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Sample records for preliminary randomized controlled

  1. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    PubMed

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  2. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  3. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

    PubMed Central

    Zywiak, William H.; Edwards, Steven M.; Tidey, Jennifer W.; Swift, Robert M.; Kenna, George A.

    2014-01-01

    Rationale There is presently no approved single treatment for dual alcohol and nicotine dependencies. Objective This pilot study investigated baclofen effects in alcoholic smokers. Methods This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. Results Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. Conclusions This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies. PMID:24973894

  4. Effects of therapeutic recreation on adults with ASD and ID: a preliminary randomized control trial.

    PubMed

    García-Villamisar, D; Dattilo, J; Muela, C

    2017-04-01

    The purpose of this research was to examine effects of a therapeutic recreation (TR) program designed to increase executive function (EF), social skills, adaptive behaviours and well-being of adults with autism spectrum disorder (ASD) and intellectual disability (ID). A preliminary pre-test, post-test randomized control group experimental design was used to measure effects of a 40-week TR program designed to increase EF (TR-EF). The TR-EF used instructional electronically based games delivered during 200 1-h sessions (5/week). Participants (experimental group, n = 19; wait-list group, n = 18) were evaluated at baseline and 10 months later. There was a positive and direct impact of the program on several EF and indirect effect on social skills, adaptive behaviour and personal well-being. Findings provide support for inclusion of EF enrichment as a way to enhance effects of TR interventions for adults with ASD and ID. Preliminary results of this study can be considered in planning TR services in the future. In addition to TR-EF program primary effects on EF, there were indirect benefits on adaptive behaviours, personal well-being and social skills. © 2016 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

  5. A preliminary randomized controlled trial of a distress tolerance treatment for opioid dependent persons initiating buprenorphine.

    PubMed

    Stein, Michael D; Herman, Debra S; Moitra, Ethan; Hecht, Jacki; Lopez, Rosalie; Anderson, Bradley J; Brown, Richard A

    2015-02-01

    Buprenorphine opioid agonist treatment (OAT) has established efficacy for treating opioid dependency but early relapse rates are high and are often associated with withdrawal-related or emotional distress. To determine whether a novel distress tolerance (DT) intervention during buprenorphine initiation decreases opioid relapse, we conducted a preliminary randomized controlled trial with opioid-dependent outpatients. Participants received buprenorphine-naloxone induction and 3-months of maintenance buprenorphine plus seven, 50-min manualized, individual sessions (DT vs. health education (HE) control) over a 28-day period, linked to clinician medication dosing visits, and beginning 2 days prior to buprenorphine induction. Primary outcomes included use of illicit opioids (positive defined as any self-reported use in the prior 28 days or detected by urine toxicology) and treatment drop out. Among 49 participants, the mean age was 41 years, 65.3% were male. Persons randomized to DT had lower rates of opioid use at all three monthly assessments, and at 3-months, 72% of HE participants were opioid positive compared with 62.5% of DT participants. Rates of dropout were 24% and 25% in the HE and DT arms, respectively. This distress tolerance treatment produced a small, but not statistically significant reduction in opioid use during the first three months of treatment although no differences were found in drop-out rates between conditions. If replicated in a larger study, DT could offer clinicians a useful behavioral treatment to complement the effects of buprenorphine. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. Mindfulness Therapy for Maladaptive Interpersonal Dependency: A Preliminary Randomized Controlled Trial.

    PubMed

    McClintock, Andrew S; Anderson, Timothy; Cranston, Saryn

    2015-11-01

    Existing treatments for maladaptive interpersonal dependency and dependent personality disorder do not meet basic scientific standards for effectiveness. The present investigation tested the efficacy of a mindfulness-based approach: mindfulness therapy for maladaptive interpersonal dependency (MT-MID). Forty-eight participants who reported consistently high levels of maladaptive dependency (i.e., scored higher than 1 standard deviation above the mean on the Interpersonal Dependency Inventory at two separate assessments) were randomized to either 5 sessions of MT-MID or a minimal contact control. Five self-reported outcomes (mindfulness, maladaptive interpersonal dependency, helplessness, fears of negative evaluation, and excessive reassurance seeking) were assessed at pretreatment, posttreatment, and a 4-week follow-up. Intent-to-treat analyses indicated that MT-MID yielded greater improvements than the control on all 5 outcomes at posttreatment (median d=1.61) and follow-up (median d=1.51). Participants assigned to MT-MID were more likely than control participants to meet criteria for clinically significant change at posttreatment (56.5% vs. 0%) and follow-up (42.9% vs. 0%). There was also evidence that increases in mindfulness mediated the dependency-related improvements. These results provide preliminary support for the efficacy of a mindfulness-based approach for treating the symptoms of maladaptive dependency. Copyright © 2015. Published by Elsevier Ltd.

  7. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  8. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  9. A new time limited psychotherapy for BPD: preliminary results of a randomized and controlled trial.

    PubMed

    Reneses, Blanca; Galián, Miriam; Serrano, Rosario; Figuera, Diego; Fernandez Del Moral, Antonio; López-Ibor, Juan J; Fuentes, Manuel; Trujillo, Manuel

    2013-01-01

    Psychic Representation focused Psychotherapy (PRFP) is a new time limited dynamic psychotherapy for the treatment of Borderline Personality Disorder. It is a psychodynamic technique based on brief psychoanalytic psychotherapy principles. It is manualized and designed to be applied in the framework of public health care services. A randomized and controlled study with a sample of 53 patients was conducted to assess PRFP efficacy. This work presents the results for the first 44 trial completers at termination of treatment. Both groups, the experimental (n= 18) and control group (n= 26), received treatment as usual. The experimental group received an additional 20 (PRFP) sessions, conducted by four therapists with homogenous characteristics specifically trained in this technique. The main outcome variables measures were: Severity global index of SCL-90-R, Barrat Impulsivity Scale scores and Social Adaptation (SASS score). Baseline and final condition at termination was compared. Preliminary results showed significantly better outcomes for the experimental group in all the main variables measured and in most of the secondary ones. PRFP may represent an important contribution for the treatment of BPD patients. Follow-up assessment at 6 and 12 months is planned.

  10. A Preliminary Randomized Controlled Trial of a Distress Tolerance Treatment for Opioid Dependent Persons Initiating Buprenorphine

    PubMed Central

    Stein, Michael D.; Herman, Debra S.; Moitra, Ethan; Hecht, Jacki; Lopez, Rosalie; Anderson, Bradley J; Brown, Richard A.

    2014-01-01

    Background Buprenorphine opioid agonist treatment (OAT) has established efficacy for treating opioid dependency but early relapse rates are high and are often associated with withdrawal-related or emotional distress. Methods To determine whether a novel distress tolerance (DT) intervention during buprenorphine initiation decreases opioid relapse, we conducted a preliminary randomized controlled trial with opioid-dependent outpatients. Participants received buprenorphine-naloxone induction and 3-months of maintenance buprenorphine plus seven, 50-minute manualized, individual sessions (DT vs. Health Education (HE) control) over a 28-day period, linked to clinician medication dosing visits, and beginning 2 days prior to buprenorphine induction. Primary outcomes included use of illicit opioids (positive defined as any self-reported use in the prior 28 days or detected by urine toxicology) and treatment drop out. Results Among 49 participants, the mean age was 41 years, 65.3% were male. Persons randomized to DT had lower rates of opioid use at all three monthly assessments, and at 3-months, 72% of HE participants were opioid positive compared with 62.5% of DT participants. Rates of dropout were 24% and 25% in the HE and DT arms, respectively. Conclusions This distress tolerance treatment produced a small, but not statistically significant reduction in opioid use during the first three months of treatment although no differences were found in drop-out rates between conditions. If replicated in a larger study, DT could offer clinicians a useful behavioral treatment to complement the effects of buprenorphine. Trial registered at clinicaltrials.org. Trial number NCT01556087. PMID:25510307

  11. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

    PubMed

    Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

    2015-03-01

    Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe

  12. Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

    PubMed Central

    Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

    2015-01-01

    Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data

  13. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study

    PubMed Central

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-01-01

    Background The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. Material/Methods This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. Results A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients’ baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (P<0.05). Finally, heart rate was identified as a contributing factor of LLS. Conclusions These preliminary findings suggest that intravenous iron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants. PMID:26175087

  14. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study.

    PubMed

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-07-15

    The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients' baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (P<0.05). Finally, heart rate was identified as a contributing factor of LLS. These preliminary findings suggest that intravenous iron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants.

  15. Vitamin E neuroprotection against cisplatin ototoxicity: Preliminary results from a randomized, placebo-controlled trial.

    PubMed

    Villani, Veronica; Zucchella, Chiara; Cristalli, Giovanni; Galiè, Edvina; Bianco, Francesco; Giannarelli, Diana; Carpano, Silvia; Spriano, Giuseppe; Pace, Andrea

    2016-04-01

    Few studies have investigated the effect of vitamin E in reducing the cisplatin (CDDP)-induced ototoxicity. This study evaluated vitamin E supplementation as a protecting agent against CDDP-induced ototoxicity. Patients who started CDDP were randomly assigned to receive vitamin E supplementation at 400 mg per day (group 1) or placebo (group 2). Audiograms and evoked brainstem responses were obtained at baseline, and after 1, 2, and 3 months. Twenty-three patients affected by solid malignancies were enrolled (13 in group 1 and 10 in group 2). At 1 month, a significant hearing loss in group 2 at both 2000 HZ (right ear: p = .05; left ear: p = .04) and 8000 HZ (right ear: p = .04; left ear: p = .03) was detected when compared to baseline values. Audiograms did not show significant changes. At 1 month, evoked brainstem responses remained unchanged in both arms without significant differences between groups. These preliminary findings confirm the neuroprotective properties of vitamin E against the CDDP-induced ototoxicity. © 2016 Wiley Periodicals, Inc. Head Neck 38: E2118-E2121, 2016. © 2016 Wiley Periodicals, Inc.

  16. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study.

    PubMed

    Kim, Eunjung; Cain, Kevin C; Webster-Stratton, Carolyn

    2008-09-01

    Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.

  17. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    PubMed Central

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged <50 years, whereas it was not for older women. Self-reported abstinence was high at 67% and 48% for the video and telephone arm at 1 month post-quit, respectively. The rates declined to 33% for the video arm and 28% for the telephone arm at 3 months post-quit when salivary cotinine test was performed. Conclusion Findings support that both videoconferencing and telephone counseling can be effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women. PMID:27660494

  18. Evaluation of the mental health benefits of yoga in a secondary school: a preliminary randomized controlled trial.

    PubMed

    Khalsa, Sat Bir S; Hickey-Schultz, Lynn; Cohen, Deborah; Steiner, Naomi; Cope, Stephen

    2012-01-01

    The goal of this study was to evaluate potential mental health benefits of yoga for adolescents in secondary school. Students were randomly assigned to either regular physical education classes or to 11 weeks of yoga sessions based upon the Yoga Ed program over a single semester. Students completed baseline and end-program self-report measures of mood, anxiety, perceived stress, resilience, and other mental health variables. Independent evaluation of individual outcome measures revealed that yoga participants showed statistically significant differences over time relative to controls on measures of anger control and fatigue/inertia. Most outcome measures exhibited a pattern of worsening in the control group over time, whereas changes in the yoga group over time were either minimal or showed slight improvements. These preliminary results suggest that implementation of yoga is acceptable and feasible in a secondary school setting and has the potential of playing a protective or preventive role in maintaining mental health.

  19. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    PubMed Central

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  20. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    PubMed

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  1. Cognitive behaviour therapy for low self-esteem: a preliminary randomized controlled trial in a primary care setting.

    PubMed

    Waite, Polly; McManus, Freda; Shafran, Roz

    2012-12-01

    Low self-esteem (LSE) is associated with psychiatric disorder, and is distressing and debilitating in its own right. Hence, it is frequent target for treatment in cognitive behavioural interventions, yet it has rarely been the primary focus for intervention. This paper reports on a preliminary randomized controlled trial of cognitive behaviour therapy (CBT) for LSE using Fennell's (1997) cognitive conceptualisation and transdiagnostic treatment approach (1997, 1999). Twenty-two participants were randomly allocated to either immediate treatment (IT) (n=11) or to a waitlist condition (WL) (n=11). Treatment consisted of 10 sessions of individual CBT accompanied by workbooks. Participants allocated to the WL condition received the CBT intervention once the waitlist period was completed and all participants were followed up 11 weeks after completing CBT. The IT group showed significantly better functioning than the WL group on measures of LSE, overall functioning and depression and had fewer psychiatric diagnoses at the end of treatment. The WL group showed the same pattern of response to CBT as the group who had received CBT immediately. All treatment gains were maintained at follow-up assessment. The sample size is small and consists mainly of women with a high level of educational attainment and the follow-up period was relatively short. These preliminary findings suggest that a focused, brief CBT intervention can be effective in treating LSE and associated symptoms and diagnoses in a clinically representative group of individuals with a range of different and co-morbid disorders. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Development and Preliminary Evaluation of an Internet-Based Healthy Eating Program: Randomized Controlled Trial

    PubMed Central

    Jiga-Boy, Gabriela; Maio, Gregory R; Haddock, Geoffrey; Lewis, Michael

    2014-01-01

    Background The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change (analyzing one’s reasons for endorsing health values) alongside other psychological principles that have been shown to influence behavior. The program consists of phases targeting motivation (dietary feedback and advice, analyzing reasons for health values, thinking about health-related desires, and concerns), volition (implementation intentions with mental contrasting), and maintenance (reviewing tasks, weekly tips). Objective The aim was to examine the effects of the program on consumption of fruit and vegetables, saturated fat, and added sugar over a 6-month period. Methods A total of 82 females and 18 males were recruited using both online and print advertisements in the local community. They were allocated to an intervention or control group using a stratified block randomization protocol. The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures. Those allocated to the intervention group also completed the intervention tasks at these sessions. Additionally, all participants attended laboratory sessions at baseline, 3 months, and 6 months. During these sessions, participants completed a food frequency questionnaire (FFQ, the Block Fat/Sugar/Fruit/Vegetable Screener, adapted for the UK), and researchers (blind to group allocation) measured their body mass index (BMI), waist-to-hip ratio (WHR), and heart rate variability (HRV). Results Data were analyzed using a series of ANOVA models. Per protocol analysis (n=92) showed a significant interaction for fruit and vegetable consumption (P=.048); the intervention group increased their intake between baseline and 6 months (3.7 to 4.1 cups) relative to the control group (3.6 to 3.4 cups). Results also showed overall reductions in saturated fat intake (20.2 to 15.6 g, P<.001) and added sugar

  3. Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients with Major Depressive Disorder: A Preliminary Randomized Controlled Trial.

    PubMed

    Shachar-Malach, Tal; Cooper Kazaz, Rena; Constantini, Naama; Lifschytz, Tzuri; Lerer, Bernard

    2015-01-01

    Physical exercise has been shown to reduce depressive symptoms when used in combination with antidepressant medication. We report a randomized controlled trial of aerobic exercise compared to stretching as an augmentation strategy for hospitalized patients with major depression. Male or female patients, 18-80 years, diagnosed with a Major Depressive Episode, were randomly assigned to three weeks of augmentation therapy with aerobic (n=6) or stretching exercise (n=6). Depression was rated, at several time points using the 21-item Hamilton Depression Scale (HAM-D), Beck Depression Inventory (BDI) and other scales. According to the HAM-D, there were four (out of six) responders in the aerobic group, two of whom achieved remission, and none in the stretching group. According to the BDI, there were two responders in the aerobic group who were also remitters and none in the stretching group. The results of this small study suggest that aerobic exercise significantly improves treatment outcome when added to antidepressant medication. However, due to the small sample size the results must be regarded as preliminary and further studies are needed to confirm the findings.

  4. Soft Tissue Response to Titanium Abutments with Different Surface Treatment: Preliminary Histologic Report of a Randomized Controlled Trial

    PubMed Central

    Canullo, Luigi; Dehner, Jan Friedrich; Penarrocha, David; Checchi, Vittorio; Mazzoni, Annalisa; Breschi, Lorenzo

    2016-01-01

    The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with presence of few polymorphonuclear neutrophil granulocytes, and a diffuse presence of collagenization bands. Similarly, in Steam Group, the histological analysis showed a high variability of inflammatory expression factors. Tissues harvested from Control Group showed presence of few neutrophil granulocytes, moderate presence of lymphocytes, and diffuse collagenization bands in some sections, while they showed absence of acute infiltrate in 40% of sections. However, no statistical difference was found among the tested groups for each parameter (p > 0.05). Within the limit of the present study, results showed no statistically significant difference concerning inflammation and healing tendency between test and control groups. PMID:27366741

  5. Potential role of bioavailable curcumin in weight loss and omental adipose tissue decrease: preliminary data of a randomized, controlled trial in overweight people with metabolic syndrome. Preliminary study.

    PubMed

    Di Pierro, F; Bressan, A; Ranaldi, D; Rapacioli, G; Giacomelli, L; Bertuccioli, A

    2015-11-01

    This randomized, controlled study aims to evaluate the tolerability and the efficacy of curcumin in overweight subjects affected from metabolic syndrome, with a focus on impaired glucose intolerance and android-type fat accumulation. Forty-four subjects, selected among those who after 30 days of diet and intervention lifestyle have shown a weight loss < 2%, have been treated for further 30 days either with curcumin complexed with phosphatidylserine in phytosome form or with pure phosphatidylserine. Outcomes concerning anthropometric measurements and body composition were analyzed at enrollment and after 30 and 60 days. Curcumin administration increased weight loss from 1.88 to 4.91%, enhanced percentage reduction of body fat (from 0.70 to 8.43%), increased waistline reduction (from 2.36 to 4.14%), improved hip circumference reduction from 0.74 to 2.51% and enhanced reduction of BMI (from 2.10 to 6.43%) (p < 0.01 for all comparisons). Phosphatidylserine did not show any statistical significant effect. Tolerability was very good for both treatments, and no drop-out was reported. Although preliminary, our findings suggest that a bioavailable form of curcumin is well-tolerated and can positively influence weight management in overweight people.

  6. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial.

    PubMed

    McElroy, Susan L; Martens, Brian E; Mori, Nicole; Blom, Thomas J; Casuto, Leah S; Hawkins, John M; Keck, Paul E

    2015-01-01

    This study evaluated the efficacy and tolerability of lisdexamfetamine (LDX) in the treatment of bipolar depression. Twenty-five outpatients with bipolar I or II disorder and syndromal depression despite at least 4 weeks of stable mood stabilizer and/or antipsychotic therapy were randomized to receive LDX (N=11) or placebo (N=14) in an 8-week, prospective, parallel-group, double-blind study. In the primary longitudinal analysis, LDX and placebo produced similar rates of improvement in depressive symptoms as assessed by the Montgomery-Asberg Depression Scale. However, LDX was associated with a statistically significantly greater rate of improvement in self-reported depressive symptoms and daytime sleepiness, and with greater reductions in fasting levels of low-density lipoprotein and total cholesterol. In the secondary baseline-to-endpoint analysis, LDX was associated with statistically significant improvements in self-reported measures of depression, daytime sleepiness, fatigue, and binge eating, as well as with improvements in fasting levels of triglycerides and low-density lipoprotein and total cholesterol. LDX was well tolerated and was not associated with any serious adverse events, but there was one case of suspected misuse. The small sample size (because of premature study termination by the funding sponsor) may have limited the detection of important drug-placebo differences. Larger studies on the use of psychostimulants for treatment of bipolar depression seem warranted.

  7. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

    PubMed Central

    Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

  8. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: a preliminary randomized controlled trial.

    PubMed

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-08-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6-8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions' similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. © The Author(s) 2013.

  9. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    PubMed

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. Benefits of yoga for psychosocial well-being in a US high school curriculum: a preliminary randomized controlled trial.

    PubMed

    Noggle, Jessica J; Steiner, Naomi J; Minami, Takuya; Khalsa, Sat Bir S

    2012-04-01

    To test feasibility of yoga within a high school curriculum and evaluate preventive efficacy for psychosocial well-being. Grade 11 or 12 students (N = 51) who registered for physical education (PE) were cluster-randomized by class 2:1 yoga:PE-as-usual. A Kripalu-based yoga program of physical postures, breathing exercises, relaxation, and meditation was taught 2 to 3 times a week for 10 weeks. Self-report questionnaires were administered to students 1 week before and after. Primary outcome measures of psychosocial well-being were Profile of Mood States-Short Form and Positive and Negative Affect Schedule for Children. Additional measures of psychosocial well-being included Perceived Stress Scale and Inventory of Positive Psychological Attitudes. Secondary measures of self-regulatory skills included Resilience Scale, State Trait Anger Expression Inventory-2™, and Child Acceptance Mindfulness Measure. To assess feasibility, yoga students completed a program evaluation. Analyses of covariance were conducted between groups with baseline as the covariate. Although PE-as-usual students showed decreases in primary outcomes, yoga students maintained or improved. Total mood disturbance improved in yoga students and worsened in controls (p = .015), as did Profile of Mood States-Short Form (POMS-SF) Tension-Anxiety subscale (p = .002). Although positive affect remained unchanged in both, negative affect significantly worsened in controls while improving in yoga students (p = .006). Secondary outcomes were not significant. Students rated yoga fairly high, despite moderate attendance. Implementation was feasible and students generally found it beneficial. Although not causal due to small, uneven sample size, this preliminary study suggests preventive benefits in psychosocial well-being from Kripalu yoga during high school PE. These results are consistent with previously published studies of yoga in school settings.

  11. Treatment for Insomnia in Combat-Exposed OEF/OIF/OND Military Veterans: Preliminary Randomized Controlled Trial

    PubMed Central

    Germain, Anne; Richardson, Robin; Stocker, Ryan; Mammen, Oommen; Hall, Martica; Bramoweth, Adam D.; Begley, Amy; Rode, Noelle; Frank, Ellen; Haas, Gretchen; Buysse, Daniel J.

    2014-01-01

    Objective Chronic insomnia is highly prevalent among military personnel returning from Iraq and Afghanistan. We evaluated the effects of a military version of a brief behavioral treatment of insomnia (BBTI-MV) compared to an information only control (IC) condition in combat-exposed Veterans of Operations Enduring/Iraqi Freedom or Operation New Dawn (OEF/OIF/OND) on insomnia, sleep quality, and daytime symptoms of anxiety and depression. Method Forty OEF/OIF/OND Veterans (Mean age = 38.4 years old, s.d. = 11.69; 85% men; 77.5% white) were randomized to one of two conditions. BBTI-MV consisted of two in-person sessions and two telephone contacts delivered over four weeks, and included personalized recommendations to reduce insomnia. The IC condition also consisted of 2 in-person sessions two telephone contacts delivered over four weeks, and Veterans were encouraged to read written information about sleep-promoting behaviors. The Insomnia Severity Index, Pittsburgh Sleep Quality Index, PTSD Checklist, and Beck Depression and Anxiety Inventories were completed at baseline, post-treatment, and at the six-month follow-up. Results Both interventions were associated with clinically significant improvements in insomnia, although the magnitude of improvements in sleep and rates of treatment response and remission were greater for BBTI-MV compared to IC from pre- to post-treatment. Conclusion Both BBTI-MV and the provision of information were associated with clinically significant improvements in insomnia among Veterans. Despite the preliminary nature of the findings and limitations inherent to small controlled trials, the findings suggest that both approaches may provide viable options in a stepped-care approach to the treatment of insomnia in retuning combat-exposed Veterans. Larger, confirmatory effectiveness trials are required. PMID:25194223

  12. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

    PubMed

    Manchikanti, Laxmaiah; Cash, Kimberly A; McManus, Carla D; Damron, Kim S; Pampati, Vidyasagar; Falco, Frank J E

    2012-01-01

    Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. A randomized, double-blind, active, control trial. A private, interventional pain management practice, specialty referral center in the United States. This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of  >/= 50% was considered significant. Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I's significant pain relief was 70%; Group II's was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain

  13. Development and Preliminary Randomized Controlled Trial of a Distress Tolerance Treatment for Smokers With a History of Early Lapse

    PubMed Central

    2013-01-01

    Introduction: An inability to tolerate distress is a significant predictor of early smoking lapse following a cessation attempt. We conducted a preliminary randomized controlled trial to compare a distress tolerance (DT) treatment that incorporated elements of exposure-based therapies and Acceptance and Commitment Therapy to standard smoking cessation treatment (ST). Methods: Smokers with a history of early lapse in prior quit attempts received either DT (N = 27; 9 2-hr group and 6 50-min individual sessions) or ST (N = 22; 6 90-min group and 1 20-min individual session), plus 8 weeks of transdermal nicotine patch. Results: At the end of behavioral treatment, odds of abstinence among participants receiving DT were 6.46 times greater than among participants receiving ST (66.7% vs. 31.8%), equivalent to a medium- to large-effect size. Odds of abstinence for DT were still 1.73 times greater at 8 weeks, corresponding to a small- to medium-effect size, although neither this difference nor those at 13 and 26 weeks were statistically significant. Furthermore, of those who lapsed to smoking during the first week postquit, DT participants had more than 4 times greater odds of abstinence than ST participants at the end of treatment. Relative to ST, DT participants also reported a larger decrease in experiential avoidance, a hypothesized DT treatment mediator, prior to quit day. The trajectory of negative mood and withdrawal symptoms in DT differed from ST and was largely consistent with hypotheses. Conclusions: Reasons for the decrease in abstinence in DT after treatment discontinuation and suggestions for future research are discussed. PMID:23884317

  14. Children's discomfort may vary among different treatments for initial approximal caries lesions: preliminary findings of a randomized controlled clinical trial.

    PubMed

    Mattos-Silveira, Juliana; Floriano, Isabela; Ferreira, Fernanda R; Viganó, Maria Eduarda F; Mendes, Fausto M; Braga, Mariana M

    2015-07-01

    Longer and more complex dental procedures could negatively affect patient's acceptability of minimal invasive techniques. Therefore, this short communication aims to show the preliminary findings regarding children's discomfort reported after some minimal invasive treatments in treating initial caries lesions on approximal surfaces: flossing instruction, silver diamine fluoride (SDF) application and caries resin infiltration. Children allocated in the infiltration group showed higher levels of discomfort than those in the SDF and control groups. These findings suggest that the simplest interventions for approximal initial caries lesions cause less discomfort for children and should be applied where possible. © 2014 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Clinical and Radiographic Evaluation of Immediate Loaded Dental Implants With Local Application of Melatonin: A Preliminary Randomized Controlled Clinical Trial.

    PubMed

    El-Gammal, Mona Y; Salem, Ahmed S; Anees, Mohamed M; Tawfik, Mohamed A

    2016-04-01

    Immediate loading of dental implants in situations where low bone density exist, such as the posterior maxillary region, became possible recently after the introduction of biomimetic agents. This 1-year preliminary clinical trial was carried out to clinically and radiographically evaluate immediate-loaded 1-piece implants with local application of melatonin in the osteotomy site as a biomimetic material. 14 patients with missing maxillary premolars were randomized to receive 14 implants of 1-piece type that were subjected to immediate loading after 2 weeks of initial placement. Group I included 7 implants with acid-etched surface while group II included 7 implants with acid-etched surface combined with local application of melatonin gel at the osteotomy site. Patients were recalled for follow up at 1, 3, 6, and 12 months after loading. All implants were considered successful after 12 months of follow-up. Significant difference (P < 0.05) was found between both groups at 1 month of implant loading when considering the implant stability. At 1 and 3 months there were significant differences in the marginal bone level between the 2 groups. These results suggest that the local application of melatonin at the osteotomy site is associated with good stability and minimal bone resorption. However, more studies for longer follow-up periods are required to confirm the effect of melatonin hormone on osseointegration of dental implants.

  16. Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

    PubMed

    Nam, I S

    2016-01-01

    Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

  17. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial.

    PubMed

    Boitor, Mădălina; Martorella, Géraldine; Arbour, Caroline; Michaud, Cécile; Gélinas, Céline

    2015-06-01

    Although many intensive care unit patients experience significant pain, very few studies explored massage to maximize their pain relief. This study aimed to evaluate the preliminary effects of hand massage on pain after cardiac surgery in the adult intensive care unit. A pilot randomized controlled trial was used for this study. The study was conducted in a Canadian medical-surgical intensive care unit. Forty adults who were admitted to the intensive care unit after undergoing elective cardiac surgery in the previous 24 hours participated in the study. They were randomly assigned to the experimental (n = 21) or control (n = 19) group. The experimental group received a 15-minute hand massage, and the control group received a 15-minute hand-holding without massage. In both groups the intervention was followed by a 30-minute rest period. The interventions were offered on 2-3 occasions within 24 hours after surgery. Pain, muscle tension, and vital signs were assessed. Pain intensity and behavioral scores were decreased for the experimental group. Although hand massage decreased muscle tension, fluctuations in vital signs were not significant. This study supports potential benefits of hand massage for intensive care unit postoperative pain management. Although larger randomized controlled trials are necessary, this low-cost nonpharmacologic intervention can be safely administered.

  18. Preliminary antiplaque efficacy of aloe vera mouthwash on 4 day plaque re-growth model: randomized control trial.

    PubMed

    Gupta, Rajendra Kumar; Gupta, Devanand; Bhaskar, Dara John; Yadav, Ankit; Obaid, Khursheed; Mishra, Sumit

    2014-04-01

    Due to increasing resistance to antibiotics and rising incidence of oral diseases, there is a need for alternative treatment modalities to combat oral diseases. The aim of the present study was to access the effect of Aloe vera mouthwash on the dental plaque in the experimental period of 4 days and to compare it with the bench mark control chlorhexidine and placebo (saline water). A total of 300 systemically healthy subjects were randomly allocated into 3 groups: Aloe vera mouthwash group (n=100), control group (=100)-chlorhexidene group and saline water-Placebo (n=100). To begin with, Gingival index (GI) and plaque index (PI) were recorded. Then, baseline plaque scores were brought to zero by professionally cleaning the teeth with scaling and polishing. After randomization of the participants into three groups they were refrained from regular mechanical oral hygiene measures. Subjects were asked to swish with respective mouthwash (Aloe vera mouthwash, 0.2%chlorhexidine gluconate mouthwash, or normal saline) as per therapeutic dose for 4 days. The results showed that Aloe vera mouthrinse is equally effective in reducing plaque as Chlorhexidine compared to placebo over a period of 4 days. There was a significant reduction on plaque in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them (p>0.05). Aloe vera mouthwash showed no side effects. The results of the present study indicated that Aloe vera may prove an effective mouthwash due to its ability in reducing dental plaque.

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

    PubMed Central

    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. PMID:26844177

  20. Adding a Motivational Interviewing Pretreatment to Cognitive Behavioral Therapy for Generalized Anxiety Disorder: A Preliminary Randomized Controlled Trial

    PubMed Central

    Westra, Henny A.; Arkowitz, Hal; Dozois, David J.A.

    2009-01-01

    Seventy six individuals with a principal diagnosis of generalized anxiety disorder (GAD) were randomly assigned to receive either an MI pretreatment or no pretreatment (NPT), prior to receiving CBT. Significant group differences favoring the MI-CBT group were observed on the hallmark GAD symptom of worry and on therapist-rated homework compliance, which mediated the impact of treatment group on worry reduction. Adding MI pretreatment to CBT was specifically and substantively beneficial for individuals with high worry severity at baseline. There was evidence of relapse at 6-month follow-up for high severity individuals who received MI-CBT, but significant moderator effects favoring the high severity MI-CBT group were again apparent at 12-months post-treatment. Pending replication in a more controlled test, these findings suggest that MI may be a promising adjunct to CBT for GAD for those of high severity, a group which has been less responsive to CBT in past research. PMID:19665347

  1. Effect of life-style modification on postmenopausal overweight and obese Indian women: A randomized controlled 24 weeks preliminary study

    PubMed Central

    Tandon, Vishal R.; Sharma, Sudhaa; Mahajan, Annil; Mahajan, Shagun

    2014-01-01

    Aim: The aim of the following study is to evaluate the effect of life-style modification on postmenopausal (PM) overweight and obese Indian women in a randomized controlled 24 week study. Materials and Methods: Two groups were formed Group I (n = 30) was designated as intervention (dietary and exercise group) and Group II (n = 24) served as control. Comparison of weight, waist circumference (WC) and body mass index (BMI) were made and compared among two groups at 4, 8, 16 and 24 weeks. Results: Mean age at menopause was 48.35 years versus 49.65 years; mean number of menopausal symptoms were 5.70 ± 1.76 versus 5.10 ± 1.56 and mean duration since menopause was 2.70 versus 2.90 years in Groups I and II respectively. When the effect of Group I and control on weight was compared at 4, 8, 16 and 24 weeks, there was no significant difference between them up to 8 week. At 8 weeks Group I caused a significant decrease in weight (P ≤ 0.05) when compared with control arm and which continued throughout the study period (P < 0.05) at both 16 and 24 weeks. Group I produced a significant reduction in WC from 8 weeks onwards up to 24 weeks (P ≤ 0.05). BMI was statistically significant in Group I and the effect started at 4th week (P ≤ 0.05) and the differences in BMI reduction were highly significant at 16th and 24th weeks (P ≤ 0.001). Conclusion: The results of the present study strongly recommend the life-style management to be incorporated in daily style of postmenopausal women under controlled supervision. PMID:24672202

  2. Effect of life-style modification on postmenopausal overweight and obese Indian women: A randomized controlled 24 weeks preliminary study.

    PubMed

    Tandon, Vishal R; Sharma, Sudhaa; Mahajan, Annil; Mahajan, Shagun

    2014-01-01

    The aim of the following study is to evaluate the effect of life-style modification on postmenopausal (PM) overweight and obese Indian women in a randomized controlled 24 week study. Two groups were formed Group I (n = 30) was designated as intervention (dietary and exercise group) and Group II (n = 24) served as control. Comparison of weight, waist circumference (WC) and body mass index (BMI) were made and compared among two groups at 4, 8, 16 and 24 weeks. Mean age at menopause was 48.35 years versus 49.65 years; mean number of menopausal symptoms were 5.70 ± 1.76 versus 5.10 ± 1.56 and mean duration since menopause was 2.70 versus 2.90 years in Groups I and II respectively. When the effect of Group I and control on weight was compared at 4, 8, 16 and 24 weeks, there was no significant difference between them up to 8 week. At 8 weeks Group I caused a significant decrease in weight (P ≤ 0.05) when compared with control arm and which continued throughout the study period (P < 0.05) at both 16 and 24 weeks. Group I produced a significant reduction in WC from 8 weeks onwards up to 24 weeks (P ≤ 0.05). BMI was statistically significant in Group I and the effect started at 4(th) week (P ≤ 0.05) and the differences in BMI reduction were highly significant at 16(th) and 24(th) weeks (P ≤ 0.001). The results of the present study strongly recommend the life-style management to be incorporated in daily style of postmenopausal women under controlled supervision.

  3. Lovastatin for the adjunctive treatment of schizophrenia: a preliminary randomized double-blind placebo-controlled trial.

    PubMed

    Ghanizadeh, Ahmad; Rezaee, Zahra; Dehbozorgi, Sara; Berk, Michael; Akhondzadeh, Shahin

    2014-11-30

    While statins target many of the pathways to neuroprogression in schizophrenia, the safety and efficacy of statins for treating schizophrenia has never been examined. This is an 8-week randomized double blind controlled clinical trial examining the efficacy and safety of adjunctive lovastatin (20 mg/day) treatment or placebo for people with schizophrenia. The baseline characteristics of the two groups were not different. Endpoint changes in Positive and Negative Syndrome Scale (PANSS) total and subscale scores did not differ between the two groups. However there was a significant difference between the doses of risperidone used in the two groups. The mean dose in the lovastatin and placebo groups were 4.8(1.8) and 3.4(1.4) mg/day, respectively (P<.03). No serious adverse events were reported. Slowness of movements, muscle rigidity, increased appetite, and decreased energy were the most common adverse effects, and these rates did not differ between the two groups. This study failed to demonstrate a benefit of lovastatin on symptoms of schizophrenia. This combination was well tolerated. However, a higher dosage of risperidone was used for treating the disorder in those taking concomitant lovastatin compared to placebo. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  4. Acupuncture Improves Intestinal Absorption of Iron in Iron-deficient Obese Patients: A Randomized Controlled Preliminary Trial

    PubMed Central

    Xie, Xin-Cai; Cao, Yan-Qiang; Gao, Qian; Wang, Chen; Li, Man; Wei, Shou-Gang

    2017-01-01

    Background: Obesity has an adverse effect on iron status. Hepcidin-mediated inhibition of iron absorption in the duodenum is a potential mechanism. Iron-deficient obese patients have diminished response to oral iron therapy. This study was designed to assess whether acupuncture could promote the efficacy of oral iron supplementation for the treatment of obesity-related iron deficiency (ID). Methods: Sixty ID or ID anemia (IDA) patients with obesity were screened at Beijing Hospital of Traditional Chinese Medicine and were randomly allocated to receive either oral iron replacement allied with acupuncture weight loss treatment (acupuncture group, n = 30) or oral iron combined with sham-acupuncture treatment (control group, n = 30). Anthropometric parameters were measured and blood samples were tested pre- and post-treatment. Differences in the treatment outcomes of ID/IDA were compared between the two groups. Results: After 8 weeks of acupuncture treatment, there was a significant decrease in body weight, body mass index, waist circumference, and waist/hip circumference ratio of patients in the acupuncture group, while no significant changes were observed in the control group. Oral iron supplementation brought more obvious improvements of iron status indicators including absolute increases in serum iron (11.08 ± 2.19 μmol/L vs. 4.43 ± 0.47 μmol/L), transferrin saturation (11.26 ± 1.65% vs. 1.01 ± 0.23%), and hemoglobin (31.47 ± 1.19 g/L vs. 21.00 ± 2.69 g/L) in the acupuncture group than control group (all P < 0.05). Meanwhile, serum leptin (2.26 ± 0.45 ng/ml vs. 8.13 ± 0.55 ng/ml, P < 0.05) and hepcidin (3.52 ± 1.23 ng/ml vs. 6.77 ± 0.84 ng/ml, P < 0.05) concentrations declined significantly in the acupuncture group than those in the control group. Conclusion: Acupuncture-based weight loss can enhance the therapeutic effects of iron replacement therapy for obesity-related ID/IDA through improving intestinal iron absorption, probably by downregulating the

  5. The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

    PubMed

    Zorba, Pinar; Ozdemir, Leyla

    2017-04-20

    Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P < .001). Furthermore, in these 2 cycles, the incidence of nausea and retching was significantly lower in the massage group than in the inhalation group (P < .001). Nausea severity was significantly lower among patients in the massage and inhalation groups than in the control group in all 3 cycles (P < .001). Nausea severity was significantly lower in the massage and inhalation aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

  6. A Preliminary Randomized Double Blind Placebo-Controlled Trial of Intravenous Immunoglobulin for Japanese Encephalitis in Nepal

    PubMed Central

    Rayamajhi, Ajit; Nightingale, Sam; Bhatta, Nisha Keshary; Singh, Rupa; Ledger, Elizabeth; Bista, Krishna Prasad; Lewthwaite, Penny; Mahaseth, Chandeshwar; Turtle, Lance; Robinson, Jaimie Sue; Galbraith, Sareen Elizabeth; Wnek, Malgorzata; Johnson, Barbara Wilmot; Faragher, Brian

    2015-01-01

    Background Japanese encephalitis (JE) virus (JEV) is a mosquito-borne flavivirus found across Asia that is closely related to West Nile virus. There is no known antiviral treatment for any flavivirus. Results from in vitro studies and animal models suggest intravenous immunoglobulin (IVIG) containing virus-specific neutralizing antibody may be effective in improving outcome in viral encephalitis. IVIG’s anti-inflammatory properties may also be beneficial. Methodology/Principal Findings We performed a pilot feasibility randomized double-blind placebo-controlled trial of IVIG containing anti-JEV neutralizing antibody (ImmunoRel, 400mg/kg/day for 5 days) in children with suspected JE at two sites in Nepal; we also examined the effect on serum neutralizing antibody titre and cytokine profiles. 22 children were recruited, 13 of whom had confirmed JE; 11 received IVIG and 11 placebo, with no protocol violations. One child (IVIG group) died during treatment and two (placebo) subsequently following hospital discharge. Overall, there was no difference in outcome between treatment groups at discharge or follow up. Passive transfer of anti-JEV antibody was seen in JEV negative children. JEV positive children treated with IVIG had JEV-specific neutralizing antibody titres approximately 16 times higher than those treated with placebo (p=0.2), which was more than could be explained by passive transfer alone. IL-4 and IL-6 were higher in the IVIG group. Conclusions/Significance A trial of IVIG for JE in Nepal is feasible. IVIG may augment the development of neutralizing antibodies in JEV positive patients. IVIG appears an appealing option for JE treatment that warrants further study. Trial Registration ClinicalTrials.gov NCT01856205 PMID:25886645

  7. Slow cortical potential neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial

    PubMed Central

    Christiansen, Hanna; Reh, Verena; Schmidt, Martin H.; Rief, Winfried

    2014-01-01

    Background: Treatment for children with attention deficit/hyperactivity disorder (ADHD) today is predominantly pharmacological. While it is the most common treatment, it might not always be the most appropriate one. Moreover, long term effects remain unclear. Behavior therapy (BT) and non-pharmacological treatments such as neurofeedback (NF) are promising alternatives, though there are no routine outpatient care/effectiveness studies yet that have included children with medication or changes in medication. Methods/design: This paper presents the protocol of a randomized controlled trial to compare the effectiveness of a Slow Cortical Potential (SCP) NF protocol with self-management (SM) in a high frequent outpatient care setting. Both groups (NF/SM) receive a total of 30 high frequent therapy sessions. Additionally, 6 sessions are reserved for comorbid problems. The primary outcome measure is the reduction of ADHD core symptoms according to parent and teacher ratings. Preliminary Results: Untill now 58 children were included in the study (48 males), with a mean age of 8.42 (1.34) years, and a mean IQ of 110 (13.37). Conners-3 parent and teacher ratings were used to estimate core symptom change. Since the study is still ongoing, and children are in different study stages, pre-post and follow-up results are not yet available for all children included. Preliminary results suggest overall good pre-post effects, though. For parent and teacher ratings an ANOVA with repeated measures yielded overall satisfying pre-post effects (η2 0.175–0.513). Differences between groups (NF vs. SM) could not yet be established (p = 0.81). Discussion: This is the first randomized controlled trial to test the effectiveness of a NF protocol in a high frequent outpatient care setting that does not exclude children on or with changes in medication. First preliminary results show positive effects. The rationale for the trial, the design, and the strengths and limitations of the study are

  8. Depressed Adolescents Treated with Exercise (DATE): A pilot randomized controlled trial to test feasibility and establish preliminary effect sizes

    PubMed Central

    Hughes, Carroll W.; Barnes, Shauna; Barnes, Conrad; DeFina, Laura F.; Nakonezny, Paul; Emslie, Graham J.

    2013-01-01

    The Depressed Adolescents Treated with Exercise (DATE) study evaluated a standardized aerobic exercise protocol to treat nonmedicated adolescents that met DSM-IV-TR criteria for major depressive disorder. From an initial screen of 90 individuals, 30 adolescents aged 12-18 years were randomized to either vigorous exercise (EXER) (>12 kg/kcal/week [KKW]) or a control stretching (STRETCH) activity (< 4 KKW) for 12 weeks. The primary outcome measure was the blinded clinician rating of the Children's Depression Rating Scale – Revised (CDRS-R) to assess depression severity and Actical (KKW) accelerometry 24hr/7days a week to assess energy expenditure and adherence. Follow-up evaluations occurred at weeks 26 and 52. The EXER group averaged 77% adherence and the STRETCH group 81% for meeting weekly target goals for the 12 week intervention based on weekly sessions completed and meeting KKW requirements. There was a significant increase in overall weekly KKW expenditures (p < .001) for both groups with the EXER group doubling the STRETCH group in weekly energy expenditure. Depressive symptoms were significantly reduced from baseline for both groups with the EXER group improving more rapidly than STRETCH after six weeks (p < .016) and nine weeks (p < .001). Both groups continued to improve such that there were no group differences after 12 weeks (p = .07). By week 12, the exercise group had a 100% response rate (86% remission), whereas the stretch group response rate was 67% (50% remission) (p = .02). Both groups had improvements in multiple areas of psychosocial functioning related to school and relationships with parents and peers. Anthropometry reflected decreased waist, hip and thigh measurements (p = .02), more so for females than males (p = .05), but there were no weight changes for either gender. The EXER group sustained 100% remission at week 26 and 52. The STRETCH group had 80% response and 70% remission rates at week 26 and by week 52 only one had not fully

  9. Oats in the diet of children with celiac disease: preliminary results of a double-blind, randomized, placebo-controlled multicenter Italian study.

    PubMed

    Gatti, Simona; Caporelli, Nicole; Galeazzi, Tiziana; Francavilla, Ruggiero; Barbato, Maria; Roggero, Paola; Malamisura, Basilio; Iacono, Giuseppe; Budelli, Andrea; Gesuita, Rosaria; Catassi, Carlo; Lionetti, Elena

    2013-11-20

    A gluten-free diet (GFD) is currently the only available treatment for patients with celiac disease (CD). Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet "A", 3 months of standard GFD, 6 months of diet "B"), or B-A treatment (6 months of diet "B", 3 months of standard GFD, 6 months of diet "A"). A and B diets included gluten-free (GF) products (flour, pasta, biscuits, cakes and crisp toasts) with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score) and intestinal permeability tests (IPT), were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M) ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

  10. Preliminary safety evaluation and biochemical efficacy of a Carum carvi extract: results from a randomized, triple-blind, and placebo-controlled clinical trial.

