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Sample records for 6-month randomized controlled

  1. Replicating ¡Cuídate!: 6-Month Impact Findings of a Randomized Controlled Trial

    PubMed Central

    Layzer, Carolyn; Layzer, Jean; Price, Cristofer; Juras, Randall; Blocklin, Michelle; Mendez, Jacqueline

    2016-01-01

    Objectives. To test whether ¡Cuídate!, a program culturally adapted for Hispanic youths, affects sexual risk behavior. Methods. We evaluated 3 replications of ¡Cuídate! in California, Arizona, and Massachusetts in a randomized controlled trial (registry no. NCT02540304) in which 2169 primarily Hispanic participants were randomly assigned to an intervention (n = 1326) or a control (n = 870) group. Youths were surveyed at baseline (September 2012–April 2014) and 6 months postbaseline (March 2013–October 2014). We estimated pooled and subgroup impacts using a regression framework with baseline covariates to increase statistical precision (1216 youths analyzed in the treatment group, 806 analyzed in the control group). Results. We found no impacts on the study’s primary outcomes of recent sexual activity or recent unprotected sexual activity. However, ¡Cuídate! improved knowledge (10%–20% increase; P < .001), attitudes (effect size = .24; P < .001), and skills (effect size = .14; P = .002). Exploratory subgroup analyses suggest potentially problematic effects for some groups. Conclusions. Findings suggest that ¡Cuídate! was effective in improving youths’ knowledge and attitudes. However, after 6 months, these changes did not translate to improvements in reported sexual risk behaviors. PMID:27689498

  2. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial

    PubMed Central

    Levi, Erika E; Stuart, Gretchen S; Zerden, Matthew L; Garrett, Joanne M; Bryant, Amy G

    2017-01-01

    Objective To compare intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean delivery (during cesarean delivery) IUD placement versus women who planned for interval IUD placement 6 or more weeks postpartum. Methods In this non-blinded randomized trial women who were undergoing a cesarean and desired an IUD were randomized to intracesarean cesarean delivery or interval IUD placement. The primary outcome was IUD use at 6 months postpartum. A sample size of 112 (56 in each group) was planned to detect a 15% difference in IUD use at 6 months postpartum between groups. Results From March 2012 to June 2014, 172 women were screened and 112 women were randomized into the trial. Baseline characteristics were similar between groups. Data regarding IUD use at 6 months postpartum was available for 98 women, 48 and 50 women in the intracesarean and interval groups, respectively. A larger proportion of the women in the intracesarean group were using an IUD at 6 months postpartum ((40/48), 83%) compared to those in the interval group ((32/50) 64%, relative risk [RR]=1.3, 95% confidence interval [CI]: 1.02, 1.66). Among the 56 women randomized to interval IUD insertion, 22 (39%) of them never received an IUD; 14 (25%) never returned for IUD placement, five (9%) women declined an IUD, and three (5%) had a failed IUD placement. Conclusion IUD placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared to interval IUD placement. PMID:26241250

  3. 6-Month Outcomes from a Randomized Controlled Trial to Prevent Perinatal Depression in Low-Income Home Visiting Clients

    PubMed Central

    Tandon, S. Darius; Leis, Julie A.; Mendelson, Tamar; Perry, Deborah F.; Kemp, Karen

    2013-01-01

    Objectives Perinatal depression (PD) has negative consequences for mothers and children and is more prevalent among women of low socioeconomic status. Home visitation programs serve low-income pregnant women at risk for PD. This study tested the efficacy of a group-based cognitive behavioral intervention (Mothers and Babies Course; MB) in reducing depressive symptoms and preventing the onset of perinatal depression among low-income women enrolled in home visitation. Methods A randomized controlled trial was conducted. Seventy-eight women who were pregnant or had a child less than 6 months of age and who were assessed as at risk for PD were randomized to the MB intervention or usual home visiting services. Depressive symptoms were assessed at baseline and 1-week, 3- and 6-months post-intervention; depressive episodes were assessed with a clinical interview at the 6-month follow-up. Results Depressive symptoms declined at a significantly greater rate for intervention participants than usual care participants between baseline and 1-week, 3 months, and 6 months post-intervention. At the six-month follow-up, 15% of women who received the MB intervention had experienced a major depressive episode as compared with 32% of women receiving usual care. Conclusions Integrating mental health interventions into home visitation appears to be a promising approach for preventing PD. Cognitive behavioral techniques can be effective in preventing depression in perinatal populations and treating it. PMID:23793487

  4. Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial

    PubMed Central

    Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; Cho, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro

    2016-01-01

    Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Mini-Mental State Examination, and the Clock Drawing Test. Physical performance was evaluated by exercise time, the number of pedal rotation, total load, grip strength, and the Berg Balance Scale (BBS). Results In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements. Conclusion This study indicates that it is possible to improve cognitive function in older adults with moderate to severe AD through 6-month physical exercise with a multicomponent cognitive intervention. PMID:27403134

  5. A randomized controlled trial of a mindfulness-based intervention program for people with schizophrenia: 6-month follow-up

    PubMed Central

    Wang, Li-Qun; Chien, Wai Tong; Yip, Lai King; Karatzias, Thanos

    2016-01-01

    Mindfulness-based interventions have been increasingly evidenced to be effective in different mental illnesses but limited in schizophrenia. This single-blind, multisite randomized controlled trial tested the effects of a mindfulness-based psychoeducation group program (MPGP in addition to usual care) versus a conventional psychoeducation group program (CPGP) versus treatment-as-usual (TAU) alone, in schizophrenia spectrum disorders over a 6-month follow-up. In each of the two study sites (outpatient clinics), 69 outpatients with schizophrenia or its subtypes (N=138) were randomly allocated to one of the three study groups (n=46) after baseline measurements and underwent 6 months of intervention. Primary outcomes including patients’ mental state and rehospitalization rate and other secondary outcomes were assessed at entry and at 1 week and 6 months. One hundred and thirty-one (95%) participants completed the interventions assigned and one to two post-tests. Multivariate analyses of variance (followed by univariate contrast tests) indicated that the MPGP participants reported greater reductions in their psychotic symptoms (P=0.003) and length/duration of rehospitalizations (P=0.005) at 6-month follow-up. Patients in the MPGP group also reported greater improvements in their insight into illness/treatment (P=0.0008) and level of functioning (P=0.002) than the CPGP and TAU alone at the 1-week and 6-month follow-up. Overall, the findings suggest that MPGP can be useful in improving the short- to medium-term clinical outcomes of outpatients with schizophrenia spectrum disorders, not only in terms of their mental state and risk of relapse but also their insight into illness/treatment and psychosocial functioning. PMID:27994466

  6. The effect of risedronate treatment on serum cytokines in postmenopausal osteoporosis: a 6-month randomized and controlled study.

    PubMed

    Dundar, Umit; Kavuncu, Vural; Ciftci, Ihsan H; Evcik, Deniz; Solak, Ozlem; Cakir, Tuncay

    2009-01-01

    There is much evidence suggesting that the decline in ovarian function after menopause is associated with spontaneous increases in proinflammatory cytokines. Treatment with risedronate is accompanied by significant changes in bone turnover and bone mineral density. The objective of this study was to determine the effects of risedronate treatment on the level of serum cytokines including receptor activator of nuclear factor-kappaB ligand (RANKL) and osteoprotegerin among postmenopausal women with osteoporosis. The study group consisted of 61 postmenopausal women with osteoporosis. Patients were randomly divided in two groups: In group 1 (n = 41) postmenopausal women received oral risedronate (35 mg/week), calcium (1,000 mg/day), and vitamin D (400 IU/day) for 12 months. In group 2 (control group; n = 20) patients received only oral calcium (1,000 mg/day) and vitamin D (400 IU/day). Bone mineral density (BMD) of lumbar spine (L1-L4) and proximal femur were determined using dual X-ray absorptiometry at baseline and after one year. Venous blood samples were obtained for determination of serum cytokines including interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha), RANKL, osteoprotegerin, and markers of bone formation and resorption. Levels of serum cytokines were measured before therapy and after three and 6 months. Markers of bone metabolism were studied before therapy and after 6 months. In group 1 (risedronate plus calcium/vitamin D-treated patients), serum levels of RANKL and IL-1beta significantly decreased and the level of osteoprotegerin significantly increased after three and 6 months, but no significant difference was found in TNF-alpha level. In group 2, however, the level of serum cytokines did not change after three and 6 months. In cases of bone turnover, both markers of bone resorption and formation significantly decreased after 6 months in group 1. In conclusion risedronate could improve osteoporosis by increasing osteoprotegerin and

  7. Effects of growth hormone in women with abdominal adiposity: a 6-month randomized, double-blind, placebo-controlled trial

    PubMed Central

    Bredella, Miriam A.; Lin, Eleanor; Brick, Danielle J.; Gerweck, Anu V.; Harrington, Lindsey M.; Torriani, Martin; Thomas, Bijoy J.; Schoenfeld, David A.; Breggia, Anne; Rosen, Clifford J.; Hemphill, Linda C.; Wu, Zida; Rifai, Nader; Utz, Andrea L.; Miller, Karen K.

    2013-01-01

    Objective Abdominal adiposity is associated with increased cardiovascular risk and decreased growth hormone (GH) secretion. The objective of our study was to determine the effects of GH in abdominally obese women on body composition and cardiovascular risk markers. Materials and Methods In this randomized, double-blind, placebo-controlled study, 79 obese premenopausal women received GH vs. placebo for six months. Primary endpoints were: 1) total abdominal (TAT) fat by CT (body composition) and 2) high-sensitivity C-reactive protein (hsCRP) (cardiovascular risk marker). Body composition was assessed by CT, DXA and proton MR spectroscopy. Serum cardiovascular risk markers, carotid intima-media thickness and endothelial function were measured. Results Mean 6-month GH dose was 1.7±0.1 mg/day, resulting in a mean IGF-1 SDS increase from −1.7±0.08 to −0.1±0.3 in the GH group. GH administration decreased TAT and hsCRP compared with placebo. In addition, it increased thigh muscle mass and lean body mass, and decreased subcutaneous abdominal and trunk fat, tPA, apoB, and apoB/LDL compared with placebo. Visceral adipose tissue decreased and IMCL increased within the GH group. Six-month change in IGF-1 levels was negatively associated with 6-month decrease in TAT and VAT. One subject had a 2-hour glucose >200 mg/mL at 3 months; four subjects, three of whom were randomized to GH, had 2-hour glucose levels >200 mg/mL at study end. Conclusion GH administration in abdominally obese premenopausal women exerts beneficial effects on body composition and cardiovascular risk markers, but is associated with a decrease in glucose tolerance in a minority of women. PMID:22275471

  8. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  9. A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia

    PubMed Central

    2013-01-01

    Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease, lifestyle and the use of medications, which are related to weight gain. Methods A multicentric, randomized, controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program (LWP). The program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives. Patients were randomized into two groups: standard care (SC) and standard care plus intervention (LWP). Primary outcome was defined as the weight and body mass index (BMI). Results 160 patients participated in the study (81 in the intervention group and 79 in the SC group). On an intent to treat analysis, after three months the patients in the intervention group presented a decrease of 0.48 kg (CI 95% -0.65 to 1.13) while the standard care group showed an increase of 0.48 kg (CI 95% 0.13 to 0.83; p=0.055). At six-month follow-up, there was a significant weight decrease of −1.15 kg, (CI 95% -2.11 to 0.19) in the intervention group compared to a weight increase in the standard care group (+0.5 kg, CI 95% -0.42–1.42, p=0.017). Conclusion In conclusion, this was a multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight. Clinicaltrials.gov identifier NCT01368406 PMID:23418863

  10. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

    PubMed

    Luciano, Juan V; Guallar, José A; Aguado, Jaume; López-Del-Hoyo, Yolanda; Olivan, Bárbara; Magallón, Rosa; Alda, Marta; Serrano-Blanco, Antoni; Gili, Margalida; Garcia-Campayo, Javier

    2014-04-01

    In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

  11. Changes in Gait Symmetry After Training on a Treadmill with Biofeedback in Chronic Stroke Patients: A 6-Month Follow-Up from a Randomized Controlled Trial

    PubMed Central

    Drużbicki, Mariusz; Guzik, Agnieszka; Przysada, Grzegorz; Kwolek, Andrzej; Brzozowska-Magoń, Agnieszka; Sobolewski, Marek

    2016-01-01

    Background One of the most significant challenges for patients who survive a stroke is relearning basic motor tasks such as walking. The goal of this study was to evaluate whether training on a treadmill with visual biofeedback improves gait symmetry, as well as spatiotemporal and kinematic gait parameters, in stroke patients. Material/Methods Thirty patients in the chronic phase after a stroke were randomly allocated into groups with a rehabilitation program of treadmill training with or without visual biofeedback. The training program lasted 10 days. Spatiotemporal and kinematic gait parameters were evaluated. For all parameters analyzed, a symmetrical index was calculated. Follow-up studies were performed 6 months after completion of the program. Results The symmetrical index had significantly normalized in terms of the step length (p=0.006), stance phase time, and inter-limb ratio in the intervention group. After 6 months, the improvement in the symmetry of the step length had been maintained. In the control group, no statistically significant change was observed in any of the parameters tested. There was no significant difference between the intervention group and the control group on completion of the program or at 6 months following the completion of the program. Conclusions Training on a treadmill has a significant effect on the improvement of spatiotemporal parameters and symmetry of gait in patients with chronic stroke. In the group with the treadmill training using visual biofeedback, no significantly greater improvement was observed. PMID:27941712

  12. A 6-month follow-up study of the randomized controlled Ma-Pi macrobiotic dietary intervention (MADIAB trial) in type 2 diabetes

    PubMed Central

    Soare, A; Del Toro, R; Khazrai, Y M; Di Mauro, A; Fallucca, S; Angeletti, S; Skrami, E; Gesuita, R; Tuccinardi, D; Manfrini, S; Fallucca, F; Pianesi, M; Pozzilli, P

    2016-01-01

    Background: In the MADIAB trial (a 21-day randomized, controlled trial in patients with type 2 diabetes (T2D)), intervention with the Ma-Pi 2 macrobiotic diet resulted in significantly greater improvements in metabolic control compared with a standard recommended diet for patients with T2D. We report on a 6-month follow-up study, which investigated, whether these benefits extended beyond the 21-day intensive dietary intervention, in real-world conditions. Subjects: At the end of the MADIAB trial (baseline of this follow-up study), all participants continued their assigned diet (Ma-Pi or control) for 6 months. The Ma-Pi 2 group followed the Ma-Pi 4 diet during this follow-up study. Forty of the original 51 subjects (78.4%) participated in the follow-up (body mass index, 27–45 kg m−2; age, 40–75 years). Primary outcome was percentage change from baseline in HbA1c; secondary outcomes were anthropometric data and lipid panel. Results: A significantly greater median percentage reduction was observed for HbA1c in the Ma-Pi group (−11.27% (95% confidence interval (CI): −10.17; −12.36)) compared with the control group (−5.88% (95% CI: −3.79; −7.98)) (P < 0.001). Total and low-density lipoprotein (LDL) cholesterol increased in both groups with no differences between groups (P=0.331 and P=0.082, respectively). After correcting for age and gender, the Ma-Pi diet was associated with a higher percentage reduction in HbA1c (95% CI: 2.56; 7.61) and body weight (95% CI: 0.40; 3.99), and a higher percentage increase in LDL cholesterol (95% CI: −1.52; −33.16). However, all participants' total and LDL cholesterol levels remained within recommended ranges (<200 mg dl−1 and <100 mg dl−1, respectively). The Ma-Pi diet group achieved the target median HbA1c value (<5.7% (39 mmol mol−1)) at 6 months. Conclusions: Both the Ma-Pi and control diets maintained their benefits beyond the 21-day intensive monitored intervention over a 6-month follow

  13. Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study

    PubMed Central

    Stulik, Jan; Chrobok, Jan; Ruffing, Sabine; Drumm, Jörg; Sova, Laurentius; Kucera, Ravel; Vyskocil, Tomas; Steudel, Wolf Ingo

    2007-01-01

    Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications

  14. Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

    PubMed Central

    2010-01-01

    Background Melatonin is extensively used in the USA in a non-regulated manner for sleep disorders. Prolonged release melatonin (PRM) is licensed in Europe and other countries for the short term treatment of primary insomnia in patients aged 55 years and over. However, a clear definition of the target patient population and well-controlled studies of long-term efficacy and safety are lacking. It is known that melatonin production declines with age. Some young insomnia patients also may have low melatonin levels. The study investigated whether older age or low melatonin excretion is a better predictor of response to PRM, whether the efficacy observed in short-term studies is sustained during continued treatment and the long term safety of such treatment. Methods Adult outpatients (791, aged 18-80 years) with primary insomnia, were treated with placebo (2 weeks) and then randomized, double-blind to 3 weeks with PRM or placebo nightly. PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks with 2 weeks of single-blind placebo run-out. Main outcome measures were sleep latency derived from a sleep diary, Pittsburgh Sleep Quality Index (PSQI), Quality of Life (World Health Organzaton-5) Clinical Global Impression of Improvement (CGI-I) and adverse effects and vital signs recorded at each visit. Results On the primary efficacy variable, sleep latency, the effects of PRM (3 weeks) in patients with low endogenous melatonin (6-sulphatoxymelatonin [6-SMT] ≤8 μg/night) regardless of age did not differ from the placebo, whereas PRM significantly reduced sleep latency compared to the placebo in elderly patients regardless of melatonin levels (-19.1 versus -1.7 min; P = 0.002). The effects on sleep latency and additional sleep and daytime parameters that improved with PRM were maintained or enhanced over the 6-month period with no signs of tolerance. Most adverse events were mild in severity with no clinically relevant

  15. A randomized, double-blind, placebo-controlled noninferiority trial of amoxicillin for clinically diagnosed acute otitis media in children 6 months to 5 years of age

    PubMed Central

    Le Saux, Nicole; Gaboury, Isabelle; Baird, Marian; Klassen, Terry P.; MacCormick, Johnna; Blanchard, Colline; Pitters, Carrol; Sampson, Margaret; Moher, David

    2005-01-01

    Objectives Debate continues with respect to a “watch and wait” approach versus immediate antibiotic treatment for the initial treatment of acute otitis media. In this double-blind noninferiority trial, we compared clinical improvement rates at 14 days for children (6 months to 5 years of age) with acute otitis media who were randomly assigned to receive amoxicillin or placebo. Methods We enrolled healthy children who presented to clinics or the emergency department with a new episode of acute otitis media during the fall and winter months in Ottawa (from December 1999 to the end of March 2002). The children were randomly assigned to receive amoxicillin (60 mg/kg daily) or placebo for 10 days. Telephone follow-up was performed on each of days 1, 2 and 3 and once between day 10 and day 14. The primary outcome was clinical resolution of symptoms, defined as absence of receipt of an antimicrobial (other than the amoxicillin in the treatment group) at any time during the 14-day period. Secondary outcomes were the presence of pain and fever and the activity level in the first 3 days, recurrence rates, and the presence of middle ear effusion at 1 and 3 months. Results According to clinical scoring, 415 of the 512 children who could be evaluated had moderate disease. At 14 days 84.2% of the children receiving placebo and 92.8% of those receiving amoxicillin had clinical resolution of symptoms (absolute difference –8.6%, 95% confidence interval –14.4% to –3.0%). Children who received placebo had more pain and fever in the first 2 days. There were no statistical differences in adverse events between the 2 groups, nor were there any significant differences in recurrence rates or middle ear effusion at 1 and 3 months. Interpretation Our results did not support the hypothesis that placebo was noninferior to amoxicillin (i.e., that the 14-day cure rates among children with clinically diagnosed acute otitis media would not be substantially worse in the placebo group

  16. In Alzheimer’s Disease, 6-Month Treatment with GLP-1 Analog Prevents Decline of Brain Glucose Metabolism: Randomized, Placebo-Controlled, Double-Blind Clinical Trial

    PubMed Central

    Gejl, Michael; Gjedde, Albert; Egefjord, Lærke; Møller, Arne; Hansen, Søren B.; Vang, Kim; Rodell, Anders; Brændgaard, Hans; Gottrup, Hanne; Schacht, Anna; Møller, Niels; Brock, Birgitte; Rungby, Jørgen

    2016-01-01

    In animal models, the incretin hormone GLP-1 affects Alzheimer’s disease (AD). We hypothesized that treatment with GLP-1 or an analog of GLP-1 would prevent accumulation of Aβ and raise, or prevent decline of, glucose metabolism (CMRglc) in AD. In this 26-week trial, we randomized 38 patients with AD to treatment with the GLP-1 analog liraglutide (n = 18), or placebo (n = 20). We measured Aβ load in brain with tracer [11C]PIB (PIB), CMRglc with [18F]FDG (FDG), and cognition with the WMS-IV scale (ClinicalTrials.gov NCT01469351). The PIB binding increased significantly in temporal lobe in placebo and treatment patients (both P = 0.04), and in occipital lobe in treatment patients (P = 0.04). Regional and global increases of PIB retention did not differ between the groups (P ≥ 0.38). In placebo treated patients CMRglc declined in all regions, significantly so by the following means in precuneus (P = 0.009, 3.2 μmol/hg/min, 95% CI: 5.45; 0.92), and in parietal (P = 0.04, 2.1 μmol/hg/min, 95% CI: 4.21; 0.081), temporal (P = 0.046, 1.54 μmol/hg/min, 95% CI: 3.05; 0.030), and occipital (P = 0.009, 2.10 μmol/hg/min, 95% CI: 3.61; 0.59) lobes, and in cerebellum (P = 0.04, 1.54 μmol/hg/min, 95% CI: 3.01; 0.064). In contrast, the GLP-1 analog treatment caused a numerical but insignificant increase of CMRglc after 6 months. Cognitive scores did not change. We conclude that the GLP-1 analog treatment prevented the decline of CMRglc that signifies cognitive impairment, synaptic dysfunction, and disease evolution. We draw no firm conclusions from the Aβ load or cognition measures, for which the study was underpowered. PMID:27252647

  17. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial.

    PubMed

    Russell, I Jon; Mease, Philip J; Smith, Timothy R; Kajdasz, Daniel K; Wohlreich, Madelaine M; Detke, Michael J; Walker, Daniel J; Chappell, Amy S; Arnold, Lesley M

    2008-06-01

    The primary objectives of this study were to assess the efficacy and safety of duloxetine for reducing pain severity in fibromyalgia patients with or without current major depressive disorder. This was a 6-month, multicenter, randomized, double-blind, placebo-controlled study. In total, 520 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to duloxetine (20 mg/day, 60 mg/day, or 120 mg/day) or placebo, administered once daily, for 6 months (after 3 months, the duloxetine 20-mg/day group titrated to 60 mg/day). The co-primary outcome measures were the Brief Pain Inventory (BPI) average pain severity score and Patient Global Impressions of Improvement (PGI-I) score. Safety was assessed via treatment-emergent adverse events, and changes in vital sign, laboratory, and ECG measures. Compared with placebo-treated patients, those patients treated with duloxetine 120 mg/day improved significantly more on the co-primary outcome measures at 3 months (change in BPI score [-2.31 vs -1.39, P<0.001] and PGI-I [2.89 vs 3.39, P=0.004]) and at 6 months (change in BPI [-2.26 vs -1.43, P=0.003] and PGI-I [2.93 vs 3.37, P=0.012]). Compared with placebo, treatment with duloxetine 60 mg/day also significantly improved the co-primary measures at 3 months and BPI at 6 months. Duloxetine was efficacious in patients both with and without major depressive disorder. There were no clinically significant differences between treatment groups in changes in vital signs, laboratory measures, or ECG measures. Study results demonstrated that duloxetine at doses of 60 mg/day and 120 mg/day appears to be safe and efficacious in patients with fibromyalgia.

  18. Extending initial prednisolone treatment in a randomized control trial from 3 to 6 months did not significantly influence the course of illness in children with steroid-sensitive nephrotic syndrome.

    PubMed

    Sinha, Aditi; Saha, Abhijeet; Kumar, Manish; Sharma, Sonia; Afzal, Kamran; Mehta, Amarjeet; Kalaivani, Mani; Hari, Pankaj; Bagga, Arvind

    2015-01-01

    While studies show that prolonged initial prednisone therapy reduces the frequency of relapses in nephrotic syndrome, they lack power and have risk of bias. In order to examine the effect of prolonged therapy on frequency of relapses, we conducted a blinded, 1:1 randomized, placebo-controlled trial in 5 academic hospitals in India on 181 patients, 1-12 years old, with a first episode of steroid-sensitive nephrotic syndrome. Following 12 weeks of standard therapy, in random order, 92 patients received tapering prednisolone while 89 received matching-placebo on alternate days for the next 12 weeks. On intention-to-treat analyses, primary outcome of number of relapses at 1 year was 1.26 in the 6-month group and 1.54 in the 3-month group (difference -0.28; 95% confidence interval (CI) -0.75, 0.19). Relative relapse rate for 6- vs. 3-month therapy, adjusted for gender, age, and time to initial remission, was 0.70 (95% CI 0.47-1.10). Similar proportions of patients had sustained remission, frequent relapses, and adverse effects due to steroids. Adjusted hazard ratios for first relapse and frequent relapses with prolonged therapy were 0.57 (95% CI, 0.36-1.07) and 1.01 (95% CI, 0.61-1.67), respectively. Thus, extending initial prednisolone treatment from 3 to 6 months does not influence the course of illness in children with nephrotic syndrome. These findings have implications for guiding the duration of therapy of nephrotic syndrome.

  19. Randomized controlled trial of primary care physician motivational interviewing versus brief advice to engage adolescents with an Internet-based depression prevention intervention: 6-month outcomes and predictors of improvement.

    PubMed

    Hoek, Willemijn; Marko, Monika; Fogel, Joshua; Schuurmans, Josien; Gladstone, Tracy; Bradford, Nathan; Domanico, Rocco; Fagan, Blake; Bell, Carl; Reinecke, Mark A; Van Voorhees, Benjamin W

    2011-12-01

    We believe that primary care physicians could play a key role in engaging youth with a depression prevention intervention. We developed CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral and Interpersonal Training), which is an adolescent Internet-based behavior change model. We conducted a randomized comparison of two approaches in engaging adolescents with the Internet intervention: primary care physician (PCP) motivational interview + CATCH-IT Internet program (MI) vs PCP brief advice + CATCH-IT Internet program (BA). The participants (N = 84) were recruited by screening for risk of depression in 13 primary care practices. We compared depressive disorder outcomes between groups and within groups over 6 months and examined the potential predictors and moderators of outcomes across both study arms. Depressive symptom scores declined from baseline to 6 weeks with these statistically significant reductions sustained at the 6 months follow-up in both groups. No significant interactions with treatment condition were found. However, by 6 months, the MI group demonstrated significantly fewer depressive episodes and reported less hopelessness as compared with the BA group. Hierarchical linear modeling regressions showed higher ratings of ease of use of the Internet program predicting lower depressive symptom levels over 6 months. In conclusion, a primary care/Internet-based intervention model among adolescents demonstrated reductions in depressed mood over 6 months and may result in fewer depressive episodes.

  20. Efficacy of As-Needed Nalmefene in Alcohol-Dependent Patients with at Least a High Drinking Risk Level: Results from a Subgroup Analysis of Two Randomized Controlled 6-Month Studies

    PubMed Central

    van den Brink, Wim; Aubin, Henri-Jean; Bladström, Anna; Torup, Lars; Gual, Antoni; Mann, Karl

    2013-01-01

    Aims: The aim of the study was to investigate the efficacy and safety of as-needed use of nalmefene 18 mg versus placebo in reducing alcohol consumption in patients who did not reduce their alcohol consumption after an initial assessment, i.e. the pooled subgroup of patients with at least a high drinking risk level (men: >60 g/day; women: >40 g/day) at both screening and randomization from the two randomized controlled 6-month studies ESENSE 1 (NCT00811720) and ESENSE 2 (NCT00812461). Methods: Nalmefene 18 mg and placebo were taken on an as-needed basis. All the patients also received a motivational and adherence-enhancing intervention (BRENDA). The co-primary outcomes were number of heavy drinking days (HDDs) and mean total alcohol consumption (g/day) in Month 6 measured using the Timeline Follow-back method. Additionally, data on clinical improvement, liver function and safety were collected throughout the study. Results: The pooled population consisted of 667 patients: placebo n = 332; nalmefene n = 335. There was a superior effect of nalmefene compared with placebo in reducing the number of HDDs [treatment difference: −3.2 days (95% CI: −4.8; −1.6); P < 0.0001] and total alcohol consumption [treatment difference: −14.3 g/day (−20.8; −7.8); P < 0.0001] at Month 6. Improvements in clinical status and liver parameters were greater in the nalmefene group compared with the placebo group. Adverse events and adverse events leading to dropout were more common with nalmefene than placebo. Conclusion: As-needed nalmefene was efficacious in reducing alcohol consumption in patients with at least a high drinking risk level at both screening and randomization, and the effect in this subgroup was larger than in the total population. PMID:23873853

  1. No effect of 6-month intake of glucosamine sulfate on Modic changes or high intensity zones in the lumbar spine: sub-group analysis of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background The underlying pathology and natural course of Modic changes (MC) in the vertebral body marrow and high intensity zones (HIZs) in the annulus fibrosus is not completely clarified. These findings on magnetic resonance imaging (MRI) have initiated different treatments with little or unclear effect. In a randomized trial (n = 250), glucosamine sulfate (GS) had no effect on low back pain related disability. GS could still have an effect on MC and HIZ. In this sub-study, 45 patients from the trial who had MC and/or HIZ at pre-treatment underwent follow-up MRI. The aim was to examine the course of MC and HIZ and to compare this course between groups treated with 6-month intake of oral GS versus placebo. Results Of 141 pre-treatment MC in 42 (of 45) patients, 29 (20.6%) MC in 18 patients had altered type and 14 MC in 9 patients had altered size (decreased for 1 MC) 6-18 months later: odds ratio (OR) for type vs. size alterations 4.0; 95% confidence interval (CI) 1.2-17.7. No MC resolved. HIZ vanished from 3 of 23 discs in 3 of 21 patients with pre-treatment HIZ. Ten new MC (all type I or I/II) occurred in 8 patients and 2 new HIZs in 2 patients. The GS group (n = 19) and placebo group (n = 26) did not differ in proportions of MC with decreased (OR 1.6; 95% CI 0.4-6.1) or increased type I dominance at follow-up (OR placebo:GS 2.4; 95% CI 0.6-9.7), or with increased size (OR 1.0; 95% CI 0.2-4.7). HIZ vanished from 1 of 8 discs in 1 of 8 patients in the GS group vs. 2 of 15 discs in 2 of 13 patients in the placebo group (OR 0.8; 95% CI 0.02-12.2). Conclusions In this sub-group analysis of a placebo-controlled trial, the effect of GS on MC and HIZs was no different from the effect of the placebo intervention. MC and HIZs remained mostly unchanged during the 6-18 months study period. Some short term changes did occur and MC more often altered type than size. Trial registration NCT00404079 at http://www.clinicaltrial.gov. PMID:22900984

  2. Multicomponent physical exercise with simultaneous cognitive training to enhance dual-task walking of older adults: a secondary analysis of a 6-month randomized controlled trial with 1-year follow-up

    PubMed Central

    Eggenberger, Patrick; Theill, Nathan; Holenstein, Stefan; Schumacher, Vera; de Bruin, Eling D

    2015-01-01

    Background About one-third of people older than 65 years fall at least once a year. Physical exercise has been previously demonstrated to improve gait, enhance physical fitness, and prevent falls. Nonetheless, the addition of cognitive training components may potentially increase these effects, since cognitive impairment is related to gait irregularities and fall risk. We hypothesized that simultaneous cognitive–physical training would lead to greater improvements in dual-task (DT) gait compared to exclusive physical training. Methods Elderly persons older than 70 years and without cognitive impairment were randomly assigned to the following groups: 1) virtual reality video game dancing (DANCE), 2) treadmill walking with simultaneous verbal memory training (MEMORY), or 3) treadmill walking (PHYS). Each program was complemented with strength and balance exercises. Two 1-hour training sessions per week over 6 months were applied. Gait variables, functional fitness (Short Physical Performance Battery, 6-minute walk), and fall frequencies were assessed at baseline, after 3 months and 6 months, and at 1-year follow-up. Multiple regression analyses with planned comparisons were carried out. Results Eighty-nine participants were randomized to three groups initially; 71 completed the training and 47 were available at 1-year follow-up. DANCE/MEMORY showed a significant advantage compared to PHYS in DT costs of step time variability at fast walking (P=0.044). Training-specific gait adaptations were found on comparing DANCE and MEMORY: DANCE reduced step time at fast walking (P=0.007) and MEMORY reduced gait variability in DT and DT costs at preferred walking speed (both trend P=0.062). Global linear time effects showed improved gait (P<0.05), functional fitness (P<0.05), and reduced fall frequency (−77%, P<0.001). Only single-task fast walking, gait variability at preferred walking speed, and Short Physical Performance Battery were reduced at follow-up (all P<0.05 or

  3. Pain and emotions reported after childbirth and recalled 6 months later: the role of controllability.

    PubMed

    Tinti, Carla; Schmidt, Susanna; Businaro, Nicoletta

    2011-06-01

    The aim of this longitudinal study was twofold: to investigate the relationship between subjectively evaluated control, positive and negative emotional feelings, and pain intensity during childbirth; to assess the recall of these aspects of childbirth experience 6 months after delivery. Participants were 123 women who delivered naturally and spoke fluent Italian. Results showed that both immediately after delivery and 6 months later, higher subjective controllability was related to less severe reported pain, more intense positive emotions and less intense negative emotions. Furthermore, although there was no significant bias in the vividness of the recall, 6 months after delivery women reported higher subjective controllability, more intense positive emotions, less intense negative emotions and less intense pain. It is concluded that in preparing women for childbirth, two aspects deserve particular attention: the enhancement of subjectively perceived controllability and the possibility to work on both negative and positive emotions.

  4. Overcoming the need for a cold chain with conjugated meningococcal Group C vaccine: A controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months.

    PubMed

    Schöndorf, Ines; Banzhoff, Angelika; Nicolay, Uwe; Diaz-Mitoma, Francisco

    2007-01-26

    Millions of vaccine doses are wasted each year due to a lapse in recommended storage conditions. Maintaining the cold chain for vaccines is both expensive and difficult, especially in developing countries. The present study investigated the safety and immunogenicity of a single dose of the conjugated meningococcal Group C vaccine, Menjugate, stored for 6 months at room temperature (25+/-2 degrees C, N=250) or at 2-8 degrees C (N=250) when administered to 12-23 months toddlers. In the two respective groups, 87 and 88% of toddlers reached bactericidal antibodies titers of at least 1:8. The immunogenicity of Menjugate stored at room temperature was not inferior to that stored at 2-8 degrees C. The safety profile and immunogenicity of the vaccine was not influenced by the storage condition.

  5. Conditioning 1-6 Month Old Infants by Means of Myoelectrically Controlled Reinforcement.

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

    In order to evaluate possibilities of fitting myoelectrically controlled prosthetic arms on infants, this study examined whether 32 infants (1-6 months) could learn to control environmental contingencies by means of contracting the forearm flexor muscle group. Results indicated that older subjects (age greater than 104 days) demonstrated learning,…

  6. Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

    PubMed Central

    Wolf, Dörte; Otto, Joachim

    2015-01-01

    Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number 2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population. PMID:26693229

  7. Add-on prolonged-release melatonin for cognitive function and sleep in mild to moderate Alzheimer’s disease: a 6-month, randomized, placebo-controlled, multicenter trial

    PubMed Central

    Wade, Alan G; Farmer, Mildred; Harari, Gil; Fund, Naama; Laudon, Moshe; Nir, Tali; Frydman-Marom, Anat; Zisapel, Nava

    2014-01-01

    Purpose A link between poor sleep quality and Alzheimer’s disease (AD) has recently been suggested. Since endogenous melatonin levels are already reduced at preclinical AD stages, it is important to ask whether replenishing the missing hormone would be beneficial in AD and whether any such effects would be related to the presence of sleep disorder in patients. Patients and methods The effects of add-on prolonged-release melatonin (PRM) (2 mg) to standard therapy on cognitive functioning and sleep were investigated in 80 patients (men [50.7%], women [49.3%], average age 75.3 years [range, 52–85 years]) diagnosed with mild to moderate AD, with and without insomnia comorbidity, and receiving standard therapy (acetylcholinesterase inhibitors with or without memantine). In this randomized, double-blind, parallel-group study, patients were treated for 2 weeks with placebo and then randomized (1:1) to receive 2 mg of PRM or placebo nightly for 24 weeks, followed by 2 weeks placebo. The AD Assessment Scale–Cognition (ADAS-Cog), Instrumental Activities of Daily Living (IADL), Mini–Mental State Examination (MMSE), sleep, as assessed by the Pittsburgh Sleep Quality Index (PSQI) and a daily sleep diary, and safety parameters were measured. Results Patients treated with PRM (24 weeks) had significantly better cognitive performance than those treated with placebo, as measured by the IADL (P=0.004) and MMSE (P=0.044). Mean ADAS-Cog did not differ between the groups. Sleep efficiency, as measured by the PSQI, component 4, was also better with PRM (P=0.017). In the comorbid insomnia (PSQI ≥6) subgroup, PRM treatment resulted in significant and clinically meaningful effects versus the placebo, in mean IADL (P=0.032), MMSE score (+1.5 versus −3 points) (P=0.0177), and sleep efficiency (P=0.04). Median ADAS-Cog values (−3.5 versus +3 points) (P=0.045) were significantly better with PRM. Differences were more significant at longer treatment duration. PRM was well

  8. Short-burst oxygen therapy for COPD patients: a 6-month randomised, controlled study.

    PubMed

    Eaton, T; Fergusson, W; Kolbe, J; Lewis, C A; West, T

    2006-04-01

    Short-burst oxygen therapy (SBOT) remains widely advocated for patients with chronic obstructive pulmonary disease (COPD), despite a lack of supporting evidence. The aim of this randomised, double-blind, placebo-controlled, parallel group study was to determine whether SBOT improves health-related quality of life (HRQL) or reduces acute healthcare utilisation in patients discharged following an acute exacerbation of COPD. Consecutive patients were screened; 78 of 331 were eligible for randomisation to cylinder oxygen, cylinder air or usual care following discharge. Patients were elderly with high acute healthcare utilisation, forced expiratory volume in one second of <1 L and had dyspnoea limiting daily activity but were not hypoxaemic at rest. Over the 6-month study period, there were no significant differences between patient groups in HRQL (Chronic Respiratory Questionnaire (CRQ), 36-item Short-Form Health Survey, Hospital Anxiety and Depression Scale) except for CRQ emotion domain. There were no significant differences in acute healthcare utilisation. Time to readmission was greatest in the usual care group. Cylinder use was high initially, but rapidly fell to very low levels within weeks in both cylinder oxygen and air groups. In conclusion, the availability of short-burst oxygen therapy for chronic obstructive pulmonary disease patients discharged from hospital following an acute exacerbation did not improve health-related quality of life or reduce acute healthcare utilisation. These results provide no support for the widespread use of short-burst oxygen therapy.

  9. A randomized, double-blind trial comparing sertraline and fluoxetine 6-month treatment in obese patients with Binge Eating Disorder.

    PubMed

    Leombruni, Paolo; Pierò, Andrea; Lavagnino, Luca; Brustolin, Annalisa; Campisi, Stefania; Fassino, Secondo

    2008-08-01

    Previous studies support the use of selective serotonin reuptake inhibitors (SSRIs), in overweight patients with Binge Eating Disorder (BED), but results are far from conclusive. Sertraline has been studied less extensively, and there have been a few studies concerning SSRIs that report follow-up data at more than 12 weeks of follow-up. The present study assesses the effectiveness of sertraline and fluoxetine over a period of 24 weeks in obese patients with BED (DSM-IV-TR). Forty-two obese outpatients were randomized and assigned to one of two different drug treatments: 22 were treated with sertraline (dose range: 100-200 mg/day) and 20 with fluoxetine (dose range: 40-80 mg/day). Subjects were assessed at baseline and at 8, 12, and 24 weeks of treatment for binge frequency, weight loss, and severity of psychopathology. No significant differences were found between the two treatments. After 8 weeks of treatment a significant improvement in the Binge Eating Scale score and a significant weight loss emerged. These results were maintained by responders (weigh loss of at least 5% of baseline weight) over 24 weeks. The results suggest that a 6-month treatment with SSRI may be an effective option to treat patients with BED.

  10. Pre-Liver Transplant Transthoracic Echocardiogram Findings and 6-Month Post-Transplant Outcomes: A Case-Control Analysis.

    PubMed

    Konerman, Monica A; Price, Jennifer C; Campbell, Catherine Y; Eluri, Swathi; Gurakar, Ahmet; Hamilton, James; Li, Zhiping

    2016-07-05

    BACKGROUND Cardiopulmonary (CP) outcomes remain a leading cause of morbidity and mortality following liver transplantation (LT). The optimal CP risk stratification of LT candidates remains unclear. The aim of this study was to evaluate the association of pre-LT transthoracic echocardiogram (TTE) findings and 6-month post-LT outcomes. MATERIAL AND METHODS This retrospective review analyzed adults who underwent LT, comparing those who died within 6 months of LT (cases; n=38) with age- and sex-matched patients who survived >6 months (controls; n=38). Cases were categorized by cause of death (COD) defined as either a primary CP process (n=20) or a non-CP process (n=18). Data were analyzed using logistic regression and survival analysis was performed using Kaplan-Meier curves. RESULTS There was a higher odds of death within 6 months of LT with ≥ mild mitral regurgitation (OR 3.44, p=0.03) or an incomplete assessment of right ventricular systolic function (RVSF) (OR 24, p=0.004). On subgroup analysis, these findings only persisted in patients with a CP COD. Patients with CP COD were older (61 vs. 54.5, p=0.04), had longer intervals between TTE and LT (122 vs. 29 days, p=0.05), less complete assessments of RVSF (p=0.009), and lower RV fractional area change (p=0.04) compared to patients with non-CP COD. CONCLUSIONS Multiple TTE parameters were associated with patients who died within 6 months of LT, and in particular patients with a CP COD. Our findings suggest that pre-LT TTEs can convey useful CP risk stratification information and emphasizes the importance of adequately assessing these parameters prior to LT.

  11. Injectable Chemically Crosslinked Hydrogel for the Controlled Release of Bevacizumab in Vitreous: A 6-Month In Vivo Study

    PubMed Central

    Yu, Yu; Lau, Laurence Chi Ming; Lo, Amy Cheuk-yin; Chau, Ying

    2015-01-01

    Purpose To evaluate the biocompatibility and 6-month in vivo release of bevacizumab from a hyaluronic acid/dextran-based in situ hydrogel after intravitreal injection in rabbit eye. Methods The in situ hydrogel was formed by the catalyst-free chemical crosslinking between vinylsulfone functionalized hyaluronic acid (HA-VS) and thiolated dextran (Dex-SH) at physiological condition. The pH 7.4 buffered mixture containing HA-VS, Dex-SH, and bevacizumab were injected into the vitreous of rabbit eyes by a 30-G needle. The biocompatibility was evaluated by intraocular pressure measurement, binocular indirect ophthalmoscope (BIO), full-field electroretinogram (ERG), and histology. The concentrations of both total and active bevacizumab in rabbit vitreous were determined by enzyme-linked immunosorbent assay. The concentration of bevacizumab in rabbit vitreous after bolus injection was simulated by one-compartment first order elimination model. Results A transparent gel was seen in the vitreous after injection. BIO images, ERG, and histology showed that the gel does not induce hemorrhage, retinal detachment, inflammation, or other gross pathological changes in rabbit eyes after injection. While the bolus intravitreal injected bevacizumab follows the first order elimination kinetics in rabbit eye, the in situ gel formation was able to prolong the retention of bevacizumab in rabbit eye at therapeutic relevant concentration for at least 6 months. The concentration of bevacizumab 6 months after injection was about 107 times higher than bolus injection. Conclusions The new in situ hydrogel formulation of bevacizumab was biocompatible and able to prolong the retention of drug in rabbit eyes in vivo at therapeutic relevant concentration for at least 6 months. Translational Relevance Although proven to be effective, monthly intravitreal injection of bevacizumab or other protein drugs may cause various complications. Extending the residence time of protein therapeutics in the eye

  12. Maternal Nutrition and Glycaemic Index during Pregnancy Impacts on Offspring Adiposity at 6 Months of Age—Analysis from the ROLO Randomised Controlled Trial

    PubMed Central

    Horan, Mary K.; McGowan, Ciara A.; Gibney, Eileen R.; Byrne, Jacinta; Donnelly, Jean M.; McAuliffe, Fionnuala M.

    2016-01-01

    Childhood obesity is associated with increased risk of adult obesity and metabolic disease. Diet and lifestyle in pregnancy influence fetal programming; however the influence of specific dietary components, including low glycaemic index (GI), remains complex. We examined the effect of a maternal low GI dietary intervention on offspring adiposity at 6 months and explored the association between diet and lifestyle factors in pregnancy and infant body composition at 6 months. 280 6-month old infant and mother pairs from the control (n = 142) and intervention group (n = 138), who received low GI dietary advice in pregnancy, in the ROLO study were analysed. Questionnaires (food diaries and lifestyle) were completed during pregnancy, followed by maternal lifestyle and infant feeding questionnaires at 6 months postpartum. Maternal anthropometry was measured throughout pregnancy and at 6 months post-delivery, along with infant anthropometry. No difference was found in 6 months infant adiposity between control and intervention groups. Maternal trimester three GI, trimester two saturated fats and trimester one and three sodium intake were positively associated with offspring adiposity, while trimester two and three vitamin C intake was negatively associated. In conclusion associations were observed between maternal dietary intake and GI during pregnancy and offspring adiposity at 6 months of age. PMID:26742066

  13. Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation.

    PubMed

    Van Gurp, Eveline; Bustamante, Jesus; Franco, Antonio; Rostaing, Lionel; Becker, Thomas; Rondeau, Eric; Czajkowski, Zenon; Rydzewski, Andrzej; Alarcon, Antonio; Bachleda, Petr; Samlik, Jiri; Burmeister, Dirk; Pallardo, Luis; Moal, Marie-Christine; Rutkowski, Boleslaw; Wlodarczyk, Zbigniew

    2010-01-01

    In a multicenter trial, renal transplant recipients were randomized to tacrolimus with fixed-dose sirolimus (Tac/SRL, N = 318) or tacrolimus with MMF (Tac/MMF, N = 316). Targeted tacrolimus trough levels were lower in the Tac/SRL group after day 14. The primary endpoint was renal function at 6 months using creatinine clearance (Cockcroft-Gault) and was comparable at 66.4 mL/min (SE 1.4) with Tac/SRL and at 65.2mL/min (SE 1.3) with Tac/MMF (completers). Biopsy-confirmed acute rejection was 15.1% (Tac/SRL) and 12.3% (Tac/MMF). In both groups, graft survival was 93% and patient survival was 99.0%. Premature withdrawal due to an adverse event was twice as high in the Tac/SRL group, 15.1% versus 6.3%. Hypercholesterolemia incidence was higher with Tac/SRL (P < .05) while CMV, leukopenia, and diarrhea incidences were higher with Tac/MMF (P < .05). The incidence of any antidiabetic treatment for >30 consecutive days in previously nondiabetic patients was 17.8%, Tac/SRL, and 24.8%, Tac/MMF. Evaluation at 6 months showed comparable renal function using tacrolimus/sirolimus and tacrolimus/MMF regimens.

  14. Developmental milestones record - 6 months

    MedlinePlus

    Normal childhood growth milestones - 6 months; Childhood growth milestones - 6 months; Growth milestones for children - 6 months ... the weight on hands (often occurs by 4 months) Able to pick up a dropped object Able ...

  15. A standardized randomized 6-month aerobic exercise-training down-regulated pro-inflammatory genes, but up-regulated anti-inflammatory, neuron survival and axon growth-related genes.

    PubMed

    Iyalomhe, Osigbemhe; Chen, Yuanxiu; Allard, Joanne; Ntekim, Oyonumo; Johnson, Sheree; Bond, Vernon; Goerlitz, David; Li, James; Obisesan, Thomas O

    2015-09-01

    There is considerable support for the view that aerobic exercise may confer cognitive benefits to mild cognitively impaired elderly persons. However, the biological mechanisms mediating these effects are not entirely clear. As a preliminary step towards informing this gap in knowledge, we enrolled older adults confirmed to have mild cognitive impairment (MCI) in a 6-month exercise program. Male and female subjects were randomized into a 6-month program of either aerobic or stretch (control) exercise. Data collected from the first 10 completers, aerobic exercise (n=5) or stretch (control) exercise (n=5), were used to determine intervention-induced changes in the global gene expression profiles of the aerobic and stretch groups. Using microarray, we identified genes with altered expression (relative to baseline values) in response to the 6-month exercise intervention. Genes whose expression were altered by at least two-fold, and met the p-value cutoff of 0.01 were inputted into the Ingenuity Pathway Knowledge Base Library to generate gene-interaction networks. After a 6-month aerobic exercise-training, genes promoting inflammation became down-regulated, whereas genes having anti-inflammatory properties and those modulating immune function or promoting neuron survival and axon growth, became up-regulated (all fold change≥±2.0, p<0.01). These changes were not observed in the stretch group. Importantly, the differences in the expression profiles correlated with significant improvement in maximal oxygen uptake (VO2max) in the aerobic program as opposed to the stretch group. We conclude that three distinct cellular pathways may collectively influence the training effects of aerobic exercise in MCI subjects. We plan to confirm these effects using rt-PCR and correlate such changes with the cognitive phenotype.

  16. Increased sleep need and daytime sleepiness 6 months after traumatic brain injury: a prospective controlled clinical trial.

    PubMed

    Imbach, Lukas L; Valko, Philipp O; Li, Tongzhou; Maric, Angelina; Symeonidou, Evangelia-Regkina; Stover, John F; Bassetti, Claudio L; Mica, Ladislav; Werth, Esther; Baumann, Christian R

    2015-03-01

    Post-traumatic sleep-wake disturbances are common after acute traumatic brain injury. Increased sleep need per 24 h and excessive daytime sleepiness are among the most prevalent post-traumatic sleep disorders and impair quality of life of trauma patients. Nevertheless, the relation between traumatic brain injury and sleep outcome, but also the link between post-traumatic sleep problems and clinical measures in the acute phase after traumatic brain injury has so far not been addressed in a controlled and prospective approach. We therefore performed a prospective controlled clinical study to examine (i) sleep-wake outcome after traumatic brain injury; and (ii) to screen for clinical and laboratory predictors of poor sleep-wake outcome after acute traumatic brain injury. Forty-two of 60 included patients with first-ever traumatic brain injury were available for follow-up examinations. Six months after trauma, the average sleep need per 24 h as assessed by actigraphy was markedly increased in patients as compared to controls (8.3 ± 1.1 h versus 7.1 ± 0.8 h, P < 0.0001). Objective daytime sleepiness was found in 57% of trauma patients and 19% of healthy subjects, and the average sleep latency in patients was reduced to 8.7 ± 4.6 min (12.1 ± 4.7 min in controls, P = 0.0009). Patients, but not controls, markedly underestimated both excessive sleep need and excessive daytime sleepiness when assessed only by subjective means, emphasizing the unreliability of self-assessment of increased sleep propensity in traumatic brain injury patients. At polysomnography, slow wave sleep after traumatic brain injury was more consolidated. The most important risk factor for developing increased sleep need after traumatic brain injury was the presence of an intracranial haemorrhage. In conclusion, we provide controlled and objective evidence for a direct relation between sleep-wake disturbances and traumatic brain injury, and for clinically significant underestimation of post

  17. Your Child's Development: 6 Months

    MedlinePlus

    ... to 2-Year-Old Your Child's Development: 6 Months KidsHealth > For Parents > Your Child's Development: 6 Months A A A Notice your baby doing anything new? Big strides in development are happening this month. That's because the left side of the brain ...

  18. Your Child's Development: 6 Months

    MedlinePlus

    ... to 2-Year-Old Your Child's Development: 6 Months KidsHealth > For Parents > Your Child's Development: 6 Months Print A A A en español El desarrollo ... new? Big strides in development are happening this month. That's because the left side of the brain ...

  19. Efficacy of memantine in the treatment of fibromyalgia: A double-blind, randomised, controlled trial with 6-month follow-up.

    PubMed

    Olivan-Blázquez, Bárbara; Herrera-Mercadal, Paola; Puebla-Guedea, Marta; Pérez-Yus, Mari-Cruz; Andrés, Eva; Fayed, Nicolas; López-Del-Hoyo, Yolanda; Magallon, Rosa; Roca, Miquel; Garcia-Campayo, Javier

    2014-12-01

    Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen's d=1.43 at 6 months) and pain measured with a sphygmomanometer (d=1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval=2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval=3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.

  20. A CASE CONTROL STUDY OF THE EFFECTIVENESS OF TISSUE PLASMINOGEN ACTIVATOR ON 6 MONTH PATIENT-REPORTED OUTCOMES AND HEALTHCARE UTILIZATION

    PubMed Central

    Lang, Catherine E.; Bland, Marghuretta D.; Cheng, Nuo; Corbetta, Maurizio; Lee, Jin-Moo

    2014-01-01

    We examined the benefit of tissue plasminogen activator (tPA), delivered as part of usual stroke management, on patient-reported outcomes and healthcare utilization. Using a case control design, patients who received tPA as part of usual stroke management were compared with patients who would have received tPA had they arrived to the hospital within the therapeutic time window. Data were collected from surveys 6 months post stroke using standardized patient-reported outcome measures and questions about healthcare utilization. Demographic and medical data were acquired from hospital records. Patients were matched on stroke severity, age, race, and gender. Matching was done with 1:2 ratio of tPA to controls. Results were compared between groups with 1-tailed tests due to directionally-specific hypothesis in favor of the tPA group. The tPA (n = 78) and control (n = 156) groups were matched across the variables, except for stroke severity, which was better in the control group; subsequent analyses controlled for this mismatch. The tPA group reported better physical function, communication, cognitive ability, depressive symptomatology, and quality of life/participation compared to the control group. Fewer people in the tPA group reported skilled nursing facility stays, emergency department visits, and re-hospitalizations after their stroke compared to controls. Reports of other post-acute services were not different between groups. While it is known that tPA reduces disability, this is the first study to demonstrate the effectiveness of tPA in improving meaningful, patient-reported outcomes. Thus, use of tPA provides a large benefit to the daily lives of people with ischemic stroke. PMID:25440368

  1. Effect of a 6-month vegan low-carbohydrate (‘Eco-Atkins’) diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial

    PubMed Central

    Jenkins, David J A; Wong, Julia M W; Kendall, Cyril W C; Esfahani, Amin; Ng, Vivian W Y; Leong, Tracy C K; Faulkner, Dorothea A; Vidgen, Ed; Paul, Gregory; Mukherjea, Ratna; Krul, Elaine S; Singer, William

    2014-01-01

    Objective Low-carbohydrate diets may be useful for weight loss. Diets high in vegetable proteins and oils may reduce the risk of coronary heart disease. The main objective was to determine the longer term effect of a diet that was both low-carbohydrate and plant-based on weight loss and low-density lipoprotein cholesterol (LDL-C). Design, setting, participants A parallel design study of 39 overweight hyperlipidaemic men and postmenopausal women conducted at a Canadian university-affiliated hospital nutrition research centre from April 2005 to November 2006. Intervention Participants were advised to consume either a low-carbohydrate vegan diet or a high-carbohydrate lacto-ovo vegetarian diet for 6 months after completing 1-month metabolic (all foods provided) versions of these diets. The prescribed macronutrient intakes for the low-carbohydrate and high-carbohydrate diets were: 26% and 58% of energy from carbohydrate, 31% and 16% from protein and 43% and 25% from fat, respectively. Primary outcome Change in body weight. Results 23 participants (50% test, 68% control) completed the 6-month ad libitum study. The approximate 4 kg weight loss on the metabolic study was increased to −6.9 kg on low-carbohydrate and −5.8 kg on high-carbohydrate 6-month ad libitum treatments (treatment difference (95% CI) −1.1 kg (−2.1 to 0.0), p=0.047). The relative LDL-C and triglyceride reductions were also greater on the low-carbohydrate treatment (treatment difference (95% CI) −0.49 mmol/L (−0.70 to −0.28), p<0.001 and −0.34 mmol/L (−0.57 to −0.11), p=0.005, respectively), as were the total cholesterol:HDL-C and apolipoprotein B:A1 ratios (−0.57 (−0.83, −0.32), p<0.001 and −0.05 (−0.09, −0.02), p=0.003, respectively). Conclusions A self-selected low-carbohydrate vegan diet, containing increased protein and fat from gluten and soy products, nuts and vegetable oils, had lipid lowering advantages over a high-carbohydrate, low-fat weight loss

  2. Cost-utility of Group Acceptance and Commitment Therapy for Fibromyalgia versus recommended drugs: An economic analysis alongside a 6-month randomised controlled trial conducted in Spain (EFFIGACT study).

    PubMed

    Luciano, Juan V; D'Amico, Francesco; Feliu-Soler, Albert; McCracken, Lance M; Aguado, Jaume; Peñarrubia-María, María T; Knapp, Martin; Serrano-Blanco, Antoni; García-Campayo, Javier

    2017-03-22

    The aim of this study was to analyse the cost-utility of a group-based form of Acceptance and Commitment Therapy (GACT) in patients with fibromyalgia (FM) compared to patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, an RCT that focused on clinical outcomes. Health economic outcomes included health-related quality of life and healthcare use at baseline and at 6-month follow-up using the EuroQol (EQ-5D-3L) and the Client Service Receipt Inventory (CSRI), respectively. Analyses included Quality-Adjusted Life Years (QALYs), direct and indirect cost differences, and incremental cost-effectiveness ratios (ICERs). A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6 month study period compared to both control arms (GACT €824.2 ± 1,062.7 vs. RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT in comparison to RPT were due to lower costs from primary care visits and FM-related medications. The ICERs were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, ACT appears to be a cost-effective treatment in comparison to RPT in patients with FM.

  3. A randomised controlled trial of integrated electrical stimulation and physiotherapy to improve mobility for people less than 6 months post stroke.

    PubMed

    Wilkinson, Ingrid A; Burridge, Jane; Strike, Paul; Taylor, Paul

    2014-05-14

    Abstract Purpose: To investigate the feasibility of combining physiotherapy and functional electrical stimulation to improve gait post stroke. Methods: A parallel group partially single-blinded randomised clinical trial. Adults living at home, less than 6 months post stroke, were randomised to Group A (physiotherapy, n = 10) or Group B (physiotherapy and common peroneal nerve stimulation, n = 10). Assessments were conducted before randomisation (Week 1), after intervention (Week 8) and after 12 weeks follow-up (Week 20). Results: No between group differences were observed. There were statistically significant within group differences after the intervention period in both groups for walking speed and distance walked (without stimulation), Rivermead Mobility Index and Canadian Occupational Performance Measure, maintained at Week 20. There was statistically significant improvement in 10-m walking speed (Group B) when the stimulator was used at Week 8 (p = 0.03, median 0.04 m/s (8%)). Only Group B had statistically significant within group change in Rivermead Visual Gait Analysis (Week 8), maintained at Week 20. Conclusions: Integrating electrical stimulation and physiotherapy was feasible and improved walking speed. There was no evidence of a training effect compared with physiotherapy alone. One-hundred forty-four participants per group would produce an adequately powered study based on this protocol. Implications for Rehabilitation At the end of the intervention period participants using electrical stimulation to correct dropped foot walked faster. It was feasible for electrical stimulation to be combined with physiotherapy for people less than 6 months post stroke. A larger adequately powered study is required to establish whether there are training effects associated with use of stimulation in this population.

  4. Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study

    PubMed Central

    2013-01-01

    Background Given the highly debated role of dairy food consumption in modulating biomarkers of metabolic syndrome, this study was conducted to examine the influence of long-term (6 month) dairy consumption on metabolic parameters in healthy volunteers under free-living conditions without energy restriction. Methods Twenty-three healthy subjects completed a randomized, crossover trial of 12 months. Participants consumed their habitual diets and were randomly assigned to one of two treatment groups: a high dairy supplemented group instructed to consume 4 servings of dairy per day (HD); or a low dairy supplemented group limited to no more than 2 servings of dairy per day (LD). Baseline, midpoint, and endpoint metabolic responses were examined. Results Endpoint measurements of body weight and composition, energy expenditure, blood pressure, blood glucose, and blood lipid and lipoprotein responses did not differ (p > 0.05) between the LD and HD groups. HD consumption improved (p < 0.05) plasma insulin (-9%) and insulin resistance (-11%, p = 0.03) as estimated by HOMA-IR compared with the LD group. Conclusions Study results suggest that high dairy consumption (4 servings/d) may improve insulin resistance without negatively impacting bodyweight or lipid status under free-living conditions. Trial registration Trial registration: NCT01761955 PMID:23638799

  5. The Mediterranean Diet and Cognitive Function among Healthy Older Adults in a 6-Month Randomised Controlled Trial: The MedLey Study

    PubMed Central

    Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan M.; Davis, Courtney R.; Murphy, Karen J.

    2016-01-01

    Evidence from a limited number of randomised controlled intervention trials (RCTs) have shown that a Mediterranean dietary pattern may reduce the risk of cognitive decline and enhance cognitive function among healthy older adults. However, there are currently no data in non-Mediterranean older adult populations. The present study aimed to address this gap by examining the effect of a Mediterranean dietary pattern (MedDiet) for six months on aspects of cognitive function in a randomised controlled intervention trial (the MedLey study) that extended for a duration of 18 months. In the final analysed cohort, a total of 137 men and women (mean age of 72.1 ± 5.0 years) randomly assigned to either a MedDiet or control diet (HabDiet) (i.e., habitual dietary intake), were assessed on a comprehensive neuropsychological test battery, including 11 individual tests. In multivariable-adjusted models, the MedDiet group did not perform significantly better than the HabDiet control group for executive functioning (adjusted mean differences: +2.53, 95% CI −2.59 to 7.65, p = 0.33); speed of processing (adjusted mean differences: +3.24, 95% CI −1.21 to 7.70, p = 0.15); memory (adjusted mean differences: +2.00, 95% CI −3.88 to 7.88, p = 0.50); visual-spatial ability (adjusted mean differences: +0.21, 95% CI −0.38 to 0.81, 0.48); and overall age-related cognitive performance (adjusted mean differences: +7.99, 95% CI −4.00 to 19.9, p = 0.19). In conclusion, this study did not find evidence of a beneficial effect of a MedDiet intervention on cognitive function among healthy older adults. PMID:27657119

  6. Sexual Function 6 Months After First Delivery

    PubMed Central

    Brubaker, Linda; Handa, Victoria L.; Bradley, Catherine S.; Connolly, AnnaMarie; Moalli, Pamela; Brown, Morton B.; Weber, Anne

    2008-01-01

    OBJECTIVE To explore the association of anal sphincter laceration and sexual function 6 months postpartum in the Childbirth and Pelvic Symptoms (CAPS) cohort. METHODS The primary CAPS study, a prospective cohort study, was designed to estimate the postpartum prevalence and incidence of urinary and fecal incontinence. Three cohorts of new mothers (vaginal delivery with a third- or fourth-degree anal sphincter tear, vaginal delivery without a third- or fourth-degree anal sphincter tear, and cesarean delivery without labor) were compared at 6 months postpartum. Sexual function was assessed with the Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Short Form Questionnaire (PISQ-12). Urinary and fecal incontinence were assessed using the Medical Epidemiological and Social Aspects of Aging questionnaire and the Fecal Incontinence Severity Index, which is embedded within the Modified Manchester Health Questionnaire. RESULTS Most women (459 [90%]) of those with partners reported sexual activity at the 6-month visit. Fewer women whose delivery was complicated by anal sphincter laceration reported sexual activity when compared with those who delivered vaginally without sphincter laceration (88 compared with 94%, P=.028). The mean PISQ-12 score (39±4) did not differ between delivery groups (P=.92). Pain (responses of “sometimes,” “usually,” or “always”) during sex affected one of three sexually active women (164 [36%]). CONCLUSION At 6 months postpartum, primiparous women who delivered with anal sphincter laceration are less likely to report sexual activity. PMID:18448733

  7. Relationship of cravings with weight loss and hunger: results from a 6 month worksite weight loss intervention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We examined the association of food cravings with weight loss and eating behaviors in a 6 month worksite lifestyle weight loss program. This randomized controlled trial of the intervention versus a wait-listed control was conducted at 4 worksites, and 95 participants completed outcome assessments ...

  8. Effects of n-3 fatty acids, EPA v. DHA, on depressive symptoms, quality of life, memory and executive function in older adults with mild cognitive impairment: a 6-month randomised controlled trial.

    PubMed

    Sinn, Natalie; Milte, Catherine M; Street, Steven J; Buckley, Jonathan D; Coates, Alison M; Petkov, John; Howe, Peter R C

    2012-06-01

    Depressive symptoms may increase the risk of progressing from mild cognitive impairment (MCI) to dementia. Consumption of n-3 PUFA may alleviate both cognitive decline and depression. The aim of the present study was to investigate the benefits of supplementing a diet with n-3 PUFA, DHA and EPA, for depressive symptoms, quality of life (QOL) and cognition in elderly people with MCI. We conducted a 6-month double-blind, randomised controlled trial. A total of fifty people aged >65 years with MCI were allocated to receive a supplement rich in EPA (1·67 g EPA + 0·16 g DHA/d; n 17), DHA (1·55 g DHA + 0·40 g EPA/d; n 18) or the n-6 PUFA linoleic acid (LA; 2·2 g/d; n 15). Treatment allocation was by minimisation based on age, sex and depressive symptoms (Geriatric Depression Scale, GDS). Physiological and cognitive assessments, questionnaires and fatty acid composition of erythrocytes were obtained at baseline and 6 months (completers: n 40; EPA n 13, DHA n 16, LA n 11). Compared with the LA group, GDS scores improved in the EPA (P=0·04) and DHA (P=0·01) groups and verbal fluency (Initial Letter Fluency) in the DHA group (P=0·04). Improved GDS scores were correlated with increased DHA plus EPA (r 0·39, P=0·02). Improved self-reported physical health was associated with increased DHA. There were no treatment effects on other cognitive or QOL parameters. Increased intakes of DHA and EPA benefited mental health in older people with MCI. Increasing n-3 PUFA intakes may reduce depressive symptoms and the risk of progressing to dementia. This needs to be investigated in larger, depressed samples with MCI.

  9. Large Number Discrimination in 6-Month-Old Infants.

    ERIC Educational Resources Information Center

    Xu, Fei; Spelke, Elizabeth S.

    2000-01-01

    Two experiments examined 6-month-olds' ability to discriminate between visual displays of various number of dots varying in size and position, and with controls for other extraneous variables. Findings indicated that infants could discriminate between large sets on the basis of numerosity if they differed by a large ratio (8 versus 16, but not 8…

  10. Prevention of Traumatic Stress in Mothers of Preterms: 6-Month Outcomes

    PubMed Central

    St John, Nick; Lilo, Emily; Jo, Booil; Benitz, William; Stevenson, David K.; Horwitz, Sarah M.

    2014-01-01

    OBJECTIVE: Symptoms of posttraumatic stress disorder are a well-recognized phenomenon in mothers of preterm infants, with implications for maternal health and infant outcomes. This randomized controlled trial evaluated 6-month outcomes from a skills-based intervention developed to reduce symptoms of posttraumatic stress disorder, anxiety, and depression. METHODS: One hundred five mothers of preterm infants were randomly assigned to (1) a 6- or 9-session intervention based on principles of trauma-focused cognitive behavior therapy with infant redefinition or (2) a 1-session active comparison intervention based on education about the NICU and parenting of the premature infant. Outcome measures included the Davidson Trauma Scale, the Beck Depression Inventory II, and the Beck Anxiety Inventory. Participants were assessed at baseline, 4 to 5 weeks after birth, and 6 months after the birth of the infant. RESULTS: At the 6-month assessment, the differences between the intervention and comparison condition were all significant and sizable and became more pronounced when compared with the 4- to 5-week outcomes: Davidson Trauma Scale (Cohen's d = −0.74, P < .001), Beck Anxiety Inventory (Cohen's d = −0.627, P = .001), Beck Depression Inventory II (Cohen's d = −0.638, P = .002). However, there were no differences in the effect sizes between the 6- and 9-session interventions. CONCLUSIONS: A brief 6-session intervention based on principles of trauma-focused cognitive behavior therapy was effective at reducing symptoms of trauma, anxiety, and depression in mothers of preterm infants. Mothers showed increased benefits at the 6-month follow-up, suggesting that they continue to make use of techniques acquired during the intervention phase. PMID:25049338

  11. Taking Orlistat: Predicting Weight Loss over 6 Months.

    PubMed

    Hollywood, Amelia; Ogden, Jane

    2011-01-01

    This study explored the predictors of weight loss following orlistat with a focus on both baseline variables and changes in beliefs and behaviours occurring over the course of taking the drug. Patients (n = 566) prescribed orlistat completed a questionnaire at baseline and after 6 months concerning their weight, beliefs and behaviours. By 6 months the majority had lost some weight and showed improvements in diet. Many had also stopped taking the drug and a large minority reported using it flexibly as a lifestyle drug. Those who lost most weight showed a decrease in beliefs in a medical solution, a decrease in unhealthy eating, an increased belief in treatment control and an increased belief that the unpleasant consequences are both due to their eating behaviour and just part of the drug. When taken with fatty food orlistat causes symptoms such as anal leakage and oily stools. These may encourage some patients to focus on the behavioural aspects of their weight problem thus promoting the dietary changes needed for both short and longer term weight loss. When prescribing orlistat, clinicians should encourage patients to see the consequences as an education as a means to promote the effectiveness of this form of medical management.

  12. Strategy training shows promise for addressing disability in the first 6 months after stroke

    PubMed Central

    Skidmore, Elizabeth R.; Dawson, Deirdre R.; Butters, Meryl A.; Grattan, Emily S.; Juengst, Shannon B.; Whyte, Ellen M.; Begley, Amy; Holm, Margo B.; Becker, James T.

    2014-01-01

    Background Cognitive impairments occur frequently after stroke and contribute to significant disability. Strategy training shows promise but has not been examined in the acute phase of recovery. Objective We conducted a single-blind randomized pilot study estimating the effect of strategy training, relative to reflective listening (attention control), for reducing disability and executive cognitive impairments. Methods Thirty participants with acute stroke who were enrolled in inpatient rehabilitation and had cognitive impairments were randomized to receive strategy training (n=15, 10 sessions as adjunct to usual inpatient rehabilitation) or reflective listening (n=15, same dose). The Functional Independence Measure assessed disability at baseline, rehabilitation discharge, 3 and 6 months. The Color Word Interference Test of the Delis-Kaplan Executive Function System assessed selected executive cognitive impairments (inhibition, flexibility) at baseline, 3 and 6 months. Results Changes in Functional Independence Measure scores for the two groups over 6 months showed significant effects of group (F1,27=9.25, p=0.005), time (F3.74=96.00, p<0.001), and group*time interactions (F3,74=4.37, p<0.007) after controlling for baseline differences in stroke severity (F1,27=6.74, p=0.015). Color Word Interference Inhibition scores showed significant effects of group (F1,26=6.50, p=0.017), and time (F2,34=4.74, p=0.015), but the group*time interaction was not significant (F2,34=2.55, p=0.093). Color Word Interference Cognitive Flexibility scores showed significant effects of group (F1,26=23.41, p<0.001), and time (F2,34=12.77, p<0.001), and group*time interactions (F2,34=7.83, p<0.002). Interaction effects suggested greater improvements were associated with strategy training. Conclusions Strategy training shows promise for addressing disability in the first 6 months after stroke. Lessons from this pilot study may inform future clinical trials. PMID:25505221

  13. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  14. Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation

    PubMed Central

    Villablanca, Pedro A.; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schüpke, Stefanie; Briceno, David F.; Bortnick, Anna E.; Garcia, Mario J.; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish

    2016-01-01

    Abstract Background: The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement. Methods: We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel–Haenszel method. Fixed-effect models were used; if heterogeneity (I2) > 40 was identified, effects were obtained with random models. Results: Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69–1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66–1.21), non-CV mortality (OR 0.85; 95% 0.58–1.24), myocardial infarction (OR 1.10; 95% CI: 0.89–1.37), stroke (OR 0.97; 95% CI: 0.67–1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89–2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77–1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49–1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59–0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT. Conclusion: DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES. PMID:28033306

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

    PubMed

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

    2010-12-01

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

  16. Reliability of gait in multiple sclerosis over 6 months.

    PubMed

    Sosnoff, Jacob J; Klaren, Rachel E; Pilutti, Lara A; Dlugonski, Deirdre; Motl, Robert W

    2015-03-01

    Gait impairment is ubiquitous in multiple sclerosis (MS) and is often characterized by alterations in spatiotemporal parameters of gait. There is limited information concerning reliability of spatiotemporal gait parameters over clinical timescales (e.g. 6 months). The current report provides novel evidence that gait parameters of 74 ambulatory persons with MS with mild-to-moderate disability are reliable over 6-months (ICC's for overall sample range from 0.56 to 0.91) in the absence of any intervention above and beyond standard care. Such data can inform clinical decision-making and power analyses for designing RCTs (i.e., sample size estimates) involving persons with MS.

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

    PubMed

    Esala, Jennifer J; Taing, Sopheap

    2017-02-01

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

  18. Retrieval Protracts Deferred Imitation by 6-Month-Olds

    ERIC Educational Resources Information Center

    Barr, Rachel; Rovee-Collier, Carolyn; Campanella, Jennifer

    2005-01-01

    Past research using a deferred imitation task has shown that 6-month-olds remember a 3-part action sequence for only 1 day. The concept of a time window suggests that there is a limited period within which additional information can be integrated with a prior memory. Its width tracks the forgetting function of the memory. This study asked if…

  19. Investigating fatigue of less than 6 months' duration. Guidelines for family physicians.

    PubMed Central

    Godwin, M.; Delva, D.; Miller, K.; Molson, J.; Hobbs, N.; MacDonald, S.; MacLeod, C.

    1999-01-01

    OBJECTIVE: To develop an evidence-based systematic approach to assessment of adult patients who present to family physicians complaining of fatigue of less than 6 months' duration. The guidelines present investigative options, making explicit what should be considered in all cases and what should be considered only in specific situations. They aim to provide physicians with an approach that, to the extent possible, is based on evidence so that time and cost are minimized and detection and management of the cause of the fatigue are optimized. QUALITY OF EVIDENCE: MEDLINE was searched from 1966 to 1997 using the key words "family practice" and "fatigue." Articles about chronic fatigue syndrome were excluded. Articles with level 3 evidence were found, but no randomized trials, cohort studies, or case-control studies were found. Articles looking specifically at the epidemiology, demographics, investigations, and diagnoses of patients with fatigue were chosen. Articles based on studies at referral and specialty centres were given less weight than those based on studies in family physicians' offices. MAIN MESSAGE: Adherence to these guidelines will decrease the cost of investigating the symptom of fatigue and optimize diagnosis and management. This needs to be proved in practice, however, and with research that produces level 1 and 2 evidence. CONCLUSIONS: Adults presenting with fatigue of less than 6 months' duration should be assessed for psychosocial causes and should have a focused history and physical examination to determine whether further investigations should be done. The guidelines outline investigations to be considered. The elderly require special consideration. These guidelines have group validation, but they need to be tested by more physicians in various locations and types of practices. PMID:10065311

  20. Relationship of cravings with weight loss and hunger. Results from a 6 month worksite weight loss intervention.

    PubMed

    Batra, Payal; Das, Sai Krupa; Salinardi, Taylor; Robinson, Lisa; Saltzman, Edward; Scott, Tammy; Pittas, Anastassios G; Roberts, Susan B

    2013-10-01

    We examined the association of food cravings with weight loss and eating behaviors in a lifestyle intervention for weight loss in worksites. This research was part of a randomized controlled trial of a 6-month weight loss intervention versus a wait-listed control in 4 Massachusetts worksites. The intervention emphasized reducing energy intake by adherence to portion-controlled menu suggestions, and assessments were obtained in 95 participants at baseline and 6 months including non-fasting body weight, food cravings (Craving Inventory and Food Craving Questionnaire for state and trait) and the eating behavior constructs restraint, disinhibition and hunger (Eating Inventory). There were statistically significant reductions in all craving variables in the intervention group compared to the controls. Within the intervention group, changes in craving-trait were significantly associated with weight loss after controlling for baseline weight, age, gender and worksite. However, in a multivariate model with craving-trait and eating behaviors (restraint, disinhibition and hunger), hunger was the only significant predictor of weight change. In contrast to some previous reports of increased food cravings with weight loss in lifestyle interventions, this study observed a broad reduction in cravings associated with weight loss. In addition, greater reductions in craving-trait were associated with greater weight change, but craving-trait was not a significant independent correlate of weight change when hunger was included in statistical models. Studies are needed to examine the effectiveness of hunger suppressing versus craving-suppressing strategies in lifestyle interventions for obesity.

  1. Improved Squat and Gait Biomechanics 6-Months Post-Arthroscopic Surgery for Femoroacetabular Impingement

    PubMed Central

    Cvetanovich, Gregory; Farkas, Gary Jordan; Rajan, Kumar; Espinoza, Alejandro; Nho, Shane Jay

    2016-01-01

    Objectives: This study aimed to assess gait and squat biomechanics 6-months following arthroscopic surgery for femoroacetabular impingement. Methods: Symptomatic patients with clinical and radiographic diagnosis of FAI who had failed non-operative treatment underwent gait and squat analysis preoperatively and at 6-months postoperatively following arthroscopic surgery for FAI. Age- and BMI-matched controls without radiographic FAI or other lumbar or lower extremity pathology underwent a single analysis for comparison. Comparisons between preoperative and 6-month postoperative gait and squat parameters as well as comparison to the control group were performed using paired and independent sample t-tests. Statistical significance was set at p<0.05. Results: Fifteen FAI patients and 9 controls were analyzed. Age for the patients vs. controls was 28.7±9.6 y vs. 27.8±6.5 y (p>0.05), respectively; while BMI was 23.5±5.1 kg/m2 vs. 22.8±3.5 kg/m2 (p>0.05). All gait parameters were unchanged between preoperative and 6-month postoperative testing (p>0.05), with a trend toward significance for hip external rotation moment (p=0.056) (Table 1). Squat testing revealed that FAI arthroscopic surgery increased maximum hip extension (p=0.011), with a trend toward significance for hip adduction moment (p=0.059). All other squat parameters did not differ from preoperative to 6-month follow-up (p>0.05). Compared to the control group, preoperative FAI patients had reduced hip external rotation moment during gait (p=0.024), with a trend toward significance for hip abduction moment (p=0.082). No other gait or squat differences were detected between FAI patients preoperatively or 6-months postoperatively compared to controls (p>0.05). Conclusion: Biomechanical gait and squat analysis at 6-month follow-up from arthroscopic FAI surgery revealed a tendency to improve external hip rotation during gait and maximum hip extension and hip adduction during squat. Arthroscopic surgery for FAI may

  2. Tai chi improves cognitive and physical function in the elderly: a randomized controlled trial.

    PubMed

    Sun, Jiao; Kanagawa, Katsuko; Sasaki, Junko; Ooki, Syuichi; Xu, Huali; Wang, Li

    2015-05-01

    [Purpose] To investigate the effect of Tai Chi on cognitive and physical function in the elderly. [Subjects and Methods] A randomized trial design was used. A total 150 subjects were enrolled and were divided into Tai Chi and control groups. Subjects in the Tai Chi group participated Tai Chi for 6 months, and subjects in the control group participated in other non-athletic activities. [Results] There were no differences between the groups in the one leg standing time with eyes open, left grip strength, or the Frontal Assessment Battery at bedside after 3 and 6 months of intervention. The Mini-Mental State Examination scores after 3 and 6 months were higher in the Tai Chi group than in the control group. The right grip strength after 3 months increased more in the Tai Chi group than in the control group. Both the 5-m high walking speed and 10-m normal walking speed were significantly lower after 3 and 6 months of Tai Chi practice. [Conclusion] These results suggest that regular Tai Chi practice may improve cognitive and physical function in the elderly.

  3. Tai chi improves cognitive and physical function in the elderly: a randomized controlled trial

    PubMed Central

    Sun, Jiao; Kanagawa, Katsuko; Sasaki, Junko; Ooki, Syuichi; Xu, Huali; Wang, Li

    2015-01-01

    [Purpose] To investigate the effect of Tai Chi on cognitive and physical function in the elderly. [Subjects and Methods] A randomized trial design was used. A total 150 subjects were enrolled and were divided into Tai Chi and control groups. Subjects in the Tai Chi group participated Tai Chi for 6 months, and subjects in the control group participated in other non-athletic activities. [Results] There were no differences between the groups in the one leg standing time with eyes open, left grip strength, or the Frontal Assessment Battery at bedside after 3 and 6 months of intervention. The Mini-Mental State Examination scores after 3 and 6 months were higher in the Tai Chi group than in the control group. The right grip strength after 3 months increased more in the Tai Chi group than in the control group. Both the 5-m high walking speed and 10-m normal walking speed were significantly lower after 3 and 6 months of Tai Chi practice. [Conclusion] These results suggest that regular Tai Chi practice may improve cognitive and physical function in the elderly. PMID:26157242

  4. Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment

    PubMed Central

    Shin, J.H.; Gadde, K.M.; Øtbye, T.; Bray, Bray

    2014-01-01

    We evaluated weight changes in obese patients at 6-months after they ended participation in a 12-month randomized controlled trial in which they received daily placebo, zonisamide 200 mg, or zonisamide 400 mg, in addition to lifestyle counseling. Of the originally randomized 225 patients, 218 completed month-12 when study interventions were discontinued. For the 154 patients who returned for 6-month follow-up off-treatment, weight changes between month-12 and month-18 for placebo (n=53), zonisamide 200 mg (n=49), and zonisamide 400 mg groups (n=52) were 0.5 kg (95% CI, −0.8 to 1.8; 0.7%), 1.5 kg (0.2 to 2.8; 1.6%; p=0.26 vs placebo) and 2.4 kg (1.1 to 3.7; 2.6%; p=0.04 vs placebo), respectively. Our results suggest that although zonisamide 400 mg daily for 12-months resulted in greater weight loss than with placebo, weight regain after discontinuation of interventions was greater in the zonisamide 400 mg group than placebo group. PMID:25123600

  5. Impact of 6-month caloric restriction on autonomic nervous system activity in healthy, overweight, individuals.

    PubMed

    de Jonge, Lilian; Moreira, Emilia A M; Martin, Corby K; Ravussin, Eric

    2010-02-01

    Caloric restriction (CR) increases maximum lifespan but the mechanisms are unclear. Dominance of the sympathetic nervous system (SNS) over the parasympathetic nervous system (PNS) has been shown to be a strong risk factor for cardiovascular disease. Obesity and aging are associated with increased SNS activity, and weight loss and/or exercise seem to have positive effects on this balance. We therefore evaluated the effect of different approaches of CR on autonomic function in 28 overweight individuals participating in the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trial. Participants were randomized to either control, CR: 25% decrease in energy intake, CREX: 12.5% CR + 12.5% increase in energy expenditure, or LCD: low-calorie diet until 15% weight reduction followed by weight maintenance. Autonomic function was assessed by spectral analysis of heart-rate variability (HRV) while fasting and after a meal. Measurements were performed at baseline and 6 months. HR and SNS index decreased and PNS index increased in all intervention groups but reached significance only in CREX. HR and SNS index increased and PNS index decreased in response to the meal in all intervention groups. The results therefore suggest that weight loss improved SNS/PNS balance especially when CR is combined with exercise.

  6. Greater weight loss and hormonal changes after 6 months diet with carbohydrates eaten mostly at dinner.

    PubMed

    Sofer, Sigal; Eliraz, Abraham; Kaplan, Sara; Voet, Hillary; Fink, Gershon; Kima, Tzadok; Madar, Zecharia

    2011-10-01

    This study was designed to investigate the effect of a low-calorie diet with carbohydrates eaten mostly at dinner on anthropometric, hunger/satiety, biochemical, and inflammatory parameters. Hormonal secretions were also evaluated. Seventy-eight police officers (BMI >30) were randomly assigned to experimental (carbohydrates eaten mostly at dinner) or control weight loss diets for 6 months. On day 0, 7, 90, and 180 blood samples and hunger scores were collected every 4 h from 0800 to 2000 hours. Anthropometric measurements were collected throughout the study. Greater weight loss, abdominal circumference, and body fat mass reductions were observed in the experimental diet in comparison to controls. Hunger scores were lower and greater improvements in fasting glucose, average daily insulin concentrations, and homeostasis model assessment for insulin resistance (HOMA(IR)), T-cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) levels were observed in comparison to controls. The experimental diet modified daily leptin and adiponectin concentrations compared to those observed at baseline and to a control diet. A simple dietary manipulation of carbohydrate distribution appears to have additional benefits when compared to a conventional weight loss diet in individuals suffering from obesity. It might also be beneficial for individuals suffering from insulin resistance and the metabolic syndrome. Further research is required to confirm and clarify the mechanisms by which this relatively simple diet approach enhances satiety, leads to better anthropometric outcomes, and achieves improved metabolic response, compared to a more conventional dietary approach.

  7. White Matter Integrity Declined Over 6-Months, but Dance Intervention Improved Integrity of the Fornix of Older Adults.

    PubMed

    Burzynska, Agnieszka Z; Jiao, Yuqin; Knecht, Anya M; Fanning, Jason; Awick, Elizabeth A; Chen, Tammy; Gothe, Neha; Voss, Michelle W; McAuley, Edward; Kramer, Arthur F

    2017-01-01

    Degeneration of cerebral white matter (WM), or structural disconnection, is one of the major neural mechanisms driving age-related decline in cognitive functions, such as processing speed. Past cross-sectional studies have demonstrated beneficial effects of greater cardiorespiratory fitness, physical activity, cognitive training, social engagement, and nutrition on cognitive functioning and brain health in aging. Here, we collected diffusion magnetic resonance (MRI) imaging data from 174 older (age 60-79) adults to study the effects of 6-months lifestyle interventions on WM integrity. Healthy but low-active participants were randomized into Dance, Walking, Walking + Nutrition, and Active Control (stretching and toning) intervention groups (NCT01472744 on ClinicalTrials.gov). Only in the fornix there was a time × intervention group interaction of change in WM integrity: integrity declined over 6 months in all groups but increased in the Dance group. Integrity in the fornix at baseline was associated with better processing speed, however, change in fornix integrity did not correlate with change in processing speed. Next, we observed a decline in WM integrity across the majority of brain regions in all participants, regardless of the intervention group. This suggests that the aging of the brain is detectable on the scale of 6-months, which highlights the urgency of finding effective interventions to slow down this process. Magnitude of WM decline increased with age and decline in prefrontal WM was of lesser magnitude in older adults spending less time sedentary and more engaging in moderate-to-vigorous physical activity. In addition, our findings support the anterior-to-posterior gradient of greater-to-lesser decline, but only in the in the corpus callosum. Together, our findings suggest that combining physical, cognitive, and social engagement (dance) may help maintain or improve WM health and more physically active lifestyle is associated with slower WM decline

  8. White Matter Integrity Declined Over 6-Months, but Dance Intervention Improved Integrity of the Fornix of Older Adults

    PubMed Central

    Burzynska, Agnieszka Z.; Jiao, Yuqin; Knecht, Anya M.; Fanning, Jason; Awick, Elizabeth A.; Chen, Tammy; Gothe, Neha; Voss, Michelle W.; McAuley, Edward; Kramer, Arthur F.

    2017-01-01

    Degeneration of cerebral white matter (WM), or structural disconnection, is one of the major neural mechanisms driving age-related decline in cognitive functions, such as processing speed. Past cross-sectional studies have demonstrated beneficial effects of greater cardiorespiratory fitness, physical activity, cognitive training, social engagement, and nutrition on cognitive functioning and brain health in aging. Here, we collected diffusion magnetic resonance (MRI) imaging data from 174 older (age 60–79) adults to study the effects of 6-months lifestyle interventions on WM integrity. Healthy but low-active participants were randomized into Dance, Walking, Walking + Nutrition, and Active Control (stretching and toning) intervention groups (NCT01472744 on ClinicalTrials.gov). Only in the fornix there was a time × intervention group interaction of change in WM integrity: integrity declined over 6 months in all groups but increased in the Dance group. Integrity in the fornix at baseline was associated with better processing speed, however, change in fornix integrity did not correlate with change in processing speed. Next, we observed a decline in WM integrity across the majority of brain regions in all participants, regardless of the intervention group. This suggests that the aging of the brain is detectable on the scale of 6-months, which highlights the urgency of finding effective interventions to slow down this process. Magnitude of WM decline increased with age and decline in prefrontal WM was of lesser magnitude in older adults spending less time sedentary and more engaging in moderate-to-vigorous physical activity. In addition, our findings support the anterior-to-posterior gradient of greater-to-lesser decline, but only in the in the corpus callosum. Together, our findings suggest that combining physical, cognitive, and social engagement (dance) may help maintain or improve WM health and more physically active lifestyle is associated with slower WM decline

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

    PubMed Central

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

    2015-01-01

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

  10. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    PubMed Central

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P < 0.05), with the largest difference occurring at the 3-month follow-up. Remission and response rates in MBTI and MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y

  11. Internalized stigma of mental illness and depressive and psychotic symptoms in homeless veterans over 6 months.

    PubMed

    Boyd, Jennifer E; Hayward, H'Sien; Bassett, Elena D; Hoff, Rani

    2016-06-30

    We investigated the relationship between internalized stigma of mental illness at baseline and depressive and psychotic symptoms 3 and 6 months later, controlling for baseline symptoms. Data on homeless veterans with severe mental illness (SMI) were provided by the Northeast Program Evaluation Center (NEPEC) Special Needs-Chronic Mental Illness (SN-CMI) study (Kasprow and Rosenheck, 2008). The study used the Internalized Stigma of Mental Illness (ISMI) scale to measure internalized stigma at baseline and the Symptom Checklist-90-R (SCL-90-R) to measure depressive and psychotic symptoms at baseline and 3 and 6 month follow-ups. Higher levels of internalized stigma were associated with greater levels of depressive and psychotic symptoms 3 and 6 months later, even controlling for symptoms at baseline. Alienation and Discrimination Experience were the subscales most strongly associated with symptoms. Exploratory analyses of individual items yielded further insight into characteristics of potentially successful interventions that could be studied. Overall, our findings show that homeless veterans with SMI experiencing higher levels of internalized stigma are likely to experience more depression and psychosis over time. This quasi-experimental study replicates and extends findings of other studies and has implications for future controlled research into the potential long-term effects of anti-stigma interventions on mental health recovery.

  12. Aspartate aminotransferase activity in the pulp of teeth treated for 6 months with fixed orthodontic appliances

    PubMed Central

    Latkauskiene, Dalia; Racinskaite, Vilma; Skucaite, Neringa; Machiulskiene, Vita

    2015-01-01

    Objective To measure aspartate aminotransferase (AST) activity in the pulp of teeth treated with fixed appliances for 6 months, and compare it with AST activity measured in untreated teeth. Methods The study sample consisted of 16 healthy subjects (mean age 25.7 ± 4.3 years) who required the extraction of maxillary premolars for orthodontic reasons. Of these, 6 individuals had a total of 11 sound teeth extracted without any orthodontic treatment (the control group), and 10 individuals had a total of 20 sound teeth extracted after 6 months of orthodontic alignment (the experimental group). Dental pulp samples were extracted from all control and experimental teeth, and the AST activity exhibited by these samples was determined spectrophotometrically at 20℃. Results Mean AST values were 25.29 × 10-5 U/mg (standard deviation [SD] 9.95) in the control group and 27.54 × 10-5 U/mg (SD 31.81) in the experimental group. The difference between these means was not statistically significantly (p = 0.778), and the distribution of the AST values was also similar in both groups. Conclusions No statistically significant increase in AST activity in the pulp of mechanically loaded teeth was detected after 6 months of orthodontic alignment, as compared to that of teeth extracted from individuals who had not undergone orthodontic treatment. This suggests that time-related regenerative processes occur in the dental pulp. PMID:26445721

  13. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial.

    PubMed

    Praga, M; Barrio, V; Juárez, G Fernández; Luño, J

    2007-05-01

    Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy-proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05 mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.

  14. No changes of cardiometabolic and body composition parameters after 6-month add-on treatment with sarcosine in patients with schizophrenia.

    PubMed

    Strzelecki, Dominik; Kałużyńska, Olga; Szyburska, Justyna; Wlazło, Agata; Wysokiński, Adam

    2015-12-15

    This study was undertaken with the purpose to determine if there are changes in metabolic parameters during 6-month add-on treatment with sarcosine in patients with schizophrenia. This was a randomized double blind, placebo-controlled and parallel group study. Eligible participants were randomly assigned to receive 2g of sarcosine (n=30) or placebo (n=29). Sarcosine was administered as supplementation to the ongoing antipsychotic treatment. Augmentation with sarcosine had no effect on any of the analyzed cardiometabolic parameters. Also, augmentation with sarcosine had no effect on any of the analyzed body composition parameters. This is the first randomized placebo-controlled study to examine the metabolic safety of sarcosine in patients with schizophrenia. Clinically, this observation is of high importance considering how prevalent are metabolic abnormalities in patients with schizophrenia.

  15. CoCo trial: Color-coded blood pressure Control, a randomized controlled study

    PubMed Central

    Chmiel, Corinne; Senn, Oliver; Rosemann, Thomas; Del Prete, Valerio; Steurer-Stey, Claudia

    2014-01-01

    Background Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140–180 mmHg systolic BP or >90–110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. Methods In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. Results One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1) Conclusion Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care

  16. 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

  17. No Effect of Aspirin on Mammographic Density in a Randomized Controlled Clinical Trial

    PubMed Central

    McTiernan, Anne; Wang, CY; Sorensen, Bess; Xiao, Liren; Buist, Diana S. M.; Bowles, Erin J. Aiello; White, Emily; Rossing, Mary Anne; Potter, John; Urban, Nicole

    2009-01-01

    Background: Epidemiologic studies suggest a reduced risk of breast cancer among women who regularly use aspirin; a plausible mechanism is through aspirin effect on mammographic breast density, a breast cancer risk factor, possibly mediated through aspirin interference with estrogen synthesis. Methods: In a 2-arm randomized placebo-controlled clinical trial, we evaluated the effects of 6-months administration of 325 mg/day aspirin on total mammographic breast dense area and percent of the mammographic breast image occupied by dense areas (% density) in 143 postmenopausal women. Eligible women, recruited 2005-7, were healthy, not taking hormone therapy, with elevated mammographic breast density (American College of Radiology Breast Imaging Reporting and Data System (BI-RADS®) density category 2, 3 or 4) within 6 months prior to enrollment. Results: Women were a mean (s.d.) 59.5 (5.5) years. Geometric mean baseline percent density was 17.6% (95% CI 14.8, 20.9) in women randomized to aspirin and 19.2% (95% CI 16.3, 22.7) in women randomized to placebo. Percent density decreased in women randomized to aspirin by an absolute 0.8% vs. an absolute decrease of 1.2% in controls (p = 0.84). Total breast area and dense area decreased to a similar degree in women assigned to aspirin and in those assigned to placebo, with no differences statistically significantly different between trial arms. Conclusions: A single daily administration of adult-dose aspirin for 6 months had no effect on mammographic density in postmenopausal women. If aspirin affects breast cancer risk in postmenopausal women, it may do so through alternative pathways than mammographic breast density. PMID:19423529

  18. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  19. The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Kroeze, Willemieke; Oenema, Anke; Campbell, Marci; Brug, Johannes

    2008-01-01

    Objective: To test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction. Design: A 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam.…

  20. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program

    PubMed Central

    2016-01-01

    Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. PMID:27689502

  1. 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

  2. Alcohol Screening and Brief Intervention in a College Student Health Center: A Randomized Controlled Trial*

    PubMed Central

    Schaus, James F.; Sole, Mary Lou; McCoy, Thomas P.; Mullett, Natalie; O'Brien, Mary Claire

    2009-01-01

    Objective: This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students who screened positive for high-risk drinking. Method: Between November 2005 and August 2006, 8,753 students who presented as new patients to the health service at a large public university were screened for high-risk drinking, and 2,484 students (28%) screened positive on the 5/4 gender-specific high-risk drinking question (i.e., five or more drinks per occasion for men and four or more for women). Students who screened positive for high-risk drinking and consented to participate (N = 363; 52% female) were randomly assigned either to a control group (n = 182) or to an experimental group (n = 181). Participants in the experimental group received two brief intervention sessions that were founded in motivational interviewing techniques and delivered by four specially trained providers within the student health center. Data on alcohol use and related harms were obtained from a Web-based Healthy Lifestyle Questionnaire, 30-day Timeline Followback alcohol-use diaries, the Rutgers Alcohol Problem Index (RAPI), and eight items from the Drinker Inventory of Consequences-2L. Results: Repeated measures analysis showed that, compared with the control group (C), the intervention group (I) had significant reductions in typical estimated blood alcohol concentration (BAC) (C = .071 vs I = .057 at 3 months; C = .073 vs I = .057 at 6 months), peak BAC (C = .142 vs I = .112 at 3 months; C = .145 vs I = .108 at 6 months), peak number of drinks per sitting (C = 8.03 vs I = 6.87 at 3 months; C = 7.98 vs I = 6.52 at 6 months), average number of drinks per week (C = 9.47 vs I = 7.33 at 3 months; C = 8.90 vs I = 6.16 at 6 months), number of drunk episodes in a typical week (C = 1.24 vs I = 0.85 at 3 months; C = 1.10 vs I = 0.71 at 6 months), number of times taken foolish risks (C = 2.24 vs I = 1.12 at 3 months), and RAPI

  3. Association between depression in carers and malnutrition in children aged 6 months to 5 years

    PubMed Central

    Ganiyu, Adewale B.; Firth, Jacqueline A.

    2017-01-01

    Background Childhood malnutrition is an important risk factor for child mortality and underlies close to 50% of child deaths worldwide. Previous studies have found an association between maternal depression and child malnutrition, but it is not known whether this association exists in Botswana. In addition, previous studies excluded non-maternal primary caregivers (PCGs). It is unclear whether the association between primary caregiver depression and child malnutrition remains when non-maternal PCGs are included. Aim The aim of this study was to determine if there is an association between PCG depression and malnutrition in children aged between 6 months and 5 years in Mahalapye, Botswana. Setting The study was conducted in the child welfare clinics of Xhosa and Airstrip clinics, two primary health care facilities in Mahalapye, Botswana. Methods This was a case control study. Cases were malnourished children aged between 6 months and 5 years, and controls were non-malnourished children matched for age and gender. The outcome of interest was depression in the PCGs of the cases and controls, which was assessed using the Patient Health Questionnaire 9 (PHQ 9), a depression screening tool. Results From a sample of 171 children, 84 of whom were malnourished, we found that the malnourished children were significantly more likely to have depressed PCGs (odds ratio = 4.33; 95% CI: 1.89, 9.89) than non-malnourished children in the 6-month to 5-year age group; the PCGs of malnourished children also had lower educational status. Conclusion This study found a significant association between PCG depression and child malnutrition. PMID:28155288

  4. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  5. Optimal Quantum Control Using Randomized Benchmarking

    NASA Astrophysics Data System (ADS)

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

    2014-06-01

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

  6. Improving Functional Performance and Muscle Power 4-to-6 Months After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Souissi, Sabrine; Wong, Del P.; Dellal, Alexandre; Croisier, Jean-Louis; Ellouze, Zied; Chamari, Karim

    2011-01-01

    The purpose of this study was to examine the effects of 8-week retraining programs, with either two or three training sessions per week, on measures of functional performance and muscular power in athletes with anterior cruciate ligament reconstruction (ACLR). Sixteen male athletes were randomly assigned to two groups after ACLR: a functional training group (FTG, n = 8) training 2 intense sessions per week (4hrs/week), and a control group (CG, n = 8) training 3 sessions per week with moderate intensity (6hrs/week). The two groups were assessed at four and six months post-ACLR and the effects of retraining were measured using the following assessments: the functional and the muscular power tests, and the agility T-test. After retraining, the FTG had improved more than the CG in the operated leg in the single leg hop test (+34.64% vs. +10.92%; large effect), the five jump test (+8.87% vs. +5.03%; medium effect), and single leg triple jump (+32.15% vs. +16.05%; medium effect). For the agility T-test, the FTG had larger improvements (+17.26% vs. +13.03%, medium effect) as compared to the CG. For the bilateral power tests, no significant training effects were shown for the two groups in the squat jump (SJ), the counter movement jump (CMJ) and the free arms CMJ (Arm CMJ). On the other hand, the unilateral CMJ test with the injured and the uninjured legs showed a significant increase for the FTG with respect to CG (p < 0.05). The present study introduces a new training modality in rehabilitation after ACLR that results in good recovery of the operated limb along with the contra-lateral leg. This may allow the athletes to reach good functional and strength performance with only two physical training sessions per week, better preparing them for a return to sport activity at 6 months post- ACLR and eventually sparing time for a possible progressive introduction of the sport specific technical training. Key points Functional training (plyometrics, neuromuscular

  7. To Compare the Microleakage Among Experimental Adhesives Containing Nanoclay Fillers after the Storages of 24 Hours and 6 Months

    PubMed Central

    Mousavinasab, Seyed Mostafa; Atai, Mohammad; Alavi, Bagher

    2011-01-01

    Objectives: To compare the microleakage among experimental adhesives containing nanoclay fillers after the storages of 24 hours and 6 months. Materials and Methods: Class V cavities were prepared on extracted human molars with the occlusal margins located in enamel and the cervical margins in cementum. Phosphoric acid was applied to the enamel and dentin margins.Subsequently, the cavities were treated using four groups of experimental adhesive systems and restored with a resin composite. Adper Single Bond® was used as control group. After 24- hour and 6- month storages, the samples were subjected to thermocycling shocks and then immersed in silver nitrate as well as developer solution and finally evaluated for leakage. The data were analyzed using SPSS software. Results: Based on Kruskal –Wallis test, significant differences were found between groups regarding microleakage. The Mann- Whitney test showed that Leakage was significantly lower in Adper Single Bond® compared to the other groups in dentinal margins after 24 hours and 6 months and in enamel margins after 6 months. The Wilcoxon Signed Ranks test showed that the enamel leakage in experimental adhesives was significantly lower than dentinal leakage after 24 hours as well as enamel leakage in Adper Single Bond and adhesive with 0.5% PMAA-g-nanoclay was significantly lower than dentinal margins after storage period of 6 months. Conclusion: All the experimental adhesives were effective in reducing enamel leakage after 24 hours, but were not effective in reducing dentinal leakage after 24 hours as well as in enamel and dentinal leakage after a 6-month storage. No improvement was observed in the microleakage in dentin in both short (24 hrs) and long times (6 months). The high microleakage in the adhesives is probably attributed to the high concentration of HEMA in the recipe of the bonding agent. PMID:21566692

  8. Temperament, personality, and treatment outcome in major depression: a 6-month preliminary prospective study

    PubMed Central

    Kudo, Yuka; Nakagawa, Atsuo; Wake, Taisei; Ishikawa, Natsumi; Kurata, Chika; Nakahara, Mizuki; Nojima, Teruo; Mimura, Masaru

    2017-01-01

    Background Despite available treatments, major depression is a highly heterogeneous disorder, which leads to problems in classification and treatment specificity. Previous studies have reported that personality traits predict and influence the course and treatment response of depression. The Temperament and Personality Questionnaire (T&P) assesses eight major constructs of personality traits observed in those who develop depression. The aim of this study was to investigate the influence of T&P’s eight constructs on the treatment outcome of depressed patients. Patients and methods A preliminary 6-month prospective study was conducted with a sample of 51 adult patients with a diagnosis of major depressive disorder (MDD) without remarkable psychomotor disturbance using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. All patients received comprehensive assessment including the T&P at baseline. We compared each T&P construct score between patients who achieved remission and those who did not achieve remission after 6 months of treatment for depression using both subjective and objective measures. All 51 (100%) patients received the 6-month follow-up assessment. Results This study demonstrated that higher scores on T&P personal reserve predicted poorer treatment outcome in patients with MDD. Higher levels of personal reserve, rejection sensitivity, and self-criticism correlated with higher levels of depression. Higher levels of rejection sensitivity and self-criticism were associated with non-remitters; however, when we controlled for baseline depression severity, this relationship did not show significance. Conclusion Although the results are preliminary, this study suggests that high scores on T&P personal reserve predict poorer treatment outcome and T&P rejection sensitivity and self-criticism correlate with the severity of depression. Longer follow-up studies with large sample sizes are required to improve the understanding of these

  9. Prenatal maternal depression alters amygdala functional connectivity in 6-month-old infants

    PubMed Central

    Qiu, A; Anh, T T; Li, Y; Chen, H; Rifkin-Graboi, A; Broekman, B F P; Kwek, K; Saw, S-M; Chong, Y-S; Gluckman, P D; Fortier, M V; Meaney, M J

    2015-01-01

    Prenatal maternal depression is associated with alterations in the neonatal amygdala microstructure, shedding light on the timing for the influence of prenatal maternal depression on the brain structure of the offspring. This study aimed to examine the association between prenatal maternal depressive symptomatology and infant amygdala functional connectivity and to thus establish the neural functional basis for the transgenerational transmission of vulnerability for affective disorders during prenatal development. Twenty-four infants were included in this study with both structural magnetic resonance imaging (MRI) and resting-state functional MRI (fMRI) at 6 months of age. Maternal depression was assessed at 26 weeks of gestation and 3 months after delivery using the Edinburgh Postnatal Depression Scale. Linear regression was used to identify the amygdala functional networks and to examine the associations between prenatal maternal depressive symptoms and amygdala functional connectivity. Our results showed that at 6 months of age, the amygdala is functionally connected to widespread brain regions, forming the emotional regulation, sensory and perceptual, and emotional memory networks. After controlling for postnatal maternal depressive symptoms, infants born to mothers with higher prenatal maternal depressive symptoms showed greater functional connectivity of the amygdala with the left temporal cortex and insula, as well as the bilateral anterior cingulate, medial orbitofrontal and ventromedial prefrontal cortices, which are largely consistent with patterns of connectivity observed in adolescents and adults with major depressive disorder. Our study provides novel evidence that prenatal maternal depressive symptomatology alters the amygdala's functional connectivity in early postnatal life, which reveals that the neuroimaging correlates of the familial transmission of phenotypes associated with maternal mood are apparent in infants at 6 months of age. PMID:25689569

  10. Randomized controlled trial to prevent postpartum depression in mothers on public assistance

    PubMed Central

    Zlotnick, Caron; Tzilos, Golfo; Miller, Ivan; Seifer, Ronald; Stout, Robert

    2015-01-01

    Introduction Postpartum depression (PPD) is a significant and common public health problem for women. Aims To examine the efficacy of an intervention based on the principles of interpersonal therapy (IPT) in reducing the risk of PPD in pregnant women. Methods Randomized controlled trial of 205 pregnant women who were 18 years old or older, on public assistance, and at risk for PPD. Participants (mean age=23; 38% Hispanic and 23% Black) were randomized to either the IPT group intervention (n=104) or the treatment as usual control (TAU) program (n=101). Results At 6 months, the overall depression rate in the intervention group (16%) was lower than the control group (31%) and the effect of the intervention was statistically significant at p<0.05. Limitations It is unknown if findings will generalize to a more heterogeneous sample of women than the current study, such as women from a range of socio-economic and cultural backgrounds, or marital status. There was a differential amount of contact between TAU and intervention conditions. Conclusions An IPT based intervention during the prenatal period has the potential to reduce cases of PPD within 6 months postpartum in at risk mothers on public assistance. PMID:26454186

  11. 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…

  12. 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.…

  13. Pamidronate in the prevention of bone loss after liver transplantation: a randomized controlled trial.

    PubMed

    Monegal, Ana; Guañabens, Núria; Suárez, María Jesús; Suárez, Francisco; Clemente, Gerardo; García-González, Miguel; De la Mata, Manuel; Serrano, Trinidad; Casafont, Fernando; Tome, Santiago; Torne, Santiago; Barrios, Cesar; Navasa, Miquel

    2009-02-01

    Rapid bone loss and high rates of fractures occur following liver transplantation. To analyze the effect of intravenous pamidronate on bone loss after liver transplantation. A randomized, double-blind, placebo-controlled study was performed. Seventy-nine patients were randomized to two groups of treatment: the pamidronate group (n = 38) was treated with 90 mg/IV of pamidronate within the first 2 weeks and at 3 months after transplantation; the placebo group (n = 41) received glucose infusions at the same time points. All patients received calcium and vitamin D. Bone mineral density (BMD) at the lumbar spine (L(2)-L(4)) and proximal femur using dual energy X-ray absorptiometry and also spinal X-rays were performed before, and at 6 and 12 months after liver transplantation. Biochemical and hormonal determinations were performed previous to transplantation, at 24 h before and after treatment, as well as at 6 and 12 months after liver transplantation. At 12 months after transplantation, there were significant differences in lumbar BMD changes (6 months: pamidronate 1.6% vs. placebo 0.8%, P = NS; 12 months: pamidronate 2.9% vs. placebo 1%, P < 0.05). Femoral neck BMD decreased in the pamidronate- and placebo groups during the first 6 months (6 months: pamidronate -3.1% vs. placebo -2.9%, P = NS; 12 months: pamidronate -3.2% vs. placebo -3.1%, P = NS). BMD at the trochanter remained stable in the pamidronate group, whilst a reduction was observed in the placebo group at 6 months (6 months: pamidronate -0.7% vs. placebo -3.7%, P < 0.05; 12 months: pamidronate -0.5% vs. placebo -1.2%, P = NS). Moreover, no significant differences in the incidence of fractures, serum parathyroid hormone and serum 25-hydroxyvitamin D values between both groups were found. Pamidronate did not increase the risk of serious adverse events. The results of this study show that 90 mg of intravenous pamidronate within the first 2 weeks and at 3 months following liver transplantation preserve lumbar

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

    PubMed Central

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

    2014-01-01

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

  15. Efficacy of a single computer-tailored e-mail for smoking cessation: results after 6 months.

    PubMed

    Te Poel, Fam; Bolman, Catherine; Reubsaet, Astrid; de Vries, Hein

    2009-12-01

    To date, few Internet-delivered smoking cessation interventions have been tested. This study tested the efficacy, understandability, credibility and personal relevance of an e-mail-delivered computer-tailored smoking cessation intervention. It included tailored action plan feedback, as recent studies have demonstrated the importance of planning in facilitating quitting smoking. Participants (Dutch adults) were randomly assigned to the intervention (computer-tailored e-mail; N = 224) or the control group (generic, non-tailored e-mail; N = 234). The results 6 months after baseline (N = 195) showed that significantly more participants in the intervention group reported not having smoked in the last 24 hours (21.5%) and 7 days (20.4%) in contrast with participants in the control group (9.8 and 7.8%, respectively). Intention-to-treat analyses revealed similar results, though overall lower quitting percentages. Furthermore, participants in the intervention group appreciated the computer-tailored e-mail significantly more in terms of understandability, credibility and personal relevance. Hence, the computer-tailored intervention is effective for the Dutch smoking population motivated to quit smoking. Further research is needed into the efficacy of the intervention for smokers who are not motivated to quit smoking and into the benefits of (multiple) e-mail-delivered tailored letters with tailored action plan feedback over and above tailoring without action plan feedback.

  16. Determining the impact of prenatal tobacco exposure on self-regulation at 6 months.

    PubMed

    Wiebe, Sandra A; Fang, Hua; Johnson, Craig; James, Karen E; Espy, Kimberly Andrews

    2014-06-01

    Our goal in the present study was to examine the effects of maternal smoking during pregnancy on infant self-regulation, exploring birth weight as a mediator and sex as a moderator of risk. A prospective sample of 218 infants was assessed at 6 months of age. Infants completed a battery of tasks assessing working memory/inhibition, attention, and emotional reactivity and regulation. Propensity scores were used to statistically control for confounding risk factors associated with maternal smoking during pregnancy. After prenatal and postnatal confounds were controlled, prenatal tobacco exposure was related to reactivity to frustration and control of attention during stimulus encoding. Birth weight did not mediate the effect of prenatal exposure but was independently related to reactivity and working memory/inhibition. The effect of tobacco exposure was not moderated by sex.

  17. Mandibular arch orthodontic treatment stability using passive self-ligating and conventional systems in adults: A randomized controlled trial

    PubMed Central

    Wey, Mang Chek; Othman, Siti Adibah

    2017-01-01

    Objective This randomized controlled trial aimed to compare the stability of mandibular arch orthodontic treatment outcomes between passive self-ligating and conventional systems during 6 months of retention. Methods Fortyseven orthodontic patients with mild to moderate crowding malocclusions not requiring extraction were recruited based on inclusion criteria. Patients (mean age 21.58 ± 2.94 years) were randomized into two groups to receive either passive self-ligating (Damon® 3MX, n = 23) or conventional system (Gemini MBT, n = 24) orthodontic treatment. Direct measurements of the final sample comprising 20 study models per group were performed using a digital caliper at the debonding stage, and 1 month, 3 months, and 6 months after debonding. Paired t-test, independent t-test, and non-parametric test were used for statistical analysis. Results A significant increase (p < 0.01) in incisor irregularity was observed in both self-ligating and conventional system groups. A significant reduction (p < 0.01) in second interpremolar width was observed in both groups. Mandibular arch length decreased significantly (p = 0.001) in the conventional system group but not in the self-ligating system group. A similar pattern of stability was observed for intercanine width, first interpremolar width, intermolar width, and arch depth throughout the 6-month retention period after debonding. Comparison of incisor irregularity and arch dimension changes between self-ligating system and conventional system groups during the 6 months were non-significant. Conclusions The stability of treatment outcomes for mild to moderate crowding malocclusions was similar between the self-ligating system and conventional system during the first 6 months of retention. PMID:28127535

  18. A two-year randomized controlled trial of progressive resistance exercise for Parkinson's disease.

    PubMed

    Corcos, Daniel M; Robichaud, Julie A; David, Fabian J; Leurgans, Sue E; Vaillancourt, David E; Poon, Cynthia; Rafferty, Miriam R; Kohrt, Wendy M; Comella, Cynthia L

    2013-08-01

    The effects of progressive resistance exercise (PRE) on the motor signs of Parkinson's disease have not been studied in controlled trials. The objective of the current trial was to compare 6-, 12-, 18-, and 24-month outcomes of patients with Parkinson's disease who received PRE with a stretching, balance, and strengthening exercise program. The authors conducted a randomized controlled trial between September 2007 and July 2011. Pairs of patients matched by sex and off-medication scores on the Unified Parkinson's Disease Rating Scale, motor subscale (UPDRS-III), were randomly assigned to the interventions with a 1:1 allocation ratio. The PRE group performed a weight-lifting program. The modified fitness counts (mFC) group performed a stretching, balance, and strengthening exercise program. Patients exercised 2 days per week for 24 months at a gym. A personal trainer directed both weekly sessions for the first 6 months and 1 weekly session after 6 months. The primary outcome was the off-medication UPDRS-III score. Patients were followed for 24 months at 6-month intervals. Of 51 patients, 20 in the PRE group and 18 in the mFC group completed the trial. At 24 months, the mean off-medication UPDRS-III score decreased more with PRE than with mFC (mean difference, -7.3 points; 95% confidence interval, -11.3 to -3.6; P<0.001). The PRE group had 10 adverse events, and the mFC group had 7 adverse events. PRE demonstrated a statistically and clinically significant reduction in UPDRS-III scores compared with mFC and is recommended as a useful adjunct therapy to improve Parkinsonian motor signs. © 2013 Movement Disorder Society.

