A Preliminary Investigation of a Randomized Dependent Group Contingency for Hallway Transitions

ERIC Educational Resources Information Center

Deshais, Meghan A.; Fisher, Alyssa B.; Kahng, SungWoo

2018-01-01

We conducted a preliminary investigation of a randomized dependent group contingency to decrease disruptive behavior during hallway transitions. Two first-graders, identified by their classroom teacher, participated in this study. A multiple baseline across transitions was used to evaluate the effects of the randomized dependent group contingency…

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial.

PubMed

Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A

2014-09-01

To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.

Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial.

PubMed

Kort, Daniel H; Lobo, Roger A

2014-11-01

To determine the effect of cinnamon on menstrual cyclicity and metabolic dysfunction in women with polycystic ovary syndrome (PCOS). In a prospective, placebo controlled, double-blinded randomized trial, 45 women with PCOS were randomized (1:1) to receive cinnamon supplements (1.5 g/d) or placebo for 6 months. Menstrual cyclicity (average cycles/month) during the 6 months study period was compared between the 2 groups using the Mann-Whitney U test. Changes in menstrual cyclicity and insulin resistance between baseline and the 6 month study period were compared between the 2 groups using Wilcoxon signed rank tests. The 45 women were randomized, 26 women completed 3 months of the study, and 17 women completed the entire 6 months of the study. During the 6 month intervention, menstrual cycles were more frequent in patients taking cinnamon compared with patients taking placebo (median, 0.75; interquartile range, 0.5-0.83 vs median, 0.25; interquartile range, 0-0.54; P = .0085; Mann Whitney U). In patients taking cinnamon, menstrual cyclicity improved from baseline (+ 0.23 cycles/month 95% confidence interval, 0.099-0.36), yet did not improve for women taking placebo. (P = .0076, Wilcoxon signed rank). Samples (n = 5) of serum from the luteal phase in different patients within the cinnamon group were thawed and ovulatory progesterone levels (>3 ng/mL) confirmed. Luteal phase progesterone levels (>3 ng/mL, n = 5) confirmed ovulatory menses. Measures of insulin resistance or serum androgen levels did not change for either group. These preliminary data suggest that cinnamon supplementation improves menstrual cyclicity and may be an effective treatment option for some women with PCOS. Copyright © 2014 Elsevier Inc. All rights reserved.

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…

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

PubMed

Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

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

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…

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.

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

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain. A randomized, double-blind, active control trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group. The results of this study are limited by the

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.

Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial.

PubMed

Suttanon, Plaiwan; Hill, Keith D; Said, Catherine M; Williams, Susan B; Byrne, Karin N; LoGiudice, Dina; Lautenschlager, Nicola T; Dodd, Karen J

2013-05-01

To evaluate the feasibility and safety of a home-based exercise programme for people with Alzheimer's disease, and to provide preliminary evidence of programme effectiveness in improving balance and mobility and reducing falls risk. A randomized controlled trial. Community. Forty people with mild to moderate Alzheimer's disease (mean age 81.9, SD 5.72; 62.5% female). Participants were randomized to a six-month home-based individually tailored balance, strengthening and walking exercise programme (physiotherapist) or a six-month home-based education programme (control) (occupational therapist). Both programmes provided six home-visits and five follow-up phone calls. Balance, mobility, falls and falls risk were measured at baseline and programme completion. Intention-to-treat analysis using a generalized linear model with group allocation as a predictor variable was performed to evaluate programme effectiveness. Feasibility and adverse events were systematically recorded at each contact. Fifty-eight per cent of the exercise group finished the programme, completing an average of 83% of prescribed sessions, with no adverse events reported. Functional Reach improved significantly (P = 0.002) in the exercise group (mean (SD), 2.28 (4.36)) compared to the control group (-2.99 (4.87)). Significant improvement was also observed for the Falls Risk for Older People - Community score (P = 0.008) and trends for improvement on several other balance, mobility, falls and falls risk measures for the exercise group compared to the control group. The exercise programme was feasible and safe and may help improve balance and mobility performance and reduce falls risk in people with Alzheimer's disease.

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.

Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke

PubMed Central

Lee, Myung Mo; Lee, Kyeong Jin

2018-01-01

Background Virtual reality (VR) training with motion-controlled console games can be incorporated into stroke rehabilitation programs. The use of a variety of gaming software can provide the patient with an opportunity to perform activities that are exciting, entertaining, and that may not be feasible in clinical environments. The aim of this preliminary randomized controlled study was to investigate the effects of game-based VR canoe paddling training, when combined with conventional physical rehabilitation programs, on postural balance and upper extremity function in 30 patients with subacute stroke. Material/Methods Thirty patients, who were within six months following the diagnosis of stroke, were randomly allocated to either the experimental group (n=15) or the control group (n=15). All participants participated in a conventional rehabilitation program. Also, the experimental group (n=15) performed the VR canoe paddling training for 30 minutes each day, three times per week, for five weeks. After five weeks, outcomes of changes in postural balance and upper extremity function were evaluated and compared between the two groups. Results At five weeks, postural balance and upper extremity function showed significant improvements in both patients groups when compared with the baseline measurements (p<0.05). However, postural balance and upper extremity function were significantly improved in the experimental group when compared with the control group (p<0.05). Conclusions Game-based VR canoe paddling training is an effective rehabilitation therapy that enhances postural balance and upper extremity function in patients with subacute stroke when combined with conventional physical rehabilitation programs. PMID:29702630

Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke.

PubMed

Lee, Myung Mo; Lee, Kyeong Jin; Song, Chang Ho

2018-04-27

BACKGROUND Virtual reality (VR) training with motion-controlled console games can be incorporated into stroke rehabilitation programs. The use of a variety of gaming software can provide the patient with an opportunity to perform activities that are exciting, entertaining, and that may not be feasible in clinical environments. The aim of this preliminary randomized controlled study was to investigate the effects of game-based VR canoe paddling training, when combined with conventional physical rehabilitation programs, on postural balance and upper extremity function in 30 patients with subacute stroke. MATERIAL AND METHODS Thirty patients, who were within six months following the diagnosis of stroke, were randomly allocated to either the experimental group (n=15) or the control group (n=15). All participants participated in a conventional rehabilitation program. Also, the experimental group (n=15) performed the VR canoe paddling training for 30 minutes each day, three times per week, for five weeks. After five weeks, outcomes of changes in postural balance and upper extremity function were evaluated and compared between the two groups. RESULTS At five weeks, postural balance and upper extremity function showed significant improvements in both patients groups when compared with the baseline measurements (p<0.05). However, postural balance and upper extremity function were significantly improved in the experimental group when compared with the control group (p<0.05). CONCLUSIONS Game-based VR canoe paddling training is an effective rehabilitation therapy that enhances postural balance and upper extremity function in patients with subacute stroke when combined with conventional physical rehabilitation programs.

Prospective randomized controlled trial of conventional laparoscopic versus laparoendoscopic single-site radical nephrectomy for localized renal cell carcinoma: a preliminary report regarding quality of life.

PubMed

Park, Yong Hyun; Kim, Kwang Taek; Ko, Kyungtae; Kim, Hyeon Hoe

2015-03-01

The safety and efficacy of laparoendoscopic single-site surgery (LESS) for renal cell carcinoma (RCC) have not been clearly demonstrated. We aimed to present preliminary data from a prospective randomized controlled trial of LESS versus conventional laparoscopic radical nephrectomy for localized RCC. Patients with cT1-2 RCC were randomized to LESS (n = 17) or conventional laparoscopy (n = 18) group. The short-term outcome measures assessed were perioperative morbidity, postoperative pain, and quality of recovery as determined using QoR-40. No significant differences were observed between the LESS and conventional laparoscopy groups with respect to operative time (143.5 vs. 126.1 min, p = 0.218), blood loss (143.6 vs. 118.2 ml, p = 0.121), hospital stay (3.8 vs. 3.1 day s, p = 0.170), analgesic requirements (63.2 vs. 60.0 mg, p = 0.956), and complication rates (26.7 vs. 22.2 %, p = 0.767). However, postoperative quality of recovery was better in the LESS group (176.4 vs. 152.6, p = 0.005). Furthermore, quality of recovery, as measured using the QoR-40 dimensions of emotional state (39.9 vs. 34.0, p = 0.003), physical comfort (51.9 vs. 46.7, p = 0.034), psychological support (32.2 vs. 25.8, p = 0.003), and physical independence (20.7 vs. 17.5, p = 0.047), but not pain (31.8 vs. 29.6, p = 0.259), was significantly better in the LESS group. The preliminary results from this prospective trial suggest that LESS could be a safe and effective treatment option for localized RCC with equivalent surgical outcomes and improved postoperative quality of recovery compared with conventional laparoscopic surgery.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

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

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. 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. 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. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

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

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.

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.

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

A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache.

PubMed

Haas, Mitchell; Aickin, Mikel; Vavrek, Darcy

2010-01-01

The purpose of this article was to present a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial. Eighty participants with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (beta) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The patient-provider encounter was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care. Baseline patient expectancy was balanced across groups. The PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|beta| = .46-.59). Expectations had little effect on pain (abs value(beta) < .15). The patient-provider encounter had a weak effect on pain (abs value(beta)= .03-.27) and on subsequent confidence in treatment success (abs value(beta)= .09 and .12). Encouraging equipoise in the PPE and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

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.

Effect of a Counseling Session Bolstered by Text Messaging on Self-Selected Health Behaviors in College Students: A Preliminary Randomized Controlled Trial.

PubMed

Sandrick, Janice; Tracy, Doreen; Eliasson, Arn; Roth, Ashley; Bartel, Jeffrey; Simko, Melanie; Bowman, Tracy; Harouse-Bell, Karen; Kashani, Mariam; Vernalis, Marina

2017-05-17

The college experience is often the first time when young adults live independently and make their own lifestyle choices. These choices affect dietary behaviors, exercise habits, techniques to deal with stress, and decisions on sleep time, all of which direct the trajectory of future health. There is a need for effective strategies that will encourage healthy lifestyle choices in young adults attending college. This preliminary randomized controlled trial tested the effect of coaching and text messages (short message service, SMS) on self-selected health behaviors in the domains of diet, exercise, stress, and sleep. A second analysis measured the ripple effect of the intervention on health behaviors not specifically selected as a goal by participants. Full-time students aged 18-30 years were recruited by word of mouth and campuswide advertisements (flyers, posters, mailings, university website) at a small university in western Pennsylvania from January to May 2015. Exclusions included pregnancy, eating disorders, chronic medical diagnoses, and prescription medications other than birth control. Of 60 participants, 30 were randomized to receive a single face-to-face meeting with a health coach to review results of behavioral questionnaires and to set a health behavior goal for the 8-week study period. The face-to-face meeting was followed by SMS text messages designed to encourage achievement of the behavioral goal. A total of 30 control subjects underwent the same health and behavioral assessments at intake and program end but did not receive coaching or SMS text messages. The texting app showed that 87.31% (2187/2505) of messages were viewed by intervention participants. Furthermore, 28 of the 30 intervention participants and all 30 control participants provided outcome data. Among intervention participants, 22 of 30 (73%) showed improvement in health behavior goal attainment, with the whole group (n=30) showing a mean improvement of 88% (95% CI 39-136). Mean

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

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.

A randomized, controlled trial of massage therapy as a treatment for migraine.

PubMed

Lawler, Sheleigh P; Cameron, Linda D

2006-08-01

Migraine is a distressing disorder that is often triggered by stress and poor sleep. Only one randomized controlled trial (RCT) has assessed the effects of massage therapy on migraine experiences, which yielded some promising findings. An RCT was designed to replicate and extend the earlier findings using a larger sample, additional stress-related indicators, and assessments past the final session to identify longer-term effects of massage therapy on stress and migraine experiences. Migraine sufferers (N = 47) who were randomly assigned to massage or control conditions completed daily assessments of migraine experiences and sleep patterns for 13 weeks. Massage participants attended weekly massage sessions during Weeks 5 to 10. State anxiety, heart rates, and salivary cortisol were assessed before and after the sessions. Perceived stress and coping efficacy were assessed at Weeks 4, 10, and 13. Compared to control participants, massage participants exhibited greater improvements in migraine frequency and sleep quality during the intervention weeks and the 3 follow-up weeks. Trends for beneficial effects of massage therapy on perceived stress and coping efficacy were observed. During sessions, massage induced decreases in state anxiety, heart rate, and cortisol. The findings provide preliminary support for the utility of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

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.

Internet-delivered lifestyle physical activity intervention improves body composition in multiple sclerosis: preliminary evidence from a randomized controlled trial.

PubMed

Pilutti, Lara A; Dlugonski, Deirdre; Sandroff, Brian M; Klaren, Rachel E; Motl, Robert W

2014-07-01

To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis (MS). Secondary analysis of data from a randomized controlled trial. University research laboratory. Ambulatory persons with MS (N=82). A 6-month, internet-delivered physical activity behavioral intervention designed to increase lifestyle physical activity, primarily walking. The behavioral intervention was based on principles of social cognitive theory. Whole-body bone mineral content (BMC), bone mineral density (BMD), and soft tissue composition, using dual-energy x-ray absorptiometry. There were no significant differences between conditions posttrial on body composition outcomes using the adjusted critical value (P<.008). There was a significant effect of the intervention on whole-body BMC (P=.04, ω(2)<.001) and BMD (P=.01, ω(2)=.003) using the unadjusted critical value (P<.05). The effect of the intervention on percent body fat (P=.09, ω(2)=.001) and whole-body fat mass (P=.05, ω(2)=.003) approached significance using unadjusted criteria. There was not a significant effect on whole-body lean soft tissue (P=.28, ω(2)<.001) or body mass index (P=.86, ω(2)<.001). Our results provide preliminary evidence that an internet-delivered lifestyle physical activity intervention might improve bone health and body composition in MS. Such findings are important considering that physical activity is a modifiable behavior with the potential to confer long-term benefits for the prevention and management of fracture risk and comorbidities among those with MS. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

PRELIMINARY COST ESTIMATES OF POLLUTION CONTROL TECHNOLOGIES FOR GEOTHERMAL DEVELOPMENTS

EPA Science Inventory

This report provides preliminary cost estimates of air and water pollution control technologies for geothermal energy conversion facilities. Costs for solid waste disposal are also estimated. The technologies examined include those for control of hydrogen sulfide emissions and fo...

Positive psychotherapy for smoking cessation enhanced with text messaging: Protocol for a randomized controlled trial.

PubMed

Kahler, Christopher W; Surace, Anthony; Rebecca, E F; Gordon, B A; Cioe, Patricia A; Spillane, Nichea S; Parks, Acacia; Bock, Beth C; Brown, Richard A

2018-06-21

Despite reductions in cigarette smoking in the U.S., improvements in the efficacy of smoking cessation treatments are needed, as rates of sustained abstinence remain disappointingly low. Both low positive affect and high negative affect contribute to smoking relapse and constitute viable targets for smoking cessation interventions. Although some clinical trials have evaluated interventions to address depression as a smoking relapse risk factor, very few have focused on positive affect. Recently, we developed and conducted a preliminary clinical trial of a smoking cessation treatment that targets positive affect and cognitions by incorporating interventions rooted in positive psychology. The current randomized controlled trial will expand upon this preliminary trial to test whether this positive psychology-informed approach results in higher smoking cessation rates compared to a time-matched standard smoking cessation treatment control. Three hundred and forty adult daily smokers will be randomly assigned to either positive psychotherapy for smoking cessation or standard behavioral smoking cessation counseling. Participants will meet weekly with a study counselor for 6 weeks and will receive transdermal nicotine patch and text messaging smoking cessation support. Additionally, text messaging in the positive psychotherapy condition will encourage engagement in positive psychology-specific strategies for boosting mood and staying smoke free. Smoking cessation outcomes will be measured at 12, 26, and 52 weeks following target quit date. Results from this study will provide evidence on whether incorporating positive psychology interventions into smoking cessation treatment can improve smoking cessation outcomes relative to standard behavioral counseling with nicotine patch and text messaging. Copyright © 2018. Published by Elsevier Inc.

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.

Randomized Controlled Trial of Online Acceptance and Commitment Therapy for Fibromyalgia.

PubMed

Simister, Heather D; Tkachuk, Gregg A; Shay, Barbara L; Vincent, Norah; Pear, Joseph J; Skrabek, Ryan Q

2018-03-02

In this study, 67 participants (95% female) with fibromyalgia (FM) were randomly assigned to an online acceptance and commitment therapy (online ACT) and treatment as usual (TAU; ACT + TAU) protocol or a TAU control condition. Online ACT + TAU participants were asked to complete 7 modules over an 8-week period. Assessments were completed at pre-treatment, post-treatment, and 3-month follow-up periods and included measures of FM impact (primary outcome), depression, pain, sleep, 6-minute walk, sit to stand, pain acceptance (primary process variable), mindfulness, cognitive fusion, valued living, kinesiophobia, and pain catastrophizing. The results indicated that online ACT + TAU participants significantly improved in FM impact, relative to TAU (P <.001), with large between condition effect sizes at post-treatment (1.26) and follow-up (1.59). Increases in pain acceptance significantly mediated these improvements (P = .005). Significant improvements in favor of online ACT + TAU were also found on measures of depression (P = .02), pain (P = .01), and kinesiophobia (P = .001). Although preliminary, this study highlights the potential for online ACT to be an efficacious, accessible, and cost-effective treatment for people with FM and other chronic pain conditions. Online ACT reduced FM impact relative to a TAU control condition in this randomized controlled trial. Reductions in FM impact were mediated by improvements in pain acceptance. Online ACT appears to be a promising intervention for FM. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Nurse leader mindfulness meditation program for stress management: a randomized controlled trial.

PubMed

Pipe, Teri Britt; Bortz, Jennifer J; Dueck, Amylou; Pendergast, Debra; Buchda, Vicki; Summers, Jay

2009-03-01

The aim of this study was to rigorously evaluate a brief stress management intervention for nurse leaders. Despite the nursing shortage, evidence-based workplace approaches addressing nurse stress have not been well studied. Nurse leaders (n = 33) were randomly assigned to brief mindfulness meditation course (MMC) or leadership course (control). Self-report measures of stress were administered at baseline and within 1 week of course completion. Among MMC participants, change scores (from baseline to postintervention) on several subscales of the Symptom Checklist 90-Revised showed significantly more improvement in self-reported stress symptoms relative to controls. Mindfulness meditation course participants had significantly more improvement in Positive Symptom Distress Index (P = 0.010; confidence interval [CI] = -0.483 to -0.073) and Global Severity Index (P = 0.019; CI = -0.475 to -0.046) and nearly significantly more improvement in Positive Symptom Total (P = 0.066; CI = -16.66 to 0.581) compared with controls. Results support preliminary effectiveness of a 4-week MMC in reducing self-reported stress symptoms among nursing leaders.

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.

Cluster Randomized Controlled Trial

PubMed Central

Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-01-01

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

PubMed

Jacobs, Jennifer; Williams, Anna-Leila; Girard, Christine; Njike, Valentine Yanchou; Katz, David

2005-10-01

The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). This work was a randomized, double-blind, placebo-controlled trial. This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome.

PubMed

Peterson, P K; Pheley, A; Schroeppel, J; Schenck, C; Marshall, P; Kind, A; Haugland, J M; Lambrecht, L J; Swan, S; Goldsmith, S

1998-04-27

To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. An outpatient clinical trials unit. Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76%] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome.

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.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

The Efficacy of Adapted MBCT on Core Symptoms and Executive Functioning in Adults With ADHD: A Preliminary Randomized Controlled Trial.

PubMed

Hepark, Sevket; Janssen, Lotte; de Vries, Alicia; Schoenberg, Poppy L A; Donders, Rogier; Kan, Cornelis C; Speckens, Anne E M

2015-11-20

The aim of this study was to examine the effectiveness of mindfulness as a treatment for adults diagnosed with ADHD. A 12-week-adapted mindfulness-based cognitive therapy (MBCT) program is compared with a waiting list (WL) group. Adults with ADHD were randomly allocated to MBCT (n = 55) or waitlist (n = 48). Outcome measures included investigator-rated ADHD symptoms (primary), self-reported ADHD symptoms, executive functioning, depressive and anxiety symptoms, patient functioning, and mindfulness skills. MBCT resulted in a significant reduction of ADHD symptoms, both investigator-rated and self-reported, based on per-protocol and intention-to-treat analyses. Significant improvements in executive functioning and mindfulness skills were found. Additional analyses suggested that the efficacy of MBCT in reducing ADHD symptoms and improving executive functioning is partially mediated by an increase in the mindfulness skill "Act With Awareness." No improvements were observed for depressive and anxiety symptoms, and patient functioning. This study provides preliminary support for the effectiveness of MBCT for adults with ADHD. © The Author(s) 2015.

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

A Preliminary Study for Evaluating the Dose-Dependent Effect of d-Allulose for Fat Mass Reduction in Adult Humans: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Han, Youngji; Kwon, Eun-Young; Yu, Mi Kyeong; Lee, Seon Jeong; Kim, Hye-Jin; Kim, Seong-Bo; Kim, Yang Hee; Choi, Myung-Sook

2018-01-31

d-allulose is a rare sugar with zero energy that can be consumed by obese/overweight individuals. Many studies have suggested that zero-calorie d-allulose has beneficial effects on obesity-related metabolism in mouse models, but only a few studies have been performed on human subjects. Therefore, we performed a preliminary study with 121 Korean subjects (aged 20-40 years, body mass index ≥ 23 kg/m²). A randomized controlled trial involving placebo control (sucralose, 0.012 g × 2 times/day), low d-allulose (d-allulose, 4 g × 2 times/day), and high d-allulose (d-allulose, 7 g × 2 times/day) groups was designed. Parameters for body composition, nutrient intake, computed tomography (CT) scan, and plasma lipid profiles were assessed. Body fat percentage and body fat mass were significantly decreased following d-allulose supplementation. The high d-allulose group revealed a significant decrease in not only body mass index (BMI), but also total abdominal and subcutaneous fat areas measured by CT scans compared to the placebo group. There were no significant differences in nutrient intake, plasma lipid profiles, markers of liver and kidney function, and major inflammation markers among groups. These results provide useful information on the dose-dependent effect of d-allulose for overweight/obese adult humans. Based on these results, the efficacy of d-allulose for body fat reduction needs to be validated using dual energy X-ray absorption.

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.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

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

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

A novel early intervention for preschool depression: findings from a pilot randomized controlled trial.

PubMed

Luby, Joan; Lenze, Shannon; Tillman, Rebecca

2012-03-01

Validation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large effect sizes (ES) for preschool psychotherapies for several Axis I disorders suggest that earlier intervention in depression may also be promising. Therefore, a novel form of treatment for preschool depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED) was developed and tested. A preliminary randomized controlled trial (RCT) was conducted comparing PCIT-ED to psycho-education in depressed 3- to 7-year-olds and their caregivers. A total of 54 patients met symptom criteria for DSM-IV major depressive disorder and were randomized, 19 patients completed the active treatment (n = 8 dropouts) and 10 completed psycho-education (n = 17 dropouts). Both groups showed significant improvement in several domains, with PCIT-ED showing significance in a greater number of domains. An intent-to-treat analysis suggested that PCIT-ED was significantly more effective than psycho-education on executive functioning (p = .011, ES = 0.12) and emotion recognition skills (p = .002, ES = 0.83). The RCT proved feasible and suggests an individual control condition should be used in future trials to minimize differential dropout. These pilot data, although limited by power, suggest that PCIT-ED may be a promising early intervention for depression. Larger scale randomized controlled trials of PCIT-ED for depressed preschoolers are now warranted. © 2011 The Authors. Journal of Child Psychology and Psychiatry © 2011 Association for Child and Adolescent Mental Health.

Autoshaping, random control, and omission training in the rat.

PubMed

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

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

PubMed

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

2011-01-01

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. 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. 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. 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. © 2010 John Wiley & Sons A/S.

Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings.

PubMed

Epperson, C Neill; Terman, Michael; Terman, Jiuan Su; Hanusa, Barbara H; Oren, Dan A; Peindl, Kathleen S; Wisner, Katherine L

2004-03-01

Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study. In an extension of this work, we report findings from a double-blind placebo-controlled pilot study. Ten pregnant women with DSM-IV major depressive disorder were randomly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux (active) or 500 lux (placebo) light box. At the end of the randomized controlled trial, subjects had the option of continuing in a 5-week extension phase. The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status. Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results. Although there was a small mean group advantage of active treatment throughout the randomized controlled trial, it was not statistically significant. However, in the longer 10-week trial, the presence of active versus placebo light produced a clear treatment effect (p =.001) with an effect size (0.43) similar to that seen in antidepressant drug trials. Successful treatment with bright light was associated with phase advances of the melatonin rhythm. These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an expanded randomized clinical trial.

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

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

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

Online prevention of postpartum depression for Spanish- and English-speaking pregnant women: A pilot randomized controlled trial

PubMed Central

Barrera, Alinne Z.; Wickham, Robert E.; Muñoz, Ricardo F.

2015-01-01

Background Postpartum depression (PPD) is a maternal mental health problem that affects women from all regions of the world. Unfortunately, even in developed countries, half of the cases go undetected and, consequently, untreated. Individuals from low and middle income countries trend toward underutilization of mental health services, partly due to the limited number of available psychological resources. The primary aims of this pilot randomized controlled trial were to adapt to the Internet the Mothers and Babies Course/Curso Mamás y Bebés, a prevention of PPD intervention, to describe the characteristics of the pregnant women who engaged in the intervention site, and to obtain preliminary data on the efficacy of the Internet intervention to reduce the risk of PPD. Methods Pregnant women, 18 years or older who were interested in using the site for themselves were recruited and randomly assigned to a fully-automated self-help Internet intervention or to an information-only control condition. Randomized participants were invited to complete monthly depression assessments up to six months postpartum. To examine the prevention effects of the Internet intervention, pregnant women who did not meet current criteria for a major depressive episode, who engaged with the study website, and who provided depression data during the postpartum follow-up period were included in the study analyses. Results Participants were 111 predominantly Spanish-speaking (82.9%) and Latino/Hispanic (71.3%) pregnant women residing in 23 countries worldwide. The effect of the prevention intervention condition failed to reach significance at the a priori alpha-level. However, the observed coefficient trended in the hypothesized direction (b = −0.514, χ2 (1) = 3.43, p = .061; HR = 0.598). The benefits of receiving the e-MB Internet intervention was greater for pregnant women reporting high (vs. low) levels of prenatal depression symptoms (b = −0.605, χ2 (1) = 5.20, p =.023). Conclusions

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

2018-01-01

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.

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.

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

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents

ERIC Educational Resources Information Center

Gonzalez-Guarda, Rosa Maria; Guerra, Jessica E.; Cummings, Amanda A.; Pino, Karen; Becerra, Maria M.

