-12-01

    There is a need for brief effective treatment of social phobia and Imagery Rescripting (IR) is a potential candidate. The purpose of this study was to examine the efficacy of IR preceded by cognitive restructuring as a stand-alone brief treatment using a randomized controlled design. Twenty-three individuals with social phobia were randomly assigned to an IR group or to a control group. Participants in the IR group were provided with one session of imagery interviewing and two sessions of cognitive restructuring and Imagery Rescripting. Those in the control group had one session of clinical interviewing and two sessions of supportive therapy. Outcome measures including the Korean version of the social avoidance and distress scale (K-SADS) were administered before and after treatment, and at three-month follow-up. The short version of the Questionnaire upon Mental Imagery and the Traumatic Experience Scale were also administered before treatment. Participants in the IR group improved significantly on K-SADS and other outcome measures, compared to the control group. The beneficial effects of IR were maintained at three-month follow-up. It was also found that mental imagery ability and the severity of the traumatic experience did not moderate the outcome of IR. Further studies are needed to replicate the findings of our study using a large sample. The efficacy of IR as a stand-alone brief treatment was demonstrated for social phobia. The findings indicate that IR could be utilized as a cost-effective intervention for social phobia. Copyright © 2013 Elsevier Ltd. All rights reserved.

  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. The resist diabetes trial: Rationale, design, and methods of a hybrid efficacy/effectiveness intervention trial for resistance training maintenance to improve glucose homeostasis in older prediabetic adults.

    Science.gov (United States)

    Marinik, Elaina L; Kelleher, Sarah; Savla, Jyoti; Winett, Richard A; Davy, Brenda M

    2014-01-01

    Advancing age is associated with reduced levels of physical activity, increased body weight and fat, decreased lean body mass, and a high prevalence of type 2 diabetes (T2D). Resistance training (RT) increases muscle strength and lean body mass, and reduces risk of T2D among older adults. The Resist Diabetes trial will determine if a social cognitive theory (SCT)-based intervention improves RT maintenance in older, prediabetic adults, using a hybrid efficacy/effectiveness approach. Sedentary, overweight/obese (BMI: 25-39.9 kg/m(2)) adults aged 50-69 (N = 170) with prediabetes (impaired fasting glucose and/or impaired glucose tolerance) completed a supervised 3-month RT (2×/wk) initiation phase and were then randomly assigned (N = 159; 94% retention) to one of two 6-month maintenance conditions: SCT or standard care. The SCT intervention consisted of faded contacts compared to standard care. Participants continue RT at an approved, self-selected community facility during maintenance. A subsequent 6-month period involves no contact for both conditions. Assessments occur at baseline and months 3 (post-initiation), 9 (post-intervention), and 15 (six months after no contact). Primary outcomes are prediabetes indices (i.e., impaired fasting and 2-hour glucose concentration) and strength. Secondary measures include insulin sensitivity, beta-cell responsiveness, and disposition index (oral glucose and C-peptide minimal model); adherence; body composition; and SCT measures. Resist Diabetes is the first trial to examine the effectiveness of a high fidelity SCT-based intervention for maintaining RT in older adults with prediabetes to improve glucose homeostasis. Successful application of SCT constructs for RT maintenance may support translation of our RT program for diabetes prevention into community settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. 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.

  7. 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.

  8. Towards a Theory-Based Framework for Assessing the ...

    African Journals Online (AJOL)

    The theory-based framework attempts to capture ESD's complexity in terms of the ... projects in teacher education institutions in Botswana, a brief description of the ..... How the 'four pillars of learning' relate to education for sustainable human.

  9. Strengthened General Self-Efficacy with Multidisciplinary Vocational Rehabilitation in Women on Long-Term Sick Leave: A Randomised Controlled Trial.

    Science.gov (United States)

    Andersén, Åsa; Larsson, Kjerstin; Lytsy, Per; Berglund, Erik; Kristiansson, Per; Anderzén, Ingrid

    2018-01-09

    Purpose To investigate the effects of two vocational rehabilitation interventions on self-efficacy, for women on long-term sick leave ≥ 1 year due to chronic pain and/or mental illness. Methods This study uses data from a randomised controlled trial consisting of two phases and comprising 401 women on long-term sick leave. They were allocated to either (1) a multidisciplinary team assessment and multimodal intervention (TEAM), (2) acceptance and commitment therapy (ACT), or (3) control group. Data were collected through repeated measurements from self-reported questionnaires before intervention, 6 and 12 months later and registry data. Data from measurements of general self-efficacy, sociodemographics, anxiety and depression were analysed with linear regression analyses. Results During the intervention period, the women in the TEAM group's self-efficacy mean increased from 2.29 to 2.74. The adjusted linear regression model, which included group allocation, sociodemographics, self-efficacy pre-treatment, anxiety and depression showed increased self-efficacy for those in the TEAM intervention at 12 months (B = 0.25, 95% CI 0.10-0.41). ACT intervention had no effect on self-efficacy at 12 months (B = 0.02, 95% CI - 0.16 to 0.19). The results in the adjusted model also showed that higher self-efficacy at pre-treatment was associated with a higher level of self-efficacy at 12 months (B = 0.68, 95% CI 0.54-0.81). Conclusion A multidisciplinary team assessment and multimodal intervention increased self-efficacy in women on sick leave for an extremely long time (mean 7.8 years) who had a low mean level of self-efficacy prior to inclusion. Thus, self-efficacy needs to be addressed in vocational rehabilitation.

  10. Efficacy Study of the COmbination of Edoxaban and Physiotherapy on the PRevention of Venous-Thromboembolism in patients after Total Knee Arthroplasty (ESCORT-TKA Trial: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Daisuke Sueta

    2016-07-01

    Discussion: This study will provide clinical evidence on the combined efficacy and safety of edoxaban and physiotherapy compared with that of physiotherapy alone. This is will be the first prospective trial designed to explore how thrombus formation after TKA can be predicted by the T-TAS™.

  11. 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

  12. Efficacy and safety of the C-Qur™ Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stommel, Martijn W J; Strik, Chema; ten Broek, Richard P G; van Goor, Harry

    2014-09-26

    Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery. This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur™ Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, α = 0.05, 80% power). Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related

  13. 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.

  14. The efficacy of two oral hygiene regimens in reducing oral malodour: a randomised clinical trial.

    Science.gov (United States)

    Feres, Magda; Figueiredo, Luciene Cristina; Faveri, Marcelo; Guerra, Marcelo C; Mateo, Luis R; Stewart, Bernal; Williams, Malcolm; Panagakos, Foti

    2015-12-01

    This study compared the efficacy of two oral hygiene regimens in reducing oral malodour and the proportions of bacterial species involved in the production of volatile sulphur compounds. Seventy subjects who participated in a halitosis-induction phase and achieved an organoleptic score of ≥ 3.0 [time point 0 (T0)] randomised into two groups: brushing with regular fluoride toothpaste alone (control group) or brushing with regular fluoride toothpaste followed by rinsing with a 0.075% cetylpyridinium chloride (CPC) mouthwash (CPC group). Subjects followed their assigned oral hygiene regimen for 21 days. Then, they underwent an organoleptic examination and measurement of volatile sulphur compounds (VSCs) using a portable gas chromatograph, 12 hours after their last oral hygiene procedure (T1) and 4 hours after an on-site oral hygiene (T2). Microbiological samples (supragingival biofilm, tongue coating and saliva) were analysed using checkerboard DNA-DNA hybridisation. Both therapies statistically significantly improved the organoleptic scores (P oral malodour scores were reduced by 49% at the 4-hour assessment (T2) compared with those not rinsing (P oral malodour, measured organoleptically and instrumentally, and in the proportions of red-complex species when compared with brushing alone. © 2015 FDI World Dental Federation.

  15. Efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose: Results of a randomized controlled trial.

    Science.gov (United States)

    Göke, R; Eschenbach, P; Dütting, E D

    2015-06-01

    This study compared the efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose (FPG) as single-pill combinations (SPCs) with metformin. The randomized crossover, open-label, active-controlled study design assessed the FPG-lowering abilities of a vildagliptin/metformin (50/1000 mg twice daily) SPC compared with a sitagliptin/metformin (50/1000 mg twice daily) SPC after 2 weeks of treatment in 99 type 2 diabetes patients uncontrolled by stable metformin therapy (1000-2000 mg/day). The change in FPG from baseline to day 14 was significantly greater (P vildagliptin [-21.9 mg/dL (SD 27.0)] than with sitagliptin [-14.5 mg/dL (SD 23.0)]. After 14 days of treatment, the mean FPG was 137.8 mg/dL (SD 28.5) with vildagliptin and 140.1mg/dL (SD 26.5) with sitagliptin (P vildagliptin produced a significantly greater reduction in FPG vs baseline compared with sitagliptin, which may translate into clinical relevance. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  16. HIV Model Parameter Estimates from Interruption Trial Data including Drug Efficacy and Reservoir Dynamics

    Science.gov (United States)

    Luo, Rutao; Piovoso, Michael J.; Martinez-Picado, Javier; Zurakowski, Ryan

    2012-01-01

    Mathematical models based on ordinary differential equations (ODE) have had significant impact on understanding HIV disease dynamics and optimizing patient treatment. A model that characterizes the essential disease dynamics can be used for prediction only if the model parameters are identifiable from clinical data. Most previous parameter identification studies for HIV have used sparsely sampled data from the decay phase following the introduction of therapy. In this paper, model parameters are identified from frequently sampled viral-load data taken from ten patients enrolled in the previously published AutoVac HAART interruption study, providing between 69 and 114 viral load measurements from 3–5 phases of viral decay and rebound for each patient. This dataset is considerably larger than those used in previously published parameter estimation studies. Furthermore, the measurements come from two separate experimental conditions, which allows for the direct estimation of drug efficacy and reservoir contribution rates, two parameters that cannot be identified from decay-phase data alone. A Markov-Chain Monte-Carlo method is used to estimate the model parameter values, with initial estimates obtained using nonlinear least-squares methods. The posterior distributions of the parameter estimates are reported and compared for all patients. PMID:22815727

  17. 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.

  18. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

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    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.

  19. 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 Facebook Social Support Group increased steps/day significantly more (F(1,138) = 11.34, P Facebook to offer a 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.

  20. 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.

  1. 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

  2. Efficacy and tolerability of vilazodone for major depressive disorder: evidence from phase III/IV randomized controlled trials

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    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

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

    Science.gov (United States)

    Ebert, David Daniel; Lehr, Dirk; Boß, Leif; Riper, Heleen; Cuijpers, Pim; Andersson, Gerhard; Thiart, Hanne; Heber, Elena; Berking, Matthias

    2014-11-01

    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 group (WLC). One-hundred and fifty teachers with elevated depressive symptoms (Center for Epidemiologic Studies Depression Scale, CES-D ≥16) were assigned to either the iPST or WLC group. The iPST consisted of five lessons, including problem-solving and rumination techniques. Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks, three months, and six months. The primary outcome was depressive symptom severity (CES-D). Secondary outcomes included general and work-specific self-efficacy, perceived stress, pathological worries, burnout symptoms, general physical and mental health, and absenteeism. iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention (d=0.59, 95% CI 0.26-0.92), after three months (d=0.37, 95% CI 0.05-0.70) and after six months (d=0.38, 95% CI 0.05-0.70) compared to the control group. The iPST participants also displayed significantly higher improvements in secondary outcomes. However, workplace absenteeism was not significantly affected. iPST is effective in reducing symptoms of depression among teachers. Disseminated on a large scale, iPST could contribute to reducing the burden of stress-related mental health problems among teachers. Future studies should evaluate iPST approaches for use in other working populations.

  4. Comparison of the efficacy of two anesthetic techniques of mandibular primary first molar: A randomized clinical trial

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    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.

  5. Efficacy of the Fun For Wellness Online Intervention to Promote Multidimensional Well-Being: a Randomized Controlled Trial.

    Science.gov (United States)

    Myers, Nicholas D; Prilleltensky, Isaac; Prilleltensky, Ora; McMahon, Adam; Dietz, Samantha; Rubenstein, Carolyn L

    2017-11-01

    Subjective well-being refers to people's level of satisfaction with life as a whole and with multiple dimensions within it. Interventions that promote subjective well-being are important because there is evidence that physical health, mental health, substance use, and health care costs may be related to subjective well-being. Fun For Wellness (FFW) is a new online universal intervention designed to promote growth in multiple dimensions of subjective well-being. The purpose of this study was to provide an initial evaluation of the efficacy of FFW to increase subjective well-being in multiple dimensions in a universal sample. The study design was a prospective, double-blind, parallel group randomized controlled trial. Data were collected at baseline and 30 and 60 days-post baseline. A total of 479 adult employees at a major university in the southeast of the USA were enrolled. Recruitment, eligibility verification, and data collection were conducted online. Measures of interpersonal, community, occupational, physical, psychological, economic (i.e., I COPPE), and overall subjective well-being were constructed based on responses to the I COPPE Scale. A two-class linear regression model with complier average causal effect estimation was imposed for each dimension of subjective well-being. Participants who complied with the FFW intervention had significantly higher subjective well-being, as compared to potential compliers in the Usual Care group, in the following dimensions: interpersonal at 60 days, community at 30 and 60 days, psychological at 60 days, and economic at 30 and 60 days. Results from this study provide some initial evidence for both the efficacy of, and possible revisions to, the FFW intervention.

  6. 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.

  7. Efficacy of a process improvement intervention on delivery of HIV services to offenders: a multisite trial.

    Science.gov (United States)

    Pearson, Frank S; Shafer, Michael S; Dembo, Richard; Del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L; Belenko, Steven; Frisman, Linda K; Visher, Christy A; Pich, Michele; Patterson, Yvonne

    2014-12-01

    We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments.

  8. Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial.

    Science.gov (United States)

    Walsh, Terri L; Frezieres, Ron G; Peacock, Karen; Nelson, Anita L; Clark, Virginia A; Bernstein, Leslie

    2003-01-01

    To reduce unintended pregnancy and HIV infection, it is critical to develop reliable male condoms that will attract consumers who reject conventional latex condoms. In a prospective clinical trial conducted in 1998-2000, 830 monogamous couples were randomized in equal numbers to use either a nonlatex condom or a commercial natural latex condom for six months as their only method of birth control. Couples completed detailed reports for the first five condom uses and recorded intercourse and condom use in coital diaries. Pregnancy rates associated with typical and consistent condom use were calculated using life-table analysis. Rates of clinical failure (condom breakage or slippage) were determined for the first five condom uses. During the first five uses, the nonlatex condom had a higher frequency of breakage or slippage during intercourse or withdrawal (4.0%) than latex condoms (1.3%); the breakage rate for the nonlatex condom was about eight times that of latex condoms. The six-cycle typical-use pregnancy rate did not differ significantly between users of nonlatex (10.8%) and latex condoms (6.4%). The six-cycle consistent-use pregnancy rate was higher for nonlatex condom users than for latex condom users (4.9% vs. 1.0%). The data present strong indirect support for public health messages that promote the use of latex condoms and, for individuals who cannot or are unwilling to use latex condoms, the use of nonlatex condoms for prevention of pregnancy and disease.

  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 <48 h with mild to moderate dehydration, not on antibiotics and requiring oral rehydration therapy. Intervention done was DS with a dose of 1.5 g thrice daily. Freshly dissolved DS in a dose of 1.5 g thrice daily for 5 days significantly shortened the duration of acute watery 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 of an Electromechanical Gait Trainer Poststroke in Singapore: A Randomized Controlled Trial.

    Science.gov (United States)

    Chua, Joyce; Culpan, Jane; Menon, Edward

    2016-05-01

    To evaluate the longer-term effects of electromechanical gait trainers (GTs) combined with conventional physiotherapy on health status, function, and ambulation in people with subacute stroke in comparison with conventional physiotherapy given alone. Randomized controlled trial with intention-to-treat analysis. Community hospital in Singapore. Nonambulant individuals (N=106) recruited approximately 1 month poststroke. Both groups received 45 minutes of physiotherapy 6 times per week for 8 weeks as follows: the GT group received 20 minutes of GT training and 5 minutes of stance/gait training in contrast with 25 minutes of stance/gait training for the control group. Both groups completed 10 minutes of standing and 10 minutes of cycling. The primary outcome was the Functional Ambulation Category (FAC). Secondary outcomes were the Barthel Index (BI), gait speed and endurance, and Stroke Impact Scale (SIS). Measures were taken at baseline and 4, 8, 12, 24, and 48 weeks. Generalized linear model analysis showed significant improvement over time (independent of group) for the FAC, BI, and SIS physical and participation subscales. However, no significant group × time or group differences were observed for any of the outcome variables after generalized linear model analysis. The use of GTs combined with conventional physiotherapy can be as effective as conventional physiotherapy applied alone for people with subacute stroke. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. 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.

  12. Efficacy of an educational manual for childbirth companions: pilot study of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Liana Mara Rocha Teles

    2018-05-01

    Full Text Available ABSTRACT Objective: to evaluate the effectiveness of an educational manual in the instrumentalization of companions to provide support to the parturients and check its influence on the satisfaction of companions and women during vaginal delivery. Method: pilot study of a randomized controlled clinical trial with 65 companions and puerperal women (intervention = 21 and control = 44. The previous knowledge of the companions was evaluated at baseline. The Evaluation Form for Companions in the Delivery Room was used to measure the actions provided and the satisfaction with the experience, and the Questionnaire for Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery was used to evaluate the satisfaction of women with childbirth. The Student’s t-test or Wilcoxon, chi-square or Fisher’s exact test, risk ratios and 95% confidence intervals were used. Results: the companions in the intervention group performed a greater number of support actions (7.2 vs 4.6, p: 0.001 and had higher satisfaction scores (72.4 vs 64.2; p = 0.00. Puerperal women in the intervention group had higher satisfaction with childbirth (119.6 vs 107.9; p: 0.000. Conclusion: the manual was effective for the instrumentalization of companions, contributed to support actions to the parturients and had repercussions on the satisfaction of companions and women with the birthing process. RBR-776d9s

  13. Evaluating the Efficacy of the Feeding Exercise Randomized Trial in Overweight and Obese Adolescents.

    Science.gov (United States)

    Patsopoulou, Anna; Tsimtsiou, Zoi; Katsioulis, Antonios; Malissiova, Eleni; Rachiotis, George; Hadjichristodoulou, Christos

    2017-04-01

    The Feeding Exercise Trial in Adolescents (FETA) aimed to evaluate whether a community-based, parents-involving, combined physical activity and nutritional education program was effective in improving adiposity profiles in overweight and obese adolescents. A total of 181 overweight and obese adolescents aged 13-15 years old were randomized in the three study groups ("Diet & Activity," "Activity," and Control). The Activity intervention included a 45-minute, 3-day per week supervised training program, while the Diet & Activity intervention included a supplementary 15 minutes of group-based sessions attended by the parents. The intervention lasted 3 months and the participants were followed for another 3 months after the intervention. The participants were assessed for anthropometric measures and activity and fulfilled the modified version of the questionnaire "Family Eating and Activity Habits Questionnaire" (FEAHQ). Both "Activity" only and "Diet & Activity" groups reduced significantly (p obese adolescents, as well as family activity and feeding habits, maintained at 3 months follow-up.

  14. Efficacy of blood flow restriction exercise during dialysis for end stage kidney disease patients: protocol of a randomised controlled trial.

    Science.gov (United States)

    Clarkson, Matthew J; Fraser, Steve F; Bennett, Paul N; McMahon, Lawrence P; Brumby, Catherine; Warmington, Stuart A

    2017-09-11

    Exercise during haemodialysis improves strength and physical function. However, both patients and clinicians are time poor, and current exercise recommendations add an excessive time burden making exercise a rare addition to standard care. Hypothetically, blood flow restriction exercise performed during haemodialysis can provide greater value for time spent exercising, reducing this time burden while producing similar or greater outcomes. This study will explore the efficacy of blood flow restriction exercise for enhancing strength and physical function among haemodialysis patients. This is a randomised controlled trial design. A total of 75 participants will be recruited from haemodialysis clinics. Participants will be allocated to a blood flow restriction cycling group, traditional cycling group or usual care control group. Both exercising groups will complete 3 months of cycling exercise, performed intradialytically, three times per week. The blood flow restriction cycling group will complete two 10-min cycling bouts separated by a 20-min rest at a subjective effort of 15 on a 6 to 20 rating scale. This will be done with pressurised cuffs fitted proximally on the active limbs during exercise at 50% of a pre-determined limb occlusion pressure. The traditional cycling group will perform a continuous 20-min bout of exercise at a subjective effort of 12 on the same subjective effort scale. These workloads and volumes are equivalent and allow for comparison of a common blood flow restriction aerobic exercise prescription and a traditional aerobic exercise prescription. The primary outcome measures are lower limb strength, assessed by a three repetition maximum leg extension test, as well as objective measures of physical function: six-minute walk test, 30-s sit to stand, and timed up and go. Secondary outcome measures include thigh muscle cross sectional area, body composition, routine pathology, quality of life, and physical activity engagement. This study will

  15. Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial.

    Science.gov (United States)

    Doğan, Nurettin Özgür; Avcu, Nazire; Yaka, Elif; Yılmaz, Serkan; Pekdemir, Murat

    2015-07-01

    The present study aimed to compare the therapeutic efficacy of dimenhydrinate and piracetam in patients with vertigo. A blinded, parallel group, superiority, randomised clinical trial was carried out on patients who presented to the emergency department (ED) with vertigo. Healthy adult patients presenting to the ED with undifferentiated vertigo were included in the study. The efficacy of intravenous dimenhydrinate (100 mg) and intravenous piracetam (2000 mg) for reducing the intensity of vertigo was compared in two randomised treatment groups using a 10-point numeric rating scale (NRS). The determination of NRS scores was performed at presentation and at the 30th minute of presentation, after the study drug was implemented, both in immobile and ambulatory positions. The primary outcome variable was reduction in vertigo intensity documented on the NRS at the 30th minute after medication administration, analysed by intention to treat. A total of 94 patients were included in the randomisation (n=47 in both groups). The baseline NRS scores were 7.55±2.00 in the dimenhydrinate group and 8.19±1.79 in the piracetam group. The changes from baseline for dimenhydrinate and piracetam were 2.92±3.11 and 3.75±3.40 (difference -0.83 (95% CI -2.23 to 0.57)) in the immobile position and were 2.04±3.07 and 2.72±2.91 (difference -0.68 (95% CI -2.03 to 0.67)) in the ambulatory position. Rescue medication need was similar in both treatment groups (p=0.330), and only one adverse reaction was reported. We found no evidence of a difference between dimenhydrinate and piracetam in relieving the symptoms of vertigo. Clinical Trials Registration ID: NCT01890538. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  16. 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

  17. 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

  18. Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Protocol of a Randomized Controlled Trial.

    Science.gov (United States)

    Szymański, Henryk; Szajewska, Hania

    2017-08-23

    Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. However, despite proven efficacy, it remains underused. This is because oral rehydration solution neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness. Hence, there is interest in adjunctive treatments. According to the 2014 guidelines developed by the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, the use of the following probiotics may be considered in the management of children with AGE in addition to rehydration therapy: Lactobacillus rhamnosus GG (low quality of evidence; strong recommendation) and Saccharomyces boulardii (low quality of evidence; strong recommendation). Less compelling evidence is available for Lactobacillus reuteri DSM 17938 (very low quality of evidence; weak recommendation). Considering that evidence on L reuteri remains limited, the goal of the study is to assess the effectiveness of L reuteri DSM 17938 in the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately. This will be a double-blind, placebo-controlled, randomized trial. Children between 1 and 60 months of age with AGE, defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form scale or Amsterdam Stool Form scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h) lasting for no longer than 5 days, will be recruited. A total of 72 children will receive either L reuteri DSM 17938 at a dose of 2×10 8 colony-forming units twice daily or matching placebo for 5 consecutive days. A similar sample size for rotavirus vaccinated and nonvaccinated children is planned. The primary outcome measure is the duration of diarrhea. Two separate studies and reports for rotavirus vaccinated and nonvaccinated children are planned. The recruitment started in January 2017

  19. 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

  20. 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

    2014-12-01

    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. This Study investigated the cosmetic filling efficacy of Fillerina® in decreasing the skin aging signs and in improving facial volume deficiencies. 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). 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. This study demonstrated the positive filling effect of Fillerina® in decreasing the clinical signs of skin aging and in improving the face volumes. © 2014 Wiley Periodicals, Inc.

  1. Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial

    Science.gov (United States)

    Nolan, Terry; Roy-Ghanta, Sumita; Montellano, May; Weckx, Lily; Ulloa-Gutierrez, Rolando; Lazcano-Ponce, Eduardo; Kerdpanich, Angkool; Safadi, Marco Aurélio Palazzi; Cruz-Valdez, Aurelio; Litao, Sandra; Lim, Fong Seng; de Los Santos, Abiel Mascareñas; Weber, Miguel Angel Rodriguez; Tinoco, Juan-Carlos; Mezerville, Marcela Hernandez-de; Faingezicht, Idis; Kosuwon, Pensri; Lopez, Pio; Borja-Tabora, Charissa; Li, Ping; Durviaux, Serge; Fries, Louis; Dubin, Gary; Breuer, Thomas; Innis, Bruce L.; Vaughn, David W.

    2014-01-01

    Background. The vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010–2011. Methods. A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009(H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed. Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. The VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%–93.4%). The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group. Conclusion. The 4–8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics. Clinical Trials Registration. NCT01051661. PMID:24652494

  2. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial.

    Science.gov (United States)

    Hazarey, Vinay K; Sakrikar, Aditee R; Ganvir, Sindhu M

    2015-01-01

    Oral submucous fibrosis (OSF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin" are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group from the Outpatient Department. Test group patients were treated with Longvida (curcumin) lozenges and control group with Tenovate ointment (clobetasol propionate (0.05%). The treatment was given for 3 months duration and follow-up was done for 6 months. Both the groups were advised for physiotherapy exercises by mouth exercise device. The baseline and follow-up results were compared for IIO (interincisal distance on maximum mouth opening), Visual Analogue Scale (VAS) for normal food and VAS for spicy food. The test group showed 5.93 (±2.37) mm increase in mouth opening compared to 2.66 (±1.76) mm of the control group. In relation to VAS scale with spicy and normal food the average reduction was 64 (42-73) and 77 (70.5-82) as compared to 34 (14.5-64.5) and 64 (46-75.5) respectively in control group. The test group results achieved in the treatment span was sustained in the follow-up (P < 0.05) compared to control group which showed statistically significant (P < 0.05) relapse. It can be concluded that combination strategies for the management of OSF which include the stoppage of causative ill habits, appropriate medicinal and physiotherapy management is more efficient than single therapeutic modality. It is evident from the study that curcumin holds good promise in the treatment of OSF in future.

  3. Impact of Dengue Vaccination on Serological Diagnosis: Insights From Phase III Dengue Vaccine Efficacy Trials.

    Science.gov (United States)

    Plennevaux, Eric; Moureau, Annick; Arredondo-García, José L; Villar, Luis; Pitisuttithum, Punnee; Tran, Ngoc H; Bonaparte, Matthew; Chansinghakul, Danaya; Coronel, Diana L; L'Azou, Maïna; Ochiai, R Leon; Toh, Myew-Ling; Noriega, Fernando; Bouckenooghe, Alain

    2018-04-03

    We previously reported that vaccination with the tetravalent dengue vaccine (CYD-TDV; Dengvaxia) may bias the diagnosis of dengue based on immunoglobulin M (IgM) and immunoglobulin G (IgG) assessments. We undertook a post hoc pooled analysis of febrile episodes that occurred during the active surveillance phase (the 25 months after the first study injection) of 2 pivotal phase III, placebo-controlled CYD-TDV efficacy studies that involved ≥31000 children aged 2-16 years across 10 countries in Asia and Latin America. Virologically confirmed dengue (VCD) episode was defined with a positive test for dengue nonstructural protein 1 antigen or dengue polymerase chain reaction. Probable dengue episode was serologically defined as (1) IgM-positive acute- or convalescent-phase sample, or (2) IgG-positive acute-phase sample and ≥4-fold IgG increase between acute- and convalescent-phase samples. There were 1284 VCD episodes (575 and 709 in the CYD-TDV and placebo groups, respectively) and 17673 other febrile episodes (11668 and 6005, respectively). Compared with VCD, the sensitivity and specificity of probable dengue definition were 93.1% and 77.2%, respectively. Overall positive and negative predictive values were 22.9% and 99.5%, respectively, reflecting the much lower probability of correctly confirming probable dengue in a population including a vaccinated cohort. Vaccination-induced bias toward false-positive diagnosis was more pronounced among individuals seronegative at baseline. Caution will be required when interpreting IgM and IgG data obtained during routine surveillance in those vaccinated with CYD-TDV. There is an urgent need for new practical, dengue-specific diagnostic algorithms now that CYD-TDV is approved in a number of dengue-endemic countries. NCT01373281 and NCT01374516.

  4. Efficacy of Water Resistance Therapy in Subjects Diagnosed With Behavioral Dysphonia: A Randomized Controlled Trial.

    Science.gov (United States)

    Guzman, Marco; Jara, Rodrigo; Olavarria, Christian; Caceres, Paloma; Escuti, Geordette; Medina, Fernanda; Medina, Laura; Madrid, Sofia; Muñoz, Daniel; Laukkanen, Anne-Maria

    2017-05-01

    The purpose of the present study was to determine the efficacy of water resistance therapy (WRT) in a long-term period of voice treatment in subjects diagnosed with voice disorders. Twenty participants, with behavioral dysphonia, were randomly assigned to one of two treatment groups: (1) voice treatment with WRT, and (2) voice treatment with tube phonation with the distal end in air (TPA). Before and after voice therapy, participants underwent aerodynamic, electroglottographic, acoustic, and auditory-perceptual assessments. The Voice Handicap Index and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the WRT group, the exercises consisted of a sequence of five phonatory tasks performed with a drinking straw submerged 5 cm into water. For the TPA, the exercises consisted of the same phonatory tasks, and all of them were performed into the same straw but the distal end was in air. Wilcoxon test showed significant improvements for both groups for Voice Handicap Index (decrease), subglottic pressure (decrease), phonation threshold pressure (decrease), and self-perception of resonant voice quality (increase). Improvement in auditory-perceptual assessment was found only for the TPA group. No significant differences were found for any acoustic or electroglottographic variables. No significant differences were found between WRT and TPA groups for any variable. WRT and TPA may improve voice function and self-perceived voice quality in individuals with behavioral dysphonia. No differences between these therapy protocols should be expected. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  5. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sidney Glina

    2011-12-01

    Full Text Available PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs. As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174 or ketoprofen 100 mg IV plus placebo (n = 164. 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174 or ketoprofen 100 mg IV(n = 164 plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID at 30 minutes by visual analog scale (VAS (per-protocol population. An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD mPID30 min was 33.84 (24.61 and 35.16 (26.01 for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

  6. The efficacy of music therapy for people with dementia: A meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Chang, Yu-Shiun; Chu, Hsin; Yang, Chyn-Yng; Tsai, Jui-Chen; Chung, Min-Huey; Liao, Yuan-Mei; Chi, Mei-ju; Liu, Megan F; Chou, Kuei-Ru

    2015-12-01

    To (1) perform a meta-analysis of randomised controlled trials pertaining to the efficacy of music therapy on disruptive behaviours, anxiety levels, depressive moods and cognitive functioning in people with dementia; and (2) clarify which interventions, therapists and participant characteristics exerted higher and more prominent effects. Present study was the first to perform a meta-analysis that included all the randomised controlled trials found in literature relating to music therapy for people with dementia over the past 15 years. A meta-analysis study design. Quantitative studies were retrieved from PubMed, Medline, Cochrane Library Database, CINAHL, SCOPUS and PsycINFO. A meta-analysis was used to calculate the overall effect sizes of music therapy on outcome indicators. Music therapy significantly improved disruptive behaviours [Hedges' g = -0·66; 95% confidence interval (CI) = -0·44 to -0·88] and anxiety levels (Hedges' g = -0·51; 95% CI = -0·02 to -1·00) in people with dementia. Music therapy might affect depressive moods (Hedges' g = -0·39; 95% CI = 0·01 to -0·78), and cognitive functioning (Hedges' g = 0·19; 95% CI = 0·45 to -0·08). Music therapy exerted a moderately large effect on disruptive behaviours of people with dementia, a moderate effect on anxiety levels and depressive moods, and a small effect on cognitive functioning. Individual music therapy provided once a week to patients with cognitive functioning and manual guided in music intervention construction is suggested. Group music therapy is provided several times a week to reduce their disruptive behaviours, anxiety levels and depressive moods. Music therapy is a cost-effective, enjoyable, noninvasive therapy and could be useful for clinical nurses in creating an environment that is conducive to the well-being of patients with dementia. © 2015 John Wiley & Sons Ltd.

  7. Efficacy of Sacubitril/Valsartan Relative to a Prior Decompensation: The PARADIGM-HF Trial.

    Science.gov (United States)

    Solomon, Scott D; Claggett, Brian; Packer, Milton; Desai, Akshay; Zile, Michael R; Swedberg, Karl; Rouleau, Jean; Shi, Victor; Lefkowitz, Martin; McMurray, John J V

    2016-10-01

    This study assessed whether the benefit of sacubtril/valsartan therapy varied with clinical stability. Despite the benefit of sacubitril/valsartan therapy shown in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation. Outcomes were compared among patients who had prior hospitalization within 3 months of screening (n = 1,611 [19%]), between 3 and 6 months (n = 1,009 [12%]), between 6 and 12 months (n = 886 [11%]), >12 months (n = 1,746 [21%]), or who had never been hospitalized (n = 3,125 [37%]). Twenty percent of patients without prior HF hospitalization experienced a primary endpoint of cardiovascular death or heart failure (HF) hospitalization during the course of the trial. Despite the increased risk associated with more recent hospitalization, the efficacy of sacubitril/valsartan therapy did not differ from that of enalapril according to the occurrence of or time from hospitalization for HF before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality. Patients with recent HF decompensation requiring hospitalization were more likely to experience cardiovascular death or HF hospitalization than those who had never been hospitalized. Patients who were clinically stable, as shown by a remote HF hospitalization (>3 months prior to screening) or by lack of any prior HF hospitalization, were as likely to benefit from sacubitril/valsartan therapy as more recently hospitalized patients. (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure [PARADIGM-HF]; NCT01035255). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Efficacy of Risperidone Augmentation with Ondansetron in the Treatment of Negative and Depressive Symptoms in Schizophrenia: A Randomized Clinical Trial

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    Roya Samadi

    2017-01-01

    Full Text Available Background: Given the potential role of the 5-hydroxytryptamine-3 receptor in the pathogenesis of schizophrenia, this study was performed to determine whether ondansetron plus risperidone could reduce the negative and depressive symptoms in patients with treatment-resistant schizophrenia. Methods: In a double-blinded, placebo-controlled, randomized trial (IRCT registration # 201112125280N7, in 2012–2013 in Mashhad, Iran, 38 patients with treatment-resistant schizophrenia received risperidone either combined with a fixed dose (4–8 mg/d of ondansetron (n=18 or with a placebo (n=20 for 12 weeks. The patients were evaluated using the Positive and Negative Syndrome Scale (PANSS, Wechsler’s Adult Intelligence Scale-Revised (WAIS-R, and Hamilton’s Rating Scale for Depression (HRSD at baseline and 12 weeks later. Changes in the inventories were used to evaluate the efficacy of the treatment. The t test, Chi-square test, and SPSS (version 16 were used to analyze the data. The statistical significance was set at P<0.05. Results: Ondansetron plus risperidone was associated with a significantly larger improvement in the PANSS overall scale and subscales for negative symptoms and cognition than was risperidone plus placebo (P<0.001. The WAIS-R scale results indicated significant differences between the 2 groups before and after administrating the medicine and the placebo. The administration of ondansetron significantly improved visual memory based on the subtests of the WAIS (P<0.05. Ondansetron had no positive effects on depressive symptoms (effect size=0.13. Conclusion: This study confirmed that ondansetron, as an adjunct treatment, reduces negative symptoms in patients with schizophrenia and can be used as a potential adjunctive strategy particularly for negative symptoms and cognitive impairments. Trial Registration Number: IRCT201112125280N7

  9. Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Askim, Torunn; Langhammer, Birgitta; Ihle-Hansen, Hege; Gunnes, Mari; Lydersen, Stian; Indredavik, Bent

    2018-02-01

    The evidence for interventions to prevent functional decline in the long term after stroke is lacking. The aim of this trial was to evaluate the efficacy and safety of an 18-month follow-up program of individualized regular coaching on physical activity and exercise. This was a multicentre, pragmatic, single-blinded, randomized controlled trial. Adults (age ≥18 years) with first-ever or recurrent stroke, community dwelling, with modified Rankin Scale coaching on physical activity and exercise every month for 18 consecutive months. The control group received standard care. Primary outcome was the Motor Assessment Scale at end of intervention (18-month follow-up). Secondary measures were Barthel index, modified Rankin Scale, item 14 from Berg Balance Scale, Timed Up and Go test, gait speed, 6-minute walk test, and Stroke Impact Scale. Other outcomes were adverse events and compliance to the intervention assessed by training diaries and the International Physical Activity Questionnaire. Three hundred and eighty consenting participants were randomly assigned to individualized coaching (n=186) or standard care (n=194). The mean estimated difference on Motor Assessment Scale in favor of control group was -0.70 points (95% confidence interval, -2.80, 1.39), P =0.512. There were no differences between the groups on Barthel index, modified Rankin Scale, or Berg Balance Scale. The frequency of adverse events was low in both groups. Results from International Physical Activity Questionnaire and training diaries showed increased activity levels but low intensity of the exercise in the intervention group. The regular individualized coaching did not improve maintenance of motor function or the secondary outcomes compared with standard care. The intervention should be regarded as safe. Despite the neutral results, the health costs related to the intervention should be investigated. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01467206. © 2017 American Heart

  10. Efficacy of Biofeedback Therapy before and after Sphincteroplasty for Fecal Incontinence because of Obstetric Injury: A Randomized Controlled Trial

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    Leila Ghahramani

    2016-03-01

    Full Text Available Fecal incontinence is a challenging condition in that it exerts various psychosocial impacts on daily life. Different treatment modalities have been suggested for fecal incontinence. The present study aimed to evaluate the efficacy of biofeedback therapy in combination with surgery in the management of fecal incontinence. The present randomized controlled trial was performed on 27 women with a complaint of fecal incontinence because of delivery trauma. The patients underwent sphincteroplasty and levatorplasty via the same method by 2 colorectal surgeons. In Group I, biofeedback therapy was performed 3 months before and 6 months after the surgery; in Group II, biofeedback therapy was applied only 6 months after the surgery; and in Group III, only surgical management was performed. The results revealed a significant difference between the preoperative and postoperative Wexner scores of incontinence in all the 3 groups. Additionally, the difference between the preoperative and postoperative scores was significant only in Group I and Group III, but not in Group II. The reduction in the Wexner score was significantly less in Group III. However, no significant difference was observed between the 3 groups concerning the mean difference of preoperative and postoperative manometry. The present study revealed no significant role for biofeedback therapy alone in the improvement of manometric evaluation. However, the Wexner score, which is an indicator of patient satisfaction, increased with biofeedback therapy following sphincteroplasty. In general, surgical treatment is now reserved for selected patients with fecal incontinence and has recently been developed with biofeedback therapy. Trial Registration Number: IRCT201206039936N1

  11. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

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    Hengwei Jin

    2017-09-01

    Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

  12. Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial

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    Rachel Chambers

    2016-04-01

    Full Text Available Abstract Background American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. Methods/Design The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18–49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. Discussion This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other

  13. Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical Trial.