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

    PubMed

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

    2013-11-20

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

  20. Sleep and physical growth in infants during the first 6 months.

    PubMed

    Tikotzky, Liat; DE Marcas, Gali; Har-Toov, Joseph; Dollberg, Shaul; Bar-Haim, Yair; Sadeh, Avi

    2010-03-01

    The aim of this study was to explore the relationships between infant sleep patterns and infant physical growth (weight for length ratio) using both objective and subjective sleep measures. Ninety-six first-born, healthy 6-month-old infants and their parents participated in the study. Infant sleep was assessed by actigraphy for four consecutive nights and by the Brief Infant Sleep Questionnaire (BISQ). In addition, parents were asked to complete background and developmental questionnaires. Questions about feeding methods were included in the developmental questionnaire. Infants' weight and length were assessed during a standard checkup at the infant-care clinic when the infants were 6 months old. Significant correlations were found between infant sleep and growth after controlling for potential infant and family confounding factors. Actigraphic sleep percentage and reported sleep duration were correlated negatively with the weight-to-length ratio measures. Sex-related differences in the associations between sleep and physical growth were found. Breast feeding at night was correlated with a more fragmented sleep, but not with physical growth. These findings suggest that sleep is related significantly to physical growth as early as in the first months of life. The study supports increasing evidence from recent studies demonstrating a link between short sleep duration and weight gain and obesity in young children.

  1. Long-term oxandrolone treatment increases muscle protein net deposition via improving amino acid utilization in pediatric patients 6 months after burn injury

    PubMed Central

    Tuvdendorj, D.; Chinkes, DL.; Zhang, XJ.; Suman, OE.; Aarsland, A.; Ferrando, A.; Kulp, GA; Jeschke, MG.; Wolfe, RR.; Herndon, DN.

    2011-01-01

    Background We recently showed that mechanisms of protein turnover in skeletal muscle are unresponsive to amino acid (AA) infusion in severely burned pediatric patients at 6 months postinjury. In the current study, we evaluated if oxandrolone treatment affects mechanisms of protein turnover in skeletal muscle and whole-body protein breakdown in pediatric burn patients 6 months postinjury. Methods At the time of admission, patients were randomized to control or oxandrolone treatments. The treatment regimens were continued until 6 months postinjury, at which time patients (n = 26) underwent study with a stable isotope tracer infusion to measure muscle and whole-body protein turnover. Results Protein kinetics in leg muscle were expressed in nmol/min/100 ml leg volume (mean±SE). During AA infusion, rates of protein synthesis in leg muscle were increased (p < .05) in both groups (Basal vs. AA: control, 51±8 vs. 86±21; oxandrolone, 56±7 vs. 96±12). In the control group, there was also a simultaneous increase in breakdown (Basal vs. AA: 65±10 vs. 89±25), which resulted in no change in the net balance of leg muscle protein (Basal vs. AA: − 15±4 vs. − 2±10). In the oxandrolone group, protein breakdown did not change (Basal vs. AA: 80±12 vs. 77±9), leading to increased net balance (Basal vs. AA: − 24±7 vs. 19±7, p < .05). Protein breakdown at the whole-body level was not different between the groups. Conclusion Long-term oxandrolone treatment increased net deposition of leg muscle protein during AA infusion by attenuating protein breakdown, but did not affect whole-body protein breakdown. PMID:21333314

  2. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial

    PubMed Central

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer’s disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. Methods and findings This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Conclusions Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  3. Modifying Media Content for Preschool Children: A Randomized Controlled Trial

    PubMed Central

    Garrison, Michelle M.; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P.; Zhou, Chuan; Liekweg, Kimberly

    2013-01-01

    BACKGROUND: Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. METHODS: We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. RESULTS: At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78–3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06–1.30]) and the social competence subscale (1.04 [95% CI: 0.34–1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: −0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60–11.37]). CONCLUSIONS: An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior. PMID:23420911

  4. HUB city steps: a 6-month lifestyle intervention improves blood pressure among a primarily African American community

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The effectiveness of community-based participatory research (CBPR) efforts to address the disproportionate burden of hypertension among African Americans remains largely untested. The objective of this 6-month, non-controlled, pre- post-experimental intervention was to examine the effectiveness of ...

  5. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    PubMed Central

    2012-01-01

    Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes). However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-)environment interactions to obtain more insight into a) moderating effects of polymorphisms on the link between parenting and child behavior, and b) behavioral mechanisms that underlie these gene-(gene-)environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training). In a screening, families with children aged 4–8 who show mild to (sub)clinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest), after 6 months (i.e., posttest), and after 10 months (i.e., follow-up). Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-)environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s) received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and will manifest

  6. Vitamin A supplementation every 6 months with retinol in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

    PubMed Central

    Awasthi, Shally; Peto, Richard; Read, Simon; Clark, Sarah; Pande, Vinod; Bundy, Donald; the DEVTA (Deworming and Enhanced Vitamin A) team

    2013-01-01

    Summary Background In north India, vitamin A deficiency (retinol <0·70 μmol/L) is common in pre-school children and 2–3% die at ages 1·0–6·0 years. We aimed to assess whether periodic vitamin A supplementation could reduce this mortality. Methods Participants in this cluster-randomised trial were pre-school children in the defined catchment areas of 8338 state-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks (clusters) were cluster-randomly allocated in Oxford, UK, between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of retinol effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial vitamin A to sample blood (for retinol assay, technically reliable only after mid-study), examine eyes, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at ages 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly retinol supplements was 86%. Among 2581 versus 2584 children surveyed during the second half of the study, mean plasma retinol was one-sixth higher (0·72 [SE 0·01] vs 0·62 [0·01] μmol/L, increase 0·10 [SE 0·01] μmol/L) and the prevalence of severe deficiency was halved (retinol <0·35 μmol/L 6% vs 13%, decrease 7% [SE 1%]), as was that of Bitot's spots (1·4% vs 3·5%, decrease 2·1% [SE 0·7%]). Comparing the 36 retinol-allocated versus 36 control blocks in analyses of the primary outcome, deaths per child

  7. Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial

    PubMed Central

    Cunningham, Michael R.; van Zyl, Michiel A.; Antle, Becky F.; Langley, Cheri N.

    2016-01-01

    Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. PMID:27689500

  8. A postdeployment expressive writing intervention for military couples: a randomized controlled trial.

    PubMed

    Baddeley, Jenna L; Pennebaker, James W

    2011-10-01

    The current study tested the effectiveness of a brief expressive writing intervention on the marital adjustment of 102 military couples recently reunited following a deployment to Iraq or Afghanistan. Active duty soldiers and their spouses were randomly assigned to write about either their relationship or a nonemotional topic on 3 occasions on a single day. The resulting design included 4 couple-level writing topic conditions: soldier-expressive/spouse-expressive, soldier-expressive/spouse-control, soldier-control/spouse-expressive, and soldier-control/spouse-control. Participants completed marital adjustment measures before writing, 1 month, and 6 months after writing. When soldiers, but not spouses, did expressive writing, couples increased in marital satisfaction over the next month, particularly if the soldier had had high combat exposure.

  9. Safety and efficacy of a 6-month home-based exercise program in patients with facioscapulohumeral muscular dystrophy

    PubMed Central

    Bankolé, Landry-Cyrille; Millet, Guillaume Y.; Temesi, John; Bachasson, Damien; Ravelojaona, Marion; Wuyam, Bernard; Verges, Samuel; Ponsot, Elodie; Antoine, Jean-Christophe; Kadi, Fawzi; Féasson, Léonard

    2016-01-01

    Abstract Background: Previous randomized controlled trials investigating exercise training programs in facioscapulohumeral muscular dystrophy (FSHD) patients are scarce and of short duration only. This study assessed the safety and efficacy of a 6-month home-based exercise training program on fitness, muscle, and motor function in FSHD patients. Methods: Sixteen FSHD patients were randomly assigned to training (TG) and control (CG) groups (both n = 8) in a home-based exercise intervention. Training consisted of cycling 3 times weekly for 35 minutes (combination of strength, high-intensity interval, and low-intensity aerobic) at home for 24 weeks. Patients in CG also performed an identical training program (CTG) after 24 weeks. The primary outcome was change in peak oxygen uptake (VO2 peak) measured every 6 weeks. The principal secondary outcomes were maximal quadriceps strength (MVC) and local quadriceps endurance every 12 weeks. Other outcome measures included maximal aerobic power (MAP) and experienced fatigue every 6 weeks, 6-minute walking distance every 12 weeks, and muscle characteristics from vastus lateralis biopsies taken pre- and postintervention. Results: The compliance rate was 91% in TG. Significant improvements with training were observed in the VO2 peak (+19%, P = 0.002) and MAP by week 6 and further to week 24. Muscle endurance, MVC, and 6-minute walking distance increased and experienced fatigue decreased. Muscle fiber cross-sectional area and citrate synthase activity increased by 34% (P = 0.008) and 46% (P = 0.003), respectively. Dystrophic pathophysiologic patterns were not exacerbated. Similar improvements were experienced by TG and CTG. Conclusions: A combined strength and interval cycling exercise-training program compatible with patients’ daily professional and social activities leads to significant functional benefits without compromising muscle tissue. PMID:27495097

  10. Randomized Control Trial of Peer-Delivered, Modified Directly Observed Therapy for HAART in Mozambique

    PubMed Central

    Pearson, Cynthia R.; Micek, Mark A.; Simoni, Jane M.; Hoff, Peter D.; Matediana, Eduardo; Martin, Diane P.; Gloyd, Stephen S.

    2014-01-01

    Objective To assess the efficacy of a peer-delivered intervention to promote short-term (6-month) and long-term (12-month) adherence to HAART in a Mozambican clinic population. Design A 2-arm randomized controlled trial was conducted between October 2004 and June 2006. Participants Of 350 men and women (≥18 years) initiating HAART, 53.7% were female, and 97% were on 1 fixed-dose combination pill twice a day. Intervention Participants were randomly assigned to receive 6 weeks (Monday through Friday; 30 daily visits) of peer-delivered, modified directly observed therapy (mDOT) or standard care. Peers provided education about treatment and adherence and sought to identify and mitigate adherence barriers. Outcome Participants' self-reported medication adherence was assessed 6 months and 12 months after starting HAART. Adherence was defined as the proportion of prescribed doses taken over the previous 7 days. Statistical analyses were performed using intention-to-treat (missing = failure). Results Intervention participants, compared to those in standard care, showed significantly higher mean medication adherence at 6 months (92.7% vs. 84.9%, difference 7.8, 95% confidence interval [CI]: 0.0.02, 13.0) and 12 months (94.4% vs. 87.7%, difference 6.8, 95% CI: 0.9, 12.9). There were no between-arm differences in chart-abstracted CD4 counts. Conclusions A peer-delivered mDOT program may be an effective strategy to promote long-term adherence among persons initiating HAART in resource-poor settings. PMID:17693890

  11. Randomized Placebo-Controlled Phase II Trial of Autologous Mesenchymal Stem Cells in Multiple Sclerosis

    PubMed Central

    Blanco, Yolanda; Marín, Pedro; Moreno, Beatriz; Berenguer, Joan; Gabilondo, Iñigo; Martínez-Heras, Eloy; Sola-Valls, Nuria; Arnaiz, Joan-Albert; Andreu, Enrique J.; Fernández, Begoña; Bullich, Santi; Sánchez-Dalmau, Bernardo; Graus, Francesc; Villoslada, Pablo; Saiz, Albert

    2014-01-01

    Objective Uncontrolled studies of mesenchymal stem cells (MSCs) in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL) on magnetic resonance imaging (MRI) at 6 months and at the end of the study. Methods Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS) 3.0–6.5 were randomized to receive IV 1–2×106 bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite), and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects. Results At baseline 9 patients were randomized to receive MSCs (n = 5) or placebo (n = 4). One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI = 1.1–8.8 vs 12.3, 95% CI = 4.4–34.5, p = 0.064), and at the end of study to reduced mean GEL (−2.8±5.9 vs 3±5.4, p = 0.075). No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-γ+) cells in blood of MSCs treated patients. Conclusion Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266 PMID:25436769

  12. A Randomized Controlled Trial of Two Different Lengths of Nicotine Replacement Therapy for Smoking Cessation

    PubMed Central

    Abdullah, Abu S.; Hedley, Anthony J.; Chan, Sophia S. C.; Lam, Tai-Hing

    2013-01-01

    This study examined if 2-week free nicotine replacement therapy (NRT) would be more effective than 1-week free NRT to help smokers quit smoking at 6 and 12 months. In a single-blinded randomized controlled trial design, 562 Chinese smokers who attended a smoking cessation clinic in Hong Kong, China, were randomly allocated into two groups (A1 and A2): A1 (n = 284) received behavioural counselling with free NRT for 1 week; A2 (n = 278) received similar counselling with free NRT for 2 weeks. All subjects received printed self-help materials to support their quitting efforts. A structured questionnaire was used for data collection, including pattern of NRT use and self-reported 7-day point prevalence quit rate at 6 months and 12 months. Among the participants, the mean number of cigarettes smoked per day was 18.8 (SD = 10.9). By intention-to-treat analysis, 7-day point prevalence quit rates were not significantly different between A1 and A2 groups at 6-month (27.5% versus 27.3%; P = 0.97) and 12-month (21.1% versus 21.2%; P = 0.98) followup. The findings suggest that two-week free NRT was not more effective than 1-week free NRT to increase smoking cessation rate among Chinese smokers. PMID:24089693

  13. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study.

    PubMed

    Heinz, Bernd; Kasaj, Adrian; Teich, Marie; Jepsen, Søren

    2010-10-01

    The purpose of the present randomized controlled clinical study was to compare the clinical outcomes of papilla preservation flap surgery with or without the application of a novel nanocrystalline hydroxyapatite (nano-HA) bone graft substitute. Fourteen patients with paired intrabony periodontal defects of ≥ 4 mm participated in this split-mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels (PBL) from a customized acrylic stent and probing pocket depths (PPD) were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months (p < 0.05). At 6 months after therapy, the sites treated with nano-HA paste showed a reduction in mean PPD from 8.3 ± 1.2 to 4.0 ± 1.1 mm and a gain in PBL of 4.3 ± 1.4 mm, whereas in the control group, the mean PPD changed from 7.9 ± 1.2 mm to 5.0 ± 1.2 mm and PBL gain was 2.6 ± 1.4 mm. Results demonstrated statistically greater PPD reduction and PBL gain (p < 0.05) in the test group as compared with the control group. In conclusion, after 6 months, the treatment of intrabony periodontal defects with a nano-HA paste leads to significantly improved clinical outcomes when compared with papilla preservation flap surgery alone.

  14. Goal management training of executive functions in patients with spina bifida: a randomized controlled trial.

    PubMed

    Stubberud, Jan; Langenbahn, Donna; Levine, Brian; Stanghelle, Johan; Schanke, Anne-Kristine

    2013-07-01

    Executive dysfunction causes significant real-life disability for patients with spina bifida (SB). However, no previous research has been directed toward the amelioration of executive functioning deficits amongst persons with SB. Goal Management Training (GMT) is a compensatory cognitive rehabilitation approach, addressing underlying deficits in sustained attention to improve executive function. GMT has received empirical support in studies of other patient groups. The purpose of the present study was to determine the efficacy of GMT in treating subjects with SB, using inpatient intervention periods. We hypothesized post-intervention changes in scores on neuropsychological measures to reflect improved attentional control, including sustained attention and inhibitory control. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared to results of subjects in a wait-list condition (n = 14). All subjects were assessed at baseline, post-intervention, and at 6-month follow-up. Findings indicated superior effects of GMT on domain-specific neuropsychological measures and on a functional "real-life" measure, all lasting at least 6 months post-treatment. These results show that deficits in executive functioning can be ameliorated in patients with congenital brain dysfunction.

  15. Effect of Admission Hyperglycemia on 6-Month Functional Outcome in Patients with Spontaneous Cerebellar Hemorrhage

    PubMed Central

    Tao, Chuanyuan; Hu, Xin; Wang, Jiajing; You, Chao

    2017-01-01

    Background Cerebellar hemorrhage (CH) has a quite different treatment strategy and prognostic factors compared with supratentorial intracerebral hemorrhage (ICH). The prognostic role of hyperglycemia has been discussed mainly in cases of supratentorial hemorrhage; it remains to be elucidated following CH. We aimed to determine the association of hyperglycemia on admission with 6-month functional outcome in CH patients. Material/Methods We retrospectively analyzed 77 patients with acute CH between September 2010 and April 2015 in West China Hospital. Blood glucose level was measured when the patients were admitted. Primary outcome was 6-month functional outcome, which could comprehensively reflect the patient’s recovery of physical and social ability after stroke and was assessed by the modified Rankin scale (mRS). Association of hyperglycemia with functional outcome was identified in logistic regression models. Results There were 50 (64.9%) patients with poor functional outcomes. Patients with poor outcome were much older (P<0.001) and had a significantly higher glucose level on admission (P<0.001), a lower Glasgow Coma Scale score (P<0.001), a larger hematoma (P=0.003), and a higher incidence of intraventricular extension (P=0.002), brainstem compression (P=0.013), and hydrocephalus (P=0.023). Multivariate analysis showed that hyperglycemia (OR 1.50, 95% CI 1.07–2.08, P=0.017 when glucose level was analyzed as a continuous variable; OR 7.46, 95% CI 1.41–39.51, P=0.018 when glucose level was dichotomized by the critical threshold of 6.78 mmol/L) emerged as an independent predictor for adverse functional outcome at 6 months. Conclusions To the best of our knowledge, this is the first study focusing on the relationship between hyperglycemia and long-term functional outcome after CH. The study combined with previous pertinent reports definitely indicates the poor effect of hyperglycemia on both supra- and infratentorial ICH independent of hemorrhage site

  16. Effect of Admission Hyperglycemia on 6-Month Functional Outcome in Patients with Spontaneous Cerebellar Hemorrhage.

    PubMed

    Tao, Chuanyuan; Hu, Xin; Wang, Jiajing; You, Chao

    2017-03-08

    BACKGROUND Cerebellar hemorrhage (CH) has a quite different treatment strategy and prognostic factors compared with supratentorial intracerebral hemorrhage (ICH). The prognostic role of hyperglycemia has been discussed mainly in cases of supratentorial hemorrhage; it remains to be elucidated following CH. We aimed to determine the association of hyperglycemia on admission with 6-month functional outcome in CH patients. MATERIAL AND METHODS We retrospectively analyzed 77 patients with acute CH between September 2010 and April 2015 in West China Hospital. Blood glucose level was measured when the patients were admitted. Primary outcome was 6-month functional outcome, which could comprehensively reflect the patient's recovery of physical and social ability after stroke and was assessed by the modified Rankin scale (mRS). Association of hyperglycemia with functional outcome was identified in logistic regression models. RESULTS There were 50 (64.9%) patients with poor functional outcomes. Patients with poor outcome were much older (P<0.001) and had a significantly higher glucose level on admission (P<0.001), a lower Glasgow Coma Scale score (P<0.001), a larger hematoma (P=0.003), and a higher incidence of intraventricular extension (P=0.002), brainstem compression (P=0.013), and hydrocephalus (P=0.023). Multivariate analysis showed that hyperglycemia (OR 1.50, 95% CI 1.07-2.08, P=0.017 when glucose level was analyzed as a continuous variable; OR 7.46, 95% CI 1.41-39.51, P=0.018 when glucose level was dichotomized by the critical threshold of 6.78 mmol/L) emerged as an independent predictor for adverse functional outcome at 6 months. CONCLUSIONS To the best of our knowledge, this is the first study focusing on the relationship between hyperglycemia and long-term functional outcome after CH. The study combined with previous pertinent reports definitely indicates the poor effect of hyperglycemia on both supra- and infratentorial ICH independent of hemorrhage site

  17. AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.

    PubMed

    Bosiers, Marc; Peeters, Patrick; D'Archambeau, Olivier; Hendriks, Jeroen; Pilger, Ernst; Düber, Christoph; Zeller, Thomas; Gussmann, Andreas; Lohle, Paul N M; Minar, Erich; Scheinert, Dierk; Hausegger, Klaus; Schulte, Karl-Ludwig; Verbist, Jürgen; Deloose, Koen; Lammer, J

    2009-05-01

    Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

  18. Re-infection with Fasciola gigantica 6-month post-treatment with triclabendazole in cattle from mobile pastoralist husbandry systems at Lake Chad.

    PubMed

    Greter, Helena; Batil, Annour A; Alfaroukh, Idriss O; Grimm, Felix; Ngandolo, Bongo N; Keiser, Jennifer; Utzinger, Jürg; Zinsstag, Jakob; Hattendorf, Jan

    2016-10-30

    At Lake Chad in central Africa, livestock fascioliasis caused by Fasciola gigantica represents a major veterinary health problem, particularly in cattle reared in mobile pastoralist husbandry systems. We assessed re-infection after a single dose of triclabendazole with fascioliasis in cattle in a mobile pastoralist setting towards the end of the dry season. Within the cattle herds of 14 groups of mobile pastoralists, 375 cattle were randomly selected. A faecal sample was obtained from each animal to determine the prevalence of F. gigantica. Animals were administered a single oral dose of triclabendazole (12mg/kg). A second faecal sample was obtained 6-month post-treatment after cattle had returned from the annual migration cycle. Faecal samples were fixed in sodium acetate-acetic acid-formalin (SAF), and examined for F. gigantica using the sedimentation technique. From the 375 cattle enrolled at baseline, 198 animals (53%) in 12 groups of mobile pastoralists were re-sampled at the 6-month follow-up. Baseline prevalence did not differ noteworthy between animals lost to follow-up and those re-examined. At baseline, bovine fascioliasis prevalence in cattle with follow-up data was 41.9% (95% confidence interval (CI) 35.2-48.9%). At the 6-month post-treatment follow-up, the prevalence was 46.0% (95% CI 39.2-52.9%), ranging between 0% and 75% at the herd level. The mean faecal egg counts at the unit of the herd were higher at follow-up compared to baseline. The observed persistent high prevalence of F. gigantica infection in cattle shows that a single pre-rainy season treatment does not prevent rapid re-infection despite the partial migration away from the high-risk areas at Lake Chad into drier areas. A locally adapted strategic control package for fascioliasis in cattle in the Lake Chad area ought to integrate targeted triclabendazole treatment and seasonal transhumance practices.

  19. RANDOMIZED, CONTROLLED, SIX-MONTH TRIAL OF YOGA IN HEALTHY SENIORS: EFFECTS ON COGNITION AND QUALITY OF LIFE

    PubMed Central

    Oken, Barry S.; Zajdel, Daniel; Kishiyama, Shirley; Flegal, Kristin; Dehen, Cathleen; Haas, Mitchell; Kraemer, Dale F.; Lawrence, Julie; Leyva, Joanne

    2006-01-01

    Context There are potential benefits of mind-body techniques on cognitive function because the techniques involve an active attentional or mindfulness component, but this has not been fully explored. Objective To determine the effect of yoga on cognitive function, fatigue, mood, and quality of life in seniors. Design Randomized, controlled trial comparing yoga, exercise, and wait-list control groups. Participants One hundred thirty-five generally healthy men and women aged 65–85 years. Intervention Participants were randomized to 6 months of Hatha yoga class, walking exercise class, or wait-list control. Subjects assigned to classes also were asked to practice at home. Main Outcome Measures Outcome assessments performed at baseline and after the 6-month period included a battery of cognitive measures focused on attention and alertness, the primary outcome measures being performance on the Stroop Test and a quantitative electroencephalogram (EEC) measure of alertness; SF-36 health-related quality of life; Profile of Mood States; Multi-Dimensional Fatigue Inventory; and physical measures related to the interventions. Results One hundred thirty-five subjects were recruited and randomized. Seventeen subjects did not finish the 6-month intervention. There were no effects from either of the active interventions on any of the cognitive and alertness outcome measures. The yoga intervention produced improvements in physical measures (eg, timed 1-legged standing, forward flexibility) as well as a number of quality-of-life measures related to sense of well-being and energy and fatigue compared to controls. Conclusions There were no relative improvements of cognitive function among healthy seniors in the yoga or exercise group compared to the wait-list control group. Those in the yoga group showed significant improvement in quality-of-life and physical measures compared to exercise and wait-list control groups. PMID:16454146

  20. Patient Relocation in the 6 Months After Hip Fracture: Risk Factors for Fragmented Care

    PubMed Central

    Boockvar, Kenneth S.; Litke, Ann; Penrod, Joan D.; Halm, Ethan A.; Morrison, R. Sean; Silberzweig, Stacey B.; Magaziner, Jay; Koval, Kenneth; Siu, Albert L.

    2006-01-01

    OBJECTIVES To describe the incidence and patterns of patient relocation after hip fracture, identify factors associated with relocation, and examine effect of relocation on outcomes. DESIGN Prospective cohort study. SETTING Four hospitals in the New York metropolitan area. PARTICIPANTS A total of 562 patients hospitalized for hip fracture discharged alive in 1997 to 1998. MEASUREMENTS Patient characteristics and hospital course were ascertained using patient or surrogate interview, research nurse assessment, and medical record review. Patient location was ascertained at five time points using patient or surrogate interview, and hospital readmissions were identified using New York state and hospital admission databases. Mobility was measured using patient or surrogate report using the Functional Independence Measure. RESULTS During 6 months of follow-up, the mean number of relocations per patient ± standard deviation was 3.5 ± 1.5 (range 2–10). Forty-one percent of relocations were between home and hospital, 36% between rehabilitation or nursing facility and hospital, 17% between rehabilitation or nursing facility and home, and 4% between two rehabilitation/nursing facilities. In a Poisson regression model that controlled for patient characteristics, hospital course, and length of follow-up, factors associated with relocation (P <.05) were absence of dementia, in-hospital delirium, one or more new impairments at hospital discharge, hospital discharge other than to home, and not living at home alone prefracture. Relocation was not significantly associated with immobility or mortality at 6 months (odds ratio = 1.14, 95% confidence interval = 0.97–1.35). CONCLUSION Subgroups of patients with elevated risk of relocation after hip fracture may be target groups for intensive care coordination and care planning interventions. PMID:15507058

  1. 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

  2. Neural Dynamics of Audiovisual Synchrony and Asynchrony Perception in 6-Month-Old Infants

    PubMed Central

    Kopp, Franziska; Dietrich, Claudia

    2013-01-01

    Young infants are sensitive to multisensory temporal synchrony relations, but the neural dynamics of temporal interactions between vision and audition in infancy are not well understood. We investigated audiovisual synchrony and asynchrony perception in 6-month-old infants using event-related brain potentials (ERP). In a prior behavioral experiment (n = 45), infants were habituated to an audiovisual synchronous stimulus and tested for recovery of interest by presenting an asynchronous test stimulus in which the visual stream was delayed with respect to the auditory stream by 400 ms. Infants who behaviorally discriminated the change in temporal alignment were included in further analyses. In the EEG experiment (final sample: n = 15), synchronous and asynchronous stimuli (visual delay of 400 ms) were presented in random order. Results show latency shifts in the auditory ERP components N1 and P2 as well as the infant ERP component Nc. Latencies in the asynchronous condition were significantly longer than in the synchronous condition. After video onset but preceding the auditory onset, amplitude modulations propagating from posterior to anterior sites and related to the Pb component of infants’ ERP were observed. Results suggest temporal interactions between the two modalities. Specifically, they point to the significance of anticipatory visual motion for auditory processing, and indicate young infants’ predictive capacities for audiovisual temporal synchrony relations. PMID:23346071

  3. Borderline personality disorder in major depression: symptomatology, temperament, character, differential drug response, and 6-month outcome.

    PubMed

    Joyce, Peter R; Mulder, Roger T; Luty, Suzanne E; McKenzie, Janice M; Sullivan, Patrick F; Cloninger, Robert C

    2003-01-01

    Among 183 depressed patients participating in a randomized long-term treatment trial of fluoxetine and nortriptyline, 30 patients had borderline personality disorder (BPD), 53 had other personality disorders (OPD), and 100 had no personality disorders (NPD). The borderline depressed patients had earlier age of onset of their depressions, more chronic depressions, more alcohol and cannabis comorbidity, and were more likely to have histories of suicide attempts and of self-mutilation. On self-report, patients with BPD and OPD reported more phobic symptoms, greater interpersonal sensitivity, and more paranoid ideation. Uniquely, BPD patients were more angry than OPD patients. BPD patients had high novelty seeking, high harm avoidance, low self-directedness, and low cooperativeness. Depressed patients with BPD did poorly in the short term if treated with nortriptyline rather than fluoxetine. After 6 months, those with BPD had a favorable outcome in regard to depressive symptoms, social adjustment, and even improvement in the character measure of self-directedness. Those with the poorest outcome were those with OPD.

  4. Enhancing adoptive parenting: a randomized controlled trial.

    PubMed

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

    2010-10-01

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

  5. FDG-PET in Semantic Dementia after 6 Months of Memantine: an Open-Label Pilot Study

    PubMed Central

    Chow, Tiffany W.; Fam, David; Graff-Guerrero, Ariel; Verhoeff, Nicolaas P. G.; Tang-Wai, David F.; Masellis, Mario; Black, Sandra E.; Wilson, Alan A.; Houle, Sylvain; Pollock, Bruce G.

    2012-01-01

    Objectives To follow up on the increases we reported in normalized metabolic activity in salience network hubs from a 2-month open label study of memantine in frontotemporal dementia (FTD). Methods We repeated fluoro-deoxyglucose positron emission tomography (PET) after 6 months of drug use and subjected the data to an SPM analysis to reveal clusters of significant change from baseline. We also sought correlations between changes in behavioral disturbances on the Frontal Behavioral Inventory (FBI). Results Recruitment of one progressive nonfluent aphasia and one behavioral variant FTD precluded statistical analysis for any FTD subtype other than semantic dementia. The baseline-to-6-month interval showed increased normalized metabolic activity in the left orbitofrontal cortex (p<0.002) for 5 participants with semantic dementia. The 2–6 month interval revealed a late increase in normalized metabolic activity in the left insula (p<0.013), right insula (p<0.009), and left anterior cingulate (p<0.005). The right anterior cingulate showed both an initial increase and a delayed, further increase (2–6 month, p<0.016). FBI scores worsened by 43.3%. One participant with semantic dementia opted not to continue memantine beyond 2 months yet showed similar FDG-PET increases. Conclusions Increases in normalized cortical metabolic activity in salience network hubs were sustained in SD over a 6-month period. Since one participant without medication also showed these changes, further investigation is recommended through a double-blind, placebo-controlled study with FDG-PET as an outcome measure. PMID:22674572

  6. Sham Electroacupuncture Methods in Randomized Controlled Trials

    PubMed Central

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

    2017-01-01

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

  7. Vitamin D therapy to reduce blood pressure and left ventricular hypertrophy in resistant hypertension: randomized, controlled trial.

    PubMed

    Witham, Miles D; Ireland, Sheila; Houston, J Graeme; Gandy, Stephen J; Waugh, Shelley; Macdonald, Thomas M; Mackenzie, Isla S; Struthers, Allan D

    2014-04-01

    Low 25-hydroxyvitamin D levels are associated with higher prevalent blood pressure. We tested whether high-dose intermittent oral vitamin D therapy could reduce blood pressure and left ventricular mass in patients with hypertension resistant to conventional treatment. We conducted a parallel-group, double-blind, randomized placebo-controlled trial. Patients with supine office blood pressure >140/90 mm Hg on ≥3 antihypertensive agents received 100 000 U oral vitamin D3 or matching placebo every 2 months. Office and 24-hour ambulatory blood pressure, glucose, and cholesterol were measured at baseline, 2, 4, and 6 months; left ventricular mass index was measured by cardiac MRI on a subgroup at baseline and 6 months. The primary outcome was mean 24-hour ambulatory blood pressure at 6 months. A total of 68 participants were randomized, 34 in each group. Mean age was 63 (SD 11) years, mean baseline office blood pressure was 154/84 (13/10) mm Hg, and mean baseline 25-hydroxyvitamin D level was 42 (16) nmol/L. Treatment with vitamin D did not reduce 24-hour ambulatory blood pressure (adjusted treatment effects: systolic, +3 mm Hg; 95% confidence interval, -4 to +11; P=0.33; diastolic, -2 mm Hg; 95% confidence interval, -6 to +2; P=0.29); similar results were seen for office blood pressure. Left ventricular mass index was measured in a subgroup (n=25); no reduction was seen with vitamin D treatment (adjusted treatment effect, +4 g/m(2); 95% confidence interval, 0 to +7; P=0.04). There was no significant change in cholesterol or glucose levels. Thus, 6 months of intermittent, high-dose oral vitamin D3 did not reduce blood pressure or left ventricular mass in patients with resistant hypertension.

  8. Randomized Control Trial of Composite Cuspal Restorations

    PubMed Central

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

    2014-01-01

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

  9. 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

    2015-08-06

    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.

  10. 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

  11. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial

    PubMed Central

    Xiao, Guomin; Wei, Jing; Yan, Weiqi; Wang, Weimin; Lu, Zhenhui

    2008-01-01

    Background Severe traumatic brain injury (TBI) has been increasing with greater incidence of injuries from traffic or sporting accidents. Although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI. Methods A total of 159 patients who arrived within 8 hours of injury with a Glasgow Coma Score ≤ 8 were enrolled in the study. A prospective, randomized, placebo-controlled trial of progesterone was conducted in the Neurotrauma Center of our teaching hospital. The patients were randomized to receive either progesterone or placebo. The primary endpoint was the Glasgow Outcome Scale score 3 months after brain injury. Secondary efficacy endpoints included the modified Functional Independence Measure score and mortality. In a follow-up protocol at 6 months, the Glasgow Outcome Scale and the modified Functional Independence Measure scores were again determined. Results Of the 159 patients randomized, 82 received progesterone and 77 received placebo. The demographic characteristics, the mechanism of injury, and the time of treatment were compared for the two groups. After 3 months and 6 months of treatment, the dichotomized Glasgow Outcome Scale score analysis exhibited more favorable outcomes among the patients who were given progesterone compared with the control individuals (P = 0.034 and P = 0.048, respectively). The modified Functional Independence Measure scores in the progesterone group were higher than those in the placebo group at both 3-month and 6-month follow-up (P < 0.05 and P < 0.01). The mortality rate of the progesterone group was significantly lower than that of the placebo group at 6-month follow-up (P < 0.05). The mean intracranial pressure values 72 hours and 7 days after

  12. Effects of a short-term parental education program on childhood atopic dermatitis: a randomized controlled trial.

    PubMed

    Futamura, Masaki; Masuko, Ikuyo; Hayashi, Keiichi; Ohya, Yukihiro; Ito, Komei

    2013-01-01

    Parental education is important in managing childhood atopic dermatitis (AD). We evaluated the long-term effects of a 2-day parental education program (PEP) on childhood AD. In an investigator-blinded, randomized controlled trial, 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan. Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures, three practical sessions, and a group discussion. The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis (SCORAD) at 6 months. Secondary outcomes included changes in symptom scores, amount of corticosteroid used, parental quality of life as determined according to the Dermatitis Family Impact questionnaire, and change in parental anxiety regarding the use of corticosteroids in their children. Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months (mean difference 10.0, 95% confidence interval [CI] = 2.3-17.7, p = 0.01) and objective SCORAD score (mean difference 7.1, 95% CI = 0.8-13.5, p = 0.03). The sleeplessness symptom score (mean difference 1.6, 95% CI = 0.0-3.1, p = 0.048) and corticosteroid anxiety score (p = 0.02) in the PEP group were significantly better than in the control group at 6 months. There was no significant difference between groups in the amount of corticosteroid used or quality of life. The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage.

  13. Parent Management Training and Collaborative & Proactive Solutions: A Randomized Control Trial for Oppositional Youth.

    PubMed

    Ollendick, Thomas H; Greene, Ross W; Austin, Kristin E; Fraire, Maria G; Halldorsdottir, Thorhildur; Allen, Kristy Benoit; Jarrett, Matthew A; Lewis, Krystal M; Whitmore Smith, Maria; Cunningham, Natoshia R; Noguchi, Ryoichi J P; Canavera, Kristin; Wolff, Jennifer C

    2016-01-01

    This study examined the efficacy of Collaborative & Proactive Solutions (CPS) in treating oppositional defiant disorder (ODD) in youth by comparing this novel treatment to Parent Management Training (PMT), a well-established treatment, and a waitlist control (WLC) group. One hundred thirty-four youth (ages 7-14, 61.9% male, 83.6% White) who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria for ODD were randomized to CPS, PMT, or WLC groups. ODD was assessed with semistructured diagnostic interviews, clinical global severity and improvement ratings, and parent report measures. Assessments were completed pretreatment, posttreatment, and at 6 months following treatment. Responder and remitter analyses were undertaken using intent-to-treat mixed-models analyses. Chronological age, gender, and socioeconomic status as well as the presence of comorbid attention deficit/hyperactivity and anxiety disorders were examined as predictors of treatment outcome. Both treatment conditions were superior to the WLC condition but did not differ from one another in either our responder or remitter analyses. Approximately 50% of youth in both active treatments were diagnosis free and were judged to be much or very much improved at posttreatment, compared to 0% in the waitlist condition. Younger age and presence of an anxiety disorder predicted better treatment outcomes for both PMT and CPS. Treatment gains were maintained at 6-month follow-up. CPS proved to be equivalent to PMT and can be considered an evidence-based, alternative treatment for youth with ODD and their families.

  14. Manual therapies for primary chronic headaches: a systematic review of randomized controlled trials.

    PubMed

    Chaibi, Aleksander; Russell, Michael Bjørn

    2014-10-02

    This is to our knowledge the first systematic review regarding the efficacy of manual therapy randomized clinical trials (RCT) for primary chronic headaches. A comprehensive English literature search on CINHAL, Cochrane, Medline, Ovid and PubMed identified 6 RCTs all investigating chronic tension-type headache (CTTH). One study applied massage therapy and five studies applied physiotherapy. Four studies were considered to be of good methodological quality by the PEDro scale. All studies were pragmatic or used no treatment as a control group, and only two studies avoided co-intervention, which may lead to possible bias and makes interpretation of the results more difficult. The RCTs suggest that massage and physiotherapy are effective treatment options in the management of CTTH. One of the RCTs showed that physiotherapy reduced headache frequency and intensity statistical significant better than usual care by the general practitioner. The efficacy of physiotherapy at post-treatment and at 6 months follow-up equals the efficacy of tricyclic antidepressants. Effect size of physiotherapy was up to 0.62. Future manual therapy RCTs are requested addressing the efficacy in chronic migraine with and without medication overuse. Future RCTs on headache should adhere to the International Headache Society's guidelines for clinical trials, i.e., frequency as primary end-point, while duration and intensity should be secondary end-point, avoid co-intervention, includes sufficient sample size and follow-up period for at least 6 months.

  15. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial.

    PubMed

    Wu, Yung-Tsan; Ho, Tsung-Yen; Chou, Yu-Ching; Ke, Ming-Jen; Li, Tsung-Ying; Huang, Guo-Shu; Chen, Liang-Cheng

    2017-12-01

    Recently, a few small reports with short follow-up period have shown clinical benefits of platelet-rich plasma (PRP) for peripheral neuropathy including one pilot study and one small, non-randomized trial in patients with carpal tunnel syndrome (CTS). Therefore, we conducted a randomized, single-blind, controlled trial to assess the 6-month effect of PRP in patients with CTS. Sixty patients with unilateral mild-to-moderate CTS were randomized into two groups of 30, namely the PRP and control groups. In the PRP group, patients were injected with one dose of 3 mL of PRP using ultrasound guidance and the control group received a night splint through the study period. The primary outcome measure was the visual analog scale (VAS) and secondary outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score, the cross-sectional area (CSA) of the median nerve (MN), electrophysiological findings of the MN, and finger pinch strength. The evaluation was performed before treatment and at 1, 3, and 6 months post-injection. The PRP group exhibited a significant reduction in the VAS score, BCTQ score, and CSA of MN compared to the those of control group 6 months post-treatment (p < 0.05). Our study demonstrates that PRP is a safe modality that effectively relieves pain and improves disability in the patients with CTS.

  16. A 6-Month Assessment of Sleep During Naval Deployment: A Case Study of a Commanding Officer

    DTIC Science & Technology

    2015-05-01

    less than a month in duration. 1 , 10 Although useful, sleep studies of only days or weeks in duration may give an inaccurate portrayal of the...Reprint & Copyright © by the Aerospace Medical Association, Alexandria, VA. DOI: 10.3357/AMHP.4140.2015 A 6- Month Assessment of Sleep During Naval...environments , sleep debt , maritime sleep , sleep at sea , predicted eff ectiveness . Shattuck NL, Matsangas P. A 6- month assessment of sleep

  17. Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

    PubMed Central

    Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

    2014-01-01

    Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360

  18. A 6-month large-scale study into the safety of tamsulosin

    PubMed Central

    Michel, M C; Bressel, H-U; Goepel, M; Rübben, H

    2001-01-01

    Aims Tamsulosin is an α1-adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia with a tolerability similar to that of placebo in short-term, placebo-controlled studies with limited patient numbers. The present study was designed to test the safety of tamsulosin treatment in a large cohort of men during a prolonged period of time, particularly with regard to comedications. Methods A multicentre, open-label phase IIIb study with 1784 patients receiving 0.4 mg o.d. tamsulosin for 6 months was performed according to good clinical practice guidelines. The analysis was performed on an intention-to-treat basis and powered to detect adverse events (AE) occurring in 0.15% of patients with 95% confidence. Results During a total drug exposure time of 811 patient years, 386 AE were recorded in 253 patients (14.2%; 95% confidence intervals [CI] 12.0–15.2%). Twenty-nine patients suffered 44 serious AE including five fatal events (CI 0.12–0.73%) due to myocardial infarction (n = 3) and to pneumonia and a car accident (one each), but all deaths were judged to be unlikely to be related to study medication. The frequency of AE in patients without any comedication (n = 1095) was 13.0% (CI 11.3–14.9%). In a logistic regression analysis β-adrenoceptor blockers, converting enzyme inhibitors, antidiabetics and diuretics did not significantly affect the odds ratio for having AE. However, concomitant α-adrenoceptor antagonists (a protocol violation) and treatment with verapamil (which also has α-adrenoceptor antagonist activity) significantly enhanced the odds ratio for having AE to 3.87 (CI 1.52–9.85) and 3.17 (CI 1.52–6.58), respectively. Minor increases in the odds ratio, which did not reach statistical significance, were also observed for Ca2+ antagonists other than verapamil and for nitrates. Conclusions We conclude that tamsulosin has a good safety profile relative to AE rates in the placebo arms of previous studies on tamsulosin even in

  19. Differential gene expression in the liver of the African lungfish, Protopterus annectens, after 6 months of aestivation in air or 1 day of arousal from 6 months of aestivation.

    PubMed

    Hiong, Kum C; Ip, Yuen K; Wong, Wai P; Chew, Shit F

    2015-01-01

    The African lungfish, Protopterus annectens, can undergo aestivation during drought. Aestivation has three phases: induction, maintenance and arousal. The objective of this study was to examine the differential gene expression in the liver of P. annectens after 6 months (the maintenance phase) of aestivation as compared with the freshwater control, or after 1 day of arousal from 6 months aestivation as compared with 6 months of aestivation using suppression subtractive hybridization. During the maintenance phase of aestivation, the mRNA expression of argininosuccinate synthetase 1 and carbamoyl phosphate synthetase III were up-regulated, indicating an increase in the ornithine-urea cycle capacity to detoxify ammonia to urea. There was also an increase in the expression of betaine homocysteine-S-transferase 1 which could reduce and prevent the accumulation of hepatic homocysteine. On the other hand, the down-regulation of superoxide dismutase 1 expression could signify a decrease in ROS production during the maintenance phase of aestivation. In addition, the maintenance phase was marked by decreases in expressions of genes related to blood coagulation, complement fixation and iron and copper metabolism, which could be strategies used to prevent thrombosis and to conserve energy. Unlike the maintenance phase of aestivation, there were increases in expressions of genes related to nitrogen, carbohydrate and lipid metabolism and fatty acid transport after 1 day of arousal from 6 months aestivation. There were also up-regulation in expressions of genes that were involved in the electron transport system and ATP synthesis, indicating a greater demand for metabolic energy during arousal. Overall, our results signify the importance of sustaining a low rate of waste production and conservation of energy store during the maintenance phase, and the dependence on internal energy store for repair and structural modification during the arousal phase, of aestivation in the liver

  20. Differential Gene Expression in the Liver of the African Lungfish, Protopterus annectens, after 6 Months of Aestivation in Air or 1 Day of Arousal from 6 Months of Aestivation

    PubMed Central

    Hiong, Kum C.; Ip, Yuen K.; Wong, Wai P.; Chew, Shit F.

    2015-01-01

    The African lungfish, Protopterus annectens, can undergo aestivation during drought. Aestivation has three phases: induction, maintenance and arousal. The objective of this study was to examine the differential gene expression in the liver of P. annectens after 6 months (the maintenance phase) of aestivation as compared with the freshwater control, or after 1 day of arousal from 6 months aestivation as compared with 6 months of aestivation using suppression subtractive hybridization. During the maintenance phase of aestivation, the mRNA expression of argininosuccinate synthetase 1 and carbamoyl phosphate synthetase III were up-regulated, indicating an increase in the ornithine-urea cycle capacity to detoxify ammonia to urea. There was also an increase in the expression of betaine homocysteine-S-transferase 1 which could reduce and prevent the accumulation of hepatic homocysteine. On the other hand, the down-regulation of superoxide dismutase 1 expression could signify a decrease in ROS production during the maintenance phase of aestivation. In addition, the maintenance phase was marked by decreases in expressions of genes related to blood coagulation, complement fixation and iron and copper metabolism, which could be strategies used to prevent thrombosis and to conserve energy. Unlike the maintenance phase of aestivation, there were increases in expressions of genes related to nitrogen, carbohydrate and lipid metabolism and fatty acid transport after 1 day of arousal from 6 months aestivation. There were also up-regulation in expressions of genes that were involved in the electron transport system and ATP synthesis, indicating a greater demand for metabolic energy during arousal. Overall, our results signify the importance of sustaining a low rate of waste production and conservation of energy store during the maintenance phase, and the dependence on internal energy store for repair and structural modification during the arousal phase, of aestivation in the liver

  1. Brief intervention to promote smoking cessation and improve glycemic control in smokers with type 2 diabetes: a randomized controlled trial

    PubMed Central

    Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.

    2017-01-01

    The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764

  2. [The morphofunctional cellular evaluation of liver and kidney in rats in dynamics of 6-month consumption of water produced with the use of noncontact activation after electrochemical treatment].

    PubMed

    Beliaeva, N N; Rakhmanin, Iu A; Mikhailova, R I; Savostikova, O N; Gasimova, Z M; Kamenetskaia, D B; Alekseeva, A V; Vasina, D A; Ryzhova, I N

    2015-01-01

    There were investigated morphofunctional indices of liver and kidney in male outbred rats in the dynamics of the 6-months consumption of water after its noncontact activation. There were studied 4 experimental groups of animals consumed waters named as "Anolyte" and in dependence on the activation time, 3 types of catholyte water ("Catholyte--5", "Catholyte--25", "Catholyte--40"). Moscow tap water settled for a week served as control. "Anolyte" water was found to increase in the kidney the number of hypertrophied gromeruli only in 6 months, while the consumption of "Catholyte--25" water and especially, "Catholyte--40" in 1 and 6 months caused the damage of liver and kidney, and for the index of alteration of renal glomeruli after 6 months of water consumption there was revealed the dependence on the activation time of "Catalytes".

  3. Differential brain shrinkage over 6 months shows limited association with cognitive practice.

    PubMed

    Raz, Naftali; Schmiedek, Florian; Rodrigue, Karen M; Kennedy, Kristen M; Lindenberger, Ulman; Lövdén, Martin

    2013-07-01

    The brain shrinks with age, but the timing of this process and the extent of its malleability are unclear. We measured changes in regional brain volumes in younger (age 20-31) and older (age 65-80) adults twice over a 6 month period, and examined the association between changes in volume, history of hypertension, and cognitive training. Between two MRI scans, 49 participants underwent intensive practice in three cognitive domains for 100 consecutive days, whereas 23 control group members performed no laboratory cognitive tasks. Regional volumes of seven brain structures were measured manually and adjusted for intracranial volume. We observed significant mean shrinkage in the lateral prefrontal cortex, the hippocampus, the caudate nucleus, and the cerebellum, but no reliable mean change of the prefrontal white matter, orbital-frontal cortex, and the primary visual cortex. Individual differences in change were reliable in all regions. History of hypertension was associated with greater cerebellar shrinkage. The cerebellum was the only region in which significantly reduced shrinkage was apparent in the experimental group after completion of cognitive training. Thus, in healthy adults, differential brain shrinkage can be observed in a narrow time window, vascular risk may aggravate it, and intensive cognitive activity may have a limited effect on it.

  4. Metacognitive Therapy for Depression in Adults: A Waiting List Randomized Controlled Trial with Six Months Follow-Up

    PubMed Central

    Hagen, Roger; Hjemdal, Odin; Solem, Stian; Kennair, Leif Edward Ottesen; Nordahl, Hans M.; Fisher, Peter; Wells, Adrian

    2017-01-01

    This randomized controlled trial examines the efficacy of metacognitive therapy (MCT) for depression. Thirty-nine patients with depression were randomly assigned to immediate MCT (10 sessions) or a 10-week wait list period (WL). The WL-group received 10 sessions of MCT after the waiting period. Two participants dropped out from WL and none dropped out of immediate MCT treatment. Participants receiving MCT improved significantly more than the WL group. Large controlled effect sizes were observed for both depressive (d = 2.51) and anxious symptoms (d = 1.92). Approximately 70–80% could be classified as recovered at post-treatment and 6 months follow-up following immediate MCT, whilst 5% of the WL patients recovered during the waiting period. The results suggest that MCT is a promising treatment for depression. Future controlled studies should compare MCT with other active treatments. PMID:28174547

  5. Rivastigmine patch ameliorates depression in mild AD: preliminary evidence from a 6-month open-label observational study.

    PubMed

    Spalletta, Gianfranco; Gianni, Walter; Giubilei, Franco; Casini, Anna R; Sancesario, Giuseppe; Caltagirone, Carlo; Cravello, Luca

    2013-01-01

    Here we investigated the effect of the rivastigmine patch alone on depression in 50 mild Alzheimer's disease (AD) patients with comorbid major depressive episode (MDE). First diagnosis acetyl-cholinesterase inhibitor and psychoactive drug-free outpatients (n=50) were recruited in memory clinics and reassessed after 3 and 6 months. Global cognitive functioning, depressive symptoms and MDE frequency were evaluated with the Mini Mental State Examination, the CERAD Dysphoria scale and the modified DSM-IV criteria for MDE in AD. MDE frequency reduced significantly from the first diagnostic visit (100%) to the 6-month follow-up (62%). We also found a significant reduction in CERAD Dysphoria scores that decreased from 6.2±3.9 mean±standard deviation to 4.9±4.5 at the 6-month follow-up. In AD patients with MDE rivastigmine alone can have a positive impact on depressive phenomena. Thus, future controlled study are justified to definitively verify if rivastigmine alone may improve depression in AD.

  6. Randomized controlled trials - a matter of design.

    PubMed

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

    2016-01-01

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

  7. Infant sleep development from 3 to 6 months postpartum: links with maternal sleep and paternal involvement.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Volkovich, Ella; Manber, Rachel; Meiri, Gal; Shahar, Golan

    2015-03-01

    The aims of this longitudinal study were to examine (a) development of infant sleep and maternal sleep from 3 to 6 months postpartum; (b) concomitant and prospective links between maternal sleep and infant sleep; and (c) triadic links between paternal involvement in infant caregiving and maternal and infant sleep. The study included 57 families that were recruited during pregnancy. Maternal and infant sleep was assessed using actigraphy and sleep diaries for 5 nights. Both fathers and mothers completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. The results demonstrated moderate improvement in infant and maternal sleep percent between 3 and 6 months. Maternal sleep percent at 3 months significantly predicted infant sleep percent at 6 months. Greater paternal involvement in infant daytime and nighttime caregiving at 3 months significantly predicted more consolidated maternal and infant sleep at 6 months. These findings suggest that maternal sleep is an important predictor of infant sleep and that increased involvement of fathers in infant caregiving responsibilities may contribute to improvements in both maternal and infant sleep during the first 6 months postpartum.

  8. Influences of anterior capsule polishing on effective lens position after cataract surgery: a randomized controlled trial

    PubMed Central

    Gao, Yang; Dang, Guang-Fu; Wang, Xu; Duan, Lian; Wu, Xin-Yi

    2015-01-01

    To evaluate the effects of anterior capsule polishing on effective lens position (ELP) and the actual axial movements of IOLs by measuring the anterior chamber depth (ACD). This prospective randomized double-blind controlled clinical trial included patients who underwent bilateral uneventful cataract surgeries and were implanted the same IOLs (SN60WF). Extensive polishing was performed randomly in the anterior capsule of one eye with Whitman Shepherd double-ended capsule polisher, and the opposite unpolished capsule was used as the control. The ACD was measured 1 day, 1 week, 1 month, 3 months and 6 months after surgery with the anterior segment optical coherence tomography (AS-OCT). The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit. A total of 40 eyes of 20 patients were included, and 10 patients (50%) were men. All the patients underwent uneventful surgeries without intraoperative or postoperative complications, and returned on time for measurements. The mean age of them was 70.5±7.6 years (range 56 to 79 years). No significant differences were observed between the mean ELP of the control group and the polished group (P>0.05). Nevertheless, the ELPRMS of the polished group was significantly smaller than that of the control group (P=0.005). Polishing anterior capsule intraoperatively improved the axial position stability of the IOL in the long term. PMID:26550324

  9. Randomized controlled clinical trial of Blood Glucose Awareness Training (BGAT III) in Switzerland and Germany.

    PubMed

    Schachinger, Hartmut; Hegar, Karin; Hermanns, Norbert; Straumann, Madeleine; Keller, Ulrich; Fehm-Wolfsdorf, Gabriele; Berger, Willi; Cox, Daniel

    2005-12-01

    Although both diabetes and the efficacy of medical management are international issues, psycho-educational interventions might be culturally bound. Blood Glucose Awareness Training (BGAT) is a psycho-educational program for patients with type 1 diabetes mellitus. It is focused on improving recognition and management of extreme blood glucose levels, and is the best documented American psycho-educational program for this purpose. A randomized controlled clinical trial of BGAT's long-term benefits in a non-American setting has been lacking. One hundred and eleven adults with type 1 diabetes mellitus from Switzerland and Germany participated. After a 6 months baseline assessment, subjects were randomly assigned to receive either 2 months of BGAT (n = 56) or a physician-guided self-help control intervention (n = 55). BGAT improved recognition of low (p = 0.008), high (p = .03), and overall blood glucose (p = 0.001), and reduced frequency of severe hypoglycemia (p = 0.04), without compromising metabolic control. BGAT reduced both the external locus of control (p < 0.02) and fear of hypoglycemia (p < 0.02). BGAT was efficacious in reducing adverse clinical events and achieving clinically desirable goals in a European, as well as American setting.

  10. Problem-solving therapy for adults with diabetic retinopathy and diabetes-specific distress: a pilot randomized controlled trial

    PubMed Central

    Rees, Gwyneth; O'Hare, Fleur; Saeed, Marian; Sudholz, Bronwyn; Sturrock, Bonnie A; Xie, Jing; Speight, Jane; Lamoureux, Ecosse L

    2017-01-01

    Objective To provide preliminary evidence for the impact of problem-solving therapy for diabetes (PST-D) in adults with diabetic retinopathy (DR) and diabetes distress. Research design and methods In a pilot randomized controlled trial, 40 participants with DR and diabetes distress were allocated to the PST-D or control groups. Diabetes distress (DDS), depressive symptoms (PHQ-9), self-care activities (SDSCA), and HbA1c were assessed at baseline, and 3 and 6-month follow-ups. Results At the 6-month follow-up, the PST-D group showed significant improvements relative to the control group, in ‘regimen-related distress’ (PST-D: −1.3±1.4; control: −0.4±1.1), depressive symptoms (PST-D: −4.3±6.1; control: −0.3±4.6), and HbA1c (PST-D: −1.2%±1.01; control: 0.2%±1.2%) (all p<0.05). In multiple regression analysis, adjusting for baseline values and sociodemographic factors, PST-D was associated with significant improvement in ‘regimen-related distress’, depressive symptoms, and HbA1c at the 6-month follow-up (p<0.05). Conclusions PST-D is a promising intervention for improving psychological outcomes and glycemic control. A fully powered study is required to confirm these findings and examine mechanisms of change in HbA1c. Trial registration number ACTRN12616001010482; results. PMID:28243448

  11. Effects of 6 months yoga program on renal functions and quality of life in patients suffering from chronic kidney disease

    PubMed Central

    Pandey, Rajendra Kumar; Arya, Tung Vir Singh; Kumar, Amit; Yadav, Ashish

    2017-01-01

    Aim: To study the effect of 6 months yoga program in patients suffering from chronic kidney disease (CKD). Materials and Methods: Fifty-four patients with CKD were studied and divided into two groups (yoga group and control group) to see the effect of yoga in CKD. Patients in the yoga group were offered yoga therapy along with other conventional treatment modalities, while the control group was only on conventional treatment. Subjects in yoga group were trained to perform specific yogic asanas for at least 5 days a week for 40–60 min a day. Regular monitoring of blood pressure, renal function, requirement of a number of dialysis, and quality of life (QOL) indicators were done. Fifty patients (yoga – 25; control-25) completed 6 months follow-up. Results: In yoga group, a significant reduction of systolic and diastolic blood pressure, significant reduction in blood urea and serum creatinine levels, and significant improvement in physical and psychological domain of the World Health Organization QOL (as assessed by BREF QOL scores) were seen after 6 months. In control group, rise of blood pressure, deterioration of renal function, and QOL were observed. Poststudy comparison between the two groups showed a statistically significant reduction of blood pressure, nonsignificant reduction in blood urea and serum creatinine, and significant improvement in physical and psychological domain of QOL in yoga group as compared to control group. For subjects in yoga group, the need for dialysis was less when compared to control group although this difference was statistically insignificant. Except for inability of some patients to perform certain yogic asanas no adverse effect was found in the study. Conclusion: Six months yoga program is safe and effective as an adjuvant therapy in improving renal functions and QOL of CKD patients. PMID:28149061

  12. Mobile phone intervention and weight loss among overweight and obese adults: a meta-analysis of randomized controlled trials.

