To compare the effects of 2 target temperature regimens on long-term cognitive function and quality of life after cardiac arrest .


In this multicenter , international , parallel group , assessor-masked randomized clinical trial performed from November 11 , 2010 , through January 10 , 2013 , we enrolled 950 unconscious adults with cardiac arrest of presumed cardiac cause from 36 intensive care units in Europe and Australia .


Eleven patients were excluded from analysis for a total sample size of 939 .


Targeted temperature management at 33C vs 36C .


Cognitive function was measured by the Mini-Mental State Examination ( MMSE ) and assessed by observers through the Informant Questionnaire on Cognitive Decline in the Elderly ( IQCODE ) .


Patients reported their activities in daily life and mental recovery through Two Simple Questions and their quality of life through the Medical Outcomes Study 36-Item Short Form Health Survey , version 2 .


In the modified intent-to-treat population , including nonsurvivors , the median MMSE score was 14 in the 33C group ( interquartile range [ IQR ] , 0-28 ) vs 17 in the 36C group ( IQR , 0-29 ) ( P = .77 ) , and the IQCODE score was 115 ( IQR , 79-130 ) vs 115 ( IQR , 80-130 ) ( P = .57 ) in the 33C and 36C groups , respectively .


The median MMSE score for survivors was within the reference range and similar ( 33C group median , 28 ; IQR , 26-30 ; vs 36C group median , 28 ; IQR , 25-30 ; P = .61 ) .


The median IQCODE score was within the minor deficit range ( 33C group median , 79.5 ; IQR , 78.0-85 .9 ; vs 36C group median , 80.7 ; IQR , 78.0-86 .9 ; P = .04 ) .


A total of 18.8 % vs 17.5 % of survivors reported needing help with everyday activities ( P = .71 ) , and 66.5 % in the 33C group vs 61.8 % in the 36C group reported that they thought they had made a complete mental recovery ( P = .32 ) .


The mean ( SD ) mental component summary score was 49.1 ( 12.5 ) vs 49.0 ( 12.2 ) ( P = .79 ) , and the mean ( SD ) physical component summary score was 46.8 ( 13.8 ) and 47.5 ( 13.8 ) ( P = .45 ) , comparable to the population norm .


Quality of life was good and similar in patients with cardiac arrest receiving targeted temperature management at 33C or 36C .


Cognitive function was similar in both intervention groups , but many patients and observers reported impairment not detected previously by standard outcome scales .


ClinicalTrials.gov NCT01020916 .


Progression-free survival ( PFS ) is frequently used as an efficacy end point in oncology clinical trials .


However , there is limited evidence to support a positive association between improvement in PFS and improvement in health-related quality of life ( HRQoL ) .


The association between PFS and HRQoL was evaluated in two randomised trials .


Data from two randomised controlled trials in patients with non-small cell lung cancer ( NSCLC ; LUX-Lung 1 and LUX-Lung 3 ) were used to investigate HRQoL in patients to determine whether tumour progression is accompanied by worsening HRQoL .


HRQoL was assessed using the cancer-specific European Organization for Research and Treatment of Cancer ( EORTC ) core questionnaire QLQ-C30 , the EuroQol EQ-5D overall utility and EuroQol EQ visual analogue scale .


In both studies , progression was evaluated by independent review using RECIST criteria ( primary end point ) and also by investigator assessment .


The relationship between tumour progression and HRQoL was evaluated using analysis of covariance and a longitudinal model .


Compliance with HRQoL questionnaire completion was high .


In both studies , patients with progression consistently experienced numerically poorer HRQoL at the time of progression than patients without progression .


Differences in mean scores were statistically significant ( p < 0.05 ) between patients with and without progression at week 4 in all analyses in LUX-Lung 1 and at multiple time points in LUX-Lung 3 .


Results from the longitudinal analysis showed that progression ( by independent review and investigator assessment ) appears to have consistent negative impact on all three HRQoL measures ( all p < 0.0001 ) .


Tumour progression in patients with NSCLC was associated with statistically significant worsening in HRQoL .


These findings confirm the value of PFS as a patient-relevant end point .


Falls are very common , especially in adults aged 65 years and older .


Within the current international European Commission 's Seventh Framework Program ( FP7 ) project ` iStoppFalls ' an Information and Communication Technology ( ICT ) based system has been developed to regularly assess a person 's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention .


The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program , and its effectiveness to improve balance , muscle strength and quality of life in older people .


This international , multicenter study is designed as a single-blinded , two-group randomized controlled trial .


A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany ( n = 60 ) , Spain ( n = 40 ) , and Australia ( n = 60 ) between November 2013 and May 2014 .


Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home .


Participants are encouraged to exercise for a total duration of 180 minutes per week .


The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology .


Educational material about a healthy lifestyle will be provided to each participant .


Final reassessments will be conducted after 16 weeks .


The assessments include physical and cognitive tests as well as questionnaires assessing health , fear of falling , quality of life and psychosocial determinants .


Falls will be followed up for six months by monthly falls calendars .


We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people .


By using the iStoppFalls sensor-based exercise program , older people are expected to improve in balance and strength outcomes .


In addition , the exercise training may have a positive impact on quality of life by reducing the risk of falls .


Taken together with expected cognitive improvements , the individual approach of the iStoppFalls program may provide an effective model for fall prevention in older people who prefer to exercise at home .


Australian New Zealand Clinical Trials Registry Trial ID : ACTRN12614000096651.International Standard Randomised Controlled Trial Number : ISRCTN15932647 .


Polymorphisms of the HLA-DP gene are associated with the natural clearance of the hepatitis B virus in Asian patients .


To investigate the association of HLA-DP polymorphisms with response to peginterferon ( PEG-IFN ) in Caucasian chronic hepatitis B ( CHB ) patients .


We studied 262 Caucasian chronic hepatitis B patients infected with HBV genotype A or D , treated with PEG-IFN for 1 year in two randomised controlled trials ( HBV 99-01 and PARC study ) .


Response was defined as an HBV DNA < 2000 IU/mL at 6 months post-treatment .


Variations at HLA-DPA1 and HLA-DPB1 were genotyped .


Of the 262 patients , 58 % was HBeAg-positive and HBV genotype A and D was observed in 32 % and 68 % , respectively .


At 6 months post-treatment , 57 ( 22 % ) patients had achieved an HBV DNA < 2000 IU/mL .


HLA-DPB1 was independently associated with virological response [ adjusted odds ratio ( OR ) 1.8 , 95 % confidence interval ( CI ) :1.1 -3.0 , P = 0.025 ] , and with an undetectable HBV DNA ( adjusted OR 2.4 95 % CI : 1.2-4 .7 , P = 0.015 ) when adjusted for HBeAg status and other known response modifiers .


In HBeAg-positive patients , combined HBeAg seroconversion with HBV DNA < 2000 IU/mL was increasingly observed with each addition of an HLA-DPB1 G-allele ( adjusted OR 2.7 , 95 % CI : 1.2-5 .9 , P = 0.012 ) .


Furthermore , HLA-DPA1 and HLA-DPB1 haplotype block GG showed comparable results for virological and combined response .


In this large cohort of Caucasian chronic hepatitis B patients infected with HBV genotypes A or D , polymorphisms of HLA-DP are independently associated with both virological and serological response to PEG-IFN therapy at 6 months post-treatment .


It is well documented that childhood abuse , neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults , and that these experiences adversely impact child development and a wide range of adult outcomes .


However , few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness .


This study examines adverse events in childhood as predictors of duration of homelessness , psychiatric and substance use disorders , and physical health in a sample of homeless adults with mental illness .


This study was conducted using baseline data from a randomized controlled trial in Vancouver , British Columbia for participants who completed the Adverse Childhood Experiences ( ACE ) scale at 18 months follow-up ( n = 364 ) .


Primary outcomes included current mental disorders ; substance use including type , frequency and severity ; physical health ; duration of homelessness ; and vocational functioning .


In multivariable regression models , ACE total score independently predicted a range of mental health , physical health , and substance use problems , and marginally predicted duration of homelessness .


Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness .


Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems , particularly substance use problems .


Results are discussed in the context of cumulative adversity and self-trauma theory .


This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374 .


Sensory isolation in a flotation tank is a method known for inducing deep relaxation and subsequent positive health effects for patients suffering from e.g. stress or muscle tensions pains .


Very few studies have investigated this method as a preventive health-care intervention .


The purpose of this study was to evaluate the effects in healthy participants after receiving a series of flotation tank treatment .


Sixty-five participants ( 14 men and 51 women ) who were all part of a cooperative-health project initiated by their individual companies , were randomized to either a wait-list control group or a flotation tank treatment group where they participated in a seven weeks flotation program with a total of twelve flotation sessions .


Questionnaires measuring psychological and physiological variables such as stress and energy , depression and anxiety , optimism , pain , stress , sleep quality , mindfulness , and degree of altered states of consciousness were used .


Data were analysed by two-way mixed MANOVA and repeated measures ANOVA .


Stress , depression , anxiety , and worst pain were significantly decreased whereas optimism and sleep quality significantly increased for the flotation-REST group .


No significant results for the control group were seen .


There was also a significant correlation between mindfulness in daily life and degree of altered states of consciousness during the relaxation in the flotation tank .


It was concluded that flotation-REST has beneficial effects on relatively healthy participants .


Australian New Zealand Clinical Trials Registry : ACTRN12613000483752 .


Levodopa is the most effective therapy for Parkinson 's disease , but chronic treatment is associated with the development of potentially disabling motor complications .


Experimental studies suggest that motor complications are due to non-physiological , intermittent administration of the drug , and can be reduced with continuous delivery .


We aimed to assess efficacy and safety of levodopa-carbidopa intestinal gel delivered continuously through an intrajejunal percutaneous tube .


In our 12-week , randomised , double-blind , double-dummy , double-titration trial , we enrolled adults ( aged 30 years ) with advanced Parkinson 's disease and motor complications at 26 centres in Germany , New Zealand , and the USA .


Eligible participants had jejunal placement of a percutaneous gastrojejunostomy tube , and were then randomly allocated ( 1:1 ) to treatment with immediate-release oral levodopa-carbidopa plus placebo intestinal gel infusion or levodopa-carbidopa intestinal gel infusion plus oral placebo .


Randomisation was stratified by site , with a mixed block size of 2 or 4 .


The primary endpoint was change from baseline to final visit in motor off-time .


We assessed change in motor on-time without troublesome dyskinesia as a prespecified key secondary outcome .


We assessed efficacy in a full-analysis set of participants with data for baseline and at least one post-baseline assessment , and imputed missing data with the last observation carried forward approach .


We assessed safety in randomly allocated patients who underwent the percutaneous gastrojejunostomy procedure .


This study is registered with ClinicalTrials.gov , numbers NCT00660387 and NCT0357994 .


From baseline to 12 weeks in the full-analysis set , mean off-time decreased by 4.04 h ( SE 0.65 ) for 35 patients allocated to the levodopa-carbidopa intestinal gel group compared with a decrease of 2.14 h ( 0.66 ) for 31 patients allocated to immediate-release oral levodopa-carbidopa ( difference -1.91 h [ 95 % CI -3.05 to -0.76 ] ; p = 0.0015 ) .


Mean on-time without troublesome dyskinesia increased by 4.11 h ( SE 0.75 ) in the intestinal gel group and 2.24 h ( 0.76 ) in the immediate-release oral group ( difference 1.86 [ 95 % CI 0.56 to 3.17 ] ; p = 0.0059 ) .


In the safety analyses 35 ( 95 % ) of 37 patients allocated to the levodopa-carbidopa intestinal gel group had adverse events ( five [ 14 % ] serious ) , as did 34 ( 100 % ) of 34 patients allocated to the immediate-release oral levodopa-carbidopa group ( seven [ 21 % ] serious ) , mainly associated with the percutaneous gastrojejunostomy tube .


Continuous delivery of levodopa-carbidopa with an intestinal gel offers a promising option for control of advanced Parkinson 's disease with motor complications .


Benefits noted with intestinal gel delivery were of a greater magnitude than were those obtained with medical therapies to date , and our study is , to our knowledge , the first demonstration of the benefit of continuous levodopa delivery in a double-blind controlled study .


AbbVie .


Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ' efforts .


To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management .


Randomized comparative effectiveness trial .


A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system .


All patients participated with a `` CarePartner '' or informal caregiver outside their household .


Patients randomized to `` standard mHealth '' received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians .


`` mobile health + CarePartner '' ( mHealth + CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners .


At baseline , 6 , and 12 months , CarePartners completed assessments of caregiving strain , depressive symptoms , and participation in self-care support .


mHealth + CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P0 .03 ) .


That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P0 .03 for interactions between arm and baseline strain/depression at both endpoints ) .


Although most mHealth + CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P < 0.05 ) .


mHealth + CP CarePartners reported more frequently attending patients ' medical visits at 6 months ( P = 0.049 ) and greater involvement in medication adherence at both endpoints ( both P0 .032 ) .


When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms .


Feedback also increased most CarePartners ' engagement in self-care .


The VACS Index is highly predictive of all-cause mortality among HIV infected individuals within the first few years of combination antiretroviral therapy ( cART ) .


However , its accuracy among highly treatment experienced individuals and its responsiveness to treatment interventions have yet to be evaluated .


We compared the accuracy and responsiveness of the VACS Index with a Restricted Index of age and traditional HIV biomarkers among patients enrolled in the OPTIMA study .


Using data from 324/339 ( 96 % ) patients in OPTIMA , we evaluated associations between indices and mortality using Kaplan-Meier estimates , proportional hazards models , Harrel 's C-statistic and net reclassification improvement ( NRI ) .


We also determined the association between study interventions and risk scores over time , and change in score and mortality .


Both the Restricted Index ( c = 0.70 ) and VACS Index ( c = 0.74 ) predicted mortality from baseline , but discrimination was improved with the VACS Index ( NRI = 23 % ) .


Change in score from baseline to 48 weeks was more strongly associated with survival for the VACS Index than the Restricted Index with respective hazard ratios of 0.26 ( 95 % CI 0.14-0 .49 ) and 0.39 ( 95 % CI 0.22-0 .70 ) among the 25 % most improved scores , and 2.08 ( 95 % CI 1.27-3 .38 ) and 1.51 ( 95 % CI 0.90-2 .53 ) for the 25 % least improved scores .


The VACS Index predicts all-cause mortality more accurately among multi-drug resistant , treatment experienced individuals and is more responsive to changes in risk associated with treatment intervention than an index restricted to age and HIV biomarkers .


The VACS Index holds promise as an intermediate outcome for intervention research .


The purpose of this study was to compare the impact of music therapy ( MT ) versus music medicine ( MM ) interventions on psychological outcomes and pain in cancer patients and to enhance understanding of patients ' experiences of these two types of music interventions .


This study employed a mixed methods intervention design in which qualitative data were embedded within a randomized cross-over trial .


Thirty-one adult cancer patients participated in two sessions that involved interactive music making with a music therapist ( MT ) and two sessions in which they listened to pre-recorded music without the presence of a therapist ( MM ) .


Before and after each session , participants reported on their mood , anxiety , relaxation , and pain by means of visual analogue and numeric rating scales .


Thirty participants completed an exit interview .


The quantitative data suggest that both interventions were equally effective in enhancing target outcomes .


However , 77.4 % of participants expressed a preference for MT sessions .


The qualitative data indicate that music improves symptom management , embodies hope for survival , and helps connect to a pre-illness self , but may also access memories of loss and trauma .


MT sessions helped participants tap into inner resources such as playfulness and creativity .


Interactive music making also allowed for emotional expression .


Some participants preferred the familiarity and predictability of listening to pre-recorded music .


The findings of this study advocate for the use of music in cancer care .


Treatment benefits may depend on patient characteristics such as outlook on life and readiness to explore emotions related to the cancer experience .


Home and school environments conducive for unhealthy eating and physical inactivity are precursors of obesity .


The aim of this study is evaluation of the effectiveness of a multi-component school-based weight management programme for overweight and obese primary school children via a home-school joint venture .


This study made use of variety of behavioural modification strategies integrating into the Health Promoting School approach to promote healthy lifestyles .


The participants were overweight and obese students aged between 8 and 12 from six participating schools .


The interventions involved students attending ten 75 minutes after-school sessions and one 3-hour week-end session of practical interactive and fun activities on healthy eating and exercise , and meal plan together with parents and printed tailor-made management advices .


Parents received an introductory seminar with 2 sets of specially designed exercise for their overweight children .


The tools to measure bodyweight and fat percentage and standing height were bio-impedance body fat scale and a portable stadiometer .


Self-administered questionnaire was used to measure knowledge , attitudes and behaviours .


McNemar test was utilized to compare the proportions of behaviour changes within the same group to assess for the trends of changes .


BMI z-score and body fat percentage of intervention participants at baseline , 4 month and 8 month were compared pair-wisely using tests of within subject contrasts in repeated measures ANOVA to assess for programme sustainability .


Those students in the intervention group reduced their BMI z-score ( -0.21 , 95 % CI -0.34 to -0.07 , P = 0.003 ) and body fat ( -2.67 % , 95 % CI -5.12 to -0.22 , P = 0.033 ) compared to wait list control group with statistical significant , and the intervention group also had a significant reduction in BMI z-score ( -0.06 , 95 % CI -0.11 , -0.007 , P = 0.028 ) and body fat ( -1.71 % , 95 % CI , -3.44 to 0.02 , P = 0.052 ) after a 4 month maintenance period .


Improvement of dietary habits and positive attitudes towards exercise were observed among the intervention group .


School based weight management programme integrated into a Health Promoting School approach with improved school policies and environment in supporting individual skills of obese students and their parents appears to be a promising practice for sustaining weight control .


ISRCTN58795797 .


Need for recovery and work ability are strongly associated with high employee turnover , well-being and sickness absence .


However , scientific knowledge on effective interventions to improve work ability and decrease need for recovery is scarce .


Thus , the present study aims to describe the background , design and protocol of a cluster randomized controlled trial evaluating the effectiveness of an intervention to reduce need for recovery and improve work ability among industrial workers .


A two-year cluster randomized controlled design will be utilized , in which controls will also receive the intervention in year two .


More than 400 workers from three companies in Denmark will be aimed to be cluster randomized into intervention and control groups with at least 200 workers ( at least 9 work teams ) in each group .


An organizational resources audit and subsequent action planning workshop will be carried out to map the existing resources and act upon initiatives not functioning as intended .


Workshops will be conducted to train leaders and health and safety representatives in supporting and facilitating the intervention activities .


Group and individual level participatory visual mapping sessions will be carried out allowing team members to discuss current physical and psychosocial work demands and resources , and develop action plans to minimize strain and if possible , optimize the resources .


At all levels , the intervention will be integrated into the existing organization of work schedules .


An extensive process and effect evaluation on need for recovery and work ability will be carried out via questionnaires , observations , interviews and organizational data assessed at several time points throughout the intervention period .


This study primarily aims to develop , implement and evaluate an intervention based on the abovementioned features which may improve the work environment , available resources and health of industrial workers , and hence their need for recovery and work ability .


In 2-year-old children with Down 's syndrome ( DS ) , early T4 treatment was found to result in slightly better motor development and growth .


This study sought to determine long-term effects of early T4 treatment on development and growth in children with DS with either an elevated or normal neonatal TSH concentration .


Patients received a single follow-up visit 8.7 years after a randomized placebo-controlled trial ( RCT ) comparing T4 and placebo treatment during the first 2 years of life .


Dutch Academic Hospital .


All children who completed the RCT ( N = 181 , of 196 randomly assigned children ) were invited for the follow-up study .


A total of 123 participants enrolled , at a mean age of 10.7 years .