    Science.gov (United States)

    Dunn, Kelly E; Tompkins, D Andrew; Bigelow, George E; Strain, Eric C

    2017-09-01

    Opioid use disorder (OUD) is a significant public health problem. Supervised withdrawal (ie, detoxification) from opioids using clonidine or buprenorphine hydrochloride is a widely used treatment. To evaluate whether tramadol hydrochloride extended-release (ER), an approved analgesic with opioid and nonopioid mechanisms of action and low abuse potential, is effective for use in supervised withdrawal settings. A randomized clinical trial was conducted in a residential research setting with 103 participants with OUD. Participants' treatment was stabilized with morphine, 30 mg, administered subcutaneously 4 times daily. A 7-day taper using clonidine (n = 36), tramadol ER (n = 36), or buprenorphine (n = 31) was then instituted, and patients were crossed-over to double-blind placebo during a post-taper period. The study was conducted from October 25, 2010, to June 23, 2015. Retention, withdrawal symptom management, concomitant medication utilization, and naltrexone induction. Results were analyzed over time and using area under the curve for the intention-to-treat and completer groups. Of the 103 participants, 88 (85.4%) were men and 43 (41.7%) were white; mean (SD) age was 28.9 (10.4) years. Buprenorphine participants (28 [90.3%]) were significantly more likely to be retained at the end of the taper compared with clonidine participants (22 [61.1%]); tramadol ER retention was intermediate and did not differ significantly from that of the other groups (26 [72.2%]; χ2 = 8.5, P = .01). Time-course analyses of withdrawal revealed significant effects of phase (taper, post taper) for the Clinical Opiate Withdrawal Scale (COWS) score (taper mean, 5.19 [SE, .26]; post-taper mean, 3.97 [SE, .23]; F2,170 = 3.6, P = .03) and Subjective Opiate Withdrawal Scale (SOWS) score (taper mean,8.81 [SE, .40]; post-taper mean, 4.14 [SE, .30]; F2,170 = 15.7, P withdrawal severity between the taper and post-taper periods for clonidine (taper mean, 13.1; post

  14. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial.

    Science.gov (United States)

    Scheltens, Philip; Twisk, Jos W R; Blesa, Rafael; Scarpini, Elio; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Swinkels, Sophie H N; Stam, Cornelis J; de Waal, Hanneke; Wurtman, Richard J; Wieggers, Rico L; Vellas, Bruno; Kamphuis, Patrick J G H

    2012-01-01

    Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with mild AD. Patients were randomized 1:1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p = 0.023; Cohen's d = 0.21; 95% confidence interval [-0.06]-[0.49]). A trend for an effect was observed on the NTB total composite z-score (p = 0.053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.

  15. The Efficacy of Goal Setting in Cardiac Rehabilitation-a Gender-Specific Randomized Controlled Trial.

    Science.gov (United States)

    Stamm-Balderjahn, Sabine; Brünger, Martin; Michel, Anne; Bongarth, Christa; Spyra, Karla

    2016-08-08

    Patients with coronary heart disease undergo cardiac rehabilitation in order to reduce their cardiovascular risk factors. Often, however, the benefit of rehabilitation is lost over time. It is unclear whether this happens in the same way to men and women. We studied whether the setting of gender-specific behavior goals with an agreement between the doctor and the patient at the end of rehabilitation can prolong its positive effects. This study was performed with a mixed-method design. It consisted of qualitative interviews and group discussions with patients, doctors and other treating personnel, and researchers, as well as a quantitative, randomized, controlled intervention trial in which data were acquired at four time points (the beginning and end of rehabilitation and then 6 and 12 months later). 545 patients, 262 of them women (48.1%), were included. The patients were assigned to a goal checking group (n = 132), a goal setting group (n = 143), and a control group (n = 270). The primary endpoints were health-related behavior (exercise, diet, tobacco consumption), subjective state of health, and medication adherence. The secondary endpoints included physiological protection and risk factors such as blood pressure, cholesterol (HDL, LDL, and total), blood sugar, HbA1c, and body-mass index. The intervention had no demonstrable effect on the primary or secondary endpoints. The percentage of smokers declined to a similar extent in all groups from the beginning of rehabilitation to 12 months after its end (overall figures: 12.4% to 8.6%, p exercise behavior, diet, and subjective state of health also improved over the entire course of the study. Women had a healthier diet than men. Subgroup analyses indicated a possible effect of the intervention on exercise behavior in women who were employed and in men who were not (pgoal setting was not demonstrated. Therefore, no indication for its routine provision can be derived from the study results.

  16. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial.

    Science.gov (United States)

    Tanvisut, Rajavadi; Traisrisilp, Kuntharee; Tongsong, Theera

    2018-05-01

    Many strategies for labor pain management have been studied, including aromatherapy, which is a noninvasive, alternative medicine used as an adjunct for labor pain control. Nevertheless, the results were contradictory. Therefore, we conducted this study to determine the effectiveness of aromatherapy for reducing pain during labor. A randomized controlled trial was carried out on Thai laboring primigravidae who were a low-risk singleton pregnancy undergoing vaginal delivery. All participants, both study and control group, received standard obstetric care. Aromatherapy was only provided to the study group during the first stage of labor. The women rated their pain intensity by rating scales at different stages of labor. The primary outcome was pain scores and the secondary outcomes were necessity of painkiller usage, labor time, aromatherapy-associated complications, route of delivery, and Apgar scores. A total of 104 women were recruited, 52 in each group. Baseline characteristics and baseline pain scores were comparable. The median pain score of latent and early active phase was lower in the aromatherapy group, 5 vs 6 and 7 vs 8, respectively. The mean differences of pain scores between latent and early active phase and the baseline were significantly lower in the aromatherapy group, 1.88 vs 2.6 (p = 0.010) and 3.82 vs 4.39 (p = 0.031), respectively. Late active phase pain scores and other perinatal outcomes were not significantly different. Aromatherapy is helpful in reducing pain in latent and early active phase, and can probably be used as an adjunctive method for labor pain control without serious side effects.

  17. Efficacy of Chinese herbal medicine Zengru Gao to promote breastfeeding: a multicenter randomized controlled trial.

    Science.gov (United States)

    Wang, Shuaishuai; Zhang, Chi; Li, Cuishan; Li, Daocheng; He, Ping; Su, Zhaojuan; Li, Yanling; Ding, Yiling; Lu, Aiping

    2018-02-06

    Breastfeeding is recommended worldwide but not fully practiced. The first week after childbirth is regarded as a critical period for increasing breast milk production. The aim of the study was to investigate whether Chinese herbal medicine Zengru Gao would result in more women breastfeeding in the first week after childbirth. A multicenter randomized controlled trial was conducted of 588 mothers considering breastfeeding in China. Among the mothers of the intervention group, the intervention included Chinese herbal medicine Zengru Gao; among those of the control group, it did not. Primary outcomes were the percentages of fully and partially breastfeeding mothers. Secondary outcome was baby's daily formula intake. At 3 d and 7 d after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding (Z = - 3.0037, p = 0.0027). At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant (Z = - 3.0037, p = 0.0027). No statistically significant differences were detected on primary measures at 1 d. While intake of formula differed between groups at 1 d and 3 d, this difference did not achieve statistical significance, but this difference was apparent by 7 d (55.45 ± 115.39 ml/day vs 90.66 ± 153.89 ml/day). In conclusion, Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation. ChiCTR-IPR-15007376 , December 11, 2015.

  18. The efficacy of early language intervention in mainstream school settings: a randomized controlled trial.

    Science.gov (United States)

    Fricke, Silke; Burgoyne, Kelly; Bowyer-Crane, Claudine; Kyriacou, Maria; Zosimidou, Alexandra; Maxwell, Liam; Lervåg, Arne; Snowling, Margaret J; Hulme, Charles

    2017-10-01

    Oral language skills are a critical foundation for literacy and more generally for educational success. The current study shows that oral language skills can be improved by providing suitable additional help to children with language difficulties in the early stages of formal education. We conducted a randomized controlled trial with 394 children in England, comparing a 30-week oral language intervention programme starting in nursery (N = 132) with a 20-week version of the same programme starting in Reception (N = 133). The intervention groups were compared to an untreated waiting control group (N = 129). The programmes were delivered by trained teaching assistants (TAs) working in the children's schools/nurseries. All testers were blind to group allocation. Both the 20- and 30-week programmes produced improvements on primary outcome measures of oral language skill compared to the untreated control group. Effect sizes were small to moderate (20-week programme: d = .21; 30-week programme: d = .30) immediately following the intervention and were maintained at follow-up 6 months later. The difference in improvement between the 20-week and 30-week programmes was not statistically significant. Neither programme produced statistically significant improvements in children's early word reading or reading comprehension skills (secondary outcome measures). This study provides further evidence that oral language interventions can be delivered successfully by trained TAs to children with oral language difficulties in nursery and Reception classes. The methods evaluated have potentially important policy implications for early education. © 2017 Association for Child and Adolescent Mental Health.

  19. A pilot trial on safety and efficacy of erythrocyte-mediated steroid treatment in CF patients

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    Bella S

    2006-05-01

    Full Text Available Abstract Background Chronic neutrophil inflammation of the respiratory tract tissues plays a key role in the pathogenesis and in prognosis of cystic fibrosis (CF. It is evident that an anti-inflammatory therapy represents an important step in the treatment of CF patients. Corticosteroids and ibuprofen have been proven to slow down the impairment of the pulmonary function in CF patients but their use is limited by the frequency of adverse events. A novel strategy for delivering low doses of steroids for long periods through the infusion of autologous erythrocytes loaded with dexamethasone has been recently set up. A recent study suggested the feasibility of therapy with low doses of corticosteroids delivered through engineered erythrocytes in CF patients. This study presents a further analysis of safety and efficacy of this therapy. Methods The treatment group was not randomised and the assignment was based on the patient's consent. Patients entered the study if they had a forced expiratory volume in 1 second (FEV1 Results Nine patients in the experimental group received the treatment once a month for a period of 24 month. Patients did not develop diabetes, cataract, or hypertension, or other typical side effects of steroid treatment during the follow up period. There was a constant improvement of FEV1 in patients undergoing the experimental treatment compared to a gradual decrease of the same parameter in the standard therapy group (P = 0.04. The average of clinic and radiological indexes did not vary. The number of infective relapses that have required antibiotic intravenous therapy was not different in the two groups, although the average of these episodes was slightly higher in the experimental therapy group. Conclusion Intraerythrocyte corticosteroid treatment may stabilize the respiratory function in CF patients but is often considered too invasive by patients. The results obtained by our study may help planning an experimental, controlled

  20. Efficacy of Suxiao Jiuxin Pill on Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials

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    Li Ren

    2018-01-01

    Full Text Available Suxiao jiuxin pill is considered an effective ancillary drug in patients with coronary heart disease. Although numerous small, single-center clinical trials have been conducted, the benefits and harms of suxiao jiuxin pill remain controversial. We performed a meta-analysis to clarify the efficacy of suxiao jiuxin pill on patients with coronary heart disease. Randomized controlled trials were identified by using the Cochrane Library, PubMed, Web of Science, Embase, Wanfang, Weipu, and China Knowledge Resource Integrated databases (until June 2016. Pooled relative risks (RR, weighted mean differences (WMD, and 95% confidence intervals (95% CIs were estimated using random-effects models. Forty-one trials involving 6276 patients were included in our analysis. Administration of suxiao jiuxin pill significantly improved electrocardiogram (ECG results when compared with other therapies (RR 1.32, 95% CI 1.26 to 1.38, and P<0.001. Subgroup analyses revealed that suxiao jiuxin pills improve ECG results more than salvia tablets (RR 1.54, 95% CI 1.41 to 1.67, and P<0.001, isosorbide dinitrate (RR 1.14, 95% CI 1.21 to 1.44, and P=0.001, nitroglycerin (RR 1.35, 95% CI 1.16 to 1.56, and P<0.001, and other drugs (RR 1.32, 95% CI 1.21 to 1.44, and P<0.001. Available evidence additionally suggests that suxiao jiuxin pills could significantly reduce total cholesterol (WMD −0.62 mmol/L, 95% CI −1.06 to –0.18 mmol/L, and P=0.005 and low-density lipoprotein (LDL levels (WMD −1.12 mmol/L, 95% CI −1.42 to −0.82 mmol/L, and P<0.001 and increase high-density lipoprotein (HDL levels (WMD 0.32 mmol/L, 95% CI 0.07 to 0.58 mmol/L, and P=0.014. However, no significant differences were observed in total triglyceride levels, plasma viscosity, hematocrit, and fibrinogen. No incidences of adverse reactions were observed after administration of suxiao jiuxin pill. Improvements in ECG results and lipid profiles were also observed after suxiao jiuxin

  1. ISCOM-based equine influenza vaccine: Duration of immunity and randomised clinical trials to assess an accelerated schedule of immunisation and efficacy

    Directory of Open Access Journals (Sweden)

    R. Paillot

    2015-01-01

    Study 3: efficacy against Florida clade 2 EIV strain (randomised trial. Efficacy against the representative Florida clade 2 strain A/eq/Richmond/1/07 was also evaluated at the peak of immunity, shortly after 2nd vaccination (V2. Six ponies were vaccinated with EquipFT according to label (6-week interval between first and second injection and 6 control ponies received saline injections. Sixteen days after V2 (day 58, all animals were experimentally infected with A/eq/Richmond/1/07. Clinical signs of disease and virus shedding were assessed for 14 days and found to be significantly reduced in vaccinated animals.

  2. Efficacy of metronidazole versus placebo in pain control after hemorrhoidectomy: results of a controlled clinical trial

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    Sergio Solorio-López

    2015-11-01

    Full Text Available Introduction: Hemorrhoidal disease occurs in 50% of people aged > 40 years and is the most common reason for anorectal surgery. Pain is the main complication. Multiple topical and systemic drugs have been investigated for pain control, but there is no ideal treatment. Metronidazole has been shown to decrease postoperative pain but is not used widely. Objective: To evaluate the effect of oral metronidazole versus placebo and to assess postoperative pain following hemorrhoidectomy. Material and methods: Controlled clinical trial in adult patients who underwent elective hemorrhoidectomy for grade III/IV hemorrhoids. Patients were assigned to receive metronidazole (500 mg q8 h orally; study group, SG or placebo (control group, CG for 7 days after surgery. Pain was assessed using a visual analog scale after surgery. Analgesic administration (time and use of analgesics and resumption of daily life activities were also assessed. Results: Forty-four patients were included, 22 in each group. Postoperative pain differed significantly between the SG and CG at 6 h (3.86 ± 0.56, 6.64 ± 1.49, 12 h (5.59 ± 1.33, 8.82 ± 0.79, 24 h (6.86 ± 1.49, 9.73 ± 0.45, day 4 (5.32 ± 2.10, 9.50 ± 0.59, day 7 (3.14 ± 1.03, 7.36 ± 1.39, and day 14 (2.14 ± 0.46, 5.45 ± 1.29. The first analgesia dose was required at 21.27 ± 5.47 h in the CG and 7.09 ± 2.36 h in the SG (p < 0.05, the time of analgesic use was 6.86 ± 1.61 days in the CG and 13.09 ± 2.48 days in the SG (p < 0.05, and resumption of daily activities occurred at 7.59 ± 1.56 days in the CG and 14.73 ± 3.76 days in the SG (p < 0.05. Conclusion: Oral administration of metronidazole is effective in pain management after hemorrhoidectomy.

  3. Efficacy and acceptability of a home-based, family-inclusive intervention for veterans with TBI: A randomized controlled trial.

    Science.gov (United States)

    Winter, Laraine; Moriarty, Helene J; Robinson, Keith; Piersol, Catherine V; Vause-Earland, Tracey; Newhart, Brian; Iacovone, Delores Blazer; Hodgson, Nancy; Gitlin, Laura N

    2016-01-01

    Traumatic brain injury (TBI) often undermines community re-integration, impairs functioning and produces other symptoms. This study tested an innovative programme for veterans with TBI, the Veterans' In-home Programme (VIP), delivered in veterans' homes, involving a family member and targeting the environment (social and physical) to promote community re-integration, mitigate difficulty with the most troubling TBI symptoms and facilitate daily functioning. Interviews and intervention sessions were conducted in homes or by telephone. Eighty-one veterans with TBI at a VA polytrauma programme and a key family member. This was a 2-group randomized controlled trial. Control-group participants received usual-care enhanced by two attention-control telephone calls. Follow-up interviews occurred up to 4 months after baseline interview. VIP's efficacy was evaluated using measures of community re-integration, target outcomes reflecting veterans' self-identified problems and self-rated functional competence. At follow-up, VIP participants had significantly higher community re-integration scores and less difficulty managing targeted outcomes, compared to controls. Self-rated functional competence did not differ between groups. In addition, VIP's acceptability was high. A home-based, family-inclusive service for veterans with TBI shows promise for improving meaningful outcomes and warrants further research and clinical application.

  4. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    Directory of Open Access Journals (Sweden)

    Deborah Bowden

    2011-01-01

    Full Text Available This is a constructive replication of a previous trial conducted by Bowden et al. (2010, where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood.

  5. A Randomised Controlled Single-Blind Trial of the Efficacy of Reiki at Benefitting Mood and Well-Being

    Science.gov (United States)

    Bowden, Deborah; Goddard, Lorna; Gruzelier, John

    2011-01-01

    This is a constructive replication of a previous trial conducted by Bowden et al. (2010), where students who had received Reiki demonstrated greater health and mood benefits than those who received no Reiki. The current study examined impact on anxiety/depression. 40 university students—half with high depression and/or anxiety and half with low depression and/or anxiety—were randomly assigned to receive Reiki or to a non-Reiki control group. Participants experienced six 30-minute sessions over a period of two to eight weeks, where they were blind to whether noncontact Reiki was administered as their attention was absorbed in a guided relaxation. The efficacy of the intervention was assessed pre-post intervention and at five-week follow-up by self-report measures of mood, illness symptoms, and sleep. The participants with high anxiety and/or depression who received Reiki showed a progressive improvement in overall mood, which was significantly better at five-week follow-up, while no change was seen in the controls. While the Reiki group did not demonstrate the comparatively greater reduction in symptoms of illness seen in our earlier study, the findings of both studies suggest that Reiki may benefit mood. PMID:21584234

  6. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty.

    Science.gov (United States)

    Ebert, Jay R; Joss, Brendan; Jardine, Berit; Wood, David J

    2013-11-01

    To investigate the efficacy of manual lymphatic drainage (MLD) in the early postoperative period after total knee arthroplasty (TKA) to reduce edema and pain and improve knee range of motion. Prospective randomized controlled trial. Private hospital and functional rehabilitation clinic. Consecutive sample of patients (N=43; 53 knees) scheduled for TKA. MLD (vs no MLD) on days 2, 3, and 4 postoperatively. Both groups underwent conventional, concomitant physical therapy. Clinical assessment was undertaken pre- and postoperatively prior to and after the designated postoperative MLD sessions (days 2, 3, and 4) and at 6 weeks postsurgery. This included active knee flexion and extension range of motion, lower limb girths (ankle, midpatella, thigh, and calf), and knee pain using a numeric rating scale and the Knee Injury and Osteoarthritis Outcome Score. A significant group effect was observed for active knee flexion, with post hoc tests demonstrating a significantly greater active knee flexion in the MLD group when compared with the control (no MLD) group at the final measure prior to hospital discharge (day 4 postsurgery) and at 6 weeks postsurgery. There were no further group effects observed for the remaining patient-reported and functional outcomes. MLD in the early postoperative stages after TKA appears to improve active knee flexion up to 6 weeks postsurgery, in addition to conventional care. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  7. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy.