    PubMed

    Liu, Fangchao; Kong, Xiaomu; Cao, Jie; Chen, Shufeng; Li, Changwei; Huang, Jianfeng; Gu, Dongfeng; Kelly, Tanika N

    2015-03-01

    We conducted a meta-analysis of randomized controlled trials to examine the association of mobile phone intervention with net change in weight-related measures among overweight and obese adults. We searched electronic databases and conducted a bibliography review to identify articles published between the inception date of each database and March 27, 2014. Fourteen trials (including 1,337 participants in total) that met the eligibility criteria were included. Two investigators independently abstracted information on study characteristics and study outcomes. Net change estimates comparing the intervention group with the control group were pooled across trials using random-effects models. Compared with the control group, mobile phone intervention was associated with significant changes in body weight and body mass index (weight (kg)/height (m)(2)) of -1.44 kg (95% confidence interval (CI): -2.12, -0.76) and -0.24 units (95% CI: -0.40, -0.08), respectively. Subgroup analyses revealed that the associations were consistent across study-duration and intervention-type subgroups. For example, net body weight changes were -0.92 kg (95% CI: -1.58, -0.25) and -1.85 kg (95% CI: -2.99, -0.71) in trials of shorter (<6 months) and longer (≥6 months) duration, respectively. These findings provide evidence that mobile phone intervention may be a useful tool for promoting weight loss among overweight and obese adults.

  13. Problem-solving education to prevent depression among low-income mothers of preterm infants: a randomized controlled pilot trial.

    PubMed

    Silverstein, Michael; Feinberg, Emily; Cabral, Howard; Sauder, Sara; Egbert, Lucia; Schainker, Elisabeth; Kamholz, Karen; Hegel, Mark; Beardslee, William

    2011-08-01

    We sought to assess the feasibility and document key study processes of a problem-solving intervention to prevent depression among low-income mothers of preterm infants. A randomized controlled pilot trial (n = 50) of problem-solving education (PSE) was conducted. We assessed intervention provider training and fidelity; recruitment and retention of subjects; intervention acceptability; and investigators' ability to conduct monthly outcome assessments, from which we could obtain empirical estimates of depression symptoms, stress, and functioning over 6 months. Four of four bachelor-level providers were able to deliver PSE appropriately with standardized subjects within 4 weeks of training. Of 12 randomly audited PSE sessions with actual subjects, all met treatment fidelity criteria. Nineteen of 25 PSE subjects (76%) received full four-session courses; no subjects reported negative experiences with PSE. Eighty-eight percent of scheduled follow-up assessments were completed. Forty-four percent of control group mothers experienced an episode of moderately severe depression symptoms over the follow-up period, compared to 24% of PSE mothers. Control mothers experienced an average 1.19 symptomatic episodes over the 6 months of follow-up, compared to 0.52 among PSE mothers. PSE appears feasible and may be a promising strategy to prevent depression among mothers of preterm infants.

  14. A Randomized Controlled Trial of Allopurinol in Patients With Peripheral Arterial Disease

    PubMed Central

    Robertson, Alan J.; Struthers, Allan D.

    2016-01-01

    Background Patients with peripheral arterial disease (PAD) are limited by intermittent claudication in the distance they can walk. Allopurinol has been shown in coronary arterial disease to prolong exercise before angina occurs, likely by prevention of oxygen wastage in tissues and reduction of harmful oxidative stress. Methods In this study we evaluated whether allopurinol could prolong the time to development of leg pain in participants with PAD. In a double-blind, randomized controlled clinical trial participants were randomized to receive either allopurinol 300 mg twice daily or placebo for 6 months. The primary outcome was change in exercise capacity on treadmill testing at 6 months. Secondary outcomes were 6-minute walking distance, Walking Impairment Questionnaire, SF-36 questionnaire, flow-mediated dilatation, and oxidized low-density lipoprotein. Outcome measures were repeated midstudy and at the end of study. The mean age of the 50 participants was 68.4 ± 1.2 years with 39 of 50 (78%) male. Results Five participants withdrew during the study (2 active, 3 placebo). There was a significant reduction in uric acid levels in those who received active treatment of 52.1% (P < 0.001), but no significant change in either the pain-free or the maximum walking distance. Other measures of exercise capacity, blood vessel function, and the participants' own assessment of their health and walking ability also did not change during the course of the study. Conclusions Although allopurinol has been shown to be of benefit in a number of other diseases, in this study there was no evidence of any improvement after treatment in patients with PAD. PMID:26277090

  15. Connective Tissue Reflex Massage for Type 2 Diabetic Patients with Peripheral Arterial Disease: Randomized Controlled Trial

    PubMed Central

    Castro-Sánchez, Adelaida María; Moreno-Lorenzo, Carmen; Matarán-Peñarrocha, Guillermo A.; Feriche-Fernández-Castanys, Belen; Granados-Gámez, Genoveva; Quesada-Rubio, José Manuel

    2011-01-01

    The objective of this study was to evaluate the efficacy of connective tissue massage to improve blood circulation and intermittent claudication symptoms in type 2 diabetic patients. A randomized, placebo-controlled trial was undertaken. Ninety-eight type 2 diabetes patients with stage I or II-a peripheral arterial disease (PAD) (Leriche-Fontaine classification) were randomly assigned to a massage group or to a placebo group treated using disconnected magnetotherapy equipment. Peripheral arterial circulation was determined by measuring differential segmental arterial pressure, heart rate, skin temperature, oxygen saturation and skin blood flow. Measurements were taken before and at 30 min, 6 months and 1 year after the 15-week treatment. After the 15-week program, the groups differed (P < .05) in differential segmental arterial pressure in right lower limb (lower one-third of thigh, upper and lower one-third of leg) and left lower limb (lower one-third of thigh and upper and lower one-third of leg). A significant difference (P < .05) was also observed in skin blood flow in digits 1 and 4 of right foot and digits 2, 4 and 5 of left foot. ANOVA results were significant (P < .05) for right and left foot oxygen saturation but not for heart rate and temperature. At 6 months and 1 year, the groups differed in differential segmental arterial pressure in upper third of left and right legs. Connective tissue massage improves blood circulation in the lower limbs of type 2 diabetic patients at stage I or II-a and may be useful to slow the progression of PAD. PMID:19933770

  16. Perception of neon color spreading in 3-6-month-old infants.

    PubMed

    Yang, Jiale; Kanazawa, So; Yamaguchi, Masami K

    2009-12-01

    Although lots of studies about neon color spreading have been reported, few of these studies have focused on the perceptual development of it in human infants. Therefore, this study explores the perceptual development of neon color spreading in infants. In experiment 1, we examined 3-6-month-olds' perception of neon color spreading in static conditions. In experiment 2, we examined 3-6-month-olds' perception of neon color spreading in moving conditions. Our results suggest that while only 5-6-month-old infants show a preference for neon color spreading in the static condition, 3-4-month-old infants also prefer neon color spreading if motion information is available.

  17. Infants' responses to arm restraint at 2 and 6 months: a longitudinal study.

    PubMed

    Moscardino, Ughetta; Axia, Giovanna

    2006-01-01

    This study examined the continuity, stability, and change of infants' responses to a frustrating event (i.e., arm restraint) between 2 and 6 months in terms of both negative reactivity and its regulation. Fifty-two healthy, full-term infants and their mothers participated in an arm restraint procedure. Infant behaviors were observed and coded at 3-s intervals. The results showed that infants' reactivity to frustration and their ability to regulate such reactivity significantly changed in level over time. Individual differences in frustration reactivity were stable across the two ages; two regulatory behaviors (i.e., orientation to mother and avoidance) could be observed in the same percentage of babies at both 2 and 6 months. At 6 months, several significant associations between frustration reactivity and infant regulatory behaviors emerged. These findings suggest that the arm restraint procedure may be usefully employed to study individual differences in infants as young as 2 months of age.

  18. Effects of Normobaric Hyperoxia in Traumatic Brain Injury: A Randomized Controlled Clinical Trial

    PubMed Central

    Taher, Abbas; Pilehvari, Zahra; Poorolajal, Jalal; Aghajanloo, Mashhood

    2016-01-01

    Background Traumatic brain injury (TBI) is one of the important causes of morbidity and mortality throughout the world, especially in young people. In recent years normobaric hyperoxia has become an important and useful step for recovery and improvement of outcome in TBI. Objectives The purpose of this study was to evaluate the effects of normobaric hyperoxia on clinical neurological outcomes of patients with severe traumatic brain injuries. We used the Glasgow outcome scale (GOS), barthel index, and modified rankin scale (mRS) to measure the outcomes of patients with TBI. Patients and Methods Sixty-eight consecutive patients with severe TBI (mean Glasgow coma scale [GCS] score: 7.4) who met the inclusion criteria were entered in this randomized controlled clinical trial. The patients were randomized into two groups, as follows: 1) experimental: received 80% oxygen via mechanical ventilator in the first 6 hours of admission, 2) control: received 50% oxygen by mechanical ventilator in the first 6 hours of admission and then standard medical care. We measured the GOS, Barthel Index, and mRS at the time of discharge from hospital and reassessed these measurements at the 6-month follow-up after injury. Results According to our study, there were no significant sex or age differences between the two groups (P = 0.595 and 0.074). The number of days in the intensive care unit (ICU) in the control group and experimental group were 11.4 and 9.4 days, respectively (P = 0.28), while the numbers of days of general ward admission were 13.9 and 11.4 days (P = 0.137) respectively. The status of GOS at time of discharge were severe = 13 and 10, moderate = 16 and 19, and low = 5 and 5 in the control and experimental groups, respectively (P = 0.723); 6 months after injury, the scores were as follows: moderate = 16 and 9, low = 15 and 25, and severe = 3 and 0 (P = 0.024). The Barthel index scores in the control and experimental groups were 59.7 and 63.9 at time of discharge (P = 0

  19. Mini Nutritional Assessment predicts gait status and mortality 6 months after hip fracture.

    PubMed

    Gumieiro, David N; Rafacho, Bruna P M; Gonçalves, Andrea F; Tanni, Suzana E; Azevedo, Paula S; Sakane, Daniel T; Carneiro, Carlos A S; Gaspardo, David; Zornoff, Leonardo A M; Pereira, Gilberto J C; Paiva, Sergio A R; Minicucci, Marcos F

    2013-05-01

    The aim of the present study was to evaluate the Mini Nutritional Assessment (MNA), the Nutritional Risk Screening (NRS) 2002 and the American Society of Anesthesiologists Physical Status Score (ASA) as predictors of gait status and mortality 6 months after hip fracture. A total of eighty-eight consecutive patients over the age of 65 years with hip fracture admitted to an orthopaedic unit were prospectively evaluated. Within the first 72 h of admission, each patient's characteristics were recorded, and the MNA, the NRS 2002 and the ASA were performed. Gait status and mortality were evaluated 6 months after hip fracture. Of the total patients, two were excluded because of pathological fractures. The remaining eighty-six patients (aged 80·2 (sd 7·3) years) were studied. Among these patients 76·7 % were female, 69·8 % walked with or without support and 12·8 % died 6 months after the fracture. In a multivariate analysis, only the MNA was associated with gait status 6 months after hip fracture (OR 0·773, 95 % CI 0·663, 0·901; P= 0·001). In the Cox regression model, only the MNA was associated with mortality 6 months after hip fracture (hazard ratio 0·869, 95 % CI 0·757, 0·998; P= 0·04). In conclusion, the MNA best predicts gait status and mortality 6 months after hip fracture. These results suggest that the MNA should be included in the clinical stratification of patients with hip fracture to identify and treat malnutrition in order to improve the outcomes.

  20. Out-of-Hospital Hypertonic Resuscitation Following Severe Traumatic Brain Injury: A Randomized Controlled Trial

    PubMed Central

    Bulger, Eileen M.; May, Susanne; Brasel, Karen J.; Schreiber, Martin; Kerby, Jeffrey D.; Tisherman, Samuel A.; Newgard, Craig; Slutsky, Arthur; Coimbra, Raul; Emerson, Scott; Minei, Joseph P.; Bardarson, Berit; Kudenchuk, Peter; Baker, Andrew; Christenson, Jim; Idris, Ahamed; Davis, Daniel; Fabian, Timothy C.; Aufderheide, Tom P.; Callaway, Clifton; Williams, Carolyn; Banek, Jane; Vaillancourt, Christian; van Heest, Rardi; Sopko, George; Hata, J. Steven; Hoyt, David B.

    2010-01-01

    Context Hypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury (TBI). Objective To determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. Design, Setting, and Participants Multicenter, double-blind, randomized, placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium, conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock. Planned enrollment was 2122 patients. Intervention A single 250-mL bolus of 7.5% saline/6% dextran 70 (hypertonic saline/dextran), 7.5% saline (hypertonic saline), or 0.9% saline (normal saline) initiated in the out-of-hospital setting. Main Outcome Measure Six-month neurologic outcome based on the Extended Glasgow Outcome Scale (GOSE) (dichotomized as >4 or ≤4). Results The study was terminated by the data and safety monitoring board after randomization of 1331 patients, having met prespecified futility criteria. Among the 1282 patients enrolled, 6-month outcomes data were available for 1087 (85%). Baseline characteristics of the groups were equivalent. There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ≤4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, −4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, −4.0% to 9.7%]; P=.67). There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group. Survival at 28 days was 74.3% with hypertonic saline

  1. Follow-Up of the Cues and Care Trial: Mother and Infant Outcomes at 6 Months

    ERIC Educational Resources Information Center

    Feeley, Nancy; Zelkowitz, Phyllis; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

    2012-01-01

    The long-term effects of the Cues intervention to reduce anxiety and enhance the interactive behavior of mothers of very low birth weight (VLBW) infants were investigated. A randomized trial comparing the Cues intervention to an attention control condition was conducted. A total of 122 mothers of newborns weighing less than 1,500 g were…

  2. Randomized Controlled Theory-Based, E-Mail-Mediated Walking Intervention.

    PubMed

    Richards, Elizabeth A; Ogata, Niwako; Cheng, Ching-Wei

    2017-02-01

    The purpose of this study was to evaluate the ability of two concurrent randomized controlled interventions based on social cognitive theory to increase walking. A second purpose was to compare the efficacy of the intervention between two distinct groups: dog owners and non-dog owners. Adult dog owners ( n = 40) and non-dog owners ( n = 65) were randomized into control or intervention groups. Intervention groups received bi-weekly emails for first 4 weeks and then weekly email for the next 8 weeks targeting self-efficacy, social support, goal setting, and benefits/barriers to walking. Dog owner messages focused on dog walking while non-dog owners received general walking messages. Control groups received a 1-time email reviewing current physical activity guidelines. At 6 months, both intervention groups reported greater increases in walking and maintained these increases at 12 months. The greatest increases were seen in the dog owner intervention group. In conclusion, dog owners accumulated more walking, which may be attributed to the dog-owner relationship.

  3. Lifestyle Intervention on Metabolic Syndrome and its Impact on Quality of Life: A Randomized Controlled Trial

    PubMed Central

    Saboya, Patrícia Pozas; Bodanese, Luiz Carlos; Zimmermann, Paulo Roberto; Gustavo, Andreia da Silva; Macagnan, Fabricio Edler; Feoli, Ana Pandolfo; Oliveira, Margareth da Silva

    2017-01-01

    Background Lifestyle intervention programs can reduce the prevalence of metabolic syndrome (MetS) and, therefore, reduce the risk for cardiac disease, one of the main public health problems nowadays. Objective The aim of this study was to compare the effects of three types of approach for lifestyle change programs in the reduction of metabolic parameters, and to identify its impact on the quality of life (QOL) of individuals with MetS. Methods A randomized controlled trial included 72 individuals with MetS aged 30-59 years. Individuals were randomized into three groups of multidisciplinary intervention [Standard Intervention (SI) - control group; Group Intervention (GI); and Individual Intervention (II)] during 12 weeks. The primary outcome was change in the metabolic parameters, and secondarily, the improvement in QOL measures at three moments: baseline, 3 and 9 months. Results Group and individual interventions resulted in a significant reduction in body mass index, waist circumference, systolic blood pressure at 3 months and the improvement of QOL, although it was significantly associated with the physical functioning domain. However, these changes did not remain 6 months after the end of intervention. Depression and anxiety were significantly associated with worse QOL, although they showed no effect on the response to intervention. Conclusion Multidisciplinary intervention, especially in a group, might be an effective and economically feasible strategy in the control of metabolic parameters of MetS and improvement of QOL compared to SI, even in a dose-effect relationship. PMID:27982160

  4. Couple relationship education: A randomized controlled trial of professional contact and self-directed tools.

    PubMed

    Zemp, Martina; Merz, Corina A; Nussbeck, Fridtjof W; Halford, W Kim; Schaer Gmelch, Marcel; Bodenmann, Guy

    2017-04-01

    The aim of this randomized controlled trial was to examine the efficacy of an evidence-based relationship distress prevention program, the Couples Coping Enhancement Training (CCET), in dual well-earning couples and to investigate whether effects vary by (a) hours of professional contact and (b) mode of delivery (face to face vs. self-learning DVD). N = 159 couples were randomly assigned to 1 of 4 intervention conditions: (1) standard CCET (15 hours face to face), (2) compact CCET (12 hr face to face), (3) short CCET (self-learning DVD + 8 hr face to face), or (4) wait-list control group. Relationship satisfaction and dyadic coping skills were assessed by means of questionnaires completed prior to and 2 weeks after completion of the treatment, at 3-month follow-up, and at 6-month follow-up. Baseline latent change models for 2 factors showed that the CCET enhanced relationship satisfaction and dyadic coping skills in couples relative to the wait-list control group, albeit effects were small. The standard format of the CCET was not more effective than the compact or the short format indicating that reduced amount of professional contact did not decrease the treatment's efficacy and that the self-learning DVD successfully replaced the psycho-educational part of the program. Since dual earner couples usually face multiple stressors, it is a promising finding that they can strengthen their relationship with a relatively short time investment. (PsycINFO Database Record

  5. Contamination by an Active Control Condition in a Randomized Exercise Trial

    PubMed Central

    Kramer, Arthur F.; McAuley, Edward

    2016-01-01

    Contamination is commonly overlooked in randomized trials. The present study examined contamination (minutes of aerobic activity outside of exercise sessions) within an active control condition in a 6-month randomized exercise trial for older adults. We hypothesized that outside aerobic activity would be greater in the control condition compared to the intervention conditions. Participants (mean age = 65.06 years, 66.2% female) were randomly assigned to: Dance (n = 50), Walking, (n = 108), or Strength/Stretching/Stability (SSS; n = 48). Dance and Walking represented the experimental conditions and SSS the control condition. Participants attended exercise sessions three times weekly for 24 weeks. Participants recorded their physical activity outside of class on a weekly home log. Group assignment and covariates (age, gender, body mass index, exercise session intensity and enjoyment, and program adherence) were examined as predictors of weekly aerobic activity outside of exercise sessions. Participants who returned zero home logs were removed from the dataset (final N = 195). Out-of-class aerobic activity was lowest in the Walking group. Significant effects of gender, group, enjoyment, and intensity on out-of-class weekly aerobic activity were observed, all p<0.003. Higher perceived enjoyment of exercise sessions was associated with more out-of-class aerobic activity, while higher perceived intensity was associated with less out-of-class aerobic activity. A group x intensity interaction, p = 0.002, indicated that group differences in out-of-class aerobic activity were evident only among those with lower intensity perceptions. Walkers may have perceived exercise sessions as sufficient weekly exercise, while the Dance and SSS groups may have perceived the sessions as necessary, but insufficient. The lower aerobic intensity Dancers attributed to exercise sessions and non-aerobic nature of SSS may partially explain contamination observed in this study. Further

  6. The Effects of Statins on Pulmonary Artery Pressure in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

    PubMed Central

    Arian, Anahita; Moghadam, Sayyed Gholamreza Mortazavi; Kazemi, Toba; Hajihosseini, Morteza

    2017-01-01

    Objective: Pulmonary hypertension is a serious complication in patients suffering from chronic obstructive pulmonary disease (COPD). The aim of this study is to investigate the effects of atorvastatin in reducing pulmonary arterial pressure in COPD patients. Methods: This double-blind, randomized trial was conducted on 42 known cases of COPD with systolic pulmonary arterial pressure of more than 25 mmHg. The patients were randomly assigned into two groups, 21 patients with atorvastatin treatment (40 mg/daily for 6 months) and 21 patients without receiving atorvastatin. All the patients participated voluntarily and provided written informed consent. The trial was registered in the Iranian Registry of Clinical Trials. Pulmonary pressure was also anticipated by Doppler echocardiography with peak pressure gradient of tricuspid regurgitation. Both groups were tested with echocardiography to measure systolic pulmonary pressure at baseline and posttreatment. Statistical analysis includes Chi-square, Student's t-test, and Wilcoxon test. P < 0.05 was considered statistically significant. Findings: The mean age was 65.8 ± 11.5 years for atorvastatin group and 63.7 ± 7.6 years for control group (P = 0.45). Baseline and posttreatment mean systolic pulmonary artery pressure (PAP) levels in the atorvastatin group were 48.9 ± 3.3 and 38.4 ± 1.9 mmHg, respectively (P = 0.007). In the control group, mean systolic PAP levels at baseline and 6 months later were 45.6 ± 3.1 and 38.9 ± 2.4 mmHg, respectively (P = 0.073). The patients treated with atorvastatin showed significant decrease in total cholesterol (P = 0.001) and low-density lipoprotein cholesterol (P = 0.008). Conclusion: A 40 mg dose of atorvastatin daily for 6 months may have beneficial effects in reducing PAP in patients with COPD. Further studies are necessary to find long-term effects of statins in COPD patients.

  7. A Web-Based Training Program Using Cognitive Behavioral Therapy to Alleviate Psychological Distress Among Employees: Randomized Controlled Pilot Trial

    PubMed Central

    Tajima, Miyuki; Kimura, Risa; Sasaki, Norio; Somemura, Hironori; Ito, Yukio; Okanoya, June; Yamamoto, Megumi; Nakamura, Saki; Tanaka, Katsutoshi

    2014-01-01

    Background A number of psychoeducational programs based on cognitive behavioral therapy (CBT) to alleviate psychological distress have been developed for implementation in clinical settings. However, while these programs are considered critical components of stress management education in a workplace setting, they are required to be brief and simple to implement, which can hinder development. Objective The intent of the study was to examine the effects of a brief training program based on CBT in alleviating psychological distress among employees and facilitating self-evaluation of stress management skills, including improving the ability to recognize dysfunctional thinking patterns, transform dysfunctional thoughts to functional ones, cope with stress, and solve problems. Methods Of the 187 employees at an information technology company in Tokyo, Japan, 168 consented to participate in our non-blinded randomized controlled study. The training group received CBT group education by a qualified CBT expert and 1 month of follow-up Web-based CBT homework. The effects of this educational program on the psychological distress and stress management skills of employees were examined immediately after completion of training and then again after 6 months. Results Although the training group did exhibit lower mean scores on the Kessler-6 (K6) scale for psychological distress after 6 months, the difference from the control group was not significant. However, the ability of training group participants to recognize dysfunctional thinking was significantly improved both immediately after training completion and after 6 months. While the ability of participants to cope with stress was not significantly improved immediately after training, improvement was noted after 6 months in the training group. No notable improvements were observed in the ability of participants to transform thoughts from dysfunctional to functional or in problem-solving skills. A sub-analysis of participants who

  8. Perfectionism, neuroticism, and daily stress reactivity and coping effectiveness 6 months and 3 years later.

    PubMed

    Dunkley, David M; Mandel, Tobey; Ma, Denise

    2014-10-01

    The present study addressed a fundamental gap between research and clinical work by advancing longitudinal explanatory conceptualizations of stress and coping processes that trigger daily affect in the short- and long-term for individuals with higher levels of personality vulnerability. Community adults completed measures of 2 higher order dimensions of perfectionism (personal standards [PS], self-criticism [SC]), neuroticism, and conscientiousness. Then, 6 months later and again 3 years later, participants completed daily questionnaires of stress, coping, and affect for 14 consecutive days. PS was associated with aggregated daily problem-focused coping and positive reinterpretation, whereas SC was uniquely associated with daily negative social interactions, avoidant coping, negative affect, and sadness at Month 6 and Year 3. Multilevel modeling results demonstrated that both individuals with higher PS and those with higher SC were emotionally reactive to event stress, negative social interactions, and avoidant coping at Month 6 and Year 3 and to less perceived control at Year 3. Positive reinterpretation was especially effective for individuals with higher SC at Month 6 and Year 3. The effects of PS on daily stress reactivity and coping (in)effectiveness were clearly distinguished from the effects of neuroticism and conscientiousness, whereas the SC effects were due to shared overlap with PS and neuroticism. The present findings demonstrate the promise of using repeated daily diary methodologies to help therapists and clients reliably predict future client reactions to daily stressors, which, in turn, could help guide interventions to break apart dysfunctional patterns connected to distress and build resilience for vulnerable individuals.

  9. How chaosity and randomness control human health

    NASA Astrophysics Data System (ADS)

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

    2005-08-01

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

  10. Adapting Judicial Supervision to the Risk Level of Drug Offenders: Discharge and 6-month Outcomes from a Prospective Matching Study

    PubMed Central

    Marlowe, Douglas B.; Festinger, David S.; Dugosh, Karen L.; Lee, Patricia A.; Benasutti, Kathleen M.

    2007-01-01

    This article reports recent findings from a program of experimental research examining the effects of adapting judicial supervision to the risk level of drug-abusing offenders. Prior studies revealed that high-risk participants with (1) antisocial personality disorder or (2) a history of drug abuse treatment performed significantly better in drug court when they were scheduled to attend frequent, bi-weekly judicial status hearings in court. Low-risk participants performed equivalently regardless of the schedule of court hearings. The current study prospectively matched misdemeanor drug court clients to the optimal schedule of court hearings based upon an assessment of their risk status, and compared outcomes to those of clients randomly assigned to the standard schedule of court hearings. Results confirmed that high-risk participants graduated at a higher rate, provided more drug-negative urine specimens at 6 months post-admission, and reported significantly less drug use and alcohol intoxication at 6 months post-admission when they were matched to bi-weekly hearings as compared to the usual schedule of hearings. These findings yield practical information for enhancing the efficacy and cost-efficiency of drug court services. Directions for future research on adaptive programming for drug offenders are discussed. PMID:17071020

  11. Adapting judicial supervision to the risk level of drug offenders: discharge and 6-month outcomes from a prospective matching study.

    PubMed

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Lee, Patricia A; Benasutti, Kathleen M

    2007-05-01

    This article reports recent findings from a program of experimental research examining the effects of adapting judicial supervision to the risk level of drug-abusing offenders. Prior studies revealed that high-risk participants with (1) antisocial personality disorder or (2) a history of drug abuse treatment performed significantly better in drug court when they were scheduled to attend frequent, bi-weekly judicial status hearings in court. Low-risk participants performed equivalently regardless of the schedule of court hearings. The current study prospectively matched misdemeanor drug court clients to the optimal schedule of court hearings based upon an assessment of their risk status, and compared outcomes to those of clients randomly assigned to the standard schedule of court hearings. Results confirmed that high-risk participants graduated at a higher rate, provided more drug-negative urine specimens at 6 months post-admission, and reported significantly less drug use and alcohol intoxication at 6 months post-admission when they were matched to bi-weekly hearings as compared to the usual schedule of hearings. These findings yield practical information for enhancing the efficacy and cost-efficiency of drug court services. Directions for future research on adaptive programming for drug offenders are discussed.

  12. Rapidly-growing buccal mass in a 6-month-old infant.

    PubMed

    Kumar, A; Brierley, D; Hunter, K D; Lee, N

    2015-11-01

    Lipoblastoma and lipoblastomatosis are rare benign tumours of fetal-embryonal adipocytes that usually present in young children, which is why they are not often included in the differential diagnosis of soft tissue lesions in infants. We describe a case of a 6-month-old infant with an intraoral buccal lipoblastoma.

  13. Mississippi Communities for Healthy Living: Results of a 6-month nutrition education comparative effectiveness trial

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The United States Lower Mississippi Delta (LMD) region suffers from high prevalence of chronic health conditions with nutritional etiologies, including obesity, high cholesterol, hypertension, and diabetes. Responding to the need for effective nutrition interventions in the LMD, a 2-arm, 6-month, n...

  14. The Impact of SNAP-ED and EFNEP on Program Graduates 6 Months after Graduation

    ERIC Educational Resources Information Center

    Koszewski, Wanda; Sehi, Natalie; Behrends, Donnia; Tuttle, Elizabeth

    2011-01-01

    Research was conducted to determine if graduates from either the Supplemental Nutrition Assistance Program-Education or Expanded Food and Nutrition Education Program maintained behavioral changes 6 months after completing the program. Staff asked graduates to complete a 10- or 15-question behavior checklist that was identical to the entry and exit…

  15. Low-Dose Chemoreduction for Infants Diagnosed with Retinoblastoma before 6 Months of Age

    PubMed Central

    Berry, Jesse L.; Jubran, Rima; Lee, Thomas C.; Murphree, A. Linn; Lee, Diana; Kim, Jonathan W.

    2015-01-01

    Aim The purpose of this study was to evaluate the outcomes of infants diagnosed with retinoblastoma before 6 months of age, including the need for chemoreduction (CRD). In this age group, dosage of CRD was reduced due to its potential for toxicity. Methods This is a retrospective review from 2000 to 2009 that includes 126 eyes of 72 infants (18 unilateral, 54 bilateral). Systemic CRD was administered when local modalities failed or were considered inadequate. Primary outcome measures were the need for CRD and globe salvage. Results Of the 72 infants diagnosed before 6 months of age, 48 (67%) ultimately required CRD for globe salvage, 40 (56%) patients before 6 months of age. Globe salvage was achieved in 62% (78/126) of eyes overall and in 93% (68/73) of eyes with Group A-C disease. No patient was hospitalized for CRD-related illness; survival was 100%. The mean follow-up was 52.9 months (range 1-148 months). Conclusion Utilizing a combination of focal modalities and reduced-dose CRD, children diagnosed with retinoblastoma before 6 months of age attain globe salvage rates comparable to those of older age groups. Two thirds of the infants ultimately required CRD for globe salvage. Bilateral disease as well as Group D and E classification in at least one eye at presentation increased the chance of requiring CRD (p < 0.0001 and p < 0.016, respectively). PMID:27172253

  16. Perception of Speech Modulation Cues by 6-Month-Old Infants

    ERIC Educational Resources Information Center

    Cabrera, Laurianne; Bertoncini, Josiane; Lorenzi, Christian

    2013-01-01

    Purpose: The capacity of 6-month-old infants to discriminate a voicing contrast (/aba/--/apa/) on the basis of "amplitude modulation (AM) cues" and "frequency modulation (FM) cues" was evaluated. Method: Several vocoded speech conditions were designed to either degrade FM cues in 4 or 32 bands or degrade AM in 32 bands. Infants…

  17. Determining the Impact of Prenatal Tobacco Exposure on Self-Regulation at 6 Months

    ERIC Educational Resources Information Center

    Wiebe, Sandra A.; Fang, Hua; Johnson, Craig; James, Karen E.; Espy, Kimberly Andrews

    2014-01-01

    Our goal in the present study was to examine the effects of maternal smoking during pregnancy on infant self-regulation, exploring birth weight as a mediator and sex as a moderator of risk. A prospective sample of 218 infants was assessed at 6 months of age. Infants completed a battery of tasks assessing working memory/inhibition, attention, and…

  18. Goal Attribution to Schematic Animals: Do 6-Month-Olds Perceive Biological Motion as Animate?

    ERIC Educational Resources Information Center

    Schlottmann, Anne; Ray, Elizabeth

    2010-01-01

    Infants are sensitive to biological motion, but do they recognize it as animate? As a first step towards answering this question, two experiments investigated whether 6-month-olds selectively attribute goals to shapes moving like animals. We habituated infants to a square moving towards one of two targets. When target locations were switched,…

  19. Night Waking in 6-Month-Old Infants and Maternal Depressive Symptoms

    ERIC Educational Resources Information Center

    Karraker, Katherine Hildebrandt; Young, Marion

    2007-01-01

    Relations between night waking in infants and depressive symptoms in their mothers at 6 months postpartum were examined using the data from the National Institute for Child Health and Human Development Study of Early Child Care. Although more depressive symptoms were only weakly correlated with a higher frequency of infant waking, longer wake…

  20. Relationship between Visual and Tactual Exploration by 6-Month-Olds.

    ERIC Educational Resources Information Center

    Bushnell, Emily W.; And Others

    1985-01-01

    Investigating relationship between infants' visual and tactual exploration, looking and touching responses of 6-month-olds to objects only visually or tactually novel were observed. Results indicated infants were capable of tactual recognition memory, that temperature was salient object property, and that visual and tactual exploration are not…

  1. Understanding and control of random lasing

    NASA Astrophysics Data System (ADS)

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

    2003-10-01

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

  2. A primer on randomized controlled trials.

    PubMed

    Likosky, Donald S

    2006-03-01

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

  3. Fructose in Breast Milk Is Positively Associated with Infant Body Composition at 6 Months of Age

    PubMed Central

    Goran, Michael I.; Martin, Ashley A.; Alderete, Tanya L.; Fujiwara, Hideji; Fields, David A.

    2017-01-01

    Dietary sugars have been shown to promote excess adiposity among children and adults; however, no study has examined fructose in human milk and its effects on body composition during infancy. Twenty-five mother–infant dyads attended clinical visits to the Oklahoma Health Sciences Center at 1 and 6 months of infant age. Infants were exclusively breastfed for 6 months and sugars in breast milk (i.e., fructose, glucose, lactose) were measured by Liquid chromatography-mass spectrometry (LC-MS/MS) and glucose oxidase. Infant body composition was assessed using dual-energy X-ray absorptiometry at 1 and 6 months. Multiple linear regression was used to examine associations between breast milk sugars and infant body composition at 6 months of age. Fructose, glucose, and lactose were present in breast milk and stable across visits (means = 6.7 μg/mL, 255.2 μg/mL, and 7.6 g/dL, respectively). Despite its very low concentration, fructose was the only sugar significantly associated with infant body composition. A 1-μg/mL higher breast milk fructose was associated with a 257 g higher body weight (p = 0.02), 170 g higher lean mass (p = 0.01), 131 g higher fat mass (p = 0.05), and 5 g higher bone mineral content (p = 0.03). In conclusion, fructose is detectable in human breast milk and is positively associated with all components of body composition at 6 months of age. PMID:28212335

  4. Effects of a 6-month incentive-based exercise program on adherence and work capacity.

    PubMed

    Robison, J I; Rogers, M A; Carlson, J J; Mavis, B E; Stachnik, T; Stoffelmayr, B; Sprague, H A; McGrew, C R; Van Huss, W D

    1992-01-01

    The purpose of the study was to evaluate the effect of behavioral management techniques on exercise adherence linked to improvements in work capacity and maximal oxygen consumption (VO2max). One hundred thirty-seven participants in six different worksites on a university campus (five experimental and one comparison site) completed 6 months of a minimally supervised, incentive-based endurance exercise program. All participants in the experimental group contracted to engage in at least four bouts of 30 min of verified aerobic exercise within a prescribed target heart rate range each week for the duration of the program. Forty dollars deposited at the beginning of the program served as a response cost that could be lost as a result of failure to fulfill the weekly contracts. Individuals in the comparison group participated in a similar 6-month program but without the contracts and response cost strategies. Weekly adherence for both groups was strictly defined as verified fulfillment of all four bouts of exercise. Adherence for the experimental group was 97% by this definition, and adherence for the comparison group was 19% (P less than 0.01). VO2max increased 2.6% (P less than 0.01), and treadmill test time increased 16% (P less than 0.01) in the experimental group after the 6-month program, with no significant changes in the comparison group. Recovery heart rates at 2 and 4 min post-exercise were significantly lower at 6 months in the experimental group but not in the comparison group. These data provide evidence that adherence to a 6-month endurance exercise program can be improved significantly through the use of well conceived behavior management strategies.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. Fructose in Breast Milk Is Positively Associated with Infant Body Composition at 6 Months of Age.

    PubMed

    Goran, Michael I; Martin, Ashley A; Alderete, Tanya L; Fujiwara, Hideji; Fields, David A

    2017-02-16

    Dietary sugars have been shown to promote excess adiposity among children and adults; however, no study has examined fructose in human milk and its effects on body composition during infancy. Twenty-five mother-infant dyads attended clinical visits to the Oklahoma Health Sciences Center at 1 and 6 months of infant age. Infants were exclusively breastfed for 6 months and sugars in breast milk (i.e., fructose, glucose, lactose) were measured by Liquid chromatography-mass spectrometry (LC-MS/MS) and glucose oxidase. Infant body composition was assessed using dual-energy X-ray absorptiometry at 1 and 6 months. Multiple linear regression was used to examine associations between breast milk sugars and infant body composition at 6 months of age. Fructose, glucose, and lactose were present in breast milk and stable across visits (means = 6.7 μg/mL, 255.2 μg/mL, and 7.6 g/dL, respectively). Despite its very low concentration, fructose was the only sugar significantly associated with infant body composition. A 1-μg/mL higher breast milk fructose was associated with a 257 g higher body weight (p = 0.02), 170 g higher lean mass (p = 0.01), 131 g higher fat mass (p = 0.05), and 5 g higher bone mineral content (p = 0.03). In conclusion, fructose is detectable in human breast milk and is positively associated with all components of body composition at 6 months of age.

  6. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe.

    PubMed

    Pérez-Romero, P; Bulnes-Ramos, A; Torre-Cisneros, J; Gavaldá, J; Aydillo, T A; Moreno, A; Montejo, M; Fariñas, M C; Carratalá, J; Muñoz, P; Blanes, M; Fortún, J; Suárez-Benjumea, A; López-Medrano, F; Barranco, J L; Peghin, M; Roca, C; Lara, R; Cordero, E

    2015-11-01

    Preventing influenza infection early after transplantation is essential, given the disease's high mortality. A multicentre prospective cohort study in adult solid organ transplant recipients (SOTR) receiving the influenza vaccine during four consecutive influenza seasons (2009-2013) was performed to assess the immunogenicity and safety of influenza vaccination in SOTR before and 6 months after transplantation. A total of 798 SOTR, 130 of them vaccinated within 6 months of transplantation and 668 of them vaccinated more than 6 months since transplantation. Seroprotection was similar in both groups: 73.1% vs. 76.5% for A/(H1N1)pdm (p 0.49), 67.5% vs. 74.1% for A/H3N2 (p 0.17) and 84.2% vs. 85.2% for influenza B (p 0.80), respectively. Geometric mean titres after vaccination did not differ among groups: 117.32 (95% confidence interval (CI) 81.52, 168.83) vs. 87.43 (95% CI 72.87, 104.91) for A/(H1N1)pdm, 120.45 (95% CI 82.17, 176.57) vs. 97.86 (95% CI 81.34, 117.44) for A/H3N2 and 143.32 (95% CI 103.46, 198.53) vs. 145.54 (95% CI 122.35, 174.24) for influenza B, respectively. After adjusting for confounding factors, time since transplantation was not associated with response to vaccination. No cases of rejection or severe adverse events were detected in patients vaccinated within the first 6 months after transplantation. In conclusion, influenza vaccination within the first 6 months after transplantation is as safe and immunogenic as vaccination thereafter. Thus, administration of the influenza vaccine can be recommended as soon as 1 month after transplantation.

  7. HIV Transmission Risk Persists During the First 6 Months of Antiretroviral Therapy

    PubMed Central

    Mujugira, Andrew; Celum, Connie; Coombs, Robert W.; Campbell, James D.; Ndase, Patrick; Ronald, Allan; Were, Edwin; Bukusi, Elizabeth A.; Mugo, Nelly; Kiarie, James; Baeten, Jared M.

    2016-01-01

    Objective Combination antiretroviral therapy (ART) decreases the risk of sexual HIV transmission by suppressing blood and genital HIV RNA concentrations. We sought to determine HIV transmission risk prior to achieving complete viral suppression. Design Prospective cohort study. Methods Using data from the Partners PrEP Study, a prospective study of 4747 heterosexual HIV-serodiscordant couples in Kenya and Uganda, we examined multiple markers of HIV transmission risk during the first months after ART initiation: time to viral suppression in blood, persistence of HIV RNA in genital specimens, sexual risk behavior, pregnancy incidence, and HIV transmission using survival analysis and GEE logistic regression. Results The cumulative probabilities of achieving blood viral suppression (<80 copies/ml) 3, 6 and 9-months after ART initiation were 65.3%, 84.8% and 89.1%, respectively. Endocervical and seminal HIV RNA were detectable in 12% and 21% of samples obtained within 6-months of ART. Pregnancy incidence was 8.8 per 100 person-years during the first 6-months of ART, and sex unprotected by condoms was reported at 10.5% of visits. Among initially uninfected partners, HIV incidence before ART was 2.08 per 100 person-years (55 infections; 2644 person-years), 1.79 for 0–6 months after ART initiation (3 infections; 168 person-years), and 0.00 with >6 months of ART (0 infections; 167 person-years). Conclusions Residual HIV transmission risk persists during the first 6-months of ART, with incomplete viral suppression in blood and genital compartments. For HIV-serodiscordant couples in which the infected partner starts ART, other prevention options are needed, such as pre-exposure prophylaxis, until viral suppression is achieved. PMID:27070123

  8. A randomized control trial of personalized cognitive counseling to reduce sexual risk among HIV-infected men who have sex with men.

    PubMed

    Schwarcz, Sandra K; Chen, Yea-Hung; Murphy, Jessie L; Paul, Jay P; Skinta, Matthew D; Scheer, Susan; Vittinghoff, Eric; Dilley, James W

    2013-01-01

    The increased life expectancy and well-being of HIV-infected persons presents the need for effective prevention methods in this population. Personalized cognitive counseling (PCC) has been shown to reduce unprotected anal intercourse (UAI) with a partner of unknown or different serostatus among HIV-uninfected men who have sex with men (MSM). We adapted PCC for use among HIV-infected MSM and tested its efficacy against standard risk-reduction counseling in a randomized clinical trial in San Francisco. Between November 2006 and April 2010, a total of 374 HIV-infected MSM who reported UAI with two or more men of negative or unknown HIV serostatus in the previous 6 months were randomized to two sessions of PCC or standard counseling 6 months apart. The primary outcome was the number of episodes of UAI with a non-primary male partner of different or unknown serostatus in the past 90 days, measured at baseline, 6, and 12 months. Surveys assessed participant satisfaction with the counseling. The mean number of episodes of UAI at baseline did not differ between PCC and control groups (2.97 and 3.14, respectively; p=0.82). The mean number of UAI episodes declined in both groups at 6 months, declined further in the PCC group at 12 months, while increasing to baseline levels among controls; these differences were not statistically significant. Episode mean ratios were 0.76 (95% confidence interval [CI] 0.25-2.19, p=0.71) at 6 months and 0.48 (95% CI 0.12-1.84, p=0.34) at 12 months. Participants in both groups reported a high degree of satisfaction with the counseling. The findings from this randomized trial do not support the efficacy of a two-session PCC intervention at reducing UAI among HIV-infected MSM and indicate the continued need to identify and implement effective prevention methods in this population.

  9. Impact of the Konstanz method of dilemma discussion on moral judgment in allied health students: a randomized controlled study.

    PubMed

    Lerkiatbundit, Sanguan; Utaipan, Parichat; Laohawiriyanon, Chonlada; Teo, Adisa

    2006-01-01

    The objective of the study was to determine the effect of the Konstanz method of moral dilemma discussion (KMDD) on moral judgment in allied health students. The study employed the Moral Judgment Test, translated from English into Thai and validated in 247 students, as an moral judgment instrument. The scale satisfied four validity criteria: preference hierarchy, quasi-simplex structure of stage preference, affective-cognitive parallelism, and positive correlation between education and moral competence score (C-index). Test-retest reliability at a 1-month interval was 0.90. To investigate the impact of the KMDD, 83 pharmacy technician and dental nursing students were asked to participate in the study. The subjects were randomly assigned into control (n = 41) or experimental (n = 42) groups. The experimental group participated in a 90-min KMDD once a week for 6 consecutive weeks. Students in the control group also met once a week for 6 weeks to discuss the topics not related to ethics. All subjects completed the Moral Judgment Test before and after the intervention and again 6 months later. Split-plot ANOVA of the C-indexes at the beginning revealed that the experimental and control groups were not different (20.57 +/- 13.45 and 24.98 +/- 16.12). However, the experimental group scored significantly higher than the control group did after the intervention (35.18 +/- 10.96 and 24.20 +/- 14.70) and 6 months later (33.00 +/- 11.02 and 23.67 +/- 14.35). The KMDD appears to be a practical and effective intervention for developing moral judgment in allied health students. The effect on moral judgment remains at least 6 months after the intervention.

  10. Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

    PubMed Central

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-01-01

    Background & objectives: Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 200 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results: Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001) compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions: Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group. PMID:24820831

  11. Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial.

    PubMed

    Downs, Julie S; Murray, Pamela J; Bruine de Bruin, Wändi; Penrose, Joyce; Palmgren, Claire; Fischhoff, Baruch

    2004-10-01

    A longitudinal randomized design was used to evaluate the impact of a theoretically based, stand-alone interactive video intervention on 300 urban adolescent girls' (a) knowledge about sexually transmitted diseases (STDs), (b) self-reported sexual risk behavior, and (c) STD acquisition. It was compared to two controls, representing high-quality informational interventions. One used the same content in book form; the other used commercially available brochures. Following randomization, the interventions were administered at baseline, with booster sessions at 1, 3, and 6 months. Self-reports revealed that those assigned to the interactive video were significantly more likely to be abstinent in the first 3 months following initial exposure to the intervention, and experienced fewer condom failures in the following 3 months, compared to controls. Six months after enrollment, participants in the video condition were significantly less likely to report having been diagnosed with an STD. A non-significant trend in data from a clinical PCR assay of Chlamydia trachomatis was consistent with that finding.

  12. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  13. Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial.

    PubMed

    von Piekartz, Harry; Hall, Toby

    2013-08-01

    There is evidence that temporomandibular disorder (TMD) may be a contributing factor to cervicogenic headache (CGH), in part because of the influence of dysfunction of the temporomandibular joint on the cervical spine. The purpose of this randomized controlled trial was to determine whether orofacial treatment in addition to cervical manual therapy, was more effective than cervical manual therapy alone on measures of cervical movement impairment in patients with features of CGH and signs of TMD. In this study, 43 patients (27 women) with headache for more than 3-months and with some features of CGH and signs of TMD were randomly assigned to receive either cervical manual therapy (usual care) or orofacial manual therapy to address TMD in addition to usual care. Subjects were assessed at baseline, after 6 treatment sessions (3-months), and at 6-months follow-up. 38 subjects (25 female) completed all analysis at 6-months follow-up. The outcome criteria were: cervical range of movement (including the C1-2 flexion-rotation test) and manual examination of the upper 3 cervical vertebra. The group that received orofacial treatment in addition to usual care showed significant reduction in all aspects of cervical impairment after the treatment period. These improvements persisted to the 6-month follow-up, but were not observed in the usual care group at any point. These observations together with previous reports indicate that manual therapists should look for features of TMD when examining patients with headache, particularly if treatment fails when directed to the cervical spine.

  14. Sexual Function Among Overweight and Obese Women With Urinary Incontinence in a Randomized Controlled Trial of an Intensive Behavioral Weight Loss Intervention

    PubMed Central

    Huang, Alison J.; Stewart, Anita L.; Hernandez, Alexandra L.; Shen, Hui; Subak, Leslee L.

    2009-01-01

    Purpose: We examined sexual function in overweight and obese women with urinary incontinence, and evaluated the effects of an intensive behavioral weight reduction intervention on sexual function in this population. Materials and Methods: A total of 338 overweight and obese women reporting 10 or more incontinence episodes weekly were randomized to an intensive behavioral change (226) or structured education program (112) for 6 months. Sexual function was assessed using self-administered questionnaires. Multivariate regression was used to examine factors associated with baseline and 6-month change in sexual function as well as intervention effects. Results: Two-thirds of participants (233) were sexually active at baseline but more than half (188) reported low desire and a quarter (91) were sexually dissatisfied. More than half of sexually active participants (123) reported problems with arousal, lubrication, orgasm or incontinence during sex. Compared to controls women in the intervention group demonstrated a borderline increase in frequency of sexual activity at 6 months (OR 1.34, 95% CI 0.99–1.81, p = 0.06) but no differences in satisfaction (OR 1.28, 95% CI 0.83–1.99, p = 0.26), desire (OR 1.12, 95% CI 0.79–1.61, p = 0.52) or problems (β ± SE 0.03 ± 0.07, p = 0.68 for intervention effects on problems score). Neither clinical incontinence severity nor body mass index was independently associated with baseline or 6-month change in function (p >0.10 for all). Conclusions: Sexual dysfunction is common in overweight and obese women with incontinence but the severity of this dysfunction may not be directly related to the severity of incontinence or obesity. An intensive 6-month behavioral weight reduction intervention did not significantly improve sexual function in this population relative to controls. PMID:19296980

  15. Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial.

    PubMed

    Tornås, Sveinung; Løvstad, Marianne; Solbakk, Anne-Kristin; Evans, Jonathan; Endestad, Tor; Hol, Per Kristian; Schanke, Anne-Kristine; Stubberud, Jan

    2016-04-01

    Executive dysfunction is a common consequence of acquired brain injury (ABI), causing significant disability in daily life. This randomized controlled trial investigated the efficacy of Goal Management Training (GMT) in improving executive functioning in patients with chronic ABI. Seventy patients with a verified ABI and executive dysfunction were randomly allocated to GMT (n=33) or a psycho-educative active control condition, Brain Health Workshop (BHW) (n=37). In addition, all participants received external cueing by text messages. Neuropsychological tests and self-reported questionnaires of executive functioning were administered pre-intervention, immediately after intervention, and at 6 months follow-up. Assessors were blinded to group allocation. Questionnaire measures indicated significant improvement of everyday executive functioning in the GMT group, with effects lasting at least 6 months post-treatment. Both groups improved on the majority of the applied neuropsychological tests. However, improved performance on tests demanding executive attention was most prominent in the GMT group. The results indicate that GMT combined with external cueing is an effective metacognitive strategy training method, ameliorating executive dysfunction in daily life for patients with chronic ABI. The strongest effects were seen on self-report measures of executive functions 6 months post-treatment, suggesting that strategies learned in GMT were applied and consolidated in everyday life after the end of training. Furthermore, these findings show that executive dysfunction can be improved years after the ABI.

  16. Behavior Therapy for Children with Tourette Disorder: A Randomized Controlled Trial

    PubMed Central

    Piacentini, John; Woods, Douglas W.; Scahill, Lawrence; Wilhelm, Sabine; Peterson, Alan L.; Chang, Susanna; Ginsburg, Golda S.; Deckersbach, Thilo; Dziura, James; Levi-Pearl, Sue; Walkup, John T.

    2010-01-01

    Context Tourette disorder is a chronic and typically impairing childhood-onset neurological condition. Antipsychotic medications, the first-line treatments for moderate to severe tics, are often associated with adverse effects. Behavioral interventions, although promising, have not been evaluated in large-scale controlled trials. Objective To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents. Design, Setting, Participants Randomized, observer-blind, controlled trial of 126 youngsters recruited from December, 2004 through May, 2007 and aged 9–17 years with impairing Tourette or chronic tic disorder as primary diagnosis randomized to 8 sessions over 10 weeks of behavior therapy (n=61) or a control treatment consisting of supportive therapy and education (n=65). Responders received 3 monthly treatment booster sessions and were reassessed at 3- and 6-months post-treatment. Intervention Comprehensive behavioral intervention. Main Outcome Measures Yale Global Tic Severity Scale (range 0–40, score >15 indicating clinically significant tics), Clinical Global Impression-Improvement Scale (range 1-very much improved to 8-very much worse). Results Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale (24.7; CI:23.1,26.3) to 17.1 CI:15.1,19.1) from baseline to endpoint compared to the control treatment (24.6 CI:23.2,26.0) to 21.1 CI:19.2,23.0) (P<.001; 95% CI for difference between groups: 6.2, 2.0); (effect size=0.68). Compared to children in control treatment, significantly more children receiving behavioral intervention were rated as “very much” or “much improved” on the Clinical Global Impression-Improvement scale (52.5% to 18.5%, respectively; P<0.001; number-needed-to-treat=3). Attrition was low (12/126 or 9.5%); tic worsening was reported by 4% of children (5/126). Treatment gains were durable with 87% of available responders to behavior

  17. Skin and needle hygiene intervention for injection drug users: Results from a randomized, controlled Stage I pilot trial

    PubMed Central

    Phillips, Kristina T.; Stein, Michael D.; Anderson, Bradley J.; Corsi, Karen F.

    2012-01-01

    A new skin and needle hygiene intervention, designed to reduce high-risk injection practices associated with bacterial and viral infections, was tested in a pilot, randomized controlled trial. Participants included 48 active heroin injectors recruited through street outreach and randomized to either the two-session intervention or an assessment-only condition (AO) and followed for six months. The primary outcome was skin and needle cleaning behavioral skills measured by videotaped demonstration. Secondary outcomes were high-risk injection practices, intramuscular injection, and bacterial infections. Intervention participants had greater improvements on the skin (d = 1.00) and needle cleaning demonstrations (d = .52) and larger reductions in high-risk injection practices (d = .32) and intramuscular injection (d = .29), with a lower incidence rate of bacterial infections (HR = .80), at 6-months compared to AO. The new intervention appears feasible and promising as a brief intervention to reduce bacterial and viral risks associated with drug injection. PMID:22341554

  18. Randomized, controlled trial of Behavioral Family Systems Therapy for Diabetes: maintenance and generalization of effects on parent-adolescent communication.

    PubMed

    Wysocki, Tim; Harris, Michael A; Buckloh, Lisa M; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H

    2008-03-01

    We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by independent rating of videotaped family problem-solving discussions. BFST-D improved individual communication of adolescents and mothers, but not fathers. BFST-D significantly improved quality of family interaction compared to SC (10 of 12 comparisons) and ES (6 of 12 comparisons). Changes in family communication were differentially associated with changes in glycemic control, adherence, and family conflict. BFST-D improved family communication and problem solving relative to SC and modestly relative to ES.

  19. Parent Management Training (PMT) and Collaborative & Proactive Solutions (CPS): A Randomized Control Trial for Oppositional Youth

    PubMed Central

    Ollendick, Thomas H.; Greene, Ross W.; Austin, Kristin E.; Fraire, Maria G.; Halldorsdottir, Thorhildur; Allen, Kristy Benoit; Jarrett, Matthew A.; Lewis, Krystal M.; Whitmore, Maria J.; Cunningham, Natoshia R.; Noguchi, Ryoichi J. P.; Canavera, Kristin; Wolff, Jennifer C.

    2015-01-01

    Objective Examine the efficacy of Collaborative & Proactive Solutions (CPS) in treating oppositional defiant disorder (ODD) in youth by comparing this novel treatment to Parent Management Training (PMT), a well-established treatment, and a waitlist control (WLC) group. Method One hundred and thirty four youth (ages 7 – 14, 61.9% male, 83.6% white) who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria for ODD were randomized to either CPS, PMT or WLC groups. ODD was assessed with semi-structured diagnostic interviews, clinical global severity and improvement ratings, and parent report measures. Assessments were completed pre-treatment, post-treatment, and at 6 months following treatment. Responder and remitter analyses were undertaken using intent-to-treat mixed models analyses. Chronological age, gender, and socioeconomic status as well as the presence of comorbid attention deficit/hyperactivity and anxiety disorders were examined as predictors of treatment outcome. Results Both treatment conditions were superior to the WLC condition but did not differ from one another in either our responder or remitter analyses. Approximately 50% of youth in both active treatments were diagnosis free and were judged to be much or very much improved at post-treatment, compared to 0% in the waitlist condition. Younger age and presence of an anxiety disorder predicted better treatment outcomes for both PMT and CPS. Treatment gains were maintained at 6-month follow-up. Conclusions CPS proved to be equivalent to PMT and can be considered an evidence-based, alternative treatment for youth with ODD and their families. PMID:25751000

  20. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol

    PubMed Central

    Rubio-Valera, Maria; Serrano-Blanco, Antoni; Travé, Pere; Peñarrubia-María, M Teresa; Ruiz, Mar; Pujol, Marian March

    2009-01-01

    Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI). Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in

  1. Feasibility of a 6-month exercise and recreation program to improve executive functioning and memory of individuals with chronic stroke

    PubMed Central

    Rand, Debbie; Eng, Janice J.; Liu-Ambrose, Teresa; Tawashy, Amira E.