T4 or placebo treatment from the neonatal period until 2 years .


Primary : mental and motor development .


Secondary : communication skills , fine-motor coordination , height , weight , and head circumference ( HC ) .


Outcomes were compared between T4 - and placebo-treated children , and between treatment groups with either a normal ( < 5 mIU/L ) , or elevated ( 5 mIU/L ) TSH concentration at original trial entry .


Mental or motor development , communication skills , or fine-motor coordination did not differ between T4 - ( N = 64 ) and placebo-treated children ( N = 59 ) .


T4-treated children had a larger HC ( 50.4 vs 49.8 cm , P = .04 ) and tended to be taller ( 133.2 vs 131.1 cm , P = .06 ) .


These differences were somewhat greater in children with TSH 5 mIU/L ( HC : T4 , 50.5 vs placebo , 49.7 cm ; P = .01 ; height : T4 , 133.8 vs placebo , 130.8 cm ; P = .02 ) , but were not found in children with TSH < 5 mIU/L ( HC : T4 , 50.1 vs placebo , 50.0 cm ; P = .75 ; height : T4 , 132.1 vs placebo , 131.6 cm ; P = .22 ) .


Early T4 treatment of children with DS does not seem to benefit mental or motor development later in life .


However , the positive effect on growth is still measurable , especially in children with an elevated plasma TSH concentration in the neonatal period .


To compare pressure-support ventilation with spontaneous breathing through a T-tube for interrupting invasive mechanical ventilation in patients undergoing cardiac surgery with cardiopulmonary bypass .


Adults of both genders were randomly allocated to 30 minutes of either pressure-support ventilation or spontaneous ventilation with `` T-tube '' before extubation .


Manovacuometry , ventilometry and clinical evaluation were performed before the operation , immediately before and after extubation , 1h and 12h after extubation .


Twenty-eight patients were studied .


There were no deaths or pulmonary complications .


The mean aortic clamping time in the pressure support ventilation group was 62 35 minutes and 68 36 minutes in the T-tube group ( P = 0.651 ) .


The mean cardiopulmonary bypass duration in the pressure-support ventilation group was 89 44 minutes and 82 42 minutes in the T-tube group ( P = 0.75 ) .


The mean Tobin index in the pressure support ventilation group was 51 25 and 64.5 23 in the T-tube group ( P = 0.153 ) .


The duration of intensive care unit stay for the pressure support ventilation group was 2.1 0.36 days and 2.3 0.61 days in the T-tube group ( P = 0.581 ) .


The atelectasis score in the T-tube group was 0.6 0.8 and 0.5 0.6 ( P = 0.979 ) in the pressure support ventilation group .


The study groups did not differ significantly in manovacuometric and ventilometric parameters and hospital evolution .


The two trial methods evaluated for interruption of mechanical ventilation did not affect the postoperative course of patients who underwent cardiac operations with cardiopulmonary bypass .


This study represents an effort to advance our understanding of the nature of school readiness among children with language impairment ( LI ) , a population of children acknowledged to be at risk of poor academic achievement .


The academic , social-emotional , and behavioural competencies with which children arrive at kindergarten affect the nature of their future educational experiences , and their overall academic achievement .


To examine whether there are reliable profiles that characterize children with LI just prior to kindergarten entrance , and the extent to which profile membership is associated with characteristics of children 's homes and preschool experiences .


Questions addressed were twofold : ( 1 ) To what extent are there reliable profiles of children with LI with respect to their school readiness ?


( 2 ) To what extent is children 's profile membership associated with characteristics of their homes and preschool classrooms ?


Participants were 136 children with LI from early childhood special education classrooms .


We utilized latent class analysis ( LCA ) to classify individuals into profiles based on individual responses on school readiness measures .


We then used multilevel hierarchical generalized linear models to examine the relations between profile membership and children 's home/classroom experiences .


LCA analyses revealed that a four-profile solution was the most appropriate fit for the data and that classroom experiences were predictive of these profiles , such that children in classrooms with more instructional/emotional support were more likely to be placed in profiles characterized by higher school readiness skills .


These results suggest that the school readiness profiles of young children with LI are associated with the quality of children 's classroom experiences , and that high-quality classroom experiences can be influential for ensuring that young children with LI arrive in kindergarten ready to learn .


Preclinical studies have shown that low-dose methylene blue increases mitochondrial cytochrome oxidase activity in the brain and improves memory retention after learning tasks , including fear extinction .


The authors report on the first controlled experiment to examine the memory-enhancing effects of posttraining methylene blue administration on retention of fear extinction and contextual memory following fear extinction training .


Adult participants displaying marked claustrophobic fear were randomly assigned to double-blind administration of 260 mg of methylene blue ( N = 23 ) or administration of placebo ( N = 19 ) immediately following six 5-minute extinction trials in an enclosed chamber .


Retesting occurred 1 month later to assess fear renewal as indexed by peak fear during exposure to a nontraining chamber , with the prediction that the effects of methylene blue would vary as a function of fear reduction achieved during extinction training .


Incidental contextual memory was assessed 1 and 30 days after training to assess the cognitive-enhancing effects of methylene blue independent of its effects on fear attenuation .


Consistent with predictions , participants displaying low end fear posttraining showed significantly less fear at the 1-month follow-up if they received methylene blue posttraining compared with placebo .


In contrast , participants displaying moderate to high levels of posttraining fear tended to fare worse at the follow-up if they received methylene blue posttraining .


Methylene blue 's enhancement of contextual memory was unrelated to initial or posttraining claustrophobic fear .


Methylene blue enhances memory and the retention of fear extinction when administered after a successful exposure session but may have a deleterious effect on extinction when administered after an unsuccessful exposure session .


Many maternity providers recommend that women with diabetes in pregnancy express and store breast milk in late pregnancy so breast milk is available after birth , given ( 1 ) infants of these women are at increased risk of hypoglycaemia in the first 24 h of life ; and ( 2 ) the delay in lactogenesis II compared with women without diabetes that increases their infant 's risk of receiving infant formula .


The Diabetes and Antenatal Milk Expressing ( DAME ) trial will establish whether advising women with diabetes in pregnancy ( pre-existing or gestational ) to express breast milk from 36 weeks gestation increases the proportion of infants who require admission to special or neonatal intensive care units ( SCN/NICU ) compared with infants of women receiving standard care .


Secondary outcomes include birth gestation , breastfeeding outcomes and economic impact .


Women will be recruited from 34 weeks gestation to a multicentre , two arm , unblinded randomised controlled trial .


The intervention starts at 36 weeks .


Randomisation will be stratified by site , parity and diabetes type .


Women allocated to the intervention will be taught expressing and encouraged to hand express twice daily for 10 min and keep an expressing diary .


The sample size of 658 ( 329 per group ) will detect a 10 % difference in proportion of babies admitted to SCN/NICU ( 85 % power , 0.05 ) .


Data are collected at recruitment ( structured questionnaire ) , after birth ( abstracted from medical record blinded to group ) , and 2 and 12 weeks postpartum ( telephone interview ) .


the intervention group will be compared with the standard care group by intention to treat analysis , and the primary outcome compared using ( 2 ) and ORs .


Research ethics approval will be obtained from participating sites .


Results will be published in peer-reviewed journals and presented to clinicians , policymakers and study participants .


Australian Controlled Trials Register ACTRN12611000217909 .


Smoking prevalence is 49 % among Medicaid enrollees in Ohio .


The objective of this pilot project was to test a comprehensive tobacco dependence treatment program targeting rural Medicaid-enrolled smokers for both physician-level and smoker-level outcomes .


Using a group-randomized trial design , intervention group physicians ( n = 4 ) were exposed to systems-level changes in their clinics , and smokers in these clinics were offered 12 weeks of telephone cessation counseling .


Control group physicians ( n = 4 ) were given the clinician 's version of the U.S. Public Health Serivce ( USPHS ) Clinical Practice Guideline , and smokers in these clinics were given information about the Ohio Tobacco Quitline .


Physician-level and smoker-level outcomes were assessed at 1 week and 3 months , respectively .


Costs per quit were estimated .


A total of 214 Medicaid smokers were enrolled .


At 1 week , there were no reported differences in rates of being asked about tobacco use ( 68 % intervention , 58 % control ) or advised to quit ( 69 % intervention , 63 % control ) .


However , 30 % of intervention and 56 % of control smokers reported receiving a prescription for pharmacotherapy ( p < .01 ) .


At 3 months , there were no differences in quit attempts ( 58 % intervention , 64 % control ) , use of pharmacotherapy ( 34 % intervention , 46 % control ) , or abstinence ( 24 % intervention , 16 % control for self-reported abstinence ; 11 % intervention , 3.5 % control for cotinine-confirmed abstinence ) .


The intervention group proved more cost-effective at achieving confirmed quits ( $ 6,800 vs. $ 9,700 ) .


We found few differences in outcomes between physicians exposed to a brief intervention and physicians who were intensively trained .


Future studies should examine how tobacco dependence treatment can be further expanded in Medicaid programs .


To compare the efficacy of lidocaine , bupivacaine , and a mixture of both in patients undergoing peribulbar anesthesia for vitreoretinal surgery .


Cross-sectional study .


Ninety patients .


Patients who underwent vitreoretinal surgery were randomized into 3 groups based on the peribulbar injection they received : lidocaine , bupivacaine , or a combination of lidocaine and bupivacaine .


Time of onset of analgesia , akinesia , and intraoperative pain , if any , was noted .


The efficacy of the block was graded from 0 to 5 depending on the adequacy of anesthesia and akinesia and the need for local supplementation .


Mean times of onset ( standard deviation ) of sensory blockade for the lidocaine , bupivacaine , and combination groups were 2.140.18 , 2.190.13 , and 2.170.11 minutes , respectively ( P = 0.103 ) .


Mean times of onset ( standard deviation ) of motor blockade for the lidocaine , bupivacaine , and combination groups were 3.041.81 , 4.042.68 , and 3.382.48 minutes , respectively ( P = 0.255 ) .


Mean time of onset of intraoperative pain for the bupivacaine group , 149.3346.33 minutes , was prolonged significantly compared with that of the combination group , 115.8334.49 minutes , and that of the lidocaine group , 94.1749.86 minutes ( P < 0.001 ) .


Adequate anesthesia and akinesia ( grade 5 ) were achieved in 56.7 % of the patients in the bupivacaine group compared with 23.3 % in the lidocaine group and 30 % in the combination group ( P = 0.049 ) .


In peribulbar anesthesia , 0.5 % bupivacaine solution provides better quality of anesthesia than does combination 2 % lidocaine and 0.5 % bupivacaine in patients undergoing vitreoretinal surgery .


Intimate partner violence ( IPV ) and heavy drinking are co-occurring public health problems , but integrated brief interventions for these conditions have not been tested .


To determine whether a brief motivational intervention provided at the time of an emergency department ( ED ) visit reduces IPV and heavy drinking .


A randomized clinical trial conducted at 2 US academic urban EDs between January 2011 and December 2014 to assess the effectiveness of a motivational intervention for IPV-involved female ED patients ( ages : 18-64 years ; N = 600 ) who exceeded sex-specific safe drinking limits .


All received social service referrals ; 2:2:1 to brief intervention ( n = 242 ) , assessed control ( n = 237 ) , or no-contact control ( n = 121 ) .


A 20 - to 30-minute manual-guided motivational intervention ( recorded and monitored for fidelity ) delivered by master 's - level therapists with a follow-up telephone booster .


The assessed control group received the same number of assessments as the brief intervention group ; the no-contact control group was assessed only once at 3 months .


Incidents of heavy drinking and experiencing IPV measured over prespecified , 12 weekly assessments using an interactive voice response system .


Of 600 participants , 80 % were black women with a mean age of 32 years .


Retention was 89 % for 2 or more interactive voice response system calls .


Seventy-eight percent of women completed the 3-month interview , 79 % at 6 months , and 71 % at 12 months .


During the 12-week period following the brief motivational intervention , there were no significant differences between the intervention group and the assessed control group on weekly assessments for experiencing IPV ( odds ratio [ OR ] , 1.02 ; 95 % CI , 0.98-1 .06 ) or heavy drinking ( OR , 0.99 ; 95 % CI , 0.96-1 .03 ) .


From baseline to 12 weeks , the number of women with any IPV in the past week decreased from 57 % ( 134 of 237 ) in the intervention group to 43 % ( 83 of 194 ) and from 63 % ( 145 of 231 ) in the assessed control group to 41 % ( 77 of 187 ) ( absolute difference of 8 % ) .


From baseline to 12 weeks , the number of women with past week heavy drinking decreased from 51 % ( 120 of 236 ) in the intervention group to 43 % ( 83 of 194 ) and from 46 % ( 107 of 231 ) in the assessed control group to 41 % ( 77 of 187 ) ( absolute difference of 3 % ) .


At 12 months , 43 % ( 71 of 165 ) of the intervention group and 47 % ( 78 of 165 ) of the assessed control group reported no IPV during the previous 3 months and 19 % ( 29 of 152 ) of the intervention group and 24 % ( 37 of 153 ) of the control group had reduced their alcohol consumption to sex-specific National Institute on Alcohol Abuse and Alcoholism safe drinking levels .


For women experiencing IPV and heavy drinking , the use of a brief motivational intervention in the ED compared with assessed and no-contact controls did not significantly reduce the days of heavy drinking or incidents of IPV .


These findings do not support a brief motivational intervention in this setting .


clinicaltrials.gov Identifer : NCT01207258 .


Whether a coronary artery calcium ( CAC ) scan provides added value to coronary computed tomographic angiography ( CCTA ) in emergency department patients with acute chest pain remains unsettled .


We sought to determine the value of CAC scan in patients with acute chest pain undergoing CCTA .


In the multicenter Rule Out Myocardial Infarction using Computer-Assisted Tomography ( ROMICAT ) II trial , we enrolled low-intermediate risk emergency department patients with symptoms suggesting acute coronary syndrome ( ACS ) .


In this prespecified subanalysis of 473 patients ( 548 years , 53 % men ) who underwent both CAC scanning and CCTA , the ACS rate was 8 % .


Overall , 53 % of patients had CAC = 0 of whom 2 ( 0.8 % ) developed ACS , whereas 7 % had CAC > 400 with 49 % whom developed ACS .


C-statistic of CAC > 0 was 0.76 , whereas that using the optimal cut point of CAC22 was 0.81 .


Continuous CAC score had lower discriminatory capacity than CCTA ( c-statistic , 0.86 versus 0.92 ; P = 0.03 ) .


Compared with CCTA alone , there was no benefit combining CAC score with CCTA ( c-statistic , 0.93 ; P = 0.88 ) or with selective CCTA strategies after initial CAC > 0 or optimal cut point CAC22 ( P0 .09 ) .


Mean radiation dose from CAC acquisition was 1.40.7 mSv .


Higher CAC scores resulted in more nondiagnostic CCTA studies although the majority remained interpretable .


In emergency department patients with acute chest pain , CAC score does not provide incremental value beyond CCTA for ACS diagnosis .


CAC = 0 does not exclude ACS , nor a high CAC score preclude interpretation of CCTA in most patients .


Thus , CAC results should not influence the decision to proceed with CCTA , and the decision to perform a CAC scan should be balanced with the additional radiation exposure required .


http://www.clinicaltrials.gov .


Unique identifier : NCT01084239 .


The duration and exclusivity of breastfeeding in infancy have been inversely associated with future cardiometabolic risk .


We investigated the effects of an experimental intervention to promote increased duration of exclusive breastfeeding on cardiometabolic risk factors in childhood .


We followed-up children in the Promotion of Breastfeeding Intervention Trial , a cluster-randomized trial of a breastfeeding promotion intervention based on the World Health Organization/United Nations Children 's Fund Baby-Friendly Hospital Initiative .


In 1996 to 1997 , 17 046 breastfeeding mother-infant pairs were enrolled from 31 Belarusian maternity hospitals and affiliated polyclinics ( 16 intervention versus 15 control sites ) ; 13 879 ( 81.4 % ) children were followed up at 11.5 years , with 13 616 ( 79.9 % ) who had fasted and did not have diabetes mellitus .


The outcomes were blood pressure ; fasting insulin , adiponectin , glucose , and apolipoprotein A1 ; and the presence of metabolic syndrome .


Analysis was by intention to treat , accounting for clustering within hospitals/clinics .


The intervention substantially increased breastfeeding duration and exclusivity in comparison with the control arm ( 43 % versus 6 % and 7.9 % versus 0.6 % exclusively breastfed at 3 and 6 months , respectively ) .


Cluster-adjusted mean differences at 11.5 years between experimental versus control groups were as follows : 1.0 mm Hg ( 95 % confidence interval , -1.1 to 3.1 ) for systolic and 0.8 mm Hg ( -0.6 to 2.3 ) for diastolic blood pressure ; -0.1 mmol/L ( -0.2 to 0.1 ) for glucose ; 8 % ( -3 % to 34 % ) for insulin ; -0.3 g/mL ( -1.5 to 0.9 ) for adiponectin ; and 0.0 g/L ( -0.1 to 0.1 ) for apolipoprotein A1 .


The cluster-adjusted odds ratio for metabolic syndrome , comparing experimental versus control groups , was 1.21 ( 0.85 to 1.72 ) .


An intervention to improve breastfeeding duration and exclusivity among healthy term infants did not influence cardiometabolic risk factors in childhood .


Current Controlled Trials : ISRCTN37687716 ( http://www.controlled-trials.com/ISRCTN37687716 ) .


URL : http://clinicaltrials.gov .


Unique identifier : NCT01561612 .


Agitation is prevalent among people with dementia ( PWD ) in nursing homes .


It frustrates both the PWD and their caregivers .


Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies .


However , there is still a dearth of evidence to explain its effect for clinical use and further research .


The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care .


This study is a multicenter , assessor/participant/statistician-blinded , parallel group , randomized controlled trial taking place in Hong Kong nursing homes .


We have been recruiting PWD over 65 years of age in nursing homes , who are experiencing agitation ; 99 participants will be recruited in order to demonstrate a significant effect difference ( that is , f = 0.27 ) with a power of 0.8 and a significance level of 0.05 among the three groups .


Participants are assigned by permuted block randomization into three groups in a 1:1:1 ratio .


In the acupressure group , participants receive acupressure at the Fengchi ( GB20 ) , Baihui ( GV20 ) , Shenmen ( HT7 ) , Niguan ( PC6 ) and Yingtang ( EX-HN3 ) acupoints .


In the sham-acupressure group , participants receive pressure on five non-acupoints .


In the usual-care group , participants receive no intervention apart from the care provided by the nursing homes .


Participants assigned to the sham-acupressure and usual-care groups receive free acupressure , like those in the acupressure group , after completion of the study .


The whole study lasts for 30 weeks , and its primary outcome measure is agitation .


The general estimated equation model will be used to compare the effects among groups and time points .


The trial is currently recruiting participants .


This trial will provide a higher quality of evidence than previous studies on the use of acupressure for agitation in PWD .


It will also provide newer evidence on acupressure in the population of PWD with agitation for clinical application and further research , including the effect on moderating stress , the delayed effect , the added effect on the placebo , and the effect on moderating the participant 's use of psychotropic drugs .


Centre for Clinical Trials Clinical Trials Registry : CUHK_CCT00347 ( Registration date : 13 December 2012 ) .


To evaluate the effects of repeated intravitreal injections of bevacizumab ( IVB ) versus triamcinolone acetonide ( IVT ) in the treatment of acute central retinal vein occlusion ( CRVO ) .


In this randomized clinical trial , 86 eyes with recent onset ( < 12 weeks ) CRVO were assigned to two groups : IVB group ( 43 eyes ) that received three monthly injections of 1.25 mg of IVB , and IVT group ( 43 eyes ) that received two injections of 2 mg IVT 2 months apart .


Outcomes were best-corrected visual acuity ( BCVA ) , central macular thickness ( CMT ) , and intraocular pressure ( IOP ) changes .


Mean BCVA improved significantly at 6 months in both groups ; from 0.87 0.49 to 0.41 0.35 logMAR in IVB group , and from 0.81 0.45 to 0.62 0.48 logMAR in IVT group ( p < 0.001 ) .


However , between-group differences reach a significant level at months 4 ( p = 0.003 ) and 6 ( p < 0.001 ) in favour of the IVB group .


In terms of CMT reduction , the difference between the groups was statistically significant ( p = 0.002 ) at month 6 .


Significant differences were noted more in the ischaemic cases in favour of the IVB group .


Mean IOP rise was significantly higher in the IVT group at all visits .


Both 3-times monthly IVB injections and 2-times IVT injections could be effective in cases with recent onset CRVO up to 6 months .


However , considering the better outcomes after IVB injections and the potential complications of IVT injections , we would recommend prescheduled repeated IVB injections for such cases .


The observed favourable responses were more pronounced in the ischaemic types ; nevertheless , this should be confirmed in larger studies .


This randomized controlled study compared acceptance and commitment therapy ( ACT ) , cognitive-behavioral therapy ( CBT ) , and a control group .


The participants were 50 incarcerated women diagnosed with current substance use disorder .


Two psychologists carried out pre - and posttreatment assessment and a 6-month follow-up assessment using the following instruments : Anxiety Sensitivity Index , Addiction Severity Index-6 , Mini International Neuropsychiatric Interview , and Acceptance and Action Questionnaire .


The study shows that the women who received treatment benefited differentially from the interventions .


At posttreatment , CBT was more effective than ACT in reducing anxiety sensitivity ; however , at follow-up , ACT was more effective than CBT in reducing drug use ( 43.8 vs. 26.7 % , respectively ) and improving mental health ( 26.4 % vs. 19.4 % , respectively ) .


ACT may be an alternative to CBT for treatment of drug abuse and associated mental disorders .


In fact , at long-term , ACT may be more appropriate than CBT for incarcerated women who present serious problems .


Gatekeeper training ( GKT ) programs are an increasingly popular approach to addressing access to mental health care in adolescent and young adult populations .


This study evaluates the effectiveness of a widely used GKT program , Mental Health First Aid , in college student populations .


A randomized control trial was conducted on 32 colleges and universities between 2009 and 2011 .


Campus residence halls were assigned to the intervention ( Mental Health First Aid plus pre-existing trainings ) or control condition ( pre-existing trainings only ) using matched pair randomization .


The trainings were delivered to resident advisors ( RAs ) .


Outcome measures include service utilization , knowledge and attitudes about services , self-efficacy , intervention behaviors , and mental health symptoms .


Data come from two sources : ( 1 ) surveys completed by the students ( resident advisors and residents ; N = 2,543 ) , 2-3months pre - and post-intervention ; and ( 2 ) utilization records from campus mental health centers , aggregated by residence .


The training increases trainees ' self-perceived knowledge ( regression-adjusted effect size [ ES ] = .38 , p < .001 ) , self-perceived ability to identify students in distress ( ES = .19 , p = .01 ) , and confidence to help ( ES = .17 , p = .04 ) .


There are no apparent effects , however , on utilization of mental health care in the student communities in which the trainees live .


Although GKT programs are widely used to increase access to mental health care , these programs may require modifications to achieve their objectives .


To investigate whether nursing staff can successfully use the I-gel and the intubating laryngeal mask Fastrach ( ILMA ) during cardiopulmonary resuscitation .


Although tracheal intubation is considered to be the optimal method for securing the airway during cardiopulmonary resuscitation , laryngoscopy requires a high level of skill .


Forty five nurses inserted the I-gel and the ILMA in a manikin , with continuous and without chest compressions .


Mean intubation times for the ILMA and I-gel without chest compressions were 20.603.27 and 18.403.26 s , respectively ( p < 0.0005 ) .


ILMA proved more successful than the I-gel regardless of compressions .


Continuation of compressions caused a prolongation in intubation times for both the I-gel ( p < 0.0005 ) and the ILMA ( p < 0.0005 ) .


In this mannequin study , nursing staff can successfully intubate using the I-gel and the ILMA as conduits with comparable success rates , regardless of whether chest compressions are interrupted or not .


Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery .


In this prospective , randomized , double-blind study , we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding .


A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups .


Patients in the fibrinogen group received 1g of fibrinogen concentrate 30 min prior to the operation , while patients in the control group received placebo .


Post-operative bleeding volumes , prothrombin time , partial thromboplastin time , INR , hemoglobin and transfused blood products in both groups were recorded .


A strict red blood cell transfusion protocol was used in all patients .


There were no significant differences between intra-operative packed red blood cells infusion in the studied groups ( 1.01.4 in fibrinogen group , and 1.31.1 in control group ) .


Less postoperative bleeding was observed in the fibrinogen group ( 477143 versus 703179 , p = 0.0001 ) .


Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion ( p = 0.094 ) .


No thrombotic event was observed through 72 h after surgery .


Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft .


We conducted a competitive efficacy trial in order to examine whether grafting the raw area of the urethral plate ( UP ) with inner preputial skin in children with primary hypospadias ( PH ) during tubularized incised plate urethroplasty ( TIP ) improves the results of the operation .


Fifty consecutive patients with pathology ranging from glanular to proximal penile PH were randomized into two groups , comparable for age and pathology , to be operated on either with TIP or a grafted TIP ( G-TIP ) procedure .


Three patients failed the re-examination protocol , so the TIP group comprised 23 children aged 9.0 months-9 .6 years ( mean age 3.4 years ) and the G-TIP group comprised 24 children , aged 10.0 months-9 .4 years ( mean 3.5 years ) .


The patients were followed up for a period of 2-5 years ( mean 3.2 years ) .


Within the TIP group , we observed the development of fistula with concomitant neourethral stenosis in two cases ( 8.7 % ) , stenosis without fistula in four ( 17.4 % ) , and glans dehiscence in one case ( 4.35 % ) .


Within the G-TIP group there was one case of fistula without stenosis ( 4.16 % ) , no case of neourethral stenosis , and one case of glans dehiscence ( 4.16 % ) .


Two cases of non-slit-like meatus were observed in the TIP group .


The results show that the complications of neourethral stenosis are significantly reduced ( p < 0.05 ) in the G-TIP group , as is the total number of complications and unsatisfactory results .


The duration of the TIP operation was 72-110 ( mean 92 ) min , and for the G-TIP 100-136 ( mean 115 ) min .


No postoperative symptoms were observed that could be attributed to prolonged anesthesia time .


UP grafting with inner preputial skin , when added to the TIP procedure in the treatment of PH , results in a significantly smaller number of unsatisfactory results , and particularly fewer cases of neourethral stenosis .


G-TIP can be used as the procedure of choice in PH patients .


It has been suggested that the anticonvulsant drug pregabalin may be useful in some anxiety disorders .


The goal of this study was to evaluate the effectiveness of pregabalin augmentation of standard treatment ( selective serotonin reuptake inhibitors and sodium valproate ) for patients with chronic posttraumatic stress disorder ( PTSD ) .


This doubleblind , placebo-controlled clinical trial was conducted at Ibn-E-Sina Psychiatric Hospital ( Mashhad , Iran ) in 2013 .


Thirty-seven male patients diagnosed with combat-related PTSD based on DSM-IV-TR criteria were randomly assigned to two groups : 18 patients , the case group , received pregabalin ( 300 mg/day ) while 19 patients , the control group , received placebo for 6 weeks .


Assessments were done at baseline and at 2 , 4 , and 6 weeks after the onset of treatment , using the PTSD Check List-Military Version ( PCL-M ) , the Hamilton Depression Rating Scale , the Hamilton Anxiety Rating Scale , and the Spitzer Quality of Life Index .


Pregabalin was just significantly effective in improving PCL-M scores ( p = 0.045 ) in comparison to placebo .


Although depression and anxiety scores diminished significantly in both groups ( p = 0.001 and 0.0001 , respectively ) , comparison of the efficacy of pregabalin and placebo did not show significant differences in depression , anxiety , and quality of life scores ( p = 0.614 , 0.144 , and 0.076 , respectively ) .


Pregabalin effectively reduced the severity of PTSD symptoms but it was not effective in improving the severity of depression , anxiety , and quality of life .


Further investigations are required to confirm or refute these findings .


To compare the effects of local anesthetic intraperitoneal nebulization with intraperitoneal instillation during laparoscopic ovarian cystectomy on postoperative morphine consumption and pain .


Multicenter , randomized , case-control trial .


Canadian Task Force Classification I.


University hospitals in Italy .


One hundred forty patients scheduled for laparoscopic ovarian cystectomy .


Patients were randomized to receive either nebulization of ropivacaine 150 mg before surgery or instillation of ropivacaine 150 mg before surgery .


Nebulization was performed using the Aeroneb Pro device ( Aerogen , Galway , Ireland ) .


One hundred forty patients were enrolled , and 123 completed the study .


There was no difference between the 2 groups in average morphine consumption ( 7.3 7.5 mg in the nebulization group vs 9.2 7.2 mg in the instillation group ; p = .17 ) .


Eighty-two percent of patients in the nebulization group required morphine compared with 96 % in the instillation group ( p < .05 ) .


Patients receiving nebulization had a lower dynamic Numeric Ranking Scale compared with those in the instillation group in the postanesthesia care unit postanesthesia care unit and 4 hours after surgery ( p < .05 ) .


Ten patients ( 15 % ) in the nebulization group experienced shivering in the postanesthesia care unit compared with 2 patients ( 4 % ) in the instillation group ( p = .035 ) .


Nebulization of ropivacaine prevents the use of morphine in a significant proportion of patients , reduced postoperative pain during the first hours after surgery , and was associated with a higher incidence of postoperative shivering when compared with instillation .


Since 2007 , the Australian Know your numbers ( KYN ) program has been used in community settings to raise awareness about blood pressure and stroke .


In 2011 , the program was modified to include assessment for type 2 diabetes risk .


However , it is unclear which approach for assessing diabetes risk in pharmacies is best .


We compared two methods : random ( non-fasting ) blood glucose testing ( RBGT ) ; and the Australian type 2 diabetes risk assessment tool ( AUSDRISK ) ; according to 1 ) identification of ` high risk ' participants including head-to-head sensitivity and specificity ; 2 ) number of referrals to doctors ; and 3 ) feasibility of implementation .


117 Queensland pharmacies voluntarily participated and were randomly allocated to RBGT and AUSDRISK or AUSDRISK only .


Although discouraged , pharmacies were able to change allocated group prior to commencement .


AUSDRISK is a validated self-administered questionnaire used to calculate a score that determines the 5-year risk of developing type 2 diabetes .


AUSDRISK ( score 12 + ) or RBGT ( 5.6 mmol/I ) indicates a high potential risk of diabetes .


Median linear regression was used to compare the two measures .


Staff from 68 pharmacies also participated in a semi-structured interview during a site visit to provide feedback .


Data were submitted for 5,483 KYN participants ( 60 % female , 66 % aged > 55 years , 10 % history of diabetes ) .


Approximately half of the participants without existing diabetes were identified as ` high risk ' based on either RBGT or AUSDRISK score .


Among participants who undertook both measures , 32 % recorded a high RBGT and high AUSDRISK .


There was a significant association between RBGT and AUSDRISK scores .


For every one point increase in AUSDRISK score there was a half point increase in RBGT levels ( coefficient 0.55 , 95 % CI : 0.28 , 0.83 ) .


Pharmacy staff reported that AUSDRISK was a simple , low cost and efficient method of assessing diabetes risk compared with RBGT , e.g. since management of sharps is not an issue .


In a large , community-based sample of Australians about half of the participants without diabetes were at ` high risk ` of developing diabetes based on either AUSDRISK or RBGT results .


AUSDRISK was considered to be an acceptable method for assessing the risk of diabetes using opportunistic health checks in community pharmacies .


Nursing home residents often have a high number of comorbidities resulting in polypharmacy .


Inappropriate prescribing is therefore likely to occur , which in turn is expected to worsen cognitive impairment , to increase the fall risk and to decrease residents ' quality of life .


The objective of the ` Discontinuing Inappropriate Medication in Nursing Home Residents ' ( DIM-NHR ) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review ( 3MR ) that is aimed at optimising prescribing and discontinuing inappropriate medication .


A cluster randomised controlled trial will be conducted .


Elderly care physicians and their wards ( clusters ) will be randomised .


Data will be collected at baseline and 4months after the 3MR has taken place .


Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia .


The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient 's elderly care physician in collaboration with a pharmacist .


Primary outcomes-the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up .


Secondary outcomes-undertreatment , exposure to anticholinergic and sedative medicines , neuropsychiatric symptoms , cognitive function , falls , hospital admission , quality of life and cost-effectiveness .


Participant burden will be kept at a minimum .


The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur , rendering serious adverse events highly unlikely .


Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed .


This study has been registered at http://www.ClinicalTrials.gov ( trial registration number : NCT01876095 ) .


Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents .


To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia .


A 38-week , double-blind , active-controlled , non-inferiority study ; randomisation ( 2:2:1 ) to aripiprazole once-monthly 400 mg , oral aripiprazole ( 10-30 mg/day ) or aripiprazole once-monthly 50 mg ( a dose below the therapeutic threshold for assay sensitivity ) .


clinicaltrials.gov , NCT00706654 . )


A total of 1118 patients were screened , and 662 responders to oral aripiprazole were randomised .


Kaplan-Meier estimated impending relapse rates at week 26 were 7.12 % for aripiprazole once-monthly 400 mg and 7.76 % for oral aripiprazole .


This difference ( -0.64 % , 95 % CI -5.26 to 3.99 ) excluded the predefined non-inferiority margin of 11.5 % .


Treatments were superior to aripiprazole once-monthly 50 mg ( 21.80 % , P < or = 0.001 ) .


Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole , and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg .


Persons with serious mental illness ( SMI ) are disproportionately burdened by premature mortality .


This disparity is exacerbated by poor continuity of care with the health system .


The Veterans Health Administration ( VA ) developed Re-Engage , an effective population-based outreach program to identify veterans with SMI lost to care and to reconnect them with VA services .


However , such programs often encounter barriers getting implemented into routine care .


Adaptive designs are needed when the implementation intervention requires augmentation within sites that do not initially respond to an initial implementation intervention .


This protocol describes the methods used in an adaptive implementation design study that aims to compare the effectiveness of a standard implementation strategy ( Replicating Effective Programs , or REP ) with REP enhanced with External Facilitation ( enhanced REP ) to promote the uptake of Re-Engage .


This study employs a four-phase , two-arm , longitudinal , clustered randomized trial design .


VA sites ( n = 158 ) across the United States with a designated Re-Engage provider , at least one Veteran with SMI lost to care , and who received standard REP during a six-month run-in phase .


Subsequently , 88 sites with inadequate uptake were stratified at the cluster level by geographic region ( n = 4 ) and VA regional service network ( n = 20 ) and randomized to REP ( n = 49 ) vs. enhanced REP ( n = 39 ) in phase two .


The primary outcome was the percentage of veterans on each facility outreach list documented on an electronic web registry .


The intervention was at the site and network level and consisted of standard REP versus REP enhanced by external phone facilitation consults .


At 12 months , enhanced REP sites returned to standard REP and 36 sites with inadequate participation received enhanced REP for six months in phase three .


Secondary implementation outcomes included the percentage of veterans contacted directly by site providers and the percentage re-engaged in VA health services .


Adaptive implementation designs consisting of a sequence of decision rules that are tailored based on a site 's uptake of an effective program may produce more relevant , rapid , and generalizable results by more quickly validating or rejecting new implementation strategies , thus enhancing the efficiency and sustainability of implementation research and potentially leading to the rollout of more cost-efficient implementation strategies .


Current Controlled Trials ISRCTN21059161 .


This study aims to obtain preliminary data on the efficacy of yoga for reducing self-reported menopausal hot flashes in a randomized study including an attention control group .


We randomized 54 late perimenopausal women ( 2-12 mo of amenorrhea ) and postmenopausal women ( > 12 mo of amenorrhea ) -- aged 45 to 58 years and who experienced at least four hot flashes per day , on average , for at least 4 weeks -- to one of three groups : yoga , health and wellness education ( HW ) , and wait list ( WL ) .


Yoga and HW classes consisted of weekly 90-minute classes for 10 weeks .


All women completed daily hot flash diaries throughout the trial ( 10 wk ) to track the frequency and severity of hot flashes .


The mean hot flash index score is based on the number of mild , moderate , severe , and very severe hot flashes .


Hot flash frequency declined significantly across time for all three groups , with the strongest decline occurring during the first week .


There was no overall significant difference in hot flash frequency decrease over time by treatment groups , but the yoga and HW groups followed similar patterns and showed greater decreases than the WL group .


On week 10 , women in the yoga group reported an approximately 66 % decrease in hot flash frequency , women in the HW group reported a 63 % decrease , and women in the WL group reported a 36 % decrease .


The hot flash index showed a similar pattern .


Results suggest that yoga can serve as a behavioral option for reducing hot flashes but may not offer any advantage over other types of interventions .


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 .


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 .


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 .


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 .


Diabetes mellitus is an independent risk factor for lacunar strokes .


Few data are available regarding patient features , infarct location , and recurrent vascular events for patients with diabetes mellitus with lacunar stroke .


We compared features at study entry and prognosis during 3.6 years of follow-up of patients with diabetes mellitus versus patients without diabetes mellitus with recent lacunar stroke participating in the Secondary Prevention of Small Subcortical Strokes ( SPS3 ) randomized trial .


Among the 3020 participants , the prevalence of diabetes mellitus was 37 % with a mean duration of 11 years .


Diabetes mellitus was independently associated with slightly younger age ( 63 versus 64 years ; P < 0.001 ) , Hispanic ethnicity ( 36 % versus 28 % ; P < 0.0001 ) , ischemic heart disease ( 11 % versus 6 % ; P = 0.002 ) , and peripheral vascular disease ( 5 % versus 2 % ; P < 0.001 ) .


Patients with diabetes mellitus more frequently had intracranial stenosis 50 % ( P < 0.001 ) , infarcts involving the brain stem or cerebellum ( P < 0.001 ) , and more extensive white matter abnormalities ( P < 0.001 ) .


Patients with diabetes mellitus were almost twice as likely to have a recurrent stroke ( hazard ratio [ HR ] , 1.8 ; 95 % confidence interval [ CI ] , 1.4-2 .3 ) , recurrent ischemic stroke ( HR , 1.8 ; 95 % CI , 1.4-2 .4 ) , disabling/fatal stroke ( HR , 1.8 ; 95 % CI , 1.2-2 .9 ) , myocardial infarction ( HR , 1.7 ; 95 % CI , 1.0-2 .8 ) , and death ( HR , 2.1 95 % CI , 1.6-2 .8 ) compared with patients without diabetes mellitus .


Patients with diabetes mellitus with lacunar stroke have a distinctive clinical profile that includes double the prevalence of systemic and intracranial atherosclerosis , preferential involvement of the posterior circulation , and a poor prognosis for recurrent stroke and death .


http://www.clinicaltrials.gov .


Unique identifier : NCT00059306 .


Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity .


Long-term data on the durability of treatment benefit are needed .


To report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia .


In a multicenter clinical trial , 419 children with amblyopia ( visual acuity , 20/40 to 20/100 ) were randomly assigned to patching ( minimum of 6 h/d ) or atropine sulfate eyedrops , 1 % ( 1 drop daily ) , for 6 months .


Treatment after 6 months was at the discretion of the investigator .


Two years after enrollment , an unselected subgroup of 188 children were enrolled into long-term follow-up .


Initial treatment with patching or atropine with subsequent treatment at investigator discretion .


Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes .


Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR ( approximately 20/25 ) ; 59.9 % of amblyopic eyes had visual acuity of 20/25 or better and 33.3 % , 20/20 or better .


Mean interocular acuity difference ( IOD ) at 15 years of age was 0.21 logMAR ( 2.1 lines ) ; 48.3 % had an IOD of 2 or more lines and 71.4 % , 1 or more lines .


Treatment ( other than spectacles ) was prescribed for 9 participants ( 6.1 % ) aged 10 to 15 years .


Mean IOD was similar at examinations at 10 and 15 years of age ( 2.0 and 2.1 logMAR lines , respectively ; P = .39 ) .


Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial ( mean logMAR , 0.09 ) compared with those aged 5 to 6 years ( mean logMAR , 0.18 ; P < .001 ) .


When we compared subgroups based on original treatment with atropine or patching , no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age ( P = .44 and P = .43 , respectively ) .


At 15 years of age , most children treated for moderate amblyopia when younger than 7 years have good visual acuity , although mild residual amblyopia is common .


The outcome is similar regardless of initial treatment with atropine or patching .


The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age .


clinicaltrials.gov Identifier : NCT00000170 .


Total knee replacement ( TKR ) is a cost-effective treatment option for severe osteoarthritis ( OA ) .


While prevalence of OA is higher among blacks than whites , TKR rates are lower among blacks .


Physicians ' implicit preferences might explain racial differences in TKR recommendation .


The objective of this study was to evaluate whether the magnitude of implicit racial bias predicts physician recommendation of TKR for black and white patients with OA and to assess the effectiveness of a web-based instrument as an intervention to decrease the effect of implicit racial bias on physician recommendation of TKR .


In this web-based study , 543 family and internal medicine physicians were given a scenario describing either a black or white patient with severe OA refractory to medical treatment .


Questionnaires evaluating the likelihood of recommending TKR , perceived medical cooperativeness , and measures of implicit racial bias were administered .


The main outcome measures included TKR recommendation , implicit racial preference , and medical cooperativeness stereotypes measured with implicit association tests .


Subjects displayed a strong implicit preference for whites over blacks ( P < .0001 ) and associated `` medically cooperative '' with whites over blacks ( P < .0001 ) .


Physicians reported significantly greater liking for whites over blacks ( P < .0001 ) and reported believing whites were more medically cooperative than blacks ( P < .0001 ) .


Participants reported providing similar care for white and black patients ( P = .10 ) but agreed that subconscious biases could influence their treatment decisions ( P < .0001 ) .


There was no significant difference in the rate of recommendation for TKR when the patient was black ( 47 % ) versus white ( 38 % ) ( P = .439 ) , and neither implicit nor explicit racial biases predicted differential treatment recommendations by race ( all P > .06 ) .


Although participants were more likely to recommend TKR when completing the implicit association test before the decision , patient race was not significant in the association ( P = .960 ) .


Physicians possessed explicit and implicit racial biases , but those biases did not predict treatment recommendations .


Clinicians ' biases about the medical cooperativeness of blacks versus whites , however , may have influenced treatment decisions .


Antiretroviral pre-exposure prophylaxis ( PrEP ) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy .


Blood concentrations of PrEP medications are one objective marker of adherence .


In a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate ( TDF ) and TDF with emtricitabine ( FTC/TDF ) among 4747 African women and men with an HIV-infected partner , we measured plasma tenofovir concentrations from participants in the active PrEP arms : 29 HIV seroconverters ( cases ) and 196 randomly selected controls who remained uninfected .


Among controls , 71 % of visits had tenofovir concentrations > 40 ng/mL , consistent with steady-state daily dosing , compared with 21 % of cases at the visit HIV was first detected .


Pill count data indicated that 96 % of controls and 66 % of cases had > 80 % adherence for these same visits .


The estimated protective effect of PrEP against HIV , based on concentrations > 40 ng/mL , was 88 % ( 95 % confidence interval : 60 to 96 , P < 0.001 ) for individuals receiving TDF and 91 % ( 95 % confidence interval : 47 to 98 , P = 0.008 ) for individuals receiving FTC/TDF .


Controls had consistent patterns of PrEP concentrations during follow-up ; among the 81 % with concentrations > 40 ng/mL at month 1 , 75 % maintained this concentration at month 12 .


Only 5 of 29 seroconverters seemed to be consistently adherent to PrEP .


Tenofovir concentrations > 40 ng/mL were associated with older age and shorter time on study ; concentrations 40 ng/mL occurred more commonly when participants reported no sex with their HIV-infected partner .


Plasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition .


Most of those who took PrEP seemed to have high and consistent adherence .


Postoperative vision loss complicates an estimated 1 in 1,100 prone spine surgical cases .


This complication has been attributed to ischemic optic neuropathy , with one proposed reason being perioperative elevations in intraocular pressure ( IOP ) .


Previous research has studied the effects of table inclination on IOP in awake volunteers ; however , the effects in spine surgery patients have not been investigated for reverse Trendelenburg positioning using a prospective , randomized controlled study design .


To assess the effect of table inclination on IOP in patients undergoing prone spine surgery .


Single-center , prospective randomized controlled study .


Nineteen patients with no history of eye pathology , undergoing prone spine surgery at Dwight D. Eisenhower Army Medical Center , were randomly assigned to a table position : neutral , 5 , or 10 of reverse Trendelenburg .


Intraocular pressure , mean arterial pressure ( MAP ) , estimated blood loss , fluid resuscitation , and ophthalmologic complication were assessed before and after induction and at incremental times during surgery , beginning at 30 minutes , 60 minutes , and 60-minute increments thereafter .


Multivariate analyses evaluated surgical time , IOP , MAP , estimated blood loss , and fluid resuscitation as a function of table inclination to determine the effect of patient positioning on identified risk factors for postoperative vision loss .


Surgical times ranged from 33 to 325 minutes .


A rapid increase in IOP was noted after prone positioning , with continued increases as time elapsed .


The neutral group exhibited statistically higher IOP compared with the 5 reverse Trendelenburg group after 60 minutes and the 10 group through 60 minutes of surgery .


The trend continued through 120 minutes ; however , because of a lack of power , we were unable to determine the statistical significance .


There were no statistically significant differences between the 5 and 10 reverse Trendelenburg groups .


Reverse Trendelenburg positioning elicits decreased IOP compared with prone positioning for surgery times less than 120 minutes .


Ten degrees of reverse Trendelenburg attenuate the rise in IOP during prone spine surgery superiorly in comparison with 5 .


No significant complications were associated with reverse Trendelenburg positioning .


We aimed to examine the efficacy of two psycho-oncological interventions in anxiety , depression , and self-perceived as well as physiological stress in inpatients with gynaecological cancer .


Forty-five women were included in the trial .


Thirty-five were categorized as being at high risk of anxiety and depression , and were randomized to either a single psycho-oncological therapy session or a single-session relaxation intervention .


A significant decrease in anxiety [ mean ( t0 ) = 12 , mean ( t1 ) = 7.47 , p = 0.001 ] and depression [ mean ( t0 ) = 9.71 , mean ( t1 ) = 6.35 , p < 0.001 ] was observed in the psycho-oncological intervention group .


In the relaxation group , anxiety also significantly decreased [ mean ( t0 ) = 11.67 , mean ( t1 ) = 8.22 , p = 0.003 ] , whereas depression did not .


A comparative analysis of both interventions showed a trend in favour of psycho-oncological therapy for the treatment of depression ( F = 3.3 , p = 0.078 ) .


However , self-reported stress ( p = 0.031 ) and different objective stress parameters only significantly decreased in the relaxation group .


Psycho-oncological interventions should represent an essential part of interdisciplinary care for gynaecological cancer patients .


Both types of intervention may reduce anxiety .


However , the single psycho-oncological therapy session might be slightly more effective in treating depression , whereas the single-session relaxation intervention seems to have a stronger effect on physiological stress parameters .


Cash transfers ( CTs ) are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low - and middle-income countries .


The Child Support Grant ( CSG ) is the largest CT programme in South Africa , and on the continent , targeting poor children from birth until the age of 18 with a monthly sum of R300 ( USD30 ) .


Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes .


Since its implementation , one of the major concerns about the grant has been take-up rates , particularly for younger children .


This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa .


This is a descriptive study utilising data from a community-based , cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township , South Africa .


At the 12-week visit , half ( 52 % ) of the mothers who had enrolled in the study had applied for the CSG on behalf of their children , while 85 % of the mothers who had not applied were still planning to apply .


Only 38 % ( 1,327 ) of all children had received the CSG .


In this study , many mothers had not applied for the CSG in the first few months after delivery , and only a third of children had accessed the grant .


Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery .


To observe the therapeutic effect of different schemes of mild moxibustion for treatment of ( yang-deficiency induced cold-accumulation type ) knee osteoarthritis ( KOA ) .


Fifty-nine KOA patients were chosen and randomly divided into control group ( n = 30 ) and test group ( n = 29 ) .


Patients of the control group were treated by mild moxi - bustion of Neixiyan ( EX-HE4 ) and Waixiyan ( ST 35 ) for 30 min , once daily for 14 days ( two courses ) , and those of the test group were treated by mild moxibustion of EX-HE 4 and ST 35 for 30 mini once daily for 7 days ( the same to control group ) , followed by moxibustion of Yaoyangguan ( GV 3 ) and Mingmen ( GV 4 ) once daily for next 7 days more .


In addition , patients of the two groups were also treated by routine acupuncture stimulation of EX-HE 4 , ST 35 , Yanglingquan ( GB 34 ) , Kunlun ( BL 60 ) , etc. .


The interval between two therapeutic courses was one day .