2015-01-01

The purpose of this study is to evaluate the preliminary efficacy of a dating violence (DV) prevention program for Cuban American adolescents ("JOVEN"/YOUTH: "Juntos Opuestos a la Violence Entre Novios"/Together Against Dating Violence). A randomized-controlled experimental design with a delayed condition was used to evaluate…

Autoshaping, random control, and omission training in the rat1

PubMed Central

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

PubMed

Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

2015-12-01

Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A novel behavioral intervention in adolescents with type 1 diabetes mellitus improves glycemic control: preliminary results from a pilot randomized control trial.

PubMed

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

2015-04-01

The purpose of this study was to develop and pilot-test an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. 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. After 3 months, the participants in the intervention group exhibited a statistically significant decrease in A1C level (-0.5%) compared with their peers in the control group, who had an increase in A1C level (0.8%) (P = .04). The younger adolescents (10-13 years of age) demonstrated a greater response to the intervention, which was statistically significant (-1.5% vs 0.6%, P = .04), compared with the older adolescents (14-17 years of age). Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. © 2015 The Author(s).

Promoting a Positive Middle School Transition: A Randomized-Controlled Treatment Study Examining Self-Concept and Self-Esteem.

PubMed

Coelho, Vitor Alexandre; Marchante, Marta; Jimerson, Shane R

2017-03-01

The middle school transition is a salient developmental experience impacting adolescents around the world. This study employed a randomized-controlled treatment design, with randomization at the school level, to investigate the impact of a school adjustment program for middle school transition and potential gender differences. Participants included 1147 students (M age  = 9.62; SD = 0.30, 45.7 % girls), who were assessed at four time points during the transition, regarding five dimensions of self-concept (academic, social, emotional, physical and family) and self-esteem. Parallel growth curves were employed to analyze the evolution of self-concept. Following the transition to middle school, students reported lower levels of self-concept (academic, emotional and physical) and self-esteem, while participation in the intervention led to increases in self-esteem and gains in social self-concept. No gender differences were found. These results provide preliminary evidence supporting such interventions in early middle school transitions.

The Acceptability and Potential Utility of Cognitive Training to Improve Working Memory in Persons Living With HIV: A Preliminary Randomized Trial.

PubMed

Towe, Sheri L; Patel, Puja; Meade, Christina S

HIV-associated neurocognitive impairments that impact daily function persist in the era of effective antiretroviral therapy. Cognitive training, a promising low-cost intervention, has been shown to improve neurocognitive functioning in some clinical populations. We tested the feasibility, acceptability, and preliminary effects of computerized cognitive training to improve working memory in persons living with HIV infection (PLWH) and working memory impairment. In this randomized clinical trial, we assigned 21 adult PLWH to either an experimental cognitive training intervention or an attention-matched control training intervention. Participants completed 12 training sessions across 10 weeks with assessments at baseline and post-training. Session attendance was excellent and participants rated the program positively. Participants in the experimental arm demonstrated improved working memory function over time; participants in the control arm showed no change. Our results suggest that cognitive training may be a promising intervention for working memory impairment in PLWH and should be evaluated further. Copyright © 2017 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

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

PubMed

McDermott, Kelly A; Rao, Mohan Raghavendra; Nagarathna, Raghuram; Murphy, Elizabeth J; Burke, Adam; Nagendra, Ramarao Hongasandra; Hecht, Frederick M

2014-07-01

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. 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. 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 control over the course of the

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

Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial.

PubMed

Qi, Bing-Bing; Resnick, Barbara; Smeltzer, Suzanne C; Bausell, Barker

2011-01-01

: Recent Chinese immigrants have a low bone mineral density and are at a great risk for developing osteoporosis. The majority of Chinese men and women of all ages have inadequate information about their risks for developing osteoporosis and are seldom involved in preventive activities. : The aim of this study was to evaluate the preliminary effectiveness of an educational intervention based on the self-efficacy theory aimed at increasing the knowledge of osteoporosis and adoption of preventive behaviors, including regular exercise and osteoporosis medication adherence, designed for Chinese immigrants, aged 45 years or above, living in the United States. : A randomized controlled trial was employed, using a repeated-measure design. Foreign-born Mandarin-speaking Asians (n = 110) were recruited to the study, and 83 of them (mean age = 64.08 years, SD = 9.48 years) were assigned randomly to either the intervention group (n = 42) or the attention control group (n = 41). There were 63 (75.9%) women and 20 (24.1%) men. Data were collected at baseline and 2 weeks after the intervention. : The participants who received the intervention had statistically significant improvements (p < .05) at 2 weeks postintervention with respect to osteoporosis-related knowledge, self-efficacy for exercise, and osteoporosis medication adherence. Moreover, the participants in the treatment group spent more time on moderate exercise, had higher energy expenditure on exercise, and had more osteoporosis medication use at 2 weeks postintervention when compared with controls. : The intervention targeting Mandarin-speaking immigrants was effective in increasing the knowledge of osteoporosis and improving the adoption of preventive behaviors. Future research is needed to explore the long-term effect of this intervention on bone health behavior.

78 FR 42520 - Control Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On December 18, 2012, Control Technology, Inc. filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act, proposing to study...

Preliminary analysis of a membrane-based atmosphere-control subsystem

NASA Technical Reports Server (NTRS)

Mccray, Scott B.; Newbold, David D.; Ray, Rod; Ogle, Kathryn

1993-01-01

Controlled ecological life supprot systems will require subsystems for maintaining the consentrations of atmospheric gases within acceptable ranges in human habitat chambers and plant growth chambers. The goal of this work was to develop a membrane-based atmosphere comntrol (MBAC) subsystem that allows the controlled exchange of atmospheric componets (e.g., oxygen, carbon dioxide, and water vapor) between these chambers. The MBAC subsystem promises to offer a simple, nonenergy intensive method to separate, store and exchange atmospheric components, producing optimal concentrations of components in each chamber. In this paper, the results of a preliminary analysis of the MBAC subsystem for control of oxygen and nitrogen are presented. Additionally, the MBAC subsystem and its operation are described.

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

PubMed

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.

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.

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.

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.

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…

Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial.

PubMed

Cosmo, Camila; Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-05-18

The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD).

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

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.

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...

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial.

PubMed

Liu, Li; Liu, Yue-Ping; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-06-01

To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months' intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. © The Author(s) 2016.

Use of a knowledge-attitude-behaviour education programme for Chinese adults undergoing maintenance haemodialysis: Randomized controlled trial

PubMed Central

Liu, Li; Wang, Jing; An, Li-Wei; Jiao, Jian-Mei

2016-01-01

Objective To investigate the effects of a knowledge-attitude-behaviour health education model on acquisition of disease-related knowledge and self-management behaviour by patients undergoing maintenance haemodialysis. Methods Patients recently prescribed MHD were randomly assigned to a control group or an intervention group. Control group patients were treated with usual care and general education models. A specialist knowledge-attitude-behaviour health education model was applied to patients in the intervention group. Results Eighty-six patients were included (n = 43 per group). Before intervention, there were no significant between-group differences in disease knowledge and self-management behaviour. After 6 months’ intervention, a significant between-group difference in acquisition of disease knowledge was observed. Self-management behaviour scores (control of body mass, reasonable diet, correct drug intake, physical activity, correct fistula care, disease condition monitoring, psychological and social behaviours) for the intervention group were also higher than those for the control group. Conclusion These preliminary findings suggest that the knowledge-attitude-behaviour model appears to be a valuable tool for the health education of MHD patients. PMID:26951842

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.

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.

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 ...

"Congratulations, you have been randomized into the control group!(?)": issues to consider when recruiting schools for matched-pair randomized control trials of prevention programs.

PubMed

Ji, Peter; DuBois, David L; Flay, Brian R; Brechling, Vanessa

2008-03-01

Recruiting schools into a matched-pair randomized control trial (MP-RCT) to evaluate the efficacy of a school-level prevention program presents challenges for researchers. We considered which of 2 procedures would be most effective for recruiting schools into the study and assigning them to conditions. In 1 procedure (recruit and match/randomize), we would recruit schools and match them prior to randomization, and in the other (match/randomize and recruitment), we would match schools and randomize them prior to recruitment. We considered how each procedure impacted the randomization process and our ability to recruit schools into the study. After implementing the selected procedure, the equivalence of both treatment and control group schools and the participating and nonparticipating schools on school demographic variables was evaluated. We decided on the recruit and match/randomize procedure because we thought it would provide the opportunity to build rapport with the schools and prepare them for the randomization process, thereby increasing the likelihood that they would accept their randomly assigned conditions. Neither the treatment and control group schools nor the participating and nonparticipating schools exhibited statistically significant differences from each other on any of the school demographic variables. Recruitment of schools prior to matching and randomization in an MP-RCT may facilitate the recruitment of schools and thus enhance both the statistical power and the representativeness of study findings. Future research would benefit from the consideration of a broader range of variables (eg, readiness to implement a comprehensive prevention program) both in matching schools and in evaluating their representativeness to nonparticipating schools.

Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

PubMed

George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

2017-11-01

To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

Evaluating the Flipped Classroom: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PubMed

Trew, Geoffrey H; Pistofidis, George A; Brucker, Sara Y; Krämer, Bernhard; Ziegler, Nicole M; Korell, Matthias; Ritter, Henning; McConnachie, Alex; Ford, Ian; Crowe, Alison M; Estridge, Trudy D; Diamond, Michael P; De Wilde, Rudy L

2017-02-01

Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

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

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.

Double-blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients.

PubMed

Stern, Matthew B; Marek, Kenneth L; Friedman, Joseph; Hauser, Robert A; LeWitt, Peter A; Tarsy, Daniel; Olanow, C Warren

2004-08-01

Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (+/-SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (+/-1.3), -3.6 (+/-1.7), -3.6 (+/-1.2), and -0.5 (+/-0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. Copyright 2004 Movement Disorder Society

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.

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

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

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).

Learning through Interaction in Children with Autism: Preliminary Data from a Social-Communication-Based Intervention

ERIC Educational Resources Information Center

Casenhiser, Devin M.; Shanker, Stuart G.; Stieben, Jim

2013-01-01

The study evaluates a social-communication-based approach to autism intervention aimed at improving the social interaction skills of children with autism spectrum disorder. We report preliminary results from an ongoing randomized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months. Participants were assigned to either a…

Contribution of Transcranial Direct Current Stimulation on Inhibitory Control to Assess the Neurobiological Aspects of Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial

PubMed Central

Baptista, Abrahão Fontes; de Sena, Eduardo Pondé

2015-01-01

Background The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. Objective The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. Methods A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. Results The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. Conclusions The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Trial Registration Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD). PMID:25986784

Collaborative Care for Patients With Severe Personality Disorders: Preliminary Results and Active Ingredients From a Pilot Study (Part I).

PubMed

Stringer, Barbara; van Meijel, Berno; Karman, Pieter; Koekkoek, Bauke; Hoogendoorn, Adriaan W; Kerkhof, Ad J F M; Beekman, Aartjan T F

2015-07-01

To test if a collaborative care program (CCP) with nurses in a coordinating position is beneficial for patients with severe personality disorders. A pilot study with a comparative multiple case study design using mixed methods investigating active ingredients and preliminary results. Most patients, their informal caregivers, and nurses value (parts of) the CCP positively; preliminary results show a significant decrease in severity of borderline symptoms. With the CCP, we may expand the supply of available treatments for patients with (severe) personality disorders, but a larger randomized controlled trial is warranted to confirm our preliminary results. © 2014 Wiley Periodicals, Inc.

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial.

PubMed

Mao, Jun J; Li, Qing S; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D

2014-11-01

Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile ( Matricaria recutita ) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500-1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500-1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD.

Long-Term Chamomile Therapy of Generalized Anxiety Disorder: A Study Protocol for a Randomized, Double-Blind, Placebo- Controlled Trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Rockwell, Kenneth; Xie, Sharon X; Amsterdam, Jay D.

2017-01-01

Background Anxiety symptoms are among the most common reasons for consumers to use Complementary and Alternative Medicine (CAM) therapy. Although many botanicals have been proposed as putative remedies for anxiety symptoms, there has been a paucity of controlled trials of these remedies. A preliminary study of the anxiolytic effect of Chamomile (Matricaria recutita) in humans suggests that chamomile may have anxiolytic and antidepressant activity. We now seek to conduct a 5-year randomized, double-blind, placebo-substitution study to examine the short and long-term safety and efficacy of chamomile extract in Generalized Anxiety Disorder (GAD). Methods/Design 180 subjects with moderate to severe GAD will receive initial open-label pharmaceutical-grade chamomile extract 500–1,500 mg daily for 8 weeks. Responders to treatment who remain well for an additional 4 weeks of consolidation therapy, will be randomized to double-blind continuation therapy with either chamomile extract 500–1,500 mg daily or placebo for an additional 26 weeks. The primary outcome will be the time to relapse during study continuation therapy in each treatment condition. Secondary outcomes will include the proportion of subjects in each treatment condition who relapse, as well as the proportion of subjects with treatment-emergent adverse events. Quality of life ratings will also be compared between treatment conditions during short and long-term therapy. Discussion Many individuals with mental disorders decline conventional therapy and seek CAM therapies for their symptoms. Thus, the identification of effective CAM therapy is of relevance to reducing the burden of mental illness. This study builds upon our prior findings of significant superiority of chamomile versus placebo in reducing GAD symptoms. We now extend these preliminary findings by conducting a randomized long-term safety and efficacy study of chamomile in GAD. PMID:29057164

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.

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

Comparison of a Web-Based Teaching Tool and Traditional Didactic Learning for In Vitro Fertilization Patients: A Preliminary Randomized Controlled Trial.

PubMed

Vause, Tannys Dawn Reiko; Allison, David J; Vause, Tricia; Tekok-Kilic, Ayda; Ditor, David S; Min, Jason K

2018-05-01

The objective of this prospective RCT was to compare the efficacy of a web-based teaching tool to traditional didactic teaching in IVF patients. Forty women undergoing their first IVF cycle were randomly allocated to an interactive web-based teaching session or a nurse-led didactic teaching session. The primary outcome measure was participant knowledge regarding the IVF process, risks, and logistics assessed before and after the respective teaching session. Secondary outcomes included patient stress, assessed before and after the respective teaching session, and patient satisfaction, assessed following the respective teaching session and on the day of embryo transfer (following implementation of the teaching protocol). Both groups demonstrated similar and significant improvements in knowledge and stress after exposure to their respective teaching sessions. The web-based group was significantly more satisfied than the didactic teaching group. Web-based teaching was also shown to be equally effective for participants of high versus low income and education status for knowledge, stress, and satisfaction. This study provides preliminary support for the use of web-based teaching as an equally effective tool for increasing knowledge and reducing stress compared to traditional didactic teaching in IVF patients, with the added benefit of increased patient satisfaction. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

Mindfulness-based cognitive therapy may reduce thought suppression in previously suicidal participants: findings from a preliminary study.

PubMed

Hepburn, Silvia R; Crane, Catherine; Barnhofer, Thorsten; Duggan, Danielle S; Fennell, Melanie J V; Williams, J Mark G

2009-06-01

Thought suppression is a strategy aimed at mental control that may paradoxically increase the frequency of unwanted thoughts. This preliminary study examined effects of mindfulness-based cognitive therapy (MBCT) on thought suppression and depression in individuals with past depression and suicidality. In a randomized controlled trial design, 68 participants were allocated to an MBCT group or a treatment-as-usual waitlist control. Measures of thought suppression and depression were taken pre- and post-treatment. MBCT did not reduce thought suppression as measured by the White Bear Suppression Inventory, but significantly reduced self-reported attempts to suppress in the previous week. Preliminary evidence suggests that MBCT for suicidality may reduce thought suppression, but differential effects on thought suppression measures warrant further studies.

Effects of nanotechnologies-based devices on postural control in healthy subjects.

PubMed

Malchiodi Albedi, Giovanna; Corna, Stefano; Aspesi, Valentina; Clerici, Daniela; Parisio, Cinzia; Seitanidis, Jonathan; Cau, Nicola; Brugliera, Luigia; Capodaglio, Paolo

2017-09-05

The aim of the present preliminary randomized controlled study was to ascertain whether the use of newly developed nanotechnologies-based patches can influence posture control of healthy subjects. Thirty healthy female subjects (age 39.4 years, BMI 22.74 kg/m2) were randomly assigned to two groups: one with active patches and a control group with sham patches. Two patches were applied with a tape: one on the subject's sternum and the other on the C7 apophysis. Body sway during quiet upright stance was recorded with a dynamometric platform. Each subject was tested under two visual conditions, eyes open and closed. We used a blocked stratified randomization procedure conducted by a third party. Subjects wearing the sham patches showed a significant increase of the centre of pressure sway area after 4 hours when they performed the habitual moderate-intensity work activities. In the active patch group, a decrease of the sway path was evident, providing evidence of an enhanced balance control. Our preliminary findings on healthy subjects indicate that nanotechnological devices generating ultra-low electromagnetic fields can improve posture control.

Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

PubMed Central

Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

2010-01-01

Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

Turbulence flight director analysis and preliminary simulation

NASA Technical Reports Server (NTRS)

Johnson, D. E.; Klein, R. E.

1974-01-01

A control column and trottle flight director display system is synthesized for use during flight through severe turbulence. The column system is designed to minimize airspeed excursions without overdriving attitude. The throttle system is designed to augment the airspeed regulation and provide an indication of the trim thrust required for any desired flight path angle. Together they form an energy management system to provide harmonious display indications of current aircraft motions and required corrective action, minimize gust upset tendencies, minimize unsafe aircraft excursions, and maintain satisfactory ride qualities. A preliminary fixed-base piloted simulation verified the analysis and provided a shakedown for a more sophisticated moving-base simulation to be accomplished next. This preliminary simulation utilized a flight scenario concept combining piloting tasks, random turbulence, and discrete gusts to create a high but realistic pilot workload conducive to pilot error and potential upset. The turbulence director (energy management) system significantly reduced pilot workload and minimized unsafe aircraft excursions.

The Effects of the Bali Yoga Program for Breast Cancer Patients on Chemotherapy-Induced Nausea and Vomiting: Results of a Partially Randomized and Blinded Controlled Trial.

PubMed

Anestin, Annélie S; Dupuis, Gilles; Lanctôt, Dominique; Bali, Madan

2017-10-01

Complementary and alternative medicine has been shown to be beneficial in reducing chemotherapy-induced nausea and vomiting. However, conclusive results are lacking in order to confirm its usefulness. The purpose of this study was to determine whether a standardized yoga intervention could reduce these adverse symptoms. This was a partially randomized and blinded controlled trial comparing a standardized yoga intervention with standard care. Eligible patients were adults diagnosed with stages I to III breast cancer receiving chemotherapy. Patients randomized to the experimental group participated in an 8-week yoga program. There was no significant difference between the experimental and control groups on chemotherapy-induced nausea and vomiting after 8 weeks. Results suggest the yoga program is not beneficial in managing these adverse symptoms. However, considering preliminary evidence suggesting yoga's beneficial impact in cancer symptom management, methodological limitations should be explored and additional studies should be conducted.

The Efficacy and Acceptability of Third-Wave Behavioral and Cognitive eHealth Treatments: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

PubMed

O'Connor, Martin; Munnelly, Anita; Whelan, Robert; McHugh, Louise

2018-05-01

eHealth is an innovative method of delivering therapeutic content with the potential to improve access to third-wave behaviural and cognitive therapies. This systematic review and meta-analysis aimed to determine the efficacy and acceptability of third-wave eHealth treatments in improving mental health outcomes. A comprehensive search of electronic bibliographic databases including PubMed, PsycINFO, Web of Science, and CENTRAL was conducted to identify randomized controlled trials of third-wave treatments in which eHealth was the main component. Twenty-one studies were included in the review. Meta-analyses revealed that third-wave eHealth significantly outperformed inactive control conditions in improving anxiety, depression, and quality-of-life outcomes and active control conditions in alleviating anxiety and depression with small to medium effect sizes. No statistically significant differences were found relative to comparison interventions. Findings from a narrative synthesis of participant evaluation outcomes and meta-analysis of participant attrition rates provided preliminary support for the acceptability of third-wave eHealth. Third-wave eHealth treatments are efficacious in improving mental health outcomes including anxiety, depression, and quality of life, but not more so than comparison interventions. Preliminary evidence from indices of participant evaluation and attrition rates supports the acceptability of these treatments. Copyright © 2017. Published by Elsevier Ltd.

All optical mode controllable Er-doped random fiber laser with distributed Bragg gratings.

PubMed

Zhang, W L; Ma, R; Tang, C H; Rao, Y J; Zeng, X P; Yang, Z J; Wang, Z N; Gong, Y; Wang, Y S

2015-07-01

An all-optical method to control the lasing modes of Er-doped random fiber lasers (RFLs) is proposed and demonstrated. In the RFL, an Er-doped fiber (EDF) recoded with randomly separated fiber Bragg gratings (FBG) is used as the gain medium and randomly distributed reflectors, as well as the controllable element. By combining random feedback of the FBG array and Fresnel feedback of a cleaved fiber end, multi-mode coherent random lasing is obtained with a threshold of 14 mW and power efficiency of 14.4%. Moreover, a laterally-injected control light is used to induce local gain perturbation, providing additional gain for certain random resonance modes. As a result, active mode selection of the RFL is realized by changing locations of the laser cavity that is exposed to the control light.

Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue

PubMed Central

Gaede, Gunnar; Tiede, Marina; Lorenz, Ina; Brandt, Alexander U.; Pfueller, Caspar; Dörr, Jan; Bellmann-Strobl, Judith; Piper, Sophie K.; Roth, Yiftach; Zangen, Abraham; Schippling, Sven

2017-01-01

Objective: To conduct a randomized, sham-controlled phase I/IIa study to evaluate the safety and preliminary efficacy of deep brain H-coil repetitive transcranial magnetic stimulation (rTMS) over the prefrontal cortex (PFC) and the primary motor cortex (MC) in patients with MS with fatigue or depression (NCT01106365). Methods: Thirty-three patients with MS were recruited to undergo 18 consecutive rTMS sessions over 6 weeks, followed by follow-up (FU) assessments over 6 weeks. Patients were randomized to receive high-frequency stimulation of the left PFC, MC, or sham stimulation. Primary end point was the safety of stimulation. Preliminary efficacy was assessed based on changes in Fatigue Severity Scale (FSS) and Beck Depression Inventory scores. Randomization allowed only analysis of preliminary efficacy for fatigue. Results: No serious adverse events were observed. Five patients terminated participation during treatment due to mild side effects. Treatment resulted in a significant median FSS decrease of 1.0 point (95%CI [0.45,1.65]), which was sustained during FU. Conclusions: H-coil rTMS is safe and well tolerated in patients with MS. The observed sustained reduction in fatigue after subthreshold MC stimulation warrants further investigation. ClinicalTrials.gov identifier: NCT01106365. Classification of evidence: This study provides Class III evidence that rTMS of the prefrontal or primary MC is not associated with serious adverse effects, although this study is underpowered to state this with any precision. PMID:29259998

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

PubMed Central

Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post

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…

Acupuncture for migraine prophylaxis: a randomized controlled trial

PubMed Central

Li, Ying; Zheng, Hui; Witt, Claudia M.; Roll, Stephanie; Yu, Shu-guang; Yan, Jie; Sun, Guo-jie; Zhao, Ling; Huang, Wen-jing; Chang, Xiao-rong; Zhang, Hong-xing; Wang, De-jun; Lan, Lei; Zou, Ran; Liang, Fan-rong

2012-01-01

Background: Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture. Methods: We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life. Results: Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups. Interpretation: Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture. Trial Registration: Clinicaltrials.gov NCT00599586 PMID:22231691

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

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.

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…

Early rehabilitation exercise program for inpatients during an acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

PubMed

Tang, Clarice Y; Blackstock, Felicity C; Clarence, Michael; Taylor, Nicholas F

2012-01-01

To determine whether an early rehabilitation program was safe and feasible for patients during an acute exacerbation of chronic obstructive pulmonary disease (COPD). In this phase 1 randomized controlled trial, patients with an acute exacerbation of COPD admitted to the hospital were randomly allocated to a low-intensity exercise group, a moderate- to high-intensity exercise group, or a control group, who received routine physical therapy. In addition to routine physical therapy, patients in the exercise group had to participate in an exercise program. The program consisted of twice-daily aerobic and resistance exercise sessions. Primary outcomes were the number and classification of adverse events and program adherence. In 174 exercise sessions, there was 1 serious adverse event of arrhythmia in the low-intensity exercise group that resolved within 1 hour. There were 12 other minor adverse events involving 5 patients with no significant differences between groups. Patients completed an average of 80% of their scheduled sessions with no significant between-group differences. The exercise groups improved significantly in walking distance; however, no significant between-group differences were observed. There was preliminary evidence that it was safe and feasible to implement an exercise program for patients during an acute exacerbation of COPD. Additional studies with larger sample sizes are required to accurately evaluate program effectiveness.

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…

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.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

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.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial.

PubMed

Gerke, Alicia K; Pezzulo, Alejandro A; Tang, Fan; Cavanaugh, Joseph E; Bair, Thomas B; Phillips, Emily; Powers, Linda S; Monick, Martha M

2014-03-26

Vitamin D deficiency has been implicated as a factor in a number of infectious and inflammatory lung diseases. In the lung, alveolar macrophages play a key role in inflammation and defense of infection, but there are little data exploring the immunomodulatory effects of vitamin D on innate lung immunity in humans. The objective of this study was to determine the effects of vitamin D supplementation on gene expression of alveolar macrophages. We performed a parallel, double-blind, placebo-controlled, randomized trial to determine the effects of vitamin D on alveolar macrophage gene expression. Vitamin D3 (1000 international units/day) or placebo was administered to adults for three months. Bronchoscopy was performed pre- and post-intervention to obtain alveolar macrophages. Messenger RNA was isolated from the macrophages and subjected to whole genome exon array analysis. The primary outcome was differential gene expression of the alveolar macrophage in response to vitamin D supplementation. Specific genes underwent validation by polymerase chain reaction methods. Fifty-eight subjects were randomized to vitamin D (n = 28) or placebo (n = 30). There was a marginal overall difference between treatment group and placebo group in the change of 25-hydroxyvitaminD levels (4.43 ng/ml vs. 0.2 ng/ml, p = 0.10). Whole genome exon array analysis revealed differential gene expression associated with change in serum vitamin D levels in the treated group. CCL8/MCP-2 was the top-regulated cytokine gene and was further validated. Although only a non-significant increased trend was seen in serum vitamin D levels, subjects treated with vitamin D supplementation had immune-related differential gene expression in alveolar macrophages. ClinicalTrials.org: NCT01967628.

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.

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, η p 2 =0.04), peak power output (F(2150)=8.16, p<0.01, η p 2 =0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, η p 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.

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

DTIC Science & Technology

2016-03-01

AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...Caring Letters for Military Suicide Prevention: A Randomized 5a. CONTRACT NUMBER Controlled Trial 5b. GRANT NUMBER W81XWH-11-2-0123 5c. PROGRAM...determine if the intervention is effective in preventing suicide and suicidal behaviors among Service Members and Veterans. The “caring letters

Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

DTIC Science & Technology

2017-03-01

AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...Caring Letters for Military Suicide Prevention: A Randomized 5a. CONTRACT NUMBER Controlled Trial 5b. GRANT NUMBER W81XWH-11-2-0123 5c. PROGRAM...determine if the intervention is effective in preventing suicide and suicidal behaviors among Service Members and Veterans. The “caring letters” concept

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

Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study.

PubMed

Bergman, R Lindsey; Gonzalez, Araceli; Piacentini, John; Keller, Melody L

2013-10-01

To evaluate the feasibility, acceptability, and preliminary efficacy of a novel behavioral intervention for reducing symptoms of selective mutism and increasing functional speech. A total of 21 children ages 4 to 8 with primary selective mutism were randomized to 24 weeks of Integrated Behavior Therapy for Selective Mutism (IBTSM) or a 12-week Waitlist control. Clinical outcomes were assessed using blind independent evaluators, parent-, and teacher-report, and an objective behavioral measure. Treatment recipients completed a three-month follow-up to assess durability of treatment gains. Data indicated increased functional speaking behavior post-treatment as rated by parents and teachers, with a high rate of treatment responders as rated by blind independent evaluators (75%). Conversely, children in the Waitlist comparison group did not experience significant improvements in speaking behaviors. Children who received IBTSM also demonstrated significant improvements in number of words spoken at school compared to baseline, however, significant group differences did not emerge. Treatment recipients also experienced significant reductions in social anxiety per parent, but not teacher, report. Clinical gains were maintained over 3 month follow-up. IBTSM appears to be a promising new intervention that is efficacious in increasing functional speaking behaviors, feasible, and acceptable to parents and teachers. Copyright © 2013 Elsevier Ltd. All rights reserved.

Does perturbation-based balance training prevent falls? Systematic review and meta-analysis of preliminary randomized controlled trials.

PubMed

Mansfield, Avril; Wong, Jennifer S; Bryce, Jessica; Knorr, Svetlana; Patterson, Kara K

2015-05-01

Older adults and individuals with neurological conditions are at an increased risk for falls. Although physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation-based balance training on falls in daily life. MEDLINE (1946-July 2014), EMBASE (1974-July 2014), PEDro (all dates), CENTRAL (1991-July 2014), and Google Scholar (all dates) were the data sources used in this study. Randomized controlled trials written in English were included if they focused on perturbation-based balance training among older adults or individuals with neurological conditions and collected falls data posttraining. Two investigators extracted data independently. Study authors were contacted to obtain missing information. A PEDro score was obtained for each study. Primary outcomes were proportion of participants who reported one or more falls (ie, number of "fallers") and the total number of falls. The risk ratio (proportion of fallers) and rate ratio (number of falls) were entered into the analysis. Eight studies involving 404 participants were included. Participants who completed perturbation-based balance training were less likely to report a fall (overall risk ratio=0.71; 95% confidence interval=0.52, 0.96; P=.02) and reported fewer falls than those in the control groups (overall rate ratio=0.54; 95% confidence interval=0.34, 0.85; P=.007). Study authors do not always identify that they have included perturbation training in their intervention; therefore, it is possible that some appropriate studies were not included. Study designs were heterogeneous, preventing subanalyses. Perturbation-based balance training appears to reduce fall risk among older adults and individuals with Parkinson disease. © 2015 American Physical Therapy Association.

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.

A BRIEF ECOLOGICAL MOMENTARY INTERVENTION FOR GENERALIZED ANXIETY DISORDER: A RANDOMIZED CONTROLLED TRIAL OF THE WORRY OUTCOME JOURNAL.

PubMed

LaFreniere, Lucas S; Newman, Michelle G

2016-09-01

The efficacy of many cognitive behavioral component interventions has not been examined, with worry outcome monitoring among them. To address this issue, 51 participants with clinical levels of generalized anxiety disorder were randomly assigned to a treatment or control condition for 10 days. The treatment condition consisted of a brief ecological momentary intervention termed the Worry Outcome Journal (WOJ). WOJ participants recorded worries and tracked their outcomes, rating worry distress, interference, and expected outcome probabilities. Thought log (TL) control participants completed a record of their everyday thoughts and rated associated distress. All participants made four entries on paper each day when randomly prompted by text message. They then entered their paper contents online each night. After 30 days they reviewed their contents electronically and completed follow-up measures. Primary results revealed significant reductions in worry for WOJ users compared to TL users at postintervention. A marginally significant difference was found at 20-day follow-up and treatment gains were maintained. Secondary analyses showed no harmful increases in worry beliefs for WOJ users, as well as preliminary evidence for decreases in beliefs about the uncontrollability of thoughts in both groups. The WOJ may be a viable therapist-independent treatment for reducing worry, even after only 10 days of use. © 2016 Wiley Periodicals, Inc.

Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.

PubMed

Flanagan, Julianne C; Sippel, Lauren M; Wahlquist, Amy; Moran-Santa Maria, Megan M; Back, Sudie E

2018-03-01

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition for which Prolonged Exposure (PE) therapy is highly efficacious. However, for some individuals, premature dropout and residual PTSD symptoms remain obstacles. The neuropeptide oxytocin is a promising candidate to enhance PE due to its ability to enhance 1) prosocial cognition and behavior, which are theorized to promote positive working alliance, and 2) extinction learning, which is the central mechanism of action underlying successful PE treatment. Despite a robust theoretical rationale, no studies to date have combined evidence-based psychotherapy for PTSD with oxytocin. This randomized, placebo-controlled, double-blind pilot trial examined the feasibility, safety, and preliminary efficacy of augmenting PE with oxytocin. Participants were 17 individuals with diverse index traumas. Participants self-administered intranasal oxytocin (40 IU) or matching placebo 45 min prior to each weekly PE therapy session. One adverse event occurred in the placebo group and three individuals dropped out (17.6%; 2 oxytocin group and 1 placebo group). The oxytocin group demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores, although these differences did not reach statistical significance. Although preliminary, the findings support the feasibility of oxytocin combined with PE. Adequately powered studies are necessary to determine whether oxytocin enhances PE treatment outcomes and to examine potential mechanisms, such as accelerating extinction learning, enhancing early response, and preventing premature dropout. NCT03238924. Copyright © 2017. Published by Elsevier Ltd.

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

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

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

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. 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., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. 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 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. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead 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 allocation of patients among the treatment arms

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

PubMed

Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

PubMed Central

Marsac, Meghan L.; Kohser, Kristen L.; Winston, Flaura K.; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Background Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Discussion Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study

Oral curcumin for Alzheimer's disease: tolerability and efficacy in a 24-week randomized, double blind, placebo-controlled study.

PubMed

Ringman, John M; Frautschy, Sally A; Teng, Edmond; Begum, Aynun N; Bardens, Jenny; Beigi, Maryam; Gylys, Karen H; Badmaev, Vladimir; Heath, Dennis D; Apostolova, Liana G; Porter, Verna; Vanek, Zeba; Marshall, Gad A; Hellemann, Gerhard; Sugar, Catherine; Masterman, Donna L; Montine, Thomas J; Cummings, Jeffrey L; Cole, Greg M

2012-01-01

Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation. It reduces pathology in transgenic models of Alzheimer's disease (AD) and is a promising candidate for treating human AD. The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD. We performed a 24-week randomized, double blind, placebo-controlled study of Curcumin C3 Complex(®) with an open-label extension to 48 weeks. Thirty-six persons with mild-to-moderate AD were randomized to receive placebo, 2 grams/day, or 4 grams/day of oral curcumin for 24 weeks. For weeks 24 through 48, subjects that were receiving curcumin continued with the same dose, while subjects previously receiving placebo were randomized in a 1:1 ratio to 2 grams/day or 4 grams/day. The primary outcome measures were incidence of adverse events, changes in clinical laboratory tests and the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) at 24 weeks in those completing the study. Secondary outcome measures included the Neuropsychiatric Inventory (NPI), the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale, levels of Aβ1-40 and Aβ1-42 in plasma and levels of Aβ1-42, t-tau, p-tau181 and F2-isoprostanes in cerebrospinal fluid. Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured. Mean age of completers (n = 30) was 73.5 years and mean Mini-Mental Status Examination (MMSE) score was 22.5. One subject withdrew in the placebo (8%, worsened memory) and 5/24 subjects withdrew in the curcumin group (21%, 3 due to gastrointestinal symptoms). Curcumin C3 Complex(®) was associated with lowered hematocrit and increased glucose levels that were clinically insignificant. There were no differences between

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.

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.

A Randomized Controlled Trial of an Electronic Informed Consent Process

PubMed Central

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

2018-01-01

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. PMID:25747685

A Preliminary Randomized Controlled Trial of Contingency Management for Alcohol Use Reduction Using a Transdermal Alcohol Sensor

PubMed Central

Barnett, Nancy P.; Celio, Mark A.; Tidey, Jennifer W.; Murphy, James G.; Colby, Suzanne M.; Swift, Robert M.

2017-01-01

Aims We tested the efficacy of daily contingent reinforcement for reducing alcohol use compared with (yoked) noncontingent reinforcement (NR) using a transdermal alcohol sensor to detect alcohol use. Design Pilot randomized controlled design with one baseline week, three intervention weeks, and one-month follow up. Setting New England, USA. Participants Heavy drinking adults (46.7% female) not seeking treatment were randomized to 1) an escalating schedule of cash reinforcement (CR; n =15) for days on which alcohol was neither reported nor detected or 2) yoked NR (n =15). Intervention and comparator Reinforcement for CR participants started at $5 and increased $2 every subsequent day on which alcohol was not detected or reported, to a maximum of $17. Participants received no reinforcement for days on which alcohol use was detected or reported, and the reinforcer value was re-set to $5 the day after a drinking day. NR participants were yoked to the daily reinforcer value of an individual in the CR condition, in order of enrollment. Paired participants in CR and NR therefore received the same amount of money, but the amount for the NR participant was not behavior-related. Measurements The primary outcome was percent days without sensor-detected drinking. Secondary outcomes were number of consecutive days with no detected drinking, peak transdermal alcohol concentration (TAC), self-reported drinks per week, and drinking below NIH low-risk guidelines. Findings Controlling for baseline, CR had higher percent days with no drinking detected (54.3%) than NR (31.2%) during intervention weeks (p = .05, Cohen’s d = 0.74; 95% CI: 007–1.47). The longest period of consecutive days with no drinking detected was 8.0 for CR vs. 2.9 for NR (p = .03, d = 0.85; 95% CI: .08–1.61). Peak TAC during intervention showed a nonsignificant group difference (p = .20; d = .48; 95% CI: .00–1.18); a similar result was found for drinks per week (p = .12; d = .59; 95% CI: .00–1.30). Four

Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

PubMed

Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

2012-01-25

Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

A culturally tailored Internet cancer support group for Asian American breast cancer survivors: A randomized controlled pilot intervention study.

PubMed

Chee, Wonshik; Lee, Yaelim; Im, Eun-Ok; Chee, Eunice; Tsai, Hsiu-Min; Nishigaki, Masakazu; Yeo, Seon Ae; Schapira, Marilyn M; Mao, Jun James

2017-07-01

Introduction The necessity of culturally competent Internet Cancer Support Groups (ICSGs) for ethnic minorities has recently been highlighted in order to increase its attractiveness and usage. The purpose of this study was to determine the preliminary efficacy of a culturally tailored registered-nurse-moderated ICSG for Asian American breast cancer survivors in enhancing the women's breast cancer survivorship experience. Methods The study included two phases: (a) a usability test and an expert review; and (b) a randomized controlled pilot intervention study. The usability test was conducted among five Asian American breast cancer survivors using a one-month online forum, and the expert review was conducted among five experts using the Cognitive Walkthrough method. The randomized controlled pilot intervention study (a pre-test and post-test design) was conducted among 65 Asian American breast cancer survivors. The data were analysed using content analysis and descriptive and inferential statistics including the repeated ANOVA. Results All users and experts positively evaluated the program and provided their suggestions for the display, educational contents, and user-friendly structure. There were significant positive changes in the support care needs and physical and psychological symptoms ( p < 0.05) of the control group. There were significant negative changes in the uncertainty level of the intervention group ( p < 0.10). Controlling for background and disease factors, the intervention group showed significantly greater improvements than the control group in physical and psychological symptoms and quality of life ( p < 0.10). Discussion The findings supported the positive effects of ICSGs on support care needs, psychological and physical symptoms, and quality of life.

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…

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.

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

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...

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

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.…

Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

PubMed

Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

2017-08-01

Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of

Preliminary control law and hardware designs for a ride quality augmentation system for commuter aircraft. Phase 2

NASA Technical Reports Server (NTRS)

Davis, D. J.; Linse, D. J.; Suikat, R.; Entz, D. P.

1986-01-01

The continued investigation of the design of Ride Quality Augmentation Systems (RQAS) for commuter aircraft is described. The purpose of these RQAS is the reduction of the vertical and lateral acceleration response of the aircraft due to atmospheric turbulence by the application of active control. The current investigations include the refinement of the sample data feedback control laws based on the control-rate-weighting and output-weighting optimal control design techniqes. These control designs were evaluated using aircraft time simulations driven by Dryden spectra turbulence. Fixed gain controllers were tested throughout the aircrft operating envelope. The preliminary design of the hardware modifications necessary to implement and test the RQAS on a commuter aircraft is included. These include a separate surface elevator and the flap modifications to provide both direct lift and roll control. A preliminary failure mode investigation was made for the proposed configuration. The results indicate that vertical acceleration reductions of 45% and lateral reductions of more than 50% are possible. A fixed gain controller appears to be feasible with only minor response degradation.

Hypospadias repair using laser tissue soldering (LTS): preliminary results of a prospective randomized study

NASA Astrophysics Data System (ADS)

Kirsch, Andrew J.; Cooper, Christopher S.; Canning, Douglas A.; Snyder, Howard M., III; Zderic, Stephen A.

1998-07-01

Purpose: The purpose of this study was to evaluate laser tissue soldering using an 808 nm diode laser and wavelength- matched human albumin solder for urethral surgery in children. Methods: Currently, 30 boys, ages 3 months to 8 years were randomized to standard suturing (n equals 22) or 'sutureless' laser hypospadias repair (n equals 18). Laser soldering was performed with a human albumin solder doped with indocyanine green dye (2.5 mg/ml) using a laser power output of 0.5 W, pulse duration of 0.5 sec, and interval of 0.1 sec. Power density was approximately 16 W/cm2. In the laser group, sutures were used for tissue alignment only. At the time of surgery, neourethral and penile lengths, operative time for urethral repair, and number of sutures/throws were measured. Postoperatively, patients were examined for complications of wound healing, stricture, or fistula formation. Results: Mean age, severity of urethral defect, type of repair, and neourethra length were equivalent between the two groups. Operative time was significantly faster for laser soldering in both simple (1.6 plus or minus 0.21 min, p less than 0.001) and complex (5.4 plus or minus 0.28 min, p less than 0.0001) hypospadias repairs compared to controls (10.6 plus or minus 1.4 min and 27.8 plus or minus 2.9 min, respectively). The mean number of sutures used in the laser group for simple and complex repairs (3.3 plus or minus 0.3 and 8.1 plus or minus 0.64, respectively) were significantly (p less than 0.0001) less than for controls (8.2 plus or minus 0.84 and 20 plus or minus 2.3, respectively). Followup was between 3 months and 14 months. The overall complication rate in the laser group (11%) was lower than the controls (23%). However, statistical significance (p less than 0.05) was achieved only for the subgroup of patients undergoing simple repairs (LTS, 100% success versus suturing, 69% success). Conclusions: These preliminary results indicate that laser tissue soldering for hypospadias repair

The impact of two workplace-based health risk appraisal interventions on employee lifestyle parameters, mental health and work ability: results of a randomized controlled trial.

PubMed

Addley, K; Boyd, S; Kerr, R; McQuillan, P; Houdmont, J; McCrory, M

2014-04-01

Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental health and work ability in a UK context. A total of 180 employees were randomized into one of three groups: Group A (HRA augmented with health promotion and education activities), Group B (HRA only) and Group C (control, no intervention). After 12 months, changes in mean scoring in 10 lifestyle, mental health and work ability indices were compared, Groups A and B demonstrated non-significant improvements in 70% and 80%, respectively, compared with controls (40%). Odds ratios revealed that, compared with the control group, Group A was 29.2 (95% CI: 9.22-92.27) times more likely to report a perceived change in lifestyle behaviour; Group B 4.4 times (95% CI: 1.65-11.44). In conclusion, participation in the HRA was associated with a higher likelihood of perceived lifestyle behaviour change which was further increased in the augmented HRA group, thereby providing preliminary evidence that HRA and augmented HRA in particular may help UK employees make positive healthy lifestyle changes.

Online distribution channel increases article usage on Mendeley: a randomized controlled trial.

PubMed

Kudlow, Paul; Cockerill, Matthew; Toccalino, Danielle; Dziadyk, Devin Bissky; Rutledge, Alan; Shachak, Aviv; McIntyre, Roger S; Ravindran, Arun; Eysenbach, Gunther

2017-01-01

Prior research shows that article reader counts (i.e. saves) on the online reference manager, Mendeley, correlate to future citations. There are currently no evidenced-based distribution strategies that have been shown to increase article saves on Mendeley. We conducted a 4-week randomized controlled trial to examine how promotion of article links in a novel online cross-publisher distribution channel (TrendMD) affect article saves on Mendeley. Four hundred articles published in the Journal of Medical Internet Research were randomized to either the TrendMD arm ( n  = 200) or the control arm ( n  = 200) of the study. Our primary outcome compares the 4-week mean Mendeley saves of articles randomized to TrendMD versus control. Articles randomized to TrendMD showed a 77% increase in article saves on Mendeley relative to control. The difference in mean Mendeley saves for TrendMD articles versus control was 2.7, 95% CI (2.63, 2.77), and statistically significant ( p  < 0.01). There was a positive correlation between pageviews driven by TrendMD and article saves on Mendeley (Spearman's rho r  = 0.60). This is the first randomized controlled trial to show how an online cross-publisher distribution channel (TrendMD) enhances article saves on Mendeley. While replication and further study are needed, these data suggest that cross-publisher article recommendations via TrendMD may enhance citations of scholarly articles.

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

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.

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

2018-04-01

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.

Overview of the preliminary design of the ITER plasma control system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Snipes, J. A.; Albanese, R.; Ambrosino, G.

An overview of the Preliminary Design of the ITER Plasma Control System (PCS) is described here, which focusses on the needs for 1st plasma and early plasma operation in hydrogen/helium (H/He) up to a plasma current of 15 MA with moderate auxiliary heating power in low confinement mode (L-mode). Candidate control schemes for basic magnetic control, including divertor operation and kinetic control of the electron density with gas puffing and pellet injection, were developed. Commissioning of the auxiliary heating systems is included as well as support functions for stray field topology and real-time plasma boundary reconstruction. Initial exception handling schemesmore » for faults of essential plant systems and for disruption protection were developed. The PCS architecture was also developed to be capable of handling basic control for early commissioning and the advanced control functions that will be needed for future high performance operation. A plasma control simulator is also being developed to test and validate control schemes. To handle the complexity of the ITER PCS, a systems engineering approach has been adopted with the development of a plasma control database to keep track of all control requirements.« less

Overview of the preliminary design of the ITER plasma control system

NASA Astrophysics Data System (ADS)

Snipes, J. A.; Albanese, R.; Ambrosino, G.; Ambrosino, R.; Amoskov, V.; Blanken, T. C.; Bremond, S.; Cinque, M.; de Tommasi, G.; de Vries, P. C.; Eidietis, N.; Felici, F.; Felton, R.; Ferron, J.; Formisano, A.; Gribov, Y.; Hosokawa, M.; Hyatt, A.; Humphreys, D.; Jackson, G.; Kavin, A.; Khayrutdinov, R.; Kim, D.; Kim, S. H.; Konovalov, S.; Lamzin, E.; Lehnen, M.; Lukash, V.; Lomas, P.; Mattei, M.; Mineev, A.; Moreau, P.; Neu, G.; Nouailletas, R.; Pautasso, G.; Pironti, A.; Rapson, C.; Raupp, G.; Ravensbergen, T.; Rimini, F.; Schneider, M.; Travere, J.-M.; Treutterer, W.; Villone, F.; Walker, M.; Welander, A.; Winter, A.; Zabeo, L.

2017-12-01

An overview of the preliminary design of the ITER plasma control system (PCS) is described here, which focusses on the needs for 1st plasma and early plasma operation in hydrogen/helium (H/He) up to a plasma current of 15 MA with moderate auxiliary heating power in low confinement mode (L-mode). Candidate control schemes for basic magnetic control, including divertor operation and kinetic control of the electron density with gas puffing and pellet injection, were developed. Commissioning of the auxiliary heating systems is included as well as support functions for stray field topology and real-time plasma boundary reconstruction. Initial exception handling schemes for faults of essential plant systems and for disruption protection were developed. The PCS architecture was also developed to be capable of handling basic control for early commissioning and the advanced control functions that will be needed for future high performance operation. A plasma control simulator is also being developed to test and validate control schemes. To handle the complexity of the ITER PCS, a systems engineering approach has been adopted with the development of a plasma control database to keep track of all control requirements.

Overview of the preliminary design of the ITER plasma control system

DOE PAGES

Snipes, J. A.; Albanese, R.; Ambrosino, G.; ...

2017-09-11

An overview of the Preliminary Design of the ITER Plasma Control System (PCS) is described here, which focusses on the needs for 1st plasma and early plasma operation in hydrogen/helium (H/He) up to a plasma current of 15 MA with moderate auxiliary heating power in low confinement mode (L-mode). Candidate control schemes for basic magnetic control, including divertor operation and kinetic control of the electron density with gas puffing and pellet injection, were developed. Commissioning of the auxiliary heating systems is included as well as support functions for stray field topology and real-time plasma boundary reconstruction. Initial exception handling schemesmore » for faults of essential plant systems and for disruption protection were developed. The PCS architecture was also developed to be capable of handling basic control for early commissioning and the advanced control functions that will be needed for future high performance operation. A plasma control simulator is also being developed to test and validate control schemes. To handle the complexity of the ITER PCS, a systems engineering approach has been adopted with the development of a plasma control database to keep track of all control requirements.« less

Random Forest Application for NEXRAD Radar Data Quality Control

NASA Astrophysics Data System (ADS)

Keem, M.; Seo, B. C.; Krajewski, W. F.

2017-12-01

Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e

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…

A preliminary randomized controlled trial of contingency management for alcohol use reduction using a transdermal alcohol sensor.

PubMed

Barnett, Nancy P; Celio, Mark A; Tidey, Jennifer W; Murphy, James G; Colby, Suzanne M; Swift, Robert M

2017-06-01

We tested the efficacy of daily contingent reinforcement for reducing alcohol use compared with (yoked) non-contingent reinforcement (NR) using a transdermal alcohol sensor to detect alcohol use. Pilot randomized controlled design with 1 baseline week, 3 intervention weeks and 1-month follow-up. New England, USA. Heavy drinking adults (46.7% female) not seeking treatment were randomized to (1) an escalating schedule of cash reinforcement (CR; n = 15) for days on which alcohol was neither reported nor detected or (2) yoked NR (n = 15). Reinforcement for CR participants started at $5 and increased $2 every subsequent day on which alcohol was not detected or reported, to a maximum of $17. Participants received no reinforcement for days on which alcohol use was detected or reported, and the reinforcer value was re-set to $5 the day after a drinking day. NR participants were yoked to the daily reinforcer value of an individual in the CR condition, in order of enrollment. Paired participants in CR and NR therefore received the same amount of money, but the amount for the NR participant was not behavior-related. The primary outcome was percentage of days without sensor-detected drinking. Secondary outcomes were number of consecutive days with no detected drinking, peak transdermal alcohol concentration (TAC), self-reported drinks per week and drinking below NIH low-risk guidelines. Controlling for baseline, CR had a higher percentage of days with no drinking detected (54.3%) than NR (31.2%) during intervention weeks [P = 0.05, Cohen's d = 0.74; 95% confidence interval (CI) = 0.007-1.47]. The longest period of consecutive days with no drinking detected was 8.0 for CR versus 2.9 for NR (P = 0.03, d = 0.85; 95% CI = 0.08-1.61). Peak TAC during intervention showed a non-significant group difference (P = 0.20; d = 0.48; 95% CI = 0.00-1.18); a similar result was found for drinks per week (P = 0.12; d = 0.59; 95% CI = 0.00-1.30). Four times more

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

Analysis of random drop for gateway congestion control. M.S. Thesis

NASA Technical Reports Server (NTRS)

Hashem, Emam Salaheddin

1989-01-01

Lately, the growing demand on the Internet has prompted the need for more effective congestion control policies. Currently No Gateway Policy is used to relieve and signal congestion, which leads to unfair service to the individual users and a degradation of overall network performance. Network simulation was used to illustrate the character of Internet congestion and its causes. A newly proposed gateway congestion control policy, called Random Drop, was considered as a promising solution to the pressing problem. Random Drop relieves resource congestion upon buffer overflow by choosing a random packet from the service queue to be dropped. The random choice should result in a drop distribution proportional to the bandwidth distribution among all contending TCP connections, thus applying the necessary fairness. Nonetheless, the simulation experiments demonstrate several shortcomings with this policy. Because Random Drop is a congestion control policy, which is not applied until congestion has already occurred, it usually results in a high drop rate that hurts too many connections including well-behaved ones. Even though the number of packets dropped is different from one connection to another depending on the buffer utilization upon overflow, the TCP recovery overhead is high enough to neutralize these differences, causing unfair congestion penalties. Besides, the drop distribution itself is an inaccurate representation of the average bandwidth distribution, missing much important information about the bandwidth utilization between buffer overflow events. A modification of Random Drop to do congestion avoidance by applying the policy early was also proposed. Early Random Drop has the advantage of avoiding the high drop rate of buffer overflow. The early application of the policy removes the pressure of congestion relief and allows more accurate signaling of congestion. To be used effectively, algorithms for the dynamic adjustment of the parameters of Early Random Drop

A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group

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

PubMed

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

2016-02-01

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

Identifying, Visualizing, and Fusing Social Media Data to Support Nonproliferation and Arms Control Treaty Verification: Preliminary Results

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gastelum, Zoe N.; Cramer, Nicholas O.; Benz, Jacob M.