    2011-01-01

    Background Physical activity has been shown to be beneficial for improving cognitive function in healthy older adults. However there is limited research on the benefits of physical activity on cognitive performance after stroke. Objective To determine if a combined exercise and recreation program can improve the executive functioning and memory in individuals with chronic stroke. Methods 11 ambulatory subjects with chronic stroke (mean age 67±10.8 years) participated in a 6 month program of exercise for 2 hours and recreation for 1 hour weekly. Executive functions and memory were assessed at baseline, 3, and 6 months by a battery of standard neuropsychological tests including response inhibition, cognitive flexibility, dual task (motor plus cognitive) and memory. Motor ability was also assessed. Non-parametric statistics were used to assess the differences between the three assessments. Results At baseline, substantial deficits in all aspects of executive functioning were revealed. From baseline to 3 mo, the mean improvement was 10±14% (χ2=9.3, p=0.0025) for the dual task (Walking while Talking), −3±22% (χ2=2.4, p>0.05) for response inhibition (Stroop test) and 61±69% (χ2=8.0, p=0.04) for memory (Rey Auditory Verbal Learning Test - long delay). From baseline to 6 months, the mean improvement was 7±7.5% (χ2=12.0, p=0.007) for response inhibition (Stroop Test). In addition, knee strength and walking speed improved significantly at 3 months. Conclusions This pilot study suggests that exercise and recreation may improve memory and executive functions of community dwelling individuals with stroke. Further studies require a larger sample size and a control group. PMID:20460494

  2. Juvenile traumatic brain injury evolves into a chronic brain disorder: behavioral and histological changes over 6 Months

    PubMed Central

    Kamper, Joel E.; Pop, Viorela; Fukuda, Andrew; Ajao, David; Hartman, Richard; Badaut, Jérôme

    2014-01-01

    Traumatic brain injury (TBI) refers to physical trauma to the brain that can lead to motor and cognitive dysfunctions. TBI is particularly serious in infants and young children, often leading to long-term functional impairments. Although clinical research is useful for quantifying and observing the effects of these injuries, few studies have empirically assessed the long-term effects of juvenile TBI (jTBI) on behavior and histology. After a controlled cortical impact delivered to postnatal 17d rats, functional abilities were measured after 3, 5, and 6 months using open field (activity levels), zero maze (anxiety-like behaviors), rotarod (sensorimotor abilities, coordination, and balance), and water maze (spatial learning and memory, swim speed, turn bias). Sensorimotor function was impaired for up to 6 months in jTBI animals, which showed no improvement from repeated test exposure. Although spatial learning was not impaired, spatial memory deficits were observed in jTBI animals starting at 3 months after injury. Magnetic resonance imaging and histological data revealed that the effects of jTBI were evolving for up to 6 months post-injury, with reduced cortical thickness, decreased corpus callosum area and CA1 neuronal cell death in jTBI animals distant of the impact site. These findings suggest that this model of jTBI produces long-term impairments comparable to those reported clinically. Although some deficits were stable over time, the variable nature of other deficits (e.g., memory) as well as changing properties of the lesion itself, suggest that the effects of a single jTBI produce a chronic brain disorder with long-term complications. PMID:24076005

  3. Multiple Shaker Random Vibration Control--An Update

    SciTech Connect

    Smallwood, D.O.

    1999-02-18

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

  4. Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol

    PubMed Central

    2013-01-01

    Background Over 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach - SystemCHANGE™ - to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal. Methods We will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment. Discussion This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors. Trial registration ClinicalTrials.gov Identifier: NCT01776034 PMID:23782741

  5. Effects of Low Dose Metformin in Adolescents with Type I Diabetes Mellitus: A Randomized, Double-Blinded Placebo-Controlled Study

    PubMed Central

    Nadeau, Kristen; Chow, Kelsey; Alam, Lyla; Lindquist, Kara; Cambell, Sarah; McFann, Kim; Klingensmith, Georgeanna; Walravens, Phillipe

    2014-01-01

    Background Insulin resistance increases during adolescence in those with type 1 diabetes (T1DM), complicating glycemic control and potentially increasing cardiovascular disease (CVD) risk. Metformin, typically used in type 2 diabetes (T2DM), is a possible adjunct therapy in T1DM to help improve glycemic control and insulin sensitivity. Objective We hypothesized that metformin would improve metabolic parameters in adolescents with T1DM. Design, Setting, and Participants This randomized, double-blinded, placebo-controlled trial included 74 pubertal adolescents (ages 13–20 years) with T1DM. Participants were randomized to receive either metformin or placebo for six months. HbA1c, insulin dose, waist circumference, BMI, and blood pressure were measured at baseline, 3 and 6 months, with fasting lipids measured at baseline and 6 months. Results Total daily insulin dose, BMI Z-score and waist circumference significantly decreased at 3 and 6 months compared to baseline within the metformin group, even among normal-weight participants. In placebo group, total insulin dose and systolic blood pressure increased significantly at 3 months and total insulin dose increased significantly at 6 months. No significant change was observed in HbA1c at any time point between metformin and placebo groups or within either group. Conclusions Low-dose metformin likely improves BMI as well as insulin sensitivity in T1DM adolescents, as indicated by a decrease in total daily insulin dose. The decrease in waist circumference indicates that fat distribution is also likely impacted by metformin in T1DM. Further studies with higher metformin doses and more detailed measurements are needed to confirm these results, their underlying mechanisms, and potential impact on CVD in T1DM youth. PMID:24698216

  6. A prospective study of atopic dermatitis managed without topical corticosteroids for a 6-month period

    PubMed Central

    Fukaya, Mototsugu; Sato, Kenji; Yamada, Takahiro; Sato, Mitsuko; Fujisawa, Shigeki; Minaguchi, Satoko; Kimata, Hajime; Dozono, Haruhiko

    2016-01-01

    Topical corticosteroids (TCS) are regarded as the mainstay treatment for atopic dermatitis (AD). As AD has a tendency to heal naturally, the long-term efficacy of TCS in AD management should be compared with the outcomes seen in patients with AD not using TCS. However, there are few long-term studies that consider patients with AD not using TCS. We designed a prospective multicenter cohort study to assess the clinical outcomes in patients with AD who did not use TCS for 6 months and then compared our results with an earlier study by Furue et al which considered AD patients using TCS over 6 months. Our patients’ clinical improvement was comparable with the patients described in Furue’s research. In light of this, it is reasonable for physicians to manage AD patients who decline TCS, as the expected long-term prognosis is similar whether they use TCS or not. PMID:27445501

  7. The posterior iris-claw lens outcome study: 6-month follow-up

    PubMed Central

    Jare, Nana Madhukar; Kesari, Ashwini Ganesh; Gadkari, Salil S; Deshpande, Madan D

    2016-01-01

    Purpose: The purpose of this study was to evaluate functional and anatomical outcomes of posterior iris-claw intraocular lens (IOL) implant for correction of aphakia in eyes with inadequate capsular support. Materials and Methods: Prospective case series of 108 aphakic eyes with inadequate capsular support which underwent posterior iris-claw IOL with a 6-month follow-up period was conducted. The cases belonged to two clinical settings: elective secondary implantation and those with intraoperative posterior dislocation of cataractous lens or IOL. Main outcome measures were visual acuity, anterior chamber reaction, stability of IOL, endothelial cell count, intraocular pressure (IOP), and cystoid macular edema (CME). Results: The mean best-corrected visual acuity was LogMAR 0.25. None had chronic anterior chamber inflammation. The mean difference in central endothelial counts before surgery and 1 month after surgery was 104.21 cell/mm2 (4.92%). There was no statistically significant difference in central endothelial cell count at 1 and 6 months (P = 0.91) and also in the central macular thickness at preoperative and after 6 months suggestive of CME (P = 0.078). Three eyes had raised IOP which were managed with neodymium-doped yttrium aluminum garnet laser peripheral iridotomy. There were no IOL dislocations or other adverse events in our series. Conclusion: Posterior chamber iris-claw lenses are a good option in eyes with inadequate posterior capsular support. Chronic inflammation, poor lens stability, or significant central endothelial cell loss was not observed during the 6-month follow-up period. PMID:28112126

  8. Effect of calcium polycarbophil on bowel function after restorative proctocolectomy for ulcerative colitis: a randomized controlled trial.

    PubMed

    Shibata, Chikashi; Funayama, Yuji; Fukushima, Kouhei; Takahashi, Ken-Ichi; Ogawa, Hitoshi; Haneda, Sho; Watanabe, Kazuhiro; Kudoh, Katsuyoshi; Kohyama, Atsushi; Hayashi, Kei-Ichi; Sasaki, Iwao

    2007-06-01

    The aim of the present study was to determine if calcium polycarbophil ameliorates diarrhea after ileal J-pouch anal anastomosis for ulcerative colitis. Twenty-one randomized patients were given either bifidobacterium (3 g/day) plus calcium polycarbophil (3 g/day), in the polycarbophil group (11 patients), or bifidobacterium (3 g/day), in the control group (10 patients), p.o. for 6 months. Anal manometry was performed and bowel function (stool frequency, stool consistency, and nighttime soiling) was assessed via a questionnaire before and 1, 3, and 6 months after drug administration. Eight patients were deemed eligible in each group; five patients were excluded from the study, including two patients whose stool consistency was too firm and who experienced difficulty in defecating attributed to polycarbophil. Anal manometry and stool consistency did not change with time and did not differ between the polycarbophil and the control groups. Stool frequency decreased with time in both groups and did not differ between the groups. Nighttime soiling improved with time in the polycarbophil group but did not change in the control subjects. These results suggest that polycarbophil might be able to improve nighttime soiling without obviously affecting stool frequency and consistency after ileal J-pouch anal anastomosis for ulcerative colitis.

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

    PubMed

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

    2014-08-01

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

  10. Word learning in 6-month-olds: fast encoding-weak retention.

    PubMed

    Friedrich, Manuela; Friederici, Angela D

    2011-11-01

    There has been general consensus that initial word learning during early infancy is a slow and time-consuming process that requires very frequent exposure, whereas later in development, infants are able to quickly learn a novel word for a novel meaning. From the perspective of memory maturation, this shift in behavioral development might represent a shift from slow procedural to fast declarative memory formation. Alternatively, it might be caused by the maturation of specific brain structures within the declarative memory system that may support lexical mapping from the very first. Here, we used the neurophysiological method of ERPs to watch the brain activity of 6-month-old infants, when repeatedly presented with object-word pairs in a cross-modal learning paradigm. We report first evidence that infants as young as 6 months are able to associate objects and words after only very few exposures. A memory test 1 day later showed that infants did not fully forget this newly acquired knowledge, although the ERP effects indicated it to be less stable than immediately after encoding. The combined results suggest that already at 6 months the encoding process of word learning is based on fast declarative memory formation, but limitations in the consolidation of declarative memory diminish the long lasting effect in lexical-semantic memory at that age.

  11. Association of serum 25-hydroxyvitamin D with symptoms of depression after 6 months in stroke patients.

    PubMed

    Yue, Wei; Xiang, Lei; Zhang, Ya-Jing; Ji, Yong; Li, Xin

    2014-11-01

    Our aim was to determine whether there was a relationship between 25-hydroxyvitamin D (25[OH] D) and post-stroke depression (PSD). Two hundred and forty-four ischemic stroke patients admitted to the hospital within the first 24 h after stroke onset were consecutively recruited and followed up for 6 months. Clinical information was collected. Serum 25[OH] D levels were measured at baseline. Based on the symptoms, diagnoses of depression were made in accordance with DSM-IV criteria for depression at 6-month after stroke. At 6-month, 91 patients (37.3 %) showed depression and in 60 patients (24.6 %) this depression was classified as major. There was a significant difference in median serum 25[OH] D levels between PSD patients and no depression cases [8.3 (IQR, 6.8-9.5) vs. 15.6 (IQR, 13.2-20.3) ng/ml, respectively; P < 0.001]. Serum 25[OH] D levels ≤ 11.2 ng/ml were independently associated with PSD [odds ratio 10.32, 95 % confidence interval 4.97-28.63; P < 0.001], after adjusting for possible confounders. Serum 25[OH] D levels reduced at admission was found to be associated with PSD. Additional research is needed on vitamin D supplementation to improve the outcome of patients with PSD.

  12. Repairing the Brain by SCF+G-CSF Treatment at 6 Months Postexperimental Stroke

    PubMed Central

    Cui, Lili; Wang, Dandan; McGillis, Sandra; Kyle, Michele

    2016-01-01

    Stroke, a leading cause of adult disability in the world, is a severe medical condition with limited treatment. Physical therapy, the only treatment available for stroke rehabilitation, appears to be effective within 6 months post-stroke. Here, we have mechanistically determined the efficacy of combined two hematopoietic growth factors, stem cell factor (SCF) and granulocyte-colony stimulating factor (G-CSF; SCF + G-CSF), in brain repair 6 months after cortical infarct induction in the transgenic mice carrying yellow fluorescent protein in Layer V pyramidal neurons (Thy1-YFP-H). Using a combination of live brain imaging, whole brain imaging, molecular manipulation, synaptic and vascular assessments, and motor function examination, we found that SCF + G-CSF promoted mushroom spine formation, enlarged postsynaptic membrane size, and increased postsynaptic density-95 accumulation and blood vessel density in the peri-infarct cavity cortex; and that SCF + G-CSF treatment improved motor functional recovery. The SCF + G-CSF-enhanced motor functional recovery was dependent on the synaptic and vascular regeneration in the peri-infarct cavity cortex. These data suggest that a stroke-damaged brain is repairable by SCF + G-CSF even 6 months after the lesion occurs. This study provides novel insights into the development of new restorative strategies for stroke recovery. PMID:27511907

  13. A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain [ISRCTN 16558617

    PubMed Central

    Manchikanti, Laxmaiah; Boswell, Mark V; Rivera, Jose J; Pampati, Vidya Sagar; Damron, Kim S; McManus, Carla D; Brandon, Doris E; Wilson, Sue R

    2005-01-01

    Background Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described. Methods A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid. Results Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status. Conclusion Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects. PMID:16000173

  14. Research to Encourage Exercise for Fibromyalgia (REEF): Use of Motivational Interviewing, Outcomes from a Randomized Controlled Trial

    PubMed Central

    Ang, Dennis C.; Kaleth, Anthony S.; Bigatti, Silvia; Mazzuca, Steven A.; Jensen, Mark P.; Hilligoss, Janna; Slaven, James; Saha, Chandan

    2012-01-01

    Objectives Regular exercise is associated with important benefits in patients with fibromyalgia (FM). Unfortunately, long-term maintenance of exercise after a structured program is rare. The present study tested the efficacy of Motivational Interviewing (MI) to promote exercise and improve symptoms in patients with FM. Methods 216 patients with FM were randomized to 6 MI sessions (n=107) or an equal number of FM self-management lessons (education control/EC, n=109). Co-primary endpoints were an increase of 30 minutes in moderate-vigorous physical activity and improvement in the Fibromyalgia Impact Questionnaire-Physical Impairment (FIQ-PI) score, assessed at pre-treatment, post-treatment, and 3- and 6-month follow-up. Secondary outcomes included clinically meaningful improvements in FIQ score, pain severity ratings, and a 6-minute walk test. Results There were no significant treatment group differences in either co-primary endpoint at 6-month follow-up. However, more MI participants than controls exhibited meaningful improvements in FIQ score at 6-month follow-up (62.9% vs. 49.5%, p=0.06). Compared to EC subjects, MI subjects also displayed a larger increment in their 6-minute walk test (43.9 vs. 24.8 meters, p=0.03). Additionally, MI was superior to EC in increasing the number of hours of physical activity immediately post-intervention and in reducing pain severity both immediately after the intervention and at 3-month follow-up. Conclusions Despite a lack of benefits on long term outcome, MI appears to have short-term benefits with respect to self-report physical activity and clinical outcomes. This is the first study in FM that explicitly addresses exercise maintenance as a primary aim. PMID:23042474

  15. A Mobile Phone App Intervention Targeting Fruit and Vegetable Consumption: The Efficacy of Textual and Auditory Tailored Health Information Tested in a Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Mobile phone apps are increasingly used to deliver health interventions, which provide the opportunity to present health information via different communication modes. However, scientific evidence regarding the effects of such health apps is scarce. Objective In a randomized controlled trial, we tested the efficacy of a 6-month intervention delivered via a mobile phone app that communicated either textual or auditory tailored health information aimed at stimulating fruit and vegetable intake. A control condition in which no health information was given was added. Perceived own health and health literacy were included as moderators to assess for which groups the interventions could possibly lead to health behavior change. Methods After downloading the mobile phone app, respondents were exposed monthly to either text-based or audio-based tailored health information and feedback over a period of 6 months via the mobile phone app. In addition, respondents in the control condition only completed the baseline and posttest measures. Within a community sample (online recruitment), self-reported fruit and vegetable intake at 6-month follow-up was our primary outcome measure. Results In total, 146 respondents (ranging from 40 to 58 per condition) completed the study (attrition rate 55%). A significant main effect of condition was found on fruit intake (P=.049, partial η2=0.04). A higher fruit intake was found after exposure to the auditory information, especially in recipients with a poor perceived own health (P=.003, partial η2=0.08). In addition, health literacy moderated the effect of condition on vegetable intake 6 months later (P<.001, partial η2=.11). A higher vegetable intake was found for recipients with high health literacy after exposure to the textual or auditory intervention compared to the control condition (contrasts P=.07 and P=.004, respectively). In the case of relatively low health literacy, vegetable intake was the highest in the control

  16. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial

    PubMed Central

    Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

    2016-01-01

    Background Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. Objective This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. Methods A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. Results An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F 1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F 1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. Conclusions This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. Trial Registration German Clinical Trials

  17. A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes. Methods/Design This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion. Discussion This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of

  18. Multisystemic Therapy for Adolescents with Poorly Controlled Type I Diabetes: Stability of Treatment Effects in a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Ellis, Deborah A.; Templin, Thomas; Naar-King, Sylvie; Frey, Maureen A.; Cunningham, Phillippe B.; Podolski, Cheryl-Lynn; Cakan, Nedim

    2007-01-01

    The primary purpose of the present study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, improved regimen adherence, metabolic control, and rates of hospitalization for diabetic ketoacidosis (DKA) among adolescents with chronically poorly controlled Type 1 diabetes 6 months after the completion of…

  19. Effect of a 6-month school-based physical activity program on body composition and physical fitness in lean and obese schoolchildren.

    PubMed

    Thivel, David; Isacco, Laurie; Lazaar, Nordine; Aucouturier, Julien; Ratel, Sébastien; Doré, Eric; Meyer, Martine; Duché, Pascale

    2011-11-01

    Few studies have investigated the impact of school-based physical activity interventions on anthropometric characteristics concomitantly with aerobic and anaerobic capacities in young children. The present study aimed to assess the effect of a 6-month physical activity program on body composition and physical fitness among primary schoolchildren. Four hundred fifty-seven children aged 6 to 10 years were randomly assigned to the intervention group (229 children) or observational group (228 children). Participants' height and weight were assessed, and obesity was determined using French reference curves for BMI. The sum of the four skinfolds and fat-free mass were determined. Ground tests were used to assess aerobic (20-m shuttle run test) and anaerobic (cycling peak power) fitness before and after a 6-month physical activity intervention. The anthropometric modifications obtained over the 6 months cannot be attributed to the intervention as the ANOVA revealed no group effect (intervention vs. group). However, anaerobic and aerobic fitness were significantly improved, thanks to the program in both lean and obese children. A 6-month school-based physical activity intervention in 6- to 10-year-old children did not yield positive anthropometric improvements, but appears effective in terms of aerobic and anaerobic physical fitness. Two physical activity sessions per week in addition to standard physical education classes in primary schoolchildren bring effective results for the prevention of childhood obesity.

  20. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial.

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  2. Randomized trial comparing mindfulness training for smokers to a matched control

    PubMed Central

    Davis, James M.; Manley, Alison R.; Goldberg, Simon B.; Smith, Stevens S.; Jorenby, Douglas E.

    2014-01-01

    Smoking continues to take an enormous toll on society, and although most smokers would like to quit, most are unsuccessful using existing therapies. These findings call on researchers to develop and test therapies that provide higher rates of long-term smoking abstinence. We report results of a randomized controlled trial comparing a novel smoking cessation treatment using mindfulness training to a matched control based on the American Lung Association's Freedom From Smoking program. Data were collected on 175 low socioeconomic status smokers in 2011-2012 in a medium sized Midwestern city. A significant difference was not found in the primary outcome; intent-to-treat biochemically confirmed 6-month smoking abstinence rates were Mindfulness = 25.0%, Control= 17.9% (p = 0.35). Differences favoring the mindfulness condition were found on measures of urges and changes in mindfulness, perceived stress, and experiential avoidance. While no significant differences were found in quit rates, the mindfulness intervention resulted in positive outcomes. PMID:24957302

  3. Relationship between neurocognitive functioning and medication management ability over the first 6 months following allogeneic stem cell transplantation.

    PubMed

    Mayo, S; Messner, H A; Rourke, S B; Howell, D; Victor, J C; Kuruvilla, J; Lipton, J H; Gupta, V; Kim, D D; Piescic, C; Breen, D; Lambie, A; Loach, D; Michelis, F V; Alam, N; Uhm, J; McGillis, L; Metcalfe, K

    2016-06-01

    Although neurocognitive impairment has been established as a major issue among cancer survivors, the real-world consequences of this impairment are unclear. This study investigated the relationship between neurocognitive functioning and medication management ability over time among 58 patients treated with allogeneic hematopoietic stem cell transplantation (HCT). Participants completed a neuropsychological test battery and a simulated medication management task at three time points: pre-transplant (T0), Day 100 (T1) and 6 months post transplant (T2). Neurocognitively impaired participants performed worse on the medication management task than neurocognitively normal participants at each time point, and were more likely to score in the impaired range of medication management ability post transplant (72% vs 20%, P<0.001 at T1; 67% vs 23%, P=0.013 at T2). In multivariate analyses, worse performance in executive functioning/working memory consistently predicted impaired medication management ability, even when controlling for sociodemographic and clinical confounders (odds ratio=0.89, 95% confidence interval (0.80, 0.98), P=0.023). Lower physical symptom distress also predicted impaired medication management ability, but this effect decreased over time. Self-reported cognitive problems were not correlated with medication management ability at any time point. Findings suggest that poor neurocognitive functioning, particularly in the domain of executive functioning/working memory, is associated with worse medication management ability within the first 6 months after allogeneic HCT.

  4. Effects of Voice Rehabilitation After Radiation Therapy for Laryngeal Cancer: A Randomized Controlled Study

    SciTech Connect

    Tuomi, Lisa; Andréll, Paulin

    2014-08-01

    Background: Patients treated with radiation therapy for laryngeal cancer often experience voice problems. The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist. Methods and Materials: Sixty-nine male patients irradiated for laryngeal cancer participated. Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy. Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group. Furthermore, comparisons with 23 healthy control individuals were made. Acoustic analyses were performed for all patients, including the healthy control individuals. The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function. Results: The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation. Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function, whereas the control group did not. Conclusion: Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements. The patients experienced better voice function after rehabilitation. Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes. Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy, particularly for patients with supraglottic tumors.

  5. LEARN 2 MOVE 7-12 years: a randomized controlled trial on the effects of a physical activity stimulation program in children with cerebral palsy

    PubMed Central

    2010-01-01

    Background Regular participation in physical activities is important for all children to stay fit and healthy. Children with cerebral palsy have reduced levels of physical activity, compared to typically developing children. The aim of the LEARN 2 MOVE 7-12 study is to improve physical activity by means of a physical activity stimulation program, consisting of a lifestyle intervention and a fitness training program. Methods/Design This study will be a 6-month single-blinded randomized controlled trial with a 6-month follow up. Fifty children with spastic cerebral palsy, aged 7 to 12 years, with Gross Motor Function Classification System levels I-III, will be recruited in pediatric physiotherapy practices and special schools for children with disabilities. The children will be randomly assigned to either the intervention group or control group. The children in the control group will continue with their regular pediatric physiotherapy, and the children in the intervention group will participate in a 6-month physical activity stimulation program. The physical activity stimulation program consists of a 6-month lifestyle intervention, in combination with a 4-month fitness training program. The lifestyle intervention includes counseling the child and the parents to adopt an active lifestyle through Motivational Interviewing, and home-based physiotherapy to practise mobility-related activities in the daily situation. Data will be collected just before the start of the intervention (T0), after the 4-month fitness training program (T4), after the 6-month lifestyle intervention (T6), and after six months of follow-up (T12). Primary outcomes are physical activity, measured with the StepWatch Activity Monitor and with self-reports. Secondary outcomes are fitness, capacity of mobility, social participation and health-related quality of life. A random coefficient analysis will be performed to determine differences in treatment effect between the control group and the

  6. Randomized, Controlled Trial of Behavioral Family Systems Therapy for Diabetes: Maintenance and Generalization of Effects on Parent-Adolescent Communication

    ERIC Educational Resources Information Center

    Wysocki, Tim; Harris, Michael A.; Buckloh, Lisa M.; Mertlich, Deborah; Lochrie, Amanda Sobel; Taylor, Alexandra; Sadler, Michelle; White, Neil H.

    2008-01-01

    We report a randomized trial of a revised Behavioral Family Systems Therapy for Diabetes (BFST-D) intervention. Families of 104 adolescents with diabetes were randomized to standard care (SC) or to 6 months of an educational support group (ES) or BFST-D. Family communication and problem-solving skills were assessed at 0, 6, 12, and 18 months by…

  7. Comprehensive Approach to Lower Blood Pressure (CALM-BP): a randomized controlled trial of a multifactorial lifestyle intervention.

    PubMed

    Ziv, A; Vogel, O; Keret, D; Pintov, S; Bodenstein, E; Wolkomir, K; Doenyas, K; Mirovski, Y; Efrati, S

    2013-10-01

    Complementary medicine advocates the use of a multifactorial approach to address the varied aspects of hypertension. The aim of this study was to compare the blood pressure (BP) effect and medication use of a novel Comprehensive Approach to Lowering Measured Blood Pressure (CALM-BP), based on complementary medicine principles, with the standard recommended Dietary Approach to Stop Hypertension (DASH). A total of 113 patients treated with antihypertensive drugs were randomly assigned to either CALM-BP treatment (consisting of rice diet, walks, yoga, relaxation and stress management) or to a DASH+exercise control group (consisting of DASH and walks). Ambulatory 24-h and home BP were monitored over a 16-week programme, followed by 6 months of maintenance period. Medications were reduced if systolic BP dropped below 110 mm Hg accompanied by symptoms. In addition to BP reduction, medications were reduced because of symptomatic hypotension in 70.7% of the CALM-BP group compared with 32.7% in the DASH group, P<0.0001. After 6 months, medication status was not altered in the majority of individuals. Significant reductions in body mass index, cholesterol and improved quality-of-life scores were observed only in the CALM-BP group. Lifestyle and diet modifications based on complementary medicine principles are highly effective with respect to BP control, medication use and cardiovascular risk factors.

  8. Enhancement of couples' communication and dyadic coping by a self-directed approach: a randomized controlled trial.

    PubMed

    Bodenmann, Guy; Hilpert, Peter; Nussbeck, Fridtjof W; Bradbury, Thomas N

    2014-08-01

    Although prevention of relationship distress and dissolution has potential to strengthen the well-being of partners and any children they are raising, dissemination of prevention programs can be limited because couples face many barriers to in-person participation. An alternative strategy, providing couples with an instructional DVD, is tested in the present study, in which 330 Caucasian couples (N = 660 participants; mean age: men 41.4 years, women 40.0 years) were randomly assigned to a DVD group without any further support, a DVD group with technical telephone coaching, or a wait-list control group. Couples completed questionnaires at pretest, posttest, and 3 and 6 months after completion of the intervention. Self-report measures of dyadic coping, communication quality, ineffective arguing, and relationship satisfaction were used to test whether the intervention groups improved in comparison with the control group. Women in both intervention groups increased in dyadic coping, reduced conflict behavior, and were more satisfied with their relationship 6 months after the intervention. Effects for men were mixed. Participants with poorer skills reported stronger improvement. Intimate relationships can, within limits, be positively influenced by a self-directed approach. Effective dissemination of principles underlying successful relationships can be facilitated through the use of emerging low-cost tools and technologies.

  9. Effects of Weight Loss on Foot Structure and Function in Obese Adults: A Pilot Randomized Controlled Trial

    PubMed Central

    Song, Jinsup; Kane, Reagan; Tango, Dana N.; Vander Veur, Stephanie S.; Furmato, James; Komaroff, Eugene; Foster, Gary D.

    2015-01-01

    Objective To investigate the effects of weight reduction on foot structure, gait, and dynamic plantar loading in obese adults. Design In a 3-month randomized-controlled trial, participants were randomized to receive either a weight loss intervention based on portion-controlled meals or a delayed-treatment control. Participants 41 adults (32 F, 9 M) with a mean + SD age of 56.2 + 4.7 years and a BMI of 35.9 + 4.2 kg/m2. Measurements Arch Height Index (AHI), Malleolar Valgus Index (MVI), spatial and temporal gait parameters, plantar peak pressure (PP) and weight were measured at baseline, 3, and 6 months. Results The intervention group experienced significantly greater weight loss than did the control group (5.9 ± 4.0 kg versus 1.9 ± 3.2 kg, p = 0.001) after 3 months. There were no differences between the groups in anatomical foot structure or gait. However, the treatment group showed a significantly reduced PP than the control group beneath the lateral arch and the metatarsals 4 (all P values < .05) at 3 months. The change in PP correlated significantly with the change in weight at the metatarsal 2 (r=0.57, p=0.0219), metatarsal 3 (r=0.56, p=0.0064) and the medial arch (r=0.26, p<0.0001) at 6 months. Conclusion This was the first RCT designed to assess the effects of weight loss on foot structure, gait, and plantar loading in obese adults. Even a modest weight loss significantly reduced the dynamic plantar loading in obese adults. However, weight loss appeared to have no effects on foot structure and gait. PMID:25245307

  10. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    PubMed Central

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  11. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial

    PubMed Central

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V.; Dhananjaya, Kiran Murthy

    2014-01-01

    Background: Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70–80% of prisoners have been identified as current smokers. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Materials and Methods: A randomized controlled trial was planned among male prisoners in Central Jail, Bangalore city. There were 1600 convicted prisoners. A self-administered questionnaire was given to the prisoners to assess their smoking behavior by which prevalence of tobacco smoking was found. Exactly 1352 tobacco users were studied. Among them, there were 1252 smokers. Based on inclusion criteria and informed consent given by the prisoners, a sample of 600 was chosen for the study by systematic random sampling. Among the 600 prisoners, 300 were randomly selected for the study group and 300 for the control group. Results: Prevalence of tobacco smoking among the prisoners was 92.60%. In the present study, after smoking cessation intervention, 17% showed no change in smoking, 21.66% reduced smoking, 16% stopped smoking, and 45.33% relapsed (P < 0.0001) at the end of 6-month follow-up in the study group. Conclusion: Tobacco use was high among the prisoners. Tobacco reduction is possible in the prison even if the living conditions are not favorable. Relatively high rate of relapse in our study indicates that some policies should be adopted to improve smokers’ information on consequences of tobacco on health and motivational intervention should be added to prisoners. PMID:25558450

  12. 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

  13. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    DTIC Science & Technology

    2016-03-01

    of Defense (DoD) Telemedicine and Advanced Technology Research Center (TATRC) funded randomized controlled trial of the Caring Letters intervention to...AWARD NUMBER: W81XWH-11-2-0123 TITLE: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial PRINCIPAL INVESTIGATOR: Dr...U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved for Public Release

  14. Infants, mothers, and dyadic contributions to stability and prediction of social stress response at 6 months.

    PubMed

    Provenzi, Livio; Olson, Karen L; Montirosso, Rosario; Tronick, Ed

    2016-01-01

    The study of infants' interactive style and social stress response to repeated stress exposures is of great interest for developmental and clinical psychologists. Stable maternal and dyadic behavior is critical to sustain infants' development of an adaptive social stress response, but the association between infants' interactive style and social stress response has received scant attention in previous literature. In the present article, overtime stability of infant, maternal, and dyadic behaviors was measured across 2 social stress (i.e., Face-to-Face Still-Face, FFSF) exposures, separated by 15 days. Moreover, infant, maternal, and dyadic behaviors were simultaneously assessed as predictors of infants' social stress to both FFSF exposures. Eighty-one mother-infant dyads underwent the FFSF twice, at 6 months (Exposure 1: the first social stress) and at 6 months and 15 days (Exposure 2: repeated social stress). Infant and mother behavior and dyadic synchrony were microanalytically coded. Overall, individual behavioral stability emerged between FFSF exposures. Infants' response to the first stress was predicted by infant behavior during Exposure 1 Play. Infants' response to the repeated social stress was predicted by infants' response to the first exposure to the Still-Face and by infants' behavior and dyadic synchrony during Exposure 2 Play. Findings reveal stability for individual, but not for dyadic, behavior between 2 social stress exposures at 6 months. Infants' response to repeated social stress was predicted by infants' earlier stress response, infants' own behavior in play, and dyadic synchrony. No predictive effects of maternal behavior were found. Insights for research and clinical work are discussed.

  15. Data analysis of 87 tic patients for 6 months' treatment in a Korean medicine clinic.

    PubMed

    Chun, Young-Ho; Kim, Won-Ill; Kim, Bo-Kyung

    2013-10-01

    This study was carried out to investigate the relationship between the therapeutic effects of treatment for tic disorder and Korean medicine clinical tests, including body mass index (BMI) and heart variability rate (HRV). This study was not a clinical trial, but a data analysis of 87 tic patients who were treated for 6 months during the time period from Nov. 2010 to Jan. 2012. The clinical evaluation of the symptoms was recorded using the Korean version of the Yale Global Tic Severity Scale (YGTSS). The BMI and the HRV were measured according to a schedule, and various kinds of statistical methods were used. Among the 87 patients, the number of males was 3.34 times the number of females, and 58 patients (66.7%) had been suffering for more than 12 months. The onset age of the males was significantly lower than that of the females, and males had the symptoms longer than females had. Also, males with a family history of tics were 2.5 times as many as females, and their onset ages were substantially lower. At the first medical examinations, the average score on the YGTSS was 34.08, and it decreased linearly as the treatment progressed. After 4 and 6 months of treatment, it had decreased significantly. The YGTSS score and the period of suffering correlated positively. At the first visit, each HRV datum was in the normal range. After the 6 months' treatment, Ln (TP), Ln (LF), and Ln (HF) had dropped substantially in the normal range while Ln (VLF) and the LF/HF ratio had not changed in a meaningful way. During the treatment period, the BMI stayed relatively constant without any meaningful changes.

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

    NASA Technical Reports Server (NTRS)

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

    1990-01-01

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

  17. RANDOM ACCESS CONTROL OF ELECTROLUMINESCENT ELEMENTS.

    DTIC Science & Technology

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

  18. Increased physical activity improves sleep and mood outcomes in inactive people with insomnia: a randomized controlled trial.

    PubMed

    Hartescu, Iuliana; Morgan, Kevin; Stevinson, Clare D

    2015-10-01

    While high levels of activity and exercise training have been associated with improvements in sleep quality, minimum levels of activity likely to improve sleep outcomes have not been explored. A two-armed parallel randomized controlled trial (N=41; 30 females) was designed to assess whether increasing physical activity to the level recommended in public health guidelines can improve sleep quality among inactive adults meeting research diagnostic criteria for insomnia. The intervention consisted of a monitored program of ≥150 min of moderate- to vigorous-intensity physical activity per week, for 6 months. The principal end-point was the Insomnia Severity Index at 6 months post-baseline. Secondary outcomes included measures of mood, fatigue and daytime sleepiness. Activity and light exposure were monitored throughout the trial using accelerometry and actigraphy. At 6 months post-baseline, the physical activity group showed significantly reduced insomnia symptom severity (F(8,26) = 5.16, P = 0.03), with an average reduction of four points on the Insomnia Severity Index; and significantly reduced depression and anxiety scores (F(6,28) = 5.61, P = 0.02; and F(6,28) = 4.41, P = 0.05, respectively). All of the changes were independent of daily light exposure. Daytime fatigue showed no significant effect of the intervention (F(8,26) = 1.84, P = 0.18). Adherence and retention were high. Internationally recommended minimum levels of physical activity improve daytime and night-time symptoms of chronic insomnia independent of daily light exposure levels.

  19. Resistive Exercise for Arthritic Cartilage Health (REACH): A randomized double-blind, sham-exercise controlled trial

    PubMed Central

    Lange, Angela K; Vanwanseele, Benedicte; Foroughi, Nasim; Baker, Michael K; Shnier, Ronald; Smith, Richard M; Singh, Maria A Fiatarone

    2009-01-01

    Background This article provides the rationale and methodology, of the first randomised controlled trial to our knowledge designed to assess the efficacy of progressive resistance training on cartilage morphology in women with knee osteoarthritis. Development and progression of osteoarthritis is multifactorial, with obesity, quadriceps weakness, joint malalignment, and abnormal mechanical joint forces particularly relevant to this study. Progressive resistance training has been reported to improve pain and disability in osteoarthritic cohorts. However, the disease-modifying potential of progressive resistance training for the articular cartilage degeneration characteristic of osteoarthritis is unknown. Our aim was to investigate the effect of high intensity progressive resistance training on articular cartilage degeneration in women with knee osteoarthritis. Methods Our cohort consisted of women over 40 years of age with primary knee osteoarthritis, according to the American College of Rheumatology clinical criteria. Primary outcome was blinded measurement of cartilage morphology via magnetic resonance imaging scan of the tibiofemoral joint. Secondary outcomes included walking endurance, balance, muscle strength, endurance, power, and velocity, body composition, pain, disability, depressive symptoms, and quality of life. Participants were randomized into a supervised progressive resistance training or sham-exercise group. The progressive resistance training group trained muscles around the hip and knee at 80% of their peak strength and progressed 3% per session, 3 days per week for 6 months. The sham-exercise group completed all exercises except hip adduction, but without added resistance or progression. Outcomes were repeated at 3 and 6 months, except for the magnetic resonance imaging scan, which was only repeated at 6 months. Discussion Our results will provide an evaluation of the disease-modifying potential of progressive resistance training for osteoarthritis

  20. Peer Network Counseling with Urban Adolescents: A Randomized Controlled Trial with Moderate Substance Users.

    PubMed

    Mason, Michael; Light, John; Campbell, Leah; Keyser-Marcus, Lori; Crewe, Stephanie; Way, Thomas; Saunders, Heather; King, Laura; Zaharakis, Nikola M; McHenry, Chantal

    2015-11-01

    Close peer networks can affect adolescents' health behaviors by altering their social environments, and thus their risk for and protection against substance use involvement. We tested a 20 minute intervention named Peer Network Counseling that integrates motivational interviewing and peer network strategies with 119 urban adolescents who reported occasional or problem substance use. Adolescents presenting at primary care clinic were randomized to intervention or control conditions and followed for 6 months. Mixed-effect latent growth models were used to evaluate intervention effects on trajectories of alcohol and marijuana use, offers to use substances, and moderation models to test for interactions between intervention condition and peer network characteristics. A significant intervention effect was found for boys for offers to use alcohol from friends (p<.05), along with a trend significant effect for alcohol use (p<.08). Intervention was more effective in reducing marijuana use, vs. control, for participants with more peer social support (p<.001) and with more peer encouragement for prosocial behavior (school, clubs, sports, religious activities); however, intervention did not affect these network characteristics. Results provide support to continue this line of research to test brief interventions that activate protective peer network characteristics among at-risk adolescents, while also raising some interesting gender-based intervention questions for future research.

  1. Local application of hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial.

    PubMed

    Fawzy El-Sayed, Karim M; Dahaba, Moushira A; Aboul-Ela, Shadw; Darhous, Mona S

    2012-08-01

    Hyaluronic acid application has been proven to be beneficial in a number of medical disciplines. The aim of the current study was to clinically evaluate the effect of local application of hyaluronan gel in conjunction with periodontal surgery. Fourteen patients with chronic periodontitis having four interproximal intrabony defects (≥3 mm) with probing depth values >5 mm were included in this split-mouth study. Following initial nonsurgical periodontal therapy and re-evaluation, defects were randomly assigned to be treated with modified Widman flap (MWF) surgery in conjunction with either 0.8% hyaluronan gel (test) or placebo gel (control) application. Clinical attachment level (CAL), probing depth (PD), gingival recession (GR), plaque index (PI), and bleeding on probing (BOP) values were taken at baseline and 3 and 6 months. Differences between test and control sites were evaluated using a Wilcoxon signed-rank and a McNemar test. A Friedman and a Cochran test were used to test equal ranks over time. Statistically significant differences were noted for CAL and GR (P < 0.05) in favor of the test sites. No significant differences were found regarding PD, BOP, or PI values (P > 0.05). Hyaluronan gel application in conjunction with periodontal surgery appears to result in significant improvement of CAL and in a reduction in GR. Hyaluronan gel application appears to improve the clinical outcome of MWF surgery.

  2. Intervention for infants with brain injury: Results of a randomized controlled study

    PubMed Central

    Badr, Lina Kurdahi; Garg, Meena; Kamath, Meghna

    2009-01-01

    A randomized clinical trail (RCT) employed a 12-month individualized cognitive/sensorimotor stimulation program to look at the efficacy of the intervention on 62 infants with suspected brain injury. The control group infants received the State-funded follow-up program provided by the Los Angeles (LA) Regional Centers while the intervention group received intensive stimulation using the Curriculum and Monitoring System (CAMS) taught by public health nurses (PHNs). The developmental assessments and outcome measures were performed at 6, 12 and 18 months corrected age and included the Bayley motor and mental development, the Home, mother–infant interaction (Nursing Child Assessment Feeding Scale (NCAFS) and Nursing Child Assessment Teaching Scale (NCATS)), parental stress and social support. At 18 months, 43 infants remained in the study. The results indicate that the intervention had minimal positive effects on the Bayley mental and motor development scores of infants in the intervention group. Likewise, the intervention did not contribute to less stress or better mother–infant interaction at 12 or 18 months although there were significant differences in the NCAFS scores favoring the intervention group at 6 months. There was a significant trend, however, for the control group to have a significant decrease over time on the Bayley mental scores. Although the sample was not large and attrition was at 31%, this study provides further support to the minimal effects of stimulation and home intervention for infants with brain injury and who may have more significant factors contributing to their developmental outcome. PMID:17138264

  3. Remineralization of demineralized bone matrix in critical size cranial defects in rats: A 6-month follow-up study.

    PubMed

    Horváthy, Dénes B; Vácz, Gabriella; Toró, Ildikó; Szabó, Tamás; May, Zoltán; Duarte, Miguel; Hornyák, István; Szabó, Bence T; Dobó-Nagy, Csaba; Doros, Attila; Lacza, Zsombor

    2016-10-01

    The key drawback of using demineralized bone matrix (DBM) is its low initial mechanical stability due to the severe depletion of mineral content. In the present study, we investigated the long-term regeneration of DBM in a critical size bone defect model and investigated the remineralization after 6 months. Bone defects were created in the cranium of male Wistar rats which were filled with DBM or left empty as negative control. In vivo bone formation was monitored with computed tomography after 11, 19, and 26 weeks postoperatively. After 6 months, parietal bones were subjected to micro-CT. Mineral content was determined with spectrophotometric analysis. After 11 weeks the DBM-filled bone defects were completely closed, while empty defects were still open. Density of the DBM-treated group increased significantly while the controls remained unchanged. Quantitative analysis by micro-CT confirmed the in vivo results, bone volume/tissue volume was significantly lower in the controls than in the DBM group. The demineralization procedure depleted the key minerals of the bone to a very low level. Six months after implantation Ca, P, Na, Mg, Zn, and Cr contents were completely restored to the normal level, while K, Sr, and Mn were only partially restored. The remineralization process of DBM is largely complete by the 6th month after implantation in terms of bone density, structure, and key mineral levels. Although DBM does not provide sufficient sources for any of these minerals, it induces a faster and more complete regeneration process. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1336-1342, 2016.

  4. A Cornea Substitute Derived from Fish Scale: 6-Month Followup on Rabbit Model

    PubMed Central

    Yuan, Fei; Wang, Liyan; Lin, Chien-Chen; Chou, Cheng-Hung; Li, Lei

    2014-01-01

    A fish scale-derived cornea substitute (Biocornea) is proposed as an alternative for human donor corneal tissue. We adopt a regenerative medicine approach to design a primary alternative to the use of fish scale for restoring sight by corneal replacement. Biocornea with corneal multilayer arrangement collagen was implanted to rabbits by pocket implantation. Our study demonstrated the safety and detailed morphologic and physiologic results from the 6 months of followup of rabbit model. In the peripheral Biocornea, the collagen fibrils were arranged in reticular fashion. Slit lamp examination showed that haze and an ulcer were not observed in all groups at 3 months postoperatively while all corneas with Biocornea were clear at both 3 months and 6 months postoperatively. The interface of Biocornea and stromal tissue were filled successfully and without observable immune cells at postoperative day 180. Moreover, the Biocornea was not dissolved and degenerated but remained transparent and showed no apparent fragmentation. Our study demonstrated that the Biocornea derived from fish scale as a good substitute had high biocompatibility and support function after a long-term evaluation. This revealed that the new approach of using Biocornea may yield an ideal artificial cornea substitute for long-term inlay placement. PMID:25089206

  5. Implications of newborn amygdala connectivity for fear and cognitive development at 6-months-of-age

    PubMed Central

    Graham, Alice M.; Buss, Claudia; Rasmussen, Jerod M.; Rudolph, Marc D.; Demeter, Damion V.; Gilmore, John H.; Styner, Martin; Entringer, Sonja; Wadhwa, Pathik D.; Fair, Damien A.

    2015-01-01

    The first year of life is an important period for emergence of fear in humans. While animal models have revealed developmental changes in amygdala circuitry accompanying emerging fear, human neural systems involved in early fear development remain poorly understood. To increase understanding of the neural foundations of human fear, it is important to consider parallel cognitive development, which may modulate associations between typical development of early fear and subsequent risk for fear-related psychopathology. We, therefore, examined amygdala functional connectivity with rs-fcMRI in 48 neonates (M=3.65 weeks, SD=1.72), and measured fear and cognitive development at 6-months-of-age. Stronger, positive neonatal amygdala connectivity to several regions, including bilateral anterior insula and ventral striatum, was prospectively associated with higher fear at 6-months. Stronger amygdala connectivity to ventral anterior cingulate/anterior medial prefrontal cortex predicted a specific phenotype of higher fear combined with more advanced cognitive development. Overall, findings demonstrate unique profiles of neonatal amygdala functional connectivity related to emerging fear and cognitive development, which may have implications for normative and pathological fear in later years. Consideration of infant fear in the context of cognitive development will likely contribute to a more nuanced understanding of fear, its neural bases, and its implications for future mental health. PMID:26499255

  6. In Vivo Remodeling of Fibroblast-Derived Vascular Scaffolds Implanted for 6 Months in Rats

    PubMed Central

    Tondreau, Maxime Y.; Laterreur, Véronique; Vallières, Karine; Gauvin, Robert; Bourget, Jean-Michel; Tremblay, Catherine; Lacroix, Dan; Germain, Lucie; Ruel, Jean

    2016-01-01

    There is a clinical need for tissue-engineered small-diameter (<6 mm) vascular grafts since clinical applications are halted by the limited suitability of autologous or synthetic grafts. This study uses the self-assembly approach to produce a fibroblast-derived decellularized vascular scaffold (FDVS) that can be available off-the-shelf. Briefly, extracellular matrix scaffolds were produced using human dermal fibroblasts sheets rolled around a mandrel, maintained in culture to allow for the formation of cohesive and three-dimensional tubular constructs, and decellularized by immersion in deionized water. The FDVSs were implanted as an aortic interpositional graft in six Sprague-Dawley rats for 6 months. Five out of the six implants were still patent 6 months after the surgery. Histological analysis showed the infiltration of cells on both abluminal and luminal sides, and immunofluorescence analysis suggested the formation of neomedia comprised of smooth muscle cells and lined underneath with an endothelium. Furthermore, to verify the feasibility of producing tissue-engineered blood vessels of clinically relevant length and diameter, scaffolds with a 4.6 mm inner diameter and 17 cm in length were fabricated with success and stored for an extended period of time, while maintaining suitable properties following the storage period. This novel demonstration of the potential of the FDVS could accelerate the clinical availability of tissue-engineered blood vessels and warrants further preclinical studies. PMID:27999795

  7. A 6-month analysis of training-intensity distribution and physiological adaptation in Ironman triathletes.

    PubMed

    Neal, Craig M; Hunter, Angus M; Galloway, Stuart D R

    2011-11-01

    In the present study, we analysed the training-intensity distribution and physiological adaptations over a 6-month period preceding an Ironman triathlon race. Ten athletes (mean ± s: age 43 ± 3 years, mass 78.3 ± 10.3 kg, stature 1.79 ± 0.05 m) participated in the study. The study consisted of three training periods (A, B, C), each of approximately 2 months' duration, and four testing weeks. Testing consisted of incremental tests to exhaustion for swimming, cycling and running, and assessments for anthropometry plus cardiovascular and pulmonary measures. The lactate threshold and the lactate turnpoint were used to demarcate three discipline-specific, exercise-intensity zones. The mean percentage of time spent in zones 1, 2, and 3 was 69 ± 9%, 25 ± 8%, and 6 ± 2% for periods A-C combined. Only modest physiological adaptation occurred throughout the 6-month period, with small to moderate effect sizes at best. Relationships between the training volume/training load and the training-intensity distribution with the changes in key measures of adaptation were weak and probably reflect differences in initial training status. Our results suggest that the effects of intensity distribution are small over short-term training periods and future experimental research is needed to clarify the potential impact of intensity distribution on physiological adaptation.

  8. Practice effects on the WAIS-III across 3- and 6-month intervals.

    PubMed

    Basso, Michael R; Carona, Francine D; Lowery, Natasha; Axelrod, Bradley N

    2002-02-01

    Fifty-one participants (age M = 24.6; education M = 14.4 years) were administered the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) at baseline and at an interval of either 3 or 6 months later. Full Scale IQ (FSIQ), Verbal IQ (VIQ), Performance IQ (PIQ), Verbal Comprehension Index (VCI), Perceptual Organization Index (POI), and Processing Speed Index (PSI) scores improved significantly across time, whereas no significant change occurred on the Working Memory Index. Specifically, test scores increased approximately 3, 11, 6, 4, 8, and 7 points, respectively on the VIQ, PIQ, FSIQ, VCI, POI, and PSI for both groups. Notably, the degree of improvement was similar regardless of whether the inter-test interval was 3 or 6 months. These findings suggest that prior exposure to the WAIS-III yields considerable increases in test scores. Reliable change indices indicated that large confidence intervals might be expected. As such, users of the WAIS-III should interpret reevaluations across these intervals cautiously.

  9. Bone Formation in Maxillary Sinus Lift Using Autogenous Bone Graft at 2 and 6 Months.

    PubMed

    Netto, Henrique Duque; Miranda Chaves, Maria das Graças Alfonso; Aatrstrup, Beatriz; Guerra, Renata; Olate, Sergio

    2016-09-01

    The aim of this study is to compare the bone formation in maxillary sinus lift with an autogenous bone graft in histological evaluation at 2 or 6 months. A comparative study was designed where 10 patients with missing teeth bilaterally in the posterior zone of the maxilla were selected. Patients received a particulate autogenous bone graft under the same surgical conditions, selecting a site to collect a biopsy and histological study at two months and another at six months postoperatively. Histomorphometry was performed and were used Kolmogorov-Smirnov test, student's t-test and Spearman's correlation coefficient, considering a value of p<0.05. Differences were observed in inflammatory infiltrate and vascularization characteristics; however, the group analyzed at two months presented 38.12% ± 6.64 % of mineralized tissue, whereas the group studied at 6 months presented an average of 38.45 ± 9.27 %. There were no statistical differences between the groups. It is concluded that the bone formation may be similar in intrasinus particulate autogenous bone grafts in evaluations at two or six months; under these conditions, early installation of implants is viable.

  10. Infant Humor Perception from 3- to 6-months and Attachment at One Year

    PubMed Central

    Mireault, Gina; Sparrow, John; Poutre, Merlin; Perdue, Brittany; Macke, Laura

    2012-01-01

    Infancy is a critical time for the development of secure attachment, which is facilitated by emotionally synchronous interactions with parents. Humor development, which includes shared laughter and joint attention to an event, emerges concurrently with attachment, but little is known regarding the relationship, if any, between humor development and attachment in the first year. Thirty 3-month-old infants were videoed at home each month until they were 6-months old while their parents attempted to amuse them. Frequency of infants’ smiles and laughs served as a measure of “state humor”, and the smiling/laughing subscale of the Infant Behavior Questionnaire-Revised served as a measure of “trait humor”. State and trait humor were not correlated. Lower trait humor as 6 months predicted higher attachment security on the Attachment Q-sort at 12-months (r=. 46), suggesting that less good-humored infants elicit greater parental engagement, which works to the benefit of attachment, or vice versa. Future studies should examine the importance of smiling and laughter as they relate to other developmental phenomena in the first year. PMID:22982281

  11. Implications of newborn amygdala connectivity for fear and cognitive development at 6-months-of-age.

    PubMed

    Graham, Alice M; Buss, Claudia; Rasmussen, Jerod M; Rudolph, Marc D; Demeter, Damion V; Gilmore, John H; Styner, Martin; Entringer, Sonja; Wadhwa, Pathik D; Fair, Damien A

    2016-04-01

    The first year of life is an important period for emergence of fear in humans. While animal models have revealed developmental changes in amygdala circuitry accompanying emerging fear, human neural systems involved in early fear development remain poorly understood. To increase understanding of the neural foundations of human fear, it is important to consider parallel cognitive development, which may modulate associations between typical development of early fear and subsequent risk for fear-related psychopathology. We, therefore, examined amygdala functional connectivity with rs-fcMRI in 48 neonates (M=3.65 weeks, SD=1.72), and measured fear and cognitive development at 6-months-of-age. Stronger, positive neonatal amygdala connectivity to several regions, including bilateral anterior insula and ventral striatum, was prospectively associated with higher fear at 6-months. Stronger amygdala connectivity to ventral anterior cingulate/anterior medial prefrontal cortex predicted a specific phenotype of higher fear combined with more advanced cognitive development. Overall, findings demonstrate unique profiles of neonatal amygdala functional connectivity related to emerging fear and cognitive development, which may have implications for normative and pathological fear in later years. Consideration of infant fear in the context of cognitive development will likely contribute to a more nuanced understanding of fear, its neural bases, and its implications for future mental health.

  12. 6-month evaluation of JinHuang Chinese herbal medicine study in asymptomatic HIV infected Thais.

    PubMed

    Maek-a-nantawat, Wirach; Pitisuttithum, Punnee; Bussaratid, Valai; Chamnachanan, Supat; Naksrisook, Supa; Peonim, Wantanee; Thantamnu, Narumon; Muanaum, Rungrapat; Ngamdee, Vatcharachai

    2003-06-01

    Good results of in vitro study of anti-HIV effects of JinHuang, a Chinese herbal medicine led to in vivo study of safety and efficacy among asymptomatic HIV infected individuals. It was a prospective open study of 21 asymptomatic HIV infected Thai volunteers. Twelve and 9 were female and male, respectively, with mean age of 29.24 +/- 3.94 years. JinHuang preparation, 6 capsules and 2 bottles of liquid formula orally three times a day, was given on an outpatient basis initially for 6 months. Regular close monitoring and follow-up were done. The side effects reported included : increased bowel movements (81%), vague taste, and smell of drug after initiation (52%). No serious adverse event related to JinHuang was detected during study. No significant changes in terms of log viral load and CD4 count were observed after 6-months' duration. Most of the patients felt that the quality of life was better in terms of better appetite, good sleep and healthy during study participation, however, these were subjective.

  13. Ultrasonographic features of vascular closure devices: initial and 6-month follow-up results

    PubMed Central

    2014-01-01

    Purpose: This study aimed to evaluate the ultrasonographic findings for various types of vascular closure devices (VCDs) immediately after the angiographic procedure and at 6-month follow-up. Methods: We included 18 VCDs including Angio-Seal (n=4), FemoSeal (n=8), ExoSeal (n=3), Perclose (n=2), and StarClose (n=1) in this study. Four patients were implanted with 2 VCDs at the each side of bilateral femoral arteries, while the remaining 8 patients were inserted 1 VCD at the right femoral artery. Ultrasonography was performed within 10 days and at approximately 6 months after the angiographic procedure. Ultrasonographic morphology of the attached VCD and its relationship with the arterial wall were analyzed. Results: Initial ultrasonography revealed the attached VCD as the relevant unique structure with successful deployment and hemostasis. Follow-up ultrasonography demonstrated partial absorption of hemostatic materials in cases of Angio-Seal (n=3), FemoSeal (n=5), and ExoSeal (n=3), changes in the soft tissue surrounding the femoral artery in case of Angio-Seal (n=1), arterial intimal hyperplasia in cases of FemoSeal (n=3), and no gross changes as compared with the initial ultrasonographic findings in cases of Perclose (n=2) and StarClose (n=1). Conclusion: Initial ultrasonographic evaluation reflected the unique structure of each VCD, with most of them being easily distinguishable. Follow-up ultrasonography revealed various changes in the affected vessels. PMID:25145584

  14. Increases in kidney volume in autosomal dominant polycystic kidney disease can be detected within 6 months.

    PubMed

    Kistler, Andreas D; Poster, Diane; Krauer, Fabienne; Weishaupt, Dominik; Raina, Shagun; Senn, Oliver; Binet, Isabelle; Spanaus, Katharina; Wüthrich, Rudolf P; Serra, Andreas L

    2009-01-01

    Kidney volume growth is considered the best surrogate marker predicting the decline of renal function in autosomal dominant polycystic kidney disease. To assess the therapeutic benefit of new drugs more rapidly, changes in kidney volume need to be determined over a short time interval. Here we measured renal volume changes by manual segmentation volumetry applied to magnetic resonance imaging scans obtained with an optimized T1-weighted acquisition protocol without gadolinium-based contrast agents. One hundred young patients with autosomal dominant polycystic kidney disease and preserved renal function had a significant increase in total kidney volume by 2.71+/-4.82% in 6 months. Volume measurements were highly reproducible and accurate, as indicated by correlation coefficients of 1.000 for intra-observer and 0.996 for inter-observer agreement, with acceptable within-subject standard deviations. The change in renal volume correlated with baseline total kidney volume in all age subgroups. Total kidney volume positively correlated with male gender, hypertension, albuminuria and a history of macrohematuria but negatively with creatinine clearance. Albuminuria was associated with accelerated volume progression. Our study shows that increases in kidney volume can be reliably measured over a 6 month period in early autosomal dominant polycystic kidney disease using unenhanced magnetic resonance imaging sequences.

  15. Bone Formation in Maxillary Sinus Lift Using Autogenous Bone Graft at 2 and 6 Months

    PubMed Central

    Netto, Henrique Duque; Miranda Chaves, Maria das Graças Alfonso; Aatrstrup, Beatriz; Guerra, Renata; Olate, Sergio

    2016-01-01

    SUMMARY The aim of this study is to compare the bone formation in maxillary sinus lift with an autogenous bone graft in histological evaluation at 2 or 6 months. A comparative study was designed where 10 patients with missing teeth bilaterally in the posterior zone of the maxilla were selected. Patients received a particulate autogenous bone graft under the same surgical conditions, selecting a site to collect a biopsy and histological study at two months and another at six months postoperatively. Histomorphometry was performed and were used Kolmogorov-Smirnov test, student’s t-test and Spearman’s correlation coefficient, considering a value of p<0.05. Differences were observed in inflammatory infiltrate and vascularization characteristics; however, the group analyzed at two months presented 38.12% ± 6.64 % of mineralized tissue, whereas the group studied at 6 months presented an average of 38.45 ± 9.27 %. There were no statistical differences between the groups. It is concluded that the bone formation may be similar in intrasinus particulate autogenous bone grafts in evaluations at two or six months; under these conditions, early installation of implants is viable. PMID:27867255

  16. Sitting equilibrium 2 weeks after a stroke can predict the walking ability after 6 months.

    PubMed

    Feigin, L; Sharon, B; Czaczkes, B; Rosin, A J

    1996-01-01

    The prediction of mobility soon after a stroke should allow proper selection for rehabilitation and suggest the long-term prognosis of gait ability. Stable gait is related to midline body orientation and equilibrium mechanisms. We proposed that the sitting balance during the 1st, 2nd, or 3rd weeks after a hemiplegia could be a prognostic indicator for gait at 6 and 12 months. Sitting equilibrium measured in hospital was correlated with gait at the time of discharge and after 6 and 12 months, assessed by standing up, walking, and climbing stairs. The power in the affected limbs in hospital was also correlated with gait at those times. In the 134 patients followed up at 6 months, the correlation of equilibrium with gait at 6 months was r = 0.675 (p < 0.0001), and that of arm power with gait was r = 0.551 (p < 0.0001). Correlations with gait at 12 months were smaller and less meaningful. Assessment of sitting balance, even before the patient can stand, forms an important part of early management of the stroke patient.

  17. Optimizing parent-infant sleep from birth to 6 months: a new paradigm.

    PubMed

    Whittingham, Koa; Douglas, Pamela

    2014-01-01

    Currently, the dominant paradigm for infant sleep from birth to 6 months is behavioral sleep interventions that aim to entrain the infant's biological patterns of sleep using techniques such as delayed response to cues, feed-play-sleep routines, sleep algorithms, and education of parents about "tired cues" and "overstimulation." A recent systematic literature review has identified that while behavioral sleep interventions may modestly increase the length of time an infant sleeps at night without signaling, they are not associated with improved infant or maternal outcomes and may have unintended negative consequences (Douglas & Hill, 2013). This article reviews the empirical literature on behavioral infant sleep interventions, sleep regulation, and sleep disturbance. Based on the available scientific literature, a new paradigm for infant sleep intervention, from birth to 6 months of age, is proposed. This new approach, the Possums Sleep Intervention, integrates interdisciplinary knowledge from developmental psychology, medical science, lactation science, evolutionary science, and neuroscience with third-wave contextual behaviorism, acceptance and commitment therapy, to create a unique, new intervention that supports parental flexibility, cued care, and the establishment of healthy biopsychosocial rhythms.

  18. Respiratory training as strategy to prevent cognitive decline in aging: a randomized controlled trial

    PubMed Central

    Ferreira, Leandro; Tanaka, Kátia; Santos-Galduróz, Ruth Ferreira; Galduróz, José Carlos Fernandes

    2015-01-01

    Background Inadequate oxygenation may cause lesions and brain atrophy during aging. Studies show a positive association between pulmonary function and the cognitive performance of individuals from middle age on. Objective To investigate the effect of aerobic physical exercises and respiratory training on the blood oxygenation, pulmonary functions, and cognition of the elderly. Design This was a randomized and controlled trial with three parallel groups. A total of 195 community-dwelling elderly were assessed for eligibility; only n=102 were included and allocated into the three groups, but after 6 months, n=68 were analyzed in the final sample. Participants were randomized into a social interaction group (the control group), an aerobic exercise group (the “walking” group), or a respiratory training group (the “breathing” group). The main outcome measures were the Wechsler Adult Intelligence Scale, Wechsler Memory Scale, Wisconsin Card Sorting Test, respiratory muscular strength, cirtometry (thoracic–abdominal circumference); oxygen saturation in arterial blood (SpO2), and hemogram. Results No differences were observed for any of the blood parameters. Aerobic exercise and respiratory training were effective in improving the pulmonary parameters. Better cognitive performance was observed for the breathing group as regards abstraction and mental flexibility. The walking group remained stable in the cognitive performance of most of the tests, except attention. The control group presented worst performance in mental manipulation of information, abstraction, mental flexibility, and attention. Conclusion Our results showed that both the walking and breathing groups presented improvement of pulmonary function. However, only the breathing group showed improved cognitive function (abstraction, mental flexibility). The improvement in cognitive functions cannot be explained by blood parameters, such as SpO2, erythrocytes, hemoglobin, and hematocrit. PMID:25848235

  19. Sustained effects of online genetics education: a randomized controlled trial on oncogenetics.

    PubMed

    Houwink, Elisa J F; van Teeffelen, Sarah R; Muijtjens, Arno M M; Henneman, Lidewij; Jacobi, Florijn; van Luijk, Scheltus J; Dinant, Geert Jan; van der Vleuten, Cees; Cornel, Martina C

    2014-03-01

    Medical professionals are increasingly expected to deliver genetic services in daily patient care. However, genetics education is considered to be suboptimal and in urgent need of revision and innovation. We designed a Genetics e-learning Continuing Professional Development (CPD) module aimed at improving general practitioners' (GPs') knowledge about oncogenetics, and we conducted a randomized controlled trial to evaluate the outcomes at the first two levels of the Kirkpatrick framework (satisfaction, learning and behavior). Between September 2011 and March 2012, a parallel-group, pre- and post-retention (6-month follow-up) controlled group intervention trial was conducted, with repeated measurements using validated questionnaires. Eighty Dutch GP volunteers were randomly assigned to the intervention or the control group. Satisfaction with the module was high, with the three item's scores in the range 4.1-4.3 (5-point scale) and a global score of 7.9 (10-point scale). Knowledge gains post test and at retention test were 0.055 (P<0.05) and 0.079 (P<0.01), respectively, with moderate effect sizes (0.27 and 0.31, respectively). The participants appreciated applicability in daily practice of knowledge aspects (item scores 3.3-3.8, five-point scale), but scores on self-reported identification of disease, referral to a specialist and knowledge about the possibilities/limitations of genetic testing were near neutral (2.7-2.8, five-point scale). The Genetics e-learning CPD module proved to be a feasible, satisfactory and clinically applicable method to improve oncogenetics knowledge. The educational effects can inform further development of online genetics modules aimed at improving physicians' genetics knowledge and could potentially be relevant internationally and across a wider range of potential audiences.

  20. Sustained effects of online genetics education: a randomized controlled trial on oncogenetics

    PubMed Central

    Houwink, Elisa JF; van Teeffelen, Sarah R; Muijtjens, Arno MM; Henneman, Lidewij; Jacobi, Florijn; van Luijk, Scheltus J; Jan Dinant, Geert; van der Vleuten, Cees; Cornel, Martina C

    2014-01-01

    Medical professionals are increasingly expected to deliver genetic services in daily patient care. However, genetics education is considered to be suboptimal and in urgent need of revision and innovation. We designed a Genetics e-learning Continuing Professional Development (CPD) module aimed at improving general practitioners' (GPs') knowledge about oncogenetics, and we conducted a randomized controlled trial to evaluate the outcomes at the first two levels of the Kirkpatrick framework (satisfaction, learning and behavior). Between September 2011 and March 2012, a parallel-group, pre- and post-retention (6-month follow-up) controlled group intervention trial was conducted, with repeated measurements using validated questionnaires. Eighty Dutch GP volunteers were randomly assigned to the intervention or the control group. Satisfaction with the module was high, with the three item's scores in the range 4.1–4.3 (5-point scale) and a global score of 7.9 (10-point scale). Knowledge gains post test and at retention test were 0.055 (P<0.05) and 0.079 (P<0.01), respectively, with moderate effect sizes (0.27 and 0.31, respectively). The participants appreciated applicability in daily practice of knowledge aspects (item scores 3.3–3.8, five-point scale), but scores on self-reported identification of disease, referral to a specialist and knowledge about the possibilities/limitations of genetic testing were near neutral (2.7–2.8, five-point scale). The Genetics e-learning CPD module proved to be a feasible, satisfactory and clinically applicable method to improve oncogenetics knowledge. The educational effects can inform further development of online genetics modules aimed at improving physicians' genetics knowledge and could potentially be relevant internationally and across a wider range of potential audiences. PMID:23942200

  1. Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis.

    PubMed

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

    2014-02-01

    The present study adopted a randomized controlled trial design and examined the effect of a physical activity behavioral intervention on cognitive and walking performance among persons with MS who have mild or moderate disability status. A total of 82 MS patients were randomly allocated into intervention or wait-list control conditions. The intervention condition received a theory-based program for increasing physical activity behavior that was delivered via the Internet, and one-on-one video chat sessions with a behavior-change coach. Participants completed self-report measures of physical activity and disability status, and underwent the oral Symbol Digit Modalities Test (SDMT) and 6-minute walk (6MW) test before and after the 6-month period. Analysis using mixed-model ANOVA indicated a significant time × condition × disability group interaction on SDMT scores (p = 0.02, partial-η (2) = 0.08), such that persons with mild disability in the intervention condition demonstrated a clinically meaningful improvement in SDMT scores (~6 point change). There was a further significant time × condition interaction on 6MW distance (p = 0.02, partial-η (2) = 0.07), such that those in the intervention condition demonstrated an increase in 6MW distance relative to those in the control group. The current study supports physical activity as a promising tool for managing cognitive impairment and impaired walking performance in persons with MS, and suggests that physical activity might have specific effects on cognition and non-specific effects on walking performance in this population.

  2. Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study

    PubMed Central

    Duhon, Bradley S; Cher, Daniel J; Wine, Kathryn D; Lockstadt, Harry; Kovalsky, Don; Soo, Cheng-Lun

    2013-01-01

    Background Sacroiliac (SI) joint pain is an often overlooked cause of low back pain. SI joint arthrodesis has been reported to relieve pain and improve quality of life in patients suffering from degeneration or disruption of the SI joint who have failed non-surgical care. We report herein early results of a multicenter prospective single-arm cohort of patients with SI joint degeneration or disruption who underwent minimally invasive fusion using the iFuse Implant System®. Methods The safety cohort includes 94 subjects at 23 sites with chronic SI joint pain who met study eligibility criteria and underwent minimally invasive SI joint fusion with the iFuse Implant System® between August 2012 and September 2013. Subjects underwent structured assessments preoperatively, immediately postoperatively, and at 1, 3, and 6 months postoperatively, including SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQoL-5D (EQ-5D). Patient satisfaction with surgery was assessed at 6 months. The effectiveness cohort includes the 32 subjects who have had 6-month follow-up to date. Results Mean subject age was 51 years (n=94, safety cohort) and 66% of patients were women. Subjects were highly debilitated at baseline (mean VAS pain score 78, mean ODI score 54). Three implants were used in 80% of patients; two patients underwent staged bilateral implants. Twenty-three adverse events occurred within 1 month of surgery and 29 additional events occurred between 30 days and latest follow-up. Six adverse events were severe but none were device-related. Complete 6-month postoperative follow-up was available in 26 subjects. In the effectiveness cohort, mean (± standard deviation) SI joint pain improved from a baseline score of 76 (±16.2) to a 6-month score of 29.3 (±23.3, an improvement of 49 points, P<0.0001), mean ODI improved from 55.3 (±10.7) to 38.9 (±18.5, an improvement of 15.8 points, P<0.0001) and SF-36 PCS improved

  3. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    PubMed Central

    Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P

  4. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial.

    PubMed

    Esmaeilzadeh, Hossein; Nabavi, Mohammad; Aryan, Zahra; Arshi, Saba; Bemanian, Mohammad Hassan; Fallahpour, Morteza; Mortazavi, Negar

    2015-10-01

    The effect of aspirin desensitization (AD) on immunologic profile of patients with AERD has been poorly understood. This study is aimed at investigating the effect of AD on clinical and immunological markers of patients with AERD. This randomized double-blind placebo-controlled trial comprised 34 adult patients (67.6% female) with chronic rhinosinusitis, nasal polyps, and aspirin-intolerant asthma. The active group underwent AD over a 2-day period with increasing doses of aspirin (60, 125, 325, and 625 mg), followed by receiving aspirin 625 mg twice daily for 6 months. Symptom scores and medication needs of patients with AERD who have undergone AD were significantly lower compared to the placebo group after 6 months (7.5 ± 3.5 vs. 10.6 ± 3.8 and 9.3 ± 2.0 vs. 11.0 ± 3.1, respectively, all p < 0.05). However, no significant difference was observed in serum concentration of IL-10, IFN-γ, and TGF-β between two groups neither at baseline nor at the end of study.

  5. Reduction of atherogenic risk in patients with type 2 diabetes by curcuminoid extract: a randomized controlled trial.

    PubMed

    Chuengsamarn, Somlak; Rattanamongkolgul, Suthee; Phonrat, Benjaluck; Tungtrongchitr, Rungsunn; Jirawatnotai, Siwanon

    2014-02-01

    Curcumin is a phytocompound found in the root of turmeric, a common herbal ingredient in many Asian cuisines. The compound contains anti-inflammatory activity, which is mediated through an up-regulation of adiponectin and reduction of leptin. Consumption of curcumin was shown to prevent some deteriorative conditions caused by inflammation, such as ulcerative colitis, rheumatoid arthritis and esophagitis, and so on. Inflammation-associated cardiovascular conditions such as atherosclerosis are common in diabetes patients. The anti-inflammation effect of curcumin might be beneficial to prevent such condition in these patients. We aim to evaluate an antiatherosclerosis effect of curcumin in diabetes patients. Effects of curcumin on risk factors for atherosclerosis were investigated in a 6-month randomized, double-blinded and placebo-controlled clinical trial that included subjects diagnosed with type 2 diabetes. An atherosclerosis parameter, the pulse wave velocity, and other metabolic parameters in patients treated with placebo and curcumin were compared. Our results showed that curcumin intervention significantly reduced pulse wave velocity, increased level of serum adiponectin and decreased level of leptin. These results are associated with reduced levels of homeostasis model assessment-insulin resistance, triglyceride, uric acid, visceral fat and total body fat. In summary, a 6-month curcumin intervention in type 2 diabetic population lowered the atherogenic risks. In addition, the extract helped to improve relevant metabolic profiles in this high-risk population.

  6. Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial

    PubMed Central

    Gilburt, Helen; Burns, Tom; Copello, Alex; Crawford, Michael; Day, Ed; Deluca, Paolo; Godfrey, Christine; Parrott, Steve; Rose, Abigail; Sinclair, Julia; Coulton, Simon

    2017-01-01

    Abstract Aims A pilot randomized controlled trial (RCT) to assess the feasibility and potential efficacy of assertive community treatment (ACT) in adults with alcohol dependence. Methods Single blind, individually randomized, pilot RCT of 12 months of ACT plus treatment as usual (TAU) versus TAU alone in adults (age 18+ years) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services. ACT aimed to actively engage participants for 12 months with assertive, regular, minimum weekly contact. ACT was combined with TAU. TAU comprised access to the full range of services provided by the community teams. Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up. Analysis of covariance was conducted using 80% confidence intervals, appropriate in the context of a pilot trial. Results A total of 94 participants were randomized, 45 in ACT and 49 in TAU. Follow-up was achieved with 98 and 88%, respectively at 12 months. Those in ACT had better treatment engagement, and were more often seen in their homes or local community than TAU participants. At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures. The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months. The ACT group had less unplanned healthcare use than TAU. Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population. Trial registration ISRCTN22775534 PMID:27940571

  7. Six-Month Outcomes of a Web-Based Intervention for Users of Amphetamine-Type Stimulants: Randomized Controlled Trial

    PubMed Central

    McKetin, Rebecca; Kay-Lambkin, Frances; Carron-Arthur, Bradley; Bennett, Anthony; Bennett, Kylie; Christensen, Helen; Griffiths, Kathleen M

    2015-01-01

    Background The use of amphetamine-type stimulants (ATS) places a large burden on health services. Objective The aim was to evaluate the effectiveness of a self-guided Web-based intervention (“breakingtheice”) for ATS users over 6 months via a free-to-access site. Methods We conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement. The main outcome was self-reported ATS use in the past 3 months assessed at 3- and 6-month follow-ups using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Secondary outcomes were help-seeking intentions (general help-seeking questionnaire), actual help seeking (actual help-seeking questionnaire), psychological distress (Kessler 10), polydrug use (ASSIST), quality of life (European Health Interview Survey), days out of role, and readiness to change. Follow-up data were evaluated using an intention-to-treat (ITT) analysis with a group by time interaction. Results We randomized 160 people (intervention: n=81; control: n=79). At 6 months, 38 of 81 (47%) intervention and 41 of 79 (52%) control participants provided data. ATS scores significantly declined for both groups, but the interaction effect was not significant. There were significant ITT time by group interactions for actual help seeking (rate ratio [RR] 2.16; d=0.45) and help-seeking intentions (RR 1.17; d=0.32), with help seeking increasing for the intervention group and declining for the control group. There were also significant interactions for days completely (RR 0.50) and partially (RR 0.74) out of role favoring the intervention group. However, 37% (30/81) of the intervention group did not complete even 1 module. Conclusions This self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role, but it did not reduce ATS use. Thus, this program provides a means of engaging with

  8. Changes of quality of life and cognitive function in individuals with Internet gaming disorder: A 6-month follow-up.

    PubMed

    Lim, Jae-A; Lee, Jun-Young; Jung, Hee Yeon; Sohn, Bo Kyung; Choi, Sam-Wook; Kim, Yeon Jin; Kim, Dai-Jin; Choi, Jung-Seok

    2016-12-01

    Internet gaming disorder (IGD) contributes to poor quality of life (QOL) and cognitive dysfunction and is increasingly recognized as a social problem in various countries. However, no evidence exists to determine whether QOL and cognitive dysfunction stabilize after appropriate management. The present study addressed improvement in QOL and cognitive functioning associated with changes in addiction symptoms following outpatient management for IGD. A total of 84 young males (IGD group: N = 44, mean age: 19.159 ± 5.216 years; healthy control group: N = 40, mean age: 21.375 ± 6.307 years) participated in this study. We administered self-report questionnaires at baseline to assess clinical and psychological characteristics, and conducted traditional and computerized neuropsychological tests. Nineteen patients with IGD completed follow-up tests in the same manner after 6 months of outpatient treatment, which included pharmacotherapy with selective serotonin reuptake inhibitors. A baseline comparison of patients with IGD against the healthy control group showed that the IGD patients had more symptoms of depression and anxiety, higher degrees of impulsiveness and anger/aggression, higher levels of distress, poorer QOL, and impaired response inhibition. After 6 months of treatment, patients with IGD showed significant improvements in the severity of IGD, as well as in QOL, response inhibition, and executive functioning. Additionally, a stepwise multiple regression analysis revealed a favorable prognosis for IGD patients with low working memory functioning and high executive functioning at baseline. These results provide evidence regarding longitudinal changes in QOL and cognitive function following psychiatric intervention for IGD. Furthermore, it appears that response inhibition may be an objective state marker underlying the pathophysiology of IGD.

  9. Skeletal Muscle Is Anabolically Unresponsive to an Amino Acid Infusion in Pediatric Burn Patients 6 Months Postinjury

    PubMed Central

    Tuvdendorj, Demidmaa; Chinkes, David L.; Zhang, Xiao-Jun; Sheffield-Moore, Melinda; Herndon, David N.

    2013-01-01

    Objective To evaluate leg muscle, whole-body muscle, and whole-body non-muscle protein response to anabolic signaling of amino acids in pediatric burn patients at 6 months after injury. Background Burn injury is associated with a catabolic state persisting years after the injury. The tissue response to nutritional signaling (eg, amino acids) plays a critical role in tissue protein net balance via coordination of protein synthesis and breakdown mechanisms. Methods A total of 10 patients (7.4 ± 3.8 years; 27.4 ± 14.7 kg) and 5 healthy young males (22 ± 3 years; 76 ± 15 kg) underwent an 8-hour stable isotope infusion study. During the last 3 hours, an amino acid solution (10% Travasol, Clintec Nutrition, Deerfield, IL) was infused. Femoral arterial and venous blood samples and muscle biopsy samples were collected throughout the study. A P value of less than 0.05 was considered statistically different. Results During amino acid infusion, leg muscle protein synthesis rate significantly increased (P < 0.05) in both groups, however, in the burn group, protein breakdown also increased, although nonsignificantly. As a result, protein net balance remained negative. In the control group, breakdown nonsignificantly decreased resulting in a significant increase (P < 0.05) in muscle protein net balance. Whole-body protein breakdown was significantly higher in the burn patients. Conclusion In pediatric burn patients at 6 months postinjury, leg muscle protein net deposition is unresponsive to amino acid infusion; and whole-body protein breakdown is significantly higher than in the control group. PMID:21263308

  10. Multiple input/output random vibration control system

    NASA Technical Reports Server (NTRS)

    Unruh, James F.

    1988-01-01

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

  11. 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…

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

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

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

  13. DVD training for depression identification and treatment in older adults: a two-group, randomized, wait-list control study.

    PubMed

    Lysack, Cathy; Leach, Carrie; Russo, Theresa; Paulson, Daniel; Lichtenberg, Peter A

    2013-01-01

    OBJECTIVE. To test the effectiveness of an educational intervention aimed at improving mental health knowledge and skills in occupational therapists working with older rehabilitation patients. METHOD. The DVD-format educational intervention was evaluated using a two-group randomized wait-list control design. Occupational therapists (n = 75) completed a 32-item knowledge questionnaire at three time points. Patient charts were reviewed (n = 960) at 3 months before and 3 and 6 months after DVD training to evaluate clinical practice change. RESULTS. A two-way analysis of variance showed knowledge scores increased significantly for both groups after DVD training. A significant Group × Time interaction and significant main effects for time and group were found. Chart review data also showed significant increases in desired clinical behaviors in both groups after training. The greatest single item of clinical practice change was use of a standardized depression screen. CONCLUSION. DVD-based training can significantly improve mental health practice.

  14. FOXP3 mRNA expression at 6 months of age is higher in infants who develop atopic dermatitis, but is not affected by giving probiotics from birth.

    PubMed

    Taylor, Angie L; Hale, Jasmine; Hales, Belinda J; Dunstan, Janet A; Thomas, Wayne R; Prescott, Susan L

    2007-02-01

    Factors that influence immune regulation in early life may be implicated in the rise in allergic disease, including reduced microbial burden. The aim of the study was to examine the infant regulatory T-cell function in relation to (a) probiotic supplementation for the first 6 months of life and (b) the subsequent development of an early allergic phenotype. Two hundred and thirty-one allergic, pregnant women were recruited into a randomized, controlled trial. The infants received either a probiotic or placebo daily for the first 6 months of life. One hundred and seventy-eight children completed the study, with blood samples available from 118 (60 placebo; 58 probiotic). CD4(+)CD25(+)CTLA4(+)T-regulatory phenotype and allergen-induced FOXP3 mRNA expression were compared in relation to this intervention as well as according to evidence of early disease (atopic dermatitis). The administration of probiotics was not associated with any significant differences in the proportion of circulating CD4(+)CD25(+)CTLA4(+)cells, or in the resting expression of FOXP3. There were also no relationships between these parameters and patterns of gut colonization, and this probiotic did not reduce the risk of atopic dermatitis. Children who developed atopic dermatitis (n = 36/118) had significantly higher induced FOXP3 expression following stimulation with both house dust mite (HDM) (p = 0.017) and ovalbumin (OVA) allergens (p = 0.021) than those that did not develop atopic dermatitis. Although this relationship was seen in both the probiotic and placebo groups, it was more pronounced in the probiotic group. However, regression analysis demonstrated that higher allergen-induced FOXP3 expression was predicted by the presence of atopic dermatitis (p = 0.018) rather than probiotics supplementation (p = 0.217). The higher levels of allergen-induced FOXP3 in atopic dermatitis suggest activation of these compensatory mechanisms rather than a primary defect in this pathway. Probiotic

  15. Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol

    PubMed Central

    2013-01-01

    Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the

  16. Hygienic-dietary recommendations for major depression treatment: Study protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice. Methods Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up. Discussion We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs. Trial registration ISRCTN73931675 PMID:23158080

  17. Therapy for couples after an affair: a randomized-controlled trial.

    PubMed

    Kröger, Christoph; Reißner, Timo; Vasterling, Ilka; Schütz, Kristina; Kliem, Sören

    2012-12-01

    To examine the efficacy of a couples treatment approach for promoting recovery from a recently disclosed affair, 89 couples that disclosed an affair by one of the partners in the past 6 months were randomly assigned to treatment (n = 46) or to a control group that waited about 3 months for treatment (n = 43). The couples completed self-report measures (Beck Depression Inventory, Impact of Event Scale-Revised, Partnership Questionnaire) at pre- and post-treatment. Since about half of the couples dropped out for various reasons (e.g., ongoing affair, separation), we used multiple imputations to handle the missing data problem. We analyzed the dyadic data with hierarchical linear modeling in a two-level model. Significant improvements on scores of anxiety corresponded with large effect sizes for both partners. Yet significant improvements on depression scores were only found for the unfaithful partner with moderate effect size. Results suggest that the treatment can improve individual complaints, but not relationship satisfaction in a sufficient amount for both partners. Hence, future research should address how this intervention could encourage couples to maintain therapy, and how they might achieve more and sustained improvement in relationship satisfaction.

  18. Improvement in physiological and psychological parameters after 6 months of yoga practice.

    PubMed

    Rocha, K K F; Ribeiro, A M; Rocha, K C F; Sousa, M B C; Albuquerque, F S; Ribeiro, S; Silva, R H

    2012-06-01

    Yoga is believed to have beneficial effects on cognition, attenuation of emotional intensity and stress reduction. Previous studies were mainly performed on eastern experienced practitioners or unhealthy subjects undergoing concomitant conventional therapies. Further investigation is needed on the effects of yoga per se, as well as its possible preventive benefits on healthy subjects. We investigated the effects of yoga on memory and psychophysiological parameters related to stress, comparing yoga practice and conventional physical exercises in healthy men (previously yoga-naïve). Memory tests, salivary cortisol levels and stress, anxiety, and depression inventories were assessed before and after 6 months of practice. Yoga practitioners showed improvement of the memory performance, as well as improvements in psychophysiological parameters. The present results suggest that regular yoga practice can improve aspects of cognition and quality of life for healthy individuals. An indirect influence of emotional state on cognitive improvement promoted by yoga practice can be proposed.

  19. A 6-Month-Old Infant With Different Capnography Values in Polysomnography.

    PubMed

    DelRosso, Lourdes M; Palacay, Pacifico; Ly, Ngoc P

    2017-02-01

    A 6-month-old infant with a past medical history of hypoxic ischemic encephalopathy was referred for evaluation of snoring. She was born at 41 weeks' gestational age to a 25-year-old gravida 1, para 1 mother via vacuum-assisted delivery due to cardiac decelerations. The infant's Apgar scores were 1, 4, and 6 with nuchal cord and meconium at delivery. She was started on positive-pressure ventilation but eventually required intubation at approximately 40 minutes of life. Brain MRI showed abnormal areas of restricted diffusion, involving the corpus callosum, bilateral posterior limb of the internal capsules, and possible scattered areas of frontal and occipital lobe cortices.

  20. December 2000: 6 month old boy with 2 week history of progressive lethargy.

    PubMed

    Fan, X; Larson, T C; Jennings, M T; Tulipan, N B; Toms, S A; Johnson, M D

    2001-04-01

    This 6-month-old Caucasian boy presented with a 10-day history of lethargy, obtundation, inability to hold his head up and mild torticollis. MRI and CT scans showed a large solid and cystic mass involving the right temporal, parietal and occipital lobes, pineal, superior pons, mesencephalon and posterior right thalamus. He underwent craniotomy initially for a partial tumor resection with an intraoperative diagnosis of desmoplastic astrocytoma. With immunohistochemistry and special stains the diagnosis of desmoplastic infantile ganglioglioma (DIG) was made. A near total resection was performed a week after initial resection.The patient then was treated with chemotherapy. Two months later an MRI showed tumor growth. Following additional aggressive chemotherapy, an MRI at 5 months post-resection indicated further tumor progression. This case illustrates that some DIGs may behave more aggressively than typical WHO grade I lesions.

  1. [Myocardiosis in a 6-month-old Lawson's Dragon (Pogona henrylawsonii)].

    PubMed

    Günther, P; Wohlsein, P; Junginger, J; Dziallas, P; Fehr, M; Mathes, K

    2013-01-01

    In a 6-month-old, chronically inappetent Lawsons's Dragon (Pogona henrylawsonii) with stunted growth a hyperdense cardiac region was found using radiology and computed tomography. At necropsy a profound necrosis of the myocardium with dystrophic calcification was diagnosed. In contrast to the frequently seen metastatic mineralisation of soft tissues, mainly due to poor husbandry, primary tissue destruction is the cause for dystrophic calcification. In reptiles, this is a rarely described form of calcification. Possible causes are infectious processes, nutritional or metabolic insufficiencies, intoxications or genetic components. In the presented case the aetiology could not be determined. In conclusion, dystrophic calcifications should be considered as a differential diagnosis in reptiles with soft tissue mineralisation.

  2. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon

    PubMed Central

    Casapía, Martín; Aguilar, Eder; Silva, Hermánn; Montresor, Antonio; Rahme, Elham; Fraser, William D.; Marquis, Grace S.; Vercruysse, Jozef; Allen, Lindsay H.; Blouin, Brittany; Razuri, Hugo; Pezo, Lidsky

    2017-01-01

    Background Nutritional interventions targeting the critical growth and development period before two years of age can have the greatest impact on health trajectories over the life course. Compelling evidence has demonstrated that interventions investing in maternal health in the first 1000 days of life are beneficial for both mothers and their children. One such potential intervention is deworming integrated into maternal postpartum care in areas where soil-transmitted helminth (STH) infections are endemic. Methodology/Principal Findings From February to August 2014, 1010 mother-infant pairs were recruited into a trial aimed at assessing the effectiveness of maternal postpartum deworming on infant and maternal health outcomes. Following delivery, mothers were randomly assigned to receive either single-dose 400 mg albendazole or placebo. Participants were followed-up at 1 and 6 months postpartum. There was no statistically significant difference in mean weight gain between infants in the experimental and control groups (mean difference: -0.02; 95% CI: -0.1, 0.08) at 6 months of age. Further, deworming had no effect on measured infant morbidity indicators. However, ad hoc analyses restricted to mothers who tested positive for STHs at baseline suggest that infants of mothers in the experimental group had greater mean length gain in cm (mean difference: 0.8; 95% CI: 0.1, 1.4) and length-for-age z-score (mean difference: 0.5; 95% CI: 0.2, 0.8) at 6 months of age. Conclusions/Significance In a study population composed of both STH-infected and uninfected mothers, maternal postpartum deworming was insufficient to impact infant growth and morbidity indicators up to 6 months postpartum. Among STH-infected mothers, however, important improvements in infant length gain and length-for-age were observed. The benefits of maternal postpartum deworming should be further investigated in study populations having higher overall prevalences and intensities of STH infections and, in

  3. Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

    PubMed Central

    Livingstone, Katherine M; Fallaize, Rosalind; Kolossa, Silvia; Hallmann, Jacqueline; San-Cristobal, Rodrigo; Navas-Carretero, Santiago; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Moschonis, George; Lambrinou, Christina-Paulina; Surwillo, Agnieszka; Godlewska, Magdalena; Hoonhout, Jettie; Goris, Annelies; Macready, Anna L; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Michael J; Mathers, John C; Saris, Wim HM

    2016-01-01

    Background There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies

  4. HUB city steps: a 6-month lifestyle intervention improves blood pressure among a primarily African-American community.

    PubMed

    Zoellner, Jamie; Connell, Carol; Madson, Michael B; Thomson, Jessica L; Landry, Alicia S; Fontenot Molaison, Elaine; Blakely Reed, Vickie; Yadrick, Kathleen

    2014-04-01

    The effectiveness of community-based participatory research (CBPR) efforts to address the disproportionate burden of hypertension among African Americans remains largely untested. The objective of this 6-month, noncontrolled, pre-/post-experimental intervention was to examine the effectiveness of a CBPR intervention in achieving improvements in blood pressure, anthropometric measures, biological measures, and diet. Conducted in 2010, this multicomponent lifestyle intervention included motivational enhancement, social support provided by peer coaches, pedometer diary self-monitoring, and monthly nutrition and physical activity education sessions. Of 269 enrolled participants, 94% were African American and 85% were female. Statistical analysis included generalized linear mixed models using maximum likelihood estimation. From baseline to 6 months, blood pressure decreased significantly: mean (± standard deviation) systolic blood pressure decreased from 126.0 ± 19.1 to 119.6 ± 15.8 mm Hg, P=0.0002; mean diastolic blood pressure decreased from 83.2 ± 12.3 to 78.6 ± 11.1 mm Hg, P<0.0001). Sugar intake also decreased significantly as compared with baseline (by approximately 3 tsp; P<0.0001). Time differences were not apparent for any other measures. Results from this study suggest that CBPR efforts are a viable and effective strategy for implementing nonpharmacologic, multicomponent, lifestyle interventions that can help address the persistent racial and ethnic disparities in hypertension treatment and control. Outcome findings help fill gaps in the literature for effectively translating lifestyle interventions to reach and engage African-American communities to reduce the burden of hypertension.

  5. Efficacy of Personalized Normative Feedback as a Brief Intervention for College Student Gambling: A Randomized Controlled Trial

    PubMed Central

    Neighbors, Clayton; Rodriguez, Lindsey M.; Rinker, Dipali V.; Agana, Maigen; Gonzales, Rubi G.; Tackett, Jennifer L.; Foster, Dawn W.

    2016-01-01

    Objective Social influences on gambling among adolescents and adults have been well documented and may be particularly evident among college students, who have higher rates of problem and pathological gambling relative to the general population. Personalized normative feedback (PNF) is a brief intervention designed to correct misperceptions regarding the prevalence of problematic behavior by showing individuals engaging in such behaviors that their own behavior is atypical with respect to actual norms. The current randomized controlled trial evaluated a computer-delivered PNF intervention for problem gambling college students. Method Following a baseline assessment, 252 college student gamblers scoring 2+ on the South Oaks Gambling Screen (SOGS) were randomly assigned to receive PNF or attention-control feedback. Follow-up assessments were completed 3 and 6 months postintervention. Results Results indicated significant intervention effects in reducing perceived norms for quantities lost and won, and in reducing actual quantity lost and gambling problems at the 3-month follow-up. All intervention effects except reduced gambling problems remained at the 6-month follow-up. Mediation results indicated that changes in perceived norms at 3 months mediated the intervention effects. Further, the intervention effects were moderated by self-identification with other student gamblers, suggesting that PNF worked better at reducing gambling for those who more strongly identified with other student gamblers. Conclusions Results support the use of PNF as a stand-alone brief intervention for at-risk gambling students. Extending this approach more broadly may provide an accessible, empirically supported gambling prevention option for universities and related institutions. PMID:26009785

  6. Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

    PubMed Central

    Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

    2014-01-01

    Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

  7. Impact of Osteopathic Treatment on Pain in Adult Patients with Cystic Fibrosis – A Pilot Randomized Controlled Study

    PubMed Central

    Hubert, Dominique; Soubeiran, Lucile; Gourmelon, Fabrice; Grenet, Dominique; Serreau, Raphaël; Perrodeau, Elodie; Zegarra-Parodi, Rafael; Boutron, Isabelle

    2014-01-01

    Background Pain is a common complication in patients with cystic fibrosis (CF) and is associated with shorter survival. We evaluated the impact of osteopathic manipulative treatment (OMT) on pain in adults with CF. Methods A pilot multicenter randomized controlled trial was conducted with three parallel arms: OMT (group A, 16 patients), sham OMT (sham treatment, group B, 8 patients) and no treatment (group C, 8 patients). Medical investigators and patients were double-blind to treatment for groups A and B, who received OMT or sham OMT monthly for 6 months. Pain was rated as a composite of its intensity and duration over the previous month. The evolution of chest/back pain after 6 months was compared between group A and groups B+C combined (control group). The evolution of cervical pain, headache and quality of life (QOL) were similarly evaluated. Results There was no statistically significant difference between the treatment and control groups in the decrease of chest/back pain (difference = −2.20 IC95% [−4.81; 0.42], p = 0.098); also, group A did not differ from group B. However, chest/back pain decreased more in groups A (p = 0.002) and B (p = 0.006) than in group C. Cervical pain, headache and QOL scores did not differ between the treatment and control groups. Conclusion This pilot study demonstrated the feasibility of evaluating the efficacy of OMT to treat the pain of patients with CF. The lack of difference between the group treated with OMT and the control group may be due to the small number of patients included in this trial, which also precludes any definitive conclusion about the greater decrease of pain in patients receiving OMT or sham OMT than in those with no intervention. Trial Registration ClinicalTrials.gov NCT01293019 PMID:25029347

  8. Multilevel Growth Curve Analyses of Treatment Effects of a Web-Based Intervention for Stress Reduction: Randomized Controlled Trial

    PubMed Central

    Raeder, Sabine; Kraft, Pål; Bjørkli, Cato Alexander

    2013-01-01

    Background Stress is commonly experienced by many people and it is a contributing factor to many mental and physical health conditions, However, few efforts have been made to develop and test the effects of interventions for stress. Objective The aim of this study was to examine the effects of a Web-based stress-reduction intervention on stress, investigate mindfulness and procrastination as potential mediators of any treatment effects, and test whether the intervention is equally effective for females as males, all ages, and all levels of education. Methods We employed a randomized controlled trial in this study. Participants were recruited online via Facebook and randomly assigned to either the stress intervention or a control condition. The Web-based stress intervention was fully automated and consisted of 13 sessions over 1 month. The controls were informed that they would get access to the intervention after the final data collection. Data were collected at baseline and at 1, 2, and 6 months after intervention onset by means of online questionnaires. Outcomes were stress, mindfulness, and procrastination, which were all measured at every measurement occasion. Results A total of 259 participants were included and were allocated to either the stress intervention (n=126) or the control condition (n=133). Participants in the intervention and control group were comparable at baseline; however, results revealed that participants in the stress intervention followed a statistically different (ie, cubic) developmental trajectory in stress levels over time compared to the controls. A growth curve analysis showed that participants in the stress intervention (unstandardized beta coefficient [B]=–3.45, P=.008) recovered more quickly compared to the control group (B=–0.81, P=.34) from baseline to 1 month. Although participants in the stress intervention did show increases in stress levels during the study period (B=2.23, P=.008), long-term stress levels did decrease

  9. Psychosocial sequelae of the 1989 Newcastle earthquake: I. Community disaster experiences and psychological morbidity 6 months post-disaster.

    PubMed

    Carr, V J; Lewin, T J; Webster, R A; Hazell, P L; Kenardy, J A; Carter, G L

    1995-05-01

    A stratified random sample of 3007 Australian adults completed a screening questionnaire 6 months after the 1989 Newcastle earthquake. Information was obtained on initial earthquake experiences and reactions, use of specific services, social support, coping strategies and psychological morbidity. This questionnaire was the first phase of the Quake Impact Study, a longitudinal project investigating the psychosocial impact of the earthquake. Two weighted indices of exposure were developed: a threat index, which measured exposure to injury or the possibility of injury; and a disruption index, which measured experiences of property damage, displacement and other losses. Levels of exposure to threat and disruption events were significant predictors of morbidity on both the General Health Questionnaire and Impact of Event Scale, as were coping style and gender. Effects of exposure to threat and disruption were largely additive, with higher exposure being associated with greater use of support services, higher perceived stressfulness and more severe psychological morbidity. Use of avoidance as a coping strategy, female gender, lower social support and being older were also associated with higher post-disaster psychological distress. It was estimated that 14.8% of the population was exposed to high levels of threat or disruption, of whom approximately 25% experienced moderate to severe psychological distress as a direct result of the disaster. It was further estimated that 18.3% of those exposed to high levels of threat were at risk of developing post-traumatic stress disorder, representing approximately 2% of the city's adult population.

  10. Randomized, controlled trial of glucose-sparing peritoneal dialysis in diabetic patients.

    PubMed

    Li, Philip K T; Culleton, Bruce F; Ariza, Amaury; Do, Jun-Young; Johnson, David W; Sanabria, Mauricio; Shockley, Ty R; Story, Ken; Vatazin, Andrey; Verrelli, Mauro; Yu, Alex W; Bargman, Joanne M

    2013-11-01

    Glucose-containing peritoneal dialysis solutions may exacerbate metabolic abnormalities and increase cardiovascular risk in diabetic patients. Here, we examined whether a low-glucose regimen improves metabolic control in diabetic patients undergoing peritoneal dialysis. Eligible patients were randomly assigned in a 1:1 manner to the control group (dextrose solutions only) or to the low-glucose intervention group (IMPENDIA trial: combination of dextrose-based solution, icodextrin and amino acids; EDEN trial: a different dextrose-based solution, icodextrin and amino acids) and followed for 6 months. Combining both studies, 251 patients were allocated to control (n=127) or intervention (n=124) across 11 countries. The primary endpoint was change in glycated hemoglobin from baseline. Mean glycated hemoglobin at baseline was similar in both groups. In the intention-to-treat population, the mean glycated hemoglobin profile improved in the intervention group but remained unchanged in the control group (0.5% difference between groups; 95% confidence interval, 0.1% to 0.8%; P=0.006). Serum triglyceride, very-low-density lipoprotein, and apolipoprotein B levels also improved in the intervention group. Deaths and serious adverse events, including several related to extracellular fluid volume expansion, increased in the intervention group, however. These data suggest that a low-glucose dialysis regimen improves metabolic indices in diabetic patients receiving peritoneal dialysis but may be associated with an increased risk of extracellular fluid volume expansion. Thus, use of glucose-sparing regimens in peritoneal dialysis patients should be accompanied by close monitoring of fluid volume status.

  11. A prospective study of iron status in exclusively breastfed term infants up to 6 months of age

    PubMed Central

    Raj, Shashi; Faridi, MMA; Rusia, Usha; Singh, Om

    2008-01-01

    Background Can exclusive breastfeeding until six months of age maintain optimum iron status in term babies? We evaluated iron status of exclusively breastfed term infants in relation to breast milk iron and lactoferrin. Methods In this prospective study in Delhi, India, during the period 2003–2004 normally delivered babies of non-anemic [(Hemoglobin (Hb) = 11 g/dl, n = 68] and anemic (Hb 7 – 10.9 g/dl, n = 61) mothers were followed until 6 months of age. Iron parameters were measured in the cord blood at 14 weeks and 6 months. Breast milk iron and lactoferrin were measured at the same intervals. Results Iron parameters in babies of both groups were within normal limits at birth, 14 weeks and 6 months. Mean breast milk iron and lactoferrin in non-anemic (day 1: 0.89, 6 months: 0.26 mg/l; day 1: 12.02, 6 months: 5.85 mg/ml) and anemic mothers (day 1: 0.86, 6 months: 0.27 mg/l; day 1: 12.91, 6 months: 6.37 mg/ml) were not different on day one or at other times. No relationship was found between breast milk iron, lactoferrin and iron status of the babies. Conclusion Exclusively breastfed infants of non-anemic and anemic mothers did not develop iron deficiency or iron deficiency anemia by six months of age. PMID:18312681

  12. Immunotoxicological Evaluation of Genetically Modified Rice Expressing Cry1Ab/Ac Protein (TT51-1) by a 6-Month Feeding Study on Cynomolgus Monkeys

    PubMed Central

    Tan, Xiaoyan; Zhou, Xiaobing; Tang, Yao; Lv, Jianjun; Zhang, Lin; Sun, Li; Yang, Yanwei; Miao, Yufa; Jiang, Hua; Chen, Gaofeng; Huang, Zhiying; Wang, Xue

    2016-01-01

    The present study was performed to evaluate the food safety of TT51-1, a new type of genetically modified rice that expresses the Cry1Ab/Ac protein (Bt toxin) and is highly resistant to most lepidopteran pests. Sixteen male and 16 female cynomolgus monkeys were randomly divided into four groups: conventional rice (non-genetically modified rice, non-GM rice), positive control, 17.5% genetically modified rice (GM rice) and 70% GM rice. Monkeys in the non-GM rice, positive control, and GM rice groups were fed on diets containing 70% non-GM rice, 17.5% GM rice or 70% GM rice, respectively, for 182 days, whereas animals in the positive group were intravenously injected with cyclophosphamide every other day for a total of four injections before the last treatment. Six months of treatment did not yield abnormal observations. Specifically, the following parameters did not significantly differ between the non-GM rice group and GM rice groups: body weight, food consumption, electrocardiogram, hematology, immuno-phenotyping of lymphocytes in the peripheral blood, mitogen-induced peripheral blood lymphocyte proliferation, splenocyte proliferation, KLH-T cell-dependent antibody response, organ weights and ratios, and histological appearance (p>0.05). Animals from the GM rice group differed from animals in the non-GM rice group (p<0.05) in several parameters: specifically, their body temperatures and serum alanine aminotransferase (ALT) levels were higher, whereas their levels of serum K+, Cl- and cytokines (IL-2, IL-4 and IL-5) were lower. Because dose- or time-dependent changes were not observed in this study and animals appeared histologically normal, the aforementioned differences were not considered to be adverse or related to the treatment with GM rice. In conclusion, a 6-month feeding study of TT51-1 did not show adverse immunotoxicological effects on cynomolgus monkeys. PMID:27684490

  13. Immunotoxicological Evaluation of Genetically Modified Rice Expressing Cry1Ab/Ac Protein (TT51-1) by a 6-Month Feeding Study on Cynomolgus Monkeys.

    PubMed

    Tan, Xiaoyan; Zhou, Xiaobing; Tang, Yao; Lv, Jianjun; Zhang, Lin; Sun, Li; Yang, Yanwei; Miao, Yufa; Jiang, Hua; Chen, Gaofeng; Huang, Zhiying; Wang, Xue

    The present study was performed to evaluate the food safety of TT51-1, a new type of genetically modified rice that expresses the Cry1Ab/Ac protein (Bt toxin) and is highly resistant to most lepidopteran pests. Sixteen male and 16 female cynomolgus monkeys were randomly divided into four groups: conventional rice (non-genetically modified rice, non-GM rice), positive control, 17.5% genetically modified rice (GM rice) and 70% GM rice. Monkeys in the non-GM rice, positive control, and GM rice groups were fed on diets containing 70% non-GM rice, 17.5% GM rice or 70% GM rice, respectively, for 182 days, whereas animals in the positive group were intravenously injected with cyclophosphamide every other day for a total of four injections before the last treatment. Six months of treatment did not yield abnormal observations. Specifically, the following parameters did not significantly differ between the non-GM rice group and GM rice groups: body weight, food consumption, electrocardiogram, hematology, immuno-phenotyping of lymphocytes in the peripheral blood, mitogen-induced peripheral blood lymphocyte proliferation, splenocyte proliferation, KLH-T cell-dependent antibody response, organ weights and ratios, and histological appearance (p>0.05). Animals from the GM rice group differed from animals in the non-GM rice group (p<0.05) in several parameters: specifically, their body temperatures and serum alanine aminotransferase (ALT) levels were higher, whereas their levels of serum K+, Cl- and cytokines (IL-2, IL-4 and IL-5) were lower. Because dose- or time-dependent changes were not observed in this study and animals appeared histologically normal, the aforementioned differences were not considered to be adverse or related to the treatment with GM rice. In conclusion, a 6-month feeding study of TT51-1 did not show adverse immunotoxicological effects on cynomolgus monkeys.

  14. Effects of Concurrent Topotecan and Radiation on 6-Month Progression-Free Survival in the Primary Treatment of Glioblastoma Multiforme

    SciTech Connect

    Grabenbauer, Gerhard G. Gerber, Klaus-Dieter; Ganslandt, Oliver; Richter, Andrea M.S.; Klautke, Gunther; Birkmann, Josef; Meyer, Martin

    2009-09-01

    Purpose: To report a prospective, randomized, Phase II trial of radiotherapy with and without topotecan for the treatment of glioblastoma. Patients and Methods: Inclusion criteria were histology of glioblastoma, age <60 years, and Eastern Cooperative Oncology Group status 0-2. Patients were stratified according to recursive partitioning analysis class, center, and enzyme-inducing antiepileptic medication. Magnetic resonance imaging scans, neurologic examinations, and quality of life assessments were done every 3 months. The primary endpoint was the progression-free survival rate at 6 months (6-m-PFS). This trial was designed as an exploratory, randomized, Phase II trial with an accrual of 140 patients to detect a difference of 15-20% in 6-m-PFS. An interim analysis was scheduled after 60 patients. Median follow-up was 14 months (range, 1-50 months). Results: The 6-m-PFS was 56% and 40% for patients with and without topotecan, respectively. This benefit disappeared within 2 months. Mean (range) progression-free survival time was 8 (5-10.9) months and 6.7 (4-9.5) months for patients with and without topotecan, respectively. The corresponding 2-year-overall survival rates were 28% vs. 22% (nonsignificant difference), and mean (range) survival time was 20.7 (13.9-27.5) months vs. 18.9 (13.5-24.4) months (nonsignificant difference). Conclusions: A slight but measurable increase of 16% was detected in 6-m-PFS for patients receiving topotecan with radiation as compared with patients having radiotherapy alone. These data might support further investigations into topotecan for the treatment of glioblastoma.

  15. The impact of an alcohol harm reduction intervention on interpersonal violence and engagement in sex work among female sex workers in Mombasa, Kenya: Results from a randomized controlled trial*

    PubMed Central

    Parcesepe, Angela M.; L'Engle, Kelly L.; Martin, Sandra L.; Green, Sherri; Sinkele, William; Suchindran, Chirayath; Speizer, Ilene S.; Mwarogo, Peter; Kingola, Nzioki

    2016-01-01

    Aims To evaluate whether an alcohol harm reduction intervention was associated with reduced interpersonal violence or engagement in sex work among female sex workers (FSWs) in Mombasa, Kenya. Design Randomized controlled trial. Setting HIV prevention drop-in centers in Mombasa, Kenya. Participants 818 women 18 or older in Mombasa who visited HIV prevention drop-in centers, were moderate-risk drinkers and engaged in transactional sex in past six months (410 and 408 in intervention and control arms, respectively). Intervention 6 session alcohol harm reduction intervention. Comparator 6 session non-alcohol related nutrition intervention. Measurements In-person interviews were conducted at enrollment, immediately post-intervention and 6-months post-intervention. General linear mixed models examined associations between intervention assignment and recent violence (physical violence, verbal abuse, and being robbed in the past 30 days) from paying and non-paying sex partners and engagement in sex work in the past 30 days. Findings The alcohol intervention was associated with statistically significant decreases in physical violence from paying partners at 6 months post-intervention and verbal abuse from paying partners immediately post-intervention and 6-months post-intervention. Those assigned to the alcohol intervention had significantly reduced odds of engaging in sex work immediately post-intervention and 6-months post-intervention. Conclusions The alcohol intervention was associated with reductions in some forms of violence and with reductions in engagement in sex work among FSWs in Mombasa, Kenya. PMID:26872880

  16. Imipramine and pregabalin combination for painful polyneuropathy: a randomized controlled trial.

    PubMed

    Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B; Brøsen, Kim; Jensen, Troels S; Sindrup, Søren H

    2015-05-01

    Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy vs placebo. Patients with polyneuropathy and symptoms for more than 6 months, age 20 to 85 years, pain intensity ≥4 on a 0- to 10-point numeric rating scale (NRS) and pain at least 4 days a week were included in the trial. A total of 262 patients were screened for participation, 73 patients were randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P < 0.001), imipramine (-1.08 NRS points, P < 0.001), and pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain scores than both monotherapies: combination vs imipramine (P = 0.009), combination vs pregabalin (P < 0.001). During combination therapy, the dropout rate was higher and the patients reported a higher rate and severity of side effects. Combination of moderate doses of the tricyclic antidepressant imipramine and pregabalin could be considered as an alternative to high-dosage monotherapy. However, the trial also emphasized that balance between efficacy and safety is an issue.

  17. Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

    PubMed

    van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

    2014-11-01

    Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM.

  18. Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children

    PubMed Central

    Ochoa, Theresa J.; Chea-Woo, Elsa; Baiocchi, Nelly; Pecho, Iris; Campos, Miguel; Prada, Ana; Valdiviezo, Gladys; Lluque, Angela; Lai, Dejian; Cleary, Thomas G.

    2012-01-01

    Objective To determine the effect of bovine lactoferrin on prevention of diarrhea in children. Study design We conducted a community-based randomized double-blind placebo controlled trial comparing supplementation with bovine lactoferrin versus placebo. Previously weaned children were enrolled at 12–18 months and followed for 6 months with daily home visits for data collection and supplement administration. Anthropometric measures were done monthly. Results 555 children were randomized: 277 to lactoferrin and 278 to placebo; 65 dropped out; 147,894 doses were administered (92% compliance). Overall there were 91,446 child-days of observation and 1,235 diarrhea episodes lasting 6,219 days. The main pathogens isolated during diarrheal episodes were norovirus (35.0%), enteropathogenic E. coli (11.4%), Campylobacter (10.6%), enteroaggregative E. coli (8.4%), enterotoxigenic E. coli (6.9%) and Shigella (6.6%). The diarrhea incidence was not different between groups: 5.4 vs. 5.2 episodes/child/year for lactoferrin and placebo, respectively (p=0.375). However, the diarrhea longitudinal prevalence was lower in the lactoferrin group (6.6% vs. 7.0%, p=0.017) as well as the median duration of episodes (4.8 vs. 5.3 days, p=0.046), proportion of episodes with moderate or severe dehydration (1.0% vs. 2.6%, p=0.045) and liquid stools load (95.0 vs. 98.6) liquid stools/child/year, p<0.001). There were no adverse events related to the intervention. Conclusions Although there was no decrease in diarrhea incidence, longitudinal prevalence and severity were decreased with lactoferrin. PMID:22939927

  19. DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL OF BENFOTIAMINE FOR SEVERE ALCOHOL DEPENDENCE

    PubMed Central

    Manzardo, Ann M.; He, Jianghua; Poje, Albert; Penick, Elizabeth C.; Campbell, Jan; Butler, Merlin G.

    2013-01-01

    Background Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analogue, benfotiamine (BF), and BF’s effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. Methods A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Results Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, −611±380 Std Dev; PL: N=11, −159±562 Std Dev, p-value=0.02). Conclusions BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. PMID:23992649

  20. Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial

    PubMed Central

    Baker, Katie; Griffith, Julia; Oleski, Jessica L; Palumbo, Ashley; Walkosz, Barbara J; Hillhouse, Joel; Henry, Kimberly L; Buller, David B

    2016-01-01

    Background Indoor tanning elevates the risk for melanoma, which is now the most common cancer in US women aged 25-29. Public policies restricting access to indoor tanning by minors to reduce melanoma morbidity and mortality in teens are emerging. In the United States, the most common policy restricting indoor tanning in minors involves parents providing either written or in person consent for the minor to purchase a tanning visit. The effectiveness of this policy relies on parents being properly educated about the harms of indoor tanning to their children. Objective This randomized controlled trial will test the efficacy of a Facebook-delivered health communication intervention targeting mothers of teenage girls. The intervention will use health communication and behavioral modification strategies to reduce mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning relative to an attention-control condition with the ultimate goal of reducing indoor tanning in both daughters and mothers. Methods The study is a 12-month randomized controlled trial comparing 2 conditions: an attention control Facebook private group where content will be relevant to teen health with 25% focused on prescription drug abuse, a topic unrelated to tanning; and the intervention condition will enter participants into a Facebook private group where 25% of the teen health content will be focused on indoor tanning. A cohort of 2000 mother-teen daughter dyads will be recruited to participate in this study. Only mothers will participate in the Facebook groups. Both mothers and daughters will complete measures at baseline, end of intervention (1-year) and 6 months post-intervention. Primary outcomes include mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning, teenage daughters’ perception of their mothers’ permissiveness, and indoor tanning by both mothers and daughters. Results The first dyad was enrolled on March 31, 2016, and we

  1. Is there an effect of intranasal insulin on development and behaviour in Phelan-McDermid syndrome? A randomized, double-blind, placebo-controlled trial

    PubMed Central

    Zwanenburg, Renée J; Bocca, Gianni; Ruiter, Selma A J; Dillingh, Jan H; Flapper, Boudien C T; van den Heuvel, Edwin R; van Ravenswaaij-Arts, Conny M A

    2016-01-01

    Phelan-McDermid syndrome (PMS) or 22q13.3 deletion syndrome is a rare neurodevelopmental disorder with at least 60 children and 35 adults diagnosed in the Netherlands. Clinical features are moderate to severe intellectual disability and behavioural problems in the autism spectrum. Other researchers had observed a beneficial effect of intranasal insulin on development and behaviour in a pilot study in six children with PMS. To validate this effect, we conducted a randomized, double-blind, placebo-controlled clinical trial using a stepped-wedge design. From March 2013 to June 2015, 25 children aged 1–16 years with a molecularly confirmed 22q13.3 deletion including the SHANK3 gene participated in the clinical trial for a period of 18 months. Starting 6 months before the trial, children were systematically assessed for cognitive, language and motor development and for adaptive, social and emotional behaviour every 6 months. The second, third and fourth assessments were followed by daily nose sprays containing either intranasal insulin or intranasal placebo for a 6-month period. A fifth assessment was done directly after the end of the trial. Intranasal insulin did not cause serious adverse events. It increased the level of developmental functioning by 0.4–1.4 months per 6-month period, but the effect was not statistically significant in this small group. We found a stronger effect of intranasal insulin, being significant for cognition and social skills, for children older than 3 years, who usually show a decrease of developmental growth. However, clinical trials in larger study populations are required to prove the therapeutic effect of intranasal insulin in PMS. PMID:27577546

  2. Decreased serum hepcidin and improved functional iron status 6 months after restrictive bariatric surgery.

    PubMed

    Tussing-Humphreys, Lisa M; Nemeth, Elizabeta; Fantuzzi, Giamila; Freels, Sally; Holterman, Ai-xuan L; Galvani, Carlos; Ayloo, Subhashini; Vitello, Joseph; Braunschweig, Carol

    2010-10-01

    Excess adiposity is associated with low-grade inflammation and decreased iron status. Iron depletion in obesity is thought to be mediated by an inflammation-induced increase in the body's main regulator of iron homeostasis, hepcidin. Elevated hepcidin can result in iron depletion as it prevents the release of dietary iron absorbed into the enterocytes, limiting replenishment of body iron losses. Weight reduction is associated with decreased inflammation; however, the impact of reduced inflammation on iron status and systemic hepcidin in obese individuals remains unknown. We determined prospectively the impact of weight loss on iron status parameters, serum hepcidin, inflammation, and dietary iron in 20 obese premenopausal females 6 months after restrictive bariatric surgery. At baseline, the presence of iron depletion was high with 45% of the women having serum transferrin receptor (sTfR) >28.1 nmol/l. Differences between baseline and 6 months after surgery for BMI (47.56 vs. 39.55 kg/m(2); P < 0.0001), C-reactive protein (CRP) (10.83 vs. 5.71 mg/l; P < 0.0001), sTfR (29.97 vs. 23.08 nmol/l; P = 0.001), and serum hepcidin (111.25 vs. 31.35 ng/ml; P < 0.0001) were significantly lower, whereas hemoglobin (Hb) (12.10 vs. 13.30 g/dl; P < 0.0001) and hematocrit (Hct) (36.58 vs. 38.78%; P = 0.001) were significantly higher. Ferritin and transferrin saturation (Tsat) showed minimal improvement at follow-up. At baseline, hepcidin was not correlated with sTfR (r = 0.02); however, at follow-up, significant correlations were found (r = -0.58). Change in interleukin-6 (IL-6) from baseline was marginally associated with decreased log serum hepcidin (Δ IL-6: β = -0.22; P = 0.15), whereas change in BMI or weight was not. No significant difference in dietary iron was noted after surgery. Weight loss in obese premenopausal women is associated with reduced serum hepcidin and inflammation. Reduction in inflammation and hepcidin likely allow for enhanced dietary iron

  3. Internet-delivered cognitive-behavioral treatment for adolescents with chronic pain and their parents: a randomized controlled multicenter trial.

    PubMed

    Palermo, Tonya M; Law, Emily F; Fales, Jessica; Bromberg, Maggie H; Jessen-Fiddick, Tricia; Tai, Gabrielle

    2016-01-01

    Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent's pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families.

  4. Oral Microbiota in Infants Fed a Formula Supplemented with Bovine Milk Fat Globule Membranes - A Randomized Controlled Trial

    PubMed Central

    Timby, Niklas; Domellöf, Magnus; Holgerson, Pernilla Lif; West, Christina E.; Lönnerdal, Bo; Hernell, Olle; Johansson, Ingegerd

    2017-01-01

    Background In a recent study, supplementation of infant formula with milk fat globule membranes (MFGM) decreased the incidence of otitis media in infants <6 months of age. Objectives The aim of the present study was to characterize the oral microbiota in infants fed MFGM-supplemented formula and compare it to that of infants fed standard formula or breast milk. Methods In a prospective double-blinded randomized controlled trial, exclusively formula-fed infants <2 months of age were randomized to be fed experimental formula (EF, n = 80) with reduced energy and protein and supplemented with a bovine MFGM concentrate, or standard formula (SF, n = 80) until 6 months of age. A breast-fed reference (BFR, n = 80) group was also recruited. The oral microbiota was analyzed at 4 (n = 124) and 12 (n = 166) months of age using Illumina MiSeq multiplex sequencing and taxonomic resolution against the HOMD 16S rDNA database of oral bacteria. Results Species richness in the oral samples did not differ between the EF and SF groups, but partial least square modeling identified a few taxa that were significantly associated with being in either group, e.g. lower level of Moraxella catarrhalis in the EF group. Infants in the BFR group had significantly lower species richness at 4 months of age and their microbiota pattern differed markedly from the formula-fed groups. Conclusions Supplementation of infant formula with MFGM yielded moderate effects on the oral microbiome. Moraxella catarrhalis was less prevalent in infants fed EF than in those fed SF and may be associated with the decrease in otitis media seen in the same group. PMID:28099499

  5. A Randomized Controlled Trial of Telephone-Delivered Cognitive-Behavioral Therapy for Late-life Anxiety Disorders

    PubMed Central

    Brenes, Gretchen A.; Miller, Michael E.; Williamson, Jeff D.; McCall, W. Vaughn; Knudson, Mark; Stanley, Melinda A.

    2011-01-01

    Objectives Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder. Design Randomized controlled trial. Setting Participants' homes. Participants Sixty participants ≥ 60 years of age with a diagnosis of Generalized Anxiety Disorder, Panic Disorder, or Anxiety Disorder Not Otherwise Specified. Intervention CBT-T vs. information-only comparison. Measurements Co-primary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment. Results CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the post-treatment assessment; however, only the reductions in worry were maintained by the 6 month follow-up assessment (ES = 0.80). Conclusions These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects. PMID:22828172

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  7. 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…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  9. A Randomized Controlled Trial of Two Online Mathematics Curricula

    ERIC Educational Resources Information Center

    Wang, Haiwen; Woodworth, Katrina

    2011-01-01

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

  10. 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…

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  12. 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…

  13. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial

    PubMed Central

    Koliwad, Suneil; Poon, Tak; Xiao, Lan; Lv, Nan; Griggs, Robert; Ma, Jun

    2016-01-01

    Background Effective lifestyle interventions targeting high-risk adults that are both practical for use in ambulatory care settings and scalable at a population management level are needed. Objective Our aim was to examine the potential effectiveness, feasibility, and acceptability of delivering an evidence-based Electronic Cardio-Metabolic Program (eCMP) for improving health-related quality of life, improving health behaviors, and reducing cardiometabolic risk factors in ambulatory care high-risk adults. Methods We conducted a randomized, wait-list controlled trial with 74 adults aged ≥18 years recruited from a large multispecialty health care organization. Inclusion criteria were (1) BMI ≥35 kg/m2 and prediabetes, previous gestational diabetes and/or metabolic syndrome, or (2) BMI ≥30 kg/m2 and type 2 diabetes and/or cardiovascular disease. Participants had a mean age of 59.7 years (SD 11.2), BMI 37.1 kg/m2 (SD 5.4) and were 59.5% female, 82.4% white. Participants were randomized to participate in eCMP immediately (n=37) or 3 months later (n=37). eCMP is a 6-month program utilizing video conferencing, online tools, and pre-recorded didactic videos to deliver evidence-based curricula. Blinded outcome assessments were conducted at 3 and 6 months postbaseline. Data were collected and analyzed between 2014 and 2015. The primary outcome was health-related quality of life. Secondary outcomes included biometric cardiometabolic risk factors (eg, body weight), self-reported diet and physical activity, mental health status, retention, session attendance, and participant satisfaction. Results Change in quality of life was not significant in both immediate and delayed participants. Both groups significantly lost weight and reduced waist circumference at 6 months, with some cardiometabolic factors trending accordingly. Significant reduction in self-reported anxiety and perceived stress was seen in the immediate intervention group at 6 months. Retention rate was 93% at 3

  14. Adherence to a Smartphone Application for Weight Loss Compared to Website and Paper Diary: Pilot Randomized Controlled Trial

    PubMed Central

    Burley, Victoria Jane; Nykjaer, Camilla; Cade, Janet Elizabeth

    2013-01-01

    Background There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity. Objective The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone app, compared to a website and paper diary. Methods A sample of 128 overweight volunteers were randomized to receive a weight management intervention delivered by smartphone app, website, or paper diary. The smartphone app intervention, My Meal Mate (MMM), was developed by the research team using an evidence-based behavioral approach. The app incorporates goal setting, self-monitoring of diet and activity, and feedback via weekly text message. The website group used an existing commercially available slimming website from a company called Weight Loss Resources who also provided the paper diaries. The comparator groups delivered a similar self-monitoring intervention to the app, but by different modes of delivery. Participants were recruited by email, intranet, newsletters, and posters from large local employers. Trial duration was 6 months. The intervention and comparator groups were self-directed with no ongoing human input from the research team. The only face-to-face components were at baseline enrollment and brief follow-up sessions at 6 weeks and 6 months to take anthropometric measures and administer questionnaires. Results Trial retention was 40/43 (93%) in the smartphone group, 19/42 (55%) in the website group, and 20/43 (53%) in

  15. 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

  16. A 6 month evaluation of a non-powered hybrid mattress replacement system.

    PubMed

    Newton, Heather

    2015-11-11

    In 2013, the Royal Cornwall Hospitals NHS Trust undertook a 6-week evaluation of the AtmosAir 4000 non-powered reactive pressure redistribution mattress replacement system to determine its suitability in supporting the prevention of pressure ulcers in high-risk patients (phase one). The results demonstrated that the AtmosAir 4000 mattress system, together with skin assessment and repositioning regimes, met the pressure ulcer preventative needs of patients at high and very high risk of developing pressure ulcers. It also resulted in a notable reduction in the use of dynamic air mattresses. Consequently, 50 AtmosAir 4000 mattresses were purchased for two acute medical wards in the evaluation site, where the majority of patients are elderly with an acute medical condition. This article discusses the second phase where an audit compares the number of hospital-acquired pressure ulcers reported over a 6-month period with the equivalent time period in 2014. Results show that the number of pressure ulcers reduced by 65% and 50% in the two wards. The number of dynamic mattresses used on the two wards reduced significantly from 28 to 7, which represents a 75% reduction in usage.

  17. The impact of fecal and urinary incontinence on quality of life 6 months after childbirth

    PubMed Central

    Handa, Victoria L.; Zyczynski, Halina M.; Burgio, Kathryn L.; Fitzgerald, Mary Pat; Borello-France, Diane; Janz, Nancy K.; Fine, Paul M.; Whitehead, William; Brown, Morton B.; Weber, Anne M.

    2011-01-01

    Objective The objective of the study was to investigate the impact of postpartum fecal incontinence (FI) and urinary incontinence (UI) on quality of life (QOL). Study Design Seven hundred fifty-nine primiparous women in the Childbirth and Pelvic Symptoms study were interviewed 6 months postpartum. FI and UI were assessed with validated questionnaires. We measured QOL with SF-12 summary scores, health utility index score (a measure of self-rated overall health), and the modified Manchester Health Questionnaire. Results Women with FI had worse self-rated health utility index scores (85.1 ± 9.8 vs 88.0 ± 11.6, P = .02) and Medical Outcomes Study Short Form Health Survey (SF-12) mental summary scores (46.8 ± 9.2 vs 51.1 ± 8.7, P < .0001) than women without FI or flatal incontinence. Women with UI had worse SF-12 mental summary scores (48.3 ± 9.8 vs 51.6 ± 7.8, P < .01) and self-rated health utility index scores (84.1 ± 12.5 vs 88.7 ± 10.1, P < .01) than women without UI. Women with both FI and UI had the lowest SF-12 mental summary scores (44.5 ± 9.0). Conclusion Six months after delivery, women experiencing FI or UI reported negative effects on health-related QOL. FI and UI together have a greater impact than either condition alone. PMID:18060960

  18. In vivo response of AZ31 alloy as biliary stents: a 6 months evaluation in rabbits

    PubMed Central

    Liu, Yang; Zheng, Shengmin; Li, Nan; Guo, Huahu; Zheng, Yufeng; Peng, Jirun

    2017-01-01

    Mg-based metallic materials have been making continuing progress as vascular stents. However, the research of Mg-based materials as non-vascular stents is still at its primary stage. AZ31 stents hereby were implanted into the common bile duct of rabbits for 6 months. The results revealed an existence of 93.82 ± 1.36% and 30.89 ± 2.46% of the original volume after 1 and 3 month, respectively. Whole blood tests indicated an inflammation decreasing to normal level after 3 month implantation. A benign host response was observed via H&E staining. Nonuniform corrosion at the two ends of the stents was observed and considered the results of flow or local inflammation. Moreover, the application of Mg-based materials for different stenting treatment were reviewed and compared. Esophagus was hypothesized most destructive, whilst blood vessel and bile duct considered similar and less destructive. Trachea and nasal cavity were thought to be mildest. PMID:28084306

  19. Object engagement and manipulation in extremely preterm and full term infants at 6 months of age.

    PubMed

    Zuccarini, Mariagrazia; Sansavini, Alessandra; Iverson, Jana M; Savini, Silvia; Guarini, Annalisa; Alessandroni, Rosina; Faldella, Giacomo; Aureli, Tiziana

    2016-08-01

    Delays in the motor domain have been frequently observed in preterm children, especially those born at an extremely low gestational age (ELGA;<28 weeks GA). However, early motor exploration has received relatively little attention despite its relevance for object knowledge and its impact on cognitive and language development. The present study aimed at comparing early object exploration in 20 ELGA and 20 full-term (FT) infants at 6 months of age during a 5-minute mother-infant play interaction. Object engagement (visual vs manual), visual object engagement (no act vs reach), manual object engagement (passive vs active), and active object manipulation (mouthing, transferring, banging, turn/rotating, shaking, fingering) were analyzed. Moreover, the Griffiths Mental Development Scales 0-2 years (1996) were administered to the infants. Relative to FT peers, ELGA infants spent more time in visual engagement, and less time in manual engagement, active manipulation, mouthing, and turning/rotating. Moreover, they had lower scores on general psychomotor development, eye & hand coordination, and performance abilities. Close relationships emerged between manual object engagement and psychomotor development. Clinical implications of these results in terms of early evaluation of action schemes in ELGA infants and the provision of intervention programs for supporting these abilities are discussed.

  20. Prospective predictors of adolescent suicidality: 6-month post-hospitalization follow-up

    PubMed Central

    Yen, S.; Weinstock, L. M.; Andover, M. S.; Sheets, E. S.; Selby, E. A.; Spirito, A.

    2013-01-01

    Background The aim of this study was to examine prospective predictors of suicide events, defined as suicide attempts or emergency interventions to reduce suicide risk, in 119 adolescents admitted to an in-patient psychiatric unit for suicidal behaviors and followed naturalistically for 6 months. Method Structured diagnostic interviews and self-report instruments were administered to adolescent participants and their parent(s) to assess demographic variables, history of suicidal behavior, psychiatric disorders, family environment and personality/temperament. Results Baseline variables that significantly predicted time to a suicide event during follow-up were Black race, high suicidal ideation in the past month, post-traumatic stress disorder (PTSD), childhood sexual abuse (CSA), borderline personality disorder (BPD), low scores on positive affectivity, and high scores on aggression. In a multivariate Cox regression analysis, only Black race, CSA, positive affect intensity and high aggression scores remained significant. Conclusions Our findings suggest the following for adolescent populations: (1) in a very high-risk population, risk factors for future attempts may be more difficult to ascertain and some established risk factors (e.g. past suicide attempt) may not distinguish as well; and (2) cross-cutting constructs (e.g. affective and behavioral dysregulation) that underlie multiple psychiatric disorders may be stronger predictors of recurrent suicide events than psychiatric diagnoses. Our finding with respect to positive affect intensity is novel and may have practical implications for the assessment and treatment of adolescent suicide attempters. PMID:22932393

  1. In vivo response of AZ31 alloy as biliary stents: a 6 months evaluation in rabbits

    NASA Astrophysics Data System (ADS)

    Liu, Yang; Zheng, Shengmin; Li, Nan; Guo, Huahu; Zheng, Yufeng; Peng, Jirun

    2017-01-01

    Mg-based metallic materials have been making continuing progress as vascular stents. However, the research of Mg-based materials as non-vascular stents is still at its primary stage. AZ31 stents hereby were implanted into the common bile duct of rabbits for 6 months. The results revealed an existence of 93.82 ± 1.36% and 30.89 ± 2.46% of the original volume after 1 and 3 month, respectively. Whole blood tests indicated an inflammation decreasing to normal level after 3 month implantation. A benign host response was observed via H&E staining. Nonuniform corrosion at the two ends of the stents was observed and considered the results of flow or local inflammation. Moreover, the application of Mg-based materials for different stenting treatment were reviewed and compared. Esophagus was hypothesized most destructive, whilst blood vessel and bile duct considered similar and less destructive. Trachea and nasal cavity were thought to be mildest.

  2. Development of Specific Aspects of Spirituality during a 6-Month Intensive Yoga Practice

    PubMed Central

    Büssing, Arndt; Hedtstück, Anemone; Khalsa, Sat Bir S.; Ostermann, Thomas; Heusser, Peter

    2012-01-01

    The majority of research on yoga focuses on its psychophysiological and therapeutic benefits, while the spiritual aspects are rarely addressed. Changes of specific aspects of spirituality were thus investigated among 160 individuals (91% women, mean age 40.9 ± 8.3 years; 57% Christians) starting a 2-year yoga teacher training. We used standardized questionnaires to measure aspects of spirituality (ASP), mindfulness (FMI—Freiburg Mindfulness Inventory), life satisfaction (BMLSS—Brief Multidimensional Life Satisfaction Scale), and positive mood (lightheartedness/relief). At the start of the course, scores of the respective ASP subscales for search for insight/wisdom, transcendence conviction, and conscious interactions/compassion were high, while those for religious orientation were low. Within the 6 month observation period, both conscious interactions/compassion (effect size, Cohen's d = .33), Religious orientation (d = .21), Lightheartedness/Relief (d = .75) and mindfulness (d = .53) increased significantly. Particularly non-religious/non-spiritual individuals showed moderate effects for an increase of conscious interactions/compassion. The results from this study suggest that an intensive yoga practice (1) may significantly increase specific aspects of practitioners' spirituality, mindfulness, and mood, (2) that these changes are dependent in part on their original spiritual/religious self-perception, and (3) that there are strong correlations amongst these constructs (i.e., conscious interactions/compassion, and mindfulness). PMID:22852023

  3. Atypical cry acoustics in 6-month-old infants at risk for autism spectrum disorder.

    PubMed

    Sheinkopf, Stephen J; Iverson, Jana M; Rinaldi, Melissa L; Lester, Barry M

    2012-10-01

    This study examined differences in acoustic characteristics of infant cries in a sample of babies at risk for autism and a low-risk comparison group. Cry samples derived from vocal recordings of 6-month-old infants at risk for autism spectrum disorder (ASD; n = 21) and low-risk infants (n = 18) were subjected to acoustic analyses using analysis software designed for this purpose. Cries were categorized as either pain-related or non-pain-related based on videotape coding. At-risk infants produced pain-related cries with higher and more variable fundamental frequency (F (0) ) than low-risk infants. At-risk infants later classified with ASD at 36 months had among the highest F (0) values for both types of cries and produced cries that were more poorly phonated than those of nonautistic infants, reflecting cries that were less likely to be produced in a voiced mode. These results provide preliminary evidence that disruptions in cry acoustics may be part of an atypical vocal signature of autism in early life.

  4. Individual experiences following a 6-month exercise intervention: A qualitative study

    PubMed Central

    Kerkelä, Ellen Staveborg; Jonsson, Linus; Lindwall, Magnus; Strand, Jennifer

    2015-01-01

    Purpose Dropout is a common problem in various exercise interventions. The individual's experience is believed to greatly impact dropout, yet little is known about the individual experiences of taking part in exercise interventions. The aim of this study was to examine individuals’ experiences following a self-determination theory–based exercise intervention in order to gain understanding of how standardized interventions can be adjusted to fit individuals’ specific needs, capacities, and circumstances. Methods A qualitative approach with semi-structured interviews was conducted with eight informants (three male and five female) aged between 26 and 47 years, whom all had participated in a 6-month exercise intervention with individual coaching based on self-determination theory and motivational interviewing. The interviews were analyzed thematically with an inductive approach. Results Aspects that influenced the informants’ motivation and participation in the exercise intervention were linked to three themes: the frames of the intervention, measurable changes, and the individual's context. The themes present information about the process and to what extent the informants felt that the intervention was adapted to fit their lives and needs. Conclusions This study emphasizes the importance of individualizing exercise interventions to support individuals’ diverse capacities and psychological needs. PMID:26282865

  5. Quit rates at 6 months in a pharmacist-led smoking cessation service in Malaysia

    PubMed Central

    Fai, Sui Chee; Yen, Gan Kim; Malik, Nurdiyana

    2016-01-01

    Background: Smoking cessation clinics have been established in Malaysia since 2004, but wide variations in success rates have been observed. This study aimed to evaluate the proposed pharmacist-led Integrated Quit Smoking Service (IQSS) in Sabah, Malaysia, and identify factors associated with successful smoking cessation. Methods: Data from 176 participants were collected from one of the quit-smoking centres in Sabah, Malaysia. Pharmacists, doctors and nurses were involved throughout the study. Any health care provider can refer patients for smoking cessation, and free pharmacotherapy and counselling was provided during the cessation period for up to 3 months. Information on demographic characteristics, smoking behaviours, follow-up and pharmacotherapy were collected. The main outcome measure was the abstinence from smoking, which was verified through carbon monoxide in expired air during the 6-month follow-up. Results: A 42.6% success rate was achieved in IQSS. Smoking behaviour such as lower cigarette intake and lower Fagerström score were identified as factors associated with success. On top of that, a longer duration of follow-up and more frequent visits were significantly associated with success in quitting smoking. Conclusion: Collaboration among health care practitioners should be the main focus, and we need a combination of proven effective modalities in order to create an ideal smoking cessation module. PMID:27708676

  6. Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

    2008-01-01

    This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

  7. Unusual pediatric co-morbility: autoimmune thyroiditis and cortico-resistant nephrotic syndrome in a 6-month-old Italian patient.

    PubMed

    Urbano, Flavia; Acquafredda, Angelo; Aceto, Gabriella; Penza, Rosa; Cavallo, Luciano

    2012-10-23

    We report on a case of autoimmune thyroiditis in a 6-month-old patient with cortico-resistant nephrotic syndrome. Normal serum levels of thyroid hormons and thyroid-stimulating hormone were detected with high titers of circulant antithyroid antibodies and a dysomogeneous ultrasound appearance of the gland, typical of autoimmune thyroiditis. The research of maternal thyroid antibodies was negative. This is the first case of autoimmune thyroiditis found in such a young patient with pre-existing nephrotic syndrome ever described in literature. This association is random because nephrotic syndrome does not have an autoimmune pathogenesis and the genes involved in autoimmune thyroiditis are not related to those of nephrotic syndrome.

  8. Effect of pharmaceutical care on medication adherence and hospital admission in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled study

    PubMed Central

    Wei, Li; Yang, Xinyun; Li, Jie; Liu, Lianghui; Luo, Hongying; Zheng, Zeguang

    2014-01-01

    Background Poor adherence leads to a high rate of exacerbation and poor health-related quality of life (HRQoL) in patients with chronic obstructive pulmonary disease (COPD). However, few strategies are acceptable and effective in improving medication adherence. We investigated whether pharmaceutical care by clinical pharmacists could reinforce medication adherence to reduce exacerbation and improve HRQoL. Methods A randomized controlled study was carried out at The First Affiliated Hospital of Guangzhou Medical University from February 2012 to January 2014. Non-adherence patients were randomly assigned to receive pharmaceutical care or to usual care. The pharmaceutical care consisted of individualized education and a series of telephone counseling for 6 months provided by clinical pharmacists. Medication adherence was measured by pill counts plus direct interview at 1- and 6-month pharmaceutical care and one-year follow-up. Severe exacerbations were defined as events that led to hospitalization for acute COPD attack. An interview was conducted to investigate hospital admissions and evaluate severe exacerbations at one-year follow-up. HRQoL was measured by St George’s Respiratory Questionnaire at 6 months. Results At 6-month pharmaceutical care and one-year follow-up, the pharmaceutical care group exhibited higher medication adherence than the usual care group (73.4±11.1 vs. 55.7±11.9, P=0.016 and 54.4±12.5 vs. 66.5±8.6, P=0.039, respectively). There are 60 acute exacerbations resulted in a hospital admission in the usual group while 37 ones in the pharmaceutical care group during one-year follow-up (P=0.01). Hospital admissions due to acute exacerbation in the pharmaceutical care group were 56.3% less than the usual care group (P=0.01). There was a significant difference in the symptoms and impact subscales respectively at 6-month pharmaceutical care between two groups (P=0.032, P=0.018). Conclusions Individualized pharmaceutical care improved medication

  9. Effects of Video Game Training on Behavioral and Electrophysiological Measures of Attention and Memory: Protocol for a Randomized Controlled Trial

    PubMed Central

    Mayas, Julia; Ruiz-Marquez, Eloisa; Prieto, Antonio; Toril, Pilar; Ponce de Leon, Laura; de Ceballos, Maria L; Reales Avilés, José Manuel

    2017-01-01

    Background Neuroplasticity-based approaches seem to offer promising ways of maintaining cognitive health in older adults and postponing the onset of cognitive decline symptoms. Although previous research suggests that training can produce transfer effects, this study was designed to overcome some limitations of previous studies by incorporating an active control group and the assessment of training expectations. Objective The main objectives of this study are (1) to evaluate the effects of a randomized computer-based intervention consisting of training older adults with nonaction video games on brain and cognitive functions that decline with age, including attention and spatial working memory, using behavioral measures and electrophysiological recordings (event-related potentials [ERPs]) just after training and after a 6-month no-contact period; (2) to explore whether motivation, engagement, or expectations might account for possible training-related improvements; and (3) to examine whether inflammatory mechanisms assessed with noninvasive measurement of C-reactive protein in saliva impair cognitive training-induced effects. A better understanding of these mechanisms could elucidate pathways that could be targeted in the future by either behavioral or neuropsychological interventions. Methods A single-blinded randomized controlled trial with an experimental group and an active control group, pretest, posttest, and 6-month follow-up repeated measures design is used in this study. A total of 75 cognitively healthy older adults were randomly distributed into experimental and active control groups. Participants in the experimental group received 16 1-hour training sessions with cognitive nonaction video games selected from Lumosity, a commercial brain training package. The active control group received the same number of training sessions with The Sims and SimCity, a simulation strategy game. Results We have recruited participants, have conducted the training protocol

  10. Early sensory re-education of the hand after peripheral nerve repair based on mirror therapy: a randomized controlled trial

    PubMed Central

    Paula, Mayara H.; Barbosa, Rafael I.; Marcolino, Alexandre M.; Elui, Valéria M. C.; Rosén, Birgitta; Fonseca, Marisa C. R.

    2016-01-01

    BACKGROUND: Mirror therapy has been used as an alternative stimulus to feed the somatosensory cortex in an attempt to preserve hand cortical representation with better functional results. OBJECTIVE: To analyze the short-term functional outcome of an early re-education program using mirror therapy compared to a late classic sensory program for hand nerve repair. METHOD: This is a randomized controlled trial. We assessed 20 patients with median and ulnar nerve and flexor tendon repair using the Rosen Score combined with the DASH questionnaire. The early phase group using mirror therapy began on the first postoperative week and lasted 5 months. The control group received classic sensory re-education when the protective sensation threshold was restored. All participants received a patient education booklet and were submitted to the modified Duran protocol for flexor tendon repair. The assessments were performed by the same investigator blinded to the allocated treatment. Mann-Whitney Test and Effect Size using Cohen's d score were used for inter-group comparisons at 3 and 6 months after intervention. RESULTS: The primary outcome (Rosen score) values for the Mirror Therapy group and classic therapy control group after 3 and 6 months were 1.68 (SD=0.5); 1.96 (SD=0.56) and 1.65 (SD=0.52); 1.51 (SD=0.62), respectively. No between-group differences were observed. CONCLUSION: Although some clinical improvement was observed, mirror therapy was not shown to be more effective than late sensory re-education in an intermediate phase of nerve repair in the hand. Replication is needed to confirm these findings. PMID:26786080

  11. Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial

    PubMed Central

    Celis-Morales, Carlos; Fallaize, Rosalind; Macready, Anna L; Kolossa, Silvia; Woolhead, Clara; O'Donovan, Clare B; Forster, Hannah; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Lambrinou, Christina-Paulina; Moschonis, George; Surwillo, Agnieszka; Godlewska, Magdalena; Goris, Annelies; Hoonhout, Jettie; Drevon, Christian A; Manios, Yannis; Traczyk, Iwona; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Martinez, J Alfredo; Lovegrove, Julie A; Gibney, Michael J; Daniel, Hannelore; Mathers, John C; Saris, Wim HM

    2015-01-01

    Background The high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults. Objective It is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice. Methods A total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months. Results While 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively

  12. Effects of an Interactive School-Based Program for Preventing Adolescent Sexual Harassment: A Cluster-Randomized Controlled Evaluation Study.

    PubMed

    de Lijster, Gaby P A; Felten, Hanneke; Kok, Gerjo; Kocken, Paul L

    2016-05-01

    Many adolescents experience sexual harassment and victims of sexual harassment have higher risks regarding well-being and health behaviors such as higher risks of suicidal thoughts, suicidal ideation and feeling unsafe at school. A peer-performed play and school lessons on preventing sexual harassment behavior were presented to secondary school students. We evaluated its effectiveness, using a cluster-randomized controlled design to assign schools to an experimental condition [n = 14 schools; 431 students (51 % female)] and a control condition [n = 11 schools; 384 students (51 % female)]. To measure the effects of the intervention at first post-test and 6-month follow-up, our multilevel analyses used a two-level random intercept model. Outcome measures were sexual harassment behaviors, behavioral determinants and distal factors influencing these behaviors. At post-test, students in the experimental group reported a reduced intention to commit sexual harassment behavior and higher self-efficacy in rejecting it. At post-test and follow-up there was a significant positive effect on social norms for rejecting sexual harassment behavior. At follow-up, sexual self-esteem was higher in students in the experimental group than in the control group. Effects on these determinants will benefit adolescents' future sexual behaviors. In combination, the play and lessons, possibly together with continued sexual health education and skills programs on social-emotional learning in subsequent school years, have potential for preventing sexual harassment behavior.

  13. RANDOMIZED CONTROLLED TRIAL OF PARENT-INFANT PSYCHOTHERAPY FOR PARENTS WITH MENTAL HEALTH PROBLEMS AND YOUNG INFANTS.

    PubMed

    Fonagy, Peter; Sleed, Michelle; Baradon, Tessa

    2016-01-01

    There is a dearth of good-quality research investigating the outcomes of psychoanalytic parent-infant psychotherapy (PIP). This randomized controlled trial investigated the outcomes of PIP for parents with mental health problems who also were experiencing high levels of social adversity and their young infants (<12 months). Dyads were clinically referred and randomly allocated to PIP or a control condition of standard secondary and specialist primary care treatment (n = 38 in each group). Outcomes were assessed at baseline and at 6-month and 12-month follow-ups. The primary outcome was infant development. Secondary outcomes included parent-infant interaction, maternal psychopathology, maternal representations, maternal reflective functioning, and infant attachment. There were no differential effects over time between the groups on measures of infant development, parent-infant interaction, or maternal reflective functioning. Infant attachment classifications, measured only at the 12-month follow-up, did not differ between the groups. There were favorable outcomes over time for the PIP-treated dyads relative to the control group on several measures of maternal mental health, parenting stress, and parental representations of the baby and their relationship. The findings indicate potential benefits of parent-infant psychotherapy for improving mothers' psychological well-being and their representations of their baby and the parent-infant relationship.

  14. A randomized clinical trial comparing general exercise, McKenzie treatment and a control group in patients with neck pain.

    PubMed

    Kjellman, Görel; Oberg, Birgitta

    2002-07-01

    Seventy-seven patients with neck pain in the primary health care were included in a prospective, randomized clinical trial and randomly assigned to general exercise, McKenzie treatment, or a control group. Seventy patients completed the treatment; response rate 93% at 12-month follow-up. All three groups showed significant improvement regarding the main outcomes, pain intensity and Neck Disability Index, even at 12-month follow-up, but there was no significant difference between the groups. In all, 79% reported that they were better or completely restored after treatment, although 51% reported constant/daily pain. In the McKenzie group compared with the control group, a tendency toward greater improvement was noted for pain intensity at 3 weeks and at 6-month follow-up, and for post-treatment Neck Disability Index. Significant improvement in Distress and Risk Assessment Method scores was shown in the McKenzie group only. The three groups had similar recurrence rates, although after 12 months the McKenzie group showed a tendency toward fewer visits for additional health care. The study did not provide a definite evidence of treatment efficacy in patients with neck pain, however, there was a tendency toward a better outcome with the two active alternatives compared with the control group.

  15. Effect of Aerobic Exercise on Cognition, Academic Achievement, and Psychosocial Function in Children: A Systematic Review of Randomized Control Trials

    PubMed Central

    Lees, Caitlin

    2013-01-01

    Introduction Although the effects of aerobic physical activity (APA) on children’s physical health is well characterized, the effect of aerobic physical activity on cognition, academic achievement, and psychosocial function has not yet been established. This systematic review provides an overview of research elucidating the relationship between aerobic physical activity and children’s cognition, academic achievement, and psychosocial function. Methods A systematic review of English articles was performed in April 2013 using MEDLINE, Cochrane, PsycINFO, SPORTDiscus, and EMBASE. Additional studies were identified through back-searching bibliographies. Only randomized control trials with an intervention of aerobic physical activity in children younger than 19 years that measured psychological, behavioral, cognitive, or academic outcomes were included. Results We found 8 relevant randomized control trials that met our inclusion criteria and extracted relevant data and evaluated the methodologic quality of the studies. Of the 8 studies identified, 2 studies were crossover randomized control trials studying the effects of acute aerobic physical activity on cognitive performance. Six studies were parallel-group randomized control studies, of which only 2 had a follow-up period of longer than 6 months. All studies showed that APA had a generally positive impact on children’s cognition and psychosocial function. However, this relationship was found to be minimal in many studies and in some measures, no significant improvement was seen at all. There was no documentation of APA having any negative impact on children’s cognition and psychosocial health, even in cases where school curriculum time was reassigned from classroom teaching to aerobic physical activity. Conclusion APA is positively associated with cognition, academic achievement, behavior, and psychosocial functioning outcomes. More rigorous trials with adequate sample sizes assessing the impact of APA on

  16. Recovery from visual neglect after right hemisphere stroke: does starting point in cancellation tasks change after 6 months?

    PubMed

    Kettunen, J E; Nurmi, M; Dastidar, P; Jehkonen, M

    2012-01-01

    In the acute phase of stroke, patients with left visual neglect (VN) automatically orient to the right hemispace. This study examined the presence of rightward bias after right hemisphere stroke within 10 days of stroke onset and after 6 months. Our sample comprised 43 patients and 49 healthy controls. Presence of VN was evaluated with the six conventional subtests of the Behavioral Inattention Test (BITC). Starting points were determined in three BITC cancellation tasks by measuring the distance between the starting point and the median line of the stimulus sheet in centimeters. Activities of daily living (ADL) were assessed with the Barthel Index. At baseline VN patients showed more robust rightward bias than patients without VN. The magnitude of rightward bias decreased clearly in the VN patients at follow-up. A favorable ADL outcome was observed in 90% of the patients with VN and in all of the patients without VN. The magnitude of rightward bias differed clearly between the patient groups and controls. Our result implies that VN was likely to have improved as measured by BITC sum scores, but symptoms of rightward attention bias were still detected. We therefore suggest that, for clinical purposes, it is important that attention bias is measured accurately after right hemisphere stroke.

  17. A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component.

    PubMed

    Atkinson, J Hampton; Slater, Mark A; Capparelli, Edmund V; Patel, Shetal M; Wolfson, Tanya; Gamst, Anthony; Abramson, Ian S; Wallace, Mark S; Funk, Stephen D; Rutledge, Thomas R; Wetherell, Julie L; Matthews, Scott C; Zisook, Sidney; Garfin, Steven R

    2016-07-01

    Gabapentin is prescribed for analgesia in chronic low back pain, yet there are no controlled trials supporting this practice. This randomized, 2-arm, 12-week, parallel group study compared gabapentin (forced titration up to 3600 mg daily) with inert placebo. The primary efficacy measure was change in pain intensity from baseline to the last week on treatment measured by the Descriptor Differential Scale; the secondary outcome was disability (Oswestry Disability Index). The intention-to-treat analysis comprised 108 randomized patients with chronic back pain (daily pain for ≥6 months) whose pain did (43%) or did not radiate into the lower extremity. Random effects regression models which did not impute missing scores were used to analyze outcome data. Pain intensity decreased significantly over time (P < 0.0001) with subjects on gabapentin or placebo, reporting reductions of about 30% from baseline, but did not differ significantly between groups (P = 0.423). The same results pertained for disability scores. In responder analyses of those who completed 12 weeks (N = 72), the proportion reporting at least 30% or 50% reduction in pain intensity, or at least "Minimal Improvement" on the Physician Clinical Global Impression of Change did not differ significantly between groups. There were no significant differences in analgesia between participants with radiating (n = 46) and nonradiating (n = 62) pain either within or between treatment arms. There was no significant correlation between gabapentin plasma concentration and pain intensity. Gabapentin appears to be ineffective for analgesia in chronic low back pain with or without a radiating component.

  18. A Randomized, Controlled Trial of Home Injury Hazard Reduction: The HOME Injury Study

    PubMed Central

    Phelan, Kieran J.; Khoury, Jane; Xu, Yingying; Liddy, Stacey; Hornung, Richard; Lanphear, Bruce P.

    2013-01-01

    Objective Test the efficacy of an intervention of safety device installation on medically-attended injury in children birth to 3 years of age. Design A nested, prospective, randomized, controlled trial. Setting Indoor environment of housing units of mothers and children. Participants Mothers and their children enrolled in a birth cohort examining the effects of prevalent neurotoxicants on child development, the Home Observation and Measures of the Environment (HOME) Study. Intervention Installation of multiple, passive measures (stairgates, window locks, smoke & carbon monoxide detectors, to reduce exposure to injury hazards present in housing units. Outcome measure Self-reported and medically-attended and modifiable injury. Methods 1263 (14%) prenatal patients were eligible, 413 (33%) agreed to participate and 355 were randomly assigned to the experimental (n=181) or control (n=174) groups. Injury hazards were assessed at home visits by teams of trained research assistants using a validated survey. Safety devices were installed in intervention homes. Intention-to-treat analyses to test efficacy were conducted on: 1) total injury rates and 2) on injuries deemed, a priori, modifiable by the installation of safety devices. Rates of medically attended injuries (phone calls, office or emergency visits) were calculated using generalized estimating equations. Results The mean age of the children at intervention was 6 months. Injury hazards were significantly reduced in the intervention but not in control group homes at one and two years (p<0.004). There was not a significant difference in the rate for all medically-attended injuries in intervention compared with control group children, 14.3 (95%CI 9.7, 21.1) vs. 20.8 (14.4, 29.9) per 100 child-years (p=0.17) respectively; but there was a significant reduction in modifiable medically attended injuries in intervention compared with control group children, 2.3 (1.0, 5.5) vs. 7.7 (4.2, 14.2) per 100 child-years, respectively

  19. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early laparoscopic cholecystectomy

  20. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

    PubMed

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

  1. One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study

    PubMed Central

    Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

    2015-01-01

    The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up. PMID:26380359

  2. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    PubMed

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains.

  3. Efficacy of an HIV/STI Sexual Risk-Reduction Intervention for African American Adolescent Girls in Juvenile Detention Centers: A Randomized Controlled Trial

    PubMed Central

    DiClemente, Ralph J.; Davis, Teaniese L.; Swartzendruber, Andrea; Fasula, Amy M.; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C.; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M.; Brown, Jennifer L.; Staples-Horne, Michelle

    2014-01-01

    Background Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. Objective The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. Methods We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N=188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. Intervention The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment and counseling. Results At the 6-month assessment (3-months post-intervention) Imara participants reported higher condom use self-efficacy (p<0.001), HIV/STI knowledge (p<0.001), and condom use skills (p<0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Conclusions Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

  4. A randomized, double-blind, placebo-controlled study to test the efficacy of topical 2-hydroxypropyl-Beta-cyclodextrin in the prophylaxis of recurrent herpes labialis.

    PubMed

    Senti, Gabriela; Iannaccone, Reto; Graf, Nicole; Felder, Manuela; Tay, Fabian; Kündig, Thomas

    2013-01-01

    Herpes labialis affects one third of the population. We evaluated the topical application of an antiviral compound, hydroxypropyl-β-cyclodextrin (2-HPβCD), in reducing herpes labialis relapses. In this double-blind, randomized, placebo-controlled trial, 40 patients were randomized to a polyethylene glycol (PEG) formulation containing 20% 2-HPβCD or to a vehicle control arm. The gel was applied to the lips twice daily for 6 months. The primary objective was reducing herpes relapses. Surprisingly, the drug group had significantly more relapses than the vehicle group (p = 0.003). While the median numbers of relapses in the preceding year were 12 in the vehicle group and 10 in the drug group, both groups experienced very few relapses during the 6-month treatment period, with a median of 0 in the vehicle group and a median of 2 in the drug group. The impressive reduction of relapses in both groups may be due to a placebo effect or due to the topical treatment with PEG.

  5. Control with a random access protocol and packet dropouts

    NASA Astrophysics Data System (ADS)

    Wang, Liyuan; Guo, Ge

    2016-08-01

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

  6. Olfactory function following open rhinoplasty: A 6-month follow-up study

    PubMed Central

    Shemshadi, Hashem; Azimian, Mojtaba; Onsori, Mohammad Ali; AzizAbadi Farahani, Mahdi

    2008-01-01

    Background Patients undergoing any type of nasal surgery may experience degrees of postoperative olfactory dysfunction. We sought to investigate "when" the olfactory function recovers to its preoperative levels. Methods In this cohort design, 40 of 65 esthetic open rhinoplasty candidates with equal gender distribution, who met the inclusion criteria, were assessed for their olfactory function using the Smell Identification Test (SIT) with 40 familiar odors in sniffing bottles. All the patients were evaluated for the SIT scores preoperatively and postoperatively (at week 1, week 6, and month 6). Results At postoperative week one, 87.5% of the patients had anosmia, and the rest exhibited at least moderate levels of hyposmia. The anosmia, which was the dominant pattern at postoperative week 1, resolved and converted to various levels of hyposmia, so that no one at postoperative week 6 showed any such complain. At postoperative week six, 85% of the subjects experienced degrees of hyposmia, almost all being mild to moderate. At postoperative six month, the olfactory function had already reverted to the preoperative levels: no anosmia or moderate to severe hyposmia. A repeated ANOVA was indicative of significant differences in the olfactory function at the different time points. According to our post hoc Benfronney, the preoperative scores had a significant difference with those at postoperative week 1, week 6, but not with the ones at month 6. Conclusion Esthetic open rhinoplasty may be accompanied by some degrees of postoperative olfactory dysfunction. Patients need a time interval of 6 weeks to 6 months to fully recover their baseline olfactory function. PMID:18831771

  7. A randomized controlled trial of a brief versus standard group parenting program for toddler aggression.

    PubMed

    Tully, Lucy A; Hunt, Caroline

    2016-11-17

    Physical aggression (PA) in the toddler years is common and developmentally normal, however, longitudinal research shows that frequent PA is highly stable and associated with long-term negative outcomes. Significant research has demonstrated the efficacy of parenting interventions for reducing externalizing behavior in children yet their typical length may overburden families, leading to low participation rates and high attrition rates. To increase the reach of parenting interventions and impact on the prevalence of externalizing behavior problems, brief interventions are needed. This RCT compared a standard (8 session) group Triple P to a brief (3 session) discussion group and a waitlist control for reducing toddler PA, dysfunctional parenting and related aspects of parent functioning. Sixty-nine self-referred families of toddlers with PA were randomized to the respective conditions. At post-assessment, families in the standard intervention had significantly lower levels of observed child aversive behavior, mother reports of PA and dysfunctional parenting, and higher levels of mother- and partner-rated behavioral self-efficacy than the waitlist control. Families in the standard intervention also had significantly lower levels mother-rated dysfunctional parenting than the brief intervention, and the brief intervention had significantly lower levels of mother-rated dysfunctional parenting than waitlist. There were no significant group differences at post-assessment for measures of parental negative affect or satisfaction with the partner relationship. By 6 month follow-up, families in the brief and standard intervention did not differ significantly on any measure. The implications of the findings to delivery of brief parenting interventions are discussed. Aggr. Behav. 9999:1-13, 2016. © 2016 Wiley Periodicals, Inc.

  8. Educating Resident Physicians Using Virtual Case-Based Simulation Improves Diabetes Management: A Randomized Controlled Trial

    PubMed Central

    Sperl-Hillen, JoAnn; O’Connor, Patrick J.; Ekstrom, Heidi L.; Rush, William A.; Asche, Stephen E.; Fernandes, Omar D.; Apana, Deepika; Amundson, Gerald H.; Johnson, Paul E.; Curran, Debra M.

    2014-01-01

    Purpose To test a virtual case-based Simulated Diabetes Education (SimDE) intervention developed to teach primary care residents how to manage diabetes. Method Nineteen primary care residency programs, with 341 volunteer residents in all post-graduate years (PGY), were randomly assigned to a SimDE intervention group or control group (CG). The web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models. Eighteen distinct learning cases (L-cases) were assigned to SimDE residents over 6 months from 2010–2011. Impact was assessed using performance on 4 virtual assessment cases (A-cases), an objective knowledge test, and pre-post changes in self-assessed diabetes knowledge and confidence. Group comparisons were analyzed using generalized linear mixed models, controlling for clustering of residents within residency programs and differences in baseline knowledge. Results The percentage of residents appropriately achieving A-case composite clinical goals for glucose, blood pressure, and lipids was: A-Case 1, SimDE = 21.2%, CG = 1.8%, P = .002; A-Case 2, SimDE = 15.7%, CG = 4.7%, P = .02; A-Case 3, SimDE = 48.0%, CG = 10.4%, P < .001; A-Case 4, SimDE = 42.1%, CG = 18.7%, P = .004. The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants. Conclusions A virtual case-based simulated diabetes education intervention improved diabetes management skills, knowledge, and confidence for primary care residents. PMID:25006707

  9. Effectiveness of Therapeutic Massage for Generalized Anxiety Disorder: A Randomized Controlled Trial

    PubMed Central

    Sherman, Karen J.; Ludman, Evette J.; Cook, Andrea J.; Hawkes, Rene J.; Roy-Byrne, Peter P.; Bentley, Susan; Brooks, Marissa Z.; Cherkin, Daniel C.

    2010-01-01

    Background Although massage is one of the most popular complementary and alternative medical (CAM) treatments for anxiety, its effectiveness has never been rigorously evaluated for a diagnosed anxiety disorder. This study evaluates the effectiveness of therapeutic massage for persons with generalized anxiety disorder (GAD). Methods Sixty-eight persons with GAD were randomized to therapeutic massage (n=23), thermotherapy (n=22) or relaxing room therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes included 50% reduction in HARS and symptom resolution of GAD, changes in depressive symptoms (PHQ-8), worry and GAD-related disability. We compared changes in these outcomes in the massage and control groups post- treatment and at 6 months using generalized estimating equation (GEE) regression. Results All groups had improved by the end of treatment (adjusted mean change scores for the HARS ranged from −10.0 to −13.0; p< 0.001) and maintained their gains at the 26 week follow-up. No differences were seen between groups (p=0.39). Symptom reduction and resolution of GAD, depressive symptoms, worry and disability showed similar patterns. Conclusions Massage was not superior to the control treatments, and all showed some clinically important improvements, likely due to some beneficial but generalized relaxation response. Because the relaxing room treatment is substantially less expensive than the other treatments, a similar treatment packaged in a clinically credible manner might be the most cost effective option for persons with GAD who want to try relaxation-oriented CAM therapies. PMID:20186971

  10. Influence of refractory ceramic fibres - asbestos substitute - on the selected parameters of bronchoalveolar lavage 6 months after intratracheal instillation to W-rats.

    PubMed

    Hurbánková, Marta; Cerná, Silvia; Gergelová, Petra; Wimmerová, Sona

    2005-12-01

    Industrial fibrous dusts are applied in many industrial branches and represent adverse factors in occupational and environmental area. Refractory ceramic fibers (RCFs) - amorphous alumina silicates - are used as one kind of asbestos substitutes. Because RCFs are relatively durable and some RCFs are respirable, they may present a potential health hazard by inhalation. The aim of present work was to find out the subchronic effect of RCFs on selected parameters of bronchoalveolar lavage (BAL) in W-rats, confirm the biopersistence of RCFs after 6 month instillation and contribute to the understanding of the pathomechanism of lung injury after fibrous dust exposure. Wistar rats were intratracheally instilled with 4 mg/animal of RCFs - exposed group and with 0.4 ml saline solution/animal - control group. Animals were sacrificed after 6 month exposure. Bronchoalveolar lavage (BAL) was performed and selected BAL parameters (mainly inflammatory and cytotoxic) were examined. After treatment with RCFs the following changes were observed: statistically significant increase in proportion of lymphocytes and polymorphonuclears as well as in % of immature alveolar macrophages (AM) and phagocytic activity of AM; statistically significant decrease in viability of AM and proportion of AM (from the differential cell count) in comparison with the control group. The results of this study indicated that RCFs even 6 months after intratracheal instillation very significantly changed the majority of examined BAL parameters. The presence of inflammatory and cytotoxic response in lung may signalize beginning or developing disease process.

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

    PubMed Central

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

    2014-01-01

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

  12. The Relationship Between Parental Stress and Postpartum Depression Among Adolescent Mothers Enrolled in a Randomized Controlled Prevention Trial

    PubMed Central

    Phipps, Maureen G.; Triche, Elizabeth W.; Zlotnick, Caron

    2015-01-01

    Given the high co-occurrence of depression and parental stress among adolescent mothers, we evaluated the relationship between parental stress and postpartum depression among primiparous adolescent mothers. We conducted an observational analysis among a cohort of 106 adolescent mothers at 289 postpartum visits who were enrolled in a randomized controlled trial to prevent postpartum depression. Parental stress was measured using the Parenting Stress Index, short form. The Structured Clinical Interview for DSM-IV Childhood Diagnoses was administered to assess for postpartum depression; subthreshold depression was assessed using the Children's Depression Rating Scale, revised version. Generalized estimating equations were utilized to assess the relationship of parental stress on postpartum depression during the first 6 months postpartum. We present adjusted odds ratios (AOR) controlling for study arm, age, born in the United States, prior history of depression, and number of study visits. The median age was 16 years, 53 % were Latina, and 16 % reported a past history of depression. Nineteen adolescents (19 %) were diagnosed with postpartum depression and 25 % experienced high levels of parental stress through 6 months postpartum. Adolescent mothers who reported higher levels of parental stress were at significantly increased risk for postpartum depression [AOR 1.06 (95 % CI 1.04–1.09); p < 0.0001]. High levels of parental stress predicted subsequent postpartum depression when assessing parental stress at visits prior to a depression diagnosis to determine whether we could establish a temporal association [AOR 1.06 (95 % CI 1.02– 1.09); p < 0.01]. Parental stress was also a risk factor for subthreshold depression [AOR 1.04 (95 % CI 1.01– 1.07); p < 0.01]. Parental stress was a significant risk factor for developing both postpartum depression as well as subthreshold depression among adolescent mothers. Interventions that target a reduction in parental stress may

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

    PubMed

    Niemi, Anna-Kaisa

    2017-04-03

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

  14. Do empowered stroke patients perform better at self-management and functional recovery after a stroke? A randomized controlled trial

    PubMed Central

    Sit, Janet WH; Chair, Sek Ying; Choi, Kai Chow; Chan, Carmen WH; Lee, Diana TF; Chan, Aileen WK; Cheung, Jo LK; Tang, Siu Wai; Chan, Po Shan; Taylor-Piliae, Ruth E

    2016-01-01

    Background Self-management after a stroke is a challenge because of multifaceted care needs and complex disabling consequences that cause further hindrance to patient participation. A 13-week stroke patient empowerment intervention (Health Empowerment Intervention for Stroke Self-management [HEISS]) was developed to enhance patients’ ability to participate in self-management. Purpose To examine the effects of the empowerment intervention on stroke patients’ self-efficacy, self-management behavior, and functional recovery. Methods This is a single-blind randomized controlled trial with stroke survivors assigned to either a control group (CG) receiving usual ambulatory rehabilitation care or the HEISS in addition to usual care (intervention group [IG]). Outcome data were collected at baseline (T0), 1 week (T1), 3 months (T2), and 6 months (T3) postintervention. Data were analyzed on the intention-to-treat principle. The generalized estimating equation model was used to assess the differential change of self-efficacy in illness management, self-management behaviors (cognitive symptom management, communication with physician, medication adherence, and self-blood pressure monitoring), and functional recovery (Barthel and Lawton indices) across time points (baseline = T0, 1 week = T1, 3 months = T2, and 6 months = T3 postintervention) between the two groups. Results A total of 210 (CG =105, IG =105) Hong Kong Chinese stroke survivors (mean age =69 years, 49% women, 72% ischemic stroke, 89% hemiparesis, and 63% tactile sensory deficit) were enrolled in the study. Those in IG reported better self-efficacy in illness management 3-month (P=0.011) and 6-month (P=0.012) postintervention, along with better self-management behaviors at all follow-up time points (all P<0.05), apart from medication adherence (P>0.05). Those in IG had significantly better functional recovery (Barthel, all P<0.05; Lawton, all P<0.001), compared to CG. The overall dropout rate was 16

  15. Family Intervention for Obese/Overweight Children Using Portion Control Strategy (FOCUS) for Weight Control

    PubMed Central

    Ho, Josephine; Pedersen, Sue D.; Virtanen, Heidi; Nettel-Aguirre, Alberto; Huang, Carol

    2016-01-01

    Nutritional counseling for children with obesity is an important component of management. This randomized controlled trial was conducted to compare change in body mass index (BMI) z score after 6 months. Children 8 to 16 years with a BMI greater than the 85th percentile were randomized to standard of care nutrition counseling versus intervention with standard nutrition counseling including portion control tool training for the family. Measures were completed at baseline, 3 months, and 6 months. Fifty-one children were randomized to control and 48 to intervention. Mean age was 11 years (SD = 2.2). Mean BMI z score was 2.7 (SD = 0.4). Forty-five percent were male (n = 45). Follow-up at 6 months was 73.7% (73/99). Although no differences were seen between the groups, there was a significant decrease in BMI z score between baseline and 6 months within each group. PMID:27699184

  16. Predicting mothers' decisions to introduce complementary feeding at 6 months. An investigation using an extended theory of planned behaviour.

    PubMed

    Hamilton, Kyra; Daniels, Lynne; White, Katherine M; Murray, Nicole; Walsh, Anne

    2011-06-01

    In Australia and other developed countries there is poor adherence to guidelines recommending the introduction of complementary feeding to infants at 6 months of age. We aimed to investigate, via adopting a theory of planned behaviour framework and incorporating additional normative and demographic influences, mothers' complementary feeding intentions and behaviour. Participants were 375 primiparas who completed an initial questionnaire (infant age 13±3 weeks) that assessed the theory of planned behaviour constructs of attitude, subjective norm, and perceived behavioural control, as well as group norm and additional maternal and infant variables of mothers' age, education level, weight status perception, current maternal feeding practices, and infant birth weight. Approximately, 3 months after completion of the main questionnaire, mothers completed a follow-up questionnaire that assessed the age in months at which the infant was first introduced to solids. The theory of planned behaviour variables of attitude and subjective norm, along with group norm, predicted intentions, with intention, mothers' age (older more likely), and weight status perception (overweight less likely) predicting behaviour. Overall, the results highlight the importance of attitudes, normative influences, and individual characteristics in complementary feeding decision-making which should be considered when designing interventions aimed at improving adherence to current maternal feeding guidelines.

  17. Walking direction triggers visuo-spatial orienting in 6-month-old infants and adults: An eye tracking study.

    PubMed

    Bardi, Lara; Di Giorgio, Elisa; Lunghi, Marco; Troje, Nikolaus F; Simion, Francesca

    2015-08-01

    The present study investigates whether the walking direction of a biological motion point-light display can trigger visuo-spatial attention in 6-month-old infants. A cueing paradigm and the recording of eye movements in a free viewing condition were employed. A control group of adults took part in the experiment. Participants were presented with a central point-light display depicting a walking human, followed by a single peripheral target. In experiment 1, the central biological motion stimulus depicting a walking human could be upright or upside-down and was facing either left or right. Results revealed that the latency of saccades toward the peripheral target was modulated by the congruency between the facing direction of the cue and the position of the target. In infants, as well as in adults, saccade latencies were shorter when the target appeared in the position signalled by the facing direction of the point-light walker (congruent trials) than when the target appeared in the contralateral position (incongruent trials). This cueing effect was present only when the biological motion cue was presented in the upright condition and not when the display was inverted. In experiment 2, a rolling point-light circle with unambiguous direction was adopted. Here, adults were influenced by the direction of the central cue. However no effect of congruency was found in infants. This result suggests that biological motion has a priority as a cue for spatial attention during development.

  18. No harmful effect of different Coca-cola beverages after 6 months of intake on rat testes.

    PubMed

    Tóthová, Lubomíra; Hodosy, Július; Mettenburg, Kathryn; Fábryová, Helena; Wagnerová, Alexandra; Bábíčková, Janka; Okuliarová, Monika; Zeman, Michal; Celec, Peter

    2013-12-01

    Our laboratory recently reported that a 3-month exposure of rats to cola-like beverages induced sex hormone changes. The aim of the study was to investigate the effects of various types of Coca-cola intake with different composition for 6 months on oxidative status in testes and testosterone in adult male rats. Fifty adult male Wistar rats were divided into control group drinking water, and groups drinking different Coca-cola beverages (regular Coca-cola, Coca-cola caffeine-free, Coca-cola Light and Coca-cola Zero). Oxidative and carbonyl stress markers were measured in the testicular tissue to assess oxidative status together with testicular and plasma testosterone. StAR expression in testes as a marker of steroidogenesis was quantified. No significant differences were found between the groups in any of the measured parameters. In conclusion, oxidative and carbonyl stress in testicular tissue were not influenced by drinking any type of Coca-cola. Additionally, testosterone in testes and in plasma, as well as testicular StAR expression were comparable among the groups.