    Science.gov (United States)

    Tupper-Carey, Darell Alexander; Fathil, Shahridan Mohd; Tan, Yin Kiat Glenn; Kan, Yuk Man; Cheong, Chern Yuen; Siddiqui, Fahad Javaid; Assam, Pryseley Nkouibert

    2017-08-01

    We conducted a single-centre, prospective randomised clinical trial to investigate the analgesic efficacy of transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic appendicectomy. Patients undergoing urgent laparoscopic appendicectomy under general anaesthesia alone (control group) and general anaesthesia supplemented by TAP block (TAP intervention group) were compared. All patients received a multimodal analgesia regime, which included postoperative morphine via a patient-controlled analgesia device. The primary endpoints were morphine consumption at 12 hours and 24 hours postoperatively. Secondary endpoints included pain scores, incidence of nausea and vomiting, and time to hospital discharge. A total of 58 patients were recruited, with 29 patients in each group. Mean postoperative morphine consumption at 12 hours (control group: 11.45 ± 7.64 mg, TAP intervention group: 9.79 ± 8.09 mg; p = 0.4264) and 24 hours (control group: 13.38 ± 8.72 mg, TAP intervention group: 11.31 ± 8.66 mg; p = 0.3686) for the control and TAP intervention groups were not statistically different. Secondary outcomes were also not different between the two groups. Length of stay in the post-anaesthesia care unit was significantly shorter for the TAP intervention group, with a trend toward faster hospital discharge being observed. TAP block, a regional anaesthetic procedure performed immediately prior to skin incision for laparoscopic appendicectomy, did not significantly improve postoperative analgesia outcomes. Copyright: © Singapore Medical Association

  8. Efficacy and safety of fasudil in patients with subarachnoid hemorrhage. Final results of a randomized trial of fasudil versus nimodipine

    International Nuclear Information System (INIS)

    Zhao Jizong; Zhou Dingbiao; Guo Jing

    2011-01-01

    Fasudil is believed to be at least equally effective as nimodipine for the prevention of cerebral vasospasm and subsequent ischemic injury in patients undergoing surgery for subarachnoid hemorrhage (SAH). We report the final results of a randomized, open trial to compare the efficacy and safety of fasudil with nimodipine. A total of 63 patients undergoing surgery for SAH received fasudil and 66 received nimodipine between 1998 and 2004. Symptomatic vasospasm, low density areas on computed tomography (CT), clinical outcomes, and adverse events were all recorded, and the results were compared between the fasudil and nimodipine groups. Absence of symptomatic vasospasm, occurrence of low density areas associated with vasospasm on CT, and occurrence of adverse events were similar between the two groups. The clinical outcomes were more favorable in the fasudil group than in the nimodipine group (p=0.040). The proportion of patients with good clinical outcome was 74.5% (41/55) in the fasudil group and 61.7% (37/60) in the nimodipine group. There were no serious adverse events reported in the fasudil group. The present results suggest that fasudil is equally or more effective than nimodipine for the prevention of cerebral vasospasm and subsequent ischemic injury in patients undergoing surgery for SAH. (author)

  9. Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized Controlled Trial from a Developing Country.

    Science.gov (United States)

    Das, Susrut; Gupta, Pradeep Kumar; Das, Rashmi Ranjan

    2016-12-01

    To study the efficacy and safety of Saccharomyces boulardii (SB) in acute childhood rotavirus diarrhea. Children (3 months to 5 years) with WHO-defined acute watery diarrhea and stool rotavirus positive (n  =  60) were randomized into intervention (n  =  30) and control (n  =  30) groups. The intervention group received SB (500 mg/day) for 5 days. The median duration (hours) of diarrhea was significantly shorter in the intervention group (60 vs. 89; 95% CI: -41.2 to - 16.8). A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to - 0.54) was also seen in the intervention group, but no significant difference was seen for fever and vomiting. There was also no difference between the two groups in the proportion of children requiring parenteral rehydration and persistence of diarrhea lasting beyond day 7. There was no report of any adverse events. The present trial showed that SB is effective and safe in acute rotavirus diarrhea. © The Author [2016]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    A. A. Harandi

    2011-01-01

    Full Text Available Objective. To investigate the safety and efficacy of MLC601 (NeuroAid as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 1 month ischemic stroke. All patients were given either MLC601 (100 patients or placebo (50 patients, 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P>.05. Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P<.001. Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

  11. Efficacy of single buccal infiltrations for maxillary first molars in patients with irreversible pulpitis: a randomized controlled clinical trial.

    Science.gov (United States)

    Atasoy Ulusoy, Ö İ; Alaçam, T

    2014-03-01

    To evaluate the efficacy of a single buccal infitration using 4% articaine hydrochloride (HCl) with 1 : 100,000 epinephrine or 4% articaine HCl with 1 : 100 000 epinephrine bitartrate for obtaining adequate pulpal anaesthesia in the palatal roots of maxillary first molars associated with irreversible pulpitis. In this single-blind randomized clinical trial, fifty subjects were randomly allocated to receive maxillary buccal injections of 1.5 mL 4% articaine with 1 : 100,000 epinephrine (n = 25) or 1.5 mL 4% articaine with 1 : 100,000 epinephrine bitartrate (n = 25). Visual analogue scale (VAS) scores and pulse rate measurements were recorded during access cavity preparation and initial file placement into the mesiobuccal, distobuccal and palatal canals. Data were analysed using Duncan and t-tests. There was no significant difference between the two anaesthetic solutions regarding the VAS scores and pulse rate measurements during endodontic procedures. The mean VAS ratings of the 50 patients during file placement into the palatal canals were significantly higher compared with the other three root canal procedures (P pulpitis. © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  12. Efficacy of chlorophyll c2 for seasonal allergic rhinitis: single-center double-blind randomized control trial.

    Science.gov (United States)

    Fujiwara, Takashi; Nishida, Naoya; Nota, Jumpei; Kitani, Takashi; Aoishi, Kunihide; Takahashi, Hirotaka; Sugahara, Takuya; Hato, Naohito

    2016-12-01

    Chlorophyll c2 extracted from Sargassum horneri improved allergic symptoms in an animal model of allergic rhinitis. In the present study, we explored the efficacy of chlorophyll c2 in patients with seasonal allergic rhinitis. This was a single-center, randomized, double-blind placebo-controlled trial. Sixty-six patients aged 20-43 years, each with a 2-year history of seasonal allergic rhinitis, were randomly assigned to receive either a single daily dose (0.7 mg) of chlorophyll c2 or placebo for 12 weeks. The use of medications including H1-antihistamines and topical nasal steroids was recorded by rescue medication scores (RMSs) noted after 4, 8, and 12 weeks of treatment. Disease-specific quality of life was measured using the Japan Rhinitis Quality of Life Questionnaire (JRQLQ) both before and after 4, 8, and 12 weeks of treatment. The RMS at 8 weeks was significantly better in the chlorophyll c2 than the placebo group (mean RMS difference = -3.09; 95 % confidence interval = -5.96 to -0.22); the mean RMS at 4 weeks was only slightly better in the chlorophyll c2 group. The JRQLQ scores did not differ significantly between the two groups. Chlorophyll c2 would have a potential to be an alternative treatment for allergic rhinitis.

  13. Comparison of clinical efficacy and safety of thermotherapy versus cryotherapy in treatment of skin warts: A randomized controlled trial.

    Science.gov (United States)

    Izadi Firouzabadi, Leila; Khamesipour, Ali; Ghandi, Narges; Hosseini, Hamed; Teymourpour, Amir; Firooz, Alireza

    2018-01-01

    The effect of thermotherapy in the treatment of skin warts in comparison to cryotherapy, as the standard conventional method, has remained uncertain. This study aimed to assess the clinical efficacy and safety of thermotherapy and cryotherapy in removing skin warts. This randomized controlled trial was conducted on 52 patients aged 18 years and over with ≤ 10 skin warts. The participants were randomly assigned into two groups to receive cryotherapy (every 2 to 3 weeks up to six sessions if required) or thermotherapy (one session). The patients in both groups were followed every 2 to 3 weeks for the first three months, and then three months after the last treatment session. The clearance rate was 79.2% in the thermotherapy group and 58.3% in the cryotherapy group with no significant difference (p = 0.212). The rate of scarring in the thermotherapy group was 20% (p = .018). A higher clearance rate was achieved in the thermotherapy group. However, this result was not statistically significant. There were some minimal post-treatment complications. Patients needed only one session of thermotherapy. Due to the risk of scarring, we suggest thermotherapy only as a suitable treatment method for palmoplantar warts. © 2017 Wiley Periodicals, Inc.

  14. Efficacy of Chlorhexidine, Xylitol, and Chlorhexidine + Xylitol against Dental Plaque, Gingivitis, and Salivary Streptococcus mutans Load: A Randomised Controlled Trial.

    Science.gov (United States)

    Marya, Charu Mohan; Taneja, Pratibha; Nagpal, Ruchi; Marya, Vandana; Oberoi, Sukhvinder Singh; Arora, Dimple

    To compare the antiplaque, antigingivitis and antibacterial efficacy of chlorhexidine (CHX), XYL and a mouthwash combining CHX and XYL against Streptococcus mutans (S. mutans). A parallel design, randomised controlled trial was conducted among 75 dental students. Participants were randomised into CHX, CHX+XYL and XYL-only groups using the lottery method. Subjects were instructed to use 10 ml of the provided mouthwash for 15 s twice daily for 3 weeks. All the outcome measures, gingival index (GI), plaque index (PI) and number of salivary S. mutans CFU were recorded at baseline and 3 weeks post intervention. Nonparametric tests were used for inferential statistics. All outcome variables (GI, PI scores and log10 salivary S. mutans counts) decreased significantly from baseline compared to post intervention among all three groups. Intergroup comparison demonstrated that reduction in GI was not significantly different among the three groups. The decrease in PI scores was found to be significantly higher in the XYL group, while the decrease in the log10 salivary S. mutans count was significantly higher in the CHX+XYL group. The present study provided sufficient data to suggest that all the three mouthwashes are effective against plaque, gingivitis and S. mutans load in saliva. Further investigations should be carried out to confirm the results and develop strategies for using such products to prevent tooth decay.

  15. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bruno Teixeira Bernardes

    Full Text Available CONTEXT AND OBJECTIVE: Previous studies have shown that women with pelvic floor dysfunctions present decreased cross-sectional area (CSA of the levator ani muscle. One way to assess the effects of training programs is to measure the CSA of the muscle, using ultrasonography. The aim here was to evaluate the efficacy of pelvic floor muscle training and hypopressive exercises for increasing the CSA of the levator ani muscle in women with pelvic organ prolapse. DESIGN AND SETTING: Prospective randomized controlled trial at the Urogynecology outpatient clinic of Universidade Federal de São Paulo. METHODS: Fifty-eight women with stage II pelvic organ prolapse were divided into three groups for physiotherapy: a pelvic floor muscle training group (GI; a hypopressive exercise group (GII; and a control group (GIII. The patients underwent transperineal ultrasonographic evaluation using a transducer of frequency 4-9 MHz. The (CSA of the levator ani muscle was measured before physiotherapy and after 12 weeks of treatment. RESULTS: The groups were homogeneous regarding age, number of pregnancies, number of vaginal deliveries, body mass index and hormonal status. Statistically significant differences in CSA were found in GI and GII from before to after the treatment (P < 0.001, but not in relation to GIII (P = 0.816. CONCLUSIONS: The CSA of the levator ani muscle increased significantly with physiotherapy among the women with pelvic organ prolapse. Pelvic floor muscle training and hypopressive exercises produced similar improvements in the CSA of the levator ani muscle.

  16. A randomized controlled trial testing the efficacy of a brief cannabis universal prevention program among adolescents in primary care.

    Science.gov (United States)

    Walton, Maureen A; Resko, Stella; Barry, Kristen L; Chermack, Stephen T; Zucker, Robert A; Zimmerman, Marc A; Booth, Brenda M; Blow, Frederic C

    2014-05-01

    To examine the efficacy of a brief intervention delivered by a therapist (TBI) or a computer (CBI) in preventing cannabis use among adolescents in urban primary care clinics. A randomized controlled trial comparing: CBI and TBI versus control. Urban primary care clinics in the United States. Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P cannabis use at 3 and 6 months (P cannabis use or frequency, but had significantly less other drug use at 3 months (P prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. © 2013 Society for the Study of Addiction.

  17. The Efficacy of Guanxinning Injection in Treating Angina Pectoris: Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Jia, Yongliang; Leung, Siu-wai; Lee, Ming-Yuen; Cui, Guozhen; Huang, Xiaohui; Pan, Fongha

    2013-01-01

    Objective. The randomized controlled trials (RCTs) on Guanxinning injection (GXN) in treating angina pectoris were published only in Chinese and have not been systematically reviewed. This study aims to provide a PRISMA-compliant and internationally accessible systematic review to evaluate the efficacy of GXN in treating angina pectoris. Methods. The RCTs were included according to prespecified eligibility criteria. Meta-analysis was performed to evaluate the symptomatic (SYMPTOMS) and electrocardiographic (ECG) improvements after treatment. Odds ratios (ORs) were used to measure effect sizes. Subgroup analysis, sensitivity analysis, and metaregression were conducted to evaluate the robustness of the results. Results. Sixty-five RCTs published between 2002 and 2012 with 6064 participants were included. Overall ORs comparing GXN with other drugs were 3.32 (95% CI: [2.72, 4.04]) in SYMPTOMS and 2.59 (95% CI: [2.14, 3.15]) in ECG. Subgroup analysis, sensitivity analysis, and metaregression found no statistically significant dependence of overall ORs upon specific study characteristics. Conclusion. This meta-analysis of eligible RCTs provides evidence that GXN is effective in treating angina pectoris. This evidence warrants further RCTs of higher quality, longer follow-up periods, larger sample sizes, and multicentres/multicountries for more extensive subgroup, sensitivity, and metaregression analyses. PMID:23634167

  18. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial.

    Science.gov (United States)

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2015-10-01

    The aim was to evaluate efficacy of "Tailored Physical Activity" (TPA) versus a reference group (REF) in reducing the number of self-reported days of sickness absence for health care workers in the Sonderborg Municipality. In this randomised controlled trial, all participants (n = 54) received health guidance for 1.5 h and were randomised to TPA or REF. The primary aim was to make a comparison of participants' self-reported sickness absence due to musculoskeletal troubles measured three months after baseline. Secondary outcomes included anthropometric, health-related and physical capacity measures. A TPA intervention was not significantly more effective than REF in reducing sickness absence caused by musculoskeletal troubles. However, there were significant improvements for TPA participants compared to REF in reducing pain intensity from 47.9 mm to 21.8 mm (p health care workers since participants achieved a substantial effect on their experience of pain, on their work ability and on their fear of physical movement relating to pain. Moreover, a difference in aerobic capacity was apparent between the sample groups. TPA however, had no significant effect in reducing sickness absence days. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Randomised clinical trial: efficacy, safety and dosage of adjunctive allopurinol in azathioprine/mercaptopurine nonresponders (AAA Study).

    Science.gov (United States)

    Friedman, A B; Brown, S J; Bampton, P; Barclay, M L; Chung, A; Macrae, F A; McKenzie, J; Reynolds, J; Gibson, P R; Hanauer, S B; Sparrow, M P

    2018-04-01

    Thiopurine hypermethylation towards 6-methylmercaptopurine (6MMP) instead of 6-thioguanine nucleotides (6TGN) is associated with inefficacy in patients with IBD. Allopurinol reverses such hypermethylation. To prospectively determine efficacy of allopurinol-thiopurine combination and to compare 2 doses of allopurinol. In a multicentre, double-blind trial, patients with clinically active or steroid-dependent IBD and thiopurine shunting were randomised to 50 or 100 mg/d allopurinol and 25% of their screening thiopurine dose, which was subsequently optimised, aiming for 6TGN of 260-500 pmol/8x10 8 RBCs. The primary endpoint was steroid-free clinical remission at 24 weeks. Of 73 patients, 39 (53% [95% CI 42-65]) achieved steroid-free remission, (54% with 50 mg/d and 53% with 100 mg/d). 81% were able to discontinue steroids. Therapeutic 6TGN levels were achieved in both groups. Final thiopurine doses were lower with 100 mg/d allopurinol (P stability and lower thiopurine dose without additional toxicity. © 2018 John Wiley & Sons Ltd.

  20. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: A two-phase randomized controlled trial*

    Science.gov (United States)

    Lofwall, Michelle R.; Babalonis, Shanna; Nuzzo, Paul A.; Siegel, Anthony; Campbell, Charles; Walsh, Sharon L.

    2013-01-01

    Background Tramadol is an atypical analgesic with monoamine and modest mu opioid agonist activity. The purpose of this study was to evaluate: 1) the efficacy of extended-release (ER) tramadol in treating prescription opioid withdrawal and 2) whether cessation of ER tramadol produces opioid withdrawal. Methods Prescription opioid users with current opioid dependence and observed withdrawal participated in this inpatient, two-phase double blind, randomized placebo-controlled trial. In Phase 1 (days 1-7), participants were randomly assigned to matched oral placebo or ER tramadol (200 or 600 mg daily). In Phase 2 (days 8-13), all participants underwent double blind crossover to placebo. Breakthrough withdrawal medications were available for all subjects. Enrollment continued until 12 completers/group was achieved. Results Use of breakthrough withdrawal medication differed significantly (popioid withdrawal. Mild opioid withdrawal occurred after cessation of treatment with 600 mg tramadol. These data support the continued investigation of tramadol as a treatment for opioid withdrawal. PMID:23755929

  1. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial.

    Science.gov (United States)

    Lofwall, Michelle R; Babalonis, Shanna; Nuzzo, Paul A; Siegel, Anthony; Campbell, Charles; Walsh, Sharon L

    2013-11-01

    Tramadol is an atypical analgesic with monoamine and modest mu opioid agonist activity. The purpose of this study was to evaluate: (1) the efficacy of extended-release (ER) tramadol in treating prescription opioid withdrawal and (2) whether cessation of ER tramadol produces opioid withdrawal. Prescription opioid users with current opioid dependence and observed withdrawal participated in this inpatient, two-phase double blind, randomized placebo-controlled trial. In Phase 1 (days 1-7), participants were randomly assigned to matched oral placebo or ER tramadol (200 or 600 mg daily). In Phase 2 (days 8-13), all participants underwent double blind crossover to placebo. Breakthrough withdrawal medications were available for all subjects. Enrollment continued until 12 completers/group was achieved. Use of breakthrough withdrawal medication differed significantly (popioid withdrawal. Mild opioid withdrawal occurred after cessation of treatment with 600 mg tramadol. These data support the continued investigation of tramadol as a treatment for opioid withdrawal. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  2. Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

    Science.gov (United States)

    Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

    2015-01-01

    Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

  3. Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data From the Efficacy Trial for Lunch Is in the Bag.

    Science.gov (United States)

    Roberts-Gray, Cindy; Sweitzer, Sara J; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E; Briley, Margaret E; Hoelscher, Deanna M

    2017-08-01

    A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the Lunch Is in the Bag intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). To examine the utility of structuring the trial's process evaluation to forecast use, sustainability, and readiness of the intervention for wider dissemination and implementation. Pretrial, the research team simulated user experience to forecast use of the intervention. Multiattribute evaluation of user experience measured during the trial assessed use and sustainability of the intervention. Thematic analysis of posttrial interviews with users evaluated sustained use and readiness for wider dissemination. Moderate use was forecast by the research team. Multiattribute evaluation of activity logs, surveys, and observations during the trial indicated use consistent with the forecast except that prevalence of parents reading the newsletters was greater (83% vs. 50%) and hearing their children talk about the classroom was less (4% vs. 50%) than forecast. Early care and education center-level likelihood of sustained use was projected to be near zero. Posttrial interviews indicated use was sustained at zero centers. Structuring the efficacy trial's process evaluation as a progression of assessments of user experience produced generally accurate forecasts of use and sustainability of the intervention at the trial sites. This approach can assist interpretation of trial outcomes, aid decisions about dissemination of the intervention, and contribute to translational science for improving health.