    PubMed

    Kazemipoor, Mahnaz; Radzi, Che Wan Jasimah Bt Wan Mohamed; Hajifaraji, Majid; Cordell, Geoffrey A

    2014-10-01

    Carum carvi L. (Apiaceae) is known as caraway, and its derivatives find wide medicinal use for health purposes, including for gastrointestinal problems and obesity. Since there is inconsistency among the reports on the safety of this plant in humans, this research was aimed at assessing the safety of a characterized caraway aqueous extract (CAE) in a randomized, triple-blind, placebo-controlled study. Seventy, overweight and obese, healthy women were randomly assigned into placebo (n = 35) and plant extract (n = 35) groups. Participants received either 30 ml/day of CAE or placebo. Subjects were examined at baseline and after 12 weeks for changes in heart rate, blood pressure, urine test, 25-item blood chemistries, and general health status. No significant changes of blood pressure, heart rate, urine specific gravity, and serum blood tests were observed between the two groups before and after treatment. However, in the complete blood count test, red blood cell levels were significantly (p < 0.01) increased, and platelet distribution width was significantly decreased after the dietary CAE treatment, as compared with placebo. No negative changes were observed in the general health status of the two groups. This preliminary study suggests that the oral intake of CAE appears to be without any adverse effects at a dosage of 30 ml daily for a period of 12 weeks.

  11. Oats in the Diet of Children with Celiac Disease: Preliminary Results of a Double-Blind, Randomized, Placebo-Controlled Multicenter Italian Study

    PubMed Central

    Gatti, Simona; Caporelli, Nicole; Galeazzi, Tiziana; Francavilla, Ruggiero; Barbato, Maria; Roggero, Paola; Malamisura, Basilio; Iacono, Giuseppe; Budelli, Andrea; Gesuita, Rosaria; Catassi, Carlo; Lionetti, Elena

    2013-01-01

    A gluten-free diet (GFD) is currently the only available treatment for patients with celiac disease (CD). Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet “A”, 3 months of standard GFD, 6 months of diet “B”), or B-A treatment (6 months of diet “B”, 3 months of standard GFD, 6 months of diet “A”). A and B diets included gluten-free (GF) products (flour, pasta, biscuits, cakes and crisp toasts) with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score) and intestinal permeability tests (IPT), were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M) ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms. PMID:24264227

  12. A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Lerner, Matthew D.; Mikami, Amori Y.

    2012-01-01

    This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

  13. Impact of Cognitive Behavioral Therapy on Observed Autism Symptom Severity during School Recess: A Preliminary Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Wood, Jeffrey J.; Fujii, Cori; Renno, Patricia; Van Dyke, Marilyn

    2014-01-01

    This study compared cognitive behavioral therapy (CBT) and treatment-as-usual (TAU) in terms of effects on observed social communication-related autism symptom severity during unstructured play time at school for children with autism spectrum disorders (ASD). Thirteen children with ASD (7-11 years old) were randomly assigned to 32 sessions of CBT…

  14. A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Lerner, Matthew D.; Mikami, Amori Y.

    2012-01-01

    This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

  15. Impact of Cognitive Behavioral Therapy on Observed Autism Symptom Severity during School Recess: A Preliminary Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Wood, Jeffrey J.; Fujii, Cori; Renno, Patricia; Van Dyke, Marilyn

    2014-01-01

    This study compared cognitive behavioral therapy (CBT) and treatment-as-usual (TAU) in terms of effects on observed social communication-related autism symptom severity during unstructured play time at school for children with autism spectrum disorders (ASD). Thirteen children with ASD (7-11 years old) were randomly assigned to 32 sessions of CBT…

  16. Randomized controlled clinical pilot trial of titanium vs. glass fiber prefabricated posts: preliminary results after up to 3 years.

    PubMed

    Naumann, Michael; Sterzenbac, Guido; Alexandra, Franke; Dietrich, Thomas

    2007-01-01

    This randomized parallel-group clinical pilot study aimed to compare the clinical outcome of prefabricated rigid titanium to glass fiber endodontic posts when luted with self-adhesive universal resin cement. Ninety-eight patients in need of postendodontic restoration were assessed for eligibility. Ninety-one patients met the selection criteria and were randomized and allocated to 2 intervention groups. Forty-five participants were treated using a titanium post and 46 participants received a glass fiber post, each in combination with composite core buildups for postendodontic restoration. All posts had a diameter of 1.4 mm and a length of 13 mm and were cemented 8 mm within the root canal with self-adhesive universal resin cement. A circumferential ferrule of 2 mm was always provided. Surgical crown lengthening was necessary in 13 cases. Patients were observed in intervals of 3, 6, 12, 24, and 36 months after post placement. After 24 to 36 months (mean +/- SD: 27.9 +/- 5.6) of observation following post placement, 1 tooth was extracted because of changes of the prosthetic treatment plan. No failures were observed among the 88 patients with follow-up data. Both titanium and glass fiber reinforced composite posts result in successful treatment outcomes after 2 years. The material combination used seems to be appropriate in the short term for cementing endodontic posts, irrespective of the post material.

  17. Preliminary evaluation of a self-directed video-based 1-2-3 Magic parenting program: a randomized controlled trial.

    PubMed

    Porzig-Drummond, Renata; Stevenson, Richard J; Stevenson, Caroline

    2015-03-01

    The current study examined the effectiveness of a self-directed video-based format of the 1-2-3 Magic parenting program in reducing dysfunctional parenting and child problem behaviors. Eighty-four parents of children aged 2-10 were randomly assigned to either the intervention group (n = 43) or the waitlist control group (n = 41). Participants in the intervention group reported significantly less problem behaviors for their children, and significantly less dysfunctional parenting, at post-intervention when compared to the control group. The results were maintained at 6-month follow-up. There was no significant change on measures of parental adjustment for either group. The current results provide preliminary support for the conclusion that the video-based self-directed format of the 1-2-3 Magic parenting program is suitable as an entry-level intervention in a multi-level intervention model and is suitable for inclusion in a population approach to parenting program delivery.

  18. A randomized controlled trial of the feasibility and preliminary efficacy of a texting intervention on medication adherence in adults prescribed oral anti-cancer agents: study protocol

    PubMed Central

    SPOELSTRA, Sandra L.; GIVEN, Charles W.; SIKORSKII, Alla; COURSARIS, Constantinos K.; MAJUMDER, Atreyee; DEKOEKKOEK, Tracy; SCHUELLER, Monica; GIVEN, Barbara A.

    2015-01-01

    Aim To report a study protocol that examines feasibility, preliminary efficacy and satisfaction of a text message intervention on the outcome of medication adherence in adult patients prescribed oral anti-cancer agents. Background Administration of oral anti-cancer agents occurs in the home setting, requiring patients to self-manage the regimen as prescribed. However, many barriers to medication adherence exist: regimens are often complex, with cycling of two or more medications; side effects of treatment; most cancer patients are older with comorbid conditions and competing demands; and cognitive decline and forgetfulness may occur. Research indicates patients miss nearly one-third of the prescribed oral anti-cancer agent dosages. Text message interventions have been shown to improve medication adherence in chronic conditions other than cancer. However, a majority of those patients were less than 50 years of age and most cancer patients are diagnosed later in life. Design A two-group randomized controlled trial with repeated measures. Methods Seventy-five adult patients newly prescribed an oral anti-cancer agent will be recruited (project funded in April 2013) from community cancer centers and a specialty pharmacy. Participants will be randomized to either a control group (n=25; usual care) or an intervention group (n=50; usual care plus text messages timed to medication regimen). Outcome measures include: medication adherence, feasibility and satisfaction with the intervention. Data will be collected over 8-weeks: baseline, weekly and exit. Discussion Standardized text message intervention protocol and detailed study procedures have been developed in this study to improve medication adherence. Trial is registered at ClinicalTrials.gov (Identifier NCT01889511). PMID:26100719

  19. A randomized controlled trial of the feasibility and preliminary efficacy of a texting intervention on medication adherence in adults prescribed oral anti-cancer agents: study protocol.

    PubMed

    Spoelstra, Sandra L; Given, Charles W; Sikorskii, Alla; Coursaris, Constantinos K; Majumder, Atreyee; DeKoekkoek, Tracy; Schueller, Monica; Given, Barbara A

    2015-12-01

    The aim of this study was to report a study protocol that examines feasibility, preliminary efficacy and satisfaction of a text message intervention on the outcome of medication adherence in adult patients prescribed oral anti-cancer agents. Administration of oral anti-cancer agents occurs in the home setting, requiring patients to self-manage the regimen as prescribed. However, many barriers to medication adherence exist: regimens are often complex, with cycling of two or more medications; side effects of treatment; most cancer patients are older with comorbid conditions and competing demands; and cognitive decline and forgetfulness may occur. Research indicates patients miss nearly one-third of the prescribed oral anti-cancer agent dosages. Text message interventions have been shown to improve medication adherence in chronic conditions other than cancer. However, a majority of those patients were less than 50 years of age and most cancer patients are diagnosed later in life. A two-group randomized controlled trial with repeated measures. Seventy-five adult patients newly prescribed an oral anti-cancer agent will be recruited (project funded in April 2013) from community cancer centres and a specialty pharmacy. Participants will be randomized to either a control group (n = 25; usual care) or an intervention group (n = 50; usual care plus text messages timed to medication regimen). Outcome measures include: medication adherence, feasibility and satisfaction with the intervention. Data will be collected over 8 weeks: baseline, weekly and exit. Standardized text message intervention protocol and detailed study procedures have been developed in this study to improve medication adherence. © 2015 John Wiley & Sons Ltd.

  20. Psychosocial treatment for methamphetamine use disorders: a preliminary randomized controlled trial of cognitive behavior therapy and Acceptance and Commitment Therapy.

    PubMed

    Smout, Matthew F; Longo, Marie; Harrison, Sonia; Minniti, Rinaldo; Wickes, Wendy; White, Jason M

    2010-04-01

    Acceptance and Commitment Therapy (ACT) incorporates developments in behavior therapy, holds promise but has not been evaluated for methamphetamine use disorders. The objective of this study was to test whether ACT would increase treatment attendance and reduce methamphetamine use and related harms compared to cognitive behavior therapy (CBT). One hundred and four treatment-seeking adults with methamphetamine abuse or dependence were randomly assigned to receive 12 weekly 60-minute individual sessions of ACT or CBT. Attrition was 70% at 12 weeks and 86% at 24 weeks postentry. Per intention-to-treat analysis, there were no significant differences between the treatment groups in treatment attendance (median 3 sessions), and methamphetamine-related outcomes; however, methamphetamine use (toxicology-assessed and self-reported), negative consequences, and dependence severity significantly improved over time in both groups. Although ACT did not improve treatment outcomes or attendance compared to CBT, it may be a viable alternative to CBT for methamphetamine use disorders. Future rigorous research in this area seems warranted.

  1. The Effects of a Gentle Yoga Program on Sleep, Mood, and Blood Pressure in Older Women with Restless Legs Syndrome (RLS): A Preliminary Randomized Controlled Trial.

    PubMed

    Innes, Kim E; Selfe, Terry Kit

    2012-01-01

    Objective. To examine the effects of yoga versus an educational film program on sleep, mood, perceived stress, and sympathetic activation in older women with RLS. Methods. Participants were drawn from a larger trial regarding the effects of yoga on cardiovascular disease risk profiles in overweight, sedentary postmenopausal women. Seventy-five women were randomized to receive either an 8-week yoga (n = 38) or educational film (n = 37) program. All 75 participants completed an RLS screening questionnaire. The 20 women who met all four diagnostic criteria for RLS (n = 10 yoga, 10 film group) comprised the population for this nested study. Main outcomes assessed pre- and post-treatment included: sleep (Pittsburgh Sleep Quality Index), stress (Perceived Stress Scale), mood (Profile of Mood States, State-Trait Anxiety Inventory), blood pressure, and heart rate. Results. The yoga group demonstrated significantly greater improvements than controls in multiple domains of sleep quality and mood, and significantly greater reductions in insomnia prevalence, anxiety, perceived stress, and blood pressure (all P's≤0.05). Adjusted intergroup effect sizes for psychosocial variables were large, ranging from 1.9 for state anxiety to 2.6 for sleep quality. Conclusions. These preliminary findings suggest yoga may offer an effective intervention for improving sleep, mood, perceived stress, and blood pressure in older women with RLS.

  2. Tissue Damage Markers after a Spinal Manipulation in Healthy Subjects: A Preliminary Report of a Randomized Controlled Trial

    PubMed Central

    Achalandabaso, A.; Plaza-Manzano, G.; Lomas-Vega, R.; Martínez-Amat, A.; Camacho, M. V.; Gassó, M.; Hita-Contreras, F.; Molina, F.

    2014-01-01

    Spinal manipulation (SM) is a manual therapy technique frequently applied to treat musculoskeletal disorders because of its analgesic effects. It is defined by a manual procedure involving a directed impulse to move a joint past its physiologic range of movement (ROM). In this sense, to exceed the physiologic ROM of a joint could trigger tissue damage, which might represent an adverse effect associated with spinal manipulation. The present work tries to explore the presence of tissue damage associated with SM through the damage markers analysis. Thirty healthy subjects recruited at the University of Jaén were submitted to a placebo SM (control group; n = 10), a single lower cervical manipulation (cervical group; n = 10), and a thoracic manipulation (n = 10). Before the intervention, blood samples were extracted and centrifuged to obtain plasma and serum. The procedure was repeated right after the intervention and two hours after the intervention. Tissue damage markers creatine phosphokinase (CPK), lactate dehydrogenase (LDH), C-reactive protein (CRP), troponin-I, myoglobin, neuron-specific enolase (NSE), and aldolase were determined in samples. Statistical analysis was performed through a 3 × 3 mixed-model ANOVA. Neither cervical manipulation nor thoracic manipulation did produce significant changes in the CPK, LDH, CRP, troponin-I, myoglobin, NSE, or aldolase blood levels. Our data suggest that the mechanical strain produced by SM seems to be innocuous to the joints and surrounding tissues in healthy subjects. PMID:25609853

  3. Tissue damage markers after a spinal manipulation in healthy subjects: a preliminary report of a randomized controlled trial.

    PubMed

    Achalandabaso, A; Plaza-Manzano, G; Lomas-Vega, R; Martínez-Amat, A; Camacho, M V; Gassó, M; Hita-Contreras, F; Molina, F

    2014-01-01

    Spinal manipulation (SM) is a manual therapy technique frequently applied to treat musculoskeletal disorders because of its analgesic effects. It is defined by a manual procedure involving a directed impulse to move a joint past its physiologic range of movement (ROM). In this sense, to exceed the physiologic ROM of a joint could trigger tissue damage, which might represent an adverse effect associated with spinal manipulation. The present work tries to explore the presence of tissue damage associated with SM through the damage markers analysis. Thirty healthy subjects recruited at the University of Jaén were submitted to a placebo SM (control group; n = 10), a single lower cervical manipulation (cervical group; n = 10), and a thoracic manipulation (n = 10). Before the intervention, blood samples were extracted and centrifuged to obtain plasma and serum. The procedure was repeated right after the intervention and two hours after the intervention. Tissue damage markers creatine phosphokinase (CPK), lactate dehydrogenase (LDH), C-reactive protein (CRP), troponin-I, myoglobin, neuron-specific enolase (NSE), and aldolase were determined in samples. Statistical analysis was performed through a 3 × 3 mixed-model ANOVA. Neither cervical manipulation nor thoracic manipulation did produce significant changes in the CPK, LDH, CRP, troponin-I, myoglobin, NSE, or aldolase blood levels. Our data suggest that the mechanical strain produced by SM seems to be innocuous to the joints and surrounding tissues in healthy subjects.

  4. A Novel Behavioral Intervention in Adolescents with Type 1 Diabetes Mellitus Improves Glycemic Control: Preliminary Results from a Pilot Randomized Control Trial

    PubMed Central

    Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

    2015-01-01

    Purpose The purpose of this study is to develop and pilot an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Methods Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks including blood glucose testing and parent-adolescent communication. Results After 3 months the participants in the intervention group exhibited a statistically significant decrease in A1C levels (−0.5%) compared to their peers in the control group who had an increase in A1C levels (0.8%)(p = 0.04). The younger adolescents (ages 10–13) demonstrated a greater response to the intervention which was statistically significant (−1.5% vs. 0.6%, p = 0.04) compared with the older adolescents (ages 14–17). Conclusions Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. PMID:25614529

  5. Hypotensive resuscitation strategy reduces transfusion requirements and severe postoperative coagulopathy in trauma patients with hemorrhagic shock: preliminary results of a randomized controlled trial.

    PubMed

    Morrison, C Anne; Carrick, Matthew M; Norman, Michael A; Scott, Bradford G; Welsh, Francis J; Tsai, Peter; Liscum, Kathleen R; Wall, Matthew J; Mattox, Kenneth L

    2011-03-01

    Trauma is a leading cause of death worldwide and is thus a major public health concern. Previous studies have shown that limiting the amount of fluids given by following a strategy of permissive hypotension during the initial resuscitation period may improve trauma outcomes. This study examines the clinical outcomes from the first 90 patients enrolled in a prospective, randomized controlled trial of hypotensive resuscitation, with the primary aim of assessing the effects of a limited transfusion and intravenous (IV) fluid strategy on 30-day morbidity and mortality. Patients in hemorrhagic shock who required emergent surgery were randomized to one of the two arms of the study for intraoperative resuscitation. Those in the experimental (low mean arterial pressure [LMAP]) arm were managed with a hypotensive resuscitation strategy in which the target mean arterial pressure (MAP) was 50 mm Hg. Those in the control (high MAP [HMAP]) arm were managed with standard fluid resuscitation to a target MAP of 65 mm Hg. Patients were followed up for 30 days. Intraoperative fluid requirements, mortality, postoperative complications, and other clinical data were prospectively gathered and analyzed. Patients in the LMAP group received a significantly less blood products and total i.v. fluids during intraoperative resuscitation than those in the HMAP group. They had significantly lower mortality in the early postoperative period and a nonsignificant trend for lower mortality at 30 days. Patients in the LMAP group were significantly less likely to develop immediate postoperative coagulopathy and less likely to die from postoperatively bleeding associated with coagulopathy. Among those who developed coagulopathy in both groups, patients in the LMAP group had significantly lower international normalized ratio than those in the HMAP group, indicating a less severe coagulopathy. Hypotensive resuscitation is a safe strategy for use in the trauma population and results in a significant

  6. Randomized Controlled Trial of the Acceptability, Feasibility, and Preliminary Effects of a Cognitive Behavioral Skills Building Intervention in Adolescents with Chronic Daily Headaches: A Pilot Study

    PubMed Central

    Hickman, Carolyn; Jacobson, Diana; Melnyk, Bernadette

    2014-01-01

    Introduction The treatment challenge of adolescents with chronic daily headaches (CDHs) creates an urgent need for evidence-based interventions. Therefore, the purpose of this pilot study was to evaluate the acceptability, feasibility, and preliminary effects of a brief cognitive behavioral skills building intervention (CBSB) with thirty-six, 13-17 year-old, adolescents with CDHs and mild to moderate depressive symptoms. Methods Participants were randomly assigned either to the Creating Opportunities for Personal Empowerment Headache Education Program (COPE-HEP) or to a headache education comparison group. Results Adolescents and parents found the COPE-HEP to be highly acceptable. Medium to large positive effects were demonstrated on the adolescents’ depression in both groups and on anxiety and beliefs in the COPE-HEP group. COPE-HEP offered additional benefits of a larger decrease in adolescent anxiety over time and stronger beliefs in the teens’ ability to manage their headaches. Discussion Adolescents with CDHs and elevated depressive and anxiety symptoms should be offered headache hygiene education plus cognitive-behavioral skills building interventions. A full-scale trial to determine the more long-term benefits of COPE-HEP is now warranted. PMID:25017938

  7. Effectiveness of Healthy Relationships Video-Group—A Videoconferencing Group Intervention for Women Living with HIV: Preliminary Findings from a Randomized Controlled Trial

    PubMed Central

    Buhi, Eric R.; Baldwin, Julie; Chen, Henian; Johnson, Ayesha; Lynn, Vickie; Glueckauf, Robert

    2014-01-01

    Abstract Introduction: Expanded access to efficacious interventions is needed for women living with human immunodeficiency virus (WLH) in the United States. Availability of “prevention with (human immunodeficiency virus [HIV)] positives” interventions in rural/remote and low HIV prevalence areas remains limited, leaving WLH in these communities few options for receiving effective behavioral interventions such as Healthy Relationships (HR). Offering such programs via videoconferencing groups (VGs) may expand access. This analysis tests the effectiveness of HR-VG (versus wait-list control) for reducing sexual risk behavior among WLH and explores intervention satisfaction. Subjects and Methods: In this randomized controlled trial unprotected vaginal/anal sex occasions over the prior 3 months reported at the 6-month follow-up were compared across randomization groups through zero-inflated Poisson regression modeling, controlling for unprotected sex at baseline. Seventy-one WLH were randomized and completed the baseline assessment (n=36 intervention and n=35 control); 59 (83% in each group) had follow-up data. Results: Among those who engaged in unprotected sex at 6-month follow-up, intervention participants had approximately seven fewer unprotected occasions than control participants (95% confidence interval 5.43–7.43). Intervention participants reported high levels of satisfaction with HR-VG; 84% reported being “very satisfied” overall. Conclusions: This study found promising evidence for effective dissemination of HIV risk reduction interventions via VGs. Important next steps will be to determine whether VGs are effective with other subpopulations of people living with HIV (i.e., men and non-English speakers) and to assess cost-effectiveness. Possibilities for using VGs to expand access to other psychosocial and behavioral interventions and reduce stigma are discussed. PMID:24237482

  8. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    PubMed Central

    2010-01-01

    Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302 PMID:20334685

  9. Cognitive therapy as an early treatment for post-traumatic stress disorder in children and adolescents: a randomized controlled trial addressing preliminary efficacy and mechanisms of action.

    PubMed

    Meiser-Stedman, Richard; Smith, Patrick; McKinnon, Anna; Dixon, Clare; Trickey, David; Ehlers, Anke; Clark, David M; Boyle, Adrian; Watson, Peter; Goodyer, Ian; Dalgleish, Tim

    2017-05-01

    Few efficacious early treatments for post-traumatic stress disorder (PTSD) in children and adolescents exist. Previous trials have intervened within the first month post-trauma and focused on secondary prevention of later post-traumatic stress; however, considerable natural recovery may still occur up to 6-months post-trauma. No trials have addressed the early treatment of established PTSD (i.e. 2- to 6-months post-trauma). Twenty-nine youth (8-17 years) with PTSD (according to age-appropriate DSM-IV or ICD-10 diagnostic criteria) after a single-event trauma in the previous 2-6 months were randomly allocated to Cognitive Therapy for PTSD (CT-PTSD; n = 14) or waiting list (WL; n = 15) for 10 weeks. Significantly more participants were free of PTSD after CT-PTSD (71%) than WL (27%) at posttreatment (intent-to-treat, 95% CI for difference .04-.71). CT-PTSD yielded greater improvement on child-report questionnaire measures of PTSD, depression and anxiety; clinician-rated functioning; and parent-reported outcomes. Recovery after CT-PTSD was maintained at 6- and 12-month posttreatment. Beneficial effects of CT-PTSD were mediated through changes in appraisals and safety-seeking behaviours, as predicted by cognitive models of PTSD. CT-PTSD was considered acceptable on the basis of low dropout and high treatment credibility and therapist alliance ratings. This trial provides preliminary support for the efficacy and acceptability of CT-PTSD as an early treatment for PTSD in youth. Moreover, the trial did not support the extension of 'watchful waiting' into the 2- to 6-month post-trauma window, as significant improvements in the WL arm (particularly in terms of functioning and depression) were not observed. Replication in larger samples is needed, but attention to recruitment issues will be required. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  10. Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial.

    PubMed

    Shin, Hye Young; Suh, Mina; Baik, Hyung Won; Choi, Kui Son; Park, Boyoung; Jun, Jae Kwan; Hwang, Sang-Hyun; Kim, Byung Chang; Lee, Chan Wha; Oh, Jae Hwan; Lee, You Kyoung; Han, Dong Soo; Lee, Do-Hoon

    2016-11-15

    We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], -3.4 to 25.6) and 12.0% (95% CI, -0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.

  11. Feasibility and preliminary efficacy of the effects of flavanoid-rich purple grape juice on the vascular health of childhood cancer survivors: a randomized, controlled crossover trial.

    PubMed

    Blair, Cindy K; Kelly, Aaron S; Steinberger, Julia; Eberly, Lynn E; Napurski, Char; Robien, Kim; Neglia, Joseph P; Mulrooney, Daniel A; Ross, Julie A

    2014-12-01

    Childhood cancer survivors have an increased risk of developing cardiovascular disease following treatment, yet few interventions have been evaluated to reduce this risk. Purple grape juice (pGJ), a rich source of flavonoids with antioxidant properties, has been shown in adults to reduce oxidative stress and improve endothelial function. We examined the effects of supplementing meals with pGJ on microvascular endothelial function and markers of oxidative stress and inflammation in 24 cancer survivors (ages 10-21 years). In a randomized controlled crossover trial consisting of two, 4 week intervention periods, each preceded by a 4 week washout period, subjects received in random order 6 ounces twice daily of pGJ and clear apple juice (cAJ; similar in calories but lower in flavonoids). Measurements were obtained before and after each supplementation period; change was evaluated using mixed effects ANOVA. pGJ did not improve endothelial function, measured using digital reactive hyperemia, compared with cAJ (mean change: pGJ 0.06, cAJ 0.22; difference of mean change [95% CI]: -0.16 [-0.42 - 0.11], P = 0.25). No significant changes in plasma concentrations of oxidized-LDL, myeloperoxidase, or high sensitivity C-reactive protein were observed. After 4 weeks of daily consumption of flavonoid-rich pGJ, no measurable change in vascular function was observed in these childhood cancer survivors. © 2014 Wiley Periodicals, Inc.

  12. Genetics Moderate Alcohol and Intimate Partner Violence Treatment Outcomes in a Randomized Controlled Trial of Hazardous Drinking Men in Batterer Intervention Programs: A Preliminary Investigation

    PubMed Central

    Stuart, Gregory L.; McGeary, John; Shorey, Ryan C.; Knopik, Valerie S.

    2016-01-01

    Objective We examined whether a cumulative genetic score (CGS) containing MAOA and 5-HTTLPR polymorphisms moderated drinking and intimate partner violence (IPV) treatment outcomes in hazardous drinking men receiving batterer intervention or batterer intervention plus a brief alcohol intervention. Method We conducted a randomized controlled trial with 97 hazardous drinking men who had a relationship partner and were in batterer intervention programs. Participants were randomized to receive 40 hours of standard batterer program (SBP) or the SBP plus a 90-minute alcohol intervention (SBP+BAI). Data were collected at baseline, 3-, 6-, and 12-month follow-up, with follow-up rates of 99.0%, 97.9%, and 93.8%, respectively. Genomic DNA was extracted from saliva. Substance use was measured with the Timeline Followback Interview; IPV was assessed with the Revised Conflict Tactics Scales. The primary outcomes were drinks per drinking day (DDD), percentage of days abstinent from alcohol (PDA), frequency of physical IPV, and injuries to partners. Results Consistent with hypotheses, analyses demonstrated significant treatment condition by CGS interactions for PDA, physical violence, and injuries, but not for DDD. At high levels of the CGS, men in SBP+BAI had greater PDA (B=.16, 95%CI=.04–.27, p=.01), less physical violence perpetration (B=−1.21, 95%CI=−2.21–−.21, p=.02), and fewer injuries to partners (B=−2.37, 95%CI=−3.19–−.82, p=.00) than men in SBP. No differences between the groups in PDA, physical violence, or injuries were observed at low levels of the CGS. Conclusions Findings demonstrate the potential importance of MAOA and 5-HTTLPR polymorphisms in the treatment of IPV and drinking in men in batterer intervention programs. PMID:27018532

  13. Feasibility, Acceptability, and Preliminary Effects of the COPE Online Cognitive-Behavioral Skill-Building Program on Mental Health Outcomes and Academic Performance in Freshmen College Students: A Randomized Controlled Pilot Study.

    PubMed

    Melnyk, Bernadette Mazurek; Amaya, Megan; Szalacha, Laura A; Hoying, Jacqueline; Taylor, Tiffany; Bowersox, Kristen

    2015-08-01

    Despite the increasing prevalence of mental health disorders in university students, few receive needed evidence-based treatment. The purpose of this study was to assess the feasibility and preliminary effects of a seven-session online cognitive-behavioral skill-building intervention (i.e., COPE, Creating Opportunities for Personal Empowerment) versus a comparison group on their anxiety, depressive symptoms, and grade performance. A randomized controlled pilot study was conducted from September 2012 to May 2013 with 121 college freshmen enrolled in a required one credit survey course. Although there were no significant differences in anxiety and depressive symptoms between the groups, only COPE students with an elevated level of anxiety at baseline had a significant decline in symptoms. Grade point average was higher in COPE versus comparison students. Evaluations indicated that COPE was a positive experience for students. COPE is a promising brief intervention that can be integrated effectively into a required freshman course. © 2015 Wiley Periodicals, Inc.

  14. A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study.

    PubMed

    Man, Kee-Ming; Chen, Wen-Chi; Wang, Hwei-Ming; Chen, Huey-Yi; Shen, Jui-Lung; Chen, Lieh-Der; Tsai, Fuu-Jen; Chen, Yung-Hsiang; Yu, De-Xin; Chiang, Feng-Fan

    2013-01-01

    Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients' major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.

  15. Randomized double-blind study of the effect of dexamethasone and methylprednisolone pulse in the control of rheumatoid arthritis flare-up: a preliminary study.

    PubMed

    Sadra, Vahideh; Khabbazi, Alireza; Kolahi, Susan; Hajialiloo, Mehrzad; Ghojazadeh, Morteza

    2014-05-01

    The objective of this study was to compare the efficacy and safety of dexamethasone and methylprednisolone for pulse therapy of rheumatoid arthritis flare-up. This randomized double-blind controlled study was performed in the Emam Reza Educational Hospital of Tabriz University of Medical Sciences, Tabriz, Iran. Thirty rheumatoid arthritis patients who had severely active disease were recruited to the dexamethasone and methylprednisolone pulse groups. Disease activity of all the patients was measured by the Disease Activity Score in 28 joints (DAS28) at baseline, and days 4 and 30. The differences in the DAS28 at days 4 and 30, and the number of patients whose DAS28 obtained less than 3.2 and 2.6 in the dexamethasone and methylprednisolone groups were non-significant. There was not any significant difference between the adverse effects of the treatments in the two groups. The results of the study suggest that dexamethasone pulse therapy is a safe and effective treatment for severe rheumatoid arthritis flare-up. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  16. Evaluation of Yoga for Preventing Adolescent Substance Use Risk Factors in a Middle School Setting: A Preliminary Group-Randomized Controlled Trial.

    PubMed

    Butzer, Bethany; LoRusso, Amanda; Shin, Sunny H; Khalsa, Sat Bir S

    2017-03-01

    Adolescence is a key developmental period for preventing substance use initiation, however prevention programs solely providing educational information about the dangers of substance use rarely change adolescent substance use behaviors. Recent research suggests that mind-body practices such as yoga may have beneficial effects on several substance use risk factors, and that these practices may serve as promising interventions for preventing adolescent substance use. The primary aim of the present study was to test the efficacy of yoga for reducing substance use risk factors during early adolescence. Seventh-grade students in a public school were randomly assigned by classroom to receive either a 32-session yoga intervention (n = 117) in place of their regular physical education classes or to continue with physical-education-as-usual (n = 94). Participants (63.2 % female; 53.6 % White) completed pre- and post-intervention questionnaires assessing emotional self-regulation, perceived stress, mood impairment, impulsivity, substance use willingness, and actual substance use. Participants also completed questionnaires at 6-months and 1-year post-intervention. Results revealed that participants in the control condition were significantly more willing to try smoking cigarettes immediately post-intervention than participants in the yoga condition. Immediate pre- to post-intervention differences did not emerge for the remaining outcomes. However, long-term follow-up analyses revealed a pattern of delayed effects in which females in the yoga condition, and males in the control condition, demonstrated improvements in emotional self-control. The findings suggest that school-based yoga may have beneficial effects with regard to preventing males' and females' willingness to smoke cigarettes, as well as improving emotional self-control in females. However additional research is required, particularly with regard to the potential long-term effects of mind-body interventions

  17. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Refai, Hamida; Altahhan, Obada; Elsharkawy, Rehab

    2011-12-01

    The aim of this study was to assess the efficacy of dextrose prolotherapy for the treatment of temporomandibular joint (TMJ) hypermobility. A prospective, randomized, double-blind clinical study using a placebo control was carried out. Twelve patients with painful subluxation or dislocation of the TMJ were randomly assigned to 1 of 2 equal-sized groups. Patients in the active group received 4 injections of dextrose solution (2 mL of 10% dextrose and 1 mL of 2% mepivacaine) for each TMJ, each 6 weeks apart, whereas patients in the placebo group received injections of placebo solution (2 mL of saline solution and 1 mL of 2% mepivacaine) on the same schedule. A verbal scale expressing TMJ pain on palpation, maximal mouth opening (MMO), clicking sound, and frequency of luxations (number of locking episodes per month) were assessed at each injection appointment just before the injection procedure and 3 months after the last injection. The collected data were then statistically analyzed. By the end of the study, each group showed significant improvement in TMJ pain on palpation and number of locking episodes and insignificant improvement in clicking sound. With the exception of the MMO, there were no statistically significant differences throughout the study intervals between the active and placebo groups. The active group showed a significant reduction in MMO at the 12th week postoperatively. Differences compared with mean baseline value remained significant at the end of the follow-up period. On the other hand, the placebo group showed an insignificant difference in MMO throughout the study periods. For the last 2 intervals, the placebo group showed statistically significantly higher mean MMO values than the active group. By the end of the 12th postoperative week, the percentages of decrease in MMO were significantly greater in the active group. Prolotherapy with 10% dextrose appears promising for the treatment of symptomatic TMJ hypermobility, as evidenced by the

  18. Randomized controlled clinical trial of customized zirconia and titanium implant abutments for canine and posterior single-tooth implant reconstructions: preliminary results at 1 year of function.

    PubMed

    Sailer, Irena; Zembic, Anja; Jung, Ronald Ernst; Siegenthaler, David; Holderegger, Claudia; Hämmerle, Christoph Hans Franz

    2009-03-01

    The aim of this study was to test whether or not customized zirconia abutments exhibit the same survival rates in canine and posterior regions as titanium abutments, and to compare the esthetic result of the two abutment types. Twenty-two patients with 40 implants in posterior regions were included and the implant sites were randomly assigned to 20 customized zirconia and 20 customized titanium abutments. All-ceramic (AC) and metal-ceramic (MC) crowns were fabricated. In all except two cases, the crowns were cemented on the abutments using resin or glass-ionomer cements. Two zirconia reconstructions were screw retained. At baseline, 6 and 12 months, the reconstructions were examined for technical and biological problems. Probing pocket depth (PPD), plaque (Pl) and bleeding on probing (BOP) were assessed and compared with natural control teeth. Furthermore, the difference of color (DeltaE) of the peri-implant mucosa and the gingiva of control teeth was evaluated by means of a spectrophotometer (Spectroshade). The data were analyzed with Student's unpaired t-test, ANOVA and regression analyses. Twenty patients with 19 zirconia and 12 titanium abutments were examined at a mean follow-up of 12.6+/-2.7 months. The survival rate for reconstructions and abutments was 100%. No technical or biological problems were found at the test and control sites. Two chippings (16.7%) occurred at crowns supported by titanium abutments. No difference was found regarding PPD (meanPPD(ZrO2) 3.4+/-0.7 mm, mPPD(Ti) 3.3+/-0.6 mm), Pl (mPl(ZrO2) 0.2+/-0.3, mPl(Ti) 0.1+/-1.8) and BOP (mBOP(ZrO2) 60+/-30%, mBOP(Ti) 30+/-40%) between the two groups. Both crowns on zirconia and titanium abutments induced a similar amount of discoloration of the soft tissue compared with the gingiva at natural teeth (DeltaE(ZrO2) 8.1+/-3.9, DeltaE(Ti) 7.8+/-4.3). At 1 year, zirconia abutments exhibited the same survival and a similar esthetic outcome as titanium abutments.

  19. Preliminary randomized double-blind placebo-controlled trial of tryptophan combined with fluoxetine to treat major depressive disorder: antidepressant and hypnotic effects.

    PubMed Central

    Levitan, R D; Shen, J H; Jindal, R; Driver, H S; Kennedy, S H; Shapiro, C M

    2000-01-01

    OBJECTIVE: Because the initial phase of treatment of depression with a selective serotonin reuptake inhibitor is often complicated by a delayed onset of action of the antidepressant or severe insomnia or both, we investigated whether tryptophan, an amino acid with both antidepressant-augmenting and hypnotic effects, would benefit patients with depression at the beginning of treatment with fluoxetine. DESIGN: Randomized, double-blind, placebo-controlled trial. PATIENTS: Thirty individuals with major depressive disorder. INTERVENTIONS: Treatment over 8 weeks with 20 mg of fluoxetine per day and either tryptophan (2 to 4 g per day) or placebo. OUTCOME MEASURES: Mood was assessed using the 29-item Hamilton Depression Rating Scale (HDRS-29) and the Beck Depression Inventory (BDI). Laboratory sleep studies were done at baseline and after 4 and 8 weeks of treatment using standard procedures. RESULTS: During the first week of treatment, there was a significantly greater decrease in HDRS-29 depression scores, and a similar trend in BDI scores, in the tryptophan/fluoxetine group than in the placebo/fluoxetine group. No significant differences were noted at later time points. With respect to sleep measures, there was a significant group-by-time interaction for slow-wave sleep at week 4. Further analysis revealed a significant decrease in slow-wave sleep after 4 weeks of treatment in the placebo/fluoxetine group, but not in the tryptophan/fluoxetine group. No cases of serotonin syndrome occurred, and the combination was well tolerated, although the 4 g per day dosage of tryptophan produced daytime drowsiness. CONCLUSIONS: Combining 20 mg of fluoxetine with 2 g of tryptophan daily at the outset of treatment for major depressive disorder appears to be a safe protocol that may have both a rapid antidepressant effect and a protective effect on slow-wave sleep. Further large-scale studies are needed to confirm these initial findings. PMID:11022398

  20. Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

    PubMed

    Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

    2017-08-01

    In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  1. Is Homeopathy Effective for Hot Flashes and Other Estrogen-Withdrawl Symptoms in Breast Cancer Survivors? A Preliminary Randomized Controlled Trial

    DTIC Science & Technology

    2001-09-01

    symptoms for more than 100 years. To carry out a pilot study to determine whether there is evidence that homeopathy is an effective treatment to improve the...one month, with at least 3 hot flashes per day. Subjects have been randomized to one of three treatment arms: classical homeopathy , a combination

  2. Effect of vitamin D supplementation on cardiovascular disease risk factors and exercise performance in healthy participants: a randomized placebo-controlled preliminary study

    PubMed Central

    Al-Dujaili, Emad A. S.; Munir, Nimrah; Iniesta, Raquel Revuelta

    2016-01-01

    Background and objectives: Evidence suggests associations between vitamin D deficiency and cardiovascular disease (CVD) risk factors, including hypertension and excessive cortisol levels. Also, vitamin D levels may impact exercise performance. Thus, we aimed to investigate the effects of vitamin D intake on cardiovascular risk factors, free urinary cortisol and exercise performance. Methods: A randomized placebo-controlled single-blinded parallel trial was conducted in healthy participants (n = 15). They received 2000 IU (50 µg) vitamin D3 per day (n = 9) or placebo (lactose) (n = 6) for 14 days. Body composition, systolic blood pressure (SBP), diastolic blood pressure (DBP) and arterial elasticity (as measured by pulse wave velocity, PWV) were recorded at baseline, day 7 and day 14 of intervention. A total of two 24-hour urine samples were collected to estimate free cortisol and cortisone levels. Exercise performance was assessed at the baseline and day 14 of the intervention using a bike ergometer in which BP and PWV were measured before and after exercise. The distance cycled in 20 minutes and the Borg Scale rate of perceived exertion (RPE) were recorded. Results: In the intervention arm, at day 14, vitamin D supplementation significantly reduced SBP and DBP from 115.8 ± 17.1 and 75.4 ± 10.3 at baseline to 106.3 ± 10.9 (p = 0.022) and 68.5 ± 10.1 mmHg (p = 0.012) respectively. Also arterial stiffness was markedly reduced in the vitamin D group (from 7.45 ± 1.55 to 6.11 ± 1.89, p = 0.049). Urinary free cortisol levels and cortisol/cortisone ratio were significantly reduced from 162.65 ± 58.9 nmol/day and 2.22 ± 0.7 to 96.4 ± 37.2 (p = 0.029) and 1.04 ± 0.4 (p = 0.017) respectively. Exercise-induced SBP and DBP were significantly reduced post vitamin D intake from 130.7 ± 12.2 to 116.1 ± 8.1 (p = 0.012) and from 76.2 ± 8.4 to 70.5 ± 7.7 mmHg (p = 0.042) respectively. The distance cycled in 20 minutes significantly increased from 4.98 ± 2.65 to 6

  3. Report of a preliminary discontinued double-blind, randomized, placebo-controlled trial of the anti-TNF-α chimeric monoclonal antibody infliximab in complex regional pain syndrome.

    PubMed

    Dirckx, Maaike; Groeneweg, George; Wesseldijk, Feikje; Stronks, Dirk L; Huygen, Frank J P M

    2013-11-01

    Inflammation appears to play a role in CRPS as, for example, cytokines (like TNF-α) are involved in the affected limb. The ongoing inflammation is probably responsible for the central sensitization that sometimes occurs in CRPS. Thus, early start of a TNF-α antagonist may counteract inflammation, thereby preventing rest damage and leading to recovery of the disease. Patients (n = 13) were randomly assigned to infliximab 5 mg/kg or placebo, both administered at week 0, 2, and 6. The aim was to confirm a reduction in clinical signs of regional inflammation (based on total impairment level sumscore: ISS) after systemic administration of infliximab. Also, levels of mediators in the fluid of induced blisters were examined in relation to normalization and improvement in quality of life. Six patients received infliximab and 7, placebo. There was no significant change in total ISS score between the two groups. Similarly, no significant difference in change in cytokine levels was found between infliximab compared with placebo. However, there was a trend toward a greater reduction of TNF-α in the intervention group compared with the placebo group. A subscale of the EuroQol (ie EuroQol VAS) revealed significant decrease in health status in the intervention group compared with the placebo group. This study was terminated before the required number of participants had been reached for sufficient statistical power. Nevertheless, a trend was found toward an effect of infliximab on the initially high TNF-α concentration. © 2013 World Institute of Pain.

  4. Effect of Whole-Body-Vibration Training on Trunk-Muscle Strength and Physical Performance in Healthy Adults: Preliminary Results of a Randomized Controlled Trial.

    PubMed

    Maeda, Noriaki; Urabe, Yukio; Sasadai, Junpei; Miyamoto, Akira; Murakami, Masahito; Kato, Junichi

    2016-12-01

    Whole-body-vibration (WBV) stimulus equipment has been used as a new training method for health promotion. Its use in the clinic has expanded to the field of sports and rehabilitation for disabled patients. WBV training is rapidly gaining popularity in health and fitness centers as an alternative method for improving muscle performance. Acute positive effects of WBV have been shown on lower-extremity muscle power and vertical-jump ability; however, there have not been any studies focusing on the long-term effects of WBV for trunk muscle and dynamic balance. To investigate the effects of an 8-wk program of WBV in combination with trunk-muscle training on muscle performance in healthy, untrained adults. Laboratory-based, repeated-measures study. University laboratory. 20 healthy university men. Participants were randomly assigned to a WBV or non-WBV group. The WBV group performed a trunk-muscle-training program in combination with WBV; the non-WBV group performed the same muscle-training program without WBV for 8 wk. In the pre- and posttraining period, the participants were evaluated using the Functional Movement Screen (FMS), Y Balance Test (Y-test) (anterior, posteromedial, and posterolateral reach), trunk-muscle isometric strength (flexor, extensor, and flexor:extensor ratio), squat jump, and countermovement jump. The WBV group had greater improvement than the non-WBV group in both trunk-flexor muscle strength (P = .02) and the Y-test (anterior reach) (P = .004) between pre- and posttraining. Adding WBV to a trunk-muscle-strengthening program may improve trunk-flexor isometric strength and anterior reach during the Y-test more than training without WBV. The WBV protocol used in this study had no significant impact on FMS scores, squat jumping, countermovement jumping, trunk-extensor isometric strength, or trunk flexor:extensor ratio.

  5. Acceptance and Commitment Therapy for Depression: A Preliminary Randomized Clinical Trial for Unemployed on Long-Term Sick Leave

    ERIC Educational Resources Information Center

    Folke, Fredrik; Parling, Thomas; Melin, Lennart

    2012-01-01

    This preliminary study investigated the feasibility of a brief Acceptance and Commitment Therapy (ACT) in a Swedish sample of unemployed individuals on long-term sick leave due to depression. Participants were randomized to a nonstandardized control condition (N = 16) or to the ACT condition (N = 18) consisting of 1 individual and 5 group…

  6. Acceptance and Commitment Therapy for Depression: A Preliminary Randomized Clinical Trial for Unemployed on Long-Term Sick Leave

    ERIC Educational Resources Information Center

    Folke, Fredrik; Parling, Thomas; Melin, Lennart

    2012-01-01

    This preliminary study investigated the feasibility of a brief Acceptance and Commitment Therapy (ACT) in a Swedish sample of unemployed individuals on long-term sick leave due to depression. Participants were randomized to a nonstandardized control condition (N = 16) or to the ACT condition (N = 18) consisting of 1 individual and 5 group…

  7. Effects of Upper and Lower Cervical Spinal Manipulative Therapy on Blood Pressure and Heart Rate Variability in Volunteers and Patients With Neck Pain: A Randomized Controlled, Cross-Over, Preliminary Study.