While international nonproliferation and arms control verification capabilities have their foundations in physical and chemical sensors, state declarations, and on-site inspections, verification experts are beginning to consider the importance of open source data to complement and support traditional means of verification. One of those new, and increasingly expanding, sources of open source information is social media, which can be ingested and understood through social media analytics (SMA). Pacific Northwest National Laboratory (PNNL) is conducting research to further our ability to identify, visualize, and fuse social media data to support nonproliferation and arms control treaty verification efforts. This paper will describemore » our preliminary research to examine social media signatures of nonproliferation or arms control proxy events. We will describe the development of our preliminary nonproliferation and arms control proxy events, outline our initial findings, and propose ideas for future work.« less

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

Internet Delivered Support for Tobacco Control in Dental Practice: Randomized Controlled Trial

PubMed Central

Richman, Joshua S; Ray, Midge N; Allison, Jeroan J; Gilbert, Gregg H; Shewchuk, Richard M; Kohler, Connie L; Kiefe, Catarina I

2008-01-01

Background The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized. Objective To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings. Methods Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention. Results Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK. Conclusion This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit. Trial Registration clinicaltrials.gov NCT00627185; http://clinicaltrials.gov/ct2/show/NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj) PMID:18984559

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

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…

Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

PubMed Central

Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

2015-01-01

Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R) have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP), would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n = 14) were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control). SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control). This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors. PMID:26587287

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial.

PubMed

Chan, Aileen Wk; Yu, Doris Sf; Choi, K C

2017-01-01

To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. "Hidden elderly" is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24) and standard care control (n=24) groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale ( B =-1.32, 95% confidence interval [CI] -2.54 to -0.11, P =0.033) and the satisfaction component of the social support questionnaire ( B =3.43, 95% CI 0.10-6.76, P =0.044) than the control group. The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in improving social and psychological health suggest the need for a full-scale randomized controlled trial to reveal its empirical effects.

Perceptive rehabilitation and trunk posture alignment in patients with Parkinson disease: a single blind randomized controlled trial.

PubMed

Morrone, Michelangelo; Miccinilli, Sandra; Bravi, Marco; Paolucci, Teresa; Melgari, Jean M; Salomone, Gaetano; Picelli, Alessandro; Spadini, Ennio; Ranavolo, Alberto; Saraceni, Vincenzo M; DI Lazzaro, Vincenzo; Sterzi, Silvia

2016-12-01

Recent studies aimed to evaluate the potential effects of perceptive rehabilitation in Parkinson Disease reporting promising preliminary results for postural balance and pain symptoms. To date, no randomized controlled trial was carried out to compare the effects of perceptive rehabilitation and conventional treatment in patients with Parkinson Disease. To evaluate whether a perceptive rehabilitation treatment could be more effective than a conventional physical therapy program in improving postural control and gait pattern in patients with Parkinson Disease. Single blind, randomized controlled trial. Department of Physical and Rehabilitation Medicine of a University Hospital. Twenty outpatients affected by idiopathic Parkinson Disease at Hoehn and Yahr stage ≤3. Recruited patients were divided into two groups: the first one underwent individual treatment with Surfaces for Perceptive Rehabilitation (Su-Per), consisting of rigid wood surfaces supporting deformable latex cones of various dimensions, and the second one received conventional group physical therapy treatment. Each patient underwent a training program consisting of ten, 45-minute sessions, three days a week for 4 consecutive weeks. Each subject was evaluated before treatment, immediately after treatment and at one month of follow-up, by an optoelectronic stereophotogrammetric system for gait and posture analysis, and by a computerized platform for stabilometric assessment. Kyphosis angle decreased after ten sessions of perceptive rehabilitation, thus showing a substantial difference with respect to the control group. No significant differences were found as for gait parameters (cadence, gait speed and stride length) within Su-Per group and between groups. Parameters of static and dynamic evaluation on stabilometric platform failed to demonstrate any statistically relevant difference both within-groups and between-groups. Perceptive training may help patients affected by Parkinson Disease into restoring

The relationship between self-control, job satisfaction and life satisfaction in Chinese employees: A preliminary study.

PubMed

Dou, Kai; Nie, Yan-Gang; Wang, Yu-Jie; Liu, Yao-Zhong

2016-01-01

Previous studies have demonstrated that self-control is positively related to life satisfaction, but this association in Chinese employees and its underlying mechanism are less commonly investigated. In this preliminary study the relationships between self-control and life satisfaction and the mediating effect of job satisfaction were tested. Participants were 482 full-time employees (188 male, 294 female) from different cities in China. They answered self-report questionnaires online that assessed self-control, job satisfaction, and life satisfaction. Path analyses were conducted and bootstrap technique was used to judge the significance of the mediation. Self-control was positively related to both job and life satisfaction. More importantly, job satisfaction significantly mediated the association between self-control and life satisfaction. Furthermore, there was no significant difference in the size of the mediating effect between intrinsic and extrinsic job satisfaction. Results of this preliminary study provide further evidence of the positive association between self-control and life satisfaction. Job satisfaction is found to mediate this relationship.

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

PubMed

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

2013-03-09

Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial

PubMed Central

2013-01-01

Background Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. Methods/Design The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann–Whitney U test. Discussion The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary

Observational studies are complementary to randomized controlled trials.

PubMed

Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

2010-01-01

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

Some New Possibilities to Control Kudzu

Treesearch

Jerry L. Michael

1982-01-01

Six chemicals were tested at random with 3 replications at 3 rates for foliar activity on kudzu [Pueraria lobata (Willd.) Ohwi]. All chemicals gave some degree of control. DPX-6376, XRM-3972 (Lontrel), and Oust(TM) Weed Killer (formerly known as DPX-5648) gave more than 99% topkill for 3 l/2 months. Preliminary results...

Phone-Delivered Mindfulness Training for Patients with Implantable Cardioverter Defibrillators: Results of a Pilot Randomized Controlled Trial

PubMed Central

Salmoirago-Blotcher, Elena; Crawford, Sybil L.; Carmody, James; Rosenthal, Lawrence; Yeh, Gloria; Stanley, Mary; Rose, Karen; Browning, Clifford; Ockene, Ira S.

2013-01-01

Background The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. Purpose To determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. Methods Clinically stable outpatients were randomized to a mindfulness intervention (8 weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness; and multivariate linear regression to estimate the intervention effect on pre-post intervention changes in these variables. Results We enrolled 45 patients (23 mindfulness, 22 control; age 43–83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = .04) and anxiety (beta = − 1.15; p = .059) improved in the mindfulness group. Conclusions Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients. PMID:23605175

Coherent random lasing controlled by Brownian motion of the active scatterer

NASA Astrophysics Data System (ADS)

Liang, Shuofeng; Yin, Leicheng; Zhang, ZhenZhen; Xia, Jiangying; Xie, Kang; Zou, Gang; Hu, Zhijia; Zhang, Qijin

2018-05-01

The stability of the scattering loop is fundamental for coherent random lasing in a dynamic scattering system. In this work, fluorescence of DPP (N, N-di [3-(isobutyl polyhedral oligomeric silsesquioxanes) propyl] perylene diimide) is scattered to produce RL and we realize the transition from incoherent RL to coherent RL by controlling the Brownian motion of the scatterers (dimer aggregates of DPP) and the stability of scattering loop. To produce coherent random lasers, the loop needs to maintain a stable state within the loop-stable time, which can be determined through controlled Brownian motion of scatterers in the scattering system. The result shows that the loop-stable time is within 5.83 × 10‑5 s to 1.61 × 10‑4 s based on the transition from coherent to incoherent random lasing. The time range could be tuned by finely controlling the viscosity of the solution. This work not only develops a method to predict the loop-stable time, but also develops the study between Brownian motion and random lasers, which opens the road to a variety of novel interdisciplinary investigations involving modern statistical mechanics and disordered photonics.

THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON LOWER EXTREMITY MUSCLE PERFORMANCE: A RANDOMIZED CONTROLLED TRIAL.

PubMed

MacDonald, Nicole; Baker, Russell; Cheatham, Scott W

2016-12-01

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a non-invasive therapeutic technique used to theoretically aid in scar tissue breakdown and absorption, fascial mobilization, and improved tissue healing. Researchers have hypothesized that utilizing IASTM will improve muscular efficiency and performance; yet previous Investigations has been focused on treating injury. The purpose of this investigation was to explore the effects of IASTM on muscle performance to assess if typical treatment application affected measures of muscular performance. A pretest-posttest randomized control design. A convenience sample of 48 physically active adults (mean age 24 ± 4 years), randomly assigned to one of three groups: quadriceps treatment group, triceps surae treatment group, or control group. Participants performed a five-minute warm-up on a Monark bicycle ergometer before performing three countermovement vertical jumps (CMJ). Immediately after, the IASTM treatment was applied by one researcher for three minutes on each leg at the specified site (e.g., quadriceps) for those assigned to the treatment groups, while the control group rested for six minutes. Immediately following treatment, participants performed three additional CMJs. Pre- and post-testing included measures of vertical jump height (JH), peak power (PP) and peak velocity (PV). There were no statistically significant differences found between treatment groups in JH, PP, or PV or across pre- and post-test trials. These preliminary findings suggest that standard treatment times of IASTM do not produce an immediate effect in muscular performance in healthy participants. This may help clinicians determine the optimal sequencing of IASTM when it is part of a pre-performance warm-up program. Future research should be conducted to determine the muscle performance effects of IASTM in individuals with known myofascial restriction and to determine optimal treatment parameters, such as instrument type, amount of

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

Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

PubMed

Mehring, Michael; Haag, Max; Linde, Klaus; Wagenpfeil, Stefan; Schneider, Antonius

2014-09-24

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95

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.

Effect of Retraining Approach-Avoidance Tendencies on an Exercise Task: A Randomized Controlled Trial.

PubMed

Cheval, Boris; Sarrazin, Philippe; Pelletier, Luc; Friese, Malte

2016-12-01

Promoting regular physical activity (PA) and lessening sedentary behaviors (SB) constitute a public health priority. Recent evidence suggests that PA and SB are not only related to reflective processes (eg, behavioral intentions), but also to impulsive approach-avoidance tendencies (IAAT). This study aims to test the effect of a computerized IAAT intervention on an exercise task. Participants (N = 115) were randomly assigned to 1 of 3 experimental conditions, in which they were either trained to approach PA and avoid SB (ApPA-AvSB condition), to approach SB and avoid PA (ApSB-AvPA condition), or to approach and avoid PA and SB equally often (active control condition). The main outcome variable was the time spent carrying out a moderate intensity exercise task. IAAT toward PA decreased in the ApSB-AvPA condition, tended to increase in the ApPA-AvSB condition, and remained stable in the control condition. Most importantly, the ApPA-AvSB manipulation led to more time spent exercising than the ApSB-AvPA condition. Sensitivity analyses excluding individuals who were highly physically active further revealed that participants in the ApPA-AvSB condition spent more time exercising than participants in the control condition. These findings provide preliminary evidence that a single intervention session can successfully change impulsive approach tendencies toward PA and can increase the time devoted to an exercise task, especially among individuals who need to be more physically active. Potential implications for health behavior theories and behavior change interventions are outlined.

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…

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

Randomized Control Trials on the Dynamic Geometry Approach

ERIC Educational Resources Information Center

Jiang, Zhonghong; White, Alexander; Rosenwasser, Alana

2011-01-01

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

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

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

ERIC Educational Resources Information Center

Coalition for Evidence-Based Policy, 2005

2005-01-01

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

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.

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

PubMed

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

2011-01-31

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

A randomized controlled trial of an Internet delivered dialectical behavior therapy skills training for suicidal and heavy episodic drinkers.

PubMed

Wilks, Chelsey R; Lungu, Anita; Ang, Sin Yee; Matsumiya, Brandon; Yin, Qingqing; Linehan, Marsha M

2018-05-01

Given that alcohol misuse elevates risk of suicide death among ideators, the paucity of treatment outcome research for individuals presenting with both suicide ideation and problem drinking is particularly troubling. Dialectical behavior therapy (DBT) skills training, which effectively targets behaviors associated with emotion dysregulation including addictive and suicidal behaviors, provides a fitting model amenable to computerization. As stigma and scarcity stand as potential barriers to treatment, online dissemination platforms provide means for efficient treatment delivery that can augment the utility of suitable interventions. This pilot RCT sought to evaluate the feasibility, acceptability, and preliminary efficacy of an Internet-delivered DBT skills training intervention (iDBT-ST) for suicidal individuals who engage in heavy episodic drinking METHODS: Participants (N = 59) were randomized to receive iDBT-ST immediately or after an 8-week waiting period. Clinical outcomes were suicide ideation, alcohol use, and emotion dysregulation. Participants on average saw a significant reduction in all outcomes over the four-month study period. Compared to waitlist controls, individuals who received iDBT-ST immediately showed faster reductions in alcohol consumption. Preliminary results suggest that iDBT-ST may be a viable resource for the high-risk and underserved group represented in this study, and pathways for future development are suggested. There was difficulty retaining and engaging participants due to technological barriers. Copyright © 2018 Elsevier B.V. All rights reserved.

Effects of fucoidan from Fucus vesiculosus in reducing symptoms of osteoarthritis: a randomized placebo-controlled trial

PubMed Central

Myers, Stephen P; Mulder, Ann M; Baker, Don G; Robinson, Shelley R; Rolfe, Margaret I; Brooks, Lyndon; Fitton, J Helen

2016-01-01

Purpose Preliminary investigation of a fucoidan with demonstrated reduction in the symptoms of osteoarthritis (OA) of the hip and knee. Patients and methods A double-blind randomized controlled trial was carried out to determine the safety and efficacy of a 300 mg dose of a Fucus vesiculosus extract (85% fucoidan) over a 12-week period in a population (n=122) with mild-to-moderate OA of the hip and knee as measured by the validated instrument “Comprehensive Osteoarthritis Test.” Safety was measured by assessing cholesterol, liver function, renal function, and hematopoietic function, and closely monitoring adverse events. Result Ninety-six participants completed the study. The reduction in symptoms of OA was not significantly different from the placebo response. There were no changes in the blood measurements that were of any clinical significance during the course of the study. Conclusion The F. vesiculosus fucoidan extract was safe and well tolerated. At a dose of 300 mg, the extract showed no difference in reduction of OA symptoms from the placebo. PMID:27307702

Mindfulness-Based Stress Reduction for Overweight/Obese Women With and Without Polycystic Ovary Syndrome: Design and Methods of a Pilot Randomized Controlled Trial

PubMed Central

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M.; Gustafson, Theresa S.; Socolow, Holly; Kunselman, Allen R.; Reibel, Diane K.; Legro, Richard S.

2015-01-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese. Eighty six (86) women with body mass index ≥25 kg/m2, including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. PMID:25662105

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial.

PubMed

Fowler, Eileen G; Knutson, Loretta M; Demuth, Sharon K; Siebert, Kara L; Simms, Victoria D; Sugi, Mia H; Souza, Richard B; Karim, Roksana; Azen, Stanley P

2010-03-01

Effective interventions to improve and maintain strength (force-generating capacity) and endurance are needed for children with cerebral palsy (CP). This study was performed to examine the effects of a stationary cycling intervention on muscle strength, locomotor endurance, preferred walking speed, and gross motor function in children with spastic diplegic CP. This was a phase I randomized controlled trial with single blinding. The interventions were performed in community-based outpatient physical therapy clinics. Outcome assessments were performed in university laboratories. Sixty-two ambulatory children aged 7 to 18 years with spastic diplegic CP and Gross Motor Function Classification System levels I to III participated in this study. Participants were randomly assigned to cycling or control (no-intervention) groups. Thirty intervention sessions occurred over 12 weeks. Primary outcomes were peak knee extensor and flexor moments, the 600-Yard Walk-Run Test, the Thirty-Second Walk Test, and the Gross Motor Function Measure sections D and E (GMFM-66). Significant baseline-postintervention improvements were found for the 600-Yard Walk-Run Test, the GMFM-66, peak knee extensor moments at 120 degrees /s, and peak knee flexor moments at 30 degrees /s for the cycling group. Improved peak knee flexor moments at 120 degrees/s were found for the control group only, although not all participants could complete this speed of testing. Significant differences between the cycling and control groups based on change scores were not found for any outcomes. Limitations Heterogeneity of the patient population and intrasubject variability were limitations of the study. Significant improvements in locomotor endurance, gross motor function, and some measures of strength were found for the cycling group but not the control group, providing preliminary support for this intervention. As statistical differences were not found in baseline-postintervention change scores between the 2 groups

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…

Role of the α1 Blocker Doxazosin in Alcoholism: a Proof-of-Concept Randomized Controlled Trial

PubMed Central

Kenna, George A.; Haass-Koffler, Carolina L.; Zywiak, William H.; Edwards, Steven M.; Brickley, Michael B.; Swift, Robert M.; Leggio, Lorenzo

2015-01-01

Background Evidence suggests the norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1-blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1-blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin but has never been studied for AD. Methods A double-blind placebo-controlled randomized clinical trial was conducted in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16-mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were primary outcomes. Family history density of alcoholism (FHDA), severity of AD, and gender were a priori moderators. Results Forty-one AD individuals were randomized, 30 (doxazosin = 15) completed the treatment phase, and 28 (doxazosin = 14) also completed the follow-up. There were no significant differences between groups on DPW and HDD per week. With FHDA as a moderator, there were significant FHDA x medication interactions for both DPW [pcorrected = .001, d = 1.18] and HDD [pcorrected = .00009, d = 1.30]. Post-hoc analyses revealed that doxazosin significantly reduced alcohol drinking in AD patients with high FHDA and by contrast increased drinking in those with low FHDA. Conclusions Doxazosin may be effective selectively in AD patients with high FHDA. This study provides preliminary evidence for personalized medicine using α1-blockade to treat AD. However, confirmatory studies are required. PMID:26037245

Preliminary assessment of the robustness of dynamic inversion based flight control laws

NASA Technical Reports Server (NTRS)

Snell, S. A.

1992-01-01

Dynamic-inversion-based flight control laws present an attractive alternative to conventional gain-scheduled designs for high angle-of-attack maneuvering, where nonlinearities dominate the dynamics. Dynamic inversion is easily applied to the aircraft dynamics requiring a knowledge of the nonlinear equations of motion alone, rather than an extensive set of linearizations. However, the robustness properties of the dynamic inversion are questionable especially when considering the uncertainties involved with the aerodynamic database during post-stall flight. This paper presents a simple analysis and some preliminary results of simulations with a perturbed database. It is shown that incorporating integrators into the control loops helps to improve the performance in the presence of these perturbations.

Safety of Spectacles for Children's Vision: A Cluster-Randomized Controlled Trial.

PubMed

Ma, Xiaochen; Congdon, Nathan; Yi, Hongmei; Zhou, Zhongqiang; Pang, Xiaopeng; Meltzer, Mirjam E; Shi, Yaojiang; He, Mingguang; Liu, Yizhi; Rozelle, Scott

2015-11-01

To study safety of children's glasses in rural China, where fear that glasses harm vision is an important barrier for families and policy makers. Exploratory analysis from a cluster-randomized, investigator-masked, controlled trial. Among primary schools (n = 252) in western China, children were randomized by school to 1 of 3 interventions: free glasses provided in class, vouchers for free glasses at a local facility, or glasses prescriptions only (Control group). The main outcome of this analysis is uncorrected visual acuity after 8 months, adjusted for baseline acuity. Among 19 934 children randomly selected for screening, 5852 myopic (spherical equivalent refractive error ≤-0.5 diopters) eyes of 3001 children (14.7%, mean age 10.5 years) had VA ≤6/12 without glasses correctable to >6/12 with glasses, and were eligible. Among these, 1903 (32.5%), 1798 (30.7%), and 2151 (36.8%) were randomized to Control, Voucher, and Free Glasses, respectively. Intention-to-treat analyses were performed on all 1831 (96.2%), 1699 (94.5%), and 2007 (93.3%) eyes of children with follow-up in Control, Voucher, and Free Glasses groups. Final visual acuity for eyes of children in the treatment groups (Free Glasses and Voucher) was significantly better than for Control children, adjusting only for baseline visual acuity (difference of 0.023 logMAR units [0.23 vision chart lines, 95% CI: 0.03, 0.43]) or for other baseline factors as well (0.025 logMAR units [0.25 lines, 95% CI 0.04, 0.45]). We found no evidence that spectacles promote decline in uncorrected vision with aging among children. Copyright © 2015 Elsevier Inc. All rights reserved.

The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. Cervical disc herniation and radiculitis is one of the common conditions described responsible for chronic neck and upper extremity pain. Cervical epidural injections for managing chronic neck pain with disc herniation are one of the commonly performed non-surgical interventions in the United States. However, the literature supporting cervical interlaminar epidural steroids in managing chronic neck pain is scant. A randomized, double-blind, controlled trial. A private interventional pain management practice and specialty referral center in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis, and to evaluate the differences between local anesthetic with or without steroids. Patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of non-particulate betamethasone. Multiple outcome measures were utilized. They included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments were done at baseline and 3, 6, and 12 months post-treatment. Significant pain relief was defined as 50% or more; significant improvement in disability score was defined as a reduction of 50% or more. Significant pain relief (> or = 50%) was demonstrated in 77% of patients in both groups. Functional status improvement was demonstrated by a reduction (> or = 50%) in the NDI scores in 74% of Group I and 71% of Group II at 12 months. The overall average procedures per year

Cockroach allergen reduction by cockroach control alone in low-income urban homes: a randomized control trial.

PubMed

Sever, Michelle L; Arbes, Samuel J; Gore, J Chad; Santangelo, Richard G; Vaughn, Ben; Mitchell, Herman; Schal, Coby; Zeldin, Darryl C

2007-10-01

We previously reported significant reductions in cockroach allergen concentrations in urban homes by reducing cockroach infestations. To determine the effectiveness of pest control performed by professional entomologists, compared with commercial companies, in reducing cockroach allergen. This 3-arm randomized controlled trial enrolled 60 cockroach-infested homes in North Carolina. Homes were randomly assigned to a control group or 1 of 2 treatment groups. Treatment 1 had insecticide baits placed by entomologists from North Carolina State University. Treatment 2 received pest control from a randomly assigned commercial company. Vacuumed dust sampling and cockroach trapping were conducted at 0, 6, and 12 months. Dust samples were analyzed by ELISA. In treatment 1 homes, there were significant reductions in geometric mean trap counts compared with control and treatment 2 homes at 12 months. Relative to control, significant 12-month reductions in Bla g 1 were evident in treatment 1 homes at all sampled sites, except bedroom floor. From baseline to month 12, geometric mean Bla g 1 concentrations (U/g) decreased from 64.2 to 5.6 in kitchen, 10.6 to 1.1 in living room, 10.7 to 1.9 on bedroom floor, and 3.6 to 2.3 in bed. Treatment 2 homes showed no significant 12-month allergen reductions versus control. Reductions in Bla g 1 in cockroach-infested homes can be achieved by reducing infestations; however, the magnitude of allergen reduction is dependent on the thoroughness and effectiveness of cockroach eradication efforts. Elimination of cockroaches is an effective method for reducing exposure to cockroach allergen.

Heated hatha yoga to target cortisol reactivity to stress and affective eating in women at risk for obesity-related illnesses: A randomized controlled trial.

PubMed

Hopkins, Lindsey B; Medina, Johnna L; Baird, Scarlett O; Rosenfield, David; Powers, Mark B; Smits, Jasper A J

2016-06-01

Cortisol reactivity to stress is associated with affective eating, an important behavioral risk factor for obesity and related metabolic diseases. Yoga practice is related to decreases in stress and cortisol levels, thus emerging as a potential targeted complementary intervention for affective eating. This randomized controlled trial examined the efficacy of a heated, hatha yoga intervention for reducing cortisol reactivity to stress and affective eating. Females (N = 52; ages 25-46 years; 75% White) at risk for obesity and related illnesses were randomly assigned to 8 weeks of Bikram Yoga practice or to waitlist control. Cortisol reactivity to a laboratory stress induction were measured at Weeks 0 (pretreatment) and 9 (posttreatment). Self-reported binge eating frequency and coping motives for eating were assessed at Weeks 0, 3, 6, and 9. Among participants with elevated cortisol reactivity at pretreatment ("high reactors"), those randomized to the yoga condition evidenced greater pre- to posttreatment reductions in cortisol reactivity (p = .042, d = .85), but there were not significant condition differences for the "low reactors" (p = .178, d = .53). Yoga participants reported greater decreases in binge eating frequency (p = .040, d = .62) and eating to cope with negative affect (p = .038, d = .54). This study provides preliminary support for the efficacy of heated hatha yoga for treating physiological stress reactivity and affective eating among women at risk for obesity-related illnesses. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial.

PubMed

Alves, Fabíola K; Riccetto, Cássio; Adami, Délcia B V; Marques, Joseane; Pereira, Larissa C; Palma, Paulo; Botelho, Simone

2015-06-01

The purpose of this study was to investigate if a specific pelvic floor muscle training (PFMT) program effectively increases pelvic floor muscle (PFM) contractility and decreases anterior pelvic organ prolapse (POP) as well as urogynecological symptoms, in postmenopausal women. The mean outcome measure of this study was the pelvic floor surface electromyography (sEMG) activity. A clinical, randomized, blinded-assessor and controlled study was conducted with 46 postmenopausal women. Thirty women completed this study (mean age of 65.93 years), divided into two groups: Treatment Group - TG (n=18) and Control Group - CG (n=12). The evaluation was carried out using digital palpation, sEMG, pelvic organ prolapse quantification (POP-Q) as well as validated questionnaires by the International Consultation on Incontinence Questionnaires to investigate urogynecological symptoms. The treatment protocol consisted of 12 group sessions, twice a week, with 30 min of duration each. These data were then submitted to statistical analyses by the Statistical Analysis System for Windows software, with a significance level of 5%. The pelvic floor muscle contractility increased after PFMT, evaluated by sEMG (p=0.003) and digital palpation (p=0.001), accompanied by a decrease in urinary symptoms (p<0.001 for ICIQ-OAB scores e 0.036 for ICIQ UI-SF) as well as anterior pelvic organ prolapse (p=0.03). This preliminary study suggests that the applied PFMT program could be an effective way to increase PFM contractility, as well as to decrease both anterior pelvic organ prolapse and urinary symptoms, in postmenopausal women. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

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

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

PubMed Central

Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

2015-01-01

Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

PubMed

Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

2018-04-01

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P < .001); lower mean blood glucose (105.1 ± 8.6 mg/dL vs 112.6 ± 7.4 mg/dL, P < .001); lower rates of off

Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

PubMed

Sahebnasagh, Adeleh; Ghasemi, Arash; Akbari, Jafar; Alipour, Abbas; Lashkardoost, Hossein; Ala, Shahram; Salehifar, Ebrahim

2017-11-01

Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). There was a significant (p < 0.05) improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively. A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.

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

ERIC Educational Resources Information Center

Schweig, Jonathan David; Pane, John F.

2016-01-01

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

Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

PubMed Central

Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

2012-01-01

Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

Peak Seeking Control for Reduced Fuel Consumption with Preliminary Flight Test Results

NASA Technical Reports Server (NTRS)

Brown, Nelson

2012-01-01

The Environmentally Responsible Aviation project seeks to accomplish the simultaneous reduction of fuel burn, noise, and emissions. A project at NASA Dryden Flight Research Center is contributing to ERAs goals by exploring the practical application of real-time trim configuration optimization for enhanced performance and reduced fuel consumption. This peak-seeking control approach is based on Newton-Raphson algorithm using a time-varying Kalman filter to estimate the gradient of the performance function. In real-time operation, deflection of symmetric ailerons, trailing-edge flaps, and leading-edge flaps of a modified F-18 are directly optimized, and the horizontal stabilators and angle of attack are indirectly optimized. Preliminary results from three research flights are presented herein. The optimization system found a trim configuration that required approximately 3.5% less fuel flow than the baseline trim at the given flight condition. The algorithm consistently rediscovered the solution from several initial conditions. These preliminary results show the algorithm has good performance and is expected to show similar results at other flight conditions and aircraft configurations.

Preliminary control/structure interaction study of coupled Space Station Freedom/Assembly Work Platform/orbiter

NASA Technical Reports Server (NTRS)

Singh, Sudeep K.; Lindenmoyer, Alan J.

1989-01-01

Results are presented from a preliminary control/structure interaction study of the Space Station, the Assembly Work Platform, and the STS orbiter dynamics coupled with the orbiter and station control systems. The first three Space Station assembly flight configurations and their finite element representations are illustrated. These configurations are compared in terms of control authority in each axis and propellant usage. The control systems design parameters during assembly are computed. Although the rigid body response was acceptable with the orbiter Primary Reaction Control System, the flexible body response showed large structural deflections and loads. It was found that severe control/structure interaction occurred if the stiffness of the Assembly Work Platform was equal to that of the station truss. Also, the response of the orbiter Vernier Reaction Control System to small changes in inertia properties is examined.

Optimal strategy analysis based on robust predictive control for inventory system with random demand

NASA Astrophysics Data System (ADS)

Saputra, Aditya; Widowati, Sutrisno

2017-12-01

In this paper, the optimal strategy for a single product single supplier inventory system with random demand is analyzed by using robust predictive control with additive random parameter. We formulate the dynamical system of this system as a linear state space with additive random parameter. To determine and analyze the optimal strategy for the given inventory system, we use robust predictive control approach which gives the optimal strategy i.e. the optimal product volume that should be purchased from the supplier for each time period so that the expected cost is minimal. A numerical simulation is performed with some generated random inventory data. We simulate in MATLAB software where the inventory level must be controlled as close as possible to a set point decided by us. From the results, robust predictive control model provides the optimal strategy i.e. the optimal product volume that should be purchased and the inventory level was followed the given set point.

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

PubMed

Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

2017-04-01

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial.

PubMed

Lazarov, Amit; Pine, Daniel S; Bar-Haim, Yair

2017-07-01

Patients with social anxiety disorder exhibit increased attentional dwelling on social threats, providing a viable target for therapeutics. This randomized controlled trial examined the efficacy of a novel gaze-contingent music reward therapy for social anxiety disorder designed to reduce attention dwelling on threats. Forty patients with social anxiety disorder were randomly assigned to eight sessions of either gaze-contingent music reward therapy, designed to divert patients' gaze toward neutral stimuli rather than threat stimuli, or to a control condition. Clinician and self-report measures of social anxiety were acquired pretreatment, posttreatment, and at 3-month follow-up. Dwell time on socially threatening faces was assessed during the training sessions and at pre- and posttreatment. Gaze-contingent music reward therapy yielded greater reductions of symptoms of social anxiety disorder than the control condition on both clinician-rated and self-reported measures. Therapeutic effects were maintained at follow-up. Gaze-contingent music reward therapy, but not the control condition, also reduced dwell time on threat, which partially mediated clinical effects. Finally, gaze-contingent music reward therapy, but not the control condition, also altered dwell time on socially threatening faces not used in training, reflecting near-transfer training generalization. This is the first randomized controlled trial to examine a gaze-contingent intervention in social anxiety disorder. The results demonstrate target engagement and clinical effects. This study sets the stage for larger randomized controlled trials and testing in other emotional disorders.

EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

PubMed Central

2012-01-01

Background Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The primary objective of this randomized-controlled trial (RCT) is to study the effect of an exercise program (in- and outpatient) on immune cell recovery in patients undergoing an autologous stem cell transplantation. The secondary objective is to determine if an exercise intervention diminishes the usual deterioration in quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods This RCT has received approval from The Conjoint Health Research Ethics Board (CHREB) of the University of Calgary (Ethics ID # E-24476). Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children’s Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in- and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in

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

USDA-ARS?s Scientific Manuscript database

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

The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial.

PubMed

Gentile, Pietro; Garcovich, Simone; Bielli, Alessandra; Scioli, Maria Giovanna; Orlandi, Augusto; Cervelli, Valerio

2015-11-01

Platelet-rich plasma (PRP) has emerged as a new treatment modality in regenerative plastic surgery, and preliminary evidence suggests that it might have a beneficial role in hair regrowth. Here, we report the results of a randomized, evaluator-blinded, placebo-controlled, half-head group study to compare, with the aid of computerized trichograms, hair regrowth with PRP versus placebo. The safety and clinical efficacy of autologous PRP injections for pattern hair loss were investigated. PRP, prepared from a small volume of blood, was injected on half of the selected patients' scalps with pattern hair loss. The other half was treated with placebo. Three treatments were administered to each patient at 30-day intervals. The endpoints were hair regrowth, hair dystrophy as measured by dermoscopy, burning or itching sensation, and cell proliferation as measured by Ki67 evaluation. Patients were followed for 2 years. Of the 23 patients enrolled, 3 were excluded. At the end of the 3 treatment cycles, the patients presented clinical improvement in the mean number of hairs, with a mean increase of 33.6 hairs in the target area, and a mean increase in total hair density of 45.9 hairs per cm² compared with baseline values. No side effects were noted during treatment. Microscopic evaluation showed the increase of epidermis thickness and of the number of hair follicles 2 weeks after the last PRP treatment compared with baseline value (p < .05). We also observed an increase of Ki67(+) keratinocytes in the epidermis and of hair follicular bulge cells, and a slight increase of small blood vessels around hair follicles in the treated skin compared with baseline (p < .05). Relapse of androgenic alopecia was not evaluated in all patients until 12 months after the last treatment. After 12 months, 4 patients reported progressive hair loss; this was more evident 16 months after the last treatment. Those four patients were re-treated. Our data clearly highlight the positive effects of PRP

Association Splitting: A randomized controlled trial of a new method to reduce craving among inpatients with alcohol dependence.

PubMed

Schneider, Brooke C; Moritz, Steffen; Hottenrott, Birgit; Reimer, Jens; Andreou, Christina; Jelinek, Lena

2016-04-30

Association Splitting, a novel cognitive intervention, was tested in patients with alcohol dependence as an add-on intervention in an initial randomized controlled trial. Preliminary support for Association Splitting has been found in patients with obsessive-compulsive disorder, as well as in an online pilot study of patients with alcohol use disorders. The present variant sought to reduce craving by strengthening neutral associations with alcohol-related stimuli, thus, altering cognitive networks. Eighty-four inpatients with verified diagnoses of alcohol dependence, who were currently undergoing inpatient treatment, were randomly assigned to Association Splitting or Exercise Therapy. Craving was measured at baseline, 4-week follow-up, and six months later with the Obsessive-Compulsive Drinking Scale (primary outcome) and the Alcohol Craving Questionnaire. There was no advantage for Association Splitting after three treatment sessions relative to Exercise Therapy. Among Association Splitting participants, 51.9% endorsed a subjective decline in craving and 88.9% indicated that they would use Association Splitting in the future. Despite high acceptance, an additional benefit of Association Splitting beyond standard inpatient treatment was not found. Given that participants were concurrently undergoing inpatient treatment and Association Splitting has previously shown moderate effects, modification of the study design may improve the potential to detect significant effects in future trials. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

Memantine as an Adjuvant Treatment for Obsessive Compulsive Symptoms in Manic Phase of Bipolar Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

PubMed

Sahraian, Ali; Jahromi, Leila Razeghian; Ghanizadeh, Ahmad; Mowla, Arash

2017-04-01

The aim of this study is to examine the effects of memantine as an adjuvant treatment for obsessive compulsive (OC) symptoms in patients with bipolar disorder (BD) type I, manic phase. In this 16-week double-blind placebo-controlled randomized clinical trial, 58 patients in the manic phase of BD who had OC symptoms were randomly allocated to receive memantine or placebo plus their routine medications (lithium + olanzapine + clonazepam). The Yale Brown Obsessive Compulsive Behavior Scale was used to assess the outcomes. Adverse effects were also recorded. Thirty-eight patients (19 in the memantine group and 19 in the placebo group) completed the trial. Throughout the trial, the mean score decreased from 20.26 ± 5.91 to 9.73 ± 5.44 in the memantine group (P < 0.000) and from 22.89 ± 5.70 to 16.63 ± 4.00 in the placebo group (P < 0.000). At the end of the study, 15 (78.94%) patients in the memantine group and 7 (36.84%) patients in the placebo group demonstrated more than 34% decline in the Yale Brown Obsessive Compulsive Behavior Scale score (P < 0.01). No serious adverse effects were reported. Our double-blind controlled clinical trial showed that memantine is an effective adjuvant agent for reducing OC symptoms in patients with BD. However, it needs to be noted that our study is preliminary, and larger double-blind controlled studies are needed to confirm the results.

Emotional Freedom Techniques in the Treatment of Unhealthy Eating Behaviors and Related Psychological Constructs in Adolescents: A Randomized Controlled Pilot Trial.

PubMed

Stapleton, Peta; Chatwin, Hannah; William, Mary; Hutton, Amanda; Pain, Amanda; Porter, Brett; Sheldon, Terri

2016-01-01

In Australia and throughout much of the world, rates of obesity continue to climb as do the prevalence of eating disorders, particularly in adolescents. Psychological consequences of childhood obesity include low self-esteem, depression, body dissatisfaction, and social maladjustment (Young-Hyman et al., 2012). This feasibility study sought to examine the impact of a six-week Emotional Freedom Techniques (EFT) group treatment program upon eating behaviours, self-esteem, compassion, and psychological symptoms. Forty-four students were randomly allocated to either the EFT group or the waitlist control group. Results revealed a delayed effect for both groups at post-intervention, with improved eating habits, self-esteem, and compassion at follow-up. Findings provide preliminary support for EFT as an effective treatment strategy for increasing healthy eating behaviours and improving associated weight-related psychopathology. Copyright © 2016 Elsevier Inc. All rights reserved.

Pediatric selective mutism therapy: a randomized controlled trial.

PubMed

Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

2017-10-01

Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (P<0.001), Withdrawn (P=0.007) and Internalizing problems (P=0.020). Regarding SM severity according to SMQ assessment, children of group A showed a reduction of SM symptoms in all situations (school, P=0.003; family, P=0.018; and social, P=0.030 situations) and in SMQ total score (P<0.001). Our preliminary results suggest the positive effect of the psychomotor treatment in rehabilitative program for children affected by selective mutism, even if further studies are needed. The present study

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

ERIC Educational Resources Information Center

Bell, Chloe E.; Robbins, Steven J.

2007-01-01

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

Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

PubMed Central

Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

2015-01-01

Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

Concentrating solar collector subsystem: Preliminary design package

NASA Technical Reports Server (NTRS)

1977-01-01

Preliminary design data are presented for a concentrating solar collector including an attitude controller. Provided are schedules, technical status, all documents required for preliminary design, and other program activities.

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

PubMed

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up (p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up (p < 0.05). Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

'On Your Feet to Earn Your Seat', a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial.

PubMed

Gardner, Benjamin; Thuné-Boyle, Ingela; Iliffe, Steve; Fox, Kenneth R; Jefferis, Barbara J; Hamer, Mark; Tyler, Nick; Wardle, Jane

2014-09-20

Many older adults are both highly sedentary (that is, spend considerable amounts of time sitting) and physically inactive (that is, do little physical activity). This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ('tips') designed both to reduce sedentary behaviour and to increase physical activity in older adults. The intervention is based on the 'habit formation' model, which proposes that consistent repetition leads to behaviour becoming automatic, sustaining activity gains over time. The intervention is being developed iteratively, in line with Medical Research Council complex intervention guidelines. Selection of activity tips was informed by semi-structured interviews and focus groups with older adults, and input from a multidisciplinary expert panel. An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement. An exploratory randomized controlled trial will be conducted within a primary care setting, comparing the tips booklet with a control fact sheet. Retired, inactive and sedentary adults (n = 120) aged 60 to 74 years, with no physical impairments precluding light physical activity, will be recruited from general practices in north London, UK. The primary outcomes are recruitment and attrition rates. Secondary outcomes are changes in behaviour, habit, health and wellbeing over 12 weeks. Data will be used to inform study procedures for a future, larger-scale definitive randomized controlled trial. Current Controlled Trials ISRCTN47901994.

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

PubMed

Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

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.

A preliminary, controlled investigation of magnesium L-aspartate hydrochloride for illicit cocaine and opiate use in methadone-maintained patients.

PubMed

Margolin, Arthur; Kantak, Kathleen; Copenhaver, Michael; Avants, S Kelly

2003-01-01

Based on pre-clinical studies suggesting that magnesium (Mg) reduces cocaine self-administration and potentiates the antinociceptive effects of morphine, we conducted a preliminary randomized clinical trial investigating Mg for the treatment of illicit cocaine and opiate use. Eighteen methadone-maintained patients who used illicit opiates and cocaine received either Mg (732 mg/day) or placebo for 12 weeks. Overall, findings showed that the percentage of urine screens testing positive for opiates in the Mg group (22.6%) was half that of the placebo group (46.4%), p = .04; the difference was even greater in the "medication compliant" sample (Mg: 16.3%, placebo: 47.9%), p = .02. Cocaine craving was lower in the Mg compared to the placebo group, but there was no difference between groups in cocaine use. These preliminary findings suggest that Mg may have a beneficial effect for reducing illicit opiate use. It is possible that a higher dose of Mg than was used in this study may be needed to decrease cocaine use.

Greenridge Multi-Pollutant Control Project Preliminary Public Design Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.« less

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Self-compassion training for binge eating disorder: a pilot randomized controlled trial.

PubMed

Kelly, Allison C; Carter, Jacqueline C

2015-09-01

The present pilot study sought to compare a compassion-focused therapy (CFT)-based self-help intervention for binge eating disorder (BED) to a behaviourally based intervention. Forty-one individuals with BED were randomly assigned to 3 weeks of food planning plus self-compassion exercises; food planning plus behavioural strategies; or a wait-list control condition. Participants completed weekly measures of binge eating and self-compassion; pre- and post-intervention measures of eating disorder pathology and depressive symptoms; and a baseline measure assessing fear of self-compassion. Results showed that: (1) perceived credibility, expectancy, and compliance did not differ between the two interventions; (2) both interventions reduced weekly binge days more than the control condition; (3) the self-compassion intervention reduced global eating disorder pathology, eating concerns, and weight concerns more than the other conditions; (4) the self-compassion intervention increased self-compassion more than the other conditions; and (5) participants low in fear of self-compassion derived significantly more benefits from the self-compassion intervention than those high in fear of self-compassion. Findings offer preliminary support for the usefulness of CFT-based interventions for BED sufferers. Results also suggest that for individuals to benefit from self-compassion training, assessing and lowering fear of self-compassion will be crucial. Individuals with BED perceive self-compassion training self-help interventions, derived from CFT, to be as credible and as likely to help as behaviourally based interventions. The cultivation of self-compassion may be an effective approach for reducing binge eating, and eating, and weight concerns in individuals with BED. Teaching individuals with BED CFT-based self-help exercises may increase their self-compassion levels over a short period of time. It may be important for clinicians to assess and target clients' fear of self

A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

PubMed

Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

2016-01-01

Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Irisin and exercise training in humans - results from a randomized controlled training trial.

PubMed

Hecksteden, Anne; Wegmann, Melissa; Steffen, Anke; Kraushaar, Jochen; Morsch, Arne; Ruppenthal, Sandra; Kaestner, Lars; Meyer, Tim

2013-11-05

The recent discovery of a new myokine (irisin) potentially involved in health-related training effects has gained great attention, but evidence for a training-induced increase in irisin remains preliminary. Therefore, the present study aimed to determine whether irisin concentration is increased after regular exercise training in humans. In a randomized controlled design, two guideline conforming training interventions were studied. Inclusion criteria were age 30 to 60 years, <1 hour/week regular activity, non-smoker, and absence of major diseases. 102 participants could be included in the analysis. Subjects in the training groups exercised 3 times per week for 26 weeks. The minimum compliance was defined at 70%. Aerobic endurance training (AET) consisted of 45 minutes of walking/running at 60% heart rate reserve. Strength endurance training (SET) consisted of 8 machine-based exercises (2 sets of 15 repetitions with 100% of the 20 repetition maximum). Serum irisin concentrations in frozen serum samples were determined in a single blinded measurement immediately after the end of the training study. Physical performance provided positive control for the overall efficacy of training. Differences between groups were tested for significance using analysis of variance. For post hoc comparisons with the control group, Dunnett's test was used. Maximum performance increased significantly in the training groups compared with controls (controls: ±0.0 ± 0.7 km/h; AET: 1.1 ± 0.6 km/h, P < 0.01; SET: +0.5 ± 0.7 km/h, P = 0.01). Changes in irisin did not differ between groups (controls: 101 ± 81 ng/ml; AET: 44 ± 93 ng/ml; SET: 60 ± 92 ng/ml; in both cases: P = 0.99 (one-tailed testing), 1-β error probability = 0.7). The general upward trend was mainly accounted for by a negative association of irisin concentration with the storage duration of frozen serum samples (P < 0.01, β = -0.33). After arithmetically eliminating this confounder, the differences between groups

Role of the α1 blocker doxazosin in alcoholism: a proof-of-concept randomized controlled trial.

PubMed

Kenna, George A; Haass-Koffler, Carolina L; Zywiak, William H; Edwards, Steven M; Brickley, Michael B; Swift, Robert M; Leggio, Lorenzo

2016-07-01

Evidence suggests that the norepinephrine system represents an important treatment target for alcohol dependence (AD) and the α1 -blocker prazosin may reduce alcohol drinking in rodents and alcoholic patients. The α1 -blocker doxazosin demonstrates a more favorable pharmacokinetic profile than prazosin, but has never been studied for AD. A double-blind placebo-controlled randomized clinical trial was conducted in AD individuals seeking outpatient treatment. Doxazosin or matched placebo was titrated to 16 mg/day (or maximum tolerable dose). Drinks per week (DPW) and heavy drinking days (HDD) per week were the primary outcomes. Family history density of alcoholism (FHDA), severity of AD and gender were a priori moderators. Forty-one AD individuals were randomized, 30 (doxazosin = 15) completed the treatment phase and 28 (doxazosin = 14) also completed the follow-up. There were no significant differences between groups on DPW and HDD per week. With FHDA as a moderator, there were significant FHDA × medication interactions for both DPW (pcorrected  = 0.001, d = 1.18) and HDD (pcorrected  = 0.00009, d = 1.30). Post hoc analyses revealed that doxazosin significantly reduced alcohol drinking in AD patients with high FHDA and by contrast increased drinking in those with low FHDA. Doxazosin may be effective selectively in AD patients with high FHDA. This study provides preliminary evidence for personalized medicine using α1 -blockade to treat AD. However, confirmatory studies are required. © 2015 Society for the Study of Addiction.

Mindfulness-based stress reduction for overweight/obese women with and without polycystic ovary syndrome: design and methods of a pilot randomized controlled trial.

PubMed

Raja-Khan, Nazia; Agito, Katrina; Shah, Julie; Stetter, Christy M; Gustafson, Theresa S; Socolow, Holly; Kunselman, Allen R; Reibel, Diane K; Legro, Richard S

2015-03-01

Mindfulness-based stress reduction (MBSR) may be beneficial for overweight/obese women, including women with polycystic ovary syndrome (PCOS), as it has been shown to reduce psychological distress and improve quality of life in other patient populations. Preliminary studies suggest that MBSR may also have salutary effects on blood pressure and blood glucose. This paper describes the design and methods of an ongoing pilot randomized controlled trial evaluating the feasibility and effects of MBSR in PCOS and non-PCOS women who are overweight or obese (NCT01464398). Eighty six (86) women with body mass index ≥ 25 kg/m(2), including 31 women with PCOS, have been randomized to 8 weeks of MBSR or health education control, and followed for 16 weeks. The primary outcome is mindfulness assessed with the Toronto Mindfulness Scale. Secondary outcomes include measures of blood pressure, blood glucose, quality of life, anxiety and depression. Our overall hypothesis is that MBSR will increase mindfulness and ultimately lead to favorable changes in blood pressure, blood glucose, psychological distress and quality of life in PCOS and non-PCOS women. This would support the integration of MBSR with conventional medical treatments to reduce psychological distress, cardiovascular disease and diabetes in PCOS and non-PCOS women who are overweight or obese. Copyright © 2015 Elsevier Inc. All rights reserved.

Randomness in Competitions

NASA Astrophysics Data System (ADS)

Ben-Naim, E.; Hengartner, N. W.; Redner, S.; Vazquez, F.

2013-05-01

We study the effects of randomness on competitions based on an elementary random process in which there is a finite probability that a weaker team upsets a stronger team. We apply this model to sports leagues and sports tournaments, and compare the theoretical results with empirical data. Our model shows that single-elimination tournaments are efficient but unfair: the number of games is proportional to the number of teams N, but the probability that the weakest team wins decays only algebraically with N. In contrast, leagues, where every team plays every other team, are fair but inefficient: the top √{N} of teams remain in contention for the championship, while the probability that the weakest team becomes champion is exponentially small. We also propose a gradual elimination schedule that consists of a preliminary round and a championship round. Initially, teams play a small number of preliminary games, and subsequently, a few teams qualify for the championship round. This algorithm is fair and efficient: the best team wins with a high probability and the number of games scales as N 9/5, whereas traditional leagues require N 3 games to fairly determine a champion.

A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

PubMed

Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

2017-01-01

Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

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

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

ERIC Educational Resources Information Center

Iriyama, Yae; Murayama, Nobuko

2014-01-01

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

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.

Positive psychology interventions for patients with heart disease: a preliminary randomized trial

PubMed Central

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

Objective Positive psychological 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. Method Participants were randomly assigned to receive one of three different six-week face-to-face interventions or a wait-list control condition. We assessed intervention feasibility and compared changes in psychological outcome measures post-intervention (7 weeks) and at follow-up (15 weeks) between intervention and control participants. Across the interventions, 74% of assigned sessions were completed. Results 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% confidence interval [CI]=8.66–20.2, p<.001), depression (β=−3.87, 95% CI=−7.72 to 0.02, p=.049), and hope (β=7.12, 95% CI=1.25–13.00, p=.017), with moderate-large effect sizes. Efficacy of the three interventions was similar. Conclusions Future studies are needed to identify an optimal positive psychology intervention for cardiac patients. PMID:27137709

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

PubMed

Benyamin, Ramsin M; Staats, Peter S

2015-01-01

Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

Randomized Controlled Ethanol Cookstove Intervention and Blood Pressure in Pregnant Nigerian Women.

PubMed

Alexander, Donee; Northcross, Amanda; Wilson, Nathaniel; Dutta, Anindita; Pandya, Rishi; Ibigbami, Tope; Adu, Damilola; Olamijulo, John; Morhason-Bello, Oludare; Karrison, Theodore; Ojengbede, Oladosu; Olopade, Christopher O

2017-06-15

Hypertension during pregnancy is a leading cause of maternal mortality. Exposure to household air pollution elevates blood pressure (BP). To investigate the ability of a clean cookstove intervention to lower BP during pregnancy. We conducted a randomized controlled trial in Nigeria. Pregnant women cooking with kerosene or firewood were randomly assigned to an ethanol arm (n = 162) or a control arm (n = 162). BP measurements were taken during six antenatal visits. In the primary analysis, we compared ethanol users with control subjects. In subgroup analyses, we compared baseline kerosene users assigned to the intervention with kerosene control subjects and compared baseline firewood users assigned to ethanol with firewood control subjects. The change in diastolic blood pressure (DBP) over time was significantly different between ethanol users and control subjects (P = 0.040); systolic blood pressure (SBP) did not differ (P = 0.86). In subgroup analyses, there was no significant intervention effect for SBP; a significant difference for DBP (P = 0.031) existed among preintervention kerosene users. At the last visit, mean DBP was 2.8 mm Hg higher in control subjects than in ethanol users (3.6 mm Hg greater in control subjects than in ethanol users among preintervention kerosene users), and 6.4% of control subjects were hypertensive (SBP ≥140 and/or DBP ≥90 mm Hg) versus 1.9% of ethanol users (P = 0.051). Among preintervention kerosene users, 8.8% of control subjects were hypertensive compared with 1.8% of ethanol users (P = 0.029). To our knowledge, this is the first cookstove randomized controlled trial examining prenatal BP. Ethanol cookstoves have potential to reduce DBP and hypertension during pregnancy. Accordingly, clean cooking fuels may reduce adverse health impacts associated with household air pollution. Clinical trial registered with www.clinicaltrials.gov (NCT02394574).

Physical activity measurements affected participants' behavior in a randomized controlled trial.

PubMed

van Sluijs, Esther M F; van Poppel, Mireille N M; Twisk, Jos W R; van Mechelen, Willem

2006-04-01

Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

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

PubMed

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

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention.

PubMed

Fox, Caroline S; Gurary, Ellen B; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

2016-04-27

A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30-day page views. Whether insufficient social media intensity contributed to these results is uncertain. Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journal's accounts. To increase social media intensity, a larger base of followers was built using advertising and organic growth, and posts were presented in triplicate and boosted on Facebook and retweeted on Twitter. The primary outcome was 30-day page views. Stopping rules were established at the point that 50% of the manuscripts were randomized and had 30-day follow-up to compare groups on 30-day page views. The trial was stopped for futility on September 26, 2015. Overall, 74 manuscripts were randomized to receive social media exposure, and 78 manuscripts were randomized to the control arm. The intervention and control arms were similar based on article type (P=0.85), geographic location of the corresponding author (P=0.33), and whether the manuscript had an editorial (P=0.80). Median number of 30-day page views was 499.5 in the social media arm and 450.5 in the control arm; there was no evidence of a treatment effect (P=0.38). There were no statistically significant interactions of treatment by manuscript type (P=0.86), by corresponding author (P=0.35), by trimester of publication date (P=0.34), or by editorial status (P=0.79). A more intensive social media strategy did not result in increased 30-day page views of original research. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Moxibustion for breech version: a randomized controlled trial.

PubMed

Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

2009-11-01

To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

A new compound control method for sine-on-random mixed vibration test

NASA Astrophysics Data System (ADS)

Zhang, Buyun; Wang, Ruochen; Zeng, Falin

2017-09-01

Vibration environmental test (VET) is one of the important and effective methods to provide supports for the strength design, reliability and durability test of mechanical products. A new separation control strategy was proposed to apply in multiple-input multiple-output (MIMO) sine on random (SOR) mixed mode vibration test, which is the advanced and intensive test type of VET. As the key problem of the strategy, correlation integral method was applied to separate the mixed signals which included random and sinusoidal components. The feedback control formula of MIMO linear random vibration system was systematically deduced in frequency domain, and Jacobi control algorithm was proposed in view of the elements, such as self-spectrum, coherence, and phase of power spectral density (PSD) matrix. Based on the excessive correction of excitation in sine vibration test, compression factor was introduced to reduce the excitation correction, avoiding the destruction to vibration table or other devices. The two methods were synthesized to be applied in MIMO SOR vibration test system. In the final, verification test system with the vibration of a cantilever beam as the control object was established to verify the reliability and effectiveness of the methods proposed in the paper. The test results show that the exceeding values can be controlled in the tolerance range of references accurately, and the method can supply theory and application supports for mechanical engineering.

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Randomized controlled trials in mild cognitive impairment

PubMed Central

Thomas, Ronald G.; Aisen, Paul S.; Mohs, Richard C.; Carrillo, Maria C.; Albert, Marilyn S.

2017-01-01

Objective: To examine the variability in performance among placebo groups in randomized controlled trials for mild cognitive impairment (MCI). Methods: Placebo group data were obtained from 2 National Institute on Aging (NIA) MCI randomized controlled trials, the Alzheimer's Disease Cooperative Study (ADCS) MCI trial and the Alzheimer's Disease Neuroimaging Initiative (ADNI), which is a simulated clinical trial, in addition to industry-sponsored clinical trials involving rivastigmine, galantamine, rofecoxib, and donepezil. The data were collated for common measurement instruments. The performance of the placebo participants from these studies was tracked on the Alzheimer's Disease Assessment Scale–cognitive subscale, Mini-Mental State Examination, and Clinical Dementia Rating–sum of boxes, and for progression on these measures to prespecified clinical study endpoints. APOE status, where available, was also analyzed for its effects. Results: The progression to clinical endpoints varied a great deal among the trials. The expected performances were seen for the participants in the 2 NIA trials, ADCS and ADNI, with generally worsening of performance over time; however, the industry-sponsored trials largely showed stable or improved performance in their placebo participants. APOE4 carrier status influenced results in an expected fashion on the study outcomes, including rates of progression and cognitive subscales. Conclusions: In spite of apparently similar criteria for MCI being adopted by the 7 studies, the implementation of the criteria varied a great deal. Several explanations including instruments used to characterize participants and variability among study populations contributed to the findings. PMID:28381516

Preliminary Findings on Rural Homelessness in Ohio.

ERIC Educational Resources Information Center

First, Richard J.; And Others

This report is designed to present preliminary findings from the first comprehensive study of rural homelessness in the United States. The study was conducted during the first 6 months of 1990, and data were collected from interviews with 921 homeless adults in 21 randomly selected rural counties in Ohio. The sample counties represent 26% of the…

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective

Comparison of handheld computer-assisted and conventional paper chart documentation of medical records. A randomized, controlled trial.

PubMed

Stengel, Dirk; Bauwens, Kai; Walter, Martin; Köpfer, Thilo; Ekkernkamp, Axel

2004-03-01

. Various learning curve effects were observed with different operators. Study physicians assigned slightly better practicability ratings to the handheld device. The preliminary data from this study suggest that handheld computers may improve the quality of hospital charts in orthopaedic surgery. Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Randomized Controlled Pilot Trial of Mindfulness Training for Stress Reduction during Pregnancy

PubMed Central

Guardino, Christine M.; Dunkel Schetter, Christine; Bower, Julienne E.; Lu, Michael C.; Smalley, Susan L.

2014-01-01

This randomized controlled pilot trial tested a 6-week mindfulness-based intervention in a sample of pregnant women experiencing high levels of perceived stress and pregnancy anxiety. Forty-seven women enrolled between 10 and 25 weeks gestation were randomly assigned to either a series of weekly Mindful Awareness Practices (MAPS) classes (n = 24) with home practice or to a reading control condition (n = 23). Hierarchical linear models of between-group differences in change over time demonstrated that participants in the mindfulness intervention experienced larger decreases from pre-to post-intervention in pregnancy-specific anxiety and pregnancy-related anxiety than participants in the reading control condition. However, these effects were not sustained through follow-up at six weeks post-intervention. Participants in both groups experienced increased mindfulness, as well as decreased perceived stress and state anxiety over the course of the intervention and follow-up periods. This study is one of the first randomized controlled pilot trials of a mindfulness meditation intervention during pregnancy and provides some evidence that mindfulness training during pregnancy may effectively reduce pregnancy-related anxiety and worry. We discuss some of the dilemmas in pursuing this translational strategy and offer suggestions for researchers interested in conducting mind-body interventions during pregnancy. PMID:24180264

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study.

PubMed

Hancock, Laura M; Bruce, Jared M; Bruce, Amanda S; Lynch, Sharon G

2015-01-01

Between 40-65% of multiple sclerosis patients experience cognitive deficits, with processing speed and working memory most commonly affected. This pilot study investigated the effect of computerized cognitive training focused on improving processing speed and working memory. Participants were randomized into either an active or a sham training group and engaged in six weeks of training. The active training group improved on a measure of processing speed and attention following cognitive training, and data trended toward significance on measures of other domains. Results provide preliminary evidence that cognitive training with multiple sclerosis patients may produce moderate improvement in select areas of cognitive functioning.

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

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.

Placebo-Controlled Trial of Familiar Auditory Sensory Training for Acute Severe Traumatic Brain Injury: A Preliminary Report.

PubMed

Pape, Theresa Louise-Bender; Rosenow, Joshua M; Steiner, Monica; Parrish, Todd; Guernon, Ann; Harton, Brett; Patil, Vijaya; Bhaumik, Dulal K; McNamee, Shane; Walker, Matthew; Froehlich, Kathleen; Burress, Catherine; Odle, Cheryl; Wang, Xue; Herrold, Amy A; Zhao, Weihan; Reda, Domenic; Mallinson, Trudy; Conneely, Mark; Nemeth, Alexander J

2015-07-01

Sensory stimulation is often provided to persons incurring severe traumatic brain injury (TBI), but therapeutic effects are unclear. This preliminary study investigated neurobehavioral and neurophysiological effects related to sensory stimulation on global neurobehavioral functioning, arousal, and awareness. A double-blind randomized placebo-controlled trial where 15 participants in states of disordered consciousness (DOC), an average of 70 days after TBI, were provided either the Familiar Auditory Sensory Training (FAST) or Placebo of silence. Global neurobehavioral functioning was measured with the Disorders of Consciousness Scale (DOCS). Arousal and awareness were measured with the Coma-Near-Coma (CNC) scale. Neurophysiological effect was measured using functional magnetic resonance imaging (fMRI). FAST (n = 8) and Placebo (n = 7) groups each showed neurobehavioral improvement. Mean DOCS change (FAST = 13.5, SD = 8.2; Placebo = 18.9, SD = 15.6) was not different, but FAST patients had significantly (P = .049; 95% confidence interval [CI] = -1.51, -.005) more CNC gains (FAST = 1.01, SD = 0.60; Placebo = 0.25, SD = 0.70). Mixed-effects models confirm CNC findings (P = .002). Treatment effect, based on CNC, is large (d = 1.88, 95% CI = 0.77, 3.00). Number needed to treat is 2. FAST patients had more fMRI activation in language regions and whole brain (P values <.05) resembling healthy controls' activation. For persons with DOC 29 to 170 days after TBI, FAST resulted in CNC gains and increased neural responsivity to vocal stimuli in language regions. Clinicians should consider providing the FAST to support patient engagement in neurorehabilitation. © The Author(s) 2015.

The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results.

PubMed

Oberbaum, Menachem; Galoyan, Narine; Lerner-Geva, Liat; Singer, Shepherd Roee; Grisaru, Sorina; Shashar, David; Samueloff, Arnon

2005-06-01

To evaluate the effect of Arnica Montana and Bellis perennis on postpartum blood loss. Double blind, placebo-controlled, randomized, clinical trial. Department of Gynecology, Shaare Zedek Medical Center, Jerusalem. Forty parturients were randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=14), Arnica montana C30 and Bellis perennis C30 (n=14), or double placebo (n=12). After 48 h the Arnica/placebo was halted, and patients continued the Bellis/placebo until cessation of lochia. Hemoglobin levels (Hb) at 48 and 72 h postpartum. At 72 h postpartum, mean Hb levels remained similar after treatment with homeopathic remedies (12.7 versus 12.4) as compared to a significant decrease in Hb levels in the placebo group (12.7 versus 11.6; p<0.05), in spite of less favorable initial characteristics of the treatment group. The mean difference in Hb levels at 72 h postpartum was -0.29 (95% CI -1.09; 0.52) in the treatment group and -1.18 (95% CI -1.82; -0.54) in the placebo group (p<0.05). Treatment with homeopathic Arnica montana and Bellis perennis may reduce postpartum blood loss, as compared with placebo.

Educational interventions to improve screening mammography interpretation: a randomized, controlled trial

PubMed Central

BM, Geller; A, Bogart; PA, Carney; EA, Sickles; RA, Smith; B, Monsees; LW, Bassett; DM, Buist; K, Kerlikowske; T, Onega; B, Yankaskas; S, Haneuse; DA, Hill; M, Wallis; DL, Miglioretti

2014-01-01

Purpose Conduct a randomized controlled trial of educational interventions to improve performance of screening mammography interpretation. Materials and Methods We randomly assigned physicians who interpret mammography to one of three groups: (1) self-paced DVD; (2) live, expert-led educational session; or (3) control. The DVD and live interventions used mammography cases of varying difficulty and associated teaching points. Interpretive performance was compared using a pre-/post-test design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall, and each were compared using logistic regression adjusting for pre-test performance. Results 102 radiologists completed all aspects of the trial. After adjustment for pre-intervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than controls (95% confidence interval [CI]: 1.00, 1.81; P=0.050). The odds of improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR]=1.94, 95% CI: 1.24, 3.05; P=0.004) and cancer status (OR=1.81, 95% CI: 1.01, 3.23; P=0.045) were significantly improved for DVD participants compared to controls with no significant change in specificity. For the live-intervention group, specificity was significantly lower than the control group (OR relative to expert recall=0.80; 95% CI: 0.64, 1.00; P=0.048; OR relative to cancer=0.79; 95% CI: 0.65, 0.95; P=0.015). Conclusion In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in mammography interpretive screening performance on a test-set, which could translate into improved clinical interpretative performance. PMID:24848854

Educational interventions to improve screening mammography interpretation: a randomized controlled trial.

PubMed

Geller, Berta M; Bogart, Andy; Carney, Patricia A; Sickles, Edward A; Smith, Robert; Monsees, Barbara; Bassett, Lawrence W; Buist, Diana M; Kerlikowske, Karla; Onega, Tracy; Yankaskas, Bonnie C; Haneuse, Sebastien; Hill, Deirdre; Wallis, Matthew G; Miglioretti, Diana

2014-06-01

The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation. We randomly assigned physicians who interpret mammography to one of three groups: self-paced DVD, live expert-led educational seminar, or control. The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points. Interpretive performance was compared using a pretest-posttest design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall. The performance measures for each group were compared using logistic regression adjusting for pretest performance. One hundred two radiologists completed all aspects of the trial. After adjustment for preintervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects (95% CI, 1.00-1.81; p = 0.050). The odds of an improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR] = 1.94; 95% CI, 1.24-3.05; p = 0.004) and cancer status (OR = 1.81; 95% CI, 1.01-3.23; p = 0.045) were significantly improved for DVD participants compared with control subjects, with no significant change in specificity. For the seminar group, specificity was significantly lower than the control group (OR relative to expert recall = 0.80; 95% CI, 0.64-1.00; p = 0.048; OR relative to cancer status = 0.79; 95% CI, 0.65-0.95; p = 0.015). In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set, which could translate into improved interpretative performance in clinical practice.

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

PubMed

Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

2013-01-01

Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P < 0.001). Follow-up also found a significant reduction in pain intensity in the electroacupuncture group compared with the control group (P < 0.001). Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

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

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…

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.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

2016-02-01

Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

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

ERIC Educational Resources Information Center

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

2017-01-01

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

A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly.

PubMed

Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

2015-01-01

There is growing evidence that cognitive training (CT) can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG)-based brain-computer interface (BCI) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list control (n=18) arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which was translated and culturally adapted for the Chinese-speaking local population. Users were asked about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

A randomized controlled trial of the different impression methods for the complete denture fabrication: Patient reported outcomes.

PubMed

Jo, Ayami; Kanazawa, Manabu; Sato, Yusuke; Iwaki, Maiko; Akiba, Norihisa; Minakuchi, Shunsuke

2015-08-01

To compare the effect of conventional complete dentures (CD) fabricated using two different impression methods on patient-reported outcomes in a randomized controlled trial (RCT). A cross-over RCT was performed with edentulous patients, required maxillomandibular CDs. Mandibular CDs were fabricated using two different methods. The conventional method used a custom tray border moulded with impression compound and a silicone. The simplified used a stock tray and an alginate. Participants were randomly divided into two groups. The C-S group had the conventional method used first, followed by the simplified. The S-C group was in the reverse order. Adjustment was performed four times. A wash out period was set for 1 month. The primary outcome was general patient satisfaction, measured using visual analogue scales, and the secondary outcome was oral health-related quality of life, measured using the Japanese version of the Oral Health Impact Profile for edentulous (OHIP-EDENT-J) questionnaire scores. Twenty-four participants completed the trial. With regard to general patient satisfaction, the conventional method was significantly more acceptable than the simplified. No significant differences were observed between the two methods in the OHIP-EDENT-J scores. This study showed CDs fabricated with a conventional method were significantly more highly rated for general patient satisfaction than a simplified. CDs, fabricated with the conventional method that included a preliminary impression made using alginate in a stock tray and subsequently a final impression made using silicone in a border moulded custom tray resulted in higher general patient satisfaction. UMIN000009875. Copyright © 2015 Elsevier Ltd. All rights reserved.

Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy

PubMed Central

Bricker, Jonathan B.; Mull, Kristin; Kientz, Julie A.; Vilardaga, Roger M.; Mercer, Laina D.; Akioka, Katrina; Heffner, Jaimee L.

2014-01-01

Background There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered Acceptance and Commitment Therapy (ACT) application for smoking cessation versus an application following US Clinical Practice Guidelines. Method Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (N = 196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p <.0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n = 88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:25085225

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

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

PubMed

Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

Motivational interviewing and screening colonoscopy in high-risk individuals. A randomized controlled trial.

PubMed

Salimzadeh, Hamideh; Khabiri, Roghaye; Khazaee-Pool, Maryam; Salimzadeh, Somayeh; Delavari, Alireza

2018-06-01

To measure the impact of motivational interviewing (MI) on cancer knowledge and screening practice among first degree relatives (FDRs) of patients with colon cancer. This randomized controlled trial targeted patients with colon cancer first to recruit their possible FDRs. Digit randomization of the eligible index patients into intervention or control groups resulted in allocating their belonging FDRs to the same study arm. FDRs (n = 120) in intervention arm received MI counseling on phone by a trained oncology nurse and FDRs (n = 120) in control group received standard generic information by a physician on phone. Primary outcome was the rate of documented colonoscopy in FDRs within six months after the baseline. A total of 227 FDRs were followed up, 115 in the intervention and 112 in the control group. At follow-up, the uptake of screening colonoscopy in the intervention group was 83.5% versus 48.2% in controls (crude odds ratio, 5.4; 95% confidence interval, 2.9-10.0, P < .001). This was the first randomized controlled trial in Iran that confirmed the efficaciousness of a phone-based MI counseling in improving colonoscopy uptake among family members of patients with colon cancer. Phone-based motivational counseling that involves trained nurses or health providers seems to be feasible approach in Iran health system and enhances screening for colon cancer. Copyright © 2018 Elsevier B.V. All rights reserved.

Digital servo control of random sound test excitation. [in reverberant acoustic chamber

NASA Technical Reports Server (NTRS)

Nakich, R. B. (Inventor)

1974-01-01

A digital servocontrol system for random noise excitation of a test object in a reverberant acoustic chamber employs a plurality of sensors spaced in the sound field to produce signals in separate channels which are decorrelated and averaged. The average signal is divided into a plurality of adjacent frequency bands cyclically sampled by a time division multiplex system, converted into digital form, and compared to a predetermined spectrum value stored in digital form. The results of the comparisons are used to control a time-shared up-down counter to develop gain control signals for the respective frequency bands in the spectrum of random sound energy picked up by the microphones.

Building Kindergartners' Number Sense: A Randomized Controlled Study.

PubMed

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

2012-08-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Transient Oscilliations in Mechanical Systems of Automatic Control with Random Parameters

NASA Astrophysics Data System (ADS)

Royev, B.; Vinokur, A.; Kulikov, G.

2018-04-01

Transient oscillations in mechanical systems of automatic control with random parameters is a relevant but insufficiently studied issue. In this paper, a modified spectral method was applied to investigate the problem. The nature of dynamic processes and the phase portraits are analyzed depending on the amplitude and frequency of external influence. It is evident from the obtained results, that the dynamic phenomena occurring in the systems with random parameters under external influence are complex, and their study requires further investigation.

Effects of mindfulness meditation on chronic pain: a randomized controlled trial.

PubMed

la Cour, Peter; Petersen, Marian

2015-04-01

This randomized controlled clinical trial investigated the effects of mindfulness meditation on chronic pain. A total of 109 patients with nonspecific chronic pain were randomized to either a standardized mindfulness meditation program (mindfulness-based stress reduction [MBSR]) or to a wait list control. Pain, physical function, mental function, pain acceptance, and health-related quality of life were measured. The SF36 vitality scale was chosen as the primary outcome measure; the primary end point was after completing the MBSR course. Within a 2.5-year period, 43 of the 109 randomized patients completed the mindfulness program, while 47 remained in the control group. Data were compared at three time points: at baseline, after completion of the course/waiting period, and at the 6-month follow-up. Significant effect (Cohen's d = 0.39) was found on the primary outcome measure, the SF36 vitality scale. On the secondary variables, significant medium to large size effects (Cohen's d = 0.37-0.71) were found for lower general anxiety and depression, better mental quality of life (psychological well-being), feeling in control of the pain, and higher pain acceptance. Small (nonsignificant) effect sizes were found for pain measures. There were no significant differences in the measures just after the intervention vs the 6-month follow-up. A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions in patients with long-lasting chronic pain. © 2014 American Academy of Pain Medicine.

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

Sulodexide for kidney protection in type 2 diabetes patients with microalbuminuria: a randomized controlled trial.

PubMed

Lewis, Edmund J; Lewis, Julia B; Greene, Tom; Hunsicker, Lawrence G; Berl, Tomas; Pohl, Marc A; de Zeeuw, Dick; Heerspink, Hiddo Lambers; Rohde, Richard D; Atkins, Robert C; Reutens, Anne T; Packham, David K; Raz, Itamar

2011-11-01

Sulodexide, a heterogenous group of sulfated glycosaminoglycans, includes low-molecular-weight heparin (~80% ± 8%), high-molecular-weight heparin (~5% ± 3%), and dermatan (~20% ± 8%), with a mean molecular weight of ~9 kDa. The drug is absorbed orally and has no anticoagulant effect in the doses used. Small preliminary studies consistently showed sulodexide to be associated with decreased albuminuria in patients with diabetes. We conducted a multicenter placebo-controlled double-blinded study to determine the effect of sulodexide on urine albumin excretion in patients with type 2 diabetic nephropathy. Patients with type 2 diabetes and urine albumin-creatinine ratios (ACRs) of 35-200 mg/g in men and 45-200 mg/g in women were enrolled. Serum creatinine level was <1.5 mg/dL. Blood pressure goal was 130/80 mm Hg. A maximum US Food and Drug Administration-approved dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for a minimum of 4 months before randomization was required. The study drug was sulodexide, 200 mg/d. The primary end point was normoalbuminuria (ACR <20 mg/g and a decrease >25%) or 50% decrease in baseline ACR. In 1,056 randomly assigned patients with a mean baseline ACR of 107.8 ± 83.7 mg/g, comparing the sulodexide versus placebo groups, the primary end point was achieved in 16.5% versus 18.4%; normoalbuminuria, in 7.9% versus 6.1%; and a 50% decrease in albuminuria, in 15.4% versus 17.6%. The relative probability of any given change in albuminuria was identical in both groups. We were unable to determine whether the administered sulodexide was absorbed from the gastrointestinal tract. Sulodexide failed to decrease urine albumin excretion in patients with type 2 diabetic nephropathy and microalbuminuria. Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Online Activities for Enhancing Sex Education Curricula: Preliminary Evidence on the Effectiveness of the Abstinence and Contraception Education Storehouse

PubMed Central

Raghupathy, Shobana; Klein, Charles; Card, Josefina

2013-01-01

The purpose of this research was to conduct a preliminary evaluation of the Abstinence and Contraception Education Storehouse (ACES), a digital, classroom-based resource designed to supplement existing sex education curricula with highly interactive materials such as video clips, multimedia polls and quizzes, and audiovisual demonstrations. 335 students ages 14–19 were randomly assigned to an ACES–based (treatment) or a standard (control) sex education curriculum. Data were collected at the onset of the intervention and 3-months after the completion of the intervention. Preliminary results were highly encouraging, with ACES participants who were sexually initiated at baseline reporting at the 3-month follow-up significant reductions in the number of times they had sex in the past four weeks. Both sexually initiated and non-sexually initiated youth who experienced the ACES curriculum also demonstrated greater intent to abstain from the sex during the follow-up period than those in the control group. PMID:24078799

Online Activities for Enhancing Sex Education Curricula: Preliminary Evidence on the Effectiveness of the Abstinence and Contraception Education Storehouse.

PubMed

Raghupathy, Shobana; Klein, Charles; Card, Josefina

2013-01-01

The purpose of this research was to conduct a preliminary evaluation of the Abstinence and Contraception Education Storehouse (ACES), a digital, classroom-based resource designed to supplement existing sex education curricula with highly interactive materials such as video clips, multimedia polls and quizzes, and audiovisual demonstrations. 335 students ages 14-19 were randomly assigned to an ACES-based (treatment) or a standard (control) sex education curriculum. Data were collected at the onset of the intervention and 3-months after the completion of the intervention. Preliminary results were highly encouraging, with ACES participants who were sexually initiated at baseline reporting at the 3-month follow-up significant reductions in the number of times they had sex in the past four weeks. Both sexually initiated and non-sexually initiated youth who experienced the ACES curriculum also demonstrated greater intent to abstain from the sex during the follow-up period than those in the control group.

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

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.

Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial.

PubMed

Limsanon, Thatsanee; Kalayasiri, Rasmon

2015-03-01

Cigarette craving usually occurs in conjunction with unpleasant feelings, including stress, as part of a withdrawal syndrome. Progressive muscle relaxation (PMR), a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation, may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms. Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital, Bangkok, Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism. Participants were asked to refrain from smoking for at least 3 hours before the visit (acute abstinence) and were randomly allocated to a 1-session PMR group (n =16) or a control activity group (e.g., reading newspaper, n =16). The intervention group was instructed to practice PMR individually in a quiet, private, air-conditioned room for about 20minutes. Craving, other substance-related feelings, and autonomic nervous responses (e.g., blood pressure and pulse rate) were assessed immediately before and after the 1-session intervention. There were no differences in demographics, cigarette use/dependence, and baseline craving characteristics between the PMR and control groups. However, the control group had higher levels of high and paranoia feeling, and pulse rate than the PMR group at baseline. After practicing PMR, but not after a control activity, smokers undergoing acute abstinence had significantly lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than at baseline. After controlling for baseline differences, abstaining smokers using PMR had lower levels of cigarette craving, withdrawal symptoms, and systolic blood pressure than smokers who undertook a control activity. PMR significantly reduces cigarette craving, withdrawal symptoms, and blood pressure in smokers undergoing acute abstinence. PMR may be used as an adjunct to cigarette dependency treatments

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…

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

ERIC Educational Resources Information Center

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

2009-01-01

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

A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia.

PubMed

Vizzotto, Adriana D B; Celestino, Diego L; Buchain, Patricia C; Oliveira, Alexandra M; Oliveira, Graça M R; Di Sarno, Elaine S; Napolitano, Isabel C; Elkis, Helio

2016-11-30

Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population. The Positive and Negative Syndrome Scale (PANSS) was used for monitoring symptom severity. Results showed significant statistical differences, favoring the OGI group in terms of improvement on the BADS, both in subtests (Action Program and Key Search) and the total score. Improvements in EFs were observed by families in various dimensions as measured by different subtests of the ILSS-BR inventory. The OGI group showed no significant results in secondary outcomes (DAFS-BR) except in terms of improvement of communication skills. Although preliminary, our results indicate that the OGI method is efficacious and effective for patients with TRS. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effects of exercises on Bell's palsy: systematic review of randomized controlled trials.

PubMed

Cardoso, Jefferson Rosa; Teixeira, Elsie Cobra; Moreira, Michelle Damasceno; Fávero, Francis Meire; Fontes, Sissy Veloso; Bulle de Oliveira, Acary Souza

2008-06-01

This study examined the effects of facial exercises associated either with mirror or electromyogram (EMG) biofeedback with respect to complications of delayed recovery in Bell's palsy. Patients with unilateral idiopathic facial palsy were included in this review. Facial exercises associated with mirror and/or EMG biofeedback as treatment. Report of facial symmetry, synkinesis, lip mobility, and physical and social aspects. Four studies of 132 met the eligibility criteria. The studies described mime therapy versus control (n = 50), mirror biofeedback exercise versus control (n = 27), "small" mirror movements versus conventional neuromuscular retraining (n = 10), and EMG biofeedback + mirror training versus mirror training alone. The treatment length varied from 1 to 12 months. Because of the small number of randomized controlled trials, it was not possible to analyze if the exercises, associated either with mirror or EMG biofeedback, were effective. In summary, the available evidence from randomized controlled trials is not yet strong enough to become integrated into clinical practice.

Patient satisfaction with different interpreting methods: a randomized controlled trial.

PubMed

Gany, Francesca; Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C; Changrani, Jyotsna

2007-11-01

Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health

Review of Randomized Controlled Trials of Massage in Preterm Infants

PubMed Central

Niemi, Anna-Kaisa

2017-01-01

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. PMID:28368368

The Mark Coventry, MD, Award: Oral Antibiotics Reduce Reinfection After Two-Stage Exchange: A Multicenter, Randomized Controlled Trial.

PubMed

Frank, Jonathan M; Kayupov, Erdan; Moric, Mario; Segreti, John; Hansen, Erik; Hartman, Curtis; Okroj, Kamil; Belden, Katherine; Roslund, Brian; Silibovsky, Randi; Parvizi, Javad; Della Valle, Craig J

2017-01-01

for inclusion in this analysis. The mean followup was 14 months in the antibiotic group and 10 months in the control group. Patients treated with oral antibiotics failed secondary to infection less frequently than those not treated with antibiotics (5% [three of 59] versus 19% [nine of 48]; hazard ratio, 4.37; 95% confidence interval, 1.297-19.748; p = 0.016). Three patients had an adverse reaction to the oral antibiotics severe enough to cause them to stop taking the antibiotics early, and four patients who were randomized to that group did not take the antibiotics as directed. With the numbers available, there were no differences between the study groups in terms of the likelihood that an infection after treatment would be with a new organism (eight of nine in the control group versus one of three in the treatment group, p = 0.087). This multicenter randomized trial suggests that at short-term followup, the addition of 3 months of oral antibiotics appeared to improve infection-free survival. As a planned interim analysis, however, these results may change as the study reaches closure and the safety profile may yet prove risky. Further followup of this cohort of patients will be necessary to determine whether these preliminary results are durable over time. Level I, therapeutic study.

FPGA and USB based control board for quantum random number generator

NASA Astrophysics Data System (ADS)

Wang, Jian; Wan, Xu; Zhang, Hong-Fei; Gao, Yuan; Chen, Teng-Yun; Liang, Hao

2009-09-01

The design and implementation of FPGA-and-USB-based control board for quantum experiments are discussed. The usage of quantum true random number generator, control- logic in FPGA and communication with computer through USB protocol are proposed in this paper. Programmable controlled signal input and output ports are implemented. The error-detections of data frame header and frame length are designed. This board has been used in our decoy-state based quantum key distribution (QKD) system successfully.

Feedback on oral presentations during pediatric clerkships: a randomized controlled trial.

PubMed

Sox, Colin M; Dell, Michael; Phillipi, Carrie A; Cabral, Howard J; Vargas, Gabriela; Lewin, Linda O

2014-11-01

To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students' subsequent presentations. We conducted a single-blind, 3-arm, cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine, University of Maryland School of Medicine, Oregon Health & Science University, and Case Western Reserve University School of Medicine. Blocks of students at each school were randomly assigned to experience either (1) no formal presentation feedback (control) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a (2) single-item (simple) or (3) 18-item (detailed) evaluation form. At the clerkship end, overall quality of subjects' presentations was rated by faculty blinded to randomization status, and subjects reported whether their presentations had improved. Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school. A total of 476 participants were evenly divided into the 3 arms, which had similar characteristics. Compared with controls, presentation quality was significantly associated with participating in detailed (coefficient: 0.38; 95% confidence interval [CI]: 0.07-0.69) but not simple (coefficient: 0.16; 95% CI: -0.12-0.43) feedback sessions. Similarly, student self-report of presentation improvement was significantly associated with participating in detailed (odds ratio: 2.16; 95% CI: 1.11-4.18] but not simple (odds ratio: 1.89; 95% CI: 0.91-3.93) feedback sessions. Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls. Copyright © 2014 by the American Academy of Pediatrics.

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).

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

PubMed Central

LoRusso, Amanda; Shin, Sunny H.; Khalsa, Sat Bir S.

2016-01-01

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 in

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

Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation.

PubMed

Gumus, Koray; Schuetzle, Karri L; Pflugfelder, Stephen C

2017-05-01

The aim of the study was to investigate the effects of the Allergan Intranasal Tear Neurostimulator (ITN) on conjunctival goblet cell (GC) degranulation. A randomized, double-masked, placebo-controlled crossover trial. A total of 15 subjects (5 normal and 10 dry eye) were enrolled in a 3-visit study consisting of 1 screening and 2 separate randomized-masked ITN treatments (sham extranasal or intranasal). Tear meniscus height (TMH) was measured by anterior segment optical coherence tomography before and after applications. Impression cytology (IC) was taken from the bulbar conjunctiva of the right eye for periodic acid-Schiff staining and from the left eye for MUC5AC mucin immunostaining at baseline and after each treatment. The ratio of degranulated to nondegranulated GCs was measured as a marker of secretion. In all participants, both inferior bulbar (IB) and temporal bulbar (TB) cytology specimens stained for MUC5AC revealed a significantly higher ratio of degranulated to nondegranulated GCs after the ITN (IB: 2.28 ± 1.27 and TB: 1.81 ± 1.01) compared to baseline (IB: 0.56 ± 0.55, P = .015) (TB: 0.56 ± 0.32, P = .003) and extranasal sham application (IB: 0.37 ± 0.29, P = .001) (TB: 0.39 ± 0.33, P = .001). When the same analysis was repeated in the dry eye or control groups, the ratio was significantly higher after ITN than the baseline ratio and ratio after extranasal application in both groups (P < .05). Moreover, although control subjects had a higher ratio of degranulated to nondegranulated GCs at baseline (0.75 ± 0.52) compared with the dry eye group (0.41 ± 0.27), the ratio became slightly higher in dry eye (2.04 ± 1.12 vs 1.99 ± 1.21 in control) after the ITN application. There was no significant difference between the IB or TB conjunctiva locations in terms of the effectiveness of the ITN application on conjunctival goblet cell secretory response. These preliminary results document that the Allergan ITN can stimulate degranulation of goblet

Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial.

PubMed

Schreier, Hannah M C; Schonert-Reichl, Kimberly A; Chen, Edith

2013-04-01

The idea that individuals who help others incur health benefits themselves suggests a novel approach to improving health while simultaneously promoting greater civic orientation in our society. The present study is the first experimental trial, to our knowledge, of whether regular volunteering can reduce cardiovascular risk factors in adolescents. To test a novel intervention that assigned adolescents to volunteer with elementary school-aged children as a means of improving adolescents' cardiovascular risk profiles. Randomized controlled trial, with measurements taken at baseline and 4 months later (postintervention). Urban public high school in western Canada. One hundred six 10th-grade high school students who were fluent in English and free of chronic illnesses. Weekly volunteering with elementary school-aged children for 2 months vs wait-list control group. Cardiovascular risk markers of C-reactive protein level, interleukin 6 level, total cholesterol level, and body mass index. No statistically significant group differences were found at baseline. Postintervention, adolescents in the intervention group showed significantly lower interleukin 6 levels (log10 mean difference, 0.13; 95% CI, 0.004 to 0.251), cholesterol levels (log10 mean difference, 0.03; 95% CI, 0.003 to 0.059), and body mass index (mean difference, 0.39; 95% CI, 0.07 to 0.71) compared with adolescents in the control group. Effects for C-reactive protein level were marginal (log10 mean difference, 0.13; 95% CI, -0.011 to 0.275). Preliminary analyses within the intervention group suggest that those who increased the most in empathy and altruistic behaviors, and who decreased the most in negative mood, also showed the greatest decreases in cardiovascular risk over time. Adolescents who volunteer to help others also benefit themselves, suggesting a novel way to improve health. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01698034.

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Open-closed-loop iterative learning control for a class of nonlinear systems with random data dropouts

NASA Astrophysics Data System (ADS)

Cheng, X. Y.; Wang, H. B.; Jia, Y. L.; Dong, YH

2018-05-01

In this paper, an open-closed-loop iterative learning control (ILC) algorithm is constructed for a class of nonlinear systems subjecting to random data dropouts. The ILC algorithm is implemented by a networked control system (NCS), where only the off-line data is transmitted by network while the real-time data is delivered in the point-to-point way. Thus, there are two controllers rather than one in the control system, which makes better use of the saved and current information and thereby improves the performance achieved by open-loop control alone. During the transfer of off-line data between the nonlinear plant and the remote controller data dropout occurs randomly and the data dropout rate is modeled as a binary Bernoulli random variable. Both measurement and control data dropouts are taken into consideration simultaneously. The convergence criterion is derived based on rigorous analysis. Finally, the simulation results verify the effectiveness of the proposed method.

Lower reinjury rate with a coach-controlled rehabilitation program in amateur male soccer: a randomized controlled trial.

PubMed

Hägglund, Martin; Waldén, Markus; Ekstrand, Jan

2007-09-01

Soccer injuries are common, and athletes returning to play after injury are especially at risk. Few studies have investigated how to prevent reinjury. The rate of reinjury is reduced using a coach-controlled rehabilitation program. Randomized controlled trial; Level of evidence, 1. Twenty-four male amateur soccer teams were randomized into an intervention (n = 282) and control group (n = 300). The intervention was implemented by team coaches and consisted of information about risk factors for reinjury, rehabilitation principles, and a 10-step progressive rehabilitation program including return to play criteria. During the 2003 season, coaches reported individual exposure and all time loss injuries were evaluated by a doctor and a physiotherapist. Four teams (n = 100) withdrew from the study after randomization, leaving 10 teams with 241 players for analysis in both groups. There were 90 injured players (132 injuries) in the intervention group, and 10 of these (11%) suffered 14 reinjuries during the season. In the control group, 23 of 79 injured players (29%) had 40 recurrences (134 injuries). A Cox regression analysis showed a 66% reinjury risk reduction in the intervention group for all injury locations (hazard ratio [HR] 0.34, 95% confidence interval [CI] 0.16-0.72, P = .0047) and 75% for lower limb injuries (HR 0.25, 95% CI 0.11-0.57, P < .001). The preventive effect was greatest within the first week of return to play. Injured players in the intervention group complied with the intervention for 90 of 132 injuries (68%). The reinjury rate in amateur male soccer players was reduced after a controlled rehabilitation program implemented by coaches.

Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache.

PubMed

Zhao, Lei; Guo, Yi; Wang, Wei; Yan, Li-juan

2011-08-01

To evaluate the effectiveness of acupuncture as a treatment for neurovascular headache and to analyze the current situation related to acupuncture treatment. PubMed database (1966-2010), EMBASE database (1986-2010), Cochrane Library (Issue 1, 2010), Chinese Biomedical Literature Database (1979-2010), China HowNet Knowledge Database (1979-2010), VIP Journals Database (1989-2010), and Wanfang database (1998-2010) were retrieved. Randomized or quasi-randomized controlled studies were included. The priority was given to high-quality randomized, controlled trials. Statistical outcome indicators were measured using RevMan 5.0.20 software. A total of 16 articles and 1 535 cases were included. Meta-analysis showed a significant difference between the acupuncture therapy and Western medicine therapy [combined RR (random efficacy model)=1.46, 95% CI (1.21, 1.75), Z=3.96, P<0.0001], indicating an obvious superior effect of the acupuncture therapy; significant difference also existed between the comprehensive acupuncture therapy and acupuncture therapy alone [combined RR (fixed efficacy model)=3.35, 95% CI (1.92, 5.82), Z=4.28, P<0.0001], indicating that acupuncture combined with other therapies, such as points injection, scalp acupuncture, auricular acupuncture, etc., were superior to the conventional body acupuncture therapy alone. The inclusion of limited clinical studies had verified the efficacy of acupuncture in the treatment of neurovascular headache. Although acupuncture or its combined therapies provides certain advantages, most clinical studies are of small sample sizes. Large sample size, randomized, controlled trials are needed in the future for more definitive results.

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…

Computer-Assisted Learning in Elementary Reading: A Randomized Control Trial

ERIC Educational Resources Information Center

Shannon, Lisa Cassidy; Styers, Mary Koenig; Wilkerson, Stephanie Baird; Peery, Elizabeth

2015-01-01

This study evaluated the efficacy of Accelerated Reader, a computer-based learning program, at improving student reading. Accelerated Reader is a progress-monitoring, assessment, and practice tool that supports classroom instruction and guides independent reading. Researchers used a randomized controlled trial to evaluate the program with 344…

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

PubMed

Duran, Marta; Pérez, Eulàlia; Abanades, Sergio; Vidal, Xavier; Saura, Cristina; Majem, Margarita; Arriola, Edurne; Rabanal, Manel; Pastor, Antoni; Farré, Magí; Rams, Neus; Laporte, Joan-Ramon; Capellà, Dolors

2010-11-01

Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV. Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response. Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups. Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial. © 2010 Department of Health, Generalitat of Catalonia. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.

Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial.

PubMed

Nagao, Mizuho; Ikeda, Masanori; Fukuda, Norimasa; Habukawa, Chizu; Kitamura, Tetsuro; Katsunuma, Toshio; Fujisawa, Takao

2018-01-01

While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β 2 -agonists in this population, we conducted a randomized controlled trial. Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β 2 -agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219. From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033). Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial.

PubMed

Wilks, Chelsey; Yin, Qingqing; Ang, Sin Yee; Matsumiya, Brandon; Lungu, Anita; Linehan, Marsha

2017-10-25

The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high

Working Memory Training for Adolescents with Cannabis Use Disorders: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Sweeney, Mary M.; Rass, Olga; DiClemente, Cara; Schacht, Rebecca L.; Vo, Hoa T.; Fishman, Marc J.; Leoutsakos, Jeannie-Marie S.; Mintzer, Miriam Z.; Johnson, Matthew W.

2018-01-01

Adolescent cannabis use is associated with working memory impairment. The present randomized controlled trial assigned adolescents ages 14 to 21 enrolled in cannabis use treatment to receive either working memory training (experimental group) or a control training (control group) as an adjunctive treatment. Cognitive function, drug use, and other…

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

PubMed

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

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.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely

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

PubMed Central

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

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial.

PubMed

Bogaerts, An; Verschueren, Sabine; Delecluse, Christophe; Claessens, Albrecht L; Boonen, Steven

2007-07-01

This randomized controlled trial investigated the effects of a 12 month whole body vibration training program on postural control in healthy older adults. Two hundred and twenty people were randomly assigned to a whole body vibration group (n=94), a fitness group (n=60) or a control group (n=66). The whole body vibration and fitness groups trained three times a week for 1 year. The vibration group performed exercises on a vibration platform and the fitness group performed cardiovascular, strength, balance and stretching exercises. Balance was measured using dynamic computerized posturography at baseline and after 6 and 12 months. Whole body vibration training was associated with reduced falls frequency on a moving platform when vision was disturbed and improvements in the response to toes down rotations at the ankle induced by the moving platform. The fitness group showed reduced falls frequency on the moving surface when vision was disturbed. Thus, whole body vibration training may improve some aspects of postural control in community dwelling older individuals.

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

Building Kindergartners’ Number Sense: A Randomized Controlled Study

PubMed Central

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

2015-01-01

Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

Incentive Spirometry after Lung Resection: A Randomized Controlled Trial.

PubMed

Malik, Peter Ra; Fahim, Christine; Vernon, Jordyn; Thomas, Priya; Schieman, Colin; Finley, Christian J; Agzarian, John; Shargall, Yaron; Farrokhyar, Forough; Hanna, Wael C

2018-04-24

Incentive spirometry (IS) is thought to reduce the incidence of postoperative pulmonary complications (PPC) after lung resection. We sought to determine whether the addition of IS to routine physiotherapy following lung resection results in a lower rate of PPC, as compared to physiotherapy alone. A single-blind prospective randomized controlled trial was conducted in adults undergoing lung resection. Individuals with previous lung surgery or home oxygen were excluded. Participants randomized to the control arm (PHY) received routine physiotherapy alone (deep breathing, ambulation and shoulder exercises). Those randomized to the intervention arm (PHY/IS) received IS in addition to routine physiotherapy. The trial was powered to detect a 10% difference in the rate of PPC (beta=80%). Student's t-test and chi-square were utilized for continuous and categorical variables respectively, with a significance level of p=0.05. A total of 387 participants (n=195 PHY/IS; n=192 PHY) were randomized between 2014-2017. Baseline characteristics were comparable for both arms. The majority of patients underwent a pulmonary lobectomy (PHY/IS=59.5%, PHY=61.0%, p=0.84), with no difference in the rates of minimally invasive and open procedures. There were no differences in the incidence of PPC at 30 days postoperatively (PHY/IS=12.3%, PHY=13.0%, p=0.88). There were no differences in rates of pneumonia (PHY/IS=4.6%, PHY=7.8%, p=0.21), mechanical ventilation (PHY/IS=2.1%, PHY=1.0%, p=0.41), home-oxygen (PHY/IS=13.8%, PHY=14.6%, p=0.89), hospital length of stay (PHY/IS=4 days, PHY=4 days, p=0.34), or rate of readmission to hospital (PHY/IS=10.3%, PH=9.9%, p=1.00). The addition of IS to routine postoperative physiotherapy does not reduce the incidence of PPC after lung resection. Copyright © 2018. Published by Elsevier Inc.

Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

PubMed Central

Wang, Jingen; Zhou, Yongfei; Xia, Shuxia; Zhu, Zunwei; Jia, Linghua; Liu, Yong; Jiang, Min

2014-01-01

Background We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd. Material/Methods Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted. Results Intraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05). Conclusions This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT. PMID:24647226

Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

PubMed

Toth, Maria; Marcantonio, Edward R; Davis, Roger B; Walton, Tracy; Kahn, Janet R; Phillips, Russell S

2013-07-01

The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

Cultural participation and health: a randomized controlled trial among medical care staff.

PubMed

Bygren, Lars Olov; Weissglas, Gösta; Wikström, Britt-Maj; Konlaan, Boinkum Benson; Grjibovski, Andrej; Karlsson, Ann-Brith; Andersson, Sven-Olof; Sjöström, Michael

2009-05-01

Population studies demonstrate that attending cultural events is conducive to improved health when baseline health, income, education, and health habits are taken into account. Animal experiments suggest possible mechanisms. We studied the link in humans between attending cultural events and health in a randomized controlled trial. Members of the local government officers' union in the health services in Umeå, Sweden, were invited to the experiment and 101 people registered for fine arts visits once a week for 8 weeks. They chose films, concerts, or art exhibitions visits, or singing in a choir and were then randomized into 51 cases, starting at once, and 50 controls starting after the trial. Health was assessed before randomization and after the experimental period using the instrument for perceived health, short form (SF)-36, and tests of episodic memory, saliva-cortisol and immunoglobulin. The results were analyzed using a mixed design analysis of variance. The SF-36 Composite Score called physical health improved in the intervention group and decreased among controls during the experiment (F(1,87) = 7.06, p = .009). The individual factor of the SF-36 called social functioning, improved more in the intervention group than among controls (F(1,98) = 8.11, p = .005) as well as the factor vitality (F(1,98) = 5.26, p = .024). The six other factors and the Mental Health Composite Score, episodic memory, cortisol and immunoglobulin levels did not change otherwise than among controls. Mechanisms are left to be identified. Fine arts stimulations improved perceived physical health, social functioning, and vitality.

Clinical and cost-effectiveness of therapist-guided internet-delivered cognitive behavior therapy for older adults with symptoms of anxiety: a randomized controlled trial.

PubMed

Dear, Blake F; Zou, Judy B; Ali, Shehzad; Lorian, Carolyn N; Johnston, Luke; Sheehan, Joanne; Staples, Lauren G; Gandy, Milena; Fogliati, Vincent J; Klein, Britt; Titov, Nickolai

2015-03-01

There is preliminary support for internet-delivered cognitive behaviour therapy (iCBT) as a way of improving access to treatment among older adults with anxiety. The aim of this randomized controlled trial (RCT) was to examine the efficacy, long-term outcomes, and cost-effectiveness of an iCBT program for adults over 60 years of age with anxiety. Successful applicants were randomly allocated to either the treatment group (n=35) or the waitlist control group (n=37). The online treatment course was delivered over 8 weeks and provided with brief weekly contact with a clinical psychologist via telephone or secure email. Eighty-four percent of participants completed the iCBT course within the 8 weeks and 90% provided data at posttreatment. Significantly lower scores on measures of anxiety (Cohen's d=1.43; 95% CI: 0.89 - 1.93) and depression (Cohen's d=1.79; 95% CI: 1.21 - 2.32) were found among the treatment group compared to the control group at posttreatment. These lower scores were maintained at 3-month and 12-month follow-up and the treatment group rated the iCBT treatment as acceptable. The treatment group had slightly higher costs ($92.2; 95% CI: $38.7 to $149.2) and Quality-Adjusted Life-Years (QALYs=0.010; 95% CI: 0.003 to 0.018) than the control group at posttreatment and the intervention was found to have a greater than 95% probability of being cost-effective. The results support iCBT as an efficacious and cost-effective treatment option for older adults with symptoms of anxiety. Australian and New Zealand Clinical Trials Registry: ACTRN12611000929909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000929909. Copyright © 2014. Published by Elsevier Ltd.

Impact of Patient Education on Influenza Vaccine Uptake among Community-Dwelling Elderly: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Leung, Ka Chun; Mui, Carlo; Chiu, Wing Yan; Ng, Yuk Yiu; Chen, Matthew H. Y.; Ho, Pui Hung; Kwok, Chun Pong; Lam, Suki S. M.; Wong, Chun Yip; Wong, Kit Yee; Pang, Herbert H.

2017-01-01

This randomized controlled trial aimed to test the effectiveness of brief face-to-face patient education in increasing influenza vaccination rate among elderly in the community. Recruitment and intervention were conducted at two general outpatient clinics in Hong Kong. 529 eligible patients were randomly assigned to intervention or control group…

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

PubMed

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

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

ERIC Educational Resources Information Center

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

2013-01-01

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

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 quality of life scores. Five patients withdrew before initiation of treatment, and final analysis consisted of n =21 in each group. There was a greater increase in total neuropathy score from baseline to final assessment in the control arm compared with the intervention arm (6.1±6.2-8.6±7.9 controls; 7.8±7.4-8.2±7.5 intervention; change 2.8±3.3-0.4±2.2, respectively; P <0.01). The intervention significantly reduced mean serum potassium compared with controls (4.6±0.1-4.8±0.1 mEq/L mean recorded every 6 months over the trial duration; P =0.03). There were no adverse changes in other nutritional parameters. Improved gait speed was also noted in the intervention arm compared with the control arm, with a mean increase of 0.15±0.17 m/s in the intervention group versus 0.02±0.16 m/s in the control group ( P =0.01). Our results provide important preliminary evidence that dietary potassium restriction confers neuroprotection in CKD and should be confirmed in a larger

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

PubMed

Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

2010-07-01

To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

Method of preliminary localization of the iris in biometric access control systems

NASA Astrophysics Data System (ADS)

Minacova, N.; Petrov, I.

2015-10-01

This paper presents a method of preliminary localization of the iris, based on the stable brightness features of the iris in images of the eye. In tests on images of eyes from publicly available databases method showed good accuracy and speed compared to existing methods preliminary localization.

Low-Dose Oral Sirolimus and the Risk of Menstrual-Cycle Disturbances and Ovarian Cysts: Analysis of the Randomized Controlled SUISSE ADPKD Trial

PubMed Central

Braun, Matthias; Young, James; Reiner, Cäcilia S.; Poster, Diane; Krauer, Fabienne; Kistler, Andreas D.; Kristanto, Paulus; Wang, Xueqi; Liu, Yang; Loffing, Johannes; Andreisek, Gustav; von Eckardstein, Arnold; Senn, Oliver; Wüthrich, Rudolf P.; Serra, Andreas L.

2012-01-01

Sirolimus has been approved for clinical use in non proliferative and proliferative disorders. It inhibits the mammalian target of rapamycin (mTOR) signaling pathway which is also known to regulate ovarian morphology and function. Preliminary observational data suggest the potential for ovarian toxicity but this issue has not been studied in randomized controlled trials. We reviewed the self-reported occurrence of menstrual cycle disturbances and the appearance of ovarian cysts post hoc in an open label randomized controlled phase II trial conducted at the University Hospital Zürich between March 2006 and March 2010. Adult females with autosomal dominant polycystic kidney disease, an inherited kidney disease not known to affect ovarian morphology and function, were treated with 1.3 to 1.5 mg sirolimus per day for a median of 19 months (N = 21) or standard care (N = 18). Sirolimus increased the risk of both oligoamenorrhea (hazard ratio [HR] 4.3, 95% confidence interval [CI] 1.1 to 29) and ovarian cysts (HR 4.4, CI 1.1 to 26); one patient was cystectomized five months after starting treatment with sirolimus. We also studied mechanisms of sirolimus-associated ovarian toxicity in rats. Sirolimus amplified signaling in rat ovarian follicles through the pro-proliferative phosphatidylinositol 3-kinase pathway. Low dose oral sirolimus increases the risk of menstrual cycle disturbances and ovarian cysts and monitoring of sirolimus-associated ovarian toxicity is warranted and might guide clinical practice with mammalian target of rapamycin inhibitors. Trial Registration ClinicalTrials.gov NCT00346918 PMID:23071528

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

PubMed

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

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. 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. 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. 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, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

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

Yoga for generalized anxiety disorder: design of a randomized controlled clinical trial.

PubMed

Hofmann, Stefan G; Curtiss, Joshua; Khalsa, Sat Bir S; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-09-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to be the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N=95) to both CBT for GAD (N=95) and stress education (N=40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. Copyright © 2015 Elsevier Inc. All rights reserved.

Yoga for Generalized Anxiety Disorder: Design of a Randomized Controlled Clinical Trial

PubMed Central

Hofmann, Stefan G.; Curtiss, Joshua; Khalsa, Sat Bir S.; Hoge, Elizabeth; Rosenfield, David; Bui, Eric; Keshaviah, Aparna; Simon, Naomi

2015-01-01

Generalized anxiety disorder (GAD) is a common disorder associated with significant distress and interference. Although cognitive behavioral therapy (CBT) has been shown to the most effective form of psychotherapy, few patients receive or have access to this intervention. Yoga therapy offers another promising, yet under-researched, intervention that is gaining increasing popularity in the general public, as an anxiety reduction intervention. The purpose of this innovative clinical trial protocol is to investigate the efficacy of a Kundalini Yoga intervention, relative to CBT and a control condition. Kundalini yoga and CBT are compared with each other in a noninferiority test and both treatments are compared to stress education training, an attention control intervention, in superiority tests. The sample will consist of 230 individuals with a primary DSM-5 diagnosis of GAD. This randomized controlled trial will compare yoga (N = 95) to both CBT for GAD (N=95) and stress education (N = 40), a commonly used control condition. All three treatments will be administered by two instructors in a group format over 12 weekly sessions with four to six patients per group. Groups will be randomized using permuted block randomization, which will be stratified by site. Treatment outcome will be evaluated bi-weekly and at 6 month follow-up. Furthermore, potential mediators of treatment outcome will be investigated. Given the individual and economic burden associated with GAD, identifying accessible alternative behavioral treatments will have substantive public health implications. PMID:26255236

Impact of Playing Exergames on Mood States: A Randomized Controlled Trial.

PubMed

Huang, Han-Chung; Wong, May-Kuen; Yang, Ya-Hui; Chiu, Hsin-Ying; Teng, Ching-I

2017-04-01

To examine how playing exergames impacts the mood states of university students and staff, and whether such an impact depends on gender and players' previous exercise time. This study was designed as a randomized controlled trial. It enrolled 337 participants and randomly assigned them to an intervention group (n = 168) or a control group (n = 167). A 2-week exergame program was designed for the participants in the intervention group. They were required to play exergames for 30 consecutive minutes each week for 2 weeks and respond to the items measuring vigor, happiness, and perceived stress. All measures were administered before and after the study. Repeated measures analysis of variances were conducted. Playing exergames enhanced vigor and happiness for participants in the intervention group. This group exhibited more positive change in vigor and happiness than the control group. This effect of playing exergames was not moderated by gender, age, occupation (student or staff), or previous exercise time. Playing exergames may induce positive mood states among university students and staff.

Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

PubMed Central

Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

Randomized controlled trial of a comprehensive stroke education program for patients and caregivers.

PubMed

Rodgers, H; Atkinson, C; Bond, S; Suddes, M; Dobson, R; Curless, R

1999-12-01

We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers. Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures. Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups. Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group.

A meta-analysis of randomized controlled trials of azilsartan therapy for blood pressure reduction.

PubMed

Takagi, Hisato; Mizuno, Yusuke; Niwa, Masao; Goto, Shin-Nosuke; Umemoto, Takuya

2014-05-01

Although there have been a number of azilsartan trials, no meta-analysis of the findings has been conducted to date. We performed the first meta-analysis of randomized controlled trials of azilsartan therapy for the reduction of blood pressure (BP) in patients with hypertension. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched from the beginning of the records through March 2013 using web-based search engines (PubMed and OVID). Eligible studies were prospective randomized controlled trials of azilsartan (including azilsartan medoxomil) vs. any control therapy that reported clinic or 24-h mean BP as an outcome. For each study, data for the changes from baseline to final clinic systolic BP (SBP) and diastolic BP (DBP) in both the azilsartan group and the control group were used to generate mean differences and 95% confidence intervals (CIs). Of 27 potentially relevant articles screened initially, 7 reports of randomized trials of azilsartan or azilsartan medoxomil therapy enrolling a total of 6152 patients with hypertension were identified and included. Pooled analysis suggested a significant reduction in BP changes among patients randomized to 40 mg of azilsartan vs. control therapy (clinic SBP: -4.20 mm Hg; 95% CI: -6.05 to -2.35 mm Hg; P<0.00001; clinic DBP: -2.58 mm Hg; 95% CI: -3.69 to -1.48 mm Hg; P<0.00001; 24-h mean SBP: -3.33 mm Hg; 95% CI: -4.74 to -1.93 mm Hg; P<0.00001; 24-h mean DBP: -2.12 mm Hg; 95% CI: -2.74 to -1.49 mm Hg; P<0.00001). In conclusion, azilsartan therapy appears to provide a greater reduction in BP than control therapy in patients with hypertension.

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

2017-12-01

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.

After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

ERIC Educational Resources Information Center

McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

2006-01-01

This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

PubMed

Howie, Amanda J; Malouff, John M

2014-01-01

Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

Synbiotics could not reduce the scoring of childhood atopic dermatitis (SCORAD): a randomized double blind placebo-controlled trial.

PubMed

Shafiei, Alireza; Moin, Mostafa; Pourpak, Zahra; Gharagozlou, Mohammad; Aghamohammadi, Asghar; Aghamohamadi, Asghar; Sajedi, Vahid; soheili, Habib; Sotoodeh, Soheila; Movahedi, Masoud

2011-03-01

Despite preliminary evidence, the role of probiotic and synbiotic in treatment of the atopic dermatitis has shown varying results. We aimed to evaluate whether synbiotic supplementation decrease severity of atopic dermatitis (AD) in childhood. In a randomized double blind-placebo controlled trial, we evaluated the synbiotic supplementation efficiency on the treatment of atopic dermatitis. Infants aged 1-36 months with moderate to severe atopic dermatitis were randomized (n=41) and received either synbiotic (probiotic plus prebiotic) (n=20) or placebo (n=21) daily as a powder for two months. Emollient (Eucerin) and topical corticosteroid (Hydrocortisone) were permitted. Children were scored for severity of atopic dermatitis (SCORAD). Also allergen Skin Prick Tests (SPT), IgE blood level and eosinophil count were measured at first visit. Patients' SCORAD were reevaluated at the end of intervention. We followed 36 out of 41 subjects for two months (drop out rate = 9%). In the whole group, the mean Total SCORAD (at base line 40.93) decreased by 56% (p=0.00). The mean Objective SCORAD (at base line 31.29) decreased by 53% (p=0.00). There was no significant difference in the mean decrease of total SCORAD between placebo (22.3) and synbiotic groups (24.2). There was also no difference between two intervention groups in the mean decrease of total SCORAD regarding to different demographic, clinical and para clinical subgroups. This study could not confirm synbiotic as an effective treatment for childhood atopic dermatitis and further studies are needed. These findings challenge the role of synbiotics in the treatment of childhood atopic dermatitis.

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

PubMed Central

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

PubMed

Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

2017-02-23

Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

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…

Resistant hypertension optimal treatment trial: a randomized controlled trial.

PubMed

Krieger, Eduardo M; Drager, Luciano F; Giorgi, Dante Marcelo Artigas; Krieger, Jose Eduardo; Pereira, Alexandre Costa; Barreto-Filho, José Augusto Soares; da Rocha Nogueira, Armando; Mill, José Geraldo

2014-01-01

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen. © 2013 Wiley Periodicals, Inc.

Random fiber lasers based on artificially controlled backscattering fibers

NASA Astrophysics Data System (ADS)

Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

2017-10-01

The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

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.

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

A brief randomized controlled intervention targeting parents improves grades during middle school.

PubMed

Destin, Mesmin; Svoboda, Ryan C

2017-04-01

Despite a growing number of brief, psychosocial interventions that improve academic achievement, little research investigates how to leverage parents during such efforts. We designed and tested a randomized controlled intervention targeting parents to influence important discussions about the future and responses to academic difficulty experienced by their adolescent during eighth grade in the United States. We recruited experienced parents to convey the main messages of the intervention in a parent panel format. As expected, current parents who were randomly assigned to observe the parent panel subsequently planned to talk with their adolescents sooner about future opportunities and to respond more positively to experiences of academic difficulty than parents who were randomly assigned to a control group. The intervention also led to a significant increase in student grades, which was mediated by parents' responses to academic difficulty. We suggest an increase in experimental research that utilizes parents to influence student achievement. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

PubMed

De Pascale, Gennaro; Pennisi, Mariano Alberto; Vallecoccia, Maria Sole; Bello, Giuseppe; Maviglia, Riccardo; Montini, Luca; Di Gravio, Valentina; Cutuli, Salvatore Lucio; Conti, Giorgio; Antonelli, Massimo

2017-01-01

To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS). This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually. No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01) and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality. The use AG 100 system and AG tube in critically

Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

PubMed

Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

2010-11-30

Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be

How to Do Random Allocation (Randomization)

PubMed Central

Shin, Wonshik

2014-01-01

Purpose To explain the concept and procedure of random allocation as used in a randomized controlled study. Methods We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper. PMID:24605197

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

ERIC Educational Resources Information Center

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

2011-01-01

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

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Mindfulness training for smoking cessation: A meta-analysis of randomized-controlled trials.

PubMed

Oikonomou, Maria Theodora; Arvanitis, Marios; Sokolove, Robert L

2017-12-01

Recent studies have shown that mindfulness training has a promising potential for smoking treatment. In order to examine the efficacy of mindfulness training in smoking cessation, we performed a systematic review of the literature and meta-analysis of randomized controlled trials. Four randomized controlled trials with 474 patients were included in our analysis. The results showed that 25.2 percent of participants remained abstinent for more than 4 months in the mindfulness group compared to 13.6 percent of those who received usual care therapy (relative risk, 1.88; 95 percent confidence interval, 1.04-3.40). Our results suggest that mindfulness training may have an important role to play in efforts to lower cigarette smoking rates.

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Pedometer Use in University Freshmen: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

LeCheminant, James D.; Smith, John D.; Covington, N. Kay; Hardin-Renschen, Tracie; Heden, Tim

2011-01-01

Objectives: To describe activity patterns associated with a pedometer intervention in university freshmen and compare the intervention participants to controls for several health outcomes. Methods: Forty-six university freshmen were randomized to a group that wore a pedometer across the academic year with a goal of 10,000 steps/day or to a control…

Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

PubMed Central

Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

2013-01-01

Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial

PubMed Central

Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C.; Changrani, Jyotsna

2007-01-01

Background Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. Methods 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. Results 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (β 0.10, 95% CI 0.02–0.18, scale 0–1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. Conclusions While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged

Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

PubMed

Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

2015-04-01

The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

Treating neurocysticercosis medically: a systematic review of randomized, controlled trials.

PubMed

Salinas, R; Counsell, C; Prasad, K; Gelband, H; Garner, P

1999-11-01

To summarize the evidence from randomized controlled trials on the effects of cysticidal therapy used for treating human cysticercosis. Published and unpublished studies in any language identified through MEDLINE (1966 - June 1999) specialized databases, abstracts, proceedings and contact with experts were analysed. Those which compared, using randomized or quasi-randomized methods, any cysticidal drug with placebo or symptomatic therapy were entered in the study. Data were extracted independently by two reviewers and trial quality assessed. Meta-analysis using fixed effects models calculated provided there was no significant heterogeneity, expressed as relative risk. Four trials met the inclusion criteria, treating intraparenchymatous neurocysticercosis with either albendazole or praziquantel compared to placebo or no treatment. In the two trials reporting clinical outcomes, treatment was not associated with a reduction in the risk of seizures, although numbers were small (RR 0.95, 95% CI 0.59-1.51). Four trials reported radiological outcomes, and cysticidal treatment was associated with a lower risk of cyst persistence of scans taken within six months of start of treatment (RR 0.83, 95% CI 0.70-0.99). Subsidiary analysis assuming different outcomes in patients lost to follow-up did not alter the findings of the main analysis. There is insufficient evidence to determine whether cysticidal therapy is of any clinical benefit to patients with neurocysticercosis. The review does not exclude the possibility that more patients remain seizure-free when treated with cysticidal drugs. Further testing through placebo-controlled trials is required.

A randomized, double-blind, placebo controlled, parallel group, efficacy study of alpha BRAIN® administered orally.

PubMed

Solomon, Todd M; Leech, Jarrett; deBros, Guy B; Murphy, Cynthia A; Budson, Andrew E; Vassey, Elizabeth A; Solomon, Paul R

2016-03-01

Alpha BRAIN® is a nootropic supplement that purports to enhance cognitive functioning in healthy adults. The goal of this study was to investigate the efficacy of this self-described cognitive enhancing nootropic on cognitive functioning in a group of healthy adults by utilizing a randomized, double blind, placebo-controlled design. A total of 63-treatment naïve individuals between 18 and 35 years of age completed the randomized, double-blind, placebo controlled trial. All participants completed a 2-week placebo run in before receiving active product, Alpha BRAIN® or new placebo, for 6 weeks. Participants undertook a battery of neuropsychological tests at randomization and at study completion. Primary outcome measures included a battery of neuropsychological tests and measures of sleep. Compared with placebo, Alpha BRAIN® significantly improved on tasks of delayed verbal recall and executive functioning. Results also indicated significant time-by-group interaction in delayed verbal recall for the Alpha BRAIN® group. The use of Alpha BRAIN® for 6 weeks significantly improved recent verbal memory when compared with controls, in a group of healthy adults. While the outcome of the study is encouraging, this is the first randomized controlled trial of Alpha BRAIN®, and the results merit further study. Copyright © 2016 John Wiley & Sons, Ltd.

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

PubMed

Bricker, Jonathan B; Mull, Kristin E; Kientz, Julie A; Vilardaga, Roger; Mercer, Laina D; Akioka, Katrina J; Heffner, Jaimee L

2014-10-01

There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

Efficacy of treatment for somatoform disorders: a review of randomized controlled trials.

PubMed

Kroenke, Kurt

2007-12-01

To review the evidence from randomized clinical trials (RCTs) that have focused on the treatment of patients with Diagnostic and Statistical Manual of Mental Disorders, 4(th) Edition (DSM-IV) somatoform disorders. Although somatoform disorders are among the most common mental disorders presenting in the general medical setting, the strength of evidence for specific treatments has not been well synthesized. MEDLINE search of articles published in English from 1966 to 2006, using the following search terms: randomized clinical trial, somatoform disorders, somatization disorder, undifferentiated somatoform disorder, hypochrondriasis, conversion disorder, pain disorder, and body dysmorphic disorder. A total of 34 RCTs involving 3922 patients were included. Two thirds of the studies involved somatization disorder (n = 4 studies) and lower threshold variants, such as abridged somatization disorder (n = 9) and medically unexplained symptoms (n = 10). Cognitive behavioral therapy (CBT) was effective in most studies (11 of 13), as were antidepressants in a small number (4 of 5) of studies. RCTs examining a variety of other treatments showed benefit in half (8 of 16) of the studies, the most consistent evidence existing for a consultation letter to the primary care physician. Effective treatments have been established for all somatoform disorders except conversion disorder (1 of 3 studies showing benefit) and pain disorder (no studies reported). CBT is the best established treatment for a variety of somatoform disorders, with some benefit also demonstrated for a consultation letter to the primary care physician. Preliminary but not yet conclusive evidence exists for antidepressants.

Effects of Omega-3 Fatty Acids on Resting Cerebral Perfusion in Patients with Mild Cognitive Impairment: A Randomized Controlled Trial.

PubMed

Schwarz, C; Wirth, M; Gerischer, L; Grittner, U; Witte, A V; Köbe, T; Flöel, A

2018-01-01

Alteration of cerebral perfusion can be considered as a possible therapeutic target in mild cognitive impairment. This randomized, placebo-controlled, double-blind proof-of-concept study assessed effects of omega-3 fatty acids on cerebral perfusion in patients with mild cognitive impairment. In thirteen patients (omega:n=5; placebo:n=8) cerebral perfusion was measured before and after 26-weeks intervention within posterior cortical regions using magnetic resonance imaging. There was a medium effect of intervention on cerebral blood flow (η2=0.122) and blood volume (η2=0.098). The omega group showed an increase in blood flow (mean difference: 0.02 [corresponds to 26.1%], 95% confidence interval:0.00-0.05) and blood volume (mean difference: 0.08 [corresponds to 18.5%], 95% confidence interval:0.01-0.15), which was not observed in the placebo group. These preliminary findings suggest that omega-3 fatty acids supplementation may improve perfusion in cerebral regions typically affected in mild cognitive impairment.Regulation of perfusion may help to maintain brain structure and function and potentially delay conversion to dementia.

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

ERIC Educational Resources Information Center

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

2017-01-01

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

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

ERIC Educational Resources Information Center

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

2016-01-01

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

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

PubMed

Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

2013-05-01

This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

The impact of metformin, oral contraceptives, and lifestyle modification on polycystic ovary syndrome in obese adolescent women in two randomized, placebo-controlled clinical trials.

PubMed

Hoeger, Kathleen; Davidson, Kristen; Kochman, Lynda; Cherry, Tracy; Kopin, Laurie; Guzick, David S

2008-11-01

Polycystic ovary syndrome (PCOS) presents in adolescence, and obesity is a common finding. The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear. We investigated the effects of metformin, oral contraceptives (OCs), and/or lifestyle modification in obese adolescent women with PCOS. Two small, randomized, placebo-controlled clinical trials were performed. A total of 79 obese adolescent women with PCOS participated. In the single treatment trial, subjects were randomized to metformin, placebo, a lifestyle modification program, or OC. In the combined treatment trial, all subjects received lifestyle modification and OC and were randomized to metformin or placebo. Serum concentrations of androgens and lipids were measured. Lifestyle modification alone resulted in a 59% reduction in free androgen index with a 122% increase in SHBG. OC resulted in a significant decrease in total testosterone (44%) and free androgen index (86%) but also resulted in an increase in C-reactive protein (39.7%) and cholesterol (14%). The combination of lifestyle modification, OC, and metformin resulted in a 55% decrease in total testosterone, as compared to 33% with combined treatment and placebo, a 4% reduction in waist circumference, and a significant increase in HDL (46%). In these preliminary trials, both lifestyle modification and OCs significantly reduce androgens and increase SHBG in obese adolescents with PCOS. Metformin, in combination with lifestyle modification and OC, reduces central adiposity, reduces total testosterone, and increases HDL, but does not enhance overall weight reduction.

Random fiber laser based on artificially controlled backscattering fibers.

PubMed

Wang, Xiaoliang; Chen, Daru; Li, Haitao; She, Lijuan; Wu, Qiong

2018-01-10

The random fiber laser (RFL), which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previously reported RFLs are based on distributed feedback of Rayleigh scattering amplified through the stimulated Raman-Brillouin scattering effect in single-mode fibers, which require long-distance (tens of kilometers) single-mode fibers and high threshold, up to watt level, due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open-cavity RFL based on a segment of an artificially controlled backscattering single-mode fiber with a length of 210 m, 310 m, or 390 m. A fiber Bragg grating with a central wavelength of 1530 nm and a segment of artificially controlled backscattering single-mode fiber fabricated by using a femtosecond laser form the half-open cavity. The proposed RFL achieves thresholds of 25 mW, 30 mW, and 30 mW, respectively. Random lasing at a wavelength of 1530 nm and extinction ratio of 50 dB is achieved when a segment of 5 m erbium-doped fiber is pumped by a 980 nm laser diode in the RFL. A novel RFL with many short cavities has been achieved with low threshold.

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

PubMed

Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

2012-10-03

Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation

A randomized controlled trial of intranasal ketamine in migraine with prolonged aura.

PubMed

Afridi, Shazia K; Giffin, Nicola J; Kaube, Holger; Goadsby, Peter J

2013-02-12

The aim of our study was to test the hypothesis that ketamine would affect aura in a randomized controlled double-blind trial, and thus to provide direct evidence for the role of glutamatergic transmission in human aura. We performed a double-blinded, randomized parallel-group controlled study investigating the effect of 25 mg intranasal ketamine on migraine with prolonged aura in 30 migraineurs using 2 mg intranasal midazolam as an active control. Each subject recorded data from 3 episodes of migraine. Eighteen subjects completed the study. Ketamine reduced the severity (p = 0.032) but not duration of aura in this group, whereas midazolam had no effect. These data provide translational evidence for the potential importance of glutamatergic mechanisms in migraine aura and offer a pharmacologic parallel between animal experimental work on cortical spreading depression and the clinical problem. This study provides class III evidence that intranasal ketamine is effective in reducing aura severity in patients with migraine with prolonged aura.

Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

NASA Astrophysics Data System (ADS)

Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

2018-02-01

The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

PubMed Central

2016-01-01

Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial.

PubMed

Giosan, Cezar; Cobeanu, Oana; Mogoaşe, Cristina; Szentagotai, Aurora; Mureşan, Vlad; Boian, Rareș

2017-05-12

Depression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of "apps." Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms. However, this small number of studies reports a low statistical power and they have not yet been replicated. Moreover, none of them included an active placebo comparison group. This is problematic, as a "digital placebo effect" may explain some of the positive effects documented until now. The aim of this study is to test a newly developed mobile app firmly grounded in the CBT theory of depression to determine whether this app is clinically useful in decreasing moderate depressive symptoms when compared with an active placebo. Additionally, we are interested in the app's effect on emotional wellbeing and depressogenic cognitions. Romanian-speaking adults (18 years and older) with access to a computer and the Internet and owning a smartphone are included in the study. A randomized, three-arm clinical trial is being conducted (i.e., active intervention, placebo intervention and delayed intervention). Two hundred and twenty participants with moderate depressive symptoms (i.e., obtaining scores >9 and ≤16 on the Patient Health Questionnaire, PHQ-9) will be randomized to the three conditions. Participants undergoing therapy, presenting serious mental health problems, or legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active and placebo interventions will use the smartphone app for 6�

Randomized controlled trials in dentistry: common pitfalls and how to avoid them.

PubMed

Fleming, Padhraig S; Lynch, Christopher D; Pandis, Nikolaos

2014-08-01

Clinical trials are used to appraise the effectiveness of clinical interventions throughout medicine and dentistry. Randomized controlled trials (RCTs) are established as the optimal primary design and are published with increasing frequency within the biomedical sciences, including dentistry. This review outlines common pitfalls associated with the conduct of randomized controlled trials in dentistry. Common failings in RCT design leading to various types of bias including selection, performance, detection and attrition bias are discussed in this review. Moreover, methods of minimizing and eliminating bias are presented to ensure that maximal benefit is derived from RCTs within dentistry. Well-designed RCTs have both upstream and downstream uses acting as a template for development and populating systematic reviews to permit more precise estimates of treatment efficacy and effectiveness. However, there is increasing awareness of waste in clinical research, whereby resource-intensive studies fail to provide a commensurate level of scientific evidence. Waste may stem either from inappropriate design or from inadequate reporting of RCTs; the importance of robust conduct of RCTs within dentistry is clear. Optimal reporting of randomized controlled trials within dentistry is necessary to ensure that trials are reliable and valid. Common shortcomings leading to important forms or bias are discussed and approaches to minimizing these issues are outlined. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

PubMed

Back, Sudie E; McCauley, Jenna L; Korte, Kristina J; Gros, Daniel F; Leavitt, Virginia; Gray, Kevin M; Hamner, Mark B; DeSantis, Stacia M; Malcolm, Robert; Brady, Kathleen T; Kalivas, Peter W

2016-11-01

The antioxidant N-acetylcysteine is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders (SUDs). This study explored the efficacy of N-acetylcysteine in the treatment of posttraumatic stress disorder (PTSD), which frequently co-occurs with SUD and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Veterans with PTSD and SUD per DSM-IV criteria (N = 35) were randomly assigned to receive a double-blind, 8-week course of N-acetylcysteine (2,400 mg/d) or placebo plus cognitive-behavioral therapy for SUD (between March 2013 and April 2014). Primary outcome measures included PTSD symptoms (Clinician-Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analog Scale). Substance use and depression were also assessed. Participants treated with N-acetylcysteine compared to placebo evidenced significant improvements in PTSD symptoms, craving, and depression (β values < -0.33; P values < .05). Substance use was low for both groups, and no significant between-group differences were observed. N-acetylcysteine was well tolerated, and retention was high. This is the first randomized controlled trial to investigate N-acetylcysteine as a pharmacologic treatment for PTSD and SUD. Although preliminary, the findings provide initial support for the use of N-acetylcysteine in combination with psychotherapy among individuals with co-occurring PTSD and SUD. ClinicalTrials.gov identifier: NCT02499029. © Copyright 2016 Physicians Postgraduate Press, Inc.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

Treatment Preferences Affect the Therapeutic Alliance: Implications for Randomized Controlled Trials

ERIC Educational Resources Information Center

Iacoviello, Brian M.; McCarthy, Kevin Scott; Barrett, Marna S.; Rynn, Moira; Gallop, Robert; Barber, Jacques P.

2007-01-01

The influence of treatment preferences on the development of the therapeutic alliance was investigated. Seventy-five patients were followed while participating in a randomized controlled trial comparing supportive-expressive psychotherapy with sertraline or pill placebo in the treatment of major depressive disorder. Therapeutic alliance was…

Resistance training for hot flushes in postmenopausal women: Randomized controlled trial protocol.

PubMed

Berin, Emilia; Hammar, Mats L; Lindblom, Hanna; Lindh-Åstrand, Lotta; Spetz Holm, Anna-Clara E

2016-03-01

Hot flushes and night sweats affect 75% of all women after menopause and is a common reason for decreased quality of life in mid-aged women. Hormone therapy is effective in ameliorating symptoms but cannot be used by all women due to contraindications and side effects. Engagement in regular exercise is associated with fewer hot flushes in observational studies, but aerobic exercise has not proven effective in randomized controlled trials. It remains to be determined whether resistance training is effective in reducing hot flushes and improves quality of life in symptomatic postmenopausal women. The aim of this study is to investigate the effect of standardized resistance training on hot flushes and other health parameters in postmenopausal women. This is an open, parallel-group, randomized controlled intervention study conducted in Linköping, Sweden. Sixty symptomatic and sedentary postmenopausal women with a mean of at least four moderate to severe hot flushes per day or 28 per week will be randomized to an exercise intervention or unchanged physical activity (control group). The intervention consists of 15 weeks of standardized resistance training performed three times a week under supervision of a physiotherapist. The primary outcome is hot flush frequency assessed by self-reported hot flush diaries, and the difference in change from baseline to week 15 will be compared between the intervention group and the control group. The intention is that this trial will contribute to the evidence base regarding effective treatment for hot flushes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.

PubMed

Lee, Tih-Shih; Goh, Siau Juinn Alexa; Quek, Shin Yi; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Teng, Stephanie Sze Wei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Ng, Tze Pin; Lee, Jimmy; Keefe, Richard; Krishnan, K Ranga Rama

2013-01-01

Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and

Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial.

PubMed

Bernhard, Molly C; Li, Peng; Allison, David B; Gohlke, Julia M

2015-01-01

We hypothesized that exposure to temperatures above the thermoneutral zone (TNZ) would decrease food intake in young adults in a sedentary office environment over a 2-h period. Participants wearing standardized clothing were randomized to perform routine office work in the TNZ, considered control (19-20°C), or above the TNZ considered warmer (26-27°C) using a parallel-group design (n = 11 and 9, respectively). Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, first, and second hour during this lunchtime study. Heat dissipation was estimated using peripheral temperature. General linear models were built to examine the effects of thermal treatment on caloric intake and potential mediation by heat dissipation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April to May 2014. During the 2-h stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (p = 0.024) in both groups and there was no significant association between caloric intake and participant's body mass index (BMI). After controlling for thermal treatment, gender and BMI, the participant's peripheral temperature was significantly associated with caloric intake (p = 0.002), suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature suggesting increased heat dissipation, participants ate 85.9 kcal less food. This pilot study provided preliminary evidence of effects of thermal environment on food intake. It suggests that decreased food intake in the experimental (warmer) environment is potentially mediated through thermoregulatory mechanisms.

Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.