  4. Correlates of Exercise Self-efficacy in a Randomized Trial of Mind-Body Exercise in Patients With Chronic Heart Failure.

    Science.gov (United States)

    Yeh, Gloria Y; Mu, Lin; Davis, Roger B; Wayne, Peter M

    2016-01-01

    Exercise self-efficacy is one of the strongest predictors of physical activity behavior. Prior literature suggests that tai chi, a mind-body exercise, may increase self-efficacy; however, this is not extensively studied. Little is known about the factors associated with development of exercise self-efficacy in a population with heart failure. We utilized data from a randomized controlled trial of 12 weeks of group tai chi classes versus education in patients with chronic heart failure (n = 100). Multivariable linear regression was used to explore possible correlates of change in exercise self-efficacy in the entire sample and in the subgroup who received tai chi (n = 50). Covariates included baseline quality of life, social support, functional parameters, physical activity, serum biomarkers, sociodemographics, and clinical heart failure parameters. Baseline 6-minute walk (β=-0.0003, SE = 0.0001, P = .02) and fatigue score (β= 0.03, SE = 0.01, P = .004) were significantly associated with change in self-efficacy, with those in the lowest tertile for 6-minute walk and higher tertiles for fatigue score experiencing the greatest change. Intervention group assignment was highly significant, with self-efficacy significantly improved in the tai chi group compared to the education control over 12 weeks (β= 0.39, SE = 0.11, P heart failure who are deconditioned, with lower functional status and mood.

  5. Evaluation of a social cognitive theory-based yoga intervention to reduce anxiety.

    Science.gov (United States)

    Mehta, Purvi; Sharma, Manoj

    Yoga is often viewed as a form of alternative and complementary medicine, as it strives to achieve equilibrium between the body and mind that aids healing. Studies have shown the beneficial role of yoga in anxiety reduction. The purpose of this study was to design and evaluate a 10-week social cognitive theory based yoga intervention to reduce anxiety. The yoga intervention utilized the constructs of behavioral capability, expectations, self-efficacy for yoga from social cognitive theory, and included asanas (postures), pranayama (breathing techniques), shava asana (relaxation), and dhyana (meditation). A one-between and one-within group, quasi-experimental design was utilized for evaluation. Scales measuring expectations from yoga, self-efficacy for yoga, and Speilberger's State Trait Anxiety Inventory, were administered before and after the intervention. Repeated measures analyses of variance (ANOVA) were performed to compare pre-test and post-test scores in the two groups. Yoga as an approach shows promising results for anxiety reduction.

  6. Efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy: a randomized double-blind controlled trial

    OpenAIRE

    Pontip Meteerattanapipat; Vorapong Phupong

    2017-01-01

    The aim of this study was to compare the therapeutic efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. A double-blinded, randomized, controlled trial was conducted. One hundred pregnant women at less than 36 weeks gestation with heartburn at least twice per week were randomized to either alginate-based reflux suppressant or to magnesium-aluminium antacid gel. Details of heartburn were recorded before beginning the treatm...

  7. Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

    OpenAIRE

    Ueda, Takeshi; Uemura, Hirotsugu; Tomita, Yoshihiko; Tsukamoto, Taiji; Kanayama, Hiroomi; Shinohara, Nobuo; Tarazi, Jamal; Chen, Connie; Kim, Sinil; Ozono, Seiichiro; Naito, Seiji; Akaza, Hideyuki

    2013-01-01

    Objective Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. The efficacy and safety of axitinib in Japanese patients with metastatic renal cell carcinoma were evaluated. Methods A subgroup analysis was conducted in Japanese patients enrolled in the randomized Phase III trial of axitinib versus sorafenib after failure of one prior systemic therapy for metastatic renal cell carcinoma. Results Twenty-five (of 361) and 29 (o...

  8. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    OpenAIRE

    Anna-Carlotta Zarski; Anna-Carlotta Zarski; Matthias Berking; David Daniel Ebert

    2018-01-01

    IntroductionGenito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an In...

  9. Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

    OpenAIRE

    Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

    2018-01-01

    Introduction Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce. Aim This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an...

  10. Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

    Science.gov (United States)

    Nasstasia, Yasmina; Baker, Amanda L; Halpin, Sean A; Hides, Leanne; Lewin, Terry J; Kelly, Brian J; Callister, Robin

    2018-03-01

    Recent meta-analytic reviews suggest exercise can reduce depression severity among adults with major depressive disorder (MDD); however, efficacy studies with depressed youth are limited. Few studies have investigated the efficacy of multi-modal exercise interventions in this population, addressed treatment engagement, or explored the differential effects of exercise on depressive symptom profiles. This paper describes the study protocol and recruitment pattern for an assessor blinded, two-arm randomised controlled trial investigating the efficacy of an integrated motivational interviewing (MI) and multi-modal exercise intervention in youth diagnosed with MDD. Associations between depressive symptom profiles (cognitive, somatic and affective) and psychological, physiological (fitness), and biological (blood biomarker) outcomes will also be examined. Participants aged 15-25 years with current MDD were recruited. Eligible participants were randomised and stratified according to gender and depression severity to either an immediate or delayed (control) group. The immediate group received a brief MI intervention followed by a 12-week small group exercise intervention (3 times per week for 1 h), all delivered by personal trainers. The delayed control group received the same intervention 12-weeks later. Both groups were reassessed at mid-treatment or mid-control, post-treatment or post-control, and follow-up (12 weeks post-treatment). 68 participants were recruited and randomly allocated to an intervention group. This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.

  11. The efficacy of an intraoperative cell saver during cardiac surgery: a meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Guyan; Bainbridge, Daniel; Martin, Janet; Cheng, Davy

    2009-08-01

    Cell salvage may be used during cardiac surgery to avoid allogeneic blood transfusion. It has also been claimed to improve patient outcomes by removing debris from shed blood, which may increase the risk of stroke or neurocognitive dysfunction. In this study, we sought to determine the overall safety and efficacy of cell salvage in cardiac surgery by performing a systematic review and meta-analysis of published randomized controlled trials. A comprehensive search was undertaken to identify all randomized trials of cell saver use during cardiac surgery. MEDLINE, Cochrane Library, EMBASE, and abstract databases were searched up to November 2008. All randomized trials comparing cell saver use and no cell saver use in cardiac surgery and reporting at least one predefined clinical outcome were included. The random effects model was used to calculate the odds ratios (OR, 95% confidence intervals [CI]) and the weighted mean differences (WMD, 95% CI) for dichotomous and continuous variables, respectively. Thirty-one randomized trials involving 2282 patients were included in the meta-analysis. During cardiac surgery, the use of an intraoperative cell saver reduced the rate of exposure to any allogeneic blood product (OR 0.63, 95% CI: 0.43-0.94, P = 0.02) and red blood cells (OR 0.60, 95% CI: 0.39-0.92, P = 0.02) and decreased the mean volume of total allogeneic blood products transfused per patient (WMD -256 mL, 95% CI: -416 to -95 mL, P = 0.002). There was no difference in hospital mortality (OR 0.65, 95% CI: 0.25-1.68, P = 0.37), postoperative stroke or transient ischemia attack (OR 0.59, 95% CI: 0.20-1.76, P = 0.34), atrial fibrillation (OR 0.92, 95% CI: 0.69-1.23, P = 0.56), renal dysfunction (OR 0.86, 95% CI: 0.41-1.80, P = 0.70), infection (OR 1.25, 95% CI: 0.75-2.10, P = 0.39), patients requiring fresh frozen plasma (OR 1.16, 95% CI: 0.82-1.66, P = 0.40), and patients requiring platelet transfusions (OR 0.90, 95% CI: 0.63-1.28, P = 0.55) between cell saver and

  12. Analysis of V2 antibody responses induced in vaccinees in the ALVAC/AIDSVAX HIV-1 vaccine efficacy trial.

    Directory of Open Access Journals (Sweden)

    Susan Zolla-Pazner

    Full Text Available The RV144 clinical trial of a prime/boost immunizing regimen using recombinant canary pox (ALVAC-HIV and two gp120 proteins (AIDSVAX B and E was previously shown to have a 31.2% efficacy rate. Plasma specimens from vaccine and placebo recipients were used in an extensive set of assays to identify correlates of HIV-1 infection risk. Of six primary variables that were studied, only one displayed a significant inverse correlation with risk of infection: the antibody (Ab response to a fusion protein containing the V1 and V2 regions of gp120 (gp70-V1V2. This finding prompted a thorough examination of the results generated with the complete panel of 13 assays measuring various V2 Abs in the stored plasma used in the initial pilot studies and those used in the subsequent case-control study. The studies revealed that the ALVAC-HIV/AIDSVAX vaccine induced V2-specific Abs that cross-react with multiple HIV-1 subgroups and recognize both conformational and linear epitopes. The conformational epitope was present on gp70-V1V2, while the predominant linear V2 epitope mapped to residues 165-178, immediately N-terminal to the putative α4β7 binding motif in the mid-loop region of V2. Odds ratios (ORs were calculated to compare the risk of infection with data from 12 V2 assays, and in 11 of these, the ORs were ≤1, reaching statistical significance for two of the variables: Ab responses to gp70-V1V2 and to overlapping V2 linear peptides. It remains to be determined whether anti-V2 Ab responses were directly responsible for the reduced infection rate in RV144 and whether anti-V2 Abs will prove to be important with other candidate HIV vaccines that show efficacy, however, the results support continued dissection of Ab responses to the V2 region which may illuminate mechanisms of protection from HIV-1 infection and may facilitate the development of an effective HIV-1 vaccine.

  13. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

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    Oluwatoyosi B. A. Owoeye

    2014-06-01

    Full Text Available 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.

  14. Readiness to Change Over Time: Change Commitment and Change Efficacy in a Workplace Health-Promotion Trial

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    Christian D. Helfrich

    2018-04-01

    Full Text Available IntroductionOrganizational readiness to change may be a key determinant of implementation success and a mediator of the effectiveness of implementation interventions. If organizational readiness can be reliably and validly assessed at the outset of a change initiative, it could be used to assess the effectiveness of implementation-support activities by measuring changes in readiness factors over time.MethodsWe analyzed two waves of readiness-to-change survey data collected as part of a three-arm, randomized controlled trial to implement evidence-based health promotion practices in small worksites in low-wage industries. We measured five readiness factors: context (favorable broader conditions; change valence (valuing health promotion; information assessment (demands and resources to implement health promotion; change commitment (an intention to implement health promotion; and change efficacy (a belief in shared ability to implement health promotion. We expected commitment and efficacy to increase at intervention sites along with their self-reported effort to implement health promotion practices, termed wellness-program effort. We compared means between baseline and 15 months, and between intervention and control sites. We used linear regression to test whether intervention and control sites differed in their change-readiness scores over time.ResultsOnly context and change commitment met reliability thresholds. Change commitment declined significantly for both control (−0.39 and interventions sites (−0.29 from baseline to 15 months, while context did not change for either. Only wellness program effort at 15 months, but not at baseline, differed significantly between control and intervention sites (1.20 controls, 2.02 intervention. Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1 intervention sites exhibited significantly smaller change in

  15. Efficacy and feasibility of frontozygomatic angle approach for extra oral maxillary nerve block in oral surgery: a descriptive clinical trial.

    Science.gov (United States)

    Radder, Kiran; Shah, Ashwin; Fatima, Shereen; Kothari, Chaitanya; Zakaullah, Syed; Siddiqua, Aaisha

    2014-09-01

    Pain control is an integral part of minor oral surgery and maxillary/mandibular nerve blocks have proved promising in achieving the same. Although intra oral techniques of maxillary nerve block are common and are widely used, there are certain inherent disadvantages and potential complications. Less commonly described in the literature, the extra oral techniques have a wide spectrum of indications as well as can be more advantageous than the intra oral approach. This prospective clinical trial is an attempt to evaluate the feasibility and the efficacy of the extra oral frontozygomatic approach to the foramen rotundum to block the maxillary nerve. Sample size was 100 patients and the inclusion criteria were patients of ASA I or II category who needed extraction of a minimum of 4 maxillary teeth in the same quadrant in a single sitting while exclusion criteria were patients with a history of allergy to local anesthesia, medically compromised patients in whom dental extraction was contraindicated. Mean age was 71.9 years and 56 patients were males while 44 were females. Only a single quadrant (first or second) was chosen as the operative site in each patient and local anaesthesia was secured using a 21 gauge 89 mm long spinal needle with frontozygomatic angle approach and the parameters used were pain experienced during the injection, onset of subjective symptoms, time required for the peak effect (objective symptoms), pain during extraction and the duration of anesthesia. All the parameters were expressed as mean values with standard deviations. A successful anesthesia was secured in first attempt in 98 patients while in 2 patients, the procedure had to be repeated owing to the difficulty in reaching the target site. A majority of the patients i.e., 71 % scored 0-2 (no pain) on visual analogue scale (VAS) while only 2 patients experienced a moderate degree of pain. Subjective symptoms were reported in 27.24 s (mean value) and 12.93 s (mean value) in the palate

  16. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION.

    Science.gov (United States)

    Vidrine, Damon J; Fletcher, Faith E; Danysh, Heather E; Marani, Salma; Vidrine, Jennifer Irvin; Cantor, Scott B; Prokhorov, Alexander V

    2012-08-25

    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. 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 cessation intervention treatment groups. It is

  17. Readiness to Change Over Time: Change Commitment and Change Efficacy in a Workplace Health-Promotion Trial.

    Science.gov (United States)

    Helfrich, Christian D; Kohn, Marlana J; Stapleton, Austin; Allen, Claire L; Hammerback, Kristen Elizabeth; Chan, K C Gary; Parrish, Amanda T; Ryan, Daron E; Weiner, Bryan J; Harris, Jeffrey R; Hannon, Peggy A

    2018-01-01

    Organizational readiness to change may be a key determinant of implementation success and a mediator of the effectiveness of implementation interventions. If organizational readiness can be reliably and validly assessed at the outset of a change initiative, it could be used to assess the effectiveness of implementation-support activities by measuring changes in readiness factors over time. We analyzed two waves of readiness-to-change survey data collected as part of a three-arm, randomized controlled trial to implement evidence-based health promotion practices in small worksites in low-wage industries. We measured five readiness factors: context (favorable broader conditions); change valence (valuing health promotion); information assessment (demands and resources to implement health promotion); change commitment (an intention to implement health promotion); and change efficacy (a belief in shared ability to implement health promotion). We expected commitment and efficacy to increase at intervention sites along with their self-reported effort to implement health promotion practices, termed wellness-program effort. We compared means between baseline and 15 months, and between intervention and control sites. We used linear regression to test whether intervention and control sites differed in their change-readiness scores over time. Only context and change commitment met reliability thresholds. Change commitment declined significantly for both control (-0.39) and interventions sites (-0.29) from baseline to 15 months, while context did not change for either. Only wellness program effort at 15 months, but not at baseline, differed significantly between control and intervention sites (1.20 controls, 2.02 intervention). Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1) intervention sites exhibited significantly smaller change in context scores relative to control sites

  18. Efficacy, acceptability, and safety of adjunctive aripiprazole in treatment-resistant depression: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Luan SX

    2018-02-01

    Full Text Available Shuxin Luan,1,2 Hongquan Wan,2 Lei Zhang,3 Hua Zhao1,4 1Department of Physiology, College of Basic Medical Sciences, Jilin University, Changchun, China; 2Department of Mental Health, The First Hospital of Jilin University, Changchun, China; 3Department of Radiology, The First Hospital of Jilin University, Changchun, China; 4Neuroscience Research Center, The First Hospital of Jilin University, Changchun, China Background: Treatment-resistant depression (TRD is common and potentially life-threatening in adults, and the benefits and risks of adjunctive aripiprazole in these patients remain controversial. Therefore, we conducted a meta-analysis of randomized controlled trials (RCTs to assess the efficacy, acceptability, safety, and quality of life of adjunctive aripiprazole in patients with TRD.Methods: RCTs published in PubMed, Web of Science, and Embase were systematically reviewed to evaluate the efficacy and safety profiles of TRD patients who were treated with adjunctive aripiprazole. The main outcome measures included response rate, remission rate, changes from baseline in Montgomery–Asberg Depression Rating Scale (MADRS, Clinical Global Impression-severity (CGI-S, Clinical Global Impression-improvement (CGI-I, 17-Item Hamilton Rating Scale for Depression (HAM-D17, Sheehan Disability scale (SDS, and Inventory of Depressive Symptomatology Self-Report Scale (IDS-SR, discontinuation due to adverse events, and adverse events. Risk ratio (RR or weight mean difference with 95% confidence intervals (CIs were pooled using a fixed-effects or random-effects model according to the heterogeneity among studies.Results: A total of 8 RCTs involving 2,260 patients were included in this meta-analysis. Adjunctive aripiprazole was associated with a significantly higher remission rate (RR =1.64, 95% CI: 1.42 to 1.89; P<0.001 and response rate (RR =1.45, 95% CI: 1.13 to 1.87; P=0.004 than other treatments. Moreover, adjunctive aripiprazole had greater changes in

  19. Efficacy of a movement control injury prevention programme in adult men's community rugby union: a cluster randomised controlled trial.

    Science.gov (United States)

    Attwood, Matthew J; Roberts, Simon P; Trewartha, Grant; England, Mike E; Stokes, Keith A

    2018-03-01

    Exercise programmes aimed at reducing injury have been shown to be efficacious for some non-collision sports, but evidence in adult men's collision sports such as rugby union is lacking. To evaluate the efficacy of a movement control injury prevention exercise programme for reducing match injuries in adult men's community rugby union players. 856 clubs were invited to participate in this prospective cluster randomised (single-blind) controlled trial where clubs were the unit of randomisation. 81 volunteered and were randomly assigned (intervention/control). A 42-week exercise programme was followed throughout the season. The control programme reflected 'normal practice' exercises, whereas the intervention focused on proprioception, balance, cutting, landing and resistance exercises.Outcome measures were match injury incidence and burden for: (1) all ≥8 days time-loss injuries and (2) targeted (lower limb, shoulder, head and neck, excluding fractures and lacerations) ≥8 days time-loss injuries. Poisson regression identified no clear effects on overall injury outcomes. A likely beneficial difference in targeted injury incidence (rate ratio (RR), 90% CI=0.6, 0.4 to 1.0) was identified, with a 40% reduction in lower-limb incidence (RR, 90% CI=0.6, 0.4 to 1.0) and a 60% reduction in concussion incidence (RR, 90% CI=0.4, 0.2 to 0.7) in the intervention group. Comparison between arms for clubs with highest compliance (≥median compliance) demonstrated very likely beneficial 60% reductions in targeted injury incidence (RR, 90% CI=0.4, 0.2 to 0.8) and targeted injury burden (RR, 90% CI=0.4, 0.2 to 0.7). The movement control injury prevention programme resulted in likely beneficial reductions in lower-limb injuries and concussion. Higher intervention compliance was associated with reduced targeted injury incidence and burden. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

  20. Impact of a parent-child sexual communication campaign: results from a controlled efficacy trial of parents.

    Science.gov (United States)

    Davis, Kevin C; Blitstein, Jonathan L; Evans, W Douglas; Kamyab, Kian

    2010-07-21

    Prior research supports the notion that parents have the ability to influence their children's decisions regarding sexual behavior. Yet parent-based approaches to curbing teen pregnancy and STDs have been relatively unexplored. The Parents Speak Up National Campaign (PSUNC) is a multimedia campaign that attempts to fill this void by targeting parents of teens to encourage parent-child communication about waiting to have sex. The campaign follows a theoretical framework that identifies cognitions that are targeted in campaign messages and theorized to influence parent-child communication. While a previous experimental study showed PSUNC messages to be effective in increasing parent-child communication, it did not address how these effects manifest through the PSUNC theoretical framework. The current study examines the PSUNC theoretical framework by 1) estimating the impact of PSUNC on specific cognitions identified in the theoretical framework and 2) examining whether those cognitions are indeed associated with parent-child communication Our study consists of a randomized efficacy trial of PSUNC messages under controlled conditions. A sample of 1,969 parents was randomly assigned to treatment (PSUNC exposure) and control (no exposure) conditions. Parents were surveyed at baseline, 4 weeks, 6 months, 12 months, and 18 months post-baseline. Linear regression procedures were used in our analyses. Outcome variables included self-efficacy to communicate with child, long-term outcome expectations that communication would be successful, and norms on appropriate age for sexual initiation. We first estimated multivariable models to test whether these cognitive variables predict parent-child communication longitudinally. Longitudinal change in each cognitive variable was then estimated as a function of treatment condition, controlling for baseline individual characteristics. Norms related to appropriate age for sexual initiation and outcome expectations that communication

  1. Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: a phase II clinical trial.

    Science.gov (United States)

    Glina, Sidney; Toscano, Iderpol; Gomatzky, Celso; de Góes, Plínio Moreira; Júnior, Archimedes Nardozza; Claro, Joaquim Francisco de Almeida; Pagani, Eduardo

    2009-02-01

    Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. IIEF erectile domain scores before and after the use of medications were (mean +/- standard deviation [SD]): placebo: 11.9 +/- 3.4 and 12.6 +/- 5.5; LC 20 mg: 15.8 +/- 4.1 and 18.9 +/- 6.6; LC 40 mg: 11.9 +/- 4.4 and 15.4 +/- 8.1; LC 80 mg: 14.2 +/- 4.7 and 22.8 +/- 6.0 (ANOVA P < 0.01). The SEP-2 scores before and after the use of medications were (Mean +/- SD): placebo: 71.0 +/- 33.1 and 51.2 +/- 43.1; LC 20 mg 70.3 +/- 34.2 and 75.5 +/- 31.5; LC 40 mg: 48.4 +/- 42.1 and 60.8 +/- 42.5; LC 80 mg: 68.6 +/- 33.5 and 89.6 +/- 26.0. The SEP-3 scores were: placebo 23.3 +/- 27.6 and 33.6 +/- 42.3; LC 20 mg: 32.3 +/- 38.9 and 51.2 +/- 41.7; LC 40 mg: 39.7 +/- 44.7 and 46.7 +/- 41.1; LC 80 mg* 17.2 +/- 29.5 and 74.3 +/- 36.4 (*P < 0.05 for difference to placebo). The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated.

  2. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.

    Science.gov (United States)

    Glina, Sidney; Fonseca, Gilvan N; Bertero, Eduardo B; Damião, Ronaldo; Rocha, Luíz C A; Jardim, Carlos R F; Cairoli, Carlos E; Teloken, Cláudio; Torres, Luiz O; Faria, Geraldo E; da Silva, Marcelo B; Pagani, Eduardo

    2010-05-01

    This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. Expanding information on LC efficacy and safety. International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. LC showed a satisfactory efficacy-safety profile for oral therapy of ED.

  3. Impact of a parent-child sexual communication campaign: results from a controlled efficacy trial of parents

    Directory of Open Access Journals (Sweden)

    Evans W Douglas

    2010-07-01

    Full Text Available Abstract Background Prior research supports the notion that parents have the ability to influence their children's decisions regarding sexual behavior. Yet parent-based approaches to curbing teen pregnancy and STDs have been relatively unexplored. The Parents Speak Up National Campaign (PSUNC is a multimedia campaign that attempts to fill this void by targeting parents of teens to encourage parent-child communication about waiting to have sex. The campaign follows a theoretical framework that identifies cognitions that are targeted in campaign messages and theorized to influence parent-child communication. While a previous experimental study showed PSUNC messages to be effective in increasing parent-child communication, it did not address how these effects manifest through the PSUNC theoretical framework. The current study examines the PSUNC theoretical framework by 1 estimating the impact of PSUNC on specific cognitions identified in the theoretical framework and 2 examining whether those cognitions are indeed associated with parent-child communication Methods Our study consists of a randomized efficacy trial of PSUNC messages under controlled conditions. A sample of 1,969 parents was randomly assigned to treatment (PSUNC exposure and control (no exposure conditions. Parents were surveyed at baseline, 4 weeks, 6 months, 12 months, and 18 months post-baseline. Linear regression procedures were used in our analyses. Outcome variables included self-efficacy to communicate with child, long-term outcome expectations that communication would be successful, and norms on appropriate age for sexual initiation. We first estimated multivariable models to test whether these cognitive variables predict parent-child communication longitudinally. Longitudinal change in each cognitive variable was then estimated as a function of treatment condition, controlling for baseline individual characteristics. Results Norms related to appropriate age for sexual

  4. Seated T'ai Chi in Older Taiwanese People Using Wheelchairs: A Randomized Controlled Trial Investigating Mood States and Self-Efficacy.

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    Hsu, Chen-Yuan; Moyle, Wendy; Cooke, Marie; Jones, Cindy

    2016-12-01

    There is growing interest in t'ai chi, but little research has addressed whether t'ai chi is effective in older people using wheelchairs for mobilization. The aim of this study was to compare the effects of seated t'ai chi exercise and usual standard activities on mood states and self-efficacy in older people living in a long-term care facility and using wheelchairs for mobilization. Randomized controlled trial (trial registration no. ACTRN12613000029796). One long-term-care facility in Taiwan. Sixty participants were randomly assigned by a computer-generated random sequence to a t'ai chi group (n = 30) or a usual exercise and entertainment activities group (n = 30). Seated t'ai chi exercise for 40 minutes three times a week for 26 weeks was provided. Mood states (Profile of Mood States Short Form [POMS-SF]) and self-efficacy (Self-Efficacy for Exercise [SEE]). At week 26, participants in the t'ai chi group reported significantly lower mood states on the fatigue-inertia dimension of the POMS-SF (mean score ± standard deviation, 3.56 ± 3.71) than did the control group (mean score, 7.16 ± 6.36) (F [1, 58] = 7.15; p self-efficacy for older people using wheelchairs.

  5. Efficacy of an Iranian herbal preparation (Lax-Asab in treating functional constipation: A randomized, placebo-controlled clinical trial

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    Mohammad Hossein Somi

    2015-07-01

    Full Text Available Functional constipation is a common clinical complaint of patients with unsatisfactory treatment outcome. We designed this study to evaluate the efficiency of a traditional herbal preparation (Lax-Asab in treating chronic constipation. In this double-blind, randomized, placebo-controlled clinical trial, participants with chronic constipation (n = 48 were randomly selected to receive either the Lax-Asab powder (n = 24 or placebo (n = 24 on alternative days for 4 weeks. The Lax-Asab powder contains equal amounts of Cassia angustifolia Vahl. (狹葉番瀉葉 xiá yè fān xiè yè, Mentha piperita L. (胡椒薄荷 hú jiāo bò hé, Zingiber officinale Rosc. (生薑 shēng jiāng, Glycyrrhiza glabra L. (甘草 gān cǎo. A total of 40 patients completed the study. We determined the severity of constipation based on defecation frequency (per week and defecation difficulties. Of the total of 48 patients who participated, 40 completed the trial [24 men (60%, mean age, 21.0 ± 4.2 years; 16 women (40%, mean age, 20.1 ± 4.3 years]. The mean of weekly defecation frequency increased in both groups; from 1.8 ± 0.41 to 4.8 ± 1.12 times in patients who received Lax-Asab and from 1.7 ± 0.44 to 2.2 ± 0.61 times in patients who received placebo. A time–treatment interaction showed that this increase was significantly higher in the intervention group. Defecation difficulties improved significantly more in patients who received Lax-Asab than patients who received placebo. There was no statistically significant difference between the two groups with regard to the side effects observed. This study confirms the efficacy and tolerability of an Iranian herbal preparation, Lax-Asab, in treating patients with chronic functional constipation.

  6. Reappraisal of metformin efficacy in the treatment of type 2 diabetes: a meta-analysis of randomised controlled trials.

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    Rémy Boussageon

    Full Text Available BACKGROUND: The UK Prospective Diabetes Study showed that metformin decreases mortality compared to diet alone in overweight patients with type 2 diabetes mellitus. Since then, it has been the first-line treatment in overweight patients with type 2 diabetes. However, metformin-sulphonylurea bitherapy may increase mortality. METHODS AND FINDINGS: This meta-analysis of randomised controlled trials evaluated metformin efficacy (in studies of metformin versus diet alone, versus placebo, and versus no treatment; metformin as an add-on therapy; and metformin withdrawal against cardiovascular morbidity or mortality in patients with type 2 diabetes. We searched Medline, Embase, and the Cochrane database. Primary end points were all-cause mortality and cardiovascular death. Secondary end points included all myocardial infarctions, all strokes, congestive heart failure, peripheral vascular disease, leg amputations, and microvascular complications. Thirteen randomised controlled trials (13,110 patients were retrieved; 9,560 patients were given metformin, and 3,550 patients were given conventional treatment or placebo. Metformin did not significantly affect the primary outcomes all-cause mortality, risk ratio (RR=0.99 (95% CI: 0.75 to 1.31, and cardiovascular mortality, RR=1.05 (95% CI: 0.67 to 1.64. The secondary outcomes were also unaffected by metformin treatment: all myocardial infarctions, RR=0.90 (95% CI: 0.74 to 1.09; all strokes, RR=0.76 (95% CI: 0.51 to 1.14; heart failure, RR=1.03 (95% CI: 0.67 to 1.59; peripheral vascular disease, RR=0.90 (95% CI: 0.46 to 1.78; leg amputations, RR=1.04 (95% CI: 0.44 to 2.44; and microvascular complications, RR=0.83 (95% CI: 0.59 to 1.17. For all-cause mortality and cardiovascular mortality, there was significant heterogeneity when including the UK Prospective Diabetes Study subgroups (I(2=41% and 59%. There was significant interaction with sulphonylurea as a concomitant treatment for myocardial infarction (p=0

  7. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial.

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    Mehta, Rajvi; Platt, Alyssa C; Sun, Xizi; Desai, Mukesh; Clements, Dennis; Turner, Elizabeth L

    2017-03-01

    Background: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron. Objective: We assessed the efficacy of the consumption of iron-supplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration Indian women of reproductive age. Design: The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively. Results: Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04). Conclusions: The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat anemia

  8. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

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    Munneke, Marten; Nijkrake, Maarten J; Keus, Samyra Hj; Kwakkel, Gert; Berendse, Henk W; Roos, Raymund Ac; Borm, George F; Adang, Eddy M; Overeem, Sebastiaan; Bloem, Bastiaan R

    2010-01-01

    Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes. Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694. We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399). Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters. ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust

  9. Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

    Science.gov (United States)

    Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

    2017-12-15

    Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  10. Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial.

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    Matsumoto, Yukihiro; Ohashi, Yuichi; Watanabe, Hitoshi; Tsubota, Kazuo

    2012-10-01

    To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1%, n = 96; 3%, n = 96) or placebo ophthalmic solution (n = 94). After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1% or 3% diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Fluorescein corneal staining scores significantly improved with both 1% and 3% topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1% and 3% diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Both 1% and 3% diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  11. Novel devices for individualized controlled inhalation can optimize aerosol therapy in efficacy, patient care and power of clinical trials

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    Fischer A

    2009-12-01

    Full Text Available Abstract In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional parameters. Beside its pharmacology the active agent is furthermore determined by its aerosol characteristics as particle diameter, particle density, hygroscopicity and electrical charge. The patient related factors like age and stage of pulmonary disease will be additionally affected by the individual breathing pattern and morphometry of the lower airways. A number of these parameters with essential impact on the pulmonary drug deposition can be influenced by the performance of the inhalation system. Therefore, the optimization of nebulisation technology was a major part of aerosol science in the last decade. At this time the control of inspiration volume and air flow as well as the administration of a defined aerosol bolus was in the main focus. Up to date a more efficient and a more targeted pulmonary drug deposition - e.g., in the alveoli - will be provided by novel devices which also allow shorter treatment times and a better reproducibility of the administered lung doses. By such means of precise dosing and drug targeting the efficacy of inhalation therapy can be upgraded, e.g., the continuous inhalation of budesonide in asthma. From a patients' perspective an optimized inhalation manoeuvre means less side effects, e.g., in cystic fibrosis therapy the reduced oropharyngeal tobramycin exposure causes fewer bronchial irritations. Respecting to shorter treatment times also, this result in an improved quality of life and compliance. For clinical trials the scaling down of dose variability in combination with enhanced pulmonary deposition reduces the number of patients to be included and the requirement of pharmaceutical

  12. Randomised controlled trial of the onset of analgesic efficacy of dexketoprofen and diclofenac in lower limb injury

    Science.gov (United States)

    Leman, P; Kapadia, Y; Herington, J

    2003-01-01

    Objective: To assess the time of onset and difference in analgesic efficacy of oral dexketoprofen compared with oral diclofenac in patients with acute lower limb injury. Design: A prospective, double blind, randomised controlled trial. Interventions: Patients who fitted the study criteria were given either 25 mg oral dexketoprofen trometamol or 50 mg sodium diclofenac immediately after triage; baseline and 15 minute pain scores were then recorded for one hour. Results: 122 patients were studied (diclofenac = 57 and dexketoprofen = 65). There were no significant differences in age, sex, type of injury, or baseline pain scores between the two groups. The differences in group mean pain scores between diclofenac and dexketoprofen at 15, 30, 45, and 60 minutes were; 0.53 (95% confidence intervals -0.03 to 1.09), 0.70 (0.16 to 1.24), 0.89 (0.32 to 1.47), and 0.83 (0.21 to 1.45). Odds ratios for a decrease in pain score of at least 1 from baseline (on the 11 point scale) when given dexketoprofen rather than diclofenac at 15, 30, 45, and 60 minutes were; 2.66 (1.19 to 5.98), 3.52 (1.60 to 7.73), 4.48 (1.72 to 11.65), and 5.54 (1.90 to 16.15). Corresponding odds ratios for a decrease in pain score of ⩾2 were; 6.88 (1.48 to 32.0), 3.79 (1.59 to 9.01), 5.19 (2.29 to 11.78), and 5.87 (2.68 to 12.88). Conclusions: Dexketoprofen trometamol is an effective and rapidly acting analgesic for the treatment of acute musculoskeletal injuries. PMID:14623834

  13. Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial.

    Science.gov (United States)

    Esparza-Villalpando, Vicente; Chavarria-Bolaños, Daniel; Gordillo-Moscoso, Antonio; Masuoka-Ito, David; Martinez-Rider, Ricardo; Isiordia-Espinoza, Mario; Pozos-Guillen, Amaury

    2016-09-01

    The aim of this study was to compare the efficacy of preoperative and postoperative dexketoprofen trometamol for pain control after third molar surgery. Sixty subjects indicated for impacted mandibular third molar surgery were randomly assigned to two groups: preoperative (group 1, n = 30) and postoperative (group 2, n = 30) administration. Group 1 received 25 mg of dexketoprofen trometamol 30 min before surgery and 1 placebo capsule (same color and size with active drug) immediately after surgery. Group 2 received the placebo capsule 30 min before surgery and 25 mg of dexketoprofen trometamol immediately after surgery. Pain intensity was assessed using a numeric rating scale (NRS) during the first 8 h. The time of the need for a second dose of dexketoprofen trometamol, after the first administration, was recorded. The data were analyzed using mixed-model repeated-measures (MMRM), Wilcoxon rank-sum, and Kaplan-Meier analysis. After the 8 h period, no statistically significant difference was observed in the intensity of pain (MMRM, p = 0.41); and no significant difference in the time for a second dose (p = 0.956). In conclusion, preoperative administration of dexketoprofen trometamol is a reasonable clinical approach that is as effective as conventional postoperative pharmacological treatment, with the advantage of allowing early analgesia before pain develops. (ClinicalTrials.gov: NCT02380001). Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

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

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    Falgun Indravadan Vyas

    2014-01-01

    Full Text Available 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, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry. Results: Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05; however, the difference was not clinically significant (<1΀C. The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1 st h (P = 0.04. Highest fall of temperature was noted in the 1 st h of drug administration in all the groups. No serious adverse events were observed in any of the groups. Conclusion: Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.

  15. The efficacy of moisture retentive ointment in the mangement of cutaneous wounds and ulcers: A multicenter clinical trial

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    Atiyeh B

    2003-01-01

    Full Text Available Local management of chronic wounds and ulcers remains one of the most costly unsolved problems in health care today. With proper clinical management, most chronic wound healing problems can be resolved and healing expected, though recurrence may be common. The recent logarithmic growth in our knowledge about wound healing and the appreciation of the importance of a moist environment in optimal wound healing has led to the introduction of new and exciting therapeutic modalities. In view of the many practical disadvantages as well as the serious complications of currently available moisture retentive dressings when applied to chronic contaminated wounds, a prospective multicenter clinical trial was conducted from December 1999 to November 2000 to evaluate the safety and efficacy of a newly introduced moisture retentive ointment (MEBO: Moist Exposed Burn Ointment (Julphar - Gulf Pharmaceutical Industries, UAE in the local wound care of problematic non-healing wounds. The active component of the ointment is β-sitosterol in a base of beeswax, sesame oil and other components. Though it was not a comparative study, the ointment was found to induce rapid reduction in ulcer size even after a prolonged stagnant state with other therapeutic modalities without complications such as skin maceration, unmanageable excessive exudation, and wound infection. As expected with such chronic wounds, the healing potential of local ointment application is limited by the mere size of the original defect and the underlying pathologies and associated diseases. however, the safety and practicality of simple ointment application was found to be a valid alternative treatment for local management of chronic wounds.

  16. A prospective randomized trial comparing the efficacy of Letrozole and Clomiphene citrate in induction of ovulation in polycystic ovarian syndrome

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    Kallol Kumar Roy

    2012-01-01

    Full Text Available Objectives: To compare the efficacy of letrozole and clomiphene citrate (CC in patients of anovulatory polycystic ovarian syndrome (PCOS with infertility. Materials and Methods: This prospective randomized clinical trial included 204 patients of PCOS. 98 patients (294 cycles received 2.5-5 mg of letrozole; 106 patients (318 cycles received 50-100 mg of CC (both orally from Days 3-7 of menstrual cycle. The treatment continued for three cycles in both the groups. Main outcome measures: ovulation rate, endometrial thickness, and pregnancy rate. Statistical analysis was done using SPSS 13 software. P value less than 0.05 was considered significant. Results: The mean number of dominant follicles in letrozole groups and CC groups was 1.86±0.26 and 1.92±0.17, respectively (P=0.126. Number of ovulatory cycle in letrozole group was 196 (66.6% versus 216 (67.9% in CC group (P=0.712. The mean mid-cycle endometrial thickness was 9.1±0.3 mm in letrozole group and 6.3±1.1 in CC group, which was statistically significant (P=0.014. The mean Estradiol [E2] level in clomiphene citrate group was significantly higher in CC group (364.2±71.4 pg/mL than letrozole group (248.2± 42.2 pg/mL. 43 patients from the letrozole group (43.8% and 28 patients from the CC group (26.4% became pregnant. Conclusion: Letrozole and CC have comparable ovulation rate. The effect of letrozole showed a better endometrial response and pregnancy rate compared with CC.