    PubMed

    Win, Ni Ni; Jorgensen, Anna Maria S; Chen, Yu Sui; Haneline, Michael T

    2015-03-01

    The aims of this study were to examine autonomic nervous system responses by using heart rate variability analysis (HRV), hemodynamic parameters and numeric pain scale (NPS) when either upper (C1 and C2) or lower (C6 and C7) cervical segments were manipulated in volunteers, and whether such response would be altered in acute mechanical neck pain patients after spinal manipulative therapy (SMT). A randomized controlled, cross-over, preliminary study was conducted on 10 asymptomatic normotensive volunteers and 10 normotensive patients complaining of acute neck pain. HRV, blood pressure (BP) and heart rate (HR), and NPS were recorded after upper cervical and lower cervical segments SMT in volunteer and patient groups. The standard deviation of average normal to normal R-R intervals (SDNN) increased (83.54 ± 22 vs. 105.41 ± 20; P = .02) after upper cervical SMT. The normalized unit of high frequency (nuHF), which shows parasympathetic activity, was predominant (40.18 ± 9 vs. 46.08 ± 14) after upper cervical SMT (P = .03) with a significant decrease (109 ± 10 vs. 98 ± 5) in systolic BP (P = .002). Low frequency to high frequency (LF/HF) ratio, which shows predominance of sympathetic activity increased (1.05 ± 0.7 vs. 1.51 ± 0.5; P = .02) after lower cervical SMT in the healthy volunteers group. However, there was an increase in SDNN (70.48 ± 18 vs. 90.23 ± 20; P = .02 and 75.19 ± 16 vs 97.52 ± 22; P = .01), a decrease in LF/HF ratio (1.33 ± 0.3 vs. 0.81 ± 0.2; P = .001 and 1.22 ± 0.4 vs. 0.86 ± 0.3; P = .02), which was associated with decreased systolic BP (105 ± 10 vs. 95 ± 9; P = .01 and 102 ± 9 vs. 91 ± 10; P = .02) and NPS scores (3 ± 1 vs. 0; P = .01 and 3 ± 1 vs. 1 ± 1; P = .03) following both upper and lower cervical SMT in the patient's group. The baseline HR was 67 ± 9 vs 64 ± 5 (upper cervical) and 65 ± 7 vs 69 ± 11 (lower cervical) in both the healthy volunteer' and patient' groups. Upper cervical SMT enhances dominance of

  8. Effects of Upper and Lower Cervical Spinal Manipulative Therapy on Blood Pressure and Heart Rate Variability in Volunteers and Patients With Neck Pain: A Randomized Controlled, Cross-Over, Preliminary Study

    PubMed Central

    Win, Ni Ni; Jorgensen, Anna Maria S.; Chen, Yu Sui; Haneline, Michael T.

    2015-01-01

    Objective The aims of this study were to examine autonomic nervous system responses by using heart rate variability analysis (HRV), hemodynamic parameters and numeric pain scale (NPS) when either upper (C1 and C2) or lower (C6 and C7) cervical segments were manipulated in volunteers, and whether such response would be altered in acute mechanical neck pain patients after spinal manipulative therapy (SMT). Methods A randomized controlled, cross-over, preliminary study was conducted on 10 asymptomatic normotensive volunteers and 10 normotensive patients complaining of acute neck pain. HRV, blood pressure (BP) and heart rate (HR), and NPS were recorded after upper cervical and lower cervical segments SMT in volunteer and patient groups. Results The standard deviation of average normal to normal R-R intervals (SDNN) increased (83.54 ± 22 vs. 105.41 ± 20; P = .02) after upper cervical SMT. The normalized unit of high frequency (nuHF), which shows parasympathetic activity, was predominant (40.18 ± 9 vs. 46.08 ± 14) after upper cervical SMT (P = .03) with a significant decrease (109 ± 10 vs. 98 ± 5) in systolic BP (P = .002). Low frequency to high frequency (LF/HF) ratio, which shows predominance of sympathetic activity increased (1.05 ± 0.7 vs. 1.51 ± 0.5; P = .02) after lower cervical SMT in the healthy volunteers group. However, there was an increase in SDNN (70.48 ± 18 vs. 90.23 ± 20; P = .02 and 75.19 ± 16 vs 97.52 ± 22; P = .01), a decrease in LF/HF ratio (1.33 ± 0.3 vs. 0.81 ± 0.2; P = .001 and 1.22 ± 0.4 vs. 0.86 ± 0.3; P = .02), which was associated with decreased systolic BP (105 ± 10 vs. 95 ± 9; P = .01 and 102 ± 9 vs. 91 ± 10; P = .02) and NPS scores (3 ± 1 vs. 0; P = .01 and 3 ± 1 vs. 1 ± 1; P = .03) following both upper and lower cervical SMT in the patient’s group. The baseline HR was 67 ± 9 vs 64 ± 5 (upper cervical) and 65 ± 7 vs 69 ± 11 (lower cervical) in both the healthy volunteer’ and patient’ groups. Conclusion Upper

  9. Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial.

    PubMed

    Galante, E; Venturini, G; Fiaccadori, C

    2007-01-01

    Dementia is a highly invalidating condition and, given the progressive aging of the population, one of the major issues that health systems will have to face in future years. Recently there has been an increase in the potential of diagnostic tools and pharmacological treatments for dementia; moreover, considerable interest has been expressed regarding non pharmacological interventions. However, the current evidence in support of non pharmacological treatments in patients affected by dementia still does not allow to draw definitive conclusions on what is the most effective treatment to apply, largely because of methodological difficulties and limitations of the studies so far carried out due to the complex nature of the disease. To address this need, we carried out a single blind randomized controlled study on the efficacy of computer cognitive rehabilitation in patients with mild cognitive decline. We here present preliminary data on 11 patients with diagnosis of Alzheimer's Disease (AD) and mild cognitive decline randomly assigned to treatment (a) or control (b) condition (i.e. specific vs. aspecific treatment). The specific treatment (a) consisted in a cycle of 12 individual sessions of computer exercises, while the control condition (b) consisted in sessions of semi-structured interviews with patients, conducted with the same frequency and time period as (a). Cognitive, behavioural and functional assessment was performed by an expert evaluator, blinded to the patients' group allocation. Preliminary results show a significant performance decline only in the control group at the 9-month follow-up compared to both baseline and the 3-month follow-up. Our results suggest that computer based cognitive training in patients with AD and mild cognitive decline is effective at least in delaying the continuous progression of cognitive impairment in AD.

  10. Supervisory control of remote manipulation: A preliminary evaluation

    NASA Technical Reports Server (NTRS)

    Starr, G. P.

    1981-01-01

    A system for supervisory control is described, and preliminary results are presented. Supervisory control, where control is traded between man and computer, offers benefits in the control of a remote manipulator. The system has the potential to accomplish sophisticated tasks. It is indicated that supervisory control yields lower task completion times and is preferred over manual control.

  11. Brief Narrative Exposure Therapy for Posttraumatic Stress in Iraqi Refugees: A Preliminary Randomized Clinical Trial

    PubMed Central

    Hijazi, Alaa M.; Lumley, Mark A.; Ziadni, Maisa S.; Haddad, Luay; Rapport, Lisa J.; Arnetz, Bengt B.

    2014-01-01

    Many Iraqi refugees suffer from posttraumatic stress. Efficient, culturally-sensitive interventions are needed, and so we adapted narrative exposure therapy into a brief version (brief NET) and tested its effects in a sample of traumatized Iraqi refugees. Iraqi refugees in the U.S. reporting elevated posttraumatic stress (N=63) were randomized to brief NET or waitlist control conditions in a 2:1 ratio; brief NET was 3 sessions, conducted individually, in Arabic. Positive indicators (posttraumatic growth and well-being) and symptoms (posttraumatic stress, depressive, and somatic) were assessed at baseline and 2- and 4-month follow-ups. Treatment participation (95.1% completion) and study retention (98.4% provided follow-up data) were very high. Significant condition by time interactions showed that brief NET led to greater posttraumatic growth (Effect size; ES=0.83) and well-being (ES=0.54) through 4 months than the control. Brief NET reduced symptoms of posttraumatic stress (ES=-0.48) and depression (ES=-0.46) compared to control, but only at 2 months; symptoms of controls decreased from 2 to 4 months, eliminating condition differences at 4 months. Three sessions of NET increased growth and well-being and led to symptom reduction in highly traumatized Iraqi refugees. This preliminary study suggests that brief NET is both acceptable and potentially efficacious in traumatized Middle Eastern refugees. PMID:24866253

  12. Efficacy of antimicrobial coating suture coated polyglactin 910 with tricosan (Vicryl plus) compared with polyglactin 910 (Vicryl) in reduced surgical site infection of appendicitis, double blind randomized control trial, preliminary safety report.

    PubMed

    Mingmalairak, Chatchai; Ungbhakorn, Pookate; Paocharoen, Veeraya

    2009-06-01

    To evaluate the efficacy and safety of new antibacterial suture (Vicryl Plus) compared with a traditional braided suture (Vicryl) in a clinical study. The primary goal was to study effectiveness on reduced surgical site infection in an appendectomy operation. The authors' secondary goal was to analyze the safety and physical properties of Vicryl plus. This was a prospective, randomized, controlled, double blind, comparative, single-center study. After appendectomy was done, the patients were randomized in two groups: Vicryl Plus and Vicryl to selected suture for suturing the abdominal sheath. The surgical site infection was evaluated for 30 days, 6 months, and 1 year. The surgeons and attending doctor were blind to the type of suture. This is the primary report of the first 100 patients. There was no difference in demographic and preoperative clinical in both groups. Although there was no statistical difference in the surgical site infection of Vicryl and Vicryl Plus (8 and 10%, p = 0.05), one case of deep surgical site infection was detected in the Vicryl group. No complications and no difference in related suture materials were detected. Coated polyglactin 910 with tricosan (Vicryl Plus) is safe and satisfactory in surgical practice. Surgical site infection of appendectomy seemed too to be comparable between coated polyglactin 910 with tricosan (Vicryl Plus) and traditional polyglactin 910 (Vicryl) group.

  13. Energy efficient engine: Control system preliminary definition report

    SciTech Connect

    Howe, D.C.

    1986-09-01

    The object of the Control Preliminary Definition Program was to define a preliminary control system concept as a part of the Energy Efficient Engine program. The program was limited to a conceptual definition of a full authority digital electronic control system. System requirements were determined and a control system was conceptually defined to these requirements. Areas requiring technological development were identified and a plan was established for implementing the identified technological features, including a control technology demonstration. A significant element of this program was a study of the potential benefits of closed-loop active clearance control, along with laboratory tests of candidate clearance sensor elements for a closed loop system.

  14. Energy Efficient Engine: Control system preliminary definition report

    NASA Technical Reports Server (NTRS)

    Howe, David C.

    1986-01-01

    The object of the Control Preliminary Definition Program was to define a preliminary control system concept as a part of the Energy Efficient Engine program. The program was limited to a conceptual definition of a full authority digital electronic control system. System requirements were determined and a control system was conceptually defined to these requirements. Areas requiring technological development were identified and a plan was established for implementing the identified technological features, including a control technology demonstration. A significant element of this program was a study of the potential benefits of closed-loop active clearance control, along with laboratory tests of candidate clearance sensor elements for a closed loop system.

  15. Short-Term-Effectiveness of a Relationship Education Program for Distressed Military Couples, in the Context of Foreign Assignments for the German Armed Forces. Preliminary Findings From a Randomized Controlled Study.

    PubMed

    Kröger, Christoph; Kliem, Sören; Zimmermann, Peter; Kowalski, Jens

    2017-06-26

    This study examines the short-term effectiveness of a relationship education program designed for military couples. Distressed couples were randomly placed in either a wait-list control group or an intervention group. We conducted training sessions before a 3-month foreign assignment, and refresher courses approximately 6-week post-assignment. We analyzed the dyadic data of 32 couples, using hierarchical linear modeling in a two-level model. Reduction in unresolved conflicts was found in the intervention group, with large pre-post effects for both partners. Relationship satisfaction scores were improved, with moderate-to-large effects only for soldiers, rather than their partners. Post-follow-up effect sizes suggested further improvement in the intervention group. Future research should examine the long-term effectiveness of this treatment. © 2017 American Association for Marriage and Family Therapy.

  16. Brief narrative exposure therapy for posttraumatic stress in Iraqi refugees: a preliminary randomized clinical trial.

    PubMed

    Hijazi, Alaa M; Lumley, Mark A; Ziadni, Maisa S; Haddad, Luay; Rapport, Lisa J; Arnetz, Bengt B

    2014-06-01

    Many Iraqi refugees suffer from posttraumatic stress. Efficient, culturally sensitive interventions are needed, and so we adapted narrative exposure therapy into a brief version (brief NET) and tested its effects in a sample of traumatized Iraqi refugees. Iraqi refugees in the United States reporting elevated posttraumatic stress (N = 63) were randomized to brief NET or waitlist control conditions in a 2:1 ratio; brief NET was 3 sessions, conducted individually, in Arabic. Positive indicators (posttraumatic growth and well-being) and symptoms (posttraumatic stress, depressive, and somatic) were assessed at baseline and 2- and 4-month follow-up. Treatment participation (95.1% completion) and study retention (98.4% provided follow-up data) were very high. Significant condition by time interactions showed that those receiving brief NET had greater posttraumatic growth (d = 0.83) and well-being (d = 0.54) through 4 months than controls. Brief NET reduced symptoms of posttraumatic stress (d = -0.48) and depression (d = -0.46) more, but only at 2 months; symptoms of controls also decreased from 2 to 4 months, eliminating condition differences at 4 months. Three sessions of brief NET increased growth and well-being and led to symptom reduction in highly traumatized Iraqi refugees. This preliminary study suggests that brief NET is both acceptable and potentially efficacious in traumatized Iraqi refugees. Copyright © 2014 International Society for Traumatic Stress Studies.

  17. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

    PubMed

    Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

    2001-10-01

    A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

  18. Optimal Quantum Control Using Randomized Benchmarking

    NASA Astrophysics Data System (ADS)

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

    2014-06-01

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

  19. Networked Dynamic Systems: Identification, Controllability, and Randomness

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

    The presented dissertation aims to develop a graph-centric framework for the analysis and synthesis of networked dynamic systems (NDS) consisting of multiple dynamic units that interact via an interconnection topology. We examined three categories of network problems, namely, identification, controllability, and randomness. In network identification, as a subclass of inverse problems, we made an explicit relation between the input-output behavior of an NDS and the underlying interacting network. In network controllability, we provided structural and algebraic insights into features of the network that enable external signal(s) to control the state of the nodes in the network for certain classes of interconnections, namely, path, circulant, and Cartesian networks. We also examined the relation between network controllability and the symmetry structure of the graph. Motivated by the analysis results for the controllability and observability of deterministic networks, a natural question is whether randomness in the network layer or in the layer of inputs and outputs generically leads to favorable system theoretic properties. In this direction, we examined system theoretic properties of random networks including controllability, observability, and performance of optimal feedback controllers and estimators. We explored some of the ramifications of such an analysis framework in opinion dynamics over social networks and sensor networks in estimating the real-time position of a Seaglider from experimental data.

  20. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    ERIC Educational Resources Information Center

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

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

  1. ASSISTments Dataset from Multiple Randomized Controlled Experiments

    ERIC Educational Resources Information Center

    Selent, Douglas; Patikorn, Thanaporn; Heffernan, Neil

    2016-01-01

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

  2. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Gallagher, H. Alix; Roschelle, Jeremy; Feng, Mingyu

    2014-01-01

    The objective of this study was to look across strategies used in a wide range of studies to build a framework for researchers to use in conceptualizing the recruitment process. This paper harvests lessons learned across 19 randomized controlled trials in K-12 school settings conducted by a leading research organization to identify strategies that…

  3. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  4. A computer controlled pulsatile pump: preliminary study.

    PubMed

    Zwarts, M S; Topaz, S R; Jones, D N; Kolff, W J

    1996-12-01

    A Stepper Motor Driven Reciprocating Pump (SDRP) can replace roller pumps and rotary pumps for cardio pulmonary bypass, hemodialysis and regional perfusion. The blood pumping ventricles are basically the same as ventricles used for air driven artificial hearts and ventricular assist devices. The electric stepper motor uses a flexible linkage belt to produce a reciprocating movement, which pushes a hard sphere into the diaphragm of the blood ventricles. The SDRP generates pulsatile flow and has a small priming volume. The preset power level of the motor driver limits the maximum potential outflow pressure, so the driver acts as a safety device. A double pump can be made by connecting two fluid pumping chambers to opposing sides of the motor base. Each pump generates pulsatile flow. Pressure and flow studies with water were undertaken. Preliminary blood studies showed low hemolysis, even when circulating a small amount of blood up to 16 hours.

  5. Alternatives to the Randomized Controlled Trial

    PubMed Central

    West, Stephen G.; Duan, Naihua; Pequegnat, Willo; Gaist, Paul; Des Jarlais, Don C.; Holtgrave, David; Szapocznik, José; Fishbein, Martin; Rapkin, Bruce; Clatts, Michael; Mullen, Patricia Dolan

    2008-01-01

    Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented. PMID:18556609

  6. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  7. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  8. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  9. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  10. A pilot randomized controlled trial of deprescribing.

    PubMed

    Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

    2011-04-01

    Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

  11. Preliminary Quality Control System Design for the Pell Grant Program.

    ERIC Educational Resources Information Center

    Advanced Technology, Inc., Reston, VA.

    A preliminary design for a quality control (QC) system for the Pell Grant Program is proposed, based on the needs of the Office of Student Financial Assistance (OSFA). The applicability of the general design for other student aid programs administered by OSFA is also considered. The following steps included in a strategic approach to QC system…

  12. Recent randomized controlled trials in otolaryngology.

    PubMed

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  13. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

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

    2016-01-01

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

  14. Short-term supplementation of acute long-chain omega-3 polyunsaturated fatty acids may alter depression status and decrease symptomology among young adults with depression: A preliminary randomized and placebo controlled trial.

    PubMed

    Ginty, Annie T; Conklin, Sarah M

    2015-09-30

    The current study examined the psychological effects of acute and low-dose long-chain omega-3 polyunsaturated fatty acids (LCPUFAs) supplementation on young adults with depressive symptoms. Participants (N=23, M age (SD)=20.2 (1.25), 78% female), with a Beck Depression Inventory (BDI) score of greater than 10, were randomly assigned to a placebo (corn oil) or LCPUFAs group (1.4g of eicosapentaenoic and docosahexaeonic acids) and were instructed to consume the assigned capsules daily for 21-days. BDI was completed prior to supplementation and at day 21. Group differences in depression status on day 21 were analyzed using chi-square tests. After 21-days of supplementation, there was a significant difference in depression status between groups. 67% of the LCPUFAs no longer met criteria for being depressed, while only 20% in the placebo group were no longer depressed. A mixed ANOVA revealed a significant group x time interaction for BDI scores. Post-hoc analyses revealed the LCPFUAs group had a significant reduction in BDI scores over time, while the placebo group's scores did not significantly change. These findings suggest that LCPUFAs may alter depression and depressive symptomology in young adults in a relatively short amount of time.

  15. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

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

    2010-10-01

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

  16. Sham Electroacupuncture Methods in Randomized Controlled Trials

    PubMed Central

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

    2017-01-01

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

  17. Neurosurgical Randomized Controlled Trials-Distance Travelled.

    PubMed

    Azad, Tej D; Veeravagu, Anand; Mittal, Vaishali; Esparza, Rogelio; Johnson, Eli; Ioannidis, John P A; Grant, Gerald A

    2017-06-21

    The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). To systematically assess the design and quality characteristics of neurosurgical RCTs. From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. The median sample size in the 401 eligible RCTs was 73 patients with a mean patient age of 49.6. Only 111 trials (27.1%) described allocation concealment, 140 (34.6%) provided power calculations, and 117 (28.9%) were adequately powered. Significant efficacy or trend for efficacy was claimed in 226 reports (56.4%), no difference between the procedures was found in 166 trials (41.4%), and significant harm was reported in 9 trials (2.2%). Trials with a larger sample size were more likely to report randomization mode, specify allocation concealment, and power calculations (all P < .001). Government funding was associated with better specification of power calculations ( P = .008) and of allocation concealment ( P = .026), while industry funding was associated with reporting significant efficacy ( P = .02). Reporting of funding, specification of randomization mode and primary outcomes, and mention of power calculations improved significantly (all, P < .05) over time. Several aspects of the design and reporting of RCTs on neurosurgical procedures have improved over time. Better powered and accurately reported trials are needed in neurosurgery to deliver evidence-based care and achieve optimal outcomes.

  18. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

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

    2014-01-01

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

  19. Does mindfulness have potential in eating disorders prevention? A preliminary controlled trial with young adult women.

    PubMed

    Atkinson, Melissa J; Wade, Tracey D

    2016-06-01

    This preliminary randomized controlled trial assessed the feasibility of a pilot mindfulness-based intervention with respect to reducing the risk of eating disorders in young women. Forty-four young adult women with body image concerns (Mage  = 20.57, SD = 3.22) were randomly allocated to a mindfulness-based or a dissonance-based intervention (3 × 1 h weekly sessions), or to assessment-only control. Self-report measures of eating disorder risk factors, symptoms and related psychosocial impairment were compared at baseline, post-intervention, and at 1- and 6-month follow up. At post-intervention, acceptability ratings for both interventions were high. Mindfulness participants demonstrated statistically significant improvements relative to control at post-intervention for weight and shape concern, dietary restraint, thin ideal internalization, eating disorder symptoms and related psychosocial impairment; however, these gains were largely lost over follow up. Dissonance participants did not show statistically significant improvements relative to control on any outcomes, despite small to moderate effect sizes. These preliminary findings demonstrate the acceptability and short-term efficacy of a mindfulness-based approach to reducing the risk of disordered eating in young women. This provides support for the continued evaluation of mindfulness in the prevention and early intervention of eating disorders, with increased efforts to produce maintenance of intervention gains. © 2014 Wiley Publishing Asia Pty Ltd.

  20. Preliminary design of the Space Station internal thermal control system

    NASA Technical Reports Server (NTRS)

    Herrin, Mark T.; Patterson, David W.; Turner, Larry D.

    1987-01-01

    The baseline preliminary design configuration of the Internal Thermal Control system (ITCS) of the U.S. Space Station pressurized elements (i.e., the Habitation and U.S. Laboratory modules, pressurized logistics carrier, and resources nodes) is defined. The ITCS is composed of both active and passive components. The subsystems which comprise the ITCS are identified and their functional descriptions are provided. The significant trades and analyses, which were performed during Phase B (i.e., the preliminary design phase) that resulted in the design described herein, are discussed. The ITCS interfaces with the station's central Heat Rejection and Transport System (HRTS), other systems, and externally attached pressurized payloads are described. Requirements on the ITCS with regard to redundancy and experiment support are also addressed.

  1. Biocontamination Control for Spacesuit Garments - A Preliminary Study

    NASA Technical Reports Server (NTRS)

    Rhodes, Richard A.; Orndoff, Evelyne; Korona, F. Adam; Poritz, Darwin; Smith, Jelanie; Wong, Wing

    2011-01-01

    This paper outlines a preliminary study that was conducted to review, test, and improve on current space suit biocontamination control. Biocontamination from crew members can cause space suit damage and objectionable odors and lead to crew member health hazards. An understanding of the level of biocontamination is necessary to mitigate its effects. A series of tests were conducted with the intent of evaluating current suit materials, ground and on-orbit disinfectants, and potential commercial off-the-shelf antimicrobial materials. Included in this paper is a discussion of the test methodology, results, and analysis method.

  2. Preliminary data from a randomized pilot study of web-based functional analytic psychotherapy therapist training.

    PubMed

    Kanter, Jonathan W; Tsai, Mavis; Holman, Gareth; Koerner, Kelly

    2013-06-01

    Therapists of many persuasions emphasize the therapy relationship in their work, a priority backed by strong empirical evidence. Training in how to maximize the power and potential of the therapy relationship, however, has lagged behind. A novel approach to using the therapy relationship and to training therapists in its use is provided by Functional Analytic Psychotherapy (FAP). FAP training involves eight 2-hr weekly training sessions conducted online using web-conferencing technology. The training integrates behavioral principles with a focus on trainee-trainer and trainee-trainee relationships in a highly structured course that evokes the desirable FAP therapist-trainee behaviors and collectively shapes the behaviors through reinforcement by the trainer and other trainees. In a preliminary study, 16 therapist-trainees were randomly assigned to receive either immediate FAP training or training after a waitlist period. Significant and large effects of training were found on both self-reported and observer-assessed measures for the first training group, and the waitlist training group replicated the first training group with significant within-subject change over the course of training. Finally, qualitative feedback from therapists indicated high satisfaction with the primary elements of the training protocol. Several important limitations to this preliminary study are discussed.

  3. Preliminary results of laser ablation of the prostate versus TURP: a randomized study

    NASA Astrophysics Data System (ADS)

    Shaffer, Brian S.; Costello, Anthony J.

    1993-05-01

    Preliminary results of a randomized study comparing laser ablation of the prostate (LAP) to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia are reviewed. Forty-five men enrolled in the study had a minimum 6 week followup. Preoperative AUA symptom scores, peak urinary flow rates, and post-void residual urines (PVR) were compared to postoperative values. The TURP group (22 men) did better than its LAP cohort (23 men) with a mean decrease in symptom score of 70% versus 47%, a mean increase in flow rate of 83% versus 53%, and a mean decrease in PVR of 51% versus 28%, respectively, at 12 weeks. LAP patients had less complications associated with impotence and retrograde ejaculation, required urethral catheters for less time, and had shorter hospital stays. With the development of more durable and reflective fibers the difference in efficacy between TURP and LAP should diminish while the benefits of LAP are preserved.

  4. Randomized controlled trials - a matter of design.

    PubMed

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

    2016-01-01

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

  5. Pediatric Nephrologists’ Beliefs Regarding Randomized Controlled Trials

    PubMed Central

    Wightman, Aaron G; Oron, Assaf P; Symons, Jordan M; Flynn, Joseph T

    2014-01-01

    Background Pediatrics and pediatric nephrology lag behind adult medicine in producing randomized controlled trials (RCTs). Physician attitudes have been shown to play a significant role in RCT enrollment. Methods We surveyed members of the American Society of Pediatric Nephrology regarding beliefs about RCTs and factors influencing decisions to recommend RCT enrollment. Regression analyses were used to identify effects of variables on an aggregate score summarizing attitudes toward RCTs. Results 130 replies were received. 66% had enrolled patients in RCTs. Respondents in practice >15 years were more likely to have recruited a patient to a RCT than those in practice <5 years. Respondents were more willing to recommend RCT enrollment if the study was multicenter, patients were sicker or had a poorer prognosis, or if the parent or participant received a financial incentive versus the provider. In multiple regression analysis, history of enrolling patients in a RCT was the only significant predictor of higher aggregate RCT-friendly attitude. Conclusions Many pediatric nephrologists have never enrolled a patient in a RCT, particularly those in practice <5 years. Respondents who have not enrolled patients in RCTs have a less RCT-friendly attitude. Provision of improved training and resources might increase participation of junior providers in RCTs. PMID:24379023

  6. Preliminary Investigation of Workload on Intrastate Bus Traffic Controllers

    NASA Astrophysics Data System (ADS)

    Yen Bin, Teo; Azlis-Sani, Jalil; Nur Annuar Mohd Yunos, Muhammad; Ismail, S. M. Sabri S. M.; Tajedi, Noor Aqilah Ahmad

    2016-11-01

    The daily routine of bus traffic controller which involves high mental processes would have a direct impact on the level of workload. To date, the level of workload on the bus traffic controllers in Malaysia is relatively unknown. Excessive workload on bus traffic controllers would affect the control and efficiency of the system. This paper served to study the workload on bus traffic controllers and justify the needs to conduct further detailed research on this field. The objectives of this research are to identify the level of workload on the intrastate bus traffic controllers. Based on the results, recommendations will be proposed for improvements and future studies. The level of workload for the bus traffic controllers is quantified using questionnaire adapted from NASA TLX. Interview sessions were conducted for validation of workload. Sixteen respondents were involved and it was found that the average level of workload based on NASA TLX was 6.91. It was found that workload is not affected by gender and marital status. This study also showed that the level of workload and working experience of bus traffic controllers has a strong positive linear relationship. This study would serve as a guidance and reference related to this field. Since this study is a preliminary investigation, further detailed studies could be conducted to obtain a better comprehension regarding the bus traffic controllers.

  7. Evaluating cognitive effort in a randomized controlled trial.

    PubMed

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

    2016-09-01

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

  8. The electronically-controlled axis-traction handle: preliminary report.

    PubMed

    Perone, Nicola

    2010-10-01

    The scope of this preliminary report is to illustrate the performance characteristics of an electronically-controlled axis-traction handle. Preclinical testing was conducted with a prototype of the innovative device, using a childbirth simulator. The simulated forceps deliveries demonstrated that the innovative device allows the obstetrician to measure (unencumbered by dials, scales and cable connections) the traction applied, to be alerted when the preset 50 lbs (22.68 kg) safety limit is approached, and to generate a hard copy print-out of the traction data. The electronically-controlled axis-traction handle represents a major technologic advance, that could help improve the training and safe practice of forceps deliveries. © 2010 The Author. Journal of Obstetrics and Gynaecology Research © 2010 Japan Society of Obstetrics and Gynecology.

  9. Preliminary supersonic flight test evaluation of performance seeking control

    NASA Technical Reports Server (NTRS)

    Orme, John S.; Gilyard, Glenn B.

    1993-01-01

    Digital flight and engine control, powerful onboard computers, and sophisticated controls techniques may improve aircraft performance by maximizing fuel efficiency, maximizing thrust, and extending engine life. An adaptive performance seeking control system for optimizing the quasi-steady state performance of an F-15 aircraft was developed and flight tested. This system has three optimization modes: minimum fuel, maximum thrust, and minimum fan turbine inlet temperature. Tests of the minimum fuel and fan turbine inlet temperature modes were performed at a constant thrust. Supersonic single-engine flight tests of the three modes were conducted using varied after burning power settings. At supersonic conditions, the performance seeking control law optimizes the integrated airframe, inlet, and engine. At subsonic conditions, only the engine is optimized. Supersonic flight tests showed improvements in thrust of 9 percent, increases in fuel savings of 8 percent, and reductions of up to 85 deg R in turbine temperatures for all three modes. The supersonic performance seeking control structure is described and preliminary results of supersonic performance seeking control tests are given. These findings have implications for improving performance of civilian and military aircraft.

  10. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

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

    2005-08-01

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

  11. Understanding and control of random lasing

    NASA Astrophysics Data System (ADS)

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

    2003-10-01

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

  12. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

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

  13. Phoebe: A preliminary control network and rotational elements

    NASA Technical Reports Server (NTRS)

    Colvin, Tim R.; Davies, Merton E.; Rogers, Patricia G.; Heller, Jeanne (Editor)

    1989-01-01

    A preliminary control network for the Saturnian satellite Phoebe was determined based upon 6 distinct albedo features mapped on 16 Voyager 2 images. Using an existing map and an analytical triangulation program which minimized the measurement error, the north pole of Phoebe was calculated to be alpha sub 0 = 355.0 deg + or - 9.6 deg, delta sub 0 = 68.7 deg + or - 7.9 deg, where alpha sub 0, delta sub 0 are standard equatorial coordinates with equinox J2000 at epoch J2000. The prime meridian of Phoebe was computed to be W = 304.7 deg + 930.833872d, where d is the interval in days from JD 2451545.0 TDB.

  14. Efficacy of fentanyl transdermal patch in pain control after lower third molar surgery: A preliminary study

    PubMed Central

    Vasovic, Miroslav; Andric, Miroslav; Todorovic, Ljubomir; Kokovic, Vladimir

    2016-01-01

    Background Surgical removal of impacted lower third molars is a common oral surgical procedure, generally followed by moderate to severe postoperative pain. Transdermal drug delivery as a concept offers interesting possibilities for postoperative pain control. The aim of this study was to evaluate the efficacy of transdermal system with fentanyl in relieving pain following impacted lower third molar surgery. Material and Methods Seventeen patients with bilateral impacted lower third molars were included in this preliminary study. For postoperative pain control, patients randomly received a fentanyl patch plus placebo tablet after the first operation and regular (placebo) patch and an analgesic, after the second operation. Analgesia was evaluated during first 24 hours postoperatively according to patients’ reports about time of first pain appearance and additional analgesic consumption. Pain severity was rated using a 10 cm long visual analogue scale (VAS). Results Intensity of postoperative pain and postoperative analgesic consumption were significantly lower after the Fentanyl Transdermal System (FTS) was applied (p<0.05). Duration of postoperative analgesia was significantly higher with FTS when compared to control treatment (p<0.05). Conclusions Based on the results of this preliminary study, transdermal system with fentanyl significantly reduced postoperative pain after third molar surgery. Key words:Analgesia, fentanyl, transdermal administration, third molar surgery, acute pain, postoperative care. PMID:27475691

  15. Multiple Shaker Random Vibration Control--An Update

    SciTech Connect

    Smallwood, D.O.

    1999-02-18

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

  16. Greenridge Multi-Pollutant Control Project Preliminary Public Design Report

    SciTech Connect

    Connell, Daniel P

    2009-01-12

    commercial readiness of an emissions control system that is specifically designed to meet the environmental compliance requirements of these smaller coal-fired EGUs. The multi-pollutant control system is being installed and tested on the AES Greenidge Unit 4 (Boiler 6) by a team including CONSOL Energy Inc. as prime contractor, AES Greenidge LLC as host site owner, and Babcock Power Environmental Inc. as engineering, procurement, and construction contractor. All funding for the project is being provided by the U.S. Department of Energy, through its National Energy Technology Laboratory, and by AES Greenidge. AES Greenidge Unit 4 is a 107 MW{sub e} (net), 1950s vintage, tangentially-fired, reheat unit that is representative of many of the 440 smaller coal-fired units identified above. Following design and construction, the multi-pollutant control system will be demonstrated over an approximately 20-month period while the unit fires 2-4% sulfur eastern U.S. bituminous coal and co-fires up to 10% biomass. This Preliminary Public Design Report is the first in a series of two reports describing the design of the multi-pollutant control facility that is being demonstrated at AES Greenidge. Its purpose is to consolidate for public use all available nonproprietary design information on the Greenidge Multi-Pollutant Control Project. As such, the report includes a discussion of the process concept, design objectives, design considerations, and uncertainties associated with the multi-pollutant control system and also summarizes the design of major process components and balance of plant considerations for the AES Greenidge Unit 4 installation. The Final Public Design Report, the second report in the series, will update this Preliminary Public Design Report to reflect the final, as-built design of the facility and to incorporate data on capital costs and projected operating costs.

  17. Analyzing Randomized Controlled Interventions: Three Notes for Applied Linguists

    ERIC Educational Resources Information Center

    Vanhove, Jan

    2015-01-01

    I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a) checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b) using repeated measures ANOVA to analyze pretest-posttest designs, and…

  18. Meditation for migraines: a pilot randomized controlled trial.

    PubMed

    Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

    2014-10-01

    Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P

  19. Preliminary Field Evaluation of Mercury Control Using Combustion Modifications

    SciTech Connect

    V. Lissianski; P. Maly; T. Marquez

    2005-01-22

    In this project EER conducted a preliminary field evaluation of the integrated approach for mercury (Hg) and NO{sub x} control. The approach enhanced the 'naturally occurring' Hg capture by fly ash through combustion optimization, increasing carbon in ash content, and lowering ESP temperature. The evaluation took place in Green Station Units 1 and 2 located near Henderson, Kentucky and operated by Western Kentucky Energy. Units 1 and 2 are equipped with cold-side ESPs and wet scrubbers. Green Station Units 1 and 2 typically fire two types of fuel: a bituminous coal and a blend of bituminous coals based on availability. Testing of Hg emissions in Unit 2 without reburning system in operation and at minimum OFA demonstrated that efficiencies of Hg reduction downstream of the ESP were 30-40%. Testing also demonstrated that OFA system operation at 22% air resulted in 10% incremental increase in Hg removal efficiency at the ESP outlet. About 80% of Hg in flue gas at ESP outlet was present in the oxidized form. Testing of Hg emissions under reburning conditions showed that Hg emissions decreased with LOI increase and ESP temperature decrease. Testing demonstrated that maximum Hg reduction downstream of ESP was 40-45% at ESP temperatures higher than 300 F and 60-80% at ESP temperatures lower than 300 F. The program objective to demonstrate 80% Hg removal at the ESP outlet has been met.

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

    NASA Technical Reports Server (NTRS)

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

    1990-01-01

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

  1. Mindfulness training for loneliness among Chinese college students: A pilot randomized controlled trial.

    PubMed

    Zhang, Na; Fan, Fu-Min; Huang, Si-Yuan; Rodriguez, Marcus A

    2016-10-05

    Loneliness has been found to predict a wide range of physical and mental health problems. It is suggested that China's One-Child Policy places young Chinese people at a particularly high risk for loneliness. Although loneliness is most prevalent in late adolescence and early adulthood, interventions have primarily targeted children or older adults with limited success. The current study examines a pilot randomized controlled trial of a mindfulness training program among Chinese college students. Participants with elevated loneliness (N = 50, ages 17-25) were randomized into either an 8-week mindfulness training or a control group. Self-reported measures of loneliness and mindfulness were administered at baseline and posttest. The training group also completed a program evaluation form and a 3-month follow-up assessment. Results provided preliminary evidence indicating that the intervention was feasible and effective at reducing loneliness among Chinese college students. Limitations and future directions were discussed.

  2. Yoga in the treatment of eating disorders within a residential program: A randomized controlled trial.

    PubMed

    Pacanowski, Carly R; Diers, Lisa; Crosby, Ross D; Neumark-Sztainer, Dianne

    2017-01-01

    To investigate the effect of yoga on negative affect (an eating disorders risk factor), 38 individuals in a residential eating disorder treatment program were randomized to a control or yoga intervention: 1 hour of yoga before dinner for 5 days. Negative affect was assessed pre- and post-meal. Mixed-effects models compared negative affect between groups during the intervention period. Yoga significantly reduced pre-meal negative affect compared to treatment as usual; however, the effect was attenuated post-meal. Many eating disorders programs incorporate yoga into treatment. This preliminary evidence sets the stage for larger studies examining yoga and eating disorder treatment and prevention.

  3. Bio-Contamination Control for Spacesuit Garments - A Preliminary Study

    NASA Technical Reports Server (NTRS)

    Rhodes, Richard; Korona, Adam; Orndoff, Evelyn; Ott, Mark; Poritz, Darwin

    2010-01-01

    This paper outlines a preliminary study to review, test, and improve upon the current state of spacesuit bio-contamination control. The study includes an evaluation of current and advanced suit materials, ground and on-orbit cleaning methods, and microbial test and analysis methods. The first aspect of this study was to identify potential anti-microbial textiles and cleaning agents, and to review current microbial test methods. The anti-microbial cleaning agent and textile market survey included a review of current commercial-off-the-shelf (COTS) products that could potentially be used as future space flight hardware. This review included replacements for any of the softgood layers that may become contaminated during an extravehicular activity (EVA), including the pressure bladder, liquid cooling garment, and ancillary comfort undergarment. After a series of COTS anti-microbial textiles and clean ing agents were identified, a series of four tests were conducted: (1) a stacked configuration test that was conducted in order to review how bio-contamination would propagate through the various suit layers, (2) a individual materials test that evaluated how well each softgood layer either promoted or repressed growth, (3) a cleaning agent test that evaluated the efficacy on each of the baseline bladders, and (4) an evaluation of various COTS anti-microbial textiles. All antimicrobial COTS materials tested appeared to control bacteria colony forming unit (CFU) growth better than the Thermal Comfort Undergarment (TCU) and ACES Liquid Cooling Garment (LCG)/EMU Liquid Cooling Ventilation Garment (LCVG) materials currently in use. However, a comparison of fungi CFU growth in COTS to current suit materials appeared to vary per material. All cleaning agents tested in this study appeared to inhibit the level of bacteria and fungi growth to acceptable levels for short duration tests. While several trends can be obtained from the current analysis, a series of test improvements are

  4. Preliminary Experimental Analysis of Soil Stabilizers for Contamination Control

    SciTech Connect

    Lagos, L.; Varona, J.; Zidan, A.; Gudavalli, R.; Wu, Kuang-His

    2006-07-01

    A major focus of Department of Energy's (DOE's) environmental management mission at the Hanford site involves characterizing and remediating contaminated soil and groundwater; stabilizing contaminated soil; remediating disposal sites; decontaminating and decommissioning structures, and demolishing former plutonium production process buildings, nuclear reactors, and separation plants; maintaining inactive waste sites; transitioning facilities into the surveillance and maintenance program; and mitigating effects to biological and cultural resources from site development and environmental cleanup and restoration activities. For example, a total of 470,914 metric tons of contaminated soil from 100 Areas remediation activities were disposed at the Environmental Restoration Disposal Facility (ERDF) during 2004. The Applied Research Center (ARC) at Florida International University (FIU) is supporting the Hanford's site remediation program by analyzing the effectiveness of several soil stabilizers (fixatives) for contamination control during excavation activities. The study is focusing on determining the effects of varying soil conditions, temperature, humidity and wind velocity on the effectiveness of the candidate stabilizers. The test matrix consists of a soil penetration-depth study, wind tunnel experiments for determination of threshold velocity, and temperature and moisture-controlled drying/curing experiments. These three set of experiments are designed to verify performance metrics, as well as provide insight into what fundamental forces are altered by the use of the stabilizer. This paper only presents the preliminary results obtained during wind tunnel experiments using dry Hanford soil samples (with 2.7% moisture by weight). These dry soil samples were exposed to varying wind speeds from 2.22 m/sec to 8.88 m/sec. Furthermore, airborne particulate data was collected for the dry Hanford soil experiments using an aerosol analyzer instrument. (authors)

  5. RANDOM ACCESS CONTROL OF ELECTROLUMINESCENT ELEMENTS.

    DTIC Science & Technology

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

  6. History of the Athens Canadian Random Bred and the Athens Random Bred control populations.

    PubMed

    Collins, K E; Marks, H L; Aggrey, S E; Lacy, M P; Wilson, J L

    2016-05-01

    The University of Georgia maintains two meat-type chicken control strains: the Athens Random Bred (ARB) and the Athens Canadian Random Bred (ACRB). The Athens Random Bred was developed from colored plumage commercial meat chicken strains in 1956. The ACRB is a replicate population of the Ottawa Meat Control strain which was developed in 1955 from white plumage commercial meat-type chickens. These genetic lines have been extremely valuable research resources and have been used extensively to provide comparative context to modern meat-type strains. The ACRB may be the oldest pedigreed control commercial meat-type chicken still in existence today. This paper reviews the history of the breed backgrounds for both control populations and reviews research utilizing the ACRB. © 2016 Poultry Science Association Inc.

  7. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

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

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

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

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

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  11. Preliminary control system design and analysis for the Space Station Furnace Facility thermal control system

    NASA Technical Reports Server (NTRS)

    Jackson, M. E.

    1995-01-01

    This report presents the Space Station Furnace Facility (SSFF) thermal control system (TCS) preliminary control system design and analysis. The SSFF provides the necessary core systems to operate various materials processing furnaces. The TCS is defined as one of the core systems, and its function is to collect excess heat from furnaces and to provide precise cold temperature control of components and of certain furnace zones. Physical interconnection of parallel thermal control subsystems through a common pump implies the description of the TCS by coupled nonlinear differential equations in pressure and flow. This report formulates the system equations and develops the controllers that cause the interconnected subsystems to satisfy flow rate tracking requirements. Extensive digital simulation results are presented to show the flow rate tracking performance.

  12. Random allocation in controlled clinical trials: a review.

    PubMed

    Egbewale, Bolaji Emmanuel

    2014-01-01

    An allocation strategy that allows for chance placement of participants to study groups is crucial to the experimental nature of randomised controlled trials. Following decades of the discovery of randomisation considerable erroneous opinion and misrepresentations of its concept both in principle and practice still exists. In some circles, opinions are also divided on the strength and weaknesses of each of the random allocation strategies. This review provides an update on various random allocation techniques so as to correct existing misconceptions on this all important procedure. This is a review of literatures published in the Pubmed database on concepts of common allocation techniques used in controlled clinical trials. Allocation methods that use; case record number, date of birth, date of presentation, haphazard or alternating assignment are non-random allocation techniques and should not be confused as random methods. Four main random allocation techniques were identified. Minimisation procedure though not fully a random technique, however, proffers solution to the limitations of stratification at balancing for multiple prognostic factors, as the procedure makes treatment groups similar in several important features even in small sample trials. Even though generation of allocation sequence by simple randomisation procedure is easily facilitated, a major drawback of the technique is that treatment groups can by chance end up being dissimilar both in size and composition of prognostic factors. More complex allocation techniques that yield more comparable treatment groups also have certain drawbacks. However, it is important that whichever allocation technique is employed, unpredictability of random assignment should not be compromised.

