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###24491034

BACKGROUND The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .

BACKGROUND This paper describes the design and evaluation of Positive Outlook , an online program aiming to enhance the self-management skills of gay men living with HIV .

METHODS This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group .

METHODS The intervention group will participate in the online group program ` Positive Outlook ' .

METHODS The program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with HIV in daily life .

METHODS Participants will access the program for a minimum of 90 minutes per week over seven weeks .

METHODS Primary outcomes are domain specific self-efficacy , HIV related quality of life , and outcomes of health education .

METHODS Secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support .

METHODS Data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at 12 week follow-up .

CONCLUSIONS Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV .

BACKGROUND ACTRN12612000642886 .

###20497432

BACKGROUND The aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy .

METHODS A total of 29 patients suffering from thyroid ophthalmopathy were included in this study .

METHODS Patients were randomized into two groups : group I included 15 patients treated with oral prednisolone and group II included 14 patients treated with peribulbar triamcinolone orbital injection .

METHODS Only 12 patients in both groups ( 16 female and 8 male ) completed the study .

RESULTS Both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases .

RESULTS Mean exophthalmometry value before treatment was 22.6 1.98 mm that decreased to 18.6 0.996 mm in group I , compared with 23 1.86 mm that decreased to 19.08 1.16 mm in group II .

RESULTS Mean initial clinical activity score was 4.75 1.2 and 5 1.3 for group I and group II before treatment , respectively , which dropped to 0.83 1.2 and 0.83 1.02 , 6 months after treatment , respectively .

RESULTS There was no change in the best-corrected visual acuity in both groups .

RESULTS There was an increase in body weight , blood sugar , blood pressure and gastritis in group I in 66.7 % , 33.3 % , 50 % and 75 % , respectively , compared with 0 % , 0 % , 8.3 % and 8.3 % in group II .

RESULTS No adverse local side effects were observed in group II .

CONCLUSIONS Orbital steroid injection for thyroid-related ophthalmopathy is effective and safe .

CONCLUSIONS It eliminates the adverse reactions associated with oral corticosteroid use .

###19062107

OBJECTIVE The aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy .

METHODS Families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = 116 ; 58 families in each group ) .

METHODS The intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure .

METHODS The level of postoperative pain and nausea was scored in the postanesthesia care unit ( PACU ) during the first postoperative hour , as well as at 2 , 4 , 8 and 24h postoperatively .

METHODS The first scoring in PACU was performed by the attending nurse with a 0-10 scale .

METHODS The rest of the estimations were made independently and simultaneously by the children using a VAS scale , and by the parents using a 0-10 scale .

RESULTS The children in the control group were in more pain in the PACU than the children in the intervention group , and the difference between the groups was statistically significant ( p = 0.0002 ) .

RESULTS All pain scores , according to the children and the parents , increased after the surgery .

RESULTS In both groups the highest score values were found at home 8h after surgery , and no significant difference was found between the study groups .

RESULTS On the first postoperative morning , the children in the control group were in pain ( p = 0.047 ) .

RESULTS The children did not have significant nausea in the PACU , but the nausea increased postoperatively .

RESULTS Four hours after surgery the children were most nauseous according to all estimations ( 60 % , n = 116 ) .

RESULTS More than half of the children vomited and most vomited clotted blood .

RESULTS Nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood .

RESULTS The incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant .

RESULTS However , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting .

CONCLUSIONS The preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting .

###19769482

OBJECTIVE To explore the effects of GengNianLe ( GNL , also called perimenopausal depression relieving formula ) , a defined formula of Chinese medicinal herbs in relieving perimenopausal depression in Chinese women .

METHODS Between September 2004 and April 2008 , 47 Chinese women were randomized into a GNL group ( n = 21 ) and a control group which received tibolone ( n = 26 ) using a randomization chart .

METHODS Depression was rated with the 24-item Hamilton Depression Scale ( HAMD ) .

METHODS The serum levels of follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and estradiol ( E ( 2 ) ) were detected before and after the treatment .

RESULTS After 12 weeks of treatment , HAMD scores in both groups decreased significantly ( p < 0.05 ) with no significant difference between the groups ( p > 0.05 ) .

RESULTS The levels of FSH decreased significantly and the level of E ( 2 ) increased significantly in both groups , and they changed more in the control group .

RESULTS No side-effect of treatment was reported in either group during treatment .

CONCLUSIONS The Chinese medicinal formula GNL showed promise in relieving perimenopausal depression and merits further study .

###26077436

BACKGROUND Topical formulations of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption .

BACKGROUND We conducted randomized , crossover studies that compared the pharmacokinetics ( PK ) , bioequivalence and safety of topical diclofenac sodium 2 % twice daily ( BID ) , diclofenac sodium 1.5 % four times daily ( QID ) and oral diclofenac sodium in healthy subjects .

METHODS The results of three bioequivalence studies are reviewed .

METHODS Healthy adult subjects ( n = 76 ) applied topical diclofenac sodium 2 % solution ( 40.4 mg/2 mL ) BID ; or 1.5 % solution ( 19.3 mg/40 drops ) QID to each knee for 7.5 consecutive days separated by a washout period .

METHODS Subjects ( n = 22 ) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days .

METHODS Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 ( steady state ) , and diclofenac PK parameters were estimated by noncompartmental methods .

RESULTS The studies demonstrated comparable bioequivalence between the 2 % and 1.5 % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately 93 % less ) .

RESULTS Daily systemic exposure was comparable between the two formulations with only a 12 % difference in the AUCss ( 0-24 ) ( p = 0.140 ) .

RESULTS Furthermore , both topical solutions demonstrated delayed elimination with a t ( 1/2 ) of 4 - to 6-fold longer , as compared to oral diclofenac .

RESULTS The 2 % solution provided more consistent dosing relative to the 1.5 % solution when comparing AUCss ( 0-24 ) and Cmaxss across studies .

RESULTS Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac .

CONCLUSIONS The steady-state PK profile of topical diclofenac 2 % solution administered BID is similar to that of the 1.5 % solution administered QID .

CONCLUSIONS Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration .

CONCLUSIONS ( Study 2 was registered with ClinicalTrials.gov ; NCT01202799 ; https://clinicaltrials.gov/ct2/results?term=01202799&Search=Search ) .

###20656965

BACKGROUND No long-term studies have been reported on the effect of training programs on driving after stroke .

OBJECTIVE The authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at 5 years poststroke .

OBJECTIVE A second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving .

METHODS In a previously reported randomized controlled trial , 83 stroke survivors received 15 hours of simulator training ( n = 42 ) or cognitive therapy ( n = 41 ) .

METHODS In this 5-year follow-up study , 61 participants were reassessed .

METHODS Fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; 44 participants ( simulator group , n = 21 ; cognitive group , n = 23 ) completed all assessments .

METHODS The primary outcome measures were fitness-to-drive decision and current driving status .

RESULTS The authors found that 5 years after stroke , 18 of 30 participants ( 60 % ) in the simulator group were considered fit to drive , compared with 15 of 31 ( 48 % ) in the cognitive group ( P = .36 ) ; 34 of 61 ( 56 % ) participants were driving .

RESULTS Current drivers were younger ( P = .04 ) , had higher Barthel scores ( P = .008 ) , had less comorbidity ( P = .01 ) , and were less severely depressed ( P = .02 ) than those who gave up driving .

CONCLUSIONS The advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at 6 months poststroke , had faded 5 years later .

CONCLUSIONS Poststroke drivers were younger and less severely affected and depressed than nondrivers .

###17889242

BACKGROUND The potential of insecticide-treated bednets ( ITNs ) to contribute to child survival has been well documented in randomised controlled trials .

BACKGROUND ITN coverage has increased rapidly in Kenya from 7 % in 2004 to 67 % in 2006 .

BACKGROUND We aimed to assess the extent to which this investment has led to improvements in child survival .

METHODS A dynamic cohort of about 3500 children aged 1-59 months were enumerated three times at yearly intervals in 72 rural clusters located in four districts of Kenya .

METHODS The effect of ITN use on mortality was assessed with Poisson regression to take account of potential effect-modifying and confounding covariates .

RESULTS 100 children died over 2 years .

RESULTS Overall mortality rates were much the same in the first and second years of the study ( 14.5 per 1000 person-years in the first year and 15.4 per 1000 person-years in the second ) .

RESULTS After adjustment for age , time period , and a number of other possible confounding variables , ITN use was associated with a 44 % reduction in mortality ( mortality rate ratio 0.56 , 95 % CI 0.33-0 .96 ; p = 0.04 ) .

RESULTS This level of protection corresponds to about seven deaths averted for every 1000 ITNs distributed .

CONCLUSIONS A combined approach of social marketing followed by mass free distribution of ITNs translated into child survival effects that are comparable with those seen in previous randomised controlled trials .

###23615091

BACKGROUND Cortical stimulation mapping ( CSM ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy .

BACKGROUND Visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping .