Science.gov

Sample records for 12-month randomized controlled

  1. Replicating Reducing the Risk: 12-Month Impacts of a Cluster Randomized Controlled Trial

    PubMed Central

    Blocklin, Michelle; Layzer, Jean; Price, Cristofer; Juras, Randall; Freiman, Lesley

    2016-01-01

    Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or “business as usual.” Youths completed Web-based surveys at baseline (preintervention, August 2012–January 2014) and 12 months later (August 2013–January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. PMID:27689492

  2. Improving Physical Health in Patients with Chronic Mental Disorders: 12-Month Results from a Randomized Controlled Collaborative Care Trial

    PubMed Central

    Kilbourne, Amy M.; Barbaresso, Michelle M.; Lai, Zongshan; Nord, Kristina M.; Bramlet, Margretta; Goodrich, David E.; Post, Edward P.; Almirall, Daniel; Bauer, Mark S.

    2015-01-01

    Objective Persons with chronic mental disorders are disproportionately burdened with physical health conditions. We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months. Method This single-blind randomized controlled effectiveness study of a collaborative care model was conducted at a mid-western Veterans Affairs urban outpatient mental health clinic. Patients (N=293 out of 474 eligible approached) with an ICD-9-CM diagnosis of schizophrenia, bipolar disorder, or major depressive disorder and at least one cardiovascular disease risk factor were consented and randomized (02/24/10 to 04/29/15) to Life Goals (N=146) or usual care (N=147). A total of 287 completed baseline assessments and 245 completed 12-month follow-up assessments. Life Goals included five weekly sessions that provided semi-structured guidance on managing physical and mental health symptoms through healthy behavior changes, augmented by ongoing care coordination. The primary outcome was change in physical health-related quality of life score (VR-12 physical health component score). Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months (blood pressure, lipids, weight), mental health-related quality of life, and mental health symptoms. Results Among patients completing baseline and 12-month outcomes assessments (N=245), the mean age was 55.3 (SD=10.8; range 28-75 years) and 15.4% were female. Intent-to-treat analysis revealed that compared to those in usual care, patients randomized to Life Goals had slightly increased VR-12 physical health scores (coefficient=3.21;p=0.01). Conclusion Patients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life. PMID:27780336

  3. Peak Oxygen Uptake after Cardiac Rehabilitation: A Randomized Controlled Trial of a 12-Month Maintenance Program versus Usual Care

    PubMed Central

    Madssen, Erik; Arbo, Ingerid; Granøien, Ingrid; Walderhaug, Liv; Moholdt, Trine

    2014-01-01

    Background Exercise capacity is a strong predictor of survival in patients with coronary artery disease (CAD). Exercise capacity improves after cardiac rehabilitation exercise training, but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program. There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients. We therefore assessed if a 12-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care. Materials and Methods Two-centre, open, parallel randomized controlled trial with 12 months follow-up comparing usual care to a maintenance program. The maintenance program consisted of one monthly supervised high intensity interval training session, a written exercise program and exercise diary, and a maximum exercise test every third month during follow-up. Forty-nine patients (15 women) on optimal medical treatment were included following discharge from cardiac rehabilitation. The primary endpoint was change in peak oxygen uptake at follow-up; secondary endpoints were physical activity level, quality of life and blood markers of cardiovascular risk. Results There was no change in peak oxygen uptake from baseline to follow-up in either group (intervention group 27.9 (±4.7) to 28.8 (±5.6) mL·kg (-1) min (−1), control group 32.0 (±6.2) to 32.8 (±5.8) mL·kg (−1) min (−1), with no between-group difference, p = 0.22). Quality of life and blood biomarkers remained essentially unchanged, and both self-reported and measured physical activity levels were similar between groups after 12 months. Conclusions A maintenance exercise program for 12 months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care. This suggests that infrequent supervised high intensity interval training sessions are

  4. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2014-01-01

    Plantar fasciitis is the most common cause of heel pain in adults. A novel alternative medical instrument, the miniscalpel-needle (MSN), which is based on an acupuncture needle, has been recently developed in China. The objective of this study was to evaluate the effectiveness of the MSN release treatment versus that of traditional steroid injection for plantar fasciitis. Patients with plantar fasciitis were randomly assigned to 2 groups and followed up for 12 months, with 29 receiving MSN treatment and 25 receiving steroid injection treatment. The results showed that visual analog scale scores for morning pain, active pain, and overall heel pain all were decreased significantly in the MSN group from 1 to 12 months after treatment. In contrast, treatment with steroid injection showed a significant effect only at the 1-month follow-up but not at 6 or 12 months after treatment. Moreover, the MSN group achieved more rapid and sustained improvements than the steroid group throughout the duration of this study. No severe side effects were observed with MSN treatment. Our data suggest that the MSN release treatment is safe and has a significant benefit for plantar fasciitis compared to steroid injection. PMID:25114704

  5. 12 month changes in dietary intake of adolescent girls attending schools in low-income communities following the NEAT Girls cluster randomized controlled trial.

    PubMed

    Collins, Clare E; Dewar, Deborah L; Schumacher, Tracy L; Finn, Tara; Morgan, Philip J; Lubans, David R

    2014-02-01

    Poor dietary habits and obesity are more prevalent in lower socio-economic status (SES) communities. The NEAT Girls cluster randomized controlled trial was a school-based obesity prevention program targeting adolescent girls in low SES schools in NSW, Australia. The aim was to evaluate the 12-month impact of key nutrition program messages on dietary intake and food behaviors. Diet was assessed using a validated semi-quantitative food frequency questionnaire (FFQ). Individual foods were categorized into nutrient-dense or energy-dense, nutrient-poor food groups and the percentage contribution to total energy intake calculated. Participants were aged 13.2±0.5years (n=330). There were no statistically significant group-by-time effects for dietary intake or food related behaviors, with 12-month trends suggesting more intervention group girls had improved water intakes (59% consuming⩽three glasses per day to 54% at 12 months vs. 50% to 61% in controls, p=0.052), with a greater proportion consuming < one sweetened beverage per day (24-41% vs. 34-37% in controls, p=0.057). Further research including more intensive nutrition intervention strategies are required to evaluate whether dietary intake in adolescent girls attending schools in low SES communities can be optimized.

  6. Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial.

    PubMed

    Olafsen, Kåre S; Rønning, John A; Handegård, Bjørn Helge; Ulvund, Stein Erik; Dahl, Lauritz Bredrup; Kaaresen, Per Ivar

    2012-02-01

    Temperamental regulatory competence and social communication in term and preterm infants at 12 months corrected age was studied in a randomized controlled intervention trial aimed at enhancing maternal sensitive responsiveness. Surviving infants <2000 g from a geographically defined area were randomized to an intervention (71) or a control group (69), and compared with term infants (74). The intervention was a modified version of the "Mother-Infant Transaction Program". Regulatory competence was measured with the Infant Behavior Questionnaire, and social communication with the Early Social Communication Scales. Preterm intervention infants with low regulatory competence had higher responding to joint attention than preterm control infants. A sensitizing intervention may moderate the association between temperament and social communication, and thus allow an alternative functional outlet for preterm infants low in regulatory competence. The finding may have implications for conceptualizations of the role of early sensitizing interventions in promoting important developmental outcomes for premature infants.

  7. Cluster-randomized, controlled 12-month trial to evaluate the effect of a parental psychoeducation program on medication persistence in children with attention-deficit/hyperactivity disorder

    PubMed Central

    Montoya, Alonso; Hervás, Amaia; Fuentes, Joaquín; Cardo, Esther; Polavieja, Pepa; Quintero, Javier; Tannock, Rosemary

    2014-01-01

    Background This multicenter, cluster-randomized, nonblinded study evaluated the effect of parental psychoeducation on medication persistence among children and adolescents with newly diagnosed attention-deficit/hyperactivity disorder (ADHD). Methods Patients received standard medication alone or medication plus a parental psychoeducation program, and were followed for 12 months. The primary endpoint was time to withdrawal or termination of medication due to any cause. Secondary endpoints included change in ADHD symptom severity, functional outcome, program satisfaction, and safety. Results A total of 208 patients completed the study, which was terminated early because recruitment had ceased. At 12 months, there was no significant difference between the psychoeducation and control groups in the proportion of patients who discontinued pharmacologic treatment (13.2% versus 14.3%, respectively; size effect −0.3, P=0.34; hazard ratio 0.72, 95% confidence interval 0.36–1.43). Psychoeducation was associated with a significantly greater improvement in ADHD symptoms but not in functional outcome. Parental satisfaction with psychoeducation was high, and satisfaction with pharmacologic treatment was significantly greater in the psychoeducation group. There were no safety concerns. Conclusion No significant advantage for parental psychoeducation plus medication over medication alone in terms of time to medication withdrawal was observed. Psychoeducation had inconsistent but interesting effects on other outcomes. PMID:24966679

  8. Additive effects of nutritional supplementation, together with bisphosphonates, on bone mineral density after hip fracture: a 12-month randomized controlled study

    PubMed Central

    Flodin, Lena; Sääf, Maria; Cederholm, Tommy; Al-Ani, Amer N; Ackermann, Paul W; Samnegård, Eva; Dalen, Nils; Hedström, Margareta

    2014-01-01

    Background After a hip fracture, a catabolic state develops, with increased bone loss during the first year. The aim of this study was to evaluate the effects of postoperative treatment with calcium, vitamin D, and bisphosphonates (alone or together) with nutritional supplementation on total hip and total body bone mineral density (BMD). Methods Seventy-nine patients (56 women), with a mean age of 79 years (range, 61–96 years) and with a recent hip fracture, who were ambulatory before fracture and without severe cognitive impairment, were included. Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly) for 12 months (B; n=28), treatment with bisphosphonates along with nutritional supplementation (40 g protein, 600 kcal daily) for the first 6 months (BN; n=26), or to controls (C; n=25). All participants received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6, and 12 months. Marker of bone resorption C-terminal telopeptide of collagen I and 25-hydroxy vitamin D were analyzed in serum. Results Analysis of complete cases (70/79 at 6 months and 67/79 at 12 months) showed an increase in total hip BMD of 0.7% in the BN group, whereas the B and C groups lost 1.1% and 2.4% of BMD, respectively, between baseline and 6 months (P=0.071, between groups). There was no change in total body BMD between baseline and 12 months in the BN group, whereas the B group and C group both lost BMD, with C losing more than B (P=0.009). Intention-to-treat analysis was in concordance with the complete cases analyses. Conclusion Protein-and energy-rich supplementation in addition to calcium, vitamin D, and bisphosphonate therapy had additive effects on total body BMD and total hip BMD among elderly hip fracture patients. PMID:25045257

  9. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial.

    PubMed

    Blasco, Jordi; Martinez-Ferrer, Angeles; Macho, Juan; San Roman, Luis; Pomés, Jaume; Carrasco, Josep; Monegal, Ana; Guañabens, Nuria; Peris, Pilar

    2012-05-01

    Uncertainty regarding the benefits of vertebroplasty (VP) for the treatment of acute osteoporotic vertebral fractures has recently arisen. A prospective, controlled, randomized single-center trial (ClinicalTrials.gov registration number NCT00994032) was designed to compare the effects of VP versus conservative treatment on the quality of life and pain in patients with painful osteoporotic vertebral fractures, new fractures and secondary adverse effects were also analyzed during a 12-month follow-up period. A total of 125 patients were randomly assigned to receive conservative treatment or VP. The primary end point was to compare the evolution of the quality of life (Quality of Life Questionnaire of the European Foundation for Osteoporosis [Qualeffo-41] and pain (Visual Analogue Scale [VAS]) during a 12 month follow-up. Secondary outcomes included comparison of analgesic consumption, clinical complications, and radiological vertebral fractures at the same time points. Both arms showed significant improvement in VAS scores at all time points, with greater improvement (p = 0.035) in the VP group at the 2-month follow-up. Significant improvement in Qualeffo total score was seen in the VP group throughout the study, whereas this was not seen in the conservative treatment arm until the 6-month follow-up. VP treatment was associated with a significantly increased incidence of vertebral fractures (odds ratio [OR], 2 · 78; 95% confidence interval [CI], 1.02-7.62, p = 0.0462). VP and conservative treatment are both associated with significant improvement in pain and quality of life in patients with painful osteoporotic vertebral fractures over a 1-year follow-up period. VP achieved faster pain relief with significant improvement in the pain score at the 2-month follow-up but was associated with a higher incidence in vertebral fractures.

  10. High-load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12-month follow-up.

    PubMed

    Rathleff, M S; Mølgaard, C M; Fredberg, U; Kaalund, S; Andersen, K B; Jensen, T T; Aaskov, S; Olesen, J L

    2015-06-01

    The aim of this study was to investigate the effectiveness of shoe inserts and plantar fascia-specific stretching vs shoe inserts and high-load strength training in patients with plantar fasciitis. Forty-eight patients with ultrasonography-verified plantar fasciitis were randomized to shoe inserts and daily plantar-specific stretching (the stretch group) or shoe inserts and high-load progressive strength training (the strength group) performed every second day. High-load strength training consisted of unilateral heel raises with a towel inserted under the toes. Primary outcome was the foot function index (FFI) at 3 months. Additional follow-ups were performed at 1, 6, and 12 months. At the primary endpoint, at 3 months, the strength group had a FFI that was 29 points lower [95% confidence interval (CI): 6-52, P = 0.016] compared with the stretch group. At 1, 6, and 12 months, there were no differences between groups (P > 0.34). At 12 months, the FFI was 22 points (95% CI: 9-36) in the strength group and 16 points (95% CI: 0-32) in the stretch group. There were no differences in any of the secondary outcomes. A simple progressive exercise protocol, performed every second day, resulted in superior self-reported outcome after 3 months compared with plantar-specific stretching. High-load strength training may aid in a quicker reduction in pain and improvements in function.

  11. Technology-assisted balance and gait training reduces falls in patients with Parkinson's disease: a randomized controlled trial with 12-month follow-up.

    PubMed

    Shen, Xia; Mak, Margaret K Y

    2015-02-01

    Objective. To examine the effects of technology-assisted balance and gait training on reducing falls in patients with Parkinson's disease (PD). Methods. Eligible subjects were randomly allocated to an experimental group given technology-assisted balance and gait training (BAL, n = 26) and an active control group undertaking strengthening exercises (CON, n = 25). The training in each group lasted for 3 months. The number of fallers and fall rate were used as primary outcomes, and single-leg-stance-time, latency of postural response to perturbation, self-selected gait velocity, and stride length as secondary outcomes. Fall incidence was recorded over 15 months after the baseline assessment (Pre). Other tests were performed at Pre, after 3-month intervention (Post(3m)), at 3 months (Post(6m)), and 12 months (Post(15m)) after treatment completion. Results. Forty-five subjects who completed the 3-month training were included in the data analysis. There were fewer fallers in the BAL than in the CON group at Post(3m), Post(6m), and Post(15m) (P < .05). In addition, the BAL group had lower fall rate than the CON group at Post(3m) and Post(6m) (incidence rate ratio: 0.111-0.188, P < .05), and marginally so at Post(15m) (incidence rate ratio: 0.407, P = .057). Compared with the CON subjects, the BAL subjects demonstrated greater reduction in the postural response latency and increase in the stride length against baseline at each assessment interval (P < .05), and marginally more increases of single-leg-stance-time at Post(3m) (P = .064), Post(6m) (P = .041) and Post(15m) (P = .087). Conclusions. Our positive findings provide evidence for the clinical use of technology-assisted balance and gait training in reducing falls in people with PD.

  12. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes

    PubMed Central

    Polly, David W.; Wine, Kathryn D.; Whang, Peter G.; Frank, Clay J.; Harvey, Charles F.; Lockstadt, Harry; Glaser, John A.; Limoni, Robert P.; Sembrano, Jonathan N.

    2015-01-01

    BACKGROUND: Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS: Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (≥ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION: This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. ABBREVIATIONS: EQ-5D, EuroQoL-5D INSITE, Investigation of Sacroiliac Fusion Treatment MCS, mental component summary NSM, nonsurgical management ODI, Oswestry Disability Index PCS, physical component summary RFA, radiofrequency ablation SF

  13. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases.

    PubMed

    Miyauchi, Akimitsu; Matsumoto, Toshio; Sugimoto, Toshitsugu; Tsujimoto, Mika; Warner, Margaret R; Nakamura, Toshitaka

    2010-09-01

    This multicenter study assessed the safety and efficacy of teriparatide 20 microg/day in Japanese men and women with osteoporosis at high risk of fracture during a 12-month, randomized, double-blind, placebo-controlled treatment period followed by second and third treatment periods (to 18 and 24 months, respectively,) in which all subjects received open-label teriparatide. Subjects (93% female; median age 70 years) were randomized 2:1 to teriparatide versus placebo (randomized at baseline, teriparatide n=137, placebo-teriparatide n=70; entering the second period, teriparatide n=119, placebo-teriparatide n=59; entering the third period, teriparatide n=102, placebo-teriparatide n=50). For subjects with measurements at 12 months, teriparatide significantly increased bone mineral density (BMD) at the lumbar spine L2-L4 (mean percent change+/-SD, teriparatide 10.04+/-5.23% versus placebo-teriparatide 0.19+/-4.33%), the femoral neck (teriparatide 2.01+/-4.63% versus placebo-teriparatide 0.44+/-3.97%), and the total hip (teriparatide 2.72+/-4.04% versus placebo-teriparatide -0.26+/-3.42%). In the placebo-teriparatide group at 24 months (12-month teriparatide dosing) BMD increased by 9.11+/-5.14% at the lumbar spine, 2.19+/-4.81% at the femoral neck and 2.46+/-3.54% at the total hip. In the teriparatide group at 18 and 24 months, BMD increased from baseline at the lumbar spine by 11.93+/-5.79% and 13.42+/-6.12%, respectively; at the femoral neck by 2.68+/-4.45% and 3.26+/-4.25%, respectively; and at the total hip by 3.02+/-3.79% and 3.67+/-3.98%, respectively. Serum procollagen I N-terminal pro-peptide (PINP) increased rapidly with teriparatide treatment (P<0.001 versus placebo at 1 month) and changed from baseline in the teriparatide and placebo-teriparatide groups at 12 months by a median of 78.95% and -17.23%, respectively, (P<0.001) and at 24 months by 49.24% and 76.12%, respectively. The incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, and

  14. Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture

    PubMed Central

    Thabane, Lehana; Adachi, Jonathan D.; Ashe, Maureen C.; Bleakney, Robert R.; Braun, E. Anne; Cheung, Angela M.; Fraser, Lisa-Ann; Gibbs, Jenna C.; Hill, Keith D.; Hodsman, Anthony B.; Kendler, David L.; Mittmann, Nicole; Prasad, Sadhana; Scherer, Samuel C.; Wark, John D.; Papaioannou, Alexandra

    2014-01-01

    Background Our goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral fracture. Objectives This pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial. Design The proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups. Setting Five Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services). Participants One hundred sixty women aged ≥65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited. Intervention The Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ≥3 times weekly. Controls will receive equal attention. Measurements Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of

  15. Neighborhood walkability, fear and risk of falling and response to walking promotion: The Easy Steps to Health 12-month randomized controlled trial

    PubMed Central

    Merom, D.; Gebel, K.; Fahey, P.; Astell-Burt, T.; Voukelatos, A.; Rissel, C.; Sherrington, C.

    2015-01-01

    In older adults the relationships between health, fall-related risk factors, perceived neighborhood walkability, walking behavior and intervention impacts are poorly understood. To determine whether: i) health and fall-related risk factors were associated with perceptions of neighborhood walkability; ii) perceived environmental attributes, and fall-related risk factors predicted change in walking behavior at 12 months; and iii) perceived environmental attributes and fall-related risk factors moderated the effect of a self-paced walking program on walking behavior. Randomized trial on walking and falls conducted between 2009 and 2012 involving 315 community-dwelling inactive adults ≥ 65 years living in Sydney, Australia. Measures were: mobility status, fall history, injurious fall and fear of falling (i.e., fall-related risk factors), health status, walking self-efficacy and 11 items from the neighborhood walkability scale and planned walking ≥ 150 min/week at 12 months. Participants with poorer mobility, fear of falling, and poor health perceived their surroundings as less walkable. Walking at 12 months was significantly greater in “less greenery” (AOR = 3.3, 95% CI: 1.11–9.98) and “high traffic” (AOR = 1.98, 95% CI: 1.00–3.91) neighborhoods. The intervention had greater effects in neighborhoods perceived to have poorer pedestrian infrastructure (p for interaction = 0.036). Low perceived walkability was shaped by health status and did not appear to be a barrier to walking behavior. There appears to be a greater impact of, and thus, need for, interventions to encourage walking in environments perceived not to have supportive walking infrastructure. Future studies on built environments and walking should gather information on fall-related risk factors to better understand how these characteristics interact. PMID:26844140

  16. The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12 month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome

    PubMed Central

    Lackner, Jeffrey M.; Keefer, Laurie; Jaccard, James; Firth, Rebecca; Brenner, Darren; Bratten, Jason; Dunlap, Laura J.; Byroads, Mark

    2012-01-01

    Irritable bowel syndrome is a common, oftentimes disabling, gastrointestinal disorder whose full range of symptoms has no satisfactory medical or dietary treatment. One of the few empirically validated treatments includes a specific psychological therapy called cognitive behavior therapy which, if available, is typically administered over several months by trained practitioners in tertiary care settings. There is an urgent need to develop more efficient versions of CBT that require minimal professional assistance but retain the efficacy profile of clinic based CBT. The Irritable Bowel Syndrome Outcome Study (IBSOS) is a multicenter, placebo-controlled randomized trial to evaluate whether a self-administered version of CBT is, at least as efficacious as standard CBT and more efficacious than an attention control in reducing core GI symptoms of IBS and its burden (e.g. distress, quality of life impairment, etc) in moderately to severely affected IBS patients. Additional goals are to assess, at quarterly intervals, the durability of treatment response over a 12 month period; to identify clinically useful patient characteristics associated with outcome as a way of gaining an understanding of subgroups of participants for whom CBT is most beneficial; to identify theory-based change mechanisms (active ingredients) that explain how and why CBT works; and evaluate the economic costs and benefits of CBT. Between August 2010 when IBSOS began recruiting subjects and February 2012, the IBSOS randomized 171 of 480 patients. Findings have the potential to improve the health of IBS patients, reduce its social and economic costs, conserve scarce health care resources, and inform evidence-based practice guidelines. PMID:22846389

  17. Effectiveness of a 12-month randomized clinical trial to increase physical activity in multiethnic postpartum women: Results from Hawaii’s Nā Mikimiki Project

    PubMed Central

    Albright, Cheryl L.; Steffen, Alana D.; Wilkens, Lynne R.; White, Kami K.; Novotny, Rachel; Nigg, Claudio R.; Saiki, Kara; Brown, Wendy J.

    2015-01-01

    Objective Few postpartum ethnic minority women perform leisure-time moderate-to-vigorous physical activity (MVPA). The study tested the effectiveness of a 12-month tailored intervention to increase MVPA in women with infants 2–12 months old. Methods From 2008–2011, women (n=311) with infants (average age = 5.7 months) from Honolulu, Hawaii were randomly assigned to receive tailored telephone calls and access to a mom-centric website (n=154) or access to a standard PA website (n=157). MVPA was measured at baseline, 6, and 12 months using self-report and acclerometers. Results Controlling for covariates, the tailored condition significantly increased self-reported MVPA from an average of 44 to 246 minutes/week compared with 46 to 156 minutes/week for the standard condition (p=0.027). Mothers with ≥ 2 children had significantly greater increases in MVPA in response to the tailored intervention than those with one child (p=0.016). Accelerometer-measured MVPA significantly increased over time (p=0.0001), with no condition differences. There was evidence of reactivity to initially wearing accelerometers; the tailored intervention significantly increased MVPA among women with low baseline accelerometer MVPA minutes, but not among those with high minutes (pinteraction=0.053). Conclusion A tailored intervention effectively increased MVPA over 12 months in multiethnic women with infants, particularly those with more than one child. PMID:25285751

  18. Weight loss effects from vegetable intake: a 12-month randomised controlled trial

    PubMed Central

    Tapsell, L C; Batterham, M J; Thorne, R L; O'Shea, J E; Grafenauer, S J; Probst, Y C

    2014-01-01

    Background/Objectives: Direct evidence for the effects of vegetable intake on weight loss is qualified. The study aimed to assess the effect of higher vegetable consumption on weight loss. Subjects/Methods: A single blind parallel controlled trial was conducted with 120 overweight adults (mean body mass index=29.98 kg/m2) randomised to two energy deficit healthy diet advice groups differing only by doubling the serving (portion) sizes of vegetables in the comparator group. Data were analysed as intention-to-treat using a linear mixed model. Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss. Results: After 12 months, the study sample lost 6.5±5.2 kg (P<0.001 time) with no difference between groups (P>0.05 interaction). Both groups increased vegetable intake and lost weight in the first 3 months, and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables (rho=–0.217, P=0.024). Fasting glucose, insulin and triglyceride levels decreased (P<0.001 time) and high-density lipoprotein cholesterol levels increased (P<0.001 time), with no difference between groups. Weight loss was sustained for 12 months by both groups, but the comparator group reported greater hunger satisfaction (P=0.005). Conclusions: Advice to consume a healthy low-energy diet leads to sustained weight loss, with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables. In the short term, consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable. PMID:24667750

  19. Non-pharmacological, multicomponent group therapy in patients with degenerative dementia: a 12-month randomzied, controlled trial

    PubMed Central

    2011-01-01

    Background Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia. Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care. Methods A randomized, controlled, single-blind longitudinal trial was conducted with 98 patients (follow-up: n = 61) with primary degenerative dementia in five nursing homes in Bavaria, Germany. The highly standardized intervention consisted of motor stimulation, practice in activities of daily living, and cognitive stimulation (acronym MAKS). It was conducted in groups of ten patients led by two therapists for 2 hours, 6 days a week for 12 months. Control patients received treatment as usual. Cognitive function was assessed using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living (E-ADL test) at baseline and after 12 months. Results Of the 553 individuals screened, 119 (21.5%) were eligible and 98 (17.7%) were ultimately included in the study. At 12 months, the results of the per protocol analysis (n = 61) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients (ADAS-Cog: adjusted mean difference: -7.7, 95% CI -14.0 to -1.4, P = 0.018, Cohen's d = 0.45; E-ADL test: adjusted mean difference: 3.6, 95% CI 0.7 to 6.4, P = 0.015, Cohen's d = 0.50). The effect sizes for the intervention were greater in the subgroup of patients (n = 50) with mild to moderate disease (ADAS-Cog: Cohen's d = 0.67; E-ADL test: Cohen's d = 0.69). Conclusions A highly standardized, non-pharmacological, multicomponent group intervention conducted

  20. Resistance Training and Executive Functions: A 12-Month Randomised Controlled Trial

    PubMed Central

    Liu-Ambrose, Teresa; Nagamatsu, Lindsay S; Graf, Peter; Beattie, B Lynn; Ashe, Maureen C; Handy, Todd C

    2012-01-01

    BACKGROUND Cognitive decline among seniors is a pressing health care issue. Specific exercise training may combat cognitive decline. We compared the effect of once-weekly and twice-weekly resistance training with twice-weekly balance and tone exercise training on the performance of executive cognitive functions in senior women. METHODS In this single-blinded randomised trial, 155 community-dwelling women aged 65 to 75 years old living in Vancouver, Canada were randomly allocated to once-weekly resistance training (n=54), twice-weekly resistance training (n=52), or to twice-weekly balance and tone training (i.e., control group) (n=49). Primary outcome measure was performance on the Stroop Test, an executive cognitive test of selective attention and conflict resolution. Secondary outcomes of executive cognitive functions included set shifting as measured by the Trail Making Tests (Part A & B) and working memory as assessed by verbal digits forward and backward tests. Gait speed, muscular function, and whole brain volume were also secondary outcome measures. RESULTS Both resistance training groups significantly improved their performance on the Stroop Test compared with those in the balance and tone group (p≤0.03). Specifically, task performance improved by 12.6% and 10.9% in the once-weekly and twice-weekly resistance training groups respectively; it deteriorated by 0.5% in the balance and tone group. Enhanced selective attention and conflict resolution was significantly associated with increased gait speed. Also, both resistance training groups demonstrated reductions in whole brain volume compared with the balance and tone group at the end of the study (p≤0.03). CONCLUSIONS Twelve months of once-weekly or twice-weekly resistance training benefited the executive cognitive function of selective attention and conflict resolution among senior women. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00426881 PMID:20101012

  1. Controlled clinical trial addressing teeth whitening with hydrogen peroxide in adolescents: a 12-month follow-up

    PubMed Central

    Pinto, Marcelo Mendes; Gonçalves, Marcela Leticia Leal; da Mota, Ana Carolina Costa; Deana, Alessandro Melo; Olivan, Silvia Regina; Bortoletto, Carolina; de Godoy, Camila Haddad Leal; Vergilio, Katia Lumi Tanikawa; Altavista, Olga Maria; Motta, Lara J; Bussadori, Sandra Kalil

    2017-01-01

    OBJECTIVES: To evaluate the colorimetric change in incisors and canines of adolescents aged 12 to 20 years submitted to at-home whitening and to evaluate satisfaction, sensitivity and discomfort during the procedures through a questionnaire. METHOD: Thirty adolescents were randomly assigned to the following groups: 1) 6.0% hydrogen peroxide (White Class with calcium – FGM); 2) 7.5% hydrogen peroxide (White Class with calcium - FGM); 3) 10% hydrogen peroxide (Oral B 3D White – Oral-B); 4) Control group – placebo. Assessments were performed prior to treatment as well as at 7, 30, 180 and 360 days after treatment. Friedman’s ANOVA was used to analyze color. The Kruskal-Wallis test followed by Dunn’s post hoc test was used to compare the groups at the different evaluation times. Answers on the questionnaires were ranked, and non-parametrical tests were employed. The groups were compared in each period using the Kruskal-Wallis test followed by the Student-Newman-Keuls test. Categorical data were analyzed using Fisher's exact test, and the Wilcoxon test was used for the analysis of different periods. P-values were corrected using the Hyan-Holm step-down Bonferroni procedure. Clinicaltrials.gov: NCT01998386. RESULTS: Similar results were obtained one month after treatment with both tooth whitening gels and whitening strips. Patients were partially satisfied with the treatment after the first and second weeks and would recommend it. All products demonstrated color stability after 12 months of follow-up. CONCLUSIONS: The bleaching procedure was efficient, and the patients could perceive its result. Further investigations are needed to determine the effects of bleaching on young teeth. PMID:28355362

  2. A Randomized Trial of Computerized vs. In-person Brief Intervention for Illicit Drug Use in Primary Care: Outcomes through 12 months

    PubMed Central

    Gryczynski, Jan; Mitchell, Shannon Gwin; Gonzales, Arturo; Moseley, Ana; Peterson, Thomas R.; Ondersma, Steven J.; O'Grady, Kevin E.; Schwartz, Robert P.

    2014-01-01

    This study examined outcomes through 12 months from a randomized trial comparing computerized brief intervention (CBI) vs. in-person brief intervention (IBI) delivered by behavioral health counselors for adult community health center patients with moderate-level drug misuse (N= 360). Data were collected at baseline, 3-, 6-, and 12-month follow-up, and included the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and laboratory analysis of hair samples. Repeated measures analyses examined differential change over time. There were no significant differences in drug-positive hair tests over time or by condition. Global ASSIST scores decreased in both conditions (p< .001), but there were no significant differences between conditions in overall change across 12 months of follow-up (p= .13). CBI produced greater overall reductions in alcohol (p= .04) and cocaine (p= .02) ASSIST scores than IBI, with initial differences dissipating over time. Computerized brief interventions present a viable alternative to traditional in-person brief interventions. PMID:25282578

  3. Developmental milestones record - 12 months

    MedlinePlus

    Normal childhood growth milestones - 12 months; Growth milestones for children - 12 months; Childhood growth milestones - 12 months ... care provider. PHYSICAL AND MOTOR SKILLS A 12-month-old child is expected to: Be 3 times ...

  4. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

    PubMed Central

    Münch, Andreas; Bohr, Johan; Miehlke, Stephan; Benoni, Cecilia; Olesen, Martin; Öst, Åke; Strandberg, Lars; Hellström, Per M; Hertervig, Erik; Armerding, Peter; Stehlik, Jiri; Lindberg, Greger; Björk, Jan; Lapidus, Annika; Löfberg, Robert; Bonderup, Ole; Avnström, Sören; Rössle, Martin; Dilger, Karin; Mueller, Ralph; Greinwald, Roland; Tysk, Curt; Ström, Magnus

    2016-01-01

    Objective This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis. Design A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase. Results Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious. Conclusions Budesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation. Trial registration numbers http://www.clinicaltrials.gov (NCT01278082) and http

  5. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age.

    PubMed

    Vesikari, Timo; Silfverdal, Sven Arne; Boisnard, Florence; Thomas, Stéphane; Mwawasi, Grace; Reynolds, Donna

    2013-10-01

    This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP(5)-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.).

  6. Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria–Tetanus Toxoid–Five-Component Acellular Pertussis (DTaP5), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP3-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age

    PubMed Central

    Silfverdal, Sven Arne; Boisnard, Florence; Thomas, Stéphane; Mwawasi, Grace; Reynolds, Donna

    2013-01-01

    This study compared the levels of immunogenicity and safety of diphtheria–tetanus toxoid–five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP5-IPV-Hib) and DTaP3-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP5-IPV-Hib to DTaP3-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP5-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.) PMID:23966556

  7. Randomized study on the effect of single-implant versus two-implant retained overdentures on implant loss and muscle activity: a 12-month follow-up report.

    PubMed

    Alqutaibi, A Y; Kaddah, A F; Farouk, M

    2017-02-22

    The objective was to evaluate and compare single- and two-implant retained overdentures for the rehabilitation of the edentulous mandible. Fifty-six edentulous subjects were eligible for inclusion. Using a random sampling system, a single implant or two implants were placed in the mandible. After 3 months, locator attachments were connected to the implants and the denture delivered with the retentive components incorporated in the denture base. Implant failure and muscle activity were evaluated at the 3-, 6-, and 12-month follow-up examinations. The study sample comprised 56 patients (32 male, 24 female), with a mean age of 58.2 years. A total of 84 implants were placed (28 in the single-implant group and 56 in the two-implant group). All patients completed the 12 months of follow-up. No significant differences were found between subjects in the two groups with respect to implant failure. With regard to improvements in muscle activity, the two-implant group showed statistically significant but perhaps not clinically important differences. Single-implant mandibular overdentures may be suggested as an alternative treatment modality for the rehabilitation of edentulous patients who cannot afford the cost of a two-implant overdenture.

  8. Improved asthma control in patients with severe, persistent allergic asthma after 12 months of nightly temperature-controlled laminar airflow: an observational study with retrospective comparisons

    PubMed Central

    Schauer, Uwe; Bergmann, Karl-Christian; Gerstlauer, Michael; Lehmann, Sylvia; Gappa, Monika; Brenneken, Amelie; Schulz, Christian; Ahrens, Peter; Schreiber, Jens; Wittmann, Michael; Hamelmann, Eckard

    2015-01-01

    Introduction Continuous or episodic allergen exposure is a major risk factor of frequent symptoms and exacerbations for patients with allergic asthma. It has been shown that temperature-controlled laminar airflow (TLA) significantly reduced allergen exposure and airway inflammation and improved quality of life of patients with poorly controlled allergic asthma. Objective The objective was to evaluate the effects of nighttime TLA when used during real-life conditions for 12 consecutive months in addition to the patients’ regular medication. Methods This multicenter, pre- and postretrospective observational study included patients with inadequately controlled moderate-to-severe allergic asthma who received add-on treatment with TLA for 12 consecutive months. Data on medication use, asthma control, asthma symptoms, lung function, use of hospital resources, and exacerbations were collected after 4 and 12 months and compared with corresponding data collected retrospectively from medical records during the year prior to inclusion in the study. Results Data from 30 patients (mean age 28; range 8–70) completing 4 months and 27 patients completing 12 months of TLA use are presented. The mean number of exacerbations was reduced from 3.6 to 1.3 (p<0.0001), and the ratio of asthma-related emergency room visits or hospitalizations diminished from 72.4 to 23.3% (p=0.001) or from 44.8 to 20.0% (p<0.05), respectively, after 12 months of TLA use. The Asthma Control Test index increased from 14.1 to 18.5 (p<0.0001). After 4 months of TLA use, clear improvements can be shown for most variables in line with the data collected after 12 months. Conclusions The addition of TLA to the patients’ regular medication significantly reduced exacerbations, asthma symptoms, and the utilization of hospital resources. The data support that TLA may be an important new non-pharmacological approach in the management of poorly controlled allergic asthma. PMID:26557252

  9. Effect of Improving Dietary Quality on Arterial Stiffness in Subjects with Type 1 and Type 2 Diabetes: A 12 Months Randomised Controlled Trial

    PubMed Central

    Petersen, Kristina S.; Clifton, Peter M.; Lister, Natalie; Keogh, Jennifer B.

    2016-01-01

    People with diabetes have accelerated arterial stiffening. The aim of this study was to determine the effect of increasing fruit, vegetable and dairy intake for 12 months on carotid femoral pulse wave velocity (cfPWV), augmentation index (AIx), and central blood pressure (cBP), compared to a usual diet control, in people with type 1 and type 2 diabetes. In a 12 months randomised controlled trial, cfPWV, AIx and cBP were measured every 3 months. The intervention group received dietary counselling to increase consumption of fruit (+1 serving/day; 150 g/day), vegetables (+2 servings/day; 150 g/day) and dairy (+1 serving/day; 200–250 g/day) at baseline, 1, 3, 6 and 9 months. The control group continued on their usual diet. One hundred and nine participants were randomised and 92 (intervention n = 45; control n = 47) completed. At 3 months, fruit (184 g/day; p = 0.001) and dairy (83 g/day; p = 0.037) intake increased in the intervention group compared with the control group but this increase was not maintained at 12 months. After adjustment for baseline measurements there was no time by treatment effect for central systolic or diastolic BP, AIx or cfPWV. A time effect existed for AIx which modestly increased over time. Peripheral diastolic BP and central pulse pressure were improved in the intervention group compared with the control group at 12 months. In the cohort with type 1 and type 2 diabetes, improving dietary quality by increasing consumption of fruit, vegetables and dairy did not improve cBP, AIx or cfPWV, compared with a control group continuing on their usual diet, after 12 months. PMID:27338467

  10. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial

    PubMed Central

    Deer, Timothy R.; Levy, Robert M.; Kramer, Jeffery; Poree, Lawrence; Amirdelfan, Kasra; Grigsby, Eric; Staats, Peter; Burton, Allen W.; Burgher, Abram H.; Obray, Jon; Scowcroft, James; Golovac, Stan; Kapural, Leonardo; Paicius, Richard; Kim, Christopher; Pope, Jason; Yearwood, Thomas; Samuel, Sam; McRoberts, W. Porter; Cassim, Hazmer; Netherton, Mark; Miller, Nathan; Schaufele, Michael; Tavel, Edward; Davis, Timothy; Davis, Kristina; Johnson, Linda; Mekhail, Nagy

    2016-01-01

    Abstract Animal and human studies indicate that electrical stimulation of dorsal root ganglion (DRG) neurons may modulate neuropathic pain signals. ACCURATE, a pivotal, prospective, multicenter, randomized comparative effectiveness trial, was conducted in 152 subjects diagnosed with complex regional pain syndrome or causalgia in the lower extremities. Subjects received neurostimulation of the DRG or dorsal column (spinal cord stimulation, SCS). The primary end point was a composite of safety and efficacy at 3 months, and subjects were assessed through 12 months for long-term outcomes and adverse events. The predefined primary composite end point of treatment success was met for subjects with a permanent implant who reported 50% or greater decrease in visual analog scale score from preimplant baseline and who did not report any stimulation-related neurological deficits. No subjects reported stimulation-related neurological deficits. The percentage of subjects receiving ≥50% pain relief and treatment success was greater in the DRG arm (81.2%) than in the SCS arm (55.7%, P < 0.001) at 3 months. Device-related and serious adverse events were not different between the 2 groups. Dorsal root ganglion stimulation also demonstrated greater improvements in quality of life and psychological disposition. Finally, subjects using DRG stimulation reported less postural variation in paresthesia (P < 0.001) and reduced extraneous stimulation in nonpainful areas (P = 0.014), indicating DRG stimulation provided more targeted therapy to painful parts of the lower extremities. As the largest prospective, randomized comparative effectiveness trial to date, the results show that DRG stimulation provided a higher rate of treatment success with less postural variation in paresthesia intensity compared to SCS. PMID:28030470

  11. Survival analysis of banding and bonding molar tubes in adult patients over a 12-month period: a split-mouth randomized clinical trial.

    PubMed

    Oeiras, Valéria Jacques; Silva, Valéria Assis Almeida E; Azevedo, Leidiana Aguiar; Lobato, Vanessa Soares; Normando, David

    2016-12-22

    This split-mouth randomized clinical trial aimed to compare the survival rate of bonding and banding molar tubes in adult orthodontic patients. Eligibility criteria included adults (aged >18 years), no active caries, restorations, or fractures in the upper and lower molars. The main outcome was any type of first-time failure in molar tubes. A computer-generated randomization scheme was used in a 1:1 ratio. The survival rate was estimated for 32 adult patients, in whom a tube was bonded to a molar tooth using composite resin on one side and a band was cemented with glass ionomer onto the same tooth in the contralateral arch. A total of 59 banded and 59 bonded molars were followed up for 12 months. Blinding was not applicable. Survival analysis including Cox regression was used at p < 0.05. The survival rate of bonded molars was not statistically different from that of banded molars (log-rank test, p = 0.97). Hazard ratio (HR) was 0.72 (95%CI, 0.38-1.31). Bonded upper molars yielded a survival rate of 81.25% (26 out of 32) compared to 71.87% (23 out of 32) for banded upper molars. The survival rate was 66.66% (18 out of 27) for banded lower molars and 59.25% for bonded lower molars (16 out of 27). The HR for lower vs. upper arch was 2.16 (95%CI, 1.18-3.98). No serious problem was observed other than gingivitis associated with plaque accumulation. In contrast to previous studies in young patients, in adults, bonding orthodontic tubes to molars is similar to molar banding. However, both procedures had a high failure rate in the lower arch.

  12. The effects of different levels of calcium supplementation on the bone mineral status of postpartum lactating Chinese women: a 12-month randomised, double-blinded, controlled trial.

    PubMed

    Zhang, Zhe-Qing; Chen, Yu-Ming; Wang, Ruo-Qin; Huang, Zhen-Wu; Yang, Xiao-Guang; Su, Yi-Xiang

    2016-01-14

    Increasing dietary Ca intake may prevent the excessive mobilisation of bone mineral in nursing mothers. We aimed to investigate whether higher Ca intake could positively modulate the bone mineral changes in Chinese postpartum lactating women. The study was a 12-month randomised, double-blinded, parallel group trial conducted over 12 months. A total of 150 postpartum women were randomly selected to receive either 40 g of milk powder containing 300 mg of Ca and 5 μg of vitamin D (Low-Ca group) or same milk powder additionally fortified with 300 mg of Ca (Mid-Ca group) or 600 mg of Ca (High-Ca group). Bone mineral density (BMD) for the whole body, the lumbar spine, the total left hip and its sub-regions was measured using dual-energy X-ray absorptiometry. A total of 102 subjects completed the whole trial. The duration of total lactating time was 7·9 (SD 2·8) months on average. The intention-to-treat analysis yielded the following mean percentage changes in BMD for the whole body, the lumbar spine and the total left hip, respectively: -0·93 (SD 1·97), 2·11 (SD 4·90) and -1·60 (SD 2·65)% for the Low-Ca group; -0·56 (SD 1·89), 2·21 (SD 3·77) and -1·43 (SD 2·30)% for the Mid-Ca group; and -0·44 (SD 1·67), 2·32 (SD 4·66) and -0·95 (SD 4·08)% for the High-Ca group. The differences between the groups were not statistically significant (P: 0·5-0·9). The results of the complete case analysis were similar. In sum, we found no significant differences in the bone mineral changes from baseline to 12 months in postpartum lactating women consuming milk powder fortified with different levels of Ca.

  13. A 12-month clinical investigation with a 24-day regimen containing 15 microg ethinylestradiol plus 60 microg gestodene with respect to hemostasis and cycle control.

    PubMed

    Fruzzetti, F; Genazzani, A R; Ricci, C; De Negri, F; Bersi, C; Carmassi, F

    2001-06-01

    The effects of a 24-day regimen containing 15 microg ethinyl estradiol (EE) plus 60 microg gestodene on cycle control and on hemostasis, were evaluated in 58 healthy women (age 19-47 years). All women received the pill for 12 months. Withdrawal bleeding at every cycle during the tablet-free interval was experienced by 84.5% of the women. The overall incidence of irregular bleedings was 19.3%. Hemostasis was evaluated in 20 women. No changes in plasma fibrinogen concentrations, nor in prothrombin fragment F1+2 were observed. A slight increase in thrombin-antithrombin III complexes was observed after 6 and 12 months of oral contraceptive use. Antithrombin III activity significantly increased after one-year of pill intake. The concentrations of tissue plasminogen activator and plasminogen activator inhibitor, both antigen and activity, did not change. These results show that very low doses of EE, such as 15 microg, do not impair hemostasis in healthy females. However, the reduction for the EE dose is responsible of some of the effects on cycle control.

  14. Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results

    PubMed Central

    2013-01-01

    Background No study to date has evaluated the efficacy and safety of everolimus with reduced-exposure cyclosporine in Japanese de-novo renal transplant (RTx) patients. Methods This 12-month, multicenter, open-label study randomized (1:1) 122 Japanese de-novo RTx patients to either an everolimus regimen (1.5 mg/day starting dose (target trough: 3 to 8 ng/ml) + reduced-dose cyclosporine) or a mycophenolate mofetil (MMF) regimen (2 g/day + standard dose cyclosporine). All patients received basiliximab and corticosteroids. Key endpoints at month 12 were composite efficacy failure (treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up) and renal function (estimated glomerular filtration rate; Modification of Diet in Renal Disease-4). Results Clear cyclosporine exposure reduction was achieved in the everolimus group throughout the study (52% reduction at month 12). Month 12 efficacy failure rates showed everolimus 1.5 mg to be non-inferior to MMF (11.5% vs. 11.5%). The median estimated glomerular filtration rate at month 12 was 58.00 ml/minute/1.73 m2 in the everolimus group versus 55.25 ml/minute/1.73 m2 in the MMF group (P = 0.063). Overall, the incidence of adverse events was comparable between the groups with some differences in line with the known safety profile of the treatments. The everolimus group had a higher incidence of wound healing events and edema, whereas a higher rate of cytomegalovirus infections was reported in the MMF group. Conclusions This study confirmed the efficacy of everolimus 1.5 mg/day (target trough: 3 to 8 ng/ml) in Japanese RTx patients for preventing acute rejection, while allowing for substantial cyclosporine sparing. Renal function and safety findings were comparable with previous reports from other RTx populations. Trial registration ClinicalTrials.gov number: NCT00658320 PMID:23866828

  15. Oral administration of polymer hyaluronic acid alleviates symptoms of knee osteoarthritis: a double-blind, placebo-controlled study over a 12-month period.

    PubMed

    Tashiro, Toshiyuki; Seino, Satoshi; Sato, Toshihide; Matsuoka, Ryosuke; Masuda, Yasunobu; Fukui, Naoshi

    2012-01-01

    This study was conducted to investigate the efficacy of oral hyaluronic acid (HA) administration for osteoarthritis (OA) in knee joints. Sixty osteoarthritic subjects (Kellgren-Lawrence grade 2 or 3) were randomly assigned to the HA or placebo group. The subjects in the HA group were given 200 mg of HA once a day everyday for 12 months, while the subjects in the placebo group were given placebo. The subjects in both groups were requested to conduct quadriceps strengthening exercise everyday as part of the treatment. The subjects' symptoms were evaluated by the Japanese Knee Osteoarthritis Measure (JKOM) score. The symptoms of the subjects as determined by the JKOM score improved with time in both the HA and placebo groups. This improvement tended to be more obvious with the HA group, and this trend was more obvious with the subjects aged 70 years or less. For these relatively younger subjects, the JKOM score was significantly better than the one for the placebo group at the 2nd and 4th months after the initiation of administration. Oral administration of HA may improve the symptoms of knee OA in patients aged 70 years or younger when combined with the quadriceps strengthening exercise.

  16. Immunogenicity of reduced dose priming schedules of serogroup C meningococcal conjugate vaccine followed by booster at 12 months in infants: open label randomised controlled trial

    PubMed Central

    Khatami, Ameneh; McKenna, Jennifer; Campbell, Danielle; Attard-Montalto, Simon; Birks, Jacqueline; Voysey, Merryn; White, Catherine; Finn, Adam; Macloed, Emma; Faust, Saul N; Kent, Alison Louise; Heath, Paul T; Borrow, Ray; Snape, Matthew D; Pollard, Andrew J

    2015-01-01

    Objective To determine whether the immunogenicity of a single dose infant priming schedule of serogroup C meningococcal (MenC) conjugate vaccine is non-inferior to a two dose priming schedule when followed by a booster dose at age 12 months. Design Phase IV open label randomised controlled trial carried out from July 2010 until August 2013 Setting Four centres in the United Kingdom and one centre in Malta. Participants Healthy infants aged 6-12 weeks followed up until age 24 months. Interventions In the priming phase of the trial 509 infants were randomised in a 10:10:7:4 ratio into four groups to receive either a single MenC-cross reacting material 197 (CRM) dose at 3 months; two doses of MenC-CRM at 3 and 4 months; a single MenC-polysaccharide-tetanus toxoid (TT) dose at 3 months; or no MenC doses, respectively. Haemophilus influenzae type b (Hib)-MenC-TT vaccine was administered to all infants at 12 months of age. All infants also received the nationally routinely recommended vaccines. Blood samples were taken at age 5, 12, 13, and 24 months. Main outcome measure MenC serum bactericidal antibody assay with rabbit complement (rSBA) one month after the Hib-MenC-TT vaccine. Non-inferiority was met if the lower 95% confidence limit of the difference in the mean log10 MenC rSBA between the single dose MenC-CRM and the two dose MenC-CRM groups was >−0.35. Results The primary objective was met: after a Hib-MenC-TT booster dose at 12 months of age the MenC rSBA geometric mean titres induced in infants primed with a single MenC-CRM dose were not inferior to those induced in participants primed with two MenC-CRM doses in infancy (660 (95% confidence interval 498 to 876) v 295 (220 to 398)) with a corresponding difference in the mean log10 MenC rSBA of 0.35 (0.17 to 0.53) that showed superiority of the single over the two dose schedule). Exploration of differences between the priming schedules showed that one month after Hib-MenC-TT vaccination, MenC rSBA ≥1:8 was

  17. Your Child's Development: 1 Year (12 Months)

    MedlinePlus

    ... Year-Old Your Child’s Development: 1 Year (12 Months) KidsHealth > For Parents > Your Child’s Development: 1 Year (12 Months) A A A Your little one is now ... THIS TOPIC Your Child's Checkup: 1 Year (12 Months) Your Baby's Growth: 12 Months Your Baby's Hearing, ...

  18. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

    PubMed Central

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-01-01

    Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer

  19. Breastfeeding beyond 12 months. An historical perspective.

    PubMed

    Piovanetti, Y

    2001-02-01

    A decade ago, child psychiatrist Coello-Novello, in her term as Surgeon General of the United States, said, "It's the lucky baby, I feel, who continues to nurse until he's two." The accumulated evidence supports her statement. The understanding of the benefits of breastfeeding beyond 12 months should support the cultural change in which eventually prolonged breastfeeding becomes normal.

  20. Gist extraction and sleep in 12-month-old infants.

    PubMed

    Konrad, Carolin; Herbert, Jane S; Schneider, Silvia; Seehagen, Sabine

    2016-10-01

    Gist extraction is the process of excerpting shared features from a pool of new items. The present study examined sleep and the consolidation of gist in 12-month-old infants using a deferred imitation paradigm. Sixty infants were randomly assigned to a nap, a no-nap or a baseline control condition. In the nap and no-nap conditions, infants watched demonstrations of the same target actions on three different hand puppets that shared some features. During a 4-h delay, infants in the nap condition took a naturally scheduled nap while infants in the no-nap condition naturally stayed awake. Afterwards, infants were exposed to a novel forth hand puppet that combined some of the features from the previously encountered puppets. Only those infants who took a nap after learning produced a significantly higher number of target actions than infants in the baseline control condition who had not seen any demonstrations of target actions. Infants in the nap condition also produced significantly more target actions than infants in the no-nap condition. Sleep appears to support the storage of gist, which aids infants in applying recently acquired knowledge to novel circumstances.

  1. Recovery 3 and 12 months after hysterectomy

    PubMed Central

    Theunissen, Maurice; Peters, Madelon L.; Schepers, Jan; Maas, Jacques W.M.; Tournois, Fleur; van Suijlekom, Hans A.; Gramke, Hans-Fritz; Marcus, Marco A.E.

    2016-01-01

    Abstract Chronic postsurgical pain (CPSP) is 1 important aspect of surgical recovery. To improve perioperative care and postoperative recovery knowledge on predictors of impaired recovery is essential. The aim of this study is to assess predictors and epidemiological data of CPSP, physical functioning (SF-36PF, 0–100), and global surgical recovery (global surgical recovery index, 0–100%) 3 and 12 months after hysterectomy for benign indication. A prospective multicenter cohort study was performed. Sociodemographic, somatic, and psychosocial data were assessed in the week before surgery, postoperatively up to day 4, and at 3- and 12-month follow-up. Generalized linear model (CPSP) and linear-mixed model analyses (SF-36PF and global surgical recovery index) were used. Baseline data of 468 patients were collected, 412 (88%) patients provided data for 3-month evaluation and 376 (80%) patients for 12-month evaluation. After 3 and 12 months, prevalence of CPSP (numeric rating scale ≥ 4, scale 0–10) was 10.2% and 9.0%, respectively, SF-36PF means (SD) were 83.5 (20.0) and 85.9 (20.2), global surgical recovery index 88.1% (15.6) and 93.3% (13.4). Neuropathic pain was reported by 20 (5.0%) patients at 3 months and 14 (3.9%) patients at 12 months. Preoperative pain, surgery-related worries, acute postsurgical pain on day 4, and surgery-related infection were significant predictors of CPSP. Baseline level, participating center, general psychological robustness, indication, acute postsurgical pain, and surgery-related infection were significant predictors of SF-36PF. Predictors of global surgical recovery were baseline expectations, surgery-related worries, American Society of Anesthesiologists classification, type of anesthesia, acute postsurgical pain, and surgery-related infection. Several predictors were identified for CPSP, physical functioning, and global surgical recovery. Some of the identified factors are modifiable and optimization of patients’ preoperative

  2. BRAVISSIMO: 12-month results from a large scale prospective trial.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, H; Lauwers, G; Lansink, W; Vanslembroeck, K; D'archambeau, O; Hendriks, J; Lauwers, P; Vermassen, F; Randon, C; Van Herzeele, I; De Ryck, F; De Letter, J; Lanckneus, M; Van Betsbrugge, M; Thomas, B; Deleersnijder, R; Vandekerkhof, J; Baeyens, I; Berghmans, T; Buttiens, J; Van Den Brande, P; Debing, E; Rabbia, C; Ruffino, A; Tealdi, D; Nano, G; Stegher, S; Gasparini, D; Piccoli, G; Coppi, G; Silingardi, R; Cataldi, V; Paroni, G; Palazzo, V; Stella, A; Gargiulo, M; Muccini, N; Nessi, F; Ferrero, E; Pratesi, C; Fargion, A; Chiesa, R; Marone, E; Bertoglio, L; Cremonesi, A; Dozza, L; Galzerano, G; De Donato, G; Setacci, C

    2013-04-01

    The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

  3. Senses and Your 8- to 12-Month-Old

    MedlinePlus

    ... TOPIC Feeding Your 8- to 12-Month-Old Sleep and Your 8- to 12-Month-Old Your Child's Vision Communication and Your 8- to 12-Month-Old Movement, Coordination, and Your 8- to 12-Month-Old Your Baby's Growth: 8 Months Your Child's Growth Learning, Play, and ...

  4. Ethosuximide, Valproic Acid and Lamotrigine in Childhood Absence Epilepsy: Initial Monotherapy Outcomes at 12 months

    PubMed Central

    Glauser, Tracy A.; Cnaan, Avital; Shinnar, Shlomo; Hirtz, Deborah G.; Dlugos, Dennis; Masur, David; Clark, Peggy O.; Adamson, Peter C.

    2012-01-01

    Purpose Determine the optimal initial monotherapy for children with newly diagnosed childhood absence epilepsy based on 12 months of double blind therapy. Methods A double-blind, randomized controlled clinical trial compared the efficacy, tolerability and neuropsychological effects of ethosuximide, valproic acid and lamotrigine in children with newly diagnosed childhood absence epilepsy. Study medications were titrated to clinical response and subjects remained in the trial unless they reached a treatment failure criterion. Maximal target doses were ethosuximide 60 mg/kg/day or 2000 mg/day, valproic acid 60 mg/kg/day or 3000 mg/day and lamotrigine 12 mg/kg/day or 600 mg/day. Original primary outcome was at 16–20 weeks and included a video EEG assessment. For this report, the main effectiveness outcome was the freedom from failure rate 12 months after randomization and included a video EEG assessment; differential drug effects were determined by pairwise comparisons. The main cognitive outcome was the percentage of subjects experiencing attentional dysfunction at the Month 12 visit. Key Findings A total of 453 children were enrolled and randomized; seven were deemed ineligible and 446 subjects comprised the overall efficacy cohort. There were no demographic differences between the three cohorts. By 12 months after starting therapy, only 37% of all enrolled subjects were free from treatment failure on their first medication. At the Month 12 visit, the freedom-from-failure rates for ethosuximide and valproic acid were similar (45% and 44%, respectively; odds ratio with valproic acid vs. ethosuximide, 0.94; 95% confidence interval [CI], 0.60 to 1.48; P = 0.82) and were higher than the rate for lamotrigine (21%; odds ratio with ethosuximide vs. lamotrigine, 3.09; 95% CI, 1.86 to 5.13; odds ratio with valproic acid vs. lamotrigine, 2.90; 95% CI, 1.74 to 4.83; P<0.001 for both comparisons). The frequency of treatment failures due to lack of seizure control (p < 0

  5. A comparative study of diode laser and plasmakinetic in transurethral enucleation of the prostate for treating large volume benign prostatic hyperplasia: a randomized clinical trial with 12-month follow-up.

    PubMed

    Wu, Gang; Hong, Zhe; Li, Chao; Bian, Cuidong; Huang, Shengsong; Wu, Denglong

    2016-05-01

    The objective of this study is to compare the efficacy and safety of diode laser enucleation of the prostate (DiLEP) with plasmakinetic enucleation of the prostate (PKEP) for symptomatic benign prostatic hyperplasia (BPH) patients with large prostate (volume > 80 ml). From January 2013 to June 2014, 80 consecutive patients were randomized treated with DiLEP (n = 40) or PKEP (n = 40). Perioperative and postoperative outcome data were assessed during a 1-year follow-up. There were no significant preoperative differences between the two surgical groups. The mean prostate volumes in the DiLEP and PKEP groups were 98.6 and 93.3 ml, respectively. DiLEP was equivalent to PKEP in improvement in International Prostate Symptom Score (IPSS), quality of life scores, and maximum flow rate. Compared with PKEP, patients treated with DiLEP showed a lower risk of blood loss (P < 0.01), shorter bladder irrigation and catheterization times (P < 0.01), as well as shorter hospital stays (P < 0.01). Moreover, the DiLEP group was significantly superior to bipolar plasmakinetic group in the irritative symptoms. However, the operation time of the DiLEP group was longer than that of PKEP group (P = 0.02). Both DiLEP and PKEP are safe and effective methods for the treatment of BPH in large prostates (volume > 80 ml). Compared with PKEP, DiLEP provides a decreased risk of hemorrhage, reduced bladder irrigation, and catheterization times, as well as shorter hospital stays.

  6. Medical Care and Your 8- to 12-Month-Old

    MedlinePlus

    ... Old Medical Care and Your 8- to 12-Month-Old KidsHealth > For Parents > Medical Care and Your 8- to 12-Month-Old A A A What's in this article? ... baby visits during this period, once at 9 months and again at 12 months . If you have ...

  7. Learning, Play, and Your 8- to 12-Month-Old

    MedlinePlus

    ... Old Learning, Play, and Your 8- to 12-Month-Old KidsHealth > For Parents > Learning, Play, and Your 8- to 12-Month-Old A A A What's in this article? ... baby becomes more mobile during these next few months. What Is My Child Learning? Your little one ...

  8. Feeding Your 8- to 12-Month-Old

    MedlinePlus

    ... 2-Year-Old Feeding Your 8- to 12-Month-Old KidsHealth > For Parents > Feeding Your 8- to 12-Month-Old A A A What's in this article? ... a 12 meses de edad By about 8 months old, most babies are pros at handling the ...

  9. Feeding Your 8- to 12-Month-Old

    MedlinePlus

    ... 2-Year-Old Feeding Your 8- to 12-Month-Old KidsHealth > For Parents > Feeding Your 8- to 12-Month-Old Print A A A What's in this ... a 12 meses de edad By about 8 months old, most babies are pros at handling the ...

  10. Learning, Play, and Your 8- to 12-Month-Old

    MedlinePlus

    ... Old Learning, Play, and Your 8- to 12-Month-Old KidsHealth > For Parents > Learning, Play, and Your 8- to 12-Month-Old Print A A A What's in this ... baby becomes more mobile during these next few months. What Is My Child Learning? Your little one ...

  11. Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers.

    PubMed

    Jones, Hendree E; Wong, Conrad J; Tuten, Michelle; Stitzer, Maxine L

    2005-08-01

    This controlled study examined the efficacy of reinforcement-based therapy (RBT) for producing enhanced abstinence outcomes over 12 months in opioid-dependent patients exiting a brief residential detoxification. Patients were randomly assigned upon completing their medically managed taper (i.e., detoxification) to RBT (N=66) or usual care (N=64) referral to community treatment programs. The 6-month RBT program offered an array of abstinence-based incentives including rent payment for recovery housing, program-led recreational activities and skills training for procuring employment. RBT produced significantly higher self-report and urinalysis-confirmed rates of abstinence from opioids and cocaine relative to usual care at 1 (42% versus 15%) and 3 (38% versus 17%) months during treatment but not at 6 or 12 months after enrollment. The RBT but not the usual care group showed significant increases in the number of days worked and the amount of legal income earned at 3, 6 and 12 months. The results of this randomized study suggest that an intensive reinforcement-based therapy that includes abstinence-based recovery housing is a promising approach; however, further research is needed to determine the role of treatment intensity and the specific efficacy of RBT's component parts.

  12. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    ERIC Educational Resources Information Center

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  13. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

    PubMed Central

    2014-01-01

    Objective Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). Methods In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40–80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH. Results Of 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 months after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo. Conclusions The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies. PMID:23984673

  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. Eccentric decline squat protocol offers superior results at 12 months compared with traditional eccentric protocol for patellar tendinopathy in volleyball players

    PubMed Central

    Young, M; Cook, J; Purdam, C; Kiss, Z; Alfredson, H

    2005-01-01

    Background: Conservative treatment of patellar tendinopathy has been minimally investigated. Effective validated treatment protocols are required. Methods: This was a prospective randomised controlled trial of 17 elite volleyball players with clinically diagnosed and imaging confirmed patellar tendinopathy. Participants were randomly assigned to one of two treatment groups: a decline group and a step group. The decline group were required to perform single leg squats on a 25° decline board, exercising into tendon pain and progressing their exercises with load. The step group performed single leg squats on a 10 cm step, exercising without tendon pain and progressing their exercises with speed then load. All participants completed a 12 week intervention programme during their preseason. Outcome measures used were the Victorian Institute of Sport Assessment (VISA) score for knee function and 100 mm visual analogue scale (VAS) for tendon pain with activity. Measures were taken throughout the intervention period and at 12 months. Results: Both groups had improved significantly from baseline at 12 weeks and 12 months. Analysis of the likelihood of a 20 point improvement in VISA score at 12 months revealed a greater likelihood of clinical improvements in the decline group than the step group. VAS scores at 12 months did not differ between the groups. Conclusions: Both exercise protocols improved pain and sporting function in volleyball players over 12 months. This study indicates that the decline squat protocol offers greater clinical gains during a rehabilitation programme for patellar tendinopathy in athletes who continue to train and play with pain. PMID:15665207

  16. Perceptual learning: 12-month-olds' discrimination of monkey faces.

    PubMed

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-11-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following 20 s of familiarization, and two 5-s visual-paired comparison test trials, 12-month-olds failed to show discrimination. However, following 40 s of familiarization and two 10-s test trials, 12-month-olds showed reliable discrimination of novel monkey faces. A final experiment was performed demonstrating 12-month-olds' discrimination of the monkey face was due to the increased familiarization rather than increased time of visual comparison. Results are discussed in the context of perceptual narrowing, in particular the flexible nature of perceptual narrowing.

  17. Safety for Your Child: 6 to 12 Months

    MedlinePlus

    ... Share Safety for Your Child: 6 to 12 Months Page Content Article Body ​ Did you know that ... may climb before walking, or walk with support months before you expect. Your child will grasp at ...

  18. Effects of aromatase inhibition vs. testosterone in older men with low testosterone: randomized-controlled trial.

    PubMed

    Dias, J P; Melvin, D; Simonsick, E M; Carlson, O; Shardell, M D; Ferrucci, L; Chia, C W; Basaria, S; Egan, J M

    2016-01-01

    Aging in men is associated with loss of bone mass, impaired physical function and altered body composition. The objective of this proof-of-concept randomized, double-blind, placebo-controlled, parallel-group, single-center trial was to determine the relative effects of testosterone (T) and estradiol (E(2)) on bone mineral density, body composition, and physical performance in older men. The primary outcome was lumbar spine bone mineral density (BMD), and secondary outcomes were body composition, muscle strength, gait speed, and sex hormone concentrations. Forty three men (age range, 65-82 years; mean age 71 years) with low total T levels <350 ng/dL were randomized to one of three groups: 5 g transdermal testosterone gel (TT) (N = 16), anastrozole (AI) 1 mg (N = 14) or placebo daily (N = 13) for 12 months. Outcomes were assessed at baseline, 3, 6, and 12 months. Both TT and AI increased serum TT levels (>500 ng/dL, p < 0.05) compared to baseline; T values remained stable throughout the duration of the trial. At 12 months, TT improved the primary outcome of lumbar spine BMD (p < 0.01).Both interventions improved knee strength at 12 months compared to baseline (p < 0.05) while lean body mass significantly increased only in the AI group at 6 and 12 months (1.49 ± 0.38 kg, p < 0.01; 1.24 ± 0.39 kg, p < 0.05, respectively) compared to baseline. Interestingly, TT improved fast gait speed at 3 and 12 months (p < 0.01, p < 0.05, respectively). In summary, this proof-of-concept study confirms that aromatization of T is required for maintaining BMD in older men with low-T levels. The trial also uncovered the novel finding that aromatization of T is required for improvement in fast gait speed, an observation that needs to be verified in future studies.

  19. Walking and Eating Behavior of Toddlers at 12 Months Old

    ERIC Educational Resources Information Center

    Koda, Naoko; Akimoto, Yuko; Hirose, Toshiya; Hinobayashi, Toshihiko; Minami, Tetsuhiro

    2004-01-01

    Locomotive and eating behavior of 52 toddlers was observed at 12 months old in a nursery school and investigated in relation to the acquisition of independent walking. The toddlers who acquired walking ate more by themselves using the hands than the toddlers who did not start walking. This suggested that acquisition of walking was associated with…

  20. Perceptual Learning: 12-Month-Olds' Discrimination of Monkey Faces

    ERIC Educational Resources Information Center

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-01-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following…

  1. 12-Month-Olds Produce Others' Intended but Unfulfilled Acts

    ERIC Educational Resources Information Center

    Nielsen, Mark

    2009-01-01

    Following Meltzoff's (1995) behavioral reenactment paradigm, this study investigated the ability of 12-month-olds (N = 44) to reproduce a model's attempted-but-failed actions on objects. Testing was conducted using a novel set of objects designed to enable young infants to readily identify the potential outcome of the model's actions. Infants who…

  2. Wideband acoustic immittance measures: developmental characteristics (0 to 12 months).

    PubMed

    Kei, Joseph; Sanford, Chris A; Prieve, Beth A; Hunter, Lisa L

    2013-07-01

    Rapid developmental changes of the peripheral auditory system in normal infants occur in the first year of life. Specifically, the postnatal development of the external and middle ear affects all measures of external and middle ear function including wideband acoustic immittance(WAI). This article provides an overview of WAI studies in newborns and infants from a developmental perspective. Normative WAI data in newborns are fairly consistent across studies. However, there are discrepancies in some WAI measures between studies, possibly due to differences in sampling, methodology, and instrumentation. Accuracy of WAI measurements is compromised when a good probe seal cannot be maintained during testing or an inaccurate estimate of the cross-sectional area of the ear canal of newborns occurs. Comparison of WAI data between age groups from 0 to 12 months reveals maturation effects. Additional age-specific longitudinal and cross-sectional normative WAI data for infants from birth to 12 months are required to validate and consolidate existing data.

  3. 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

  4. TVT-Secur mini-sling for stress urinary incontinence: a review of outcomes at 12 months.

    PubMed

    Walsh, Colin A

    2011-09-01

    • Synthetic mid-urethral slings (MUSs) are considered the first choice surgical procedure for stress urinary incontinence. Recent publications have raised concerns about the efficacy of third generation single-incision mini-slings. The present paper is a systematic review of studies reporting 12-month outcomes after the TVT-Secur (TVT-S) procedure. • Pubmed/Medline online databases, abstracts from recent International Continence Society and International Urogynecological Association annual scientific meetings and the Clinicaltrials.gov and Controlled-trials.com online trial registries were searched for English-language articles containing the terms 'TVT-Secur', 'TVT Secur' or 'mini-sling'. The primary outcomes were objective and subjective cure rates at 12 months. Secondary outcomes included peri-operative (vaginal perforation, urinary retention, urinary tract infection [UTI]) and postoperative (mesh exposure, de novo overactive bladder (OAB), dyspareunia and return to theatre) complication rates. • Among 1178 women undergoing the TVT-S procedure, from 10 studies, both objective and subjective cure rate at 12 months was 76%, with objective cure significantly higher in women undergoing the 'U-type' approach. Vaginal perforation was a complication in 1.5% of cases, with a 2.4% incidence of mesh exposure in the first year. The incidence of de novo OAB symptoms was 10%. Rates of urinary retention (2.3%), UTI (4.4%), dyspareunia (1%) and return to theatre for complications (0.8%) were low. In the first year after a TVT-S procedure 5% of women required repeat continence surgery. • Longer-term studies and randomized comparisons with more established MUSs are required before TVT-S should be routinely used in the surgical treatment of stress urinary incontinence.

  5. African American community members sustain favorable blood pressure outcomes through 12-month telephone motivational interviewing (MI) maintenance

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Community approaches offer promise for addressing disparities experienced by African Americans in hypertension prevalence, treatment, and control. HUB City Steps, a community-based participatory research lifestyle intervention, tracked participants through a 12-month MI maintenance phase following a...

  6. Maternal Antenatal Depression and Infant Disorganized Attachment at 12 months

    PubMed Central

    Hayes, Lisa J.; Goodman, Sherryl H.; Carlson, Elizabeth

    2012-01-01

    Although high rates of attachment disorganization have been observed in infants of depressed mothers, little is known about the role of antenatal depression as a precursor to infant attachment disorganization. The primary aim of this study was to examine associations between maternal antenatal depression and infant disorganization at 12 months in a sample of women (N = 79) at risk for perinatal depression. A secondary aim was to test the roles of maternal postpartum depression and maternal parenting quality as potential moderators of this predicted association. Among women with histories of major depressive episodes, maternal depressive symptoms were assessed at multiple times during pregnancy and the first year postpartum, maternal parenting quality was measured at 3 months postpartum, and attachment disorganization was assessed at 12 months postpartum. Results revealed that infants classified as disorganized had mothers with higher levels of depressive symptoms during pregnancy compared to infants classified as organized. Maternal parenting quality moderated this association, as exposure to higher levels of maternal depressive symptoms during pregnancy was only associated with higher rates of infant disorganized attachment when maternal parenting at 3 months was less optimal. These findings suggest that enhancing maternal parenting behaviors during this early period in development has the potential to alter pathways to disorganized attachment among infants exposed to antenatal maternal depressive symptoms, which could have enduring consequences for child wellbeing. PMID:23216358

  7. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

    PubMed

    Kezirian, Eric J; Goding, George S; Malhotra, Atul; O'Donoghue, Fergal J; Zammit, Gary; Wheatley, John R; Catcheside, Peter G; Smith, Philip L; Schwartz, Alan R; Walsh, Jennifer H; Maddison, Kathleen J; Claman, David M; Huntley, Tod; Park, Steven Y; Campbell, Matthew C; Palme, Carsten E; Iber, Conrad; Eastwood, Peter R; Hillman, David R; Barnes, Maree

    2014-02-01

    Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P < 0.001) from baseline to 12 months in apnea-hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h(-1) ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.

  8. Language Differences at 12 Months in Infants Who Develop Autism Spectrum Disorder.

    PubMed

    Lazenby, DeWayne C; Sideridis, Georgios D; Huntington, Noelle; Prante, Matthew; Dale, Philip S; Curtin, Suzanne; Henkel, Lisa; Iverson, Jana M; Carver, Leslie; Dobkins, Karen; Akshoomoff, Natacha; Tagavi, Daina; Nelson, Charles A; Tager-Flusberg, Helen

    2016-03-01

    Little is known about early language development in infants who later develop autism spectrum disorder (ASD). We analyzed prospective data from 346 infants, some of whom were at high risk for developing ASD, to determine if language differences could be detected at 12 months of age in the infants who later were diagnosed with ASD. Analyses revealed lower receptive and expressive language scores in infants who later were diagnosed with ASD. Controlling for overall ability to understand and produce single words, a Rasch analysis indicated that infants who later developed ASD had a higher degree of statistically unexpected word understanding and production. At 12 months of age, quantitative and qualitative language patterns distinguished infants who later developed ASD from those who did not.

  9. 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

  10. Risks and Benefits of Dual Antiplatelet Therapy Beyond 12 Months After Coronary Stenting

    PubMed Central

    Dadjou, Yahya; Safavi, Salar; Kojuri, Javad

    2016-01-01

    Abstract The optimal duration of dual antiplatelet therapy (DAT) after coronary stenting remains poorly define. The aim of this study was to evaluate the impact of longer than 24 months DAT in patients who received drug-eluting and bare-metal stents. A total of 1010 individuals who underwent elective, urgent or emergency coronary angioplasty with intended stent implantation at reference or specialized cardiac hospitals were randomized to receive long-term and short-term DAT to determine the benefits and adverse effects of long-term DAT. Total of 508 patients were randomized to long-term and 502 patients to <1 year DAT, and all of them were followed for more than 36 months for major adverse cardiac and cerebvascular events and bleeding major adverse cardiac and cerebvascular events (MACCE) Mean age of the 1010 patients (364 women and 646 men) was 60 years. Stent reocclusion occurred in 15 patients. Mean Syntax score was 23.00 ± 5.08 for whole samples, 25.00 ± 5.27 in 28 patients with MACCE and 23 ± 5.00 in 982 patients without MACCE (P = 0.057). According to all specified bleeding definitions, clopidogrel therapy for >12 months was not associated with a greater risk of hemorrhage. A regimen of >12 months of clopidogrel therapy in patients who had received drug-eluting or bare-metal stents did not differ significantly from a regimen of <12 months on clopidogrel with regard to MACCE. Long-term DAT might not significantly affect the reduction in the risk of death from any cause, myocardial infarction, or stroke, and not associated with minor or major bleeding events. PMID:27258494

  11. Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

    PubMed Central

    Tang, Wenyi; Yeh, James; Chen, Jian; Liu, Mao; Ke, Jianting; Tan, Guangyi; Lin, Xiufang

    2016-01-01

    Background The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear. Methods Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process. Results Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40–0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20–0.62; P<0.001) in the >12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23–2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups. Conclusions The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation. PMID:27747163

  12. Statin Induced Regression of Cardiomyopathy Trial: A Randomized, Placebo-controlled Double-blind Trial

    PubMed Central

    Hersi, Ahmad; Giannoccaro, J. Peter; Howarth, Andrew; Exner, Derek; Weeks, Sarah; Eitel, Ingo; Herman, R. Cameron; Duff, Henry; Ritchie, Debbie; Mcrae, Maureen; Sheldon, Robert

    2016-01-01

    Background: Hypertrophic cardiomyopathy (HCM), characterized by a thickened, fibrotic myocardium, remains the most common cause of sudden cardiac death in young adults. Based on animal and clinical data, we hypothesized that atorvastatin would induce left ventricular (LV) mass regression. Methods: Statin Induced Regression of Cardiomyopathy Trial (SIRCAT) was a randomized, placebo-controlled study. The primary endpoint was change in LV mass measured by cardiac magnetic resonance imaging 12 months after treatment with once-daily atorvastatin 80 mg or placebo. A key secondary endpoint was diastolic dysfunction measured echocardiographically by transmitral flow velocities. SIRCAT is registered with www.clinicaltrials.gov (NCT00317967). Results: Of 222 screened patients, 22 were randomized evenly to atorvastatin and placebo. The mean age was 47 ± 10 years, and 15 (68%) were male. All subjects completed the protocol. At baseline, LV masses were 197 ± 76 g and 205 ± 82 g in the placebo and atorvastatin groups, respectively. After 12 months treatment, the LV masses in the placebo and atorvastatin groups were 196 ± 80 versus 206 ± 92 g (P = 0.80), respectively. Echocardiographic indices were not different in the two groups at baseline. After 12 months, diastolic dysfunction as assessed using transmitral flow velocities E/E', A/A', and peak systolic mitral velocity showed no benefit from atorvastatin. Conclusions: In patients with HCM, atorvastatin did not cause LV mass regression or improvements in LV diastolic function.

  13. 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

  14. Disclosure of Genetic Information and Change in Dietary Intake: A Randomized Controlled Trial

    PubMed Central

    Nielsen, Daiva E.; El-Sohemy, Ahmed

    2014-01-01

    Background Proponents of consumer genetic tests claim that the information can positively impact health behaviors and aid in chronic disease prevention. However, the effects of disclosing genetic information on dietary intake behavior are not clear. Methods A double-blinded, parallel group, 2∶1 online randomized controlled trial was conducted to determine the short- and long-term effects of disclosing nutrition-related genetic information for personalized nutrition on dietary intakes of caffeine, vitamin C, added sugars, and sodium. Participants were healthy men and women aged 20–35 years (n = 138). The intervention group (n = 92) received personalized DNA-based dietary advice for 12-months and the control group (n = 46) received general dietary recommendations with no genetic information for 12-months. Food frequency questionnaires were collected at baseline and 3- and 12-months after the intervention to assess dietary intakes. General linear models were used to compare changes in intakes between those receiving general dietary advice and those receiving DNA-based dietary advice. Results Compared to the control group, no significant changes to dietary intakes of the nutrients were observed at 3-months. At 12-months, participants in the intervention group who possessed a risk version of the ACE gene, and were advised to limit their sodium intake, significantly reduced their sodium intake (mg/day) compared to the control group (−287.3±114.1 vs. 129.8±118.2, p = 0.008). Those who had the non-risk version of ACE did not significantly change their sodium intake compared to the control group (12-months: −244.2±150.2, p = 0.11). Among those with the risk version of the ACE gene, the proportion who met the targeted recommendation of 1500 mg/day increased from 19% at baseline to 34% after 12 months (p = 0.06). Conclusions These findings demonstrate that disclosing genetic information for personalized nutrition results in greater changes

  15. Lifetime and 12-month prevalence, severity and unmet need for treatment of common mental disorders in Japan: results from the final dataset of World Mental Health Japan Survey

    PubMed Central

    Ishikawa, H.; Kawakami, N.; Kessler, R. C.

    2016-01-01

    Background The aim of this study is to estimate the lifetime and 12-month prevalence, severity, and treatment of Diagnostic and Statistical Manual of Mental Disorders 4th ed. (DSM-IV) mental disorders in Japan based on the final data set of the World Mental Health Japan Survey conducted in 2002–2006. Methods Face-to-face household interviews of 4,130 respondents who were randomly selected from Japanese-speaking residents aged 20 years or older were conducted from 2002 to 2006 in 11 community populations in Japan (overall response rate, 56%). The World Mental Health version of the World Health Organization Composite International Diagnostic Interview (WMH-CIDI), a fully structured lay administered psychiatric diagnostic interview, was used for diagnostic assessment. Results Lifetime/12-month prevalence of any DSM-IV common mental disorders in Japan was estimated to be 20.3/7.6%. Rank-order of four classes of mental disorders was anxiety disorders (8.1/4.9%), substance disorders (7.4/1.0%), mood disorders (6.5/2.3%), and impulse control disorders (2.0/0.7%). The most common individual disorders were alcohol abuse/dependence (7.3/0.9%), major depressive disorder (6.1/2.2%), specific phobia (3.4/2.3%), and generalized anxiety disorder (2.6/1.3%). While the lifetime prevalence of any mental disorder was greater for males and the middle-aged, the persistence (proportion of 12-month cases among lifetime cases) of any mental disorder was greater for females and younger respondents. Among those with any 12-month disorder, 15.3% were classified as severe, 44.1% moderate, and 40.6% mild. Although a strong association between severity and service use was found, only 21.9% of respondents with any 12-month disorder sought treatment within the last 12 months; only 37.0% of severe cases received medical care. The mental health specialty sector was the most common resource used in Japan. Although the prevalence of mental disorders were quite low, mental disorders were the second

  16. Suicide attempts within 12 months of treatment for substance use disorders.

    PubMed

    Britton, Peter C; Conner, Kenneth R

    2010-02-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment were examined. Participants included 2,966 patients with one or more SUDs. By 12 months, 77 (2.6%) subjects had attempted suicide. Multivariate logistic regression analyses were used to identify variables associated with SA. Variables collected at baseline that were associated with SA included lifetime histories of SA, suicidal ideation (SI), depression, cocaine as primary substance of use, outpatient methadone treatment, and short-term inpatient treatment. Male sex, older age, and minority race or ethnicity were associated with lower likelihood of SA. After controlling for baseline predictors, variables assessed at 12 months associated with SA included SI during follow-up and daily or more use of cocaine. The data contribute to a small but growing literature of prospective studies of SA among treated SUDs, and suggest that SUDs with cocaine use disorders in particular should be a focus of prevention efforts.

  17. 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.

  18. 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

  19. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study

    PubMed Central

    Rana, Vivek; Srivastava, Nikhil; Chandna, Preetika

    2015-01-01

    ABSTRACT Background: Vital pulpotomy is a single-stage procedure of surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. Aims and objectives: The aim of this study was to compare the clinical and radiographic success rates for ferric sulfate (FS), electrosurgery (ES) and laser pulpotomy in human primary molars. Materials and methods: In a randomized clinical trial, 30 primary molars indicated for pulpotomy in children aged 4 to 10 years were treated using either a FS (10 teeth), ES technique (10 teeth) and laser (10 teeth). Following the pulpotomy, the teeth were evaluated for clinical and radiographic success at 3, 6, 9 and 12 months on the basis of the presence of pain, sinus, mobility, internal and external resorption, periapical radiolucency, calcification in the canal and bone loss. Statistical analysis: The data were assessed with Chi-square test. Results: After 12 months of follow-up, both clinical and radiographic success rates were 100% in the laser group but only 80% in both ES and FS groups. There was statistically significant difference between the success rates of three groups (p < 0.05). Conclusion: Laser pulpotomy showed better clinical as well as radiographical results than ES and FS pulpotomy. Laser pulpotomy was also found superior in terms of operating time, patient cooperation, ease of use and pain. Although results of the study showed the failure rates for electrosurgical pulpotomy to be equal to those for FS pulpotomy, electrosurgical pulpotomy being a nonpharmacological technique considered more favorable. Further studies using larger sample size and longer evaluation periods are suggested. How to cite this article: Gupta G, Rana V, Srivastava N, Chandna P. Laser Pulpotomy–An Effective Alternative to Conventional Techniques: A 12 Months Clinicoradiographic Study. Int J Clin Pediatr Dent 2015;8(1):18-21. PMID:26124576

  20. 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.

  1. 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.

  2. 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

  3. Language development at 18 months is related to multimodal communicative strategies at 12 months.

    PubMed

    Igualada, Alfonso; Bosch, Laura; Prieto, Pilar

    2015-05-01

    The present study investigated the degree to which an infants' use of simultaneous gesture-speech combinations during controlled social interactions predicts later language development. Nineteen infants participated in a declarative pointing task involving three different social conditions: two experimental conditions (a) available, when the adult was visually attending to the infant but did not attend to the object of reference jointly with the child, and (b) unavailable, when the adult was not visually attending to neither the infant nor the object; and (c) a baseline condition, when the adult jointly engaged with the infant's object of reference. At 12 months of age measures related to infants' speech-only productions, pointing-only gestures, and simultaneous pointing-speech combinations were obtained in each of the three social conditions. Each child's lexical and grammatical output was assessed at 18 months of age through parental report. Results revealed a significant interaction between social condition and type of communicative production. Specifically, only simultaneous pointing-speech combinations increased in frequency during the available condition compared to baseline, while no differences were found for speech-only and pointing-only productions. Moreover, simultaneous pointing-speech combinations in the available condition at 12 months positively correlated with lexical and grammatical development at 18 months of age. The ability to selectively use this multimodal communicative strategy to engage the adult in joint attention by drawing his attention toward an unseen event or object reveals 12-month-olds' clear understanding of referential cues that are relevant for language development. This strategy to successfully initiate and maintain joint attention is related to language development as it increases learning opportunities from social interactions.

  4. Porcine Subintestinal Submucousal Graft Augmentation for Rectocele Repair: A Randomized Controlled Trial

    PubMed Central

    Sung, Vivian W.; Rardin, Charles R.; Raker, Christina A.; LaSala, Christine A.; Myers, Deborah L.

    2011-01-01

    Objective To estimate the effect of porcine subintestinal submucosal graft augmentation on improving anatomic and subjective rectocele repair outcomes compared to native tissue repair. Methods We conducted a randomized controlled trial at two sites, including women with at least Stage 2 symptomatic rectocele. Anatomic and subjective outcomes (vaginal bulge and defecatory) were collected 12 months postoperatively, including blinded pelvic organ prolapse quantification (POP-Q) examinations. Anatomic failure was defined as points Ap or Bp ≥ −1 on POPQ. Subjective failure was defined as no improvement or worsening of symptoms. We estimated number needed to treat (NNT) and adjusted odds ratios (AOR). Assuming graft use is associated with 93% anatomic success, 63 women per group would be needed to detect a 20% difference at alpha=0.05 and beta=0.20. Results One-hundred sixty women were randomized; 137 had 12-month anatomic data (67 graft; 70 control). There was no difference in anatomic failure (12% versus 9%, P=0.5), vaginal bulge symptom failure (3% versus 7%, P=0.4, NNT 26) or defecatory symptom failure (44% versus 45%, P=0.9, NNT 91) for graft versus control, respectively. Both groups reported improvement in vaginal bulge and defecatory symptoms (P<.05 for all). On multiple logistic regression graft use was not associated with a decreased odds of anatomic failure (AOR 1.36, 95% CI 0.44–4.25), vaginal bulge symptoms (AOR 0.46, 95% CI 0.08–2.68), or defecatory symptoms (AOR 0.98, 95% CI 0.48–2.03). Conclusions Although rectocele repair by either approach is associated with improved symptoms, subintestinal submucosal graft augmentation was not superior to native tissue for anatomic or subjective outcomes at 12 months. PMID:22183220

  5. The TeleGuard trial of additional telemedicine care in CAD patients. 2 Morbidity and mortality after 12 months.

    PubMed

    Waldmann, Annika; Katalinic, Alexander; Schwaab, Bernhard; Richardt, Gert; Sheikhzadeh, Abdolhamid; Raspe, Heiner

    2008-01-01

    In the TeleGuard trial, 1500 patients with established coronary artery disease (CAD) were recruited and randomized to control or intervention groups. Patients in the intervention group were equipped with a 12-lead event recorder and could contact a call centre and transmit an ECG whenever they wished. In a 12-month study, the composite endpoint (all-cause mortality, myocardial infarction, re-hospitalization or re-vascularization) was seen in 40% of the intervention patients and in 38% of the control patients. In both groups, approximately 40% were re-hospitalized. In total, 73 patients experienced re-vascularization, 75 showed an infarction and 33 died. Equipping CAD patients with a 12-lead ECG device and providing a telemedicine centre with 24-hour availability did not decrease risk for the composite endpoint (re-hospitalization, re-vascularization, (subsequent) myocardial infarction and/or death). It is likely that the clinical pathway used in the telemedicine centre led to an increased hospital admission rate in the intervention group.

  6. The Primary Prevention of PTSD in Firefighters: Preliminary Results of an RCT with 12-Month Follow-Up

    PubMed Central

    Rees, Clare S.; Mazzucchelli, Trevor G.; Kane, Robert T.

    2016-01-01

    Aim To develop and evaluate an evidence-based and theory driven program for the primary prevention of Post-traumatic Stress Disorder (PTSD). Design A pre-intervention / post-intervention / follow up control group design with clustered random allocation of participants to groups was used. The “control” group received “Training as Usual” (TAU). Method Participants were 45 career recruits within the recruit school at the Department of Fire and Emergency Services (DFES) in Western Australia. The intervention group received a four-hour resilience training intervention (Mental Agility and Psychological Strength training) as part of their recruit training school curriculum. Data was collected at baseline and at 6- and 12-months post intervention. Results We found no evidence that the intervention was effective in the primary prevention of mental health issues, nor did we find any significant impact of MAPS training on social support or coping strategies. A significant difference across conditions in trauma knowledge is indicative of some impact of the MAPS program. Conclusion While the key hypotheses were not supported, this study is the first randomised control trial investigating the primary prevention of PTSD. Practical barriers around the implementation of this program, including constraints within the recruit school, may inform the design and implementation of similar programs in the future. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12615001362583 PMID:27382968

  7. 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.

  8. 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.

  9. National High Blood Pressure 12-Month Kit. May 1988.

    ERIC Educational Resources Information Center

    National Heart and Lung Inst. (DHHS/NIH), Bethesda, MD. National High Blood Pressure Education Program.

    Part I of this kit provides information for program planners and health professionals on ways to overcome barriers to health care among the medically underserved, promote high blood pressure control through the media and other community channels, and improve adherence to treatment among hypertensive patients. It lists additional resources for…

  10. Sibling Interaction of Children with Autism: Development over 12 Months

    ERIC Educational Resources Information Center

    Knott, Fiona; Lewis, Charlie; Williams, Tim

    2007-01-01

    While deficits in social interaction are central to autism, the sibling relationship has been found to provide a key medium for the development of such skills. Naturalistic observations of sibling pairs including children with autism and controls with Down syndrome were made across two time periods, twelve months apart. Consistent with the…

  11. 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

  12. A 12 month clinical study of bond failures of recycled versus new stainless steel orthodontic brackets.

    PubMed

    Cacciafesta, Vittorio; Sfondrini, Maria Francesca; Melsen, Birte; Scribante, Andrea

    2004-08-01

    The purpose of this prospective longitudinal randomized study was to compare the clinical performance of recycled brackets with that of new stainless steel brackets (Orthos). Twenty patients treated with fixed appliances were included in the investigation. Using a 'split-mouth' design, the dentition of each patient was divided into four quadrants. In 11 randomly selected patients, the maxillary left and mandibular right quadrants were bonded with recycled brackets, and the remaining quadrants with new stainless steel brackets. In the other nine patients the quadrants were inverted. Three hundred and ten stainless steel brackets were examined: 156 were recycled and the remaining 154 were new. All the brackets were bonded with a self-cured resin-modified glass ionomer (GC Fuji Ortho). The number, cause, and date of bracket failures were recorded over 12 months. Statistical analysis was performed by means of a paired t-test, Kaplan-Meier survival estimates, and the log-rank test. No statistically significant differences were found between: (a) the total bond failure rate of recycled and new stainless steel brackets; (b) the upper and lower arches; (c) the anterior and posterior segments. These findings demonstrate that recycling metallic orthodontic brackets can be of benefit to the profession, both economically and ecologically, as long as the orthodontist is aware of the various aspects of the recycling methods, and that patients are informed about the type of bracket that will be used for their treatment.

  13. Clinical evaluation of fiber-reinforced composite crowns in pulp-treated primary molars: 12-month results

    PubMed Central

    Mohammadzadeh, Zahra; Parisay, Iman; Mehrabkhani, Maryam; Madani, Azam Sadat; Mazhari, Fatemeh

    2016-01-01

    Objective: The aim of this study was to evaluate the clinical performance of tooth-colored fiber-reinforced composite (FRC) crowns in pulp-treated second primary mandibular teeth. Materials and Methods: This split-mouth randomized, clinical trial performed on 67 children between 3 and 6 years with two primary mandibular second molars requiring pulp treatment. After pulp therapy, the teeth were randomly assigned to stainless steel crown (SSC) or FRC crown groups. Modified United States Public Health Service criteria were used to evaluate marginal integrity, marginal discoloration, and secondary caries in FRC crowns at intervals of 3, 6, and 12 months. Retention rate and gingival health were also compared between the two groups. The data were analyzed using Friedman, Cochran, and McNemar's tests at a significance level of 0.05. Results: Intact marginal integrity in FRC crowns at 3, 6, and 12 months were 93.2%, 94.8%, and 94.2%, respectively. Marginal discoloration and secondary caries were not found at any of the FRC crowns. The retention rates of the FRC crowns were 100%, 98.3%, and 89.7% at 3, 6 and 12 months, respectively, whereas all the SSCs were found to be present and intact after 12 months (P = 0.016). There was no statistically significant difference between the two groups in gingival health. Conclusion: According to the results of this study, it seems that when esthetics is a concern, in cooperative patients with good oral hygiene, FRC crowns can be considered as a valuable procedure. PMID:28042269

  14. Factors associated with parental perception of child vulnerability 12 months after abnormal newborn screening results.

    PubMed

    Tluczek, Audrey; McKechnie, Anne Chevalier; Brown, Roger L

    2011-10-01

    We identified factors associated with elevated parental perceptions of child vulnerability (PPCV) 12 months after newborn screening (NBS) of 136 children: healthy, normal results (H, n = 37), cystic fibrosis carriers (CF-C, n = 40), congenital hypothyroidism (CH, n = 36), and cystic fibrosis (CF, n = 23). Controlling for infant and parent characteristics, mixed logit structural equation modeling showed direct paths to elevated PPCV included parent female sex, CF diagnosis, and high documented illness frequency. PPCV was positively associated with maternal parenting stress. Infants with CF and CF carriers had significantly more documented illness frequency than H group infants. The CH group did not differ significantly from the H group and had no paths to PPCV. Unexpectedly high documented illness frequency among infants who are CF carriers warrants further investigation.

  15. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up.

    PubMed

    Hunger, Christina; Weinhold, Jan; Bornhäuser, Annette; Link, Leoni; Schweitzer, Jochen

    2015-06-01

    In a previous randomized controlled trial (RCT), short-term efficacy of family constellation seminars (FCSs) in a general population sample was demonstrated. In this article, we examined mid- and long-term stability of these effects. Participants were 104 adults (M = 47 years; SD = 9; 84% female) who were part of the intervention group in the original RCT (3-day FCS; 64 active participants and 40 observing participants). FCSs were carried out according to manuals. It was predicted that FCSs would improve psychological functioning (Outcome Questionnaire OQ-45.2) at 8- and 12-month follow-up. Additionally, we assessed the effects of FCSs on psychological distress, motivational incongruence, individuals' experience in their personal social systems, and overall goal attainment. Participants yielded significant improvement in psychological functioning (d = 0.41 at 8-month follow-up, p = .000; d = 0.40 at 12-month follow-up, p = .000). Results were confirmed for psychological distress, motivational incongruence, the participants' experience in their personal social systems, and overall goal attainment. No adverse events were reported. This study provides first evidence for the mid- and long-term efficacy of FCSs in a nonclinical population. The implications of the findings are discussed.

  16. 26 CFR 1.443-1 - Returns for periods of less than 12 months.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the short period is as follows: Taxable income exclusive of net long-term capital gain $40,000 Net long-term capital gain 10,000 Taxable income for short period before annualizing 50,000 Taxable income... term “12-month period” means the 12-month period ending at the close of the last day of the...

  17. The Development of Rational Imitation in 9- and 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Zmyj, Norbert; Daum, Moritz M.; Aschersleben, Gisa

    2009-01-01

    Studies on rational imitation have provided evidence for the fact that infants as young as 12 months of age engage in rational imitation. However, the developmental onset of this ability is unclear. In this study, we investigated whether 9- and 12-month-olds detect voluntary and implicit as well as nonvoluntary and explicit constraints in the head…

  18. Severity of 12-Month DSM-IV Disorders in the National Comorbidity Survey Replication Adolescent Supplement

    PubMed Central

    Kessler, Ronald C.; Avenevoli, Shelli; Costello, Jane; Green, Jennifer Greif; Gruber, Michael J.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Nancy A.; Zaslavsky, Alan M.; Merikangas, Kathleen Ries

    2012-01-01

    were generally nonsignificant after controlling for disorder type and number. Conclusions The high estimated 12-month prevalence of DSM-IV disorders among US adolescents is largely due to mild cases. The significant between-disorder differences in risk of SED and the significant effect of high comorbidity have important public health implications for targeting interventions. PMID:22474106

  19. 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

  20. 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.

  1. A Web-Based Lifestyle Intervention for Women With Recent Gestational Diabetes Mellitus: A Randomized Controlled Trial

    PubMed Central

    NICKLAS, Jacinda M.; ZERA, Chloe A.; ENGLAND, Lucinda J.; ROSNER, Bernard A.; HORTON, Edward; LEVKOFF, Sue E.; SEELY, Ellen W.

    2014-01-01

    Objective To test the feasibility and effectiveness of a web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus (GDM) to reduce postpartum weight retention. Methods We randomly allocated 75 women with recent GDM to either a web-based lifestyle program (Balance after Baby) delivered over the first postpartum year or to a control group. Primary outcomes were change in body weight at 12 months from 1) first postpartum measured weight, and 2) self-reported prepregnancy weight. Results There were no significant differences in baseline characteristics between groups including age, BMI, race and income status. Women assigned to the Balance after Baby program (n=36, 3 lost to follow-up) lost a mean of 2.8 kgs (95% CI −4.8 to −0.7) from 6 weeks to 12 months postpartum while the control group (n=39, 1 lost to follow-up) gained a mean of 0.5 kgs (−1.4 to +2.4) (p=0.022). Women in the intervention were closer to prepregnancy weight at 12 months postpartum (mean change −0.7 kgs; −3.5 to +2.2), compared to women in the control arm (+4.0 kgs; +1.3 to +6.8) (p=0.035). Conclusion A web-based lifestyle modification program for women with recent GDM decreased postpartum weight retention. PMID:25162257

  2. A calcium-collagen chelate dietary supplement attenuates bone loss in postmenopausal women with osteopenia: a randomized controlled trial.

    PubMed

    Elam, Marcus L; Johnson, Sarah A; Hooshmand, Shirin; Feresin, Rafaela G; Payton, Mark E; Gu, Jennifer; Arjmandi, Bahram H

    2015-03-01

    Menopause leads to an increased risk for osteoporosis in women. Although drug therapies exist, increasing numbers of people prefer alternative therapies such as dietary supplements, for example, calcium, vitamin D, and collagen hydrolysates for the prevention and treatment of osteoporosis. We have previously shown that a 3-month intervention using a calcium-collagen chelate (CC) dietary supplement was efficacious in improving bone mineral density (BMD) and blood biomarkers of bone turnover in osteopenic postmenopausal women. This study reports the long-term efficacy of CC in reducing bone loss in postmenopausal women with osteopenia. Thirty-nine women were randomly assigned to one of two groups: 5 g of CC containing 500 mg of elemental calcium and 200 IU vitamin D (1,25-dihydroxyvitamin D3) or control (500 mg of calcium and 200 IU vitamin D) daily for 12 months. Total body, lumbar, and hip BMD were evaluated at baseline, 6 and 12 months using dual-energy X-ray absorptiometry. Blood was collected at baseline, 6 and 12 months to assess levels of blood biomarkers of bone turnover. Intent-to-treat (ITT) analysis was performed using repeated measures analysis of variance pairwise comparisons and multivariate analysis to assess time and group interactions. The loss of whole body BMD in women taking CC was substantially lower than that of the control group at 12 months in those who completed the study and the ITT analysis, respectively (CC: -1.33% and -0.33% vs. control: -3.75% and -2.17%; P=.026, P=.035). The CC group had significantly reduced levels of sclerostin and tartrate-resistant acid phosphatase isoform 5b (TRAP5b) (P<.05), and higher bone-specific alkaline phosphatase/TRAP5b ratio (P<.05) than control at 6 months. These results support the use of CC in reducing bone loss in osteopenic postmenopausal women.

  3. Reporting Randomized Controlled Trials in Education

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  4. 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.…

  5. Extracorporeal shock wave lithotripsy in infants less than 12-month old.

    PubMed

    Turna, Burak; Tekin, Ali; Yağmur, İsmail; Nazlı, Oktay

    2016-10-01

    There is a lack of literature on children compared to adults regarding the long-term effects of extracorporeal shock wave lithotripsy (SWL), specifically in infants. The aim of the present study was to analyze the efficacy and safety of SWL in infants and also evaluate its potential adverse effects in the mid-term. Between May 1999 and December 2013, 36 infants with 39 renal units underwent SWL treatment for kidney stones with an electrohydraulic lithotripter (Dornier MPL 9000/ELMED Multimed Classic). All children were less than 12-month old. The mid-term effects of SWL were examined at the last follow-up by measuring arterial blood pressure, random blood glucose level and ipsilateral kidney size. Evaluation of treatment and its consequences was based on clinical examination, blood tests and conventional imaging (plain abdominal radiography and ultrasound). Overall stone-free rate was 84.6 % after 3-month follow-up without any major complications. Mid-term follow-up was available in 20 of 36 children with a mean follow-up of 3.2 ± 2.8 years (range 0.5-15.3). None of the infants were found to develop new onset of hypertension or diabetes. All treated infant kidneys' sizes were in the normal percentile range. SWL for management of infant kidney stones is effective and safe in the mid-term.

  6. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis.

    PubMed Central

    Pulido, Jose S

    2002-01-01

    OBJECTIVE: To evaluate the safety and efficacy of Rheopheresis blood filtration to treat intermediate- to late-stage preangiogenic age-related macular degeneration (AMD) with soft drusen. DESIGN: Multicenter, prospective, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS: First 43 randomized patients (28 Rheopheresis and 15 placebo-control patients) with available baseline and 3-month postbaseline best corrected visual acuity (BCVA) measurements and intermediate- to late-stage preangiogenic AMD with multiple large soft drusen and elevated serum levels of targeted macromolecules. INTERVENTION: Patients were randomly assigned to receive eight Rheopheresis or eight placebo procedures over 10 weeks. MAIN OUTCOME MEASURES: ETDRS BCVA measurements at baseline, 3, 6, 9, and 12 months postbaseline. RESULTS: In primary eyes, the mean LogMAR line difference between Rheopheresis and placebo-control eyes was 1.6 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0011, repeated measures analysis). Thirteen percent of Rheopheresis compared with 0% of placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Four percent of Rheopheresis compared with 18% of placebo-control eyes had a > or = 3-line loss in BCVA. The subgroup of patients whose primary eyes had baseline BCVA worse than 20/40 demonstrated a mean LogMAR difference between Rheopheresis and placebo-control eyes equaling 3.0 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0014, repeated measures analysis). Sixteen percent of Rheopheresis compared with 0% of the placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Five percent of Rheopheresis compared with 29% of placebo-control eyes had a > or = 3-line loss in BCVA. Fifty-eight percent of Rheopheresis eyes improved to 20/40 or better, compared with 14% of placebo-control

  7. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    ERIC Educational Resources Information Center

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  8. A Randomized Controlled Pilot Study of an HIV Risk-Reduction Intervention for Sub-Saharan African University Students

    PubMed Central

    Heeren, G. Anita; Jemmott, John B.; Ngwane, Zolani; Mandeya, Andrew; Tyler, Joanne C.

    2012-01-01

    This pilot study used a randomized controlled trial to test the efficacy of an HIV risk-reduction intervention for university students in Eastern Cape Province, South Africa. Randomly selected second-year students were randomized to one of two interventions based on social cognitive theory and qualitative research: HIV risk-reduction, targeting sexual-risk behaviors; health-promotion control, targeting health behaviors unrelated to sexual risks. Participants completed behavioral assessments via audio computer-assisted self-interviewing pre-intervention, 6, and 12 months post intervention, with 97.2% retained at 12-month follow-up. Averaged over the 2 follow-ups, HIV risk-reduction intervention participants reported less unprotected vaginal intercourse and more frequent condom use than control participants, with greater efficacy in non-South Africans than South Africans. Positive changes were also observed on theoretical mediators of condom use that the intervention targeted. Interventions based on social cognitive theory integrated with qualitative information from the population may reduce sexual risk behaviors among university students in sub-Saharan Africa. PMID:22246515

  9. A double-blinded, randomized controlled trial of zoledronate therapy for HIV-associated osteopenia and osteoporosis

    PubMed Central

    Huang, Jeannie; Meixner, Linda; Fernandez, Susan; McCutchan, J. Allen

    2012-01-01

    Objective To evaluate the efficacy of a single dose of intravenous zoledronate for the treatment of HIV-associated osteopenia and osteoporosis. Design A double-blinded, randomized, placebo-controlled, 12 month trial of 5 mg intravenous zoledronate dose to treat 30 HIV-infected men and women with osteopenia and osteoporosis. Methods Following zoledronate or placebo infusions, participants were followed for 12 months on daily calcium and vitamin D supplements. Lumbar spine and hip bone density was assessed at baseline, 6 and 12 months. Biomarkers of bone metabolism were measured at baseline, 2 weeks, 3, 6, 9, and 12 months. Student’s t-test and repeated measure analyses were used to evaluate bone density and bone marker changes over time. Results In the 30 HIV-infected men (27) and women (3) in the trial, median T-scores at entry were -1.7 for the lumbar spine and -1.4 for the hip. Median CD4 count was 461 cells/μL, 93% had HIV-RNA viral loads <400 copies/mL, and 97% were taking antiretroviral medications. Bone density measured either absolutely or as sex-adjusted T-scores significantly improved in zoledronate recipients as compared to minimal changes in those receiving placebo. Bone resorption markers significantly decreased over the study period in the zoledronate recipients as compared to placebo controls. No acute infusion reactions were detected, but one patient developed uveitis, a recognized complication of zoledronate, which responded to therapy. Conclusions In this small study, annual zoledronate appears to be a safe and effective therapy for HIV-associated bone loss. PMID:19050386

  10. Unexpected Arrest-Related Deaths in America: 12 Months of Open Source Surveillance

    PubMed Central

    Ho, Jeffrey D.; Heegaard, William G.; Dawes, Donald M.; Natarajan, Sridhar; Reardon, Robert F.; Miner, James R.

    2009-01-01

    Introduction: Sudden, unexpected arrest-related death (ARD) has been associated with drug abuse, extreme delirium or certain police practices. There is insufficient surveillance and causation data available. We report 12 months of surveillance data using a novel data collection methodology. Methods: We used an open-source, prospective method to collect 12 consecutive months of data, including demographics, behavior, illicit substance use, control methods used, and time of collapse after law enforcement contact. Descriptive analysis and chi-square testing were applied. Results: There were 162 ARD events reported that met inclusion criteria. The majority were male with mean age 36 years, and involved bizarre, agitated behavior and reports of drug abuse just prior to death. Law enforcement control techniques included none (14%); empty-hand techniques (69%); intermediate weapons such as TASER® device, impact weapon or chemical irritant spray (52%); and deadly force (12%). Time from contact to subject collapse included instantaneous (13%), within the first hour (53%) and 1–48 hours (35%). Significant collapse time associations occurred with the use of certain intermediate weapons. Conclusion: This surveillance report can be a foundation for discussing ARD. These data support the premise that ARDs primarily occur in persons with a certain demographic and behavior profile that includes middle-aged males exhibiting agitated, bizarre behavior generally following illicit drug abuse. Collapse time associations were demonstrated with the use of TASER devices and impact weapons. We recommend further study in this area to validate our data collection method and findings. PMID:19561821

  11. Effects of 12 Months Continuous Positive Airway Pressure on Sympathetic Activity Related Brainstem Function and Structure in Obstructive Sleep Apnea

    PubMed Central

    Henderson, Luke A.; Fatouleh, Rania H.; Lundblad, Linda C.; McKenzie, David K.; Macefield, Vaughan G.

    2016-01-01

    Muscle sympathetic nerve activity (MSNA) is greatly elevated in patients with obstructive sleep apnea (OSA) during normoxic daytime wakefulness. Increased MSNA is a precursor to hypertension and elevated cardiovascular morbidity and mortality. However, the mechanisms underlying the high MSNA in OSA are not well understood. In this study we used concurrent microneurography and magnetic resonance imaging to explore MSNA-related brainstem activity changes and anatomical changes in 15 control and 15 OSA subjects before and after 6 and 12 months of continuous positive airway pressure (CPAP) treatment. We found that following 6 and 12 months of CPAP treatment, resting MSNA levels were significantly reduced in individuals with OSA. Furthermore, this MSNA reduction was associated with restoration of MSNA-related brainstem activity and structural changes in the medullary raphe, rostral ventrolateral medulla, dorsolateral pons, and ventral midbrain. This restoration occurred after 6 months of CPAP treatment and was maintained following 12 months CPAP. These findings show that continual CPAP treatment is an effective long-term treatment for elevated MSNA likely due to its effects on restoring brainstem structure and function. PMID:27013952

  12. Parents’ perceived treatment match and treatment retention over 12 months among youth in the LAMS study

    PubMed Central

    Young, Andrea S.; Horwitz, Sarah M.; Findling, Robert L.; Youngstrom, Eric A.; Arnold, L. Eugene; Fristad, Mary A.

    2015-01-01

    Objective The goal of these analyses was to describe the 12-month prevalence and identify predictors of mental health services retention for youth, ages 6–12 years, using data from the Longitudinal Assessment of Manic Symptoms (LAMS) study. Methods In a longitudinal cohort study, 416 children and their parents completed measures of mental health services use and parents’ perception of the services and semi-structured psychodiagnostic interviews at a baseline and 12-month assessment. Logistic regression analyses examined the effects of demographic and clinical variables and parents’ perception of how well their children’s treatment matched their needs on 12-month treatment retention. Results Sixty-nine percent of youth (n=289) continued to use services at 12 months. White race (p<.001) and greater functional impairment (p=.024) were associated with treatment retention; greater perceived treatment match at baseline significantly predicted retention above and beyond the effects of sociodemographic and clinical variables (p=.001). Conclusions White race and parents’ perceptions about appropriateness of treatment predict 12-month treatment retention. PMID:26522675

  13. A Randomized Controlled Trial of Celecoxib to Prevent Recurrence of Non-Muscle–Invasive Bladder Cancer

    PubMed Central

    Sabichi, Anita L.; Lee, J. Jack; Grossman, H. Barton; Liu, Suyu; Richmond, Ellen; Czerniak, Bogdan A.; De la Cerda, Jorge; Eagle, Craig; Viner, Jaye L.; Palmer, J. Lynn; Lerner, Seth P.

    2014-01-01

    Significant morbidity and expense result from frequent recurrences of non-muscle invasive bladder cancer (NMIBC) after standard treatment, and carcinoma in situ (Tis) is a poor prognostic factor. Predicated on observational and preclinical data strongly supporting cyclooxygenase-2 (COX-2) in the pathogenesis, and the activity of COX-2 inhibitors, in bladder cancer, we conducted a randomized, double-blind, placebo-controlled trial to determine if celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at high risk for recurrence. 146 patients were randomized to celecoxib (200 mg) or placebo orally twice daily for at least 12 months. The average treatment duration was 1.25 years. Primary intent-to-treat analysis revealed celecoxib did not statistically significantly prolong TTR compared with placebo (P = 0.17, log-rank). With a median follow-up of 2.49 years the relative risk of recurrence in the celecoxib vs placebo arms was 0.64 (95% CI, 0.38, 1.17). The recurrence-free rate at 12 months with celecoxib was 88% (95% CI, 0.81,0.96) versus 78% (95% CI, 0.69, 0.89) with placebo. After controlling for covariates with Cox regression analysis, recurrence rates did not differ between the two study arms (HR = 0.69; 95% CI, 0.37,1.29). Celecoxib had a marginally significant effect on reducing metachronous recurrences (vs. placebo) with hazard ratio of 0.56 (95% CI, 0.3,1.06; P=0.075). Celecoxib was well tolerated, with similar adverse events and quality-of-life in both arms. Our clinical trial results do not show a clinical benefit for celecoxib in preventing NMIBC recurrence but further investigation of COX-2 inhibitors in this setting is warranted. PMID:21881030

  14. Effect of denosumab on Japanese patients with rheumatoid arthritis: a dose–response study of AMG 162 (Denosumab) in patients with RheumatoId arthritis on methotrexate to Validate inhibitory effect on bone Erosion (DRIVE)—a 12-month, multicentre, randomised, double-blind, placebo-controlled, phase II clinical trial

    PubMed Central

    Takeuchi, Tsutomu; Tanaka, Yoshiya; Ishiguro, Naoki; Yamanaka, Hisashi; Yoneda, Toshiyuki; Ohira, Takeshi; Okubo, Naoki; Genant, Harry K

    2016-01-01

    Objectives To evaluate efficacy and safety of three different regimens of denosumab, a fully human monoclonal antibody to receptor activator of nuclear factor kappa B (RANK) ligand (RANKL), for Japanese patients with rheumatoid arthritis (RA). Methods In this multicentre, randomised, placebo-controlled phase II study, 350 Japanese patients with RA between 6 months and <5 years, stratified by glucocorticoid use and rheumatoid factor status, were randomly assigned to subcutaneous injections of placebo or denosumab 60 mg every 6 months (Q6M), every 3 months (Q3M) or every 2 months (Q2M). All patients basically continued methotrexate treatment and had a supplement of calcium and vitamin D throughout the study. The primary endpoint was change in the modified Sharp erosion score from baseline to 12 months. Results Denosumab significantly inhibited the progression of bone erosion at 12 months compared with the placebo, and the mean changes of the modified Sharp erosion score at 12 months from baseline were 0.99, 0.27 (compared with placebo, p=0.0082), 0.14 (p=0.0036) and 0.09 (p<0.0001) in the placebo, Q6M, Q3M and Q2M, respectively. Secondary endpoint analysis revealed that denosumab also significantly inhibited the increase of the modified total Sharp score compared with the placebo, with no obvious evidence of an effect on joint space narrowing for denosumab. As shown in previous studies, denosumab increased bone mineral density. No apparent difference was observed in the safety profiles of denosumab and placebo. Conclusions Addition of denosumab to methotrexate has potential as a new therapeutic option for patients with RA with risk factors of joint destruction. Trial registration number JapicCTI-101263. PMID:26585988

  15. 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

  16. Long Term Effects on Risk Factors for Cardiovascular Disease after 12-Months of Aerobic Exercise Intervention - A Worksite RCT among Cleaners

    PubMed Central

    Korshøj, Mette; Lidegaard, Mark; Krustrup, Peter; Jørgensen, Marie Birk; Søgaard, Karen; Holtermann, Andreas

    2016-01-01

    Objectives Occupational groups exposed to high occupational physical activity have an increased risk for cardiovascular disease (CVD). This may be explained by the high relative aerobic workload. Enhanced cardiorespiratory fitness reduces the relative aerobic workload. Thus, the aim was to evaluate the 12-months effects of worksite aerobic exercise on risk factors for CVD among cleaners. Methods One hundred and sixteen cleaners aged 18–65 years were randomized to a group performing aerobic exercise and a reference group receiving lectures. Outcomes were collected at baseline and after 12-months. A repeated measures 2×2 multi-adjusted mixed-model design was applied to compare the between-group differences using intention-to-treat analysis. Results Between-group differences (p<0.05) were found favouring the aerobic exercise group: cardiorespiratory fitness 2.15 (SE 1.03) mlO2/min/kg, aerobic workload -2.15 (SE 1.06) %HRR, resting HR -5.31 (SE 1.61) beats/min, high sensitive C-reactive protein -0.65 (SE 0.24) μg/ml. The blood pressure was unaltered. Stratified analyses on relative aerobic workload at baseline revealed that those with relative aerobic workloads ≥30% of HRR seems to impose a notable adverse effect on resting and ambulatory blood pressure. Conclusion This long-term worksite aerobic exercise intervention among cleaners led to several beneficial effects, but also potential adverse effects among those with high relative aerobic workloads. Trial Registration Controlled-Trials.com ISRCTN86682076 PMID:27513932

  17. HERMITAGE – A Randomized Controlled Trial to Reduce Sexually Transmitted Infections and HIV-risk Behaviors among HIV-infected Russian Drinkers

    PubMed Central

    Samet, Jeffrey H.; Raj, Anita; Cheng, Debbie M.; Blokhina, Elena; Bridden, Carly; Chaisson, Christine E.; Walley, Alexander Y.; Palfai, Tibor P.; Quinn, Emily K.; Zvartau, Edwin; Lioznov, Dmitry; Krupitsky, Evgeny

    2014-01-01

    Aims This study assessed the effectiveness of HERMITAGE (HIV’s Evolution in Russia - Mitigating Infection Transmission and Alcoholism in a Growing Epidemic), an adapted secondary HIV prevention intervention, compared with an attention control condition in decreasing sexually transmitted infections (STIs) and sex and drug risk behaviors among Russian HIV-infected heavy drinkers. Design We conducted a single-blinded, two-armed, randomized controlled trial with 12-month follow-up. Setting The study was conducted in St. Petersburg, Russia. Participants were recruited from four HIV and addiction clinical sites. The intervention was conducted at Botkin Infectious Disease Hospital. Participants HIV-infected persons with past 6-month risky sex and heavy alcohol consumption (n=700) were randomized to the HERMITAGE intervention (n=350) or an attention control condition (n=350). Intervention A Healthy Relationships Intervention stressing disclosure of HIV serostatus and condom use, adapted for a Russian clinical setting with two individual sessions and three small group sessions. Measurements The primary outcome was incident STI by laboratory test at 12-month follow-up. Secondary outcomes included change in unprotected sex and several alcohol and injection drug use (IDU) variables. Findings Participants had the following baseline characteristics: 59% male, mean age 30, 60% past year IDU, 15.4% prevalent STI and mean CD4 cell count 413/μl. Assessment occurred among 75% and 71% of participants at 6 and 12-months, respectively. STIs occurred in 20 subjects (8%) in the intervention group and 28 subjects (12%) in the control group at 12-month follow-up; logistic regression analyses found no significant difference between groups (adjusted odds ratio 0.69; 95% CI: 0.36-1.30; P=0.25). Both groups decreased unsafe behaviors, although no significant differences between groups were found. Conclusions The HERMITAGE HIV risk reduction intervention does not appear to reduce sexually

  18. 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.

  19. Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Osteoarthritis (OA) is the most common type of arthritis, causing significant joint pain and disability. It is already a major cause of healthcare expenditure and its incidence will further increase with the ageing population. Current treatments for OA have major limitations and new analgesic treatments are needed. Synovitis is prevalent in OA and is associated with pain. Hydroxychloroquine is used in routine practice for treating synovitis in inflammatory arthritides, such as rheumatoid arthritis. We propose that treating patients with symptomatic hand OA with hydroxychloroquine will be a practical and safe treatment to reduce synovitis and pain. Methods/design HERO is an investigator-initiated, multicentre, randomized, double-blind, placebo-controlled trial. A total of 252 subjects with symptomatic hand OA will be recruited across primary and secondary care sites in the UK and randomized on a 1:1 basis to active treatment or placebo for 12 months. Daily medication dose will range from 200 to 400 mg according to ideal body weight. The primary endpoint is change in average hand pain during the previous two weeks (measured on a numerical rating scale (NRS)) between baseline and six months. Secondary endpoints include other self-reported pain, function and quality-of-life measures and radiographic structural change at 12 months. A health economics analysis will also be performed. An ultrasound substudy will be conducted to examine baseline levels of synovitis. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modelling analyses. All analyses will be conducted on an intention-to-treat basis. Discussion The HERO trial is designed to examine whether hydroxychloroquine is an effective analgesic treatment for OA and whether it provides any long-term structural benefit. The ultrasound substudy will address whether baseline synovitis is a predictor of therapeutic response. This will potentially

  20. 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

  1. 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

  2. Employment-based reinforcement of adherence to oral naltrexone in unemployed injection drug users: 12-month outcomes.

    PubMed

    Dunn, Kelly; DeFulio, Anthony; Everly, Jeffrey J; Donlin, Wendy D; Aklin, Will M; Nuzzo, Paul A; Leoutsakos, Jeannie-Marie S; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E; Silverman, Kenneth

    2015-06-01

    Oral naltrexone could be a promising relapse-prevention pharmacotherapy for recently detoxified opioid-dependent patients; however, interventions are often needed to promote adherence with this treatment approach. We recently conducted a study to evaluate a 26-week employment-based reinforcement intervention of oral naltrexone in unemployed injection drug users (Dunn et al., 2013). Participants were randomly assigned into a contingency (n = 35) group required to ingest naltrexone under staff observation to gain entry into a therapeutic workplace or a prescription (n = 32) group given a take-home supply of oral naltrexone and access to the workplace without observed ingestion. Monthly urine samples were collected and analyzed for evidence for naltrexone adherence, opioid use, and cocaine use. As previously reported, contingency participants provided significantly more naltrexone-positive urine samples than prescription participants during the 26-week intervention period. The goal of this current study is to report the 12-month outcomes, which occurred 6 months after the intervention ended. Results at the 12-month visit showed no between-groups differences in naltrexone-positive, opioid-negative, or cocaine-negative urine samples and no participant self-reported using naltrexone at the follow-up visit. These results show that even after a period of successfully reinforced oral naltrexone adherence, longer-term naltrexone use is unlikely to be maintained after reinforcement contingencies are discontinued. (PsycINFO Database Record

  3. Employment-based Reinforcement of Adherence to Oral Naltrexone in Unemployed Injection Drug Users: 12-month Outcomes

    PubMed Central

    Dunn, Kelly; DeFulio, Anthony; Everly, Jeffrey J.; Donlin, Wendy D.; Aklin, Will M.; Nuzzo, Paul A.; Leoutsakos, Jeannie-Marie S.; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E.; Silverman, Kenneth

    2015-01-01

    Oral naltrexone could be a promising relapse prevention pharmacotherapy for recently detoxified opioid-dependent patients, however interventions are often needed to promote adherence with this treatment approach. We recently conducted a study to evaluate a 26-week employment-based reinforcement intervention of oral naltrexone in unemployed injection drug users (Dunn et al., 2013). Participants were randomly assigned into a Contingency (n=35) group required to ingest naltrexone under staff observation to gain entry into a therapeutic workplace, or a Prescription (n=32) group given a take-home supply of oral naltrexone and access to the workplace without observed ingestion. Monthly urine samples were collected and analyzed for evidence for naltrexone adherence, opioid use, and cocaine use. As previously reported, Contingency participants provided significantly more naltrexone-positive urine samples than Prescription participants during the 26-week intervention period. The goal of this current study is to report the 12-month outcomes, which occurred 6 months after the intervention ended. Results at the 12-month visit showed no between-group differences in naltrexone-positive, opioid-negative, or cocaine-negative urine samples, and no participant self-reported using naltrexone at the follow-up visit. These results show that even after a period of successfully reinforced oral naltrexone adherence longer-term naltrexone use is unlikely to be maintained after reinforcement contingencies are discontinued. PMID:25134047

  4. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  5. The Closed Equilibrated Biological Aquatic System: A 12 months Test of an Artificial Aquatic Ecosystem

    NASA Astrophysics Data System (ADS)

    Blüm, V.; Andriske, M.; Ludwig, Ch.; Paaßen, U.; Voeste, D.

    1999-01-01

    The ``Closed Equilibrated Biological Aquatic System'' (C.E.B.A.S.) is finally disposed for long-term multi-generation experiments with aquatic organisms in a space station. Therefore a minimum operation time of three month is required. It is verified in three versions of laboratory prototypes. The third one passed successfully a 12 months mid-term test in 1995/96 thus demonstrating its high biological stability. The third version of the C.E.B.A.S. consists of a 100 l animal tank, two plant cultivators with a volume of 15 l each with independent illuminations, a 3.0 l semibiological ``mechanical'' filter, a 3.0 l bacteria filter, a heating/cooling device and a dummy filter unit. The live-bearing teleost Xiphophorus helleri is the vertebrate and the pulmonate water snail Biomphalaria glabrata the invertebrate experimental animal in the system. The rootless higher water plant Ceratophyllum demersum is the producer organism. Ammonia oxidizing bacteria and other microorganisms settle in the filters. A simple data acquisition is combined with temperature and plant illumination control. Besides of the space aspects the C.E.B.A.S. proved to be an extremely suitable tool to investigate the organism and subcomponent interactions in a well defined terrestrial aquatic closed ecosystem by providing physical, chemical and biological data which allow an approach to a comprehensive system analysis. Moreover the C.E.B.A.S. is the base for the development of innovative combined animal-plant aquaculture systems for human nutrition on earth which could be implemented into bioregenerative life support systems with a higher degree of complexity suitable for lunar or planetary bases.

  6. Postpartum Varicose Veins: Supplementation with Pycnogenol or Elastic Compression-A 12-Month Follow-Up.

    PubMed

    Belcaro, Gianni; Dugall, Mark; Luzzi, Roberta; Ippolito, Edmondo; Cesarone, M Rosaria

    2017-03-01

    This open registry aimed to evaluate the clinical evolution of postpartum varicose veins (VVs), in healthy women after the second pregnancy, how these veins regain shape and competence, and possible treatments. The registry included two groups of women: (1) those who used elastic compression stockings, and (2) who used an oral venotonic agent (Pycnogenol, 100 mg/d). A total of 12 evaluation targets were established. Minor symptoms were scored in an analogue scale line. A visual analogue scale line evaluated the overall satisfaction relative to elastic compression or Pycnogenol. Overall 133 women completed the registry evaluation with at least 3 months of follow-up. The resulting two registry groups were comparable. At 3 and 6 months in the Pycnogenol group the number of veins and incompetent sites were lower. At 6 months there were 13.3% of patients with edema in controls versus 3.2% in the Pycnogenol group. Spider veins decreased in Pycnogenol patients. Cramps and other minor symptoms were less common in the Pycnogenol group. In both groups there was a significant improvement at 6 months with better results in the Pycnogenol group. The need for treatment was limited with a decreased need for sclerotherapy, surgery, and conservative treatments in the Pycnogenol group. The overall satisfaction was higher among Pycnogenol patients, and compliance was optimal. Re-evaluation at 12 months indicated that the variations in VVs and spider vein clusters and the associated symptoms did not change. Most remodeling appeared to happen within 6 months after the pregnancy. It was concluded that the use of Pycnogenol improves signs/symptoms of postpartum VVs, and venous function and shape seem to return faster to prepartum, physiological pattern with its use.

  7. Change in sexual activity 12 months after ART initiation among HIV-positive Mozambicans.

    PubMed

    Pearson, Cynthia R; Cassels, Susan; Kurth, Ann E; Montoya, Pablo; Micek, Mark A; Gloyd, Stephen S

    2011-05-01

    We assessed sexual behaviors before and 12-months after ART initiation among 277 Mozambicans attending an HIV clinic. Measured behaviors included the number of sexual partners, condom use, concurrent relationships, disclosure of HIV status, alcohol use, and partners' serostatus. Compared to before ART initiation, increases were seen 12 months after ART in the proportion of participants who were sexually active (48% vs. 64% respondents, P < 0.001) and the proportion of participants with HIV-negative or unknown serostatus partners (45% vs. 80%, P < 0.001). Almost all (96%) concurrent partnerships reported at 12 months formed after ART initiation. Although reported correct and consist condom use increased, the number of unprotected sexual relationships remained the same (n = 45). Non-disclosure of HIV-serostatus to sexual partners was the only significant predictor of practicing unprotected sex with partners of HIV-negative or unknown serostatus. Sexual activity among HIV-positive persons on ART increased 12 months after ART initiation. Ongoing secondary transmission prevention programs addressing sexual activity with multiple partners, disclosure to partners and consistent condom use with serodisconcordant partners must be incorporated throughout HIV care programs.

  8. FedEx Express Gasoline Hybrid Electric Delivery Truck Evaluation: 12-Month Report

    SciTech Connect

    Barnitt, R.

    2011-01-01

    This report summarizes the data obtained in a 12-month comparison of three gasoline hybrid electric delivery vehicles with three comparable diesel vehicles. The data show that there was no statistical difference between operating cost per mile of the two groups of vehicles. As expected, tailpipe emissions were considerably lower across all drive cycles for the gHEV than for the diesel vehicle.

  9. Change in Sexual Activity 12 Months After ART Initiation Among HIV-Positive Mozambicans

    PubMed Central

    Cassels, Susan; Kurth, Ann E.; Montoya, Pablo; Micek, Mark A.; Gloyd, Stephen S.

    2012-01-01

    We assessed sexual behaviors before and 12-months after ART initiation among 277 Mozambicans attending an HIV clinic. Measured behaviors included the number of sexual partners, condom use, concurrent relationships, disclosure of HIV status, alcohol use, and partners’ serostatus. Compared to before ART initiation, increases were seen 12 months after ART in the proportion of participants who were sexually active (48% vs. 64% respondents, P < 0.001) and the proportion of participants with HIV-negative or unknown serostatus partners (45% vs. 80%, P < 0.001). Almost all (96%) concurrent partnerships reported at 12 months formed after ART initiation. Although reported correct and consist condom use increased, the number of unprotected sexual relationships remained the same (n = 45). Non-disclosure of HIV-serostatus to sexual partners was the only significant predictor of practicing unprotected sex with partners of HIV-negative or unknown serostatus. Sexual activity among HIV-positive persons on ART increased 12 months after ART initiation. Ongoing secondary transmission prevention programs addressing sexual activity with multiple partners, disclosure to partners and consistent condom use with serodisconcordant partners must be incorporated throughout HIV care programs. PMID:21082338

  10. Metacognitive functioning predicts positive and negative symptoms over 12 months in first episode psychosis.

    PubMed

    McLeod, Hamish J; Gumley, Andrew I; Macbeth, Angus; Schwannauer, Matthias; Lysaker, Paul H

    2014-07-01

    The negative symptoms of schizophrenia are a major source of impairment and distress but both pharmacological and psychological treatment options provide only modest benefit. Developing more effective psychological treatments for negative symptoms will require a more sophisticated understanding of the psychological processes that are implicated in their development and maintenance. We extended previous work by demonstrating that metacognitive functioning is related to negative symptom expression across the first 12 months of first episode psychosis (FEP). Previous studies in this area have either been cross-sectional or have used much older participants with long-standing symptoms. In this study, forty-five FEP participants were assessed three times over 12 months and provided data on PANSS rated symptoms, premorbid adjustment, metacognitive functioning, and DUP. Step-wise linear regression showed that adding metacognition scores to known predictors of negative symptoms (baseline symptom severity, gender, DUP, and premorbid academic and social adjustment) accounted for 62% of the variance in PANSS negative symptom scores at six months and 38% at 12 months. The same predictors also explained 47% of the variance in positive symptoms at both six and 12 months. However, exploration of the simple correlations between PANSS symptom scores and metacognition suggests a stronger univariate relationship between metacognition and negative symptoms. Overall, the results indicate that problems with mental state processing may be important determinants of negative symptom expression from the very early stages of psychosis. These results provide further evidence that metacognitive functioning is a potentially relevant target for psychological interventions.

  11. Case Study Analyses of Play Behaviors of 12-Month-Old Infants Later Diagnosed with Autism

    ERIC Educational Resources Information Center

    Mulligan, Shelley

    2015-01-01

    Case study research methodology was used to describe the play behaviors of three infants at 12 months of age, who were later diagnosed with an autism spectrum disorder. Data included standardized test scores, and analyses of video footage of semi-structured play sessions from infants identified as high risk for autism, because of having a sibling…

  12. Vowel Production in 7- to 12-Month-Old Infants with Hearing Loss

    ERIC Educational Resources Information Center

    Nelson, Rebecca; Yoshinaga-Itano, Christine; Rothpletz, Ann; Sedey, Allison

    2007-01-01

    The purpose of this study was to examine vowel production in 7- to 12-month-old infants with hearing loss. Fifty-four infants were divided into three groups according to degree of hearing loss (mild-to-moderate, moderately severe-to-severe, profound), and their vocalizations were phonetically transcribed from 30-minute videotaped samples. These…

  13. Atypical Object Exploration at 12 Months of Age Is Associated with Autism in a Prospective Sample

    ERIC Educational Resources Information Center

    Ozonoff, Sally; Macari, Suzanne; Young, Gregory S.; Goldring, Stacy; Thompson, Meagan; Rogers, Sally J.

    2008-01-01

    This prospective study examined object exploration behavior in 66 12-month-old infants, of whom nine were subsequently diagnosed with an autism spectrum disorder. Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development. A task was developed that afforded specific opportunities…

  14. Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

    ERIC Educational Resources Information Center

    Britton, Peter C.; Conner, Kenneth R.

    2010-01-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment…

  15. Upper limb module in non-ambulant patients with spinal muscular atrophy: 12 month changes.

    PubMed

    Sivo, Serena; Mazzone, Elena; Antonaci, Laura; De Sanctis, Roberto; Fanelli, Lavinia; Palermo, Concetta; Montes, Jacqueline; Pane, Marika; Mercuri, Eugenio

    2015-03-01

    Recent studies have suggested that in non-ambulant patients affected by spinal muscular atrophy the Upper Limb Module can increase the range of activities assessed by the Hammersmith Functional Motor Scale Expanded. The aim of this study was to establish 12-month changes in the Upper Limb Module in a cohort of non-ambulant spinal muscular atrophy patients and their correlation with changes on the Hammersmith Functional Motor Scale Expanded. The Upper Limb Module scores ranged between 0 and 17 (mean 10.23, SD 4.81) at baseline and between 1 and 17 at 12 months (mean 10.27, SD 4.74). The Hammersmith Functional Motor Scale Expanded scores ranged between 0 and 34 (mean 12.43, SD 9.13) at baseline and between 0 and 34 at 12 months (mean 12.08, SD 9.21). The correlation betweeen the two scales was 0.65 at baseline and 0.72 on the 12 month changes. Our results confirm that the Upper Limb Module can capture functional changes in non-ambulant spinal muscular atrophy patients not otherwise captured by the other scale and that the combination of the two measures allows to capture changes in different subgroups of patients in whom baseline scores and functional changes may be influenced by several variables such as age.

  16. Physical outcomes of patients with burn injuries--a 12 month follow-up.

    PubMed

    Jarrett, Mark; McMahon, Margaret; Stiller, Kathy

    2008-01-01

    There is only limited research documenting functional ability, physical fitness, and health related quality of life after burn injury. The objective of this study was to measure a comprehensive range of physiotherapy-related outcomes over a 12-month period for patients with significant burn injuries. A prospective study was performed on consecutive patients admitted to the Royal Adelaide Hospital over a 12-month period. Outcomes were measured at admission and discharge from hospital and at 1, 3, 6, and 12 months, and comprised the: Medical Outcomes Study 36-Item Short Form Health Survey, Quick Disabilities of the Arm, Shoulder and Hand questionnaire, Lower Extremity Functional Scale questionnaire, shuttle walk test, grip strength and scar appearance using the Matching Assessment with Photographs of Scars. A total of 86 patients (74 male, mean age 38 years) participated. There was a significant deterioration in all outcomes in the first few months after burn injury, with most outcomes improving towards baseline levels by 6 months. However, lower limb function (Lower Extremity Functional Scale) remained significantly reduced at 12 months and functional exercise capacity (shuttle walk test) was still markedly reduced at 6 months compared with predicted normal values. The total burn surface area significantly affected many of the outcomes. In conclusion, for this sample of patients after burn injury, there was an acceptable rate of recovery for physiotherapy-related outcomes, in that most measures had returned to near baseline levels by 6 months postinjury, with the exception of lower limb function and functional exercise capacity.

  17. 12-Month Follow-Up of Fluoxetine and Cognitive Behavioral Therapy for Binge Eating Disorder

    ERIC Educational Resources Information Center

    Grilo, Carlos M.; Crosby, Ross D.; Wilson, G. Terence; Masheb, Robin M.

    2012-01-01

    Objective: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.…

  18. Evidence for a Unitary Goal Concept in 12-Month-Old Infants

    ERIC Educational Resources Information Center

    Biro, Szilvia; Verschoor, Stephan; Coenen, Lot

    2011-01-01

    We investigated whether infants can transfer their goal attribution between situations that contain different types of information about the goal. We found that 12-month-olds who had attributed a goal based on the causal efficacy of a means-end action generated expectations about the actor's action in another scenario in which the actor could…

  19. Class Matters: 12-Month-Olds' Word-Object Associations Privilege Content over Function Words

    ERIC Educational Resources Information Center

    MacKenzie, Heather; Curtin, Suzanne; Graham, Susan A.

    2012-01-01

    A fundamental step in learning words is the development of an association between a sound pattern and an element in the environment. Here we explore the nature of this associative ability in 12-month-olds, examining whether it is constrained to privilege particular word forms over others. Forty-eight infants were presented with sets of novel…

  20. The Flexibility of 12-Month-Olds' Preferences for Phonologically Appropriate Object Labels

    ERIC Educational Resources Information Center

    MacKenzie, Heather K.; Graham, Susan A.; Curtin, Suzanne; Archer, Stephanie L.

    2014-01-01

    We explored 12-month-olds' flexibility in accepting phonotactically illegal or ill-formed word forms in a modified associative-learning task. Sixty-four English-learning infants were presented with a training phase that either clarified the purpose of a sound--object association task or left the task ambiguous. Infants were then habituated to sets…

  1. Auditory Temporal Pattern Perception in 6- and 12-Month-Old Infants.

    ERIC Educational Resources Information Center

    Morrongiello, Barbara A.

    1984-01-01

    A go/no-go conditioned head-turn paradigm was used to examine the abilities of 6- and 12-month-olds to discriminate changes in temporal grouping and their perception of absolute and relative timing information when listening to patterns of white-noise bursts. (Author/RH)

  2. Speech Production in 12-Month-Old Children with and without Hearing Loss

    ERIC Educational Resources Information Center

    McGowan, Richard S.; Nittrouer, Susan; Chenausky, Karen

    2008-01-01

    Purpose: The purpose of this study was to compare speech production at 12 months of age for children with hearing loss (HL) who were identified and received intervention before 6 months of age with those of children with normal hearing (NH). Method: The speech production of 10 children with NH was compared with that of 10 children with HL whose…

  3. Adherence to Glaucoma Medications Over 12 Months in Two US Community Pharmacy Chains

    PubMed Central

    Feehan, Michael; Munger, Mark A.; Cooper, Daniel K.; Hess, Kyle T.; Durante, Richard; Jones, Gregory J.; Montuoro, Jaime; Morrison, Margaux A.; Clegg, Daniel; Crandall, Alan S.; DeAngelis, Margaret M.

    2016-01-01

    This study determined the degree of adherence to medications for glaucoma among patients refilling prescriptions in community pharmacies. Methods: Data abstracted from the dispensing records for 3615 adult patients (18 years or older, predominantly over 45) receiving glaucoma medications from two retail pharmacy chains (64 stores in total) were analyzed. From a 24-month historic data capture period, the 12-month levels of adherence were determined using standard metrics, the proportion of days covered (PDC) and the medication possession ratio (MPR). The overall 12-month mean PDC was only 57%, and the mean MPR was 71%. Using a criterion by which 80% coverage was considered satisfactory adherence, only 30% had satisfactory overall 12-month PDC coverage, and only 37% had satisfactory overall 12-month MPR coverage. Refill adherence increased with age and was highest in the 65-and-older age group (p < 0.001). Differential adherence was found across medication classes, with the highest satisfactory coverage seen for those taking alpha2-adrenergic agonists (PDC = 36.0%; MPR = 47.6%) down to those taking direct cholinergic agonists (PDC = 25.0%; MPR = 31.2%) and combination products (PDC = 22.7%; MPR = 31.0%). Adherence to glaucoma medications in the community setting, as measured by pharmacy refill data, is very poor and represents a critical target for intervention. Community pharmacists are well positioned to monitor and reinforce adherence in this population. PMID:27618115

  4. Skeletal findings in the first 12 months following initiation of glucocorticoid therapy for pediatric nephrotic syndrome

    PubMed Central

    Phan, V; Blydt-Hansen, T; Feber, J; Alos, N; Arora, S; Atkinson, S; Bell, L; Clarson, C; Couch, R; Cummings, EA; Filler, G; Grant, RM; Grimmer, J; Hebert, D; Lentle, B; Ma, J; Matzinger, M; Midgley, J; Pinsk, M; Rodd, C; Shenouda, N; Stein, R; Stephure, D; Taback, S; Williams, K; Rauch, F; Siminoski, K; Ward, LM

    2014-01-01

    Introduction Vertebral fracture (VF) incidence following glucocorticoid (GC) initiation has not been previously reported in pediatric nephrotic syndrome. Methods VF were assessed on radiographs (Genant method); lumbar spine bone mineral density (LS BMD) was evaluated by dual-energy x-ray absorptiometry. Results Sixty-five children were followed to 12 months post-GC initiation (median age: 5.4 years, range 2.3 to 17.9). Three of 54 children with radiographs (6%, 95% CI 2 to 15%) had incident VF at 1 year. The mean LS BMD Z-score was below the healthy average at baseline (mean ± SD −0.5 ± 1.1 p=0.001) and at 3 months (−0.6 ± 1.1 p<0.001), but not at 6 months (−0.3 ± 1.3, p=0.066) or 12 months (−0.3 ± 1.2, p=0.066). Mixed effect modeling showed a significant increase in LS BMD Z-scores between 3 and 12 months (0.22 SD, 95% CI 0.08 to 0.36, p=0.003). A sub-group (N=16; 25%) had LS BMD Z-scores that were ≤ −1.0 at 12 months. In these children, each additional 1000 mg/m2 of GC received in the first 3 months was associated with a decrease in LS BMD Z-score by 0.39 at 12 months (95% CI, −0.71 to −0.07; p=0.017). Conclusions The incidence of VF at 1 year was low and LS BMD Z-scores improved by 12 months in the majority. Twenty-five percent of children had LS BMD Z-scores ≤ −1.0 at 12 months. In these children, LS BMD Z-scores were inversely associated with early GC exposure, despite similar GC exposure compared to the rest of the cohort. PMID:23948876

  5. Gastrointestinal tract development in red deer (Cervus elaphus) calves from 1 to 12 months of age.

    PubMed

    Hammond, K J; Hoskin, S O; Jopson, N B; Mackintosh, C G; Hofstra, G; Thompson, B R; Stevens, D R

    2013-11-01

    This study provides a detailed description of the development of the gastrointestinal tract (GIT) of farmed red deer (Cervus elaphus) calves over the first 12 months of age. GIT development was measured using a combination of computerised tomography (CT) scanning and traditional slaughter plus dissection techniques. Red deer calves of a known birth date were randomly assigned to two treatment groups. A group of five animals were repeatedly CT scanned at 31, 63, 92, 135, 207, 275 and 351 days of age to identify GIT organs and determine their volume. From a group of 20 animals, subsets of four individuals were also scanned at corresponding ages (except 135 days of age). They were immediately euthanised and dissected after CT scanning to compare CT-scanned results with actual anatomical measurements. Individual organ weights were compared with their respective organ volumes determined by CT scanning and were found to have a strong, positive relationship. The combined rumen and reticulum (RR) CT-scanned volume was compared with its volume determined by the water-displacement technique and this also showed good correlation between the two techniques (R = 0.92). The allometric growth rates of organs, relative to animal live weight gains, in descending order, were the rumen, omasum, reticulum, abomasum, caecum blind sac, kidneys, spleen and liver. The red deer GIT was continuing to grow and develop when the last measurement was taken at 351 days of age. The greatest growth of the RR, when expressed in terms of empty weight, was between 31 and 92 days of age. Compared with sheep and cattle, it appears that the red deer have a similar or greater rate of RR development up until approximately 60 to 90 days of age; however, the final increments of GIT maturity in deer may take longer to complete, with the empty weight of the RR gaining 7.5 g/day between 275 and 351 days of age. CT scanning was validated in this study as a viable technique to follow GIT development in the same

  6. 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

  7. Mindfulness meditation and cognitive behavioral therapy for insomnia: a naturalistic 12-month follow-up.

    PubMed

    Ong, Jason C; Shapiro, Shauna L; Manber, Rachel

    2009-01-01

    A unique intervention combining mindfulness meditation with cognitive behavioral therapy for insomnia (CBT-I) has been shown to have acute benefits at posttreatment in an open label study. The aim of the present study was to examine the long-term effects of this integrated intervention on measures of sleep and sleep-related distress in an attempt to characterize the natural course of insomnia following this treatment and to identify predictors of poor long-term outcome. Analyses were conducted on 21 participants, who provided follow-up data at six and 12 months posttreatment. At each time point, participants completed one week of sleep and meditation diaries and questionnaires related to mindfulness, sleep, and sleep-related distress, including the Pre-Sleep Arousal Scale, the Glasgow Sleep Effort Scale, the Kentucky Inventory of Mindfulness Skills, and the Insomnia Episode Questionnaire. Analyses examining the pattern of change across time (baseline, end of treatment, six months, and 12 months) revealed that several sleep-related benefits were maintained during the 12-month follow-up period. Participants who reported at least one insomnia episode (>or=1 month) during the follow-up period had higher scores on the Pre-Sleep Arousal Scale (P < .05) and the Glasgow Sleep Effort Scale (P < .05) at end of treatment compared with those with no insomnia episodes. Correlations between mindfulness skills and insomnia symptoms revealed significant negative correlations (P < .05) between mindfulness skills and daytime sleepiness at each of the three time points but not with nocturnal symptoms of insomnia. These results suggest that most sleep-related benefits of an intervention combining CBT-I and mindfulness meditation were maintained during the 12-month follow-up period, with indications that higher presleep arousal and sleep effort at end of treatment constitute a risk for occurrence of insomnia during the 12 months following treatment.

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

    PubMed Central

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

    2015-01-01

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

  9. Impact of online patient reminders to improve asthma care: A randomized controlled trial

    PubMed Central

    Pool, Andrew C.; Kraschnewski, Jennifer L.; Poger, Jennifer M.; Smyth, Joshua; Stuckey, Heather L.; Craig, Timothy J.; Lehman, Erik B.; Yang, Chengwu; Sciamanna, Christopher N.

    2017-01-01

    Importance Asthma is one of the most burdensome chronic illnesses in the US. Despite widespread dissemination of evidence-based guidelines, more than half of the adults with asthma have uncontrolled symptoms. Objective To examine the efficacy of an online tool designed to improve asthma control. Design 12-month single blind randomized controlled trial of the online tool (Intervention condition, IC) versus an active control tool (CC). Setting Patients enrolled in an insurance plan. Participants Participants were 408 adults (21–60 years of age) with persistent asthma. Intervention At least once each month and before provider visits, participants in the IC answered questions online about their asthma symptoms, asthma medications and asthma care received from providers, such as an asthma management plan. The tool then provided tailored feedback to remind patients 1) to ask health care providers specific questions that may improve asthma control (e.g., additional controller medications) and 2) to consistently perform specific self-care behaviors (e.g., proper inhaler technique). Participants in the CC received similar questions and feedback, yet focused instead on preventive services unrelated to asthma control (e.g., cancer screening). Main outcome measures The main outcome measure was asthma control, as assessed by the 5-question Asthma Control Test (ACT). Secondary outcomes included quality of life, medication use and healthcare utilization (e.g., emergency department visits). Results After 12 months, 323 participants completed follow-up measures (79.2%). Participants in the IC reported a greater mean improvement in the ACT score than participants in the CC (2.3 vs. 1.2; p = 0.02) and 9 of 11 individual asthma control survey items showed non-significant improvements favoring the IC. No differences were observed in medication adherence, number of asthma controller medications or health care utilization. Conclusion and relevance Simple and brief online patient

  10. 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.

  11. Xerostomia and quality of life after intensity-modulated radiotherapy vs. conventional radiotherapy for early-stage nasopharyngeal carcinoma: Initial report on a randomized controlled clinical trial

    SciTech Connect

    Pow, Edmond; Kwong, Dora; McMillan, Anne S. . E-mail: annemcmillan@hku.hk; Wong, May; Sham, Jonathan; Leung, Lucullus; Leung, W. Keung

    2006-11-15

    Purpose: To compare directly the effect of intensity-modulated radiotherapy (IMRT) vs. conventional radiotherapy (CRT) on salivary flow and quality of life (QoL) in patients with early-stage nasopharyngeal carcinoma (NPC). Methods and Materials: Fifty-one patients with T2, N0/N1, M0 NPC took part in a randomized controlled clinical study and received IMRT or CRT. Stimulated whole (SWS) and parotid (SPS) saliva flow were measured and Medical Outcomes Short Form 36 (SF-36), European Organization for Research and Treatment of Cancer (EORTC) core quetionnaire, and EORTC head-and-neck module (QLQ-H and N35) were completed at baseline and 2, 6, and 12 months after radiotherapy. Results: Forty-six patients (88%) were in disease remission 12 months after radiotherapy. At 12 months postradiotherapy, 12 (50.0%) and 20 patients (83.3%) in the IMRT group had recovered at least 25% of preradiotherapy SWS and SPS flow respectively, compared with 1 (4.8%) and 2 patients (9.5%), respectively, in the CRT group. Global health scores showed continuous improvement in QoL after both treatments (p < 0.001). However, after 12 months subscale scores for role-physical, bodily pain, and physical function were significantly higher in the IMRT group, indicating a better condition (p < 0.05). Dry mouth and sticky saliva were problems in both groups 2 months after treatment. In the IMRT group, there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy. Conclusions: IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease. The findings support the case for assessment of health-related QoL in relation to head-and-neck cancer using a site-specific approach.

  12. Everolimus With Reduced Tacrolimus Improves Renal Function in De Novo Liver Transplant Recipients: A Randomized Controlled Trial

    PubMed Central

    De Simone, P; Nevens, F; De Carlis, L; Metselaar, H J; Beckebaum, S; Saliba, F; Jonas, S; Sudan, D; Fung, J; Fischer, L; Duvoux, C; Chavin, K D; Koneru, B; Huang, M A; Chapman, W C; Foltys, D; Witte, S; Jiang, H; Hexham, J M; Junge, G

    2012-01-01

    In a prospective, multicenter, open-label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced-exposure tacrolimus (EVR+Reduced TAC) or (iii) standard-exposure tacrolimus (TAC Control). Randomization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy-proven acute rejection (tBPAR). EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint (tBPAR, graft loss or death at 12 months posttransplantation): 6.7% versus 9.7% (−3.0%; 95% CI −8.7, 2.6%; p<0.001 for noninferiority [12% margin]). tBPAR occurred in 2.9% of EVR+Reduced TAC patients versus 7.0% of TAC Controls (p = 0.035). The change in adjusted estimated GFR from randomization to month 12 was superior with EVR+Reduced TAC versus TAC Control (difference 8.50 mL/min/1.73 m2, 97.5% CI 3.74, 13.27 mL/min/1.73 m2, p<0.001 for superiority). Drug discontinuation for adverse events occurred in 25.7% of EVR+Reduced TAC and 14.1% of TAC Controls (relative risk 1.82, 95% CI 1.25, 2.66). Relative risk of serious infections between the EVR+Reduced TAC group versus TAC Controls was 1.76 (95% CI 1.03, 3.00). Everolimus facilitates early tacrolimus minimization with comparable efficacy and superior renal function, compared to a standard tacrolimus exposure regimen 12 months after liver transplantation. PMID:22882750

  13. Effects of Duchenne muscular dystrophy on muscle stiffness and response to electrically-induced muscle contraction: A 12-month follow-up.

    PubMed

    Lacourpaille, Lilian; Gross, Raphaël; Hug, François; Guével, Arnaud; Péréon, Yann; Magot, Armelle; Hogrel, Jean-Yves; Nordez, Antoine

    2017-03-01

    The present study aimed to assess the ability of muscle stiffness (shear modulus) and response to electrically-induced muscle contraction to detect changes in muscle properties over a 12-month period in children with Duchenne muscular dystrophy (DMD). Ten children with DMD and nine age-matched healthy male controls participated in two experimental sessions (T0 and T+12months) separated by 12.4 ± 0.9 months. Two contractions of the biceps brachii were electrically-induced during which an ultrasound probe was placed over the muscle. The resting shear modulus was measured using elastography from six muscles. Evoked maximal torque was increased at T+12months in controls (+11.2 ± 7.6%, P <0.001) but was not modified in children with DMD (P = 0.222). Electromechanical delay (+12.9 ± 11.3%, P <0.001) and its force transmission component (+10.1 ± 21.6%, P = 0.003) were significantly longer at T+12months than T0 for children with DMD. The results revealed an increase in muscle stiffness at T+12months in children with DMD for tibialis anterior (+75.1 ± 93.5%, P= 0.043), gastrocnemius medialis (+144.8 ± 180.6%, P= 0.050) and triceps brachii (+35.5 ± 32.2%, P= 0.005). This 12-month follow-up study demonstrates that electromechanical delay and elastography may help detect subtle muscle impairments in patients with DMD. These sensitive outcomes may improve the follow-up of innovative therapeutic interventions within the field of DMD.

  14. Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial.

    PubMed

    Broderick, Joan E; Keefe, Francis J; Bruckenthal, Patricia; Junghaenel, Doerte U; Schneider, Stefan; Schwartz, Joseph E; Kaell, Alan T; Caldwell, David S; McKee, Daphne; Reed, Shelby; Gould, Elaine

    2014-09-01

    A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients' doctors' offices (N=129 patients); the control group received usual care (N=127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain.

  15. The association between self-reported racial discrimination and 12-month DSM-IV mental disorders among Asian Americans nationwide

    PubMed Central

    Spencer, Michael; Chen, Juan; Yip, Tiffany; Takeuchi, David T.

    2007-01-01

    Growing research finds that reports of discrimination are associated with mental health. However, many US studies are focused on regional samples and do not control for important confounders such as other stressors and health conditions. The present study examines the association between self-reported racial discrimination and DSM-IV defined mental disorders among Asian respondents to the 2002–2003 US National Latino and Asian American Study (n=2,047). Logistic regression analyses indicated that self-reported racial discrimination was associated with greater odds of having any DSM-IV disorder, depressive disorder, or anxiety disorder within the past 12 months -- controlling for sociodemographic characteristics, acculturative stress, family cohesion, poverty, self-rated health, chronic physical conditions, and social desirability. Further, multinomial logistic regression found that individuals who reported discrimination were at a twofold greater risk of having one disorder within the past 12 months, and a threefold greater risk of having two or more disorders. Thus, self-reported discrimination was associated with increased risk of mental disorders among Asian Americans across the United States and this relationship was not explained by social desirability, physical health, other stressors, and sociodemographic factors. Should these associations ultimately be shown enduring and causal, they suggest that policies designed to reduce discrimination may help improve mental health. PMID:17374553

  16. Parent-Infant Vocalisations at 12 Months Predict Psychopathology at 7 Years

    ERIC Educational Resources Information Center

    Allely, C. S.; Purves, D.; McConnachie, A.; Marwick, H.; Johnson, P.; Doolin, O.; Puckering, C.; Golding, J.; Gillberg, C.; Wilson, P.

    2013-01-01

    This study investigated the utility of adult and infant vocalisation in the prediction of child psychopathology. Families were sampled from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Vocalisation patterns were obtained from 180 videos (60 cases and 120 randomly selected sex-matched controls) of parent-infant…

  17. 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

  18. Improving district facility readiness: a 12-month evaluation of a data-driven health systems strengthening intervention in rural Rwanda

    PubMed Central

    Iyer, Hari S.; Kamanzi, Emmanuel; Mugunga, Jean Claude; Finnegan, Karen; Uwingabiye, Alice; Shyaka, Edward; Niyonzima, Saleh; Hirschhorn, Lisa R.; Drobac, Peter C.

    2015-01-01

    Background While health systems strengthening (HSS) interventions are recommended by global health policy experts to improve population health in resource-limited settings, few examples exist of evaluations of HSS interventions conducted at the district level. In 2009, a partnership between Partners In Health (PIH), a non-governmental organization, and the Rwandan Ministry of Health (RMOH) was provided funds to implement and evaluate a district-level HSS intervention in two rural districts of Rwanda. Design The partnership provided limited funds to 14 health centers for targeted systems support in 2010; six others received support prior to the intervention (reference). RMOH health systems norms were mapped across the WHO HSS framework, scored from 0 to 10 and incorporated into a rapid survey assessing 11 domains of facility readiness. Stakeholder meetings allowed partnership leaders to review results, set priorities, and allocate resources. Investments included salary support, infrastructure improvements, medical equipment, and social support for patients. We compared facility domain scores from the start of the intervention to 12 months and tested for correlation between change in score and change in funding allocation to assess equity in our approach. Results We found significant improvements among intervention facilities from baseline to 12 months across several domains [infrastructure (+4, p=0.0001), clinical services (+1.2, p=0.03), infection and sanitation control (+0.6, p=0.03), medical equipment (+1.0, p=0.02), information use (+2, p=0.002)]. Composite score across domains improved from 6.2 at baseline to 7.4 at 12 months (p=0.002). Across facilities, 50% had composite scores greater than the average score among reference facilities (7.4) at 12 months compared to none at baseline. Conclusions Rapid facility surveys, stakeholder engagement, and information feedback can be used for gap analysis and resource allocation. This approach can achieve effective use

  19. Coping and Parenting: Mediators of 12-Month Outcomes of a Family Group Cognitive-Behavioral Preventive Intervention with Families of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Champion, Jennifer E.; Forehand, Rex; Cole, David A.; Reeslund, Kristen L.; Fear, Jessica; Hardcastle, Emily J.; Keller, Gary; Rakow, Aaron; Garai, Emily; Merchant, Mary Jane; Roberts, Lorinda

    2011-01-01

    In a randomized clinical trial with 111 families of parents with a history of major depressive disorder (86% mothers; 86% Caucasian), changes in adolescents’ (mean age 11 years; 42% female) coping and parents’ parenting skills were examined as mediators of the effects of a family group cognitive behavioral preventive intervention on adolescents’ internalizing and externalizing symptoms. Changes in hypothesized mediators were assessed at 6-months and changes in adolescents’ symptoms were measured at 12-month follow-up. Significant differences favoring the family intervention as compared with a written information comparison condition were found for changes in composite measures of parent-adolescent reports of adolescents’ use of secondary control coping skills and direct observations of parents’ positive parenting skills. Changes in adolescents’ secondary control coping and positive parenting mediated the effects of the intervention on depressive, internalizing and externalizing symptoms accounting for approximately half of the effect of the intervention on the outcomes. Further, reciprocal relations between children’s internalizing symptoms and parenting were found from baseline to 6-month follow-up. Implications for the prevention of psychopathology in offspring of depressed parents are highlighted. PMID:20873898

  20. MOTHER-INFANT INTERACTION AT 12 MONTHS IN PRENATALLY COCAINE-EXPOSED CHILDREN

    PubMed Central

    Ukeje, Ikechukwu; Bendersky, Margaret; Lewis, Michael

    2006-01-01

    This study examined mother-infant interactions of 12-month-old African-American prenatally cocaine-exposed infants and their mothers. Videotaped observations were made during a free-play dyadic interaction, a brief separation, and a reunion period. Videotapes were coded for maternal and child behaviors during each phase of the procedure. Although there were few differences in interactive behaviors between prenatally cocaine-exposed and nonexposed children and their mothers, children who were prenatally exposed to cocaine ignored their mother’s departure (odds ratio [OR] = 3.0, p < .05) during separation significantly more often than nonexposed subjects. In addition, mothers who abused cocaine engaged in significantly more verbal behavior (F(2,104) = 7.00, p < .001) with their children than mothers of nonexposed children. These findings indicate that women who used cocaine during pregnancy may not differ from nonusers in their interactions with their 12-month-old infants. PMID:11417936

  1. Lifetime and 12-Month Nonsuicidal Self-Injury and Academic Performance in College Freshmen.

    PubMed

    Kiekens, Glenn; Claes, Laurence; Demyttenaere, Koen; Auerbach, Randy P; Green, Jennifer G; Kessler, Ronald C; Mortier, Philippe; Nock, Matthew K; Bruffaerts, Ronny

    2016-10-01

    We examined whether nonsuicidal self-injury (NSSI) is associated with academic performance in college freshmen, using census-based web surveys (N = 7,527; response = 65.4%). NSSI was assessed with items from the Self-Injurious Thoughts and Behaviors Interview and subsequently linked with the administratively recorded academic year percentage (AYP). Freshmen with lifetime and 12-month NSSI showed a reduction in AYP of 3.4% and 5.9%, respectively. The college environment was found to moderate the effect of 12-month NSSI, with more strongly reduced AYPs in departments with higher-than-average mean departmental AYPs. The findings suggest that overall stress and test anxiety are underlying processes between NSSI membership and academic performance.

  2. Atypical object exploration at 12 months of age is associated with autism in a prospective sample.

    PubMed

    Ozonoff, Sally; Macari, Suzanne; Young, Gregory S; Goldring, Stacy; Thompson, Meagan; Rogers, Sally J

    2008-09-01

    This prospective study examined object exploration behavior in 66 12-month-old infants, of whom nine were subsequently diagnosed with an autism spectrum disorder. Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development. A task was developed that afforded specific opportunities for a range of repetitive uses of objects and was coded blind to outcome status. The autism/ASD outcome group displayed significantly more spinning, rotating, and unusual visual exploration of objects than two comparison groups. The average unusual visual exploration score of the autism/ASD group was over four standard deviations above the mean of the group with no concerns at outcome. Repetitive behaviors at 12 months were significantly related to cognitive and symptomatic status at 36 month outcome. These results suggest that repetitive or stereotyped behaviors may be present earlier than initially thought in very young children developing the autism phenotype.

  3. The relationship between attention and deferred imitation in 12-month-old infants.

    PubMed

    Zmyj, Norbert; Schölmerich, Axel; Daum, Moritz M

    2017-03-01

    Imitation is a frequent behavior in the first years of life, and serves both a social function (e.g., to interact with others) and a cognitive function (e.g., to learn a new skill). Infants differ in their temperament, and temperament might be related to the dominance of one function of imitation. In this study, we investigated whether temperament and deferred imitation are related in 12-month-old infants. Temperament was measured via the Infant Behavior Questionnaire Revised (IBQ-R) and parts of the Laboratory Temperament Assessment Battery (Lab-TAB). Deferred imitation was measured via the Frankfurt Imitation Test for 12-month-olds (FIT-12). Regression analyses revealed that the duration of orienting (IBQ-R) and the latency of the first look away in the Task Orientation task (Lab-TAB) predicted the infants' imitation score. These results suggest that attention-related processes may play a major role when infants start to imitate.

  4. 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).

  5. Factors that can predict pain with walking, 12 months after total knee arthroplasty

    PubMed Central

    Lindberg, Maren Falch; Miaskowski, Christine; RustøEn, Tone; Rosseland, Leiv Arne; Cooper, Bruce A; Lerdal, Anners

    2016-01-01

    Background and purpose — Functional limitations after total knee arthroplasty (TKA) are common. In this longitudinal study, we wanted to identify subgroups of patients with distinct trajectories of pain-related interference with walking during the first year after TKA and to determine which demographic, clinical, symptom-related, and psychological characteristics were associated with being part of this subgroup. Patients and methods — Patients scheduled for primary TKA for osteoarthritis (n = 202) completed questionnaires that evaluated perception of pain, fatigue, anxiety, depression, and illness on the day before surgery. Clinical characteristics were obtained from the medical records. Interference of pain with walking was assessed preoperatively, on postoperative day 4, and at 6 weeks, 3 months, and 12 months after TKA. Results — Using growth mixture modeling, 2 subgroups of patients were identified with distinct trajectories of pain-related interference with walking over time. Patients in the Continuous Improvement class (n = 157, 78%) had lower preoperative interference scores and reported a gradual decline in pain-related interference with walking over the first 12 months after TKA. Patients in the Recurrent Interference class (n = 45, 22%) reported a high degree of preoperative pain-related interference with walking, initial improvement during the first 3 months after TKA, and then a gradual increase—returning to preoperative levels at 12 months. Patients in the Recurrent Interference class had higher preoperative pain, fatigue, and depression scores, and poorer perception of illness than the Continuous Improvement class. Interpretation — 1 in 5 patients did not improve in pain-related interference with walking at 12 months after TKA. Future studies should test the efficacy of interventions designed to modify preoperative characteristics. PMID:27658970

  6. Factors that can predict pain with walking, 12 months after total knee arthroplasty.

    PubMed

    Lindberg, Maren Falch; Miaskowski, Christine; RustøEn, Tone; Rosseland, Leiv Arne; Cooper, Bruce A; Lerdal, Anners

    2016-12-01

    Background and purpose - Functional limitations after total knee arthroplasty (TKA) are common. In this longitudinal study, we wanted to identify subgroups of patients with distinct trajectories of pain-related interference with walking during the first year after TKA and to determine which demographic, clinical, symptom-related, and psychological characteristics were associated with being part of this subgroup. Patients and methods - Patients scheduled for primary TKA for osteoarthritis (n = 202) completed questionnaires that evaluated perception of pain, fatigue, anxiety, depression, and illness on the day before surgery. Clinical characteristics were obtained from the medical records. Interference of pain with walking was assessed preoperatively, on postoperative day 4, and at 6 weeks, 3 months, and 12 months after TKA. Results - Using growth mixture modeling, 2 subgroups of patients were identified with distinct trajectories of pain-related interference with walking over time. Patients in the Continuous Improvement class (n = 157, 78%) had lower preoperative interference scores and reported a gradual decline in pain-related interference with walking over the first 12 months after TKA. Patients in the Recurrent Interference class (n = 45, 22%) reported a high degree of preoperative pain-related interference with walking, initial improvement during the first 3 months after TKA, and then a gradual increase-returning to preoperative levels at 12 months. Patients in the Recurrent Interference class had higher preoperative pain, fatigue, and depression scores, and poorer perception of illness than the Continuous Improvement class. Interpretation - 1 in 5 patients did not improve in pain-related interference with walking at 12 months after TKA. Future studies should test the efficacy of interventions designed to modify preoperative characteristics.

  7. 6 Minute Walk Test in Duchenne MD Patients with Different Mutations: 12 Month Changes

    PubMed Central

    Pane, Marika; Mazzone, Elena S.; Sormani, Maria Pia; Messina, Sonia; Vita, Gian Luca; Fanelli, Lavinia; Berardinelli, Angela; Torrente, Yvan; D'Amico, Adele; Lanzillotta, Valentina; Viggiano, Emanuela; D'Ambrosio, Paola; Cavallaro, Filippo; Frosini, Silvia; Bello, Luca; Bonfiglio, Serena; Scalise, Roberta; De Sanctis, Roberto; Rolle, Enrica; Bianco, Flaviana; Van der Haawue, Marlene; Magri, Francesca; Palermo, Concetta; Rossi, Francesca; Donati, Maria Alice; Alfonsi, Chiara; Sacchini, Michele; Arnoldi, Maria Teresa; Baranello, Giovanni; Mongini, Tiziana; Pini, Antonella; Battini, Roberta; Pegoraro, Elena; Previtali, Stefano C.; Napolitano, Sara; Bruno, Claudio; Politano, Luisa; Comi, Giacomo P.; Bertini, Enrico; Morandi, Lucia; Gualandi, Francesca; Ferlini, Alessandra; Goemans, Nathalie; Mercuri, Eugenio

    2014-01-01

    Objective In the last few years some of the therapeutical approaches for Duchenne muscular dystrophy (DMD) are specifically targeting distinct groups of mutations, such as deletions eligible for skipping of individual exons. The aim of this observational study was to establish whether patients with distinct groups of mutations have different profiles of changes on the 6 minute walk test (6MWT) over a 12 month period. Methods The 6MWT was performed in 191 ambulant DMD boys at baseline and 12 months later. The results were analysed using a test for heterogeneity in order to establish possible differences among different types of mutations (deletions, duplications, point mutations) and among subgroups of deletions eligible to skip individual exons. Results At baseline the 6MWD ranged between 180 and 560,80 metres (mean 378,06, SD 74,13). The 12 month changes ranged between −325 and 175 (mean −10.8 meters, SD 69.2). Although boys with duplications had better results than those with the other types of mutations, the difference was not significant. Similarly, boys eligible for skipping of the exon 44 had better baseline results and less drastic changes than those eligible for skipping exon 45 or 53, but the difference was not significant. Conclusions even if there are some differences among subgroups, the mean 12 month changes in each subgroup were all within a narrow Range: from the mean of the whole DMD cohort. This information will be of help at the time of designing clinical trials with small numbers of eligible patients. PMID:24421885

  8. Weight Lifting and Physical Function Among Survivors of Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial

    PubMed Central

    Brown, Justin C.; Schmitz, Kathryn H.

    2015-01-01

    Purpose Survivors of breast cancer may experience deterioration of physical function. This is important because poor physical function may be associated with premature mortality, injurious falls, bone fracture, and disability. We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer. Methods Between October 2005 and August 2008, we conducted a single-blind, 12-month, randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among 295 survivors of nonmetastatic breast cancer. In this post hoc analysis of data from the Physical Activity and Lymphedema Trial, we examined incident deterioration of physical function after 12 months, defined as a ≥ 10-point decrease in the physical function subscale of the Medical Outcomes Short-Form 36-item questionnaire. Results The proportion of participants who experienced incident physical function deterioration after 12 months was 16.3% (24/147) in the control group and 8.1% (12/148) in the weight lifting group (relative risk, 0.49; 95% CI, 0.25 to 0.96; P = .04). No serious or unexpected adverse events occurred that were related to weight lifting. Conclusion Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer. These data are hypothesis generating. Future studies should directly compare the efficacy of weight lifting with other modalities of exercise, such as brisk walking, to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer. PMID:25964257

  9. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial

    PubMed Central

    Chacon, Sandra; Elliott, Marc N.; Bruno, Yovana; Chavis, Toni; Biely, Christopher; Bethell, Christina D.; Contreras, Sandra; Mimila, Naomi A.; Mercado, Jeffrey; Chung, Paul J.

    2016-01-01

    OBJECTIVE: The goal of this study was to examine the effects of a new model for well-child care (WCC), the Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT), on WCC quality and health care utilization among low-income families. METHODS: PARENT includes 4 elements designed by using a stakeholder-engaged process: (1) a parent coach (ie, health educator) to provide anticipatory guidance, psychosocial screening and referral, and developmental/behavioral guidance and screening at each well-visit; (2) a Web-based tool for previsit screening; (3) an automated text message service to provide periodic, age-specific health messages to families; and (4) a brief, problem-focused encounter with the pediatric clinician. The Promoting Healthy Development Survey–PLUS was used to assess receipt of recommended WCC services at 12 months’ postenrollment. Intervention effects were examined by using bivariate analyses. RESULTS: A total of 251 parents with a child aged ≤12 months were randomized to receive either the control (usual WCC) or the intervention (PARENT); 90% completed the 12-month assessment. Mean child age at enrollment was 4.5 months; 64% had an annual household income less than $20 000. Baseline characteristics for the intervention and control groups were similar. Intervention parents scored higher on all preventive care measures (anticipatory guidance, health information, psychosocial assessment, developmental screening, and parental developmental/behavioral concerns addressed) and experiences of care measures (family-centeredness, helpfulness, and overall rating of care). Fifty-two percent fewer intervention children had ≥2 emergency department visits over the 12-month period. There were no significant differences in WCC or sick visits/urgent care utilization. CONCLUSIONS: A parent coach–led model for WCC may improve the receipt of comprehensive WCC for low-income families, and it may potentially lead to cost savings by reducing emergency

  10. Social and Behavioral Outcomes following Childhood Traumatic Brain Injury: What Predicts Outcome at 12 Months Post-Insult?

    PubMed

    Catroppa, Cathy; Hearps, Stephen; Crossley, Louise; Yeates, Keith; Beauchamp, Miriam; Fusella, Jessica; Anderson, Vicki

    2017-04-01

    This study sought to investigate social and behavioral outcomes 12 months following childhood traumatic brain injury (TBI) and to identify predictors of these outcomes. The study also compared rates of impairment in social and behavioral outcomes at 12 months post-injury between children with TBI and a typically developing (TD) control group. The study comprised 114 children ages 5.5 to 16.0 years, 79 with mild, moderate, or severe TBI and 35 TD children, group-matched for age, sex and socio-economic status. Children with TBI were recruited via consecutive hospital admissions and TD children from the community. Social and behavioral outcomes were measured via parent-rated questionnaires. Analysis of covariance models identified a significant mean difference between the mild and moderate groups for social problems only, but the moderate and severe TBI groups showed a higher rate of impairment, particularly in externalizing problems. Pre-injury function, injury severity, parent mental health, and child self-esteem all contributed significantly to predicting social and behavioral outcomes. Both injury and non-injury factors should be considered when identifying children at risk for long-term difficulties in social and behavioral domains.

  11. Effectiveness of a Worksite Mindfulness-Related Multi-Component Health Promotion Intervention on Work Engagement and Mental Health: Results of a Randomized Controlled Trial

    PubMed Central

    van Berkel, Jantien; Boot, Cécile R. L.; Proper, Karin I.; Bongers, Paulien M.; van der Beek, Allard J.

    2014-01-01

    Objectives The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness. Methods In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129) received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models. Results There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference) and subgroups based on baseline work engagement scores showed no significant differences either. Conclusions This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months. Trial registration Netherlands Trial Register NTR2199 PMID:24489648

  12. 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.

  13. Evaluation of tumor-derived MRI-texture features for discrimination of molecular subtypes and prediction of 12-month survival status in glioblastoma

    PubMed Central

    Yang, Dalu; Rao, Ganesh; Martinez, Juan; Veeraraghavan, Ashok; Rao, Arvind

    2015-01-01

    Purpose: Glioblastoma multiforme (GBM) is the most common and aggressive primary brain cancer. Four molecular subtypes of GBM have been described but can only be determined by an invasive brain biopsy. The goal of this study is to evaluate the utility of texture features extracted from magnetic resonance imaging (MRI) scans as a potential noninvasive method to characterize molecular subtypes of GBM and to predict 12-month overall survival status for GBM patients. Methods: The authors manually segmented the tumor regions from postcontrast T1 weighted and T2 fluid-attenuated inversion recovery (FLAIR) MRI scans of 82 patients with de novo GBM. For each patient, the authors extracted five sets of computer-extracted texture features, namely, 48 segmentation-based fractal texture analysis (SFTA) features, 576 histogram of oriented gradients (HOGs) features, 44 run-length matrix (RLM) features, 256 local binary patterns features, and 52 Haralick features, from the tumor slice corresponding to the maximum tumor area in axial, sagittal, and coronal planes, respectively. The authors used an ensemble classifier called random forest on each feature family to predict GBM molecular subtypes and 12-month survival status (a dichotomized version of overall survival at the 12-month time point indicating if the patient was alive or not at 12 months). The performance of the prediction was quantified and compared using receiver operating characteristic (ROC) curves. Results: With the appropriate combination of texture feature set, image plane (axial, coronal, or sagittal), and MRI sequence, the area under ROC curve values for predicting different molecular subtypes and 12-month survival status are 0.72 for classical (with Haralick features on T1 postcontrast axial scan), 0.70 for mesenchymal (with HOG features on T2 FLAIR axial scan), 0.75 for neural (with RLM features on T2 FLAIR axial scan), 0.82 for proneural (with SFTA features on T1 postcontrast coronal scan), and 0.69 for 12

  14. The effect of a micronutrient-fortified complementary food on micronutrient status, growth and development of 6- to 12-month-old disadvantaged urban South African infants.

    PubMed

    Oelofse, A; Van Raaij, J M A; Benade, A J S; Dhansay, M A; Tolboom, J J M; Hautvast, J G A J

    2003-09-01

    The study was conducted to look at the effectiveness of a multimicronutrient-fortified complementary food on the micronutrient status, linear growth and psychomotor development of 6- to 12-month-old infants from a black urban disadvantaged community in the Western Cape, South Africa. The study was designed as an intervention study. In both the experimental and control groups, serum retinol concentration showed a decline over the intervention period of 6 months. The decline was less pronounced in the experimental group. This resulted in a significantly (P<005) higher serum retinol concentration at 12 months in the experimental group (26.8+/-5.8 microg/dl) compared with the control group (21.4+/-5 microg/dl). Serum iron concentration also declined over the intervention period. The decline was less pronounced in the experimental group. No difference was observed in haemoglobin levels between the groups at 12 months. Serum zinc concentration did not differ significantly between the two groups at follow up. Weight gain over the 6 months period did not differ significantly between the experimental (2.1+/-0.9 kg) and control groups (2.1+/-1.2 kg). There was no difference in linear growth between the experimental (10.0+/-1.5 cm) and control group (10.1+/-2.1 cm) at the end of the follow-up period. Weight and length at 6 months significantly predicted weight and length at 12 months. No difference was observed in psychomotor developmental scores between the two groups after 6 months of intervention. Introducing a multimicronutrient-fortified complementary food into the diet of 6- to 12-month-old infants seemed to have an arresting effect on declining serum retinol and iron concentration in the experimental group. No benefit was observed in serum zinc concentration, linear growth and psychomotor development.

  15. Similar immunogenicity of measles-mumps-rubella (MMR) vaccine administrated at 8 months versus 12 months age in children.

    PubMed

    He, Hanqing; Chen, Enfu; Chen, Haiping; Wang, Zhifang; Li, Qian; Yan, Rui; Guo, Jing; Zhou, Yang; Pan, Jinren; Xie, Shuyun

    2014-06-30

    Two doses of measles-mumps-rubella (MMR) strategy has been recommended by World Health Organization and is also widely adopted in many countries. In order to provide the evidence for perfecting the immunization strategy of MMR, this study evaluated the safety and immunogenicity of MMR with different two-dose schedule in infants. 280 participants were enrolled and randomly allocated to Group 1 (first dose at 8 months) or Group 2 (first dose at 12 months), and both groups administered the second dose at 10 months later. Solicited local and general symptoms after each vaccination with MMR were mild and infrequent in all participants of two groups. After administration of the first dose of MMR, seropositive rates were 100% in both groups for measles, 89.3% in Group 1 and 87.1% in Group 2 for mumps (P=0.578), 92.0% in Group 1 and 92.9% in Group 2 (P=0.393). The seropositive rates of mumps decreased significantly (from >86% to <65%) both in two groups (P<0.001) 10 months after the first dose of MMR, but no significant change was found in measles and rubella. All children get the positive titer for three vaccines in two groups after given the second dose MMR, higher seroconversion rate was found for mumps both in two groups (71.7% vs 77.2%, P=0.370). In conclusion, this study indicated that the MMR was well tolerated and immunogenic against measles, mumps and rubella with schedule of first dose both at 8 months and 12 months age. Our findings strongly supported that two doses of MMR can be introduced by replacing the first dose of MR in current EPI with MMR at 8 months age and the second dose at 18 months in China.

  16. Do patients with bipolar disorder and subsyndromal symptoms benefit from functional remediation? A 12-month follow-up study.

    PubMed

    Sanchez-Moreno, Jose; Bonnín, Caterina; González-Pinto, Ana; Amann, Benedikt L; Solé, Brisa; Balanzá-Martínez, Vicent; Arango, Celso; Jimenez, Esther; Tabarés-Seisdedos, Rafael; Garcia-Portilla, M Paz; Ibáñez, Angela; Crespo, Jose Manuel; Ayuso-Mateos, Jose Luis; Vieta, Eduard; Martinez-Aran, Anabel; Torrent, Carla

    2017-01-23

    We analyzed the efficacy of functional remediation, in a sample of patients with bipolar disorder who presented with subsyndromal symptoms. From a total sample of 239 patients with bipolar I and II disorder, according to DSM-IV-TR diagnostic criteria, entering a randomized clinical trial, those patients who presented with subsyndromal symptoms were selected based on a method already described by Berk and colleagues was applied. It consists of using the Clinical Global Impression-Bipolar version (CGI-BP) to establish the scores of the Hamilton Depression Rating Scale (HAM-D) and of the Young Mania Rating Scale (YMRS) that correspond with 1 in the CGI-BP. Functional outcome and mood symptoms were assessed at 6 and at 12-month follow-up. A total of 99 patients were selected for this post-hoc analysis, allocated as follows: functional remediation (n=33); psychoeducation (n=37) and treatment as usual (TAU,n=29). The repeated-measures analyses at 12-month follow-up revealed a significant group x time interaction in favour of the patients who received functional remediation when compared to psychoeducation and TAU (F=2.93; p=0.02) at improving psychosocial functioning. Finally, mood symptoms did not significantly change in any of the three groups at any time of follow-up, as shown by the non-significant group x time interaction effect in HAM-D scores (F=1.57; p=0.18) and YMRS scores (F=1.51; p=0.20). Bipolar patients with subsyndromal symptoms improve their functional outcome when exposed to functional remediation regardless of the persistence of mood symptomatology.

  17. School-Based Randomized Controlled Trial of an HIV/STD Risk-Reduction Intervention for South African Adolescents

    PubMed Central

    Jemmott, John B.; Jemmott, Loretta S.; O’Leary, Ann; Ngwane, Zolani; Icard, Larry D.; Bellamy, Scarlett L.; Jones, Shasta F.; Landis, J. Richard; Heeren, G. Anita; Tyler, Joanne C.; Makiwane, Monde B.

    2015-01-01

    Objectives We tested the efficacy of a school-based HIV/STD risk-reduction intervention for South African adolescents. Design A cluster-randomized controlled design, with assessments of self-reported sexual behavior collected pre-intervention and 3, 6, and 12 months post-intervention. Setting Primary schools in a large Black township and a neighboring rural settlement in Eastern Cape Province, South Africa. Participants 9 of 17 matched-pairs of schools were randomly selected. Grade 6 learners with parent/guardian consent were eligible. Interventions Two 6-session interventions based on behavior-change theories and qualitative research: HIV/STD risk-reduction intervention targeted sexual-risk behaviors; attention-matched health-promotion control intervention targeted health issues unrelated to sexual behavior. Main Outcome Measures The primary outcome was self-report of unprotected vaginal intercourse in the previous 3 months averaged over the 3 follow-ups. Secondary outcomes were other sexual behaviors. Results A total of 1,057 (94.5%) of 1,118 eligible learners (mean age = 12.4 years) participated, with 96.7% retained at the 12-month follow-up. Generalized estimating equations analyses, adjusting for clustering from 18 schools, revealed that averaged over the 3 follow-ups a significantly smaller percentage of HIV/STD risk-reduction intervention participants reported having unprotected vaginal intercourse (OR = 0.51; 95% CI, 0.30-0.85), vaginal intercourse (OR = 0.62; 95% CI, 0.42-0.94), and multiple sexual partners (OR = 0.50; 95% CI, 0.28-0.89), when adjusted for baseline prevalences, compared with health-promotion control participants. Conclusions This is the first large-scale community-level randomized intervention trial to obtain significant effects on HIV/STD sexual-risk behavior among South African adolescents in the earliest stages of entry into sexual activity. PMID:20921349

  18. 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

  19. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register Chi

  20. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Ravn, Henrik; Batista, Celso Soares Pereira; Rodrigues, Amabelia

    2016-01-01

    Background Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have

  1. Greater weight loss among men participating in a commercial weight loss program: a pooled analysis of 2 randomized controlled trials.

    PubMed

    Barraj, Leila M; Murphy, Mary M; Heshka, Stanley; Katz, David L

    2014-02-01

    Being overweight and obese are significant health concerns for men and women, yet despite comparable needs for effective weight loss and maintenance strategies, little is known about the success of commercial weight loss programs in men. This study tests the hypothesis that men participating in a commercial weight loss program (Weight Watchers) had significantly greater weight loss than men receiving limited support from health professionals for weight loss (controls). A pooled analysis of weight loss and related physiologic parameter data from 2 randomized clinical trials was conducted. After 12 months, analysis of covariance tests showed that men in the commercial program group (n = 85) lost significantly more weight (P < .01) than men in the control group (n = 84); similar significant differences were observed for body mass index and waist circumference. These results suggest that participation in a commercial weight loss program may be a more effective means to lose weight and maintain weight loss.

  2. CUMULATIVE TRAUMAS AND RISK THRESHOLDS: 12-MONTH PTSD IN THE WORLD MENTAL HEALTH (WMH) SURVEYS

    PubMed Central

    Karam, Elie G.; Friedman, Matthew J.; Hill, Eric D.; Kessler, Ronald C.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Laura; Shahly, Victoria; Angermeyer, Matthias C.; Bromet, Evelyn J.; de Girolamo, Giovanni; de Graaf, Ron; Demyttenaere, Koen; Ferry, Finola; Florescu, Silvia E.; Haro, Josep Maria; He, Yanling; Karam, Aimee N.; Kawakami, Norito; Kovess-Masfety, Viviane; Medina-Mora, María Elena; Browne, Mark A. Oakley; Posada-Villa, José A.; Shalev, Arieh Y.; Stein, Dan J.; Viana, Maria Carmen; Zarkov, Zahari; Koenen, Karestan C.

    2014-01-01

    Background Clinical research suggests that posttraumatic stress disorder (PTSD) patients exposed to multiple traumatic events (TEs) rather than a single TE have increased morbidity and dysfunction. Although epidemiological surveys in the United States and Europe also document high rates of multiple TE exposure, no population-based cross-national data have examined this issue. Methods Data were analyzed from 20 population surveys in the World Health Organization World Mental Health Survey Initiative (n 51,295 aged 18+). The Composite International Diagnostic Interview (3.0) assessed 12-month PTSD and other common DSM-IV disorders. Respondents with 12-month PTSD were assessed for single versus multiple TEs implicated in their symptoms. Associations were examined with age of onset (AOO), functional impairment, comorbidity, and PTSD symptom counts. Results 19.8% of respondents with 12-month PTSD reported that their symptoms were associated with multiple TEs. Cases who associated their PTSD with four or more TEs had greater functional impairment, an earlier AOO, longer duration, higher comorbidity with mood and anxiety disorders, elevated hyper-arousal symptoms, higher proportional exposures to partner physical abuse and other types of physical assault, and lower proportional exposure to unexpected death of a loved one than cases with fewer associated TEs. Conclusions A risk threshold was observed in this large-scale cross-national database wherein cases who associated their PTSD with four or more TEs presented a more “complex” clinical picture with substantially greater functional impairment and greater morbidity than other cases of PTSD. PTSD cases associated with four or more TEs may merit specific and targeted intervention strategies. Depression and Anxiety 31:130–142, 2014. PMID:23983056

  3. Socio-demographic inequalities and teeth extraction in the last 12 months in Italy

    PubMed Central

    La Torre, Giuseppe; Romeo, Umberto; Iarocci, Gianluca; Brugnoletti, Orlando; Semyonov, Leda; Galanakis, Alexandros; Barbato, Ersilia

    2014-01-01

    Summary Aims Teeth loss represents a major concern for the global oral health status of a population. The aim of this study was to describe the prevalence of teeth extraction among the Italian adult population, analyzing the association between teeth extraction in the last 12 months and socio-demographic characteristics. Methods This cross-sectional study is based on the national survey ‘Health Conditions and Healthcare Services Use’, carried out by the Italian National Centre of Statistics (ISTAT) in 2005. A univariate analysis was performed to investigate the association between the dependent and the independent variables (teeth extraction Vs socio-demographic characteristics). Multiple logistic regression analysis was conducted to assess the influence on the outcome (teeth extraction Yes/No). Results The present study highlights the relationship between teeth extraction and socio-demographic factors. Out of 128,040 individuals, the sampled population consisted of 124,677 subjects, representing 56,400,323 individuals in the Italian population. The prevalence of teeth extraction in the last 12 months was 8.2%. Subjects who underwent teeth extraction in the last 12 months were prevalent female (8.6%), smokers (10.4%), with a primary education (9.2%), married (9.2%), in poor health conditions (9.3%), age category of 55–64 years (11.1%), from Northeast of Italy (8.5%), with scarce household income (8.4%). The multivariate analysis confirmed most of the results of the univariate analysis. Conclusions Inequalities in health among groups of various socioeconomic status constitute one of the main challenges for public health; these inequalities might be reduced by improving educational opportunities, income distribution, health-related behaviour, or accessibility to health care. PMID:25774248

  4. Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

    PubMed Central

    Wolf, Michael S.; Kaiser, Darren; Morrow, Daniel G.

    2016-01-01

    Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633. PMID:27699179

  5. Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial

    PubMed Central

    Pal, Sebely; Ho, Suleen; Gahler, Roland J.; Wood, Simon

    2017-01-01

    Higher fibre intakes are associated with risk reduction for chronic diseases. This study investigated the effects of supplementation with PolyGlycopleX® (PGX), a complexed polysaccharide, on insulin, glucose and lipids in overweight and obese individuals. In this double-blind 12 months study, participants were randomised into three groups: control (rice flour); PGX or psyllium (PSY). Participants followed their usual lifestyle and diet but consumed 5 g of their supplement before meals. Insulin was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months and in the PSY group compared to control at 12 months. Serum glucose was significantly lower in the PGX group at 3 months compared to control. Total cholesterol was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months. High density lipoprotein (HDL) cholesterol was significantly increased in the PGX group compared to control at 12 months. low density lipoprotein (LDL) cholesterol was significantly lower in the PGX group at 3 and 6 months compared to control and in the PSY group at 3 months compared to control. A simple strategy of fibre supplementation may offer an effective solution to glucose, insulin and lipid management without the need for other nutrient modification. PMID:28146065

  6. Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial

    PubMed Central

    2015-01-01

    Background Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the

  7. Plasma arc versus halogen light curing of orthodontic brackets: a 12-month clinical study of bond failures.

    PubMed

    Sfondrini, Maria Francesca; Cacciafesta, Vittorio; Scribante, Andrea; Klersy, Catherine

    2004-03-01

    The purpose of this randomized clinical trial was to evaluate the clinical performance of brackets cured with 2 different light-curing units (conventional halogen light and plasma arc light); 83 patients treated with fixed appliances were included in the study. With the "split-mouth" design, each patient's mouth was divided into 4 quadrants. In 42 randomly selected patients, the maxillary left and mandibular right quadrants were cured with the halogen light, and the remaining quadrants were cured with the plasma arc light. In the other 41 patients, the quadrants were inverted. A total of 1434 stainless steel brackets were examined: 717 were cured with a conventional halogen light for 20 seconds; the remaining 717 were cured with the plasma arc light for 5 seconds. The number, cause, and date of bracket failures were recorded for each light-curing unit over 12 months. Statistical analysis was performed with the Fisher exact test, the Kaplan-Meier survival estimates, and the log-rank test. No statistically significant differences were found between the total bond failure rates of the brackets cured with the halogen light and those cured with the plasma arc light. Neither were significant differences found when the clinical performances of the maxillary versus mandibular arches or the anterior versus posterior segments were compared. These findings demonstrate that plasma arc lights are an advantageous alternative to conventional light curing, because they significantly reduce the curing time of orthodontic brackets without affecting the bond failure rate.

  8. 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.

  9. 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.

  10. 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.

  11. Cognitive-Behavioral Health-Promotion Intervention Increases Fruit and Vegetable Consumption and Physical Activity among South African Adolescents: A Cluster-Randomized Controlled Trial

    PubMed Central

    Jemmott, John B.; Jemmott, Loretta S.; O’Leary, Ann; Ngwane, Zolani; Icard, Larry; Bellamy, Scarlett; Jones, Shasta; Landis, J. Richard; Heeren, G. Anita; Tyler, Joanne; Makiwane, Monde B.

    2015-01-01

    Rates of chronic diseases are high among Black South Africans. Few studies have tested cognitive-behavioral health-promotion interventions to reduce chronic diseases in South Africa. We tested the efficacy of such an intervention among adolescents in a cluster-randomized controlled trial. We randomly selected 9 of 17 matched-pairs of schools and randomized one school in each pair to the cognitive-behavioral health-promotion intervention designed to encourage health-related behaviors and the other to a HIV/STD risk-reduction intervention that served as the control. Interventions were based on social cognitive theory, the theory of planned behavior, and qualitative data from the target population. Data collectors, blind to participants’ intervention, administered confidential assessments at baseline and 3, 6, and 12 months post-intervention. Primary outcomes were fruit and vegetable consumption and physical activity. Participants were 1,057 grade 6 learners (mean age = 12.4 years), with 96.7% retained at 12-month follow-up. Generalized estimating equations revealed that averaged over the follow-ups, a greater percentage of health-promotion intervention participants than HIV/STD control participants met 5-a-Day fruit and vegetable and physical activity guidelines. The intervention also increased health-promotion knowledge, attitude, and intention, but did not decrease substance use or substance-use attitude and intention. The findings suggest that theory-based, contextually appropriate interventions may increase health behaviors among young adolescents in sub-Saharan Africa. PMID:21318928

  12. Effectiveness of etofenamate for treatment of knee osteoarthritis: a randomized controlled trial

    PubMed Central

    Güner, Savaş; Gökalp, Mehmet Ata; Gözen, Abdurrahim; Ünsal, Seyyid Şerif; Güner, Şükriye İlkay

    2016-01-01

    The intramuscular application of etofenamate in the treatment of knee osteoarthritis was not observed in the existing English language literature. The objectives of this study were to compare the efficacy of etofenamate versus hyaluronic acid (HA) in reducing joint pain and functional improvement for mild to moderate knee osteoarthritis. The patients were randomly divided into etofenamate (n=29) and HA (n=30) groups. Intramuscular etofenamate injection was administered as a series of seven intramuscular injections at intervals of 1 day. Intra-articular HA injection was administered as a series of three intra-articular injections at intervals of 1 week. Clinical evaluation was made before the first injection and again both 6 and 12 months after the last injection. The evaluation consisted of patient-assessed pain on a visual analog scale (VAS) and on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Statistical significance was found for the etofenamate group when comparing preinjection with 12 months postinjection VAS scores (P<0.05). Statistical significance was also found for the HA group when comparing preinjection with 12 months postinjection VAS and WOMAC scores (P<0.05). However, there was no significant difference between the etofenamate and HA groups in terms of VAS or WOMAC scores measured at 12 months after injection (P>0.05). Results from this study indicated that, etofenamate treatment was not significantly more effective than HA treatment. However, both methods were effective and successful in treating knee osteoarthritis. PMID:27881922

  13. 20 CFR 404.251 - Subsequent entitlement to benefits less than 12 months after entitlement to disability benefits...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Subsequent entitlement to benefits less than 12 months after entitlement to disability benefits ended. 404.251 Section 404.251 Employees' Benefits... Subsequent entitlement to benefits less than 12 months after entitlement to disability benefits ended....

  14. The 12-Month Prevalence of DSM-IV Anxiety Disorders among Nigerian Secondary School Adolescents Aged 13-18 Years

    ERIC Educational Resources Information Center

    Adewuya, Abiodun O.; Ola, Bola A.; Adewumi, Tomi A.

    2007-01-01

    Aims: To estimate the 12-month prevalence of DSM-IV-specific anxiety disorders among Nigerian secondary school adolescents aged 13-18 years. Method: A representative sample of adolescents (n=1090) from senior secondary schools in a semi-urban town in Nigeria was assessed for the 12-month prevalence of DSM-IV-specific anxiety. Results: The 12-month…

  15. Identification of Infants at Risk for Autism Spectrum Disorder and Developmental Language Delay Prior to 12 Months

    ERIC Educational Resources Information Center

    Samango-Sprouse, Carole A.; Stapleton, Emily J.; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L.; Gropman, Andrea L.

    2015-01-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum…

  16. 77 FR 27386 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 12-Month... Wildlife and Plants. Upon publication of this 12-month petition finding, we will add the Arapahoe snowfly... to revise the Federal Lists of Threatened and Endangered Wildlife and Plants that...

  17. The Effect of Deworming on Growth in One-Year-Old Children Living in a Soil-Transmitted Helminth-Endemic Area of Peru: A Randomized Controlled Trial

    PubMed Central

    Joseph, Serene A.; Casapía, Martín; Montresor, Antonio; Rahme, Elham; Ward, Brian J.; Marquis, Grace S.; Pezo, Lidsky; Blouin, Brittany; Maheu-Giroux, Mathieu; Gyorkos, Theresa W.

    2015-01-01

    Background Appropriate health and nutrition interventions to prevent long-term adverse effects in children are necessary before two years of age. One such intervention may include population-based deworming, recommended as of 12 months of age by the World Health Organization in soil-transmitted helminth (STH)-endemic areas; however, the benefit of deworming has been understudied in early preschool-age children. Methodology/Principal Findings A randomized, double-blind, placebo-controlled trial was conducted to determine the effect of deworming (500 mg single-dose crushed mebendazole tablet) on growth in one-year-old children in Iquitos, Peru. Children were enrolled during their routine 12-month growth and development clinic visit and followed up at their 18 and 24-month visits. Children were randomly allocated to: Group 1: deworming at 12 months and placebo at 18 months; Group 2: placebo at 12 months and deworming at 18 months; Group 3: deworming at both 12 and 18 months; or Group 4: placebo at both 12 and 18 months (i.e. control group). The primary outcome was weight gain at the 24-month visit. An intention-to-treat approach was used. A total of 1760 children were enrolled between September 2011 and June 2012. Follow-up of 1563 children (88.8%) was completed by July 2013. STH infection was of low prevalence and predominantly light intensity in the study population. All groups gained between 1.93 and 2.05 kg on average over 12 months; the average difference in weight gain (kg) compared to placebo was: 0.05 (95% CI: -0.05, 0.17) in Group 1; -0.07 (95%CI: -0.17, 0.04) in Group 2; and 0.04 (95%CI: -0.06, 0.14) in Group 3. There was no statistically significant difference in weight gain in any of the deworming intervention groups compared to the control group. Conclusions Overall, with one year of follow-up, no effect of deworming on growth could be detected in this population of preschool-age children. Low baseline STH prevalence and intensity and/or access to

  18. Cost of Living with Parkinson's Disease over 12 Months in Australia: A Prospective Cohort Study

    PubMed Central

    Abimanyi-Ochom, Julie; Lane, Lisa; Murphy, Anna T.; Morris, Meg E.; Iansek, Robert

    2017-01-01

    Background. Parkinson disease (PD) is a costly chronic condition in terms of managing both motor and nonmotor symptoms. The burden of disease is high for individuals, caregivers, and the health system. The aim of this study is to estimate the annual cost of PD from the household, health system, and societal perspectives. Methods. A prospective cohort study of newly referred people with PD to a specialist PD clinic in Melbourne, Australia. Participants completed baseline and monthly health resource use questionnaires and Medicare data were collected over 12 months. Results. 87 patients completed the 12-month follow-up assessments. The mean annual cost per person to the health care system was $32,556 AUD. The burden to society was an additional $45,000 per annum per person with PD. The largest component of health system costs were for hospitalisation (69% of total costs). The costs for people with moderate to severe disease were almost 4 times those with mild PD ($63,569 versus $17,537 p < 0.001). Conclusion. PD is associated with significant costs to individuals and to society. Costs escalated with disease severity suggesting that the burden to society is likely to grow with the increasing disease prevalence that is associated with population ageing. PMID:28352490

  19. Psychosocial and neurocognitive functioning in unipolar and bipolar depression: a 12-month prospective study.

    PubMed

    Godard, Julie; Baruch, Philippe; Grondin, Simon; Lafleur, Martin F

    2012-03-30

    Previous studies have revealed psychosocial and cognitive impairments in patients during unipolar and bipolar depression, which persist even in subsyndromal and euthymic states. Currently, little is known about the nature and the extent of psychosocial and cognitive deficits during depression. The aim of the present study was to characterize psychosocial and cognitive profiles among unipolar (MDD) and bipolar (BD) patients during a major depressive episode and to compare the profiles of the patient groups. Depressed patients with MDD (n=13) and BD (n=11) were followed over a period of 12 months. Clinical, psychosocial and neuropsychological assessments were conducted at baseline and at 6-week, 4-month, 8-month and 12-month follow-ups. In the case of severe mood disorders, psychosocial and neurocognitive functioning seem similar among MDD and BD patients during a depressive episode. All MDD and BD patients had global psychosocial dysfunction, characterized by occupational and relational impairments. Furthermore, the neurocognitive profile was heterogeneous with regard to the nature and extent of cognitive deficits but attentional processes were frequently compromised. After 1 year of treatment, occupational and relational impairments, as well as neurocognitive dysfunction, persisted sufficiently to alter daily functioning.

  20. Effects of a 12-Month Pedometer-Based Walking Intervention in Women of Low Socioeconomic Status

    PubMed Central

    Hornbuckle, Lyndsey M.; Kingsley, J. Derek; Kushnick, Michael R.; Moffatt, Robert J.; Haymes, Emily M.; Miles, Rebecca; Toole, Tonya; Panton, Lynn B.

    2016-01-01

    This study examined the effects of a 12-month walking intervention in overweight/obese, low socioeconomic women. Forty-six women (48.2 ± 8.0 years) entered the study. Outcomes included weight, waist and hip circumferences, body mass index (BMI), blood pressure, glycosylated hemoglobin, blood lipids, fibrinogen, and high-sensitivity C-reactive protein (hsCRP). Both intention-to-treat analyses in all participants and group analyses in study completers only (3K group = increased steps/day by ≥3,000; No Δ group = did not increase steps/day by ≥3,000) were conducted. Group × time ANOVA was used. In study completers, 3K significantly increased steps/day (6,903 ± 3,328 to 12,323 ± 5,736) compared to No Δ (4,926 ± 3,374 to 5,174 ± 3,095) from baseline to 12 months. There was a significant time effect for weight (P = 0.030), BMI (P = 0.029), and hsCRP (P = 0.044). Low socioeconomic women who adhere to a long-term, pedometer-based walking intervention significantly increased steps/day and may improve body weight, BMI, and hsCRP. This could help reduce health disparities in this population over time. PMID:27746679

  1. Cost of Living with Parkinson's Disease over 12 Months in Australia: A Prospective Cohort Study.

    PubMed

    Bohingamu Mudiyanselage, Shalika; Watts, Jennifer J; Abimanyi-Ochom, Julie; Lane, Lisa; Murphy, Anna T; Morris, Meg E; Iansek, Robert

    2017-01-01

    Background. Parkinson disease (PD) is a costly chronic condition in terms of managing both motor and nonmotor symptoms. The burden of disease is high for individuals, caregivers, and the health system. The aim of this study is to estimate the annual cost of PD from the household, health system, and societal perspectives. Methods. A prospective cohort study of newly referred people with PD to a specialist PD clinic in Melbourne, Australia. Participants completed baseline and monthly health resource use questionnaires and Medicare data were collected over 12 months. Results. 87 patients completed the 12-month follow-up assessments. The mean annual cost per person to the health care system was $32,556 AUD. The burden to society was an additional $45,000 per annum per person with PD. The largest component of health system costs were for hospitalisation (69% of total costs). The costs for people with moderate to severe disease were almost 4 times those with mild PD ($63,569 versus $17,537 p < 0.001). Conclusion. PD is associated with significant costs to individuals and to society. Costs escalated with disease severity suggesting that the burden to society is likely to grow with the increasing disease prevalence that is associated with population ageing.

  2. Does contingency in adults' responding influence 12-month-old infants' social referencing?

    PubMed

    Stenberg, Gunilla

    2016-12-07

    In two experiments we examined the influence of contingent versus non-contingent responding on infant social referencing behavior. EXPERIMENT 1: Forty 12-month-old infants were exposed to an ambiguous toy in a social referencing situation. In one condition an unfamiliar adult who in a previous play situation had responded contingently to the infant's looks gave the infant positive information about the toy. In the other condition an unfamiliar adult who previously had not responded contingently delivered the positive information. EXPERIMENT 2: Forty-eight 12-month-old infants participated in Experiment 2. In this experiment it was examined whether the familiarity of the adult influences infants' reactions to contingency in responding. In one condition a parent who previously had responded contingently to the infant's looks provided positive information about the ambiguous toy, and in the other condition a parent who previously had not responded contingently provided the positive information. The infants looked more at the contingent experimenter in Experimenter 1, and also played more with the toy after receiving positive information from the contingent experimenter. No differences in looking at the parent and in playing with the toy were found in Experiment 2. The results indicate that contingency in responding, as well as the familiarity of the adult, influence infants' social referencing behavior.

  3. Long-term memory, forgetting, and deferred imitation in 12-month-old infants

    PubMed Central

    Klein, Pamela J.; Meltzoff, Andrew N.

    2013-01-01

    Long-term recall memory, as indexed by deferred imitation, was assessed in 12-month-old infants. Independent groups of infants were tested after retention intervals of 3 min, 1 week and 4 weeks. Deferred imitation was assessed using the ‘observation-only’ procedure in which infants were not allowed motor practice on the tasks before the delay was imposed. Thus, the memory could not have been based on re-accessing a motor habit, because none was formed in the first place. After the delay, memory was assessed either in the same or a different environmental context from the one in which the adult had originally demonstrated the acts. In Experiments 1 and 3, infants observed the target acts while in an unusual environment (an orange and white polka-dot tent), and recall memory was tested in an ordinary room. In Experiment 2, infants observed the target acts in their homes and were tested for memory in a university room. The results showed recall memory after all retention intervals, including the 4 week delay, with no effect of context change. Interestingly, the forgetting function showed that the bulk of the forgetting occurred during the first week. The findings of recall memory without motor practice support the view that infants as young as 12 months old use a declarative (nonprocedural) memory system to span delay intervals as long as 4 weeks. PMID:25147475

  4. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    PubMed

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  5. 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

  6. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.

    PubMed

    Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D; Lewis, Megan A; Kramer, M Kaye; Snowden, Mark B; Rosas, Lisa G; Xiao, Lan; Blonstein, Andrea C

    2015-07-01

    Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.

  7. Research Aimed at Improving Both Mood and Weight (RAINBOW) in Primary Care: A Type 1 hybrid design randomized controlled trial

    PubMed Central

    Ma, Jun; Yank, Veronica; Lv, Nan; Goldhaber-Fiebert, Jeremy D.; Lewis, Megan A.; Kramer, M. Kaye; Snowden, Mark B.; Rosas, Lisa G.; Xiao, Lan; Blonstein, Andrea C.

    2015-01-01

    Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n=404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system’s services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance™). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE’s cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated—through a new model of accessible and integrative lifestyle medicine and mental health expertise—in primary care. PMID:26096714

  8. 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

  9. 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.

  10. Brief Intervention in the Emergency Department Among Mexican-Origin Young Adults at the US–Mexico Border: Outcomes of a Randomized Controlled Clinical Trial Using Promotores†

    PubMed Central

    Cherpitel, Cheryl J.; Ye, Yu; Bond, Jason; Woolard, Robert; Villalobos, Susana; Bernstein, Judith; Bernstein, Edward; Ramos, Rebeca

    2016-01-01

    Aims A randomized controlled trial of brief intervention (BI), for drinking and related problems, using peer health promotion advocates (promotores), was conducted among at-risk and alcohol-dependent Mexican-origin young adult emergency department (ED) patients, aged 18–30. Methods Six hundred and ninety-eight patients were randomized to: screened only (n = 78), assessed (n = 310) and intervention (n = 310). Primary outcomes were at-risk drinking and Rapid Alcohol Problems Screen (RAPS4) scores. Secondary outcomes were drinking days per week, drinks per drinking day, maximum drinks in a day and negative consequences of drinking. Results At 3- and 12-month follow-up the intervention condition showed significantly lower values or trends on all outcome variables compared to the assessed condition, with the exception of the RAPS4 score; e.g. at-risk drinking days dropped from 2.9 to 1.7 at 3 months for the assessed condition and from 3.2 to 1.2 for the intervention condition. Using random effects modeling controlling for demographics and baseline values, the intervention condition showed significantly greater improvement in all consumption measures at 12 months, but not in the RAPS4 or negative consequences of drinking. Improvements in outcomes were significantly more evident for non-injured patients, those reporting drinking prior to the event, and those lower on risk taking disposition. Conclusions At 12-month follow-up this study demonstrated significantly improved drinking outcomes for Mexican-origin young adults in the ED who received a BI delivered by promotores compared to those who did not. Trial Register ClinicalTrials.gov. Clinical Trial Registration Number NCT02056535. PMID:26243733

  11. Neuroprotection after a first episode of mania: a randomized controlled maintenance trial comparing the effects of lithium and quetiapine on grey and white matter volume.

    PubMed

    Berk, M; Dandash, O; Daglas, R; Cotton, S M; Allott, K; Fornito, A; Suo, C; Klauser, P; Liberg, B; Henry, L; Macneil, C; Hasty, M; McGorry, P; Pantelis, Cs; Yücel, M

    2017-01-24

    Lithium and quetiapine are effective treatments for bipolar disorder, but their potential neuroprotective effects in humans remain unclear. A single blinded equivalence randomized controlled maintenance trial was conducted in a prospective cohort of first-episode mania (FEM) patients (n=26) to longitudinally compare the putative protective effects of lithium and quetapine on grey and white matter volume. A healthy control sample was also collected (n=20). Using structural MRI scans, voxel-wise grey and white matter volumes at baseline and changes over time in response to treatment were investigated. Patients were assessed at three time points (baseline, 3 and 12-month follow-up), whereas healthy controls were assessed at two time points (baseline and 12-month follow-up). Patients were randomized to lithium (serum level 0.6 mmol l(-1), n=20) or quetiapine (flexibly dosed up to 800 mg per day, n=19) monotherapy. At baseline, compared with healthy control subjects, patients with FEM showed reduced grey matter in the orbitofrontal cortex, anterior cingulate, inferior frontal gyrus and cerebellum. In addition, patients had reduced internal capsule white matter volume bilaterally (t1,66>3.20, P<0.01). Longitudinally, there was a significant treatment × time effect only in the white matter of the left internal capsule (F2,112=8.54, P<0.01). Post hoc testing showed that, compared with baseline, lithium was more effective than quetiapine in slowing the progression of white matter volume reduction after 12 months (t1,24=3.76, P<0.01). Our data support the role of lithium but not quetiapine therapy in limiting white matter reduction early in the illness course after FEM.

  12. Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy.

    PubMed

    van Lankveld, Jacques J D M; ter Kuile, Moniek M; de Groot, H Ellen; Melles, Reinhilde; Nefs, Janneke; Zandbergen, Maartje

    2006-02-01

    Women with lifelong vaginismus (N=117) were randomly assigned to cognitive-behavioral group therapy, cognitive-behavioral bibliotherapy, or a waiting list. Manualized treatment comprised sexual education, relaxation exercises, gradual exposure, cognitive therapy, and sensate focus therapy. Group therapy consisted of ten 2-hr sessions with 6 to 9 participants per group. Assistance with minimal-contact bibliotherapy consisted of 6 biweekly, 15-min telephone contacts. Twenty-one percent of the participants left the study before posttreatment assessment. Intent-to-treat analysis revealed that successful intercourse at posttreatment was reported by 14% of the treated participants compared with none of the participants in the control condition. At the 12-month follow-up 21% of the group therapy participants and 15% of the bibliotherapy participants, respectively, reported successful intercourse. Cognitive-behavioral treatment of lifelong vaginismus was thus found to be efficacious, but the small effect size of the treatment warrants future efforts to improve the treatment.

  13. 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.

  14. The Impact of Screening, Brief Intervention and Referral for Treatment in Emergency Department Patients’ Alcohol Use: A 3-, 6- and 12-month Follow-up

    PubMed Central

    2010-01-01

    Aims: This study aims to determine the impact of Screening, Brief Intervention and Referral for Treatment (SBIRT) in reducing alcohol consumption in emergency department (ED) patients at 3, 6, and 12 months following exposure to the intervention. Methods: Patients drinking above the low-risk limits (at-risk to dependence), as defined by National Institute of Alcohol Abuse and Alcoholism (NIAAA), were recruited from 14 sites nationwide from April to August 2004. A quasi-experimental comparison group design included sequential recruitment of intervention and control patients at each site. Control patients received a written handout. The Intervention group received the handout and participated in a brief negotiated interview with direct referral for treatment if indicated. Follow-up surveys were conducted at 3, 6, and 12 months by telephone using an Interactive Voice Response (IVR) system. Results: Of the 1132 eligible patients consented and enrolled (581 control, 551 intervention), 699 (63%), 575 (52%) and 433 (38%) completed follow-up surveys via IVR at 3, 6, and 12 months, respectively. Regression analysis adjusting for the clustered sampling design and using multiple imputation procedures to account for subject attrition revealed that those receiving SBIRT reported roughly three drinks less per week than controls (B = −3.00, SE = 1.06, P < 0.05) and the level of maximum drinks per occasion was approximately three-fourths of a drink less than controls (B = -0.76, SE = 0.29, P < 0.05) at 3 months. At 6 and 12 months post-intervention, these effects had weakened considerably and were no longer statistically or substantively significant. Conclusion: SBIRT delivered by ED providers appears to have short-term effectiveness in reducing at-risk drinking, but multi-contact interventions or booster programs may be necessary to maintain long-term reductions in risky drinking. PMID:20876217

  15. Prevalence, correlates, and comorbidity of 12-Month tobacco dependence among ever-smokers in South Korea, during 1984-2001.

    PubMed

    Jeon, Hong Jin; Hahm, Bong-Jin; Lee, Hae-Woo; Hong, Jin Pyo; Bae, Jae-Nam; Park, Jong Ik; Kim, Jang-Kyu; Bae, Ahn; Park, Jong Han; Chung, Eun-Kee; Shin, Jong-Ho; Choi, Yong-Seoung; Chung, In-Won; Lee, Hyo Jung; Cho, Maeng Je

    2008-04-01

    The rate of dependence among ever-users of a drug indicates the risk of developing dependence once an individual has been exposed to the drug. This is the first study to investigate 12-month tobacco dependence (TD) among ever-smokers in a community-based population. Analyses were based on two national studies of representative samples aged 18-64 in 1984 (n=5,025) and in 2001 (n=6,275), conducted with household visits and face-to-face interviews. The rates of 12-month TD among ever-smokers in men showed no significant difference between 51.6% in 1984 and 50.6% in 2001. On the contrary, the rates in women significantly increased from 33.3% in 1984 to 52.8% in 2001. After adjusting for the sociodemographic variables, 'male gender' was significantly associated with 12-month TD among eversmokers in 1984, but not in 2001. 'Unmarried' was significantly associated in 2001 but not in 1984. 'Alcohol dependence' was the only psychiatric disorder associated with 12-month TD in both study years. In conclusion, 12-month TD was found in about 50% of ever-smokers, and gender differences between the rates of 12-month TD which was observed in 1984 disappeared in 2001. Individuals with 12-month TD showed higher comorbidity with alcohol dependence than ever-smokers without TD.

  16. Gender and discipline in 5-12-month-old infants: a longitudinal study.

    PubMed

    Ahl, Richard Evan; Fausto-Sterling, Anne; García-Coll, Cynthia; Seifer, Ronald

    2013-04-01

    We examined the effects of infant age and gender on the behaviors of infants and mothers during discipline interactions using longitudinal, naturalistic, home-based, taped observations of 16 mother-infant dyads (eight males and eight females). These observations were conducted between the child ages of 5 and 12 months and used a devised Maternal Discipline Coding System to code for the occurrence of discipline events. During discipline interactions, mothers vocalized longer, used harsher tones, and used more explanations with older compared to younger infants. Male infants were more likely than female infants to cry or whine during discipline events. Mothers of male infants used longer vocalizations, more words, and more affectionate terms than mothers of female infants. Male infants were more difficult during discipline interactions than female infants, but it appeared that mothers of males responded to this difficulty by using milder discipline techniques.

  17. Proteomic characterization of human milk fat globule membrane proteins during a 12 month lactation period.

    PubMed

    Liao, Yalin; Alvarado, Rudy; Phinney, Brett; Lönnerdal, Bo

    2011-08-05

    The milk fat globule membrane (MFGM) contains proteins which have been implicated in a variety of health benefits. Milk fat globule membrane proteins were isolated from human milk during a 12 month lactation period and subjected to in-solution digestion and liquid chromatography tandem mass spectrometry analysis. Data were pooled, and our results showed that 191 proteins were identified. Relative quantification of the identified MFGM proteins during the course of lactation was performed by label free spectral counting and differentiation expression analysis, which showed some proteins decreasing during the course of lactation whereas some increased or remained at a relatively constant level. The human MFGM proteins are distributed between intracellular, extracellular, and membrane-associated proteins, and they are mainly involved in cell communication and signal transduction, immune function, metabolism and energy production. This study provides more insights into the dynamic composition of human MFGM proteins, which in turn will enhance our understanding of the physiological significance of MFGM proteins.

  18. The role of verbal labels on flexible memory retrieval at 12-months of age.

    PubMed

    Taylor, Gemma; Liu, Hao; Herbert, Jane S

    2016-11-01

    The provision of verbal labels enhances 12-month-old infants' memory flexibility across a form change in a puppet imitation task (Herbert, 2011), although the mechanisms for this effect remain unclear. Here we investigate whether verbal labels can scaffold flexible memory retrieval when task difficulty increases and consider the mechanism responsible for the effect of language cues on early memory flexibility. Twelve-month-old infants were provided with English, Chinese, or empty language cues during a difficult imitation task, a combined change in the puppet's colour and form at the test (Hayne et al., 1997). Imitation performance by infants in the English language condition only exceeded baseline performance after the 10-min delay. Thus, verbal labels facilitated flexible memory retrieval on this task. There were no correlations between infants' language comprehension and imitation performance. Thus, it is likely that verbal labels facilitate both attention and categorisation during encoding and retrieval.

  19. Factors associated with recurrent tuberculosis more than 12 months after treatment completion

    PubMed Central

    Kim, Lindsay; Moonan, Patrick K.; Heilig, Charles M.; Yelk Woodruff, Rachel S.; Kammerer, J. Steve; Haddad, Maryam B.

    2016-01-01

    SUMMARY Setting Even in persons with complete treatment of their first tuberculosis (TB) episode, patients with a TB history are at higher risk for having TB. Objective Describe factors from the initial TB episode associated with recurrent TB among patients who completed treatment and remained free of TB for at least 12 months. Design US TB cases, stratified by birth origin, during 1993–2006 were examined. Cox proportional hazards regression was employed to assess the association of factors during the initial episode with recurrence at least 12 months after treatment completion. Results Among 632 US-born patients, TB recurrence was associated with age 25–44 (adjusted hazard ratio [aHR] 1.77, 99% confidence interval [CI] 1.02–3.09, attributable fraction [AF] 1%–34%), substance use (aHR 1.57, 99%CI 1.23–2.02, AF 8%–22%), and treatment supervised by health departments (aHR 1.42, 99%CI 1.03–1.97, AF 2%–28%). Among 211 foreign-born patients, recurrence was associated with HIV infection (aHR 2.24, 99%CI 1.27–3.98, AF 2%–9%) and smear-positive TB (aHR 1.56, 99%CI 1.06–2.30, AF 3%–33%). Conclusion Factors associated with recurrence differed by birth origin and might be useful for anticipating greater risk for recurrent TB among certain patients with a TB history. PMID:26688528

  20. Mild pituitary phenotype in 3- and 12-month-old Aip-deficient male mice.

    PubMed

    Lecoq, Anne-Lise; Zizzari, Philippe; Hage, Mirella; Decourtye, Lyvianne; Adam, Clovis; Viengchareun, Say; Veldhuis, Johannes D; Geoffroy, Valérie; Lombès, Marc; Tolle, Virginie; Guillou, Anne; Karhu, Auli; Kappeler, Laurent; Chanson, Philippe; Kamenický, Peter

    2016-10-01

    Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene predispose humans to pituitary adenomas, particularly of the somatotroph lineage. Mice with global heterozygous inactivation of Aip (Aip(+/-)) also develop pituitary adenomas but differ from AIP-mutated patients by the high penetrance of pituitary disease. The endocrine phenotype of these mice is unknown. The aim of this study was to determine the endocrine phenotype of Aip(+/-) mice by assessing the somatic growth, ultradian pattern of GH secretion and IGF1 concentrations of longitudinally followed male mice at 3 and 12 months of age. As the early stages of pituitary tumorigenesis are controversial, we also studied the pituitary histology and somatotroph cell proliferation in these mice. Aip(+/-) mice did not develop gigantism but exhibited a leaner phenotype than wild-type mice. Analysis of GH pulsatility by deconvolution in 12-month-old Aip(+/-) mice showed a mild increase in total GH secretion, a conserved GH pulsatility pattern, but a normal IGF1 concentration. No pituitary adenomas were detected up to 12 months of age. An increased ex vivo response to GHRH of pituitary explants from 3-month-old Aip(+/-) mice, together with areas of enlarged acini identified on reticulin staining in the pituitary of some Aip(+/-) mice, was suggestive of somatotroph hyperplasia. Global heterozygous Aip deficiency in mice is accompanied by subtle increase in GH secretion, which does not result in gigantism. The absence of pituitary adenomas in 12-month-old Aip(+/-) mice in our experimental conditions demonstrates the important phenotypic variability of this congenic mouse model.

  1. Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

    PubMed

    Kleczynski, Pawel; Dziewierz, Artur; Bagienski, Maciej; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-02-07

    Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

  2. Comparison of Bone Loss around Bone Platform Shift and Non-Bone Platform Shift Implants After 12 Months

    PubMed Central

    Rokn, Amir Reza; Badri, Samareh; Rasouli Ghahroudi, Amir Alireza; Manasheof, Rebeca; Kharazi Fard, Mohamad Javad; Barikani, Hamidreza

    2015-01-01

    Objectives: The aim of the present randomized clinical trial was to evaluate marginal bone loss around two types of implants modified at the neck area: Nobel Active and Nobel Replace Groovy, both manufactured by Nobel Biocare. Materials and Methods: A total of 25 Nobel Active and 21 Nobel Replace Groovy implants were included in the present study. The implants were placed based on the relevant protocol and patient inclusion and exclusion criteria. The amount of bone loss around implants was compared at 6 and 12-month intervals using digital periapical radiographs. Results: The mean bone loss values in the Nobel Active and Nobel Replace Groovy groups were 0.682 mm and 0.645 mm, respectively, with no statistically significant difference based on the results of independent t-test (P=0.802). Conclusion: Use of both implant types yielded favorable results, with high durability. The two implant types exhibited no superiority over each other in terms of bone loss. PMID:26622270

  3. 12-months metabolic changes among gender dysphoric individuals under cross-sex hormone treatment: a targeted metabolomics study

    PubMed Central

    Auer, Matthias K.; Cecil, Alexander; Roepke, Yasmin; Bultynck, Charlotte; Pas, Charlotte; Fuss, Johannes; Prehn, Cornelia; Wang-Sattler, Rui; Adamski, Jerzy; Stalla, Günter K.; T’Sjoen, Guy

    2016-01-01

    Metabolomic analyses in epidemiological studies have demonstrated a strong sexual dimorphism for most metabolites. Cross-sex hormone treatment (CSH) in transgender individuals enables the study of metabolites in a cross-gender setting. Targeted metabolomic profiling of serum of fasting transmen and transwomen at baseline and following 12 months of CSH (N = 20/group) was performed. Changes in 186 serum metabolites and metabolite ratios were determined by targeted metabolomics analysis based on ESI-LC-MS/MS. RandomForest (RF) analysis was applied to detect metabolites of highest interest for grouping of transwomen and transmen before and after initiation of CSH. Principal component analysis (PCA) was performed to check whether group differentiation was achievable according to these variables and to see if changes in metabolite levels could be explained by a priori gender differences. PCA predicted grouping of individuals-determined by the citrulline/arginine-ratio and the amino acids lysine, alanine and asymmetric dimethylarginine - in addition to the expected grouping due to changes in sex steroids and body composition. The fact that most of the investigated metabolites did, however, not change, indicates that the majority of sex dependent differences in metabolites reported in the literature before may primarily not be attributable to sex hormones but to other gender-differences. PMID:27833161

  4. The Origins of 12-Month Attachment: A Microanalysis of 4-Month Mother-Infant Interaction

    PubMed Central

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2013-01-01

    A detailed microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of essential communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1s time base; mother and infant facial-visual “engagement” variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual’s own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual’s behavior that were correlated with the partner’s previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother

  5. The origins of 12-month attachment: a microanalysis of 4-month mother-infant interaction.

    PubMed

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2010-01-01

    A microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1 s time base; mother and infant facial-visual "engagement" variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual's own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual's behavior that were correlated with the partner's previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother, yielded comparable numbers

  6. Influence of chlorhexidine concentration on the durability of etch-and-rinse dentin bonds: a 12-month in vitro study

    PubMed Central

    Breschi, Lorenzo; Cammelli, Federica; Visintini, Erika; Mazzoni, Annalisa; Vita, Francesca; Carrilho, Marcela; Cadenaro, Milena; Foulger, Stephen; Tay, Franklin R; Pashley, David; Di Lenarda, Roberto

    2013-01-01

    Objective To investigate the effect of 0.2% and 2% chlorhexidine (CHX) used as a therapeutic primer on the long-term bond strengths of two etch-and-rinse adhesive systems. Methods Adper Scotchbond 1XT (SB1) and XP-Bond (XPB) were evaluated. Etched dentin substrates were assigned to six treatment groups: (1) 0.2% CHX + SB1; (2) 2% CHX + SB1; (3) SB1 (control); (4) 0.2% CHX + XPB; (5) 2% CHX + XPB; (6) XPB (control). Composite build-ups were made and beams prepared for microtensile bond strength test. Beams were divided in three subgroups and either immediately pulled to failure or stored in artificial saliva for 6 or 12 months prior to testing. Data were evaluated by three-way ANOVA. Additional adhesive interfaces were prepared to investigate nanoleakage expression by TEM. Results SB1 and XPB showed similar immediate bond strength values with or without CHX pre-treatment (p>0.05). After 12 months, bonds fell from 43.9 ± 9.5 MPa to 20.1 ± 5.4 MPa and from 39.6 ± 9.4 MPa to 14.2 ± 5.0 MPa in control specimens for SB1 and XPB respectively, while bond fell only from 41.9±9.6MPa to 33.2 ± 8.3 MPa and 38.3 ± 8.9 MPa to 26.5 ± 10.9 (for SB1 and XPB respectively) when 0.2% CHX was previously used. CHX concentration did not affect bond strength values (0.2% vs 2%, p>.05). Nanoleakage increased during aging in controls, but reduced silver deposits were found in CHX-treated specimens. Conclusions Chlorhexidine significantly reduced the loss of bond strength seen in control bonds. Since no bacterial growth was present in the aging conditions, the results of this study suggest that endogenous factors thought to degrade the adhesive interface can be inhibited by CHX. Further in vivo trials should confirm the role of CHX in bond durability. PMID:19603582

  7. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  8. 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

  9. The effect of occupational therapy in patients with chronic obstructive pulmonary disease: A randomized controlled trial.

    PubMed

    Martinsen, Unni; Bentzen, Hege; Holter, Morag Kelly; Nilsen, Tove; Skullerud, Hallvard; Mowinckel, Petter; Kjeken, Ingvild

    2017-03-01

    Aim The main aim of this study was to evaluate the effect of individualized occupational therapy in patients with chronic obstructive pulmonary disease (COPD). Additionally, the authors wanted to explore the occupational problems experienced in daily life by individuals with COPD. Methods A total of 52 patients were randomly assigned to the intervention group (occupational therapy) or control group (treatment as usual). The primary outcome was assessed using the Canadian Occupational Performance Measure (COPM), and participants were assessed at baseline and after four and 12 months. Results There were no treatment effects on occupational performance or satisfaction with performance, as measured by the COPM. However, we found a significant effect in favour of the intervention group at exertion when performing an individually chosen activity, and in the activity dimension of St George's Respiratory Questionnaire. A total of 595 occupational problems were reported, most frequently within mobility, active recreation, and household management. Conclusions The results show that, compared with the usual care, individualized occupational therapy did not improve occupational performance or satisfaction with performance. Small but significant changes in activity performance in favour of the intervention group were found in some of the secondary outcomes.

  10. Randomized Controlled Trial of Personalized Motivational Interventions in Substance Using Patients With Facial Injuries

    PubMed Central

    Shetty, Vivek; Murphy, Debra A.; Zigler, Corwin; Yamashita, Dennis-Duke R.; Belin, Thomas R.

    2011-01-01

    Purpose The proximate use of illicit drugs or alcohol (substance use) is the most common precipitator of facial injuries among socioeconomically disadvantaged populations. Reducing these risky behaviors could minimize adverse health sequelae and potential reinjury. The objective of our study was to test whether a culturally competent, personalized motivational intervention incorporated into surgical care could significantly reduce existing substance use behaviors in facial injury patients. Patients and Methods Substance-using subjects (n = 218) presenting with facial injuries to a level 1 trauma center were randomly assigned to either a personalized motivational intervention (PMI) condition or a health-information (HI) control condition. After a brief assessment of the individual’s substance use severity and willingness to change these behaviors, both groups attended 2 counseling sessions with a trained interventionist. The PMI subjects (n = 118) received individualized, motivational interventions, whereas the HI subjects (n = 100) received only general health information. Both groups were reassessed at 6 and 12 months postinjury, and changes in substance-use patterns were measured to assess the effects of intervention. Results The PMI and HI groups were closely matched on their sociodemographic and substance use characteristics. Subjects in the PMI group showed statistically significant declines in drug use at both the 6- and 12-month assessments. The intervention’s effect on lowering illicit drug use was greatest at the 6-month assessment but had weakened by the 1-year follow-up. The efficacy of the PMI was moderated by an individual’s initial drug use severity; individuals with greater drug use dependency at baseline were seen to have larger intervention effects, as did individuals who were most aware of their drug problem and willing to change their substance use behaviors. Unlike illicit drug use, changes in alcohol use did not differ significantly

  11. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  12. A Randomized Controlled Trial of Clinician-Supported Problem-Solving Bibliotherapy for Family Caregivers of People With First-Episode Psychosis.

    PubMed

    Chien, Wai Tong; Thompson, David R; Lubman, Dan I; McCann, Terence V

    2016-11-01

    Family interventions for first-episode psychosis (FEP) are an integral component of treatment, with positive effects mainly on patients' mental state and relapse rate. However, comparatively little attention has been paid to the effects of family interventions on caregivers' stress coping and well-being, especially in non-Western countries. We aimed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy (CSPSB) for Chinese family caregivers of people with FEP in improving family burden and carers' problem-solving and caregiving experience, and in reducing psychotic symptoms and duration of re-hospitalizations, compared with those only received usual outpatient family support (UOFS). A randomized controlled trial was conducted across 2 early psychosis clinics in Hong Kong, where there might be inadequate usual family support services for FEP patients. A total of 116 caregivers were randomly selected, and after baseline measurement, randomly assigned to the CSPSB or UOFS. They were also assessed at 1-week and 6- and 12-month post-intervention. Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and duration of re-hospitalizations, than the UOFS group at 6- and 12-month follow-up. CSPSB produces moderate long-term benefits to caregivers and FEP patients, and is a low-cost adjunct to UOFS.

  13. A Randomized Controlled Trial of Clinician-Supported Problem-Solving Bibliotherapy for Family Caregivers of People With First-Episode Psychosis

    PubMed Central

    Chien, Wai Tong; Thompson, David R.; Lubman, Dan I.; McCann, Terence V.

    2016-01-01

    Family interventions for first-episode psychosis (FEP) are an integral component of treatment, with positive effects mainly on patients’ mental state and relapse rate. However, comparatively little attention has been paid to the effects of family interventions on caregivers’ stress coping and well-being, especially in non-Western countries. We aimed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy (CSPSB) for Chinese family caregivers of people with FEP in improving family burden and carers’ problem-solving and caregiving experience, and in reducing psychotic symptoms and duration of re-hospitalizations, compared with those only received usual outpatient family support (UOFS). A randomized controlled trial was conducted across 2 early psychosis clinics in Hong Kong, where there might be inadequate usual family support services for FEP patients. A total of 116 caregivers were randomly selected, and after baseline measurement, randomly assigned to the CSPSB or UOFS. They were also assessed at 1-week and 6- and 12-month post-intervention. Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and duration of re-hospitalizations, than the UOFS group at 6- and 12-month follow-up. CSPSB produces moderate long-term benefits to caregivers and FEP patients, and is a low-cost adjunct to UOFS. PMID:27147450

  14. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2010-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted. PMID:19968378

  15. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents.

    PubMed

    Compas, Bruce E; Forehand, Rex; Keller, Gary; Champion, Jennifer E; Rakow, Aaron; Reeslund, Kristen L; McKee, Laura; Fear, Jessica M; Colletti, Christina J M; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K; Cole, David A

    2009-12-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted.

  16. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial

    PubMed Central

    Michaelson, Peter; Gard, Gunvor; Eriksson, Margareta K

    2016-01-01

    Background Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). Objective The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. Methods A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. Results Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample

  17. 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

  18. Post-thoracotomy pain syndrome and sensory disturbances following thoracotomy at 6- and 12-month follow-ups

    PubMed Central

    Hetmann, Fredrik; Kongsgaard, Ulf E; Sandvik, Leiv; Schou-Bredal, Inger

    2017-01-01

    Background Persistent pain affects a large proportion of patients after thoracotomy and is associated with sensory disturbances. The objective of this prospective study was to investigate the time course of pain and sensory disturbances over a 12-month period. Methods Patients scheduled for thoracotomy were recruited. Data were collected on the day before surgery, including baseline characteristics and the presence of any preoperative pain. At 6- and 12-month follow-ups, data on pain were collected using the Brief Pain Inventory-Short Form, and perceived sensory disturbances around the thoracotomy scar were recorded from a self-exploration test. Results At 12 months after surgery, 97 patients had complete data including baseline and 6-and 12-month measurements. Almost half of the patients reported post-thoracotomy pain at the follow-ups. However, 20% of the patients not reporting post-thoracotomy pain at 6 months did report it at 12 months. Between 40% and 60% of patients experienced some kind of sensory disturbance at 6 months. A small decline in some kind of sensory disturbance was reported by 20%–50% of patients at 12 months. Conclusion A proportion of patients experienced either resolved or delayed onset of pain. Sensory changes were strongly associated with post-thoracotomy pain syndrome, but were also present in a large proportion of patients without it. PMID:28356766

  19. 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.

  20. Randomized Controlled Trial of a Community Health Worker Self-Management Support Intervention Among Low-Income Adults With Diabetes, Seattle, Washington, 2010–2014

    PubMed Central

    Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Hebert, Paul; Lessler, Dan; Krieger, James

    2017-01-01

    Introduction Community health workers (CHWs) can improve diabetes outcomes; however, questions remain about translating research findings into practical low-intensity models for safety-net providers. We tested the effectiveness of a home-based low-intensity CHW intervention for improving health outcomes among low-income adults with diabetes. Methods Low-income patients with glycated hemoglobin A1c (HbA1c) of 8.0% or higher in the 12 months before enrollment from 3 safety-net providers were randomized to a 12-month CHW-delivered diabetes self-management intervention or usual care. CHWs were based at a local health department. The primary outcome was change in HbA1c from baseline enrollment to 12 months; secondary outcomes included blood pressure and lipid levels, quality of life, and health care use. Results The change in HbA1c in the intervention group (n = 145) (unadjusted mean of 9.09% to 8.58%, change of −0.51) compared with the control group (n = 142) (9.04% to 8.71%, change of −0.33) was not significant (P = .54). In an analysis of participants with poor glycemic control (HbA1c >10%), the intervention group had a 1.23-point greater decrease in HbA1c compared with controls (P = .046). For the entire study population, we found a decrease in reported physician visits (P < .001) and no improvement in health-related quality of life (P = .07) in the intervention group compared with the control group. Conclusion A low-intensity CHW-delivered intervention to support diabetes self-management did not significantly improve HbA1c relative to usual care. Among the subgroup of participants with poor glycemic control (HbA1c >10% at baseline), the intervention was effective. PMID:28182863

  1. Family-Based Cluster Randomized Controlled Trial Enhancing Physical Activity and Motor Competence in 4–7-Year-Old Children

    PubMed Central

    Laukkanen, Arto; Pesola, Arto Juhani; Heikkinen, Risto; Sääkslahti, Arja Kaarina; Finni, Taija

    2015-01-01

    Little is known of how to involve families in physical activity (PA) interventions for children. In this cluster randomized controlled trial, we recruited families with four- to seven-year-old children to participate in a year-long study where parents in the intervention group families (n = 46) received tailored counseling to increase children’s PA. Structured PA was not served. Control group families (n = 45) did not receive any counseling. PA in all children (n = 91; mean age 6.16 ± 1.13 years at the baseline) was measured by accelerometers at the baseline and after three, six, nine and 12 months. Motor competence (MC) (n = 89) was measured at the baseline and after six and 12 months by a KTK (KörperkoordinationsTest für Kinder) and throwing and catching a ball (TCB) protocols. The effect of parental counseling on study outcomes was analyzed by a linear mixed-effects model fit by REML and by a Mann-Whitney U test in the case of the TCB. As season was hypothesized to affect counseling effect, an interaction of season on the study outcomes was examined. The results show significant decrease of MVPA in the intervention group when compared to the control group (p < .05). The TCB showed a nearly significant improvement at six months in the intervention group compared to the controls (p = .051), but not at 12 months. The intervention group had a steadier development of the KTK when the interaction of season was taken into account. In conclusion, more knowledge of family constructs associating with the effectiveness of counseling is needed for understanding how to enhance PA in children by parents. However, a hypothesis may be put forward that family-based counseling during an inactive season rather than an active season may provide a more lasting effect on the development of KTK in children. Trial Registration Controlled-Trials.com ISRCTN28668090 PMID:26502183

  2. 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

  3. Home-Based Psychiatric Outpatient Care Through Videoconferencing for Depression: A Randomized Controlled Follow-Up Trial

    PubMed Central

    Rössler, Wulf

    2016-01-01

    Background There is a tremendous opportunity for innovative mental health care solutions such as psychiatric care through videoconferencing to increase the number of people who have access to quality care. However, studies are needed to generate empirical evidence on the use of psychiatric outpatient care via videoconferencing, particularly in low- and middle-income countries and clinically unsupervised settings. Objective The objective of this study was to evaluate the effectiveness and feasibility of home-based treatment for mild depression through psychiatric consultations via videoconferencing. Methods A randomized controlled trial with a 6- and 12-month follow-up including adults with mild depression treated in an ambulatory setting was conducted. In total, 107 participants were randomly allocated to the videoconferencing intervention group (n=53) or the face-to-face group (F2F; n=54). The groups did not differ with respect to demographic characteristics at baseline. The F2F group completed monthly follow-up consultations in person. The videoconferencing group received monthly follow-up consultations with a psychiatrist through videoconferencing at home. At baseline and after 6 and 12 months, in-person assessments were conducted with all participants. Clinical outcomes (severity of depression, mental health status, medication course, and relapses), satisfaction with treatment, therapeutic relationship, treatment adherence (appointment compliance and dropouts), and medication adherence were assessed. Results The severity of depression decreased significantly over the 12-month follow-up in both the groups. There was a significant difference between groups regarding treatment outcomes throughout the follow-up period, with better results in the videoconferencing group. There were 4 relapses in the F2F group and only 1 in the videoconferencing group. No significant differences between groups regarding mental health status, satisfaction with treatment, therapeutic

  4. A Randomized Placebo-controlled Trial to Test a Genetically-informed Biomarker ForPersonalizing Treatment for Tobacco Dependence

    PubMed Central

    Lerman, Caryn; Schnoll, Robert A.; Hawk, Larry W.; Cinciripini, Paul; George, Tony P.; Wileyto, E. Paul; Swan, Gary E.; Benowitz, Neal I.; Heitjan, Daniel F.; Tyndale, Rachel F.

    2015-01-01

    Summary Background There is substantial variability in therapeutic response and adverse effects with pharmacotherapies for tobacco dependence. Biomarkers to optimize treatment choice for individual smokers may improve treatment outcomes.Wetested whether a genetically-informed biomarker of nicotine clearance, the nicotine metabolite ratio (NMR; 3’hydroxycotinine/cotinine), predicts response to nicotine patch vs. varenicline for smoking cessation. Methods AnNMR-stratified multicenter, randomized, placebo-controlled clinical trial was conducted from November 2010-September 2013 at 4 sites. Treatment-seeking smokers (1246: 662 slow metabolizers; 584 normal metabolizers) were randomized to 11-weeks of nicotine patch (active patch + placebo pill), varenicline (active pill + placebo patch), or placebo (placebo pill + patch), plus behavioral counseling; an intent-to-treat analysis was conducted. Participants were followed for 12-months following the target quit date.The primary endpoint was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT) to estimate the pharmacologic effect of treatment by NMR. Secondary outcomes were side-effects, withdrawal symptoms, and 6- and 12-month abstinence rates. ClinicalTrials.govregistration: NCT01314001 Findings In the longitudinal model including all time points, the NMR-by-treatment interaction was significant (ratio of odds ratios (ORR)=1·96; CI=(1·11, 3·46); p=0·02). The results indicate that varenicline was more efficacious than nicotine patch for normal metabolizers, whilethe efficacy was equivalent for slow metabolizers. In cross-sectional analyses, the interaction was significant at EOT (ORR)=1·89; CI=(1·02, 3·45); p=0·04) andat 6-months (ORR=2·07; CI=(1·01, 4·22); p=0·05), but not at 12-months (p=0·14). An NMR-by-treatment interaction showed that slow (vs. normal) metabolizers reported greater overallside-effects severity with vareniclinevs. placebo (β−1·06; CI=(−2·08, −0

  5. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow

  6. A randomized, controlled trial of everolimus-based dual immunosuppression versus standard of care in de novo kidney transplant recipients.

    PubMed

    Chadban, Steven J; Eris, Josette Marie; Kanellis, John; Pilmore, Helen; Lee, Po Chang; Lim, Soo Kun; Woodcock, Chad; Kurstjens, Nicol; Russ, Graeme

    2014-03-01

    Kidney transplant recipients receiving calcineurin inhibitor-based immunosuppression incur increased long-term risks of cancer and kidney fibrosis. Switch to mammalian target of rapamycin (mTOR) inhibitors may reduce these risks. Steroid or Cyclosporin Removal After Transplant using Everolimus (SOCRATES), a 36-month, prospective, multinational, open-label, randomized controlled trial for de novo kidney transplant recipients, assessed whether everolimus switch could enable elimination of mycophenolate plus either steroids or CNI without compromising efficacy. Patients received cyclosporin, mycophenolate and steroids for the first 14 days then everolimus with mycophenolate and CNIwithdrawal (CNI-WD); everolimus with mycophenolate and steroid withdrawal (steroid-WD); or cyclosporin, mycophenolate and steroids (control). 126 patients were randomized. The steroid WD arm was terminated prematurely because of excess discontinuations. Mean eGFR at month 12 for CNI-WD versus control was 65.1 ml/min/1.73 m2 vs. 67.1 ml/min/1.73 m2 by ITT, which met predefined noninferiority criteria (P=0.026). The CNI-WD group experienced a higher rate of BPAR(31% vs. control 13%, P=0.048) and showed a trend towards higher composite treatment failure (BPAR, graft loss, death, loss to follow-up). The 12 month results from SOCRATES show noninferiority in eGFR, but a significant excess of acute rejection when everolimus was commenced at week 2 to enable a progressive withdrawal of mycophenolate and cyclosporin in kidney transplant recipients.

  7. A randomized controlled trial of HAART versus HAART and chemotherapy in therapy-naïve patients with HIV-associated Kaposi sarcoma in South Africa

    PubMed Central

    Mosam, Anisa; Shaik, Fahmida; Uldrick, Thomas S.; Esterhuizen, Tonya; Friedland, Gerald H.; Scadden, David T.; Aboobaker, Jamila; Coovadia, Hoosen M.

    2012-01-01

    Background The optimal approach to HIV-associated KS (HIV-KS) in sub-Saharan Africa is unknown. With large-scale rollout of highly active antiretroviral therapy (HAART) in South Africa, we hypothesized survival in HIV-KS would improve and administration of chemotherapy in addition to HAART would be feasible and improve KS-specific outcomes. Methods We conducted a randomized, controlled, open-label trial with intention-to-treat analysis. Treatment-naïve patients from King Edward VIII Hospital, Durban, South Africa, a public-sector tertiary referral center, with HIV-KS, but no symptomatic visceral disease or fungating lesions requiring urgent chemotherapy, were randomized to HAART alone or HAART and chemotherapy (CXT). HAART arm received stavudine, lamivudine and nevirapine (Triomune®); CXT arm received Triomune® plus bleomycin, doxorubicin, and vincristine (ABV) every 3 weeks. When ABV was not available, oral etoposide (50-100 mg days 1-21 of a 28 day cycle) was substituted. Primary outcome was overall KS response using AIDS Clinical Trial Group criteria 12 months after HAART initiation. Secondary comparisons included: time to response, progression-free survival, overall survival, adverse events, HIV control, CD4 reconstitution, adherence and quality-of-life. Results 59 subjects were randomized to HAART, 53 to CXT. 12-month overall KS response was 39% in the HAART arm and 66% in the CXT arm (difference 27%; 95% CI 9%-43%, p=0.005). At 12 months, 77% were alive (no survival difference between arms, p=0.49), 82% had HIV viral load <50 copies/mL without difference between arms, (p=0.47); CD4 counts and QOL measures improved in all patients. Conclusions HAART with chemotherapy produced higher overall KS response over 12 months, while HAART alone provided similar improvement in survival and select measures of morbidity. In Africa, with high prevalence of HIV and HHV-8 and limited resources, HAART alone provides important benefit in patients with HIV-KS. PMID:22395672

  8. Day Hospital Treatment for Anorexia Nervosa: A 12-Month Follow-up Study.

    PubMed

    Abbate-Daga, Giovanni; Marzola, Enrica; De-Bacco, Carlotta; Buzzichelli, Sara; Brustolin, Annalisa; Campisi, Stefania; Amianto, Federico; Migliaretti, Giuseppe; Fassino, Secondo

    2015-09-01

    Day hospitals (DHs) represent a treatment option for anorexia nervosa (AN), a mental disorder that is difficult to treat and has no evidence-based treatments available. We aimed to determine the effectiveness of a DH treatment that was specifically focused on the emotions of severe AN patients. Body mass index and eating psychopathology were the primary outcome measures. Fifty-six adult patients with AN were assessed upon admission, at the end of treatment (EOT) and at a 12-month follow-up evaluation (T18) using Eating Disorders Inventory-2, Beck Depression Inventory, Hamilton Rating Scale for Anxiety and Brief Social Phobia Scale. All participants received a multidisciplinary treatment programme that focused on psychodynamic psychotherapy. Seventy-eight per cent of participants reported positive outcomes at EOT and 68% at T18. Moreover, 82.1% and 65.4% of long-standing patients showed positive outcomes at EOT and T18, respectively. All measures of psychopathology were significantly improved at EOT and were maintained at follow-up. Our DH was effective at treating severe AN patients; however, further investigations of the processes of change are warranted.

  9. Determinants of return to work 12 months after total hip and knee arthroplasty.

    PubMed

    Leichtenberg, C S; Tilbury, C; Kuijer, Ppfm; Verdegaal, Shm; Wolterbeek, R; Nelissen, Rghh; Frings-Dresen, Mhw; Vliet Vlieland, Tpm

    2016-07-01

    Introduction A substantial number of patients undergoing total hip or knee arthroplasty (THA or TKA) do not or only partially return to work. This study aimed to identify differences in determinants of return to work in THA and TKA. Methods We conducted a prospective, observational study of working patients aged <65 years undergoing THA or TKA for osteoarthritis. The primary outcome was full versus partial or no return to work 12 months postoperatively. Factors analysed included preoperative sociodemographic and work characteristics, alongside the Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), and Oxford Hip and Knee Scores. Results Of 67 THA and 56 TKA patients, 9 (13%) and 10 (19%), respectively, returned partially and 5 (7%) and 6 (11%), respectively, did not return to work 1 year postoperatively. Preoperative factors associated with partial or no return to work in THA patients were self-employment, absence from work and a better HOOS Activities of Daily Living (ADL) subscale score, whereas only work absence was relevant in TKA patients. Type of surgery modified the impact of ADL scores on return to work. Conclusions In both THA and TKA, absence from work affected return to work, whereas self-employment and better preoperative ADL subscale scores were also associated in THA patients. The impact of ADL scores on return to work was modified by type of surgery. These results suggest that strategies aiming to influence modifiable factors should consider THA and TKA separately.

  10. UNC-Emory Infant Atlases for Macaque Brain Image Analysis: Postnatal Brain Development through 12 Months

    PubMed Central

    Shi, Yundi; Budin, Francois; Yapuncich, Eva; Rumple, Ashley; Young, Jeffrey T.; Payne, Christa; Zhang, Xiaodong; Hu, Xiaoping; Godfrey, Jodi; Howell, Brittany; Sanchez, Mar M.; Styner, Martin A.

    2017-01-01

    Computational anatomical atlases have shown to be of immense value in neuroimaging as they provide age appropriate reference spaces alongside ancillary anatomical information for automated analysis such as subcortical structural definitions, cortical parcellations or white fiber tract regions. Standard workflows in neuroimaging necessitate such atlases to be appropriately selected for the subject population of interest. This is especially of importance in early postnatal brain development, where rapid changes in brain shape and appearance render neuroimaging workflows sensitive to the appropriate atlas choice. We present here a set of novel computation atlases for structural MRI and Diffusion Tensor Imaging as crucial resource for the analysis of MRI data from non-human primate rhesus monkey (Macaca mulatta) data in early postnatal brain development. Forty socially-housed infant macaques were scanned longitudinally at ages 2 weeks, 3, 6, and 12 months in order to create cross-sectional structural and DTI atlases via unbiased atlas building at each of these ages. Probabilistic spatial prior definitions for the major tissue classes were trained on each atlas with expert manual segmentations. In this article we present the development and use of these atlases with publicly available tools, as well as the atlases themselves, which are publicly disseminated to the scientific community. PMID:28119564

  11. Determinants of return to work 12 months after total hip and knee arthroplasty

    PubMed Central

    Tilbury, C; Kuijer, PPFM; Verdegaal, SHM; Wolterbeek, R; Nelissen, RGHH; Frings-Dresen, MHW; Vliet Vlieland, TPM

    2016-01-01

    Introduction A substantial number of patients undergoing total hip or knee arthroplasty (THA or TKA) do not or only partially return to work. This study aimed to identify differences in determinants of return to work in THA and TKA. Methods We conducted a prospective, observational study of working patients aged <65 years undergoing THA or TKA for osteoarthritis. The primary outcome was full versus partial or no return to work 12 months postoperatively. Factors analysed included preoperative sociodemographic and work characteristics, alongside the Hip Disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), and Oxford Hip and Knee Scores. Results Of 67 THA and 56 TKA patients, 9 (13%) and 10 (19%), respectively, returned partially and 5 (7%) and 6 (11%), respectively, did not return to work 1 year postoperatively. Preoperative factors associated with partial or no return to work in THA patients were self-employment, absence from work and a better HOOS Activities of Daily Living (ADL) subscale score, whereas only work absence was relevant in TKA patients. Type of surgery modified the impact of ADL scores on return to work. Conclusions In both THA and TKA, absence from work affected return to work, whereas self-employment and better preoperative ADL subscale scores were also associated in THA patients. The impact of ADL scores on return to work was modified by type of surgery. These results suggest that strategies aiming to influence modifiable factors should consider THA and TKA separately. PMID:27138849

  12. A pandemic influenza vaccine in India: from strain to sale within 12 months.

    PubMed

    Dhere, Rajeev; Yeolekar, Leena; Kulkarni, Prasad; Menon, Ravi; Vaidya, Vivek; Ganguly, Milan; Tyagi, Parikshit; Barde, Prajakt; Jadhav, Suresh

    2011-07-01

    In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months' post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

  13. Social Looking, Social Referencing and Humor Perception in 6-and-12-month-old Infants

    PubMed Central

    Mireault, Gina C.; Crockenberg, Susan C.; Sparrow, John E.; Pettinato, Christine A.; Woodard, Kelly C.; Malzac, Kirsten

    2014-01-01

    Social referencing refers to infants' use of caregivers as emotional referents in ambiguous situations (Walden, 1993). Studies of social referencing typically require ambulation, thereby over-looking younger, non-ambulatory infants (i.e., ≤ 8-mos) and resulting in a widespread assumption that young infants do not employ this strategy. Using a novel approach that does not require mobility, we found that when parents provided unsolicited affective cues during an ambiguous-absurd (i.e., humorous) event, 6-month-olds employ one component of social referencing, social looking Additionally, 6-month-olds who did not laugh at the event were significantly more likely to look toward parents than their counterparts who found the event funny. Sequential analyses revealed that, following a reference to a smiling parent, 6-month olds were more likely to smile at the parent, but by 12 months were more likely to smile at the event suggesting that older infants are influenced by parental affect in humorous situations. The developmental implications of these findings are discussed, as well as the usefulness of studying humor for understanding important developmental phenomena. PMID:25061893

  14. Social looking, social referencing and humor perception in 6- and-12-month-old infants.

    PubMed

    Mireault, Gina C; Crockenberg, Susan C; Sparrow, John E; Pettinato, Christine A; Woodard, Kelly C; Malzac, Kirsten

    2014-11-01

    Social referencing refers to infants' use of caregivers as emotional referents in ambiguous situations (Walden, 1993). Studies of social referencing typically require ambulation, thereby over-looking younger, non-ambulatory infants (i.e., ≤8-months) and resulting in a widespread assumption that young infants do not employ this strategy. Using a novel approach that does not require mobility, we found that when parents provided unsolicited affective cues during an ambiguous-absurd (i.e., humorous) event, 6-month-olds employ one component of social referencing, social looking Additionally, 6-month-olds who did not laugh at the event were significantly more likely to look toward parents than their counterparts who found the event funny. Sequential analyses revealed that, following a reference to a smiling parent, 6-month olds were more likely to smile at the parent, but by 12 months were more likely to smile at the event suggesting that older infants are influenced by parental affect in humorous situations. The developmental implications of these findings are discussed, as well as the usefulness of studying humor for understanding important developmental phenomena.

  15. Evaluation of orthodontic treatment after 1 year of retention--a randomized controlled trial.

    PubMed

    Edman Tynelius, G; Bondemark, L; Lilja-Karlander, E

    2010-10-01

    The aim of this study was to use a randomized controlled trial methodology to evaluate and compare three different retention methods. The capacity of the retention methods to retain orthodontic treatment results was in this first phase analysed on a short-term basis, i.e. after 1 year of retention. The subjects were recruited from adolescents undergoing fixed appliance treatment at an orthodontic clinic in the National Health Service (NHS) in Sweden between 2001 and 2007. Seventy-five patients (45 girls and 30 boys with a mean age of 14.4 years at the start of retention) were randomized into three retention systems; a vacuum-formed retainer in the maxilla and bonded canine-to-canine retainer in the mandible (group V-CTC), a vacuum-formed retainer in the maxilla combined with stripping of the 10 proximal surfaces of the lower mandibular anterior teeth (group V-S), and a prefabricated positioner covering the teeth in the maxilla and mandible (group P). The main outcome measures were: Little's irregularity index (LII), intercanine and intermolar width, arch length, overjet, and overbite. Registrations were made before orthodontic treatment, when the fixed orthodontic appliance was removed, and after 12 months in retention. Differences in means between groups were tested by one-way analysis of variance. After 1 year of retention, no clinically significant difference in retention capacity was found between the three retention methods. Small but significant differences (P < 0.05) were observed between the V-CTC and V-S groups regarding mandibular canine width, mandibular arch length, and overbite. In group P, two patients failed to co-operate.

  16. Effects of a Web-Based Patient Activation Intervention to Overcome Clinical Inertia on Blood Pressure Control: Cluster Randomized Controlled Trial

    PubMed Central

    Thiboutot, Jeffrey; Falkner, Bonita; Kephart, Donna K; Stuckey, Heather L; Adelman, Alan M; Curry, William J; Lehman, Erik B

    2013-01-01

    Background Only approximately half of patients with hypertension have their blood pressure controlled, due in large part to the tendency of primary care providers (PCPs) not to intensify treatment when blood pressure values are elevated. Objective This study tested the effect of an intervention designed to help patients ask questions at the point of care to encourage PCPs to appropriately intensify blood pressure treatment. Methods PCPs and their patients with hypertension (N=500) were recruited by letter and randomized into 2 study groups: (1) intervention condition in which patients used a fully automated website each month to receive tailored messages suggesting questions to ask their PCP to improve blood pressure control, and (2) control condition in which a similar tool suggested questions to ask about preventive services (eg, cancer screening). The Web-based tool was designed to be used during each of the 12 study months and before scheduled visits with PCPs. The primary outcome was the percentage of patients in both conditions with controlled blood pressure. Results Of 500 enrolled patients (intervention condition: n=282; control condition: n=218), 418 (83.6%) completed the 12-month follow-up visit. At baseline, 289 (61.5%) of participants had controlled blood pressure. Most (411/500, 82.2%) participants used the intervention during at least 6 of 12 months and 222 (62.5%) reported asking questions directly from the Web-based tool. There were no group differences in asking about medication intensification and there were no differences in blood pressure control after 12 months between the intervention condition (201/282, 71.3%) and control condition (143/218, 65.6%; P=.27) groups. More intervention condition participants discussed having a creatinine test (92, 52.6% vs 49, 35.5%; P=.02) and urine protein test (81, 44.8% vs 21, 14.6%; P<.001), but no group differences were observed in the rate of testing. The control condition participants reported more

  17. Reducing child conduct disordered behaviour and improving parent mental health in disadvantaged families: a 12-month follow-up and cost analysis of a parenting intervention.

    PubMed

    McGilloway, Sinead; NiMhaille, Grainne; Bywater, Tracey; Leckey, Yvonne; Kelly, Paul; Furlong, Mairead; Comiskey, Catherine; O'Neill, Donal; Donnelly, Michael

    2014-09-01

    The effectiveness of the Incredible Years Basic parent programme (IYBP) in reducing child conduct problems and improving parent competencies and mental health was examined in a 12-month follow-up. Pre- to post-intervention service use and related costs were also analysed. A total of 103 families and their children (aged 32-88 months), who previously participated in a randomised controlled trial of the IYBP, took part in a 12-month follow-up assessment. Child and parent behaviour and well-being were measured using psychometric and observational measures. An intention-to-treat analysis was carried out using a one-way repeated measures ANOVA. Pairwise comparisons were subsequently conducted to determine whether treatment outcomes were sustained 1 year post-baseline assessment. Results indicate that post-intervention improvements in child conduct problems, parenting behaviour and parental mental health were maintained. Service use and associated costs continued to decline. The results indicate that parent-focused interventions, implemented in the early years, can result in improvements in child and parent behaviour and well-being 12 months later. A reduced reliance on formal services is also indicated.

  18. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

    PubMed

    Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

    2016-05-01

    Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414).

  19. A smartphone application to support recovery from alcoholism: A randomized controlled trial

    PubMed Central

    Gustafson, David H.; McTavish, Fiona M.; Chih, Ming-Yuan; Atwood, Amy K.; A. Johnson, Roberta; G. Boyle, Michael; S. Levy, Michael; Driscoll, Hilary; M. Chisholm, Steven; Dillenburg, Lisa; Isham, Andrew; Shah, Dhavan

    2014-01-01

    Importance: Patients leaving treatment for alcohol-use disorders (AUDs) are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. Objective: To determine whether patients leaving residential treatment for AUDs with a smartphone application to support recovery have fewer risky drinking days than control-group patients. Design: An un-blinded randomized controlled trial. Patients were randomized to treatment as usual or treatment as usual plus a smartphone with A-CHESS, an application designed to improve continuing care for AUDs. “A-CHESS” stands for Addiction – Comprehensive Health Enhancement Support System. Setting: Three residential programs operated by one treatment organization in the Midwestern US and 2 residential programs operated by one organization in the Northeastern US. Participants: 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment. 179 were randomized to the control group and 170 to the treatment group. Intervention: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention lasted 8 months and the follow-up period lasted 4 months. Main Outcome Measure: Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded, for men, 4 standard drinks and for women, 3 standard drinks. Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. Results: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days

  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. Cutting-Balloon Angioplasty Versus Balloon Angioplasty as Treatment for Short Atherosclerotic Lesions in the Superficial Femoral Artery: Randomized Controlled Trial

    SciTech Connect

    Poncyljusz, Wojciech Falkowski, Aleksander; Safranow, Krzysztof Rac, Monika; Zawierucha, Dariusz

    2013-12-15

    Purpose: To evaluate the treatments of a short-segment atherosclerotic stenosis in the superficial femoral arteries with the cutting balloon angioplasty (CBA) versus conventional balloon angioplasty [percutaneous transluminal angioplasty (PTA)] in a randomized controlled trial. Material and Methods: The study group comprised 60 patients (33 men, 27 women; average age 64 years) with a short ({<=}5 cm) focal SFA de novo atherosclerotic stenosis associated with a history of intermittent claudication or rest pain. The primary end point of this study was the rate of binary restenosis in the treated segment 12 months after the intervention. All patients were evenly randomized to either the PTA or CBA treatment arms. Follow-up angiograms and ankle-brachial index (ABI) measurements were performed after 12 months. The evaluation of the restenosis rates and factors influencing its occurrence were calculated by logistic regression analysis. Results: In the intention-to-treat analysis, restenosis rates after 2-month follow-up were 9 of 30 (30 %) in the PTA group and 4 of 30 (13 %) in the CBA group (p = 0.117). In the actual treatment analysis, after exclusion of patients who required nitinol stent placement for a suboptimal result after angioplasty alone (5 patients in the PTA group and none in the CBA group), restenosis rates were 9 of 25 (36 %) and 4 of 30 (13 %), respectively (p = 0.049). In the intention-to-treat analysis there were also significant differences in ABI values between the PTA and CBA groups at 0.77 {+-} 0.11 versus 0.82 {+-} 0.12, respectively (p = 0.039), at 12 months. Conclusion: Based on the presented results of the trial, CBA seems to be a safer and more effective than PTA for treatment of short atherosclerotic lesions in the superior femoral artery.

  2. Dairy consumption and cardiometabolic health: outcomes of a 12-month crossover trial

    PubMed Central

    2012-01-01

    Background A growing body of research suggests that regular consumption of dairy foods may counteract obesity and other components of the metabolic syndrome. However, human intervention trials are lacking. We aimed to determine the cardiometabolic health effects of increasing the consumption of reduced fat dairy foods in adults with habitually low dairy intakes in the absence of energy restriction. Methods An intervention trial was undertaken in 61 overweight or obese adults who were randomly assigned to a high dairy diet (HD, 4 serves of reduced fat dairy/day) or a low dairy control diet (LD, ≤1 serve/day) for 6 months then crossed over to the alternate diet for a further 6 months. A range of anthropometric and cardiometabolic parameters including body composition, metabolic rate, blood lipids, blood pressure and arterial compliance were assessed at the end of each diet phase. Results Total energy intake was 1120 kJ/day higher during the HD phase, resulting in slight weight gain during this period. However, there were no significant differences between HD and LD in absolute measures of waist circumference, body weight, fat mass or any other cardiometabolic parameter. Conclusion Recommended intakes of reduced fat dairy products may be incorporated into the diet of overweight adults without adversely affecting markers of cardiometabolic health. Trial Registration The trial was registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12608000538347) on 24th October, 2008. PMID:22433747

  3. Using Community Health Workers to Improve Clinical Outcomes Among People Living with HIV: A Randomized Controlled Trial

    PubMed Central

    Jones, Jamal; Arheart, Kristopher; Kobetz, Erin; Chida, Natasha; Baer, Shelly; Powell, Alexis; Symes, Stephen; Hunte, Tai; Monroe, Anne; Carrasquillo, Olveen

    2014-01-01

    AIDS-related mortality remains a leading cause of preventable death among African-Americans. We sought to determine if community health workers could improve clinical outcomes among vulnerable African-Americans living with HIV in Miami, Florida. We recruited 91 medically indigent persons with HIV viral loads ≥1,000 and/or a CD4 cell count ≤350. Patients were randomized to a community health worker (CHW) intervention or control group. Viral load and CD4 cell count data were abstracted from electronic medical records. At 12 months, the mean VL in the intervention group was log 0.9 copies/μL lower than the control group. The CD4 counts were not significantly different among the groups. Compared to the control group, patients randomized to CHWs experienced statistically significant improvements in HIV viral load. Larger multi-site studies of longer duration are needed to determine whether CHWs should be incorporated into standard treatment models for vulnerable populations living with HIV. PMID:23515640

  4. An Internet-based program for depressive symptoms using human and automated support: a randomized controlled trial

    PubMed Central

    Mira, Adriana; Bretón-López, Juana; García-Palacios, Azucena; Quero, Soledad; Baños, Rosa María; Botella, Cristina

    2017-01-01

    Purpose The purpose of this study was to analyze the efficacy of an Internet-based program for depressive symptoms using automated support by information and communication technologies (ICTs) and human support. Patients and methods An Internet-based program was used to teach adaptive ways to cope with depressive symptoms and daily problems. A total of 124 participants who were experiencing at least one stressful event that caused interference in their lives, many of whom had clinically significant depressive symptoms, were randomly assigned into either an intervention group with ICT support (automated mobile phone messages, automated emails, and continued feedback through the program); an intervention group with ICT support plus human support (brief weekly support phone call without clinical content); or a waiting-list control. At pre-, post-, and 12-month follow-up, they completed depression, anxiety, positive and negative effect, and perceived stress measures. Results were analyzed using both intention-to-treat and completers data. The majority were women (67.7%), with a mean age of 35.6 years (standard deviation =9.7). Results The analysis showed that the two intervention groups improved significantly pre- to posttreatment, compared with the control group. Furthermore, improvements were maintained at the 12-month follow-up. Adherence and satisfaction with the program was high in both conditions. Conclusion The Internet-based program was effective and well accepted, with and without human support, showing that ICT-based automated support may be useful. It is essential to continue to study other ICT strategies for providing support.

  5. Emergency Department–Based Brief Intervention to Reduce Risky Driving and Hazardous/Harmful Drinking in Young Adults: A Randomized Controlled Trial

    PubMed Central

    Sommers, Marilyn S.; Lyons, Michael S.; Fargo, Jamison D.; Sommers, Benjamin D.; McDonald, Catherine C.; Shope, Jean T.; Fleming, Michael F.

    2014-01-01

    Background Risky driving and hazardous drinking are associated with significant human and economic costs. Brief interventions for more than one risky behavior have the potential to reduce health-compromising behaviors in populations with multiple risk-taking behaviors such as young adults. Emergency department (ED) visits provide a window of opportunity for interventions meant to reduce both risky driving and hazardous drinking. Methods We determined the efficacy of a Screening, Brief Intervention, and Referral to Treatment (SBIRT) protocol addressing risky driving and hazardous drinking. We used a randomized controlled trial design with follow-ups through 12 months. ED patients aged 18 to 44 who screened positive for both behaviors (n = 476) were randomized to brief intervention (BIG), contact control (CCG), or no-contact control (NCG) groups. The BIG (n = 150) received a 20-minute assessment and two 20-minute interventions. The CCG (n = 162) received a 20-minute assessment at baseline and no intervention. The NCG (n = 164) were asked for contact information at baseline and had no assessment or intervention. Outcomes at 3, 6, 9, and 12 months were self-reported driving behaviors and alcohol consumption. Results Outcomes were significantly lower in BIG compared with CCG through 6 or 9 months, but not at 12 months: Safety belt use at 3 months (adjusted odds ratio [AOR], 0.22; 95% confidence interval [CI], 0.08 to 0.65); 6 months (AOR, 0.13; 95% CI, 0.04 to 0.42); and 9 months (AOR, 0.18; 95% CI, 0.06 to 0.56); binge drinking at 3 months (adjusted rate ratio [ARR] 0.84; 95% CI, 0.74 to 0.97) and 6 months (ARR, 0.81; 95% CI, 0.67 to 0.97); and ≥ 5 standard drinks/d at 3 months (AOR, 0.43; 95% CI, 0.20 to 0.91) and 6 months (AOR, 0.41; 95% CI, 0.17 to 0.98). No substantial differences were observed between BIG and NCG at 12 months. Conclusions Our findings indicate that SBIRT reduced risky driving and hazardous drinking in young adults, but its effects did not

  6. 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.

  7. 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…

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

    NASA Technical Reports Server (NTRS)

    Perlmutter, M.

    1974-01-01

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

  9. Three-dimensional analysis of cranial growth from 6 to 12 months of age.

    PubMed

    Meyer-Marcotty, P; Böhm, H; Linz, C; Kochel, J; Stellzig-Eisenhauer, A; Schweitzer, T

    2014-10-01

    The aim of this study was to generate three-dimensional data of the physiological growth of the infant's cranium in the significant growth phase from 6 to 12 months of age. In a longitudinal observational study non-invasive 3D data using an optical surface scanner were generated of the entire head of 52 Caucasian infants (27 females and 25 males) between the ages of 6 (T1) and 12 (T2) months. The circumference of the head increased by 6.51 per cent (from 43.50 to 46.33cm). Analysis of width and length showed that the head grows 2.84 per cent more in length, resulting in a decrease in the cranial index of 2.52 per cent (from 83.87 to 81.76 per cent). The highest increment observed was in the total volume of the cranium, with an increase of 18.76 per cent (from 1229.01 to 1459.57cm(3)). Comparison of the left and right sides of the head by measuring the diagonal symmetry difference showed a difference of only 0.37cm. Overall, the symmetry-related parameters showed an almost symmetric development of the cranium in infants. The findings should provide valuable information on physiological growth and development of the infant's cranium. Therefore the high growth rate of the cranium in the first year of life suggests that this period is a critical period in which the disruption of developmental processes may have long-lasting effects on the morphology of the cranium with a prognostically unfavourable effect of the further growth of the viscerocranium.

  10. Beneficial effects of multisensory and cognitive stimulation in institutionalized elderly: 12-months follow-up.

    PubMed

    de Macedo, Liliane Dias E Dias; De Oliveira, Thaís Cristina Galdino; Soares, Fernanda Cabral; Bento-Torres, João; Bento-Torres, Natáli Valim Oliver; Anthony, Daniel Clive; Picanço-Diniz, Cristovam Wanderley

    2015-01-01

    We previously demonstrated the beneficial effects of a multisensory and cognitive stimulation program, consisting of 48 sessions, twice a week, to improve the cognition of elderly subjects living either in long-term care institutions (institutionalized - I) or in communities with their families (noninstitutionalized - NI). In the present study, we evaluated these subjects after the end of the intervention and compared the rate of age-related cognitive decline of those living in an enriched community environment (NI group, n=15, 74.1±3.9 years old) with those living in the impoverished environment of long-term care institutions (I group, n=20, 75.1±6.8 years old). Both groups participated fully in our stimulation program. Over 1 year, we conducted revaluations at five time points (2 months, 4 months, 6 months, 8 months, and 12 months) after the completion of the intervention. Both elderly groups were evaluated with the mini-mental state examination and selected language tests. Progressive cognitive decline was observed in both groups over the period. Indeed, it took only 4-6 months after the end of the stimulation program for significant reductions in language test scores to become apparent. However, earlier reductions in test scores were mainly associated with I group, and linguistic prosody test scores were significantly affected by institutionalization and time, two variables that interacted and reduced these scores. Moreover, I group reduced the Montréal cognitive assessment battery language tests scores 4 months before NI group. It remains to be investigated what mechanisms may explain the earlier and more intense language losses in institutionalized elderly.

  11. Beneficial effects of multisensory and cognitive stimulation in institutionalized elderly: 12-months follow-up

    PubMed Central

    Dias E Dias de Macedo, Liliane; De Oliveira, Thaís Cristina Galdino; Soares, Fernanda Cabral; Bento-Torres, João; Bento-Torres, Natáli Valim Oliver; Anthony, Daniel Clive; Picanço-Diniz, Cristovam Wanderley

    2015-01-01

    We previously demonstrated the beneficial effects of a multisensory and cognitive stimulation program, consisting of 48 sessions, twice a week, to improve the cognition of elderly subjects living either in long-term care institutions (institutionalized – I) or in communities with their families (noninstitutionalized – NI). In the present study, we evaluated these subjects after the end of the intervention and compared the rate of age-related cognitive decline of those living in an enriched community environment (NI group, n=15, 74.1±3.9 years old) with those living in the impoverished environment of long-term care institutions (I group, n=20, 75.1±6.8 years old). Both groups participated fully in our stimulation program. Over 1 year, we conducted revaluations at five time points (2 months, 4 months, 6 months, 8 months, and 12 months) after the completion of the intervention. Both elderly groups were evaluated with the mini-mental state examination and selected language tests. Progressive cognitive decline was observed in both groups over the period. Indeed, it took only 4–6 months after the end of the stimulation program for significant reductions in language test scores to become apparent. However, earlier reductions in test scores were mainly associated with I group, and linguistic prosody test scores were significantly affected by institutionalization and time, two variables that interacted and reduced these scores. Moreover, I group reduced the Montréal cognitive assessment battery language tests scores 4 months before NI group. It remains to be investigated what mechanisms may explain the earlier and more intense language losses in institutionalized elderly. PMID:26316730

  12. Outcome of anthroposophic medication therapy in chronic disease: A 12-month prospective cohort study

    PubMed Central

    Hamre, Harald J; Witt, Claudia M; Glockmann, Anja; Ziegler, Renatus; Kienle, Gunver S; Willich, Stefan N; Kiene, Helmut

    2008-01-01

    Background Anthroposophic medications (AMED) are prescribed in 56 countries. Objective To study clinical outcomes in patients prescribed AMED for chronic disease. Design Prospective cohort study. Setting 110 medical practices in Germany. Participants 665 consecutive outpatients aged 1–71 years, prescribed AMED for mental, respiratory, musculoskeletal, neurological, genitourinary, and other chronic diseases. Main outcomes Disease and Symptom Scores (physicians’ and patients’ assessment, 0–10) and SF-36. Results During the first six months, an average of 1.5 AMED per patient was used, in total 652 different AMED. Origin of AMED was mineral (8.0% of 652 AMED), botanical (39.0%), zoological (7.2%), chemically defined (13.0%), and mixed (33.0%). From baseline to six-month-follow-up, all outcomes improved significantly: Disease Score improved by mean 3.15 points (95% confidence interval 2.97–3.34, p < 0.001), Symptom Score by 2.43 points (2.23–2.63, p < 0.001), SF-36 Physical Component Summary by 3.04 points (2.16–3.91, p < 0.001), and SF-36 Mental Component Summary by 5.75 points (4.59–6.92, p < 0.001). All improvements were maintained at 12-month follow-up. Improvements were similar in adult men and women, in children, and in patients not using adjunctive therapies. Conclusion Outpatients using AMED for chronic disease had long-term reduction of disease severity and improvement of quality of life. PMID:19920891

  13. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    PubMed Central

    2012-01-01

    Background Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID) consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value < 0.05 was considered statistically significant. Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I

  14. Is there a role of pulsed electromagnetic fields in management of patellofemoral pain syndrome? Randomized controlled study at one year follow-up.

    PubMed

    Servodio Iammarrone, Clemente; Cadossi, Matteo; Sambri, Andrea; Grosso, Eugenio; Corrado, Bruno; Servodio Iammarrone, Fernanda

    2016-02-01

    Patellofemoral pain syndrome (PFPS) is a common cause of recurrent or chronic knee pain in young adults, generally located in the retropatellar region. Etiology is controversial and includes several factors, such as anatomical defects, muscular imbalance, or joint overuse. Good results have been reported with exercise therapy, including home exercise program (HEP). Joint inflammation with increase of pro-inflammatory cytokines levels in the synovial fluid might be seen especially when chondromalacia becomes evident. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has shown anti-inflammatory effects and anabolic chondrocyte activity. The purpose of this randomized controlled study was to evaluate if the combination of HEP with PEMFs was more effective than HEP alone in PFPS treatment. Thirty-one PFPS patients were enrolled in this study. All patients were instructed to train with HEP. Patients in the PEMFs group associated HEP with PEMFs. Function and pain were assessed with Victorian Institute of Sport Assessment score (VISA), Visual Analog Scale (VAS), and Feller's Patella Score at baseline at 2, 6, and 12 months of follow-up. Drug assumption was also recorded. Increase in VISA score was significantly higher in PEMFs group compared to controls at 6 and 12 months, as well as the increase in the Feller's Patella Score at 12 months. VAS score became significantly lower in the PEMFs group with respect to control group since 6 month follow-up. Pain reduction obtained with PEMFs enhanced practicing therapeutic exercises leading to a better recovery process; this is extremely important in addressing the expectations of young patients, who wish to return to sporting activities.

  15. Validity of 12-Month Falls Recall in Community-Dwelling Older Women Participating in a Clinical Trial.

    PubMed

    Sanders, Kerrie M; Stuart, Amanda L; Scott, David; Kotowicz, Mark A; Nicholson, Geoff C

    2015-01-01

    Objectives. To compare 12-month falls recall with falls reported prospectively on daily falls calendars in a clinical trial of women aged ≥70 years. Methods. 2,096 community-dwelling women at high risk of falls and/or fracture completed a daily falls calendar and standardised interviews when falls were recorded, for 12 months. Data were compared to a 12-month falls recall question that categorised falls status as "no falls," "a few times," "several," and "regular" falls. Results. 898 (43%) participants reported a fall on daily falls calendars of whom 692 (77%) recalled fall(s) at 12 months. Participants who did not recall a fall were older (median 79.3 years versus 77.8 years, P = 0.028). Smaller proportions of fallers who sustained an injury or accessed health care failed to recall a fall (all P < 0.04). Among participants who recalled "no fall," 85% reported zero falls on daily calendars. Few women selected falls categories of "several times" or "regular" (4.1% and 0.4%, resp.) and the sensitivity of these categories was low (30% to 33%). Simply categorising participants into fallers or nonfallers had 77% sensitivity and 94% specificity. Conclusion. For studies where intensive ascertainment of falls is not feasible, 12-month falls recall questions with fewer responses may be an acceptable alternative.

  16. Finasteride in the treatment of Taiwanese men with androgenetic alopecia: a 12-month open-label study.

    PubMed

    Lin, Jeng-Hsien; Chen, Wen-Chieh

    2002-08-01

    Finasteride 1 mg/day is effective in the treatment of androgenetic alopecia (AGA). Our open-label study assessed the efficacy and safety of finasteride for the treatment of Taiwanese men with AGA. We enrolled 34 Taiwanese men (aged 18-40 yr) with AGA of modified Norwood/Hamilton scale (MNHS) grade II-V. In investigator assessments at 12 months, five of 21 subjects (23.8%) had two-grade improvement in MNHS grade and 12 of 21 subjects (57.1%) had one-grade improvement; the others remained at the same grade. In global photographic evaluation, five of 31 subjects (15.1%) had observable hair growth at 6 months and 11 of 21 subjects (52.4%) had observable hair growth at 12 months. Patient self-assessment of hair growth was favorable across all questions in the treatment course, more significantly at 12 months than at 6 months; nine of 21 subjects (42.9%) were satisfied with their overall appearance at 12 months. Serum prostate specific antigen levels had decreased by 23.4% at 12 months. Adverse effects, including abnormal liver function (5/34), were minimal, and the causal relationship with finasteride could not be established. Thus, in Taiwanese men with AGA, finasteride 1 mg/day for 1 year slowed the progression of hair loss and increased hair growth.

  17. A Randomized Controlled Trial Comparing Suture-Fixation Mucopexy and Doppler-Guided Hemorrhoidal Artery Ligation in Patients with Grade III Hemorrhoids

    PubMed Central

    Zhai, Min; Zhang, Yong-An; Wang, Zhen-Yi; Sun, Jian-Hua; Wen, Jie; Zhang, Qi; Li, Jin-De; Wu, Yi-Zheng; Zhou, Feng; Xu, Hui-Lei

    2016-01-01

    Background. We aimed to evaluate the effectiveness of a suture-fixation mucopexy procedure by comparing with Doppler-guided hemorrhoidal artery ligation (DGHAL) in the management of patients with grade III hemorrhoids. Methods. This was a randomized controlled trial. One hundred patients with grade III hemorrhoids were randomly assigned to receive suture-fixation mucopexy (n = 50) or DGHAL (n = 50). Outcome assessments were performed at 2 weeks, 12 months, and 24 months. Assessments included resolution of clinical symptoms, postoperative complications, duration of hospitalization, and total costs. Results. At 2 weeks, one (2%) patient in suture-fixation group and four (8%) patients in DGHAL group had persistent prolapsing hemorrhoids. Postoperative bleeding was observed in two patients (4%) in suture-fixation group and one patient in DGHAL group. There was no significant difference in short-term recurrence between groups. Postoperative complications and duration of hospitalization were comparable between the two groups. Rates of recurrence of prolapse or bleeding at 12 months did not differ between groups. However, recurrence of prolapse at 24 months was significantly more common in DGHAL group (19.0% versus 2.3%, p = 0.030). Conclusions. Compared with DGHAL, the suture-fixation mucopexy technique had comparable short-term outcomes and favorable long-term outcomes. PMID:27066071

  18. The effects of office ergonomic training on musculoskeletal complaints, sickness absence, and psychological well-being: a cluster randomized control trial.

    PubMed

    Mahmud, Norashikin; Kenny, Dianna T; Md Zein, Raemy; Hassan, Siti Nurani

    2015-03-01

    This study explored whether musculoskeletal complaints can be reduced by the provision of ergonomics education. A cluster randomized controlled trial study was conducted in which 3 units were randomized to intervention and received training and 3 units were given a leaflet. The effect of intervention on knowledge, workstation practices, musculoskeletal complaints, sickness absence, and psychological well-being were assessed at 6 and 12 months. Although there was no increment of knowledge among workers, significant improvements in workstation practices in the use of monitor, keyboard, and chair were observed. There were significant reductions in neck and upper and lower back complaints among workers but these did not translate into fewer days lost from work. Workers' stress was found to be significantly reduced across the studies. In conclusion, office ergonomics training can be beneficial in reducing musculoskeletal risks and stress among workers.

  19. Effects of computer training and Internet usage on the well-being and quality of life of older adults: a randomized, controlled study.

    PubMed

    Slegers, Karin; van Boxtel, Martin P J; Jolles, Jelle

    2008-05-01

    The quality of life of older adults may be improved by the use of computer or Web-based services. A limited number of experimental studies on this topic have shown mixed results. We carried out a randomized, controlled intervention study that aimed to examine the causal relationship between computer use and measures of physical well-being, social well-being, emotional well-being, development and activity, and autonomy. We randomly assigned a group of 191 participants to an intervention group, a training-no intervention group, or a no training-no intervention group. A fourth group consisted of 45 participants with no interest in computer use. We collected data at baseline, after 4 months, and after 12 months. The results showed that using computers and the Internet neither positively nor negatively influenced everyday functioning, well-being and mood, and the social network of healthy older individuals. We discuss possibilities for future studies.

  20. Efficacy, Safety and Cost of Insecticide Treated Wall Lining, Insecticide Treated Bed Nets and Indoor Wall Wash with Lime for Visceral Leishmaniasis Vector Control in the Indian Sub-continent: A Multi-country Cluster Randomized Controlled Trial

    PubMed Central

    Das, Pradeep; Ghosh, Debashis; Priyanka, Jyoti; Matlashewski, Greg; Kroeger, Axel; Upfill-Brown, Alexander

    2016-01-01

    Background We investigated the efficacy, safety and cost of lime wash of household walls plus treatment of sand fly breeding places with bleach (i.e. environmental management or EM), insecticide impregnated durable wall lining (DWL), and bed net impregnation with slow release insecticide (ITN) for sand fly control in the Indian sub-continent. Methods This multi-country cluster randomized controlled trial had 24 clusters in each three sites with eight clusters per high, medium or low sand fly density stratum. Every cluster included 45–50 households. Five households from each cluster were randomly selected for entomological measurements including sand fly density and mortality at one, three, nine and twelve months post intervention. Household interviews were conducted for socioeconomic information and intervention acceptability assessment. Cost for each intervention was calculated. There was a control group without intervention. Findings Sand fly mortality [mean and 95%CI] ranged from 84% (81%-87%) at one month to 74% (71%-78%) at 12 months for DWL, 75% (71%-79%) at one month to 49% (43%-55%) at twelve months for ITN, and 44% (34%-53%) at one month to 22% (14%-29%) at twelve months for EM. Adjusted intervention effect on sand fly density measured by incidence rate ratio ranged from 0.28 (0.23–0.34) at one month to 0.62 (0.51–0.75) at 12 months for DWL; 0.72 (0.62–0.85) at one month to 1.02 (0.86–1.22) at 12 months for ITN; and 0.89 (0.76–1.03) at one months to 1.49 (1.26–1.74) at 12 months for EM. Household acceptance of EM was 74% compared to 94% for both DWL and ITN. Operational cost per household in USD was about 5, 8, and 2 for EM, DWL and ITN, respectively. Minimal adverse reactions were reported for EM and ITN while 36% of households with DWL reported transient itching. Interpretation DWL is the most effective, durable and acceptable control method followed by ITN. The Visceral Leishmaniasis (VL) Elimination Program in the Indian sub

  1. Analysis of correlation between initial alveolar bone density and apical root resorption after 12 months of orthodontic treatment without extraction

    PubMed Central

    Scheibel, Paula Cabrini; Ramos, Adilson Luiz; Iwaki, Lilian Cristina Vessoni; Micheletti, Kelly Regina

    2014-01-01

    OBJECTIVE: The aim of the present study was to investigate the correlation between initial alveolar bone density of upper central incisors (ABD-UI) and external apical root resorption (EARR) after 12 months of orthodontic movement in cases without extraction. METHODS: A total of 47 orthodontic patients 11 years old or older were submitted to periapical radiography of upper incisors prior to treatment (T1) and after 12 months of treatment (T2). ABD-UI and EARR were measured by means of densitometry. RESULTS: No statistically significant correlation was found between initial ABD-UI and EARR at T2 (r = 0.149; p = 0.157). CONCLUSION: Based on the present findings, alveolar density assessed through periapical radiography is not predictive of root resorption after 12 months of orthodontic treatment in cases without extraction. PMID:25715722

  2. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial

    PubMed Central

    Robinson, Robert G.; Jorge, Ricardo E.; Moser, David J.; Acion, Laura; Solodkin, Ana; Small, Steven L.; Fonzetti, Pasquale; Hegel, Mark; Arndt, Stephan

    2009-01-01

    Context Depression occurs in more than half of patients who have experienced a stroke. Poststroke depression has been shown in numerous studies to be associated with both impaired recovery in activities of daily living and increased mortality. Prevention of depression thus represents a potentially important goal. Objective To determine whether treatment with escitalopram or problem-solving therapy over the first year following acute stroke will decrease the number of depression cases that develop compared with placebo medication. Design, Setting, and Participants A multisite randomized controlled trial for prevention of depression among 176 nondepressed patients was conducted within 3 months following acute stroke from July 9, 2003, to October 1, 2007. The 12-month trial included 3 groups: a double-blind placebo-controlled comparison of escitalopram (n=59) with placebo (n=58), and a nonblinded problem-solving therapy group (n=59). Main Outcome Measures The main outcome measure was the development of major or minor poststroke depression based on symptoms elicited by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the diagnostic criteria from DSM-IV for depression due to stroke with major depressivelike episode or minor depression (ie, research criteria). Results Patients who received placebo were significantly more likely to develop depression than individuals who received escitalopram (11 major and 2 minor cases of depression [22.4%] vs 3 major and 2 min or cases of depression [8.5%], adjusted hazard ratio [HR], 4.5; 95% confidence interval [CI], 2.4–8.2; P<.001) and also more likely than individuals who received problem-solving therapy (5 major and 2 minor cases of depression [11.9%], adjusted HR, 2.2; 95% CI, 1.4–3.5; P<.001). These results were adjusted for history of mood disorders and remained significant after considering possible confounders such as age, sex, treatment site

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

    PubMed Central

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

    2015-01-01

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

  4. Randomized controlled trial to test a computerized psychosocial cancer assessment and referral program: methods and research design.

    PubMed

    O'Hea, Erin L; Cutillo, Alexandra; Dietzen, Laura; Harralson, Tina; Grissom, Grant; Person, Sharina; Boudreaux, Edwin D

    2013-05-01

    The National Cancer Coalition Network, National Cancer Institute, and American College of Surgeons all emphasize the need for oncology providers to identify, address, and monitor psychosocial needs of their patients. The Mental Health Assessment and Dynamic Referral for Oncology (MHADRO) is a patient-driven, computerized, psychosocial assessment that identifies, addresses, and monitors physical, psychological, and social issues faced by oncology patients. This paper presents the methodology of a randomized controlled trial (RCT) that tested the impact of the MHADRO on patient outcomes at 2, 6, and 12 months. Patient outcomes including overall psychological distress, depression, anxiety, functional disability, and use of psychosocial resources will be presented in future publications after all follow-up data is gathered. Eight hundred and thirty six cancer patients with heterogeneous diagnoses, across three comprehensive cancer centers in different parts of the United States, were randomized to the MHADRO (intervention) or an assessment-only control group. Patients in the intervention group were provided detailed, personalized reports and, when needed, referrals to mental health services; their oncology provider received detailed reports designed to foster clinical decision making. Those patients who demonstrated high levels of psychosocial problems were given the option to authorize that a copy of their report be sent electronically to a "best match" mental health professional. Demographic and patient cancer-related data as well as comparisons between patients who were enrolled and those who declined enrollment are presented. Challenges encountered during the RCT and strategies used to address them are discussed.

  5. Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Lack of adherence to recommended treatment for obstructive sleep apnea remains an ongoing public health challenge. Despite evidence that continuous positive airway pressure (CPAP) is effective and improves overall quality of life, adherence with the use of CPAP in certain racial/ethnic groups, especially blacks, is suboptimal. Evidence indicates that the incidence and prevalence of obstructive sleep apnea are higher among blacks, relative to whites, and blacks are less likely to adhere to recommended treatment compared with other racial/ethnic groups. Methods Using a two-arm randomized controlled design, this study will evaluate the effectiveness of a culturally and linguistically tailored telephone-delivered intervention to promote adherence to physician-recommended sleep apnea assessment and treatment among blacks with metabolic syndrome, versus an attention-control arm. The intervention is designed to foster adherence to recommended sleep apnea care using the stages-of-change model. The intervention will be delivered entirely over the telephone. Participants in the intervention arm will receive 10 phone calls to address challenges and barriers to recommended care. Outcomes will be assessed at baseline, and at 6- and 12-months post-randomization. Discussion This tailored behavioral intervention will improve adherence to sleep apnea assessment and treatment among blacks with metabolic syndrome. We expect to demonstrate that this intervention modality is feasible in terms of time and cost and can be replicated in populations with similar racial/ethnic backgrounds. Trial registration The study is registered at clinicaltrials.gov NCT01946659 (February 2013) PMID:24925227

  6. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    PubMed Central

    Stegink-Jansen, Caroline W.

    2015-01-01

    Introduction. Patients with chronic lateral elbow (LE) tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1) to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE) for patients with chronic LE tendinopathy, and (2) to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment. Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities. Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows) were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows) or EE treatment (56 elbows). Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments. Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047) and in maximum grip strength (p = 0.008) than EE subjects. Astym therapy also resolved 20/21 (95.7%) of the EE non-responders, who showed improvements in DASH scores (p < 0.005), pain with activity (p = 0.002), and function (p = 0.004) following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported. Conclusion. This study

  7. Web-based acceptance and commitment therapy for depressive symptoms with minimal support: a randomized controlled trial.

    PubMed

    Lappalainen, Päivi; Langrial, Sitwat; Oinas-Kukkonen, Harri; Tolvanen, Asko; Lappalainen, Raimo

    2015-11-01

    Low-intensity interventions for people suffering from depressive symptoms are highly desirable. The aim of the present study was to investigate the outcomes of a web-based acceptance and commitment therapy (ACT)-based intervention without face-to-face contact for people suffering from depressive symptoms. Participants (N = 39) with depressive symptoms were randomly assigned to an Internet-delivered acceptance and commitment therapy (iACT) intervention or a waiting list control condition (WLC). Participants were evaluated with standardized self-reporting measures (Beck Depression Inventory [BDI-II], Symptom Checklist-90 [SCL-90], Acceptance and Action Questionnaire [AAQ-2], Five Facet Mindfulness Questionnaire [FFMQ], Automatic Thoughts Questionnaire [ATQ], and White Bear Suppression Inventory [WBSI]) at pre- and post-measurement. Long-term effects in the iACT group were examined using a 12-month follow-up. The iACT program comprised home assignments, online feedback given by master's-level students of psychology over a 7-week intervention period, and automated email-based reminders. Significant effects were observed in favor of the iACT group on depression symptomatology (between effect sizes [ESs] at post-treatment, iACT/WLC, g = .83), psychological and physiological symptoms (g = .60), psychological flexibility (g = .67), mindfulness skills (g = .53), and frequency of automatic thoughts (g = .57) as well as thought suppression (g = .53). The treatment effects in the iACT group were maintained over the 12-month follow-up period (within-iACT ES: BDI-II, g = 1.33; SCL-90, g = 1.04; ATQF/B [Frequency/Believability], FFMQ, WBSI, AAQ-II, g = .74-1.08). The iACT participants stated that they would be happy to recommend the same intervention to others with depressive symptoms. We conclude that an ACT-based guided Internet-delivered treatment with minimal contact can be effective for people with depressive symptoms.

  8. A Randomized Controlled Study of Effects of Dietary Magnesium Oxide Supplementation on Bone Mineral Content in Healthy Girls

    PubMed Central

    Carpenter, Thomas O.; DeLucia, Maria C.; Zhang, Jane Hongyuan; Bejnerowicz, Gina; Tartamella, Lisa; Dziura, James; Petersen, Kitt Falk; Befroy, Douglas; Cohen, Dorothy

    2010-01-01

    Context The role of magnesium (Mg) as a determinant of bone mass has not been extensively explored. Limited studies suggest that dietary Mg intake and bone mineral density are correlated in adults, but no data from interventional studies in children and adolescents are available. Objective We sought to determine whether Mg supplementation in periadolescent girls enhances accrual of bone mass. Design We carried out a prospective, placebo-controlled, randomized, one-year double-blind trial of Mg supplementation. Setting The study was conducted in the Clinical Research Centers at Yale University School of Medicine. Patients or Other Participants Healthy 8- to 14-yr-old Caucasian girls were recruited from community pediatricians’ offices. Dietary diaries from over 120 volunteers were analyzed, and those with dietary Mg intake of less than 220 mg/d were invited to participate in the intervention. Intervention Magnesium (300 mg elemental Mg per day in two divided doses) or placebo was given orally for 12 months. Main Outcome Measure The primary outcome measure was interval change in bone mineral content (BMC) of the total hip, femoral neck, Ward’s area, and lumbar spine (L1–L4) after 12 months of Mg supplementation. Results Significantly increased accrual (P = 0.05) in integrated hip BMC occurred in the Mg-supplemented vs. placebo group. Trends for a positive Mg effect were evident in the pre- and early puberty and in mid-late puberty. Lumbar spinal BMC accrual was slightly (but not significantly) greater in the Mg-treated group. Compliance was excellent; 73% of capsules were ingested as inferred by pill counts. Serum mineral levels, calciotropic hormones, and bone markers were similar between groups. Conclusions Oral Mg oxide capsules are safe and well tolerated. A positive effect of Mg supplementation on integrated hip BMC was evident in this small cohort. PMID:17018656

  9. Acupuncture for Dysphagia after Chemoradiation in Head and Neck Cancer: Rationale and Design of a Randomized, Sham-Controlled Trial

    PubMed Central

    Lu, Weidong; Wayne, Peter M.; Davis, Roger B.; Buring, Julie E.; Li, Hailun; Goguen, Laura A.; Rosenthal, David S.; Tishler, Roy B.; Posner, Marshall R.; Haddad, Robert I.

    2012-01-01

    Introduction Dysphagia is a common side effect following chemoradiation therapy (CRT) in head and neck cancer (HNC) patients. Current dysphagia management includes swallowing therapy and dilation procedures, but these treatments have limitations. While acupuncture has been reported to positively impact swallowing function and quality of life (QOL) in patients with dysphagia, current evidence is inconclusive. Material and Methods In an ongoing trial, 42 squamous cell carcinoma HNC patients, who are receiving platinum-based CRT with curative intent, are being recruited from a comprehensive cancer center. They are randomized to 12 sessions of either active acupuncture or to sham acupuncture during and following CRT over a 24-week period. Blinded research staff assesses outcomes at baseline, 20 weeks post-CRT (end of acupuncture), and 12 months after baseline (6-month follow-up). The primary outcome is change in M.D. Anderson Dysphagia Inventory score from baseline to 12 months. Secondary outcomes include QOL measures pertaining to HNC patients. In addition, a subset of study patients are tested for salivary flow rates and cytokines, including plasma transforming growth factor –β1 and interleukin 6 (n=10 per arm), to preliminarily explore the biological mechanisms of acupuncture for dysphagia. Discussion This paper addresses unique challenges related to study design in nonpharmacological, sham-controlled acupuncture trials including development of evidence-based credible verum and sham treatment protocols, blinding, and assuring fidelity of treatment. Results of this study will inform the feasibility of conducting a large scale trial and will provide preliminary evidence regarding the value of acupuncture for dysphagia in HNC patients. PMID:22406102

  10. Balance and Gait Training With Augmented Feedback Improves Balance Confidence in People With Parkinson's Disease: A Randomized Controlled Trial.

    PubMed

    Shen, Xia; Mak, Margaret K Y

    2014-07-01

    Background Fear of falling has been identified as an important and independent fall-risk predictor in patients with Parkinson's disease (PD). However, there are inconsistent findings on the effects of balance and gait training on balance confidence. Objective To explore whether balance and gait training with augmented feedback can enhance balance confidence in PD patients immediately after treatment and at 3- and 12-month follow-ups. Methods A total of 51 PD patients were randomly assigned to a balance and gait training (BAL) group or to an active control (CON) group. The BAL group received balance and gait training with augmented feedback, whereas CON participants received lower-limb strength training for 12 weeks. Outcome measures included Activities-Specific Balance Confidence (ABC) Scale, limits-of-stability test, single-leg-stance test, and spatiotemporal gait characteristics. All tests were administered before intervention (Pre), immediately after training (Post), and at 3 months (Post3m) and 12 months (Post12m) after treatment completion. Results The ABC score improved marginally at Post and significantly at Post3m and Post12m only in the BAL group (P < .017). Both participant groups increased their end point excursion at Post, but only the BAL group maintained the improvement at Post3m. The BAL group maintained significantly longer time-to-loss-of-balance during the single-leg stance test than the CON group at Post3m and Post12m (P < .05). For gait characteristics, both participant groups increased gait velocity, but only the BAL group increased stride length at Post, Post3m, and Post12m (P < .017). Conclusions Positive findings from this study provide evidence that BAL with augmented feedback could enhance balance confidence and balance and gait performance in patients with PD.

  11. Preventing Obesity Among Adolescent Girls: One-Year Outcomes of the Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) Cluster Randomized Controlled Trial.

    PubMed

    Lubans, David R; Morgan, Philip J; Okely, Anthony D; Dewar, Deborah; Collins, Clare E; Batterham, Marijka; Callister, Robin; Plotnikoff, Ronald C

    2012-09-01

    OBJECTIVE To evaluate the impact of a 12-month multicomponent school-based obesity prevention program, Nutrition and Enjoyable Activity for Teen Girls among adolescent girls. DESIGN Group randomized controlled trial with 12-month follow-up. SETTING Twelve secondary schools in low-income communities in the Hunter and Central Coast regions of New South Wales, Australia. PARTICIPANTS Three hundred fifty-seven adolescent girls aged 12 to 14 years. INTERVENTION A multicomponent school-based intervention program tailored for adolescent girls. The intervention was based on social cognitive theory and included teacher professional development, enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity sessions, handbooks and pedometers for self-monitoring, parent newsletters, and text messaging for social support. MAIN OUTCOME MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z score, body fat percentage, physical activity, screen time, dietary intake, and self-esteem. RESULTS After 12 months, changes in BMI (adjusted mean difference, -0.19; 95% CI, -0.70 to 0.33), BMI z score (mean, -0.08; 95% CI, -0.20 to 0.04), and body fat percentage (mean, -1.09; 95% CI, -2.88 to 0.70) were in favor of the intervention, but they were not statistically different from those in the control group. Changes in screen time were statistically significant (mean, -30.67 min/d; 95% CI, -62.43 to -1.06), but there were no group by time effects for physical activity, dietary behavior, or self-esteem. CONCLUSIONS A school-based intervention tailored for adolescent girls from schools located in low-income communities did not significantly reduce BMI gain. However, changes in body composition were of a magnitude similar to previous studies and may be associated with clinically important health outcomes. TRIAL REGISTRATION anzctr.org.au Identifier: 12610000330044.

  12. Storage Life of Fully Compounded Rubber Stocks. Part 2: 12 Months’ Storage Testing. Part 3: Subsequent Ageing Behaviour

    DTIC Science & Technology

    1973-04-01

    AD-AO08 566 STORAGE LIFE OF FULLY COMPOUNDED RUBBER STOCKS. PART 2: 12 MONTHS" STORAGE TESTING. PART 3: SUBSEQUENT AGEING BEHAVIOUR K. J. Ledbury, et...Compounded Rubber Stocks Part 2. 12 Months’ Storage Testing Part 3. Subsequent Ageing Behaviour K. J. Ledbury R. W. Richards A. L. Stokoo April 1973 DDC I...Agency’s 6a.Sponsoring Agency (Contract Authority) me and Location Code (if known) 7. Title 3TORAGE LIFE OF FULLY COMPOUIDED RUBBER STOCKS PART Z: 12

  13. Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.

    PubMed

    Luijsterburg, Pim A J; Verhagen, Arianne P; Ostelo, Raymond W J G; van den Hoogen, Hans J M M; Peul, Wilco C; Avezaat, Cees J J; Koes, Bart W

    2008-04-01

    A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only. To assess the effectiveness of PT additional to general practitioners' care compared to general practitioners' care alone, in patients with acute sciatica. There is a lack of knowledge concerning the effectiveness of PT in patients with sciatica. The primary outcome was patients' global perceived effect (GPE). Secondary outcomes were severity of leg and back pain, severity of disability, general health and absence from work. The outcomes were measured at 3, 6, 12 and 52 weeks after randomisation. At 3 months follow-up, 70% of the intervention group and 62% of the control group reported improvement (RR 1.1; 95% CI 0.9-1.5). At 12 months follow-up, 79% of the intervention group and 56% of the control group reported improvement (RR 1.4; 95% CI 1.1; 1.8). No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up. At 12 months follow-up, evidence was found that PT added to general practitioners' care is only more effective regarding GPE, and not more cost-effective in the treatment of patients with acute sciatica than general practitioners' care alone. There are indications that PT is especially effective regarding GPE in patients reporting severe disability at presentation.

  14. 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

  15. Prediction model for outcome after low-back surgery: individualized likelihood of complication, hospital readmission, return to work, and 12-month improvement in functional disability.

    PubMed

    McGirt, Matthew J; Sivaganesan, Ahilan; Asher, Anthony L; Devin, Clinton J

    2015-12-01

    OBJECT Lumbar spine surgery has been demonstrated to be efficacious for many degenerative spine conditions. However, there is wide variability in outcome after spine surgery at the individual patient level. All stakeholders in spine care will benefit from identification of the unique patient or disease subgroups that are least likely to benefit from surgery, are prone to costly complications, and have increased health care utilization. There remains a large demand for individual patient-level predictive analytics to guide decision support to optimize outcomes at the patient and population levels. METHODS One thousand eight hundred three consecutive patients undergoing spine surgery for various degenerative lumbar diagnoses were prospectively enrolled and followed for 1 year. A comprehensive patient interview and health assessment was performed at baseline and at 3 and 12 months after surgery. All predictive covariates were selected a priori. Eighty percent of the sample was randomly selected for model development, and 20% for model validation. Linear regression was performed with Bayesian model averaging to model 12-month ODI (Oswestry Disability Index). Logistic regression with Bayesian model averaging was used to model likelihood of complications, 30-day readmission, need for inpatient rehabilitation, and return to work. Goodness-of-fit was assessed via R(2) for 12-month ODI and via the c-statistic, area under the receiver operating characteristic curve (AUC), for the categorical endpoints. Discrimination (predictive performance) was assessed, using R(2) for the ODI model and the c-statistic for the categorical endpoint models. Calibration was assessed using a plot of predicted versus observed values for the ODI model and the Hosmer-Lemeshow test for the categorical endpoint models. RESULTS On average, all patient-reported outcomes (PROs) were improved after surgery (ODI baseline vs 12 month: 50.4 vs 29.5%, p < 0.001). Complications occurred in 121 patients (6

  16. 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…

  17. 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…

  18. 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…

  19. 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…

  20. 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…

  1. 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…

  2. 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…

  3. A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial

    PubMed Central

    Dorrestijn, Oscar; Stevens, Martin; Diercks, Ron L; van der Meer, Klaas; Winters, Jan C

    2007-01-01

    Background Subacromial impingement syndrome (SIS) is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT), which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery. Methods/Design The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT). Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group) or continuation of usual medical care (control group). The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses. Discussion The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial impingement syndrome are

  4. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial

    PubMed Central

    2010-01-01

    Background To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. Methods/design The study is a cluster-randomized controlled trial design (randomized at the supervisor level), with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1) changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2) improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3) enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. Discussion The intervention 'Staying healthy at work' has the potential to provide

  5. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.

    PubMed

    Mason, Ashley E; Epel, Elissa S; Kristeller, Jean; Moran, Patricia J; Dallman, Mary; Lustig, Robert H; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A; Hecht, Frederick M; Daubenmier, Jennifer

    2016-04-01

    We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

  6. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial

    PubMed Central

    Epel, Elissa S.; Kristeller, Jean; Moran, Patricia J.; Dallman, Mary; Lustig, Robert H.; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A.; Hecht, Frederick M.; Daubenmier, Jennifer

    2016-01-01

    We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78 % women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels. PMID:26563148

  7. Screening and Brief Interventions for Hazardous and Harmful Alcohol Use among University Students in South Africa: Results from a Randomized Controlled Trial

    PubMed Central

    Pengpid, Supa; Peltzer, Karl; van der Heever, Hendry; Skaal, Linda

    2013-01-01

    The aim of this study was to assess the effectiveness of Screening and Brief Intervention (SBI) for alcohol problems among university students in South Africa. The study design for this efficacy study is a randomized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting. The unit of randomization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus. University students were screened for alcohol problems, and those identified as hazardous or harmful drinkers were randomized into an experimental or control group. The experimental group received one brief counseling session on alcohol risk reduction, while the control group received a health education leaflet. Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 (21.1%) tested positive for the Alcohol Use Disorder Identification Test (AUDIT) (score 8 or more). Among the 147 (96.7%) university students who also attended the 12-month follow-up session, the intervention effect on the AUDIT score was −1.5, which was statistically significant (P = 0.009). Further, the depression scores marginally significantly decreased over time across treatment groups, while other substance use (tobacco and cannabis use), self-rated health status and Posttraumatic Stress Disorder (PTSD) scores did not change over time across treatment groups. The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa. The short duration of the brief intervention makes it a realistic candidate for use in a university setting. PMID:23698697

  8. 12-month intravascular ultrasound observations from BiOSS® first-in-man studies.

    PubMed

    Gil, Robert J; Bil, Jacek; Costa, Ricardo A; Gil, Katarzyna E; Vassiliev, Dobrin

    2016-09-01

    The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The

  9. Northern Eurasia Earth Science Partnership Initiative in the past 12 months: An Update

    NASA Astrophysics Data System (ADS)

    Groisman, Pavel; Lowford, Richard

    2013-04-01

    Eight years ago Northern Eurasia Earth Science Partnership Initiative (NEESPI) was launched with the release of its Science Plan (http://neespi.org). Gradually, the Initiative was joined by numerous international projects launched in EU, Russia, the United States, Canada, Japan, and China. Throughout its duration, NEESPI served and is serving as an umbrella for more than 155 individual international research projects. Currently, the total number of the ongoing NEESPI projects (as on January 2013) is 48 and has changed but slightly compared to its peak (87 in 2008). The past 12 months (from the previous EGU Assembly) were extremely productive in the NEESPI outreach. We organized three Open Science Sessions at the three major Geoscience Unions/Assembly Meetings (JpGU, AGU, and this EGU Session) and three International NEESPI Workshops. The programs of two of these Workshops (in Yoshkar Ola and Irkutsk, Russia) included Summer Schools for early career scientists. More than 150 peer-reviewed papers, books, and/or book chapters were published in 2012 or are in press (this list was still incomplete at the time of preparation of this abstract). In particular, a suite of 25 peer-reviewed NEESPI articles was published in the Forth Special NEESPI Issue of "Environmental Research Letters" (ERL) http://iopscience.iop.org/1748-9326/focus/NEESPI3 (this is the third ERL Issue). In December 2012, the next Special ERL NEESPI Issue was launched http://iopscience.iop.org/1748-9326/focus/NEESPI4. Northern Eurasia is a large study domain. Therefore, it was decided to describe the latest findings related to its environmental changes in several regional monographs in English. Three books on Environmental Changes in the NEESPI domain were published by the University of Helsinki (Groisman et al. 2012), "Akademperiodyka" (Groisman and Lyalko 2012), and Springer Publishing House (Groisman and Gutman 2013) being devoted to the high latitudes of Eurasia, to Eastern Europe, and to Siberia

  10. 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

  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. 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

  13. 77 FR 57921 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List 14 Aquatic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-18

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the basalt juga (Juga new species (n. sp.) 2), canary duskysnail (Colligyrus convexus), cinnamon juga (Juga n. sp. 3), Columbia duskysnail (Colligyrus n. sp. 1), Fredenburg pebblesnail (Fluminicola n. sp. 11), Goose Valley pebblesnail (Fluminicola anserinus), Hat Creek pebblesnail (Fluminicola......

  14. 12-Month and Lifetime Prevalence of Suicide Attempts among Black Adolescents in the National Survey of American Life

    ERIC Educational Resources Information Center

    Joe, Sean; Baser, Raymond S.; Neighbors, Harold W.; Caldwell, Cleopatra H.; Jackson, James S.

    2009-01-01

    The data from the National Survey of American life on the suicidal behavior of 1,170 African American and Caribbean black adolescents aged 13 to 17 shows that black adolescents report having a lifetime prevalence of 7.5 percent for suicidal ideation and 2.7 percent for attempts. The 12-month prevalence of suicidal ideation is 3.2 percent and…

  15. 77 FR 52650 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Platte...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Platte River caddisfly (Ironoquia plattensis) as an endangered or threatened species and to designate critical habitat under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that listing the Platte River caddisfly as......

  16. Correlation of serum KL-6 and CC16 levels with neurodevelopmental outcome in premature infants at 12 months corrected age

    PubMed Central

    Zhang, Zhiqun; Lu, Hui; Zhu, Yunxia; Xiang, Junhua; Huang, Xianmei

    2015-01-01

    The aim of this study was to evaluate KL-6 and CC16 levels and their correlation with neurodevelopmental outcome among very low birth weight pre-term infants at 12 months corrected age. This prospective cohort study was performed from 2011 to 2013 by enrolling pre-term neonates of gestational age ≤ 32 weeks and birth weight ≤ 1500 g. Serum KL-6 and CC16 levels were determined 7 days after birth and their correlation with neurodevelopment was evaluated using Gesell Mental Developmental Scales. Of the 86 eligible pre-term infants, 63 completed follow-up, of which 15 had bronchopulmonary dysplasia. At 12 months corrected age, 49 infants had favorable outcomes and 14 infants had poor neurodevelopmental outcome. KL-6 levels were higher and CC16 levels were lower in infants with poor neurodevelopmental outcome compared with those infants who had favourable neurodevelopmental outcome. Serum KL-6 levels less than 90.0 ng/ml and CC16 levels greater than 320.0 pg/ml at 7 days of life were found to be predictive of a favourable outcome at 12 months corrected age. These biological markers could predict neurodevelopmental outcome at 12 months corrected age in very low birth weight premature infants, and help the clinician plan early therapeutic interventions to minimize or avoid poor neurodevelopmental outcome. PMID:25631862

  17. Iron deficiency anemia among Jewish and Arab infants at 6 and 12 months of age in Hadera, Israel.

    PubMed

    Lavon, B; Tulchinsky, T H; Preger, M; Said, R; Kaufman, S

    1985-02-01

    Infants attending six Family Health Centers of the Israel Ministry of Health in various Jewish and Arab localities in the Hadera subdistrict were examined for hemoglobin levels at 6 and 12 months of age. The prevalence of anemia (hemoglobin less than 11 g/dl) among Jewish infants rose from a total of 44.7 to 60% from 6 to 12 months. For the Arab infants, the prevalence of anemia increased from a total of 43.7% at 6 months to 71.0% at 12. The prevalence of severe anemia (less than 10 g/dl) for the Jewish infants rose from 4.5 to 13.1% and for the Arab infants from 7.7 to 19.6%. Of the Jewish infants with a hemoglobin level less than 10 g/dl at 6 months, 50% were still less than 10 g/dl at 12 months. Of the Arab infants less than 10 g/dl at 6 months, 36.4% were still at that level at 12 months. The lack of routine iron supplementation as a preventive procedure and the routine use of cow's milk for infant feeding are the probable causes of this high prevalence of iron deficiency anemia.

  18. 77 FR 19597 - Listing Endangered and Threatened Species; 12-Month Finding on a Petition To List Chinook Salmon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...We, NMFS, announce a 12-month finding on a petition to list the Chinook salmon (Oncorhynchus tshawytscha) in the Upper Klamath and Trinity Rivers Basin (UKTR) as threatened or endangered and designate critical habitat under the Endangered Species Act (ESA). We have reviewed the status of the UKTR Chinook salmon Evolutionarily Significant Unit (ESU) and considered the best scientific and......

  19. Validity of the Fine Motor Area of the 12-Month Ages and Stages Questionnaire in Infants Following Major Surgery

    ERIC Educational Resources Information Center

    Smith, Cally; Wallen, Margaret; Walker, Karen; Bundy, Anita; Rolinson, Rachel; Badawi, Nadia

    2012-01-01

    The Ages and Stages Questionnaires (ASQ) are parent-report screening tools to identify infants at risk of developmental difficulties. The purpose of this study was to examine validity and internal reliability of the fine motor developmental area of the ASQ, 2nd edition (ASQ2-FM) for screening 12-month-old infants following major surgery. The…

  20. 76 FR 42631 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Pinus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list Pinus albicaulis (whitebark pine) as threatened or endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing P. albicaulis as threatened or endangered is......

  1. The First Year Inventory: A Longitudinal Follow-Up of 12-Month-Old to 3-Year-Old Children

    ERIC Educational Resources Information Center

    Turner-Brown, Lauren M.; Baranek, Grace T.; Reznick, J Steven; Watson, Linda R.; Crais, Elizabeth R.

    2013-01-01

    The First Year Inventory is a parent-report measure designed to identify 12-month-old infants at risk for autism spectrum disorder. First Year Inventory taps behaviors that indicate risk in the developmental domains of sensory--regulatory and social--communication functioning. This longitudinal study is a follow-up of 699 children at 3 years of…

  2. 76 FR 44547 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Giant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the giant Palouse earthworm (Driloleirus americanus) as threatened or endangered as petitioned, and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing the giant......

  3. 76 FR 62213 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Mohave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Mohave ground squirrel (Spermophilus mohavensis) as endangered or threatened under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial information, we find that listing the Mohave ground squirrel is not warranted at this time.......

  4. 75 FR 57720 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List Agave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ...We, the Fish and Wildlife Service (Service), announce a 12- month finding on a petition to list the plant Agave eggersiana (no common name) as endangered under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing A. eggersiana is warranted. Currently, however, listing A. eggersiana is precluded by higher......

  5. 75 FR 78029 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the North...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the North American wolverine (Gulo gulo luscus) as an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that the North American wolverine occurring in the contiguous United......

  6. 75 FR 67925 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List Cirsium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ...We, the U.S. Fish and Wildlife Service, announce a 12-month finding on a petition to list Cirsium wrightii (Wright's marsh thistle) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that listing C. wrightii as endangered or threatened throughout its......

  7. 75 FR 56028 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List Sprague's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-15

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Sprague's pipit (Anthus spragueii) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended (ESA). After review of all available scientific and commercial information, we find that listing the Sprague's pipit as endangered or......

  8. 75 FR 78093 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Sonoran...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ...We, the U.S. Fish and Wildlife Service, announce a 12-month finding on a petition to list the Sonoran population of the desert tortoise (Gopherus agassizii) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing the Sonoran population of......

  9. Disruptions in Brain Networks of Older Fallers Are Associated with Subsequent Cognitive Decline: A 12-Month Prospective Exploratory Study

    PubMed Central

    Hsu, Chun Liang; Voss, Michelle W.; Handy, Todd C.; Davis, Jennifer C.; Nagamatsu, Lindsay S.; Chan, Alison; Bolandzadeh, Niousha; Liu-Ambrose, Teresa

    2014-01-01

    Cognitive impairment and impaired mobility are major public health concerns. There is growing recognition that impaired mobility is an early biomarker of cognitive impairment and dementia. The neural basis for this association is currently unclear. We propose disrupted functional connectivity as a potential mechanism. In this 12-month prospective exploratory study, we compared functional connectivity of four brain networks– the default mode network (DMN), fronto-executive network (FEN), fronto-parietal network (FPN), and the primary motor sensory network (SMN) – between community-dwelling older adults with ≥ two falls in the last 12 months and their non-falling counterparts (≤ one fall in the last 12 months). Functional connectivity was examined both at rest and during a simple motor tapping task. Compared with non-fallers, fallers showed more connectivity between the DMN and FPN during right finger tapping (p = 0.04), and significantly less functional connectivity between the SMN and FPN during rest (p≤0.05). Less connectivity between the SMN and FPN during rest was significantly associated with greater decline in both cognitive function and mobility over the12-month period (r = −0.32 and 0.33 respectively; p≤0.04). Thus, a recent history of multiple falls among older adults without a diagnosis of dementia may indicate sub-clinical changes in brain function and increased risk for subsequent decline. PMID:24699668

  10. 75 FR 30757 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to Delist Cirsium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ...We, the U.S. Fish and Wildlife Service, announce a 12-month finding on a petition to remove Cirsium vinaceum (Sacramento Mountains thistle) from the Federal List of Threatened and Endangered Plants under the Endangered Species Act. After reviewing the best scientific and commercial information available, we find that delisting C. vinaceum is not warranted. However, we ask the public to submit......

  11. Video Analysis of Sensory-Motor Features in Infants with Fragile X Syndrome at 9-12 Months of Age

    ERIC Educational Resources Information Center

    Baranek, Grace T.; Danko, Cassandra D.; Skinner, Martie L.; Donald B., Jr.; Hatton, Deborah D.; Roberts, Jane E.; Mirrett, Penny L.

    2005-01-01

    This study utilized retrospective video analysis to distinguish sensory-motor patterns in infants with fragile X syndrome (FXS) (n=11) from other infants [i.e., autism (n=11), other developmental delay (n=10), typical (n=11)] at 9-12 months of age. Measures of development, autistic features, and FMRP were assessed at the time of entry into the…

  12. 76 FR 61855 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Cactus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the cactus ferruginous pygmy-owl (Glaucidium brasilianum cactorum) as threatened or endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). Additionally, the petition requested that we recognize and list a western subspecies of the cactus......

  13. 78 FR 61763 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Kittlitz's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-03

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Kittlitz's murrelet (Brachyramphus brevirostris) as an endangered or threatened species and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After a review of the best available scientific and commercial information, we find that listing the......

  14. 75 FR 13909 - Endangered and Threatened Wildlife and Plants; 12-Month Findings for Petitions to List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ...We, the U.S. Fish and Wildlife Service (Service), announce three 12-month findings on petitions to list three entities of the greater sage-grouse (Centrocercus urophasianus) as threatened or endangered under the Endangered Species Act of 1973, as amended (Act). We find that listing the greater sage-grouse (rangewide) is warranted, but precluded by higher priority listing actions. We will......

  15. 76 FR 7633 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the Pacific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-10

    ...We, the U.S. Fish and Wildlife Service, announce a 12-month finding on a petition to list the Pacific walrus (Odobenus rosmarus divergens) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended. After review of all the available scientific and commercial information, we find that listing the Pacific walrus as endangered or threatened......

  16. Health-related quality of life and functional changes in DMD: A 12-month longitudinal cohort study

    PubMed Central

    Messina, Sonia; Vita, Gian Luca; Sframeli, Maria; Mondello, Stefania; Mazzone, Elena; D'Amico, Adele; Berardinelli, Angela; La Rosa, Matteo; Bruno, Claudio; Distefano, Maria Grazia; Baranello, Giovanni; Barcellona, Costanza; Scutifero, Marianna; Marcato, Sonia; Palmieri, Arianna; Politano, Luisa; Morandi, Lucia; Mongini, Tiziana; Pegoraro, Elena; D'Angelo, Maria Grazia; Pane, Marika; Rodolico, Carmelo; Minetti, Carlo; Bertini, Enrico; Vita, Giuseppe; Mercuri, Eugenio

    2016-01-01

    In Duchenne muscular dystrophy (DMD) little has been reported on the association between clinical outcome measures and patient health-related quality of life (HRQOL) tools. Our study evaluated the relationship between 12 month changes on the Generic Core Scales (GCS), the Multidimensional Fatigue Scale and the Neuromuscular Module of the PedsQLTM with several outcome measures (6 minute walk test, North Star Ambulatory Assessment and timed items) in ambulatory DMD. Ninety-eight ambulatory DMD in a multicentric setting were included in the study. At baseline, the PedsQLTM inventories correlated with almost all the functional measures On the Child Self-Report there was a significant decrease between baseline and 12 months on the PedsQLTM GCS and its first domain, in parallel with the decrement in the functional outcome measures. Correlation between the 12 month changes on the PedsQLTM inventories and functional measures were almost all negligible. Similar results were obtained on the Parent Proxy-Report. In conclusion, PedsQLTM correlates with the level of impairment at baseline, but this does not hold true when 12 month changes are considered. Further studies comparing different tools are needed to better elucidate the complexity of the relationship between HRQOL and functional performances. PMID:26916554

  17. Immunogenicity and safety of a trivalent inactivated 2010-2011 influenza vaccine in Taiwan infants aged 6-12 months.

    PubMed

    Hwang, Kao-Pin; Hsu, Yu-Lung; Hsieh, Tsung-Hsueh; Lin, Hsiao-Chuan; Yen, Ting-Yu; Wei, Hsiu-Mei; Lin, Hung-Chih; Chen, An-Chyi; Chow, Julie Chi; Huang, Li-Min

    2014-05-01

    This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-naïve infants aged 6-12 months, and was conducted from November 2010 to May 2011. Fifty-nine infants aged 6-12 months received two doses of trivalent inactivated influenza vaccine 4 weeks apart. Hemagglutination inhibition titers were measured 4 weeks after the two doses of study vaccine. Based on the assumption that a hemagglutination inhibition titer of 1:40 or greater against the antigen would be protective in adults, two doses of the study vaccine generated a protective immune response of 63.2% against influenza A(H1N1), 82.5% against influenza A(H3N2) and 38.6% against influenza B viruses in infants aged 6-12 months. The geometric mean fold rises against influenza type A and B viruses also met the European Medicines Agency criteria for flu vaccines. The solicited events within 7 days after vaccination were mild in intensity. No deaths or adverse events such as optic neuritis, cranial neuropathy, and brachial neuropathy or Guillain-Barre syndrome were reported. Two doses of inactivated influenza vaccine were well tolerated and induced a protective immune response against influenza in infants aged 6-12 months.

  18. 77 FR 61375 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on Petitions To List the Mexican...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 12-Month Finding on Petitions To List the Mexican Gray Wolf as an Endangered Subspecies or Distinct Population... two petitions to list the Mexican gray wolf (Canis lupus baileyi) (Mexican wolf) as an...

  19. Adherence to Self-Monitoring via Interactive Voice Response Technology in an eHealth Intervention Targeting Weight Gain Prevention Among Black Women: Randomized Controlled Trial

    PubMed Central

    2014-01-01

    Background eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity. Objective This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention. Methods The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call. Results Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =−.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (−1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference −0.94 kg, 95% CI −1.64 to −0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring. Conclusions Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence

  20. A randomized, controlled trial of disease management modules, including telepsychiatric care, for depression in rural primary care.

    PubMed

    Hilty, Donald M; Marks, Shayna; Wegelin, Jacob; Callahan, Edward J; Nesbitt, Thomas S

    2007-02-01

    Introduction. Disease management modules (DMM), including education, tracking, support, and medical care, have improved health for patients with asthma and diabetes. For rural patients, novel ways of delivery are needed to access clinical expertise from urban or academic specialists. Telemedicine (telephone and televideo) could be instrumental in this process, though no randomized, controlled trials have assessed their effectiveness.Methods. Self-report and structured psychiatric interviews were used to screen potential depressed subjects. Subjects were randomized to: 1) usual care with a DMM using telephone and self-report questionnaires; or 2) a DMM using telephone, questionnaires, and monthly televideo psychiatric consultation emphasizing primary care physician (PCP) skill development. Subjects' depressive symptoms, health status, and satisfaction with care were tabulated at three, six, and 12 months after study entry.Results. There was significant clinical improvement for depression in both groups, with a trend toward significance in the more intensive module. Satisfaction and retention was superior in the more intensive group. There was no overall change in health functioning in either group.Conclusions. Intensive modules using telepsychiatric educational interventions toward PCPs may be superior, but the most critical ingredient may be administrative tracking of patients, prompted intervention by PCPs, and (when necessary) new ideas by a specialist.

  1. Verapamil is Less Effective than Triamcinolone for Prevention of Keloid Scar Recurrence After Excision in a Randomized Controlled Trial.

    PubMed

    Danielsen, Patricia L; Rea, Suzanne M; Wood, Fiona M; Fear, Mark W; Viola, Helena M; Hool, Livia C; Gankande, Thilanee U; Alghamdi, Mansour; Stevenson, Andrew W; Manzur, Mitali; Wallace, Hilary J

    2016-08-23

    A double-blind randomized controlled trial with a paired split-scar design compared verapamil, an L-type Ca2+ channel antagonist, and triamcinolone for prevention of keloid recurrence after excision. Ca2+ channel blocking activity of verapamil in keloid cells was explored. One keloid was excised per subject and each wound half randomized to receive intralesional injections of triamcinolone (10 mg/ml) or verapamil (2.5 mg/ml) at monthly intervals (4 doses). Interim analysis was performed after 14 subjects were completed. Survival analysis demonstrated significantly higher keloid recurrence with verapamil compared to triamcinolone 12 months post-surgery (log-rank test, p = 0.01) and higher overall risk of recurrence with verapamil (hazard ratio 8.44, 95% CI 1.62-44.05). The study was terminated early according to the stopping guideline (p < 0.05). Verapamil is safe but not as effective as triamcinolone in preventing keloid recurrence after excision. Further study is necessary to determine if clinical response to verapamil is linked to modulation of intracellular Ca2+.

  2. A randomized controlled trial of home visits by neighborhood mentor mothers to improve children's nutrition in South Africa

    PubMed Central

    le Roux, Ingrid M.; le Roux, Karl; Mbeutu, Kwanie; Comulada, W. Scott; Desmond, Katherine A.; Rotheram-Borus, Mary Jane

    2011-01-01

    Malnourished children and babies with birth weights under 2500 g are at high risk for negative outcomes over their lifespans. Philani, a paraprofessional home visiting program, was developed to improve nutritional outcomes for young children in South Africa. One “mentor mother” was recruited from each of 37 neighborhoods in Cape Town, South Africa. Mentor mothers were trained to conduct home visits to weigh children under six years old and to support mothers to problem-solve life challenges, especially around nutrition. Households with underweight children were assigned randomly on a 2:1 ratio to the Philani program (n = 500) or to a standard care condition (n = 179); selection effects occurred and children in the intervention households weighed less at recruitment. Children were evaluated over a one-year period (n = 679 at recruitment and n = 638 with at least one follow-up; 94%). Longitudinal random effects models indicated that, over 12 months, the children in the intervention condition gained significantly more weight than children in the control condition. Mentor mothers who are positive peer deviants may be a viable strategy that is efficacious and can build community, and the use of mentor mothers for other problems in South Africa is discussed. PMID:22299019

  3. Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Pulp necrosis is one of the main complications of dental trauma. When it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. A therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling. The aim of this prospective randomized clinical trial is to compare Mineral Trioxide Aggregate(MTA)with Calcium Hydroxide(CH)as materials used to induce root-end closure in necrotic permanent immature incisors. Methods/Design This study, promoted by AP-HP, was approved by the ethics committee(CPP Paris Ile de France IV). 34 children aged from 6 to 18 years and presenting a non-vital permanent incisor are selected. Prior to treatment, an appropriate written consent has to be obtained from both parents and from children. Patients are then randomly assigned to either the MTA(experimental)or CH(control)groups. Recalls are performed after 3, 6 and 12 months to determine the presence or absence of a calcified apical barrier through the use of clinical and radiographic exams. Additional criteria such as clinical symptoms, apical radiolucencies, periapical index(PAI)are also noted. Trial registration ClinicalTrials.gov no. NCT00472173 (First inclusion: May 10, 2007; Last inclusion: April 23, 2009; study completed: April 15, 2010) PMID:21752247

  4. 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.

  5. Patterns of mother-infant interaction from 3 to 12 months among dyads with substance abuse and psychiatric problems.

    PubMed

    Siqveland, Torill S; Haabrekke, Kristin; Wentzel-Larsen, Tore; Moe, Vibeke

    2014-11-01

    The aim of this study was to investigate the development of mother-infant interaction patterns from 3 to 12 months among three groups of mother-baby pairs recruited during pregnancy: one group from residential substance abuse treatment (n=28), a second group from psychiatric outpatient treatment (n=22), and a third group from well-baby clinics (n=30). The mother-infant interaction at 3 and 12 months was assessed by the Parent-Child Early Relational Assessment (PCERA), which consists of maternal, child and dyadic subscales (Clark, 2006). Linear mixed effects models were used to analyze group differences and the changes in mother-infant interaction from 3 to 12 months. At 3 months, pairwise comparisons showed that the group with psychiatric problems had significantly more difficulties in the mother-infant interaction than the two other groups. The group with substance abuse problems was not significantly different from the two other groups. At 12 months, the mother-infant pairs in the substance abuse group showed significantly more relational disturbances than the non-clinical pairs, as well as a poorer affective quality of interaction than the dyads in the group with psychiatric problems. Analysis of change from 3 to 12 months showed that difficulties in the interaction increased among the mother-baby pairs in the substance abuse group, while improvements were displayed in the two other groups. These results underline that mother-infant pairs at double risk due to maternal substance abuse and other non-optimal factors, are in need for long-term follow up in order to prevent the development of negative interactional patterns.

  6. Predicting the Onset of Anxiety Syndromes at 12 Months in Primary Care Attendees. The PredictA-Spain Study

    PubMed Central

    Moreno-Peral, Patricia; Luna, Juan de Dios; Marston, Louise; King, Michael; Nazareth, Irwin; Motrico, Emma; GildeGómez-Barragán, María Josefa; Torres-González, Francisco; Montón-Franco, Carmen; Sánchez-Celaya, Marta; Díaz-Barreiros, Miguel Ángel; Vicens, Catalina; Muñoz-Bravo, Carlos; Bellón, Juan Ángel

    2014-01-01

    Background There are no risk algorithms for the onset of anxiety syndromes at 12 months in primary care. We aimed to develop and validate internally a risk algorithm to predict the onset of anxiety syndromes at 12 months. Methods A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multilevel logistic regression and inverse probability weighting to build the risk algorithm. Our main outcome was generalized anxiety, panic and other non-specific anxiety syndromes as measured by the Primary Care Evaluation of Mental Disorders, Patient Health Questionnaire (PRIME-MD-PHQ). We recruited 3,564 adult primary care attendees without anxiety syndromes from 174 family physicians and 32 health centers in 6 Spanish provinces. Results The cumulative 12-month incidence of anxiety syndromes was 12.2%. The predictA-Spain risk algorithm included the following predictors of anxiety syndromes: province; sex (female); younger age; taking medicines for anxiety, depression or stress; worse physical and mental quality of life (SF-12); dissatisfaction with paid and unpaid work; perception of financial strain; and the interactions sex*age, sex*perception of financial strain, and age*dissatisfaction with paid work. The C-index was 0.80 (95% confidence interval = 0.78–0.83) and the Hedges' g = 1.17 (95% confidence interval = 1.04–1.29). The Copas shrinkage factor was 0.98 and calibration plots showed an accurate goodness of fit. Conclusions The predictA-Spain risk algorithm is valid to predict anxiety syndromes at 12 months. Although external validation is required, the predictA-Spain is available for use as a predictive tool in the prevention of anxiety syndromes in primary care. PMID:25184313

  7. Hyponatremia at discharge as a predictor of 12-month clinical outcomes in hospital survivors after acute myocardial infarction.

    PubMed

    Bae, Myung Hwan; Kim, Jae Hee; Jang, Se Yong; Park, Sun Hee; Lee, Jang Hoon; Yang, Dong Heon; Park, Hun Sik; Cho, Yongkeun; Chae, Shung Chull

    2017-02-01

    Hyponatremia in the early phase of acute myocardial infarction (AMI) is a well-known predictor of poor prognosis. However, little is known about the clinical implication of sodium levels at discharge in hospital survivors after AMI. The study included 1290 consecutive patients (64 ± 12 years; 877 men) who survived the index hospitalization after AMI. We determined the 12-month mortality rates of these patients. Patients who died during the 12-month follow-up had lower sodium levels at discharge than those who had survived (137 ± 6 vs. 139 ± 4 mmol/L; P < 0.014). Hyponatremia at discharge, defined as a serum sodium level ≤135 mmol/L, was present in 210 patients (16.3 %). In the Cox-proportional hazard model, hyponatremia at discharge (hazard ratio, 2.264; 95 % confidence interval, 1.119-4.579; P = 0.023) was an independent predictor of 12-month mortality. Moreover, hyponatremia at discharge had an incremental prognostic value over conventional risk factors (χ (2) = 7, P = 0.007), and conventional risk factors and log N-terminal Pro-B-type natriuretic peptide combined (χ (2) = 5, P = 0.021). In the subgroup analysis, the 12-month mortality of patients with hyponatremia at discharge was significantly higher than in those without, irrespective of age, Killip class, left ventricular ejection fraction, percutaneous coronary intervention at index hospitalization, and prescription of diuretics at discharge. Hyponatremia at discharge is an independent predictor of 12-month mortality in hospital survivors after AMI.

  8. High Incidence of Vertebral Fractures in Children with Acute Lymphoblastic Leukemia 12 Months After the Initiation of Therapy

    PubMed Central

    Alos, Nathalie; Grant, Ronald; Ramsay, Timothy; Halton, Jacqueline; Cummings, Elizabeth A.; Miettunen, Paivi M.; Abish, Sharon; Atkinson, Stephanie; Barr, Ronald; Cabral, David A.; Cairney, Elizabeth; Couch, Robert; Dix, David B.; Fernandez, Conrad V.; Hay, John; Israels, Sara; Laverdière, Caroline; Lentle, Brian; Lewis, Victor; Matzinger, MaryAnn; Rodd, Celia; Shenouda, Nazih; Stein, Robert; Stephure, David; Taback, Shayne; Wilson, Beverly; Williams, Kathryn; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M.

    2014-01-01

    Purpose Vertebral fractures due to osteoporosis are a potential complication of childhood acute lymphoblastic leukemia (ALL). To date, the incidence of vertebral fractures during ALL treatment has not been reported. Patient and Methods We prospectively evaluated 155 children with ALL during the first 12 months of leukemia therapy. Lateral thoracolumbar spine radiographs were obtained at baseline and 12 months. Vertebral bodies were assessed for incident vertebral fractures using the Genant semi-quantitative method, and relevant clinical indices such as spine bone mineral density (BMD), back pain and the presence of vertebral fractures at baseline were analyzed for association with incident vertebral fractures. Results Of the 155 children, 25 (16%, 95% Confidence Interval (CI) 11% to 23%) had a total of 61 incident vertebral fractures, of which 32 (52%) were moderate or severe. Thirteen of the 25 children with incident vertebral fractures (52%) also had fractures at baseline. Vertebral fractures at baseline increased the odds of an incident fracture at 12 months by an odds ratio of 7.3 (95% CI 2.3 to 23.1, p = 0.001). In addition, for every one standard deviation reduction in spine BMD Z-score at baseline, there was 1.8-fold increased odds of incident vertebral fracture at 12 months (95% CI 1.2 to 2.7, p = 0.006). Conclusion Children with ALL have a high incidence of vertebral fractures after 12 months of chemotherapy, and the presence of vertebral fractures and reductions in spine BMD Z-scores at baseline are highly associated clinical features. PMID:22734031

  9. Shamba Maisha: Randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes in Kenya

    PubMed Central

    WEISER, Sheri D.; BUKUSI, Elizabeth A.; STEINFELD, Rachel L.; FRONGILLO, Edward A.; WEKE, Elly; DWORKIN, Shari L.; PUSATERI, Kyle; SHIBOSKI, Stephen; SCOW, Kate; BUTLER, Lisa M.; COHEN, Craig R.

    2015-01-01

    Objectives Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. Design Pilot cluster randomized controlled trial Methods The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for one year. Data were collected on nutritional parameters, CD4 T lymphocyte counts, and HIV RNA. Difference in difference fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. Results We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/mm3, p<0.001) and proportion virologically suppressed in the intervention arm compared to the control arm (comparative improvement in proportion of 0.33 suppressed, OR 7.6, 95% CI: 2.2–26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, p<0.001) and frequency of food consumption (9.4 times per week greater frequency, p=0.013) compared to controls. Conclusion Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity. PMID:26214684

  10. 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.

  11. Effects of a 12-Month Complex Proprioceptive-Coordinative Training Program on Soccer Performance in Prepubertal Boys Aged 10-11 Years.

    PubMed

    Boraczyński, Michał; Sozański, Henryk; Boraczyński, Tomasz

    2017-03-31

    The aim was to examine the effects of a series of on-field proprioceptive-coordinative (P-C) exercises on motor performance (MP) in prepubertal soccer players. Fifty-three male soccer players aged 10.1-11.8 years were randomized among two experimental programs receiving P-C training (P-CT; n = 26) or regular training (RT; n = 27). A control group (C; n = 22) consisted of age-matched (10.3-11.9 years) cohorts not involved in any regular physical activity. Both experimental groups completed an identical 12-month comprehensive soccer program except training in P-CT was modified to substitute small-sided conditioning games with 24 multi-mode P-C exercises with modulated exercise intensity (every 8-9 weeks based on predicted HRmax). Pre-, peri-, and post-training measures included anthropometry and five tests assessing soccer-specific MP: movement rhythm (turning the ball backwards - T1), motor adaptation (running with the ball around poles - T2), spatial orientation (running to sequentially numbered balls - T3), balance (single-leg static balance - T4), and kinesthetic differentiation of movement (landing the ball on a 2 × 2 m sector - T5). Repeated measures ANOVA revealed no significant between-group differences for age, anthropometry and BF% at baseline. Significant main effects for group (P-CT vs. RT) were found in all tests (T1-T5) and main effects for time (group P-CT) in T3-T5, while a significant group × time interaction was observed only in T4 (F = 2.98, p = 0.0204). Post-hoc tests indicated that P-CT attained significantly better results than RT at peri-training (by 26.4%; p < 0.01) and post-training (by 31.9%, p < 0.01). Modulated exercise intensity had little effect on soccer performance (T1-T3, T5). Based on the results, it is recommended that the training of young soccer players be supplemented with the bilateral balance exercises and games employed in the study. Furthermore, the suitability of monitoring HR in P-C exercises targeting the analyzed MP

  12. Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients

    PubMed Central

    Figus, M; Nardi, M; Piaggi, P; Sartini, M; Guidi, G; Martini, L; Lazzeri, S

    2014-01-01

    Purpose To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions. Methods This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01% (n=30) or bimatoprost 0.03% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test. Results Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01% group from baseline 4.7±3.8 to 2.9±2.3 (P<0.001) and 2.5±2.0 (P<0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P=0.003 and P<0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01% group compared with the bimatoprost 0.03% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01% group at each follow-up visit (P<0.05) and in comparison with bimatoprost 0.03% (P<0.05). Conclusion The results of this trial suggest that bimatoprost 0.01% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03% eye drops. PMID:24434659

  13. Randomized controlled trial of motivational enhancement therapy with nontreatment-seeking adolescent cannabis users: a further test of the teen marijuana check-up.

    PubMed

    Walker, Denise D; Stephens, Robert; Roffman, Roger; Demarce, Josephine; Lozano, Brian; Towe, Sheri; Berg, Belinda

    2011-09-01

    Cannabis use adversely affects adolescents and interventions that are attractive to adolescents are needed. This trial compared the effects of a brief motivational intervention for cannabis use with a brief educational feedback control and a no-assessment control. Participants were randomized into one of three treatment conditions: Motivational Enhancement Therapy (MET), Educational Feedback Control (EFC), or Delayed Feedback Control (DFC). Those who were assigned to MET and EFC were administered a computerized baseline assessment immediately following randomization and completed assessments at the 3- and 12-month follow-up periods. Participants in the DFC condition were not assessed until the 3-month follow-up. Following the completion of treatment sessions, all participants were offered up to four optional individual treatment sessions aimed at cessation of cannabis use. The research was conducted in high schools in Seattle, Washington. The participant s included 310 self-referred adolescents who smoked cannabis regularly. The main outcome measures included days of cannabis use, associated negative consequences, and engagement in additional treatment. At the 3-month follow-up, participants in both the MET and EFC conditions reported significantly fewer days of cannabis use and negative consequences compared to those in the DFC. The frequency of cannabis use was less in MET relative to EFC at 3 months, but it did not translate to differences in negative consequences. Reductions in use and problems were sustained at 12 months, but there were no differences between MET and EFC interventions. Engagement in additional treatment was minimal and did not differ by condition. Brief interventions can attract adolescent cannabis users and have positive impacts on them, but the mechanisms of the effects are yet to be identified.

  14. 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

  15. 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.

  16. 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

  17. Meeting Postpartum Women’s Family Planning Needs Through Integrated Family Planning and Immunization Services: Results of a Cluster-Randomized Controlled Trial in Rwanda

    PubMed Central

    Dulli, Lisa S; Eichleay, Marga; Rademacher, Kate; Sortijas, Steve; Nsengiyumva, Théophile

    2016-01-01

    ABSTRACT Objective The primary objective of this study was to test the effectiveness of integrating family planning service components into infant immunization services to increase modern contraceptive method use among postpartum women. Methods The study was a separate sample, parallel, cluster-randomized controlled trial. Fourteen randomly selected primary health facilities were equally allocated to intervention (integrated family planning and immunization services at the same time and location) and control groups (standard immunization services only). At baseline (May–June 2010), we interviewed postpartum women attending immunization services for their infant aged 6 to 12 months using a structured questionnaire. A separate sample of postpartum women was interviewed 16 months later after implementation of the experimental health service intervention. We used linear mixed regression models to test the study hypothesis that postpartum women attending immunization services for their infants aged 6–12 months in the intervention facilities will be more likely to use a modern contraceptive method than postpartum women attending immunization services for their infants aged 6–12 months in control group facilities. Results We interviewed and analyzed data for 825 women from the intervention group and 829 women from the control group. Results showed the intervention had a statistically significant, positive effect on modern contraceptive method use among intervention group participants compared with control group participants (regression coefficient, 0.15; 90% confidence interval [CI], 0.04 to 0.26). Although we conducted a 1-sided significance test, this effect was also significant at the 2-sided test with alpha = .05. Among those women who did not initiate a contraceptive method, awaiting the return of menses was the most common reason cited for non-use of a method. Women in both study groups overwhelmingly supported the concept of integrating family planning

  18. Effects of Miniscalpel-Needle Release on Chronic Neck Pain: A Retrospective Analysis with 12-Month Follow-Up

    PubMed Central

    Li, Shuming; Shen, Tong; Liang, Yongshan; Zhang, Ying; Bai, Bo

    2015-01-01

    Objective Chronic neck pain is a highly prevalent condition, and is often treated with non-steroidal anti-inflammatory drugs. Limited clinical studies with short-term follow-up have shown promising efficacy of acupuncture as well as miniscalpel-needle (MSN) release. In this retrospective study, we examined whether MSN release could produce long-lasting relief in patients with chronic neck pain. Methods We retrieved the medical records of all patients receiving weekly MSN release treatment for chronic neck pain at this institution during a period from May 2012 to December 2013. Only cases with the following information at prior to, and 1, 6, and 12 months after the treatment, were included in the analysis: neck disability index (NDI), numerical pain rating scale (NPRS), and active cervical range of motion (CROM). The primary analysis of interest is comparison of the 12-month measures with the baseline. Patients who took analgesic drugs or massage within 2 weeks prior to assessment were excluded from the analysis. For MSN release, tender points were identified manually by an experienced physician, and did not necessarily follow the traditional acupuncture system. MSN was inserted vertically (parallel to the spine) until breaking through resistance and patient reporting of distention, soreness or heaviness. The depth of the needling ranged from 10 to 50 mm. The release was carried out by moving the MSN up and down 3–5 times without rotation. Results A total of 559 cases (patients receiving weekly MSN release treatment for chronic neck pain) were screened. The number of cases with complete information (NDI, NPRS, and CROM at baseline, 1, 6 and 12 months after last treatment) was 180. After excluding the cases with analgesic treatment or massage within 2 weeks of assessment (n = 53), a total of 127 cases were included in data analysis. The number of MSN release session was 7 (range: 4–11). At 12 months after the treatment, both NPRS and NDI were significantly lower

  19. Effect of recent spinal cord injury on wnt signaling antagonists (sclerostin and dkk-1) and their relationship with bone loss. A 12-month prospective study.

    PubMed

    Gifre, Laia; Vidal, Joan; Carrasco, Josep L; Filella, Xavier; Ruiz-Gaspà, Silvia; Muxi, Africa; Portell, Enric; Monegal, Ana; Guañabens, Nuria; Peris, Pilar

    2015-06-01

    Spinal cord injury (SCI) has been associated with a marked increase in bone loss and bone remodeling, especially short-term after injury. The absence of mechanical load, mediated by osteocyte mechanosensory function, seems to be a causative factor related to bone loss in this condition. However, the pathogenesis and clinical management of this process remain unclear. Therefore, the aim of the study was to analyze the effect of recent SCI on the Wnt pathway antagonists, sclerostin and Dickkopf (Dkk-1), and their relationship with bone turnover and bone mineral density (BMD) evolution. Forty-two patients (aged 35 ± 14yrs) with a recent (<6months) complete SCI were prospectively included. Sclerostin and Dkk-1, bone turnover markers (bone formation: PINP, bone ALP; resorption: sCTx) and BMD (lumbar spine, proximal femur, total body and lower extremities [DXA]) were assessed at baseline and at 6 and 12 months. The results were compared with a healthy control group. 22/42 patients completed the 12-month follow-up. At baseline, SCI patients showed a marked increase in bone markers (PINP and sCTx), remaining significantly increased at up to 6 months of follow-up. Additionally, they presented significantly increased Dkk-1 values throughout the study, whereas sclerostin values did not significantly change. BMD markedly decreased at the proximal femur (-20.2 ± 5.4%, p < 0.01), total body (-5.7 ± 2.2%, p = 0.02) and lower extremities (-13.1 ± 4.5%, p = 0.01) at 12 months. Consequently, 59% of patients developed densitometric osteoporosis at 12 months. Patients with higher Dkk-1 values (>58 pmol/L) at baseline showed higher sublesional BMD loss. In conclusion, this study shows that short-term after SCI there is a marked increase in bone turnover and bone loss, the latter associated with an increase in Dkk-1 serum levels. The persistence of increased levels of this Wnt antagonist throughout the study and their relationship with the magnitude of

  20. 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.

  1. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial

    PubMed Central

    Szaflarski, Jerzy P.; Ball, Angel L.; Vannest, Jennifer; Dietz, Aimee R.; Allendorfer, Jane B.; Martin, Amber N.; Hart, Kimberly; Lindsell, Christopher J.

    2015-01-01

    Background Few studies have documented the possibility of treatment-induced improvements in language functions 12 months or longer after stroke. The purpose of the current study was to provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to provide the data needed to design an appropriately powered trial. Material/Methods This was a randomized, controlled, single-blinded, pilot trial. We identified 32 patients with chronic post-stroke aphasia. Of these, 27 were offered participation, and 24 were randomized (CONSORT diagram): 14 to CIAT and to 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours of therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). To maintain blinding, clinicians treating patients (CIAT group) did not communicate with other team members and the testing team members were blinded to treatment group assignment. Results Overall, the results of this pilot trial support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. Conclusions In this randomized, controlled, and blinded pilot study, intensive language therapy (CIAT) led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial

  2. Randomized controlled trial of stereotactic 11-G vacuum-assisted core biopsy for the diagnosis and management of mammographic microcalcification

    PubMed Central

    Maxwell, Anthony J; Morris, Julie; Lim, Yit Y; Harake, MD Janick; Whiteside, Sigrid

    2016-01-01

    Objective: To compare the accuracy of 11-G vacuum-assisted biopsy (VAB) with 14-G core needle biopsy (CNB) to diagnose mammographic microcalcification (MM) and effect on surgical outcomes. Methods: Following ethical approval, VAB and CNB (control) were compared in a randomized prospective study for first-line diagnosis of MM and subsequent surgical outcomes in two breast-screening units. Participants gave written informed consent. Exclusions included comorbidity precluding surgery, prior ipsilateral breast cancer and lesions >40 mm requiring mastectomy as first surgical procedure. The final pathological diagnosis was compared with the initial biopsy result. Quality-of-life (QOL) questionnaires were administered at baseline, 2, 6 and 12 months. 110 participants were required to show a 25% improvement in diagnosis with VAB compared with CNB (90% power). Results: Eligibility was assessed for 787 cases; 129 females recalled from the National Health Service breast screening programme were randomized. Diagnostic accuracy of VAB was 86% and that of CNB was 84%. Using VAB, 2/14 (14.3%) cases upgraded from ductal carcinoma in situ to invasion at surgery and 3/19 (15.8%) using CNB. Following VAB 7/16 (44%) cases required repeat surgery vs 7/24 (29%) after CNB. Both groups recorded significant worsening of functional QOL measures and increased breast pain at follow-up. Conclusion: VAB and CNB were equally accurate at diagnosing MM, and no significant differences in surgical outcomes were observed. Advances in knowledge: The first randomized controlled study of VAB for diagnosis of microcalcification using digital mammography showed no difference in diagnostic accuracy of VAB and CNB, or in the proportion of participants needing repeat non-operative biopsy or second therapeutic operation to treat malignancy. PMID:26654214

  3. 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

  4. [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.

  5. A 12-Month Follow-Up of Homogeneous and Heterogeneous Anxiety Management Training.

    ERIC Educational Resources Information Center

    Deffenbacher, Jerry L.; Michaels, Ann C.

    1981-01-01

    A follow-up study found that both homogeneous and heterogeneous anxiety management training (AMT) led to continued reports of significantly less debilitating test or speech anxiety than the controls. The combined AMT group reported significantly less nontargeted anxiety than the combined control group on one of two nontargeted anxiety measures.…

  6. Physical activity and resting pulse rate in older adults: findings from a randomized controlled trial

    PubMed Central

    ó Hartaigh, Bríain; Pahor, Marco; Buford, Thomas W.; Dodson, John A.; Forman, Daniel E.; Gill, Thomas M.

    2014-01-01

    Background Elevated resting pulse rate (RPR) is a well-recognized risk factor for adverse outcomes. Epidemiological evidence supports the beneficial effects of regular exercise for lowering RPR, but studies are mainly confined to persons younger than 65 years. We set out to evaluate the utility of a physical activity (PA) intervention for slowing RPR among older adults. Methods A total of 424 seniors (ages 70-89 years) were randomized to a moderate intensity PA intervention or an education-based “successful aging” (SA) health program. RPR was assessed at baseline, 6 months and 12 months. Longitudinal differences in RPR were evaluated between treatment groups using generalized estimating equation (GEE) models, reporting unstandardized beta coefficients (β) with robust standard errors (SE). Results Increased frequency and duration of aerobic training was observed for the PA group at 6 and 12 months as compared with the SA group (P <0.001). In both groups, RPR remained unchanged over the course of the 12-month study period (P =0.67). No significant improvement was observed (β [SE] = 0.58 [0.88], P =0.51) for RPR when treatment groups were compared using the GEE method. Comparable results were found after omitting participants with a pacemaker, cardiac arrhythmia, or who were receiving beta-blockers. Conclusions Twelve months of moderate intensity aerobic training did not improve RPR among older adults. Additional studies are needed to determine whether physical activity of longer duration and/or greater intensity can slow RPR in older persons. PMID:25262271

  7. 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 of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet

  8. Randomized controlled trial of standard versus double dose cotrimoxazole for childhood pneumonia in Pakistan.

    PubMed Central

    Rasmussen, Zeba A.; Bari, Abdul; Qazi, Shamim; Rehman, Gul; Azam, Iqbal; Khan, SherBaz; Aziz, Farida; Rafi, Sadia; Roghani, Mehr Taj; Iqbal, Imran; Nagi, Abdul Ghaffar; Hussain, Waqar; Bano, Nahida; van Latum, Late J. C.; Khan, Mushtaq

    2005-01-01

    OBJECTIVE: Increasing concern over bacterial resistance to cotrimoxazole, which is recommended by WHO as a first-line drug for treating non-severe pneumonia, led to the suggestion that this might not be optimal therapy. However, changing to alternative antimicrobial agents, such as amoxicillin, is costly. We compared the clinical efficacy of twice-daily cotrimoxazole in standard versus double dosage for treating non-severe pneumonia in children. METHODS: A randomized controlled multicentre trial was implemented in seven hospital outpatient departments and two community health programmes. A total of 1143 children aged 2-59 months with non-severe pneumonia were randomly allocated to receive 4 mg trimethoprim plus 20 mg sulfamethoxazole/kg of body weight or 8 mg trimethoprim plus 40 mg sulfamethoxazole/kg of body weight orally twice-daily for 5 days Treatment failure occurred when a child required a change of therapy, died or was lost to follow-up. Children required a change of therapy if their condition worsened (they developed chest indrawing or danger signs) or if at 48 hours after enrollment, their clinical condition was the same (defined as having a respiratory rate that was 5 breaths/minute higher or lower than at the time of enrollment). FINDINGS: The results of 1134 children were analysed: 578 were assigned to the standard dose of cotrimoxazole and 556 to the double dose. Treatment failed in 112 children (19.4%) in the standard group and 118 (21.2%) in the double-dose group (relative risk 1.10; 95% confidence interval = 0.87-1.37). Using multivariate analysis we found that treatment was more likely to fail in children who were not given the medicine correctly (P = 0.001), in those younger than 12 months (P = 0.004), those who had used antibiotics previously (P = 0.002), those whose respiratory rate was > or =20 breaths/minute above the age-specific cut-off point (P = 0.006), and those from urban areas (P = 0.042). CONCLUSION: Both standard and double strength

  9. Sailing Can Improve Quality of Life of People with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

    PubMed Central

    Carta, Mauro Giovanni; Maggiani, Federica; Pilutzu, Laura; Moro, Maria Francesca; Mura, Gioia; Sancassiani, Federica; Vellante, Vellante; Migliaccio, Gian Mario; Machado, Sergio; Nardi, Antonio Egidio; Preti, Antonio

    2014-01-01

    The aim of this study was to evaluate the impact of a sailing rehabilitation program on the quality of life (QoL) in a sample of patients with severe mental disorders. The study adopted a randomized, crossover, waiting-list controlled design. The participants enrolled in the study were outpatients diagnosed with severe chronic mental disorders. The participants (N=40) exposed to rehabilitation with sailing took part in a series of supervised cruises near the gulf of Cagliari, South Sardinia, and showed a statistically significant improvement of their quality of life compared to the control group. This improvement was comparable to the improvement in psychopathologic status and social functioning as shown in a previous report of the same research project. The improvement was maintained at follow-up only during the trial and for a few months later: after 12 months, patients returned to their baseline values and their quality of life showed a worsening trend. This is the first study to show that rehabilitation with sailing may improve the quality of life of people with severe chronic mental disorders. In all likelihood, a program grounded on learning how to manage a sailing vessel - during which patients perform cruises that emphasize the exploration of the marine environment by sailing - might be interesting enough and capture the attention of the patients so as to favour greater effectiveness of standard rehabilitation protocols, but this should be specifically tested. PMID:25191521

  10. Sailing can improve quality of life of people with severe mental disorders: results of a cross over randomized controlled trial.

    PubMed

    Carta, Mauro Giovanni; Maggiani, Federica; Pilutzu, Laura; Moro, Maria Francesca; Mura, Gioia; Sancassiani, Federica; Vellante, Vellante; Migliaccio, Gian Mario; Machado, Sergio; Nardi, Antonio Egidio; Preti, Antonio

    2014-01-01

    The aim of this study was to evaluate the impact of a sailing rehabilitation program on the quality of life (QoL) in a sample of patients with severe mental disorders. The study adopted a randomized, crossover, waiting-list controlled design. The participants enrolled in the study were outpatients diagnosed with severe chronic mental disorders. The participants (N=40) exposed to rehabilitation with sailing took part in a series of supervised cruises near the gulf of Cagliari, South Sardinia, and showed a statistically significant improvement of their quality of life compared to the control group. This improvement was comparable to the improvement in psychopathologic status and social functioning as shown in a previous report of the same research project. The improvement was maintained at follow-up only during the trial and for a few months later: after 12 months, patients returned to their baseline values and their quality of life showed a worsening trend. This is the first study to show that rehabilitation with sailing may improve the quality of life of people with severe chronic mental disorders. In all likelihood, a program grounded on learning how to manage a sailing vessel - during which patients perform cruises that emphasize the exploration of the marine environment by sailing - might be interesting enough and capture the attention of the patients so as to favour greater effectiveness of standard rehabilitation protocols, but this should be specifically tested.

  11. Sailing for Rehabilitation of Patients with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

    PubMed Central

    Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

    2014-01-01

    This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness. PMID:25191520

  12. Sailing for rehabilitation of patients with severe mental disorders: results of a cross over randomized controlled trial.

    PubMed

    Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

    2014-01-01

    This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness.

  13. Motivational interviewing and problem solving treatment to reduce type 2 diabetes and cardiovascular disease risk in real life: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Intensive lifestyle interventions in well-controlled settings are effective in lowering the risk of chronic diseases such as type 2 diabetes (T2DM) and cardiovascular diseases (CVD), but there are still no effective lifestyle interventions for everyday practice. In the Hoorn Prevention Study we aimed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality, and to motivate changes in lifestyle behaviors. Methods The Hoorn Prevention Study is a parallel group randomized controlled trial, implemented in the region of West-Friesland, the Netherlands. 622 adults with ≥10% estimated risk of T2DM and/or CVD mortality were randomly assigned and monitored over a period of 12 months. The intervention group (n=314) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment, provided by trained practice nurses in 12 general practices. The control group (n=308) received existing health brochures. Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities (ARIC) Study, and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation (SCORE) formula. Secondary outcomes included lifestyle behavior (diet, physical activity and smoking). The research assistants, the principal investigator and the general practitioners were blinded to group assignment. Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure, adjusted for baseline values. Results 536 (86.2%) of the 622 participants (age 43.5 years) completed the 6-month follow-up, and 502 (81.2%) completed the 12-month follow-up. The mean baseline T2DM risk was 18.9% (SD 8.2) and the mean CVD mortality risk was 3.8% (SD 3.0). The intervention group participated in a median of 2 sessions. Intention

  14. Screening for Autism Spectrum Disorders in 12-Month-Old High-Risk Siblings by Parental Report

    PubMed Central

    Macari, Suzanne; Chen, Grace; Campbell, Daniel; Leventhal, John M.; Weitzman, Carol; Chawarska, Katarzyna

    2014-01-01

    This study examines whether parental report of social-communicative and repetitive behaviors at 12 months can be helpful in identifying autism spectrum disorder (ASD) in younger siblings of children with ASD [high-risk (HR)-siblings]. Parents of HR-siblings and infants without a family history of ASD completed the First Year Inventory at 12 months. Developmental outcomes were based on 24- or 36-month assessments. HR-siblings later diagnosed with ASD showed greater impairments in social communication than those with other developmental outcomes based on parental and clinician ratings. Parental report of decline in play and communication and impaired vocal imitation correctly classified a majority of ASD cases with high specificity. These preliminary findings have important implications for the development of early screening instruments for ASD in HR-siblings. PMID:25149178

  15. 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

  16. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months

    PubMed Central

    Park, So Yun; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-01-01

    Objective To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. Methods We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Results Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. Conclusion The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women. PMID:28090460

  17. 76 FR 61895 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ...We, the U.S. Fish and Wildlife Service, announce a 12-month finding on a petition to list the northern leopard frog (Lithobates (=Rana) pipiens) under the Endangered Species Act of 1973, as amended (Act). After review of the best scientific and commercial information, we find that listing the northern leopard frog is not warranted at this time. However, we ask the public to submit to us any......

  18. 77 FR 19755 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the San...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the San Francisco Bay-Delta distinct population segment (Bay Delta DPS) of longfin smelt as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of the best available scientific and commercial information, we find......

  19. 76 FR 55169 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on Five Petitions To List Seven...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on five petitions to list seven species of Hawaiian yellow-faced bees (Hylaeus anthracinus, H. assimulans, H. facilis, H. hilaris, H. kuakea, H. longiceps, and H. mana) as endangered and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific......

  20. 76 FR 45129 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Gopher...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the gopher tortoise (Gopherus polyphemus) in the eastern portion of its range (east of the Mobile and Tombigbee Rivers) as threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended. In this finding, we also evaluate whether the status of the gopher......

  1. 75 FR 17352 - Endangered and Threatened Wildlife and Plants; 12-month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the mountain whitefish (Prosopium williamsoni) in the Big Lost River, Idaho, as endangered or threatened under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that the mountain whitefish in the Big Lost River does not......

  2. Incident Vertebral Fractures among Children with Rheumatic Disorders 12 Months Post-Glucocorticoid Initiation: a National Observational Study

    PubMed Central

    Rodd, Celia; Lang, Bianca; Ramsay, Timothy; Alos, Nathalie; Huber, Adam M.; Cabral, David A.; Scuccimarri, Rosie; Miettunen, Paivi M.; Roth, Johannes; Atkinson, Stephanie A.; Couch, Robert; Cummings, Elizabeth A.; Dent, Peter B.; Ellsworth, Janet; Hay, John; Houghton, Kristin; Jurencak, Roman; Larché, Maggie; LeBlanc, Claire; Oen, Kiem; Saint-Cyr, Claire; Stein, Robert; Stephure, David; Taback, Shayne; Lentle, Brian; Matzinger, MaryAnn; Shenouda, Nazih; Moher, David; Rauch, Frank; Siminoski, Kerry; Ward, Leanne M.

    2014-01-01

    Objectives To determine the frequency of incident vertebral fractures (IVF) 12 months after glucocorticoid (GC) initiation in children with rheumatic diseases and to identify children at higher risk. Methods Children with rheumatic diseases initiating GC were enrolled in a prospective observational study. Annual spine radiographs were evaluated using the Genant semi-quantitative method. Spine areal bone mineral density (aBMD) was measured every 6 months. Clinical features, including cumulative GC dose, back pain, disease and physical activity, calcium and vitamin D intake, and spine aBMD Z-scores were analyzed for association with IVF. Results Seven (6%) of 118 children (95% Confidence Interval 2.9 to 11.7) had IVF. Their diagnoses were: juvenile dermatomyositis (n = 2), systemic lupus erythematosus (n = 3), systemic vasculitis (n = 1) and mixed connective tissue disease (n = 1). One child was omitted from the analyses after 4 months because of osteoporosis treatment for symptomatic IVF. Children with IVF received on average 50% more GC than those without (p=0.030), had a greater increase in body mass index (BMI) at 6 months (p=0.010), and had greater decrements in spine aBMD Z-scores in the first 6 months (p=0.048). Four (67%) of 6 children with IVF and data to 12 months had spine aBMD Z-scores less than −2.0 at 12 months compared to 16% of children without IVF (p=0.011). Conclusions The incidence of VF 12 months following GC initiation was 6%; most children were asymptomatic. Children with IVF received more GC, had greater increases in BMI and greater declines in spine aBMD Z-scores in the first 6 months. PMID:22213727

  3. 77 FR 29077 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To Downlist Three...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-16

    ...We, the U.S. Fish and Wildlife Service, announce our 12-month findings on a petition to reclassify San Clemente Island lotus, and San Clemente Island paintbrush under the Endangered Species Act are warranted and we propose to change the status of these two species from endangered to threatened. We also propose to correct the scientific and common names of San Clement Island lotus. We are also......

  4. 76 FR 63479 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Two South...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ...We, the U.S. Fish and Wildlife Service, announce a status review (12-month finding) on a petition to list the blue-headed macaw (Primolius couloni) and grey-cheeked parakeet (Brotogeris pyrrhoptera) as threatened or endangered under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that listing the blue-headed......

  5. 75 FR 6437 - Endangered and Threatened Wildlife and Plants; 12-month Finding on a Petition to List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the American pika (Ochotona princeps) as threatened or endangered under the Endangered Species Act of 1973, as amended. After review of all available scientific and commercial information, we find that listing the American pika, at the species level or any of the five recognized subspecies (O.......

  6. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    PubMed Central

    Mathiesen, Elisabeth R.; Hod, Moshe; Ivanisevic, Marina; Duran Garcia, Santiago; Brøndsted, Lise; Jovanovič, Lois; Damm, Peter; McCance, David R.

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8–12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account. RESULTS A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8–12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, –0.06% [95% CI –0.21 to 0.08]; per protocol, –0.15% [–0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups. CONCLUSIONS Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable. PMID:22851598

  7. Social cognition in schizophrenia, Part 2: 12-month stability and prediction of functional outcome in first-episode patients.

    PubMed

    Horan, William P; Green, Michael F; DeGroot, Michael; Fiske, Alan; Hellemann, Gerhard; Kee, Kimmy; Kern, Robert S; Lee, Junghee; Sergi, Mark J; Subotnik, Kenneth L; Sugar, Catherine A; Ventura, Joseph; Nuechterlein, Keith H

    2012-06-01

    This study evaluated the longitudinal stability and functional correlates of social cognition during the early course of schizophrenia. Fifty-five first-episode schizophrenia patients completed baseline and 12-month follow-up assessments of 3 key domains of social cognition (emotional processing, theory of mind, and social/relationship perception), as well as clinical ratings of real-world functioning and symptoms. Scores on all 3 social cognitive tests demonstrated good longitudinal stability with test-retest correlations exceeding .70. Higher baseline and 12-month social cognition scores were both robustly associated with significantly better work functioning, independent living, and social functioning at the 12-month follow-up assessment. Furthermore, cross-lagged panel analyses were consistent with a causal model in which baseline social cognition drove later functional outcome in the domain of work, above and beyond the contribution of symptoms. Social cognitive impairments are relatively stable, functionally relevant features of early schizophrenia. These results extend findings from a companion study, which showed stable impairments across patients in prodromal, first-episode, and chronic phases of illness on the same measures. Social cognitive impairments may serve as useful vulnerability indicators and early clinical intervention targets.

  8. Identification of infants at risk for autism spectrum disorder and developmental language delay prior to 12 months.

    PubMed

    Samango-Sprouse, Carole A; Stapleton, Emily J; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L; Gropman, Andrea L

    2015-04-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum disorder and developmental learning delay, not affected by literacy or primary parental language, and provide immediate determination of risk for autism spectrum disorder. An abrupt head circumference acceleration and the absence of head tilt reflex by 9 months were used to identify infants at risk for autism spectrum disorder. Stability of early findings was then investigated when compared to comprehensive standardized neurodevelopmental assessment results and complete neurological and genetics evaluations. A total of 1024 typically developing infants were enrolled by 9 months, with 14 identified as at risk for autism spectrum disorder and 33 for developmental learning delay. There was a good positive predictive value for the identification of autism spectrum disorder prior to 12 months. This study demonstrates an efficient means to identify infants at risk for autism spectrum disorder by 9 months of age and serves to alert primary care providers of infants who are vulnerable for autism spectrum disorder before symptoms are discernible by clinical judgment of primary care providers, parental concerns, or by screening questionnaires.

  9. Early adolescents' perceptions of their mother's anxious parenting as a predictor of anxiety symptoms 12 months later.

    PubMed

    Rapee, Ronald M

    2009-11-01

    Parental overprotection and modeling of fearful behaviors have been proposed to play a central role in the development of anxiety. Yet there have been few longitudinal examinations of these relationships and virtually none focusing on the adolescent period. The current study measured adolescent perceptions of maternal anxious parenting (a combination of overprotection and expression of anxiety), mothers' levels of anxiousness, and adolescents' anxiety symptoms in 421 girls in grade 7 and their mothers. Measures were repeated 12 months later. When the adolescent's self report of anxiety was used as the outcome, the adolescent's perception of maternal anxious parenting significantly predicted adolescent anxiety 12 months later. When the mother's report of adolescent anxiety was used as the outcome adolescent anxiety significantly predicted adolescent perceptions of maternal anxious parenting 12 months later. Maternal anxiousness predicted the adolescent's perception of anxious parenting, but meditational relationships were not significant in either model. The data are partly consistent with reciprocal influence models of parent/child relationships but point to the importance of informant perspectives in determining relationships between these complex variables.

  10. A comparison of the carcass and meat quality of Martina Franca donkey foals aged 8 or 12 months.

    PubMed

    Polidori, Paolo; Pucciarelli, Stefania; Ariani, Ambra; Polzonetti, Valeria; Vincenzetti, Silvia

    2015-08-01

    The effects of slaughter age (8 vs 12 months) were investigated on meat and carcass quality obtained from Martina Franca donkey foals. Sixteen male foals were used, eight were slaughtered at 8 months of age with a mean (±s.e.) final body weight of 101±18kg and the remaining 8 foals slaughtered at 12 months of age with a mean final body weight of 122±13kg. Carcass weight and dressing percentage were higher (P<0.05) in older foals. Shear force value was lower (P<0.05) in donkeys slaughtered at 8 months of age (54.03N) compared to the same muscle Longissimus Thoracis et Lumborum (LTL) collected in older animals (62.66N). Muscle glycogen content was higher (P<0.05) in foals slaughtered at 12months of age. Donkey foal meat showed an interesting content of essential amino acids and a notable percentage of unsaturated fatty acids in both groups of animals, giving a high nutritional value to this alternative red meat.

  11. Maternal prenatal felt security and infant health at birth interact to predict infant fussing and crying at 12 months postpartum.

    PubMed

    Sawada, Natsumi; Gagné, Faby M; Séguin, Louise; Kramer, Michael S; McNamara, Helen; Platt, Robert W; Goulet, Lise; Meaney, Michael J; Lydon, John E

    2015-08-01

    Infants born with medical problems are at risk for less optimal developmental outcomes. This may be, in part, because neonatal medical problems are associated with maternal distress, which may adversely impact infants. However, the reserve capacity model suggests that an individual's bank of psychosocial resources buffers the adverse effects of later-encountered stressors. This prospective longitudinal study examined whether preexisting maternal psychosocial resources, conceptualized as felt security in close relationships, moderate the association between neonatal medical problems and infant fussing and crying 12 months postpartum. Maternal felt security was measured by assessing its indicators in 5,092 pregnant women. At birth, infants were classified as healthy or having a medical problem. At 12 months, experience sampling was used to assess daily maternal reports of fussing and crying in 135 mothers of infants who were healthy or had medical problems at birth. Confirmatory factor analyses revealed that attachment, relationship quality, self-esteem, and social support can be conceptualized as indicators of a single felt security factor. Multiple regression analyses revealed that prenatal maternal felt security interacts with infant health at birth to predict fussing and crying at 12 months. Among infants born with medical problems, higher felt security predicted decreased fussing and crying. Maternal felt security assessed before birth dampens the association between neonatal medical problems and subsequent infant behavior. This supports the hypothesis that psychosocial resources in reserve can be called upon in the face of a stressor to reduce its adverse effects on the self or others.

  12. Mobile Technology for Vegetable Consumption: A Randomized Controlled Pilot Study in Overweight Adults

    PubMed Central

    Mathur, Maya; King, Abby C

    2016-01-01

    Background Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale, but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults. Objective The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption. Methods A total of 17 overweight adults aged 42.0 (SD 7.3) years with a body mass index (BMI) of 32.0 (SD 3.5) kg/m2 were randomized to the use of Vegethon (a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption, goal setting, feedback, and social comparison) or a wait-listed control condition. All participants were recruited from an ongoing 12-month weight loss trial (parent trial). Researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire administered at baseline and 12 weeks after randomization. An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions, controlling for baseline. App usability and satisfaction were measured via a 21-item post-intervention questionnaire. Results Using intention-to-treat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD 0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it. Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study (adjusted mean difference: 7.4 servings; 95% CI 1.4-13.5; P=.02). Among secondary outcomes defined a priori, there was significantly greater

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

    PubMed Central

    Carey, Michael P.; Senn, Theresa E.; Walsh, Jennifer L.; Coury-Doniger, Patricia; Urban, Marguerite A.; Fortune, Thierry; Vanable, Peter A.; Carey, Kate B.

    2014-01-01

    We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

  18. Action Production Influences 12-Month-Old Infants' Attention to Others' Actions

    ERIC Educational Resources Information Center

    Cannon, Erin N.; Woodward, Amanda L.; Gredeback, Gustaf; von Hofsten, Claes; Turek, Colleen

    2012-01-01

    Recent work implicates a link between action control systems and action understanding. In this study, we investigated the role of the motor system in the development of visual anticipation of others' actions. Twelve-month-olds engaged in behavioral and observation tasks. "Containment activity", infants' spontaneous engagement in producing…

  19. Respecting the circle of life: one year outcomes from a randomized controlled comparison of an HIV risk reduction intervention for American Indian adolescents.

    PubMed

    Tingey, Lauren; Mullany, Britta; Chambers, Rachel; Hastings, Ranelda; Lee, Angelita; Parker, Anthony; Barlow, Allison; Rompalo, Anne

    2015-01-01

    Potential for widespread transmission of HIV/AIDS among American Indian (AI) adolescents exists, yet no evidence-based interventions (EBIs) have been adapted and evaluated with this population. Intensive psychoeducation may improve knowledge and decision-making which could potentially translate to reductions in HIV risk behaviors. A peer group randomized controlled comparison of an adapted EBI vs. control was delivered over an eight-day summer basketball camp in one reservation-based tribal community to adolescents ages 13-19. Outcome data were gathered immediately post-camp and at 6 and 12 months follow-up. Self-selected peer groups were randomized to intervention (n = 138) or control (n = 129) conditions for a total sample of 267 participants (56.2% female), mean age 15.1 years (SD = 1.7). Intervention participants had better condom use self-efficacy post-camp (Adjusted Mean Difference [AMD] = -0.75, p < 0.005) and at 6 (AMD = -0.44, p < 0.005) and 12 months (AMD = -0.23, p < 0.05) follow-up. Intervention participants also had higher HIV prevention and transmission knowledge (post-camp: AMD = 0.07, p < 0.01; 6 months: AMD = 0.06, p < 0.01) were more likely to believe condoms prevent sexually transmitted infections (post-camp: RR = 1.41, p < 0.005; 6 months: RR = 1.34, p < 0.05), to talk with an adult about HIV/AIDS (post-camp: RR=1.78, p < 0.005; 6 months: RR = 1.14, p < 0.005), had higher partner negotiation efficacy related to substance use during sex (post-camp: AMD = 0.37, p < 0.01), and were more likely to intend to use a condom (post-camp: RR = 1.39, p < 0.01). The adapted intervention had short- and medium-term impacts on AI adolescent risk for HIV/AIDS, but attenuated at 12 months. Intervention delivery through a community-based camp is feasible and acceptable with strong retention. Additional study is needed to evaluate the adapted intervention's impact on sexual risk behaviors and if booster sessions and parent involvement translate to long-term impacts.

  20. 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

  1. 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.

  2. Effects of a couple-based intervention to reduce risks for HIV, HCV, and STIs among drug-involved heterosexual couples in Kazakhstan: A randomized controlled trial

    PubMed Central

    El-Bassel, Nabila; Gilbert, Louisa; Terlikbayeva, Assel; Beyrer, Chris; Wu, Elwin; Chang, Mingway; Hunt, Tim; Ismayilova, Leyla; Shaw, Stacey A.; Primbetova, Sholpan; Rozental, Yelena; Zhussupov, Baurzhan; Tukeyev, Marat

    2014-01-01

    Objective Project Renaissance is a randomized controlled trial of an HIV/HCV/STI prevention intervention conducted in Almaty, Kazakhstan. We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV, HCV, sexually transmitted infections (STI), rates of unprotected sex, and unsafe injection over the 12-month follow up period compared to those assigned to an attention control arm. Design A total of 300 couples (600 participants) where one or both partners reported injecting drugs in the past 90 days were randomized to one of two arms: (1) a five-session HIV/HCV/STI prevention intervention (Risk Reduction: RR), or (2) a five-session Wellness Promotion (WP) intervention. Results Over the 12-month follow up period, assignment to RR compared to WP significantly lowered the incidence of HCV infection by 69% (IRR=0.31, 95% CI=0.10 – 0.90, p=0.031). Although differences were not statistically significant, RR participants had a lower incidence of HIV infection by 51% (IRR=0.49, 95% CI=0.16 – 1.48, p=0.204) and any STI by 37% (IRR=0.63, 95%=0.21 – 1.93, p=0.418) than WP participants. RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners (IRR=0.58, 95% CI=0.36 – 0.93, p=0.024) and more consistent condom use (OR=2.30, 95% CI=1.33 – 4.00, p=0.003) over the entire follow-up period compared to WP participants. Conclusion Project Renaissance demonstrated a significant effect for biological and behavioral endpoints. Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs, drug treatment, and criminal justice settings. PMID:24991973

  3. The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial

    PubMed Central

    Giné-Garriga, Maria; Martin-Borràs, Carme; Puig-Ribera, Anna; Martín-Cantera, Carlos; Solà, Mercè; Cuesta-Vargas, Antonio

    2013-01-01

    Background Effective promotion of exercise could result in substantial savings in healthcare cost expenses in terms of direct medical costs, such as the number of medical appointments. However, this is hampered by our limited knowledge of how to achieve sustained increases in physical activity. Objectives To assess the effectiveness of a Primary Health Care (PHC) based physical activity program in reducing the total number of visits to the healthcare center among inactive patients, over a 15-month period. Research Design Randomized controlled trial. Subjects Three hundred and sixty-two (n = 362) inactive patients suffering from at least one chronic condition were included. One hundred and eighty-three patients (n = 183; mean (SD); 68.3 (8.8) years; 118 women) were randomly allocated to the physical activity program (IG). One hundred and seventy-nine patients (n = 179; 67.2 (9.1) years; 106 women) were allocated to the control group (CG). The IG went through a three-month standardized physical activity program led by physical activity specialists and linked to community resources. Measures The total number of medical appointments to the PHC, during twelve months before and after the program, was registered. Self-reported health status (SF-12 version 2) was assessed at baseline (month 0), at the end of the intervention (month 3), and at 12 months follow-up after the end of the intervention (month 15). Results The IG had a significantly reduced number of visits during the 12 months after the intervention: 14.8 (8.5). The CG remained about the same: 18.2 (11.1) (P = .002). Conclusions Our findings indicate that a 3-month physical activity program linked to community resources is a short-duration, effective and sustainable intervention in inactive patients to decrease rates of PHC visits. Trial Registration ClinicalTrials.gov NCT00714831 PMID:23805219

  4. 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).

  5. Benzodiazepine Discontinuation among Adults with GAD: A Randomized Trial of Cognitive-Behavioral Therapy

    ERIC Educational Resources Information Center

    Gosselin, Patrick; Ladouceur, Robert; Morin, Charles M.; Dugas, Michel J.; Baillargeon, Lucie

    2006-01-01

    This study evaluated the specific effectiveness of cognitive-behavior therapy (CBT) combined with medication tapering for benzodiazepine discontinuation among generalized anxiety disorder (GAD) patients by using a nonspecific therapy control group. Sixty-one patients who had used benzodiazepines for more than 12 months were randomly assigned to…

  6. A Natural Product Telomerase Activator Lengthens Telomeres in Humans: A Randomized, Double Blind, and Placebo Controlled Study

    PubMed Central

    Salvador, Laura; Singaravelu, Gunasekaran; Harley, Calvin B.; Flom, Peter; Suram, Anitha

    2016-01-01

    Abstract TA-65 is a dietary supplement based on an improved formulation of a small molecule telomerase activator that was discovered in a systematic screening of natural product extracts from traditional Chinese medicines. This study summarizes the findings on telomere length (TL) changes from a randomized, double blind, placebo controlled study of TA-65 over a 1 year period. The study was conducted on 117 relatively healthy cytomegalovirus-positive subjects aged 53–87 years old. Subjects taking the low dose of TA-65 (250 U) significantly increased TL over the 12 months period (530 ± 180 bp; p = 0.005), whereas subjects in the placebo group significantly lost TL (290 ± 100 bp; p = 0.01). The high dose of TA-65 (1000 U) showed a trend of improvements in TL compared with that of the placebo group; however, the improvements did not reach statistical significance. TL changes in the low-dose group were similar for both median and 20th percentile TLs. The findings suggest that TA-65 can lengthen telomeres in a statistically and possibly clinically significant manner. PMID:26950204

  7. Factors associated with high use of a workplace web-based stress management program in a randomized controlled intervention study.

    PubMed

    Hasson, H; Brown, C; Hasson, D

    2010-08-01

    In web-based health promotion programs, large variations in participant engagement are common. The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management. Two versions of the program were offered to randomly selected departments in IT and media companies. A static version of the program including health screening tool, diary and information about stress was offered to the control group. Additional materials, i.e. interactive, cognitive-based and classical stress management exercises and a chat room, were offered to the intervention group. Baseline data regarding participants' demographics, health (self-ratings and biological measures), lifestyle, work-related factors and group membership were analyzed to study determinants of employees' participation in the program during a period of 12 months. Multiple logistic regression analysis was used and found intervention group membership, being a woman, having at most a secondary education, regular physical exercise habits and having positive expectations of the program were significant predictors of high use. The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program. Implications for those developing and implementing future web-based health promotion activities are discussed.

  8. A Natural Product Telomerase Activator Lengthens Telomeres in Humans: A Randomized, Double Blind, and Placebo Controlled Study.

    PubMed

    Salvador, Laura; Singaravelu, Gunasekaran; Harley, Calvin B; Flom, Peter; Suram, Anitha; Raffaele, Joseph M

    2016-12-01

    TA-65 is a dietary supplement based on an improved formulation of a small molecule telomerase activator that was discovered in a systematic screening of natural product extracts from traditional Chinese medicines. This study summarizes the findings on telomere length (TL) changes from a randomized, double blind, placebo controlled study of TA-65 over a 1 year period. The study was conducted on 117 relatively healthy cytomegalovirus-positive subjects aged 53-87 years old. Subjects taking the low dose of TA-65 (250 U) significantly increased TL over the 12 months period (530 ± 180 bp; p = 0.005), whereas subjects in the placebo group significantly lost TL (290 ± 100 bp; p = 0.01). The high dose of TA-65 (1000 U) showed a trend of improvements in TL compared with that of the placebo group; however, the improvements did not reach statistical significance. TL changes in the low-dose group were similar for both median and 20th percentile TLs. The findings suggest that TA-65 can lengthen telomeres in a statistically and possibly clinically significant manner.

  9. From Online Randomized Controlled Trials to Participant Preference Studies: Morphing the San Francisco Stop Smoking Site into a Worldwide Smoking Cessation Resource

    PubMed Central

    Aguilera, Adrian; Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J

    2012-01-01

    Background Internet interventions have the potential to address many of the health problems that produce the greatest global burden of disease. We present a study illustrating this potential. The Spanish/English San Francisco Stop Smoking Internet site, which yielded quit rates of 20% or more at 12 months in published randomized controlled trials (RCTs), was modified to make it accessible to Spanish- and English-speaking smokers 18 years of age or older anywhere in the world. Objective To illustrate that Internet interventions designed to conduct RCTs can be adapted to serve as universal health care resources. We also examine quit rates obtained in the current participant preference study (in which users could choose from all elements tested in previous RCTs) to determine whether they differ from the quit rates found in the RCTs. Methods We modified the San Francisco Stop Smoking Internet site so that, instead of being randomly assigned to a specific intervention, participants could personalize the site by choosing among nine site elements (eg, stop smoking guide, reminder emails, journal, mood management intervention, or virtual group). Participants completed a baseline assessment, and reported smoking and mood data at 1-, 3-, 6-, and 12-month follow-ups. We assessed the modified website’s reach and outcomes (quit rates), and compared the quit rates of the current participant preference study with those of the previous RCTs. Results In the first year of recruitment, 94,158 individuals from 152 countries and territories visited the site; 13,488 participants left some data; 9173 signed consent; 7763 completed the baseline survey; and 1955, 1362, 1106, and 1096 left 1-, 3-, 6-, and 12-month data, respectively. Observed quit rates were 38.1% (n = 668), 44.9% (n = 546), 43.6% (n = 431), and 45.4% (n = 449), respectively. The current participant preference study yielded higher observed quit rates (odds ratio 1.30) than the previous RCT when controlling for

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Cardiovascular effects of dietary salt intake in aged healthy cats: a 2-year prospective randomized, blinded, and controlled study.

    PubMed

    Chetboul, Valérie; Reynolds, Brice Stéphane; Trehiou-Sechi, Emilie; Nguyen, Patrick; Concordet, Didier; Sampedrano, Carolina Carlos; Testault, Isabelle; Elliott, Jonathan; Abadie, Jérôme; Biourge, Vincent; Lefebvre, Hervé Pierre

    2014-01-01

    High salt dry expanded diets are commercially available for cats to increase water intake and urine volume, as part of the prevention or treatment of naturally occurring urinary stone formation (calcium oxalates and struvites). However, chronic high salt intake may have potential cardiovascular adverse effects in both humans, especially in aging individuals, and several animal models. The objective of this prospective, randomized, blinded, and controlled study was to assess the long-term cardiovascular effects of high salt intake in healthy aged cats. Twenty healthy neutered cats (10.1 ± 2.4 years) were randomly allocated into 2 matched groups. One group was fed a high salt diet (3.1 g/Mcal sodium, 5.5 g/Mcal chloride) and the other group a control diet of same composition except for salt content (1.0 g/Mcal sodium, 2.2 g/Mcal chloride). Clinical examination, systolic and diastolic arterial blood pressure measurements, standard transthoracic echocardiography and conventional Doppler examinations were repeatedly performed on non-sedated cats by trained observers before and over 24 months after diet implementation. Radial and longitudinal velocities of the left ventricular free wall and the interventricular septum were also assessed in systole and diastole using 2-dimensional color tissue Doppler imaging. Statistics were performed using a general linear model. No significant effect of dietary salt intake was observed on systolic and diastolic arterial blood pressure values. Out of the 33 tested imaging variables, the only one affected by dietary salt intake was the radial early on late diastolic velocity ratio assessed in the endocardium of the left ventricular free wall, statistically lower in the high salt diet group at 12 months only (P = 0.044). In conclusion, in this study involving healthy aged cats, chronic high dietary salt intake was not associated with an increased risk of systemic arterial hypertension and myocardial dysfunction, as observed in some

  16. Low intensity vs. self-guided Internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study

    PubMed Central

    2013-01-01

    Background Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system. Methods The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed. Discussion The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting. Trial registration Clinical Trials NCT01611818 PMID:23312003

  17. Brief Intervention Decreases Drinking Frequency in HIV-Infected, Heavy Drinking Women: Results of a Randomized Controlled Trial

    PubMed Central

    Chander, Geetanjali; Hutton, Heidi E.; Lau, Bryan; Xu, Xiaoqiang; McCaul, Mary E.

    2015-01-01

    Objective Hazardous alcohol use by HIV-infected women is associated with poor HIV outcomes and HIV transmission risk behaviors. We examined the effectiveness of brief alcohol intervention (BI) among hazardous drinking women receiving care in an urban, HIV clinic. Methods Women were randomized to a 2-session BI or usual care. Outcomes assessed at baseline, 3, 6 and 12 months included 90-day frequency of any alcohol use and heavy/binge drinking (≥4 drinks per occasion), and average drinks per drinking episode. Secondary outcomes included HIV medication and appointment adherence, HIV1-RNA suppression, and days of unprotected vaginal sex. We examined intervention effectiveness using generalized mixed effect models and quantile regression. Results Of 148 eligible women, 74 were randomized to each arm. In mixed effects models, 90-day drinking frequency decreased among intervention group compared to control, with women in the intervention condition less likely to have a drinking day (OR: 0.42 (95% CI: 0.23–0.75). Heavy/binge drinking days and drinks per drinking day did not differ significantly between groups. Quantile regression demonstrated a decrease in drinking frequency in the middle to upper ranges of the distribution of drinking days and heavy/binge drinking days that differed significantly between intervention and control conditions. At follow-up, the intervention group had significantly fewer episodes of unprotected vaginal sex. No intervention effects were observed for other outcomes. Conclusions Brief alcohol intervention reduces frequency of alcohol use and unprotected vaginal sex among HIV-infected women. More intensive services may be needed to lower drinks per drinking day and enhance care for more severely affected drinkers. PMID:25967270

  18. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial.

    PubMed

    Taverner, Murray; Loughnan, Terence

    2014-02-01

    Shoulder pain is the third most common musculoskeletal problem and accounts for 5% of general practitioner consultations. Although many treatments are described, there is no consensus on optimal treatment and up to 40% of patients still have pain 12 months after initially seeking help for pain. Previously, the effect of transcutaneous pulsed radiofrequency treatment (TCPRFT) was evaluated in a retrospective audit that showed good pain relief for a mean 395 days and justified this randomized sham controlled trial. In this study, 51 patients entered into a randomized double-blinded, placebo controlled study of TCPRFT. Patients were assessed at 4 and 12 weeks by a blinded observer and compared with baseline. We observed sustained reductions in pain at night, pain with activity, and functional improvement at 4 and 12 weeks with active but not sham TCPRFT. The 25 subjects who received active treatment showed statistically significant reductions of 24/100 in pain at night and 20/100 of pain with activity at 4 weeks and 18/100 and 19/100, respectively, at 12 weeks from baseline. Statistically significant lower Brief Pain Inventory pain and function scores (4 and 12 weeks), improved pain self-efficacy (4 weeks), Oxford Shoulder scores (12 weeks), and internal rotation (12 weeks) were seen. Pain at both rest and shoulder elevation were not improved by active treatment. No complications were seen. This study of a simple, low risk, outpatient treatment confirms the findings of our earlier study of TCPRFT for knee pain and shoulder pain audit that transcutaneous pulsed radiofrequency treatment may help some people with painful shoulders.

  19. A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

    PubMed Central

    Brown, Devin L.; Conley, Kathleen M.; Sánchez, Brisa N.; Resnicow, Kenneth; Cowdery, Joan E.; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E.; Lisabeth, Lynda D.; Morgenstern, Lewis B.

    2015-01-01

    Background and Purpose The Stroke Health and Risk Education (SHARE) Project was a cluster-randomized, faith-based, culturally-sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the three outcomes was significant at the 0.05/3 level. Results Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53; 84% were Hispanic/Latino; 64% were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day (95% CI: 0.08, 0.42), p = 0.002), a greater decrease in sodium intake (−123.17 mg/day (−194.76, −51.59), p=0.04), but no difference in change in moderate or greater intensity physical activity (−27 MET-minutes per week (−526, 471), p=0.56). Conclusions This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary endpoint. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. PMID:26374480

  20. 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.

  1. A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial

    PubMed Central

    Lorig, Kate; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

    2016-01-01

    Background Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. Objective The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention Methods Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. Results A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. Conclusions Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year. PMID:27979790

  2. Correlation of EEG, CT, and MRI Brain with Neurological Outcome at 12 Months in Term Newborns with Hypoxic Ischemic Encephalopathy

    PubMed Central

    Jose, Annu; Matthai, John; Paul, Sarah

    2013-01-01

    Objective: To correlate electroencephalogram (EEG), computed tomography (CT), and magnetic resonance imaging (MRI) brain with neurological outcome at 12 months in term neonates with hypoxic ischemic encephalopathy. Design: Prospective observational study. Setting: Neonatal intensive care unit (NICU) in a tertiary care teaching hospital. Materials and Methods: The study was conducted between June 2010 and November 2011. Consecutive term neonates with perinatal asphyxia and hypoxic ischemic encephalopathy were the subjects. All babies were managed as per standard protocol. EEG was done as soon as the baby was stable and CT brain within 7 days. MRI was done at 3 months. Neurodevelpmental assessment was done at 12 months. Results: Of the 31 babies, four died and one was lost to follow-up. Neurodevelopmental at 12 months of age was normal in 15 babies. EEG was normal in six babies and all of them had a normal neurodevelopment. Thirteen of the 14 babies with burst suppression pattern were abnormal (P<0.001). CT brain was normal in 14 and all of them had normal neurodevelopment (P<0.001), while 11 of the 12 with cerebral edema had abnormal outcome (P<0.001). Of the 16 babies with normal MRI, 14 were normal, while all six babies with abnormal signals in the cortex and thalamus had abnormal outcome (P=0.002). Conclusions: A normal EEG and CT brain in a term newborn with hypoxic ischemic encephalopathy (HIE) is associated with good neurological outcome. Burst suppression pattern in EEG, bleeds, or hypodensities in the CT and involvement of basal ganglia/thalamus in the MRI are predictors of abnormal outcome. PMID:24251256

  3. Bridging the Gap across the Transition to Coparenthood: Triadic Interactions and Coparenting Representations from Pregnancy through 12 Months Postpartum

    PubMed Central

    Kuersten-Hogan, Regina

    2017-01-01

    Most family researchers agree that the coparenting relationship emerges some time during the transition to parenthood, though it is unclear whether it originates in pregnancy. Previous studies demonstrated that couples' positive representations of their future coparenting relationship and harmonious coparenting behaviors observed during prenatal triadic interactions predicted better postpartum functioning. However, previous studies did not simultaneously assess prenatal coparenting behaviors and representations as predictors of postpartum coparenting. If the coparenting relationship originates during pregnancy, these behavioral and cognitive aspects of prenatal coparenting should show associations with their postpartum counterparts. Based on family systems-, attachment-, and social-learning theory, the first aim in this study was to explore whether prenatal coparenting representations and behaviors are associated with postpartum coparenting, which would suggest that both cognitive and behavioral aspects of the coparenting relationship emerge during pregnancy. A second aim was to determine whether parental coparenting representations are consistent with concurrently observed coparenting behaviors. A sample of 55 couples expecting their first child was observed during triadic interactions during pregnancy and at 3- and 12-months postpartum. Observations were coded using the Coparenting and Family Rating System. Composite scores were formed to reflect harmonious and antagonistic coparenting behaviors. Parents' representations of harmonious and antagonistic coparenting were assessed via interviews and questionnaires during pregnancy and at 3- and 12-months postpartum. Results indicated that prenatal representations of harmonious and antagonistic coparenting were associated with and predicted unique variance in respective postpartum coparenting representations. Prenatal coparenting behaviors were also associated with coparenting behaviors observed during 3-months

  4. Risk factors associated with high thyroglobulin level following radioactive iodine ablation, measured 12 months after treatment for papillary thyroid carcinoma

    PubMed Central

    Kim, Eun Young; Hyun, Kee Hoon; Park, Yong Lai; Park, Chan Heun

    2017-01-01

    Purpose The measurement of serum thyroglobulin (Tg) of papillary thyroid carcinoma patients, 12 months after total thyroidectomy and radioactive iodine (RAI) ablation following thyroxine hormone withdrawal (T4-off Tg) or recombinant human thyroid-stimulating hormone stimulation (rhTSH-Tg), is standard method for monitoring disease status. The aim of this study was to find predictive factors for detectable T4-off Tg during follow-up. Methods A retrospective review was conducted of 329 patients who underwent total thyroidectomy and RAI ablation between October 2008 and August 2012. Subjects were assigned to high (>1 ng/mL, n = 53) and low (≤1 ng/mL, n = 276) groups, based on T4-off Tg measured 12 months postoperatively. Demographic and clinicopathological characteristics at diagnosis and follow-up were compared between the 2 groups. Results The low and high T4-off Tg groups differed with respect to tumor size, preoperative Tg, ablative Tg, cervical lymph node metastasis, thyroglobulinemia out of proportion to results of diagnostic whole body scan, and American Thyroid Association 3-level stratification and restratification. Multivariate analysis confirmed that ablative Tg > 1.0 ng/mL (odds ratio [OR], 10.801; P = 0.001), more than 5 cervical lymph node metastasis (OR, 6.491; P = 0.003), and thyroglobulinemia out of proportion (OR, 9.221; P = 0.000) were risk factors. Conclusion Ablative Tg >1.0 ng/mL, more than 5 cervical lymph node metastasis, and thyroglobulinemia out of proportion were independent factors for T4-off Tg >1 ng/mL 12 months postoperative. In low-risk patients without these risk factors, the possible omission of Tg measurements could be considered during follow-up. PMID:28090499

  5. Factors Associated with Suicide Outcomes 12-months After Screening Positive for Suicide Risk in the Emergency Department

    PubMed Central

    Arias, Sarah A.; Miller, Ivan; Camargo, Carlos A.; Sullivan, Ashley F.; Goldstein, Amy B.; Allen, Michael H.; Manton, Anne P.; Boudreaux, Edwin D.

    2016-01-01

    Objective The main objective is to identify which patient characteristics have the strongest association with suicide outcomes during the 12-months after the index emergency department (ED) visit. Methods Data were analyzed from the first two phases of the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE). The ED-SAFE study, a quasi-experimental, interrupted time series design, involved participation from eight general medical EDs across the United States. Participants included adults presenting to the ED with active suicidal ideation or an attempt in the last week. Data collection included baseline interview; 6- and 12-month chart reviews; and 6-, 12-, 24-, 36-, and 52-week telephone follow-up assessments. Regression analyses were conducted. Results Among 874 participants, the median age was 37 years (interquartile range 27–47) with 56% female (n=488), 74% white (n=649), and 13% Hispanic (n=113). At baseline, 577 (66%) had suicidal ideation only while 297 (34%) had a suicide attempt in the past week. Data sufficient to determine outcomes were available for 782 (90%). In the 12-months after the index ED visit, 195 (25%) had documentation of at least one suicide attempt or suicide. High school education or less, an ED visit in the preceding 6 months, prior non-suicidal self-injury (NSSI), current alcohol misuse, and intent or plan were predictive of future suicidal behavior. Conclusions and Relevance Continuing to build an understanding of the factors associated with future suicide behaviors for this population will help guide design and implementation of improved suicide screening and interventions in the ED and allocation of scarce resources. PMID:26620285

  6. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants From Birth to 12 Months of Age

    PubMed Central

    Vandenplas, Yvan; Abkari, Abdelhak; Bellaiche, Marc; Benninga, Marc; Chouraqui, Jean Pierre; ÇokuÐraþ, FügenÇullu; Harb, Tracy; Hegar, Badriul; Lifschitz, Carlos; Ludwig, Thomas; Miqdady, Mohamed; de Morais, Mauro Batista; Osatakul, Seksit; Salvatore, Silvia; Shamir, Raanan; Staiano, Annamaria; Szajewska, Hania; Thapar, Nikhil

    2015-01-01

    ABSTRACT Objectives: The aim of the study was to review published evidence and the opinion of practising clinicians on the prevalence and long-term health consequences of functional gastrointestinal symptoms in infants younger than 12 months. Methods: PubMed was searched from inception to November 2014 to find articles reporting the prevalence and long-term health outcomes of infantile colic, regurgitation, functional constipation, functional diarrhoea, and dyschezia in infants younger than <12 months. A questionnaire was sent to practising clinicians worldwide, and a group of 15 international experts met to discuss the likely frequency and longer-term consequences of these symptoms. Results: The literature search identified 30 studies reporting the prevalence of infantile colic (2%–73%), 13 that of regurgitation (3%–87%), 8 that of functional constipation (0.05%–39.3%), 2 that of functional diarrhoea (2%–4.1%), and 3 that of dyschezia (0.9%–5.6%). The studies varied in design, populations investigated, and definition of the symptoms. Questionnaires were received from 369 respondents. The experts agreed that the likely prevalences for colic, regurgitation, and functional constipation were 20%, 30%, and 15%, respectively. The limited data in the literature for functional diarrhoea and dyschezia suggest prevalences <10%. Infantile colic may be associated with future health problems in a subset of infants. Conclusions: Functional gastrointestinal symptoms appear to occur in a significant proportion of infants younger than 12 months and may have an impact on future health outcomes. Prospective collection of data according to agreed criteria is needed to obtain more accurate estimates of the prevalence and consequences of these symptoms. PMID:26308317

  7. The Influence of Back Pain and Urinary Incontinence on Daily Tasks of Mothers at 12 Months Postpartum

    PubMed Central

    McDonald, Sheila W.; Tough, Suzanne C.

    2015-01-01

    Objective The present study examined back pain (BP) and/or urinary incontinence (UI) impact on the ability to perform daily tasks at 12 months after childbirth in healthy reproductive women who sought maternity care in community based family practice clinics. Methods This study is a secondary analysis from the All Our Babies Study, a prospective, community-based pregnancy cohort in Calgary, Alberta. Maternal self-reported information on demographics, lifestyle, experiences with pregnancy and childbirth, occurrence of BP, UI and consequent impairment of daily tasks were collected by questionnaires administered before 25 weeks, at 34-36 weeks gestation and at 4 and 12 months postpartum. The occurrence and severity of BP and UI at one year after childbirth was assessed using descriptive and bivariate analyses. Logistic regression models examined the association between demographic and obstetrical variables and the severity of functional impairment due to UI and BP. Results From 1574 women with singleton pregnancies included in the study, 1212 (77%) experienced BP, 773 (49%) UI, and 620 (40%) both BP and UI. From the 821 women reporting impairment of daily tasks due to BP, 199 (24 %) were moderately and 90 (11%) severely affected with the remainder, 532 (64%) being mildly affected. From 267 women with functional impairment due to UI, 52 (19%) reported moderately to severe impairment in their ability to perform daily tasks. Obesity and parity were risk factors for impairment of daily functioning due to BP, whereas obesity and vaginal delivery increased the risk of moderate to severe impairment due to UI. Conclusions BP and UI are common occurrences 1 year after childbirth. Maternal performance of daily tasks and women’s health and quality of life are more often impaired due to BP than UI. Our study brings new evidence of the risk factors that predict severity and impact of these conditions on women functioning at 12 months postpartum. PMID:26083252

  8. Disturbed intracortical excitability in early Parkinson's disease is l-DOPA dose related: a prospective 12-month paired TMS study.

    PubMed

    Bares, Martin; Kanovský, Petr; Rektor, Ivan

    2007-12-01

    We were interested to know if chronic l-DOPA treatment in Parkinson's disease (PD) patients could restore impairment of the intracortical excitability, when this difference could occur, and if it was related to the total daily dose of l-DOPA. Twelve patients with early PD were studied using paired transcranial magnetic stimulation before the administration of l-DOPA, and then after 3, 6, and 12 months of l-DOPA treatment. The level of disturbed intracortical excitability strongly correlated with the total daily dose of l-DOPA. The level of cortical excitability in PD patients seems to be indirectly related to the nigro-striatal functioning.

  9. Plasma arc versus halogen light-curing of adhesive-precoated orthodontic brackets: a 12-month clinical study of bond failures.

    PubMed

    Cacciafesta, Vittorio; Sfondrini, Maria Francesca; Scribante, Andrea

    2004-08-01

    The purpose of this randomized clinical trial was to evaluate the performance of adhesive-precoated brackets cured with 2 different light-curing units (conventional halogen light and plasma arc light). Thirty patients treated with fixed appliances were included in the investigation. Each patient's mouth was divided by the split-mouth design into 4 quadrants. In 15 randomly selected patients, the maxillary left and mandibular right quadrants were cured with the halogen light, and the remaining quadrants were cured with the plasma arc light. In the other 15 patients, the quadrants were inverted. A total of 600 adhesive precoated stainless steel brackets were examined: 300 were cured with a conventional halogen light for 20 seconds, and the others were cured with the plasma arc light for 5 seconds. The number, cause, and date of bracket failures were recorded for each light-curing unit over 12 months. Statistical analysis was performed with the Fisher exact test, Kaplan-Meier survival estimates, and the log-rank test. No statistically significant differences in bond failure rates were found between the adhesive-precoated brackets cured with the halogen light and those cured with the plasma arc light; neither were any significant differences in performance found with each light-curing unit between the maxillary and mandibular arches. Plasma arc lights can be considered an advantageous alternative to conventional light curing, because they enable the clinician to reduce the curing time of adhesive-precoated orthodontic brackets without significantly affecting their bond failure rate.

  10. Standardization for subgroup analysis in randomized controlled trials.

    PubMed

    Varadhan, Ravi; Wang, Sue-Jane

    2014-01-01

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

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

    PubMed

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

    2005-09-01

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

  12. 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

  13. The efficacy and tolerability of risedronate on bone mineral density and bone turnover markers in osteoporotic Chinese women: a randomized placebo-controlled study.

    PubMed

    Leung, Jenny Y Y; Ho, Andrew Y Y; Ip, T P; Lee, Gavin; Kung, Annie W C

    2005-02-01

    Osteoporosis has become an important health problem in postmenopausal Asian populations as the prevalence of hip and vertebral fractures in some Asian countries has risen to approach that of Caucasian populations. Risedronate, a pyridinyl-bisphosphonate agent, is a potent inhibitor of bone resorption. Risedronate increases bone mineral density (BMD), reduces markers of bone turnover, and reduces the risk of fractures in Caucasian postmenopausal women. To determine the efficacy and tolerability of risedronate in Chinese, a multicenter, randomized, double blind, placebo controlled study was performed in Hong Kong. Sixty-five (65) postmenopausal osteoporotic Southern Chinese women, aged 67+/-6 years, were randomly assigned to receive either risedronate 5 mg daily (n=31) or placebo (n=34) for 12 months. All women received calcium carbonate 500 mg daily and vitamin D 400 IU daily. Mean baseline BMD T-score at the spine and total hip was -3.4 and -2.6, respectively. A significant increase in spine BMD was already evident at month 3 of risedronate treatment (P<0.001). Risedronate significantly increased BMD and reduced bone turnover markers as compared with placebo. The risedronate group had significant increase in BMD at 12 months at both the spine and hip when compared with the placebo group (L1-4 6.6% vs. 0.4%, P<0.001; total hip 2.7% vs. 0.3, P<0.0001; femoral neck 1.8% vs. 1.1%, P<0.02; trochanter 4% vs. 1.1%, P<0.0001, respectively). Significant changes in urine N-telopeptide (NTx) and serum osteocalcin were evident as early as 1 and 3 months, respectively, with risedronate treatment. No significant changes were seen in both BMD and bone markers in the placebo group. Risedronate was well tolerated without major adverse effects. We conclude that risedronate is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis in Asian population.

  14. Effects of insecticide-treated bednets during early infancy in an African area of intense malaria transmission: a randomized controlled trial.

    PubMed Central

    Müller, Olaf; Traoré, Corneille; Kouyaté, Bocar; Yé, Yazoumé; Frey, Claudia; Coulibaly, Boubacar; Becher, Heiko

    2006-01-01

    OBJECTIVE: Insecticide-impregnated bednets and curtains have been shown by many studies to be effective against malaria. However, because of possible interactions with immunity development, treated bednets may cause no effect at all or even an increase in malaria morbidity and mortality in areas of high transmission. To clarify this issue, we did a randomized controlled trial to assess the long-term effects of bednet protection during early infancy. METHODS: A total of 3387 neonates from 41 villages in rural Burkina Faso were individually randomized to receive either bednet protection from birth (group A) or from age 6 months (group B). Primary outcomes were all-cause mortality in all study children and incidence of falciparum malaria in a representative subsample of the study population. FINDINGS: After a mean follow-up of 27 months, there were 129 deaths in group A and 128 deaths in group B rate ratio (RR) 1.0 (95% confidence interval (CI): 0.78-1.27)). Falciparum malaria incidence was lower in group A than in group B, during early (0-5 months) and late infancy (6-12 months) (RR 3.1, 95% CI: 2.0-4.9; RR 1.3, 95% CI: 1.1-1.6) and rates of moderate to severe anaemia were significantly lower during late infancy (11.5% vs 23.3%, P = 0.008), but there were no differences between groups in these parameters in children older than 12 months. CONCLUSION: The findings from this study provide additional evidence for the efficacy of insecticide-treated nets in young children living in areas of intense malaria transmission. PMID:16501729

  15. An open randomized active-controlled clinical trial with low-dose SKA cytokines versus DMARDs evaluating low disease activity maintenance in patients with rheumatoid arthritis

    PubMed Central

    Martin-Martin, LS; Giovannangeli, F; Bizzi, E; Massafra, U; Ballanti, E; Cassol, M; Migliore, A

    2017-01-01

    Background Biologic agents are currently the strongest immunosuppressive drugs able to induce remission in rheumatoid arthritis (RA). One of the objectives of the medical scientific community now is how to maintain remission or low disease activity (LDA). The aim of this trial is to evaluate the contribution of low-dose sequential kinetic activation (SKA) IL-4, IL-10, and anti-IL-1 antibodies (10 fg/mL) in patients affected by RA in maintaining LDA or remission obtained after biological therapy. Method This is a randomized, open, active-controlled, prospective, Phase IV trial. Disease activity score (DAS28), clinical disease activity index, simplified disease activity index, erythrocyte sedimentation rate and C-reactive protein levels, global health assessment, and pain visual analog scale were evaluated at baseline visit and then every 3 months together with an assessment of side effects till 12 months. Thirty-nine RA patients were enrolled and randomized to continue disease-modifying antirheumatic drugs (DMARDs) therapy or to receive a combination of SKA low-dose cytokines formulated in concentration of 10 fg/mL orally administered at a dose of 20 drops/d for 12 consecutive months. Results The rate of maintenance of LDA at 12 months was superior in the group treated with low-dose cytokines compared with patients treated with DMARDs, 66.7% and 42.1%, respectively; however, the difference between the groups was not statistically significant. No side effects were reported in both groups. Conclusion This is the first study using a combination of three low-dose cytokines in RA, after data published on psoriasis. These data suggest that the use of a combination of low-dose SKA cytokines may be an opportunity to explore in the management of RA.

  16. Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study

    PubMed Central

    2012-01-01

    Background Traditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years. This study aimed to evaluate the efficacy and safety of the comprehensive therapy based on the three common TCM patterns in stable COPD patients. Methods A four-center, open-label randomized controlled method was conducted. A total of 352 patients were divided into the trial group (n = 176, treated with conventional Western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on the TCM patterns respectively) and the control group (n = 176, treated with conventional Western medicine). The frequency and duration of acute exacerbation, lung function, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scale and quality of life were observed during a 6-month treatment period and at a further 12-month follow-up. Results A total of 306 patients completed the study fully. The full analysis set (FAS) population was 350 and the per-protocol analysis set (PPS) population was 306. After the 6-month treatment and 12-month follow-up, there were significant differences between the trial and control group in the following: frequency of acute exacerbation (FAS: P = 0.000; PPS: P = 0.000); duration of acute exacerbation (FAS: P = 0.000; PPS: P = 0.001); FEV1 (FAS: P = 0.007; PPS: P = 0.008); symptoms (FAS: P = 0.001; PPS: P = 0.001); 6MWD (FAS: P = 0.045; PPS: P = 0.042); dyspnea scale (FAS: P = 0.002; PPS: P = 0.004); and physical domain (FAS: P = 0.000; PPS: P = 0.000), psychological domain (FAS: P = 0.008; PPS: P = 0.011), social domain (FAS: P = 0.001; PPS: P = 0.000) and environment domain (FAS: P = 0.015; PPS: P = 0.009) of the WHOQOL-BREF questionnaire. There were no differences between the trial and control group in FVC, FEV1% and adverse events. Conclusions Based on the TCM patterns, Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on measured

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

    NASA Astrophysics Data System (ADS)

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

    2004-07-01

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

  18. Neural correlates of face processing in etiologically-distinct 12-month-old infants at high-risk of autism spectrum disorder.

    PubMed

    Guy, Maggie W; Richards, John E; Tonnsen, Bridgette L; Roberts, Jane E

    2017-03-16

    Neural correlates of face processing were examined in 12-month-olds at high-risk for autism spectrum disorder (ASD), including 21 siblings of children with ASD (ASIBs) and 15 infants with fragile X syndrome (FXS), as well as 21 low-risk (LR) controls. Event-related potentials were recorded to familiar and novel face and toy stimuli. All infants demonstrated greater N290 amplitude to faces than toys. At the Nc component, LR infants showed greater amplitude to novel stimuli than to their mother's face and own toy, whereas infants with FXS showed the opposite pattern of responses and ASIBs did not differentiate based on familiarity. These results reflect developing face specialization across high- and low-risk infants and reveal neural patterns that distinguish between groups at high-risk for ASD.

  19. Effectiveness of a Web-Based Physical Activity Intervention in Patients With Knee and/or Hip Osteoarthritis: Randomized Controlled Trial

    PubMed Central

    Veenhof, Cindy; Van Beek, Karin EC; Spreeuwenberg, Peter MM; Dekker, Joost; De Bakker, Dinny H

    2013-01-01

    Background Patients with knee and/or hip osteoarthritis (OA) are less physically active than the general population, while the benefits of physical activity (PA) have been well documented. Based on the behavioral graded activity treatment, we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA, entitled “Join2move”. The Join2move intervention is a self-paced 9-week PA program in which the patient’s favorite recreational activity is gradually increased in a time-contingent way. Objective The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA, physical function, and self-perceived effect compared with a waiting list control group. Methods The study design was a two-armed randomized controlled trial which was not blinded. Volunteers were recruited via articles in newspapers and health-related websites. Eligibility criteria for participants were: (1) aged 50-75 years, (2) self-reported knee and/or hip OA, (3) self-reported inactivity (30 minutes of moderate PA, 5 times or less per week), (4) no face-to-face consultation with a health care provider other than general practitioners, for OA in the last 6 months, (5) ability to access the Internet weekly, and (6) no contra-indications to exercise without supervision. Baseline, 3-month, and 12-month follow-up data were collected through online questionnaires. Primary outcomes were PA, physical function, and self-perceived effect. In a subgroup of participants, PA was measured objectively using accelerometers. Secondary outcomes were pain, fatigue, anxiety, depression, symptoms, quality of life, self-efficacy, pain coping, and locus of control. Results Of the 581 interested respondents, 199 eligible participants were randomly assigned to the intervention (n=100) or waiting list control group (n=99). Response rates of questionnaires were 84.4% (168/199) after 3 months and

  20. Comparative effectiveness of next generation genomic sequencing for disease diagnosis: Design of a randomized controlled trial in patients with colorectal cancer/polyposi