  13. Positive Psychology Interventions for Patients With Heart Disease: A Preliminary Randomized Trial.

    PubMed

    Nikrahan, Gholam Reza; Suarez, Laura; Asgari, Karim; Beach, Scott R; Celano, Christopher M; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Abbas, Rezaei; Huffman, Jeff C

    2016-01-01

    Positive psychologic characteristics have been linked to superior cardiac outcomes. Accordingly, in this exploratory study, we assessed positive psychology interventions in patients who had recently undergone a procedure to treat cardiovascular disease. Participants were randomly assigned to receive 1 of 3 different 6-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychologic outcome measures postintervention (7wk) and at follow-up (15wk) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. When comparing outcomes between interventions and control participants (N = 55 total), there were no between-group differences post-intervention, but at follow-up intervention participants had greater improvements in happiness (β = 14.43, 95% CI: 8.66-20.2, p < 0.001), depression (β = -3.87, 95% CI: -7.72 to 0.02, p = 0.049), and hope (β = 7.12, 95% CI: 1.25-13.00, p =0.017), with moderate-large effect sizes. Efficacy of the 3 interventions was similar. Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  14. Occupational Performance Coaching for Stroke Survivors: A Pilot Randomized Controlled Trial.

    PubMed

    Kessler, Dorothy; Egan, Mary; Dubouloz, Claire-Jehanne; McEwen, Sara; Graham, Fiona P

    We examined the feasibility of study procedures and explored the potential efficacy of Occupational Performance Coaching for stroke survivors (OPC-Stroke), an intervention designed to improve participation after stroke. In this pilot randomized controlled trial, 21 participants were randomized to receive the intervention or usual care. Recruitment, retention, and outcome completion rates were calculated. Direction of change and effect sizes were examined for the outcomes of participation, goal performance and satisfaction, goal self-efficacy, emotional well-being, and cognition. Rates of recruitment (66%) and retention (81%) were satisfactory. Participation scores improved for both groups with different trajectories. Results showed a moderate effect of OPC-Stroke for goal performance (η²partial d = .075) and satisfaction (η²partial d = .078) and a large effect for cognition (η²partial d = .167). Other outcome measures did not change as expected. Study procedures were generally feasible. Preliminary findings support testing to examine the efficacy of OPC-Stroke.

  15. 75 FR 55764 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Preliminary Results of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... International Trade Administration Dynamic Random Access Memory Semiconductors From the Republic of Korea... administrative review of the countervailing duty order on dynamic random access memory semiconductors from the... countervailing duty order on dynamic random access memory semiconductors (``DRAMS'') From the Republic of...

  16. PRELIMINARY RESULTS: EVALUATIONS OF THE ALTERNATIVE ASBESTOS CONTROL METHOD FOR BUILDING DEMOLITION

    EPA Science Inventory

    This presentation describes the preliminary results of the evaluations of the alternative asbestos control method for demolishing buildings containing asbestos, and are covered under the regulatory requirements of the Asbestos NESHAP. This abstract and presentation are based, at ...

  17. PRELIMINARY RESULTS: EVALUATIONS OF THE ALTERNATIVE ASBESTOS CONTROL METHOD FOR BUILDING DEMOLITION

    EPA Science Inventory

    This presentation describes the preliminary results of the evaluations of the alternative asbestos control method for demolishing buildings containing asbestos, and are covered under the regulatory requirements of the Asbestos NESHAP. This abstract and presentation are based, at ...

  18. A Preliminary Pilot Randomized Crossover Study of Uzara (Xysmalobium undulatum) versus Ibuprofen in the Treatment of Primary Dysmenorrhea

    PubMed Central

    Abd-El-Maeboud, Karim H. I.; Kortam, Mohamed A. M. F.; Ali, Mohamed S.; Ibrahim, Mostafa I.; Mohamed, Radwa M. M. Z.

    2014-01-01

    Objective Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen. Materials and Methods This randomized, comparative two way cross-over study comprised 60 single female students at Faculty of Medicine, Ain Shams University, Egypt, aged 19–28 years with moderate (n = 46) or severe (n = 14) primary dysmenorrhea. Participants were randomized to take either uzara (80 mg/8 hours for two doses, then 40 mg/8 hours) then ibuprofen (400 mg/6 hours) in two subsequent cycles or vice versa. The pain intensity, using VAS, was recorded immediately before taking the medication (0 hour) and after 4, 12, 24, 48–60, 96–120 hours. Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less, patient's global evaluation of the drug, absence from school, the use of a rescue medication, and, in those who continued the treatment, the pain intensity difference (PID) at different points after start of medication and its sum (SPID). Results Uzara was comparably effective to ibuprofen (78.3% vs. 86.7% of cycles; respectively), with comparable rates of effectiveness on global evaluation (being around 50% for either drug), and rates of school absences (11.7% vs. 13.3%; respectively). The need for rescue medication was different (18.3% and 10%; respectively), albeit with no statistical significance. The means of PID at different time points and SPID were comparable, with significantly lower average mean of VAS scores compared to that felt with no medication (1.6 vs. 6.8, p<0.001). Side effects were less with uzara than ibuprofen (0% vs. 8.3%, p<0.05). Conclusions Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects. These findings need to be confirmed by a properly designed trial with a larger sample size. Trial Registration Current Controlled Trials ISRCTN25618258 PMID:25119571

  19. Antidepressants as analgesics: a review of randomized controlled trials.

    PubMed Central

    Lynch, M E

    2001-01-01

    This review provides an overview of 59 randomized placebo-controlled trials that examined the analgesic effect of antidepressants. To summarize, there is significant evidence that the tricyclic group of antidepressants is analgesic and that trazodone is not; the data regarding selective serotonin reuptake inhibitors are conflicting. To date, there are no randomized controlled trials examining the potential analgesic action of nefazodone or venlafaxine, but on the basis of initial clinical reports and its structural similarity to other analgesics, venlafaxine shows promise as an analgesic. PMID:11212591

  20. Feasibility and Preliminary Efficacy of an After-School Program for Middle Schoolers with ADHD: A Randomized Trial in a Large Public Middle School

    ERIC Educational Resources Information Center

    Molina, Brooke S. G.; Flory, Kate; Bukstein, Oscar G.; Greiner, Andrew R.; Baker, Jennifer L.; Krug, Vicky; Evans, Steven W.

    2008-01-01

    Objective: This pilot study tests the feasibility and preliminary efficacy of an after-school treatment program for middle schoolers with ADHD using a randomized clinical trial design. Method: A total of 23 students with ADHD (25% female, 48% African American) from a large public middle school were randomly assigned to a 10-week program or to…

  1. Feasibility and Preliminary Efficacy of an After-School Program for Middle Schoolers with ADHD: A Randomized Trial in a Large Public Middle School

    ERIC Educational Resources Information Center

    Molina, Brooke S. G.; Flory, Kate; Bukstein, Oscar G.; Greiner, Andrew R.; Baker, Jennifer L.; Krug, Vicky; Evans, Steven W.

    2008-01-01

    Objective: This pilot study tests the feasibility and preliminary efficacy of an after-school treatment program for middle schoolers with ADHD using a randomized clinical trial design. Method: A total of 23 students with ADHD (25% female, 48% African American) from a large public middle school were randomly assigned to a 10-week program or to…

  2. Crossflow instability control on a swept-wing: Preliminary studies

    NASA Technical Reports Server (NTRS)

    Bridges, David H.

    1994-01-01

    The pressure distribution on a swept wing causes the streamlines at the edge of the boundary layer to be curved. This pressure gradient normal to the external streamline creates a velocity component normal to the external streamline within the boundary layer which is referred to as the crossflow velocity. Because the crossflow velocity profile perpendicular to the wing surface has an inflection point, the profile is unstable. The stationary instability mode takes the form of crossflow vortices. Under these conditions, the boundary layer on the wing is extremely unstable and transition to turbulent flow takes place much closer to the leading edge of the wing than it would on an unswept wing. Higher skin friction drag is associated with turbulent flow, and so better aircraft performance could be obtained if the crossflow could be eliminated One method of controlling crossflow that is being investigated is boundary-layer suction. An extensive airfoil suction experiment in the 8 feet Transonic Pressure Tunnel (TPT) at NASA Langley Research Center will begin late in 1994. Because of the size, complexity, and expense associated with this test, a number of 'risk-reduction' tests are currently being conducted. The 20 x 28 in. Shear Flow Control Tunnel at NASA Langley is being used for some of these tests. Prior to the summer of 1994, a flat plate with a swept leading edge was installed in the 20 x 28 in. tunnel, with a displacement body mounted on the tunnel ceiling that created a pressure distribution on the plate similar to the pressure distribution on a swept wing. The flow over the plate was investigated during the summer of 1994 using a laser Doppler velocimeter (LDV) system. The LDV measurements indicated the possible presence of multiple disturbance modes, a rarely-seen phenomena since, in most tests, one disturbance mode dominates. The possible existence of multiple disturbance modes in the flat plate boundary layer, however, means that the flow in the 20 x 28 in

  3. A randomized controlled trial of an electronic informed consent process.

    PubMed

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  4. Adaptive adjustment of the randomization ratio using historical control data

    PubMed Central

    Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

    2013-01-01

    Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal

  5. EMG assessment of analgesia in treatment of posttonsillectomy pain: random allocation, preliminary report.

    PubMed

    Vaiman, Michael; Krakovski, Daniel

    2012-02-01

    Surface electromyographic (sEMG) study of posttonsillectomy swallow-evoked muscular reactions was performed to assess validity of EMG in evaluation of analgesic drugs. Sixty randomly chosen operated adults were divided into group 1 (n=30) treated with oxycodone, and group 2 (n=30) treated with placebo. Pain assessment included visual analog scale (VAS) pain score and EMG data: the timing, electric amplitude, and graphic patterns of muscular activity. We investigated masseter, infrahyoid, and submental-submandibular muscles. Records from trapezius muscle were used for control. The results were compared with previously established normative database. The sEMG data were compared with VAS score. Oxycodone significantly reduced VAS pain score and changed muscle reactions to analgesia (amplitude) as was recorded by sEMG, whereas placebo reduced VAS pain score nonsignificantly and changed the reaction of the trapezius muscle only. Analgesia smoothes the recorded swallow peaks and increases time of deglutition. Statistically significant difference in muscle reactions was detected between the 2 groups. sEMG might be used for quantitative evaluation of analgesic drugs by assessment of muscular reactions to pain and to analgesia. This method might add quantitative justification to the information obtained by VAS pain testing and clinical data.

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  7. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

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

  8. In School Settings, Are All RCTs (Randomized Control Trials) Exploratory?

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

    The motivation for this paper is the authors' recent work on several randomized control trials in which they found the primary result, which averaged across subgroups or sites, to be moderated by demographic or site characteristics. They are led to examine a distinction that the Institute of Education Sciences (IES) makes between "confirmatory"…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  11. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  14. In School Settings, Are All RCTs (Randomized Control Trials) Exploratory?

    ERIC Educational Resources Information Center

    Newman, Denis; Jaciw, Andrew P.

    2012-01-01

    The motivation for this paper is the authors' recent work on several randomized control trials in which they found the primary result, which averaged across subgroups or sites, to be moderated by demographic or site characteristics. They are led to examine a distinction that the Institute of Education Sciences (IES) makes between "confirmatory"…

  15. Asthma Self-Management Model: Randomized Controlled Trial

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    DTIC Science & Technology

    2014-09-26

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

  20. Retention of Statistical Concepts in a Preliminary Randomization-Based Introductory Statistics Curriculum

    ERIC Educational Resources Information Center

    Tintle, Nathan; Topliff, Kylie; VanderStoep, Jill; Holmes, Vicki-Lynn; Swanson, Todd

    2012-01-01

    Previous research suggests that a randomization-based introductory statistics course may improve student learning compared to the consensus curriculum. However, it is unclear whether these gains are retained by students post-course. We compared the conceptual understanding of a cohort of students who took a randomization-based curriculum (n = 76)…

  1. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    PubMed Central

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  2. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

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

  3. What's in placebos: who knows? Analysis of randomized, controlled trials.

    PubMed

    Golomb, Beatrice A; Erickson, Laura C; Koperski, Sabrina; Sack, Deanna; Enkin, Murray; Howick, Jeremy

    2010-10-19

    No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting. To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials. 4 English-language general and internal medicine journals with high impact factors. 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009. Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus. Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002). Journals with high impact factors may not be representative. Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Niemi, Anna-Kaisa

    2017-04-03

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

  6. [Preliminary results of DERMATEL: prospective randomized study comparing synchronous and asynchronous modalities of teledermatology].

    PubMed

    Romero, G; García, M; Vera, E; Martínez, C; Cortina, P; Sánchez, P; Guerra, A

    2006-12-01

    There is considerable variability in the results of studies that evaluate diagnostic reliability in teledermatology. There are only two studies that compare the synchronous and asynchronous modalities of teleconsult in the same sample. We present the results of the pilot project DERMATEL, a study of diagnostic concordance that aims to increase the evidence of these aspects. One-hundred-fifty.nine patients referred by the general practitioner in the first consult were randomized (algorithm 3:2:1) in three arms: asyncronous teledermatology (store-and-forward or SAF), synchronous teldermatology (real-time or VTC), and conventional consult (CC). We used high-quality, fixed digital images in all cases. The patients on the VTC teledermatology arm were also evaluated by videoconference. Finally all patients attended a face-to-face consult, considered the gold standard of patient care. A second dermatologist evaluated the diagnostic and management concordance between the teleconsults and the face-to-face consults. One-hundred.forty-seven patients completed the study as follows: 74 in the SAF teledermatology arm, 47 in the VTC teledermatology arm and 26 in the conventional consult (control group). The teledermatological (SAF and VTC) and face-to-face evaluations were identical in 100 of 121 patients (82.6%). The errors were mild in 14 cases (11.6%) and severe in 7 (5.8%). The diagnostic concordance was very high (kappa=0,813). The errors grouped by diseases were as follows: 6/54 (11%) for tumors, 10/30 (33.3%) for inflammatory conditions, 1/20 (5%) for infectious diseases, 3/12 (25%) for alopecia/acne and 1/5 (20%) for others. There were 15 errors in the SAF teledermatology arm (20.3%) and 6 in the VTC teledermatology arm (12.8%); these differences were not statistically significant (chi2 1.12; p=0.288). The reliability of dermatological teleconsult is very high, especially for tumoral or infectious diseases. The synchronous interaction with audio requires more resources

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

    PubMed

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

    2013-08-01

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

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

    PubMed

    Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry

    2015-05-19

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

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

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

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

  10. APPENDIX C. PRELIMINARY ESTIMATES OF COSTS OF MERCURY EMISSION CONTROL TECHNOLOGIES FOR ELECTRIC UTILITY BOILERS

    EPA Science Inventory

    This appendix describes the development of a preliminary assessment of the performance and cost of mercury emission control technologies for utility boilers. It is to supplement an EPA examination of the co-benefits of potential pollution control options for the electric power in...

  11. Preliminary Guidelines For Using Suppression Fires to Control Wildfires in the Southeast

    Treesearch

    Robert W. Cooper

    1969-01-01

    Suppression firing is defied as the application of fire to speed or strengthen control action on free-burning wildfires. The key to successful suppression firing is availability of personnel knowledgeable in specific application plus an adequate supply of manpower and equipment to contain the set fire. Preliminary guidelines for the use of this fire-control tool are...

  12. APPENDIX C. PRELIMINARY ESTIMATES OF COSTS OF MERCURY EMISSION CONTROL TECHNOLOGIES FOR ELECTRIC UTILITY BOILERS

    EPA Science Inventory

    This appendix describes the development of a preliminary assessment of the performance and cost of mercury emission control technologies for utility boilers. It is to supplement an EPA examination of the co-benefits of potential pollution control options for the electric power in...

  13. Remote ischemic preconditioning in cyanosed neonates undergoing cardiopulmonary bypass: a randomized controlled trial.

    PubMed

    Jones, Bryn O; Pepe, Salvatore; Sheeran, Freya L; Donath, Susan; Hardy, Pollyanna; Shekerdemian, Lara; Penny, Daniel J; McKenzie, Ian; Horton, Stephen; Brizard, Christian P; d'Udekem, Yves; Konstantinov, Igor E; Cheung, Michael M H

    2013-12-01

    The myocardial protective effect of remote ischemic preconditioning has been demonstrated in heterogeneous groups of patients undergoing cardiac surgery. No studies have examined this technique in neonates. The present study was performed to examine the remote ischemic preconditioning efficacy in this high-risk patient group. A preliminary, randomized, controlled trial was conducted to investigate whether remote ischemic preconditioning in cyanosed neonates undergoing cardiac surgery confers protection against cardiopulmonary bypass. Two groups of neonates undergoing cardiac surgery were recruited for the present study: patients with transposition of the great arteries undergoing the arterial switch procedure and patients with hypoplastic left heart syndrome undergoing the Norwood procedure. The subjects were randomized to the remote ischemic preconditioning or sham control groups. Remote ischemic preconditioning was induced by four 5-minute cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Troponin I and the biomarkers for renal and cerebral injury were measured pre- and postoperatively. A total of 39 neonates were recruited-20 with transposition of the great arteries and 19 with hypoplastic left heart syndrome. Of the 39 neonates, 20 were randomized to remote ischemic preconditioning and 19 to the sham control group. The baseline demographics appeared similar between the randomized groups. The cardiopulmonary bypass and crossclamp times were not significantly different between the 2 groups. The troponin I levels were not significantly different at 6 hours after cardiopulmonary bypass nor were the postoperative inotrope requirements. Markers of renal (neutrophil gelatinase-associated lipocalin) and cerebral injury (S100b, neuron-specific enolase) were not significantly different between the 2 groups. Our data suggest that remote ischemic preconditioning in hypoxic neonates undergoing cardiopulmonary bypass surgery does not provide

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

    DTIC Science & Technology

    2008-05-01

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

  15. Zonisamide for Bipolar Depression: A Randomized, Double Blind, Placebo-Controlled, Adjunctive Trial

    PubMed Central

    Dauphinais, Deborah; Knable, Michael; Rosenthal, Joshua; Polanski, Mark; Rosenthal, Norman

    2011-01-01

    Objective This is the first multicenter, double blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of adjunctive zonisamide for the treatment of bipolar depression. Experimental design One hundred two patients with bipolar disorder, type I or II in the depressed phase of illness were randomized to either adjunctive zonisamide or placebo. The study consisted of three phases, a 7 to 30 day screening and stabilization phase, 6 weeks of blinded treatment and a 1 to 3 week discontinuation phase. MADRS score was the primary outcome variable. Secondary outcome measures included the YMRS, CGI-S, CGI-I, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), and an a priori analysis of response and remission. Metabolic parameters including weight, waist-hip ratio, body mass index, fasting glucose, cholesterol and triglyceride levels were also evaluated. Side effects were measured using the SAFTEE. Principal observations There were no statistically significant differences in response between subjects treated with adjunctive zonisamide vs. placebo controls for the primary or secondary outcome measures. There were also no differences between the groups with regard to response rate or remission rate. Conclusions In contrast to preliminary open label studies that suggested a role for zonisamide in bipolar depression, we could not confirm these results in a large double blind controlled study. PMID:27738356

  16. Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients

    PubMed Central

    Russell, Cynthia; Conn, Vicki; Ashbaugh, Catherine; Madsen, Richard; Wakefield, Mark; Webb, Andrew; Coffey, Deanna; Peace, Leanne

    2011-01-01

    Background Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients, yet there is a paucity of studies testing interventions in this area. Methods Using a randomized controlled trial design, 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring. Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management. The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person’s life routines, important people, and possible solutions to enhance medication taking. The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring. Results The mean medication adherence score for the continuous self-improvement intervention group (n = 8) was statistically significantly higher than the attention control group’s (n = 5) mean medication adherence score (p = 0.03). The continuous self-improvement intervention effect size (Cohen’s d) was large at 1.4. Participants’ perceptions of the intervention were highly favorable. Conclusions The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients. A fully-powered study with a diverse sample is needed to confirm these preliminary findings. PMID:21077956

  17. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    PubMed Central

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

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

    PubMed

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

    2015-04-01

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

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

    PubMed

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

    2014-12-01

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

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

    NASA Technical Reports Server (NTRS)

    Han, Kuoruey

    1990-01-01

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

  1. PRELIMINARY FIELD EVALUATION OF MERCURY CONTROL USING COMBUSTION MODIFICATIONS

    SciTech Connect

    Vitali Lissianski; Antonio Marquez

    2004-02-19

    In this project General Electric Energy and Environmental Research Corporation conducts a preliminary field evaluation of a novel technology, referred to as Hg/NO{sub x}, that can reduce emissions of both mercury (Hg) and oxides of nitrogen (NO{sub x}) from coal-fired power plants. The evaluation takes place in Green Station Unit 2 operated by Western Kentucky Energy. Reduction of Hg and NO{sub x} emissions in Unit 2 is achieved using coal reburning. Activities during first project year (January 23, 2003--January 22, 2004) included measurements of baseline Hg emissions in Unit 2 and pilot-scale testing. Baseline testing of Hg emissions in Green Unit 2 has been completed. Two fuels were tested with OFA system operating at minimum air flow. Mercury emissions were measured at ESP inlet and outlet, and at the stack using Ontario Hydro revised method. Testing demonstrated that baseline Hg reductions at ESP outlet and stack were 30-45% and 70-80%, respectively. Pilot-scale testing demonstrated good agreement with baseline measurements in Unit 2. Testing showed that fuel composition had an effect on the efficiency of Hg absorption on fly ash. Maximum achieved Hg removal in reburning was close to 90%. Maximum achieved Hg reduction at air staging conditions was 60%. Testing also demonstrated that lowering ESP temperature improved efficiency of Hg removal.

  2. Speech motor control and chronic back pain: a preliminary investigation.

    PubMed

    Roy, Nelson; Volinn, Ernest; Merrill, Ray M; Chapman, C Richard

    2009-01-01

    Chronic back pain and its sequelae can influence cognitive, affective, and neuromuscular functioning. Speech production--a complex sensorimotor activity--integrates shared cognitive, neuromuscular, and musculoskeletal resources, and therefore could be altered by chronic pain. The purpose of this preliminary investigation was twofold: 1) to determine whether speech alternating motion rates (i.e., speech AMRs) which require rapid, reciprocally coordinated articulatory movements were associated with chronic back pain; and 2) to identify factors that might mediate any observed alterations. Fifty participants, fully or partially disabled by chronic back pain, completed standardized protocols related to pain, depression, disability, medications, as well as speech AMRs. Higher levels of back pain were significantly associated with slower speech AMRs. Stepwise multiple regression assessed the unique and cumulative effects of specific variables such as degree of back pain, depression, level of disability, and medication use on speech motor performance. Speech motor slowness was uniquely related to back pain and the use of nonprescription pain medications, but not to level of depression or disability. Chronic back pain independently influences speech motor rates. Several explanatory models are proposed including pain-induced centrally mediated motor retardation/inhibition, reduced selective attention, and peripherally based "bracing/holding" of shared musculoskeletal environments.

  3. Preliminary investigations into UHCRE thermal control materials (A0178)

    NASA Technical Reports Server (NTRS)

    Levadou, Francois; Froggatt, Mike; Rott, Martin; Schneider, Eberhard

    1992-01-01

    An overview of the initial work that was done in the ESTEC Materials and Processes Division to evaluate the effect of space environment on the thermal blankets of the Ultra-Heavy Cosmic Ray Nuclei Experiments (UHCRE) is presented. The topics covered include: (1) a preliminary survey of the perforations of the two-thirds of the thermal blanket returned to ESTEC; (2) thermo-optical properties and thickness recessions of three samples cut from each of the third center parts of the 16 thermal blankets were measured and effects of environments (sun illumination and atomic oxygen fluences); (3) contamination was analyzed on trays, external blanket and internal aluminized Kapton foil by IR technique and scanning electron microscopy SEM/EDX examination; (4) the pattern of contamination on the Al Kapton foils was observed, sketched, and related to atomic oxygen flow; and (5) the Long Duration Exposure Facility (LDEF) yaw angle misorientation was evaluated from the contaminated areas visible on some of the trays. In addition, impacts of micrometeoroids and space debris were experimentally simulated on spare flight thermal blankets. Relations between penetration/perforation hole characteristics and projectile parameters were established.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-07-06

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

  6. A Randomized Controlled Trial of Caries Prevention in Dental Practice.

    PubMed

    Tickle, M; O'Neill, C; Donaldson, M; Birch, S; Noble, S; Killough, S; Murphy, L; Greer, M; Brodison, J; Verghis, R; Worthington, H V

    2017-07-01

    We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once

  7. Preliminary criteria for the fracture control of space shuttle structures

    NASA Technical Reports Server (NTRS)

    1971-01-01

    The complex and multidisciplinary factors are presented which relate to the prevention of structural failure due to the initiation or propagation of cracks or crack-like defects. The fracture control criteria are applicable to space shuttle components which are: (1) susceptible to cracking or fracture on the basis of anticipated loads and environment, and (2) critical to either crew safety or system performance. The criteria define the design, fabrication, environmental control, inspection, maintenance, repair, and verification procedures required for adequate fracture control.

  8. Tibetan sound meditation for cognitive dysfunction: results of a randomized controlled pilot trial.

    PubMed

    Milbury, K; Chaoul, A; Biegler, K; Wangyal, T; Spelman, A; Meyers, C A; Arun, B; Palmer, J L; Taylor, J; Cohen, L

    2013-10-01

    Although chemotherapy-induced cognitive impairment is common among breast cancer patients, evidence for effective interventions addressing cognitive deficits is limited. This randomized controlled trial examined the feasibility and preliminary efficacy of a Tibetan Sound Meditation (TSM) program to improve cognitive function and quality of life in breast cancer patients. Forty-seven breast cancer patients (mean age 56.3 years), who were staged I-III at diagnosis, 6-60 months post-chemotherapy, and reported cognitive impairment at study entry were recruited. Participants were randomized to either two weekly TSM sessions for 6 weeks or a wait list control group. Neuropsychological assessments were completed at baseline and 1 month post-treatment. Self-report measures of cognitive function (Functional Assessment of Cancer Therapy (FACT)-Cog), quality of life (SF-36), depressive symptoms (Center for Epidemiologic Studies Depression Scale), sleep disturbance (Pittsburgh Sleep Quality Index), fatigue (Brief Fatigue Inventory), and spirituality (FACT-Sp) were completed at baseline, the end of treatment, and 1 month later. Relative to the control group, women in the TSM group performed better on the verbal memory test (Rey Auditory Verbal Learning Test trial 1) (p = 0.06) and the short-term memory and processing speed task (Digit Symbol) (p = 0.09) and reported improved cognitive function (p = 0.06), cognitive abilities (p = 0.08), mental health (p = 0.04), and spirituality (p = 0.05) at the end of treatment but not 1 month later. This randomized controlled trial revealed that TSM program appears to be a feasible and acceptable intervention and may be associated with short-term improvements in objective and subjective cognitive function as well as mental health and spirituality in breast cancer patients. Copyright © 2013 John Wiley & Sons, Ltd.

  9. A Multicenter, Randomized, Controlled Trial of Osteopathic Manipulative Treatment on Preterms

    PubMed Central

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D’Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D’Incecco, Carmine; Barlafante, Gina

    2015-01-01

    Background Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. Materials and Methods The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. Results A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Conclusions Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants. PMID:25974071

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

    PubMed Central

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

    2014-01-01

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

  11. Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial.

    PubMed

    Raith, Wolfgang; Schmölzer, Georg M; Resch, Bernhard; Reiterer, Fritz; Avian, Alexander; Koestenberger, Martin; Urlesberger, Berndt

    2015-11-01

    Neonatal abstinence syndrome (NAS) is usually treated with opiate derivatives and supported with nonpharmacological treatment. This prospective, randomized, controlled, blinded, single-center study was carried out between March 2009 and November 2014. Newborn infants diagnosed with NAS after maternal opioid substitution therapy were eligible for inclusion. Infants were randomly allocated to the acupuncture group (combining laser acupuncture and pharmacological therapy of morphine and phenobarbital) or control group (pharmacological therapy alone). Laser acupuncture was performed with a LABpen MED 10 (675 nm/10 mW) at 5 ear and 4 body acupuncture points, bilaterally, and sessions were repeated every day. The primary outcome measure was duration of oral morphine therapy for NAS. Secondary outcomes included highest single Finnegan score, time to highest single Finnegan score, maximum amount of oral morphine solution (in milliliters per kilogram and milligrams per kilogram), time to maximum amount of oral morphine solution, and length of hospital stay. Twenty-eight newborns (14 in each group) were eligible for analysis. Duration of oral morphine therapy was significantly reduced in the acupuncture group compared with the control group (28 vs 39 days, respectively, P = .019). In addition, we observed a significantly reduced length of hospital stay in the acupuncture group compared with the control group (35 days [interquartile range 25 to 47] vs 50 days [36 to 66], P = .048). Adjunctive laser acupuncture significantly reduced the duration of morphine therapy in newborns with NAS. Copyright © 2015 by the American Academy of Pediatrics.

  12. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    PubMed

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

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

  13. Vibration Control of Deployable Astromast Boom: Preliminary Experiments

    NASA Technical Reports Server (NTRS)

    Swaminadham, M.; Hamilton, David A.

    1994-01-01

    This paper deals with the dynamic characterization of a flexible aerospace solar boom. The modeling issues and sine dwell vibration testing to determine natural frequencies and mode shapes of a continuous-longer on deployable ASTROMAST lattice boom are discussed. The details of the proof-of-concept piezoelectric active vibration experiments on a simple cantilever beam to control its vibrations are presented. The control parameters like voltage to the controller crystal and its location are investigated, to determine the effectiveness of control element to suppress selected resonant vibrations of the test specimen. Details of this experiment and plans for its future adaptation to the prototype structure are also discussed.

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

    NASA Astrophysics Data System (ADS)

    Politis, Gerasimos; Politis, Konstantinos

    2014-05-01

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

  15. Improvement in bronchial squamous metaplasia in smokers treated with folate and vitamin B/sub 12/: report of a preliminary randomized, double-blind intervention trial

    SciTech Connect

    Heimburger, D.C.; Alexander, C.B.; Birch, R.; Butterworth, C.E. Jr.; Bailey, W.C.; Krumdieck, C.L.

    1988-03-11

    To test whether changes in folate and vitamin B/sub 12/ nutrition modify the severity of potentially premalignant lesions identified by cytology in sputum samples of smokers, the authors conducted a randomized, controlled prospective intervention trial in smokers with bronchial squamous metaplasia. Seventy-three men with a history of 20 or more pack-years of cigarette smoking who had metaplasia on one or more sputum samples were stratified according to smoking level and randomly assigned to four months' treatment with either placebo or 10 mg of folate plus 500 ..mu..g of hydroxocobalamin. Direct cytological comparison of the two groups after four months showed significantly greater reduction of atypia in the supplemented group. This provides preliminary evidence that atypical bronchial squamous metaplasia may be reduced by supplementation with folate and vitamin B/sub 12/. However, the significance of these findings is tempered by substantial spontaneous variation in sputum cytologies, the small study population, the short duration of the trial, and the supraphysiological doses of folate and B/sub 12/ used. The results should not be construed as pointing to a potential way of preventing lung cancer in individuals who continue to smoke or as supporting self-medication with large doses of folate or B/sub 12/ by smokers.

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

    PubMed

    Esala, Jennifer J; Taing, Sopheap

    2017-02-01

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

  17. A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

    PubMed

    Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

    2017-08-31

    The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values < 0.05). One patient in the control group experienced ecchymosis. All implants were successful in function. Application of laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

  18. Preliminary statistical assessment towards characterization of biobotic control.

    PubMed

    Latif, Tahmid; Meng Yang; Lobaton, Edgar; Bozkurt, Alper

    2016-08-01

    Biobotic research involving neurostimulation of instrumented insects to control their locomotion is finding potential as an alternative solution towards development of centimeter-scale distributed swarm robotics. To improve the reliability of biobotic agents, their control mechanism needs to be precisely characterized. To achieve this goal, this paper presents our initial efforts for statistical assessment of the angular response of roach biobots to the applied bioelectrical stimulus. Subsequent findings can help to understand the effect of each stimulation parameter individually or collectively and eventually reach reliable and consistent biobotic control suitable for real life scenarios.

  19. Cognitive remediation for depressed inpatients: Results of a pilot randomized controlled trial.

    PubMed

    Trapp, Wolfgang; Engel, Sinha; Hajak, Goeran; Lautenbacher, Stefan; Gallhofer, Bernd

    2016-01-01

    Neurocognitive deficits that persist despite antidepressive treatment and affect social and vocational functioning are well documented in major depressive disorder. Cognitive training approaches have proven successful in ameliorating these deficits in other psychiatric groups, but very few studies have been conducted in unipolar depressive patients by now. In contrast to previous studies solely including outpatients, effects of a cognitive remediation intervention on neurocognitive functioning of depressed inpatients were assessed by the present study. A randomized controlled trial was carried out with 46 depressed inpatients of a psychiatric hospital. Patients were randomly assigned to either a control group that received standard drug and non-drug (cognitive behavioural, occupational, sports, relaxation and music therapy) antidepressive treatment or a remediation group that additionally received 12 sessions of cognitive training for a total of 4 weeks (three sessions per week). An intent to treat analysis and a last observation carried forward method was used for data analyses. Patients of the remediation group demonstrated greater improvements in neurocognitive measures of verbal and nonverbal memory, working memory and executive function (Cohen's d effect sizes between .52 and .98). These results provide preliminary evidence that cognitive remediation interventions can be successfully applied also in psychiatric inpatients experiencing an acute depressive episode. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  20. Systematically developed pilot randomized controlled trial of exercise and cognition in persons with multiple sclerosis.

    PubMed

    Sandroff, Brian M; Balto, Julia M; Klaren, Rachel E; Sommer, Sarah K; DeLuca, John; Motl, Robert W

    2016-10-01

    Cognitive impairment is common and debilitating among persons with multiple sclerosis (MS) and might be managed with exercise training. The present pilot study adopted a single-blind randomized controlled trial (RCT) design and is the first to examine the effect of a systematically developed, progressive treadmill walking exercise training intervention on cognition among fully ambulatory persons with MS. Ten fully ambulatory females with MS were randomly assigned into exercise training intervention or waitlist control conditions. The intervention condition involved 12 weeks of supervised, progressive chronic treadmill walking exercise training. Participants underwent measures of cognition (i.e., cognitive processing speed (CPS), executive function), walking performance, and cardiorespiratory fitness before and after the 12-week period; baseline and follow-up assessments were performed by blinded assessors. Overall, there were large intervention effects on CPS (d = 0.95), walking performance (d = 0.76), and cardiorespiratory fitness (d > 1.08). The change in cardiorespiratory fitness was significantly associated with change in CPS (r = .60), but not walking performance. This small pilot RCT provides preliminary proof-of-concept data supporting progressive treadmill walking exercise training for potentially improving CPS, walking performance, and cardiorespiratory fitness in fully ambulatory persons with MS, and that improved fitness might be a possible mechanism for improved CPS.

  1. Aquatic physical therapy for children with developmental coordination disorder: a pilot randomized controlled trial.

    PubMed

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-05-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7 years 1 month; 10 males) with DCD were randomly allocated to receive either six sessions of aquatic therapy (once weekly session of 30 min for 6-8 weeks) or to a wait-list (control group). The intervention and measures were demonstrated to be feasible, but barriers, such as limited appointment times and accessibility, were encountered. Analysis of covariance indicated that at posttest, mean scores on the Movement Assessment Battery were higher for children who received aquatic therapy compared to those on the wait-list (p = .057). Similar trends were noted on the physical competence portion of the Pictorial Scale of Perceived Competence and Social Acceptance (p = .058). Participation levels, as measured by a parent questionnaire, showed improvement for both groups. Potential facilitators and barriers to implementation of an aquatic therapy for children with DCD are discussed.

  2. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. Methods/Design This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days. Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. Discussion To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. Trial registration ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013. PMID:25306234

  3. Merocel versus Nasopore for Nasal Packing: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Jianzhang; Cai, Changping; Wang, Shili

    2014-01-01

    Objective To compare the clinical outcomes, including efficacy and complications, of Merocel versus Nasopore as a nasal packing material after nasal surgery. Methods Relevant randomized controlled trials were identified from electronic databases (The Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure and Chinese Biomedical Database). Conference proceedings and references from identified trials and review articles were also searched. Outcome measures were pain during nasal packing, pain and bleeding upon packing removal, pressure sensation, nasal blockage, formation of synechiae, mucosal healing, and patients' general satisfaction. Results Seven randomized controlled trials met criteria for analysis. Compared with Merocel, Nasopore significantly reduced patients' subjective symptoms including in situ pain (pain experienced while packing is in place), nasal pressure, pain and bleeding during packing removal, and increased patients' general satisfaction with nasal packing. There were no significant differences in nasal obstruction, adhesion and mucosal healing between the Merocel and Nasopore groups. Conclusions Preliminary evidence suggests that Nasopore may be superior to Merocel as a nasal packing material with regard to in situ pain, pain and bleeding upon removal, pressure, and general satisfaction and does not differ from Merocel in terms of nasal obstruction, tissue adhesion, and long-term mucosal healing. PMID:24710428

  4. Complementary and alternative medicine (CAM) in reproductive-age women: a review of randomized controlled trials.

    PubMed

    Fugh-Berman, Adriane; Kronenberg, Fredi

    2003-01-01

    Complementary and alternative medicine (CAM) therapies are widely used in the general population. This paper reviews randomized controlled trials of CAM therapies for obstetrical and gynecologic conditions and presents therapies that are likely to be used by women of reproductive age and by pregnant women. Sources included English-language papers in MEDLINE 1966-2002 and AMED (1985-2000) and the authors' extensive holdings. Randomized controlled clinical trials of CAM therapies for obstetric and gynecologic conditions. Clinical information was extracted from the articles and summarized in tabular form or in the text. Ninety-three trials were identified, 45 of which were for pregnancy-related conditions, 33 of which were for premenstrual syndrome, and 13 of which were for dysmenorrhea. Data support the use of acupressure for nausea of pregnancy and calcium for PMS. Preliminary studies indicate a role for further research on Vitamin B6 or ginger for nausea and vomiting of pregnancy; calcium, magnesium, Vitamin B6, or chaste-tree berry extract for PMS; and a low-fat diet, exercise, or fish oil supplementation for dysmenorrhea. Limited evidence supports the efficacy of some CAM therapies. Exposure of women of reproductive age to these therapies can be expected.

  5. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    PubMed

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  6. Nonlinear feedback method of robot control - A preliminary experimental study

    NASA Technical Reports Server (NTRS)

    Tarn, T. J.; Ganguly, S.; Li, Z.; Bejczy, A. K.

    1990-01-01

    The nonlinear feedback method of robot control has been experimentally implemented on two PUMA 560 robot arms. The feasibility of the proposed controller, which was shown viable through simulation results earlier, is stressed. The servomechanism operates in task space, and the nonlinear feedback takes care of the necessary transformations to compute the necessary joint currents. A discussion is presented of the implementation with details of the experiments performed. The performance of the controller is encouraging but was limited to 100-Hz sampling frequency and to derived velocity information at the time of the experimentation. The setup of the lab, the software aspects, results, and the control hardware architecture that has recently been implemented are discussed.

  7. Nonlinear feedback method of robot control - A preliminary experimental study

    NASA Technical Reports Server (NTRS)

    Tarn, T. J.; Ganguly, S.; Li, Z.; Bejczy, A. K.

    1990-01-01

    The nonlinear feedback method of robot control has been experimentally implemented on two PUMA 560 robot arms. The feasibility of the proposed controller, which was shown viable through simulation results earlier, is stressed. The servomechanism operates in task space, and the nonlinear feedback takes care of the necessary transformations to compute the necessary joint currents. A discussion is presented of the implementation with details of the experiments performed. The performance of the controller is encouraging but was limited to 100-Hz sampling frequency and to derived velocity information at the time of the experimentation. The setup of the lab, the software aspects, results, and the control hardware architecture that has recently been implemented are discussed.

  8. Partner randomized controlled trial: study protocol and coaching intervention.

    PubMed

    Garbutt, Jane M; Highstein, Gabrielle; Yan, Yan; Strunk, Robert C

    2012-04-02

    Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year

  9. Partner randomized controlled trial: study protocol and coaching intervention

    PubMed Central

    2012-01-01

    Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance

  10. Preliminary Assessment of Optimal Longitudinal-Mode Control for Drag Reduction through Distributed Aeroelastic Shaping

    NASA Technical Reports Server (NTRS)

    Ippolito, Corey; Nguyen, Nhan; Lohn, Jason; Dolan, John

    2014-01-01

    The emergence of advanced lightweight materials is resulting in a new generation of lighter, flexible, more-efficient airframes that are enabling concepts for active aeroelastic wing-shape control to achieve greater flight efficiency and increased safety margins. These elastically shaped aircraft concepts require non-traditional methods for large-scale multi-objective flight control that simultaneously seek to gain aerodynamic efficiency in terms of drag reduction while performing traditional command-tracking tasks as part of a complete guidance and navigation solution. This paper presents results from a preliminary study of a notional multi-objective control law for an aeroelastic flexible-wing aircraft controlled through distributed continuous leading and trailing edge control surface actuators. This preliminary study develops and analyzes a multi-objective control law derived from optimal linear quadratic methods on a longitudinal vehicle dynamics model with coupled aeroelastic dynamics. The controller tracks commanded attack-angle while minimizing drag and controlling wing twist and bend. This paper presents an overview of the elastic aircraft concept, outlines the coupled vehicle model, presents the preliminary control law formulation and implementation, presents results from simulation, provides analysis, and concludes by identifying possible future areas for research

  11. A preliminary look at control augmented dynamic response of structures

    NASA Technical Reports Server (NTRS)

    Ryan, R. S.; Jewell, R. E.

    1983-01-01

    The augmentation of structural characteristics, mass, damping, and stiffness through the use of control theory in lieu of structural redesign or augmentation was reported. The standard single-degree-of-freedom system was followed by a treatment of the same system using control augmentation. The system was extended to elastic structures using single and multisensor approaches and concludes with a brief discussion of potential application to large orbiting space structures.

  12. Epicatechin, procyanidins, cocoa, and appetite: a randomized controlled trial.

    PubMed

    Greenberg, James A; O'Donnell, Ryan; Shurpin, Miriam; Kordunova, Dorina

    2016-09-01

    In 2 randomized controlled trials, it was reported that dark chocolate acutely decreased appetite in human subjects, but the authors did not assess the types or concentrations of cocoa compounds that are needed. Other studies have suggested that the cocoa compounds epicatechin and procyanidins may be involved. We sought to test the hypotheses that, compared with placebo (an alkalized cocoa mixture containing essentially no epicatechin or procyanidins), the following beverages cause a decrease in appetite: 1) a nonalkalized cocoa mixture; 2) epicatechin plus placebo; and 3) procyanidins plus placebo. We measured the concentrations of cocoa compounds in all beverages. We used a 4-way randomized, crossover, placebo-controlled trial that was balanced for period and carryover effects in 28 healthy, young-adult men. We also conducted a smaller (n = 14), parallel, secondary randomized trial in which we explored the effects of higher doses of epicatechin and procyanidins. Our primary measure of appetite was ad libitum pizza intake 150 min after beverage ingestion. We used a linear mixed-model analysis. Intakes of beverages with the nonalkalized cocoa mixture that contained 0.6 mg epicatechin, 0.2 mg catechin, and 2.9 mg monomer-decamer procyanidins/kg body weight did not decrease pizza intake significantly (P = 0.29) compared with intake of the placebo. In the smaller secondary trial, a combination of epicatechin and the nonalkalized cocoa mixture that contained 1.6 mg epicatechin/kg body weight significantly decreased pizza intake by 18.7% (P = 0.04). Our nonalkalized cocoa mixture was associated with an acute decrease in food intake only after being supplemented with epicatechin. It is possible that epicatechin at a dose of >1.6 mg/kg body weight, alone or in concert with appropriate catalytic cocoa compounds, may be useful for helping people control their food intakes. This trial was registered at clinicaltrials.gov as NCT02408289. © 2016 American Society for Nutrition.

  13. A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities.

    PubMed

    Lewis, Vivian; Martina, Camille A; McDermott, Michael P; Trief, Paula M; Goodman, Steven R; Morse, Gene D; LaGuardia, Jennifer G; Sharp, Daryl; Ryan, Richard M

    2016-07-01

    To conduct a randomized controlled trial to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010 to 2013 into mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows, and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability.The primary analysis was a comparison of intervention effects on changes in protégés' satisfaction of their basic psychological needs (competence, autonomy, and relatedness) with their mentor. They completed a well-validated, online questionnaire every two months for one year. There was no significant effect at the end of one year of either mentor training or peer mentoring on protégés' psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés' overall psychological need satisfaction with their mentor at two months, the time point closest to completing mentor training. This randomized controlled trial showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study.

  14. Preliminary Attitude Control Studies for the ASTER Mission

    NASA Astrophysics Data System (ADS)

    Victorino Sarli, Bruno; Luís da Silva, André; Paglione, Pedro

    2013-10-01

    This work discusses an attitude control study for the ASTER mission, the first Brazilian mission to the deep space. The study is part of a larger scenario that is the development of optimal trajectories to navigate in the 2001 SN263 asteroid system, together with the generation of orbit and attitude controllers for autonomous operation. The spacecraft attitude is defined from the orientation of the body reference system to the Local Vertical Local Horizontal (LVLH) of a circular orbit around the Alpha asteroid. The rotational equations of motion involve the dynamic equations, where the three angular speeds are generated from a set of three reaction wheels and the gravitational torque. The rotational kinematics is represented in the Euler angles format. The controller is developed via the linear quadratic regulator approach with output feedback. It involves the generation of a stability augmentation (SAS) loop and a tracking outer loop, with a compensator of desired structure. It was chosen the feedback of the p, q and r angular speeds in the SAS, one for each reaction wheel. In the outer loop, it was chosen a proportional integral compensator. The parameters are tuned using a numerical minimization that represents a linear quadratic cost, with weightings in the tracking error and controls. Simulations are performed with the nonlinear model. For small angle manoeuvres, the linear results with reaction wheels or thrusters are reasonable, but, for larger manoeuvres, nonlinear control techniques shall be applied, for example, the sliding mode control.

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

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

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

  16. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  18. Individual and Family Factors Impacting Diabetic Control for the Adolescent: A Preliminary Study.

    ERIC Educational Resources Information Center

    Lawler, Mary; And Others

    Sixteen adolescents between the ages of 15 and 18 years and their parents participated in a preliminary study on the impact of family and individual factors on diabetes control for the adolescent. It was hypothesized that there was a relationship between the adolescent's perception of adolescent development, social support, depression, family…

  19. Identifying Efficacious Treatment Components of Panic Control Treatment for Adolescents: A Preliminary Examination

    ERIC Educational Resources Information Center

    Micco, Jamie A.; Choate-Summers, Molly L.; Ehrenreich, Jill T.; Pincus, Donna B.; Mattis, Sara G.

    2007-01-01

    Panic Control Treatment for Adolescents (PCT-A) is a developmentally sensitive and efficacious treatment for adolescents with panic disorder. The present study is a preliminary examination of the relative efficacy of individual treatment components in PCT-A in a sample of treatment completers; the study identified when rapid improvements in panic…

  20. PRELIMINARY PERFORMANCE AND COST ESTIMATES OF MERCURY EMISSION CONTROL OPTIONS FOR ELECTRIC UTILITY BOILERS

    EPA Science Inventory


    The paper discusses preliminary performance and cost estimates of mercury emission control options for electric utility boilers. Under the Clean Air Act Amendments of 1990, EPA had to determine whether mercury emissions from coal-fired power plants should be regulated. To a...

  1. PRELIMINARY PERFORMANCE AND COST ESTIMATES OF MERCURY EMISSION CONTROL OPTIONS FOR ELECTRIC UTILITY BOILERS

    EPA Science Inventory


    The paper discusses preliminary performance and cost estimates of mercury emission control options for electric utility boilers. Under the Clean Air Act Amendments of 1990, EPA had to determine whether mercury emissions from coal-fired power plants should be regulated. To a...

  2. Identifying Efficacious Treatment Components of Panic Control Treatment for Adolescents: A Preliminary Examination

    ERIC Educational Resources Information Center

    Micco, Jamie A.; Choate-Summers, Molly L.; Ehrenreich, Jill T.; Pincus, Donna B.; Mattis, Sara G.

    2007-01-01

    Panic Control Treatment for Adolescents (PCT-A) is a developmentally sensitive and efficacious treatment for adolescents with panic disorder. The present study is a preliminary examination of the relative efficacy of individual treatment components in PCT-A in a sample of treatment completers; the study identified when rapid improvements in panic…

  3. Mental practice enhances surgical technical skills: a randomized controlled study.

    PubMed

    Arora, Sonal; Aggarwal, Rajesh; Sirimanna, Pramudith; Moran, Aidan; Grantcharov, Teodor; Kneebone, Roger; Sevdalis, Nick; Darzi, Ara

    2011-02-01

    To assess the effects of mental practice on surgical performance. Increasing concerns for patient safety have highlighted a need for alternative training strategies outside the operating room. Mental practice (MP), "the cognitive rehearsal of a task before performance," has been successful in sport and music to enhance skill. This study investigates whether MP enhances performance in laparoscopic surgery. After baseline skills testing, 20 novice surgeons underwent training on an evidence-based virtual reality curriculum. After randomization using the closed envelope technique, all participants performed 5 Virtual Reality (VR) laparoscopic cholecystectomies (LC). Mental practice participants performed 30 minutes of MP before each LC; control participants viewed an online lecture. Technical performance was assessed using video Objective Structured Assessment of Technical Skills-based global ratings scale (scored from 7 to 35). Mental imagery was assessed using a previously validated Mental Imagery Questionnaire. Eighteen participants completed the study. There were no intergroup differences in baseline technical ability. Learning curves were demonstrated for both MP and control groups. Mental practice was superior to control (global ratings) for the first LC (median 20 vs 15, P = 0.005), second LC (20.5 vs 13.5, P = 0.001), third LC (24 vs 15.5, P < 0.001), fourth LC (25.5 vs 15.5, P < 0.001) and the fifth LC (27.5 vs 19.5, P = 0.00). The imagery for the MP group was also significantly superior to the control group across all sessions (P < 0.05). Improved imagery significantly correlated with better quality of performance (ρ 0.51–0.62, Ps < 0.05). This is the first randomized controlled study to show that MP enhances the quality of performance based on VR laparoscopic cholecystectomy. This may be a time- and cost-effective strategy to augment traditional training in the OR thus potentially improving patient care.

  4. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

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

    PubMed

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

    2009-09-01

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

  6. Preliminary software development for optical mirror figure control

    NASA Technical Reports Server (NTRS)

    Mackinnon, D.

    1970-01-01

    The maintenance of accurate primary mirror figure in the face of environmental disturbances is the key to the achievement of diffraction-limited performance in a large space telescope. In order to develop the concepts of optical mirror figure control, an experimental program was initiated. A major component in this experiment will be an XDS Sigma 5.7 digital computer which will realize the control algorithm. A software package is described which realizes linear optimal, simplified linear, and iterative optimal control algorithms. The software, in addition, provides for interactive communication between the operator and the computer, and interaction between the computer and the experimental hardware elements. A brief description of a small hybrid computer system is also presented.

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  9. Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence.

    PubMed

    Longo, Marie; Wickes, Wendy; Smout, Matthew; Harrison, Sonia; Cahill, Sharon; White, Jason M

    2010-01-01

    To investigate the safety and efficacy of once-daily supervised oral administration of sustained-release dexamphetamine in people dependent on methamphetamine. Randomized, double-blind, placebo-controlled trial. Forty-nine methamphetamine-dependent drug users from Drug and Alcohol Services South Australia (DASSA) clinics. Participants were assigned randomly to receive up to 110 mg/day sustained-release dexamphetamine (n = 23) or placebo (n = 26) for a maximum of 12 weeks, with gradual reduction of the study medication over an additional 4 weeks. Medication was taken daily under pharmacist supervision. Primary outcome measures included treatment retention, measures of methamphetamine consumption (self-report and hair analysis), degree of methamphetamine dependence and severity of methamphetamine withdrawal. Hair samples were analysed for methamphetamine using liquid chromatography-mass spectrometry. Treatment retention was significantly different between groups, with those who received dexamphetamine remaining in treatment for an average of 86.3 days compared with 48.6 days for those receiving placebo (P = 0.014). There were significant reductions in self-reported methamphetamine use between baseline and follow-up within each group (P < 0.0001), with a trend to a greater reduction among the dexamphetamine group (P = 0.086). Based on hair analysis, there was a significant decrease in methamphetamine concentration for both groups (P < 0.0001). At follow-up, degree of methamphetamine dependence was significantly lower in the dexamphetamine group (P = 0.042). Dexamphetamine maintenance was not associated with serious adverse events. The results of this preliminary study have demonstrated that a maintenance pharmacotherapy programme of daily sustained-release amphetamine dispensing under pharmacist supervision is both feasible and safe. The increased retention in the dexamphetamine group, together with the general decreases in methamphetamine use, degree of dependence

  10. A Preliminary Analysis of California's New Local Control Funding Formula

    ERIC Educational Resources Information Center

    Wolf, Rebecca; Sands, Janelle

    2016-01-01

    California recently overhauled its K-12 public education finance system. Enacted in 2013, the Local Control Funding Formula (LCFF) replaced California's 40-year-old funding formula. The LCFF increases district officials' fiscal flexibility; provides more resources to districts serving larger proportions of low-income, English learner (EL), and…

  11. 1984 Automated Authority Control Opinion Poll: A Preliminary Analysis.

    ERIC Educational Resources Information Center

    Tillett, Barbara B.

    1985-01-01

    Discusses results of opinion poll conducted by Library and Information Technology Association of 334 academic, public, government, and corporate libraries concerning authority control in the online environment. Use of authority files on bibliographic utilities, presence of online catalogs, Library of Congress authority records, and comments from…

  12. Auricular Acupressure on Specific Points for Hemodialysis Patients with Insomnia: A Pilot Randomized Controlled Trial

    PubMed Central

    Wu, Yuchi; Su, Guobin; Chen, Shuhui; Guo, Xinfeng; Wu, Xiuqing; Liu, Xusheng; Lin, Qizhan

    2015-01-01

    Objectives To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA) on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD) patients with insomnia. Methods Sixty three (63) eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32), or sham AA (SAA) group received AA on points irrelevant to insomnia treatment (n=31) for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI) global score by 3 points and more. Results Fifty-eight (58) participants completed the trial and five dropped out. Twenty participants in AA group (62.5%) and ten in SAA group (32.3%) responded to the eight-week interventions (χ2 = 5.77, P = 0.02). PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18) and 2.26 ± 3.89 (95%CI -3.68, -0.83) in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed. Conclusion Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-12002272. PMID:25874938

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

    PubMed

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

    2005-09-01

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

  14. Standardization for subgroup analysis in randomized controlled trials.

    PubMed

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

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

  15. Psychosocial Telephone Intervention for Dementia Caregivers: A Randomized, Controlled Trial

    PubMed Central

    Tremont, Geoffrey; Davis, Jennifer D.; Papandonatos, George D.; Ott, Brian R.; Fortinsky, Richard H.; Gozalo, Pedro; Yue, Mun Sang; Bryant, Kimberly; Christine, Grover; Bishop, Duane S.

    2014-01-01

    Background Identifying effective and accessible interventions for dementia caregivers is critical as dementia prevalence increases. Objective Examine the effects of a telephone-based intervention on caregiver well-being. Design Randomized, controlled trial. Setting Academic medical center. Participants 250 distressed, family, dementia caregivers. Intervention Caregivers randomized to receive 16 telephone contacts over 6 months of either the Family Intervention: Telephone Tracking–Caregiver (FITT-C) or Telephone Support (TS). Outcome Primary outcome variables were family caregivers’ depressive symptoms, burden, and reactions to care recipients’ behavior problems at 6 months. Results The FITT-C intervention resulted in significantly improved caregiver depressive symptoms (p = 0.003; 27% net improvement) and less severe reactions to care-recipient depressive behaviors (p = 0.009; 29% net improvement) compared to the control condition (TS). Conclusion An entirely telephone-based intervention improves caregivers’ depressive symptoms and reactions to behavior problems in the care recipient and is comparable to reported results of face-to-face interventions. PMID:25074341

  16. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    PubMed

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  17. Random total antiepileptic drug levels and seizure control during pregnancy.

    PubMed

    Al-Bunyan, M A

    2001-04-01

    To study the correlation of randomly-tested total antiepileptic plasma levels and seizure control in a retrospectively collected group of pregnant epileptic Saudi women. The medical records of 30 Saudi epileptic female patients were reviewed during their subsequent pregnancies (total of 50). The type of antiepileptic drugs used during each pregnancy, the dose of each drug and the corresponding total plasma levels were noted. Antiepileptic drugs assay were carried out randomly during pregnancy either by TDX or a sensitive high performance liquid chromatography method. A total of 50 pregnancies were studied. The most common seizure type in these women was complex partial seizure followed by primary generalized epilepsy, myoclonic seizures and of least occurrence was the simple partial seizure with secondary generalization. All patients were received antiepileptic drugs, including either carbamazepine, phenytoin, valporic acid, phenobarbitone or clonazepam. In a total of 24 pregnancies (48%), the serum levels of antiepileptic drugs were subtherapeutic during the first trimester. Recurrent seizures occurred in a total of 20 pregnancies (40%) especially in the 3rd trimester. It is concluded that subtherapeutic serum levels of antiepileptic drugs correlated highly with the increased frequency of seizure in these pregnant women. Monitoring of state of seizure control in epileptic pregnant women should be made regularly during the course of their pregnancies.

  18. Random total antiepilectic drug levels and seizure control during pregnancy.

    PubMed

    Al-Bunyan, M A

    2001-04-01

    To study the correlation of randomly-tested total antiepileptic plasma levels and seizure control in a retrospectively collected group of pregnant epileptic Saudi women. The medical records of 30 Saudi epileptic female patients were reviewed during their subsequent pregnancies (total of 50). The type of antiepileptic drugs used during each pregnancy, the dose of each drug and the corresponding total plasma levels were noted. Antiepileptic drugs assay were carried out randomly during pregnancy either by TDX or a sensitive high performance liquid chromatography method. A total of 50 pregnancies were studied. The most common seizure type in these women was complex partial seizure followed by primary generalized epilepsy, myoclonic seizures and of least occurrence was the simple partial seizure with secondary generalization. All patients were received antiepileptic drugs, including either carbamazepine, phenytoin, valporic acid, phenobarbitone or clonazepam. In a total of 24 pregnancies (48%), the serum levels of antiepileptic drugs were subtherapeutic during the first trimester. Recurrent seizures occurred in a total of 20 pregnancies (40%) especially in the 3rd trimester. It is concluded that subtherapeutic serum levels of antiepileptic drugs correlated highly with the increased frequency of seizure in these pregnant women. Monitoring of state of seizure control in epileptic pregnant women should be made regularly during the course of their pregnancies.

  19. Bibliometric analysis of the literature of randomized controlled trials

    PubMed Central

    Tsay, Ming-yueh; Yang, Yen-hsu

    2005-01-01

    Objective: Evidence-based medicine (EBM) is a significant issue and the randomized controlled trial (RCT) literature plays a fundamental role in developing EBM. This study investigates the features of RCT literature based on bibliometric methods. Growth of the literature, publication types, languages, publication countries, and research subjects are addressed. The distribution of journal articles was also examined utilizing Bradford's law and Bradford-Zipf's law. Method: The MEDLINE database was searched for articles indexed under the publication type “Randomized Control Trial,” and articles retrieved were counted and analyzed using Microsoft Access, Microsoft Excel, and PERL. Results: From 1990 to 2001, a total of 114,850 citations dealing with RCTs were retrieved. The literature growth rate, from 1965 to 2001, is steadily rising and follows an exponential model. Journal articles are the predominant form of publication, and the multicenter study is extensively used. English is the most commonly used language. Conclusions: Generally, RCTs are found in publications concentrating on cardiovascular disease, cancer, asthma, postoperative conditon, health, and anesthetics. Zone analysis and graphical formulation from Bradford's law of scattering shows variations from the standard Bradford model. Forty-two core journals were identified using Bradford's law. PMID:16239941

  20. A randomized controlled trial of home tooth-whitening products.

    PubMed

    Lo, Edward C M; Wong, Anthony H H; McGrath, Colman

    2007-10-01

    To evaluate the effectiveness of two marketed home tooth-whitening products. A randomized controlled clinical trial involving 87 adults who were randomly allocated into one of three groups: (1) 6% hydrogen peroxide whitening strips, (2) 18% carbamide peroxide whitening gel, and (3) a placebo (fluoride toothpaste) control group. Subjects were instructed individually and then used the given product daily for 2 consecutive weeks. Color was determined in brightness (L*), yellowness (b*) and redness (a*) [color space] at baseline and 8 weeks after dispensing the product by employing a high resolution digital camera (Fuji HC1000 CCD) to image the subject's anterior maxillary teeth under standard polarized lighting conditions. The subjects also completed a questionnaire on self-satisfaction with the treatment outcome. One-way ANOVA (Bonferroni test) demonstrated significant differences in color between the three groups with changes in brightness (L*, P< 0.001), yellowness (b*, P< 0.001) and redness (a*, P < 0.001). Changes in L* a* b* was greatest among those who used the 6% hydrogen peroxide whitening strips. Subjects in the whitening strip group also rated that product significantly (P < 0.01) more favorably than other groups with respect to the amount of whiteness improvement, as well as whitening satisfaction and overall impression while there is no significant difference between the whitening gel and the placebo groups.

  1. Psychosocial telephone intervention for dementia caregivers: A randomized, controlled trial.

    PubMed

    Tremont, Geoffrey; Davis, Jennifer D; Papandonatos, George D; Ott, Brian R; Fortinsky, Richard H; Gozalo, Pedro; Yue, Mun Sang; Bryant, Kimberly; Grover, Christine; Bishop, Duane S

    2015-05-01

    Identifying effective and accessible interventions for dementia caregivers is critical as dementia prevalence increases. Examine the effects of a telephone-based intervention on caregiver well-being. Randomized, controlled trial. Academic medical center. Two hundred and fifty distressed, family, dementia caregivers. Caregivers randomized to receive 16 telephone contacts over 6 months of either the Family Intervention: Telephone Tracking-Caregiver (FITT-C) or Telephone Support (TS). Primary outcome variables were family caregivers' depressive symptoms, burden, and reactions to care recipients' behavior problems at 6 months. The FITT-C intervention resulted in significantly improved caregiver depressive symptoms (P = .003; 27% net improvement) and less severe reactions to care-recipient depressive behaviors (P = .009; 29% net improvement) compared with the control condition (TS). An entirely telephone-based intervention improves caregivers' depressive symptoms and reactions to behavior problems in the care recipient and is comparable with reported results of face-to-face interventions. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  2. Online psychoeducational support for infertile women: a randomized controlled trial

    PubMed Central

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  3. Randomized Controlled Trial of Primary Care Pediatric Parenting Programs

    PubMed Central

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

    2011-01-01

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

  4. Preliminary demonstration of a robust controller design method

    NASA Technical Reports Server (NTRS)

    Anderson, L. R.

    1980-01-01

    Alternative computational procedures for obtaining a feedback control law which yields a control signal based on measurable quantitites are evaluated. The three methods evaluated are: (1) the standard linear quadratic regulator design model; (2) minimization of the norm of the feedback matrix, k via nonlinear programming subject to the constraint that the closed loop eigenvalues be in a specified domain in the complex plane; and (3) maximize the angles between the closed loop eigenvectors in combination with minimizing the norm of K also via the constrained nonlinear programming. The third or robust design method was chosen to yield a closed loop system whose eigenvalues are insensitive to small changes in the A and B matrices. The relationship between orthogonality of closed loop eigenvectors and the sensitivity of closed loop eigenvalues is described. Computer programs are described.

  5. Esophageal balloon tamponade versus esophageal stent in controlling acute refractory variceal bleeding: A multicenter randomized, controlled trial.

    PubMed

    Escorsell, Àngels; Pavel, Oana; Cárdenas, Andrés; Morillas, Rosa; Llop, Elba; Villanueva, Càndid; Garcia-Pagán, Juan C; Bosch, Jaime

    2016-06-01

    Balloon tamponade is recommended only as a "bridge" to definitive therapy in patients with cirrhosis and massive or refractory esophageal variceal bleeding (EVB), but is frequently associated with rebleeding and severe complications. Preliminary, noncontrolled data suggest that a self-expandable, esophageal covered metal stent (SX-ELLA Danis; Ella-CS, Hradec Kralove, Czech Republic) may be an effective and safer alternative to balloon tamponade. We conducted a randomized, controlled trial aimed at comparing esophageal stent versus balloon tamponade in patients with cirrhosis and EVB refractory to medical and endoscopic treatment. Primary endpoint was success of therapy, defined as survival at day 15 with control of bleeding and without serious adverse events (SAEs). Twenty-eight patients were randomized to Sengstaken-Blakemore tube (n = 15) or SX-ELLA Danis stent (n = 13). Patients were comparable in severity of liver failure, active bleeding at endoscopy, and initial therapy. Success of therapy was more frequent in the esophageal stent than in balloon tamponade group (66% vs. 20%; P = 0.025). Moreover, control of bleeding was higher (85% vs. 47%; P = 0.037) and transfusional requirements (2 vs 6 PRBC; P = 0.08) and SAEs lower (15% vs. 47%; P = 0.077) in the esophageal stent group. TIPS was used more frequently in the tamponade group (4 vs. 10; P = 0.12). There were no significant differences in 6-week survival (54% vs. 40%; P = 0.46). Esophageal stents have greater efficacy with less SAEs than balloon tamponade in the control of EVB in treatment failures. Our findings favor the use of esophageal stents in patients with EVB uncontrolled with medical and endoscopic treatment. (Hepatology 2016;63:1957-1967). © 2015 by the American Association for the Study of Liver Diseases.

  6. Preliminary control technology assessment of Mansfield Sanitary, Incorporated, Errysville, Ohio

    SciTech Connect

    Cooper, T.

    1982-03-01

    A visit was made to the Mansfield Sanitary Facility, Perrysville, Ohio to evaluate control methods in place at the site to protect workers from on the job hazards. This facility used a variety of clays, parting compounds, and color additives to blend, form, dry, fire, package, and ship as ceramic plumbing products. Clays used include feldspar, pearless china clay, and nepheline syenite from various suppliers. Other raw materials included Millwood sand, gum, cultozine-fuchsine, industrial plaster, stain, glaze, magnesium aluminum silicate, talc, feldspar, and zirconium silicate. The company made good use of several ventilation techniques at loading stations, transfer points, automatic assembly lines, and the glazing stations. Parting dust became airborne when applied to the molds and while the mold was being dried. Exhaust-ventilation booths used for the spraying of glaze appeared to be very effective. Several areas in which dust-control methods appeared inadequate were noted. The author recommends that some of the work practices and personal protective equipment used as controls should be examined in an in-depth evaluation and documentation.

  7. Preliminary Screening of Potential Control Products against Drosophila suzukii

    PubMed Central

    Cuthbertson, Andrew G. S.; Collins, Debbie A.; Blackburn, Lisa F.; Audsley, Neil; Bell, Howard A.

    2014-01-01

    The first recording of Drosophila suzukii in the UK occurred in the south of England during August 2012. Since then sticky traps have continued to record the presence of individuals. Several products (both chemical and biological) were investigated for their efficacy against different life-stages of the pest. Both direct and indirect exposure to control products was assessed. Spinosad, chlorantraniliprole and the experimental product, TA2674, showed excellent potential as control agents when used as either a pre- or post-dipping treatment for blueberries with mortalities of 100%, 93% and 98% mortality, respectively, being achieved following pre-treatment. Direct spray application of all products tested had limited impact upon adult flies. Highest mortality (68%) was achieved following direct application of TA2674. Entomopathogenic agents (nematodes and fungi) tested appeared to reduce fly population development (ranges of 34–44% mortality obtained) but would seem unable to eradicate outbreaks. The potential of the tested products to control D. suzukii is discussed. PMID:26462696

  8. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    PubMed

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  9. A preliminary 6 DOF attitude and translation control system design for Starprobe

    NASA Technical Reports Server (NTRS)

    Mak, P.; Mettler, E.; Vijayarahgavan, A.

    1981-01-01

    The extreme thermal environment near perihelion and the high-accuracy gravitational science experiments impose unique design requirements on various subsystems of Starprobe. This paper examines some of these requirements and their impact on the preliminary design of a six-degree-of-freedom attitude and translational control system. Attention is given to design considerations, the baseline attitude/translational control system, system modeling, and simulation studies.

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

    PubMed Central

    2014-01-01

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

  11. Secnidazole Treatment of Bacterial Vaginosis: A Randomized Controlled Trial.

    PubMed

    Hillier, Sharon L; Nyirjesy, Paul; Waldbaum, Arthur S; Schwebke, Jane R; Morgan, Franklin G; Adetoro, Nikki A; Braun, Carol J

    2017-08-01

    To evaluate secnidazole as a single oral dose treatment for bacterial vaginosis in a phase 2 randomized, double-blind, placebo-controlled study. In a phase 2, randomized, double-blind, dose-ranging, placebo-controlled study, women with bacterial vaginosis who met all Amsel criteria (discharge; pH 4.7 or greater; 20% or greater clue cells; positive whiff test) were randomized one to one to one at 24 U.S. centers to 1 or 2 g secnidazole compared with placebo. The primary endpoint was clinical cure (normalization of discharge, amine odor, and clue cells) 21-30 days after treatment. Secondary endpoints included microbiologic cure, defined as a Nugent score of 0-3, and therapeutic cure, defined as meeting criteria for both clinical and microbiologic cure. The modified intent to treat was used for efficacy analyses and included all randomized patients who met the enrollment criteria. Assuming a clinical cure rate of 40% in the active groups and 15% in the placebo group, a sample size of 52 patients per group provided approximately 80% power to detect a significant difference between groups (.05 level [two-sided]) using a Cochran-Mantel-Haenszel test. Between May and September 2014, 215 patients were enrolled. In the intent-to-treat population, the clinical cure rate was 65.3% for the 2-g group, 49.3% for the 1-g group, and 19.4% for the placebo group. The modified intent-to-treat population included 188 women (median age 33 years; 32% with four or more bacterial vaginosis episodes in the previous year; 54% black) with baseline Nugent scores 4 or greater. Clinical, microbiologic, and therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%, 6.5%, and 6.5% for placebo, respectively (P<.05 for secnidazole compared with placebo; all endpoints). Both doses were well-tolerated. Oral granules containing 1 and 2 g secnidazole were superior to placebo in bacterial vaginosis treatment (P<.001 for

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

    NASA Astrophysics Data System (ADS)

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

    2004-07-01

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

  13. A Randomized Study Comparing the Shaker Exercise with Traditional Therapy: A Preliminary Study

    PubMed Central

    Rademaker, Alfred; Pauloski, Barbara Roa; Kelly, Amy; Stangl-McBreen, Carrie; Antinoja, Jodi; Grande, Barbara; Farquharson, Julie; Kern, Mark; Easterling, Caryn; Shaker, Reza

    2010-01-01

    Seven institutions participated in this small clinical trial that included 19 patients who exhibited oropharyngeal dysphagia on videofluorography (VFG) involving the upper esophageal sphincter (UES) and who had a 3-month history of aspiration. All patients were randomized to either traditional swallowing therapy or the Shaker exercise for 6 weeks. Each patient received a modified barium swallow pre- and post-therapy, including two swallows each of 3 ml and 5 ml liquid barium and 3 ml barium pudding. Each videofluorographic study was sent to a central laboratory and digitized in order to measure hyoid and larynx movement as well as UES opening. Fourteen patients received both pre-and post-therapy VFG studies. There was significantly less aspiration post-therapy in patients in the Shaker group. Residue in the various oral and pharyngeal locations did not differ between the groups. With traditional therapy, there were several significant increases from pre- to post-therapy, including superior laryngeal movement and superior hyoid movement on 3-ml pudding swallows and anterior laryngeal movement on 3-ml liquid boluses, indicating significant improvement in swallowing physiology. After both types of therapy there is a significant increase in UES opening width on 3-ml paste swallows. PMID:19472007

  14. Randomized trial of trigger point acupuncture treatment for chronic shoulder pain: a preliminary study.

    PubMed

    Itoh, Kazunori; Saito, Shingo; Sahara, Shunsaku; Naitoh, Yuki; Imai, Kenji; Kitakoji, Hiroshi

    2014-04-01

    There is evidence for the efficacy of acupuncture treatment for chronic shoulder pain, but it remains unclear which acupuncture modes are most effective. We compared the effect of trigger point acupuncture (TrP), with that of sham (SH) acupuncture treatments, on pain and shoulder function in patients with chronic shoulder pain. The participants were 18 patients (15 women, 3 men; aged 42-65 years) with nonradiating shoulder pain for at least 6 months and normal neurological findings. The participants were randomized into two groups, each receiving five treatment sessions. The TrP group received treatment at trigger points for the muscle, while the other group received SH acupuncture treatment on the same muscle. Outcome measures were pain intensity (visual analogue scale, VAS) and shoulder function (Constant-Murley Score: CMS). After treatment, pain intensity between pretreatment and 5 weeks after TrP decreased significantly (p<0.001). Shoulder function also increased significantly between pretreatment and 5 weeks after TrP (p<0.001). A comparison using the area under the outcome curves demonstrated a significant difference between groups (p=0.024). Compared with SH acupuncture therapy, TrP therapy appears more effective for chronic shoulder pain. Copyright © 2014. Published by Elsevier B.V.

  15. Effects of trigger point acupuncture treatment on temporomandibular disorders: a preliminary randomized clinical trial.

    PubMed

    Itoh, Kazunori; Asai, Sayo; Ohyabu, Hideaki; Imai, Kenji; Kitakoji, Hiroshi

    2012-04-01

    We compared the effects of trigger point acupuncture with that of sham acupuncture treatments on pain and oral function in patients with temporomandibular disorders (TMDs). This 10-week study included 16 volunteers from an acupuncture school with complaints of chronic temporomandibular joint myofascial pain for at least 6 months. The participants were randomized to one of two groups, each receiving five acupuncture treatment sessions. The trigger point acupuncture group received treatment at trigger points for the same muscle, while the other acupuncture group received sham treatment on the trigger points. Outcome measures were pain intensity (visual analogue scale) and oral function (maximal mouth opening). After treatment, pain intensity was less in the trigger point acupuncture group than in the sham treatment group, but oral function remained unchanged in both groups. Pain intensity decreased significantly between pretreatment and 5 weeks after trigger point (p<0.001) and sham acupunctures (p<0.050). Group comparison using the area under the curve demonstrated a significant difference between groups (p=0.0152). Compared with sham acupuncture therapy, trigger point acupuncture therapy may be more effective for chronic temporomandibular joint myofascial pain. Copyright © 2012. Published by Elsevier B.V.

  16. Reengaging veterans with serious mental illness into care: preliminary results from a national randomized trial.

    PubMed

    Kilbourne, Amy M; Goodrich, David E; Lai, Zongshan; Almirall, Daniel; Nord, Kristina M; Bowersox, Nicholas W; Abraham, Kristen M

    2015-01-01

    This study compared effectiveness of an enhanced versus standard implementation strategy (Replicating Effective Programs [REP]) on site-level uptake of Re-Engage, a national program for veterans with serious mental illness. Mental health providers at 158 Veterans Affairs (VA) facilities were given REP-based manuals and training in Re-Engage, which involved identifying veterans who had not been seen in VA care for at least one year, documenting their clinical status, and coordinating further health care. After six months, facilities not responding to REP (N=88) were randomized to receive six months of facilitation (enhanced REP) or continued standard REP. Site-level uptake was defined as percentage of patients (N=1,531) with updated documentation or with whom contact was attempted. Rate of Re-Engage uptake was greater for enhanced REP sites compared with standard REP sites (41% versus 31%, p=.01). Total REP facilitation time was 7.3 hours per site for six months. Added facilitation improved short-term uptake of a national mental health program.

  17. Interpersonal psychotherapy (IPT) for major depression following perinatal loss: a pilot randomized controlled trial.

    PubMed

    Johnson, Jennifer E; Price, Ann Back; Kao, Jennifer Chienwen; Fernandes, Karen; Stout, Robert; Gobin, Robyn L; Zlotnick, Caron

    2016-10-01

    This randomized controlled pilot trial examined the feasibility, acceptability, and preliminary efficacy of an adapted interpersonal psychotherapy (IPT) for major depressive disorder (MDD) following perinatal loss (miscarriage, stillbirth, or early neonatal death). Fifty women who experienced a perinatal loss within the past 18 months, whose current depressive episode onset occurred during or after the loss, were randomized to the group IPT adapted for perinatal loss (the Group IPT for Major Depression Following Perinatal Loss manual developed for this study is available at no cost by contacting either of the first two authors) or to the group Coping with Depression (CWD), a cognitive behavioral treatment which did not focus on perinatal loss nor social support. Assessments occurred at baseline, treatment weeks 4 and 8, post-treatment, and 3 and 6 months after the end of treatment. IPT was feasible and acceptable in this population. Although some participants were initially hesitant to discuss their losses in a group (as occurred in IPT but not CWD), end of treatment satisfaction scores were significantly (p = 0.001) higher in IPT than in CWD. Confidence intervals around between-groups effect sizes favored IPT for reductions in depressive symptoms during treatment as well as for improvement in mode-specific targets (social support, grief symptoms) and recovery from a post-traumatic stress disorder over follow-up. This group IPT treatment adapted for MDD after perinatal loss is feasible, acceptable, and possibly efficacious.

  18. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy.

    PubMed

    Nordin, Linda; Rorsman, Ia

    2012-01-01

    The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress. Randomized controlled trial with assessment at pretreatment, end of treatment, and at 3-month follow-up. Multiple sclerosis outpatients with elevated symptoms of anxiety and/or depression (n = 21). Patients were randomly assigned to acceptance and commitment therapy or relaxation training. Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions, group discussions, and exercises. Outcome was assessed by self-rated symptoms of anxiety, depression, and a measure of acceptance. At 3-month follow-up, the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up. The results reflect the different emphases of the therapies. Acceptance and commitment therapy is aimed at living an active, valued life and increasing acceptance, while relaxation training focuses directly on coping strategies to handle emotional symptoms. The results are preliminary, but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis.

  19. Two Novel Treatments to Reduce Overeating in Overweight Children: A Randomized Controlled Trial

    PubMed Central

    Boutelle, Kerri N.; Peterson, Carol B.; Rydell, Sarah A.; Zucker, Nancy L.; Cafri, Guy; Harnack, Lisa

    2014-01-01

    Objective Our purpose in this study was to examine 2 treatments targeted at reducing eating in the absence of hunger in overweight and obese children. Method Thirty-six overweight and obese 8- to 12-year-old children (58% female; mean age = 10.3 years, SD = 1.3), with high scores on eating in the absence of hunger, and their parents were randomly assigned to an 8-week children's appetite awareness training or cue exposure treatment–food. Children completed an eating in the absence of hunger (EAH) paradigm, an Eating Disorder Examination interview for children, and three 24-hr dietary recalls, and their height and weight were measured. Parents completed the EAH Questionnaire and the Binge Eating Scale, and their height and weight were measured. Assessments were conducted at baseline, posttreatment, and 6 and 12 months posttreatment. Results Results showed that both treatments resulted in significant decreases in binge eating in children over time. Additionally, children in the food cue exposure treatment showed significant decreases in EAH posttreatment and 6 months posttreatment, but children in the appetite awareness training showed no change in EAH. Neither treatment produced significant effects on caloric intake in children or on any of the parent outcomes. Conclusions This study demonstrates that training in food cue responsitivity and appetite awareness has the potential to be efficacious for reducing EAH and binge eating in children. Because these data are preliminary, further treatment development and randomized controlled studies are needed. PMID:22122291

  20. Direct-to-consumer marketing of psychological treatments: A randomized controlled trial.

    PubMed

    Gallo, Kaitlin P; Comer, Jonathan S; Barlow, David H; Clarke, Roberta N; Antony, Martin M

    2015-10-01

    Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Participants (N = 344; 75.0% female, mean age = 18.6 years, 48.5% non-Hispanic White) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were a PT campaign, a PT informing about medication side effects campaign, a medication campaign, and a neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. (c) 2015 APA, all rights reserved).

  1. Direct-to-Consumer Marketing of Psychological Treatments: A Randomized Controlled Trial

    PubMed Central

    Gallo, Kaitlin P.; Comer, Jonathan S.; Barlow, David H.; Clarke, Roberta N.; Antony, Martin M.

    2015-01-01

    Objective Although direct-to-consumer (DTC) marketing of pharmacologic interventions is effective and common, similar approaches have yet to be evaluated in the promotion of psychological treatments (PTs). This is the first randomized controlled trial evaluating the potential of DTC marketing of PTs. Method Participants (N=344; 75.0% female, mean age=18.6, 48.5% non-Hispanic Caucasian) were randomly assigned to consume one of four extended commercial campaigns embedded within unrelated programming across 3 weeks. The four campaign conditions were: [1] PT campaign; [2] PT informing about Medication Side Effects campaign; [3] Medication campaign; and [4] Neutral campaign. Attitudes about and intention to seek psychological treatment were assessed prior to campaign exposure (T1), 1 week following the final week of campaign exposure (T2), and at a 3-month follow-up evaluation (T3). Results The percentage of participants who newly intended psychological treatment at T2 or T3 differed by condition, with those assigned to the PT campaign slightly more likely to have intended to receive psychological treatment at T2 or T3 than those in other conditions. Baseline reports of emotional symptoms moderated the effect of condition on attitudes toward PT and perceived likelihood of seeking treatment in the future. Conclusions Findings support the preliminary utility of DTC marketing of psychological treatments. Increasing consumer knowledge of PTs may be a worthwhile complement to current dissemination and implementation efforts aimed at promoting the uptake of PTs in mental health care. PMID:26098374

  2. Brain plasticity following MI-BCI training combined with tDCS in a randomized trial in chronic subcortical stroke subjects: a preliminary study.

    PubMed

    Hong, Xin; Lu, Zhong Kang; Teh, Irvin; Nasrallah, Fatima Ali; Teo, Wei Peng; Ang, Kai Keng; Phua, Kok Soon; Guan, Cuntai; Chew, Effie; Chuang, Kai-Hsiang

    2017-08-23

    Brain-computer interface-assisted motor imagery (MI-BCI) or transcranial direct current stimulation (tDCS) has been used in stroke rehabilitation, though their combinatory effect is unknown. We investigated brain plasticity following a combined MI-BCI and tDCS intervention in chronic subcortical stroke patients with unilateral upper limb disability. Nineteen patients were randomized into tDCS and sham-tDCS groups. Diffusion and perfusion MRI, and transcranial magnetic stimulation were used to study structural connectivity, cerebral blood flow (CBF), and corticospinal excitability, respectively, before and 4 weeks after the 2-week intervention. After quality control, thirteen subjects were included in the CBF analysis. Eleven healthy controls underwent 2 sessions of MRI for reproducibility study. Whereas motor performance showed comparable improvement, long-lasting neuroplasticity can only be detected in the tDCS group, where white matter integrity in the ipsilesional corticospinal tract and bilateral corpus callosum was increased but sensorimotor CBF was decreased, particularly in the ipsilesional side. CBF change in the bilateral parietal cortices also correlated with motor function improvement, consistent with the increased white matter integrity in the corpus callosum connecting these regions, suggesting an involvement of interhemispheric interaction. The preliminary results indicate that tDCS may facilitate neuroplasticity and suggest the potential for refining rehabilitation strategies for stroke patients.

  3. Classroom and simulation team training: a randomized controlled trial.

    PubMed

    Clay-Williams, Robyn; McIntosh, Catherine A; Kerridge, Ross; Braithwaite, Jeffrey

    2013-07-01

    To test the hypotheses that classroom and simulation-based crew resource management (CRM) training interventions improve teamwork attitudes and behaviours of participants and that classroom training combined with simulation-based training provide synergistic improvements. A randomized controlled trial. Area Health Service in New South Wales, Australia. A total of 157 doctors, nurses and midwives randomized into one of four groups, consisting of three intervention groups and a control group. One-day CRM-based classroom course; one-day CRM style simulation-based training or classroom training followed by simulation-based training. Pre- and post-test quantitative participant teamwork attitudes, and post-test quantitative trainee reactions, knowledge and behaviour. Ninety-four doctors, nurses and midwives completed pre-intervention attitude questionnaires and 60 clinicians completed post-intervention assessments. No positive changes in teamwork attitudes were found associated with classroom or simulation training. Positive changes were found in knowledge (mean difference 1.50, 95% confidence interval (CI) 0.58-2.43, P = 0.002), self-assessed teamwork behaviour (mean difference 2.69, 95% CI 0.90-6.13, P = 0.009) and independently observed teamwork behaviour (mean difference 2.30, 95% CI 0.30-4.30, P = 0.027) when classroom-only trained group was compared with control; however, these changes were not found in the group that received classroom followed by simulation training. Classroom-based training alone resulted in improvements in participant knowledge and observed teamwork behaviour. The study found no additional impact of simulation training.

  4. Brief Cognitive-Behavioral and Relaxation Training Interventions for Breast Cancer: A Randomized Controlled Trial

    PubMed Central

    Gudenkauf, Lisa M.; Antoni, Michael H.; Stagl, Jamie M.; Lechner, Suzanne C.; Jutagir, Devika R.; Bouchard, Laura C.; Blomberg, Bonnie B.; Glück, Stefan; Derhagopian, Robert P.; Giron, Gladys L.; Avisar, Eli; Torres-Salichs, Manuel A.; Carver, Charles S.

    2015-01-01

    Objective Women with breast cancer (BCa) report elevated distress post-surgery. Group-based cognitive-behavioral stress management (CBSM) following surgery improves psychological adaptation, though its key mechanisms remain speculative. This randomized controlled dismantling trial compared two interventions featuring elements thought to drive CBSM effects: a 5-week Cognitive-Behavioral Training (CBT) and 5-week Relaxation Training (RT) vs. a 5-week Health Education (HE) control group. Method Women with stage 0-III BCa (N = 183) were randomized to CBT, RT, or HE condition 2–10 weeks post-surgery. Psychosocial measures were collected at baseline (T1) and post-intervention (T2). Repeated-measures ANOVAs tested whether CBT and RT treatments improved primary measures of psychological adaptation and secondary measures of stress management resource perceptions from pre- to post-intervention relative to HE. Results Both CBT and RT groups reported reduced depressive affect. The CBT group reported improved emotional well-being/quality of life and less cancer-specific thought intrusions. The RT group reported improvements on illness-related social disruption. Regarding stress management resources, the CBT group reported increased reliability of social support networks, while the RT group reported increased confidence in relaxation skills. Psychological adaptation and stress management resource constructs were unchanged in the HE control group. Conclusions Non-metastatic breast cancer patients participating in two forms of brief, 5-week group-based stress management intervention after surgery showed improvements in psychological adaptation and stress management resources compared to an attention-matched control group. Findings provide preliminary support suggesting that using brief group-based stress management interventions may promote adaptation among non-metastatic breast cancer patients. PMID:25939017

  5. Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

    PubMed

    Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

    2017-10-01

    Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, ηp(2)=0.04), peak power output (F(2150)=8.16, p<0.01, ηp(2)=0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, ηp(2)=0.05), but not gait outcomes, for those who underwent the intervention compared with those who underwent the control condition. This RCT provides novel, preliminary evidence that multimodal exercise training may improve endurance walking performance and cognitive processing speed, perhaps based on improvements in cardiorespiratory capacity, in persons with MS with substantial mobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. A Preliminary Cost Study of the Dual Mode Inverter Controller

    SciTech Connect

    McKeever, J.W.

    2005-01-28

    In 1998, the Power Electronics and Electric Machinery Research Center (PEEMRC) at the Oak Ridge National Laboratory (ORNL) started a program to investigate alternate field weakening schemes for permanent magnet (PM) motors. The adjective ''alternate'' was used because at that time, outside research emphasis was on motors with interior-mounted PMs (IPMs). The PEEMRC emphasis was placed on motors with surface-mounted PMs (SPMs) because of the relative ease of manufacturing SPM motors compared with the IPM motors. Today the PEEMRC is continuing research on SPMs while examining the IPMs that have been developed by industry. Out of this task--the goal of which was to find ways to drive PM motors that inherently have low inductance at high speeds where their back-emf exceeds the supply voltage--ORNL developed and demonstrated the dual mode inverter control (DMIC) [1,2] method of field weakening for SPM motors. The predecessor of DMIC is conventional phase advance (CPA), which was developed by UQM Technologies, Inc. [3]. Fig. 1 shows the three sets of anti-parallel thyristors in the dashed box that comprise the DMIC. If one removes the dashed box by shorting each set of anti-parallel thyristors, the configuration becomes a conventional full bridge inverter on the left driving a three phase motor on the right. CPA may be used to drive this configuration ORNL's initial analyses of CPA and DMIC were based on driving motors with trapezoidal back-emfs [4-6], obtained using double layer lapped stator windings with one slot per pole per phase. A PM motor with a sinusoidal back-emf obtained with two poles per slot per phase has been analyzed under DMIC operation as a University of Tennessee-Knoxville (UTK) doctoral dissertation [7]. In the process of this research, ORNL has completed an analysis that explains and quantifies the role of inductance in these methods of control. The Appendix includes information on the equations for the three components of phase inductance, L{sub gap

  7. Preliminary results on noncollocated torque control of space robot actuators

    NASA Technical Reports Server (NTRS)

    Tilley, Scott W.; Francis, Colin M.; Emerick, Ken; Hollars, Michael G.

    1989-01-01

    In the Space Station era, more operations will be performed robotically in space in the areas of servicing, assembly, and experiment tending among others. These robots may have various sets of requirements for accuracy, speed, and force generation, but there will be design constraints such as size, mass, and power dissipation limits. For actuation, a leading motor candidate is a dc brushless type, and there are numerous potential drive trains each with its own advantages and disadvantages. This experiment uses a harmonic drive and addresses some inherent limitations, namely its backdriveability and low frequency structural resonances. These effects are controlled and diminished by instrumenting the actuator system with a torque transducer on the output shaft. This noncollocated loop is closed to ensure that the commanded torque is accurately delivered to the manipulator link. The actuator system is modelled and its essential parameters identified. The nonlinear model for simulations will include inertias, gearing, stiction, flexibility, and the effects of output load variations. A linear model is extracted and used for designing the noncollocated torque and position feedback loops. These loops are simulated with the structural frequency encountered in the testbed system. Simulation results are given for various commands in position. The use of torque feedback is demonstrated to yield superior performance in settling time and positioning accuracy. An experimental setup being finished consists of a bench mounted motor and harmonic drive actuator system. A torque transducer and two position encoders, each with sufficient resolution and bandwidth, will provide sensory information. Parameters of the physical system are being identified and matched to analytical predictions. Initial feedback control laws will be incorporated in the bench test equipment and various experiments run to validate the designs. The status of these experiments is given.

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

    PubMed Central

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

    2012-01-01

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

  9. A Serious Game to Increase Healthy Food Consumption in Overweight or Obese Adults: Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Obesity is a growing global issue that is linked to cognitive and psychological deficits. Objective This preliminary study investigated the efficacy of training to improve inhibitory control (IC), a process linked to overeating, on consumption and cognitive control factors. Methods This study utilized a multisession mobile phone–based intervention to train IC in an overweight and obese population using a randomized waitlist-control design. A combination of self-assessment questionnaires and psychophysiological measures was used to assess the efficacy of the intervention in terms of improved general IC and modified food consumption after training. Attitudes toward food were also assessed to determine their mediating role in food choices. A total of 58 participants (47 female) completed 2 assessment sessions 3 weeks apart, with 2 weeks of intervention training for the training group during this time. The groups did not differ in baseline demographics including age, body mass index, and inhibitory control. Results Inhibitory control ability improved across the training sessions, with increases in P3 amplitude implying increased cognitive control over responses. Inhibitory control training was associated with increased healthy and reduced unhealthy food consumption in a taste test and in the week following training, as measured by the Healthy Eating Quiz and the food consumption test. Cognitive restraint was enhanced after training for the training but not the waitlist condition in the Three-Factor Eating Questionnaire, implying that attempts to avoid unhealthy foods in the future will be easier for the training group participants. Conclusions Inhibitory control training delivered via a purpose-designed mobile phone app is easy to complete, is convenient, and can increase cognitive restraint and reduce unhealthy food consumption. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12616000263493; http

  10. Intuitive control of a powered prosthetic leg during ambulation: a randomized clinical trial.

    PubMed

    Hargrove, Levi J; Young, Aaron J; Simon, Ann M; Fey, Nicholas P; Lipschutz, Robert D; Finucane, Suzanne B; Halsne, Elizabeth G; Ingraham, Kimberly A; Kuiken, Todd A

    2015-06-09

    Some patients with lower leg amputations may be candidates for motorized prosthetic limbs. Optimal control of such devices requires accurate classification of the patient's ambulation mode (eg, on level ground or ascending stairs) and natural transitions between different ambulation modes. To determine the effect of including electromyographic (EMG) data and historical information from prior gait strides in a real-time control system for a powered prosthetic leg capable of level-ground walking, stair ascent and descent, ramp ascent and descent, and natural transitions between these ambulation modes. Blinded, randomized crossover clinical trial conducted between August 2012 and November 2013 in a research laboratory at the Rehabilitation Institute of Chicago. Participants were 7 patients with unilateral above-knee (n = 6) or knee-disarticulation (n = 1) amputations. All patients were capable of ambulation within their home and community using a passive prosthesis (ie, one that does not provide external power). Electrodes were placed over 9 residual limb muscles and EMG signals were recorded as patients ambulated and completed 20 circuit trials involving level-ground walking, ramp ascent and descent, and stair ascent and descent. Data were acquired simultaneously from 13 mechanical sensors embedded on the prosthesis. Two real-time pattern recognition algorithms, using either (1) mechanical sensor data alone or (2) mechanical sensor data in combination with EMG data and historical information from earlier in the gait cycle, were evaluated. The order in which patients used each configuration was randomized (1:1 blocked randomization) and double-blinded so patients and experimenters did not know which control configuration was being used. The main outcome of the study was classification error for each real-time control system. Classification error is defined as the percentage of steps incorrectly predicted by the control system. Including EMG signals and

  11. Liquid Medication Errors and Dosing Tools: A Randomized Controlled Experiment.

    PubMed

    Yin, H Shonna; Parker, Ruth M; Sanders, Lee M; Dreyer, Benard P; Mendelsohn, Alan L; Bailey, Stacy; Patel, Deesha A; Jimenez, Jessica J; Kim, Kwang-Youn A; Jacobson, Kara; Hedlund, Laurie; Smith, Michelle C J; Maness Harris, Leslie; McFadden, Terri; Wolf, Michael S

    2016-10-01

    Poorly designed labels and packaging are key contributors to medication errors. To identify attributes of labels and dosing tools that could be improved, we examined the extent to which dosing error rates are affected by tool characteristics (ie, type, marking complexity) and discordance between units of measurement on labels and dosing tools; along with differences by health literacy and language. Randomized controlled experiment in 3 urban pediatric clinics. English- or Spanish-speaking parents (n = 2110) of children ≤8 years old were randomly assigned to 1 of 5 study arms and given labels and dosing tools that varied in unit pairings. Each parent measured 9 doses of medication (3 amounts [2.5, 5, and 7.5 mL] and 3 tools [1 cup, 2 syringes (0.2- and 0.5-mL increments)]), in random order. Outcome assessed was dosing error (>20% deviation; large error defined as > 2 times the dose). A total of 84.4% of parents made ≥1 dosing error (21.0% ≥1 large error). More errors were seen with cups than syringes (adjusted odds ratio = 4.6; 95% confidence interval, 4.2-5.1) across health literacy and language groups (P < .001 for interactions), especially for smaller doses. No differences in error rates were seen between the 2 syringe types. Use of a teaspoon-only label (with a milliliter and teaspoon tool) was associated with more errors than when milliliter-only labels and tools were used (adjusted odds ratio = 1.2; 95% confidence interval, 1.01-1.4). Recommending oral syringes over cups, particularly for smaller doses, should be part of a comprehensive pediatric labeling and dosing strategy to reduce medication errors. Copyright © 2016 by the American Academy of Pediatrics.

  12. Preconception maternal nutrition: a multi-site randomized controlled trial

    PubMed Central

    2014-01-01

    Background Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy. Methods/Study design This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: ≥ 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none. 192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Discussion Positive results of this trial will support a paradigm shift in attention to nutrition of all females of

  13. Individual placement and support in Sweden - a randomized controlled trial.

    PubMed

    Bejerholm, Ulrika; Areberg, Cecilia; Hofgren, Caisa; Sandlund, Mikael; Rinaldi, Miles

    2015-01-01

    Currently there is no evidence on the effectiveness of Individual Placement and Support (IPS) in Sweden. To determine the effectiveness of IPS on vocational outcomes among people with severe mental illness (SMI) in a Swedish context. A secondary aim was to evaluate a community integration effect. A randomized controlled trial with a parallel design was used. Mental health outpatients with SMI were randomized to IPS or traditional vocational rehabilitation (TVR) services. The allocation status was assessor-blinded. The primary outcome was competitive employment. All vocational outcomes were collected continuously, and socio-demographic and clinical variables at baseline, 6 and 18 months. The trial is registered with ClinicalTrials.gov: NCT00960024. One hundred and twenty participants were randomized. Eighty seven per cent were assessed after 6 months, and 73% after 18 months. IPS was more effective than TVR in terms of gaining employment at 18-month follow-up (46% vs. 11%; difference 36%, 95% CI 18-54), along with the amount of working hours and weeks, longer job tenure periods and income. Cox regression analysis showed that IPS participants gained employment five times quicker than those in TVR. Ninety per cent of the IPS participants became involved in work, internships or education, i.e. activities integrated in mainstream community settings, while 24% in the TVR group achieved this. IPS is effective in a Swedish context in terms of gaining employment and becoming integrated within the local community. The welfare system presented obstacles for gaining competitive employment directly and it was indicated that internships delayed time to first competitive employment.

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

    PubMed

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

    2009-04-01

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

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

    PubMed Central

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

    2014-01-01

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

  16. Preliminary design of a tip-jet-driven heavy lift helicopter incorporating circulation control

    NASA Technical Reports Server (NTRS)

    Head, R. E.

    1981-01-01

    This report describes a preliminary design study for a Very Heavy Lift Helicopter (VHLH) that is powered by jets at the blade tips and is controlled by circulation control applied to the main rotor blades. The main thrust of the program was to integrate a tip-jet-powered helicopter design computer program developed by Hughes Helicopters, Inc. (HHI) with circulation control data generated by the David Taylor Naval Ship Research and Development Center (DTNSRDC). This work combined the computer program integration work with an air vehicle preliminary design study to size the helicopter and describe its features. The result of this study is the sizing of a four-engined helicopter with a 185 foot diameter, two-bladed main rotor that is designed to carry the XM-1 Main Battle Tank 100 nautical miles in a ship-to-shore Marine Corps assault mission.

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

    PubMed

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

    2010-12-01

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

  18. Reiki for the Treatment of Fibromyalgia: A Randomized Controlled Trial

    PubMed Central

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack

    2008-01-01

    Abstract Objective Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. Design This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. Setting/location The study setting was private medical offices in the Seattle, Washington metropolitan area. Subjects The subjects were comprised 100 adults with fibromyalgia. Intervention Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). Outcome measures The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by selfreport. Improvement between groups was examined in an intention-to-treat analysis. Results Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Conclusion Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms. PMID:18991519

  19. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    PubMed

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

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

    PubMed Central

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

    2016-01-01

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

  1. Improving pediatric prevention via the internet: a randomized, controlled trial.

    PubMed

    Christakis, Dimitri A; Zimmerman, Frederick J; Rivara, Frederick P; Ebel, Beth

    2006-09-01

    Innovations to improve the delivery of pediatric preventive care are needed. We enrolled children, 0 to 11 years of age, into a factorial, randomized, controlled trial of a tailored, evidence-based, Web site (MyHealthyChild) that provided information on prevention topics before a scheduled well-child visit. There were 2 components of the intervention, namely, parental Web content and provider notification. Parental Web content provided information to parents about prevention topics; provider notification communicated to physicians topics that were of interest to parents. We assigned 887 children randomly to 4 groups (usual care, content only, content and notification, or notification only). Outcomes were determined with telephone follow-up surveys conducted 2 to 4 weeks after the visit. Poisson regression analysis was used to determine the independent effects of each intervention on the number of topics discussed and the number of preventive practices implemented. Parents in the notification/content group and in the notification-only group reported discussing more MyHealthyChild topics with their provider. Parents in the notification/content group and in the content-only group reported implementing more MyHealthyChild topic suggestions (such as use of a safety device). A Web-based intervention can activate parents to discuss prevention topics with their child's provider. Delivery of tailored content can promote preventive practices.

  2. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    PubMed

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  3. Preliminary experiments on active control of fan noise from a turbofan engine

    NASA Technical Reports Server (NTRS)

    Thomas, R. H.; Burdisso, R. A.; Fuller, C. R.; O'Brien, W. F.

    1993-01-01

    In the preliminary experiments reported here, active acoustic sources positioned around the circumference of a turbofan engine were used to control the fan noise radiated forward through the inlet. The main objective was to demonstrate the potential of active techniques to alleviate the noise pollution that will be produced by the next generation of larger engines. A reduction of up to 19 dB in the radiation directivity was demonstrated in a zone that encompasses a 30-deg angle, near the error sensor, while spillover effects were observed toward the lateral direction. The simultaneous control of two tones was also demonstrated using two identical controllers in a parallel control configuration.

  4. Preliminary Experimental Results on Controlled Cardiac Computed Tomography: A Phantom Study

    PubMed Central

    Lu, Yang; Cai, Zhijun; Wang, Ge; Zhao, Jun; Bai, Er-Wei

    2010-01-01

    In this paper, we present the preliminary experimental results on controlled cardiac computed tomography (CT), which aims to reduce the motion artifacts by means of controlling the x-ray source rotation speed. An innovative cardiac phantom enables us to perform this experiment without modifying the scanner. It is the first experiment on the cardiac CT with speed controlled x-ray source. Experimental results demonstrate that the proposed method successfully separates the phantom images at different phases (improve the temporal resolution) though controlling the x-ray speed. PMID:19696470

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

    DTIC Science & Technology

    2016-10-01

    implement and evaluate a cost effective, web based self-paced training program to provide skills-oriented continuing education for mental health...total, 139 continuing education certificates were issued. c. Presentations of preliminary findings i. Preliminary findings for baseline and main...number of N = 420.  All post-test and follow-up questionnaires were completed in October 2015.  139 continuing education certificates were issues

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

    PubMed

    Schmidt, Jennifer; Martin, Alexandra

    2015-12-01

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

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2008-01-01

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

  9. Treating depression and substance use: A randomized controlled trial

    PubMed Central

    Hunter, Sarah B.; Watkins, Katherine E.; Hepner, Kimberly A.; Paddock, Susan M.; Munjas, Brett; Osilla, Karen C.; Perry, Suzanne

    2012-01-01

    Few integrated substance use and depression treatments have been developed for delivery in outpatient substance abuse treatment settings. To meet the call for more ‘transportable’ interventions, we conducted a pilot study to test a group cognitive behavioral therapy (CBT) for depression and substance use that was designed for delivery by outpatient substance abuse treatment counselors. Seventy-three outpatient clients were randomized to usual care enhanced with group CBT or usual care alone, and assessed at three time points (baseline, three and six months post-baseline). Our results demonstrated that the treatment was acceptable and feasible for delivery by substance abuse treatment staff, despite challenges with recruiting clients. Both depressive symptoms and substance use were reduced by the intervention, but were not significantly different from the control group. These results suggest that further research is warranted to enhance the effectiveness of treatment for co-occurring disorders in these settings. PMID:22301087

  10. Randomized controlled trial quality in pediatric physical therapy.

    PubMed

    Paci, Matteo; Landi, Niccolò; Marchettini, Mariangela; Baccini, Marco

    2014-08-01

    The aim of this study is to describe the reported quality of randomized controlled trials (RCTs) in pediatric physical therapy (PPT) and changes with time. All RCTs sourced from PEDro database and scored using the PEDro scale were included. RCTs were classified as high- or low quality both with the original cut-off of 6 and a modified cut-off of 5. The relationship between PEDro scores and year of publication was also investigated. One thousand three hundred sixty-seven articles were analyzed. According to the PEDro scale original and modified cut-off, 29% and 56% of the articles were classified as high-quality studies, respectively. The number of RCTs and the average PEDro score increased between 1962 and 2012. However, since some items of the scale could be more frequently satisfied, a further improvement of the quality of RCTs in PPT is recommended.

  11. Family Caregiver Training Program (FCTP): A Randomized Controlled Trial.

    PubMed

    DiZazzo-Miller, Rosanne; Winston, Kristin; Winkler, Sandra L; Donovan, Mary L

    The purpose of this study was to examine the effectiveness of the Family Caregiver Training Program (FCTP) for caregivers of people with dementia. A random assignment control group research design with a 3-mo follow-up was implemented. Thirty-six family caregivers of people with dementia demonstrated an increase in activity of daily living (ADL) knowledge (p < .001) and maintenance of that knowledge 3 mo posttest. Caregiver confidence, regardless of group assignment, improved; however, it was not maintained. Burden, depression, and occupational performance and satisfaction remained unchanged for the intervention group; however, physical health as it pertained to quality of life improved 3 mo posttest (p < .001). Findings demonstrate that the FCTP can effectively provide knowledge to family caregivers on how to assist people with dementia with ADLs. Even when standard care was provided, there was limited information on ADLs that family caregivers faced daily.

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

    PubMed

    Resnik, David B

    2008-01-01

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

  13. [Insulin infusion in intensive care: randomized controlled trial].

    PubMed

    Miranda, Milena Penteado Ferraro; Crespo, Jeiel Carlos Lamonica; Secoli, Silvia Regina

    2013-06-01

    This randomized controlled trial compared the use of an intensive and conventional insulin protocol on clinical outcomes in patients with severe sepsis and septic shock, in the first 72 hours. It was conducted at a university hospital in the city of São Paulo. Patients (n=46) were allocated into two groups: intensive glycemic (blood glucose between 80-110mg/dl) and conventional (180-220mg/dl). The Student's t-test and chi-square test were used for data analysis. A statistically significant (p<0.001) difference was observed in mean glycemia, but there was no difference in the variables of mean minimum arterial pressure (p=0.06) or maximum (p=0.11), serum creatinine (p=0,33) or in mortality (p=0.11). Although there was no difference between the groups regarding mortality, hemodynamic instability in the conventional group was longer and the only deaths occurred in it.

  14. A Novel Recruitment Message to Increase Enrollment into a Smoking Cessation Treatment Program: Preliminary Results from a Randomized Triala

    PubMed Central

    Schnoll, Robert A.; Cappella, Joseph; Lerman, Caryn; Pinto, Angela; Patterson, Freda; Wileyto, E. Paul; Leone, Frank

    2014-01-01

    Most smokers do not utilize approved interventions for nicotine dependence, reducing the probability of cessation. Smoking cessation programs typically use recruitment messages emphasizing the health threats of smoking. Augmenting this threat message by describing the genetic aspects of nicotine addiction may enhance enrollment into a cessation program. During telephone recruitment, 125 treatment-seeking smokers were randomized to receive by phone either a standard threat message or a threat plus genetic prime message and were offered open-label varenicline and counseling. There was a greater rate of enrollment into the cessation program for the threat plus genetic prime participants (51.7%) vs. the threat-only participants (37.7%; p = .03). Smokers who self-identified from racial/ethnic minority groups were less likely to enroll in the cessation program (p = .01) vs. smokers who self-identified as Caucasian. These preliminary data suggest that a simple, affordable, and transportable communication approach enhances enrollment of smokers into a smoking cessation program. A larger clinical trial to evaluate a genetic prime message for improving recruitment into smoking cessation programs is warranted. PMID:21667366

  15. Can typical US home visits affect infant attachment? Preliminary findings from a randomized trial of Healthy Families Durham.

    PubMed

    Berlin, Lisa J; Martoccio, Tiffany L; Appleyard Carmody, Karen; Goodman, W Benjamin; O'Donnell, Karen; Williams, Janis; Murphy, Robert A; Dodge, Kenneth A

    2017-07-17

    US government-funded early home visiting services are expanding significantly. The most widely implemented home visiting models target at-risk new mothers and their infants. Such home visiting programs typically aim to support infant-parent relationships; yet, such programs' effects on infant attachment quality per se are as yet untested. Given these programs' aims, and the crucial role of early attachments in human development, it is important to understand attachment processes in home visited families. The current, preliminary study examined 94 high-risk mother-infant dyads participating in a randomized evaluation of the Healthy Families Durham (HFD) home visiting program. We tested (a) infant attachment security and disorganization as predictors of toddler behavior problems and (b) program effects on attachment security and disorganization. We found that (a) infant attachment disorganization (but not security) predicted toddler behavior problems and (b) participation in HFD did not significantly affect infant attachment security or disorganization. Findings are discussed in terms of the potential for attachment-specific interventions to enhance the typical array of home visiting services.

  16. Preliminary Seafloor Controlled Source EM Results From APPLE

    NASA Astrophysics Data System (ADS)

    Behrens, J. P.; MacGregor, L.; Constable, S.; Everett, M.

    2001-12-01

    Certain events in the life cycle of oceanic lithosphere are dominantly two-dimensional. These include formation of crust at axial spreading centers and deformation at the lithosphere - asthenosphere boundary. These processes may result in an electrically anisotropic oceanic lithosphere by creating conductive pathways in preferred orientations. Controlled Source Electromagnetic (CSEM) soundings and Magnetotelluric (MT) soundings were made during the Anisotropy and Physics of the Pacific Lithosphere Experiment (APPLE), carried out in February/March 2001 approximately 600 km west of San Diego, California. Twenty seafloor electromagnetic field sensors were deployed: 4 long-wire CSEM recorders with 200 m electrode offsets, 6 high-frequency MT/CSEM recorders with two orthogonal 10 m offset electrodes and two orthogonal induction coil magnetometers, and 10 low-frequency MT recorders with a three-component fluxgate magnetometer and two orthogonal 10 m electric dipoles, 5 of which also recorded CSEM data. Every instrument was recovered, with data, during this primary cruise and a follow-up recovery cruise for the long-period instruments in August 2001. The deep-towed EM transmitter (DASI) was a 100 m horizontal electric dipole, which was towed in a 30 km radius circle around a central core of recorders. A radial tow was also performed. DASI transmitted a 4 Hz square wave throughout the CSEM phase of the experiment. Initial processing of the CSEM data reveals evidence of crustal anisotropy. In particular, transmitted electromagnetic energy is attenuated more strongly when propagating from west to east than from north to south. The difference in attenuation is about a factor of two, at a range of 30 km and a frequency of 4Hz. This confirms earlier results from the PEGASUS experiment, which proposed that oceanic lower crust and upper mantle with east-west trending lineaments of increased conductivity will exhibit greater attenuation of electric fields in the east

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

    PubMed

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

    2008-08-01

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

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

    PubMed

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

    2010-08-01

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

  19. [Randomized controlled study on acupuncture treatment for chronic fatigue syndrome].

    PubMed

    Chen, Xing-Hua; Li, Lu-Qian; Zhang, Wen; Yang, Juan; Dai, Yi-Shuang; Xu, Dong-Hua; Tang, Chun-Zhi

    2010-07-01

    To observe the therapeutic effect of acpuncture treatment for chronic fatigue syndrome (CFS). Nighty cases of CFS were randomly divided into an observation group and a control group, 45 cases in each group. The observation group was treated with acupunture at Renying (ST 9), Fengfu (GV 16), Baihui (GV 20); the control group was treated with 250 mL 5% Glucose injectio combined with 20 mL Shenmai injectio. Fatigue Scale (FS) was used to compare the scores between the two groups after treatment. The total scores in the observation group were 9.37 +/- 2.33 and 5.41 +/- 1.96 before and after treatment respectively, and in the control group, they were 9.08 +/- 2.27 and 7.34 +/- 2.03 respectively. FS brainwork integral, physical fatigue integral, and total integral all decreased after treatment in two groups (all P < 0.001), and it decreased much more obviously in the observation group (P < 0.05, P < 0.01). Both of the acpuncture treatment and Shenmai injectio are able to decrease fatigue scale score, improve the fatigue symptoms of CFS patients, and the effect of acupucture treatment is obviously superior to that of Shenmai injectio.

  20. Biofeedback Training in Crisis Managers: A Randomized Controlled Trial.

    PubMed

    Janka, A; Adler, C; Brunner, B; Oppenrieder, S; Duschek, S

    2017-06-01

    Working in crisis environments represents a major challenge, especially for executive personnel engaged in directing disaster operations, i.e. crisis managers. Crisis management involves operating under conditions of extreme stress resulting, for instance, from high-level decision-making, principal responsibility for personnel, multitasking or working under conditions of risk and time pressure. The present study aimed to investigate the efficacy of a newly developed biofeedback training procedure based on electrodermal activity, especially designed for the target group of crisis managers. The training comprised exercises promoting acquisition of control over sympathetic arousal under resting conditions and during exposure to visual, acoustic and cognitive stressors resembling situations related to crisis management. In a randomized controlled design, 36 crisis managers were assigned to either a biofeedback training group or waiting list control group. Subjective stress was assessed using the Perceived Stress Scale. In the training group, stress level markedly decreased; the decrease remained stable at follow-up 2 months after the training. The results indicate that biofeedback training in crisis management is an effective method for stress management that may help to reduce vulnerability to stress-related performance decline and stress-related disease.

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

    PubMed

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

    2007-05-01

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

  2. A Randomized Controlled Trial of Mentoring Interventions for Underrepresented Minorities

    PubMed Central

    Lewis, Vivian; Martina, Camille A.; McDermott, Michael P.; Trief, Paula; Goodman, Steven R.; Morse, Gene D.; LaGuardia, Jennifer G.; Sharp, Daryl; Ryan, Richard M.

    2015-01-01

    Purpose To conduct a randomized controlled trial (RCT) to evaluate the effects of different mentoring interventions on the basic psychological need satisfaction of underrepresented minorities and women in academia. Method Participants were 150 mentor/protégé dyads from three academic medical centers and eight other colleges and universities in western and central New York, randomized from 2010–2013 into: mentor training (using principles of self-determination theory); peer mentoring for protégés; mentor training and peer mentoring for protégés combined; or control/usual practice. Protégé participants were graduate students, fellows and junior faculty who were from underrepresented groups based on race, ethnicity, gender, or disability. The primary analysis was a comparison of intervention effects on changes in protégés’ satisfaction of their basic psychological needs (competence, autonomy and relatedness) with their mentor. They completed a well-validated, online questionnaire every 2 months for 1 year. Results There was no significant effect at the end of 1 year of either mentor training or peer mentoring on protégés’ psychological basic need satisfaction with mentor specifically or at work in general. Exploratory analyses showed a significant effect of the mentor-based intervention on the protégés’ overall psychological need satisfaction with their mentor at 2 months, the time point closest to completing mentor training. Conclusions This RCT showed a potential short-term effect of mentor training on changing basic psychological need satisfaction of underrepresented scholars with their mentors. Despite the lack of sustained effect of either mentor training or peer mentoring, these short-term changes suggest feasibility and potential for future study. PMID:26717501

  3. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    PubMed

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; De Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-07-17

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated: 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial; and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 weeks and 12 months. Male fans of 2 ice hockey teams (35-65 years; body-mass index ≥28 kg/m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (Wait-list Control). Hockey FIT includes a 12-week active phase (weekly, coach-led group meetings including provision of dietary information, practice of behaviour change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-week minimally-supported phase (smartphone app for sustaining physical activity; private online social network; standardized emails; booster session/reunion). Measurement at baseline and 12 weeks (both groups), and 12 months (intervention group only), included clinical outcomes (e.g., weight) and self-reported physical activity, diet, self-rated health. Eighty men were recruited in 4 weeks; trial retention was >80% at 12 weeks and >75% at 12 months. At 12 weeks, the intervention group lost 3.6 (95% CI: -5.26, -1.90) kg more than the comparator (p<0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet and self-rated health at 12 weeks; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and thus, evidence to proceed with a definitive trial.

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

    PubMed Central

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

    2009-01-01

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

  5. Randomized controlled trials: who fails run-in?

    PubMed

    Rees, Judy R; Mott, Leila A; Barry, Elizabeth L; Baron, John A; Figueiredo, Jane C; Robertson, Douglas J; Bresalier, Robert S; Peacock, Janet L

    2016-07-29

    Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability. We conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires (SAQs) and a questionnaire administered by staff. Participants in the full factorial randomization (calcium, vitamin D, both, or neither) received a placebo during a 3-month single-blinded run-in; women electing to take calcium enrolled in a two-group randomization (calcium with vitamin D, or calcium alone) and received calcium during the run-in. Using logistic regression models, we examined baseline factors associated with RIF in three subgroups: men (N = 1606) and women (N = 301) in the full factorial randomization and women in the two-group randomization (N = 666). Overall, 314/2573 (12 %) participants failed run-in; 211 (67 %) took fewer than 80 % of their tablets (poor adherence), and 103 (33 %) withdrew or were uncooperative. In multivariable models, 8- to 13-fold variation was seen by study center in odds of RIF risk in the two largest groups. In men, RIF decreased with age (adjusted odds ratio [OR] per 5 years 0.85 [95 % confidence interval, CI; 0.76-0.96]) and was associated with being single (OR 1.65 [95 % CI; 1.10-2.47]), not graduating from high school (OR 2.77 [95 % CI; 1.58-4.85]), and missing SAQ data (OR 1.97 [1.40-2.76]). Among women, RIF was associated primarily with health-related factors; RIF risk was lower with higher physical health score (OR 0.73 [95 % CI; 0.62-0.86]) and baseline multivitamin use (OR 0.44 [95 % CI; 0.26-0.75]). Women in the 5-year colonoscopy surveillance interval were at greater risk of RIF than those with 3-year follow-up (OR 1.91 [95 % CI; 1.08-3.37]), and the number of prescription medicines taken was also

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

    PubMed Central

    2016-01-01

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

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

    PubMed

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

    2016-10-13

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

  8. Electroacupuncture for Primary Insomnia: A Randomized Controlled Trial

    PubMed Central

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Shi-Ping; Yap, Tuan-Gee; Law, Andrew C.K.

    2009-01-01

    Study Objectives: To evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia. Design: Randomized, single-blind, placebo-controlled, parallel-group. Setting: A university-based sleep clinic. Participants: Community sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization. Intervention: Electroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points. Measurements and Results: Self-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity. Conclusion: We found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture

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

    PubMed Central

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

    2014-01-01

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

  10. Early Intervention for Toddlers With Language Delays: A Randomized Controlled Trial

    PubMed Central

    Kaiser, Ann P.

    2015-01-01

    OBJECTIVE: Early interventions for toddlers with expressive and receptive language delays have not resulted in positive expressive language outcomes. This randomized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays. METHODS: Participants included 97 toddlers, who were between 24 and 42 months with language scores at least 1.33 SDs below the normative mean and no other developmental delays, and their caregivers. Toddlers were randomly assigned to the caregiver-implemented intervention or a usual-care control group. Caregivers and children participated in 28 sessions in which caregivers were taught to implement the intervention. The primary outcome was the Preschool Language Scale, Fourth Edition, a broad-based measure of language. Outcome measurement was not blinded. RESULTS: Caregivers in the intervention improved their use of all language facilitation strategies, such as matched turns (adjusted mean difference, intervention-control, 40; 95% confidence interval 34 to 46; P < .01). Children in the intervention group had significantly better receptive language skills (5.3; 95% confidence interval 0.15 to 10.4), but not broad-based expressive language skills (0.37, 95% confidence interval −4.5 to 5.3; P = .88). CONCLUSIONS: This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children’s language skills. Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes. Research on adaptations for families from culturally and linguistically diverse backgrounds is needed. PMID:25733749

  11. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

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

    PubMed Central

    2012-01-01

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

  13. Pilot Randomized Controlled Trial of Internet-delivered Cognitive-Behavioral Treatment for Pediatric Headache

    PubMed Central

    Law, Emily F.; Beals-Erickson, Sarah E.; Noel, Melanie; Claar, Robyn; Palermo, Tonya M.

    2015-01-01

    Objective To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Background Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. Methods We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-Based Management of Adolescent Pain (Web-MAP). Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between the ages of 11–17 years old, and had recurrent headache for three months or more as diagnosed by a pediatric neurologist. Eighty-three youth enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Results Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multi-level modeling was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to three-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, p < .001). However, there was no statistically significant difference between the Internet CBT group and the specialized headache treatment group at post-treatment or follow

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  16. Control Capacity and A Random Sampling Method in Exploring Controllability of Complex Networks

    PubMed Central

    Jia, Tao; Barabási, Albert-László

    2013-01-01

    Controlling complex systems is a fundamental challenge of network science. Recent advances indicate that control over the system can be achieved through a minimum driver node set (MDS). The existence of multiple MDS's suggests that nodes do not participate in control equally, prompting us to quantify their participations. Here we introduce control capacity quantifying the likelihood that a node is a driver node. To efficiently measure this quantity, we develop a random sampling algorithm. This algorithm not only provides a statistical estimate of the control capacity, but also bridges the gap between multiple microscopic control configurations and macroscopic properties of the network under control. We demonstrate that the possibility of being a driver node decreases with a node's in-degree and is independent of its out-degree. Given the inherent multiplicity of MDS's, our findings offer tools to explore control in various complex systems. PMID:23912679

  17. Teaching children to cross streets safely: a randomized, controlled trial.

    PubMed

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

    2014-07-01

    Child pedestrian injury is a global public health challenge. This randomized, controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and Web sites, plus no-training control, to improve children's street-crossing ability. Pedestrian safety was evaluated among 231 7- and 8-year-olds using both streetside (field) and laboratory-based (virtual environment) trials before intervention group assignment, immediately posttraining, and 6 months posttraining. All training groups received 6 30-min sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior postintervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly posttraining than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in postintervention VR trials. Children showed minimal change in attention to traffic posttraining. Children trained with videos/websites showed minimal learning. Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds' street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly disseminated.

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

    PubMed Central

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

    2014-01-01

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

  19. Cardiopulmonary resuscitation support application on a smartphone - randomized controlled trial.

    PubMed

    Sakai, Tomohiko; Kitamura, Tetsuhisa; Nishiyama, Chika; Murakami, Yukiko; Ando, Masahiko; Kawamura, Takashi; Tasaki, Osamu; Kuwagata, Yasuyuki; Shimazu, Takeshi; Iwami, Taku

    2015-01-01

    This simulation trial aimed to compare the quality of cardiopulmonary resuscitation (CPR) with and without the newly-developed CPR support application on smartphones. In this trial, participants were randomly assigned to either the CPR support application group or the control group, stratified by sex and previous CPR training. Participants' CPR skills were evaluated by a 2-min case-based scenario test using the Leardal Resusci Anne PC Skill reporting Manikin System(®). The outcome measures were the proportion of chest compressions performed in each group and the number of total chest compressions and appropriate chest compressions performed during the 2-min test period. A total of 84 participants were enrolled and completed the protocol. All participants in the CPR support application group performed chest compressions, compared with only 31 (75.6%) in the control group (P<0.001). Among participants who performed chest compressions during the 2-min test period, the number of total chest compressions was significantly higher in the CPR support application group than in the control group (211.6±29.5 vs. 77.0±43.3, P<0.001). The number of appropriate chest compressions tended to be greater in the CPR support application group than in the control group, although it was statistically insignificant (30.3±57.3 vs. 17.2±28.7, P=0.246). In this cohort of laypersons, the newly-developed CPR support application for smartphones contributed to increasing the implementation rate and the number of total chest compressions performed and may assist in improving the survival rate for out-of-hospital cardiac arrests (UMIN000004740).

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

    PubMed

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

    2010-04-01

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

  1. Mobile health, exercise and metabolic risk: a randomized controlled trial.

    PubMed

    Petrella, Robert J; Stuckey, Melanie I; Shapiro, Sheree; Gill, Dawn P

    2014-10-18

    It was hypothesized that a mobile health (mHealth) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12 weeks, which would be better maintained over 52 weeks, compared to the active control intervention. Eligible participants (≥2 metabolic syndrome risk factors) were randomized to the mHealth intervention (n = 75) or the active control group (n = 74). Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12, 24 and 52 weeks. Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity. Analyses were conducted on 67 participants in the intervention group (aged 56.7 ± 9.7 years; 71.6% female) and 60 participants in the active control group (aged 59.1 ± 8.4 years; 76.7% female). At 12 weeks, baseline adjusted mean change in systolic blood pressure (primary outcome) was greater in the active control group compared to the intervention group (-5.68 mmHg; 95% CI -10.86 to -0.50 mmHg; p = 0.03), but there were no differences between groups in mean change for secondary outcomes. Over 52-weeks, the difference in mean change for systolic blood pressure was no longer apparent between groups, but remained significant across the entire population (time: p < 0.001). In participants with increased cardiometabolic risk, exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention, though over 52 weeks, improvements were equal between interventions. ClinicalTrials.gov http://NCT01944124.

  2. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.

    PubMed

    Carson, James W; Carson, Kimberly M; Olsen, Maren K; Sanders, Linda; Porter, Laura S

    2017-03-13

    Women with metastatic breast cancer (MBC) have average life expectancies of about 2 years, and report high levels of disease-related symptoms including pain, fatigue, sleep disturbance, psychological distress, and functional impairment. There is growing recognition of the limitations of medical approaches to managing such symptoms. Yoga is a mind-body discipline that has demonstrated a positive impact on psychological and functional health in early stage breast cancer patients and survivors, but has not been rigorously studied in advanced cancer samples. This randomized controlled trial examines the feasibility and initial efficacy of a Mindful Yoga program, compared with a social support condition that controls for attention, on measures of disease-related symptoms such as pain and fatigue. The study will be completed by December 2017. Sixty-five women with MBC age ≥ 18 are being identified and randomized with a 2:1 allocation to Mindful Yoga or a support group control intervention. The 120-min intervention sessions take place weekly for 8 weeks. The study is conducted at an urban tertiary care academic medical center located in Durham, North Carolina. The primary feasibility outcome is attendance at intervention sessions. Efficacy outcomes include pain, fatigue, sleep quality, psychological distress, mindfulness and functional capacity at post-intervention, 3-month follow-up, and 6-month follow-up. In this article, we present the challenges of designing a randomized controlled trial with long-term follow-up among women with MBC. These challenges include ensuring adequate recruitment including of minorities, limiting and controlling for selection bias, tailoring of the yoga intervention to address special needs, and maximizing adherence and retention. This project will provide important information regarding yoga as an intervention for women with advanced cancer, including preliminary data on the psychological and functional effects of yoga for MBC

  3. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

    PubMed

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-05-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

  4. Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

    PubMed Central

    Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

    2011-01-01

    Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

  5. Random drug testing to reduce the incidence of addiction in anesthesia residents: preliminary results from one program.

    PubMed

    Fitzsimons, Michael G; Baker, Keith H; Lowenstein, Edward; Zapol, Warren M

    2008-08-01

    Substance abuse occurs in approximately 1%-2% of anesthesia residents and nearly 80% of programs have had one or more resident (s) with such a problem. Education and control efforts have failed to reduce the frequency of substance abuse. Anesthesia providers have a professional obligation to be drug-free for the well being of their patients. We have instituted a program of preplacement and random urine testing of residents in anesthesiology in an attempt to decrease the incidence of substance abuse. We demonstrate that such a program is feasible, despite logistic and cultural obstacles. Larger multi-institutional studies will be required to determine whether instituting a program of random urine testing decreases the incidence of substance abuse in anesthesiology residents.

  6. Preliminary design study of a lateral-directional control system using thrust vectoring

    NASA Technical Reports Server (NTRS)

    Lallman, F. J.

    1985-01-01

    A preliminary design of a lateral-directional control system for a fighter airplane capable of controlled operation at extreme angles of attack is developed. The subject airplane is representative of a modern twin-engine high-performance jet fighter, is equipped with ailerons, rudder, and independent horizontal-tail surfaces. Idealized bidirectional thrust-vectoring engine nozzles are appended to the mathematic model of the airplane to provide additional control moments. Optimal schedules for lateral and directional pseudo control variables are calculated. Use of pseudo controls results in coordinated operation of the aerodynamic and thrust-vectoring controls with minimum coupling between the lateral and directional airplane dynamics. Linear quadratic regulator designs are used to specify a preliminary flight control system to improve the stability and response characteristics of the airplane. Simulated responses to step pilot control inputs are stable and well behaved. For lateral stick deflections, peak stability axis roll rates are between 1.25 and 1.60 rad/sec over an angle-of-attack range of 10 deg to 70 deg. For rudder pedal deflections, the roll rates accompanying the sideslip responses can be arrested by small lateral stick motions.

  7. Preliminary assessment of a lower-limb exoskeleton controller for guiding leg movement in overground walking.

    PubMed

    Martinez, Andres; Lawson, Brian; Goldfarb, Michael

    2017-07-01

    This paper describes the design, implementation, and preliminary validation of a controller for a powered lower-limb exoskeleton that reshapes a user's leg movement during over-ground walking. The intended application of the controller is to facilitate gait training for individuals suffering from post-stroke hemiparesis. The controller mimics a kinematic constraint between the knee and hip joints during the swing phase of gait, such that movement is not dependent on time (i.e., step time is determined entirely by the user). The controller additionally incorporates real-time path planning adjustment that allows step length to be adjusted by the user. As such, the controller provides movement coordination, but still enables a user to retain the step-to-step variability required to maintain balance during walking. As a preliminary assessment of efficacy, the controller was implemented on a lower limb exoskeleton and tested on a healthy subject, who walked at varying speeds without the use of a stability aid, with and without the proposed controller. The data indicates that the exoskeleton with controller provided the intended extent of movement coordination, while still allowing the subject to maintain walking balance.

  8. Acupuncture for posttraumatic stress disorder: a randomized controlled pilot trial.

    PubMed

    Hollifield, Michael; Sinclair-Lian, Nityamo; Warner, Teddy D; Hammerschlag, Richard

    2007-06-01

    The purpose of the study was to evaluate the potential efficacy and acceptability of accupuncture for posttraumatic stress disorder (PTSD). People diagnosed with PTSD were randomized to either an empirically developed accupuncture treatment (ACU), a group cognitive-behavioral therapy (CBT), or a wait-list control (WLC). The primary outcome measure was self-reported PTSD symptoms at baseline, end treatment, and 3-month follow-up. Repeated measures MANOVA was used to detect predicted Group X Time effects in both intent-to-treat (ITT) and treatment completion models. Compared with the WLC condition in the ITT model, accupuncture provided large treatment effects for PTSD (F [1, 46] = 12.60; p < 0.01; Cohen's d = 1.29), similar in magnitude to group CBT (F [1, 47] = 12.45; p < 0.01; d = 1.42) (ACU vs. CBT, d = 0.29). Symptom reductions at end treatment were maintained at 3-month follow-up for both interventions. Accupuncture may be an efficacious and acceptable nonexposure treatment option for PTSD. Larger trials with additional controls and methods are warranted to replicate and extend these findings.

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

    PubMed

    Doiron, Jason P; Nicki, Richard M

    2007-01-01

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

  10. HealthLinks Randomized Controlled Trial: Design and Baseline Results

    PubMed Central

    Hammerback, Kristen; Allen, Claire L.; Parrish, Amanda T.; Chan, K. Gary; Kohn, Marlana J.; Teague, Sara; Beresford, Shirley A.A.; Helfrich, Christian D.; Harris, Jeffrey R.

    2016-01-01

    Small employers, especially those in low-wage industries, frequently lack the capacity and resources to implement evidence-based health promotion interventions without support and assistance. The purpose of this paper is to (a) describe the intervention design and study protocol of the HealthLinks Trial and (b) report baseline findings. This study is a three-arm randomized controlled trial testing the impact of the HealthLinks intervention on worksites’ adoption and implementation of evidence-based interventions. Group 1 will receive HealthLinks, Group 2 will receive HealthLinks plus wellness committees, and Group 3 will be a delayed control group. Seventy-eight employers are participating in the study; 3302 employees across the worksites participated in baseline data collection. Employers and employees will participate in follow-up surveys at one and two years after baseline to measure implementation (one year) and maintenance (two years) of HealthLinks interventions. Study outcomes will determine whether HealthLinks is an effective approach to increasing evidence-based health promotion in small, low-wage worksites and whether wellness committees are a capacity-building tool that increases HealthLinks’ effectiveness. PMID:26946121

  11. Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies.

    PubMed

    Balasingam, Shobana; Wilder-Smith, Annelies

    2016-08-01

    Controlled human infection, the intentional infection of healthy volunteers, allows disease pathogenesis to be studied and vaccines and therapeutic interventions to be evaluated in a controlled setting. A systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform was performed. The primary objective was to document the scope of trials performed to date and the main efficacy outcome in the trials. The secondary objective was to assess safety and identify serious adverse events. The PubMed database was searched for randomized controlled influenza human challenge studies with predetermined search terms. Review papers, papers without outcomes, community-acquired infections, duplicated data, pathogenesis studies, and observational studies were excluded. Twenty-six randomized controlled trials published between 1947 and 2014 fit the study inclusion criteria. Two-thirds of these trials investigated antivirals and one-third investigated influenza vaccines. Among 2462 subjects inoculated with influenza virus, the incidence of serious adverse events was low (0.04%). These challenge studies helped to down-select three antivirals and one vaccine that were subsequently approved by the US Food and Drug Administration (FDA). Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Status report and preliminary results of the spacecraft control laboratory experiment

    NASA Technical Reports Server (NTRS)

    Williams, Jeffrey P.

    1987-01-01

    The Spacecraft Control Laboratory Experiment (SCOLE) was conceived to provide a physical test bed for investigation of control techniques for large flexible spacecraft. The SCOLE problem is defined as two design challenges. The first challenge is to design control laws for a mathematical model of a large antenna attached to the space shuttle by a long flexible mast. The second challenge is to design and implement a control scheme on a laboratory representation of the structure modelled in the first part. Control sensors and actuators are typical of those which the control designer would have to deal with on an actual spacecraft. The primary control processing computer is representative of the capacity and speed which may be expected in actual flight computers. A brief description is given of the laboratory apparatus along with some preliminary results of structural dynamics tests and actuator effectiveness tests.

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

    PubMed Central

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

    2016-01-01

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

  14. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    PubMed Central

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  15. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial.

    PubMed

    Rabago, David; Patterson, Jeffrey J; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A; Zgierska, Aleksandra

    2013-01-01

    Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.

  16. [Chuzhen therapy for sub-health: a randomized controlled study].

    PubMed

    Hu, You-Ping; Xu, Zhen-Jie; Wu, Jia; Xing, Lin; Zhang, Lei-Xiao; Zhang, Jin-Xing; Tan, Hui; Mao, Shi-Zhi; Zhou, Cong-Quan

    2012-11-01

    To observe the effect on intervention of sub-health with pestle needle (Chuzhen). Randomized controlled trail was adopted for this research. One hundred and fifty-three cases were randomly divided into two groups of a Chuzhen group (79 cases) and a massage group (74 cases). Acupoint of Bazhen (Baihui Bazhen, Shendao Bazhen, Zhiyang Bazhen, Mingmen Bazhen, Yaoyangguan Bazhen), Hechelu on the head, the neck and the lumbar area were adopted in Chuzhen group. While regular whole-body massage was applied in the massage group. The human sub-health score, the cornell medical index (CMI) and thermal texture maps system (TTM) technology of the two groups before and after the intervention were observed. 1) After treatment, sub-health condition score, the CMI score, the M-R score and the TTM index were all increased in both groups (all P<0.01) 2) Comparison of D-value of the two groups before and after the intervention: the level of the sub-health score, the total score of CMI, and the index of sleep, pressure, Governor Vessel, Hukou (first web), blood lipid, viscosity of blood, microcirculation of TTM index of the Chuzhen group changed more obvious (all P<0.01), but there was no statistic significances in the M-R score and blood sugar of the TTM (both P>0.05). 3) The sub-health condition score in Chuzhen group was higher than that in the massage group (P<0.01). Chuzhen therapy has definite effect on intervention of sub-health, which is better than regular general massage.

  17. Teaching Parents About Responsive Feeding Through a Vicarious Learning Video: A Pilot Randomized Controlled Trial.

    PubMed

    Ledoux, Tracey; Robinson, Jessica; Baranowski, Tom; O'Connor, Daniel P

    2017-06-01

    The American Academy of Pediatrics and World Health Organization recommend responsive feeding (RF) to promote healthy eating behaviors in early childhood. This project developed and tested a vicarious learning video to teach parents RF practices. A RF vicarious learning video was developed using community-based participatory research methods. Fifty parents of preschoolers were randomly assigned to watch Happier Meals or a control video about education. Knowledge and beliefs about RF practices were measured 1 week before and immediately after intervention. Experimental group participants also completed measures of narrative engagement and video acceptability. Seventy-four percent of the sample was White, 90% had at least a college degree, 96% were married, and 88% made >$50,000/year. RF knowledge increased ( p = .03) and positive beliefs about some unresponsive feeding practices decreased ( ps < .05) more among experimental than control parents. Knowledge and belief changes were associated with video engagement ( ps < .05). Parents perceived Happier Meals as highly relevant, applicable, and informative. Community-based participatory research methods were instrumental in developing this vicarious learning video, with preliminary evidence of effectiveness in teaching parents about RF. Happier Meals is freely available for parents or community health workers to use when working with families to promote healthy eating behaviors in early childhood.

  18. Randomized controlled trial of yoga for chronic poststroke hemiparesis: motor function, mental health, and quality of life outcomes.

    PubMed

    Immink, Maarten A; Hillier, Susan; Petkov, John

    2014-01-01

    To assess the efficacy of yoga for motor function, mental health, and quality of life outcomes in persons with chronic poststroke hemiparesis. Twenty-two individuals participated in a randomized controlled trial involving assessment of task-orientated function, balance, mobility, depression, anxiety, and quality of life domains before and after either a 10-week yoga intervention (n = 11) or no treatment (n = 11). The yoga intervention did not result in any significant improvements in objective motor function measures, however there was a significant improvement in quality of life associated with perceived motor function (P = .0001) and improvements in perceived recovery approached significance (P = .072). Memory-related quality of life scores significantly improved after yoga intervention (P = .022), and those participating in the intervention exhibited clinically relevant decreases in state and trait anxiety. Preliminary results offer promise for yoga as an intervention to address mental health and quality of life in persons with stroke-related activity limitations. There is a need to more rigorously evaluate these yoga benefits with a larger randomized controlled trial, which, based on this preliminary trial, is feasible.

  19. Exercise therapy in hip osteoarthritis--a randomized controlled trial.

    PubMed

    Krauß, Inga; Steinhilber, Benjamin; Haupt, Georg; Miller, Regina; Martus, Peter; Janßen, Pia

    2014-09-01

    Roughly one in ten persons in the industrialized world suffers from hip osteoarthritis, a disease for which there is no cure. The goal of conservative therapy is to relieve symptoms, preferably with methods that let patients assume responsibility for their own treatment, e.g., physical training. In a randomized controlled trial, we studied the effectiveness of twelve weeks of exercise therapy in patients with hip osteoarthritis (THüKo), compared to no treatment (control group) and placebo ultrasound treatment of the hip (placebo ultrasound group). The primary endpoint was a comparison of the pain scores of the intervention versus control groups on the generic SF-36 health questionnaire. Secondary endpoints included comparisons across all three study groups of scores on the 7 other scales of the SF-36 and on the pain, physical function, and stiffness scales of the osteoarthritis-specific WOMAC Index. The statistical analysis was performed with ANCOVA, with baseline values as a covariate. Between-group effects were subsequently tested pairwise (two-tailed t-tests, alpha = 0.05). As for the primary endpoint, pain reduction was significantly greater in the intervention than in the control group (mean difference 5.7 points, 95% confidence interval [CI] 0.4-11.1 points, p = 0.034). The comparisons across all three study groups (i.e., secondary endpoints, with 71 subjects in the intervention group, 68 in the control group, and 70 in the placebo group) revealed no significant between-group effects with respect to the SF-36. On the WOMAC Index, however, statistically significant differences were found for pain reduction between the intervention and control group (mean difference 7.4 points, 95% CI 3.0-11.8, p = 0.001) and between the intervention and placebo group (mean difference 5.1 points, 95% CI 0.7-9.4, p = 0.024). Comparable mean differences were also found for functional improvement. Twelve weeks of exercise therapy in hip osteoarthritis patients of normal vitality

  20. Acupuncture in Menopause (AIM) Study: a Pragmatic, Randomized Controlled Trial

    PubMed Central

    Avis, Nancy E.; Coeytaux, Remy R.; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2015-01-01

    Objective to evaluate the short- and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. Methods A total of 209 perimenopausal and postmenopausal women aged 45-60 experiencing ≥4 VMS per day recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. Results VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (p<0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (p<0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained post treatment. Statistically significant clinical improvement was observed after 3 acupuncture treatments and maximum clinical effects occurred after a median of 8 treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. Conclusions We found that a course of acupuncture treatments was associated with significant reduction in VMS, as well as several quality of life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment. PMID:27023860

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  3. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol.

    PubMed

    Garrison, Kathleen A; Pal, Prasanta; Rojiani, Rahil; Dallery, Jesse; O'Malley, Stephanie S; Brewer, Judson A

    2015-04-14

    Tobacco use is responsible for the death of about 1 in 10 individuals worldwide. Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation. Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training. This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up. A two-group parallel-randomized clinical trial with allocation concealment will be conducted. Group assignment will be concealed from study researchers through to follow-up. The study will be conducted by smartphone and online. Daily smokers who are interested in quitting smoking and own a smartphone (n = 140) will be recruited through study advertisements posted online. After completion of a baseline survey, participants will be allocated randomly to the control or intervention group. Participants in both groups will receive a 22-day smartphone-based treatment program for smoking. Participants in the intervention group will receive mobile mindfulness training plus experience sampling. Participants in the control group will receive experience sampling-only. The primary outcome measure will be one-week point prevalence abstinence from smoking (at 6-months follow-up) assessed using carbon monoxide breath monitoring, which will be validated through smartphone-based video chat. This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation. Such an intervention may provide treatment in-hand, in real-world contexts, to help individuals quit smoking. Clinicaltrials.gov NCT02134509 . Registered 7 May 2014.

  4. A feasibility and pilot randomized controlled trial of the "Timing it Right Stroke Family Support Program".

    PubMed

    Cameron, Jill I; Naglie, Gary; Green, Theresa L; Gignac, Monique A M; Bayley, Mark; Huijbregts, Maria; Silver, Frank L; Czerwonka, Anna

    2015-11-01

    Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data. Multi-site mixed method randomized controlled trial. Acute and community care in three Canadian cities. Caregivers were family members or friends providing care to individuals who experienced their first stroke. The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care. Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver. Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction. Preliminary findings suggest the research design is feasible, caregivers' needs are complex, and the support intervention may enhance caregivers' perceived support and mastery. The intervention will be tested further in a large scale trial. © The Author(s) 2014.

  5. Use of prior manufacturer specifications with Bayesian logic eludes preliminary phase issues in quality control: an example in a hemostasis laboratory.

    PubMed

    Tsiamyrtzis, Panagiotis; Sobas, Frédéric; Négrier, Claude

    2015-07-01

    The present study seeks to demonstrate the feasibility of avoiding the preliminary phase, which is mandatory in all conventional approaches for internal quality control (IQC) management. Apart from savings on the resources consumed by the preliminary phase, the alternative approach described here is able to detect any analytic problems during the startup and provide a foundation for subsequent conventional assessment. A new dynamically updated predictive control chart (PCC) is used. Being Bayesian in concept, it utilizes available prior information. The manufacturer's prior quality control target value, the manufacturer's maximum acceptable interassay coefficient of variation value and the interassay standard deviation value defined during method validation in each laboratory, allow online IQC management. An Excel template, downloadable from journal website, allows easy implementation of this alternative approach in any laboratory. In the practical case of prothrombin percentage measurement, PCC gave no false alarms with respect to the 1ks rule (with same 5% false-alarm probability on a single control sample) during an overlap phase between two IQC batches. Moreover, PCCs were as effective as the 1ks rule in detecting increases in both random and systematic error after the minimal preliminary phase required by medical biology guidelines. PCCs can improve efficiency in medical biology laboratories.

  6. A Randomized Controlled Study of Neurofeedback for Chronic PTSD

    PubMed Central

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

    2016-01-01

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

  7. Worksite intervention effects on physical health: a randomized controlled trial.

    PubMed

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

    2006-09-01

    Overweight and physical inactivity are risk factors for increased disease burden and health care expenditure. Well-designed studies are still needed to determine the treatment efficacy of worksite interventions targeting such risk factors. This randomized controlled trial was conducted at one of Australia's casinos in 2002-2003, to investigate the effects of a comprehensive exercise and lifestyle intervention on physical fitness. Only 6.4% of the workforce expressed interest in being study participants. Seventy-three employees (aged 32 +/- 8 years, 51% overweight/obese, 73% shift workers and 52% women) were recruited and randomized to treatment or wait-list control groups for 24 weeks, 44 of whom completed the intervention. Components of the intervention include supervised moderate-to-high intensity exercise including combined aerobic (at least 20 min duration 3 days/week) and weight-training (for an estimated 30 min completed 2-3 days/week), and dietary/health education (delivered via group seminars, one-on-one counselling and literature through the provision of a worksite manual). ANCOVA, by intention-to-treat and of study completers, found significant between-group differences in the mean waist circumference and predicted maximal oxygen uptake (VO2max), favouring the intervention, but effects were concentrated in one subject. For study completers, between-group differences in the mean waist circumference (82.3 +/- 9.2 versus 90.5 +/- 17.8 cm, p = 0.01) and predicted VO2max (47 versus 41 ml/kg/min, p < 0.001) remained significant without the outlier, favouring the intervention. Higher intervention compliance predicted greater improvements in physical fitness. No significant effects on body mass or body mass index were found. This worksite intervention significantly improved waist circumference and aerobic fitness in healthy but sedentary employees, most of whom were shift workers. Worksite interventions have the potential to counter the increasing burden of

  8. Rehabilitation in advanced, progressive, recurrent cancer: a randomized controlled trial.

    PubMed

    Jones, Louise; Fitzgerald, Gail; Leurent, Baptiste; Round, Jeffrey; Eades, Jane; Davis, Sarah; Gishen, Faye; Holman, Amanda; Hopkins, Katherine; Tookman, Adrian

    2013-09-01

    Two million people across the U.K. are living with cancer, often experienced as a long-term condition. They may have unmet needs after active treatment. Rehabilitation aims to address these needs, maximize psychological and physical function, and enable minimum dependency regardless of life expectancy. We aimed to test, in a randomized controlled trial, the clinical and cost effectiveness of a rehabilitation intervention for patients with advanced, recurrent cancer. We conducted a two-arm, wait-list control, randomized trial of a complex rehabilitation intervention delivered by a hospice-based multidisciplinary team vs. usual care for active, progressive, recurrent hematological and breast malignancies, with a follow-up at three months. The primary outcome was the psychological subscale of the Supportive Care Needs Survey (SCNS). Secondary outcomes were other domains of the SCNS, psychological status, continuity of care, quality of life, and resource use. Forty-one participants were enrolled and 36 completed the trial. The primary outcome was significantly lower in the intervention arm (adjusted difference -16.8, 95% CI -28.34 to -5.3; P = 0.006). The SCNS physical and patient care subscales (-14.2, 95% CI -26.2 to -2.2; P = 0.02 and -7.4, 95% CI -13.7 to -1.1; P = 0.02, respectively) and self-reported health state (12.8, 95% CI 3.2 to 22.4; P = 0.01) also differed significantly. The incremental cost-effectiveness ratio was £19,390 per quality-adjusted life year. This intervention significantly reduced the unmet needs of cancer survivors and it is likely that it is cost-effective. Despite small numbers, the main effect size was robust. We recommend implementation alongside evaluation in wider clinical settings and patient populations. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2011-01-01

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

  10. Women's experiences as members of attention control and experimental intervention groups in a randomized controlled trial.

    PubMed

    Beal, Claudia C; Stuifbergen, Alexa; Volker, Deborah; Becker, Heather

    2009-12-01

    Attention control groups are often used in research testing the efficacy of psychosocial and behavioural interventions in order to control for placebo effects. The authors conducted a descriptive qualitative study to investigate how participants viewed their experiences in attention control and experimental intervention groups following a randomized controlled trial for women with fibromyalgia syndrome. Moderately structured interviews were conducted with 18 women (12 from the experimental intervention group and 6 from the attention control group). Members of the control group reported some benefits but few behavioural changes as a result of participating in the RCT, and some participants expressed disappointment at not receiving the intervention. Perceptions of changes in attitudes towards fibromyalgia syndrome and behaviours reported by the intervention group appear to be consistent with the theory underlying the intervention. Possible placebo effects identified in both groups include negative and positive social interactions with other participants.

  11. Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trial.

    PubMed

    Gupta, Samir; Faughnan, Marie E; Lilly, Les; Hutchison, Stuart; Fowler, Robert; Bayoumi, Ahmed M

    2010-12-01

    The hepatopulmonary syndrome occurs in up to one-third of patients with cirrhosis. Animal models of this disease suggest that endotoxemia might cause nitric oxide-mediated vascular dilatation that can be inhibited by the antibiotic norfloxacin. We sought to test this hypothesis in humans. We conducted a pilot randomized, controlled crossover trial of norfloxacin 400 mg twice daily for 4 weeks with a 4-week washout period to assess the feasibility of a larger trial. The primary clinical end point was change in alveolar-arterial oxygen gradient (AaDO₂). Recruitment was challenging, and change in AaDO₂ was highly variable. We recruited 9 adults (1 woman; age, 60 ± 9 years; AaDO₂, 50 ± 22 mm Hg). AaDO₂ decreased by 0.8 ± 4.8 and 3.4 ± 12.4 mm Hg while on norfloxacin and placebo, respectively (P = .59). Recruitment difficulties and variability of the primary outcome measure suggest the need for a multicenter clinical research network for future therapeutic trials in this disease. There was no major effect of norfloxacin on gas exchange in patients with hepatopulmonary syndrome. Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-10-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-07-01

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

  14. Randomized controlled trials – a matter of design

    PubMed Central

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

    2016-01-01

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

  15. Custom-tailored spatial mode sorting by controlled random scattering

    NASA Astrophysics Data System (ADS)

    Fickler, Robert; Ginoya, Manit; Boyd, Robert W.

    2017-04-01

    The need to increase data transfer rates constitutes a key challenge in modern information-driven societies. Taking advantage of the transverse spatial modes of light to encode more information is a promising avenue for both classical and quantum photonics. However, to ease access to the encoded information, it is essential to be able to sort spatial modes into different output channels. Here, we introduce a way to customize the sorting of arbitrary spatial light modes. Our method relies on the high degree of control over random scattering processes by preshaping of the phase structure of the incident light. We demonstrate experimentally that various sets of modes, irrespective of their specific modal structure, can be transformed to a broad range of output channel arrangements. Thus, our method enables full access to all of the information encoded in the transverse structure of the field; for example, azimuthal and radial modes. We also demonstrate that coherence is retained in this complex mode transformation, which opens up applications in quantum and classical information science.

  16. Randomized controlled trial of ionization and photoelectric smoke alarm functionality.

    PubMed

    Mueller, B A; Sidman, E A; Alter, H; Perkins, R; Grossman, D C

    2008-04-01

    To compare functionality, reasons for non-function, and nuisance alarm levels of two common types of smoke alarms after installation in low- to mid-level income households in King County, Washington. Randomized controlled trial of 761 households. An ionization or photoelectric smoke alarm was installed between June 1, 2000 and July 31, 2002. Main outcome measures were: percentage of study alarms that were working, observed reasons for non-functional status, and self-reported frequency of nuisance alarms at 9 and 15 months of follow-up. At 9 months after installation, 20% of ionization, vs 5% of photoelectric alarms were non-functional, a difference that persisted at 15 months, with the most common reasons for both types being a disconnected or absent battery. The risk ratio for ionization, relative to photoelectric alarms, being non-functional or removed was 2.7 (95% CI 1.8 to 4.1) at 15 months of follow-up. These findings were not altered by educational level, or the presence of smokers, children <5 years, or adults > or =65 years. Burn prevention efforts are geared towards increasing smoke alarm ownership and improving maintenance of functional status. Results suggest that the selective use of photoelectric alarms by fire injury prevention programs or consumers may provide longer-term protection in similar populations. Designing smoke alarms that minimize nuisance alarming may also result in longer term functionality.

  17. Carnosine Treatment for Gulf War Illness: A Randomized Controlled Trial

    PubMed Central

    Baraniuk, James N.; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib U.; Timbol, Christian R.

    2013-01-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (β-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

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

    PubMed

    Wingerchuk, Dean M; Noseworthy, John H

    2002-04-23

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

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

    PubMed

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

    2015-08-01

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

  20. Preliminary Design and Analysis of the ARES Atmospheric Flight Vehicle Thermal Control System

    NASA Technical Reports Server (NTRS)

    Gasbarre, J. F.; Dillman, R. A.

    2003-01-01

    The Aerial Regional-scale Environmental Survey (ARES) is a proposed 2007 Mars Scout Mission that will be the first mission to deploy an atmospheric flight vehicle (AFV) on another planet. This paper will describe the preliminary design and analysis of the AFV thermal control system for its flight through the Martian atmosphere and also present other analyses broadening the scope of that design to include other phases of the ARES mission. Initial analyses are discussed and results of trade studies are presented which detail the design process for AFV thermal control. Finally, results of the most recent AFV thermal analysis are shown and the plans for future work are discussed.

  1. Response of lead-acid batteries to chopper-controlled discharge: Preliminary results

    NASA Technical Reports Server (NTRS)

    Cataldo, R. L.

    1978-01-01

    The preliminary results of simulated electric vehicle, chopper, speed controller discharge of a battery show energy output losses up to 25 percent compared to constant current discharges at the same average discharge current of 100 amperes. These energy losses are manifested as temperature rises during discharge, amounting to a two-fold increase for a 400-ampere pulse compared to the constant current case. Because of the potentially large energy inefficiency, the results suggest that electric vehicle battery/speed controller interaction must be carefully considered in vehicle design.

  2. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial.

    PubMed

    Titov, Nickolai; Andrews, Gavin; Johnston, Luke; Robinson, Emma; Spence, Jay

    2010-09-01

    Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen's d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic

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

    PubMed

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  5. Modifying media content for preschool children: a randomized controlled trial.

    PubMed

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

    2013-03-01

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

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

    PubMed Central

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

    2013-01-01

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

  7. Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial.

    PubMed

    Wicksell, R K; Kemani, M; Jensen, K; Kosek, E; Kadetoff, D; Sorjonen, K; Ingvar, M; Olsson, G L

    2013-04-01

    Fibromyalgia (FM) is characterized by widespread pain and co-morbid symptoms such as fatigue and depression. For FM, medical treatments alone appear insufficient. Recent meta-analyses point to the utility of cognitive behaviour therapy (CBT), but effects are moderate. Within the continuous development of CBT, the empirical support for acceptance and commitment therapy (ACT) has increased rapidly. ACT focuses on improving functioning by increasing the patient's ability to act in accordance with personal values also in the presence of pain and distress (i.e., psychological flexibility). However, no study has yet explored the utility of ACT in FM. To evaluate the efficacy of ACT for FM and the role of psychological inflexibility as a mediator of improvement. In this randomized controlled trial, ACT was evaluated in comparison to a waiting list control condition. Forty women diagnosed with FM participated in the study. Assessments were made pre- and post-treatment and at 3 months of follow-up. The ACT intervention consisted of 12 weekly group sessions. Significant differences in favour of ACT were seen in pain-related functioning, FM impact, mental health-related quality of life, self-efficacy, depression, anxiety and psychological inflexibility. Changes in psychological inflexibility during the course of treatment were found to mediate pre- to follow-up improvements in outcome variables. The results correspond with previous studies on ACT for chronic pain and suggest the utility of ACT for FM as well as the role of psychological inflexibility as a mediator of improvement. © 2012 European Federation of International Association for the Study of Pain Chapters.

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

    PubMed Central

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

    2017-01-01

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

  9. Parent Mentors and Insuring Uninsured Children: A Randomized Controlled Trial

    PubMed Central

    Lin, Hua; Walker, Candy; Lee, Michael; Currie, Janet M.; Allgeyer, Rick; Fierro, Marco; Henry, Monica; Portillo, Alberto; Massey, Kenneth

    2016-01-01

    BACKGROUND: Six million US children are uninsured, despite two-thirds being eligible for Medicaid/Children’s Health Insurance Program (CHIP), and minority children are at especially high risk. The most effective way to insure uninsured children, however, is unclear. METHODS: We conducted a randomized trial of the effects of parent mentors (PMs) on insuring uninsured minority children. PMs were experienced parents with ≥1 Medicaid/CHIP-covered child who received 2 days of training, then assisted families for 1 year with insurance applications, retaining coverage, medical homes, and social needs; controls received traditional Medicaid/CHIP outreach. The primary outcome was obtaining insurance 1 year post-enrollment. RESULTS: We enrolled 237 participants (114 controls; 123 in PM group). PMs were more effective (P< .05 for all comparisons) than traditional methods in insuring children (95% vs 68%), and achieving faster coverage (median = 62 vs 140 days), high parental satisfaction (84% vs 62%), and coverage renewal (85% vs 60%). PM children were less likely to have no primary care provider (15% vs 39%), problems getting specialty care (11% vs 46%), unmet preventive (4% vs 22%) or dental (18% vs 31%) care needs, dissatisfaction with doctors (6% vs 16%), and needed additional income for medical expenses (6% vs 13%). Two years post-PM cessation, more PM children were insured (100% vs 76%). PMs cost $53.05 per child per month, but saved $6045.22 per child insured per year. CONCLUSIONS: PMs are more effective than traditional Medicaid/CHIP methods in insuring uninsured minority children, improving health care access, and achieving parental satisfaction, but are inexpensive and highly cost-effective. PMID:27244706

  10. Phytothermotherapy in osteoarthritis: a randomized controlled clinical trial.

    PubMed

    Fioravanti, Antonella; Bellisai, Barbara; Iacoponi, Francesca; Manica, Patrizia; Galeazzi, Mauro

    2011-05-01

    The aim of this study was to assess the efficacy of adding a cycle of phytothermotherapy (a traditional treatment with fermenting grass used in Trentino-Alto Adige, Italy) to the usual drug treatment, in patients with primary symptomatic osteoarthritis (OA) of the knee, hip, or lumbar spine. In this randomized, single-blind, controlled trial, 218 outpatients were enrolled; 109 patients were treated with a cycle of phytothermotherapy at the thermal resort of Garniga Terme (Trento, Italy) for 10 days; the other 109 patients continued regular outpatient care. Patients were assessed at baseline, after 2 weeks, and after 3 months from the beginning of the study and were evaluated using a visual analogue scale (VAS) for spontaneous pain, a Health Assessment Questionnaire, the Lequesne index for hip and knee osteoarthritis, and the Rolland Morris Questionnaire for lumbar spine OA and symptomatic drug consumption. In patients treated with phytothermotherapy, a significant improvement of VAS and a reduction of nonsteroidal anti-inflammatory drug consumption at the end of treatment and 3 months later were observed. In the control group, no significant differences were noted. The analyses performed separately for each subgroup for OA localization showed that the best results were evident in lumbar spine OA. Concerning tolerability, in the group treated with phytothermotherapy 10% of patients presented side-effects due to treatment, but these were of low intensity and did not interrupt the therapy. In conclusion, the results show beneficial effects of a cycle of phytothermotherapy in patients with OA of the hip, knee, or lumbar spine. Phytothermotherapy may therefore be a useful aid alongside the usual pharmacologic and physiokinesic therapies, or may be used as a valid alternative for patients who do not tolerate pharmacologic treatments.

  11. Sexual Arousal and Self-Control: Results from a Preliminary Experimental Test of the Stability of Self-Control

    ERIC Educational Resources Information Center

    Bouffard, Jeffrey; Kunzi, Tasha

    2012-01-01

    A central proposition of Gottfredson and Hirschi's (1990) General Theory of Crime is the relative stability of low self-control, however research on "self-control strength" suggests that it may vary across contexts. The current study examines these differing conceptions by randomly assigning participants to one of two sexual arousal conditions or…

  12. Sexual Arousal and Self-Control: Results from a Preliminary Experimental Test of the Stability of Self-Control

    ERIC Educational Resources Information Center

    Bouffard, Jeffrey; Kunzi, Tasha

    2012-01-01

    A central proposition of Gottfredson and Hirschi's (1990) General Theory of Crime is the relative stability of low self-control, however research on "self-control strength" suggests that it may vary across contexts. The current study examines these differing conceptions by randomly assigning participants to one of two sexual arousal conditions or…

  13. Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials.

    PubMed

    Terhorst, Lauren; Schneider, Michael J; Kim, Kevin H; Goozdich, Lee M; Stilley, Carol S

    2011-09-01

    The purpose of this study was to systematically review the literature for randomized trials of complementary and alternative medicine (CAM) interventions for fibromyalgia (FM). A comprehensive literature search was conducted. Databases included the Cochrane library, PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health, Natural Medicines Comprehensive Database Manual, Alternative and Natural Therapy Index System (MANTIS), Index for Chiropractic Literature, and Allied and Complementary Medicine (AMED). Inclusion criteria were (a) subjects were diagnosed with fibromyalgia and (b) the study design was a randomized controlled trial that compared a CAM therapy vs a control group. Studies were subgrouped by CAM treatment into 11 categories. Evidence tables and forest plots were organized to display quality ratings and effect sizes of each study. The literature search yielded 1,722 results; 102 abstracts were selected as potential articles for inclusion. Sixty studies met criteria and were rated by 2 reviewers; 18 were rated as good quality; 20, moderate; 18, low; and 4, very low. Synthesis of information for CAM categories represented by more than 5 studies revealed that balneotherapy and mind-body therapies were effective in treating FM pain. This study analyzed recent studies and focused exclusively on randomized controlled trials. Despite common use of manual therapies such as massage and manipulation to treat patients with FM, there is a paucity of quality clinical trials investigating these particular CAM categories. Most of these studies identified were preliminary or pilot studies, thus had small sample sizes and were likely underpowered. Two CAM categories showed the most promising findings, balneotherapy and mind-body therapies. Most of the other CAM categories showed a trend favoring the treatment group. It appears that several CAM therapies show some preliminary treatment effect for FM pain, but larger trials that are more adequately powered are

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers. Copyright 2009 S. Karger AG, Basel.

  16. Distributor-type fuel injection pump with preliminary injection control device

    SciTech Connect

    Taira, S.; Ishibashi, T.

    1987-01-13

    A distributor-type fuel injection pump is described for an internal combustion engine having at least one cylinder, the fuel injection pump comprising: (a) a housing having a fuel chamber defined therein; (b) fuel supply means for supplying fuel to the fuel chamber under pressure dependent upon engine r.p.m.; (c) a barrel mounted within the housing and having a distribution hole communicating with the engine cylinder; (d) a plunger mounted within the barrel for axial and rotary motion therein and defining jointly with the barrel a pump working chamber communicating with the fuel chamber. The plunger has a main discharge port communicating at one end with the pump working chamber and alignable with the distribution hole for effecting a main fuel injection, and a preliminary discharge port communicating with the pump working chamber and alignable with the distribution hole before the alignment of the main discharge port with the distribution hole, thereby effecting a preliminary fuel injection before the main injection; and (e) means operatively connected with the plunger and actuatable in response to pressure within the fuel chamber, for controlling fuel injection timing. The control means includes a first means, actuatable in response to the pressure within the fuel chamber, for effecting the preliminary fuel injection when the pressure within the fuel chamber is at less than a predetermined value, and a second means, actuatable in response to the pressure within the fuel chamber, for preventing the preliminary fuel injection when the pressure within the fuel chamber is above the predetermined value.

  17. Amoxicillin for acute rhinosinusitis: A randomized controlled trial

    PubMed Central

    Garbutt, Jane M.; Banister, Christina; Spitznagel, Edward; Piccirillo, Jay F.

    2013-01-01

    Context Evidence to support antibiotic treatment for acute rhinosinusitis is scant, yet antibiotics are commonly used. Objective To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis. Design Randomized placebo-controlled trial Participants and Setting Adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1st 2006 and May 1st 2009 Interventions Ten-day course of either amoxicillin (1500mg/day) or placebo administered in three doses/day. All patients received a 5-7-day supply of symptomatic treatments for pain, fever, cough and nasal congestion to use as needed. Main Outcome Measures The primary outcome was improvement in the disease-specific quality of life after 3–4 days of treatment assessed with the SNOT-16 (minimally important difference 0.5 on 0 to 3 scale). Secondary outcomes included the patients' retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at Days 3, 7, 10 and 28. Results 166 adults (36% male, 78% Caucasian) were randomized to amoxicillin (85) or placebo (81); 92% concurrently used ≥1 symptomatic treatment (amoxicillin, 94%, placebo 90%, p=0.34). The mean change in SNOT-16 scores was not significantly different between groups on Day 3 (mean difference between groups 0.03, 95% CI −0.12 to 0.19) and Day 10, but differed at Day 7 favoring amoxicillin (mean difference between groups 0.19, 95% CI 0.024 to 0.35). At Day 7 more participants treated with amoxicillin reported symptom improvement (74% vs. 56%, p=0.0205; NNT = 6, 95% CI 3 to 34), with no difference at Day-3 or Day-10. No between group differences were found for any other secondary outcomes. No serious adverse events occurred. Conclusion Among patients with acute rhinosinusitis, a 10-day

  18. Software tools and preliminary design of a control system for the 40m OAN radiotelescope

    NASA Astrophysics Data System (ADS)

    de Vicente, P.; Bolaño, R.

    2004-07-01

    The Observatorio Astronómico Nacional (OAN) is building a 40m radiotelescope in its facilities in Yebes (Spain) which will be delivered by April 2004. The servosystem will be controlled by an ACU (Antenna Control Unit), a real time computer running VxWorks which will be commanded from a remote computer (RCC) or from a local computer (LCC) which will act as console. We present the tools we have chosen to develop and use the control system for the RCC and the criteria followed for the choices we made. We also present a preliminary design of the control system on which we are currently working. The RCC will run a server which communicates with the ACU using sockets and with the clients, receivers and backends using OmniOrb, a free implementation of CORBA. Clients running Python will allow the users to control the antenna from any host connected to a LAN or a secure Internet connection.

  19. Analysis and Preliminary Design of an Advanced Technology Transport Flight Control System

    NASA Technical Reports Server (NTRS)

    Frazzini, R.; Vaughn, D.

    1975-01-01

    The analysis and preliminary design of an advanced technology transport aircraft flight control system using avionics and flight control concepts appropriate to the 1980-1985 time period are discussed. Specifically, the techniques and requirements of the flight control system were established, a number of candidate configurations were defined, and an evaluation of these configurations was performed to establish a recommended approach. Candidate configurations based on redundant integration of various sensor types, computational methods, servo actuator arrangements and data-transfer techniques were defined to the functional module and piece-part level. Life-cycle costs, for the flight control configurations, as determined in an operational environment model for 200 aircraft over a 15-year service life, were the basis of the optimum configuration selection tradeoff. The recommended system concept is a quad digital computer configuration utilizing a small microprocessor for input/output control, a hexad skewed set of conventional sensors for body rate and body acceleration, and triple integrated actuators.

  20. Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial

    PubMed Central

    Featherstone, Katie; Donovan, Jenny L

    1998-01-01

    Objectives To explore trial participants’ understandings of randomisation. Design In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. Setting The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. Subjects 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. Interventions and outcome measures Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Results Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. Conclusions The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent. Key messagesMost trial participants were able to recall and

  1. A pilot randomized controlled trial to improve geriatric frailty.

    PubMed

    Chan, Ding-Cheng Derrick; Tsou, Hsiao-Hui; Yang, Rong-Sen; Tsauo, Jau-Yih; Chen, Ching-Yu; Hsiung, Chao Agnes; Kuo, Ken N

    2012-09-25

    Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome. This RCT enrolled 117 older adults (65-79 years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ≥1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n = 55 or problem solving therapy, PST, n = 57) or controls (non-EN, n = 62 or non-PST, n = 60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3 month. Subjects were followed at 3, 6, and 12 months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions. Mean age was 71.4 ± 3.7 years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p = 0.008) at 3 months, but not 6 or 12 months. They also had more increase of serum 25(OH) vitamin D level (4.9 ± 7.7 vs 1.2 ± 5.4, p = 0.006) and lower percentage of osteopenia (74% vs 89% p = 0.042) at 12 months. PST group subjects had better improvement (2.7 ± 6.1 vs 0.2 ± 6.7, p = 0.035, 6-month) and less deterioration (-3.5 ± 9.7 vs -7.1 ± 8.7, p = 0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also

  2. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study.

    PubMed

    Schreiber, Courtney A; Ratcliffe, Sarah J; Barnhart, Kurt T

    2010-05-01

    The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity. We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms. Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20-1.60; p=.23). A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies.

  3. Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial.

    PubMed

    Bignall, Whitney Janee Raglin; Luberto, Christina Marie; Cornette, Adrianne Falkenberg; Haj-Hamed, Monzer; Cotton, Sian

    2015-01-01

    Asthma affects approximately seven million children/adolescents in the USA, with African-American children disproportionately affected. Breathing retraining techniques have been shown to improve asthma outcomes in adults, though research in youth is limited. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a school-based randomized controlled trial of breathing retraining for asthma outcomes and anxiety symptoms in a sample of urban, African-American adolescents. Adolescents were randomized into either the intervention group (20-min breathing retraining plus education) or control group (20-min standard education). Participants completed two study visits, one month apart. Asthma control, asthma quality of life and lung functioning (FEV1 and peak flow) were the primary outcomes, and state anxiety (pre-post the intervention) and trait anxiety (over the one-month period) were the secondary outcomes. Thirty-three African-American adolescents participated in the study, with a 90% retention rate between visit 1 and visit 2. Asthma control and asthma quality of life, significantly improved over time (p ≤ 0.01) with no differences between intervention and control groups. State anxiety significantly decreased (p ≤ 0.01) immediately post intervention at both time points with no differences between groups. There were no significant differences found in lung functioning or trait anxiety over the one-month time period. These preliminary results suggest that breathing retraining is a feasible, acceptable and potentially efficacious intervention (although no significant differences between groups were found) for improving asthma symptoms in urban adolescents with asthma in a school-based setting.

  4. Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial.

    PubMed

    Ichinose-Tsuno, Akiko; Aoki, Akira; Takeuchi, Yasuo; Kirikae, Teruo; Shimbo, Takuro; Lee, Masaichi-Chang-Il; Yoshino, Fumihiko; Maruoka, Yutaka; Itoh, Toshiyuki; Ishikawa, Isao; Izumi, Yuichi

    2014-12-15

    Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque

  5. Nasal oxytocin for social deficits in childhood autism: a randomized controlled trial.

    PubMed

    Dadds, Mark R; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-03-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day 'live-in' intervention using a double-blind randomized control trial. 38 male youths (7-16 years old) with autism spectrum disorders were administered 24 or 12 international units (depending on weight) intranasal placebo or oxytocin once daily over four consecutive days. The oxytocin or placebo was administered during parent-child interaction training sessions. Parent and child behaviours were assessed using parent reports, clinician ratings, and independent observations, at multiple time points to measure side-effects; social interaction skills; repetitive behaviours; emotion recognition and diagnostic status. Compared to placebo, intranasal oxytocin did not significantly improve emotion recognition, social interaction skills, or general behavioral adjustment in male youths with autism spectrum disorders. The results show that the benefits of nasal oxytocin for young individuals with autism spectrum disorders may be more circumscribed than suggested by previous studies, and suggest caution in recommending it as an intervention that is broadly effective.

  6. Cue-centered treatment for youth exposed to interpersonal violence: a randomized controlled trial.

    PubMed

    Carrion, Victor G; Kletter, Hilit; Weems, Carl F; Berry, Rebecca Rialon; Rettger, John P

    2013-12-01

    This study provides preliminary evidence of the feasibility and efficacy of the Stanford cue-centered treatment for reducing posttraumatic stress, depression, and anxiety in children chronically exposed to violence. Sixty-five youth aged 8–17 years were recruited from 13 schools. Participants were randomly assigned to cue-centered treatment or a waitlist control group. Assessments were conducted at 4 discrete time points. Self-report measures assessed youth symptoms of posttraumatic stress disorder (PTSD), anxiety, and depression.Self-report ratings of caregiver anxiety and depression as well as caregiver report of child PTSD were also obtained. Therapists evaluated participants’ overall symptom improvement across treatment sessions. Hierarchal linear modeling analyses showed that compared to the waitlist group, the cue-centered treatment group had greater reductions in PTSD symptoms both by caregiver and child report, as well as caregiver anxiety. Cue-centered treatment, a hybrid trauma intervention merging diverse theoretical approaches, demonstrated feasibility,adherence, and efficacy in treating youth with a history of interpersonal violence.

  7. Preliminary results of a prospective randomized trial of restrictive versus standard fluid regime in elective open abdominal aortic aneurysm repair.

    PubMed

    McArdle, Geralde T; McAuley, Daniel F; McKinley, Andrew; Blair, Paul; Hoper, Margaret; Harkin, Denis W

    2009-07-01

    Open abdominal aortic aneurysm (AAA) repair is associated with a significant morbidity (primarily respiratory and cardiac complications) and an overall mortality rate of 4% to 10%. We tested the hypothesis that perioperative fluid restriction would reduce complications and improve outcome after elective open AAA repair. In a prospective randomized control trial, patients undergoing elective open infra-renal AAA repair were randomized to a "standard" or "restricted" perioperative fluid administration group. Primary outcome measure was rate of major complications (MC) after AAA repair and secondary outcome measures included: Sequential Organ Failure Assessment Score; FiO2/PO2 ratio; Urinary Albumin/Creatinine Ratio; Length-of-stay in, intensive care unit, high dependency unit, in-hospital. This prospective Randomized Controlled Trial was registered in a publicly accessible database and has the following ID number ISRCTN27753612. Overall 22 patients were randomized, 1 was excluded on a priori criteria, leaving standard group (11) and restricted group (10) for analysis. No significant difference was noted between groups in respect to age, gender, American Society Anesthesiology class, Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity scores, operation time, and operation blood loss. There were no in-hospital deaths and no 30-day mortality. The cumulative fluid balance on day 5 postoperative was for standard group, 8242 +/- 714 mL, compared with restricted group, 2570 +/- 977 mL, P < 0.01. MC were significantly reduced in the restricted group (n = 10), 1 MC, compared with standard group (n = 11), 14 MC, P < 0.024. Total and postoperative length-of-stay in-hospital was significantly reduced in the restricted group, 9 +/- 1 and 8 +/- 1 days, compared with standard group, 18 +/- 5 and 16 +/- 5 days, P < 0.01 and P < 0.025, respectively. Serious complications are common after elective open AAA repair, and we have shown for the first

  8. Validity Study of Video Teleconsultation for the Management of Diabetes: A Pilot Randomized Controlled Trial.

    PubMed

    Fatehi, Farhad; Gray, Leonard C; Russell, Anthony W; Paul, Sanjoy K

    2015-10-01

    A large proportion of diabetes patients do not receive a basic minimum of standard care. Telemedicine holds the promise of improving access to health care. However, the validity of remote consultation for diabetes has not been well researched. This pilot randomized control trial was designed to evaluate the agreement on prescription decisions of endocrinologists between two consultation formats: videoconferencing and face-to-face (in-person) consultation. Seventy-three patients were randomized to telemedicine (n=36) and reference group (n=37). Each study patient in the telemedicine group received one face-to-face consultation and one video consultation. The reference group received two face-to-face consultations. The paired consultations for each patient were performed by two different endocrinologists. The level of agreement between endocrinologists was evaluated by comparing their recommendations on antidiabetes and cardioprotective medications. The level of agreement between two endocrinologists on changing antidiabetes drugs was 64% in the telemedicine group and 78% in the reference group. Although the level of agreement was lower when one of the consultations was provided via videoconference, the difference was not significant. The level of agreement on changing cardiovascular drugs was 78% in the telemedicine group and 76% in the reference group, again not significantly different. The results of this study demonstrate the preliminary evidence on the validity of recommendations made by endocrinologists via video consultation. Known limitations of videoconferencing for clinical purposes did not have remarkable impact on the outcome of consultation in terms of adjustment of patient's medications. Video teleconsultation can substitute for a considerable proportion of conventional outpatient specialty consultations for people with diabetes.

  9. Internet-Based, Randomized Controlled Trial of Omega-3 Fatty Acids for Hyperactivity in Autism

    PubMed Central

    Bent, Stephen; Hendren, Robert L.; Zandi, Tara; Law, Kiely; Choi, Jae-Eun; Widjaja, Felicia; Kalb, Luther; Nestle, Jay; Law, Paul

    2014-01-01

    Objective Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, internet-based clinical trial design to evaluate the efficacy of this supplement. Method E-mail invitations were sent to parents of children aged 5-8 enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist. Results During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9 point greater improvement in the omega-3 group, 95% CI -2.2 to 5.2). Side effects were rare and not associated with omega-3 fatty acids. Participant feedback was positive. Conclusion Internet-based randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information—Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT01694667. PMID:24839884

  10. Mindfulness meditation for younger breast cancer survivors: a randomized controlled trial.

    PubMed

    Bower, Julienne E; Crosswell, Alexandra D; Stanton, Annette L; Crespi, Catherine M; Winston, Diana; Arevalo, Jesusa; Ma, Jeffrey; Cole, Steve W; Ganz, Patricia A

    2015-04-15

    Premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment. Targeted interventions are needed to address the needs of this vulnerable group. This randomized trial provided the first evaluation of a brief, mindfulness-based intervention for younger breast cancer survivors designed to reduce stress, depression, and inflammatory activity. Women diagnosed with early stage breast cancer at or before age 50 who had completed cancer treatment were randomly assigned to a 6-week Mindful Awareness Practices (MAPS) intervention group (n = 39) or to a wait-list control group (n = 32). Participants completed questionnaires before and after the intervention to assess stress and depressive symptoms (primary outcomes) as well as physical symptoms, cancer-related distress, and positive outcomes. Blood samples were collected to examine genomic and circulating markers of inflammation. Participants also completed questionnaires at a 3-month follow-up assessment. In linear mixed models, the MAPS intervention led to significant reductions in perceived stress (P = .004) and marginal reductions in depressive symptoms (P = .094), as well as significant reductions in proinflammatory gene expression (P = .009) and inflammatory signaling (P = .001) at postintervention. Improvements in secondary outcomes included reduced fatigue, sleep disturbance, and vasomotor symptoms and increased peace and meaning and positive affect (P < .05 for all). Intervention effects on psychological and behavioral measures were not maintained at the 3-month follow-up assessment, although reductions in cancer-related distress were observed at that assessment. A brief, mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress, behavioral symptoms, and proinflammatory signaling in younger breast cancer survivors. © 2014 American Cancer Society.

  11. Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

    PubMed Central

    Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

    2016-01-01

    This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

  12. Mindfulness meditation for younger breast cancer survivors: A randomized controlled trial

    PubMed Central

    Bower, Julienne E.; Crosswell, Alexandra D.; Stanton, Annette L.; Crespi, Catherine M.; Winston, Diana; Arevalo, Jesusa; Ma, Jeffrey; Cole, Steve W.; Ganz, Patricia A.

    2014-01-01

    Purpose Premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment. Targeted interventions are needed to address the needs of this vulnerable group. Methods This randomized trial provided the first evaluation of a brief mindfulness-based intervention for younger breast cancer survivors designed to reduce stress, depression, and inflammatory activity. Women diagnosed with early-stage breast cancer before age 50 who had completed cancer treatment were randomly assigned to a 6-week Mindful Awareness Practices (MAPS) intervention (n = 39) or wait-list control (n = 32). Participants completed questionnaires at pre- and post-intervention to assess stress and depressive symptoms (primary outcomes) as well as physical symptoms, cancer-related distress, and positive outcomes. Blood samples were collected to examine genomic and circulating markers of inflammation. Participants also completed questionnaires at a three-month follow-up. Results In linear mixed models, the MAPS intervention led to significant reductions in perceived stress (P = .004) and marginal reductions in depressive symptoms (P = .094), as well as significant reductions in pro-inflammatory gene expression (P = .009) and inflammatory signaling (P = .001) at post-intervention. Improvements in secondary outcomes included reduced fatigue, sleep disturbance, and vasomotor symptoms and increased peace and meaning and positive affect (Ps < .05). Intervention effects on psychological and behavioral measures were not maintained at three-month follow-up, though reductions in cancer-related distress were observed at this assessment. Conclusions A brief mindfulness-based intervention showed preliminary short-term efficacy in reducing stress, behavioral symptoms, and pro-inflammatory signaling in younger breast cancer survivors. PMID:25537522

  13. Vagus nerve stimulation therapy for partial-onset seizures: a randomized active-control trial.

    PubMed

    Handforth, A; DeGiorgio, C M; Schachter, S C; Uthman, B M; Naritoku, D K; Tecoma, E S; Henry, T R; Collins, S D; Vaughn, B V; Gilmartin, R C; Labar, D R; Morris, G L; Salinsky, M C; Osorio, I; Ristanovic, R K; Labiner, D M; Jones, J C; Murphy, J V; Ney, G C; Wheless, J W

    1998-07-01

    The purpose of this multicenter, add-on, double-blind, randomized, active-control study was to compare the efficacy and safety of presumably therapeutic (high) vagus nerve stimulation with less (low) stimulation. Chronic intermittent left vagus nerve stimulation has been shown in animal models and in preliminary clinical trials to suppress the occurrence of seizures. Patients had at least six partial-onset seizures over 30 days involving complex partial or secondarily generalized seizures. Concurrent antiepileptic drugs were unaltered. After a 3-month baseline, patients were surgically implanted with stimulating leads coiled around the left vagus nerve and connected to an infraclavicular subcutaneous programmable pacemaker-like generator. After randomization, device initiation, and a 2-week ramp-up period, patients were assessed for seizure counts and safety over 3 months. The primary efficacy variable was the percentage change in total seizure frequency compared with baseline. Patients receiving high stimulation (94 patients, ages 13 to 54 years) had an average 28% reduction in total seizure frequency compared with a 15% reduction in the low stimulation group (102 patients, ages 15 to 60 year; p = 0.04). The high-stimulation group also had greater improvements on global evaluation scores, as rated by a blinded interviewer and the patient. High stimulation was associated with more voice alteration and dyspnea. No changes in physiologic indicators of gastric, cardiac, or pulmonary functions occurred. Vagus nerve stimulation is an effective and safe adjunctive treatment for patients with refractory partial-onset seizures. It represents the advent of a new, nonpharmacologic treatment for epilepsy.

  14. Chinese Health Improvement Profile for people with severe mental illness: A cluster-randomized, controlled trial.

    PubMed

    Bressington, Daniel; Chien, Wai Tong; Mui, Jolene; Lam, Kar Kei Claire; Mahfoud, Ziyad; White, Jacquie; Gray, Richard

    2017-08-07

    The aim of the present study was to establish the feasibility of conducting a full-scale trial and to estimate the preliminary effect of a Chinese Health Improvement Profile (CHIP) intervention on self-reported physical well-being of people with severe mental illness (SMI). The study used a parallel-group, open-label, cluster-randomized, controlled trial (RCT) design. Twelve community psychiatric nurses (CPN) and their corresponding 137 patients with SMI were randomized into the CHIP or treatment-as-usual (TAU) groups. After training, the CPN completed the CHIP at baseline and 12 months, and the findings were used to devise an individualized care plan to promote health behaviour change. Patients were assessed at baseline and 6 and 12 months after starting the intervention. There was an observed positive trend of improvement on the physical component subscale of SF12v2 in the CHIP group compared to the TAU group after 12 months, but the difference did not reach statistical significance (P = 0.138). The mental component subscale showed a similar positive trend (P = 0.077). CHIP participants were more satisfied with their physical health care than TAU patients (P = 0.009), and the CPN were positive about the usefulness/acceptability of the intervention. There were significant within-group improvements in the total numbers of physical health risks, as indicated by the CHIP items (P = 0.005). The findings suggest that it is feasible to conduct a full-scale RCT of the CHIP in future. The CHIP is an intervention that can be used within routine CPN practice, and could result in small-modest improvements in the physical well-being of people with SMI. © 2017 Australian College of Mental Health Nurses Inc.

  15. Combining Cognitive Behavioral Therapy and Milnacipran for Fibromyalgia: A Feasibility Randomized-controlled Trial

    PubMed Central

    Ang, Dennis C.; Jensen, Mark P.; Steiner, Jennifer L.; Hilligoss, Janna; Gracely, Richard H.; Saha, Chandan

    2012-01-01

    Objectives To evaluate the feasibility of a randomized-controlled trial (RCT) and to obtain estimates of the effects of combined cognitive behavioral therapy (CBT) and milnacipran for the treatment of fibromyalgia (FM). Methods Fifty eight patients with FM were randomized to one of the 3 treatment arms: (1) combination therapy (n=20), (2) milnacipran + education (n=19), and (3) placebo + CBT (n=19). Subjects received either milnacipran (100 mg/day) or placebo. Subjects also received 8 sessions of phone-delivered CBT or educational instructions, but only from baseline to week 9. Assessments were conducted at baseline, week 9 and 21. The primary endpoints were baseline to week 21 changes in weekly average pain intensity and physical function (SF-36 physical function scale). Results Compared to milnacipran, combination therapy demonstrated a moderate effect on improving SF-36 physical function (mean difference (SE) = 9.42 (5.48), p=0.09, effect size (ES) =0.60) and in reducing weekly average pain intensity (mean difference (SE) = −1.18 (0.62), p=0.07, ES=0.67). Compared to milnacipran, CBT had a moderate to large effect in improving SF-36 physical function (mean difference (SE) = 11.0 (5.66), p=0.06, ES=0.70). Despite the presence of concomitant centrally-acting therapies, dropout rate was lower than anticipated (15% at week 21). Importantly, at least 6 out of the 8 phone-based therapy sessions were successfully completed by 89% of the subjects; and adherence to the treatment protocols was >95%. Conclusions In this pilot study, a therapeutic approach that combines phone-based CBT and milnacipran was feasible and acceptable. Moreover, the preliminary data supports conducting a fully powered RCT. PMID:23446065

  16. A novel nonpharmacological intervention - breathing-controlled electrical stimulation for neuropathic pain management after spinal cord injury - a preliminary study.

    PubMed

    Li, Shengai; Davis, Matthew; Frontera, Joel E; Li, Sheng

    2016-01-01

    The objective of this study was to examine the effectiveness of a novel nonpharmacological intervention - breathing-controlled electrical stimulation (BreEStim) - for neuropathic pain management in spinal cord injury (SCI) patients. There were two experiments: 1) to compare the effectiveness between BreEStim and conventional electrical stimulation (EStim) in Experiment (Exp) 1 and 2) to examine the dose-response effect of BreEStim in Exp 2. In Exp 1, 13 SCI subjects (6 males and 7 females, history of SCI: 58.2 months, from 7 to 150 months, impairments ranging from C4 AIS B to L1 AIS B) received both BreEStim and EStim in a randomized order with at least 3 days apart. A total of 120 electrical stimuli to the median nerve transcutaneously were triggered by voluntary inhalation during BreEStim or were randomly delivered during EStim. In Exp 2, a subset of 7 subjects received BreEStim120 and 240 stimuli randomly on two different days with 7 days apart (BreEStim120 vs BreEStim240). The primary outcome variable was the visual analog scale (VAS) score. In Exp 1, both BreEStim and EStim showed significant analgesic effects. Reduction in VAS score was significantly greater after BreEStim (2.6±0.3) than after EStim (0.8±0.3) (P<0.001). The duration of analgesic effect was significantly longer after BreEStim (14.2±6 hours) than after EStim (1.9±1 hours) (P=0.04). In Exp 2, BreEStim120 and BreEStim240 had similar degree and duration of analgesic effects. The findings from this preliminary study suggest that BreEStim is an effective alternative nonpharmacological treatment for chronic neuropathic pain in patients suffering from SCI.

  17. Postural control and shoulder steadiness in F-16 pilots: a randomized controlled study.

    PubMed

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S; Toft, Palle; Jørgensen, Marie B; Søgaard, Karen; Sjøgaard, Gisela

    2014-04-01

    During maneuvering, fighter pilots experience loads of up to 50-70 kg on their necks. Neck disorders are common and have been linked to impairment in muscle control. We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain. The current study reports the results of the secondary objective, which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief. In a parallel, single-blinded, randomized controlled study, 55 F-16 pilots were evaluated at baseline and randomized to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. At follow-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain. Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed.

  18. Fundamental movement skills in preschoolers: a randomized controlled trial targeting object control proficiency.

    PubMed

    Donath, L; Faude, O; Hagmann, S; Roth, R; Zahner, L

    2015-11-01

    Adequately developed fundamental movement skills, particularly object control dimensions, are considered essential to learn more complex movement patterns and to increase the likelihood to successfully participate in organized and non-organized sports during later years. Thus, the present randomized controlled trial aimed at improving object control dimensions at an early state in a kindergarten setting. Catching, throwing, kicking, rolling and stationary dribbling were assessed via gross motor development 2 (TGMD-2) testing in 41 normally developed preschoolers. On a cluster-randomized basis [strata: age, sex and body mass index (BMI)], three kindergartens were randomly assigned to an intervention group (n = 22, INT, age: 4.6 ± 1.0 years; BMI: 16.2 ± 1.1 kg/m(2) ) and three to a control group (n = 19, CON: age: 4.5 ± 1.2 years; BMI: 16.8 ± 1.2 kg/m(2) ). Twelve structured training sessions were given within 6 weeks (12 sessions). The total training volume was 330 min. Moderate time × group interaction were observed for the total sum score (Δ+22%, P = 0.05) and dribbling (Δ+41%, P = 0.002). Adjusting for baseline differences analyses of covariance did not affect these results. Interestingly, likely to most likely practically worthwhile effects were detected for the total sum score, catching and dribbling. Object control dimensions such as dribbling and catching that apparently rely on rhythmical movement patterns and anticipatory eye-hand coordination seem to benefit from short-term object control training. These skills are considered important for successful team-sport participation and appropriate sportive motor development. © 2015 John Wiley & Sons Ltd.

  19. Randomized controlled trials: still the backbone of vascular surgery?

    PubMed

    Naylor, A R

    Prior to the introduction of evidence-based medicine, decision-making was largely based upon 'intuitive reasoning', whereby senior clinicians dictated practice based upon personal dogma, personal experience and (often) biased observational studies. This era began to end (in vascular surgery) following completion of the landmark randomized trials in carotid disease, which recruited patients throughout the 1980s. Despite scepticism amongst some surgeons of the time these particular randomized trials have stood the test of time and remain the cornerstone of virtually every guideline of practice to this day. The carotid randomized trials became a beacon for using 'evidence' rather than 'intuitive reasoning' and randomized trials have now been used to determine optimal practice in a plethora of carotid surgery and stenting trials, lower limb revascularization and numerous aortic aneurysm based studies. The literature abounds with situations where practice (previously based on observational study data) was changed overnight following publication of a well-designed randomized trial. However, while observational studies are prone to selection bias, randomized trials bring their own unique limitations including problems with external validity, they take too long to complete, they are very expensive, they are notorious for problems with recruitment and they can frequently become obsolete. This has led to a (not unreasonable) call for more observational studies to be used in the development of practice guidelines. Unfortunately, the principle guideline bodies around the world, e.g. National Institute for Health and Care Excellence (NICE) and the American Heart Association (AHA), prioritize randomized trial evidence above all else. Until that changes, guideline makers will find it very difficult to deviate from using historical randomized trial evidence, even when high quality observational data suggest that 'real world' practice bears little comparison to that reported in the

  20. Parents and Tots Together: Pilot randomized controlled trial of a family-based obesity prevention intervention in Canada.

    PubMed

    Walton, Kathryn; Filion, A Jordan; Gross, Deborah; Morrongiello, Barbara; Darlington, Gerarda; Randall Simpson, Janis; Hou, Sharon; Haines, Jess

    2016-03-16

    To test the feasibility, acceptability and preliminary impact of Parents and Tots Together (PTT), a family-based obesity prevention intervention, in Canada. Canadian parents of preschoolers (aged 2-5 years). Ontario Early Years centres in southwestern Ontario. A pilot randomized controlled trial involving 48 parents who received either the PTT intervention (n = 27) or an attention-matched control home safety intervention (n = 21). To evaluate the feasibility of PTT, we assessed participant retention and outcome evaluation completion rates. To evaluate acceptability, we assessed program attendance and parents' responses to program satisfaction surveys. To evaluate preliminary impact, we assessed children's body mass index (BMI) at baseline, after intervention (end of 9-week intervention) and at 9-month follow-up. As well, at each time point, parents completed surveys assessing stress and self-efficacy related to parenting, children's sleep, activity, TV viewing and diet. Retention rates were high in the intervention (93%) and control (84%) study arms, and 87% of parents reported that they would highly recommend PTT to a friend. At 9-month follow-up, intervention parents reported lower parenting stress (β^ = 15.83, 95% confidence interval [CI] -29.57, -2.07, p = 0.02) and greater self-efficacy in managing their child's behaviour (β^ = 0.16, 95% CI 0.002, 0.33, p = 0.05) than control parents. PTT had minimal influence on children's weight-related behaviours and BMI. The results suggest that PTT can feasibly be implemented and tested in the Canadian context. Preliminary impact results suggest that the program may be effective in changing general parenting; however, program content should be modified to adequately address children's weight-related behaviours.

  1. Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial

    PubMed Central

    Imhoff-Kunsch, Beth; Stein, Aryeh D.; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle

    2011-01-01

    OBJECTIVE: Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. METHODS: In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. RESULTS: Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58–1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and “other illness,” respectively, but 74% longer duration of vomiting (all P < .05). CONCLUSIONS: DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months. PMID:21807696

  2. Randomized Controlled Trials of Pediatric Massage: A Review

    PubMed Central

    Moyer, Christopher A.

    2007-01-01

    The existing reviews of massage therapy (MT) research are either limited to infants, adults, or were conducted prior to the publication of the most recent studies using pediatric samples. Randomized controlled trials (RCTs) of pediatric MT are reviewed. A literature search yielded 24 RCTs of pediatric MT, defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age. Because RCTs of pediatric MT varied considerably in the amount and types of data reported, quantitative and narrative review methods were both used. Single-dose and multiple-dose effects were examined separately. Among single-dose effects, significant reductions of state anxiety were observed at the first session (g = 0.59, P < 0.05) and the last session (g = 1.10, P < 0.01) of a course of treatment. Effects for salivary cortisol (g = 0.28), negative mood (g = 0.52) and behavior (g = 0.37) were non-significant. Three of eleven multiple-dose effects were statistically significant. These were trait anxiety (g = 0.94, P < 0.05), muscle tone (g = 0.90, P < 0.01) and arthritis pain (g = 1.33, P < 0.01). Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results. MT benefits pediatric recipients, though not as universally as sometimes reported. Numerous weaknesses endemic to MT research (e.g. low statistical power, frequent failure to report basic descriptive statistics) are identified, and recommendations for future pediatric MT research are discussed. PMID:17342238

  3. Clinical randomized controlled trial of chemomechanical caries removal (Carisolv).

    PubMed

    Lozano-Chourio, M A; Zambrano, O; González, H; Quero, M

    2006-05-01

    The purpose of this study was to compare the chemomechanical caries-removal system (Carisolv) with high-speed excavation in cavitated occlusal caries of primary molars. Design and setting. The study was a randomized controlled, clinical trial in which the two techniques were compared in each subject. Participants were chosen from public schools, in Maracaibo County, Zulia State, Venezuela. The sample consisted of 80 primary molars selected from 40 children (mean age 7.7+/-0.7 years). Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions. The outcome variables were: clinically complete caries removal, size of the opening of the cavity, volume of carious tissue removed, pain during caries removal, anaesthesia requested by the patient, caries-removal time, and behaviour and preference of patients. All treated molars were clinically caries free whichever caries-removal procedure was used. When Carisolv' was used the final cavity entrance sizes were smaller (P<0.001) and the estimated volume of tissue removed was less (P<0.001). The time taken for caries removal was three times longer (7.51+/-1.83 min, P<0.001). Some pain was reported by seven (17.5%) participants when Carisolv was used, compared with 16 (40%) when high-speed excavation was used (P<0.05). Using the Carisolv method there was a higher proportion of patients with positive behaviour (P<0.01), and 71.0% (P<0.05) preferred this treatment. Carisolv is an effective clinical alternative treatment for the removal of occlusal dentinal caries in cavitated primary molars; it is more conservative of dental tissue and appeared to be more comfortable for most patients, although the clinical time spent is longer than when using high-speed excavation.

  4. Design and Validity of Randomized Controlled Dental Restorative Trials

    PubMed Central

    Göstemeyer, Gerd; Blunck, Uwe; Paris, Sebastian; Schwendicke, Falk

    2016-01-01

    Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51). Follow-up was 24 (20/48) months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90%) used US Public Health Service (USPHS) criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2), longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures. PMID:28773493

  5. Internet-based randomized controlled trials: a systematic review

    PubMed Central

    Mathieu, Erin; McGeechan, Kevin; Barratt, Alexandra; Herbert, Robert

    2013-01-01

    Background The internet is increasingly being used to conduct randomized controlled trials (RCTs). Knowledge of the types of interventions evaluated and the methodological quality of these trials could inform decisions about whether to conduct future trials using conventional methods, fully online or a mixture of the two. Objective To identify and describe the scope of internet-based RCTs for human health condition interventions and evaluate their methodological quality. Methods A systematic review of RCTs of any health intervention conducted fully or primarily on the internet was carried out. Results 23 fully and 27 primarily internet-based RCTs were identified. The first was conducted in 2000. The majority of trials evaluated interventions that involved providing health information to participants, but a few evaluated self-administered interventions (eg, valerian, stretching). Methodological quality was variable and the methods were generally poorly reported. The risk of bias was low in only a small number of trials; most had substantial methodological shortcomings. Only one trial was identified as meeting all criteria for adequate methodological quality. A particular problem was high rates of loss to follow-up (fully online: mean 47%; primarily online: mean 36%). Conclusions It is theoretically possible but perhaps difficult to test the effectiveness of health interventions rigorously with RCTs conducted fully or primarily over the internet. The use of the internet to conduct trials is more suited to pragmatic rather than explanatory trials. The main limitation of these trials is that they typically experience high rates of loss to follow-up. Methodological standards now accepted for traditional RCTs needs to be evident for online RCTs as well, especially in reporting of their methods. PMID:23065196

  6. The HONEYPOT randomized controlled trial statistical analysis plan.

    PubMed

    Pascoe, Elaine Mary; Lo, Serigne; Scaria, Anish; Badve, Sunil V; Beller, Elaine Mary; Cass, Alan; Hawley, Carmel Mary; Johnson, David W

    2013-01-01

    The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial. Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes. A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

  7. The HONEYPOT Randomized Controlled Trial Statistical Analysis Plan

    PubMed Central

    Pascoe, Elaine Mary; Lo, Serigne; Scaria, Anish; Badve, Sunil V.; Beller, Elaine Mary; Cass, Alan; Hawley, Carmel Mary; Johnson, David W.

    2013-01-01

    ♦ Background: The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. ♦ Objective: To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial. ♦ Methods: Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes. ♦ Results: A statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ♦ Conclusions: Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results. PMID:23843589

  8. Sample size in orthodontic randomized controlled trials: are numbers justified?

    PubMed

    Koletsi, Despina; Pandis, Nikolaos; Fleming, Padhraig S

    2014-02-01

    Sample size calculations are advocated by the Consolidated Standards of Reporting Trials (CONSORT) group to justify sample sizes in randomized controlled trials (RCTs). This study aimed to analyse the reporting of sample size calculations in trials published as RCTs in orthodontic speciality journals. The performance of sample size calculations was assessed and calculations verified where possible. Related aspects, including number of authors; parallel, split-mouth, or other design; single- or multi-centre study; region of publication; type of data analysis (intention-to-treat or per-protocol basis); and number of participants recruited and lost to follow-up, were considered. Of 139 RCTs identified, complete sample size calculations were reported in 41 studies (29.5 per cent). Parallel designs were typically adopted (n = 113; 81 per cent), with 80 per cent (n = 111) involving two arms and 16 per cent having three arms. Data analysis was conducted on an intention-to-treat (ITT) basis in a small minority of studies (n = 18; 13 per cent). According to the calculations presented, overall, a median of 46 participants were required to demonstrate sufficient power to highlight meaningful differences (typically at a power of 80 per cent). The median number of participants recruited was 60, with a median of 4 participants being lost to follow-up. Our finding indicates good agreement between projected numbers required and those verified (median discrepancy: 5.3 per cent), although only a minority of trials (29.5 per cent) could be examined. Although sample size calculations are often reported in trials published as RCTs in orthodontic speciality journals, presentation is suboptimal and in need of significant improvement.

  9. Exercise training and habitual physical activity: a randomized controlled trial.

    PubMed

    Swift, Damon L; Johannsen, Neil M; Tudor-Locke, Catrine; Earnest, Conrad P; Johnson, William D; Blair, Steven N; Sénéchal, Martin; Church, Timothy S

    2012-12-01

    Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown. To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure. Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012. Postmenopausal women in a supervised exercise trial. Women (n=325) were randomized to 4, 8, or 12 kcal/kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions. Changes in waist circumference and weight. Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: -4.8 cm vs low: -1.4 cm, p=0.03); 8 (high: -4.2 cm vs low: -0.4 cm, p=0.03), and 12 kcal/kg per week groups (high: -4.1 cm vs low: -0.7 cm, p=0.05). For all groups, p-trend≤0.03. A trend was observed for greater weight reduction with higher steps/day in the 4 kcal/kg per week group (p-trend=0.04) but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05). In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  10. Personal health records and hypertension control: a randomized trial.

    PubMed

    Wagner, Peggy J; Dias, James; Howard, Shalon; Kintziger, Kristina W; Hudson, Matthew F; Seol, Yoon-Ho; Sodomka, Pat

    2012-01-01

    To examine the impact of a personal health record (PHR) in patients with hypertension measured by changes in biological outcomes, patient empowerment, patient perception of quality of care, and use of medical services. A cluster-randomized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics. 453 of 1686 (26.4%) patients approached were included in the analyses. A PHR tethered to the patient's electronic medical record (EMR) was the primary intervention and included security measures, patient control of access, limited transmission of EMR data, blood pressure (BP) tracking, and appointment assistance. BP was the main outcome measure. Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale. Quality of care was assessed using the Clinician and Group Assessment Score (CAHPS) and the Patient Assessment of Chronic Illness Care. Frequency of use of medical services was self-reported. No impact of the PHR was observed on BP, patient activation, patient perceived quality, or medical utilization in the intention-to-treat analysis. Sub-analysis of intervention patients self-identified as active PHR users (25.7% of those with available information) showed a 5.25-point reduction in diastolic BP. Younger age, self-reported computer skills, and more positive provider communication ratings were associated with frequency of PHR use. Few patients provided with a PHR actually used the PHR with any frequency. Thus simply providing a PHR may have limited impact on patient BP, empowerment, satisfaction with care, or use of health services without additional education or clinical intervention designed to increase PHR use. http://ClinicalTrials.gov Identifier: NCT01317537.

  11. Randomized controlled trial of Cassia alata Linn. for constipation.

    PubMed

    Thamlikitkul, V; Bunyapraphatsara, N; Dechatiwongse, T; Theerapong, S; Chantrakul, C; Thanaveerasuwan, T; Nimitnon, S; Boonroj, P; Punkrut, W; Gingsungneon, V

    1990-04-01

    Cassia alata Linn. is a medical plant. Its leaves have been claimed to be effective as a laxative. The studies done so far have shown no toxicity as a result of consuming Cassia alata Linn. leaves. The plant has been found to contain anthraquinones, presumed to be the active ingredient causing the laxative effect. The objective of the study was to test efficacy of Cassia alata Linn. leaves for treatment of constipation compared with a placebo and mist. alba in a multicenter randomized controlled trial carried out in one provincial and 5 community hospitals. Eighty adult patients admitted to 5 community hospitals and one provincial hospital with at least 72 hours of constipation were included in the study. Twenty-eight patients were in the placebo group, 28 in the mist. alba group, and 24 in Cassia alata Linn. group. Each patient was given 120 ml of fluid with caramel color, mist. alba, or Cassia alata Linn. infusion at bed time. Evaluation was performed after 24 hours whether the patient defecated or not. The characteristics of the patients among the three groups were not different. Eighteen per cent of patients in the placebo group passed stools within 24 hours, whereas, 86 and 83 per cent of patients in mist. alba and Cassia alata Linn. groups respectively, passed stools. The differences observed between placebo and mist. alba, placebo and Cassia alata Linn. were statistically highly significant, P less than 0.001 and clinically important. Minimal self-limited side effects, i.e., nausea, dyspepsia, abdominal pain and diarrhea were noted in 16-25 per cent of the patients.(ABSTRACT TRUNCATED AT 250 WORDS)

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

    PubMed

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

    2010-06-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-12-01

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

  14. Oxytocin and autism: a systematic review of randomized controlled trials.

    PubMed

    Preti, Antonio; Melis, Mariangela; Siddi, Sara; Vellante, Marcello; Doneddu, Giuseppe; Fadda, Roberta

    2014-03-01

    Little is known about the effectiveness of pharmacological interventions on autism spectrum disorder (ASD). This is a systematic review of the randomized controlled trials (RCTs) of oxytocin interventions in autism, made from January 1990 to September 2013. A search of computerized databases was supplemented by manual search in the bibliographies of key publications. The methodological quality of the studies included in the review was evaluated independently by two researchers, according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. The review yielded seven RCTs, including 101 subjects with ASD (males=95) and 8 males with Fragile X syndrome. The main categories of target symptoms tested in the studies were repetitive behaviors, eye gaze, and emotion recognition. The studies had a medium to high risk of bias. Most studies had small samples (median=15). All the studies but one reported statistically significant between-group differences on at least one outcome variable. Most findings were characterized by medium effect size. Only one study had evidence that the improvement in emotion recognition was maintained after 6 weeks of treatment with intranasal oxytocin. Overall, oxytocin was well tolerated and side effects, when present, were generally rated as mild; however, restlessness, increased irritability, and increased energy occurred more often under oxytocin. RCTs of oxytocin interventions in autism yielded potentially promising findings in measures of emotion recognition and eye gaze, which are impaired early in the course of the ASD condition and might disrupt social skills learning in developing children. There is a need for larger, more methodologically rigorous RCTs in this area. Future studies should be better powered to estimate outcomes with medium to low effect size, and should try to enroll female participants, who were rarely considered in previous studies. Risk of bias should be minimized. Human long

  15. Impaired motor unit control in paretic muscle post stroke assessed using surface electromyography: a preliminary report.

    PubMed

    Hu, Xiaogang; Suresh, Aneesha K; Li, Xiaoyan; Rymer, William Zev; Suresh, Nina L

    2012-01-01

    The objective of this preliminary study was to examine the possible contribution of disordered control of motor unit (MU) recruitment and firing patterns in muscle weakness post-stroke. A novel surface EMG (sEMG) recording and decomposition system was used to record sEMG signals and extract single MU activities from the first dorsal interosseous muscle (FDI) of two hemiparetic stroke survivors. To characterize MU reorganization, an estimate of the motor unit action potential (MUAP) amplitude was derived using spike triggered averaging of the sEMG signal. The MUs suitable for further analysis were selected using a set of statistical tests that assessed the variability of the morphological characteristics of the MUAPs. Our preliminary results suggest a disrupted orderly recruitment based on MUAP size, a compressed recruitment range, and reduced firing rates evident in the paretic muscle compared with the contralateral muscle of one subject with moderate impairment. In contrast, the MU organization was largely similar bilaterally for the subject with minor impairment. The preliminary results suggest that MU organizational changes with respect to recruitment and rate modulation can contribute to muscle weakness post-stroke. The contrasting results of the two subjects indicate that the degree of MU reorganization may be associated with the degree of the functional impairment, which reveals the differential diagnostic capability of the sEMG decomposition system.

  16. A Preliminary Data Model for Orbital Flight Dynamics in Shuttle Mission Control

    NASA Technical Reports Server (NTRS)

    ONeill, John; Shalin, Valerie L.

    2000-01-01

    The Orbital Flight Dynamics group in Shuttle Mission Control is investigating new user interfaces in a project called RIOTS [RIOTS 2000]. Traditionally, the individual functions of hardware and software guide the design of displays, which results in an aggregated, if not integrated interface. The human work system has then been designed and trained to navigate, operate and integrate the processors and displays. The aim of RIOTS is to reduce the cognitive demands of the flight controllers by redesigning the user interface to support the work of the flight controller. This document supports the RIOTS project by defining a preliminary data model for Orbital Flight Dynamics. Section 2 defines an information-centric perspective. An information-centric approach aims to reduce the cognitive workload of the flight controllers by reducing the need for manual integration of information across processors and displays. Section 3 describes the Orbital Flight Dynamics domain. Section 4 defines the preliminary data model for Orbital Flight Dynamics. Section 5 examines the implications of mapping the data model to Orbital Flight Dynamics current information systems. Two recurring patterns are identified in the Orbital Flight Dynamics work the iteration/rework cycle and the decision-making/information integration/mirroring role relationship. Section 6 identifies new requirements on Orbital Flight Dynamics work and makes recommendations based on changing the information environment, changing the implementation of the data model, and changing the two recurring patterns.

  17. A preliminary investigation of the use of throttles for emergency flight control

    NASA Technical Reports Server (NTRS)

    Burcham, F. W., Jr.; Fullerton, C. Gordon; Gilyard, Glenn B.; Wolf, Thomas D.; Stewart, James F.

    1991-01-01

    A preliminary investigation was conducted regarding the use of throttles for emergency flight control of a multiengine aircraft. Several airplanes including a light twin-engine piston-powered airplane, jet transports, and a high performance fighter were studied during flight and piloted simulations. Simulation studies used the B-720, B-727, MD-11, and F-15 aircraft. Flight studies used the Lear 24, Piper PA-30, and F-15 airplanes. Based on simulator and flight results, all the airplanes exhibited some control capability with throttles. With piloted simulators, landings using manual throttles-only control were extremely difficult. An augmented control system was developed that converts conventional pilot stick inputs into appropriate throttle commands. With the augmented system, the B-720 and F-15 simulations were evaluated and could be landed successfully. Flight and simulation data were compared for the F-15 airplane.

  18. Computerized Cognitive Behavioral Therapy to Treat Emotional Distress After Stroke: A Feasibility Randomized Controlled Trial

    PubMed Central

    Yates, Matthew; Wagner, Adam P; Watson, Peter; Gracey, Fergus; Ring, Howard; Bateman, Andrew

    2017-01-01

    Background Depression and anxiety are common complications following stroke. Symptoms could be treatable with psychological therapy, but there is little research on its efficacy. Objectives The aim of this study was to investigate (1) the acceptability and feasibility of computerized cognitive behavioral therapy (cCBT) to treat symptoms of depression and anxiety and (2) a trial design for comparing the efficacy of cCBT compared with an active comparator. Methods Of the total 134 people screened for symptoms of depression and anxiety following stroke, 28 were cluster randomized in blocks with an allocation ratio 2:1 to cCBT (n=19) or an active comparator of computerized cognitive remediation therapy (cCRT, n=9). Qualitative and quantitative feedback was sought on the acceptability and feasibility of both interventions, alongside measuring levels of depression, anxiety, and activities of daily living before, immediately after, and 3 months post treatment. Results Both cCBT and cCRT groups were rated as near equally useful (mean = 6.4 vs 6.5, d=0.05), while cCBT was somewhat less relevant (mean = 5.5 vs 6.5, d=0.45) but somewhat easier to use (mean = 7.0 vs 6.3, d=0.31). Participants tolerated randomization and dropout rates were comparable with similar trials, with only 3 participants discontinuing due to potential adverse effects; however, dropout was higher from the cCBT arm (7/19, 37% vs 1/9, 11% for cCRT). The trial design required small alterations and highlighted that future-related studies should control for participants receiving antidepressant medication, which significantly differed between groups (P=.05). Descriptive statistics of the proposed outcome measures and qualitative feedback about the cCBT intervention are reported. Conclusions A pragmatic approach is required to deliver computerized interventions to accommodate individual needs. We report a preliminary investigation to inform the development of a full randomized controlled trial for testing the

  19. Bupropion for Overweight Women with Binge Eating Disorder: Randomized Double-blind Placebo-controlled Trial

    PubMed Central

    White, Marney A.; Grilo, Carlos M.

    2014-01-01

    Background Binge eating disorder (BED) is defined by recurrent binge eating (eating unusually large quantities of food during which a subjective loss of control is experienced), marked distress about the binge eating, and the absence of inappropriate weight compensatory behaviors. BED is strongly associated with excess weight and many available psychological and pharmacological approaches fail to produce much weight loss. The objective of this study was to perform a randomized placebo-controlled trial to evaluate the short-term efficacy of bupropion for the treatment of BED in overweight and obese women. Methods Sixty-one overweight and obese (Mean BMI=35.8) women with BED were randomly assigned to receive bupropion (300 mg/d) or placebo for 8 weeks. Participants were enrolled from November 2006 to December 2010. No dietary or lifestyle intervention was given. Primary outcome measures were binge-eating frequency and percent BMI loss. Secondary outcome measures were dimensional measures of eating disorder psychopathology, food craving, and depression levels. Results Eighty-nine percent of randomized participants completed the trial without differential dropout between bupropion and placebo. Mixed effects analyses revealed significant time effects for all outcomes but that bupropion and placebo did not differ significantly on any outcome measure except for weight loss. Participants taking bupropion lost significantly more weight (1.8% BMI loss versus 0.6% BMI loss; F=10.57, p=002). Conclusions Bupropion was well tolerated and produced significantly greater – albeit quite modest – short-term weight loss in overweight and obese women with BED. Bupropion did not improve binge eating, food craving, or associated eating disorder features or depression relative to placebo. Our findings do not support bupropion as a stand-alone treatment for BED. The preliminary findings regarding short-term weight losses suggest the need for larger and longer-term trials to evaluate

  20. Computerized Cognitive Behavioral Therapy to Treat Emotional Distress After Stroke: A Feasibility Randomized Controlled Trial.

    PubMed

    Simblett, Sara K; Yates, Matthew; Wagner, Adam P; Watson, Peter; Gracey, Fergus; Ring, Howard; Bateman, Andrew

    2017-05-31

    Depression and anxiety are common complications following stroke. Symptoms could be treatable with psychological therapy, but there is little research on its efficacy. The aim of this study was to investigate (1) the acceptability and feasibility of computerized cognitive behavioral therapy (cCBT) to treat symptoms of depression and anxiety and (2) a trial design for comparing the efficacy of cCBT compared with an active comparator. Of the total 134 people screened for symptoms of depression and anxiety following stroke, 28 were cluster randomized in blocks with an allocation ratio 2:1 to cCBT (n=19) or an active comparator of computerized cognitive remediation therapy (cCRT, n=9). Qualitative and quantitative feedback was sought on the acceptability and feasibility of both interventions, alongside measuring levels of depression, anxiety, and activities of daily living before, immediately after, and 3 months post treatment. Both cCBT and cCRT groups were rated as near equally useful (mean = 6.4 vs 6.5, d=0.05), while cCBT was somewhat less relevant (mean = 5.5 vs 6.5, d=0.45) but somewhat easier to use (mean = 7.0 vs 6.3, d=0.31). Participants tolerated randomization and dropout rates were comparable with similar trials, with only 3 participants discontinuing due to potential adverse effects; however, dropout was higher from the cCBT arm (7/19, 37% vs 1/9, 11% for cCRT). The trial design required small alterations and highlighted that future-related studies should control for participants receiving antidepressant medication, which significantly differed between groups (P=.05). Descriptive statistics of the proposed outcome measures and qualitative feedback about the cCBT intervention are reported. A pragmatic approach is required to deliver computerized interventions to accommodate individual needs. We report a preliminary investigation to inform the development of a full randomized controlled trial for testing the efficacy of computerized interventions for people

  1. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial

    PubMed Central

    2010-01-01

    Background Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks. Methods/Design A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and

  2. Summary report: A preliminary investigation into the use of fuzzy logic for the control of redundant manipulators

    NASA Technical Reports Server (NTRS)

    Cheatham, John B., Jr.; Magee, Kevin N.

    1991-01-01

    The Rice University Department of Mechanical Engineering and Materials Sciences' Robotics Group designed and built an eight degree of freedom redundant manipulator. Fuzzy logic was proposed as a control scheme for tasks not directly controlled by a human operator. In preliminary work, fuzzy logic control was implemented for a camera tracking system and a six degree of freedom manipulator. Both preliminary systems use real time vision data as input to fuzzy controllers. Related projects include integration of tactile sensing and fuzzy control of a redundant snake-like arm that is under construction.

  3. A Randomized Controlled Trial of Storytelling as a Communication Tool

    PubMed Central

    Hartling, Lisa; Scott, Shannon D.; Johnson, David W.; Bishop, Ted; Klassen, Terry P.

    2013-01-01

    Introduction Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. Results There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Conclusions Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes. Trial Registration Current Controlled

  4. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    PubMed Central

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

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

    PubMed Central

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

    2015-01-01

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

  6. A Culturally Adapted Physical Activity intervention for Latinas A Randomized Controlled Trial

    PubMed Central

    Pekmezi, Dorothy W.; Neighbors, Charles J.; Lee, Christina S.; Gans, Kim M.; Bock, Beth C.; Morrow, Kathleen M.; Marquez, Becky; Dunsiger, Shira; Marcus, Bess H.

    2010-01-01

    Background In the U.S., Latinos report particularly high levels of inactivity and related chronic illnesses and are in need of intervention. Thus, the purpose of the current study was to culturally and linguistically adapt an empirically supported, individually tailored physical activity print intervention for Latinos and then conduct an RCT of the modified program. Design RCT Setting/Participants The sample included 93 overweight/obese (80%) Latinas with low income and acculturation. Intervention Data were collected in 2007–2008 and analyzed by intent-to-treat in 2009. Participants were randomly assigned to either: (1) a culturally and linguistically adapted physical activity intervention (Seamos Activas), or (2) a wellness contact control condition. Main outcome measures Self report physical activity, as measured pre- and post- intervention (6 months, 87% retention) by the 7-Day Physical Activity Recall. Results Moderate-intensity (or greater) physical activity increased from an average of 16.56 minutes/week (SD=25.76) at baseline to 147.27 (SD=241.55) at 6 months in the intervention arm (n=45) and from 11.88 minutes/week (SD=21.99) to 96.79 (SD=118.49) in the wellness contact control arm (n=48). No between-group differences were seen in overall physical activity. Intervention participants reported significantly greater increases in cognitive [F(1,91)= 9.53, p = .003] and behavioral processes of change [F(1,91)= 8.37, p = .005] and available physical activity supplies and equipment at home [F(1,91)=4.17, p=.04] than control participants. Conclusions Results supported the hypothesized feasibility, acceptability, and preliminary efficacy of individually tailored physical activity print interventions among Latinas. While more research is needed to corroborate these findings, such high-reach, low-cost approaches have great potential to positively affect public health. PMID:19944914

  7. Randomized Controlled Trial of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Insomnia

    PubMed Central

    Arnedt, J. Todd; Cuddihy, Leisha; Swanson, Leslie M.; Pickett, Scott; Aikens, James; Chervin, Ronald D.

    2013-01-01

    Study Objectives: To compare the efficacy of telephone-delivered cognitive-behavioral therapy for insomnia to an information pamphlet control on sleep and daytime functioning at pretreatment, posttreatment, and 12-wk follow-up. Design: Randomized controlled parallel trial. Setting: N/A. Participants: Thirty individuals with chronic insomnia (27 women, age 39.1 ± 14.4 years, insomnia duration 8.7 ± 10.7 years). Interventions: Cognitive behavioral therapy for insomnia (CBTI) delivered in up to eight weekly telephone sessions (CBTI-Phone, n = 15) versus an information pamphlet control (IPC, n = 15). Measurements and Results: Sleep/wake diary, sleep-related questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, 16-item Dysfunctional Beliefs and Attitudes about Sleep), and daytime symptom assessments (fatigue, depression, anxiety, and quality of life) were completed at pretreatment, posttreatment, and 12-wk follow-up. Linear mixed models indicated that sleep/wake diary sleep efficiency and total sleep time improved significantly at posttreatment in both groups and remained stable at 12-wk follow-up. More CBTI-Phone than IPC patients showed posttreatment improvements in unhelpful sleep-related cognitions (P < 0.001) and were classified as “in remission” from insomnia at follow-up (P < 0.05). Posttreatment effect sizes on most daytime symptoms were large (Cohen d = 0.8–2.5) for CBTI-Phone patients and small to moderate (Cohen d = -0.1–0.6) for IPC patients. All CBTI-Phone patients completed posttreatment and 12-wk follow-up assessments, but three IPC patients discontinued the study. Conclusions: The findings provide preliminary support for telephone-delivered CBTI in the treatment of chronic insomnia. Future larger-scale studies with more diverse samples are warranted. Some individuals with insomnia may also benefit from pamphlet-delivered CBTI with brief telephone support. Citation: Arnedt JT; Cuddihy L; Swanson LM; Pickett S; Aikens J

  8. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial.

    PubMed

    Paineau, Damien L; Beaufils, François; Boulier, Alain; Cassuto, Dominique-Adèle; Chwalow, Judith; Combris, Pierre; Couet, Charles; Jouret, Béatrice; Lafay, Lionel; Laville, Martine; Mahe, Sylvain; Ricour, Claude; Romon, Monique; Simon, Chantal; Tauber, Maïté; Valensi, Paul; Chapalain, Véronique; Zourabichvili, Othar; Bornet, Francis

    2008-01-01

    To test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in free-living (noninstitutionalized) children and parents. Randomized controlled trial. Fifty-four elementary schools in Paris, France. One thousand thirteen children (mean age, 7.7 years) and 1013 parents (mean age, 40.5 years). Families were randomly assigned to group A (advised to reduce fat and to increase complex carbohydrate intake), group B (advised to reduce both fat and sugar and to increase complex carbohydrate intake), or a control group (given no advice). Groups A and B received monthly phone counseling and Internet-based monitoring for 8 months. Changes in nutritional intake, body mass index (calculated as weight in kilograms divided by height in meters squared), fat mass, physical activity, blood indicators, and quality of life. Compared with controls, participants in the intervention groups achieved their nutritional targets for fat intake and to a smaller extent for sugar and complex carbohydrate intake, leading to a decrease in energy intake (children, P < .001; parents, P = .02). Mean changes in body mass index were similar among children (group A, + 0.05, 95% confidence interval [CI], - 0.06 to 0.16; group B, + 0.10, 95% CI, - 0.03 to 0.23; control group, + 0.13, 95% CI, 0.04-0.22; P = .45), but differed in parents (group A, + 0.13, 95% CI, - 0.01 to 0.27; group B, - 0.02, 95% CI, - 0.14 to 0.11; control group, + 0.24, 95% CI, 0.13-0.34; P = .001), with a significant difference between group B and the control group (P = .01). Family dietary coaching improves nutritional intake in free-living children and parents, with beneficial effects on weight control in parents. Trial Registration clinicaltrials.gov Identifier: NCT00456911.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-09-01

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

  11. Soft tissue cell adhesion to titanium abutments after different cleaning procedures: Preliminary results of a randomized clinical trial

    PubMed Central

    Canullo, Luigi; Peñarrocha-Oltra, David; Marchionni, Silvia; Bagán, Leticia; Micarelli, Costanza

    2014-01-01

    Objectives: A randomized controlled trial was performed to assess soft tissue cell adhesion to implant titanium abutments subjected to different cleaning procedures and test if plasma cleaning can enhance cell adhesion at an early healing time. Study Design: Eighteen patients with osseointegrated and submerged implants were included. Before re-opening, 18 abutments were divided in 3 groups corresponding to different clinical conditions with different cleaning processes: no treatment (G1), laboratory customization and cleaning by steam (G2), cleaning by plasma of Argon (G3). Abutments were removed after 1 week and scanning electron microscopy was used to analyze cell adhesion to the abutment surface quantitatively (percentage of area occupied by cells) and qualitatively (aspect of adhered cells and presence of contaminants). Results: Mean percentages of area occupied by cells were 17.6 ± 22.7%, 16.5 ± 12.9% and 46.3 ± 27.9% for G1, G2 and G3 respectively. Differences were statistically significant between G1 and G3 (p=0.030), close to significance between G2 and G3 (p=0.056), and non-significant between G1 and G2 (p=0.530). The proportion of samples presenting adhered cells was homogeneous among the 3 groups (p-valor = 1.000). In all cases cells presented a flattened aspect; in 2 cases cells were less efficiently adhered and in 1 case cells presented filipodia. Three cases showed contamination with cocobacteria. Conclusions: Within the limits of the present study, plasma of Argon may enhance cell adhesion to titanium abutments, even at the early stage of soft tissue healing. Further studies with greater samples are necessary to confirm these findings. Key words:Connective tissue, dental abutments, randomized controlled trial, clinical research, glow discharged abutment, plasma cleaning. PMID:24121917

  12. Randomized, Controlled Trial of the Effect of Dietary Potassium Restriction on Nerve Function in CKD.

    PubMed

    Arnold, Ria; Pianta, Timothy J; Pussell, Bruce A; Kirby, Adrienne; O'Brien, Kate; Sullivan, Karen; Holyday, Margaret; Cormack, Christine; Kiernan, Matthew C; Krishnan, Arun V

    2017-10-06

    Neuromuscular complications are almost universal in CKD by the time that a patient commences dialysis. Recent studies have indicated that chronic hyperkalemia may contribute to the development of neuropathy in CKD. This study was undertaken to determine whether dietary restriction of potassium intake may be a neuroprotective factor in CKD. A 24-month prospective, single-blind, randomized, controlled trial was undertaken in 47 consecutively recruited patients with stages 3 and 4 CKD. The intervention arm (n=23) was prescribed a diet focusing on potassium restriction to meet a monthly serum potassium level of ≤4.5 mEq/L, with oral sodium polystyrene sulfonate provided if dietary advice failed to achieve the target. The control arm (n=24) received dietary advice regarding general nutrition. The primary outcome was the change in the total neuropathy score evaluated by a blinded observer. Secondary outcomes included electrolyte levels, gait speed, neurophysiologic parameters, and health-related