  17. Efficacy of cognitive-behavioral therapy in patients with bipolar disorder: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chiang, Kai-Jo; Tsai, Jui-Chen; Liu, Doresses; Lin, Chueh-Ho; Chiu, Huei-Ling; Chou, Kuei-Ru

    2017-01-01

    Although cognitive behavioral therapy (CBT) is considered a promising adjuvant to pharmacotherapy for treating bipolar disorder (BD), its efficacy is unproven. The present review and meta-analysis evaluated the treatment outcomes of patients with BD treated with CBT plus medication and compared these data with the outcomes of those who received standard care alone. Electronic searches from inception to July 31, 2016, were performed using PubMed, Medline OVID, Cochrane Library, EMBASE, CINAHL plus, and PsycINFO. In the extensive electronic literature search, keywords such as "bipolar disorder," "manic-depressive psychosis," "bipolar affective disorder," "bipolar depression," "cognitive therapy," "cognitive-behavioral therapy," and "psychotherapy" were transformed into MeSH terms, and only randomized controlled trials (RCTs) were included. The pooled odds ratios (ORs) of relapse rates and Hedges's g, along with 95% confidence intervals (CIs), for the mean differences in the levels of depression, mania, and psychosocial functioning were calculated. Further subgroup analyses were conducted according to the characteristics of the CBT approaches, patients, and therapists, if the data were available. A total of 19 RCTs comprising 1384 patients with type I or II BD were enrolled in our systematic review and meta-analysis. The main analysis revealed that CBT could lower the relapse rate (pooled OR = 0.506; 95% CI = 0.278 -0.921) and improve depressive symptoms (g = -0.494; 95% CI = -0.963 to -0.026), mania severity (g = -0.581; 95% CI = -1.127 to -0.035), and psychosocial functioning (g = 0.457; 95% CI = 0.106-0.809). CBT is effective in decreasing the relapse rate and improving depressive symptoms, mania severity, and psychosocial functioning, with a mild-to-moderate effect size. Subgroup analyses indicated that improvements in depression or mania are more potent with a CBT treatment duration of ≥90 min per session, and the relapse rate is much lower among patients with

  18. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Wolny, Tomasz; Saulicz, Edward; Linek, Paweł; Shacklock, Michael; Myśliwiec, Andrzej

    2017-05-01

    The purpose of this randomized trial was to compare the efficacy of manual therapy, including the use of neurodynamic techniques, with electrophysical modalities on patients with mild and moderate carpal tunnel syndrome (CTS). The study included 140 CTS patients who were randomly assigned to the manual therapy (MT) group, which included the use of neurodynamic techniques, functional massage, and carpal bone mobilizations techniques, or to the electrophysical modalities (EM) group, which included laser and ultrasound therapy. Nerve conduction, pain severity, symptom severity, and functional status measured by the Boston Carpal Tunnel Questionnaire were assessed before and after treatment. Therapy was conducted twice weekly and both groups received 20 therapy sessions. A baseline assessment revealed group differences in sensory conduction of the median nerve (P < .01) but not in motor conduction (P = .82). Four weeks after the last treatment procedure, nerve conduction was examined again. In the MT group, median nerve sensory conduction velocity increased by 34% and motor conduction velocity by 6% (in both cases, P < .01). There was no change in median nerve sensory and motor conduction velocities in the EM. Distal motor latency was decreased (P < .01) in both groups. A baseline assessment revealed no group differences in pain severity, symptom severity, or functional status. Immediately after therapy, analysis of variance revealed group differences in pain severity (P < .01), with a reduction in pain in both groups (MT: 290%, P < .01; EM: 47%, P < .01). There were group differences in symptom severity (P < .01) and function (P < .01) on the Boston Carpal Tunnel Questionnaire. Both groups had an improvement in functional status (MT: 47%, P < .01; EM: 9%, P < .01) and a reduction in subjective CTS symptoms (MT: 67%, P < .01; EM: 15%, P < .01). Both therapies had a positive effect on nerve conduction, pain reduction, functional status, and subjective symptoms in

  19. Efficacy of Prophylactic Mesh in End-Colostomy Construction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Wang, Shuanhu; Wang, Wenbin; Zhu, Bing; Song, Guolei; Jiang, Congqiao

    2016-10-01

    Parastomal hernia is a very common complication after colostomy, especially end-colostomy. It is unclear whether prophylactic placement of mesh at the time of stoma formation could prevent parastomal hernia formation after surgery for rectal cancer. A systematic review and meta-analysis were conducted to evaluate the efficacy of prophylactic mesh in end-colostomy construction. PubMed, Embase, and the Cochrane Library were searched, covering records entered from their inception to September 2015. Randomized controlled trials (RCTs) comparing stoma with mesh to stoma without mesh after surgery for rectal cancer were included. The primary outcome was the incidence of parastomal hernia. Pooled risk ratios (RR) with 95 % confidence intervals (CI) were obtained using random effects models. Six RCTs containing 309 patients were included. Parastomal hernia occurred in 24.4 % (38 of 156) of patients with mesh and 50.3 % (77 of 153) of patients without mesh. Meta-analysis showed a lower incidence of parastomal hernia (RR, 0.42; 95 % CI 0.22-0.82) and reoperation related to parastomal hernia (RR, 0.23; 95 % CI 0.06-0.89) in patients with mesh. Stoma-related morbidity was similar between mesh group and non-mesh group (RR, 0.65; 95 % CI 0.33-1.30). Prophylactic placement of a mesh at the time of a stoma formation seems to be associated with a significant reduction in the incidence of parastomal hernia and reoperation related to parastomal hernia after surgery for rectal cancer, but not the rate of stoma-related morbidity. However, the results should be interpreted with caution because of the heterogeneity among the studies.

  20. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  1. A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

    Directory of Open Access Journals (Sweden)

    Wen-Hong Lu

    2014-06-01

    Full Text Available Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV. IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487, IVD-B (n = 485 or NSV (n = 487 groups and underwent operation. Follow-up included visits at the 3 rd -6 th and 12 th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations and semen analysis. The subjects' partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV among the three groups (P > 0.05. The cumulative rates of complications at the 12 th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.

  2. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

    Science.gov (United States)

    Lee, Belinda T; Gabardi, Steven; Grafals, Monica; Hofmann, R Michael; Akalin, Enver; Aljanabi, Aws; Mandelbrot, Didier A; Adey, Deborah B; Heher, Eliot; Fan, Pang-Yen; Conte, Sarah; Dyer-Ward, Christine; Chandraker, Anil

    2014-03-01

    BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia. Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months. At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period. A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression.

  3. Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    S.A. Costigan

    2015-01-01

    Full Text Available Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6 years were randomized into one of three conditions: aerobic exercise program (AEP (n = 21, resistance and aerobic exercise program (RAP (n = 22 and control (n = 22. The 8-week intervention consisted of three HIIT sessions per week (8–10 min/session, delivered during physical education (PE lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run, muscular fitness (push-up, standing long jump tests, body composition (Body Mass Index (BMI, BMI-z scores, waist circumference and physical activity motivation (questionnaire, by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024, BMI-z (p = 0.037 and BMI (not significant in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

  4. Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.

    Science.gov (United States)

    Narang, Manish; Shah, Dheeraj; Akhtar, Hina

    2015-10-01

    To evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain. Double blind, randomized placebo-controlled trial. Pediatric Gastroenterology clinic of a teaching hospital. 132 children (age 4-12 y) with recurrent abdominal pain (Apley Criteria) randomized to receivedrotaverine (n=66) or placebo (n=66) orally. Children between 4-6 years of age received 10 mL syrup orally (20 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks while children >6 years of age received one tablet orally (40 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks. Primary: Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days. Secondary: Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects. Reduction in number of episodes of abdominal pain [mean (SD) number of episodes 10.3 (14) vs 21.6 (32.4); P=0.01] and lesser school absence [mean (SD) number of school days missed 0.25 (0.85) vs 0.71 (1.59); P=0.05] was noticed in children receiving drotaverine in comparison to those who received placebo. The number of pain-free days, were comparable in two groups [17.4 (8.2) vs 15.6 (8.7); P=0.23]. Significant improvement in parental satisfaction score was noticed on Likert scale by estimation of mood, activity, alertness, comfort and fluid intake. Frequency of adverse events during follow-up period was comparable between children receiving drotaverine or placebo (46.9% vs 46.7%; P=0.98). Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.

  5. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  6. A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

    Science.gov (United States)

    Lu, Wen-Hong; Liang, Xiao-Wei; Gu, Yi-Qun; Wu, Wei-Xiong; Bo, Li-Wei; Zheng, Tian-Gui; Chen, Zhen-Wen

    2014-01-01

    Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3rd–6th and 12th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects’ partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method. PMID:24589454

  7. Efficacy of Saccharomyces boulardii on necrotizing enterocolitis or sepsis in very low birth weight infants: a randomised controlled trial.

    Science.gov (United States)

    Serce, Ozge; Benzer, Derya; Gursoy, Tugba; Karatekin, Guner; Ovali, Fahri

    2013-12-01

    Probiotics have strain specific effects and the effects of fungi in preventing diseases in preterm infants have been investigated poorly. Saccharomyces boulardii is a yeast which acts both as a probiotic and a polyamine producer. The objective of this study was to investigate the efficacy of S. boulardii in preventing necrotizing enterocolitis (NEC) or sepsis in very low birth weight infants. A prospective, double blind, placebo controlled trial was conducted in preterm infants (≤ 32 GWs, ≤ 1500 g birth weight). They were randomized either to receive feeding supplementation with S. boulardii 50 mg/kg every 12 h or placebo, starting with the first feed until discharged. Necrotizing enterocolitis (NEC) or sepsis and NEC or death. Birth weight and gestational age of the study (n = 104) and the control (n = 104) groups were 1126 ± 232 vs 1162 ± 216 g and 28.8 ± 2.2 vs 28.7 ± 2.1 weeks, respectively. Neither the incidence of stage ≥ 2 NEC or death nor stage ≥ 2 NEC or late onset culture proven sepsis was significantly lower in the study group when compared with the control group (9.6% vs 7.7%, p = 0.62; 28.8% vs 23%, p = 0.34). Time to reach 100 mL/kg/day of enteral feeding (11.9 ± 7 vs 12.6 ± 7 days, p = 0.37) was not different between the groups. Saccharomyces boulardii did not decrease the incidence of NEC or sepsis. © 2013 Elsevier Ireland Ltd. All rights reserved.

  8. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  9. [Adolescents' affectivity and sexuality: a randomized trial of the efficacy of a school health promotion intervention in a primary school].

    Science.gov (United States)

    Del Prete, Giuseppe; Giraldi, Guglielmo; Miccoli, Silvia; Salamone, Velia; Speranza, Mariangela; Vita, Michela; Osborn, John Frederick; Boccia, Antonio; La Torre, Giuseppe

    2012-01-01

    A cluster randomised trial was conducted to evaluate the efficacy of a health promotion intervention aimed at improving knowledge and preventing sexually transmitted diseases (STD) amongst Grade 9 primary school students in Salerno (Italy). Students were randomized to either one of two groups: intervention group or control group. The intervention group was required to attend three meetings, each lasting one and a half hours. A questionnaire was then administered to both groups to evaluate knowledge of STD, contraception, sexuality, affectivity, satisfaction with interpersonal relationships with family, social groups and healthcare professionals. Variations of knowledge in the two groups were evaluated through calculation of odds ratios. Three hundred twenty-two students participated in the study. All students who received the study intervention were able to identify at least one STD post-intervention, while 2.5% of students in the control group did not indicate any. Students in the intervention group were more likely to select condoms as the most suitable contraception for young people (OR 5.54; 95% CI 3.27 -9.38), compared to controls (OR 1.91; 95% CI 1.20 - 3.05) (p = 0.002). They were also better aware of the possibility of contracting a STD even after incomplete sexual intercourse (OR 0.21, 95% CI 0.13 to 0.35), with a statistically significant difference (p <0.001) compared to the control group (OR 0.71, 95% CI 0.45 to 1.11). In addition, students in the intervention group were more likely to turn to their own parents when having doubts about sexual issues (p = 0.004) and female students to consider their gynecologist as a reference figure. In conclusion, the findings indicate that students randomized to the intervention group were more informed and aware of issues related to sexuality and its associated risks.

  10. Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial.

    Science.gov (United States)

    Costigan, S A; Eather, N; Plotnikoff, R C; Taaffe, D R; Pollock, E; Kennedy, S G; Lubans, D R

    2015-01-01

    Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT) for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6) years) were randomized into one of three conditions: aerobic exercise program (AEP) (n = 21), resistance and aerobic exercise program (RAP) (n = 22) and control (n = 22). The 8-week intervention consisted of three HIIT sessions per week (8-10 min/session), delivered during physical education (PE) lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run), muscular fitness (push-up, standing long jump tests), body composition (Body Mass Index (BMI), BMI-z scores, waist circumference) and physical activity motivation (questionnaire), by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024), BMI-z (p = 0.037) and BMI (not significant) in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

  11. The Efficacy of Postoperative Wound Infusion with Bupivacaine for Pain Control after Cesarean Delivery: Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Azin Alavi

    2007-06-01

    Full Text Available Objective: This study investigated the efficacy of bupivacaine wound infusion for pain control and opioid sparing effect after cesarean delivery.Materials and methods: We conducted a randomized double blind, placebo controlled clinical trial on 60 parturients undergoing cesarean section at a university hospital in Tehran. Patients were randomized to receive a pump infusion system that was filled with either 0.25% bupivacaine or equal volume of distilled water. A catheter was placed above the fascia and connected to electronic pump for 24 hours. Postoperative analog pain scores and morphine consumption were assessed at 6, 12 and 24 hours. Also time interval to first ambulation, length of hospitalization, complications and patient satisfaction were recorded. Data were analyzed using the SPSS software and P < 0.05 was considered statistically significant. Mann-Whitney u-test, student t-test and chi-square were used. Results: There were no differences in patient demographics and length of hospitalization and patient-generated resting pain scores between the two groups. Pain scores after coughing and leg raise during the first 6 postoperative hours were significantly less in the Bupivacaine group (P<0.001. The total dose of morphine consumption during the 24 hours study period was 2.5 ± 2.5 mg vs. 7.3 ± 2.7 mg for the bupivacaine and control groups, respectively (P<0.001. Compared with the control group, time to first ambulation was shorter in the bupivacaine group (11± 5h vs. 16 ± 4h (P< 0.01. Conclusion: Bupivacaine wound infusion was a simple and safe technique that provides effective analgesia and reduces morphine requirements after cesarean delivery.

  12. Investigating the Efficacy of Web-Based Transfer Training on Independent Wheelchair Transfers Through Randomized Controlled Trials.

    Science.gov (United States)

    Worobey, Lynn A; Rigot, Stephanie K; Hogaboom, Nathan S; Venus, Chris; Boninger, Michael L

    2018-01-01

    To determine the efficacy of a web-based transfer training module at improving transfer technique across 3 groups: web-based training, in-person training (current standard of practice), and a waitlist control group (WLCG); and secondarily, to determine subject factors that can be used to predict improvements in transfer ability after training. Randomized controlled trials. Summer and winter sporting events for disabled veterans. A convenience sample (N=71) of manual and power wheelchair users who could transfer independently. An individualized, in-person transfer training session or a web-based transfer training module. The WLCG received the web training at their follow-up visit. Transfer Assessment Instrument (TAI) part 1 score was used to assess transfers at baseline, skill acquisition immediately posttraining, and skill retention after a 1- to 2-day follow-up period. The in-person and web-based training groups improved their median (interquartile range) TAI scores from 7.98 (7.18-8.46) to 9.13 (8.57-9.58; P.05). A lower initial TAI score was found to be the only significant predictor of a larger percent change in TAI score after receiving training. Transfer training can improve technique with changes retained within a short follow-up window, even among experienced wheelchair users. Web-based transfer training demonstrated comparable improvements to in-person training. With almost half of the United States population consulting online resources before a health care professional, web-based training may be an effective method to increase knowledge translation. Copyright © 2017 American Congress of Rehabilitation Medicine. All rights reserved.

  13. The impact of self-efficacy on physical activity maintenance in patients with hip osteoarthritis

    DEFF Research Database (Denmark)

    Hammer, Nanna Maria; Bieler, Theresa; Beyer, Nina Ann-Marie

    2016-01-01

    Purpose: Understanding motivational factors related to physical activity (PA) maintenance is essential in promoting long-term exercise benefits. This study explored the impact of self-efficacy (SE) on post-intervention PA maintenance in patients with hip osteoarthritis. Method: An SE-theory based...... mixed-methods sub-study of a trial investigating the effects of 4 months supervised exercise in patients with hip osteoarthritis. Questionnaire data (n = 52; baseline and 12 months) on PA and SE (Arthritis Self-Efficacy Scale, ASES, score-range 10–100) were analysed (Mann–Whitney test) for differences...... from incorporating the self-efficacy theory in the planning and execution of exercise interventions to promote post-intervention physical activity maintenance and long term health benefits. •Post-intervention physical activity maintenance may be increased by focussing on the patients’ exercise self-efficacy...

  14. Technical Note: Application of Decision Theory Based Criteria for ...

    African Journals Online (AJOL)

    Technical Note: Application of Decision Theory Based Criteria for Structural Appraisal of a Building during Construction. ... Nigerian Journal of Technology ... reliability of concrete in a structure during construction, a case study of laboratory block for College of Continuing Education, University of Port Harcourt, Rivers State.

  15. A density functional theory-based chemical potential equalisation

    Indian Academy of Sciences (India)

    A chemical potential equalisation scheme is proposed for the calculation of these quantities and hence the dipole polarizability within the framework of density functional theory based linear response theory. The resulting polarizability is expressed in terms of the contributions from individual atoms in the molecule. A few ...

  16. 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…

  17. Evaluating hydrological model performance using information theory-based metrics

    Science.gov (United States)

    The accuracy-based model performance metrics not necessarily reflect the qualitative correspondence between simulated and measured streamflow time series. The objective of this work was to use the information theory-based metrics to see whether they can be used as complementary tool for hydrologic m...

  18. Pharmacogenetic meta-analysis of baseline risk factors, pharmacodynamic, efficacy and tolerability endpoints from two large global cardiovascular outcomes trials for darapladib.

    Directory of Open Access Journals (Sweden)

    Astrid Yeo

    Full Text Available Darapladib, a lipoprotein-associated phospholipase A2 (Lp-PLA2 inhibitor, failed to demonstrate efficacy for the primary endpoints in two large phase III cardiovascular outcomes trials, one in stable coronary heart disease patients (STABILITY and one in acute coronary syndrome (SOLID-TIMI 52. No major safety signals were observed but tolerability issues of diarrhea and odor were common (up to 13%. We hypothesized that genetic variants associated with Lp-PLA2 activity may influence efficacy and tolerability and therefore performed a comprehensive pharmacogenetic analysis of both trials. We genotyped patients within the STABILITY and SOLID-TIMI 52 trials who provided a DNA sample and consent (n = 13,577 and 10,404 respectively, representing 86% and 82% of the trial participants using genome-wide arrays with exome content and performed imputation using a 1000 Genomes reference panel. We investigated baseline and change from baseline in Lp-PLA2 activity, two efficacy endpoints (major coronary events and myocardial infarction as well as tolerability parameters at genome-wide and candidate gene level using a meta-analytic approach. We replicated associations of published loci on baseline Lp-PLA2 activity (APOE, CELSR2, LPA, PLA2G7, LDLR and SCARB1 and identified three novel loci (TOMM5, FRMD5 and LPL using the GWAS-significance threshold P≤5E-08. Review of the PLA2G7 gene (encoding Lp-PLA2 within these datasets identified V279F null allele carriers as well as three other rare exonic null alleles within various ethnic groups, however none of these variants nor any other loci associated with Lp-PLA2 activity at baseline were associated with any of the drug response endpoints. The analysis of darapladib efficacy endpoints, despite low power, identified six low frequency loci with main genotype effect (though with borderline imputation scores and one common locus (minor allele frequency 0.24 with genotype by treatment interaction effect passing the GWAS

  19. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials.

    Science.gov (United States)

    Miwa, H; Uedo, N; Watari, J; Mori, Y; Sakurai, Y; Takanami, Y; Nishimura, A; Tatsumi, T; Sakaki, N

    2017-01-01

    Vonoprazan is a new potassium-competitive acid blocker for treatment of acid-related diseases. To conduct two randomised-controlled trials, to evaluate the non-inferiority of vonoprazan vs. lansoprazole, a proton pump inhibitor, for treatment of gastric ulcer (GU) or duodenal ulcer (DU). Patients aged ≥20 years with ≥1 endoscopically-confirmed GU or DU (≥5 mm white coating) were randomised 1:1 using double-dummy blinding to receive lansoprazole (30 mg) or vonoprazan (20 mg) for 8 (GU study) or 6 (DU study) weeks. The primary endpoint was the proportion of patients with endoscopically confirmed healed GU or DU. For GU, 93.5% (216/231) of vonoprazan-treated patients and 93.8% (211/225) of lansoprazole-treated patients achieved healed GU; non-inferiority of vonoprazan to lansoprazole was confirmed [difference = -0.3% (95% CI -4.750, 4.208); P = 0.0011]. For DU, 95.5% (170/178) of vonoprazan-treated patients and 98.3% (177/180) of lansoprazole-treated patients achieved healed DU; non-inferiority to lansoprazole was not confirmed [difference = -2.8% (95% CI -6.400, 0.745); P = 0.0654]. The incidences of treatment-emergent adverse events were slightly lower for GU and slightly higher for DU with vonoprazan than with lansoprazole. There was one death (subarachnoid haemorrhage) in the vonoprazan group (DU). The possibility of a relationship between this unexpected patient death and the study drug could not be ruled out. In both studies, increases in serum gastrin levels were greater in vonoprazan-treated vs. lansoprazole-treated patients; levels returned to baseline after treatment in both groups. Vonoprazan 20 mg has a similar tolerability profile to lansoprazole 30 mg and is non-inferior with respect to GU healing and has similar efficacy for DU healing. © 2016 Takeda Pharmaceutical Company, Ltd. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  20. Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial

    Science.gov (United States)

    Farris, Coreen; Fischhoff, Baruch; Rosengart, Matthew R; Angus, Derek C; Yealy, Donald M; Wallace, David J; Barnato, Amber E

    2017-01-01

    education arm completed the trial. Of these, 64/100 (64%) and 58/100 (58%), respectively, completed reassessment at six months. The mean age was 40 (SD 8.9), 283 (96%) were trained in emergency medicine, and 207 (70%) were ATLS (advanced trauma life support) certified. Physicians exposed to the game under-triaged fewer severely injured patients than those exposed to didactic education (316/596 (0.53) v 377/592 (0.64), estimated difference 0.11, 95% confidence interval 0.05 to 0.16; P<0.001). Cognitive load did not influence under-triage (161/308 (0.53) v 155/288 (0.54) in the game arm; 197/300 (0.66) v 180/292 (0.62) in the traditional educational apps arm; P=0.66). At six months, physicians exposed to the game remained less likely to under-triage patients (146/256 (0.57) v 172/232 (0.74), estimated difference 0.17, 0.09 to 0.25; P<0.001). No physician reported side effects. The sample might not reflect all emergency medicine physicians, and a small set of cases was used to assess performance. Conclusions Compared with apps based on traditional didactic education, exposure of physicians to a theoretically grounded video game improved triage decision making in a validated virtual simulation. Though the observed effect was large, the wide confidence intervals include the possibility of a small benefit, and the real world efficacy of this intervention remains uncertain. Trial registration clinicaltrials.gov; NCT02857348 (initial study)/NCT03138304 (follow-up). PMID:29233854

  1. Efficacy of site-independent telemedicine in the STRokE DOC trial: a randomised, blinded, prospective study.

    Science.gov (United States)

    Meyer, Brett C; Raman, Rema; Hemmen, Thomas; Obler, Richard; Zivin, Justin A; Rao, Ramesh; Thomas, Ronald G; Lyden, Patrick D

    2008-09-01

    different for BI (95-100) (0.6, 0.4-1.1; p=0.13) or for mRS score (0.6, 0.3-1.1; p=0.09). There was no difference in mortality (1.6, 0.8-3.4; p=0.27) or rates of intracerebral haemorrhage after treatment with thrombolytics (2 [7%] telemedicine vs 2 [8%] telephone, 0.8, 0.1-6.3; p=1.0). However, there were more incomplete data in the telephone group than in the telemedicine group (12%vs 3%, 0.2, 0.1-0.3; p=0.0001). The authors of this trial report that stroke telemedicine consultations result in more accurate decision making compared with telephone consultations and can serve as a model for the effectiveness of telemedicine in other medical specialties. The more appropriate decisions, high rates of thrombolysis use, improved data collection, low rate of intracerebral haemorrhage, low technical complications, and favourable time requirements all support the efficacy of telemedicine for making treatment decisions, and might enable more practitioners to use this medium in daily stroke care.

  2. Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    van der Heijden Marion MP

    2012-07-01

    Full Text Available Abstract Background Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM, as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account. Methods/Design This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands. Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of depression, exercise self-efficacy, Body Mass Index (BMI, blood pressure and glycemic control. Discussion We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the

  3. Efficacy of preoperative uro-stoma education on self-efficacy after Radical Cystectomy; secondary outcome of a prospective randomized controlled trial.

    Science.gov (United States)

    Jensen, Bente Thoft; Kiesbye, Berit; Soendergaard, Ingrid; Jensen, Jørgen B; Kristensen, Susanne Ammitzboell

    2017-06-01

    Radical Cystectomy with a creation of an uro-stoma is first line treatment in advanced bladder-cancer. Enhancing or maintaining an individual's condition, skills and physical wellbeing before surgery has been defined as prehabilitation. Whether preoperative stoma-education is an effective element in prehabilitation is yet to be documented. In a prospective randomized controlled design (RCT) the aim was to investigate the efficacy of a standardised preoperative stoma-education program on an individual's ability to independently change a stoma-appliance. A parent RCT-study investigated the efficacy of a multidisciplinary rehabilitation program on length of stay following cystectomy. A total of 107 patients were included in the intension-to-treat-population. Preoperatively, the intervention-group was instructed to a standardized stoma-education program consisting of areas recognized necessary to change a stoma appliance. The Urostomy Education Scale was used to measure stoma self-care at day 35, 120 and 365 postoperatively. Efficacy was expressed as a positive difference in UES-score between treatment-groups. A significant difference in mean score was found in the intervention group compared to standard of 2.7 (95% CI: 0.9; 4.5), 4.3 (95% CI: 2.1; 6.5) and 5.1 (95% CI: 2.3; 7.8) at day 35, 120 and 365 postoperatively. For the first time a study in a RCT-design have reported a positive efficacy of a short-term preoperative stoma intervention. Preoperative stoma-education is an effective intervention and adds to the evidence base of prehabilitation. Further RCT-studies powered with self-efficacy as the primer outcome are requested. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Clinical efficacy, onset time and safety of bright light therapy in acute bipolar depression as an adjunctive therapy: A randomized controlled trial.

    Science.gov (United States)

    Zhou, Tian-Hang; Dang, Wei-Min; Ma, Yan-Tao; Hu, Chang-Qing; Wang, Ning; Zhang, Guo-Yi; Wang, Gang; Shi, Chuan; Zhang, Hua; Guo, Bin; Zhou, Shu-Zhe; Feng, Lei; Geng, Shu-Xia; Tong, Yu-Zhen; Tang, Guan-Wen; He, Zhong-Kai; Zhen, Long; Yu, Xin

    2018-02-01

    Bright light therapy (BLT) is an effective treatment for seasonal affective disorder and non- seasonal depression. The efficacy of BLT in treating patients with bipolar disorder is still unknown. The aim of this study is to examine the efficacy, onset time and clinical safety of BLT in treating patients with acute bipolar depression as an adjunctive therapy (trial registration at ClinicalTrials.gov: NCT02009371). This was a multi-center, single blind, randomized clinical trial. Seventy-four participants were randomized in one of two treatment conditions: BLT and control (dim red light therapy, dRLT). Sixty-three participants completed the study (33 BLT, 30 dRLT). Light therapy lasted for two weeks, one hour every morning. All participants were required to complete several scales assessments at baseline, and at the end of weeks 1 and 2. The primary outcome measures were the clinical efficacy of BLT which was assessed by the reduction rate of HAMD-17 scores, and the onset time of BLT which was assessed by the reduction rate of QIDS-SR16 scores. The secondary outcome measures were rates of switch into hypomania or mania and adverse events. 1) Clinical efficacy: BLT showed a greater ameliorative effect on bipolar depression than the control, with response rates of 78.19% vs. 43.33% respectively (p < 0.01). 2) Onset day: Median onset day was 4.33 days in BLT group. 3) BLT-emergent hypomania: No participants experienced symptoms of hypomania. 4) Side effects: No serious adverse events were reported. BLT can be considered as an effective and safe adjunctive treatment for patients with acute bipolar depression. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

    Science.gov (United States)

    Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

    2017-09-01

    Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

  6. Efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline in Twin Families (VIPP-Twins): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Euser, Saskia; Bakermans-Kranenburg, Marian J; van den Bulk, Bianca G; Linting, Mariëlle; Damsteegt, Rani C; Vrijhof, Claudia I; van Wijk, Ilse C; Crone, Eveline A; van IJzendoorn, Marinus H

    2016-06-06

    Intervention programs with the aim of enhancing parenting quality have been found to be differentially effective in decreasing negative child outcomes such as externalizing behavioral problems, resulting in modest overall effect sizes. Here we present the protocol for a randomized controlled trial to examine the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline for Twin Families (VIPP-Twins) on parenting quality and children's behavioral control and social competence. In addition, we aim to test the differential susceptibility theory; we examine differential efficacy of the intervention based on genetic make-up or temperament for both parents and children. Lastly, we explore neurobiological mechanisms underlying intervention effects on children's developmental outcomes. The original VIPP-SD was adapted for use in families with twins. The VIPP-Twins consists of five biweekly sessions in which the families are visited at home, parent-child interactions are videotaped and parents receive positive feedback on selected video fragments. Families (N = 225) with a same sex twin (mean age = 3.6 years) were recruited to participate in the study. The study consists of four assessments. After two baseline assessments in year 1 and year 2, a random 40 % of the sample will receive the VIPP-Twins program. The first post-test assessment will be carried out one month after the intervention and there will be a long term follow-up assessment two years after the intervention. Measures include observational assessments of parenting and children's social competence and behavioral control, and neurobiological assessments (i.e., hormonal functioning and neural (re-)activity). Results of the study will provide insights in the efficacy of the VIPP-Twins and reveal moderators and mediators of program efficacy. Overall the randomized controlled trial is an experimental test of the differential susceptibility theory. Dutch Trial

  7. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

    International Nuclear Information System (INIS)

    Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk-Joon; Kim, Min Chan; Hyung, Woo Jin; Park, Young Kyu; Kim, Wook; Han, Sang-Uk

    2015-01-01

    Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. ClinicalTrial.gov, https://www.clinicaltrials.gov/ct2/show/NCT01456598?term

  8. Application in the STRATHE trial of a score system to compare the efficacy and the tolerability of different therapeutic strategies in the management of hypertension

    Directory of Open Access Journals (Sweden)

    Bernard Waeber

    2008-02-01

    Full Text Available Bernard Waeber1, Jean-Jacques Mourad21Division de Physiopathologie Clinique, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland; 2Hôpital Avicienne, Bobigny, FranceAbstract: A score system integrating the evolution of efficacy and tolerability over time was applied to a subpopulation of the STRATHE trial, a trial performed according to a parallel group design, with a double-blind, random allocation to either a fixed-dose combination strategy (perindopril/indapamide 2 mg/0.625 mg, with the possibility to increase the dose to 3 mg/0.935 mg, and 4 mg/1.250 mg if needed, n = 118, a sequential monotherapy approach (atenolol 50 mg, followed by losartan 50 mg and amlodipine 5 mg if needed, n = 108, or a stepped-care strategy (valsartan 40 mg, followed by valsartan 80 mg and valsartan 80 mg+ hydrochlorothiazide 12.5 mg if needed, n = 103. The aim was to lower blood pressure below 140/90 mmHg within a 9-month period. The treatment could be adjusted after 3 and 6 months. Only patients in whom the study protocol was strictly applied were included in this analysis. At completion of the trial the total score averaged 13.1 ± 70.5 (mean ± SD using the fixed-dose combination strategy, compared with –7.2 ± 81.0 using the sequential monotherapy approach and –17.5 ± 76.4 using the stepped-care strategy. In conclusion, the use of a score system allows the comparison of antihypertensive therapeutic strategies, taking into account at the same time efficacy and tolerability. In the STRATHE trial the best results were observed with the fixed-dose combination containing low doses of an angiotensin enzyme converting inhibitor (perindopril and a diuretic (indapamide.Keywords: antihypertensive therapy, tolerability, antihypertensive efficacy, fixed-dose combination, sequential monotherapy, stepped-care treatment

  9. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

    2014-01-01

    BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

  10. THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    I. N. Denisov

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR, the American College of Rheumatology (ACR, and the Osteoarthritis Research Society International (OARSI, many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options.Objective: to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA.Subjects and methods.The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients. The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS, WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography, patient and physician global assessments of disease activity (Likert scale, and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs. The onset the therapeutic effect of the gel and the duration of its action were recorded.Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01 and from 52±5.3 to 17±2.7 mm

  11. Efficacy of Single-Dose and Triple-Dose Albendazole and Mebendazole against Soil-Transmitted Helminths and Taenia spp.: A Randomized Controlled Trial

    Science.gov (United States)

    Steinmann, Peter; Utzinger, Jürg; Du, Zun-Wei; Jiang, Jin-Yong; Chen, Jia-Xu; Hattendorf, Jan; Zhou, Hui; Zhou, Xiao-Nong

    2011-01-01

    Background The control of soil-transmitted helminth (STH) infections currently relies on the large-scale administration of single-dose oral albendazole or mebendazole. However, these treatment regimens have limited efficacy against hookworm and Trichuris trichiura in terms of cure rates (CR), whereas fecal egg reduction rates (ERR) are generally high for all common STH species. We compared the efficacy of single-dose versus triple-dose treatment against hookworm and other STHs in a community-based randomized controlled trial in the People's Republic of China. Methodology/Principal findings The hookworm CR and fecal ERR were assessed in 314 individuals aged ≥5 years who submitted two stool samples before and 3–4 weeks after administration of single-dose oral albendazole (400 mg) or mebendazole (500 mg) or triple-dose albendazole (3×400 mg over 3 consecutive days) or mebendazole (3×500 mg over 3 consecutive days). Efficacy against T. trichiura, Ascaris lumbricoides, and Taenia spp. was also assessed. Albendazole cured significantly more hookworm infections than mebendazole in both treatment regimens (single dose: respective CRs 69% (95% confidence interval [CI]: 55–81%) and 29% (95% CI: 20–45%); triple dose: respective CRs 92% (95% CI: 81–98%) and 54% (95% CI: 46–71%)). ERRs followed the same pattern (single dose: 97% versus 84%; triple dose: 99.7% versus 96%). Triple-dose regimens outperformed single doses against T. trichiura; three doses of mebendazole – the most efficacious treatment tested – cured 71% (95% CI: 57–82%). Both single and triple doses of either drug were highly efficacious against A. lumbricoides (CR: 93–97%; ERR: all >99.9%). Triple dose regimens cured all Taenia spp. infections, whereas single dose applications cured only half of them. Conclusions/Significance Single-dose oral albendazole is more efficacious against hookworm than mebendazole. To achieve high CRs against both hookworm and T. trichiura, triple-dose regimens are

  12. "FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

    2016-04-16

    Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

  13. Efficacy and safety of human papillomavirus vaccine for primary prevention of cervical cancer: A review of evidence from phase III trials and national programs

    Directory of Open Access Journals (Sweden)

    Partha Basu

    2013-01-01

    Full Text Available The Human Papillomavirus (HPV vaccines have been widely introduced in the national immunization programs in most of the medium and high income countries following endorsement from national and international advisory bodies. HPV vaccine is unique and its introduction is challenging in many ways - it is the first vaccine developed to prevent any cancer, the vaccine is gender specific, it targets adolescent females who are difficult to reach by any health intervention programs. It is not unusual for such a vaccine to face scepticism and reservations not only from lay public but also from professionals in spite of the clinical trial results convincingly and consistently proving their efficacy and safety. Over the last few years millions of doses of the HPV vaccine have been administered round the world and the efficacy and safety data have started coming from the real life programs. A comprehensive cervical cancer control program involving HPV vaccination of the adolescent girls and screening of the adult women has been proved to be the most cost-effective approach to reduce the burden of cervical cancer. The present article discusses the justification of HPV vaccination in the backdrop of natural history of cervical cancer, the mechanism of action of the vaccines, efficacy and safety data from phase III randomized controlled trials as well as from the national immunization programs of various countries.

  14. Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kim Yoon-Bum

    2011-03-01

    Full Text Available Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE, and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. Methods/Design A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL, KRTE only group (KO, acupuncture only group (AO, and KRTE and acupuncture combined treatment group (KA. After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS and investigator global assessment (IGA from baseline to the end of the trial. Trial Registration The trial is registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000071.

  15. Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

    Science.gov (United States)

    Pollak, Kathryn I; Fish, Laura J; Lyna, Pauline; Peterson, Bercedis L; Myers, Evan R; Gao, Xiaomei; Swamy, Geeta K; Brown-Johnson, Angela; Whitecar, Paul; Bilheimer, Alicia K; Pletsch, Pamela K

    2016-10-01

    Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return). We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum. Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences ( 36% [95% confidence interval [CI]: 29-43] vs. 35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%). Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking. Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention. © The

  16. Efficacy of cognitive rehabilitation using computer software with individuals living with schizophrenia: A randomized controlled trial in Japan.

    Science.gov (United States)

    Iwata, Kazuhiko; Matsuda, Yasuhiro; Sato, Sayaka; Furukawa, Shunichi; Watanabe, Yukako; Hatsuse, Norifumi; Ikebuchi, Emi

    2017-03-01

    Cognitive impairment is common in schizophrenia, and is associated with poor psychosocial functioning. Previous studies had inconsistently shown improvement in cognitive functions with cognitive remediation therapy. This study examined whether cognitive remediation is effective in improving both cognitive and social functions in schizophrenia in outpatient settings that provide learning-based psychiatric rehabilitation. This study is the first randomized controlled trial of cognitive remediation in Japan. Study participants were individuals with schizophrenia from 6 outpatient psychiatric medical facilities who were randomly assigned either a cognitive remediation program or treatment as usual. The cognitive remediation intervention includes Cognitive training using computer software (CogPack; Japanese version) administered twice a week and a weekly group over 12 weeks and was based on the Thinking Skills for Work program. Most study participants were attending day treatment services where social skills training, psychoeducation for knowledge about schizophrenia, group activities such as recreation and sport, and other psychosocial treatment were offered. Cognitive and social functioning were assessed using the Brief Assessment of Cognition in Schizophrenia (BACS) and Life Assessment Scale for Mentally Ill (LASMI) at pre- and postintervention. Of the 60 people with schizophrenia enrolled, 29 were allocated to the cognitive remediation group and 31 were allocated to the treatment as usual group. Processing speed, executive function, and the composite score of the BACS showed significantly greater improvement for the cognitive remediation group than the treatment as usual group. In addition, there was significant improvement in interpersonal relationships and work skills on the LASMI for the cognitive remediation group compared with the treatment as usual group. Changes from pretreatment to posttreatment in verbal fluency and interpersonal relationships were

  17. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    Science.gov (United States)

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 liga