  19. Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

    PubMed Central

    Chang, Chun-Shin; Wallace, Christopher Glenn; Hsiao, Yen-Chang; Chang, Chee-Jen; Chen, Philip Kuo-Ting

    2014-01-01

    Background Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. Methods In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. Results 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Conclusion Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. Trial Registration ClinicalTrials.gov NCT01429402 PMID:25541942

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

    PubMed Central

    Joffe, Grigori; Stenberg, Jan-Henry

    2015-01-01

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

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

    PubMed

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

    2013-08-01

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

  2. Promoting “Healthy Futures” to Reduce Risk Behaviors in Urban Youth: A Randomized Controlled Trial

    PubMed Central

    Jones, Vanya; Cheng, Tina L.

    2015-01-01

    There is increasing evidence of the interconnection between educational and health outcomes. Unfortunately wide disparities exist by both socioeconomic status and race/ethnicity in educational and vocational success. This study sought to promote urban youths’ career readiness as a way to reduce involvement in risk behaviors. Two hundred primarily African-American youth (ages 14-21) were recruited from a pediatric primary care clinic. Youth randomized to the intervention received three motivational interviewing sessions focused around expectations and planning for the future. Baseline and 6-month follow-up assessments included measures of career readiness and risk behavior involvement (i.e., physical fighting, alcohol and marijuana use). At 6-months, youth randomized to the intervention condition showed increased confidence in their ability to perform the behaviors needed to reach their college/career goals. Additionally, youth randomized to the intervention arm showed decreased fighting behavior (adjusted rate ratio: .27) and marijuana use (adjusted rate ratio: .61). Assisting urban youth in thinking and planning about their future holds promise as a way to reduce their involvement in risk behaviors. This study also demonstrated that motivational interviewing may hold promise for promoting positive behaviors (i.e., career readiness). PMID:26122751

  3. Muscle Recruitment and Coordination following Constraint-Induced Movement Therapy with Electrical Stimulation on Children with Hemiplegic Cerebral Palsy: A Randomized Controlled Trial

    PubMed Central

    Xu, Kaishou; He, Lu; Mai, Jianning; Yan, Xiaohua; Chen, Ying

    2015-01-01

    Objective To investigate changes of muscle recruitment and coordination following constraint-induced movement therapy, constraint-induced movement therapy plus electrical stimulation, and traditional occupational therapy in treating hand dysfunction. Methods In a randomized, single-blind, controlled trial, children with hemiplegic cerebral palsy were randomly assigned to receive constraint-induced movement therapy (n = 22), constraint-induced movement therapy plus electrical stimulation (n = 23), or traditional occupational therapy (n = 23). Three groups received a 2-week hospital-based intervention and a 6-month home-based exercise program following hospital-based intervention. Constraint-induced movement therapy involved intensive functional training of the involved hand during which the uninvolved hand was constrained. Electrical stimulation was applied on wrist extensors of the involved hand. Traditional occupational therapy involved functional unimanual and bimanual training. All children underwent clinical assessments and surface electromyography (EMG) at baseline, 2 weeks, 3 and 6 months after treatment. Surface myoelectric signals were integrated EMG, root mean square and cocontraction ratio. Clinical measures were grip strength and upper extremity functional test. Results Constraint-induced movement therapy plus electrical stimulation group showed both a greater rate of improvement in integrated EMG of the involved wrist extensors and cocontraction ratio compared to the other two groups at 3 and 6 months, as well as improving in root mean square of the involved wrist extensors than traditional occupational therapy group (p<0.05). Positive correlations were found between both upper extremity functional test scores and integrated EMG of the involved wrist as well as grip strength and integrated EMG of the involved wrist extensors (p<0.05). Conclusions Constraint-induced movement therapy plus electrical stimulation is likely to produce the best outcome in

  4. Breast Health Intervention Effects on Knowledge and Beliefs Over Time Among Chinese American Immigrants--a Randomized Controlled Study.

    PubMed

    Lee-Lin, Frances; Pedhiwala, Nisreen; Nguyen, Thuan; Menon, Usha

    2015-09-01

    Chinese American immigrant women, nonadherent with mammography in the past 12 months, (N = 300) were enrolled in a randomized controlled trial designed to change knowledge and beliefs and increase mammogram use. This report describes intervention effects on changes in knowledge and beliefs between the control and educational groups over four time points (baseline and 3, 6, and 12 months). Variables measured included knowledge, perceived susceptibility, perceived general barriers to mammography, perceived benefits to mammography, and four cultural barriers to mammography (crisis orientation, modesty, use of Eastern medicine, reliance on others). At all three post-intervention time points, women in the education group had significantly higher knowledge scores than those in the control group, regardless of whether they had completed a mammogram during the study. Women in the education group reported higher perceived susceptibility to breast cancer at 3-month post-intervention. At 3- and 6-month post-intervention, regardless of mammogram screening completion, women reported lower concerns about modesty related to mammography when compared to the control group. By the 12-month post-intervention, women in the education group reported significantly fewer perceived barriers than the control group. A targeted breast health program successfully changed breast health knowledge and beliefs that were sustained for up to 6-12 months. Education targeted to women's knowledge and beliefs has significant potential for decreasing disparity in mammogram use among Chinese American immigrant women.

  5. Is Office-Based Counseling About Media Use, Timeouts, and Firearm Storage Effective? Results From a Cluster-Randomized, Controlled Trial

    PubMed Central

    Barkin, Shari L.; Finch, Stacia A.; Ip, Edward H.; Scheindlin, Benjamin; Craig, Joseph A.; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C.

    2015-01-01

    Objective The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. Methods In this cluster-randomized, controlled trial (2002–2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use < 120 minutes per day, use of timeouts, and use of firearm cable locks. Results Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to < 120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. Conclusions This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office

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

    DTIC Science & Technology

    2008-05-01

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

  7. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease.

    PubMed

    2013-01-01

    BACKGROUND Latrepirdine is an orally administered experimental small molecule that was initially developed as an antihistamine and subsequently was shown to stabilize mitochondrial membranes and function, which might be impaired in Huntington disease. OBJECTIVE To determine the effect of latrepirdine on cognition and global function in patients with mild to moderate Huntington disease. DESIGN Randomized, double-blind, placebo-controlled study. SETTING Sixty-four research centers in Australia, Europe, and North America. PATIENTS Four hundred three patients with mild to moderate Huntington disease and baseline cognitive impairment (Mini-Mental State Examination score, 10-26). INTERVENTION Latrepirdine (20 mg) vs matching placebo administered orally 3 times daily for 26 weeks. MAIN OUTCOME MEASURES The co-primary outcome measures were cognition as measured by the change in Mini-Mental State Examination score from baseline to week 26 and global function at week 26 as measured by the Clinician Interview-Based Impression of Change, plus carer interview, which ranges from 1 (marked improvement) to 7 (marked worsening). Secondary efficacy outcome measures included behavior, daily function, motor function, and safety. RESULTS The mean change in Mini-Mental State Examination score among participants randomized to latrepirdine (1.5-point improvement) did not differ significantly from that among participants randomized to placebo (1.3-point improvement) (P=.39). Similarly, the distribution of the Clinician Interview-Based Impression of Change, plus carer interview did not differ significantly among those randomized to latrepirdine compared with placebo (P=.84). No significant treatment effects were detected on the secondary efficacy outcome measures. The incidence of adverse events was similar between those randomized to latrepirdine (68.5%) and placebo (68.0%). CONCLUSION In patients with mild to moderate Huntington disease and cognitive impairment, treatment with

  8. Internet-Based Photoaging Within Australian Pharmacies to Promote Smoking Cessation: Randomized Controlled Trial

    PubMed Central

    Carter, Owen; Parsons, Richard; Hendrie, Delia

    2013-01-01

    Background Tobacco smoking leads to death or disability and a drain on national resources. The literature suggests that cigarette smoking continues to be a major modifiable risk factor for a variety of diseases and that smokers aged 18-30 years are relatively resistant to antismoking messages due to their widely held belief that they will not be lifelong smokers. Objective To conduct a randomized controlled trial (RCT) of a computer-generated photoaging intervention to promote smoking cessation among young adult smokers within a community pharmacy setting. Methods A trial was designed with 80% power based on the effect size observed in a published pilot study; 160 subjects were recruited (80 allocated to the control group and 80 to the intervention group) from 8 metropolitan community pharmacies located around Perth city center in Western Australia. All participants received standardized smoking cessation advice. The intervention group participants were also digitally photoaged by using the Internet-based APRIL Face Aging software so they could preview images of themselves as a lifelong smoker and as a nonsmoker. Due to the nature of the intervention, the participants and researcher could not be blinded to the study. The main outcome measure was quit attempts at 6-month follow-up, both self-reported and biochemically validated through testing for carbon monoxide (CO), and nicotine dependence assessed via the Fagerström scale. Results At 6-month follow-up, 5 of 80 control group participants (6.3%) suggested they had quit smoking, but only 1 of 80 control group participants (1.3%) consented to, and was confirmed by, CO validation. In the intervention group, 22 of 80 participants (27.5%) reported quitting, with 11 of 80 participants (13.8%) confirmed by CO testing. This difference in biochemically confirmed quit attempts was statistically significant (χ2 1=9.0, P=.003). A repeated measures analysis suggested the average intervention group smoking dependence score

  9. An Internet-Based Intervention to Promote Mental Fitness for Mildly Depressed Adults: Randomized Controlled Trial

    PubMed Central

    Haverman, Merel; Kramer, Jeannet; Westerhof, Gerben J; Riper, Heleen; Walburg, Jan A; Boon, Brigitte; Bohlmeijer, Ernst

    2013-01-01

    Background Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective Psyfit (“mental fitness online”) is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. Methods We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. Results The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen’s d=0.27, P=.06; significantly for WHO-5: Cohen’s d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen’s d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen’s d=0.32, P=.001), and depressive symptoms (Cohen’s d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen’s d=0.01, P=.90; WHO-5: Cohen’s d=0.26, P=.11), whereas depressive symptoms

  10. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial.

    PubMed

    Jeyamohan, Shiveindra B; Kenning, Tyler J; Petronis, Karen A; Feustel, Paul J; Drazin, Doniel; DiRisio, Darryl J

    2015-08-01

    OBJECT Anterior cervical discectomy and fusion (ACDF) is an effective procedure for the treatment of cervical radiculopathy and/or myelopathy; however, postoperative dysphagia is a significant concern. Dexamethasone, although potentially protective against perioperative dysphagia and airway compromise, could inhibit fusion, a generally proinflammatory process. The authors conducted a prospective, randomized, double-blinded, controlled study of the effects of steroids on swallowing, the airway, and arthrodesis related to multilevel anterior cervical reconstruction in patients who were undergoing ACDF at Albany Medical Center between 2008 and 2012. The objective of this study was to determine if perioperative steroid use improves perioperative dysphagia and airway edema. METHODS A total of 112 patients were enrolled and randomly assigned to receive saline or dexamethasone. Data gathered included demographics, functional status (including modified Japanese Orthopaedic Association myelopathy score, neck disability index, 12-Item Short-Form Health Survey score, and patient-reported visual analog scale score of axial and radiating pain), functional outcome swallowing scale score, interval postoperative imaging, fusion status, and complications/reoperations. Follow-up was performed at 1, 3, 6, 12, and 24 months, and CT was performed 6, 12, and 24 months after surgery for fusion assessment. RESULTS Baseline demographics were not significantly different between the 2 groups, indicating adequate randomization. In terms of patient-reported functional and pain-related outcomes, there were no differences in the steroid and placebo groups. However, the severity of dysphagia in the postoperative period up to 1 month proved to be significantly lower in the steroid group than in the placebo group (p = 0.027). Furthermore, airway difficulty and a need for intubation trended toward significance in the placebo group (p = 0.057). Last, fusion rates at 6 months proved to be

  11. Combination of Exercise Training and Dopamine Agonists in Patients with RLS on Dialysis: A Randomized, Double-Blind Placebo-Controlled Study.

    PubMed

    Giannaki, Christoforos D; Sakkas, Giorgos K; Karatzaferi, Christina; Maridaki, Maria D; Koutedakis, Yiannis; Hadjigeorgiou, Georgios M; Stefanidis, Ioannis

    2015-01-01

    Both exercise training and treatment with dopamine agonists (DA) have been used with success for the amelioration of uremic restless legs syndrome (RLS) symptoms. However, no data are available combining those two approaches. The aim of the current randomized, double-blind, placebo-controlled study was to investigate the effects of a 6 month intradialytic exercise training in combination with a low dose of DA in patients suffering from uremic RLS symptoms. Fourteen stable patients with RLS on hemodialysis were randomly assigned to the exercise training plus DA group and the exercise training plus placebo group. Both combinations were found to equally reduce uremic RLS symptoms by approximately 60%. The combination of low dose of DA with aerobic exercise training could be considered an alternative approach to high DA dosage regimes in reducing RLS symptoms' severity.

  12. Dynamic relation between working memory capacity and speech recognition in noise during the first 6 months of hearing aid use.

    PubMed

    Ng, Elaine H N; Classon, Elisabet; Larsby, Birgitta; Arlinger, Stig; Lunner, Thomas; Rudner, Mary; Rönnberg, Jerker

    2014-11-23

    The present study aimed to investigate the changing relationship between aided speech recognition and cognitive function during the first 6 months of hearing aid use. Twenty-seven first-time hearing aid users with symmetrical mild to moderate sensorineural hearing loss were recruited. Aided speech recognition thresholds in noise were obtained in the hearing aid fitting session as well as at 3 and 6 months postfitting. Cognitive abilities were assessed using a reading span test, which is a measure of working memory capacity, and a cognitive test battery. Results showed a significant correlation between reading span and speech reception threshold during the hearing aid fitting session. This relation was significantly weakened over the first 6 months of hearing aid use. Multiple regression analysis showed that reading span was the main predictor of speech recognition thresholds in noise when hearing aids were first fitted, but that the pure-tone average hearing threshold was the main predictor 6 months later. One way of explaining the results is that working memory capacity plays a more important role in speech recognition in noise initially rather than after 6 months of use. We propose that new hearing aid users engage working memory capacity to recognize unfamiliar processed speech signals because the phonological form of these signals cannot be automatically matched to phonological representations in long-term memory. As familiarization proceeds, the mismatch effect is alleviated, and the engagement of working memory capacity is reduced.

  13. A randomized, placebo-controlled trial of levetiracetam in central pain in multiple sclerosis.

    PubMed

    Falah, M; Madsen, C; Holbech, J V; Sindrup, S H

    2012-07-01

    Levetiracetam is an anticonvulsant which is assumed to act by modulating neurotransmitter release via binding to the vesicle protein SV2A. This could have an impact on signalling in the pain pathway. The aim of this study was to test the analgesic effect of levetiracetam in central pain in multiple sclerosis. This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000 mg/day versus placebo (6-week treatment periods). Patients with multiple sclerosis, symptoms and signs complying with central neuropathic pain and pain symptoms for more than 6 months, as well as pain intensity of more than 4 on a 0 to 10-point numeric rating scale were included in the study. The primary outcome measure was pain relief at the end of each treatment period as measured on a 6-point verbal scale. Eighty-nine patients were screened for participation and 30 patients entered the study. Twenty-seven patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.4 vs. placebo 2.1, p = 0.169), total pain intensity (levetiracetam 5.3 vs. placebo 5.7, p = 0.147) or any of the other outcome measures (p = 0.086-0.715) in the total sample of patients. However, there was significant reduction of pain, increased pain relief and/or more favourable pain relief with levetiracetam than with placebo in patients with lancinating or without touch-evoked pain (p = 0.025-0.046). This study found no effect of the anticonvulsant levetiracetam in non-selected patients with central pain in multiple sclerosis, but an effect in subgroups with specific pain symptoms was indicated.

  14. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial.

    PubMed

    Boettcher, Johanna; Aström, Viktor; Påhlsson, Daniel; Schenström, Ola; Andersson, Gerhard; Carlbring, Per

    2014-03-01

    Mindfulness-based interventions have proven effective for the transdiagnostic treatment of heterogeneous anxiety disorders. So far, no study has investigated the potential of mindfulness-based treatments when delivered remotely via the Internet. The current trial aims at evaluating the efficacy of a stand-alone, unguided, Internet-based mindfulness treatment program for anxiety. Ninety-one participants diagnosed with social anxiety disorder, generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified were randomly assigned to a mindfulness treatment group (MTG) or to an online discussion forum control group (CG). Mindfulness treatment consisted of 96 audio files with instructions for various mindfulness meditation exercises. Primary and secondary outcome measures were assessed at pre-, posttreatment, and at 6-months follow-up. Participants of the MTG showed a larger decrease of symptoms of anxiety, depression, and insomnia from pre- to postassessment than participants of the CG (Cohen's d(between)=0.36-0.99). Within effect sizes were large in the MTG (d=0.82-1.58) and small to moderate in the CG (d=0.45-0.76). In contrast to participants of the CG, participants of the MTG also achieved a moderate improvement in their quality of life. The study provided encouraging results for an Internet-based mindfulness protocol in the treatment of primary anxiety disorders. Future replications of these results will show whether Web-based mindfulness meditation can constitute a valid alternative to existing, evidence-based cognitive-behavioural Internet treatments. The trial was registered at ClinicalTrials.gov (NCT01577290).

  15. Improving completeness of electronic problem lists through clinical decision support: a randomized, controlled trial

    PubMed Central

    Pang, Justine; Feblowitz, Joshua C; Maloney, Francine L; Wilcox, Allison R; McLoughlin, Karen Sax; Ramelson, Harley; Schneider, Louise; Bates, David W

    2012-01-01

    Background Accurate clinical problem lists are critical for patient care, clinical decision support, population reporting, quality improvement, and research. However, problem lists are often incomplete or out of date. Objective To determine whether a clinical alerting system, which uses inference rules to notify providers of undocumented problems, improves problem list documentation. Study Design and Methods Inference rules for 17 conditions were constructed and an electronic health record-based intervention was evaluated to improve problem documentation. A cluster randomized trial was conducted of 11 participating clinics affiliated with a large academic medical center, totaling 28 primary care clinical areas, with 14 receiving the intervention and 14 as controls. The intervention was a clinical alert directed to the provider that suggested adding a problem to the electronic problem list based on inference rules. The primary outcome measure was acceptance of the alert. The number of study problems added in each arm as a pre-specified secondary outcome was also assessed. Data were collected during 6-month pre-intervention (11/2009–5/2010) and intervention (5/2010–11/2010) periods. Results 17 043 alerts were presented, of which 41.1% were accepted. In the intervention arm, providers documented significantly more study problems (adjusted OR=3.4, p<0.001), with an absolute difference of 6277 additional problems. In the intervention group, 70.4% of all study problems were added via the problem list alerts. Significant increases in problem notation were observed for 13 of 17 conditions. Conclusion Problem inference alerts significantly increase notation of important patient problems in primary care, which in turn has the potential to facilitate quality improvement. Trial Registration ClinicalTrials.gov: NCT01105923. PMID:22215056

  16. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior

    PubMed Central

    Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-01-01

    Background The limited or uncertain access to adequate food in elderly people includes not only economic restrictions but also inability of food utilization due to functional or cognitive impairment, health problems, and illiteracy. Objective The aim of this work is to present the protocol of the randomized controlled trial Saúde.Come Senior, an educational and motivational television (TV)-based intervention to promote healthy lifestyles and decrease food insecurity in elderly people. Methods A randomized controlled study will be conducted in subjects aged 60 years and older with food insecurity, identified at 17 primary care centers in the Lisboa e Vale do Tejo health region in Lisbon, Portugal. The primary outcome will be the changes in participants’ food insecurity score (evaluated by the Household Food Insecurity Scale) at 3 months. Change in other outcomes will be assessed (dietary habits, nutritional status, physical activity, health status, and clinical outcomes). Subjects will be followed over 6 months; the intervention will last 3 months. Data collection will be performed at 3 different time points (baseline, end of intervention at 3 months, and follow-up at 6 months). The intervention is based on an interactive TV app with an educational and motivational program specifically developed for the elderly that has weekly themes and includes daily content in video format: (1) nutrition and diet tips for healthy eating, (2) healthy, easy to cook and low-cost recipes, and (3) physical exercise programs. Furthermore, brief reminders on health behaviors will also be broadcasted through the TV app. The total duration of the study will be 6 months. The intervention is considered to be effective and meaningful if 50% of the individuals in the experimental group have a decrease of 1 point in the food insecurity score, all the remaining being unchanged. We expect to include and randomize 282 (141 experimental and 141 control) elderly with food insecurity. We will

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

    PubMed

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

    2014-12-01

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

  18. 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.

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

    PubMed

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

    2015-07-06

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

  20. 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

  1. Efficacy of Levofloxacin in the Treatment of BK Viremia: A Multicenter, Double-Blinded, Randomized, Placebo-Controlled Trial

    PubMed Central

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

    2014-01-01

    Background and objectives BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia. Design, setting, participants, & measurements Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months. Results At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period. Conclusions A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression. PMID:24482066

  2. The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes.

    PubMed

    Golomb, Beatrice A; Criqui, Michael H; White, Halbert L; Dimsdale, Joel E

    2004-04-01

    There has been persistent controversy regarding possible favorable or adverse effects of statins or of cholesterol reduction on cognition, mood and behavior (including aggressive or violent behavior), muscle function, and quality of life. The UCSD Statin Study seeks to ascertain the beneficial or adverse effects of statin cholesterol-lowering drugs on a set of noncardiac endpoints, including cognition, behavior, and serotonin biochemistry. The study will enroll 1000 subjects (minimum 20% female) of mixed ethnicity from San Diego. Subjects must be age 20 and older, postmenopausal if female, without known cardiovascular disease or diabetes, and with LDL-cholesterol between 115 and 190 mg/dl. Subjects will be randomized to a double-blind, placebo-controlled trial with assignment 1/3, 1/3, 1/3 to placebo, simvastatin 20 mg, or pravastatin 40 mg (equipotent LDL-cholesterol-lowering doses for drug arms with simvastatin and pravastatin chosen to represent the extremes of the lipophilicity spectrum) for 6 months of treatment followed by 2 months postcessation follow-up. Primary outcomes are cognition (cognitive battery), irritability/aggression (behavior measure), and serotonin (gauged by whole blood serotonin), assessed as the difference between baseline and 6 months, judging combined statin groups vs. placebo. Secondary outcomes include mood (CES-D and Wakefield depression inventory), quality of life (SF-12V), sleep (Leeds sleep scale, modified), and secondary aggression measures (Conflict Tactics Scale; Overt Aggression Scale, Modified). Cardiovascular reactivity will be examined in a 10% subset. As additional secondary endpoints, primary and selected secondary outcomes will be assessed by statin assignment (lipophilic simvastatin vs. hydrophilic pravastatin). "Reversibility" of changes, if any, at 2 months postcessation will be determined. If effects (favorable or unfavorable) are identified, we will seek to ascertain whether there are baseline variables that predict

  3. The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes

    PubMed Central

    Golomb, Beatrice A.; Criqui, Michael H.; White, Halbert L.; Dimsdale, Joel E.

    2013-01-01

    There has been persistent controversy regarding possible favorable or adverse effects of statins or of cholesterol reduction on cognition, mood and behavior (including aggressive or violent behavior), muscle function, and quality of life. The UCSD Statin Study seeks to ascertain the beneficial or adverse effects of statin cholesterol-lowering drugs on a set of noncardiac endpoints, including cognition, behavior, and serotonin biochemistry. The study will enroll 1000 subjects (minimum 20% female) of mixed ethnicity from San Diego. Subjects must be age 20 and older, postmenopausal if female, without known cardiovascular disease or diabetes, and with LDL-cholesterol between 115 and 190 mg/dl. Subjects will be randomized to a double-blind, placebo-controlled trial with assignment 1/3, 1/3, 1/3 to placebo, simvastatin 20 mg, or pravastatin 40 mg (equipotent LDL-cholesterol-lowering doses for drug arms with simvastatin and pravastatin chosen to represent the extremes of the lipophilicity spectrum) for 6 months of treatment followed by 2 months postcessation follow-up. Primary outcomes are cognition (cognitive battery), irritability/aggression (behavior measure), and serotonin (gauged by whole blood serotonin), assessed as the difference between baseline and 6 months, judging combined statin groups vs. placebo. Secondary outcomes include mood (CES-D and Wakefield depression inventory), quality of life (SF-12V), sleep (Leeds sleep scale, modified), and secondary aggression measures (Conflict Tactics Scale; Overt Aggression Scale, Modified). Cardiovascular reactivity will be examined in a 10% subset. As additional secondary endpoints, primary and selected secondary outcomes will be assessed by statin assignment (lipophilic simvastatin vs. hydrophilic pravastatin). “Reversibility” of changes, if any, at 2 months postcessation will be determined. If effects (favorable or unfavorable) are identified, we will seek to ascertain whether there are baseline variables that

  4. 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

  5. The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial.

    PubMed

    Widar, F; Kashani, H; Alsén, B; Dahlin, C; Rasmusson, L

    2015-02-01

    A randomized, prospective, controlled trial was conducted to determine the efficacy of single and repeated betamethasone doses on facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy. Thirty-seven patients (mean age 23.62 years, range 17-62 years) with either mandibular prognathism or retrognathism were enrolled consecutively into the study and divided into three groups: control (n=12), repeated dose 4+8+4mg betamethasone (n=14), single dose 16mg betamethasone (n=11). The intake of diclofenac and paracetamol was assessed individually. Measurements of facial oedema, pain, and sensitivity in the lower lip/chin were obtained 1 day, 7 days, 2 months, and 6 months postoperatively. Furthermore, we investigated the possible influences of gender, age, total operating time, amount of bleeding, postoperative hospitalization, and advancement versus setback of the mandible. A significant difference (P=0.017) was observed in percentage change between the two test groups and the control group regarding facial oedema (1 day postoperatively). Less bleeding was associated with improved pain recovery over time (P=0.043). Patients who required higher postoperative dosages of analgesics due to pain had significantly delayed recovery of the inferior alveolar nerve at 6 months postoperatively (P<0.001). Betamethasone did not reduce neurosensory disturbances over time.

  6. 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.

  7. Effectiveness of physical training for self-employed persons with musculoskeletal disorders: a randomized controlled trial

    PubMed Central

    Heinrich, Judith; Anema, Johannes R; de Vroome, Ernest MM; Blatter, Birgitte M

    2009-01-01

    Background Despite the fact that the population of self-employed persons is still growing and at risk for long term disability due to a number of risk factors, there is still a lack of information on the effectiveness of interventions for this specific group. Methods To determine the effectiveness of physical training without a cognitive behavioral component and workplace specific exercises (PT) and physical training with a cognitive behavioral component and workplace specific exercises (PTCBWE), we conducted a pragmatic Randomized Controlled Trial, stratified into two groups. Self-employed persons with a new work disability claim because of musculoskeletal disorders were randomized to PT (n = 53) or PTCBWE (n = 76), or to a corresponding usual care group (n = 50 and n = 75 respectively). Both types of training consisted of cardiovascular training, strengthening, relaxation and posture exercises and took place two or three times a week, for 1–1.5 hours, during three months, also if someone had already returned to work full-time. The primary outcome measure was claim duration (in days) during 12 months follow-up. Pain severity and functional status were secondary outcome measures. All data were assessed at baseline and at 6 and 12 months follow-up. The data with regard to claim duration were analyzed by survival analysis and Cox regression analysis. Secondary outcome measures were analyzed by means of linear regression analysis. Results After 12 months of follow-up there was no difference in claim duration between PT and usual care (Hazard Ratio 0.7; 95%CI, 0.4–1.1; p = 0.12) or PTCBWE and usual care (Hazard Ratio 0.9; 95%CI, 0.6–1.4; p = 0.72). Both types of physical training and usual care improved in pain and functional status over time, but there was only a statistically significant difference in favor of PT on pain improvement at 6 months. Conclusion In this study, physical training with and without a cognitive behavioral component and workplace specific

  8. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial

    PubMed Central

    2013-01-01

    Background The existing literature on weight management interventions targeting physical activity and healthy eating in mental health care appears to provide only limited evidence. The aim of the study was to examine the effectiveness of a 10-week health promotion intervention, followed by a 6-month follow-up period in individuals with mental disorders living in sheltered housing in the Flanders region (Belgium). Methods The study had a cluster preference randomized controlled design. Twenty-five sheltered housing organisations agreed to participate (16 in the intervention group, nine in the control group). In the intervention group, 225 individuals agreed to participate, while in the control group 99 individuals entered into the study. The main outcomes were changes in body weight, Body Mass Index, waist circumference and fat mass. Secondary outcomes consisted of changes in physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Results A significant difference was found between the intervention group and the control group regarding body weight (−0.35 vs. +0.22 kg; p=0.04), Body Mass Index (−0.12 vs. +0.08 kg/m2; p=0.04), waist circumference (−0.29 vs. + 0.55 cm; p<0.01), and fat mass (−0.99 vs. −0.12%; p<0.01). The decrease in these outcomes in the intervention group disappeared during the follow up period, except for fat mass. Within the intervention group, a larger decrease in the primary outcomes was found in the participants who completed the intervention. No significant differences between the two groups in changes in the secondary outcomes were found, except for the pedometer-determined steps/day. In the intervention group, the mean number of daily steps increased, while it decreased in the control group. Conclusions The study demonstrated that small significant improvements in the primary outcomes are possible in individuals with mental disorders. Integration of health promotion activities

  9. School-based intervention to reduce anxiety in children: study protocol for a randomized controlled trial (PACES)

    PubMed Central

    2012-01-01

    Background Emotional problems such as anxiety and low mood in children are common, impair everyday functioning and increase the risk of severe mental health disorders in adulthood. Relatively few children with emotional health problems are identified and referred for treatment indicating the need to investigate preventive approaches. Methods/Design The study is designed to be a pragmatic cluster randomized controlled trial evaluating the effectiveness of an efficacious school-based cognitive behavior therapy (CBT) prevention program (FRIENDS) on symptoms of anxiety and low mood in children 9 to 10 years of age. The unit of allocation is schools which are assigned to one of three conditions: school-led FRIENDS, health-led FRIENDS or treatment as usual. Assessments will be undertaken at baseline, 6 months and 12 months. The primary outcome measure is change on the Revised Child Anxiety and Depression Scale. Secondary outcome measures assess changes in self-esteem, worries, bullying and life satisfaction. An economic evaluation will be undertaken. Discussion As of September 2011, 41 schools have been recruited and randomized. Final 12-month assessments are scheduled to be completed by May 2013. Trial Registration ISRCTN23563048 PMID:23186118

  10. Repeated sessions of transcranial direct current stimulation for treatment of chronic subjective tinnitus: a pilot randomized controlled trial.

    PubMed

    Forogh, Bijan; Mirshaki, Zohre; Raissi, Gholam Reza; Shirazi, Ali; Mansoori, Korosh; Ahadi, Tannaz

    2016-02-01

    Subjective tinnitus is an auditory phantom sensation characterized by the perception of sound in the absence of an identifiable external source. This distressing audiological symptom can severely affect the quality of life. Transcranial direct current stimulation (tDCS) is a noninvasive technique that can induce short-term relief in tinnitus in some patients. The purpose of this pilot double-blind randomized controlled trial was to investigate whether repeated application of anodal tDCS over left temporoparietal area could induce long-lasting relief in patients with chronic tinnitus. Twenty-two patients with chronic tinnitus for at least 6 months were randomly allocated into two groups and received five sessions of anodal (N = 11) or sham (N = 11) stimulation in five consecutive days. A current intensity of 2 mA for 20 min was used for anodal stimulation. Outcomes were assessed using Persian version of tinnitus handicap inventory (THI), loudness and distress visual analog scale (VAS) scores and clinical global impression (CGI) scale. The trial is registered at the Iranian Registry of Clinical Trials (IRCT) with the reference ID of IRCT2014082018871N1. No statistically significant difference was found between anodal and sham stimulation regarding either immediate or long-lasting effects over the 2 weeks follow-up period. Deterioration of symptoms and alteration in tinnitus characteristics were reported by a few patients. There were no significant long-term beneficial effects following tDCS of the left temporoparietal area.

  11. Nonsurgical Korean Integrative Treatments for Symptomatic Lumbar Spinal Stenosis: A Three-Armed Randomized Controlled Pilot Trial Protocol

    PubMed Central

    Kim, Kiok; Shin, Kyung-Min; Lee, Jun-Hwan; Seo, Bok-Nam; Jung, So-Young; Youn, Yousuk; Lee, Sang Ho; Kim, Jaehong; Qu, Wenchun

    2016-01-01

    This is a study protocol for a pilot three-armed randomized controlled trial on nonsurgical integrative Korean medicinal treatment for symptomatic lumbar spinal stenosis (LSS). Thirty-six participants who have been diagnosed with (LSS) and recommended for spinal surgery by neurosurgeons or orthopedics and have had spinal symptoms such as severe low back pain and neurological claudication regardless of at least three months of conservative treatments will be recruited. Participants will be randomly assigned to be one of the three intervention groups, including the Mokhuri treatment program group 1 or 2 or usual care group. All treatments will be administered in inpatient units over a period of 4 weeks. The primary outcomes are 0 to 100 Visual Analogue Scales for low back pain and leg pain and the secondary outcomes are Oswestry Disability Index; EQ-5D; Roland-Morris Disability Questionnaire; Oxford Claudication Score; physical function test, including treadmill test, walking duration, and distance assessment for free leg pain; radiologic testing; and adverse events which will be assessed during the 4-week treatment period as well as after 3 and 6 months of follow-up. Then, we will assess the feasibility of the clinical trial design as well as a nonsurgical integrative treatment program. This trial is registered with CRIS registration number: KCT0001218. PMID:26941823

  12. Oral zinc sulphate supplementation for six months in SCA2 patients: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Velázquez-Pérez, Luis; Rodríguez-Chanfrau, Jorge; García-Rodríguez, Julio Cesar; Sánchez-Cruz, Gilberto; Aguilera-Rodríguez, Raúl; Rodríguez-Labrada, Roberto; Rodríguez-Díaz, Julio Cesar; Canales-Ochoa, Nalia; Gotay, Dennis Almaguer; Almaguer Mederos, Luis E; Laffita Mesa, José M; Porto-Verdecia, Marlene; Triana, Consuelo González; Pupo, Noemí Rodríguez; Batista, Idania Hidalgo; López-Hernandez, Orestes D; Polanco, Iverlis Díaz; Novas, Arelis Jayme

    2011-10-01

    Cuban patients with Spinocerebellar Ataxia type 2 (SCA2) have reduced concentrations of zinc in serum and cerebrospinal fluid (CSF). To assess the effect and safety of zinc supplementation, 36 Cuban SCA2 patients were randomly assigned to receive daily either 50 mg ZnSO(4) or placebo, together with neurorehabilitation therapy in a randomized, double-blind, placebo-controlled clinical trial during 6 months. Outcome measures included the changes of zinc levels in CSF and serum, ataxia score, oxidative stress and saccadic eye movements. At the end of the study, the Zinc-treated group showed: (i) a significant increase of the Zn levels in the CSF, (ii) mild decrease in the ataxia scale subscores for gait, posture, stance and dysdiadochocinesia (iii) reduction of lipid's oxidative damage, and (iv) reduction of saccadic latency when compared with the placebo group. The treatment was safe and well tolerated by all subjects. This study demonstrated the efficacy and safety of Zn supplementation, combined with neurorehabilitation for SCA2 patients and therefore it may encourage further studies on the clinical effect of zinc supplementation in SCA2 based in the conduction of future clinical trials with higher number of subjects.

  13. Reducing substance use risk and mental health problems among sexually assaulted adolescents: A pilot randomized controlled trial

    PubMed Central

    Danielson, Carla Kmett; McCart, Michael R.; Walsh, Kate; de Arellano, Michael A.; White, Deni; Resnick, Heidi S.

    2012-01-01

    The current study reports results from a pilot randomized controlled trial evaluating the feasibility and efficacy of Risk Reduction through Family Therapy (RRFT) for reducing substance use risk and trauma-related mental health problems among sexually assaulted adolescents. Thirty adolescents (aged 13–17 years; M=14.80; SD=1.51) who had experienced at least one sexual assault and their caregivers were randomized to RRFT or treatment as usual (TAU) conditions. Participants completed measures of substance use, substance use risk factors (e.g., family functioning), mental health problems (i.e., posttraumatic stress disorder, depression, and general internalizing/externalizing symptoms) and risky sexual behavior at four time points (baseline, post-treatment, and 3- and 6-month follow-up). Mixed-effects regression models yielded significantly greater reductions in substance use, specific substance use risk factors, and (parent-reported) PTSD, depression, and general internalizing symptoms among youth in the RRFT condition relative to youth in the TAU condition. However, significant baseline differences in functioning between the two conditions warrant caution in interpreting between-group findings. Instead, emphasis is placed on replication of feasibility findings and within-group improvements over time among the RRFT youth. PMID:22686269

  14. Lifestyle modification and weight reduction among low-income patients with the metabolic syndrome: the CHARMS randomized controlled trial.

    PubMed

    Chirinos, Diana A; Goldberg, Ronald B; Llabre, Maria M; Gellman, Marc; Gutt, Miriam; McCalla, Judith; Mendez, Armando; Schneiderman, Neil

    2016-06-01

    Although weight is an important intervention target among patients with metabolic syndrome, few trials have recruited low-income minority populations. The Community Health and Risk-reduction for Metabolic Syndrome randomized controlled trial aimed to examine the effects of a lifestyle intervention on weight and metabolic syndrome components among low-income minority adults. We randomized 120 adults with metabolic syndrome to standard medical care (N = 60) or a lifestyle intervention (N = 60). Using an intent-to-treat approach, we found significant intervention effects on weight [B = -0.452; SE = 0.122; 95 % confidence intervals (CI) -0.653 to -0.251) and glucose levels at 6-months (B = -0.522, SE = 0.234, 95 % CI -0.907 to -0.138). These changes were maintained through the 12-month assessment. No significant effects were observed on insulin resistance or other metabolic syndrome components. Our intervention was successful in achieving modest but significant weight loss and reduction in fasting glucose among low-income minority subjects with metabolic syndrome.

  15. Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

    PubMed Central

    Kadri, Reema; Hughes, Maria; Kerr, Eve A; Piette, John D; Holleman, Rob; Kim, Hyungjin Myra; Richardson, Caroline R

    2013-01-01

    Background Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. Objective The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. Methods A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. Results Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1

  16. Cognitive training for children with ADHD: a randomized controlled trial of cogmed working memory training and 'paying attention in class'.

    PubMed

    van der Donk, Marthe; Hiemstra-Beernink, Anne-Claire; Tjeenk-Kalff, Ariane; van der Leij, Aryan; Lindauer, Ramón

    2015-01-01

    The goal of this randomized controlled trial was to replicate and extend previous studies of Cogmed Working Memory Training (CWMT) in children with Attention-deficit/hyperactivity disorder (ADHD). While a large proportion of children with ADHD suffer from academic difficulties, only few previous efficacy studies have taken into account long term academic outcome measures. So far, results regarding academic outcome measures have been inconsistent. Hundred and two children with ADHD between the age of 8 and 12 years (both medicated and medication naïve) participated in current randomized controlled trial. Children were randomly assigned to CWMT or a new active combined working memory- and executive function compensatory training called 'Paying Attention in Class.' Primary outcome measures were neurocognitive functioning and academic performance. Secondary outcome measures contained ratings of behavior in class, behavior problems, and quality of life. Assessment took place before, directly after and 6 months after treatment. Results showed only one replicated treatment effect on visual spatial working memory in favor of CWMT. Effects of time were found for broad neurocognitive measures, supported by parent and teacher ratings. However, no treatment or time effects were found for the measures of academic performance, behavior in class or quality of life. We suggest that methodological and non-specific treatment factors should be taken into account when interpreting current findings. Future trials with well-blinded measures and a third 'no treatment' control group are needed before cognitive training can be supported as an evidence-based treatment of ADHD. Future research should put more effort into investigating why, how and for whom cognitive training is effective as this would also potentially lead to improved intervention- and study designs.

  17. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study.

    PubMed

    Morone, Natalia E; Greco, Carol M; Weiner, Debra K

    2008-02-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.

  18. Growth Hormone Deficiency after Treatment of Acromegaly: A Randomized, Placebo-Controlled Study of Growth Hormone Replacement

    PubMed Central

    Miller, Karen K.; Wexler, Tamara; Fazeli, Pouneh; Gunnell, Lindsay; Graham, Gwenda J.; Beauregard, Catherine; Hemphill, Linda; Nachtigall, Lisa; Loeffler, Jay; Swearingen, Brooke; Biller, Beverly M. K.; Klibanski, Anne

    2010-01-01

    Context: The effects of GH replacement therapy in patients who develop GH deficiency (GHD) after cure of acromegaly have not been established in a placebo-controlled study. Objective: The objective of the study was to determine whether GH replacement improves body composition, cardiovascular risk markers and quality of life in patients with GHD and prior acromegaly. Design: This was a 6-month, randomized, placebo-controlled study. Setting: The study was conducted at a clinical translational science center. Study Participants: Participants included 30 subjects with prior acromegaly and current GHD. Intervention: Interventions included GH or placebo. Main Outcome Measures: Body composition (dual-energy x-ray absorptiometry and cross-sectional computed tomography at L4), cardiovascular risk markers (high-sensitivity C-reactive protein (hsCRP), total, high-density lipoprotein and low-density lipoprotein cholesterol, fibrinogen, and carotid intimal-medial thickness), and quality of life were measured. Results: The mean GH dose at 6 months was 0.58 ± 0.26 mg/d. Total fat mass, visceral adipose tissue (−15.3 ± 18.6 vs. 1.3 ± 12.5%, P = 0.01), and total abdominal fat decreased, and fat-free mass increased, in the GH vs. placebo group. Mean hsCRP levels decreased, but there was no GH effect on other cardiovascular risk markers. There was no change in glycosylated hemoglobin or homeostasis model assessment insulin resistance index. Quality of life improved with GH. Side effects were minimal. Conclusions: This is the first randomized, placebo-controlled study of the effects of GH replacement therapy on body composition and cardiovascular end points in patients who have developed GH deficiency after treatment for acromegaly, a disease complicated by metabolic and body composition alterations and increased cardiovascular risk. GH replacement decreased visceral adipose tissue, increased fat-free mass, decreased hsCRP, and improved quality of life in patients with GHD after

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

    PubMed Central

    Strand, Vibeke; Sokolove, Jeremy

    2009-01-01

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

  20. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

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

    2015-01-01

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

  1. Glycaemic control with modified intensive insulin injections (MII) using insulin pens and premixed insulin in children with type-1 diabetes: a randomized controlled trial.

    PubMed

    Soliman, Ashraf T; Omar, Magdi; Rizk, Mostafa M; El Awwa, Ahmad; AlGhobashy, Fatma M

    2006-08-01

    The objective of this study was to compare glycemic control and insulin dosage in children with type 1 diabetes treated by a modified intensified insulin therapy MII using insulin pens (and premixed and regular insulin) with those on conventional insulin therapy. This was a longitudinal, randomized controlled trial for 6 months or more. From a cohort of 125 children with previously diagnosed type-1 diabetes (more than a year after diagnosis) two groups were randomly selected Group AI (n=20) and Group B (n=20). Group AI children and 10 children with recently diagnosed type 1 diabetes (Group AII) were allocated to MII using regular insulin and premixed insulin (30/70 and 40/60 and 50/50). Group B patients continued their conventional insulin therapy for the whole period of the trial. The main outcome measures were glycemic control measured by mean blood glucose concentration and percentage of glycated haemoglobin and total daily insulin dose. Mean blood glucose concentrations before the three main meals, and at midnight, (148, 147, 179 and 127 mg/dl, respectively) were lower in children receiving intensified MII compared with those receiving conventional insulin therapy (192, 174, 194 and 179 mg/dl, respectively) (standardized mean difference 34+/-15 mg/dl), equivalent to a difference of 1.9+/-0.8 mmol/l. This improved control during MII was achieved with no change in the average daily insulin dose in group-AI. In group-AII insulin dose decreased significantly during their first 6 moths of treatment (honeymooning). Glycemic control is better during MII using insulin pens and premixed and regular insulin compared with conventional insulin therapy, without any significant change in insulin dose needed to achieve this level of control. The difference in glycemic control between the two methods is significant and could reduce the risk of micro-vascular complications.

  2. Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Nonclinician Sleep Coaches: Randomized Controlled Trial

    PubMed Central

    Alessi, Cathy; Martin, Jennifer L.; Fiorentino, Lavinia; Fung, Constance H.; Dzierzewski, Joseph M.; Rodriguez Tapia, Juan C.; Song, Yeonsu; Josephson, Karen; Jouldjian, Stella; Mitchell, Michael N.

    2017-01-01

    OBJECTIVES To test a new cognitive behavioral therapy for insomnia (CBT-I) program designed for use by nonclinicians. DESIGN Randomized controlled trial. SETTING Department of Veterans Affairs healthcare system. PARTICIPANTS Community-dwelling veterans aged 60 and older who met diagnostic criteria for insomnia of 3 months duration or longer (N = 159). INTERVENTION Nonclinician “sleep coaches” delivered a five-session manual-based CBT-I program including stimulus control, sleep restriction, sleep hygiene, and cognitive therapy (individually or in small groups), with weekly telephone behavioral sleep medicine supervision. Controls received five sessions of general sleep education. MEASUREMENTS Primary outcomes, including self-reported (7-day sleep diary) sleep onset latency (SOL-D), wake after sleep onset (WASO-D), total wake time (TWT-D), and sleep efficiency (SE-D); Pittsburgh Sleep Quality Index (PSQI); and objective sleep efficiency (7-day wrist actigraphy, SE-A) were measured at baseline, at the posttreatment assessment, and at 6- and 12-month follow-up. Additional measures included the Insomnia Severity Index (ISI), depressive symptoms (Patient Health Questionnaire-9 (PHQ-9)), and quality of life (Medical Outcomes Study 12-item Short-form Survey version 2 (SF-12v2)). RESULTS Intervention subjects had greater improvement than controls between the baseline and posttreatment assessments, the baseline and 6-month assessments, and the baseline and 12-month assessments in SOL-D (−23.4, −15.8, and −17.3 minutes, respectively), TWT-D (−68.4, −37.0, and −30.9 minutes, respectively), SE-D (10.5%, 6.7%, and 5.4%, respectively), PSQI (−3.4, −2.4, and −2.1 in total score, respectively), and ISI (−4.5, −3.9, and −2.8 in total score, respectively) (all P < .05). There were no significant differences in SE-A, PHQ-9, or SF-12v2. CONCLUSION Manual-based CBT-I delivered by nonclinician sleep coaches improves sleep in older adults with chronic insomnia

  3. Improving diet, activity and wellness in adults at risk of diabetes: randomized controlled trial

    PubMed Central

    Block, G; Azar, K M J; Romanelli, R J; Block, T J; Palaniappan, L P; Dolginsky, M; Block, C H

    2016-01-01

    Objective: The purpose of this analysis is to examine the effect of an algorithm-driven online diabetes prevention program on changes in eating habits, physical activity and wellness/productivity factors. Methods: The intervention, Alive-PD, used small-step individually tailored goal setting and other features to promote changes in diet and physical activity. A 6-month randomized controlled trial was conducted among patients from a healthcare delivery system who had confirmed prediabetes (n =339). Change in weight and glycemic markers were measured in the clinic. Changes in physical activity, diet and wellness/productivity factors were self-reported. Mean age was 55 (s.d. 8.9) years, mean body mass index was 31 (s.d. 4.4) kg m−2, 68% were white and 69% were male. Results: The intervention group increased fruit/vegetable consumption by 3.71 (95% confidence interval (CI) 2.73, 4.70) times per week (effect size 0.62), and decreased refined carbohydrates by 3.77 (95% CI 3.10, 4.44) times per week both significantly (P<0.001) greater changes than in the control group. The intervention group also reported a significantly greater increase in physical activity than in the control group, effect size 0.49, P<0.001. In addition, the intervention group reported a significant increase in self-rated health, in confidence in ability to make dietary changes and in ability to accomplish tasks, and a decrease in fatigue, compared with the control group. These changes paralleled the significant treatment effects on glycemic markers and weight. Conclusions: In addition to promoting improvements in weight and glycemic markers, the Alive-PD program appears to improve eating habits and physical activity, behaviors important not just for diabetes prevention but for those with diagnosed diabetes or obesity. The improvements in wellness/productivity may derive from the diet and activity improvements, and from the satisfaction and self-efficacy of achieving goals. PMID:27643726

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  6. Conventional vs. Tablet Computer-Based Patient Education following Lung Transplantation – A Randomized Controlled Trial

    PubMed Central

    Suhling, Hendrik; Rademacher, Jessica; Zinowsky, Imke; Fuge, Jan; Greer, Mark; Warnecke, Gregor; Smits, Jacqueline M.; Bertram, Anna; Haverich, Axel; Welte, Tobias; Gottlieb, Jens

    2014-01-01

    Background Accurate immunosuppression is of critical importance in preventing rejection, while avoiding toxicity following lung transplantation. The mainstay immunosuppressants are calcineurin inhibitors, which require regular monitoring due to interactions with other medications and diet. Adherence to immunosuppression and patient knowledge is vital and can be improved through patient education. Education using tablet-computers was investigated. Objective To compare tablet-PC education and conventional education in improving immunosuppression trough levels in target range 6 months after a single education. Secondary parameters were ratio of immunosuppression level measurements divided by per protocol recommended measurements, time and patient satisfaction regarding education. Design Single-centre, open labelled randomised controlled trial. Participants Patients >6 months after lung-transplantation with <50% of calcineurin inhibitor trough levels in target range. Intervention Tablet-pc education versus personal, nurse-led education. Measurements Calcineurin inhibitor levels in target range 6 months after education, level variability, interval adherence, knowledge and adherence was studied. As outcome parameter, renal function was measured and adverse events registered. Results Sixty-four patients were 1:1 randomised for either intervention. Levels of immunosuppression 6 months after education were equal (tablet-PC 58% vs. conventional 48%, p = 0.27), both groups improved in achieving a CNI trough level within target range by either education method (delta tablet-PC 29% vs. conventional 20%). In all patients, level variability decreased (−20.4%), whereas interval adherence remained unchanged. Knowledge about immunosuppression improved by 7% and compliance tests demonstrated universal improvements with no significant difference between groups. Conclusion Education is a simple, effective tool in improving adherence to immunosuppression. Tablet-PC education was

  7. Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial

    PubMed Central

    Rossi, Roberta; Bonanni, Alice; Quinn, Robert R.; Sica, Felice; Bodria, Monica; Pasini, Andrea; Montini, Giovanni; Edefonti, Alberto; Belingheri, Mirco; De Giovanni, Donatella; Barbano, Giancarlo; Degl’Innocenti, Ludovica; Scolari, Francesco; Murer, Luisa; Reiser, Jochen; Fornoni, Alessia; Ghiggeri, Gian Marco

    2015-01-01

    Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1–16 years who had developed SDNS in the previous 6–12 months and were maintained in remission with high prednisone doses (≥0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m2; intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m2 per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for ≥1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6–13.5 years]) were enrolled and followed for ≤60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS. PMID:25592855

  8. Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial.

    PubMed

    Ravani, Pietro; Rossi, Roberta; Bonanni, Alice; Quinn, Robert R; Sica, Felice; Bodria, Monica; Pasini, Andrea; Montini, Giovanni; Edefonti, Alberto; Belingheri, Mirco; De Giovanni, Donatella; Barbano, Giancarlo; Degl'Innocenti, Ludovica; Scolari, Francesco; Murer, Luisa; Reiser, Jochen; Fornoni, Alessia; Ghiggeri, Gian Marco

    2015-09-01

    Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1-16 years who had developed SDNS in the previous 6-12 months and were maintained in remission with high prednisone doses (≥0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m(2); intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m(2) per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for ≥1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6-13.5 years]) were enrolled and followed for ≤60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS.

  9. A randomized controlled trial on the psychophysiological effects of physical exercise and Tai-chi in patients with chronic schizophrenia.

    PubMed

    Ho, Rainbow T H; Fong, Ted C T; Wan, Adrian H Y; Au-Yeung, Friendly S W; Wong, Cathy P K; Ng, Winnie Y H; Cheung, Irene K M; Lo, Phyllis H Y; Ng, S M; Chan, Cecilia L W; Chen, Eric Y H

    2016-03-01

    The chronic and prevalent natures of schizophrenia result in long-term institutionalization for the patients. Conventional treatment of anti-psychotic medication on management of psychotic symptoms often brings on severe side effects and reduces patients' well-being. Tai-chi is a mind-body exercise that underscores motor coordination and relaxation. This 3-arm randomized controlled trial investigated the psychophysiological benefits of Tai-chi on 153 chronic schizophrenia patients, who were recruited from a mental health rehab complex and randomized into Tai-chi, exercise, or waitlist control groups. Both intervention groups received 12weeks of specific intervention plus standard medication received by the controls. All participants completed psychiatric interviews, self-report questionnaires, performance tasks, and salivary cortisol measures at baseline, 3-month, and 6-month follow-up on psychotic symptoms, motor coordination, memory, daily living function, and stress. Multigroup latent growth modeling was used to evaluate the intervention effects on the outcomes. Compared to controls, the Tai-chi group showed significant decreases in motor deficits and increases in backward digit span and mean cortisol, while the exercise group displayed significant decreases in motor deficits, negative and depression symptoms and increases in forward digit span, daily living function, and mean cortisol. The two interventions did not show significantly different therapeutic effects, except for fewer symptom manifestations in the exercise group. These results suggest psychophysiological benefits for Tai-chi on chronic schizophrenia patients in terms of motor coordination and memory. Though both Tai-chi and exercise groups tended to manifest fewer symptoms than the control group, the exercise group showed better symptoms management than the Tai-chi group.

  10. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial

    PubMed Central

    Wayne, Noah; Perez, Daniel F; Kaplan, David M

    2015-01-01

    Background Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems. Objective To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes. Methods In this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]). Results A total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in

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

    PubMed

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

    2009-09-01

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

  12. Successful immunization of infants at 6 months of age with high dose Edmonston-Zagreb measles vaccine. Cite Soleil/JHU Project Team.

    PubMed

    Job, J S; Halsey, N A; Boulos, R; Holt, E; Farrell, D; Albrecht, P; Brutus, J R; Adrien, M; Andre, J; Chan, E

    1991-04-01

    A group of 2097 Haitian infants 6 to 11 months of age were randomized to receive Schwarz or Edmonston-Zagreb strain measles vaccines containing 10- to 500-fold more vaccine viral particles than standard potency vaccines. No unusual adverse reactions were noted. Edmonston-Zagreb vaccines were more effective than equivalent doses of Schwarz vaccines as measured by the proportion of vaccinated children with measles antibody concentrations greater than or equal to 200 mIU/ml 2 months after vaccination and the persistence of antibody at 18 to 24 months of age. High titer Edmonston-Zagreb vaccine administered at 6 months of age induced antibody concentrations greater than or equal to 200 mIU/ml in 83% of infants by plaque reduction neutralization and 93% of infants by enzyme-linked immunosorbent assay with high rates of antibody persistence at 12 to 24 months of age. The World Health Organization recommends high titer Edmonston-Zagreb measles vaccines for routine use at 6 months of age in areas where measles is an important cause of mortality in young infants.

  13. Touching up Mental Rotation: Effects of Manual Experience on 6-Month-Old Infants' Mental Object Rotation

    ERIC Educational Resources Information Center

    Möhring, Wenke; Frick, Andrea

    2013-01-01

    In this study, 6-month-olds' ability to mentally rotate objects was investigated using the violation-of-expectation paradigm. Forty infants watched an asymmetric object being moved straight down behind an occluder. When the occluder was lowered, it revealed the original object (possible) or its mirror image (impossible) in one of five…

  14. Cognitive-Behaviorally-Oriented Group Rehabilitation of Adults with ADHD: Results of a 6-Month Follow-Up

    ERIC Educational Resources Information Center

    Salakari, Anita; Virta, Maarit; Gronroos, Nina; Chydenius, Esa; Partinen, Markku; Vataja, Risto; Kaski, Markus; Iivanainen, Matti

    2010-01-01

    Objective: Recently, novel psychological treatments for adult ADHD have been reported with promising results. However, studies about long-term treatment effects are scanty. The authors study effects of cognitive-behaviorally-oriented group rehabilitation during a 6-month follow-up. Method: Participating in the rehabilitation were 29 adults, of…

  15. Internet-based instructor-led mindfulness for work-related rumination, fatigue, and sleep: Assessing facets of mindfulness as mechanisms of change. A randomized waitlist control trial.

    PubMed

    Querstret, Dawn; Cropley, Mark; Fife-Schaw, Chris

    2017-04-01

    This study aimed to extend our theoretical understanding of how mindfulness-based interventions exert their positive influence on measures of occupational health. Employing a randomized waitlist control study design, we sought to (a) assess an Internet-based instructor-led mindfulness intervention for its effect on key factors associated with "recovery from work," specifically, work-related rumination, fatigue, and sleep quality; (b) assess different facets of mindfulness (acting with awareness, describing, nonjudging, and nonreacting) as mechanisms of change; and (c) assess whether the effect of the intervention was maintained over time by following up our participants after 3 and 6 months. Participants who completed the mindfulness intervention (n = 60) reported significantly lower levels of work-related rumination and fatigue, and significantly higher levels of sleep quality, when compared with waitlist control participants (n = 58). Effects of the intervention were maintained at 3- and 6-month follow-up with medium to large effect sizes. The effect of the intervention was primarily explained by increased levels of only 1 facet of mindfulness (acting with awareness). This study provides support for online mindfulness interventions to aid recovery from work and furthers our understanding with regard to how mindfulness interventions exert their positive effects. (PsycINFO Database Record

  16. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect o