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Sample records for 6-month randomized controlled

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-09-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2015-07-01

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

  5. Child-Parent Psychotherapy: 6-Month Follow-up of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Lieberman, Alicia F.; Ippen, Chandra Ghosh; Van Horn, Patricia

    2006-01-01

    Objective: To examine the durability of improvement in child and maternal symptoms 6 months after termination of child-parent psychotherapy (CPP). Method: Seventy-five multiethnic preschool-age child-mother dyads from diverse socioeconomic backgrounds were randomly assigned to (1) CPP or (2) case management plus community referral for individual…

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  9. Systemic antimicrobials adjunctive to a repeated mechanical and antiseptic therapy for aggressive periodontitis: a 6-month randomized controlled trial.

    PubMed

    Varela, Victor M; Heller, Débora; Silva-Senem, Mayra X; Torres, Maria Cynésia M B; Colombo, Ana Paula V; Feres-Filho, Eduardo J

    2011-08-01

    The purpose of this study is to compare the additional benefit of systemic antimicrobials versus placebos to a repeated mechanical instrumentation combined with comprehensive local chemical plaque control for the periodontal treatment of generalized aggressive periodontitis (GAgP). This was a 6-month randomized, double-masked, placebo-controlled clinical trial. All GAgP patients received full-mouth disinfection followed by staged scaling and root planing without (placebo group; n = 17) or with (test group; n = 18) systemic antimicrobials (500 mg amoxicillin [AMX] + 250 mg metronidazole [MET]; three times a day for 10 days). Clinical parameters were measured at baseline and 3 and 6 months post-therapy. Significant differences between groups at baseline were sought by using the Mann-Whitney U test, whereas comparisons over time were examined by using a general linear model repeated measures procedure. Both groups demonstrated similar improvements in most parameters over time. The test group presented a greater mean probing depth (PD) reduction and clinical attachment level (CAL) gain at sites with initially moderate PD at 6 months (P <0.03). No differences were seen between groups regarding mean reductions and mean gains, respectively, for PD and CAL initially ≥7 mm. The test group presented a higher percentage of sites that improved ≥2 mm and ended up with PD ≤4 mm or a lower percentage of sites that worsened ≥2 mm and remained with PD >4 mm at 3 months (P <0.01). No differences were noticed between groups for these parameters at 6 months. AMX + MET brought additional clinical effects to the repeated mechanical and antiseptic treatment of GAgP in a very short time (3 months), which tended to fade away over time (6 months).

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

    PubMed

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

    2009-01-01

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

  11. Randomized controlled trial of early rehabilitation after intracerebral hemorrhage stroke: difference in outcomes within 6 months of stroke.

    PubMed

    Liu, Ning; Cadilhac, Dominique A; Andrew, Nadine E; Zeng, Lingxia; Li, Zongfang; Li, Jin; Li, Yan; Yu, Xuewen; Mi, Baibing; Li, Zhe; Xu, Honghai; Chen, Yangjing; Wang, Juan; Yao, Wanxia; Li, Kuo; Yan, Feng; Wang, Jue

    2014-12-01

    Mechanisms, acute management, and outcomes for patients who experience intracerebral hemorrhage may differ from patients with ischemic stroke. Studies of very early rehabilitation have been mainly undertaken in patients with ischemic stroke, and it is unknown if benefits apply to those with intracerebral hemorrhage. We hypothesized that early rehabilitation, within 48 hours of stroke, would improve survival and functional outcomes in patients with intracerebral hemorrhage. This was a multicenter, randomized controlled study, with blinded assessment of outcome at 3 and 6 months. Eligible patients were randomized to receive standard care or standard care plus early rehabilitation. Primary outcome includes survival. Secondary outcomes includes health-related quality of life using the 36-item Short Form Questionnaire, function measured with the modified Barthel Index, and anxiety measured with the Zung Self-Rated Anxiety Scale. Two hundred forty-three of 326 patients were randomized (mean age, 59 years; 56% men). At 6 months, patients receiving standard care were more likely to have died (adjusted hazard ratio, 4.44; 95% confidence interval [CI], 1.24-15.87); for morbidity outcomes, a 6-point difference in the Physical Component Summary score of the 36-item Short Form Questionnaire (95% CI, 4.2-8.7), a 7-point difference for the Mental Component Summary score (95% CI, 4.5-9.5), a 13-point difference in Modified Barthel Index scores (95% CI, 6.8-18.3), and a 6-point difference in Self-Rating Anxiety Scale scores (95% CI, 4.4-8.3) was reported in favor of the intervention groups. For the first time, we have shown that commencing rehabilitation within 48 hours of intracerebral hemorrhage improves survival and functional outcomes at 6 months after stroke in hospitalized patients in China. http://www.chictr.org/en. Unique identifier: ChiCTR-TRC-13004039. © 2014 American Heart Association, Inc.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

    2013-01-01

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

  15. A randomized controlled trial of the effectiveness of a one-step conditioning agent in sealant placement: 6-month results.

    PubMed

    Burbridge, L; Nugent, Z; Deery, C

    2006-11-01

    The objectives of this study were: to compare the retention of fissure sealants (sealants) placed on occlusal surfaces following the use of a self-etching priming agent and traditional acid etch; to compare the caries incidence of occlusal surfaces sealed using the two techniques; and to compare the ease of placement of sealant following the use of the two techniques, as assessed by subjects and operators. The study took the form of a randomized controlled trial conducted in UK National Health Service community dental service and dental hospital clinics. Sixty subjects were recruited to this study by seven dental professionals who placed sealants on lower permanent molar pairs. The technique used for enamel preparation prior to sealant placement on the right and left side of the lower arch was randomized. On one side of the lower arch, Xeno III was used to prepare the occlusal enamel, and on the other, phosphoric acid etch together with Prime & Bond was used. Opaque Delton was used to seal all surfaces. Subjects were blinded to the techniques used. The subjects and operators recorded their impressions of the techniques used on individual questionnaires. Forty-six (77%) of the 60 subjects were reviewed by the principal researcher after 6 months. The retention of the acid-etch group was significantly superior (P < 0.01), as was the caries preventive effect (P < 0.01). Subjects tended to report that placement of sealants was easier following enamel preparation with Xeno III (P = 0.085), and in the opinion of the operators, sealants were significantly easier to place when using Xeno III (P = 0.016). In view of the findings of this investigation, best practice for the placement of sealants remains enamel preparation with acid etch and the use of an intermediate bonding layer.

  16. Diabetic foot ulcer burden may be modified by high-dose atorvastatin: A 6-month randomized controlled pilot trial.

    PubMed

    Johansen, Odd Erik; Birkeland, Kåre Inge; Jørgensen, Anders Palmstrøm; Orvik, Elsa; Sørgård, Beate; Torjussen, Bjørn Rino; Ueland, Thor; Aukrust, Pål; Gullestad, Lars

    2009-09-01

    Diabetic foot ulcers (DFUs) are common complications of diabetes mellitus (DM), with a complex pathogenesis. Treatment is difficult and no single treatment with measurable clinical impact is available. In the present clinical pilot trial, we investigated whether statins could be of use against some of the pathogenic factors in DFUs. Thirteen diabetic patients (10 men; 11 with Type 2 DM; mean age 64 years; mean duration of DM 18 years) with neuropathic DFUs <4 months were randomized to treatment with either 10 mg (six patients; six ulcers) or 80 mg (seven patients; nine ulcers) atorvastatin for 6 months in addition to conventional DFU care (i.e. prompt debridement, DFU pressure relief, and management of any underlying infection). There were no significant differences in background factors (i.e. HbA1c 8.9%, micro- and macrovascular complications, concomitant medications) or DFU characteristics (duration, surface area, grading) between the two groups. All ulcers in the group receiving 10 mg atorvastatin healed, compared with six of nine ulcers in the group receiving 80 mg atorvastatin (NS). However, two previously healed DFUs recurred and six new DFUs developed in the low-dose group compared with none and one, respectively, in the high-dose group (P = 0.048). There was a significant decrease in C-reactive protein (-1.5 mg/L; P = 0.044) and a non-significant trend towards beneficial effects on lipids and the ankle-arm blood pressure index in the high-dose compared with the low-dose group.   We observed a possible beneficial effect of 6-months high-dose atorvastatin on DFUs, which should be tested in appropriately sized prospective studies. © 2009 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd.

  17. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial.

    PubMed

    Iorio-Siciliano, Vincenzo; Blasi, Andrea; Nicolò, Michele; Iorio-Siciliano, Alessandro; Riccitiello, Francesco; Ramaglia, Luca

    The aim of this study was to evaluate the clinical remodeling of the alveolar socket following the application of bovine-derived xenograft collagen and collagen membrane compared to natural spontaneous healing during the first 6 months following tooth extraction. A total of 20 patients with 20 fresh alveolar sockets were randomly allocated into a test or control group. After a 6-month follow-up period, surgical reentry was performed and implants were placed. Significant statistical differences were recorded in terms of vertical and horizontal bone changes between the test and control groups. Within the limitations of this study, socket preservation procedures may provide more favorable conditions for subsequent implant placement.

  18. Efficacy of a new mouth rinse formulation based on 0.07% cetylpyridinium chloride in the control of plaque and gingivitis: a 6-month randomized clinical trial.

    PubMed

    Costa, Xavier; Laguna, Estefanía; Herrera, David; Serrano, Jorge; Alonso, Bettina; Sanz, Mariano

    2013-11-01

    To assess the efficacy of a 0.07% cetylpyridinium chloride (CPC) mouth rinse in the control of plaque and gingival inflammation during a 6-month period. Adult subjects with moderate gingivitis were selected [≥40% bleeding on marginal probing (BOMP)]. After retrieving microbiological samples and evaluating the clinical parameters (plaque, BOMP and stain indexes), a professional prophylaxis was performed and subjects were randomly assigned to the test (CPC mouth rinse) or to the placebo group. Subjects were re-assessed after 3 and 6 months. A total of 67 patients (35 test, 32 placebo) were included in the analysis. At 6 months, intra-group significant plaque reductions were observed in the test group (0.691, p < 0.001), but not in the placebo (0.181, p = 0.653). At 6 months, the mean BOMP values were lower in the test group (p = 0.052). Changes between baseline and 6 months were significantly higher in the test group both for plaque (p = 0.002) and BOMP (p = 0.037) when compared with the placebo. A microbiological impact was observed in the test group, especially for Prevotella intermedia. The evaluated 0.07% CPC-based mouth rinse, used three times per day adjunctively to mechanical tooth cleaning, prevents plaque accumulation and gingival inflammation, as compared to the placebo, for at least 6 months. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

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

    2014-04-01

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

  20. Randomized Controlled Trial of Abstinence and Safer Sex Intervention for Adolescents in Singapore: 6-Month Follow-Up

    ERIC Educational Resources Information Center

    Wong, Mee Lian; Ng, Junice Y. S.; Chan, Roy K. W.; Chio, Martin T. W.; Lim, Raymond B. T.; Koh, David

    2017-01-01

    We assessed the efficacy of an individual-based behavioral intervention on sexually transmitted infections' (STI) risk-reduction behaviors in Singapore. A randomized controlled trial of a behavioral intervention compared to usual care was conducted on sexually active heterosexual adolescents aged 16-19 years attending the only public STI clinic.…

  1. Long-term efficacy of a 0.07% cetylpyridinium chloride mouth rinse in relation to plaque and gingivitis: a 6-month randomized, vehicle-controlled clinical trial.

    PubMed

    Van Leeuwen, M P C; Rosema, N A M; Versteeg, P A; Slot, D E; Van Winkelhoff, A J; Van der Weijden, G A

    2015-05-01

    To evaluate the effectiveness of 0.07% cetylpyridinium chloride (CPC) mouth rinse for reduction of gingival inflammation and inhibition of plaque compared to a vehicle control (VC) mouth rinse over a 6-month period. Participants (n = 62) used their randomly assigned product as adjunct to toothbrushing. Bleeding, plaque and staining scores were assessed at baseline, 3 and 6 months. Plaque and saliva samples were taken at each assessment monitoring possible shifts in the composition of the microbiota. A significant difference (P = 0.002) in favour of the CPC mouth rinse, with respect to plaque scores, was found. Bleeding scores at 6 months were not significantly different (P = 0.089). However, when correcting for baseline values, a tendency towards a significant difference in bleeding scores at end trail was observed in favour of the CPC mouth rinse (P = 0.061). Regarding staining at 3 and 6 months, a small but significant difference (8.6% and 10.4%, respectively) (P < 0.0001) was observed with lower scores for the VC group. There was a significant reduction in total anaerobic count in the CPC group at 6 months (P < 0.05). The ratio of aerobes/anaerobes was markedly increased at 3 months, especially in the CPC group. No further differences were observed between groups at 6 months. The use of 0.07% CPC mouth rinse was significantly more effective in reducing plaque scores than the vehicle control. Bleeding scores were not different at 6 months. The test product was well accepted and did not cause any serious clinical side effects or negatively affected the microbiota. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Effectiveness of 6 months of tailored text message reminders for obese male participants in a worksite weight loss program: randomized controlled trial.

    PubMed

    Kim, Ju-Young; Oh, Sohee; Steinhubl, Steven; Kim, Sohye; Bae, Woo Kyung; Han, Jong Soo; Kim, Jeong-Hyun; Lee, Keehyuck; Kim, Mi Jin

    2015-02-03

    Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight, but costs and insufficient sustained motivation prevent the majority of these programs from succeeding. Tailored text messaging in aiding weight management has been effective in several studies, but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program. We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration. The study was an unblinded, randomized controlled trial. Men with a body mass index greater than 25 kg/m(2) were recruited from the Korea District Heating Corporation, the Korea Expressway Corporation, and the Korea Gas Corporation. The participants were identified by nurse managers. Participants were randomly allocated to 1 of the following 2 groups for 24 weeks: (1) intervention group, which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and (2) control group, which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months. The primary outcome was the difference in weight loss at 6 months. A mixed-model repeated-measures analysis was performed to evaluate the effect of the intervention group's weight loss compared with the control group. A total of 205 obese men were randomized into either the intervention (n=104) or the control group (n=101). At the end of 6 months, the intervention group (n=63) had lost 1.71 kg (95% CI -2.53 to -0.88) and the control group (n=59) had lost 1.56 kg (95% CI -2.45 to -0.66); the difference between the 2 groups was not significant (mean difference -0.15, 95% CI -1.36 to 1.07). At the end of the study, 60% (34/57) of the intervention group

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

    PubMed Central

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

    2016-01-01

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

  4. Pilates exercise or stationary cycling for chronic nonspecific low back pain: does it matter? a randomized controlled trial with 6-month follow-up.

    PubMed

    Marshall, Paul W M; Kennedy, Suzanne; Brooks, Cristy; Lonsdale, Chris

    2013-07-01

    Randomized controlled trial. This is the companion study to a previous publication that presented 8-week pain, disability, and trunk muscle motor control results. The objective of this study was to compare the effect of 8 weeks of specific trunk exercises and stationary cycling on outcomes measures of catastrophizing and fear-avoidance beliefs (FAB) in patients with chronic nonspecific low back pain, and provide 6-month outcome data for all self-report measures. It is thought that any form of moderate-to-vigorous physical activity is sufficient to address catastrophizing and FAB, and concomitant levels of pain and disability. Sixty-four patients with low back pain were randomly assigned to 8 weeks of specific trunk exercise group (SEG), or stationary cycling group (CEG). Self-rated pain, disability, catastrophizing and FAB scores were collected before, immediately after (8 wk), and 6 months after the training program. Clinically meaningful improvements were defined as greater than a 30% reduction from baseline in pain and disability scores. "Intention-to-treat" principles were used for missing data. Per-protocol analysis was performed on participants who attended at least two-thirds of the exercise sessions. At 8 weeks, disability was significantly lower in the SEG compared with the CEG (d = 0.62, P = 0.018). Pain was reduced from baseline in both the groups after training (P < 0.05), but was lower for the SEG (P < 0.05). FAB scores were reduced in the SEG at 8 weeks, and in the CEG at 6 months. No between-group differences in FAB scores were observed. Similar reductions in catastrophizing in each group were observed at each time point. At 6 months, the overall data pattern suggested no long-term difference between groups. Per-protocol analysis of clinically meaningful improvements suggests no between-group differences for how many patients are likely to report improvement. Inferential statistics suggest greater improvements at 8 weeks, but not 6 months, for the

  5. Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial.

    PubMed

    Nelissen, Rik C; den Besten, Christine A; Mylanus, Emmanuel A M; Hol, Myrthe K S

    2016-01-01

    The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test-control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.

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

    PubMed Central

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

    2016-01-01

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

  7. Efficacy of Febuxostat for Slowing the GFR Decline in Patients With CKD and Asymptomatic Hyperuricemia: A 6-Month, Double-Blind, Randomized, Placebo-Controlled Trial.

    PubMed

    Sircar, Dipankar; Chatterjee, Soumya; Waikhom, Rajesh; Golay, Vishal; Raychaudhury, Arpita; Chatterjee, Suparna; Pandey, Rajendra

    2015-12-01

    Hyperuricemia is a putative risk factor for the progression of chronic kidney disease (CKD). We hypothesized that control of asymptomatic hyperuricemia may slow disease progression in CKD. This was a single-center, double-blind, randomized, parallel-group, placebo-controlled study. Eligible participants were adults from Eastern India aged 18 to 65 years with CKD stages 3 and 4, with asymptomatic hyperuricemia. The intervention group received febuxostat, 40mg, once daily for 6 months, while the placebo group received placebo; both groups were followed up for 6 months. The primary outcome was the proportion of patients showing a >10% decline in estimated glomerular filtration rate (eGFR) from baseline in the febuxostat and placebo groups. Secondary outcomes included changes in eGFRs in the 2 groups from baseline and at the end of the study period. 45 patients in the febuxostat group and 48 in the placebo group were analyzed. Mean eGFR in the febuxostat group showed a nonsignificant increase from 31.5±13.6 (SD) to 34.7±18.1mL/min/1.73m(2) at 6 months. With placebo, mean eGFR decreased from a baseline of 32.6±11.6 to 28.2±11.5mL/min/1.73m(2) (P=0.003). The difference between groups was 6.5 (95% CI, 0.08-12.81) mL/min/1.73m(2) at 6 months (P=0.05). 17 of 45 (38%) participants in the febuxostat group had a >10% decline in eGFR over baseline compared with 26 of 48 (54%) from the placebo group (P<0.004). Limitations of this study included small numbers of patients and short follow-up, and ∼10% of the randomly assigned population dropped out prior to completion. Febuxostat slowed the decline in eGFR in CKD stages 3 and 4 compared to placebo. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  8. Effect of whole soy and purified isoflavone daidzein on renal function--a 6-month randomized controlled trial in equol-producing postmenopausal women with prehypertension.

    PubMed

    Liu, Zhao-min; Ho, Suzanne C; Chen, Yu-ming; Tang, Nelson; Woo, Jean

    2014-09-01

    The aim of the study was to examine the long-term effect of commonly used whole soy foods (soy flour) and purified daidzein (one major isoflavone and the precursor of equol) on renal function among prehypertensive postmenopausal women who are also equol producers, a population most likely to benefit from soy intervention. This was a 6-month double-blind, randomized, placebo-controlled trial. Two hundred seventy eligible Chinese women were randomized to either one of the three treatments: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily each for 6 months. Fasting blood and 24-h urine samples were collected at the beginning and end of trial. Serum creatinine, cystatin C, urea, angiotensin-converting enzyme, minerals and 24-h urinary creatinine and minerals were analyzed. Estimated glomerular filtration rate (eGFR) was calculated with the Cockcroft-Gault and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations. Two hundred fifty-three subjects completed the study according to the protocol. Urinary isoflavones indicated good compliance of participants. No significant changes were observed in most of renal parameters, however, there was a less decrease in eGFRcockcroft in 6-month change (p=0.044) and %change (p=0.031) with whole soy intake relative to milk placebo. Subgroup analysis among women with lowered renal function suggested whole soy consumption tended to improve markers of renal function relative to control. Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function. Future trials in subjects with more declined renal function are necessary. The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737). Copyright © 2014 The Canadian Society of Clinical Chemists. Published by

  9. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial.

    PubMed

    Katsanos, Konstantinos; Karnabatidis, Dimitris; Kitrou, Panagiotis; Spiliopoulos, Stavros; Christeas, Nikolaos; Siablis, Dimitris

    2012-04-01

    To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

  10. A randomized, controlled trial of group cognitive-behavioral therapy for compulsive buying disorder: posttreatment and 6-month follow-up results.

    PubMed

    Mueller, Astrid; Mueller, Ulrike; Silbermann, Andrea; Reinecker, Hans; Bleich, Stefan; Mitchell, James E; de Zwaan, Martina

    2008-07-01

    The purpose of this study was to conduct a randomized trial comparing the efficacy of a group cognitive-behavioral therapy (CBT) intervention designed for the treatment of compulsive buying disorder to a waiting list control (WLC) group. Thirty-one patients with compulsive buying problems according to the criteria developed by McElroy et al. were assigned to receive active treatment (12 weekly sessions and 6-month follow-up) and 29 to the WLC group. The treatment was specifically aimed at interrupting and controlling the problematic buying behavior, establishing healthy purchasing patterns, restructuring maladaptive thoughts and negative feelings associated with shopping and buying, and developing healthy coping skills. Primary outcome measures were the Compulsive Buying Scale (CBS), the Yale-Brown Obsessive Compulsive Scale-Shopping Version (YBOCS-SV), and the German Compulsive Buying Scale (G-CBS). Secondary outcome measures were the Symptom Checklist-90-Revised (SCL-90-R), the Barratt Impulsiveness Scale (BIS-11), and the Saving Inventory-Revised (SI-R). The study was completed between November 2003 and May 2007 at the University Hospital of Erlangen, Bavaria, Germany. Multivariate analysis revealed significant differences between the CBT and the WLC groups on the primary outcome variables (outcome-by-time-by-group effect, Pillai's trace, F = 6.960, df = 1, p = .002). The improvement was maintained during the 6-month follow-up. The treatment did not affect other psychopathology, e.g., compulsive hoarding, impulsivity, or SCL-90-R scores. We found that lower numbers of visited group therapy sessions and higher pretreatment hoarding traits as measured with the SI-R total score were significant predictors for nonresponse. The results suggest that a disorder-specific cognitive-behavioral intervention can significantly impact compulsive buying behavior.

  11. Open- and Closed-Skill Exercise Interventions Produce Different Neurocognitive Effects on Executive Functions in the Elderly: A 6-Month Randomized, Controlled Trial.

    PubMed

    Tsai, Chia-Liang; Pan, Chien-Yu; Chen, Fu-Chen; Tseng, Yu-Ting

    2017-01-01

    This study aimed to explore the effects of open- and closed-skill exercise interventions on the neurocognitive performance of executive functions in the elderly. Sixty-four healthy elderly males were randomly assigned to either a closed-skill (bike riding or brisk walking/jogging, n = 22), open-skill (table tennis, n = 21), or control (n = 21) group. Various neuropsychological [e.g., accuracy rates (AR) and reaction time (RT)] and electrophysiological [e.g., event-related potential (ERP) P3 component] measures were assessed during a variant of the task-switching paradigm, as well as an N-back task at baseline and after either a 6-month exercise intervention or control period. The results showed that, when performing the task-switching paradigm, the two exercise groups relative to control group showed significantly faster RTs in the switch trials after the exercise intervention. However, the RT facilitation in the non-switch and switch trials post-exercise relative to pre-exercise only emerged in the open-skill group. In terms of the N-back task, the two exercise groups significantly increased ARs in the 1-back condition after the exercise intervention, and the beneficial AR effect on the 2-back condition only emerged in the closed-skill group. In addition, the two exercise groups exhibited significantly larger P3 amplitudes on the frontal-to-parietal cortex areas after the exercise intervention relative to the baseline when performing the two cognitive tasks. These neurocognitive results still remained unchanged even when the confounding factors (e.g., cardiorespiratory fitness, social participation, and BMI) were controlled for. The present study concluded that, although 6-month open- and closed-skill exercise interventions facilitate overall electrophysiological effects (i.e., increased ERP P3 amplitudes) on the frontal-to-parietal cortices in the elderly, the two exercise modes produced different levels of neuropsychologically beneficial effects on RTs of the

  12. The connecting health and technology study: a 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults.

    PubMed

    Kerr, Deborah A; Harray, Amelia J; Pollard, Christina M; Dhaliwal, Satvinder S; Delp, Edward J; Howat, Peter A; Pickering, Mark R; Ahmad, Ziad; Meng, Xingqiong; Pratt, Iain S; Wright, Janine L; Kerr, Katherine R; Boushey, Carol J

    2016-04-21

    Early adulthood represents the transition to independent living which is a period when changes in diet and body weight are likely to occur. This presents an ideal time for health interventions to reduce the effect of health problems and risk factors for chronic disease in later life. As young adults are high users of mobile devices, interventions that use this technology may improve engagement. The Connecting Health and Technology study aimed to evaluate the effectiveness of tailored dietary feedback and weekly text messaging to improve dietary intake of fruit, vegetables and junk food over 6 months among a population-based sample of men and women (aged 18-30 years). A three-arm, parallel, randomized control trial was conducted. After baseline assessments, participants were randomized to one of three groups: A) dietary feedback and weekly text messages, B) dietary feedback only or C) control group. Dietary intake was assessed using a mobile food record App (mFR) where participants captured images of foods and beverages consumed over 4-days at baseline and post-intervention. The primary outcomes were changes in serves of fruits, vegetables, energy-dense nutrient-poor (EDNP) foods and sugar-sweetened beverages (SSB). The intervention effects were assessed using linear mixed effect models for change in food group serves. Young adults (n = 247) were randomized to group A (n = 82), group B (n = 83), or group C (n = 82). Overall, no changes in food group serves for either intervention groups were observed. An unanticipated outcome was a mean weight reduction of 1.7 kg (P = .02) among the dietary feedback only. Men who received dietary feedback only, significantly reduced their serves of EDNP foods by a mean of 1.4 serves/day (P = .02). Women who received dietary feedback only significantly reduced their intake of SSB (P = .04) by an average of 0.2 serves/day compared with controls. Tailored dietary feedback only resulted in a decrease in EDNP

  13. 25-Hydroxyvitamin D concentrations in children with Crohn's disease supplemented with either 2000 or 400 IU daily for 6 months: a randomized controlled study.

    PubMed

    Wingate, Kirstin E; Jacobson, Kevan; Issenman, Robert; Carroll, Matthew; Barker, Collin; Israel, David; Brill, Herbert; Weiler, Hope; Barr, Susan I; Li, Wangyang; Lyon, Michael R; Green, Timothy J

    2014-04-01

    To assess vitamin D status of pediatric patients with Crohn's disease (CD) and to compare their serum 25-hydroxyvitamin D (s-25OHD) with established cutoffs and assess whether 6 months of supplementation with 2000 IU/d, vs 400 IU/d, would reduce the group prevalence of vitamin D below these cutoffs. Subjects 8-18 years (n = 83) with quiescent CD were randomized to either 400 or 2000 IU vitamin D3/d for 6 months. Baseline mean ± SD s-25OHD was 24 ± 8 ng/mL; 13 subjects (16%) had an s-25OHD <16 ng/mL, 27 (33%) < 20 ng/mL, and 65 (79%) < 30 ng/mL. There was no significant difference between groups in achieving the cutoffs of 16 ng/mL or 20 ng/mL at 6 months; however, only 35% of the 400 IU group achieved the greater cutoff of 30 ng/mL compared with 74% in the 2000 IU group (P < .001). Baseline adjusted mean s-25OHD concentrations at 6 months were 9.6 ng/mL (95% CI 6.0-13.2, P < .001) greater in the 2000 IU than the 400 IU group. Disease activity was not affected by supplement dose. Few subjects exceeded safety marker cutoffs, and this did not differ by dose. At baseline, a high proportion of patients had a mean s-25OHD >20 ng/mL. 2000 IU vitamin D3/d is more effective in raising s-25OHD concentrations to > 30 ng/mL in children with CD than 400 IU/d, but both treatments were equally effective at achieving 16 or 20 ng/mL. Copyright © 2014 Mosby, Inc. All rights reserved.

  14. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension.

    PubMed

    Liu, Z M; Ho, C S; Chen, Y M; Woo, J

    2015-02-01

    Hyperuricemia is a recognized risk factor for cardiovascular diseases. Soy foods contain a moderate amount of purine and may predispose to raised serum uric acid (UA). However, no study has examined the long-term effect of soy intake on UA levels. We examined whether consumption of soy foods and isoflavone extracts for 6 months altered serum UA. The analysis included two randomized controlled trials (soy protein trial and whole soy trial) among total 450 postmenopausal women with either prehypertension or prediabetes. We conducted a pooled analysis by combining participants from both the soy flour and soy protein groups (combined soy foods group), participants from both the isoflavone and daidzein groups (combined isoflavone group) and participants from both milk placebo groups. Fasting venous samples were obtained at baseline and the end of the trial for serum UA analysis. In the pooled data, 417 subjects completed the study according to protocol. The baseline serum UA levels were comparable among the three combined groups. There was a lower decrease in UA levels among women in the combined soy foods group compared with women in the other two groups (p = 0.028 and 0.026). The net decrease and % decrease in UA were 14.5 μmol/L (95 % CI 1.93-25.6, p = 0.023) or 4.9 % (95 % CI 1.3-8.5 %, p = 0.023) between the combined soy foods group and placebo group. Among Chinese postmenopausal women with either prehypertension or prediabetes, soy intake did not increase urate levels.

  15. The Impact of Aerobic Exercise on Fronto-Parietal Network Connectivity and Its Relation to Mobility: An Exploratory Analysis of a 6-Month Randomized Controlled Trial

    PubMed Central

    Hsu, Chun L.; Best, John R.; Wang, Shirley; Voss, Michelle W.; Hsiung, Robin G. Y.; Munkacsy, Michelle; Cheung, Winnie; Handy, Todd C.; Liu-Ambrose, Teresa

    2017-01-01

    Impaired mobility is a major concern for older adults and has significant consequences. While the widely accepted belief is that improved physical function underlies the effectiveness of targeted exercise training in improving mobility and reducing falls, recent evidence suggests cognitive and neural benefits gained through exercise may also play an important role in promoting mobility. However, the underlying neural mechanisms of this relationship are currently unclear. Thus, we hypothesize that 6 months of progressive aerobic exercise training would alter frontoparietal network (FPN) connectivity during a motor task among older adults with mild subcortical ischemic vascular cognitive impairment (SIVCI)—and exercise-induced changes in FPN connectivity would correlate with changes in mobility. We focused on the FPN as it is involved in top-down attentional control as well as motor planning and motor execution. Participants were randomized either to usual-care (CON), which included monthly educational materials about VCI and healthy diet; or thrice-weekly aerobic training (AT), which was walking outdoors with progressive intensity. Functional magnetic resonance imaging was acquired at baseline and trial completion, where the participants were instructed to perform bilateral finger tapping task. At trial completion, compared with AT, CON showed significantly increased FPN connectivity strength during right finger tapping (p < 0.05). Across the participants, reduced FPN connectivity was associated with greater cardiovascular capacity (p = 0.05). In the AT group, reduced FPN connectivity was significantly associated with improved mobility performance, as measured by the Timed-Up-and-Go test (r = 0.67, p = 0.02). These results suggest progressive AT may improve mobility in older adults with SIVCI via maintaining intra-network connectivity of the FPN. PMID:28713255

  16. Brief psychoeducation for bipolar disorder: impact on quality of life in young adults in a 6-month follow-up of a randomized controlled trial.

    PubMed

    Cardoso, Taiane de Azevedo; Farias, Clarisse de Azambuja; Mondin, Thaíse Campos; da Silva, Giovanna Del Grande; Souza, Luciano Dias de Mattos; da Silva, Ricardo Azevedo; Pinheiro, Karen Tavares; do Amaral, Rogério Gonçalves; Jansen, Karen

    2014-12-30

    There are scarce follow-up studies evaluating the role of psychoeducation in the treatment of bipolar disorder, especially in a young sample, with a recent diagnosis and that probably received a few previous interventions. This was a randomized clinical trial with young adults aged 18-29 years, who had been diagnosed with bipolar disorder through the Structured Clinical Interview for DSM (SCID). The evaluation of quality of life was carried out using the Medical Outcomes Survey 36-Item Short-Form Health Survey (MOS SF-36). All participants were randomized into two groups: combined intervention (psychoeducation plus medication) and treatment-as-usual (medication). The sample consisted of 61 patients divided in two groups (29 usual treatment; 32 combined intervention). The quality of life domains did not reveal statistically significant differences when comparing baseline, post-intervention and 6-month follow-up evaluations, which indicates that there is no difference between combined intervention and usual intervention regarding quality of life improvement. Both groups presented improvements in quality of life domains, except General Health and Bodily Pain, at post-intervention. Moreover, this improvement persisted at 6-month follow-up, except for the Role Physical Health domain, which remained reduced. Combined Psychoeducation plus pharmacological intervention is so effective in improving quality of life perception as it is pharmacological only intervention. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

    PubMed Central

    2010-01-01

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

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

    PubMed Central

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

    2007-01-01

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

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

    PubMed

    Wade, Alan G; Ford, Ian; Crawford, Gordon; McConnachie, Alex; Nir, Tali; Laudon, Moshe; Zisapel, Nava

    2010-08-16

    Melatonin is extensively used in the USA in a non-regulated manner for sleep disorders. Prolonged release melatonin (PRM) is licensed in Europe and other countries for the short term treatment of primary insomnia in patients aged 55 years and over. However, a clear definition of the target patient population and well-controlled studies of long-term efficacy and safety are lacking. It is known that melatonin production declines with age. Some young insomnia patients also may have low melatonin levels. The study investigated whether older age or low melatonin excretion is a better predictor of response to PRM, whether the efficacy observed in short-term studies is sustained during continued treatment and the long term safety of such treatment. Adult outpatients (791, aged 18-80 years) with primary insomnia, were treated with placebo (2 weeks) and then randomized, double-blind to 3 weeks with PRM or placebo nightly. PRM patients continued whereas placebo completers were re-randomized 1:1 to PRM or placebo for 26 weeks with 2 weeks of single-blind placebo run-out. Main outcome measures were sleep latency derived from a sleep diary, Pittsburgh Sleep Quality Index (PSQI), Quality of Life (World Health Organzaton-5) Clinical Global Impression of Improvement (CGI-I) and adverse effects and vital signs recorded at each visit. On the primary efficacy variable, sleep latency, the effects of PRM (3 weeks) in patients with low endogenous melatonin (6-sulphatoxymelatonin [6-SMT] 6-month period with no signs of tolerance. Most adverse events were mild in severity with no clinically relevant differences between PRM and

  20. Does multicomponent physical exercise with simultaneous cognitive training boost cognitive performance in older adults? A 6-month randomized controlled trial with a 1-year follow-up

    PubMed Central

    Eggenberger, Patrick; Schumacher, Vera; Angst, Marius; Theill, Nathan; de Bruin, Eling D

    2015-01-01

    Background Cognitive impairment is a health problem that concerns almost every second elderly person. Physical and cognitive training have differential positive effects on cognition, but have been rarely applied in combination. This study evaluates synergistic effects of multicomponent physical exercise complemented with novel simultaneous cognitive training on cognition in older adults. We hypothesized that simultaneous cognitive–physical components would add training specific cognitive benefits compared to exclusively physical training. Methods Seniors, older than 70 years, without cognitive impairment, were randomly assigned to either: 1) virtual reality video game dancing (DANCE), 2) treadmill walking with simultaneous verbal memory training (MEMORY), or 3) treadmill walking (PHYS). Each program was complemented with strength and balance exercises. Two 1-hour training sessions per week over 6 months were applied. Cognitive performance was assessed at baseline, after 3 and 6 months, and at 1-year follow-up. Multiple regression analyses with planned comparisons were calculated. Results Eighty-nine participants were randomized to the three groups initially, 71 completed the training, while 47 were available at 1-year follow-up. Advantages of the simultaneous cognitive–physical programs were found in two dimensions of executive function. “Shifting attention” showed a time×intervention interaction in favor of DANCE/MEMORY versus PHYS (F[2, 68] =1.95, trend P=0.075, r=0.17); and “working memory” showed a time×intervention interaction in favor of DANCE versus MEMORY (F[1, 136] =2.71, trend P=0.051, R2=0.006). Performance improvements in executive functions, long-term visual memory (episodic memory), and processing speed were maintained at follow-up in all groups. Conclusion Particular executive functions benefit from simultaneous cognitive–physical training compared to exclusively physical multicomponent training. Cognitive–physical training programs

  1. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure.

    PubMed

    Uriel, Nir; Colombo, Paolo C; Cleveland, Joseph C; Long, James W; Salerno, Christopher; Goldstein, Daniel J; Patel, Chetan B; Ewald, Gregory A; Tatooles, Antone J; Silvestry, Scott C; John, Ranjit; Caldeira, Christiano; Jeevanandam, Valluvan; Boyle, Andrew J; Sundareswaran, Kartik S; Sood, Poornima; Mehra, Mandeep R

    2017-05-23

    control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39-1.03; P=0.065). In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months. URL: http://clinicaltrials.gov. Unique identifier: NCT02224755. © 2017 American Heart Association, Inc.

  2. Microbial Enterotypes, Inferred by the Prevotella-to-Bacteroides Ratio, Remained Stable during a 6-Month Randomized Controlled Diet Intervention with the New Nordic Diet

    PubMed Central

    Licht, Tine R.; Poulsen, Sanne K.; Larsen, Thomas M.; Bahl, Martin I.

    2014-01-01

    It has been suggested that the human gut microbiota can be divided into enterotypes based on the abundance of specific bacterial groups; however, the biological significance and stability of these enterotypes remain unresolved. Here, we demonstrated that subjects (n = 62) 18 to 65 years old with central obesity and components of metabolic syndrome could be grouped into two discrete groups simply by their relative abundance of Prevotella spp. divided by Bacteroides spp. (P/B ratio) obtained by quantitative PCR analysis. Furthermore, we showed that these groups remained stable during a 6-month, controlled dietary intervention, where the effect of consuming a diet in accord with the new Nordic diet (NND) recommendations as opposed to consuming the average Danish diet (ADD) on the gut microbiota was investigated. In this study, subjects (with and without stratification according to P/B ratio) did not reveal significant changes in 35 selected bacterial taxa quantified by quantitative PCR (ADD compared to NND) resulting from the dietary interventions. However, we found higher total plasma cholesterol within the high-P/B group than in the low-P/B group after the intervention. We propose that stratification of humans based simply on their P/B ratio could allow better assessment of possible effects of interventions on the gut microbiota and physiological biomarkers. PMID:24296500

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

    PubMed Central

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

    2005-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  5. Resistance and agility training reduce fall risk in women aged 75 to 85 with low bone mass: a 6-month randomized, controlled trial.

    PubMed

    Liu-Ambrose, Teresa; Khan, Karim M; Eng, Janice J; Janssen, Patti A; Lord, Stephen R; McKay, Heather A

    2004-05-01

    To compare the effectiveness of group resistance and agility-training programs in reducing fall risk in community-dwelling older women with low bone mass. A randomized, controlled, single-blind 25-week prospective study with assessments at baseline, midpoint, and trial completion. Community center. Community-dwelling women aged 75 to 85 with low bone mass. Participants were randomly assigned to one of three groups: resistance training (n=32), agility training (n=34), and stretching (sham) exercises (n=32). The exercise classes for each study arm were held twice weekly. The primary outcome measure was fall risk (derived from weighted scores from tests of postural sway, reaction time, strength, proprioception, and vision), as measured using a Physiological Profile Assessment (PPA). Secondary outcome measures were ankle dorsiflexion strength, foot reaction time, and Community Balance and Mobility Scale score. Attendance at the exercise sessions for all three groups was excellent: resistance training (85.4%), agility training (87.3%), and stretching program (78.8%). At the end of the trial, PPA fall-risk scores were reduced by 57.3% and 47.5% in the resistance and agility-training groups, respectively, but by only 20.2% in the stretching group. In the resistance and agility groups, the reduction in fall risk was mediated primarily by improved postural stability, where sway was reduced by 30.6% and 29.2%, respectively. There were no significant differences between the groups for the secondary outcomes measures. Within the resistance-training group, reductions in sway were significantly associated with improved strength, as assessed using increased squat load used in the exercise sessions. These findings support the implementation of community-based resistance and agility-training programs to reduce fall risk in older women with low bone mass. Such programs may have particular public health benefits because it has been shown that this group is at increased risk of

  6. Both resistance and agility training increase cortical bone density in 75- to 85-year-old women with low bone mass: a 6-month randomized controlled trial.

    PubMed

    Liu-Ambrose, Teresa Y L; Khan, Karim M; Eng, Janice J; Heinonen, Ari; McKay, Heather A

    2004-01-01

    A randomized, controlled, single-blinded 25-wk prospective study was conducted to compare the effects of group-based resistance and agility training on bone, as measured by both dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT), in older women with low bone mass. Ninety-eight community-dwelling women aged 75-85 yr were randomized to one of three experimental groups: resistance training (n = 32), agility training (n = 34), or stretching (sham exercise) (n = 32). Total hip, femoral neck, and trochanteric bone mineral density (BMD) were measured by DXA. Peripheral QCT measurements were performed at the tibia and radius. The pQCT outcome measures at the shaft regions were cortical bone content, cortical bone cross-sectional area, cortical bone density, and density-weighted polar section modulus (SSI). The pQCT outcome measures at the distal sites were total bone content, total bone cross-sectional area, and total bone density. At trial completion, the agility training group significantly increased cortical bone density by 0.5 +/- 0.2% (SE) at the tibial shaft compared with a 0.4 +/- 0.3% loss in the stretching group. The resistance training group significantly increased cortical bone density (1.4 +/- 0.6%) at the radial shaft compared, with a 0.4 +/- 0.5% loss in the agility training group. No significant between-group differences were observed in the other bone outcome measures (by DXA or pQCT). Future research is needed to determine the mechanism(s) responsible for the observed adaptation of the cortical bone to mechanical loading.

  7. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase.

    PubMed

    Tan, Gabriel; Rintala, Diana H; Jensen, Mark P; Richards, J Scott; Holmes, Sally Ann; Parachuri, Rama; Lashgari-Saegh, Shamsi; Price, Larry R

    2011-01-01

    Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Multi-site, double-blind, sham-controlled study. Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess 'as-needed' CES use. Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal-Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief.

  8. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase

    PubMed Central

    Tan, Gabriel; Rintala, Diana H.; Jensen, Mark P.; Richards, J. Scott; Holmes, Sally Ann; Parachuri, Rama; Lashgari-Saegh, Shamsi; Price, Larry R.

    2011-01-01

    Background Chronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes. Objective Explore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain. Study design Multi-site, double-blind, sham-controlled study. Participants Adults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES. Intervention Application of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess ‘as-needed’ CES use. Outcome measures Change in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment. Results The active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal–Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59). Conclusions On average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief. PMID:21756567

  9. A 6-month, randomized, double-blind, placebo-controlled study evaluating the ability of a marine complex supplement to promote hair growth in men with thinning hair.

    PubMed

    Ablon, Glynis

    2016-12-01

    Male pattern baldness, or androgenetic alopecia, affects approximately 50% of the adult population and can cause poor self-image, low self-esteem and have a significant negative impact on the quality of life. An oral nutraceutical supplement based on a marine complex formulation has previously been reported to significantly increase the number of terminal hairs in women with thinning hair. The objective of this double-blind, placebo-controlled study was to confirm the beneficial effects of a similar marine complex supplement in adult male subjects with thinning hair (Viviscal(®) Man; Lifes2good, Inc., Chicago, IL, USA). Healthy adult male subjects with thinning hair associated with clinically diagnosed male pattern hair loss were enrolled and randomized to receive study drug or placebo twice daily. At Day 90, subjects indicated a significant improvement in three of six quality of life measures as well as a significant overall improvement in quality of life. After 180 days, significant increases were observed for total hair count, total hair density, and terminal hair density (for each, P = 0.001). The investigator assessments revealed significant improvements in terminal and vellus hair count and terminal hair density. Hair pull test results were significantly lower (fewer hairs removed) for study drug vs. placebo at Days 90 (P < 0.05) and 180 (P < 0.01). There were no reports of treatment-emergent adverse events. The results of this study showed for the first time that a dietary supplement containing a marine complex and other ingredients can decrease hair shedding and promote hair growth in men with thinning hair. © 2016 Wiley Periodicals, Inc.

  10. The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study.

    PubMed

    Archila, Luis; Bartizek, Robert D; Winston, J Leslie; Biesbrock, Aaron R; McClanahan, Stephen F; He, Tao

    2004-12-01

    Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice. This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months. A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported. Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.

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

    PubMed

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

    2008-06-01

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

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

    PubMed

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

    2014-01-01

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

  13. Pre-treatment microbial Prevotella-to-Bacteroides ratio, determines body fat loss success during a 6-month randomized controlled diet intervention.

    PubMed

    Hjorth, M F; Roager, H M; Larsen, T M; Poulsen, S K; Licht, T R; Bahl, M I; Zohar, Y; Astrup, A

    2017-09-08

    Based on the abundance of specific bacterial genera, the human gut microbiota can be divided into two relatively stable groups that might play a role in personalized nutrition. We studied these simplified enterotypes as prognostic markers for successful body fat loss on two different diets. A total of 62 participants with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in fiber/wholegrain or an Average Danish Diet (ADD) for 26 weeks. Participants were grouped into two discrete enterotypes by their relative abundance of Prevotella spp. divided by Bacteroides spp. (P/B ratio) obtained by quantitative PCR analysis. Modifications of dietary effects of pre-treatment P/B group were examined by linear mixed models. Among individuals with high P/B the NND resulted in a 3.15 kg (95%CI 1.55;4.76, P<0.001) larger body fat loss compared to ADD whereas no differences was observed among individuals with low P/B (0.88 kg [95% CI -0.61;2.37, P=0.25]). Consequently, a 2.27 kg (95%CI 0.09;4.45, P=0.041) difference in responsiveness to the diets were found between the two groups. In summary, subjects with high P/B-ratio appeared more susceptible to lose body fat on diets high in fiber and wholegrain than subjects with a low P/B-ratio.International Journal of Obesity accepted article preview online, 08 September 2017. doi:10.1038/ijo.2017.220.

  14. Efficacy and Safety of Linagliptin in Black/African American Patients with Type 2 Diabetes: A 6-month, Randomized, Double-blind, Placebo-controlled Study.

    PubMed

    Thrasher, James; Daniels, Kristen; Patel, Sanjay; Whetteckey, Jacqueline; Woerle, Hans-Juergen

    2014-05-01

    Although black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on antidiabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naïve or receiving one oral antidiabetes drug. Of 226 patients randomized to 24 weeks' linagliptin 5 mg/day or placebo, 208 had baseline and at least one on-treatment glycated hemoglobin (HbA1c) measurement. Mean baseline HbA1c was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA1c from baseline to week 24. By week 24, mean HbA1c changes were -0.84% with linagliptin and -0.25% with placebo (treatment difference, -0.58%; P<.001), and more patients in the linagliptin group achieved HbA1c <7.0% (26.8% vs. 8.3%; P = .001) or an HbA1c reduction ≥0.5% (54.1% vs. 30.0%; P<.001). Mean weight loss was -1.1 kg in both groups. During the treatment period, 8 of 98 linagliptin-group patients and 17 of 110 placebo-group patients required rescue therapy (odds ratio, 0.5; P = .14). For postprandial glucose, values were available for few patients (11 placebo, 10 linagliptin), and thus the between-group difference was associated with wide confidence intervals (CIs) (difference, -1.97 mg/dL; 95% CI, -53.80 to 49.86; P = .94). In the overall study population, a similar proportion of patients in both groups had adverse events (58.5% vs. 61.7%); most events were mild or moderate and considered unrelated to study drug. Investigator-defined hypoglycemia was rare (3 linagliptin-group patients and 1 placebo-group patient), with no severe events (requiring external assistance). This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes.

  15. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up.

    PubMed

    Palamara, Grazia; Gotti, Francesco; Maestri, Roberto; Bera, Rossana; Gargantini, Roberto; Bossio, Fabiola; Zivi, Ilaria; Volpe, Daniele; Ferrazzoli, Davide; Frazzitta, Giuseppe

    2017-06-01

    To assess whether a specific land-based physical intervention with the inclusion of aquatic therapy is more effective than land-based rehabilitation alone for the treatment of balance dysfunction in patients with Parkinson disease (PD), immediately after therapy and at 6 months' follow-up. Randomized controlled study with 6-month follow-up. A PD and brain injury rehabilitation department in a general hospital. Patients (N=34) with moderate-stage PD. Seventeen patients underwent a land-based rehabilitation protocol called multidisciplinary intensive rehabilitation treatment (MIRT), and 17 underwent MIRT plus aquatic therapy (MIRT-AT). The primary outcome measure was the Berg Balance Scale (BBS); secondary outcome measures were the Unified Parkinson Disease Rating Scale parts II and III (UPDRS II/III) and the Timed Up and Go (TUG) test. These measures were assessed in both groups at admission, at discharge, and after 6 months. BBS improved after treatment in both groups. Even though no statistically significant difference between groups was observed at each observation time, BBS scores at follow-up were significantly higher than at baseline in MIRT-AT patients. Both groups also showed an improvement in UPDRS II/III and TUG at the end of treatment compared with baseline, but these findings were lost at the 6-month follow-up. Aquatic therapy added to land-based rehabilitation could provide a contribution to the treatment of balance dysfunction in patients with moderate-stage PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  16. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2).

    PubMed

    Yki-Järvinen, Hannele; Bergenstal, Richard; Ziemen, Monika; Wardecki, Marek; Muehlen-Bartmer, Isabel; Boelle, Emmanuelle; Riddle, Matthew C

    2014-12-01

    To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes using basal insulin (≥42 units/day) plus oral antihyperglycemic drugs (OADs). EDITION 2 was a multicenter, open-label, two-arm study. Adults receiving basal insulin plus OADs were randomized to Gla-300 or Gla-100 once daily for 6 months. The primary end point was change in HbA1c. The main secondary end point was percentage of participants with one or more nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemic events from week 9 to month 6. Randomized participants (n = 811) had a mean (SD) HbA₁c of 8.24% (0.82) and BMI of 34.8 kg/m(2) (6.4). Glycemic control improved similarly with both basal insulins; least squares mean (SD) reduction from baseline was -0.57% (0.09) for Gla-300 and -0.56% (0.09) for Gla-100 (mean difference -0.01% [95% CI -0.14 to 0.12]), with 10% higher dose of Gla-300. Less nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia was observed with Gla-300 from week 9 to month 6 (relative risk 0.77 [95% CI 0.61-0.99]; P = 0.038) and during the first 8 weeks. Fewer nocturnal and any time (24 h) hypoglycemic events were reported during the entire 6-month period. Weight gain was lower with Gla-300 than with Gla-100 (P = 0.015). No between-treatment differences in safety parameters were identified. Gla-300 was as effective as Gla-100 and associated with a lower risk of hypoglycemia during the night and at any time of the day. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  17. Provision of micronutrient-fortified food from 6 months of age does not permit HIV-exposed uninfected Zambian children to catch up in growth to HIV-unexposed children: a randomized controlled trial.

    PubMed

    Filteau, Suzanne; Baisley, Kathy; Chisenga, Molly; Kasonka, Lackson; Gibson, Rosalind S

    2011-02-01

    HIV-exposed, uninfected (HIV-EU) children represent a large proportion of children in southern Africa. The reasons for their poorer growth and higher morbidity and mortality than their HIV-unexposed peers are unclear. We compared anthropometry of 125 HIV-EU with 382 HIV-unexposed young Zambian children participating in a trial of micronutrient-fortified complementary/replacement food. The randomized controlled trial provided children from age 6 to 18 months with a porridge flour containing either a basal or a rich level of micronutrients. Weight and length were measured 3 monthly and head and arm circumferences and triceps and subscapular skinfolds 6 monthly. There were no significant anthropometric differences between the 2 treatment groups. In unadjusted analyses, most anthropometric Z scores of HIV-EU children were lower than those of HIV-unexposed children; after adjustment for treatment arm, socioeconomic factors, breastfeeding and sex, head and arm circumference Z scores remained lower. Subscapular skinfold Z scores were lower among HIV-EU than HIV-unexposed children at 6 months but not 18 months. Socioeconomic factors accounted for some but not all of the impaired growth of HIV-EU children. Micronutrient malnutrition may not be the socioeconomic factor responsible for the growth faltering. Factors acting earlier in life had irreversible effects.

  18. Intravenous Recombinant Tissue Plasminogen Activator Does Not Impact Mortality in Acute Ischemic Stroke at Any Time Point up to 6 Months: A Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials.

    PubMed

    Kumar, Gyanendra; Uhrig, Drew; Fowler, Susan; DeLaney, Matthew C; Alexandrov, Andrei V

    2015-08-01

    Concerns about the harms of intravenous alteplase (recombinant tissue plasminogen activator) continue to deter physicians from treating patients with acute ischemic stroke with the only drug proven to positively impact outcomes and reduce disability. Recent literature indicates an increase in mortality with alteplase within 7 days, an effect that does not persist from 3 months onwards. The objective of this meta-analysis was to pool mortality estimates from randomized controlled clinical trials (RCTs) at 7 days, 30 days, 90 days, and 6 months after stroke onset. PubMed, Embase, Scopus, CENTRAL, and clinicaltrials.gov were searched through to April 2014, using "hedges" for tissue plasminogen activator, acute ischemic stroke, and placebo. Two independent authors abstracted data and assessed study quality. Data were pooled using Dersimonian and Laird's random effects model. Eleven RCTs (n = 6905) were included in the final analysis. Two authors independently performed study selection and data abstraction. There was no publication bias and total variance attributable to heterogeneity was not significant (I(2) < 50%) at any time point. There was no difference in mortality between alteplase and placebo groups at any time point. Trials that randomized patients beyond 3 h (excluded patients within the 3-h window) did not drive the mortality difference seen at any time point. Exclusion sensitivity analysis revealed that exclusion of the NINDS trial rendered the 7-day difference significant towards increased mortality with alteplase. Quality adjustment did not alter the results. Intravenous alteplase did not impact mortality in patients with acute ischemic stroke at any of the measured time points up to 6 months (i.e., there was no increase in the risk of death with alteplase). Therefore, intravenous alteplase should be given to all eligible patients with acute ischemic stroke to improve long-term neurologic outcomes. The effects of alteplase on early survival are more

  19. Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

    PubMed

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

    2017-07-01

    The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

  20. Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials.

    PubMed

    Vetrovsky, Tomas; Siranec, Michal; Parenica, Jiri; Griva, Martin; Stastny, Jiri; Precek, Jan; Pelouch, Radek; Bunc, Vaclav; Linhart, Ales; Belohlavek, Jan

    2017-07-03

    Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score. To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical

  1. A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

    PubMed

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

    2016-01-01

    Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p < 0.001), whereas a reduction was not observed in the treatment as usual group (p = 0.651). Moreover, there were significant decreases in depression, anxiety, and stress, as well as a greater increase in emotion regulation functioning, mindfulness, and quality of life observed in the intervention group 6 months after the treatment compared with the treatment as usual condition. The results of this pilot trial demonstrate that 16 weeks of ISTDP delivered by Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2015-01-01

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

  3. Effects of a 6-month exercise program on patients with multiple sclerosis: a randomized study.

    PubMed

    Romberg, A; Virtanen, A; Ruutiainen, J; Aunola, S; Karppi, S-L; Vaara, M; Surakka, J; Pohjolainen, T; Seppänen, A

    2004-12-14

    To improve walking and other aspects of physical function with a progressive 6-month exercise program in patients with multiple sclerosis (MS). MS patients with mild to moderate disability (Expanded Disability Status Scale scores 1.0 to 5.5) were randomly assigned to an exercise or control group. The intervention consisted of strength and aerobic training initiated during 3-week inpatient rehabilitation and continued for 23 weeks at home. The groups were evaluated at baseline and at 6 months. The primary outcome was walking speed, measured by 7.62 m and 500 m walk tests. Secondary outcomes included lower extremity strength, upper extremity endurance and dexterity, peak oxygen uptake, and static balance. An intention-to-treat analysis was used. Ninety-one (96%) of the 95 patients entering the study completed it. Change between groups was significant in the 7.62 m (p = 0.04) and 500 m walk tests (p = 0.01). In the 7.62 m walk test, 22% of the exercising patients showed clinically meaningful improvements. The exercise group also showed increased upper extremity endurance as compared to controls. No other noteworthy exercise-induced changes were observed. Exercise adherence varied considerably among the exercisers. Walking speed improved in this randomized study. The results confirm that exercise is safe for multiple sclerosis patients and should be recommended for those with mild to moderate disability.

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

    PubMed

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

    2011-12-01

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

  5. A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release

    PubMed Central

    Gordon, Michael S.; Kinlock, Timothy W.; Schwartz, Robert P.; O’Grady, Kevin E.

    2008-01-01

    Aims This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. Design A three-group randomized controlled trial was conducted between September 2003 and June 2005. Setting A Baltimore pre-release prison. Participants Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Intervention Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Measurements Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs. Findings Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only participants (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants. Conclusions Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories. PMID:18855822

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

    PubMed Central

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

    2013-01-01

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

  7. A 6-month maintenance therapy with adapalene-benzoyl peroxide gel prevents relapse and continuously improves efficacy among patients with severe acne vulgaris: results of a randomized controlled trial.

    PubMed

    Poulin, Y; Sanchez, N P; Bucko, A; Fowler, J; Jarratt, M; Kempers, S; Kerrouche, N; Dhuin, J-C; Kunynetz, R

    2011-06-01

    Acne vulgaris is a chronic and frequently recurring disease. A fixed-dose adapalene-benzoyl peroxide (adapalene-BPO) gel is an efficacious and safe acne treatment. To assess the long-term effect of adapalene-BPO on relapse prevention among patients with severe acne after successful initial treatments. This is a multicentre, double-blind, randomized and controlled study. In total, 243 subjects who had severe acne vulgaris and at least 50% global improvement after a previous 12-week treatment were randomized into the present study to receive adapalene-BPO gel or its vehicle once daily for 24 weeks. At week 24, compared with vehicle, adapalene-BPO resulted in significantly higher lesion maintenance success rate (defined as having at least 50% improvement in lesion counts achieved in initial treatment) for all types of lesions (total lesions: 78·9% vs. 45·8%; inflammatory lesions: 78·0% vs. 48·3%; noninflammatory lesions: 78·0% vs. 43·3%; all P < 0·001). Significantly more subjects with adapalene-BPO than with vehicle had the same or better Investigator's Global Assessment score at week 24 than at baseline (70·7% vs. 34·2%; P < 0·001). The time when 25% of subjects relapsed was 175 days with adapalene-BPO and 56 days with vehicle (17 weeks earlier; P < 0·0001). Adapalene-BPO led to further decrease of lesion counts during the study and 45·7% of subjects were 'clear' or 'almost clear' at week 24. It was also safe and well tolerated in the study. Adapalene-BPO not only prevents the occurrence of relapse among patients with severe acne, but also continues to reduce disease symptoms during 6 months. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.

  8. NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy.

    PubMed

    Azuma, Junichi; Ohno, Masako; Kubota, Ryuji; Yokota, Soichiro; Nagai, Takayuki; Tsuyuguchi, Kazunari; Okuda, Yasuhisa; Takashima, Tetsuya; Kamimura, Sayaka; Fujio, Yasushi; Kawase, Ichiro

    2013-05-01

    This study is a pharmacogenetic clinical trial designed to clarify whether the N-acetyltransferase 2 gene (NAT2) genotype-guided dosing of isoniazid improves the tolerability and efficacy of the 6-month four-drug standard regimen for newly diagnosed pulmonary tuberculosis. In a multicenter, parallel, randomized, and controlled trial with a PROBE design, patients were assigned to either conventional standard treatment (STD-treatment: approx. 5 mg/kg of isoniazid for all) or NAT2 genotype-guided treatment (PGx-treatment: approx. 7.5 mg/kg for patients homozygous for NAT2 4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2 4: intermediate acetylators; 2.5 mg/kg, patients without NAT2 4: slow acetylators). The primary outcome included incidences of 1) isoniazid-related liver injury (INH-DILI) during the first 8 weeks of therapy, and 2) early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week. One hundred and seventy-two Japanese patients (slow acetylators, 9.3 %; rapid acetylators, 53.5 %) were enrolled in this trial. In the intention-to-treat (ITT) analysis, INH-DILI occurred in 78 % of the slow acetylators in the STD-treatment, while none of the slow acetylators in the PGx-treatment experienced either INH-DILI or early treatment failure. Among the rapid acetylators, early treatment failure was observed with a significantly lower incidence rate in the PGx-treatment than in the STD-treatment (15.0 % vs. 38 %). Thus, the NAT2 genotype-guided regimen resulted in much lower incidences of unfavorable events, INH-DILI or early treatment failure, than the conventional standard regimen. Our results clearly indicate a great potential of the NAT2 genotype-guided dosing stratification of isoniazid in chemotherapy for tuberculosis.

  9. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

    PubMed

    Triratana, Terdphong; Kraivaphan, Petcharat; Amornchat, Cholticha; Mateo, Luis R; Morrison, Boyce M; Dibart, Serge; Zhang, Yun-Po

    2015-04-01

    To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

  10. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial.

    PubMed

    Boozer, C N; Daly, P A; Homel, P; Solomon, J L; Blanchard, D; Nasser, J A; Strauss, R; Meredith, T

    2002-05-01

    To examine long-term safety and efficacy for weight loss of an herbal Ma Huang and Kola nut supplement (90/192 mg/day ephedrine alkaloids/caffeine). Six-month randomized, double-blind placebo controlled trial. A total of 167 subjects (body mass index (BMI) 31.8+/-4.1 kg/m(2)) randomized to placebo (n=84) or herbal treatment (n=83) at two outpatient weight control research units. Primary outcome measurements were changes in blood pressure, heart function and body weight. Secondary variables included body composition and metabolic changes. By last observation carried forward analysis, herbal vs placebo treatment decreased body weight (-5.3+/-5.0 vs. -2.6+/-3.2 kg, P<0.001), body fat (-4.3+/-3.3 vs. -2.7+/-2.8 kg, P=0.020) and LDL-cholesterol (-8+/-20 vs. 0+/-17 mg/dl, P=0.013), and increased HDL-cholesterol (+2.7+/-5.7 vs. -0.3+/-6.7 mg/dl, P=0.004). Herbal treatment produced small changes in blood pressure variables (+3 to -5 mm Hg, P< or =0.05), and increased heart rate (4+/-9 vs. -3+/-9 bpm, P<0.001), but cardiac arrhythmias were not increased (P>0.05). By self-report, dry mouth (P<0.01), heartburn (P<0.05), and insomnia (P<0.01) were increased and diarrhea decreased (P<0.05). Irritability, nausea, chest pain and palpitations did not differ, nor did numbers of subjects who withdrew. In this 6-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg/day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events.

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

    PubMed Central

    2012-01-01

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

  12. Comparative assessment of fluoride varnish and fluoride film for remineralization of postorthodontic white spot lesions in adolescents and adults over a 6-month period: A single-center, randomized controlled clinical trial.

    PubMed

    He, Tao; Li, Xue; Dong, Ying; Zhang, Na; Zhong, Yisi; Yin, Wei; Hu, Deyu

    2016-06-01

    The objective of this 3-arm parallel randomized trial was to evaluate the effects of a fluoride varnish and a fluoride film on the remineralization of white spot lesions around orthodontic brackets after orthodontic treatment. Patients who had recently completed orthodontic treatment were randomly assigned to the varnish, film, and control groups. Eligibility criteria included age of 12 to 25 years, good general health, and at least 1 maxillary anterior tooth with a white spot lesion. The primary outcome was the decrease in the lesion volume of each patient after 6 months of treatment; fluorescence loss and area were the secondary outcome measures. Randomization was accomplished according to a computer-generated randomization schedule, and allocation concealment was achieved with nontransparent concealed envelopes. Blinding was applicable for the treatments only. The test groups received fluoride varnish or film treatment once a month for 6 months, and the control group received a placebo treatment. All patients received oral hygiene education and were required to use fluoride toothpaste daily. Quantitative light-induced fluorescence images were taken at baseline and at the 3-month and 6-month follow-ups. A mixed-effects linear model was used to analyze quantitative light-induced fluorescence parameters with confounders integrated into the model. Two hundred forty patients (mean age, 16.9 years; range, 12-25 years) with 597 teeth with a white spot lesion were randomized 1:1:1 to the varnish, film, and control groups. Baseline demographics were similar between groups, and 29 patients were lost to follow-up. The primary analysis was carried out on a per-protocol basis involving 72 patients in the control group, 69 patients in the varnish group, and 70 patients in the film group who completed the study. The product of fluorescence loss and lesion area values were statistically associated with time (estimate, -4.58; 95% confidence interval [CI], -5.84 to -3.31; P

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

    PubMed Central

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

    2015-01-01

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

  14. Long-term management of plaque and gingivitis using an alcohol-free essential oil containing mouthrinse: a 6-month randomized clinical trial.

    PubMed

    Cortelli, Sheila Cavalca; Cortelli, José Roberto; Shang, Hongyan; McGuire, James A; Charles, Christine A

    2013-06-01

    This 6-month, examiner-blind, single center, randomized, parallel group, controlled clinical trial compared the antiplaque/antigingivitis effects of an alcohol-free EO mouthrinse (LISTERINE Zero) to a negative control (5% flavored, colored hydroalcohol) and to an alcohol-free CPC-containing mouthrinse (Colgate Plax). 337 gingivitis subjects were clinically examined to determine Modified Gingival Index (MGI) and Plaque Index (PI) at baseline, 3 and 6 months. The primary efficacy variables were mean MGI and mean PI at 6 months (statistically analyzed by ANCOVA). After professional dental prophylaxis, subjects were randomly assigned to 6-month twice daily unsupervised use of alcohol-free EO, alcohol-free CPC or a negative control rinse, in conjunction with normal brushing and flossing. Safety was monitored throughout the study. 311 subjects completed the study. After 6 months of use, EO significantly reduced plaque (31.6%) and gingivitis (24.0%) compared to negative control. At 6 months, CPC also significantly reduced plaque (6.4%) and gingivitis (4.4%) compared to negative control. EO provided a 26.9% decrease in plaque and a 20.5% decrease in gingivitis compared to CPC (P < 0.001). All rinses were well tolerated. The alcohol-free EO mouthrinse demonstrated superior efficacy in reducing plaque and gingivitis over 6 months compared to both negative control and alcohol-free CPC mouthrinse.

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

    PubMed

    Tinti, Carla; Schmidt, Susanna; Businaro, Nicoletta

    2011-06-01

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

  16. Evolution of Serum 25OHD in Response to Vitamin D3-Fortified Yogurts Consumed by Healthy Menopausal Women: A 6-Month Randomized Controlled Trial Assessing the Interactions between Doses, Baseline Vitamin D Status, and Seasonality.

    PubMed

    Bonjour, Jean-Philippe; Dontot-Payen, Flore; Rouy, Emilien; Walrand, Stephane; Rousseau, Brigitte

    2017-10-04

    Adequate vitamin D status contributes to bone fragility risk reduction and possibly other pathological conditions that occur with aging. In response to pharmaceutical vitamin D3 supplements, several studies have documented the influence of doses, baseline status, and seasonality on serum 25-hydroyvitamin D (s25OHD). Using fortified yogurt, we investigated in one randomized controlled trial how both baseline status, as assessed by measuring s25OHD prior the onset of the trial, and the season of enrollment quantitatively influenced the response to the supplemented (Suppl.) of vitamin D3 (VitD3) in healthy community-dwelling women. A 24-week controlled trial was conducted in menopausal women (mean age: 61.5). Participants were randomized into 3 groups (Gr): Gr.Suppl.0, time controls maintaining dietary habits; Gr.Suppl.5 and Gr.Suppl.10 consuming one and two 125-g servings of VitD3-fortified yogurts with 5- and 10-µg daily doses, respectively. The 16 intervention weeks lasted from early January to mid-August, the 8 follow-up weeks, without product, from late August to mid-October. Before enrollment, subjects were randomized into 2 s25OHD strata: low stratum (LoStr): 25-50 nmol/L; high stratum (HiStr): >50-75 nmol/L. All enrolled participants adhered to the protocol throughout the 24-week study: Gr.Suppl.0 (n = 45), Gr.Suppl.5 (n = 44), and Gr.Suppl.10 (n = 44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than in Gr.Suppl.5. At the end of the intervention, the subject proportion with s25OHD ≥ 50 nmol/L was 37.8, 54.5, and 63.6% in Gr.Suppl.0, Gr.Suppl.5, and Gr.Suppl.10, respectively. The constant rate of s25OHD per supplemental VitD3 microgram was greater in LoStr than HiStr. The s25OHD increase was greater with late (mid-March) than early (mid-January) inclusion. This randomized trial demonstrates (1) a dose-dependent s25OHD improvement related to fortified yogurt consumption; (2) an inversely

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

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

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

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

    ERIC Educational Resources Information Center

    Stack, Dale M.; McDonnell, Paul M.

    1995-01-01

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

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

    PubMed

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

    2007-01-26

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

  20. Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial.

    PubMed

    Geidl, Wolfgang; Semrau, Jana; Streber, René; Lehbert, Nicola; Wingart, Silke; Tallner, Alexander; Wittmann, Michael; Wagner, Rupert; Schultz, Konrad; Pfeifer, Klaus

    2017-08-29

    Pulmonary rehabilitation programs often fail to substantially enhance long-term physical activity in patients with chronic obstructive pulmonary disease (COPD). The reasons for successful physical activity changes in patients with COPD are not well understood. The need to better understand the determinants of physical activity in patients with COPD and effective rehabilitation strategies to improve physical activity is evident. The STAR study (Stay Active after Rehabilitation) investigates, in a randomized controlled trial, the additional effect of a pedometer-based behavior-change intervention during inpatient pulmonary rehabilitation on objectively measured physical activity 6 weeks and 6 months post rehabilitation. The intervention uses the behavior-change techniques (1) instruction on how, where and when to perform the behavior, (2) prompt goal setting for physical activity, (3) prompt self-monitoring of behavior, and (4) feedback on behavior. The primary outcome of physical activity will be measured using a physical activity monitor (Actigraph wGT3X-BT) for a period of 7 days, firstly 2 weeks before rehabilitation begins (t0) as well as 6 weeks and 6 months after rehabilitation (t3, t4). Additionally, to predict physical activity progression after rehabilitation, a complex personal diagnostics battery, including questionnaires as well as functional assessments, is to be carried out at the start and end of rehabilitation (t1, t2). This battery is based on the foundational ideas of the Physical Activity-Related health Competence model. Five hundred and two patients with COPD, aged 18 years or older and admitted for an approved pulmonary rehabilitation, will be enrolled in the STAR study. The STAR study is designed as a randomized controlled trial to gain a better understanding of the personal determinants of physical activity in patients with COPD and to evaluate a pedometer-based physical activity-change intervention in the context of inpatient pulmonary

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

    PubMed Central

    Wolf, Dörte; Otto, Joachim

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  3. Pre- and post-treatment experiences of fear, anxiety, and pain among chronic periodontitis patients treated by scaling and root planing per quadrant versus one-stage full-mouth disinfection: a 6-month randomized controlled clinical trial.

    PubMed

    Santuchi, Camila Carvalho; Cortelli, Sheila Cavalca; Cortelli, José Roberto; Cota, Luís Otávio Miranda; Alencar, Camila Oliveira; Costa, Fernando Oliveira

    2015-11-01

    To relate the clinical effects of two different forms of non-surgical periodontal therapy - scaling and root planing per quadrant (SRP-Q) and one-stage full-mouth disinfection (FMD) - to patient-based outcomes such as fear, anxiety, and pain of moderate chronic periodontitis patients. Dental Fear Survey (DFS) and Dental Anxiety Scale (DAS) questionnaires and Visual Analogue Scale (VAS) were applied to 78 patients randomized into two groups: SRP-Q (n = 37) and FMD (n = 41). Periodontal clinical parameters: probing pocket depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI) were monitored at baseline and 6 months after treatment. Data were statistically analysed by chi-square, Fisher's exact, Mann-Whitney, Wilcoxon tests, Pearson's correlation, and Cluster analysis. All periodontal clinical parameters improved from baseline to 6 months. Patients with higher fear and anxiety showed a worse clinical periodontal status before and after treatment (mean CAL, PI, and GI). After both types of treatment, fear and anxiety decreased (FMD: p = 0.019; SRP-Q: p = 0.043) with no differences between the groups. Pain did not differ between groups (FMD: 20.6 ± 19.0 and SRP: 20.7 ± 20.0; p = 0.930). In moderate chronic periodontitis patients, SRP-Q and FMD provided periodontal clinical improvements and similar experiences of fear, anxiety, and pain. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Adherence to controller asthma medications: 6-month prevalence across a US community pharmacy chain.

    PubMed

    Feehan, M; Ranker, L; Durante, R; Cooper, D K; Jones, G J; Young, D C; Munger, M A

    2015-08-20

    Non-adherence to controller asthma medications is an important public health problem. It is estimated to occur in 30-70% of individuals and is a significant risk factor for asthma morbidity and mortality. The aim of this study was to determine the level of adherence, as indicated by refill rates, to controller asthma medications in a community pharmacy setting. Secondary analyses of a community pharmacy dispensing database in 15 locations throughout Utah. The dispensing records of 2193 patients who received controller medications for asthma in a 12-month period, and had a minimum of 6-month potential coverage (180 days) from the date of their first receipt of a controller medication in that period, were examined. Using standard metrics to gauge adherence, the proportion of days covered (PDC) and the medication possession ratio (MPR), the average coverage for controller asthma medications across a 6-month period (180 days) was poor, averaging less than 50% of days' availability. Standard cut-offs (≥80% medication availability) indicated that only 14-16% of patients had 'satisfactory' adherence over their 6-month follow-on period. Females and older patients had significantly greater satisfactory adherence. Medication adherence was significantly greater with inhaled corticosteroid (ICS)-long-acting β2 -agonist (LABA) combinations than with ICS alone. This study confirms the considerable scope of the asthma therapy non-adherence problem. Therefore, it is imperative to conduct survey-based research linked directly to pharmacy-based dispensing data to derive patient behavioural, attitudinal and environmental factors that may contribute to the issue, and then pilot and evaluate interventions for change. © 2015 John Wiley & Sons Ltd.

  5. The effect of periodontal therapy on cardiovascular risk markers: a 6-month randomized clinical trial.

    PubMed

    Caúla, André Luis; Lira-Junior, Ronaldo; Tinoco, Eduardo Muniz Barretto; Fischer, Ricardo Guimarães

    2014-09-01

    To determine the influence of non-surgical mechanical periodontal treatment on inflammatory markers related to risk for cardiovascular disease. A total of 64 patients with severe chronic periodontitis was randomly subjected to immediately periodontal treatment (test group, n = 32) or delayed periodontal treatment, without treatment during the study period (control group, n = 32). Clinical periodontal and laboratory examinations were performed at baseline (T0), 2 months (T2), and 6 months (T6) after the initial examinations (Control group) or completion of periodontal treatment (Test group). After 2 months of periodontal treatment there was a significant reduction of erythrocyte sedimentation rate (ESR) and triglycerides (p = 0.002, p = 0.004, respectively) in the test group. Median values of C-reactive protein, ESR, total cholesterol, and triglycerides were reduced after 6 month of periodontal treatment in the test group (p < 0.001, p < 0.001, p < 0.001, and p = 0.015, respectively). The non-surgical periodontal treatment was effective in reducing the levels of systemic inflammation markers and improved the lipid profile in subjects with severe chronic periodontitis. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. Clozapine and risperidone in moderately refractory schizophrenia: a 6-month randomized double-blind comparison.

    PubMed

    Schooler, Nina R; Marder, Stephen R; Chengappa, K N R; Petrides, Georgios; Ames, Donna; Wirshing, William C; McMeniman, Marjorie; Baker, Robert W; Parepally, Haranath; Umbricht, Daniel; Kane, John M

    2016-05-01

    Clozapine remains the only medication indicated for refractory schizophrenia. As new antipsychotic drugs become available, their efficacy compared to clozapine, particularly in moderately ill patients, is of great clinical interest. We compared risperidone, the first of these, to clozapine in partially responsive patients. Further, since participation of patients usually excluded from clinical trials is increasingly important, we broadened inclusion to a wider patient population. We compared clozapine (n = 53) to risperidone (n = 54) in a randomized, double-blind, 29-week trial in schizophrenia patients (diagnosed using DSM-IV) at 3 research outpatient clinics. Randomization was stratified by "narrow" or "broad" inclusion criteria. The study was conducted between December 1995 and October 1999. Time to treatment discontinuation for lack of efficacy and time to 20% improvement in the Brief Psychiatric Rating Scale psychotic symptom cluster were the primary outcome measures. There were no differences in all-cause discontinuation; clozapine-treated participants were significantly less likely to discontinue for lack of efficacy (15%) than risperidone-treated participants (38%) (Wilcoxon χ(2)1 = 6.10, P = .01). Clozapine resulted in significantly more global improvement (F2,839 = 6.07, P < .01) and asociality improvement (F2,315 = 6.64, P < .01) than risperidone. There was no difference in proportions meeting an a priori criterion of psychosis improvement (risperidone: 57%; clozapine: 71%). Significant adverse effect differences in salivation (F1 = 4.05, P < .05) (F1 = 12.13, P < .001), sweating (F1 = 5.07, P < .05), and tachycardia (F1 = 6.51, P < .05) favored risperidone. Clozapine-treated partially responsive patients were less likely to discontinue treatment for lack of efficacy and improved more globally than those treated with risperidone, although psychotic symptoms did not differ. These findings suggest that clozapine should not be restricted to the most

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

    PubMed

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

    2006-04-01

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

  8. Evaluation of crestal bone resorption around cylindrical and conical implants following 6 months of loading: A randomized clinical trial.

    PubMed

    Sargolzaie, Naser; Arab, Hamid Reza; Moghaddam, Marzieh Mohammadi

    2017-01-01

    The purpose of this clinical study was to evaluate the effect of implant body form (cylindrical and conical implants) on crestal bone levels during 6 months' follow-up after loading. A total of 32 SPI implants (19 conical implants/13 cylindrical implants) were randomly placed in 12 male patients using a submerged approach. None of the patients had compromising medical conditions or parafunctional habits. Periapical radiographs using the parallel technique were taken after clinical loading and 6 months later. Clinical indices including pocket depth and bleeding on probing (BOP) were recorded on 6-month follow-up. Data were analyzed by independent samples t-test and Chi-square test with a significance level of 0.05. Six months after loading, crestal bone loss was 0.84 (±0.29) mm around the cylindrical implants and 0.73 (±0.62) mm around the conical types, which was not significantly different (P = 0.54). Pocket depth around the cylindrical and conical implants was 2.61 (±0.45) mm and 2.36 (±0.44) mm, respectively (P = 0.13). BOP was observed among 53.8% and 47.4% of the cylindrical implants and conical (P = 0.13). Bone loss and pocket depth in the maxilla and mandible had no significant difference (P = 0.46 and P = 0.09, respectively). In this study, although bone loss and clinical parameters were slightly higher in the cylindrical implants, there was no significant difference between the conical- and cylindrical-shaped implants.

  9. Evaluation of crestal bone resorption around cylindrical and conical implants following 6 months of loading: A randomized clinical trial

    PubMed Central

    Sargolzaie, Naser; Arab, Hamid Reza; Moghaddam, Marzieh Mohammadi

    2017-01-01

    Objective: The purpose of this clinical study was to evaluate the effect of implant body form (cylindrical and conical implants) on crestal bone levels during 6 months’ follow-up after loading. Materials and Methods: A total of 32 SPI implants (19 conical implants/13 cylindrical implants) were randomly placed in 12 male patients using a submerged approach. None of the patients had compromising medical conditions or parafunctional habits. Periapical radiographs using the parallel technique were taken after clinical loading and 6 months later. Clinical indices including pocket depth and bleeding on probing (BOP) were recorded on 6-month follow-up. Data were analyzed by independent samples t-test and Chi-square test with a significance level of 0.05. Results: Six months after loading, crestal bone loss was 0.84 (±0.29) mm around the cylindrical implants and 0.73 (±0.62) mm around the conical types, which was not significantly different (P = 0.54). Pocket depth around the cylindrical and conical implants was 2.61 (±0.45) mm and 2.36 (±0.44) mm, respectively (P = 0.13). BOP was observed among 53.8% and 47.4% of the cylindrical implants and conical (P = 0.13). Bone loss and pocket depth in the maxilla and mandible had no significant difference (P = 0.46 and P = 0.09, respectively). Conclusion: In this study, although bone loss and clinical parameters were slightly higher in the cylindrical implants, there was no significant difference between the conical- and cylindrical-shaped implants.

  10. Does exercise intensity affect blood pressure and heart rate in obese adolescents? A 6-month multidisciplinary randomized intervention study.

    PubMed

    Farah, B Q; Ritti-Dias, R M; Balagopal, P B; Hill, J O; Prado, W L

    2014-04-01

    Aerobic exercise improves cardiovascular health in general, but whether the impact varies with exercise intensity is not clear. The aim of the current study was to compare the effects of a high-intensity aerobic exercise training (HIT) vs. a low-intensity aerobic exercise training (LIT) on blood pressure (BP), heart rate (HR) and heart rate variability (HRV) in obese adolescents. Forty-three (13-18 years) Tanner stage (III-IV) matched obese adolescents were studied in a randomized trial of either HIT (corresponding to the ventilatory threshold I; n = 20) or LIT (corresponding to 20% below the ventilatory threshold I; n = 23) programme for a period of 6 months. All participants also received a multidisciplinary therapy that included nutritional, psychological and clinical counselling. Both HIT and LIT sessions were isocaloric, with energy expenditure set at 350 kcal. BP, HR and HRV were measured along with markers of body adiposity and insulin resistance before and after the respective interventions. The participants in both groups had similar physical and clinical characteristics. After the 6-month intervention, systolic, diastolic and mean BP decreased (P < 0.05, for all) similarly in both groups, whereas waist circumference, HR and HRV showed beneficial changes only in the HIT group (P < 0.05). Aerobic exercise training set at a high intensity compared with the low intensity appears to have additional benefits on abdominal obesity and cardiovascular health in that it enhances the parasympathetic and autonomic modulation of the heart in obese adolescents. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

  11. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study.

    PubMed

    Nada, Aml Mohamed; Shaheen, Dalia A

    2017-01-01

    To investigate the effects of vitamin D supplementation on glucose homeostasis and lipid profile in type 2 diabetic patients who have vitamin D deficiency. One hundred twenty-five type 2 diabetic patients taking oral hypoglycemic agents as mono- or combination therapy were recruited from the diabetes and endocrinology clinic. Subject demographics, duration of diabetes, antidiabetic medication, body mass index (BMI), pulse, and blood pressure (BP) were assessed. Laboratory measurements of serum vitamin D3 level, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and lipid profile were measured. Homeostatic model assessment-insulin resistance (HOMA-IR) was calculated whenever fasting insulin (FI) was available. Forty-one patients (27 males and 14 females) were started on cholecalciferol replacement-45,000 units once weekly for 8 weeks and then 22,500 units once weekly for 16 weeks. Calcium carbonate tablets 500 mg once daily were also prescribed for the initial 2 months of treatment. Measured variables were reassessed after 6 months of replacement therapy. During the trial, subjects were instructed not to change their diabetes drugs or lifestyle. No significant association was found between vitamin D3 level and any of the measured variables apart from a significant positive correlation with blood urea nitrogen. Vitamin D3 replacement was associated with a significant increase in its level (14.0±4.0 vs 31.0 vs 7.9 ng/mL, P<0.001). This was associated with a significant reduction of HbA1c (7.9±1.7 vs 7.4%±1.2%, P=0.001) and FPG (9.1±4.3 vs 7.9±2.4 mmol/L, P=0.034). Mean reduction of HbA1c was 0.54% and that of FPG was 1.22 mmol/L. FI, c-peptide and insulin resistance (IR) were reduced but this was statistically insignificant (P=0.069, 0.376, 0.058, respectively). FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone, alkaline phosphatase, serum creatinine, and pulse rate

  12. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study

    PubMed Central

    Nada, Aml Mohamed; Shaheen, Dalia A

    2017-01-01

    Background and purpose To investigate the effects of vitamin D supplementation on glucose homeostasis and lipid profile in type 2 diabetic patients who have vitamin D deficiency. Patients and methods One hundred twenty-five type 2 diabetic patients taking oral hypoglycemic agents as mono- or combination therapy were recruited from the diabetes and endocrinology clinic. Subject demographics, duration of diabetes, antidiabetic medication, body mass index (BMI), pulse, and blood pressure (BP) were assessed. Laboratory measurements of serum vitamin D3 level, hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and lipid profile were measured. Homeostatic model assessment-insulin resistance (HOMA-IR) was calculated whenever fasting insulin (FI) was available. Forty-one patients (27 males and 14 females) were started on cholecalciferol replacement–45,000 units once weekly for 8 weeks and then 22,500 units once weekly for 16 weeks. Calcium carbonate tablets 500 mg once daily were also prescribed for the initial 2 months of treatment. Measured variables were reassessed after 6 months of replacement therapy. During the trial, subjects were instructed not to change their diabetes drugs or lifestyle. Results No significant association was found between vitamin D3 level and any of the measured variables apart from a significant positive correlation with blood urea nitrogen. Vitamin D3 replacement was associated with a significant increase in its level (14.0±4.0 vs 31.0 vs 7.9 ng/mL, P<0.001). This was associated with a significant reduction of HbA1c (7.9±1.7 vs 7.4%±1.2%, P=0.001) and FPG (9.1±4.3 vs 7.9±2.4 mmol/L, P=0.034). Mean reduction of HbA1c was 0.54% and that of FPG was 1.22 mmol/L. FI, c-peptide and insulin resistance (IR) were reduced but this was statistically insignificant (P=0.069, 0.376, 0.058, respectively). FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone

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

    PubMed

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

    2008-08-01

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

  14. Lifestyle coaching's effect on 6-month follow-up in recently homeless substance dependent veterans: a randomized study.

    PubMed

    LePage, James P; Garcia-Rea, Elizabeth A

    2012-09-01

    Behaviors and activities consistent with "healthy" lifestyles (i.e., leisure and recreational activities, social and family interactions, coping behaviors) have been shown to be related to prolonged substance dependence recovery. However, there has been little focus on systematically capitalizing on this association in treatment to improve relapse rates. The goal of this study was to determine if the inclusion of healthy lifestyle coaching, that is the encouragement of specific behaviors in a therapeutic setting, could impact time to relapse. Fifty-six veterans who were recently discharged from a Veterans Administration (VA) homeless Domiciliary Residential Rehabilitation and Treatment Program and were substance dependent were evaluated over a 6-month follow-up period. Using a partially randomized design, three groups were evaluated: 1) those followed by a therapist and coached to increase healthy behaviors, 2) those followed by a therapist and receiving only emotional support, and 3) those not followed by a therapist. Survival analyses and nonparametric evaluations were performed. Coached consumers had longer latency to relapse than noncoached and relapsed at a lower rate than those not followed by a therapist. Therapeutic interventions which focus on increasing healthy behaviors chosen by the consumer can be an important component of sustained recovery from substance dependence. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

  15. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial.

    PubMed

    Turner-McGrievy, Gabrielle M; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E; Singletary, Camelia; Muth, Eric R; Hoover, Adam W

    2017-08-01

    To examine the use of two different mobile dietary self-monitoring methods for weight loss. Adults with overweight (n = 81; mean BMI 34.7 ± 5.6 kg/m(2) ) were randomized to self-monitor their diet with a mobile app (App, n = 42) or wearable Bite Counter device (Bite, n = 39). Both groups received the same behavioral weight loss information via twice-weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (two dietary recalls) were assessed at 0, 3, and 6 months. At 6 months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8 ± 0.8 kg) than the Bite group (-3.0 ± 0.8 kg; group × time interaction: P < 0.001). Changes in energy intake (kcal/d) (-621 ± 157 App, -456 ± 167 Bite; P = 0.47) or number of days diet was tracked (90.7 ± 9.1 App, 68.4 ± 9.8 Bite; P = 0.09) did not differ between groups, but the Bite group had significant increases in physical activity metabolic equivalents (+2015.4 ± 684.6 min/wk; P = 0.02) compared to little change in the App group (-136.5 ± 630.6; P = 0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r = -0.33, P < 0.01) and number of days diet was tracked (r = -0.33, P < 0.01). While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. © 2017 The Obesity Society.

  16. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

    PubMed Central

    Krystal, Andrew D.; Erman, Milton; Zammit, Gary K.; Soubrane, C.; Roth, Thomas

    2008-01-01

    the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness. Citation: Krystal AD; Erman M; Zammit GK; Soubrane C; Roth T. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study. SLEEP 2008;31(1):79-90. PMID:18220081

  17. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study.

    PubMed

    Jouen, Anne-Lise; Narzisi, Antonio; Xavier, Jean; Tilmont, Elodie; Bodeau, Nicolas; Bono, Valentina; Ketem-Premel, Nabila; Anzalone, Salvatore; Maharatna, Koushik; Chetouani, Mohamed; Muratori, Filippo; Cohen, David

    2017-01-01

    To meet the required hours of intensive intervention for treating children with autism spectrum disorder (ASD), we developed an automated serious gaming platform (11 games) to deliver intervention at home (GOLIAH) by mapping the imitation and joint attention (JA) subset of age-adapted stimuli from the Early Start Denver Model (ESDM) intervention. Here, we report the results of a 6-month matched controlled exploratory study. From two specialized clinics, we included 14 children (age range 5-8 years) with ASD and 10 controls matched for gender, age, sites, and treatment as usual (TAU). Participants from the experimental group received in addition to TAU four 30-min sessions with GOLIAH per week at home and one at hospital for 6 months. Statistics were performed using Linear Mixed Models. Children and parents participated in 40% of the planned sessions. They were able to use the 11 games, and participants trained with GOLIAH improved time to perform the task in most JA games and imitation scores in most imitation games. GOLIAH intervention did not affect Parental Stress Index scores. At end-point, we found in both groups a significant improvement for Autism Diagnostic Observation Schedule scores, Vineland socialization score, Parental Stress Index total score, and Child Behavior Checklist internalizing, externalizing and total problems. However, we found no significant change for by time × group interaction. Despite the lack of superiority of TAU + GOLIAH versus TAU, the results are interesting both in terms of changes by using the gaming platform and lack of parental stress increase. A large randomized controlled trial with younger participants (who are the core target of ESDM model) is now discussed. This should be facilitated by computing GOLIAH for a web platform. Trial registration Clinicaltrials.gov NCT02560415.

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

    PubMed

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

    2016-07-05

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

  19. A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management: preliminary results of the impact of diet at 6 months--PREFER study.

    PubMed

    Burke, Lora E; Styn, Mindi A; Steenkiste, Ann R; Music, Edvin; Warziski, Melanie; Choo, Jina

    2006-11-01

    The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie- and fat-restricted diets [standard behavior treatment (SBT) and lacto-ovo-vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention. The study used a four-group design. Subjects (n = 182) were randomized to a treatment preference group and then to a dietary treatment group. For this report, preference groups were combined to permit comparisons by dietary treatment only (SBT, n = 98; SBT+LOV, n = 84). Additional analyses compared SBT+LOV subjects who were 100% adherent (did not consume any meat, fish, or poultry, n = 47) to those who were <100% adherent (n = 24). Significant differences were seen in the baseline to 6-month change scores between the two groups for carbohydrate consumption (p = 0.013), protein consumption (p < 0.001), polyunsaturated-to-saturated fat ratio (p = 0.009), and low-density lipoprotein-cholesterol (LDL-C) level (p = 0.013). Among SBT+LOV subjects, those who were 100% adherent experienced greater reductions in weight (p < 0.001), total cholesterol (p = 0.026), LDL-C (p = 0.034), and glucose (p = 0.002) and consumed less fat (p = 0.030) compared with those who were <100% adherent. Differences between dietary treatment groups at 6 months were minimal, most likely because one-third of the SBT+LOV group did not follow the vegetarian diet and because both groups had the same calorie and fat restrictions. SBT+LOV subjects who were 100% adherent were more successful at both weight loss and cholesterol reduction than those who were <100% adherent, suggesting that vegetarian diets are efficacious for weight and cholesterol control.

  20. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study.

    PubMed

    Krystal, Andrew D; Erman, Milton; Zammit, Gary K; Soubrane, C; Roth, Thomas

    2008-01-01

    To evaluate long-term efficacy and safety of zolpidem extended-release 3 to 7 nights/week for chronic primary insomnia. Multicenter, 25-week, phase IIIb, randomized, double-blind, placebo-controlled, parallel-group. Outpatient; visits every 4 weeks. Aged 18 to 64 years; DSM-IV criteria for chronic primary insomnia; > or =3 months of difficulty initiating or maintaining sleep or experiencing nonrestorative sleep. Single-dose zolpidem extended-release 12.5 mg (n = 669) or placebo (n = 349), self-administered from a minimum of 3 nights/week to a maximum of 7 nights/week. Patient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to week 24. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures-sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)-and next-day functioning. At week 12, PGI, Item 1 (aid to sleep), the primary endpoint, was scored as favorable (i.e., "helped me sleep") by 89.8% of zolpidem patients vs. 51.4% of placebo patients (P < 0.0001, based on rank score) and at week 24 by 92.3% of zolpidem extended-release patients vs. 59.7% of placebo patients. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1-4) and CGI-I (P < 0.0001, rank score), TST, WASO, QOS (P < 0.0001), and SOL (P < or = 0.0014); NAW (Months 2-6; P < 0.0001). Sustained improvement (P < 0.0001, all time points) was observed in morning sleepiness and ability to concentrate (P = 0.0014, month 6) with zolpidem extended-release compared with placebo. Most frequent adverse events for zolpidem extended-release were headache, anxiety and somnolence. No rebound effect was observed during the first 3 nights of discontinuation. These findings establish the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months

  1. Aerobic exercise increases hippocampal volume in older women with probable mild cognitive impairment: a 6-month randomised controlled trial.

    PubMed

    ten Brinke, Lisanne F; Bolandzadeh, Niousha; Nagamatsu, Lindsay S; Hsu, Chun Liang; Davis, Jennifer C; Miran-Khan, Karim; Liu-Ambrose, Teresa

    2015-02-01

    Mild cognitive impairment (MCI) is a well-recognised risk factor for dementia and represents a vital opportunity for intervening. Exercise is a promising strategy for combating cognitive decline by improving brain structure and function. Specifically, aerobic training (AT) improved spatial memory and hippocampal volume in healthy community-dwelling older adults. In older women with probable MCI, we previously demonstrated that resistance training (RT) and AT improved memory. In this secondary analysis, we investigated: (1) the effect of RT and AT on hippocampal volume and (2) the association between change in hippocampal volume and change in memory. 86 women aged 70-80 years with probable MCI were randomly assigned to a 6-month, twice-weekly programme of: (1) AT, (2) RT or (3) balance and tone training (BAT; ie, control). At baseline and trial completion, participants performed a 3T MRI scan to determine hippocampal volume. Verbal memory and learning were assessed by Rey's Auditory Verbal Learning Test. Compared with the BAT group, AT significantly improved left, right and total hippocampal volumes (p≤0.03). After accounting for baseline cognitive function and experimental group, increased left hippocampal volume was independently associated with reduced verbal memory and learning performance as indexed by loss after interference (r=0.42, p=0.03). Aerobic training significantly increased hippocampal volume in older women with probable MCI. More research is needed to ascertain the relevance of exercise-induced changes in hippocampal volume on memory performance in older adults with MCI. NCT00958867. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial.

    PubMed

    Bucci, C; Tremolaterra, F; Gallotta, S; Fortunato, A; Cappello, C; Ciacci, C; Iovino, P

    2014-04-01

    In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul(®)) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture. This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation). Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected. Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

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

    PubMed Central

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

    2015-01-01

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

  4. Tweets, Apps, and Pods: Results of the 6-Month Mobile Pounds Off Digitally (Mobile POD) Randomized Weight-Loss Intervention Among Adults

    PubMed Central

    Tate, Deborah

    2011-01-01

    Background Previous interventions have shown promising results using theory-based podcasts to deliver a behavioral weight-loss intervention. Objective The objective of our study was to examine whether a combination of podcasting, mobile support communication, and mobile diet monitoring can assist people in weight loss. Methods In this 6-month, minimal contact intervention, overweight (n = 96, body mass index 32.6 kg/m2) adults were recruited through television advertisements and email listservs and randomly assigned to Podcast-only or Podcast+Mobile groups. Both groups received 2 podcasts per week for 3 months and 2 minipodcasts per week for months 3–6. In addition to the podcasts, the Podcast+Mobile group was also instructed to use a diet and physical activity monitoring application (app) on their mobile device and to interact with study counselors and other participants on Twitter. Results Weight loss did not differ by group at 6 months: mean –2.7% (SD 5.6%) Podcast+Mobile, n = 47; mean –2.7% (SD 5.1%) Podcast, n = 49; P = .98. Days/week of reported diet monitoring did not differ between Podcast+Mobile (mean 2.3, SD 1.9 days/week) and Podcast groups (mean 1.9, SD 1.7 days/week; P = .28) but method of monitoring did differ. Podcast+Mobile participants were 3.5 times more likely than the Podcast group to use an app to monitor diet (P = .01), whereas the majority of Podcast participants reported using the Web (14/41, 34%) or paper (12/41, 29%). There were more downloads per episode in the Podcast+Mobile group (1.4/person) than in the Podcast group (1.1/person; P < .001). The number of podcasts participants reported downloading over the 6-month period was significantly moderately correlated with weight loss in both the Podcast+Mobile (r = –.46, P = .001) and the Podcast (r = –.53, P < .001) groups. Podcast+Mobile participants felt more user control at 3 months (P = .02), but not at 6 months, and there was a trend (P = .06) toward greater elaboration among

  5. 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.

    PubMed

    Hong, Sung-Jin; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Her, Ae-Young; Kim, Yong Hoon; Jang, Yangsoo; Hong, Myeong-Ki

    2016-07-25

    The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation. Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited. A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach. The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients with acute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428). Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-01-04

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2010-01-01

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

  9. Developmental milestones record - 6 months

    MedlinePlus

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

  10. Brief report: In-home family therapy for adolescents with poorly controlled diabetes: failure to maintain benefits at 6-month follow-up.

    PubMed

    Harris, Michael A; Harris, Brandonn S; Mertlich, Deborah

    2005-12-01

    To examine 6-month follow-up data on the effectiveness of in-home Behavioral Family Systems Therapy (BFST) for adolescents with poorly controlled diabetes, using a pilot and feasibility study. Eighteen adolescents with poorly controlled diabetes received ten 90-min sessions of in-home BFST. Diabetes-related functioning, general family functioning, and health status were assessed at baseline, immediately following treatment and 6-months after the treatment. Although the initial posttreatment follow-up evaluation indicated decreases in general family conflict, diabetes-related family conflict, and behavior problems, evaluation at a 6-month follow-up (N = 17) demonstrated that initial posttreatment improvements were no longer present for any of the variables assessed. Metabolic control remained unchanged from baseline to initial posttreatment as well as at 6-month follow-up. A plausible explanation for this finding is that participating families were experiencing distress that required longer-term treatment for enduring results, beyond what was employed in this study. Further research is necessary before in-home BFST can be considered an effective psychosocial intervention for adolescents with poorly controlled diabetes.

  11. A Standardized Randomized 6-Month Aerobic Exercise-Training Down-regulated Pro-inflammatory Genes, but Up-regulated Anti-inflammatory, Neuron Survival and Axon Growth-Related Genes

    PubMed Central

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

    2015-01-01

    There is considerable support for the view that aerobic exercise may confer cognitive benefits to mild cognitively impaired elderly persons. However, the biological mechanisms mediating these effects are not entirely clear. As a preliminary step towards informing this gap in knowledge, we enrolled older adults confirmed to have mild cognitive impairment (MCI) in a 6-month exercise program. Male and female subjects were randomized into a 6-month program of either aerobic or stretch (control) exercise. Data collected from the first 10 completers, aerobic exercise (n=5) or stretch (control) exercise (n=5), were used to determine intervention-induced changes in the global gene expression profiles of the aerobic and stretch groups. Using microarray, we identified genes with altered expression (relative to baseline values) in response to the 6-month exercise intervention. Genes whose expression were altered by at least two-fold, and met the p-value cutoff of 0.01 were inputted into the Ingenuity Pathway Knowledge Base library to generate gene-interaction networks. After a 6-month aerobic exercise-training, genes promoting inflammation became down-regulated, whereas genes having anti-inflammatory properties and those modulating immune function or promoting neuron survival and axon growth, became up-regulated (all fold change ≥ ± 2.0, p < 0.01). These changes were not observed in the stretch group. Importantly, the differences in the expression profiles correlated with significant improvement in maximal oxygen uptake (VO2max) in the aerobic program as opposed to the stretch group. We conclude that three distinct cellular pathways may collectively influence the training effects of aerobic exercise in MCI subjects. We plan to confirm these effects using rt-PCR and correlate such changes with the cognitive phenotype. PMID:25981742

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

    PubMed

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

    2015-09-01

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

  13. IDEAL: a 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease.

    PubMed

    Winblad, B; Grossberg, G; Frölich, L; Farlow, M; Zechner, S; Nagel, J; Lane, R

    2007-07-24

    The rivastigmine patch is the first transdermal treatment for Alzheimer disease (AD). By providing continuous delivery of drug into the bloodstream over 24 hours, transdermal delivery may offer benefits superior to those of oral administration. This study compared the efficacy, safety and tolerability of rivastigmine patches with capsules and placebo. IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) was a 24-week, double-blind, double-dummy, placebo- and active-controlled study. Patients with AD were randomized to placebo or one of three active treatment target dose groups: 10-cm(2) rivastigmine patch (delivering 9.5 mg/24 hours); 20-cm(2) rivastigmine patch (17.4 mg/24 hours); or 6-mg BID rivastigmine capsules. Primary efficacy measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale and Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. Secondary outcome measures assessed a range of domains, including behavior, cognitive performance, attention, executive functions, and activities of daily living. A total of 1,195 AD patients participated. All rivastigmine treatment groups showed significant improvement relative to placebo. The 10-cm(2) patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively). The 20-cm(2) patch showed earlier improvement and numerically superior cognitive scores vs the 10-cm(2) patch with similar tolerability to capsules. Local skin tolerability was good. The transdermal patch with rivastigmine may offer additional therapeutic benefits and may prove to be the best delivery system for this drug to treat AD.

  14. Life-Space Mobility Change Predicts 6-Month Mortality.

    PubMed

    Kennedy, Richard E; Sawyer, Patricia; Williams, Courtney P; Lo, Alexander X; Ritchie, Christine S; Roth, David L; Allman, Richard M; Brown, Cynthia J

    2017-04-01

    To examine 6-month change in life-space mobility as a predictor of subsequent 6-month mortality in community-dwelling older adults. Prospective cohort study. Community-dwelling older adults from five Alabama counties in the University of Alabama at Birmingham (UAB) Study of Aging. A random sample of 1,000 Medicare beneficiaries, stratified according to sex, race, and rural or urban residence, recruited between November 1999 and February 2001, followed by a telephone interview every 6 months for the subsequent 8.5 years. Mortality data were determined from informant contacts and confirmed using the National Death Index and Social Security Death Index. Life-space was measured at each interview using the UAB Life-Space Assessment, a validated instrument for assessing community mobility. Eleven thousand eight hundred seventeen 6-month life-space change scores were calculated over 8.5 years of follow-up. Generalized linear mixed models were used to test predictors of mortality at subsequent 6-month intervals. Three hundred fifty-four deaths occurred within 6 months of two sequential life-space assessments. Controlling for age, sex, race, rural or urban residence, and comorbidity, life-space score and life-space decline over the preceding 6-month interval predicted mortality. A 10-point decrease in life-space resulted in a 72% increase in odds of dying over the subsequent 6 months (odds ratio = 1.723, P < .001). Life-space score at the beginning of a 6-month interval and change in life-space over 6 months were each associated with significant differences in subsequent 6-month mortality. Life-space assessment may assist clinicians in identifying older adults at risk of short-term mortality. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  15. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial.

    PubMed

    Diener, Hans-Christoph; Agosti, Reto; Allais, Gianni; Bergmans, Paul; Bussone, Gennaro; Davies, Brendan; Ertas, Mustafa; Lanteri-Minet, Michel; Reuter, Uwe; Sánchez Del Río, Margarita; Schoenen, Jean; Schwalen, Susanne; van Oene, Joop

    2007-12-01

    Use of preventive therapy for migraine is often recommended for only 6-9 months, but no randomised, placebo-controlled trials have investigated migraine frequency after the end of prophylaxis. We assessed the effects of discontinuation of topiramate after a treatment period of 6 months. 818 patients who have migraines were enrolled from 88 clinics in 21 countries. After a 4-8-week lead-in period, patients received topiramate in a 26-week open-label phase. Daily dose was increased from 25 mg to 100 mg in steps of 25 mg every week; the dose could be adjusted further in the range 50-200 mg/day, but was stable for the final 4 weeks. Patients were randomly assigned to continue this dose or switch to placebo for a 26-week double-blind phase. The primary endpoint was the difference in number of days with migraine during the last 4 weeks of the double-blind phase compared with the last 4 weeks of the open-label phase. Analysis was by intention to treat. This trial is registered with EudraCT, number 2005-000321-29. 559 patients (68.3%) completed the open-label phase; 514 entered the double-blind phase and were assigned to topiramate (n=255) or placebo (n=259). The mean increase in number of migraine days was greater in the placebo group (1.19 days in 4 weeks, 95% CI 0.71 to 1.66; p<0.0001) than in the topiramate group (0.10, -0.36 to 0.56; p=0.5756; mean difference between groups -1.09, -1.75 to -0.43; p=0.0011) [corrected] Patients in the placebo group had a greater number of days on acute medication than did those in the topiramate group (mean difference between groups -0.95, -1.49 to -0.41; p=0.0007). Quality of life, as assessed by the MIDAS questionnaire, fell in the placebo group but remained stable in the topiramate group. Patients were more satisfied with the efficacy of topiramate than with that of placebo, whereas satisfaction with tolerability was similar in both treatment groups. Sustained benefit was reported after discontinuation of topiramate, although number

  16. Comparison of efficacy of an arginine-calcium carbonate-MFP toothpaste to a calcium carbonate-MFP toothpaste in controlling supragingival calculus formation and gingivitis: a 6-month clinical study.

    PubMed

    Li, Yiming; Lee, Sean; Stephens, Joni; Mateo, Luis R; Zhang, Yun Po; DeVizio, William

    2012-02-01

    To investigate whether the long-term use (6 months) of an arginine-calcium carbonate-MFP toothpaste would affect calculus formation and/or gingivitis when compared to a calcium carbonate-MFP toothpaste. This was a double-blind clinical study. Eligible adult subjects (120) entered a 2-month pre-test phase of the study. After receiving an evaluation of oral tissue and a dental prophylaxis, the subjects were provided with a regular fluoride toothpaste, a soft-bristled adult toothbrush with instructions to brush their teeth for 1-minute twice daily (morning and evening) for 2 months. The subjects were then examined for baseline calculus using the Volpe-Manhold Calculus Index (VMI) and gingivitis using the Löe-Silness Gingival Index (GI), along with an oral tissue examination. Qualifying subjects were randomized to two treatment groups: (1) Colgate Sensitive Pro-Relief toothpaste containing 8.0% arginine, 1450 ppm MFP and calcium carbonate (Test group), or (2) Colgate Cavity Protection toothpaste containing 1450 ppm MFP and calcium carbonate (Control group). Subjects were stratified by the VMI score and gender. After a dental prophylaxis (VMI=0), the subjects entered a 6-month test phase. Each received the assigned toothpaste and a soft-bristled adult toothbrush for home use with instructions of brushing teeth for 1 minute twice daily (morning and evening). The examinations of VMI, Löe-Silness GI and oral tissues were conducted after 3 and 6 months. Prior to each study visit, subjects refrained from brushing their teeth as well as eating and drinking for 4 hours. 99 subjects complied with the study protocol and completed the 6-month test phase. No within-treatment comparison was performed for the VMI because it was brought down to zero after the prophylaxis at the baseline of the test phase. For the Löe-Silness GI, subjects of the Test group exhibited a significant difference from baseline at the 3- and 6-month examinations. The 3-month Löe-Silness GI of the Control

  17. A randomized, double-blind, safety and tolerability study to assess the ophthalmic and renal effects of tafenoquine 200 mg weekly versus placebo for 6 months in healthy volunteers.

    PubMed

    Leary, Kevin J; Riel, Michael A; Roy, Michael J; Cantilena, Louis R; Bi, Daoqin; Brater, D Craig; van de Pol, Corina; Pruett, Khadeeja; Kerr, Caron; Veazey, James M; Beboso, Ronnie; Ohrt, Colin

    2009-08-01

    A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m(2)) after 6 months of dosing, with a treatment difference of -0.061 (95% confidence interval, -0.168, 0.045), and non-inferiority margin of -0.247 mL/s/1.73 m(2). Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-03-01

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

  20. Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial.

    PubMed

    Comulada, Angel L; Renard, Eric; Nakano, Masako; Rais, Nadeem; Mao, Xuejing; Webb, David M; Milicevic, Zvonko

    2009-09-01

    Patients with type 1 diabetes may prefer features of AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.) over insulin injection, but the two methods need to be compared for efficacy and safety. This multicenter, 6-month, parallel-group, noninferiority trial had 500 patients with type 1 diabetes randomized to morning doses of basal insulin glargine plus either preprandial injectable insulin lispro or preprandial AIR insulin. We hypothesized that AIR insulin is noninferior (upper bound of the 95% confidence interval < or = 0.4%) to insulin lispro for change-from-baseline hemoglobin A1C (A1C). Baseline A1C was 7.95 +/- 0.08% for both groups. At end point, A1C was lower with insulin lispro than with AIR insulin by 0.27% (95% confidence interval 0.11, 0.43; P< 0.001). Noninferiority of AIR insulin to insulin lispro was not demonstrated, but similar percentages of patients in each group achieved A1C <7.0% (P = 0.448). Overall daily blood glucose was similar between groups at baseline (P = 0.879) and end point (P = 0.161). Two-hour postprandial blood glucose change from baseline was significantly (P < 0.001) higher with AIR insulin (20.77 +/- 4.33 mg/dL at 3 months and 15.85 +/- 3.08 mg/dL at end point) than with insulin lispro (3.29 +/- 4.14 mg/dL at 3 months and 1.67 +/- 2.91 mg/dL at end point). Overall hypoglycemia was similar between treatment groups (P = 0.355). The AIR insulin group had greater decrease in diffusing capacity of the lung for carbon monoxide at end point (P = 0.020) and greater incidence of cough (P = 0.024) and dyspnea (P = 0.030). Body weight decreased in the AIR insulin group and increased in the insulin lispro group. Insulin lispro provided lower A1C than AIR insulin, but the difference may not be clinically relevant.

  1. Your Child's Development: 6 Months

    MedlinePlus

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

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

    PubMed

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

    2014-12-01

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

  3. Your Child's Development: 6 Months

    MedlinePlus

    ... Child Too Busy? Helping Your Child Adjust to Preschool School Lunches Kids and Food: 10 Tips for Parents Healthy Habits for TV, Video Games, and the Internet Your Child's Development: 6 Months KidsHealth > For Parents > Your Child's Development: ...

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

    PubMed

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

    2014-02-05

    Low-carbohydrate diets may be useful for weight loss. Diets high in vegetable proteins and oils may reduce the risk of coronary heart disease. The main objective was to determine the longer term effect of a diet that was both low-carbohydrate and plant-based on weight loss and low-density lipoprotein cholesterol (LDL-C). A parallel design study of 39 overweight hyperlipidaemic men and postmenopausal women conducted at a Canadian university-affiliated hospital nutrition research centre from April 2005 to November 2006. Participants were advised to consume either a low-carbohydrate vegan diet or a high-carbohydrate lacto-ovo vegetarian diet for 6 months after completing 1-month metabolic (all foods provided) versions of these diets. The prescribed macronutrient intakes for the low-carbohydrate and high-carbohydrate diets were: 26% and 58% of energy from carbohydrate, 31% and 16% from protein and 43% and 25% from fat, respectively. Change in body weight. 23 participants (50% test, 68% control) completed the 6-month ad libitum study. The approximate 4 kg weight loss on the metabolic study was increased to -6.9 kg on low-carbohydrate and -5.8 kg on high-carbohydrate 6-month ad libitum treatments (treatment difference (95% CI) -1.1 kg (-2.1 to 0.0), p=0.047). The relative LDL-C and triglyceride reductions were also greater on the low-carbohydrate treatment (treatment difference (95% CI) -0.49 mmol/L (-0.70 to -0.28), p<0.001 and -0.34 mmol/L (-0.57 to -0.11), p=0.005, respectively), as were the total cholesterol:HDL-C and apolipoprotein B:A1 ratios (-0.57 (-0.83, -0.32), p<0.001 and -0.05 (-0.09, -0.02), p=0.003, respectively). A self-selected low-carbohydrate vegan diet, containing increased protein and fat from gluten and soy products, nuts and vegetable oils, had lipid lowering advantages over a high-carbohydrate, low-fat weight loss diet, thus improving heart disease risk factors. clinicaltrials.gov (http://www.clinicaltrials.gov/), #NCT00256516.

  5. Impact of 6-month aerobic exercise on Alzheimer's symptoms.

    PubMed

    Yu, Fang; Thomas, William; Nelson, Nathaniel W; Bronas, Ulf G; Dysken, Maurice; Wyman, Jean F

    2015-06-01

    Little is known about how aerobic exercise affects Alzheimer's disease (AD). The purpose of this pilot study was to test the impact of 6-month cycling on AD symptoms in community-dwelling older adults with mild-to-moderate AD, using a single-group, repeated-measures design (n = 26). AD symptoms were measured with the AD Assessment Scale-Cognitive (ADAS-Cog), Disability in AD (DAD), and Neuropsychiatric Inventory-Caregiver (NPI-Q) scales at baseline, 3 and 6 months. Data were analyzed using mixed linear models. The ADAS-Cog, DAD, and NPI-Q severity scores remained unchanged over the 6-month period, while caregiver distress decreased 40% (p < .05). We conclude that aerobic exercise may reduce AD symptoms and appears effective in decreasing caregiver distress. Further randomized controlled trials are needed to examine the effects of aerobic exercise in AD. © The Author(s) 2013.

  6. A double-masked randomized comparison of the efficacy and safety of unoprostone with timolol and betaxolol in patients with primary open-angle glaucoma including pseudoexfoliation glaucoma or ocular hypertension. 6 month data.

    PubMed

    Nordmann, Jean-Philippe; Mertz, Beat; Yannoulis, Natalia C; Schwenninger, Christine; Kapik, Barry; Shams, Naveed

    2002-01-01

    A long-term comparison of the ocular hypotensive efficacy and safety of unoprostone isopropyl 0.15% twice daily with that of timolol maleate 0.5% twice daily and betaxolol HCl 0.5% twice daily. This was a randomized, multicenter, double-masked, active-controlled 24-month clinical trial involving 27 centers in Europe and Israel. The study population was composed of patients with primary open-angle glaucoma (including pseudoexfoliation) or ocular hypertension. After washout of antiglaucoma medications, intraocular pressure (IOP) was measured at 0, + 2, + 8, and + 12 hours. Patients were randomized in a 2:1:1 ratio to unoprostone, timolol, or betaxolol. Patients returned for examinations at 2 and 6 weeks and 3 and 6 months. 556 patients were randomized. Each drug produced a clinically and statistically (P <.001) significant reduction from baseline in 12-hour diurnal IOP at month 6 (- 4.3 mm Hg, unoprostone; - 5.8 mm Hg, timolol; - 4.9 mm Hg, betaxolol). Differences in adjusted treatment means between unoprostone and timolol and unoprostone and betaxolol were 1.57 mm Hg (95% CI: 1.00, 2.13) and 0.53 mm Hg (95% CI: - 0.03, 1.09), respectively. Unoprostone was clinically equivalent to betaxolol but did not have as great an IOP-lowering effect as timolol. Discontinued for inadequate control of IOP were 7%, 1%, and 4% of the patients for unoprostone, timolol, and betaxolol, respectively. There were no changes of note in visual acuity, pupil size, cup-to-disk ratio, visual fields, or iris color. Changes in heart rate and blood pressure were small, with no clinically significant differences between groups. Unoprostone provided a clinically significant IOP-lowering effect equivalent to betaxolol but not to timolol. The side effect profile of unoprostone appears to be comparable to other established IOP-lowering agents.

  7. Triptorelin embonate (6-month formulation).

    PubMed

    Keating, Gillian M

    2010-02-12

    A 6-month formulation of the gonadotropin-releasing hormone agonist triptorelin embonate (designed to deliver 22.5 mg of triptorelin over a 6-month period) has been developed for use in the treatment of advanced prostate cancer. Following intramuscular administration of the 6-month formulation of triptorelin embonate 22.5 mg to men with advanced prostate cancer (subset of 15 patients from the pivotal clinical trial), serum testosterone levels initially increased, followed by a rapid, sustained decrease. Castrate serum testosterone levels (i.e. < or =1.735 nmol/L) were achieved in a geometric mean time of 18.8 days. The 6-month formulation of triptorelin embonate achieved and maintained castrate serum testosterone levels in patients with advanced prostate cancer (n = 120), according to the results of the pivotal, noncomparative, multicentre trial (patients received intramuscular triptorelin embonate 22.5 mg on day 1 and at month 6 [week 24]). By day 29, 97.5% of patients had castrate serum testosterone levels. Castrate serum testosterone levels were maintained from months 2 to 12 in 93.0% of patients. Prior to the second injection at month 6, 98.3% of patients had castrate serum testosterone levels, and 98.3% of patients had castrate serum testosterone levels at study completion. The 6-month formulation of triptorelin embonate 22.5 mg was generally well tolerated in patients with advanced prostate cancer; adverse events were of mild severity in the majority of patients. Drug-related adverse events (e.g. hot flushes) were consistent with the pharmacological action of triptorelin. Injection-site reactions occurred in 6.7% of triptorelin embonate recipients.

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

    PubMed Central

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

    2014-01-01

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

  9. Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan.

    PubMed

    Suzuki, Kazuhiro; Namiki, Mikio; Fujimoto, Tsukasa; Takabayashi, Nobuyoshi; Kudou, Kentarou; Akaza, Hideyuki

    2015-12-01

    Leuprorelin acetate (TAP-144-SR) is commonly used worldwide in prostate cancer patients. This study was conducted to assess the non-inferiority of a 6-month depot formulation of TAP-144-SR (TAP-144-SR [6M]) 22.5 mg to a 3-month depot formulation of TAP-144-SR (TAP-144-SR [3M]) 11.25 mg in prostate cancer patients in Japan. This was a 48-week Phase III, open-label, parallel-group comparative study. TAP-144-SR (6M) 22.5 mg (6M group) and TAP-144-SR (3M) 11.25 mg (3M group) were administered to 81 and 79 subjects, respectively. The primary endpoint was the rate of serum testosterone suppression to the castrate level (≤100 ng/dl). Serum testosterone of all subjects excluding one subject in the 3M group was suppressed to the castrate level throughout 48 weeks. The estimated between-group difference (6M group - 3M group) in suppression rate was 1.3% (95% confidence interval: -3.4, 6.8), and its lower confidence interval was more than -10% of the pre-determined allowable limit value to judge the non-inferiority. The prostate-specific antigen concentrations were stable throughout the study in both groups. Progressive disease in the best overall response based on the Response Evaluation Criteria In Solid Tumors was 0.0% for the 6M group and 2.6% for the 3M group. Adverse events occurred in 92.6% in the 6M group and 89.9% in the 3M group. Adverse events leading to discontinuation were reported in 2.5% in the 6M group and 3.8% in the 3M group. TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for the suppressive effect on serum testosterone level. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M). © The Author 2015. Published by Oxford University Press.

  10. Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan

    PubMed Central

    Suzuki, Kazuhiro; Namiki, Mikio; Fujimoto, Tsukasa; Takabayashi, Nobuyoshi; Kudou, Kentarou; Akaza, Hideyuki

    2015-01-01

    Objective Leuprorelin acetate (TAP-144-SR) is commonly used worldwide in prostate cancer patients. This study was conducted to assess the non-inferiority of a 6-month depot formulation of TAP-144-SR (TAP-144-SR [6M]) 22.5 mg to a 3-month depot formulation of TAP-144-SR (TAP-144-SR [3M]) 11.25 mg in prostate cancer patients in Japan. Methods This was a 48-week Phase III, open-label, parallel-group comparative study. TAP-144-SR (6M) 22.5 mg (6M group) and TAP-144-SR (3M) 11.25 mg (3M group) were administered to 81 and 79 subjects, respectively. The primary endpoint was the rate of serum testosterone suppression to the castrate level (≤100 ng/dl). Results Serum testosterone of all subjects excluding one subject in the 3M group was suppressed to the castrate level throughout 48 weeks. The estimated between-group difference (6M group − 3M group) in suppression rate was 1.3% (95% confidence interval: −3.4, 6.8), and its lower confidence interval was more than −10% of the pre-determined allowable limit value to judge the non-inferiority. The prostate-specific antigen concentrations were stable throughout the study in both groups. Progressive disease in the best overall response based on the Response Evaluation Criteria In Solid Tumors was 0.0% for the 6M group and 2.6% for the 3M group. Adverse events occurred in 92.6% in the 6M group and 89.9% in the 3M group. Adverse events leading to discontinuation were reported in 2.5% in the 6M group and 3.8% in the 3M group. Conclusions TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for the suppressive effect on serum testosterone level. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M). PMID:26486824

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

    PubMed Central

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

    2014-01-01

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

  12. The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up.

    PubMed

    Chien, Wai Tong; Yip, Annie L K; Liu, Justina Y W; McMaster, Terry W

    2016-07-01

    Family intervention for psychotic disorders is an integral part of psychiatric treatment with positive effects on patients' mental state and relapse rate. However, the effect of such family-based intervention on caregivers' psychological distress and well-being, especially in non-Western countries, has received comparatively much less attention. To test the effects of guided problem-solving-based manual-guided self-learning programme for family caregivers of adults with recent-onset psychosis over a 6-month period of follow-up, when compared with those in usual family support service. A single-centre randomised controlled trial, which was registered at ClinicalTrials.gov (NCT02391649), with a repeated-measures, two-arm (parallel-group) design. One main psychiatric outpatient clinic in the New Territories of Hong Kong. A random sample of 116 family caregiverss of adult outpatients with recent-onset psychosis. Following pre-test measurement, caregivers were assigned randomly to one of two study groups: a 5-month self-help, problem-solving-based manual-guided self-learning (or bibliotherapy) programme (in addition to usual care), or usual family support service only. Varieties of patient and caregiver health outcomes were assessed and compared at baseline and at 1-week and 6-month post-intervention. One hundred and eleven (96%) caregivers completed the 6-month follow-up (two post-tests); 55 of them (95%) completed ≥4 modules and attended ≥2 review sessions (i.e., 75% of the intervention). The family participants' mean age was about 38 years and over 64% of them were female and patient's parent or spouse. Multivariate analyses of variance indicated that the manual-guided self-learning group reported significantly greater improvements than the usual care group in family burden [F(1,110)=6.21, p=0.006] and caregiving experience [F(1,110)=6.88, p=0.0004], and patients' psychotic symptoms [F(1,110)=6.25, p=0.0003], functioning [F(1,110)=7.01, p=0.0005] and number of

  13. Polydeoxyribonucleotide Injection in the Treatment of Chronic Supraspinatus Tendinopathy: A Case-Controlled, Retrospective, Comparative Study With 6-Month Follow-Up.

    PubMed

    Yoon, Young Chun; Lee, Doo-Hyung; Lee, Michael Young; Yoon, Seung-Hyun

    2017-05-01

    To determine the efficacy of polydeoxyribonucleotide (PDRN) injection for rotator cuff disease (RCD). Case-controlled, retrospective, comparative study. Outpatient clinic at a university-affiliated tertiary care hospital. Patients (N=106) with chronic nontraumatic refractory RCD who were unresponsive to at least 1 month of conservative treatment: 55 patients received PDRN injection (PDRN group) and 51 continued conservative treatment (control group). Not applicable. Shoulder Pain and Disability Index, score on a visual analog scale of the average shoulder pain level, number of analgesic ingestions per day, isometric strength of shoulder abductor, active range of motion (flexion, abduction, internal rotation, external rotation), and maximal tear size of tendon on ultrasonography at pretreatment and 3 and 6 months postinjection. There was no significant difference between the 2 groups in terms of age, sex, shoulder affected, duration of symptoms, and ultrasonographic findings at pretreatment. Compared with the control group, the treatment group showed a significant improvement in Shoulder Pain and Disability Index, visual analog scale score, and number of analgesic ingestions per day. However, there was no difference in isometric strength, active range of motion, and maximal tear size of tendon. No adverse events were reported. To our knowledge, this is the first study to assess the efficacy of PDRN injection for patients with RCD. The PDRN injection group showed improvement in pain and subjective disability in patients with RCD and continued to show improvement for 3 months thereafter; the PDRN injection can be an optional treatment for patients with chronic RCD who show no response to other treatments. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  14. Predictors of psychiatric hospitalization during 6 months of maintenance treatment with olanzapine long-acting injection: post hoc analysis of a randomized, double-blind study

    PubMed Central

    2013-01-01

    Background Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of psychiatric hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assessed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. Methods This was a post hoc exploratory analysis of data from a randomized, double-blind study comparing the safety and efficacy of olanzapine-LAI (pooled active depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 mg/4 weeks) during 6 months’ maintenance treatment of clinically stable schizophrenia outpatients (n=1064). The four psychiatric hospitalization parameters were analyzed for each treatment group. Within the olanzapine-LAI group, patients with and without hospitalization were compared on baseline characteristics. Logistic regression and Cox’s proportional hazards models were used to identify the best predictors of hospitalization. Comparisons between the treatment groups employed descriptive statistics, the Kaplan–Meier estimator and Cox’s proportional hazards models. Results Psychiatric hospitalization was best predicted by suicide threats in the 12 months before baseline and by prior hospitalization. Compared with sub-therapeutic olanzapine-LAI, olanzapine-LAI was associated with a significantly lower hospitalization rate (5.2% versus 11.1%, p < 0.01), a lower mean number of hospitalizations (0.1 versus 0.2, p = 0.01), a shorter mean duration of hospitalization (1.5 days

  15. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

    PubMed

    Siegel, Steven; Noblett, Karen; Mangel, Jeffrey; Griebling, Tomas L; Sutherland, Suzette E; Bird, Erin T; Comiter, Craig; Culkin, Daniel; Bennett, Jason; Zylstra, Samuel; Berg, Kellie Chase; Kan, Fangyu; Irwin, Christopher P

    2015-03-01

    This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency-frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  16. Consumption of sucrose-sweetened soft drinks increases plasma levels of uric acid in overweight and obese subjects: a 6-month randomised controlled trial.

    PubMed

    Bruun, J M; Maersk, M; Belza, A; Astrup, A; Richelsen, B

    2015-08-01

    Sucrose-sweetened soft drinks (SSSDs) are associated with the development of metabolic disorders. Fructose is a major component of SSSDs and is demonstrated to induce uric acid (UA) production and stimulate fat accumulation independent of excess caloric intake. UA induce insulin resistance and low-grade inflammation, suggesting that UA may have a causal role in the development of metabolic complications. The objective of this study is to investigate the long-term effects of consuming SSSDs on circulating levels of UA in overweight and obese subjects. Using a previously published study, circulating UA levels were assessed at baseline and after 6 months using chromogenic enzymatic absorptiometry. The study included 47 overweight and obese subjects without diabetes, randomised to consume 1 l daily of either SSSD (regular cola), isocaloric semi-skimmed milk, diet cola or water for 6 months. Circulating UA levels increased ~15% (P = 0.02) after the 6-month intervention in the SSSD group with no change in the other groups. In the SSSD group, circulating UA levels increased significantly after the intervention in both absolute (P = 0.005) and relative values (P = 0.004). The change in UA after the intervention correlated with changes in liver fat (P = 0.005), triglycerides (P = 0.02) and insulin (P = 0.002). In this secondary analysis daily intake of 1 l SSSD for 6 months was found to increase circulating UA levels compared with isocaloric milk, diet cola and water. Thus, a high daily intake of SSSDs in overweight and obese subjects without overt diabetes may increase the risk of developing metabolic complications through the elevation of UA. This trial is registered at ClinicalTrials.gov as NCT00777647.

  17. Comparative Effectiveness of Once-Weekly GLP-1 Receptor Agonists on 6-Month Glycemic Control and Weight Outcomes in Patients with Type 2 Diabetes.

    PubMed

    Unni, Sudhir; Wittbrodt, Eric; Ma, Junjie; Schauerhamer, Marisa; Hurd, Jeff; Ruiz-Negrón, Natalia; McAdam-Marx, Carrie

    2017-09-01

    A retrospective cohort study was conducted in patients with type 2 diabetes (T2D) in an electronic medical record database to compare real-world, 6-month A1C and weight outcomes for exenatide QW (EQW) vs. dulaglutide and vs. albiglutide. The study included 2,133 EQW, 201 dulaglutide, and 131 albiglutide patients. Overall mean (SD) age was 60 (11) years and 54% were men; neither differed between comparison groups. Mean baseline A1C was similar for EQW [8.3 (1.7)%] and dulaglutide [8.5 (1.5)% (p=0.165)], but higher for albiglutide [8.7 (1.7)% (p<0.001)]. Overall mean A1C change was -0.5 (1.5)% (p<0.001) and did not differ between comparison groups in both adjusted and unadjusted analyses. Mean weight change was -1.4 (4.7) kg for EQW and -1.6 (3.7) kg for albiglutide (p=0.579), but was greater for dulaglutide at -2.7 (5.7) kg (p=0.001). Outcomes were similar in subsets of insulin-naive patients with baseline A1C ≥7.0% or ≥9.0%. All agents significantly reduced A1C at 6 months, with no significant differences between agents or by baseline A1C in insulin-naive subgroups. This article is protected by copyright. All rights reserved.

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

    PubMed

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

    2014-05-14

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2013-01-01

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

  1. Effect of a 6-month intervention with cooking oils containing a high concentration of monounsaturated fatty acids (olive and canola oils) compared with control oil in male Asian Indians with nonalcoholic fatty liver disease.

    PubMed

    Nigam, Priyanka; Bhatt, Suryaprakash; Misra, Anoop; Chadha, Davinder S; Vaidya, Meera; Dasgupta, Jharna; Pasha, Qadar M A

    2014-04-01

    We investigated the effects of dietary intervention with canola or olive oil in comparison with commonly used refined oil in Asian Indians with nonalcoholic fatty liver disease (NAFLD). This was a 6-month intervention study including 93 males with NAFLD, matched for age and body mass index (BMI). Subjects were randomized into three groups to receive olive oil (n=30), canola oil (n=33), and commonly used soyabean/safflower oil (control; n=30) as cooking medium (not exceeding 20 g/day) along with counseling for therapeutic lifestyle changes. The BMI, fasting blood glucose (FBG) and insulin levels, lipids, homeostasis model of assessment for insulin resistance (HOMA-IR), HOMA denoting β-cell function (HOMA-βCF), and disposition index (DI) were measured at pre- and post-intervention. Data were analyzed with one-way analysis of variance (ANOVA) and Tukey's Honestly Significant Difference multiple comparison test procedures. Olive oil intervention led to a significant decrease in weight and BMI (ANOVA, P=0.01) compared with the control oil group. In a comparison of olive and canola oil, a significant decrease in fasting insulin level, HOMA-IR, HOMA-βCF, and DI (P<0.001) was observed in the olive oil group. Pre- and post-intervention analysis revealed a significant increase in high-density lipoprotein level (P=0.004) in the olive oil group and a significant decrease in FBG (P=0.03) and triglyceride (P=0.02) levels in the canola oil group. The pre- and post-intervention difference in liver span was significant only in the olive (1.14 ± 2 cm; P<0.05) and canola (0.66 ± 0.33 cm; P<0.05) oil groups. In the olive and canola oil groups, post-intervention grading of fatty liver was reduced significantly (grade I, from 73.3% to 23.3% and from 60.5% to 20%, respectively [P<0.01]; grade II, from 20% to 10% and from 33.4% to 3.3%, respectively [P<0.01]; and grade III, from 6.7% to none and from 6.1% to none, respectively). In contrast, in the control oil group no significant

  2. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results.

    PubMed

    Lim, Lyndell L; Morrison, Julie L; Constantinou, Marios; Rogers, Sophie; Sandhu, Sukhpal S; Wickremasinghe, Sanjeewa S; Kawasaki, Ryo; Al-Qureshi, Salmaan

    2016-05-01

    To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME). Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months. Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months. Change in central macular thickness (CMT) and best corrected visual acuity at 6 months. Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group. When administered at the time of cataract surgery in patients with DME, at 6 months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group. © 2016 Royal Australian and New

  3. Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study.

    PubMed

    Mankodi, Suru; Chaknis, Patricia; Panagakos, Fotinos S; DeVizio, William; Proskin, Howard M

    2011-07-01

    To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral soft and hard tissue assessments were repeated after 3 and 6 months of product use. 115 subjects complied with the protocol, and completed the 6-month examination. After 6 months of product use, subjects assigned to the Test Dentifrice group exhibited statistically significant reductions from baseline with respect to Plaque Index, Plaque Severity Index, Gingival Index, and Gingivitis Severity Index scores; and subjects assigned to the Negative Control Dentifrice group exhibited statistically significant reductions from baseline with respect to Gingival Index scores only. Relative to the Negative Control Dentifrice group, the Test Dentifrice group exhibited an 18.8% reduction in Plaque Index; a 50% reduction in Plaque Severity Index; a 19.6% reduction in Gingival Index; and a 60% reduction in Gingivitis Severity Index after 6 months, all of which were statistically significant.

  4. A 6-month clinical study assessing the safety and efficacy of two cetylpyridinium chloride mouthrinses.

    PubMed

    Stookey, George K; Beiswanger, Bradley; Mau, Melissa; Isaacs, Roger L; Witt, Jon J; Gibb, Roger

    2005-07-01

    To evaluate the effects of two experimental cetylpyridinium chloride (CPC) mouthrinses containing 0.075% and 0.10% CPC on the development of gingivitis and plaque versus a placebo control over a period of 6 months. This was a randomized, single center, parallel group, double blind, positive and placebo controlled clinical trial. A 0.12% chlorhexidine rinse served as the positive control for validation of the methodology. At the beginning of the trial, 366 subjects were balanced and randomly assigned to treatment groups. Subjects received a dental prophylaxis and began rinsing twice a day with 15 ml of their assigned mouthwash for 30 seconds after brushing their teeth. Subjects were assessed for gingivitis and gingival bleeding by the Löe-Silness Gingival Index method and plaque by the Turesky modification of Quigley Hein Plaque Index at baseline and after 3 and 6 months of product use. Oral soft tissue health was also assessed. After 3 and 6 months, subjects rinsing with either 0.075% or 0.10% CPC had significantly (P< 0.0001) less gingivitis, gingival bleeding, and plaque, on average, than those on placebo. The 6-month mean reductions in gingivitis, gingival bleeding, and plaque for the 0.075% and 0.10% CPC rinses versus placebo were 23%, 30% and 17%, and 20%, 27% and 19%, respectively. There was no statistically significant difference in efficacy between the two CPC mouthrinses. Reductions at 3 months were similar to those seen at 6 months. Significant benefits were observed with chlorhexidine, thereby validating the study. This study clearly demonstrates that CPC mouthrinses formulated to deliver therapeutic benefits when used twice daily can significantly prevent the development of gingivitis, gingival bleeding, and plaque over a 6-month period.

  5. A randomized trial assessing the effect of coumarins started before coronary angioplasty on restenosis: results of the 6-month angiographic substudy of the Balloon Angioplasty and Anticoagulation Study (BAAS).

    PubMed

    ten Berg, Jurriën M; Kelder, Johannes C; Suttorp, Maarten Jan; Verheugt, Freek W A; Plokker, H W Thijs

    2003-01-01

    Thrombus formation during coronary angioplasty may play a role in the restenosis process. The effect of pretreatment with coumarins on 6-month angiographic outcome was studied. In addition, the effect of "optimal" anticoagulation, defined as an international normalized ratio >70% of the follow-up time in the target range, was studied. A total of 261 patients were assigned to aspirin alone (ASA group) and 270 patients to aspirin plus coumarins started 1 week before the procedure (coumarin group). The mean international normalized ratio was 2.7 +/- 1.2 at the start of the procedure and 3.1 +/- 0.5 during follow up. Quantitative coronary analysis was performed on 301 lesions in the ASA group and of 297 lesions in the coumarin group. At 6 months, the minimal luminal diameter was similar in the ASA and coumarin groups. Optimal anticoagulation, however, was an independent predictor of a larger minimal luminal diameter at follow up (P =.01). Overall, coumarins do not improve angiographic outcome 6 months after coronary angioplasty.

  6. Sexual Function 6 Months After First Delivery

    PubMed Central

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

    2008-01-01

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

  7. A 12-week intervention with protein-enriched foods and drinks improved protein intake but not physical performance of older patients during the first 6 months after hospital release: a randomised controlled trial.

    PubMed

    Beelen, Janne; de Roos, Nicole M; de Groot, Lisette C P G M

    2017-06-01

    During and after hospitalisation, older adults are recommended to consume 1·2-1·5 g of protein/kg body weight per d (g/kg per d) to improve recovery. This randomised controlled trial studied the effectiveness of a 12-week intervention with protein-enriched foods and drinks by following-up seventy-five older patients (mean age: 76·8 (sd 6·9) years) during their first 6 months after hospital discharge. Primary outcomes were protein intake and physical performance (measured with Short Physical Performance Battery (SPPB)). Secondary outcomes for physical recovery were gait speed, chair-rise time, leg-extension strength, hand-grip strength, body weight, nutritional status (Mini Nutritional Assessment), independence in activities of daily living (ADL) and physical activity. The intervention group consumed more protein during the 12-week intervention period compared with the control group (P<0·01): 112 (sd 34) g/d (1·5 (sd 0·6) g/kg per d) v. 78 (sd 18) g/d (1·0 (sd 0·4) g/kg per d). SPPB total score, gait speed, chair-rise time, body weight and nutritional status improved at week 12 compared with baseline (time effect P<0·05), but were not different between groups. Leg-extension strength, hand-grip strength and independence in ADL did not change. In conclusion, protein-enriched products enabled older adults to increase their protein intake to levels that are higher than their required intake. In these older adults with already adequate protein intakes and limited physical activity, protein enrichment did not enhance physical recovery in the first 6 months after hospital discharge.

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

    PubMed

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

    2012-06-01

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

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

    USDA-ARS?s Scientific Manuscript database

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

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

    ERIC Educational Resources Information Center

    Xu, Fei; Spelke, Elizabeth S.

    2000-01-01

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

  11. Lack of long-term benefits of a 6-month heart failure disease management program.

    PubMed

    Nguyen, Viviane; Ducharme, Anique; White, Michel; Racine, Normand; O'Meara, Eileen; Zhang, Bin; Rouleau, Jean L; Brophy, James

    2007-05-01

    Heart failure (HF) represents a major burden on the health care system, causing repeated hospitalizations and numerous emergency department (ED) visits. In a 6-month randomized study of a multidisciplinary HF clinic, we have previously shown decreased hospital readmissions and improved quality of life. Despite these encouraging results, it is unknown if these beneficial effects are sustained. To assess long-term recurrent ED visits, readmissions, and mortality among HF patients who were discharged after a 6-month intensive HF management program (HFMP). Of the 230 subjects (New York Heart Association Class II-IV) who were initially randomized to standard follow-up care or to a HFMP for 6 months, 190 were studied retrospectively for long-term evaluation. Long-term data was obtained from the Quebec administrative health databases. We compared the intervention and control groups for the number of recurrent ED visits, hospital readmissions, and all-cause deaths. After a mean follow-up of 2.8 +/- 1.7 years, there was no difference in the composite end point of all-cause death, hospital admissions, and ED visits between those patients initially in the HFMP group and the controls. After multivariable adjustment, there was no difference in the composite primary endpoint (HR 1.01, 95% CI: 0.75-1.37) or in the secondary end point of all-cause death alone (HR 1.09, 95%CI:0.69-1.72) between those initially assigned to the HF clinic and those receiving usual care. For severely ill patients, the clinical and resource benefits of a 6-month HFMP are not sustained upon program cessation. Further research into the benefits of long-term HFMP is required.

  12. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial.

    PubMed

    Dutra, Bernardo Carvalho; Oliveira, Alcione Maria Soares Dutra; Oliveira, Peterson Antônio Dutra; Manzi, Flavio Ricardo; Cortelli, Sheila Cavalca; Cota, Luís Otávio de Miranda; Costa, Fernando Oliveira

    2017-01-01

    Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy.

  13. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

    PubMed Central

    DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

    2017-01-01

    Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

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

    PubMed Central

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

    2014-01-01

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

  15. Edema index-guided disease management improves 6-month outcomes of patients with acute heart failure.

    PubMed

    Liu, Min-Hui; Wang, Chao-Hung; Huang, Yu-Yen; Tung, Tao-Hsin; Lee, Chii-Ming; Yang, Ning-I; Wang, Jong-Shyan; Kuo, Li-Tang; Cherng, Wen-Jin

    2012-01-01

    The efficacy of heart failure (HF) management programs is compromised by the challenge of early identification of patients at imminent risk. Segmental multifrequency bioelectrical impedance analysis can generate an "edema index" (EI) as a surrogate for the body fluid status. In this study, we tested whether integration of EI-guided management improved the 6-month outcomes of HF patients under multidisciplinary care. In total, 159 patients with acute HF were randomized into control, case management (CM), and EI-guided CM (EI) groups (n = 53 in each group). In the EI group, a management algorithm was designed based on the measured EI. The analyzed endpoints included HF-related and all cause-related events during the 6-month follow-up period. In the 6 months, there were 11 (6.9%) deaths, 19 (11.9%) HF-related rehospitalizations, and 45 (28.3%) all-cause-related rehospitalizations. Compared to the control (26.4%) and CM groups (15.1%), the EI group had a lower rate of HF-related death and rehospitalization (3.8%, P = 0.004). Multivariate analysis revealed that EI-guided management was an independent predictor of a lower HF-related event rate (hazard ratio = 0.15, 95%CI = 0.03~0.66, P = 0.012). Patients with a higher pre-discharge EI were older, had lower blood albumin and hemoglobin levels, and had a higher functional class and incidences of diabetes mellitus and chronic kidney disease. An increase in the pre-discharge EI by 0.001 increased the HF-related event rate by 6% (P = 0.002). Use of EI-guided management lowered this risk (P = 0.03). In conclusion, an EI-based HF management program demonstrated an event-lowering effect superior to traditional nurse-led multidisciplinary care in 6 months after an acute HF episode.

  16. Cognitive behavior therapy after acquired brain injury: maintenance of therapeutic benefits at 6 months posttreatment.

    PubMed

    Arundine, April; Bradbury, Cheryl L; Dupuis, Kate; Dawson, Deirdre R; Ruttan, Lesley A; Green, Robin E A

    2012-01-01

    To examine whether 6-month posttreatment acquired brain injury (ABI) patients receiving cognitive behavior therapy (CBT) adapted for ABI would demonstrate (1) maintenance of psychological benefits, (2) better community integration, and (3) commensurate benefits for both teletherapy and face-to-face group therapy. A secondary objective was to examine the relationship between coping strategies and mood and community integration. Seventeen chronic ABI patients with elevated psychological distress. Symptom Checklist-90-Revised (SCL-90-R), Depression Anxiety Stress Scales-21 (DASS-21), Community Integration Questionnaire, and the Ways of Coping questionnaire, revised. Eleven CBT sessions provided either in a face-to-face group format or individually by telephone with outcomes measured pretreatment, posttreatment, and at 6-month follow-up. At 6-month follow-up, full-group scores were significantly better than pretreatment for psychological distress (t(16) = 6.22, P < .01, SCL-90-R; t(16) = 7.32, P < .01, DASS-21) and for community integration (t(16) = -6.15, P < .01), with negligible decrements from immediately posttreatment. Subgroup scores were comparable. Coping also improved but was uncorrelated with mood or community integration. The CBT adapted for ABI shows enduring benefits for mood and community integration. The efficacy of teletherapy obviates service access problems related to geographical remoteness and mobility restrictions. A larger, randomized, control trial that examines underlying mechanisms of efficacy is needed.

  17. A phase IV, two-armed, randomized, cross-over study comparing compliance with once-a-month administration of vitamin D3 to compliance with daily administration of a fixed-dose combination of vitamin D3 and calcium during two 6-month periods.

    PubMed

    Bruyère, O; Deroisy, R; Dardenne, N; Cavalier, E; Coffiner, M; Da Silva, S; De Niet, S; Reginster, J-Y

    2015-12-01

    In a randomized, cross-over study, once monthly administration of vitamin D3 was preferred over a once daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels. The aim of the present study was to compare a once-monthly administration of vitamin D3 to a daily administration of a fixed-dose combination of vitamin D3 and calcium during two treatment periods of 6 months. One hundred volunteers aged 50 years old or older were randomized to receive either one drinkable ampoule containing 25,000 IU vitamin D3 (D-Cure®, SMB) once monthly (group VD) or one chewable tablet containing 1000 mg calcium carbonate + 800 IU vitamin D3 (Steovit Forte®, Takeda) once daily (group VDCa) during 6 months. After the first 6 months of treatment, the groups were reversed according to the randomized cross-over design. Treatment compliance (i.e. the primary outcome), preference, acceptability and vitamin D levels and adverse events were all collected. For the two periods, the patients had a significantly higher compliance in the VD group than in the VDCa group (p < 0.0001). During the study, 50 (56.8 %) patients preferred the VD treatment, 16 (18.2 %) patients preferred the VDCa, and for 22 (25.0 %) patients, neither treatment was preferred. At the end of the first 6 months of treatment, the mean (SD) increase of 25(OH)D was 6.57 ng/mL (8.19) in the VD group and 3.88 ng/mL (10.0) in the VDCa group (p = 0.16 between groups). In this study, a once-monthly administration of vitamin D3 was preferred over a once-daily administration of a fixed-dose combination of vitamin D3 and calcium, with a better compliance but without any significant difference in the increase in vitamin D levels.

  18. Effects of 6 months of moderate aerobic exercise training on immune function in the elderly.

    PubMed

    Woods, J A; Ceddia, M A; Wolters, B W; Evans, J K; Lu, Q; McAuley, E

    1999-06-01

    The purpose of this study was to determine the effects of 6 months of moderate aerobic exercise on age-dysregulated measures of T lymphocyte and natural killer (NK) cell number and function. Previously sedentary elderly (age = 65 +/- 0.8 years) subjects were randomly assigned to supervised 3 time/week exercise intervention group (EXC, n = 14) or flexibility/toning control group (FT-CON, n = 15). Fasting resting blood samples were drawn prior to and after the 6 month intervention. The EXC group exhibited a significant (P < 0.05) 20% increase in VO2 max, whereas the FT-CON group had a smaller non-significant (P = 0.07) increase (9%). Immune results revealed that, in general, changes in immune function in response to 6 months of exercise training at an average intensity of 52% heart rate reserve (HRR) were similar when compared to FT-CON who exercised at approximately 21% HRR. There were no intervention-induced changes in total white blood cell, neutrophil, lymphocyte, monocyte, eosinophil, or basophil blood counts. Furthermore, the percentage and number of CD3+, CD4+ and CD8+ T cells in the blood remained unchanged. There was a tendency for the percentage and number of CD4+ and CD8+ näive cells (CD45RA+) to increase and for CD4+ memory cells (CD45RO+) to decrease post-intervention, especially in FT-CON. Both groups exhibited a small intervention-induced increase in the T-cell proliferative response to mitogenic stimulation: the percentage change of which was higher in the EXC group at several doses of Con A. Unstimulated NK cell cytolysis versus K562 cells tended to increase (P < 0.1) in the EXC group with little change in FT-CON. We conclude that 6 months of supervised exercise training can lead to nominal increases in some measures of immune function, while not affecting others, in previously sedentary elderly.

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

    PubMed

    Hollywood, Amelia; Ogden, Jane

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  1. A 6-month study of the effects of 0.3% triclosan/copolymer dentifrice on dental implants.

    PubMed

    Sreenivasan, Prem K; Vered, Yuval; Zini, Avi; Mann, Jonathan; Kolog, Hilla; Steinberg, Doron; Zambon, Joseph J; Haraszthy, Violet I; da Silva, Maike P; De Vizio, William

    2011-01-01

    Supportive therapy to maintain dental implants is increasingly important. This study examined the effect of a 0.3% triclosan/2% copolymer dentifrice on oral biofilms and gingival inflammation (GI) on dental implants and peri-implant tissues. One hundred and twenty adults with a dental implant and contra-lateral tooth were enrolled in this 6 month, double-blind, two-treatment, parallel group study. Sixty subjects were randomly assigned to a triclosan/copolymer dentifrice test group and 60 subjects to a fluoride dentifrice control group and instructed to brush twice daily for 6 months. At baseline, 3, and 6 months, a calibrated dentist assessed dental plaque, GI and collected supragingival dental plaque for microbiological analysis. Subjects in the triclosan/copolymer group demonstrated significantly lower levels of dental plaque, gingivitis, and bleeding on probing at 3 and 6 months at both the implant and contra-lateral tooth compared with the fluoride group (p<0.05). There were significantly fewer Gram-negative anaerobes in the triclosan/copolymer group (p<0.05) including >90% reductions in Aggregatibacter actinomycetemcomitans, Campylobacter rectus, Eubacterium saburreum, Fusobacterium nucleatum, Porphyromonas gingivalis, Prevotella melaninogenica, Solobacterium moorei, and Tannerella forsythia. Twice daily use of a triclosan/copolymer dentifrice may enhance dental implant maintenance by reducing dental plaque and GI. © 2010 John Wiley & Sons A/S.

  2. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women.

    PubMed

    Bredella, Miriam A; Gerweck, Anu V; Barber, Lauren A; Breggia, Anne; Rosen, Clifford J; Torriani, Martin; Miller, Karen K

    2014-05-01

    Abdominal adiposity is associated with low BMD and decreased growth hormone (GH) secretion, an important regulator of bone homeostasis. The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity. In a 6-month, randomized, double-blind, placebo-controlled trial we studied 79 abdominally obese premenopausal women (21-45 y) who underwent daily sc injections of GH vs. placebo. Main outcome measures were body composition by DXA and CT, bone marrow fat by proton MR spectroscopy, P1NP, CTX, 25(OH)D, hsCRP, undercarboxylated osteocalcin (ucOC), preadipocyte factor 1 (Pref 1), apolipoprotein B (ApoB), and IGF-1. GH increased IGF-1, P1NP, 25(OH)D, ucOC, bone marrow fat and lean mass, and decreased abdominal fat, hsCRP, and ApoB compared with placebo (p<0.05). There was a trend toward an increase in CTX and Pref-1. Among all participants, a 6-month increase in IGF-1 correlated with 6-month increase in P1NP (p=0.0005), suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation. A six-month decrease in abdominal fat, hsCRP, and ApoB inversely predicted 6-month change in P1NP, and 6-month increase in lean mass and 25(OH)D positively predicted 6-month change in P1NP (p≤0.05), suggesting that subjects with greatest decreases in abdominal fat, inflammation and ApoB, and the greatest increases in lean mass and 25(OH)D experienced the greatest increases in bone formation. A six-month increase in bone marrow fat correlated with 6-month increase in P1NP (trend), suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat. Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP. When IGF-1 was added to the model, it became the only predictor of P1NP. GH replacement in

  3. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women

    PubMed Central

    Bredella, Miriam A.; Gerweck, Anu V.; Barber, Lauren A.; Breggia, Anne; Rosen, Clifford J.; Torriani, Martin; Miller, Karen K.

    2014-01-01

    Purpose Abdominal adiposity is associated with low BMD and decreased growth hormone (GH) secretion, an important regulator of bone homeostasis. The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity. Materials and Methods In a 6-month, randomized, double-blind, placebo-controlled trial we studied 79 abdominally obese premenopausal women (21–45y) who underwent daily sc injections of GH vs. placebo. Main outcome measures were body composition by DXA and CT, bone marrow fat by proton MR spectroscopy, P1NP, CTX, 25(OH)D, hsCRP, undercarboxylated osteocalcin (ucOC), preadipocyte factor 1 (Pref 1), apolipoprotein B (ApoB), and IGF-1. Results GH increased IGF-1, P1NP, 25(OH)D, ucOC, bone marrow fat and lean mass, and decreased abdominal fat, hsCRP, and ApoB compared with placebo (p<0.05). There was a trend toward an increase in CTX and Pref-1. Among all participants, 6-month increase in IGF-1 correlated with 6-month increase in P1NP (p=0.0005), suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation. Six-month decrease in abdominal fat, hsCRP, and ApoB inversely predicted 6-month change in P1NP, and 6-month increase in lean mass and 25(OH)D positively predicted 6-month change in P1NP (p≤0.05), suggesting that subjects with greatest decreases in abdominal fat, inflammation and ApoB, and the greatest increases in lean mass and 25(OH)D experienced the greatest increases in bone formation. Six-month increase in bone marrow fat correlated with 6-month increase in P1NP (trend), suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat. Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP. When IGF-1 was added to the model, it became the only predictor

  4. Effect of 6 Months of Balance Training During Pulmonary Rehabilitation in Patients With COPD.

    PubMed

    Mkacher, Wajdi; Mekki, Marwa; Tabka, Zouhair; Trabelsi, Yassine

    2015-01-01

    Balance impairment is recognized as an important issue for patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to examine the effect of balance training as part of pulmonary rehabilitation (PR) on balance in COPD patients. Patients were randomly assigned to an intervention or usual care group. The intervention group underwent balance training 3 times a week for 6 months in addition to the standard PR. The control group received 6 months of the standard PR program only. Balance was assessed by the Timed Up and Go (TUG), Tinetti, Berg Balance Scale (BBS), and the Unipodal Stance (UST) tests. Balance confidence was rated using the ABC scale. Exercise tolerance was determined using a 6-Minute Walk Test. Following the completion of PR, the intervention group showed improvement in all balance measures. Only TUG, ABC, and UST scores were improved in the usual care group (P < .05). Results demonstrated significant between-group differences in TUG, Tinetti, BBS, and ABC scores (P < .01) and UST score (P < .05). Balance training incorporated into a standard PR program significantly improves scores on balance tests in COPD patients.

  5. Feeding patterns and diet -- children 6 months to 2 years

    MedlinePlus

    ... patterns and diet - children 6 months to 2 years To use the sharing features on this page, ... Clinical Assistant Professor of Pediatrics, University of Washington School of Medicine, Seattle, WA. Also reviewed by David ...

  6. Efficacy and Safety of 6-Month Nightly Ramelteon Administration in Adults with Chronic Primary Insomnia

    PubMed Central

    Mayer, Geert; Wang-Weigand, Sherry; Roth-Schechter, Barbara; Lehmann, Reiner; Staner, Corinne; Partinen, Markku

    2009-01-01

    Study Objectives: Long-duration ( ≥ 6 months) polysomnographic studies of insomnia medications are lacking. This study evaluated the long-term efficacy of ramelteon, a selective MT1/MT2 melatonin-receptor agonist used for insomnia treatment. Design: Six-month, randomized, double-blind, placebo-controlled study. Setting: Forty-six investigative sites in the United States, Europe, Russia, and Australia. Participants: Four hundred fifty-one adults (age ≥ 18 years) with chronic primary insomnia. Interventions: Ramelteon, 8 mg, or placebo 30 minutes before bedtime nightly for 6 months. Measurements: Sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights of Week 1; the last 2 nights of Months 1, 3, 5, and 6; and Nights 1 and 2 of the placebo run-out. Next-morning residual effects as well as adverse effects and vital signs were recorded at each visit. Rebound insomnia and withdrawal effects were evaluated during placebo run-out. Results: Over the 6 months of treatment, ramelteon consistently reduced latency to persistent sleep compared with baseline and with placebo; significant decreases were observed at Week 1 and Months 1, 3, 5, and 6 (P < 0.05). Ramelteon significantly reduced subjective sleep latency relative to placebo at Week 1, Month 1, and Month 5 (P < 0.05), with reductions nearing statistical significance at Months 3 and 6 (P ≤ 0.08). No significant next-morning residual effects were detected during ramelteon treatment. No withdrawal symptoms or rebound insomnia were detected after ramelteon discontinuation. Most adverse events were mild or moderate in severity. Conclusions: In adults with chronic insomnia, long-term ramelteon treatment consistently reduced sleep onset, with no next-morning residual effects or rebound insomnia or withdrawal symptoms upon discontinuation. Citation: Mayer G; Wang-Weigand S; Roth-Schechter B; Lehmann R; Staner C; Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in

  7. Virtual reality job interview training and 6-month employment outcomes for individuals with schizophrenia seeking employment.

    PubMed

    Smith, Matthew J; Fleming, Michael F; Wright, Michael A; Roberts, Andrea G; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D

    2015-08-01

    Individuals with schizophrenia have low employment rates and the job interview presents a critical barrier for them to obtain employment. Virtual reality training has demonstrated efficacy at improving interview skills and employment outcomes among multiple clinical populations. However, the effects of this training on individuals with schizophrenia are unknown. This study evaluated the efficacy of virtual reality job interview training (VR-JIT) at improving job interview skills and employment outcomes among individuals with schizophrenia in a small randomized controlled trial (n=21 VR-JIT trainees, n=11 waitlist controls). Trainees completed up to 10h of virtual interviews using VR-JIT, while controls received services as usual. Primary outcome measures included two pre-test and two post-test video-recorded role-play interviews scored by blinded raters with expertise in human resources and self-reported interviewing self-confidence. Six-month follow-up data on employment outcomes were collected. Trainees reported that the intervention was easy-to-use, helpful, and prepared them for future interviews. Trainees demonstrated increased role-play scores between pre-test and post-test while controls did not (p=0.001). After accounting for neurocognition and months since prior employment, trainees had greater odds of receiving a job offer by 6month follow-up compared to controls (OR: 8.73, p=0.04) and more training was associated with fewer weeks until receiving a job offer (r=-0.63, p<0.001). Results suggest that VR-JIT is acceptable to trainees and may be efficacious for improving job interview skills in individuals with schizophrenia. Moreover, trainees had greater odds of receiving a job offer by 6-month follow-up. Future studies could evaluate the effectiveness of VR-JIT within community-based services. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Alpha-Lipoic Acid Shows Promise to Improve Migraine in Patients with Insulin Resistance: A 6-Month Exploratory Study.

    PubMed

    Cavestro, Cinzia; Bedogni, Giorgio; Molinari, Filippo; Mandrino, Silvia; Rota, Eugenia; Frigeri, Maria Cristina

    2017-10-04

    Alpha-lipoic acid (ALA) is known to lower insulin resistance (IR), which is common among migraineurs. To assess the effect of ALA on headache in migraineurs with IR, we performed an exploratory study on a cohort of patients with migraine, followed at our Headache Center. The 32 patients took ALA 400 mg b.i.d. for 6 months in addition to their on-going treatment. The percentage of patients with a reduction of at least 50% of the attacks was 0.53 (confidence interval [95% CI] 0.36-0.70) at 2 months, 0.56 (0.39-0.73) at 4 months, and 0.69 (0.53-0.85) at 6 months. The incidence rate ratio of attacks at 6 months versus baseline was 0.48 (0.43-0.53, P < .001), corresponding to a mean (95% CI) number of attacks of 5 (4-6) versus 11 (10-12). The number of days of treatment in the previous month was 7.7 (6.8-8.7) at baseline, 5.4 (4.6-6.2) at 2 months, 5.3 (4.5-6.1) at 4 months, and 4.3 (3.6-5.0) at 6 months. Baseline and 120-min glucose and insulin and quantitative insulin sensitivity check index (QUICKI) and the Stumvoll index did not change at 6 months versus baseline. This exploratory study shows that the administration of ALA may be associated with a reduction in the number of attacks and the days of treatment in migraineurs with IR. A randomized controlled trial is needed to test this possibility.

  9. Improved nutritional status in elderly patients 6 months after stroke.

    PubMed

    Brynningsen, P K; Damsgaard, E M S; Husted, S E

    2007-01-01

    Nutritional status among stroke patients has received limited attention despite the fact, that it may have an influence on clinical outcome. Previous studies have estimated that 15-20 % of patients suffer from malnutrition in the acute phase of stroke, but so far no studies have focused on the late rehabilitation phase after stroke in the patients own home, where the attention on nutrition may be reduced. To determine the prevalence of malnutrition during 6 months of stroke rehabilitation, and to investigate the association between nutritional status, functional recovery, length of stay in hospital and infectious complications. 89 patients with ischemic stroke consecutively admitted to a geriatric stroke rehabilitation unit had their nutritional status evaluated in the hospital at 1 week and 5 weeks after stroke, and in their own home at 3 months and 6 months. Nutritional status was evaluated by body weight, body mass index (BMI), mid upper arm circumference (MAC), triceps skinfold thickness (TSF) and serum concentrations of albumin and transferrin. Malnutrition was defined if the patients had 2 or more abnormal nutritional variables. We found a significant increase in albumin from 1 week to 6 months (P < 0.0001), and a significant increase in transferrin form 5 weeks to 6 months (P < 0.05). There was no significant change in weight or BMI from 1 week to 6 months. The number of patients with 2 or more abnormal nutritional variables was 31 (35 %) at 1 week and was reduced to 20 (22 %) at 6 months. 35 % of elderly patients with ischemic stroke admitted to a geriatric rehabilitation unit were malnourished 1 week after stroke. Particularly serum proteins and body fat were affected. Follow-up of nutritional variables showed improvement for serum proteins, and 22 % of the patients were malnourished 6 months after stroke.

  10. Continuation of copper-containing intrauterine devices at 6 months.

    PubMed

    Garbers, Samantha; Haines-Stephan, Jessica; Lipton, Yael; Meserve, Allison; Spieler, Leah; Chiasson, Mary Ann

    2013-01-01

    Intrauterine devices (IUDs) are highly effective at preventing pregnancy and cost-effective. Suboptimal continuation of IUDs places women at risk of unintended pregnancy. Little is known about prevalence or predictors of discontinuation of IUDs within the first 6 months. A retrospective cohort analysis was conducted among 306 family planning patients who had a CuT380A IUD inserted from November 2008-August 2011. Rates of continuation among 283 users were calculated using survival analyses, and predictors of removal within 6 months of insertion were assessed using logistic regression. Among 306 IUD insertions, 13 (4.2%) full or partial expulsions occurred within the first 6 months: 9 (10.7%) among nulliparous and 4 (2.0%) among parous women (chi-square, p<.001). In the first 6 months, four (1.3%) pregnancies occurred among women without prior removal or expulsion of the device (unadjusted Pearl Index: 2.61 per 100 woman-years at 6 months), all among parous women. Of 283 women in continuation analyses, 26% were under 20 years old and 29% nulliparous. Most (84%) received health education specific to IUDs before insertion. Overall, 11% had their IUD removed within 6 months of insertion. In an adjusted logistic regression model, women who did not receive health education were significantly more likely (Adjusted Odds Ratio=3.37, 95% confidence interval: 1.35-8.39) to have a removal within 6 months, but no significant association was found for age, race/ethnicity or parity. Early discontinuation of IUDs was prevalent but lower among women who received method-specific health education. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study.

    PubMed

    Kurebayashi, Junichi; Toyama, Tatsuya; Sumino, Shuuji; Miyajima, Eri; Fujimoto, Tsukasa

    2017-01-01

    Leuprorelin acetate, a luteinizing hormone-releasing hormone agonist, is used worldwide in premenopausal women with hormone receptor-positive breast cancer. This study was conducted to assess the non-inferiority of the 6-month depot formulation, TAP-144-SR (6M) 22.5 mg to the 3-month depot formulation, TAP-144-SR (3M) 11.25 mg in postoperative, premenopausal patients with hormone receptor-positive breast cancer. This was a 96-week phase III, randomized, open-label, parallel-group comparative study. All patients concomitantly received oral tamoxifen (20 mg daily). The primary endpoint was the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 48. In total, 167 patients were randomized to receive TAP-144-SR (6M) (n = 83) or TAP-144-SR (3M) (n = 84) and the E2 suppression rate was 97.6 and 96.4 %, respectively. The estimated between-group difference was 1.2 % (95 % confidence interval -5.2 to 7.8). The non-inferiority of TAP-144-SR (6M) to TAP-144-SR (3M) for E2 suppression was confirmed. As for safety, common adverse events were hot flush and injection site reactions including induration, pain, and erythema in both treatment groups, which were of ≤Grade 2 in severity and not serious. No significant between-group differences in safety profiles and tolerability were observed. TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for its suppressive effect on serum E2. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M).

  12. 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

  13. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

    ERIC Educational Resources Information Center

    Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-01-01

    Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

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

    PubMed

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

    2015-03-01

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

  15. Acupuncture in Menopause (AIM) Study: a Pragmatic, Randomized Controlled Trial

    PubMed Central

    Avis, Nancy E.; Coeytaux, Remy R.; Isom, Scott; Prevette, Kristen; Morgan, Timothy

    2015-01-01

    Objective to evaluate the short- and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures. Methods A total of 209 perimenopausal and postmenopausal women aged 45-60 experiencing ≥4 VMS per day recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life. Results VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (p<0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (p<0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained post treatment. Statistically significant clinical improvement was observed after 3 acupuncture treatments and maximum clinical effects occurred after a median of 8 treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group. Conclusions We found that a course of acupuncture treatments was associated with significant reduction in VMS, as well as several quality of life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment. PMID:27023860

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

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

    ERIC Educational Resources Information Center

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

    2010-01-01

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

  18. Maternal Regulation of Infant Reactivity From 2 to 6 Months.

    ERIC Educational Resources Information Center

    Jahromi, Laudan B.; Putnam, Samuel P.; Stifter, Cynthia A.

    2004-01-01

    Previous research has investigated the effect of maternal soothing behaviors on reducing infant reactivity but not the differential effects of specific maternal behaviors on infant stress responses. The present study investigated maternal regulation of 2- and 6-month-olds' responses to an inoculation and found a significant decline with age in…

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

    ERIC Educational Resources Information Center

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

    2005-01-01

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

  20. The prevalence and factors associated with stunting among infants aged 6 months in a peri-urban South African community.

    PubMed

    Matsungo, Tonderayi M; Kruger, Herculina S; Faber, Mieke; Rothman, Marinel; Smuts, Cornelius M

    2017-09-07

    To determine the prevalence and factors associated with stunting in 6-month-old South African infants. This cross-sectional study was part of the baseline of a randomized controlled trial. Weight-for-length, length-for-age and weight-for-age Z-scores were based on the WHO classification. Blood samples were analysed for Hb, plasma ferritin and soluble transferrin receptor (sTfR). Socio-economic, breast-feeding and complementary feeding practices were assessed by questionnaire. Setting/Subjects Infants aged 6 months (n 750) from a peri-urban area of Matlosana Municipality, North West Province of South Africa. Stunting, underweight, wasting and overweight affected 28·5, 11·1, 1·7 and 10·1 % of infants, respectively. Exclusive breast-feeding to 6 months of age was reported in 5·9 % of the infants. Multivariable binary logistic regression showed that birth weight (OR=0·12; 95 % CI 0·07, 0·21, P8·3 mg/l) concentrations. The association between stunting and lower birth weight, shorter maternal height and male sex reflects possibly the intergenerational origins of stunting. Therefore, interventions that focus on improving preconceptual and maternal nutritional status, combined with strategies to promote appropriate infant feeding practices, may be an important strategy to prevent stunting in vulnerable settings.

  1. Efficacy and augmentation during 6 months of double-blind pramipexole for restless legs syndrome.

    PubMed

    Högl, Birgit; Garcia-Borreguero, Diego; Trenkwalder, Claudia; Ferini-Strambi, Luigi; Hening, Wayne; Poewe, Werner; Brenner, Stefanie S; Fraessdorf, Mandy; Busse, Michael; Albrecht, Stefan; Allen, Richard P

    2011-04-01

    Pramipexole is an effective treatment for restless legs syndrome (RLS), but no controlled studies have lasted >12 weeks. RLS patients (N=331) with pretreatment serum ferritin >30 ng/mL were randomly assigned to take double-blind optimized pramipexole (0.125-0.75 mg/d) or placebo for 26 weeks. The primary efficacy endpoint was change in International RLS Study Group Rating Scale (IRLS) score. Other endpoints assessed global change, symptoms, and QoL. Patients maintained symptom diaries. Cases meeting predefined criteria for suspected augmentation were reviewed by a blinded expert panel, which used a predefined algorithm. Among 321 patients providing post-baseline data, of whom 234 completed 26 weeks, pramipexole was more effective than placebo by multiple endpoints, including an adjusted mean IRLS score change of -13.7 vs. -11.1 (p=0.0077) and an IRLS responder rate (≥50% score reduction) of 58.6% vs. 42.8% (p=0.0044). Efficacy showed considerable country-to-country variability. Six-month incidence of confirmed augmentation was 9.2% for pramipexole and 6.0% for placebo. The rate increased with treatment duration for pramipexole but not placebo. Treatment-related adverse events (AEs) were more likely for pramipexole than for placebo, but discontinuation due to AEs was less likely. During a 6-month period, pramipexole was effective, safe, and generally well tolerated. Because risk of augmentation may have increased over 6 months, it should be studied in longer trials. Beginning or mild augmentation is difficult to distinguish from natural RLS fluctuation, at least in a non-iron-deficient population. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Triptorelin embonate: a 6-month formulation for prostate cancer.

    PubMed

    Whelan, Peter

    2010-12-01

    Luteinizing hormone releasing hormone (LH RH) agonists are the major agent for androgen deprivation therapy in advanced and metastatic prostate cancer. They also have a role in endometriosis, uterine fibroids and central precocious puberty. Triptorelin embonate 22.5 mg is a new, sustained-release, 6-month formulation of an LH RH agonist. It possesses longer duration of action than the current standard 3-month preparation and appears to have similar efficacy and side effects. The use of LH RH agonists for androgen deprivation in prostate cancer has increased considerably in the last 20 years. Recent work has shown that some of this usage has constituted overtreatment and it is within these newer paradigms of therapy that the new 6-month preparation is situated. The new 6-month LH RH preparation - triptorelin embonate - will be of help in several key areas of therapy for prostate cancer, notably as an adjunct to radiation therapy and chemotherapy. It possesses a similar effect, but with fewer side effects, than those that are now commonly available.

  3. Still nursing at 6 months: a survey of breastfeeding mothers.

    PubMed

    Augustin, Amy L; Donovan, Kathleen; Lozano, Emily A; Massucci, Diane J; Wohlgemuth, Fran

    2014-01-01

    To learn about the duration of breastfeeding and to describe the variables influencing breastfeeding practices of mothers who gave birth at a suburban community hospital. An Institutional Review Board approved this descriptive anonymous survey with 20 questions concerning patients' characteristics and experiences with breastfeeding, which was developed based on current literature. The survey was distributed to mothers through Survey Monkey via email 6 months after birth. The survey link was sent to 806 mothers, with a response rate of 50%. Over 59% were still breastfeeding at 6 months. Mothers who initiated skin-to-skin contact in the first hour had a higher rate of breastfeeding during this time frame compared to mothers who did not perform skin-to-skin contact. Women who had cesarean births and women who were primiparas reported a higher use of formula while in the hospital, and breastfed for a shorter duration. The primary reasons for stopping breastfeeding were low milk supply, returned to work, and baby did not latch and nurse well. This study adds to the knowledge base of what practices influence rates and duration of breastfeeding in the first 6 months of a baby's life. The information could enhance the care provided to mothers and babies through improving lactation programs and thereby increasing breastfeeding success rates.

  4. Prenatal Docosahexaenoic Acid Supplementation and Infant Morbidity: Randomized Controlled Trial

    PubMed Central

    Imhoff-Kunsch, Beth; Stein, Aryeh D.; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle

    2011-01-01

    OBJECTIVE: Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. METHODS: In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. RESULTS: Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58–1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P < .0001). At 6 months, infants in the DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and “other illness,” respectively, but 74% longer duration of vomiting (all P < .05). CONCLUSIONS: DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months. PMID:21807696

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2013-10-01

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

  7. Hospital discharge bags and breastfeeding at 6 months: data from the infant feeding practices study II.

    PubMed

    Sadacharan, Radha; Grossman, Xena; Matlak, Stephanie; Merewood, Anne

    2014-02-01

    Distribution of industry-sponsored formula sample packs to new mothers undermines breastfeeding. Using data from the Infant Feeding Practices Study II (IFPS II), we aimed to determine whether receipt of 4 different types of bags was associated with exclusive breastfeeding during the first 6 months of life. We extracted data from IFPS II questionnaires. Type of discharge bag received was categorized as "formula bag," "coupon bag," "breastfeeding supplies bag," or "no bag". We examined exclusive breastfeeding status at 10 weeks (post hoc) and at 6 months using univariate descriptive analyses and multivariate logistic regression models, controlling for sociodemographic and attitudinal variables. Overall, 1868 (81.4%) of women received formula bags, 96 (4.2%) received coupon bags, 46 (2.0%) received breastfeeding supplies bags, and 284 (12.4%) received no bag. By 10 weeks, recipients of breastfeeding supplies bags or no bag were significantly more likely to be exclusively breastfeeding than formula bag recipients. In the adjusted model, compared to formula bag/coupon bag recipients, recipients of breastfeeding supplies bag/no bag were significantly more likely to breastfeed exclusively for 6 months (odds ratio = 1.58; 95% confidence interval, 1.06-2.36). The vast majority of new mothers received formula sample packs at discharge, and this was associated with reduced exclusive breastfeeding at 10 weeks and 6 months. Bags containing breastfeeding supplies or no bag at all were positively associated with exclusive breastfeeding at 10 weeks and 6 months.

  8. Randomized controlled trial of a lay-facilitated angina management programme

    PubMed Central

    Furze, Gill; Cox, Helen; Morton, Veronica; Chuang, Ling-Hsiang; Lewin, Robert JP; Nelson, Pauline; Carty, Richard; Norris, Heather; Patel, Nicky; Elton, Peter

    2012-01-01

    Aims This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). Background Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. Design A randomized controlled trial comparing a lay-facilitated angina management programme with routine care from an angina nurse specialist. Methods Participants with new stable angina were randomized to the angina management programme (intervention: 70 participants) or advice from an angina nurse specialist (control: 72 participants). Primary outcome was angina frequency at 6 months; secondary outcomes at 3 and 6 months included: risk factors, physical functioning, anxiety, depression, angina misconceptions and cost utility. Follow-up was complete in March 2009. Analysis was by intention-to-treat; blind to group allocation. Results There was no important difference in angina frequency at 6 months. Secondary outcomes, assessed by either linear or logistic regression models, demonstrated important differences favouring the intervention group, at 3 months for: Anxiety, angina misconceptions and for exercise report; and at 6 months for: Anxiety; Depression; and angina misconceptions. The intervention was considered cost-effective. Conclusion The angina management programme produced some superior benefits when compared to advice from a specialist nurse. PMID:22229483

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2015-05-01

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

  11. Multisite Randomized Controlled Trial to Compare Two Methods of Tinnitus Intervention to Two Control Conditions.

    PubMed

    Henry, James A; Stewart, Barbara J; Griest, Susan; Kaelin, Christine; Zaugg, Tara L; Carlson, Kathleen

    In this four-site clinical trial, we evaluated whether tinnitus masking (TM) and tinnitus retraining therapy (TRT) decreased tinnitus severity more than the two control groups: an attention-control group that received tinnitus educational counseling (and hearing aids if needed; TED), and a 6-month-wait-list control (WLC) group. The authors hypothesized that, over the first 6 months of treatment, TM and TRT would decrease tinnitus severity in Veterans relative to TED and WLC, and that TED would decrease tinnitus severity relative to WLC. The authors also hypothesized that, over 18 months of treatment, TM and TRT would decrease tinnitus severity relative to TED. Treatment effectiveness was hypothesized not to be different across the four sites. Across four Veterans affairs medical center sites, N = 148 qualifying Veterans who experienced sufficiently bothersome tinnitus were randomized into one of the four groups. The 115 Veterans assigned to TM (n = 42), TRT (n = 34), and TED (n = 39) were considered immediate-treatment subjects; they received comparable time and attention from audiologists. The 33 Veterans assigned to WLC were, after 6 months, randomized to receive delayed treatment in TM, TRT, or TED. Assessment of outcomes took place using the Tinnitus Handicap Inventory (THI) at 0, 3, 6, 12, and 18 months. Results of a repeated measures analysis of variance using an intention-to-treat approach showed that the tinnitus severity of Veterans receiving TM, TRT, and TED significantly decreased (p < 0.05) relative to Veterans in the WLC group at 3 months (effect sizes = 0.44, 0.52, and 0.27, respectively) and at 6 months (effect sizes = 0.52, 0.56, and 0.40, respectively). Analyses comparing effectiveness of TM, TRT, and TED over 18 months revealed that the three conditions were not significantly different, but that tinnitus severity in the combined groups significantly decreased (p < 0.01) from baseline to 3 months (5.6 THI points) and from 3 to 6 months (3.7 THI

  12. Breastfeeding at 6 months and effects on infections.

    PubMed

    Chye, J K; Lim, C T

    1998-12-01

    To examine the pattern of and the influence of some socio-demographic factors on infant milk feedings, and the protective role of breastfeeding against infections. Mothers who breastfed their infants (exclusively or partially) at 6 weeks postpartum, and who had singleton pregnancies and healthy infants at birth, were interviewed when their infants had reached 6 months of age. Of the 234 mothers studied, only 31 (13%) mothers were practising exclusive breastfeeding (EBF) and 133 (57%) mothers were using exclusive infant formula feeding (EIF). Solid and semi-solid foods were introduced between 4 to 6 months of life in 89% of the infants. On logistic regression analysis, mothers who were in paid employment [OR 0.25, 95% CI 0.15, 0.42] and not breast feeding at 6 weeks [OR 0.32, 95% CI 0.19, 0.54] had decreased odds of EBF. Antenatal plans to breastfeed, breast-feeding difficulties, ethnicity, level of parental education, parental ages, fathers' income, primigravida status and infants' gender were not significant co-variates. In comparison, EIF was more likely in mothers who worked, practised mixed feedings at 6 weeks and of Chinese descent. There were no significant differences in the rates of upper respiratory tract infections (URTI) or diarrhoeal illnesses between the infants who were or were not being breast-fed. Most mothers were unable to breastfeed their infants exclusively in the recommended first 4 to 6 months of life. Complementary changes outside the hospital and maternity services are essential in improving breastfeeding rates. Breastfeeding does not appear to confer significant protection to either URTI or gastrointestinal tract infections.

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

    PubMed Central

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

    2014-01-01

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

  14. Prospective evaluation of the psychosocial impact of the first 6 months of orthodontic treatment with fixed appliance among young adults.

    PubMed

    Prado, Renata França; Ramos-Jorge, Joana; Marques, Leandro Silva; de Paiva, Saul Martins; Melgaço, Camilo Aquino; Pazzini, Camila Alessandra

    2016-07-01

    To evaluate the psychosocial impact of the first 6 months of orthodontic treatment with a fixed appliance among young adults and compare the results with those of a control group of patients awaiting treatment for malocclusion. A study was conducted with a sample of 120 patients on a waiting list for orthodontic treatment at a university. The participants were allocated to an experimental group submitted to treatment and a control group awaiting treatment. The groups were matched for sex and age. All participants were instructed to answer the Brazilian version of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) at baseline and after 6 months. Statistical analysis involved the Wilcoxon test for the total PIDAQ score and the score of each subscale. All patients participated until the end of the study. Significant differences between baseline and the 6-month evaluation were found for the total PIDAQ score as well as the dental self-confidence and social impact subscales in both groups. No differences between baseline and the 6-month evaluation were found regarding the psychological impact or esthetic concern subscales in the control group. The patients in the experimental group reported greater esthetic impact 6 months after beginning treatment (P < .001). The first 6 months of orthodontic treatment seem to improve psychosocial impact. The first 6 months of orthodontic treatment seem to improve the psychosocial impact of malocclusion. The patients analyzed in the present study reported a greater esthetic impact and less psychological impact after 6 months of using an orthodontic appliance.

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

    PubMed

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

    2010-12-01

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

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

    PubMed

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

    2010-02-01

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

  17. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial.

    PubMed

    Antosh, Danielle D; Gutman, Robert E; Park, Amy J; Sokol, Andrew I; Peterson, Joanna L; Kingsberg, Sheryl A; Iglesia, Cheryl B

    2013-06-01

    To compare rates of de novo dyspareunia in women with and without vaginal dilator use after posterior colporrhaphy. This randomized controlled trial included sexually active patients with prolapse and no bothersome baseline dyspareunia undergoing posterior colporrhaphy. Patients were randomized to daily vaginal dilator use from postoperative weeks 4 through 8 or to no dilator use. Pelvic organ prolapse quantification examination and vaginal caliber were measured at baseline, 8 weeks, and 6 months postoperatively. Sexual function was evaluated at baseline, 3 months, and 6 months postoperatively using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12. Participants completed a Patient Global Impression of Improvement at 3 months and 6 months postoperatively. Sixty patients were randomized: 30 in the dilator group and 30 in the control group. There were no differences in baseline characteristics and postoperative vaginal caliber between groups. At 3 months, 9.5% of patients reported de novo dyspareunia in the dilator group compared with 19.2% of control patients (P=.44). At 6 months, 12.5% of patients in the dilator group reported de novo dyspareunia compared with 3.8% of control patients (P=.34). There was a 13% loss-to-follow-up rate, and therefore we did not meet appropriate power to detect a difference. There were no differences in overall sexual function or Patient Global Impression of Improvement scores between groups at 3 months and 6 months. There were no significant differences in de novo dyspareunia rates, overall postoperative sexual function scores, or global improvement scores between those using vaginal dilators compared with control patients.

  18. 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).

  19. Malignant hyperthermia in a 6-month-old infant.

    PubMed

    Mathur, P R; Rundla, M; Jain, N; Mathur, V

    2016-01-01

    Malignant hyperthermia (MH) is a rare hypermetabolic disorder of skeletal muscles that manifests as a life-threatening crisis in susceptible individuals, after exposure to triggering agents, most commonly halothane and succinylcholine. MH presents with multiple nonspecific signs and laboratory findings such as tachycardia, hyperthermia, hypercarbia, acidosis, and muscle rigidity. Caffeine halothane contracture test is not available at most centers in India. Larach et al. have described a clinical grading scale for determining the MH raw score based on clinical findings and biochemical tests. The high degree of suspicion, early recognition and aggressive treatment should commence immediately. It is imperative to avoid triggering agents, such as volatile anesthetics and succinylcholine, and promote the use of total intravenous anesthesia in MH susceptible patients. We report a case of 6-month-old child undergoing laparotomy under general anesthesia, who presented with signs and symptoms of MH, had MH rank 5 and raw score 36.

  20. Functional and psychosocial effects of health qigong in patients with COPD: a randomized controlled trial.

    PubMed

    Ng, Bobby H P; Tsang, Hector W H; Jones, Alice Y M; So, C T; Mok, Thomas Y W

    2011-03-01

    The initial gain from a Pulmonary Rehabilitation Program (PRP) among patients with chronic obstructive pulmonary disease (COPD) begins to fade away 6 months after the completion of a rehabilitation program. One possible reason may be due to the poor compliance of the patients to the existing forms of home exercise program (e.g., walking, weight training activities, etc.). This study tested the efficacy of health qigong (HQG), a traditional Chinese exercise, as an adjunct home exercise program in optimizing the gains obtained from PRP until 6 months after discharge. This was a randomized controlled trial (RCT) on a mind-body exercise intervention. Eighty (80) patients with COPD receiving conventional PRP pulmonary rehabilitation program were randomized to the HQG intervention group (n = 40) and control group (n = 40). Assessments were undertaken by blinded assessors at baseline, discharge from training, and follow-up (FU) at 3 and 6 months. Primary outcomes involved functional capacity scales and secondary outcomes involved quality-of-life scales. Intention-to-treat analysis identified trends of improvement in all outcome measures in the HQG group, whereas lesser improvement and trends of deteriorations were identified in the control group. Ancillary analysis using a per-protocol method, however, identified significantly better improvements in functional capacity measures among the HQG at the 6-month FU. This RCT provided some evidence to support the positive effect of HQG as an adjunct home exercise for rehabilitation among people with COPD and to support further related research.

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

    PubMed

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

    2011-10-01

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

  2. Maternal cortisol slope at 6 months predicts infant cortisol slope and EEG power at 12 months.

    PubMed

    St John, Ashley M; Kao, Katie; Liederman, Jacqueline; Grieve, Philip G; Tarullo, Amanda R

    2017-09-01

    Physiological stress systems and the brain rapidly develop through infancy. While the roles of caregiving and environmental factors have been studied, implications of maternal physiological stress are unclear. We assessed maternal and infant diurnal cortisol when infants were 6 and 12 months. We measured 12-month infant electroencephalography (EEG) 6-9 Hz power during a social interaction. Steeper 6-month maternal slope predicted steeper 12-month infant slope controlling for 6-month infant slope and breastfeeding. Steeper 6-month maternal slope predicted lower 6-9 Hz power. Six-month maternal area under the cuve (AUCg) was unrelated to 12-month infant AUCg and 6-9 Hz power. Psychosocial, caregiving, and breastfeeding variables did not explain results. At 6 months, maternal and infant slopes correlated, as did maternal and infant AUCg. Twelve-month maternal and infant cortisol were unrelated. Results indicate maternal slope is an informative predictor of infant physiology and suggest the importance of maternal physiological stress in this developmental period. © 2017 Wiley Periodicals, Inc.

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-01-01

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

  5. A 6-month prospective study of injury in Gaelic football.

    PubMed

    Wilson, F; Caffrey, S; King, E; Casey, K; Gissane, C

    2007-05-01

    To describe the injury incidence in Gaelic football. A total of 83 players from three counties were interviewed monthly about their injury experience, during the 6 months of the playing season. The injury rate was 13.5/1000 h exposure to Gaelic football (95% CI, 10.9 to 16.6). There were nearly twice as many injuries during matches (64.4%, 95% CI, 54.1 to 73.6) as in training (35.6%, 95% CI, 26.4 to 49.5). The ankle was found to be the most commonly injured site (13.3%, 95% CI, 7.8 to 21.9). The musculotendinous unit accounted for nearly 1/3 of all injuries (31.1%). The tackle accounted for 27.8% of the injuries sustained (tackler 10%, 95% CI, 5.4 to 17.9; player being tackled 17.9%, 95% CI, 11.2 to 26.9). Of total match injuries, 56.9% (95% CI, 46.1 to 67.1) were experienced in the second half as opposed to 39.7% (95% CI, 29.8 to 50.5) in the first half. Gaelic footballers are under considerable risk of injury. Greater efforts must be made to reduce this risk so that players miss less time from sport due to injury. Risk factors for injury in Gaelic football must now be investigated so that specific interventions may be established to reduce them.

  6. Mechanism of injury affects 6-month functional outcome in children hospitalized because of severe injuries.

    PubMed

    Macpherson, Alison K; Rothman, Linda; McKeag, Alexandra Moses; Howard, Andrew

    2003-09-01

    The burden of childhood injury is often described using vital statistics for mortality and hospital admissions as a measure of morbidity. Hospital admissions, however, reflect the process of care and do not directly measure children's functional disability. The purpose of this study was to determine the influence of mechanism of injury on the functional outcome 6 months after injury in children in an inpatient trauma unit of a pediatric referral hospital. A retrospective cohort of 357 children aged 2 to 15 with an Injury Severity Score (ISS) > 12 was studied to determine the relationship between mechanism of injury (based on International Classification of Diseases, Ninth Revision e-code) and functional outcome 6 months after hospital discharge. Wee Functional Independence Measure (WeeFIM) was used to assess functional outcome. Any child with a WeeFIM score less than the maximum (of 126) attainable was classed as requiring assistance, and the relative risk of requiring assistance at 6 months was calculated for each injury mechanism. Poisson regression analysis was used to assess the importance of mechanism of injury, after adjusting for age, gender, ISS, and a primary diagnosis of central nervous system (CNS) injury. Mechanism of injury had a significant effect on the functional outcome at 6 months: 72% of pedestrians, 64% of cyclists struck by cars, and 59% of injured motor vehicle occupants required assistance during daily activities. By contrast, only 27% of those injured playing sports and 22% of cyclists injured without motor vehicle involvement required assistance. The relative risk of children requiring assistance was similar with or without adjustment for age, gender, ISS, and CNS injury. Mechanism of injury is significantly associated with requiring assistance 6 months postdischarge, even after controlling for age, injury severity, and the presence of a CNS injury. These data are important both when discussing the prognosis for an individual patient and

  7. Physical Activity Self-Monitoring and Weight Loss: 6-Month Results of the SMART Trial

    PubMed Central

    Conroy, Molly B.; Yang, Kyeongra; Elci, Okan U.; Gabriel, Kelley Pettee; Styn, Mindi A.; Wang, Jing; Kriska, Andrea M.; Sereika, Susan M.; Burke, Lora E.

    2014-01-01

    Introduction Weight loss has been associated with higher physical activity (PA) levels and frequent dietary self-monitoring. Less is known about how PA self-monitoring affects adherence to PA goals, PA levels and weight change. Methods The SMART Trial is a clinical weight loss trial in which 210 overweight adults were randomized equally to one of three arms: 1) paper record (PR); 2) personal digital assistant with self-monitoring software (PDA); and 3) PDA with daily tailored feedback message (PDA+FB). PA self-monitoring and adherence to PA goals were based on entries in weekly submitted diaries. PA levels were measured via self-report by the past 6 month Modifiable Activity Questionnaire at baseline and 6 months. Results Data are presented on 189 participants with complete 6-month PA data [84% female, 77% White, mean age: 47.3 ± 8.8 years, mean BMI: 34.1 ± 4.5 kg/m2]. Median PA level was 7.96 MET-hr-wk−1 at baseline and 13.4 MET-hr-wk−1 at 6 months, with significant PA increases in all three arms. PDA+FB arm had a higher mean number of weekly self-monitoring entries than the PR arm (3.4 vs. 2.4; p=0.003) and were more likely to maintain high (i.e., 100%) adherence to PA goals over time than the PDA (p=0.02) or PR arms (p=0.0003). Both PA self-monitoring and adherence to PA goals were related to higher PA levels at 6 months. A higher mean rate of PA self-monitoring was associated with a greater percentage of weight decrease (rho=−0.49; p<0.0001) at 6 months. Conclusions PA self-monitoring and adherence to PA goals were more likely in participants in the PDA+FB arm and in turn predicted higher PA levels and weight loss. PMID:21200337

  8. Healing process of the guinea pig common bile duct after end-to-end anastomosis: pathological evaluation after 6 months.

    PubMed

    Zhang, X; Tian, Y; Xu, Z; Wang, L; Hou, C; Ling, X

    2011-01-01

    The healing process of an injured bile duct is always associated with stricture formation, the specific mechanism of which remains unclear. Our objective in this study was to establish a guinea pig common bile duct end-to-end anastomosis (EEA) model after total transection of the common bile duct and to assess the postoperative healing process after 6 months. Thirty-two male guinea pigs were randomly divided into 4 groups with or without operation (a control group without operation and 3 groups examined 2, 3 and 6 months after biliary EEA reconstruction, respectively). Histological, immunohistochemical (proliferating cell nuclear antigen, α-smooth muscle actin, h-caldesmon, and Bcl-2 expression) and ultrastructural characteristics were examined and evaluated. Myofibroblasts (MFBs) were differentiated from smooth muscle cells by α-SMA and h-caldesmon staining. Gross inspection of operated bile ducts revealed coarctation formation at the anastomotic stoma. Histological and immunohistochemical examinations showed significant inflammatory reaction, the presence of MFBs, epithelial proliferation and glandular element hyperplasia. Bcl-2 expression decreased in groups 2 and 3, indicating an epithelial self-protecting mechanism. A guinea pig common bile duct EEA model was successfully established. Glandular elements, bile duct epithelial cells and MFBs all played crucial roles in the bile duct healing process. It seems important to elucidate the pathomechanisms of these components for restoring bile duct physiological function. Copyright © 2011 S. Karger AG, Basel.

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

    PubMed

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

    2015-05-01

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

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

    PubMed Central

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

    2015-01-01

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

  11. Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

    DTIC Science & Technology

    2010-01-01

    to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

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

    PubMed

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

    2016-06-30

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

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

    PubMed Central

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

    2015-01-01

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

  14. Perceived work ability, quality of life, and fatigue in patients with rheumatoid arthritis after a 6-month course of TNF inhibitors: prospective intervention study and partial economic evaluation.

    PubMed

    Hoving, J L; Bartelds, G M; Sluiter, J K; Sadiraj, K; Groot, I; Lems, W F; Dijkmans, B A C; Wijbrandts, C A; Tak, P P; Nurmohamed, M T; Voskuyl, A E; Frings-Dresen, M H W

    2009-01-01

    The objective of this exploratory study was to evaluate the effects and costs of a 6-month course of tumour necrosis factor (TNF) inhibitors on work ability, quality of life, and fatigue in patients with rheumatoid arthritis (RA). In this prospective single-arm intervention study 59 consecutive patients of working age with established RA were recruited from an outpatient clinic in Amsterdam, the Netherlands. All patients received fortnightly subcutaneous injections of 40 mg adalimumab. The three outcomes at baseline and 6 months were: perceived work ability [Work Ability Index (WAI)], quality of life [Rheumatoid Arthritis Quality of Life instrument (RAQoL)], and fatigue [Checklist Individual Strength (CIS), Need for Recovery (NFR) scale]. Cost data of the preceding 6 months were collected using a self-administered patient questionnaire at baseline and follow-up. At 6 months, all outcomes showed a statistically significant improvement in mean scores from baseline, ranging from 10.0% (WAI), to 11.7% (RAQoL), to 15% (NFR) (subgroup paid work, n = 26). The total mean costs showed a twofold increase in mean costs per week per patient [difference EUR 169, 95% confidence interval (CI) EUR 113-226]. In this short-term exploratory evaluation, a 6-month course of TNF inhibitors improved work ability and quality of life, and reduced fatigue in patients with established RA. These effects are associated with an increase in total healthcare costs, attributable to the costs of TNF inhibitors. Randomized controlled trials with a longer follow-up are needed to show a long-term effect on work disability and the potential cost-effectiveness of TNF inhibitors.

  15. Infant sleep and paternal involvement in infant caregiving during the first 6 months of life.

    PubMed

    Tikotzky, Liat; Sadeh, Avi; Glickman-Gavrieli, Tamar

    2011-01-01

    The goals of this study were to assess: (a) the involvement of fathers and mothers in overall and nighttime infant caregiving; (b) the links between paternal involvement in infant care and infant sleep patterns during the first 6 months. Fifty-six couples recruited during their first pregnancy, participated in the study. After delivery (1 and 6 months), both parents completed a questionnaire assessing the involvement of fathers relative to mothers in infant caregiving. Infant sleep was assessed using actigraphy and sleep diaries. Mothers were significantly more involved than fathers in daytime and nighttime caregiving. A higher involvement of fathers in overall infant care predicted and was associated with fewer infant night-wakings and with shorter total sleep time after controlling for breastfeeding. The findings highlight the importance of including fathers in developmental sleep research. Future studies should explore mechanisms underlying the relations between paternal involvement and infant sleep.

  16. Studies of blood glucose and plasma insulin in "normal" women using mechanical contraception for 6 months.

    PubMed

    Spellacy, W N; Buhi, W C; Birk, S A

    1975-12-15

    A prospective study of carbohydrate metabolism was done with 56 "normal" women who were 4 to 11 weeks post partum. Each had a 3 hour oral glucose tolerance test performed before and after 6 months of using an intrauterine contraceptive device (IUCD). The results showed only slight changes in blood glucose and plasma insulin levels between the two tests. There were elevations of the fasting and 0.5 hour glucose values and the 2 hour plasma insulin value at the 6 month test. These data provide a further understanding of the changing metabolic parameters associated with pregnancy and they also give the "control" baseline information for comparison with other postpartum studies on the metabolic effects of contraceptive steriods.

  17. Thymus size at 6 months of age and subsequent child mortality.

    PubMed

    Garly, May-Lill; Trautner, Sisse Lecanda; Marx, Charlotte; Danebod, Kamilla; Nielsen, Jens; Ravn, Henrik; Martins, Cesário Lourenco; Balé, Carlito; Aaby, Peter; Lisse, Ida Maria

    2008-11-01

    To examine determinants of thymus size at age 6 months and investigate whether thymus size at this age is a determinant of subsequent mortality. Thymus size was measured by transsternal sonography in 923 6-month-old children participating in a measles vaccination trial in Guinea-Bissau. Thymus size was strongly associated with anthropometric measurements. Boys had larger thymuses than girls, controlling for anthropometry. Crying during sonography made the thymus appear smaller. Children who were not vaccinated with Bacille Calmette-Guérin (BCG) or were vaccinated with BCG in the preceding 4 weeks before inclusion into the study had larger thymuses. Children who had malaria or had been treated with chloroquine or Quinimax in the previous week before inclusion had smaller thymuses. Controlled for background factors associated with thymus size and mortality, small thymus size remained a strong and independent risk factor for mortality (hazard ratio = 0.31; 95% confidence interval = 0.18 to 0.52). Small thymus size at age 6 months is a strong risk factor for mortality. To prevent unnecessary deaths, it is important to identify preventable factors predisposing to small thymus size.

  18. Trajectories of suicidal ideation over 6 months among 482 outpatients with bipolar disorder.

    PubMed

    Köhler-Forsberg, Ole; Madsen, Trine; Behrendt-Møller, Ida; Sylvia, Louisa; Bowden, Charles L; Gao, Keming; Bobo, William V; Trivedi, Madhukar H; Calabrese, Joseph R; Thase, Michael; Shelton, Richard C; McInnis, Melvin; Tohen, Mauricio; Ketter, Terence A; Friedman, Edward S; Deckersbach, Thilo; McElroy, Susan L; Reilly-Harrington, Noreen A; Nierenberg, Andrew A

    2017-12-01

    Suicidal ideation occurs frequently among individuals with bipolar disorder; however, its course and persistence over time remains unclear. We aimed to investigate 6-months trajectories of suicidal ideation among adults with bipolar disorder. The Bipolar CHOICE study randomized 482 outpatients with bipolar disorder to 6 months of lithium- or quetiapine-based treatment including other psychotropic medications as clinically indicated. Participants were asked at 9 visits about suicidal ideation using the Concise Health Risk Tracking scale. We performed latent Growth Mixture Modelling analysis to empirically identify trajectories of suicidal ideation. Multinomial logistic regression analyses were applied to estimate associations between trajectories and potential predictors. We identified four distinct trajectories. The Moderate-Stable group represented 11.1% and was characterized by constant suicidal ideation. The Moderate-Unstable group included 2.9% with persistent thoughts about suicide with a more fluctuating course. The third (Persistent-low, 20.8%) and fourth group (Persistent-very-low, 65.1%) were characterized by low levels of suicidal ideation. Higher depression scores and previous suicide attempts (non-significant trend) predicted membership of the Moderate-Stable group, whereas randomized treatment did not. No specific treatments against suicidal ideation were included and suicidal thoughts may persist for several years. More than one in ten adult outpatients with bipolar disorder had moderately increased suicidal ideation throughout 6 months of pharmacotherapy. The identified predictors may help clinicians to identify those with additional need for treatment against suicidal thoughts and future studies need to investigate whether targeted treatment (pharmacological and non-pharmacological) may improve the course of persistent suicidal ideation. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Guided Imagery for Total Knee Replacement: A Randomized, Placebo-Controlled Pilot Study

    PubMed Central

    Umberger, Wendy A.; Palmieri, Patrick A.; Alexander, Thomas S.; Myerscough, Rodney P.; Draucker, Claire B.; Steudte-Schmiedgen, Susann; Kirschbaum, Clemens

    2016-01-01

    Abstract Objectives: To determine the effect of guided imagery (GI) on functional outcomes of total knee replacement (TKR), explore psychological and neuroimmune mediators, and assess feasibility of study implementation. Design: Investigator-blinded, randomized, placebo-controlled pilot study. Settings: Hospital, surgeon's office, participant's home. Participants: 82 persons undergoing TKR. Interventions: Audiorecordings of TKR-specific GI scripts or placebo-control audiorecordings of audiobook segments. Outcome measures: Gait velocity and Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function scale. Results: Outcomes for 58 participants (29 receiving GI and 29 controls) were analyzed at 6 months after surgery. The most frequent reason for noncompletion was protocol-driven exclusion at 6 months for having the contralateral knee replaced before the study endpoint (n = 15). With imaging ability as a moderator, gait velocity, but not WOMAC Function score, was significantly improved at 6 months in the GI group. Participants in the GI group, but not the control group, had lower WOMAC Pain scores at 3 weeks after surgery than at baseline. Hair cortisol concentration was significantly lower at 6 months after surgery than at baseline in the GI group but not the control group. GI group participants had lower treatment adherence but greater treatment credibility than the control group. Conclusion: Randomized controlled trials of GI in the TKR population are feasible, but inclusion/exclusion criteria influence attrition. Further studies are needed to elaborate this study's findings, which suggest that guided imagery improves objective, but not patient-reported, outcomes of TKR. Hair cortisol concentration results suggest that engagement in a time-limited guided imagery intervention may contribute to stress reduction even after the intervention is terminated. Further investigation into optimal content and dosing of GI is needed. PMID:27214055

  20. Low-dosage esterified estrogens opposed by progestin at 6-month intervals.

    PubMed

    Ettinger, B; Pressman, A; Van Gessel, A

    2001-08-01

    To estimate incidence of endometrial hyperplasia, vaginal bleeding, and menopausal symptoms in women who changed from standard monthly cyclic hormone replacement therapy (HRT) to half-strength estrogen opposed by medroxyprogesterone acetate (MPA) at 6-month intervals. We identified 138 women aged 55-75 years who had regularly used HRT at a standard dosage (equivalent to 0.625 mg conjugated estrogen) opposed by cyclic monthly MPA. Each subject's HRT regimen was changed to 0.3 mg/day esterified estrogens (Estratab; Solvay Pharmaceuticals, Marietta, GA) combined with 14-day courses of MPA, 10 mg/day, every 6 months. Endometrial biopsy was repeated after 1 year of the new regimen. Any vaginal bleeding was reported in each patient's daily diary. Menopause symptoms were evaluated using the Greene Menopause Symptom Index. Among 125 women who had biopsy after 1 year of the new regimen, endometrial hyperplasia was found in two (1.6%, 95% confidence interval 0.3%, 6.2%). Of the 125 women, 44% had scheduled bleeding, and 9.4% had unscheduled bleeding. Relative to baseline vasomotor score (range 0-6), an increase of at least 2 U was reported by 20% of subjects at 6 months and by 17% of subjects at 12 months. Most women aged at least 55 years can safely switch their HRT regimen from standard dosage HRT to low-dosage estrogen opposed by MPA at 6-month intervals. Moreover, this new HRT regimen causes little vaginal bleeding while maintaining adequate control of menopausal symptoms.

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

    PubMed

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

    2016-02-01

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

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

    PubMed

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

    2015-12-15

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

  3. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial.

    PubMed

    McAlister, Finlay A; Majumdar, Sumit R; Padwal, Raj S; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Bakal, Jeffrey A; Tsuyuki, Ross; Grover, Steven; Shuaib, Ashfaq

    2014-05-13

    Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care. We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention). Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03). Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. ClinicalTrials.gov, no. NCT00931788.

  4. Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial

    PubMed Central

    McAlister, Finlay A.; Majumdar, Sumit R.; Padwal, Raj S.; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Bakal, Jeffrey A.; Tsuyuki, Ross; Grover, Steven; Shuaib, Ashfaq

    2014-01-01

    Background: Optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke, but there are substantial gaps in care, which could be addressed by nurse- or pharmacist-led care. We compared 2 types of case management (active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians) in addition to usual care. Methods: We performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets. Participants in both groups had a monthly visit for 6 months with either a nurse or pharmacist. Nurses measured cardiovascular risk factors, counselled patients and faxed results to primary care physicians (active control). Pharmacists did all of the above as well as prescribed according to treatment algorithms (intervention). Results: Most of the 279 study participants (mean age 67.6 yr, mean systolic blood pressure 134 mm Hg, mean low-density lipoprotein [LDL] cholesterol 3.23 mmol/L) were already receiving treatment at baseline (antihypertensives: 78.1%; statins: 84.6%), but none met guideline targets (systolic blood pressure ≤ 140 mm Hg, fasting LDL cholesterol ≤ 2.0 mmol/L). Substantial improvements were observed in both groups after 6 months: 43.4% of participants in the pharmacist case manager group met both systolic blood pressure and LDL guideline targets compared with 30.9% in the nurse-led group (12.5% absolute difference; number needed to treat = 8, p = 0.03). Interpretation: Compared with nurse-led case management (risk factor evaluation, counselling and feedback to primary care providers), active case management by pharmacists substantially improved risk factor control at 6 months among patients who had experienced a stroke. Trial registration: ClinicalTrials.gov, no. NCT00931788 PMID:24733770

  5. 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

  6. A training program for novice paramedics provides initial laryngeal mask airway insertion skill and improves skill retention at 6 months.

    PubMed

    Hein, Cindy; Owen, Harry; Plummer, John

    2010-02-01

    Major resuscitation councils endorse the use of the laryngeal mask airway (LMA) by paramedics for lifesaving airway interventions. Learning and maintaining adequate skill level is important for patient safety. The aim of this project was to develop a training program that provides student paramedics with initial knowledge and experience in LMA insertion skills but equally important to provide ongoing skill retention. After ethics approval and informed consent, 55 first year Paramedic degree students watched a manufacturer's LMA instruction video and practiced insertion in three different part task trainers. Six months later, subjects were randomized to an intervention (reviewing the video and 10 minutes unsupervised practice) or control group before participating in a high-fidelity simulated clinical scenario. For equity of training, the control group received the intervention after the scenario. Main outcomes measured were time to insertion; success rate; and LMA skill retention (sum of LMA orientation; cuff inflation; bite block; securing; patient positioning; and overall subject performance). Fifty subjects completed the study. Those in the intervention group displayed significantly shorter insertion times (P = 0.029), fewer attempts to achieve success (P = 0.033), and had significantly higher LMA skill performance levels (P = 0.019) at 6 months. We devised a short intervention based on our training program using a video and practice in part task trainers. In an assessment using high-fidelity simulation, we demonstrated significant improvements in maintenance of LMA insertion skills in student paramedics at 6 months. Our model of just-in-time assessment and reinforcement of training prevents skill decay and has implications for healthcare skills training in general.

  7. Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda.

    PubMed

    Averbach, Sarah; Kakaire, Othman; Kayiga, Herbert; Lester, Felicia; Sokoloff, Abby; Byamugisha, Josaphat; Dehlendorf, Christine; Steinauer, Jody

    2017-06-10

    Use of long-acting, highly effective contraception has the potential to improve women's ability to avoid short interpregnancy intervals, which are associated with an increased risk of maternal morbidity and mortality, and preterm delivery. In Uganda, contraceptive implants are not routinely available during the immediate postpartum period. The purpose of this study was to compare the proportion of women using levonorgestrel contraceptive implants at 6 months after delivery in women randomized to immediate or delayed insertion. This was a randomized controlled trial among women in Kampala, Uganda. Women who desired contraceptive implants were randomly assigned to insertion of a 2-rod contraceptive implant system containing 75 mg of levonorgestrel immediately following delivery (within 5 days of delivery and before discharge from the hospital) or delayed insertion (6 weeks postpartum). The primary outcome was implant utilization at 6 months postpartum. From June to October 2015, 205 women were randomized, 103 to the immediate group and 102 to the delayed group. Ninety-three percent completed the 6 month follow-up visit. At 6 months, implant use was higher in the immediate group compared with the delayed group (97% vs 68%; P < .001), as was the use of any highly effective contraceptive (98% vs 81%; P = .001). Women in the immediate group were more satisfied with the timing of implant placement. If given the choice, 81% of women in the immediate group and 63% of women in the delayed group would choose the same timing of placement again (P = .01). There were no serious adverse events in either group. Offering women the option of initiating contraceptive implants in the immediate postpartum period has the potential to increase contraceptive utilization, decrease unwanted pregnancies, prevent short interpregnancy intervals, and help women achieve their reproductive goals. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Environmental enrichment as an effective treatment for autism: a randomized controlled trial.

    PubMed

    Woo, Cynthia C; Leon, Michael

    2013-08-01

    Enriched sensorimotor environments enable rodents to compensate for a wide range of neurological challenges, including those induced in animal models of autism. Given the sensorimotor deficits in most children with autism, we attempted to translate that approach to their treatment. In a randomized controlled trial, 3-12 year-old children with autism were assigned to either a sensorimotor enrichment group, which received daily olfactory/tactile stimulation along with exercises that stimulated other paired sensory modalities, or to a control group. We administered tests of cognitive performance and autism severity to both groups at the initiation of the study and after 6 months. Severity of autism, as assessed with the Childhood Autism Rating Scale, improved significantly in the enriched group compared to controls. Indeed, 42% of the enriched group and only 7% of the control group had what we considered to be a clinically significant improvement of 5 points on that scale. Sensorimotor enrichment also produced a clear improvement in cognition, as determined by their Leiter-R Visualization and Reasoning scores. At 6 months, the change in average scores for the enriched group was 11.3 points higher than that for the control group. Finally, 69% of parents in the enriched group and 31% of parents in the control group reported improvement in their child over the 6-month study. Environmental enrichment therefore appears to be effective in ameliorating some of the symptoms of autism in children.

  9. Predictors of 6-month and 3-year outcomes after psychological intervention for psychogenic non epileptic seizures.

    PubMed

    Duncan, Roderick; Anderson, James; Cullen, Breda; Meldrum, Steven

    2016-03-01

    To determine outcome and its predictors following psychological intervention in people with Psychogenic Non-Epileptic Seizures (PNES) METHODS: Prospective audit of 89 consecutive patients. PNES were recorded at baseline (initial psychology appointment), at 6 months and 3 years post the initial appointment. Six-month data was obtained by face-to-face interview, while 3-year data was obtained by contacting general practitioners and by postal survey. Eight patients had stopped having PNES at the first appointment and were discharged. At 6-month follow up 43/81 patients (53.1%) were free of seizures. Predictors of cessation of seizures were: patient employed (OR 4.48, p=0.004), short waiting time for intervention (OR 0.94, p=0.018), the patient feeling they had some control over the seizures (OR 3.30, p=0.021), and an internal locus of control ((OR 7.46, p=0.001). Outcomes at 3 years based on patient report were available in 32/81 patients (36%). 11/32 patients reported being free of seizures. 50/65 patients were not accessing any healthcare for seizures. There were no significant predictors of either outcome among the variables collected. Just over half of our patients reported being free of seizures following intervention. Being employed predicted good outcome, but the best predictor of being seizure free at 6 months was having an internal locus of control. This may be useful practically and requires further study. No good predictors of long-term outcome were found, possibly because of loss to follow up. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

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

    PubMed Central

    Ganiyu, Adewale B.; Firth, Jacqueline A.

    2017-01-01

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

  11. Impact of systemic antimicrobials combined with anti-infective mechanical debridement on the microbiota of generalized aggressive periodontitis: a 6-month RCT.

    PubMed

    Heller, Débora; Varela, Victor M; Silva-Senem, Mayra Xavier E; Torres, Maria Cynesia B; Feres-Filho, Eduardo Jorge; Colombo, Ana Paula Vieira

    2011-04-01

    To compare the effects of systemic amoxicillin (AMX) plus metronidazole (MET) or placebos combined with anti-infective mechanical debridement on the sub-gingival microbiota of generalized aggressive periodontitis (GAP). The study was a 6-month randomized, double-blinded, placebo-controlled clinical trial. Thirty-one subjects received full-mouth ultrasonic debridement followed by scaling and root planing with chlorhexidine rinsing, brushing and irrigation. During mechanical therapy, subjects received systemic AMX (500mg)+MET (250mg) or placebo, t.i.d. for 10 days. Sub-gingival samples were obtained from each patient and analysed for their composition by checkerboard at baseline, 3 and 6 months post-therapy. Significant differences between groups over time were examined by General Linear Model of Repeated Measures. High levels of periodontal pathogens, as well as some "non-periodontal" species were observed. Most of the periodontal pathogens decreased significantly over time (p<0.05), whereas "non-periodontal" bacteria tended to increase in both groups. Sites that showed attachment loss and probing depth increase harboured higher levels of Dialister pneumosintes, Campylobacter rectus, Fusobacterium necrophorum, Prevotella tannerea and Peptostreptococcus anaerobius than sites that improved after both therapies (p<0.05). Systemic AMX+MET or placebos adjunctive to anti-infective mechanical debridement were comparable in lowering periodontal pathogens up to 6 months after treatment. Species not commonly associated with GAP were less affected by both therapies. © 2011 John Wiley & Sons A/S.

  12. A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy

    PubMed Central

    Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

    2016-01-01

    Objective: The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. Methods: In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. Results: 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. Conclusion: UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial. PMID:27710100

  13. A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

    PubMed

    Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

    2016-12-01

    The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

  14. Spa therapy adjunct to pharmacotherapy is beneficial in rheumatoid arthritis: a crossover randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Karagülle, Mine; Kardeş, Sinan; Dişçi, Rian; Karagülle, Müfit Zeki

    2017-09-01

    This study aims to investigate whether 2-week spa therapy, as an adjunct to usual pharmacological therapy, has any beneficial effect in patients with rheumatoid arthritis (RA). In this single-blind crossover study, 50 patients were randomly assigned in a 1:1 manner to receive usual pharmacological therapy plus 2-week spa therapy or usual pharmacological therapy alone (period 1.6 months); after a 9-month washout, patients were crossed over to the opposite assignment (period 2.6 months). Spa therapy program included a daily saline balneotherapy session at 36-37 °C for 20 min except Sundays. The clinical outcomes were evaluated at baseline, after spa therapy (2 weeks) and 3 and 6 months after the spa therapy in both period and were pain (Visual Analogue Scale (VAS)), patient and physician global assessments (VAS), Health Assessment Questionnaire (HAQ), and Disease Activity Score (DAS28). Spa therapy was superior to control therapy in improving all the assessed clinical outcomes at the end of the spa therapy. This superiority persisted significantly in physician global assessment (p = 0.010) and with a trend in favor of spa group in patient global assessment (p = 0.058), function (p = 0.092), and disease activity (p = 0.098) at 3 months. Statistically significant improvements were found in spa therapy compared to control in disease activity (p = 0.006) and patient (p = 0.020) and physician global (p = 0.011) assessments, and a trend toward improvements in pain (p = 0.069) and swollen joints (p = 0.070) at 6 months. A 2-week spa therapy adjunct to usual pharmacological therapy provided beneficial clinical effects compared to usual pharmacological therapy alone, in RA patients treated with traditional disease-modifying antirheumatic drugs. These beneficial effects may last for 6 months.

  15. Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial.

    PubMed

    He, Wei; Wang, Xiao-Yu; Zhou, Li; Li, Zhi-Mei; Jing, Xiang-Hong; Lv, Zhong-Li; Zhao, Yu-Feng; Shi, Hong; Hu, Ling; Su, Yang-Shuai; Zhu, Bing

    2015-08-21

    Recently, clinical observations reported the potential benefit of vagus nerve stimulation (VNS) for pediatric epilepsy. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is a newer non-invasive VNS, making it more accessible for treating pediatric epilepsy, yet there is limited clinical evidence for its effectiveness. A three-center, randomized, parallel, controlled trial will be carried out to evaluate whether ta-VNS improves pediatric epilepsy. Pediatric patients aged 2 to 14 years with epilepsy will be recruited and randomly assigned to transcutaneous auricular vagus nerve stimulation (ta-VNS) group, transcutaneous auricular non-vagus nerve stimulation (tan-VNS) group, and control group with a 1:1: sqrt(2) allocation, as per a computer generated randomization schedule stratified by study center using permuted blocks of random sizes. We will use Zelen's design, in which randomization occurs before informed consent. Patients in the stimulation groups will receive tan-VNS or ta-VNS three times a day for 6 months. Patients in the control group will not be provided with any stimulation during the 6 months. The guardians of the patients are required to keep a detailed diary to record the data. Outcome assessment including seizure frequency, electroencephalogram (EEG), heart rate variability (HRV) analysis, quality of life (QOL) and adverse events will be made at baseline and 2, 4 and 6 months after ta-VNS initiation. The seizure frequency and adverse events will be followed up at 1 year and 1.5 years after ta-VNS initiation. Results of this trial will help clarify whether ta-VNS treatment is beneficial for pediatric patients, and will make clear whether the anticonvulsive effect of ta-VNS is correlated with the improvement of sympathovagal imbalance. NCT02004340 . Registration date: 13 November 2013.

  16. [Comparative Effectiveness of Remote Monitoring of People with Cardiac Pacemaker versus Conventional: quality of Life at the 6 Months].

    PubMed

    López-Villegas, Antonio; Catalán-Matamoros, Daniel; Robles-Musso, Emilio; Peiró, Salvador

    2015-04-01

    The use of remote follow-up (RF) of people with pacemakers (PM) is limited in comparison to the hospital modality (HS), being still poor the scientific evidence that shows their comparative effectiveness. The aim of this study was to compare the quality of life in individuals with different modalities of follow-up. Controlled, not randomized nor masked clinical trial, with data collection at pre and post-implantation of pacemakers during the 6 months follow-up. All patients over 18 years-old who were implanted a PM during the study period were selected (n = 83), and they were assigned to RF (n = 30) or HF (n = 53) groups according to their personal characteristics and patient's preferences. Baseline characteristics and number of visits to the hospital were analysed, the EuroQol-5D (EQ5D) questionnaire was administered to evaluate the health-related quality of life, and Duke Activity Status Index (DASI) to assess the functional capacity. There were no significant differences between both groups in relation to the baseline analysis, EQ5D (RF:0.7299; HF:0.6769) and DASI (RF:21.41; HF:19.99). At 6 months the quality of life was improved in both groups (EQ5D RF:0.8613; HF:0.8175; p = 0,439) still without significant differences between them. DASI score was similar to baseline (20.51 vs 21.80). RF group performed less transmissions/visits per patient (1.57) than hospital group (1.96; relative reduction 31%; p = 0.015). Remote follow-up of people with pacemakers might be considered as an equivalent option to the hospital follow-up in relation to the quality of life and it reduces the number of hospital visits.

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

    PubMed Central

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

    2011-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  19. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial.

    PubMed

    Rendant, Daniel; Pach, Daniel; Lüdtke, Rainer; Reisshauer, Anett; Mietzner, Anna; Willich, Stefan N; Witt, Claudia M

    2011-03-15

    Randomized controlled trial. To evaluate whether qigong is more effective than no treatment and not inferior to exercise therapy. Lifetime prevalence of chronic neck pain is close to 50%. Qigong is often used by patients, although, the evidence is still unclear. Patients (aged 20-60 years) with chronic neck pain (visual analog scale, VAS ≥ 40 mm) were randomized to 1) qigong or 2) exercise therapy (18 sessions over 6 months) or 3) waiting list (no treatment). At baseline and after 3 and 6 months, patients completed standardized questionnaires assessing neck pain (VAS), neck pain and disability, and quality of life (Short Form SF-36 questionnaire, SF-36). The primary endpoint was average pain in the last 7 days on VAS at 6-month follow-up. Statistical analysis included generalized estimation equation models adjusted for baseline values and patient expectation. A total of 123 patients (aged 46 ± 11 years, 88% women) suffering from chronic neck pain for 3.2 (SD ± 1.6) years were included. After 6 months, a significant difference was seen between the qigong and waiting list control groups (VAS mean difference: -14 mm [95%CI = -23.1 to -5.4], P = 0.002). Mean improvements in the exercise group were comparable to those in the qigong group (difference between groups -0.7 mm [CI = -9.1 to 7.7]) but failed to show statistical significance (P = 0.092). Neck pain and disability, and SF-36 results also yielded superiority of qigong over no treatment and similar results in the qigong and exercise therapy groups. Qigong was more effective than no treatment in patients with chronic neck pain. Further studies could be designed without waiting list control and should use a larger sample to clarify the value of qigong compared to exercise therapy.

  20. Clinical and radiological improvement of periodontal disease in patients with type 2 diabetes mellitus treated with alendronate: a randomized, placebo-controlled trial.

    PubMed

    Rocha, M; Nava, L E; Vázquez de la Torre, C; Sánchez-Márin, F; Garay-Sevilla, M E; Malacara, J M

    2001-02-01

    Alendronate (ALN) is an aminobisphosphonate commonly used for osteoporosis in postmenopausal women. We studied the effect of ALN on bone loss prevention in type 2 diabetes mellitus patients with periodontal disease. In a controlled double-blind, randomized study we evaluated prospectively diabetic patients paired by gender and years since diagnosis for 6 months. The study included 40 patients (20 men and 20 women), 50 to 60 years old, with more than 5 years since diagnosis of diabetes and established periodontitis. They were randomly allocated to alendronate (10 mg/daily) or placebo treatment for 6 months. The endpoints of treatment were: the distance between the alveolar bone border and the cemento-enamel-junction (CEJ) evaluated by means of digital radiographic imaging, a biochemical marker of bone resorption (urine N-telopeptide) (Ntx), and periodontal parameters. Metabolic control was assessed at baseline and after 6 months. Baseline and 6-month glycated hemoglobin levels were similar in both groups. Alendronate induced a significant decrease in NTx at 6 months (P = 0.006). Periodontal parameters improved in both groups. However, they were significantly better for the ALN treated group. Alveolar bone border-CEJ distance increased in the placebo, but decreased in the ALN group (P = 0.0003). In type-2 diabetic patients, alendronate induced more improvement in alveolar bone crest height than control therapy. No differences in urinary N-telopeptide or glycated hemoglobin were observed in this short-term randomized controlled pilot trial.

  1. Postacute care for older people in community hospitals: a multicenter randomized, controlled trial.

    PubMed

    Young, John; Green, John; Forster, Anne; Small, Neil; Lowson, Karin; Bogle, Sue; George, James; Heseltine, David; Jayasuriya, Tilak; Rowe, Jed

    2007-12-01

    To compare the effects of community hospital care on independence for older people needing rehabilitation with that of general hospital care. Randomized, controlled trial. Seven community hospitals and five general hospitals in the midlands and north of England. Four hundred ninety patients needing rehabilitation after hospital admission with an acute illness. Multidisciplinary team care for older people in community hospitals. The primary outcome was the Nottingham extended activities of daily living scale (NEADL); secondary outcomes were the Barthel Index, Nottingham Health Profile, Hospital Anxiety and Depression Scale, mortality, discharge destination, 6-month residence status, and satisfaction with services. Loss of independence at 6 months was significantly less likely in the community hospital group (mean adjusted NEADL change score group difference 3.27; 95% confidence interval 0.26-6.28; P=.03). The results for the secondary outcome measures were similar for the two groups. Postacute community hospital rehabilitation care for older people is associated with greater independence.

  2. A Pilot Randomized Controlled Trial of a Commercial Diet and Exercise Weight Loss Program in Minority Breast Cancer Survivors

    PubMed Central

    Greenlee, Heather A.; Crew, Katherine D.; Mata, Jennie M.; McKinley, Paula S.; Rundle, Andrew G.; Zhang, Wenfei; Liao, Yuyan; Tsai, Wei Y.; Hershman, Dawn L.

    2015-01-01

    Objective Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival. As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage, and have higher rates of obesity, effective weight loss strategies are needed. We piloted a randomized, waitlist-controlled, crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic, African American and Afro-Caribbean breast cancer survivors. Design and Methods Women with stage 0– IIIa breast cancer ≥6 months posttreatment, sedentary, and BMI ≥25 kg/m2 were randomized to the immediate arm (IA): 6 months of the Curves program followed by 6 months of observation; or the waitlist control arm (WCA): 6 months of observation followed by 6 months of the Curves program. The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet. Results A total of 42 women enrolled (79% Hispanic, 21% black), mean age 51 (range 32–69) and mean BMI 33.2(±5.9) kg/m2; 91% were retained at month 12. At month 6, women in the IA lost an average 3.3% (±3.5%) of body weight (range: 1.7% gain to 10.6% loss), as compared with 1.8% (±2.9%) weight loss in the WCA (P = 0.04). At month 12, on average women in the IA regained some but not all of the weight lost during the first 6 months (P = 0.02). Conclusions Minority breast cancer survivors were recruited and retained in a weight loss study. Six months of the Curves program resulted in moderate weight loss, but weight loss was not maintained postintervention. Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors. PMID:23505170

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2017-01-01

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

  5. Dose-Dependent Immunological Responses after a 6-Month Course of Sublingual House Dust Mite Immunotherapy in Patients with Allergic Rhinitis.

    PubMed

    Didier, Alain; Campo, Paloma; Moreno, Francisco; Durand-Perdriel, François; Marin, Alicia; Chartier, Antoine

    2015-01-01

    House dust mite (HDM) immunotherapy has proven efficacy in treating allergic rhinitis (AR) symptoms. This trial evaluated the dose-response relationship of SLIToneULTRA® HDM mix based on immunological parameters and safety in subjects with moderate-to-severe HDM AR not controlled by symptomatic medication. A randomized, parallel-group, open-label, clinical trial compared 50/150/300 standard reactivity unit (SRU) doses of SLIToneULTRA® HDM mix for 6 months. Subjects had moderate-to-severe HDM AR, positive skin prick and IgE against Dermatophagoides pteronyssinus/Dermatophagoides farinae (DP/DF). The primary end point was change from baseline in the IgE-blocking factor against DP after 6 months. Secondary end points measured changes in the IgE-blocking factor for DP at 3 months and for DF at 3 and 6 months, and in IgG4 and specific IgE to DP/DF after 3 and 6 months. Tolerability was assessed through the evaluation of all adverse events (AEs). A total of 219 subjects were randomized and 196 completed the trial. Dose effect was significant on DP IgE-BF after 6 months (p = 0.018). The change in the DP IgE-blocking factor at a 300-SRU dose was higher than at other doses after 3 (p = 0.008) and 6 (p = 0005) months of treatment. Similar changes were observed for IgG4 and allergen-specific IgE. The number of AEs increased with the dose and were mild-to-moderate, with no severe treatment-related AEs reported. The most frequent AEs were oral/tongue pruritus, mouth oedema and abdominal upper pain. Data showed a dose-response for immunological markers and safety with a better immunological response for 300 SRU. The highest dose (300 SRU daily) was considered as the optimal maintenance dose. © 2016 The Author(s) Published by S. Karger AG, Basel.

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

    PubMed Central

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

    2011-01-01

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

  7. Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo.

    PubMed

    Roehrborn, Claus G; Casabé, Adolfo; Glina, Sidney; Sorsaburu, Sebastian; Henneges, Carsten; Viktrup, Lars

    2015-06-01

    To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371). Tadalafil

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

    PubMed Central

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

    2014-01-01

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

  9. A randomized controlled trial of extracorporeal shock wave therapy for lateral epicondylitis (tennis elbow).

    PubMed

    Staples, Margaret P; Forbes, Andrew; Ptasznik, Ronnie; Gordon, Jeanine; Buchbinder, Rachelle

    2008-10-01

    The aims of this double-blind, randomized, placebo-controlled trial were to determine whether ultrasound-guided extracorporeal shock wave therapy (ESWT) reduced pain and improved function in patients with lateral epicondylitis (tennis elbow) in the short term and intermediate term. Sixty-eight patients from community-based referring doctors were randomized to receive 3 ESWT treatments or 3 treatments at a subtherapeutic dose given at weekly intervals. Seven outcome measures relating to pain and function were collected at followup evaluations at 6 weeks, 3 months, and 6 months after completion of the treatment. The mean changes in outcome variables from baseline to 6 weeks, 3 months, and 6 months were compared for the 2 groups. The groups did not differ on demographic or clinical characteristics at baseline and there were significant improvements in almost all outcome measures for both groups over the 6-month followup period, but there were no differences between the groups even after adjusting for duration of symptoms. Our study found little evidence to support the use of ESWT for the treatment of lateral epicondylitis and is in keeping with recent systematic reviews of ESWT for lateral epicondylitis that have drawn similar conclusions.

  10. Examining the effect of three low-intensity pediatric obesity interventions: a pilot randomized controlled trial.

    PubMed

    Looney, Shannon M; Raynor, Hollie A

    2014-12-01

    Primary care is an ideal setting to treat pediatric obesity. Effective, low-intensity (≤25 contact hours over 6 months) interventions that reduce standardized body mass index (z-BMI) and can be delivered by primary care providers are needed. This pilot randomized controlled trial investigated the effect of 3 low-intensity (≤25 contact hours over 6 months) pediatric obesity treatments on z-BMI. Twenty-two families (children 8.0 ± 1.8 years, z-BMI of 2.34 ± 0.48) were randomized into 1 of 3, 6-month, low-intensity conditions: newsletter (N), newsletter and growth monitoring (N + GM), or newsletter and growth monitoring plus family-based behavioral counseling (N + GM + BC). Anthropometrics and child eating and leisure-time behaviors were measured. Mixed-factor analyses of variance found a significant (P < .05) main effect of time for z-BMI and servings per day of sugar sweetened beverages, with both decreasing over time. Low-intensity obesity treatments can reduce z-BMI and may be more feasible in primary care. © The Author(s) 2014.

  11. 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.

  12. RCT of a 6-month programmed sports therapy (PST) in patients with haemophilia - Improvement of physical fitness.

    PubMed

    Runkel, B; Czepa, D; Hilberg, T

    2016-09-01

    Physical fitness is of major importance for patients with haemophilia (PwH) but is highly influenced by bleeding episodes. Although some cohort studies describe an improvement of physical fitness after training intervention, randomized controlled studies (RCT) in PwH are still rare. The aim of this study was to prove the enhancement of physical work capacity in PwH by programmed sports therapy (PST). This RCT includes a training period over six months. Sixty-four PwH with moderate (n = 5) to severe (n = 59) haemophilia A (n = 57) and B (n = 7) were randomized into two groups - training intervention group (IG) and control group (CG) by block randomization. Complex strength measurements, joint score, coordination check and a 12-min walking test were carried out before and after training intervention. Significant differences were tested in M. triceps brachii (Δ+0.62 N kg(-1) ), biceps brachii (Δ+1.25 N kg(-1) ), latissimus dorsi (Δ+0.59 N kg(-1) ), rectus abdominis (Δ+0.51 N kg(-1) ), biceps femoris (right: Δ+0.68 N kg(-1) ; left: Δ+0.59 N kg(-1) ) and the quadriceps femoris (right: Δ+0.71 N kg(-1) ; left: Δ+0.55 N kg(-1) ) after intervention between the two groups (all p ≤ 0.003). Furthermore, an increase in distance (Δ+171.5 m) covered in the 12-min walking test (P = 0.011) was observed. Regarding one-leg stand, a significant improvement (P = 0.037) in the IG (Δ+2.2 s right leg) after intervention could be determined. For the first time, a study with a corresponding number of adult PwH in a RCT-design showed that programmed sport therapy with specific instructions over 6 months has a positive effect on physical performance of PwH, independent of constitution and disease process. © 2016 John Wiley & Sons Ltd.

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

    PubMed

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

    2014-06-01

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

  14. Effects of an anger management and stress control program on smoking cessation: a randomized controlled trial.

    PubMed

    Yalcin, Bektas Murat; Unal, Mustafa; Pirdal, Hasan; Karahan, Tevfik Fikret

    2014-01-01

    The purpose of this study was to investigate the effects of a cognitive behavioral therapy-oriented anger management and stress control program on smokers' quit rates. Of 2348 smokers, 350 were randomly allocated into study and control groups (n = 175 each). An individualized therapy cessation technique was selected for each participant (combination of behavioral counseling, nicotine replacement therapy, and/or pharmacotherapy). The participants in the control group attended a standard quit program, whereas the study group also received an additional 5-session (90 minutes each) cognitive behavioral therapy-oriented program aimed at improving their anger and stress coping skills. At the beginning of the study, both groups were asked to complete the Trait Anger Scale (TAS) of the State and Trait Anger Scale and the Self-Confident (SCS) and Hopeless (HS) subscales of the Stress Coping Styles Inventory; pretest smoking status of both groups and their coping skills were compared with each other as soon as the program ended (post-test results) and after 3 and 6 months (first and second follow-up tests). Although there was no difference between pretest scores on the TAS (P = .234), SCS (P = .130), and HS (P = .148) subscales, post-test results indicate that the study groups' TAS and HS scores decreased and SCS scores increased (P < .001), whereas there was no change in the control group (P > .05). The study group had a better quit level after 6 months compared with the control group (44% vs 27.4%; P < .001). The anger management and stress control program was found to have a significant effect on cessation (odds ratio, 2.09; 95% confidence interval, 1.14-3.85). The anger and stress coping skills program may increase the success of quitting smoking. © Copyright 2014 by the American Board of Family Medicine.

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

    PubMed

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

    2009-12-01

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

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

    PubMed

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

    2010-03-01

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

  17. 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

  18. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity.

    PubMed

    Sacher, Paul M; Kolotourou, Maria; Chadwick, Paul M; Cole, Tim J; Lawson, Margaret S; Lucas, Alan; Singhal, Atul

    2010-02-01

    The aim of this study was to evaluate the effectiveness of the Mind, Exercise, Nutrition, Do it (MEND) Program, a multicomponent community-based childhood obesity intervention (www.mendcentral.org). One hundred and sixteen obese children (BMI >or= 98 th percentile, UK 1990 reference data) were randomly assigned to intervention or waiting list control (6-month delayed intervention). Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools, followed by a 12-week free family swimming pass. Waist circumference, BMI, body composition, physical activity level, sedentary activities, cardiovascular fitness, and self-esteem were assessed at baseline and at 6 months. Children were followed up 12 months from baseline (0 and 6 months postintervention for the control and intervention group, respectively). Participants in the intervention group had a reduced waist circumference z-score (-0.37; P < 0.0001) and BMI z-score (-0.24; P < 0.0001) at 6 months when compared to the controls. Significant between-group differences were also observed in cardiovascular fitness, physical activity, sedentary behaviors, and self-esteem. Mean attendance for the MEND Program was 86%. At 12 months, children in the intervention group had reduced their waist and BMI z-scores by 0.47 (P < 0.0001) and 0.23 (P < 0.0001), respectively, and benefits in cardiovascular fitness, physical activity levels, and self-esteem were sustained. High-attendance rates suggest that families found this intensive community-based intervention acceptable. Further larger controlled trials are currently underway to confirm the promising findings of this initial trial.

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed

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

    2017-07-01

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

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

    USDA-ARS?s Scientific Manuscript database

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

  2. Randomized controlled trial of collaborative implementation intentions targeting working adults' physical activity.

    PubMed

    Prestwich, Andrew; Conner, Mark T; Lawton, Rebecca J; Ward, Jane K; Ayres, Karen; McEachan, Rosemary R C

    2012-07-01

    The research tested the efficacy of planning and partner-based interventions to promote physical activity over six months. Local government (council) employees (N = 257) were randomly allocated to one of four conditions (collaborative implementation intentions; partner-only; implementation intentions; control group) before completing measures at baseline and follow-ups at 1, 3 and 6 months. Outcome measures comprised validated self-report measures of physical activity: the international physical activity questionnaire (IPAQ; Craig et al., 2003) and self-report walking and exercise tables (SWET; Prestwich et al., 2012); psychosocial mediators (enjoyment, intention, self-efficacy, social influence); weight and waist size (baseline and 6 months only). As well as losing the most weight, there was evidence that participants in the collaborative implementation-intention group were more physically active than each of the other three groups at 1-, 3- and 6-month follow-ups. Those in the implementation-intention and partner-only conditions did not outperform the control group on most measures. Collaborative implementation intentions represent a potentially useful intervention to change important health behaviors that help reduce weight.

  3. 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.

  4. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia.

    PubMed

    Losordo, Douglas W; Kibbe, Melina R; Mendelsohn, Farrell; Marston, William; Driver, Vickie R; Sharafuddin, Melhem; Teodorescu, Victoria; Wiechmann, Bret N; Thompson, Charles; Kraiss, Larry; Carman, Teresa; Dohad, Suhail; Huang, Paul; Junge, Candice E; Story, Kenneth; Weistroffer, Tara; Thorne, Tina M; Millay, Meredith; Runyon, John Paul; Schainfeld, Robert

    2012-12-01

    Critical limb ischemia portends a risk of major amputation of 25% to 35% within 1 year of diagnosis. Preclinical studies provide evidence that intramuscular injection of autologous CD34+ cells improves limb perfusion and reduces amputation risk. In this randomized, double-blind, placebo-controlled pilot study, we evaluated the safety and efficacy of intramuscular injections of autologous CD34+ cells in subjects with moderate or high-risk critical limb ischemia, who were poor or noncandidates for surgical or percutaneous revascularization (ACT34-CLI). Twenty-eight critical limb ischemia subjects were randomized and treated: 7 to 1 × 10(5) (low-dose) and 9 to 1 × 10(6) (high-dose) autologous CD34+ cells/kg; and 12 to placebo (control). Intramuscular injections were distributed into 8 sites within the ischemic lower extremity. At 6 months postinjection, 67% of control subjects experienced a major or minor amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.137). This trend continued at 12 months, with 75% of control subjects experiencing any amputation versus 43% of low-dose and 22% of high-dose cell-treated subjects (P=0.058). Amputation incidence was lower in the combined cell-treated groups compared with control group (6 months: P=0.125; 12 months: P=0.054), with the low-dose and high-dose groups individually showing trends toward improved amputation-free survival at 6 months and 12 months. No adverse safety signal was associated with cell administration. This study provides evidence that intramuscular administration of autologous CD34+ cells was safe in this patient population. Favorable trends toward reduced amputation rates in cell-treated versus control subjects were observed. These findings warrant further exploration in later-phase clinical trials. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00616980.

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

    PubMed Central

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

    2011-01-01

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

  6. Population deworming every 6 months with albendazole in 1 million pre-school children in North India: DEVTA, a cluster-randomised trial.

    PubMed

    Awasthi, Shally; Peto, Richard; Read, Simon; Richards, Susan M; Pande, Vinod; Bundy, Donald

    2013-04-27

    In north India many pre-school children are underweight, many have intestinal worms, and 2-3% die at ages 1·0-6·0 years. We used the state-wide Integrated Child Development Service (ICDS) infrastructure to help to assess any effects of regular deworming on mortality. Participants in this cluster-randomised study were children in catchment areas of 8338 ICDS-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks were cluster-randomly allocated in Oxford between 6-monthly vitamin A (retinol capsule of 200,000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of albendazole effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6-72 months. Annually, one centre per block was randomly selected and visited by a study team 1-5 months after any trial deworming to sample faeces (for presence of worm eggs, reliably assessed only after mid-study), weigh children, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100,000 visits, 25,000 deaths at age 1·0-6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Estimated compliance with 6-monthly albendazole was 86%. Among 2589 versus 2576 children surveyed during the second half of the study, nematode egg prevalence was 16% versus 36%, and most infection was light. After at least 2 years of treatment, weight at ages 3·0-6·0 years (standardised to age 4·0 years, 50% male) was 12·72 kg albendazole versus 12·68 kg control (difference 0·04 kg, 95% CI -0·14 to 0·21, p=0·66). Comparing the 36 albendazole-allocated versus 36 control blocks in analyses of the primary outcome, deaths per child-care centre at ages 1·0-6·0 years during the 5

  7. Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

    PubMed Central

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

    2013-01-01

    Summary Background In north India many pre-school children are underweight, many have intestinal worms, and 2–3% die at ages 1·0–6·0 years. We used the state-wide Integrated Child Development Service (ICDS) infrastructure to help to assess any effects of regular deworming on mortality. Methods Participants in this cluster-randomised study were children in catchment areas of 8338 ICDS-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks were cluster-randomly allocated in Oxford between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of albendazole effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial deworming to sample faeces (for presence of worm eggs, reliably assessed only after mid-study), weigh children, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at age 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly albendazole was 86%. Among 2589 versus 2576 children surveyed during the second half of the study, nematode egg prevalence was 16% versus 36%, and most infection was light. After at least 2 years of treatment, weight at ages 3·0–6·0 years (standardised to age 4·0 years, 50% male) was 12·72 kg albendazole versus 12·68 kg control (difference 0·04 kg, 95% CI −0·14 to 0·21, p=0·66). Comparing the 36 albendazole-allocated versus 36 control blocks in analyses of the primary outcome, deaths

  8. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  9. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States.

    PubMed

    Olson, Ryan; Wipfli, Brad; Thompson, Sharon V; Elliot, Diane L; Anger, W Kent; Bodner, Todd; Hammer, Leslie B; Perrin, Nancy A

    2016-09-01

    To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = -0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers.

  10. Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

    PubMed

    Borland, Ron; Balmford, James; Benda, Peter

    2013-03-01

    To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

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

    PubMed

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

    2015-01-01

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

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

    PubMed

    Motlhatlhedi, Keneilwe; Setlhare, Vincent; Ganiyu, Adewale; Firth, Jacqueline

    2017-01-30

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

  13. Comparison of the effects of cetylpyridinium chloride with an essential oil mouth rinse on dental plaque and gingivitis - a six-month randomized controlled clinical trial.

    PubMed

    Albert-Kiszely, A; Pjetursson, B E; Salvi, G E; Witt, J; Hamilton, A; Persson, G R; Lang, N P

    2007-08-01

    To compare the effects of an experimental mouth rinse containing 0.07% cetylpyridinium chloride (CPC) (Crest Pro-Health) with those provided by a commercially available mouth rinse containing essential oils (EOs) (Listerine) on dental plaque accumulation and prevention of gingivitis in an unsupervised 6-month randomized clinical trial. This double-blind, 6-month, parallel group, positively controlled study involved 151 subjects balanced and randomly assigned to either positive control (EO) or experimental (CPC) mouth rinse treatment groups. At baseline, subjects received a dental prophylaxis procedure and began unsupervised rinsing twice a day with 20 ml of their assigned mouthwash for 30 s after brushing their teeth for 1 min. Subjects were assessed for gingivitis and gingival bleeding by the Gingival index (GI) of Löe & Silness (1963) and plaque by the Silness & Löe (1964) Plaque index at baseline and after 3 and 6 months of rinsing. At 3 and 6 months, oral soft tissue health was assessed. Microbiological samples were also taken for community profiling by the DNA checkerboard method. Results show that after 3 and 6 months of rinsing, there were no significant differences (p=0.05) between the experimental (CPC) and the positive control mouth rinse treatment groups for overall gingivitis status, gingival bleeding, and plaque accumulation. At 6 months, the covariant (baseline) adjusted mean GI and bleeding sites percentages for the CPC and the EO rinses were 0.52 and 0.53 and 8.7 and 9.3, respectively. Both mouth rinses were well tolerated by the subjects. Microbiological community profiles were similar for the two treatment groups. Statistically, a significant greater reduction in bleeding sites was observed for the CPC rinse versus the EO rinse. The essential findings of this study indicated that there was no statistically significant difference in the anti-plaque and anti-gingivitis benefits between the experimental CPC mouth rinse and the positive control EO

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

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

    ERIC Educational Resources Information Center

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

    2008-01-01

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

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

    PubMed Central

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  18. Impact of Free Glasses and a Teacher Incentive on Children's Use of Eyeglasses: A Cluster-Randomized Controlled Trial.

    PubMed

    Yi, Hongmei; Zhang, Haiqing; Ma, Xiaochen; Zhang, Linxiu; Wang, Xiuqin; Jin, Ling; Naidoo, Kovin; Minto, Hasan; Zou, Haidong; Lu, Lina; Rozelle, Scott; Congdon, Nathan

    2015-11-01

    To study the effect of free glasses combined with teacher incentives on in-school glasses wear among Chinese urban migrant children. Cluster-randomized controlled trial. Children with visual acuity (VA) ≤6/12 in either eye owing to refractive error in 94 randomly chosen primary schools underwent randomization by school to receive free glasses, education on their use, and a teacher incentive (Intervention), or glasses prescriptions only (Control). Intervention group teachers received a tablet computer if ≥80% of children given glasses wore them during unannounced visits 6 weeks and 6 months (main outcome) after intervention. Among 4376 children, 728 (16.7%, mean age 10.9 years, 51.0% boys) met enrollment criteria and were randomly allocated, 358 (49.2%, 47 schools) to Intervention and 370 (50.8%, 47 schools) to Control. Among these, 693 children (95.2%) completed the study and underwent analysis. Spectacle wear was significantly higher at 6 months among Intervention children (Observed [main outcome]: 68.3% vs 23.9%, adjusted odds ratio [OR] = 11.5, 95% confidence interval [CI] 5.91-22.5, P < .001; Self-reported: 90.6% vs 32.1%, OR = 43.7, 95% CI = 21.7-88.5, P < .001). Other predictors of observed wear at 6 months included baseline spectacle wear (P < .001), uncorrected VA <6/18 (P = .01), and parental spectacle wear (P = .02). The 6-month observed wear rate was only 41% among similar-aged children provided free glasses in our previous trial without teacher incentives. Free spectacles and teacher incentives maintain classroom wear in the large majority of children needing glasses over a school year. Low wear among Control children demonstrates the need for interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2009-01-01

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

  1. Role of spinal ultrasound in diagnosis of meningitis in infants younger than 6 months.

    PubMed

    Nepal, Pankaj; Sodhi, Kushaljit Singh; Saxena, Akshay Kumar; Bhatia, Anmol; Singhi, Sunit; Khandelwal, Niranjan

    2015-03-01

    Spinal ultrasound (US) can detect changes in CSF echogenicity and decreased cord pulsations which reflect the inflammatory changes in meningitis. Till date, there is no published data about the prospective accuracy of spinal US in meningitis. To assess accuracy of spinal US in diagnosis of meningitis in infants younger than 6 months. This was an institute ethics committee approved prospective study carried out in infants less than 6 months of age with clinical suspicion of meningitis who presented to pediatric emergency unit. 60 infants each in study and control group were enrolled. US of thoraco-lumbar spine were performed prior to lumbar puncture in all cases. We looked for the presence of echogenicity or trabeculations in posterior subarachnoid space and for presence or absence of spinal cord and nerve root pulsations on real time ultrasound. The results of spinal US were evaluated in correlation with cerebrospinal fluid analysis. Follow up ultrasounds were done in infants who showed abnormal findings after the initiation of treatment and findings compared with initial results. The study group comprised of 40 boys and 20 girls with mean age of 47.85 days. The control group comprised of 36 boys and 24 girls with a mean age of 60.53 days. 34/60 cases in study group had CSF findings suggestive of meningitis. Based on imaging parameters, spinal US had sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 67.16%, 92.3%, 93.1% and 74.64%, respectively. Chi-square test showed a statistically significant association between infants with meningitis and positive US findings (p<0.05). Spinal US findings of CSF debris, septations and decreased spinal cord pulsations can be seen in infants with meningitis. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. An Automated Internet Behavioral Weight-Loss Program by Physician Referral: A Randomized Controlled Trial

    PubMed Central

    Leahey, Tricia M.; Wing, Rena R.

    2015-01-01

    OBJECTIVE To evaluate 3- and 6-month weight-loss outcomes achieved when physicians refer overweight/obese patients to an automated 3-month Internet-based behavioral weight-loss intervention. RESEARCH DESIGN AND METHODS A total of 154 patients age 18–70 years with a BMI between 25 and 45 kg/m2 and access to a personal computer and the Internet were randomly assigned to 3 months of Internet behavioral intervention (IBI; n = 77) with 12 weekly videos teaching behavioral weight-loss skills, a platform for submitting self-monitored data, and automated feedback or an education-only Internet-delivered eating and activity control group (IDEA; n = 77). Outcome measures were weight loss after 3 months (primary outcome) and 6 months and changes in weight-control behaviors (secondary outcomes). RESULTS In intent-to-treat analyses with baseline weight carried forward for missing data, IBI produced significantly larger mean (SD) weight losses than IDEA at 3 months (5.5 kg [4.4] vs. 1.3 kg [2.1]) and 6 months (5.4 kg [5.6] vs. 1.3 kg [4.1]) (P < 0.001). Participants in IBI compared with IDEA were also more likely to achieve a clinically significant weight loss of 5% of initial body weight at 3 months (53.3 vs. 9.1%) and 6 months (48.1 vs. 15.6%) (P < 0.001) and reported more frequent use of weight control–related strategies. CONCLUSIONS Physician referral to an Internet-based behavioral weight-loss intervention produced clinically significant weight loss for over half of the patients studied. Further research is needed to determine the effectiveness of implementing this intervention more broadly within diverse health care settings. PMID:25404659

  3. Effect of 6-month supervised exercise on low-density lipoprotein apolipoprotein B kinetics in patients with type 2 diabetes mellitus.

    PubMed

    Stolinski, Michael; Alam, Saima; Jackson, Nicola C; Shojaee-Moradie, Fariba; Pentecost, Claire; Jefferson, William; Christ, Emmanuel R; Jones, Richard H; Umpleby, A Margot

    2008-11-01

    Although low-density lipoprotein (LDL) cholesterol is often normal in patients with type 2 diabetes mellitus, there is evidence for a reduced fractional catabolic rate and consequently an increased mean residence time (MRT), which can increase atherogenic risk. The dyslipidemia and insulin resistance of type 2 diabetes mellitus can be improved by aerobic exercise, but effects on LDL kinetics are unknown. The effect of 6-month supervised exercise on LDL apolipoprotein B kinetics was studied in a group of 17 patients with type 2 diabetes mellitus (mean age, 56.8 years; range, 38-68 years). Patients were randomized into a supervised group, who had a weekly training session, and an unsupervised group. LDL kinetics were measured with an infusion of 1-(13)C leucine at baseline in all groups and after 6 months of exercise in the patients. Eight body mass index-matched nondiabetic controls (mean age, 50.3 years; range, 40-67 years) were also studied at baseline only. At baseline, LDL MRT was significantly longer in the diabetic patients, whereas LDL production rate and fractional clearance rates were significantly lower than in controls. Percentage of glycated hemoglobin A(1c), body mass index, insulin sensitivity measured by the homeostasis model assessment, and very low-density lipoprotein triglyceride decreased (P < .02) in the supervised group, with no change in the unsupervised group. After 6 months, LDL cholesterol did not change in either the supervised or unsupervised group; but there was a significant change in LDL MRT between groups (P < .05) that correlated positively with very low-density lipoprotein triglyceride (r = 0.51, P < .04) and negatively with maximal oxygen uptake, a measure of fitness (r = -0.51, P = .035), in all patients. The LDL production and clearance rates did not change in either group. This study suggests that a supervised exercise program can reduce deleterious changes in LDL MRT.

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

    PubMed

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

    2017-03-08

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

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

    PubMed Central

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

    2017-01-01

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

  6. Enhancing condom use among Black male youths: a randomized controlled trial.

    PubMed

    Crosby, Richard A; Charnigo, Richard J; Salazar, Laura F; Pasternak, Ryan; Terrell, Ivy W; Ricks, JaNelle; Smith, Rachel V; Taylor, Stephanie N

    2014-11-01

    We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection (STI) clinics in 3 southern US cities. In 2010 to 2012, we screened (n = 1102) and enrolled (n = 702) youths aged 15 to 23 years who identified as Black and reported recent (past 2 months) sexual activity and randomized them to a private, brief, interactive intervention (n = 349) or an attention-equivalent control condition (n = 353). Assessments occurred at baseline and 2 and 6 months after the intervention. At 6 months, with adjustment for age and pretest nonequivalence of the outcome variable, an estimated odds ratio (EOR) of 1.63 (95% confidence interval [CI] = 1.07, 2.49; P = .02) indicated efficacy for correct condom use. An adjusted generalized estimating equations model with both 2- and 6-month condom use variables produced an EOR of 1.49 (95% CI = 1.06, 2.08; P = .02). We did not observe significant effects on chlamydia and gonorrhea incidence. This brief intervention, delivered as part of STI clinical care, could help alleviate the disproportionate STI-HIV burden among young Black men.

  7. Enhancing Condom Use Among Black Male Youths: A Randomized Controlled Trial

    PubMed Central

    Charnigo, Richard J.; Salazar, Laura F.; Pasternak, Ryan; Terrell, Ivy W.; Ricks, JaNelle; Smith, Rachel V.; Taylor, Stephanie N.

    2014-01-01

    Objectives. We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection (STI) clinics in 3 southern US cities. Methods. In 2010 to 2012, we screened (n = 1102) and enrolled (n = 702) youths aged 15 to 23 years who identified as Black and reported recent (past 2 months) sexual activity and randomized them to a private, brief, interactive intervention (n = 349) or an attention-equivalent control condition (n = 353). Assessments occurred at baseline and 2 and 6 months after the intervention. Results. At 6 months, with adjustment for age and pretest nonequivalence of the outcome variable, an estimated odds ratio (EOR) of 1.63 (95% confidence interval [CI] = 1.07, 2.49; P = .02) indicated efficacy for correct condom use. An adjusted generalized estimating equations model with both 2- and 6-month condom use variables produced an EOR of 1.49 (95% CI = 1.06, 2.08; P = .02). We did not observe significant effects on chlamydia and gonorrhea incidence. Conclusions. This brief intervention, delivered as part of STI clinical care, could help alleviate the disproportionate STI–HIV burden among young Black men. PMID:25211749

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

    PubMed Central

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

    2015-01-01

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

  9. 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.

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

    PubMed

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

    2017-10-01

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

  11. Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study.

    PubMed

    Ketter, Terence A; Amchin, Jess; Frye, Mark A; Gross, Nicholas

    2016-06-01

    Safe/well-tolerated treatments for bipolar I depression remain limited. We assessed safety/tolerability of adjunctive open-label armodafinil, a wakefulness-promoting agent evaluated in 3 acute, controlled efficacy studies with variable efficacy results. Completers of three 8-week, double-blind, placebo-controlled adjunctive armodafinil studies (150-200 mg/day added to ongoing stable maintenance doses of 1 or 2 protocol-defined mood stabilizers) in bipolar I depression could enter this 6-month, open-label extension study. Objectives included evaluation of safety/tolerability (primary) and efficacy (secondary). 867 patients enrolled; 863 received ≥1 dose of armodafinil and 506 (58%) completed the 6-month study. Headache, insomnia, and anxiety were the most common adverse events (AEs) reported, whereas akathisia, nausea, sedation/somnolence, and weight increase were uncommon. Mean measures assessing emergence of mania, anxiety, insomnia, or suicidality showed no worsening. Discontinuations due to AEs occurred in 57 (7%) patients. Serious AEs occurred in 27 (3%) patients and were considered treatment-related in 8 (1%) patients. Depressive symptoms improved over the 6 months, as did patient functioning. Lack of placebo control. Adjunctive armodafinil was generally safe and well tolerated over 6 months of open-label treatment at 150-200 mg/day when taken with protocol-defined mood stabilizers for bipolar I depression. This 6-month open-label study suggested that armodafinil augmentation of bipolar maintenance therapies may have a favorable risk profile and may improve depressive symptoms in some patients with bipolar I depression. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study

    PubMed Central

    Levine, Erica L; Askew, Sandy; Foley, Perry; Bennett, Gary G

    2013-01-01

    Background Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations. Objective This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women. Methods Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts. Results The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference –2.41 kg, 95% CI –5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=–.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence. Conclusions Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention. Trial Registration Clinicaltrials.gov: NCT00939081; http://clinicaltrials.gov/show/NCT00939081 (Archived by WebCite at http://www.webcitation.org/6Ki

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

    PubMed Central

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

    2006-01-01

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

  14. Randomized, placebo-controlled study of the efficacy of a calcium phosphate containing paste on dentin hypersensitivity.

    PubMed

    Mehta, Deepak; Gowda, Vishwas; Finger, Werner J; Sasaki, Keiichi

    2015-11-01

    Hypersensitivity of non-carious cervical lesions (DH) is a frequently encountered disease. This randomized, controlled, single-blind crossover study evaluated the effectiveness of a calcium phosphate containing desensitizer paste (TAP) on DH in comparison to water as placebo (PLA). In this clinical trial 35 patients were randomly assigned to the test and the negative control group. Using a 10cm long VAS (visual analog scale) patients should respond with DH score >6 on one tooth in each of two quadrants for allocation. Pain stimuli were a 2-seconds air blast (AB) and probe scratching (PS) of the exposed dentin. VAS scores were determined pre-operatively (PRE), immediately after treatment (POST), at 1 week, 1, 3 and finally after 6 months. Both TAP and PLA applications decreased DH significantly at POST and throughout the 6-months recalls (p<0.001). Pain reductions upon AB stimulation of TAP treated teeth, assessed at POST and 6 months were 35 and 55%, upon PS stimuli 21 and 54%, respectively. PLA treated lesions responded to AB at POST and after 6 months with 20 and 36% pain reduction, to PS with 11 and 30% pain reduction, respectively. Differences between TAP and PLA pain scores were statistically significant at all recalls (p<0.05). TAP paste reduced DH successfully during this 6-months trial. The calcium phosphate crystallites included in the paste and the presumed hydroxyapatite precipitates upon exposure to saliva were hypothetically able to occlude open dentinal tubules, at least to some extent. TAP is considered a biocompatible desensitizer paste. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  15. Teaching children to cross streets safely: a randomized, controlled trial.

    PubMed

    Schwebel, David C; McClure, Leslie A; Severson, Joan

    2014-07-01

    Child pedestrian injury is a global public health challenge. This randomized, controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and Web sites, plus no-training control, to improve children's street-crossing ability. Pedestrian safety was evaluated among 231 7- and 8-year-olds using both streetside (field) and laboratory-based (virtual environment) trials before intervention group assignment, immediately posttraining, and 6 months posttraining. All training groups received 6 30-min sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior postintervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly posttraining than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in postintervention VR trials. Children showed minimal change in attention to traffic posttraining. Children trained with videos/websites showed minimal learning. Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds' street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly disseminated.

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

    PubMed

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

    2009-05-01

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

  17. Qigong and exercise therapy for elderly patients with chronic neck pain (QIBANE): a randomized controlled study.

    PubMed

    von Trott, Philipp; Wiedemann, Anna Maria; Lüdtke, Rainer; Reishauer, Anett; Willich, Stefan N; Witt, Claudia M

    2009-05-01

    The aim of this study was to evaluate the effectiveness of qigong compared with exercise therapy and no treatment. Elderly patients with chronic neck pain (>6 months) were randomly assigned to qigong or exercise therapy (each 24 sessions over a period of 3 months) or to a waiting list control. Patients completed standardized questionnaires at baseline and after 3 and 6 months. The main outcome measure was average neck pain on the visual analogue scale after 3 months. Secondary outcomes were neck pain and disability (NPAD) and quality of life (SF-36). One hundred seventeen patients (age, 76 +/- 8 years, 95% women) were included in the intention-to-treat analysis. The average duration of neck pain was 19.0 +/- 14.9 years. After 3 months, no significant differences were observed between the qigong group and the waiting list control group (visual analogue scale mean difference, -11 mm [CI, -24.0; 2.1], P = .099) or between the qigong group and the exercise therapy group (-2.5 mm [ - 15.4; 10.3], P = .699). Results for the NPAD were similar (qigong vs waiting list -6.7 (-15.4; 2.1), P = .135; qigong vs exercise therapy 2.3 (-6.2; 10.8); P = .600). We found no significant effect after 3 months of qigong or exercise therapy compared with no treatment. Further studies should include outcomes more suitable to elderly patients, longer treatment, and patients with less chronic pain. In a randomized controlled study, we evaluated whether a treatment of 24 qigong sessions over a period of 3 months is (1) superior to no treatment and (2) superior to the same amount of exercise therapy in elderly patients (age, 76 +/- 8 years, 95% women) with long-term chronic neck pain (19.0 +/- 14.9 years). After 3 and 6 months, we found no significant differences for pain, neck pain, disability, and quality of life among the 3 groups.

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

    PubMed

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

    2003-01-01

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

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

    PubMed Central

    Kopp, Franziska; Dietrich, Claudia

    2013-01-01

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

  20. Cognitive-behaviour therapy for post-traumatic stress in schizophrenia. A randomized controlled trial.

    PubMed

    Steel, C; Hardy, A; Smith, B; Wykes, T; Rose, S; Enright, S; Hardcastle, M; Landau, S; Baksh, M F; Gottlieb, J D; Rose, D; Mueser, K T

    2017-01-01

    There is limited evidence for effective interventions in the treatment of post-traumatic stress symptoms within individuals diagnosed with schizophrenia. Clinicians have concerns about using exposure treatments with this patient group. The current trial was designed to evaluate a 16-session cognitive restructuring programme, without direct exposure, for the treatment of post-traumatic stress symptoms specifically within individuals diagnosed with schizophrenia. A multicentre randomized controlled single-blinded trial with assessments at 0 months, 6 months (post-treatment) and 12 months (follow-up) was conducted. A total of 61 participants diagnosed with schizophrenia and exhibiting post-traumatic stress symptoms were recruited. Those randomized to treatment were offered up to 16 sessions of cognitive-behaviour therapy (CBT, including psychoeducation, breathing training and cognitive restructuring) over a 6-month period, with the control group offered routine clinical services. The main outcome was blind rating of post-traumatic stress symptoms using the Clinician Administered PTSD Scale for Schizophrenia. Secondary outcomes were psychotic symptoms as measured by the Positive and Negative Symptom Scale and the Psychotic Symptom Rating Scale. Both the treatment and control groups experienced a significant decrease in post-traumatic stress symptoms over time but there was no effect of the addition of CBT on either the primary or secondary outcomes. The current trial did not demonstrate any effect in favour of CBT. Cognitive restructuring programmes may require further adaptation to promote emotional processing of traumatic memories within people diagnosed with a psychotic disorder.

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

    PubMed Central

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

    2015-01-01

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

  2. Contralaterally Controlled Functional Electrical Stimulation Improves Hand Dexterity in Chronic Hemiparesis: A Randomized Trial.

    PubMed

    Knutson, Jayme S; Gunzler, Douglas D; Wilson, Richard D; Chae, John

    2016-10-01

    It is unknown whether one method of neuromuscular electrical stimulation for poststroke upper limb rehabilitation is more effective than another. Our aim was to compare the effects of contralaterally controlled functional electrical stimulation (CCFES) with cyclic neuromuscular electrical stimulation (cNMES). Stroke patients with chronic (>6 months) moderate to severe upper extremity hemiparesis (n=80) were randomized to receive 10 sessions/wk of CCFES- or cNMES-assisted hand opening exercise at home plus 20 sessions of functional task practice in the laboratory for 12 weeks. The task practice for the CCFES group was stimulation assisted. The primary outcome was change in Box and Block Test (BBT) score at 6 months post treatment. Upper extremity Fugl-Meyer and Arm Motor Abilities Test were also measured. At 6 months post treatment, the CCFES group had greater improvement on the BBT, 4.6 (95% confidence interval [CI], 2.2-7.0), than the cNMES group, 1.8 (95% CI, 0.6-3.0), between-group difference of 2.8 (95% CI, 0.1-5.5), P=0.045. No significant between-group difference was found for the upper extremity Fugl-Meyer (P=0.888) or Arm Motor Abilities Test (P=0.096). Participants who had the largest improvements on BBT were <2 years post stroke with moderate (ie, not severe) hand impairment at baseline. Among these, the 6-month post-treatment BBT gains of the CCFES group, 9.6 (95% CI, 5.6-13.6), were greater than those of the cNMES group, 4.1 (95% CI, 1.7-6.5), between-group difference of 5.5 (95% CI, 0.8-10.2), P=0.023. CCFES improved hand dexterity more than cNMES in chronic stroke survivors. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00891319. © 2016 American Heart Association, Inc.

  3. Sexual Function and Depression Outcomes Among Breast Hypertrophy Patients Undergoing Reduction Mammaplasty: A Randomized Controlled Trial.

    PubMed

    Beraldo, Flávia N M; Veiga, Daniela F; Veiga-Filho, Joel; Garcia, Edgard S; Vilas-Bôas, Gerusa S; Juliano, Yara; Sabino-Neto, Miguel; Ferreira, Lydia M

    2016-04-01

    The breasts are important symbols of femininity and sensuality. Alterations such as breast hypertrophy can affect several aspects of women's quality of life. Breast hypertrophy is a prevalent health condition, which is treated by reduction mammaplasty. The aim of the present study was to assess sexual function and depression outcomes among breast hypertrophy patients undergoing reduction mammaplasty. Sixty breast hypertrophy patients were randomly allocated to a control group (CG) (n = 30) or a breast reduction group (BRG) (n = 30). The patients in the CG were assessed at the first appointment as well as 3 and 6 months later. The patients in the BRG were assessed preoperatively as well as 3 and 6 months postoperatively. Validated instruments, the Female Sexual Function Index and the Beck Depression Inventory, were used to assess sexual function and depression among the subjects. The results of these assessments were compared within and between groups. Twenty-seven and 29 patients in the CG and the BRG, respectively, completed the 6-month follow-up period. At baseline, the groups did not differ significantly with regard to the main demographic data. In the initial assessment, the groups did not differ significantly with regard to Female Sexual Function Index or Beck Depression Inventory scores. Compared with the CG, the BRG reported better sexual function 3 (P = 0.015) and 6 (P = 0.009) months postoperatively. Regarding depression scores, the reduction mammaplasty group had better results 6 months postoperatively (P = 0.014). Reduction mammaplasty positively affected sexual function and depression levels in breast hypertrophy patients.

  4. Mid-Treatment Sleep Duration Predicts Clinically Significant Knee Osteoarthritis Pain reduction at 6 months: Effects From a Behavioral Sleep Medicine Clinical Trial.

    PubMed

    Salwen, Jessica K; Smith, Michael T; Finan, Patrick H

    2017-02-01

    To determine the relative influence of sleep continuity (sleep efficiency, sleep onset latency, total sleep time [TST], and wake after sleep onset) on clinical pain outcomes within a trial of cognitive behavioral therapy for insomnia (CBT-I) for patients with comorbid knee osteoarthritis and insomnia. Secondary analyses were performed on data from 74 patients with comorbid insomnia and knee osteoarthritis who completed a randomized clinical trial of 8-session multicomponent CBT-I versus an active behavioral desensitization control condition (BD), including a 6-month follow-up assessment. Data used herein include daily diaries of sleep parameters, actigraphy data, and self-report questionnaires administered at specific time points. Patients who reported at least 30% improvement in self-reported pain from baseline to 6-month follow-up were considered responders (N = 31). Pain responders and nonresponders did not differ significantly at baseline across any sleep continuity measures. At mid-treatment, only TST predicted pain response via t tests and logistic regression, whereas other measures of sleep continuity were nonsignificant. Recursive partitioning analyses identified a minimum cut-point of 382 min of TST achieved at mid-treatment in order to best predict pain improvements 6-month posttreatment. Actigraphy results followed the same pattern as daily diary-based results. Clinically significant pain reductions in response to both CBT-I and BD were optimally predicted by achieving approximately 6.5 hr sleep duration by mid-treatment. Thus, tailoring interventions to increase TST early in treatment may be an effective strategy to promote long-term pain reductions. More comprehensive research on components of behavioral sleep medicine treatments that contribute to pain response is warranted.

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

    NASA Astrophysics Data System (ADS)

    Nabi-Abdolyousefi, Marzieh

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

  6. Inhaled corticosteroids for recurrent respiratory symptoms in preschool children in general practice: randomized controlled trial.

    PubMed

    Schokker, Siebrig; Kooi, Elisabeth M W; de Vries, Tjalling W; Brand, Paul L P; Mulder, Paul G H; Duiverman, Eric J; van der Molen, Thys

    2008-01-01

    Therapy with inhaled corticosteroids (ICS) is beneficial in patients with asthma. However, in preschool children with symptoms like cough, wheeze, or shortness of breath diagnosing asthma is difficult. Therefore, the role of ICS in the management of preschool children with recurrent respiratory symptoms is unclear. We assessed the effectiveness of ICS in preschool children with recurrent respiratory symptoms in general practice. In this multicenter, randomized, double blind, placebo controlled trial, 96 children aged 1-5 years consulting their general practitioners for recurrent respiratory symptoms and in whom treatment with ICS was considered by the general practitioner were randomly allocated to receive ICS (fluticasone propionate 200 mcg/day by metered dose inhaler/spacer combination) or placebo for 6 months. Outcome assessments were carried out 1, 3, and 6 months after randomization. The primary outcome measure was the symptom score (cough, shortness of breath and wheeze during day and night) as measured by a symptom diary card. Secondary endpoints were symptom-free days, use of rescue medication, adverse events, and lung function variables as measured by the interrupter technique and forced oscillation technique. During the 6 months treatment period, symptoms improved in both groups, with no differences between ICS and placebo. In addition, none of the secondary outcome parameters showed differences between both treatment groups. ICS treatment has no beneficial effect in preschool children with recurrent respiratory symptoms in general practice. We therefore recommend a watchful waiting policy with only symptomatic treatment in these children. General practitioners and pediatricians should be aware of the high probability of overtreatment when prescribing ICS in these children.

  7. 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.…

  8. 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.…

  9. Recruiting Participants for Randomized Controlled Trials

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  10. 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…

  11. Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

    PubMed

    Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

    2017-08-01

    Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

  12. 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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  15. Tailored, interactive text messages for enhancing weight loss among African American adults: the TRIMM randomized controlled trial.

    PubMed

    Lin, Michael; Mahmooth, Zayan; Dedhia, Nicket; Frutchey, Robin; Mercado, Catherine E; Epstein, David H; Preston, Kenzie L; Gibbons, Michael C; Bowie, Janice V; Labrique, Alain B; Cheskin, Lawrence J

    2015-08-01

    Helping patients control obesity remains a clinical challenge for internists, and African Americans experience obesity rates higher than other racial/ethnic groups. To investigate whether a behavioral theory-based mobile health intervention would enhance weight loss when added to standard care among overweight/obese African American adults. A randomized controlled trial of 124 adults recruited from Baltimore-area African American churches. Participant follow-up ended March 2013. Participants were randomized to standard care (included one-on-one counseling sessions with a dietitian and a physician) or standard care plus daily tailored text messages for 6 months. Text messages were delivered in phases: preparation, reinforcement of participant-selected diet and exercise goals, reflection, goal integration, weight loss methods, and maintenance. There were follow-up visits at 3, 6, and 12 months. Primary outcome was weight change from baseline to end-intervention at 6 months. Secondary outcomes included weight change at 3 months, engagement, and satisfaction with the intervention. Sixty-three participants were randomized to the mobile health intervention and 61 to standard-care control. Weights were collected in-window for 45 (36.3%) at 3 months and 51 (41.1%) at 6 months. Mean weight loss at 3 months was 2.5 kg greater in the intervention group compared with standard care (95% confidence interval [CI], -4.3 to -0.6; P < .001), and 3.4 kg greater (95% CI, -5.2 to -1.7; P = .001) at 6 months. Degree of engagement with messages was correlated with weight loss. While attrition was high, this study supports a tailored, interactive text-message intervention to enhance weight loss among obese African-American adults. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    PubMed Central

    Wey, Mang Chek; Othman, Siti Adibah

    2017-01-01

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

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

    PubMed

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

    2013-08-01

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

  18. A randomized placebo-controlled clinical trial of five smoking cessation pharmacotherapies

    PubMed Central

    Piper, Megan E.; Smith, Stevens S.; Schlam, Tanya R.; Fiore, Michael C.; Jorenby, Douglas E.; Fraser, David; Baker, Timothy B.

    2010-01-01

    Context Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use. Objective The primary objective of this research was to assess the relative efficacies of five smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons. Design This was a randomized double-blind, placebo-controlled clinical trial. Setting Smokers were recruited from the community at two urban research sites. Patients Participants were 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported: using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications. Interventions Participants were randomized to one of six treatment conditions: nicotine lozenge, nicotine patch, bupropion SR, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge or placebo. In addition, all participants received six individual counseling sessions. Main Outcome Measures The main outcome measures were biochemically-confirmed 7-day point-prevalence abstinence assessed at 1 week post-quit, end of treatment (8 weeks post-quit) and 6 months post-quit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. Results All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (OR’s = 1.63–2.34). With such protection, only the nicotine patch + nicotine lozenge (OR = 2.34, p < .001) produced significantly higher abstinence rates at 6-months post-quit than did placebo. Conclusions While the nicotine lozenge, bupropion, and bupropion + lozenge produced effects that were comparable to those

  19. Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

    PubMed

    Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

    2014-09-02

    Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months

  20. The effect of 6-month water storage on the bond strength of self-etch adhesives bonded to dentin.

    PubMed

    Zander-Grande, Christiana; Loguercio, Alessandro D; Stanislawczuk, Rodrigo; Martins, Gislaine Cristine; Gomes, Osnara Maria Mongruel; Reis, Alessandra

    2011-08-01

    To evaluate the microtensile bond strengths (microTBS) of 1-step vs. 2-step self-etch systems to dentin after 24 hours and after 6 months of water storage. Resin composite buildups were bonded to occlusal dentin of third molars using the following adhesives: Xeno IV (XE, Dentsply), G-Bond (GB, GC Inc), Clearfil S3 Bond (CS3, Kuraray); Adper Prompt L-Pop (AD, 3M ESPE); Go (GO, SDI), All Bond SE (ABSE 1-step or ABSE 2-step, Bisco) and Clearfil SE Bond (CSE, Kuraray). The bonded sticks (cross-sectioned area of 0.8-0.9 mm2) originated from the same teeth were randomly divided to be tested after 24 hours or after 6 months of water storage. The data was submitted to two-way repeated measures ANOVA and Tukey's test with and without the inclusion of premature failures (PF) (alpha = 0.05). The inclusion of PF resulted in different statistically significant means for CS3, CSE and AD (P<0.05). Only the ABSE2 showed stable bonds after 6 months of water storage (P>0.05).

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

    PubMed

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

    2013-11-20

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

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

    PubMed Central

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

    2013-01-01

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

  3. The effectiveness of Narrative Exposure Therapy with traumatised firefighters in Saudi Arabia: a randomized controlled study.

    PubMed

    Alghamdi, Mohammed; Hunt, Nigel; Thomas, Shirley

    2015-03-01

    Firefighters are exposed to many traumatic events. The psychological costs of this exposure increase the risk of Post-Traumatic Stress disorder (PTSD), depression and anxiety. This study examined the effectiveness of Narrative Exposure Therapy (NET) as a short-term treatment for reducing PTSD symptoms among Saudi firefighters. A randomized waiting-list control study was conducted with 34 traumatized firefighters were randomly allocated to NET or Waiting-list Control (WLC). The NET group received four therapy sessions of 60-90 min over a three-week period; those in the WLC condition received the same sessions after a three-week waiting period. Participants in both groups were assessed at baseline, immediately post-intervention and at 3 and 6 month follow ups. NET led to significant reductions in PTSD symptoms, anxiety and depression compared with WLC. After the WLC group received treatment, it showed the same improvements as the NET group. This occurred immediately post-treatment in both groups, but was not sustained at 3 and 6 month follow ups. Coping strategies and social support led to significant changes only in follow up times. NET was effective in reducing PTSD symptoms in traumatised Saudi firefighters. This finding could be helpful in the management of PTSD among people who work as first responders such as firefighters, police officers and emergency medical personal, as well as security officers. Copyright © 2015. Published by Elsevier Ltd.

  4. Effect on mental health of a participatory intervention to improve psychosocial work environment: a cluster randomized controlled trial among nurses.

    PubMed

    Uchiyama, Ayako; Odagiri, Yuko; Ohya, Yumiko; Takamiya, Tomoko; Inoue, Shigeru; Shimomitsu, Teruichi

    2013-01-01

    Improvement of psychosocial work environment has proved to be valuable for workers' mental health. However, limited evidence is available for the effectiveness of participatory interventions. The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment. A cluster randomized controlled trial was conducted in hospital settings. A total of 434 nurses in 24 units were randomly allocated to 11 intervention units (n=183) and 13 control units (n=218). A participatory program was provided to the intervention units for 6 months. Depressive symptoms as mental health status and psychosocial work environment, assessed by the Job Content Questionnaire, the Effort-Reward Imbalance Questionnaire, and the Quality Work Competence questionnaire, were measured before and immediately after the 6-month intervention by a self-administered questionnaire. No significant intervention effect was observed for mental health status. However, significant intervention effects were observed in psychosocial work environment aspects, such as Coworker Support (p<0.01) and Goals (p<0.01), and borderline significance was observed for Job Control (p<0.10). It is suggested that a 6-month participatory intervention is effective in improving psychosocial work environment, but not mental health, among Japanese nurses.

  5. Alternatives to the Randomized Controlled Trial

    PubMed Central

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

    2008-01-01

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

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

    PubMed

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

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

  7. 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

  8. Modifying media content for preschool children: a randomized controlled trial.

    PubMed

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

    2013-03-01

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

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

    PubMed Central

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

    2017-01-01

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

  10. Robotic gait training is not superior to conventional treadmill training in parkinson disease: a single-blind randomized controlled trial.

    PubMed

    Carda, Stefano; Invernizzi, Marco; Baricich, Alessio; Comi, Cristoforo; Croquelois, Alexandre; Cisari, Carlo

    2012-01-01

    The use of robots for gait training in Parkinson disease (PD) is growing, but no evidence points to an advantage over the standard treadmill. In this randomized, single-blind controlled trial, participants aged <75 years with early-stage PD (Hoehn-Yahr <3) were randomly allocated to 2 groups: either 30 minutes of gait training on a treadmill or in the Lokomat for 3 d/wk for 4 weeks. Patients were evaluated by a physical therapist blinded to allocation before and at the end of treatment and then at the 3- and 6-month follow-up. The primary outcome measure was the 6-minute walk test. Of 334 screened patients, the authors randomly allocated 30 to receive gait training with treadmill or the Lokomat. At baseline, the 2 groups did not differ. At the 6-month follow-up, both groups had improved significantly in the primary outcome measure (treadmill: mean = 490.95 m, 95% confidence interval [CI] = 448.56-533.34, P = .0006; Lokomat: 458.6 m, 95% CI = 417.23-499.96, P = .01), but no significant differences were found between the 2 groups (P = .53). Robotic gait training with the Lokomat is not superior to treadmill training in improving gait performance in patients with PD. Both approaches are safe, with results maintained for up to 6 months.

  11. Randomized controlled trial of thermal balloon ablation versus vaginal hysterectomy for leiomyoma-induced heavy menstrual bleeding.

    PubMed

    Jain, Prachi; Rajaram, Shalini; Gupta, Bindiya; Goel, Neerja; Srivastava, Himsweta

    2016-11-01

    To compare the efficacy of thermal balloon ablation (TBA) with that of vaginal hysterectomy in the treatment of leiomyoma-induced heavy menstrual bleeding (HMB). An open-label randomized controlled trial was conducted between November 1, 2012, and October 31, 2014, in a tertiary care hospital in Delhi, India. Eligible women with HMB (aged ≥40 years, uterus size ≤14 weeks of pregnancy, leiomyoma ≤5 cm, uterocervical length ≤12 cm) were randomly assigned (1:1) to undergo TBA or vaginal hysterectomy using computer-generated random number tables. The primary outcome was the number of women in the TBA group with HMB 6 months after surgery. Analyses were by intention to treat. Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic. TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  12. Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial.

    PubMed

    Kalita, J; Bhoi, S K; Misra, U K

    2013-07-01

    This study compares efficacy and safety of divalproate extended release (DVA-ER) and amitriptyline (AMT) in migraine. Three hundred migraineurs having >4 attacks monthly were randomized into DVA-ER or AMT. The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale (VAS). Secondary end points were functional disability, rescue medication, and adverse events. The median age was 32 years, and 241 were women. 150 patients each received DVA-ER and AMT. At 3 months, 74.7% in DVA-ER and 62% patients in AMT group improved in headache frequency (P = 0.02) and at 6 months, 65.3% and 54%, respectively (P = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA-ER and 64% in AMT (P = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA-ER group. Divalproate extended release is more effective at 3 months than AMT; however, at 6 months, both are equally effective in migraine prophylaxis. © 2013 John Wiley & Sons A/S.

  13. Color Stability of Teeth Restored with Biodentine: A 6-month In Vitro Study.

    PubMed

    Vallés, Marta; Roig, Miguel; Duran-Sindreu, Fernando; Martínez, Syani; Mercadé, Montserrat

    2015-07-01

    White mineral trioxide aggregate (WMTA) has been reported to cause dental discoloration. A previous study on the color stability of 5 calcium silicate-based materials investigated the color stability of Biodentine (Septodont, Saint-Maur-des-Fossés, France) in different experimental environments; however, no data are available on the color stability of teeth restored with Biodentine. In this study, we assessed the color stability under artificial light of ex vivo human teeth restored coronally with WMTA or Biodentine. Cavities were prepared on coronal tooth specimens and restored with WMTA + composite (n = 16), Biodentine + composite (n = 16), or composite alone (control, n = 3). Color was assessed spectrophotometrically at 6 time points (initial, 1 week, 2 weeks, 1 month, 3 months, and 6 months), and color difference values were calculated. Statistical analysis was performed using analysis of variance and the Fisher least significant difference test for which P < .05 was considered statistically significant. The WMTA group showed discoloration at 1 week, which increased over time. The Biodentine and control groups showed color stability and were not significantly different from one another. Teeth treated with WMTA exhibited discoloration, whereas those treated with Biodentine maintained color stability throughout the study. However, further in vivo studies are necessary to corroborate these results. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    Barbee, Anita P; Cunningham, Michael R; van Zyl, Michiel A; Antle, Becky F; Langley, Cheri N

    2016-09-01

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

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

    PubMed Central

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

    2016-01-01

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

  16. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

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

    PubMed Central

    2012-01-01

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

  18. Early Probiotic Supplementation for Eczema and Asthma Prevention: A Randomized Controlled Trial.

    PubMed

    Cabana, Michael D; McKean, Michelle; Caughey, Aaron B; Fong, Lawrence; Lynch, Susan; Wong, Angela; Leong, Russell; Boushey, Homer A; Hilton, Joan F

    2017-09-01

    To determine if probiotic administration during the first 6 months of life decreases childhood asthma and eczema. We conducted a randomized, double-blind controlled trial of Lactobacillus rhamnosus GG (LGG) supplementation on the cumulative incidence of eczema (primary end point) and asthma and rhinitis (secondary end points) in high-risk infants. For the first 6 months of life, intervention infants (n = 92) received a daily dose of 10 billion colony-forming units of LGG and 225 mg of inulin (Amerifit Brands, Cromwell, CT), and control infants (n = 92) received 325 mg of inulin alone. We used survival analysis methods to estimate disease incidences in the presence or absence of LGG and to estimate the efficacy of LGG in delaying or preventing these diseases. Infants were accrued over a 6-year period (median follow-up: 4.6 years; 95% retention rate at 2 years). At 2 years of age, the estimated cumulative incidence of eczema was 30.9% (95% confidence interval [CI], 21.4%-40.4%) in the control arm and 28.7% (95% CI, 19.4%-38.0%) in the LGG arm, for a hazard ratio of 0.95 (95% CI, 0.59-1.53) (log-rank P = .83). At 5 years of age, the cumulative incidence of asthma was 17.4% (95% CI, 7.6%-27.1%) in the control arm and 9.7% (95% CI, 2.7%-16.6%) in the LGG arm, for a hazard ratio of 0.88 (95% CI, 0.41-1.87) (log-rank P = .25). For high-risk infants, early LGG supplementation for the first 6 months of life does not appear to prevent the development of eczema or asthma at 2 years of age. Copyright © 2017 by the American Academy of Pediatrics.

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

    PubMed

    Baddeley, Jenna L; Pennebaker, James W

    2011-10-01

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

  20. Structured dietary intervention to facilitate weight loss after bariatric surgery: A randomized, controlled pilot study.

    PubMed

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Lutz, Calvin; Cheng, Yu; Sweeny, Gina

    2016-09-01

    To evaluate the potential utility of a structured dietary intervention to assist bariatric surgery patients with weight management. Participants who underwent Roux-en-Y gastric bypass surgery 1 year previously were randomly assigned to a structured dietary intervention incorporating portion-controlled foods (intervention, n = 20) or a comparison group (control, n = 20). Both groups received instruction in behavioral weight loss (one 60-min session) followed by four monthly coaching telephone calls. Assessments were conducted at baseline, 4 months (post-intervention), and 6 months. Participants were 85% female and 80% White. Average age was 46.9 (11.1) years, and body mass index was 31.3 (5.4) kg/m(2) at enrollment. Percent weight change from enrollment was significantly greater for intervention compared with control participants at 4 months [-4.56% vs. -0.13%, t(30)  = -3.29, P = 0.003] and 6 months [-4.07% vs. -0.14%, t(31)  = -2.03, P = 0.05]. Change in average daily calorie intake was greater among intervention compared with control [-108 vs. 116, t(30)  = -2.01, P = 0.05] at 4 months only. A structured dietary intervention increased weight loss and reduced calorie intake when initiated 1 year following Roux-en-Y gastric bypass. This approach holds promise for optimizing postsurgery lifestyle change. © 2016 The Obesity Society.

  1. Effect of 6-month calorie restriction and exercise on serum and liver lipids and markers of liver function.

    PubMed

    Larson-Meyer, D Enette; Newcomer, Bradley R; Heilbronn, Leonie K; Volaufova, Julia; Smith, Steven R; Alfonso, Anthony J; Lefevre, Michael; Rood, Jennifer C; Williamson, Donald A; Ravussin, Eric

    2008-06-01

    Nonalcoholic fatty liver disease (NAFLD) and its association with insulin resistance are increasingly recognized as major health burdens. The main objectives of this study were to assess the relation between liver lipid content and serum lipids, markers of liver function and inflammation in healthy overweight subjects, and to determine whether caloric restriction (CR) (which improves insulin resistance) reduces liver lipids in association with these same measures. Forty-six white and black overweight men and women (BMI = 24.7-31.3 kg/m(2)) were randomized to "control (CO)" = 100% energy requirements; "CR" = 25%; "caloric restriction and increased structured exercise (CR+EX)"= 12.5% CR + 12.5% increase in energy expenditure through exercise; or "low-calorie diet (LCD)" = 15% weight loss by liquid diet followed by weight-maintenance, for 6 months. Liver lipid content was assessed by magnetic resonance spectroscopy (MRS) and computed tomography (CT). Lipid concentrations, markers of liver function (alanine aminotransferase (ALT), alkaline phosphatase (ALK)), and whole-body inflammation (tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP)) were measured in fasting blood. At baseline, increased liver lipid content (by MRS) correlated (P < 0.05) with elevated fasting triglyceride (r = 0.52), ALT (r = 0.42), and hsCRP (r = 0.33) concentrations after adjusting for sex, race, and alcohol consumption. With CR, liver lipid content was significantly lowered by CR, CR+EX, and LCD (detected by MRS only). The reduction in liver lipid content, however, was not significantly correlated with the reduction in triglycerides (r = 0.26; P = 0.11) or with the changes in ALT, high-density lipoprotein (HDL)-cholesterol, or markers of whole-body inflammation. CR may be beneficial for reducing liver lipid and lowering triglycerides in overweight subjects without known NAFLD.

  2. Intravenous sodium nitrite in acute ST-elevation myocardial infarction: a randomized controlled trial (NIAMI).

    PubMed

    Siddiqi, Nishat; Neil, Christopher; Bruce, Margaret; MacLennan, Graeme; Cotton, Seonaidh; Papadopoulou, Sofia; Feelisch, Martin; Bunce, Nicholas; Lim, Pitt O; Hildick-Smith, David; Horowitz, John; Madhani, Melanie; Boon, Nicholas; Dawson, Dana; Kaski, Juan Carlos; Frenneaux, Michael

    2014-05-14

    Despite prompt revascularization of acute myocardial infarction (AMI), substantial myocardial injury may occur, in part a consequence of ischaemia reperfusion injury (IRI). There has been considerable interest in therapies that may reduce IRI. In experimental models of AMI, sodium nitrite substantially reduces IRI. In this double-blind randomized placebo controlled parallel-group trial, we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction (STEMI). A total of 229 patients presenting with acute STEMI were randomized to receive either an i.v. infusion of 70 μmol sodium nitrite (n = 118) or matching placebo (n = 111) over 5 min immediately before primary percutaneous intervention (PPCI). Patients underwent cardiac magnetic resonance imaging (CMR) at 6-8 days and at 6 months and serial blood sampling was performed over 72 h for the measurement of plasma creatine kinase (CK) and Troponin I. Myocardial infarct size (extent of late gadolinium enhancement at 6-8 days by CMR-the primary endpoint) did not differ between nitrite and placebo groups after adjustment for area at risk, diabetes status, and centre (effect size -0.7% 95% CI: -2.2%, +0.7%; P = 0.34). There were no significant differences in any of the secondary endpoints, including plasma troponin I and CK area under the curve, left ventricular volumes (LV), and ejection fraction (EF) measured at 6-8 days and at 6 months and final infarct size (FIS) measured at 6 months. Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

  3. 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

  4. A Randomized, Double Blind, Placebo-Controlled Trial of Alendronate Treatment for Fibrous Dysplasia of Bone

    PubMed Central

    Boyce, Alison M.; Kelly, Marilyn H.; Brillante, Beth A.; Kushner, Harvey; Wientroub, Shlomo; Riminucci, Mara; Bianco, Paolo; Robey, Pamela G.

    2014-01-01

    Context: Fibrous dysplasia (FD) is a rare skeletal disorder, resulting in deformity, fracture, functional impairment, and pain. Bisphosphonates have been advocated as a potential treatment. Objective: To determine the efficacy of alendronate for treatment of FD. Design: Two-year randomized, double-blind, placebo-controlled trial. Setting: Clinical research center. Patients: Forty subjects with polyostotic FD (24 adults, 16 children). Subjects were randomized and stratified by age. Interventions: Study drug was administered over a 24 month period in 6 month cycles (6 months on, 6 months off). Alendronate dosing was stratified: 40 mg daily for subjects >50 kg, 20 mg for 30–50 kg, 10 mg for 20–30 kg. Main Outcome Measures: Primary endpoints were bone turnover markers, including serum osteocalcin, and urinary NTX-telopeptides. Secondary endpoints included areal bone mineral density (aBMD), pain, skeletal disease burden score, and functional parameters including the 9-min walk test and manual muscle testing. Results: Clinical data was collected on 35 subjects who completed the study. There was a decline in NTX-telopeptides in the alendronate group (P = .006), but no significant difference in osteocalcin between groups. The alendronate group had an increase in areal BMD in normal bone at the lumbar spine (P = .006), and in predetermined regions of FD (P < .001). There were no significant differences in pain scores, skeletal disease burden scores, or functional parameters between the groups. Conclusions: Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides, and improvement in aBMD, but no significant effect on serum osteocalcin, pain, or functional parameters. PMID:25033066

  5. Secondhand Smoke Exposure Reduction Intervention in Chinese Households of Young Children: A Randomized Controlled Trial.

    PubMed

    Abdullah, Abu S; Hua, Fu; Khan, Hafiz; Xia, Xiao; Bing, Qi; Tarang, Kheradia; Winickoff, Jonathan P

    2015-01-01

    To assess whether a theory-based, community health worker-delivered intervention for household smokers will lead to reduced secondhand smoke exposure to children in Chinese families. Smoking parents or caregivers who had a child aged 5 years or younger at home were randomized to the intervention group (n = 164) to receive smoking hygiene intervention or to the comparison group (n = 154). The intervention was delivered by trained community health workers. Outcomes were assessed at 2- and 6- month follow-up. Of the 318 families randomized, 98 (60%) of 164 intervention group and 82 (53%) of 154 of controls completed 6-month follow-up assessment. At the 6-month follow-up, 62% of intervention and 45% of comparison group households adopted complete smoking restrictions at home (P = .022); total exposure (mean number of cigarettes per week ± standard deviation) from all smokers at home in the past 7 days was significantly lower among children in the intervention (3.29 ± 9.06) than the comparison (7.41 ± 14.63) group (P = .021); and mean urine cotinine level (ng/mL) was significantly lower in the intervention (0.030 ± .065) than the comparison (0.087 ± .027) group, P < .001). Participants rating of the overall usefulness of the intervention was 4.8 + 0.8 (1 standard deviation) on the 5 point scale (1 not at all and 5 = very useful). The findings of this very first study in China showed that smoking hygiene intervention was effective in reducing children's exposure to secondhand smoke. These findings have implications for the development of primary health care-based secondhand smoke exposure reduction and family oriented smoking cessation interventions as China moves toward a smoke-free society. Copyright © 2015 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  6. A pilot randomized controlled trial of deprescribing.

    PubMed

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

    2011-04-01

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

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

    PubMed Central

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

    2001-01-01

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

  8. Return to sport: Does excellent 6-month strength and function following ACL reconstruction predict midterm outcomes?

    PubMed

    Sousa, Paul L; Krych, Aaron J; Cates, Robert A; Levy, Bruce A; Stuart, Michael J; Dahm, Diane L

    2017-05-01

    The purpose of this study was to determine whether patients with excellent 6-month functional testing after ACL reconstruction had (1) higher risk of subsequent ACL tears, (2) superior knee function, and (3) increased activity levels compared to those with delayed clearance for return to sports at midterm follow-up. A total of 223 patients underwent primary ACL reconstruction by a single surgeon and had functional and isokinetic testing performed 6 months post-operatively between 1998 and 2005. Of the 223 patients, 52 (23 %) made the excellent group and were allowed return to sport at 6 months, and the remaining 171 (77 %) constituted the delayed group. Rate of ACL graft tear and native contralateral ACL tear was compared between groups. In addition, IKDC and Tegner scores were compared at a mean 4-year follow-up. The graft rupture rate was similar in the excellent group (3.8 %, n = 2) compared to the delayed group (4.7 %, n = 8; p = 0.30). However, there was a higher rate of contralateral ACL tear in the excellent group (15.4 %, n = 8 vs. 5.3 %, n = 9; p = 0.003). The excellent 6-month group had superior IKDC scores (94.3 ± 6.4 vs. 90.9 ± 9.7; p = 0.04) and Tegner scores (6.6 ± 1.8 vs. 5.7 ± 1.6; p = 0.01). Patients with an excellent performance on their isokinetic strength and functional testing at 6 months after ACL reconstruction have superior knee function and higher activity levels at midterm follow-up. However, these patients appear to be at greater risk of contralateral ACL injury, which may be related to their increased activity level. When isokinetic and functional testing is used for return-to-sport decisions, physicians should caution patients about the risk of contralateral ACL injury for high performing patients. Retrospective Review with Control, Level III.

  9. Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study

    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. However, few programs that meet American Association of Diabetes Educators standards have been translated into widespread practice. Objective This study examined the translation of the evidence-based Better Choices, Better Health-Diabetes program in both Internet and face-to-face versions. Methods We administered the Internet program nationally in the United States (n=1010). We conducted face-to-face workshops in Atlanta, Georgia; Indianapolis, Indiana; and St. Louis, Missouri (n=232). Self-report questionnaires collected health indicator, health behavior, and health care utilization measures. Questionnaires were administered on the Web or by mail. We determined hemoglobin A1c (HbA1c) from blood samples collected via mailed kits. Paired t tests determined whether changes between baseline and 6 months differed significantly from no change. Subgroup analyses determined whether participants with specific conditions benefited (high HbA1c, depression, hypoglycemia, nonadherence to medication taking, and no aerobic exercise). We calculated the percentage of participants with improvements of at least 0.4 effect size in at least one of the 5 above measures. Results Of the 1242 participants, 884 provided 6-month follow-up questionnaires. There were statistically significant improvements in 6 of 7 health indicators (including HbA1c) and in 7 of 7 behaviors. For each of the 5 conditions, there were significant improvements among those with the condition (effect sizes 0.59–1.1). A total of 662 (75.0%) of study participants improved at least 0.4 effect size in at least one criterion, and 327 (37.1%) improved in 2 or more. Conclusions The Diabetes Self-Management Program, offered in two modes, was successfully disseminated to a heterogeneous national population of members of either insured or administered health plans. Participants had small but significant benefits in multiple

  10. Posttraumatic stress disorder following traumatic injury at 6 months: associations with alcohol use and depression.

    PubMed

    Warren, Ann Marie; Foreman, Michael L; Bennett, Monica M; Petrey, Laura B; Reynolds, Megan; Patel, Sarita; Roden-Foreman, Kenleigh

    2014-02-01

    Posttraumatic stress disorder (PTSD) is progressively recognized as a psychological morbidity in injured patients. Participants in a longitudinal study were identified as PTSD positive or PTSD negative at 6 months following injury. Risky alcohol use, depression, demographic, and injury-related variables were explored. This prospective cohort included patients 18 years or older, admitted to our Level I trauma center. Outcome measures included PTSD Checklist-Civilian Version (PCL-C), Alcohol Use Disorders Identification Test (AUDIT-C), and Patient Health Questionnaire (PHQ-8). Demographic and injury variables were collected. A total of 211 participants enrolled in the study, and 118 participants completed measures at both baseline and 6 months. Of the participants, 25.4% (n = 30) screened positive for PTSD at 6 months. The entire sample showed a decline in risky alcohol use at 6 months (p = 0.0043). All PTSD-positive participants at 6 months were also positive for depression (p < 0.0001). For the entire sample, there was a 10% increase in depression from baseline to 6 months (p = 0.03). However, for those participants who were PTSD positive at 6 months, there was a 53% increase in depression from baseline (p = 0.0002) as compared with the group at 6 months without PTSD. Statistically significant differences were found between PTSD-positive and PTSD-negative participants regarding age (40.1 [15.9] vs. 50.9 [18.2], p = 0.0047), male (77% vs. 50%, p = 0.0109), penetrating injury (30% vs. 4%, p < 0.0001), PTSD history (17% vs. 4%, p = 0.0246), or other psychiatric condition (63% vs. 19%, p ≤ 0.001). PTSD was not associated with risky alcohol use at 6 months. Surprisingly, risky alcohol use declined in both groups. Incidence of PTSD (25.4%, n = 30) and risky alcohol use (25%, n = 29) were equal at 6 months. Although the American College of Surgeons' Committee on Trauma requires brief screening and intervention for risky alcohol use owing to societal impact, reinjury

  11. Low-dose B vitamins supplementation ameliorates cardiovascular risk: a double-blind randomized controlled trial in healthy Chinese elderly.

    PubMed

    Wang, Linlin; Li, Hongtian; Zhou, Yuan; Jin, Lei; Liu, Jianmeng

    2015-04-01

    We investigated whether daily supplementation with low-dose B vitamins in the healthy elderly population improves the Framingham risk score (FRS), a predictor of cardiovascular disease risk. Between 2007 and 2012, a double-blind randomized controlled trial was conducted in a rural area of North China. In all, 390 healthy participants aged 60-74 were randomly allocated to receive daily vitamin C (50 mg; control group) or vitamin C plus B vitamins (400 µg folic acid, 2 mg B6, and 10 µg B12; treatment group) for 12 months. FRSs were calculated for all 390 subjects. Folate and vitamin B12 plasma concentrations in the treatment group increased by 253 and 80%, respectively, after 6 months, stopped increasing with continued supplementation after 12 months and returned to baseline levels 6 months after supplementation cessation. Compared with the control group, there was no significant effect of B vitamin supplementation on FRSs after 6 months (mean difference -0.38; 95% CI -1.06, 0.31; p = 0.279), whereas a significant effect of supplementation was evident after 12 months (reduced magnitude 7.6%; -0.77; 95% CI -1.47, -0.06; p = 0.033). However, this reduction disappeared 6 months after supplementation stopped (-0.07; 95% CI -0.80, 0.66; p = 0.855). The reduction in FRS 12 months after supplementation was more pronounced in individuals with a folate deficiency (10.4%; -1.30; 95% CI -2.54, -0.07; p = 0.039) than in those without (4.1%; -0.38; 95% CI -1.12, 0.36; p = 0.313). B vitamins increased high-density lipoprotein cholesterol by 3.4% after 6 months (0.04; 95% CI -0.02, 0.10; p = 0.155) and by 9.2% after 12 months (0.11; 95 % CI 0.04, 0.18; p = 0.003). Compared with the control group, this change in magnitude decreased to 3.3% (0.04; 95 % CI -0.02, 0.10; p = 0.194) 6 months after supplementation cessation. Daily supplementation with a low-dose of B vitamins for 12 months reduced FRS, particularly in healthy elderly subjects with a folate deficiency. These reduced

  12. Physical complaints, medical service use, and social and employment changes following mild traumatic brain injury: a 6-month longitudinal study.

    PubMed

    Kraus, Jess; Schaffer, Kathryn; Ayers, Kathi; Stenehjem, Jerome; Shen, Haikang; Afifi, A A

    2005-01-01

    Using a prospective, dual-cohort study design in which selected preinjury factors were controlled, we present outcomes of 235 patients in a case cohort and 235 patients in a comparison cohort following emergency-department-diagnosed mild traumatic brain injury (MTBI). Symptoms, medical services use, and social and employment concerns were evaluated 6 months after the injury. After adjusting for preinjury characteristics, headaches, dizziness, vision difficulties, memory or learning problems, and alcohol intolerance were found to occur significantly more often in the MTBI cohort than in the comparison cohort. Problems sleeping, use of prescribed medications, and changes in employment were less likely in the MTBI cohort. Although MTBI is not life threatening, our findings suggest that 6 months after injury persons still have related health problems that require routine medical management.

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

    PubMed

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

    2013-07-01

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

  14. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis.

    PubMed

    Llufriu, Sara; Sepúlveda, María; 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

    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. 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 1-2×10(6) 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. 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. Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266.

  15. 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

  16. 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

  17. Exercise training and habitual physical activity: a randomized controlled trial.

    PubMed

    Swift, Damon L; Johannsen, Neil M; Tudor-Locke, Catrine; Earnest, Conrad P; Johnson, William D; Blair, Steven N; Sénéchal, Martin; Church, Timothy S

    2012-12-01

    Exercise training reduces adiposity and risk of cardiovascular disease. However, the combined effects of habitual free-living physical activity and aerobic training on waist circumference, weight, fitness, and blood pressure in postmenopausal women are unknown. To evaluate the effects of habitual physical activity levels during aerobic training on weight, waist circumference, fitness, and blood pressure. Secondary analysis of an RCT. Original data collected April 2001 to June 2005 and analyzed in 2012. Postmenopausal women in a supervised exercise trial. Women (n=325) were randomized to 4, 8, or 12 kcal/kg per week of aerobic training or a control group for 6 months. All outcome measures were collected at baseline and follow-up. Changes in dependent variables within each training group were evaluated across tertiles of pedometer-determined habitual physical activity outside exercise training sessions. Changes in waist circumference and weight. Reductions in waist circumference were significantly greater with higher steps/day accumulated outside exercise training compared to lower levels in the 4 (high: -4.8 cm vs low: -1.4 cm, p=0.03); 8 (high: -4.2 cm vs low: -0.4 cm, p=0.03), and 12 kcal/kg per week groups (high: -4.1 cm vs low: -0.7 cm, p=0.05). For all groups, p-trend≤0.03. A trend was observed for greater weight reduction with higher steps/day in the 4 kcal/kg per week group (p-trend=0.04) but not for the other exercise doses. No effects were observed for blood pressure or fitness measures (all p>0.05). In postmenopausal women, higher habitual physical activity while participating in aerobic training was associated with greater reductions in central adiposity, and was supportive of weight loss compared to lower levels. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  18. Low maternal sensitivity at 6 months of age predicts higher BMI in 48 month old girls but not boys.

    PubMed

    Wendland, Barbara E; Atkinson, Leslie; Steiner, Meir; Fleming, Alison S; Pencharz, Paul; Moss, Ellen; Gaudreau, Hélène; Silveira, Patricia P; Arenovich, Tamara; Matthews, Stephen G; Meaney, Michael J; Levitan, Robert D

    2014-11-01

    Large population-based studies suggest that systematic measures of maternal sensitivity predict later risk for overweight and obesity. More work is needed to establish the developmental timing and potential moderators of this association. The current study examined the association between maternal sensitivity at 6 months of age and BMI z score measures at 48 months of age, and whether sex moderated this association. Longitudinal Canadian cohort of children from birth (the MAVAN project). This analysis was based on a dataset of 223 children (115 boys, 108 girls) who had structured assessments of maternal sensitivity at 6 months of age and 48-month BMI data available. Mother-child interactions were videotaped and systematically scored using the Maternal Behaviour Q-Sort (MBQS)-25 items, a standardized measure of maternal sensitivity. Linear mixed-effects models and logistic regression examined whether MBQS scores at 6 months predicted BMI at 48 months, controlling for other covariates. After controlling for weight-relevant covariates, there was a significant sex by MBQS interaction (P=0.015) in predicting 48 month BMI z. Further analysis revealed a strong negative association between MBQS scores and BMI in girls (P=0.01) but not boys (P=0.72). Logistic regression confirmed that in girls only, low maternal sensitivity was associated with the higher BMI categories as defined by the WHO (i.e. "at risk for overweight" or above). A significant association between low maternal sensitivity at 6 months of age and high body mass indices was found in girls but not boys at 48 months of age. These data suggest for the first time that the link between low maternal sensitivity and early BMI z may differ between boys and girls. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. Internet-Based Brief Intervention to Prevent Unhealthy Alcohol Use among Young Men: A Randomized Controlled Trial

    PubMed Central

    Bertholet, Nicolas; Cunningham, John A.; Faouzi, Mohamed; Gaume, Jacques; Gmel, Gerhard; Burnand, Bernard; Daeppen, Jean-Bernard

    2015-01-01

    Introduction Alcohol use is one of the leading modifiable morbidity and mortality risk factors among young adults. Study Design 2 parallel-group randomized controlled trial with follow-up at 1 and 6 months. Setting/Participants Internet based study in a general population sample of young men with low-risk drinking, recruited between June 2012 and February 2013. Intervention: Internet-based brief alcohol primary prevention intervention (IBI). The IBI aims at preventing an increase in alcohol use: it consists of normative feedback, feedback on consequences, calorific value alcohol, computed blood alcohol concentration, indication that the reported alcohol use is associated with no or limited risks for health. Intervention group participants received the IBI. Control group (CG) participants completed only an assessment. Main Outcome Measures Alcohol use (number of drinks per week), binge drinking prevalence. Analyses were conducted in 2014–2015. Results Of 4365 men invited to participate, 1633 did so; 896 reported low-risk drinking and were randomized (IBI: n = 451; CG: n = 445). At baseline, 1 and 6 months, the mean (SD) number of drinks/week was 2.4(2.2), 2.3(2.6), 2.5(3.0) for IBI, and 2.4(2.3), 2.8(3.7), 2.7(3.9) for CG. Binge drinking, absent at baseline, was reported by 14.4% (IBI) and 19.0% (CG) at 1 month and by 13.3% (IBI) and 13.0% (CG) at 6 months. At 1 month, beneficial intervention effects were observed on the number of drinks/week (p = 0.05). No significant differences were observed at 6 months. Conclusion We found protective short term effects of a primary prevention IBI. Trial Registration Controlled-Trials.com ISRCTN55991918 PMID:26642329

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

    PubMed

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

    2010-10-01

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

  3. Movement skills and physical activity in obese children: randomized controlled trial.

    PubMed

    Cliff, Dylan P; Okely, Anthony D; Morgan, Philip J; Steele, Julie R; Jones, Rachel A; Colyvas, Kim; Baur, Louise A

    2011-01-01

    The purpose of this study was to evaluate the Hunter Illawarra Kids Challenge Using Parent Support physical activity program in overweight children. A multisite randomized controlled trial was conducted with three intervention arms: 1) child-centered physical activity skill development program (Activity), 2) parent-centered dietary modification program (DIET), or 3) both programs combined (PA+DIET). Movement skill proficiency, perceived athletic competence, accelerometer-assessed physical activity, and parent-reported time spent in screen behaviors were assessed at baseline, 6 months, and 12 months in 165 prepubertal children aged 5.5-9 yr (59% girls, 78% obese). Differences in changes in outcomes between groups were assessed using linear mixed models. Compared with the diet group, the activity group (mean (95% confidence interval): +7.7 units (3.8-11.6 units)) and the activity + diet group (+6.7 units (2.9-10.5 units)) displayed 11%-13% greater improvement in overall movement skill proficiency (gross motor quotient) at 6 months. Perceived athletic competence increased across groups at follow-up (across groups: 6 months = +0.21 units (0.11-0.31 units), 12 months = +0.21 units (0.07-0.35 units)). Groups did not differ statistically for change in physical activity outcomes. Total screen time (min·wk(-1)) decreased in all groups at 6 months (across groups: -385.4 (-501.0 to -269.8)) and in the activity group (-261.8 (-470.5 to -53.1)) and activity + diet group (-340.5 (-534.6 to -146.4)) at 12 months. The diet group reported greater reductions in TV or DVD viewing time at 6 months compared with the activity group (248.6 (24.0-473.3)). The activity and the activity + diet programs were efficacious in improving overweight children's movement skill proficiency. All programs were efficacious in reducing time spent in screen behaviors. Other correlates may need to be targeted in addition to movement skills to increase physical activity among overweight children.

  4. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial.

    PubMed

    Morin, Charles M; Vallières, Annie; Guay, Bernard; Ivers, Hans; Savard, Josée; Mérette, Chantal; Bastien, Célyne; Baillargeon, Lucie

    2009-05-20

    Cognitive behavioral therapy (CBT) and hypnotic medications are efficacious for short-term treatment of insomnia, but few patients achieve complete remission with any single treatment. It is unclear whether combined or maintenance therapies would enhance outcome. To evaluate the added value of medication over CBT alone for acute treatment of insomnia and the effects of maintenance therapies on long-term outcome. Prospective, randomized controlled trial involving 2-stage therapy for 160 adults with persistent insomnia treated at a university hospital sleep center in Canada between January 2002 and April 2005. Participants received CBT alone or CBT plus 10 mg/d (taken at bedtime) of zolpidem for an initial 6-week therapy, followed by extended 6-month therapy. Patients initially treated with CBT attended monthly maintenance CBT for 6 months or received no additional treatment and those initially treated with combined therapy (CBT plus 10 mg/d of zolpidem) continued with CBT plus intermittent use of zolpidem or CBT only. Sleep onset latency, time awake after sleep onset, total sleep time, and sleep efficiency derived from daily diaries (primary outcomes); treatment response and remission rates derived from the Insomnia Severity Index (secondary outcomes). Cognitive behavioral therapy used singly or in combination with zolpidem produced significant improvements in sleep latency, time awake after sleep onset, and sleep efficiency during initial therapy (all P<.001); a larger increase of sleep time was obtained with the combined approach (P = .04). Both CBT alone and CBT plus zolpidem produced similar rates of treatment responders (60% [45/75] vs 61% [45/74], respectively; P = .84) and treatment remissions (39% [29/75] vs 44% [33/74], respectively; P = .52) with the 6-week acute treatment, but combined therapy produced a higher remission rate compared with CBT alone during the 6-month extended therapy phase and the 6-month follow-up period (56% [43/74 and 32/59] vs 43

  5. Recent randomized controlled trials in otolaryngology.

    PubMed

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

    2015-03-01

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

  6. A randomized-controlled trial of low-dose doxycycline for periodontitis in smokers

    PubMed Central

    Needleman, Ian; Suvan, Jean; Gilthorpe, Mark S.; Tucker, Richard; St George, Geoff; Giannobile, William; Tonetti, Maurizio; Jarvis, Martin

    2008-01-01

    Background/Aim Tobacco use reduces the effect of non-surgical periodontal therapy. Host-modulation with low-dose doxycycline (LDD) might favour repair and promote an improved treatment response. The aim of this study was to investigate the effect of LDD in smokers on non-surgical periodontal therapy. Material and Methods This was a parallel arm, randomized, identical placebo-controlled trial with masking of examiner, care-giver, participant and statistician and 6 months of follow-up. Patients received non-surgical therapy and 3 months of test or control drug. Statistical analysis used both conventional methods and multilevel modelling. Results Eighteen control and 16 test patients completed the study. The velocity of change was statistically greater for the test group for clinical attachment level −0.19 mm/month (95% CI= −0.34, 0.04; p=0.012) and probing depth 0.30 mm/month (95% CI= −0.42, −0.17; p < 0.001). However, no differences were observed for absolute change in clinical or biochemical markers at 6 months. Conclusions This study does not provide evidence of a benefit of using LDD as an adjunct to non-surgical periodontal therapy in smokers. PMID:17324155

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

    PubMed

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

    2013-07-01

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

  8. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial.

    PubMed

    Lois, Noemi; Burr, Jennifer; Norrie, John; Vale, Luke; Cook, Jonathan; McDonald, Alison; Boachie, Charles; Ternent, Laura; McPherson, Gladys

    2011-03-01

    To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH). This was a pragmatic multicenter randomized controlled trial. Eligible participants from nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs. Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (mean difference, 4.8; 95% confidence interval [CI], -0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64-14.73; P < 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05-0.34; P < 0.001). Peeling the ILM is likely to be cost effective. There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.).

  9. The prevention of depressive symptoms in rural school children: a randomized controlled trial.

    PubMed

    Roberts, Clare; Kane, Robert; Thomson, Helen; Bishop, Brian; Hart, Bret

    2003-06-01

    A controlled trial was conducted to evaluate a prevention program aimed at reducing depressive and anxious symptoms in rural school children. Seventh-grade children with elevated depression were selected. Nine primary schools (n = 90) were randomly assigned to receive the program, and 9 control schools (n = 99) received their usual health education classes. Children completed questionnaires on depression, anxiety, explanatory style, and social skills. Parents completed the Child Behavior Checklist (T. M. Achenbach, 1991). No intervention effects were found for depression. Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention. Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only.

  10. Expressive timing in infant-directed singing between 3 and 6 months.

    PubMed

    Delavenne, Anne; Gratier, Maya; Devouche, Emmanuel

    2013-02-01

    This longitudinal study compared the temporal characteristics of maternal singing at 3 and then at 6 months. Infant-directed (ID) singing is claimed to have different functions in preverbal communication. However few studies have focused on the specific characteristics of ID singing that change across the first months of life. We aimed to explore these changes between 3 and 6 months because musical routines become prominent in the repertoire of games parents and infants spontaneously play during a period referred to as 'the period of games'. We focused specifically on expressive timing because it reflects how mothers dynamically adapt their singing to their infant's states of attention and involvement. We aimed to determine whether the expressive timing cues of maternal singing would be different at 3 and then at 6 months. To this end, the interactions of 18 mother-infant dyads were recorded while mothers were singing a popular French playsong for their infant at 3 and then at 6 months. Acoustic analyses revealed that mothers showed final-lengthening and tempo slowing for both age groups, but marked the ends of the hierarchical structural units of the song more saliently with their 6-month-olds. Unexpectedly, infant sex was also found to affect maternal singing: more exaggerated phrase-lengthening patterns were observed in singing to girls. Copyright © 2012 Elsevier Inc. All rights reserved.

  11. Impact of Maternal Selenium Status on Infant Outcome during the First 6 Months of Life

    PubMed Central

    Varsi, Kristin; Bolann, Bjørn; Torsvik, Ingrid; Rosvold Eik, Tina Constanse; Høl, Paul Johan; Bjørke-Monsen, Anne-Lise

    2017-01-01

    Pregnant women and infants are at risk for selenium deficiency, which is known to have negative effects on immune and brain function. We have investigated selenium levels in 158 healthy never-pregnant women and in 114 pregnant and lactating women and their infants at age 6 months and related this to clinical outcomes during the first 6 months of life. Neurodevelopment was assessed with the parental questionnaire Ages and Stages (ASQ) at 6 months. A maternal selenium level ≤0.90 µmol/L in pregnancy week 18 was negatively related to infant neurodevelopment at 6 months (B = −20, p = 0.01), whereas a selenium level ≤0.78 µmol/L in pregnancy week 36 was associated with an increased risk (odds ratio 4.8) of having an infant infection during the first 6 weeks of life. A low maternal selenium status in pregnancy was found to be associated with an increased risk of infant infection during the first 6 weeks of life and a lower psychomotor score at 6 months. We suggest a cutoff for maternal serum selenium deficiency of 0.90 µmol/L in pregnancy week 18 and 0.78 µmol/L in pregnancy week 36. This should be reevaluated in an intervention study. PMID:28492511

  12. Eye Movement Patterns for Novice Teen Drivers Does 6 Months of Driving Experience Make a Difference?

    PubMed Central

    Olsen, Erik C. B.; Lee, Suzanne E.; Simons-Morton, Bruce G.

    2009-01-01

    Attention to the road is essential to safe driving, but the development of appropriate eye glance scanning behaviors may require substantial driving experience. Novice teen drivers may focus almost exclusively on the road ahead rather than scanning the mirrors, and when performing secondary tasks, they may spend more time with eyes on the task than on the road. This paper examines the extent to which the scanning of novice teens improves with experience. For this study, 18 novice teen (younger than 17.5 years old) and 18 experienced adult drivers performed a set of in-vehicle tasks and a baseline driving segment on a test track, the teens within 4 weeks of licensure and then again 6 months later. This paper addresses the following questions: Did teen eye glance performance improve from initial assessment? Did teens and adults still differ after 6 months? Results for some tasks showed that rearview and left mirror–window (LM-W) glances improved for teens from initial testing to the 6-month follow-up and that some differences between teens and adults at initial testing were no longer significant at the 6-month follow-up, suggesting significant learning effects. The frequency of rearview and LM-W glances during secondary tasks improved among teens at the 6-month follow-up, but teens still had significantly fewer glances to mirrors than did adults when engaged in a secondary task. PMID:19763225

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

    PubMed

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

    2015-03-01

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

  14. Effects of 1- and 6-month spaceflight on bone mass and biochemistry in two humans.

    PubMed

    Collet, P; Uebelhart, D; Vico, L; Moro, L; Hartmann, D; Roth, M; Alexandre, C

    1997-06-01

    The bone mineral density and the biochemical parameters exploring bone cell activities were analyzed in two cosmonauts who spent 1 and 6 months, respectively, in the Russian MIR station. Measurements were performed before the flight, after the flight, and after a recovery period. At the end of the first month, peripheral QCT measurements indicated a slight decrease of trabecular bone mass in the distal tibial metaphysis. However, after 6 months of spaceflight, a more marked loss of trabecular and cortical bones was observed in the tibia, and was still significant after 6 month recovery in the trabecular compartment, whereas a decrease was no longer observed in the cortical envelope. No change was observed in either compartment of the distal radius at any time. Ultrasound BUA of the calcaneus was greatly reduced by the first month, followed by a more dramatic decrease after month 6. Ultrasound SOS detected no change. Parameters reflecting bone formation activity appeared to be depressed after both missions. In contrast, no dramatic change in resorption parameters was observed, except for a trend toward an increase in pyridinoline. In conclusion, the lower weight-bearing bones appeared more sensitive than the upper ones in terms of spaceflight-induced bone loss. This probably explained the absence of marked systemic biochemical data changes. This study further suggests that recovery in the tibial trabecular compartment 6 months after landing was not completed after a 6 month mission.

  15. Ameliorating Patient Stigma Amongst Staff Working With Personality Disorder: Randomized Controlled Trial of Self-Management Versus Skills Training.

    PubMed

    Clarke, Sue; Taylor, Georgina; Bolderston, Helen; Lancaster, Joanna; Remington, Bob

    2015-11-01

    Patients diagnosed with a personality disorder (PD) are often stigmatized by the healthcare staff who treat them. This study aimed to compare the impact on front-line staff of a self-management Acceptance and Commitment Therapy-based training intervention (ACTr) with a knowledge- and skills-based Dialectical Behaviour Training intervention (DBTr). A service-based randomized controlled trial was conducted comparing the effects of 2-day ACTr (N = 53) and DBTr (N = 47) staff workshops over 6 months. Primary outcome measures were staff attitudes towards patients and staff-patient relationships. For both interventions, staff attitudes, therapeutic relationship, and social distancing all improved pre- to postintervention, and these changes were maintained at 6-month follow-up. Although offering different resources to staff, both ACTr and DBTr were associated with an improved disposition towards PD patients. Future research could evaluate a combined approach, both for staff working with PD patients and those working with other stigmatized groups.

  16. Spatio-temporal tuning of coherent motion evoked responses in 4-6 month old infants and adults

    PubMed Central

    Hou, C.; Gilmore, R.O.; Pettet, M.W.; Norcia, A.M.

    2013-01-01

    Motion cues provide a rich source of information about translations of the observer through the environment as well as the movements of objects and surfaces. While the direction of motion can be extracted locally these local measurements are, in general, insufficient for determining object and surface motions. To study the development of local and global motion processing mechanisms, we recorded Visual Evoked Potentials (VEPs) in response to dynamic random dot displays that alternated between coherent rotational motion and random motion at 0.8 Hz. We compared the spatio-temporal tuning of the evoked response in 4-6 month old infants to that of adults by recording over a range of dot displacements and temporal update rates. Responses recorded at the frequency of the coherent motion modulation were tuned for displacement at the occipital midline in both adults in infants. Responses at lateral electrodes were tuned for speed in adults, but not in infants. Infant responses were maximal at a larger range of spatial displacement than that of adults. In contrast, responses recorded at the dot update rate showed a more similar parametric displacement tuning and scalp topography in infants and adults. Taken together, our results suggest that while local motion processing is relatively mature at 4-6 months, global integration mechanisms exhibit significant immaturities at this age. PMID:19679146

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

    PubMed Central

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

    2006-01-01

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

  18. Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial.

    PubMed

    Gordon, Glenn L; Zakko, Salam; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ronald; Barrett, Andrew C; Bortey, Enoch; Paterson, Craig; Forbes, William P; Lichtenstein, Gary R

    2016-04-01

    To evaluate the efficacy and safety of mesalamine granules 1.5 g once daily for maintenance of ulcerative colitis (UC) remission. Mesalamine is a first-line treatment for induction and maintenance of UC remission. A phase 3, randomized, double-blind, placebo-controlled trial of patients with a history of mild to moderate UC, currently in remission, who received mesalamine granules once daily for 6 months. The primary efficacy endpoint was percentage of patients maintaining UC remission at 6 months. A significantly greater percentage of patients receiving mesalamine granules versus placebo were in remission at 6 months (79.9% vs. 66.7%; P=0.03). A greater percentage of patients receiving mesalamine granules maintained a revised Sutherland Disease Activity Index (SDAI)≤2 with no individual component of revised SDAI>1 and rectal bleeding=0 at 6 months (72.0% vs. 58.1%; P=0.04). No significant differences between groups were observed for change from baseline to 6 months for total SDAI score or its components (ie, stool frequency, rectal bleeding, mucosal appearance, physician's rating of disease). Mesalamine granules treatment resulted in a significantly longer remission duration versus placebo (P=0.02) and decreased patients' risk of relapse by 43% (hazard ratio=0.57; 95% confidence interval, 0.35-0.93; P=0.02). Mesalamine granules were well tolerated, and adverse events related to hepatic, renal, and pancreatic function-potential concerns with long-term treatment-occurred at a rate similar to placebo. Once-daily mesalamine granules are efficacious and safe for the maintenance of UC remission.

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2013-01-01

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

  1. Does vitamin A supplementation protect schoolchildren from acquiring soil-transmitted helminthiasis? A randomized controlled trial.

    PubMed

    Al-Mekhlafi, Hesham M; Anuar, Tengku Shahrul; Al-Zabedi, Ebtesam M; Al-Maktari, Mohamed T; Mahdy, Mohammed A K; Ahmed, Abdulhamid; Sallam, Atiya A; Abdullah, Wan Ariffin; Moktar, Norhayati; Surin, Johari

    2014-08-15

    Despite the intensive global efforts to control intestinal parasitic infections, the prevalence of soil-transmitted helminth (STH) infections is still very high in many developing countries particularly among children in rural areas. A randomized, double-blind, placebo-controlled trial was conducted on 250 Aboriginal schoolchildren in Malaysia to investigate the effects of a single high-dose of vitamin A supplementation (200,000 IU) on STH reinfection. The effect of the supplement was assessed at 3 and 6 months after receiving interventions; after a complete 3-day deworming course of 400 mg/daily of albendazole tablets. Almost all children (98.6%) were infected with at least one STH species. The overall prevalence of ascariasis, trichuriasis and hookworm infection was 67.8%, 95.5% and 13.4%, respectively. Reinfection rates of Ascaris, Trichuris and hookworm were high; at 6 months, assessment reached 80% of the prevalence reported before treatment. There were no significant differences in the reinfection rates and intensities of STH between vitamin A supplemented-children and those who received placebo at 3 and 6 months (p > 0.05). Vitamin A supplementation showed no protective effect against STH reinfection and this could be due to the high endemicity of STH in this community. Long-term interventions to reduce poverty will help significantly in reducing this continuing problem and there is no doubt that reducing intestinal parasitic infection would have a positive impact on the health, nutrition and education of these children. This trial was registered at clinicaltrials.gov as NCT00936091.

  2. Progression of brain atrophy in PSP and CBS over 6 months and 1 year.

    PubMed

    Dutt, Shubir; Binney, Richard J; Heuer, Hilary W; Luong, Phi; Attygalle, Suneth; Bhatt, Priyanka; Marx, Gabe A; Elofson, Jonathan; Tartaglia, Maria C; Litvan, Irene; McGinnis, Scott M; Dickerson, Bradford C; Kornak, John; Waltzman, Dana; Voltarelli, Lisa; Schuff, Norbert; Rabinovici, Gil D; Kramer, Joel H; Jack, Clifford R; Miller, Bruce L; Rosen, Howard J; Boxer, Adam L

    2016-11-08

    To examine the utility and reliability of volumetric MRI in measuring disease progression in the 4 repeat tauopathies, progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS), to support clinical development of new tau-directed therapeutic agents. Six- and 12-month changes in regional MRI volumes and PSP Rating Scale scores were examined in 55 patients with PSP and 33 patients with CBS (78% amyloid PET negative) compared to 30 normal controls from a multicenter natural history study. Longitudinal voxel-based morphometric analyses identified patterns of volume loss, and region-of-interest analyses examined rates of volume loss in brainstem (midbrain, pons, superior cerebellar peduncle), cortical, and subcortical regions based on previously validated atlases. Results were compared to those in a replication cohort of 226 patients with PSP with MRI data from the AL-108-231 clinical trial. Patients with CBS exhibited greater baseline atrophy and greater longitudinal atrophy rates in cortical and basal ganglia regions than patients with PSP; however, midbrain and pontine atrophy rates were similar. Voxel-wise analyses showed distinct patterns of regional longitudinal atrophy in each group as compared to normal controls. The midbrain/pons volumetric ratio differed between diagnoses but remained stable over time. In both patient groups, brainstem atrophy rates were correlated with disease progression measured using the PSP Rating Scale. Volume loss is quantifiable over a period of 6 months in CBS and PSP. Future clinical trials may be able to combine CBS and PSP to measure therapeutic effects. © 2016 American Academy of Neurology.

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

    PubMed

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

    2009-12-01

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

  4. Infant and maternal behaviors regulate infant reactivity to novelty at 6 months.

    PubMed

    Crockenberg, Susan C; Leerkes, Esther M

    2004-11-01

    Three issues were investigated: (a) the regulatory effects of presumed infant and maternal regulation behaviors on infant distress to novelty at 6 months, (b) stability of infant regulatory effects across contexts that vary in maternal involvement, and (c) associations and temporal dynamics between infant and maternal regulation behaviors. Participants were 87 low-risk infants and their mothers, observed at 6 months postpartum during infant exposure to novel toys. Contingencies derived from sequential analyses demonstrate that, by 6 months, some infants reduce their own distress to novelty by looking away from the novel toy or self-soothing, maternal engagement and support have comparable effects, and certain infant and maternal behaviors co-occur. Moreover, infants whose mothers engaged contingently when they looked away from the novel toy expressed less distress than comparable infants whose mothers did not. These findings implicate both infants and mothers in the development of emotion regulation during the infant's first year. (c) 2004 APA, all rights reserved

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

    PubMed

    Moscardino, Ughetta; Axia, Giovanna

    2006-01-01

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

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

    PubMed

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

    2017-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2013-05-01

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

  9. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.

    PubMed

    Eadie, Jennifer; van de Water, Alexander T; Lonsdale, Chris; Tully, Mark A; van Mechelen, Willem; Boreham, Colin A; Daly, Leslie; McDonough, Suzanne M; Hurley, Deirdre A

    2013-11-01

    To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. Outpatient physiotherapy department in an academic teaching hospital. Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation. Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise). Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5). The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. 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

  11. Efficacy of the epilepsy nurse: Results of a randomized controlled study.

    PubMed

    Pfäfflin, Margarete; Schmitz, Bettina; May, Theodor W

    2016-07-01

    We investigated the efficacy of epilepsy nurses on satisfaction with counseling about epilepsy in a randomized, controlled, prospective trial. Patients with epilepsy treated by neurologists in outpatient clinics were consecutively enrolled and randomly allocated to either the epilepsy nurse (EN) group (n = 92) or the control group (n = 95). Patients in the EN group were advised according to their needs by epilepsy nurses. The control group received routine care without additional counseling. The EN group completed the questionnaires before the first consultation (T1) and 6 months later (T2); the control group completed the questionnaires twice with an interval of 6 months. Primary outcome measure was satisfaction of patients with information and