The Lysholm Knee Score Scale ( LKSS ) was used to evaluate the therapeutic effect .


Visual analogue scale ( VAS ) was employed to assess the patient 's knee-joint pain severity ( arthralgia ) , and scores of morning stiffness , arthrocele , and walking restraint degree of the knee-joint were also evaluated before and after the treatment .


After the treatment , the scores of VAS , morning stiffness , arthrocele and walking restraint degree of the knee-joint of both groups were significantly decreased ( P < 0.05 ) , and the scores of the test group were obviously lower than those of the con - trol group ( P < 0.05 ) .


The effective rate of the test group was 89.66 % ( 26/29 ) which was obviously higher than that ( 70.00 % , 21/30 ) of the control group ( P < 0.05 ) .


Mild moxibustion of Neixiyan ( EX-HE 4 ) and Waixiyan ( ST 35 , local acu - points ) , and Yaoyangguan ( GV 3 ) and Mingmen ( GV 4 ) has a better therapeutic effect for KOA patients than moxibustion of local acupoints only .


Despite the commonly observed comorbidity of alcohol and tobacco use disorders and years of research , the mechanism underlying concurrent use of alcohol and tobacco is not yet clear .


In this study , we used functional magnetic resonance imaging ( fMRI ) to investigate the relationship between brain responses to alcohol and smoking cues in 45 subjects with episodic drinking and regular smoking .


fMRI data were collected from two studies performing an alcohol-craving task and a smoking-craving task .


First , we identified brain voxels significantly activated for both substance cues and then associated the activation of these voxels with various alcohol - and nicotine-dependence measures .


Significant clusters ( cluster-wise p < .05 ) correlated with behavioral assessments were extracted , and clusters identified from both cues were compared .


The association tests with various dependence scores showed that the loss of behavioral control subcategory in the Alcohol Dependence Scale was significantly correlated with brain activation of the posterior cingulate cortex ( PCC ) and right posterior insula regardless of cue types .


Our findings suggest that the PCC and right posterior insula , each playing a role in the salience network , are affected significantly by impaired control for alcohol and in turn influence brain responses to not only alcohol but also smoking cues , providing insight to neuronal mechanisms for concurrent use or comorbidity of alcohol and nicotine dependence .


To test the effectiveness of tailored quitline ( telephone ) counselling among smoking parents recruited into cessation support through their children 's primary schools .


Two-arm randomized controlled trial with 3 - and 12-month follow-up .


Proactive telephone counselling was administered by the Dutch national quitline .


Smoking parents were recruited through their children 's primary schools and received either intensive quitline support in combination with tailored supplementary materials ( n = 256 ) or a standard self-help brochure ( n = 256 ) .


The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up .


Also measured were baseline characteristics , use of and adherence to nicotine replacement therapy and pharmacotherapy , smoking characteristics and implementation of a home smoking ban .


Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [ 34.0 versus 18.0 % , odds ratio ( OR ) = 2.35 , confidence interval ( CI ) = 1.56-3 .54 ] than those who received a standard self-help brochure .


Parents who received quitline counselling were more likely to use nicotine replacement therapy ( P < 0.001 ) than those who received a standard self-help brochure .


Among parents who did not achieve abstinence , those who received quitline counselling smoked fewer cigarettes at 3-month ( P < 0.001 ) and 12-month assessment ( P < 0.001 ) , were more likely to make a quit attempt ( P < 0.001 ) , to achieve 24 hours ' abstinence ( P < 0.001 ) and to implement a complete home smoking ban ( P < 0.01 ) .


Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking .


Prescription of generic products is a way to reduce health expense .


Bioequivalence is the most appropriate procedure to evaluate the quality and therapeutic efficacy of a generic product .


Generic prescriptions are a strategic choice in Tunisia .


We expose in this work , a bioequivalence study witch compare a generic ( test ) product : DIABENIL * manufactured by a Tunisian pharmaceutical industry Dar Essaidaly to the innovative ( reference ) product : DAONIL * of Aventis pharma laboratories .


The bioequivalence of two glibenclamide 5-mg tablets was determined in healthy human , adult volunteers after a single dose in a randomized cross-over in double blind study .


Test and reference were administered to twenty-four healthy volunteers of both sexes after overnight fasting .


In total , 15 Blood samples were collected before and following the administration of the drug .


Serum concentrations of glibenclamide were determined by validated HPLC method .


The pharmacokinetic parameters AUC0t , AUC0 , Cmax and tmax were tested for bioequivalence .


All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of 0.80-1 .25 limits .


We conclude that the two formulations exhibited comparable pharmacokinetic profiles and that the two products can be considered interchangeable in medical practice .


Because lithium exerts neuroprotective effects in preclinical models of polyglutamine disorders , our objective was to assess the safety and efficacy of lithium carbonate ( 0.5-0 .8 milliequivalents per liter ) in patients with Machado-Joseph disease ( spinocerebellar ataxia type 3 [ MJD/SCA3 ] ) .


For this phase 2 , single-center , double-blind , parallel , placebo-controlled trial ( ClinicalTrials.gov identifier NCT01096082 ) , 62 patients who had MJD/SCA3 with a disease duration 10 years and an independent gait were randomly assigned ( 1:1 ) to receive either lithium or placebo .


After 24 weeks , 169 adverse events were reported , including 50.3 % in the lithium group ( P = 1.00 ; primary safety outcome ) .


Sixty patients ( 31 in the placebo group and 29 in the lithium group ) were analyzed for efficacy ( intention-to-treat analysis ) .


Mean progression between groups did not differ according to scores on the Neurological Examination Score for the Assessment of Spinocerebellar Ataxia ( NESSCA ) after 48 weeks ( -0.35 ; 95 % confidence interval , -1.7 to 1.0 ; primary efficacy outcome ) .


The lithium group exhibited minor progression on the PATA speech-rate ( P = 0.002 ) , the nondominant Click Test ( P = 0.023 ) , the Spinocerebellar Ataxia Functional Index ( P = 0.003 ) , and the Composite Cerebellar Functional Score ( P = 0.029 ) .


Lithium was safe and well tolerated , but it had no effect on progression when measured using the NESSCA in patients with MJD/SCA3 .


This slowdown in secondary outcomes deserves further clarification .


Dihydrotestosterone is the main androgen causative of androgenetic alopecia , a psychologically and physically harmful condition warranting medical treatment .


We sought to compare the efficacy and safety of dutasteride ( type 1 and 2 5-alpha reductase inhibitor ) with finasteride ( type 2 5-alpha reductase inhibitor ) and placebo in men with androgenetic alopecia .


Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride ( 0.02 , 0.1 , or 0.5 mg/d ) , finasteride ( 1 mg/d ) , or placebo for 24 weeks .


The primary end point was hair count ( 2.54-cm diameter ) at week 24 .


Other assessments included hair count ( 1.13-cm diameter ) and width , photographic assessments ( investigators and panel ) , change in stage , and health outcomes .


In total , 917 men were randomized .


Hair count and width increased dose dependently with dutasteride .


Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth ( frontal view ; panel photographic assessment ) at week 24 compared with finasteride ( P = .003 , P = .004 , and P = .002 , respectively ) and placebo ( all P < .001 ) .


The number and severity of adverse events were similar among treatment groups .


The study was limited to 24 weeks .


Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated .


We aimed to compare the efficacy of isosorbide mononitrate and doxazosin in the treatment of lower urinary tract symptoms ( LUTS ) .


80 patients with LUTS were included in this randomized clinical study .


All patients were evaluated with uroflowmetry , post-void residual ( PVR ) urine , prostate volume , International Prostate Symptom Score ( IPSS ) , serum PSA , urinalysis and culture .


40 patients were prescribed doxazosin for 4 weeks , another 40 were prescribed isosorbide mononitrate for 4 weeks .


Urologic re-evaluation was done at the end of the study .


74 patients completed the study .


The mean age of patients was 59.6 0.7 years , the mean PSA value was 1.7 0.1 ng/ml and the mean prostate volume was 41.9 1.7 ml .


Doxazosin markedly improved IPSS ( from 16.2 0.7 to 9.5 0.5 ) , maximum urinary flow rate ( from 10.9 0.7 to 12.8 0.6 ml/s ) and PVR urine ( from 68.1 9.4 to 39.0 4.4 ml ) ( p < 0.0001 , p < 0.0001 , p = 0.0004 , respectively ) .


Isosorbide only improved IPSS ( from 16.5 0.9 to 14.6 0.8 ) ( p = 0.032 ) .


Daily administration of isosorbide does not seem to be an alternative to - blocker therapy .


Controlled , randomized novel studies are required to establish that whether nitric oxide donors are an effective alternative in LUTS treatment .


Ulinastatin was reported has positive effects on preventing post-ERCP pancreatitis and hyperamylasemia for patients in average risk .


To observe the incidence of post-ERCP pancreatitis and investigate the efficacy and feasibility of using Ulinaststin to prevent post-ERCP pancreatitis .


A total of 280 patients were randomized into two arms : an experimental arm using Ulinastatin-containing contrast medium and a control arm using the same contrast medium without Ulinastatin .


Blood amylase and urine amylase-2 were measured at three and twenty-four hours after ERCP procedure .


There were distinct differences in the incidence of post-ERCP pancreatitis and average blood amylase levels in the two arms ( p < 0.05 ) .


Post-ERCP pancreatitis was observed in 20 patients ( 7.1 % ) , including 7 ( 4.37 % ) patients in the experimental arm , and 13 ( 10.83 % ) patients in control arm .


After 3 hours of the operation , the average blood amylase levels in control and experimental arm were 224.8234.27 U/L and 189.5220.94 U/L , respectively .


Correspondingly , the levels were 233.5935.05 U/L and 187.0923.14 U/L after 24 hours .


But the difference was not statistically significant in urine amylase-2 levels , hemoleukocyte count and operation time .


The exploitation of Ulinastatin in ERCP could decrease the incidence but could not completely prevent the development of post-ERCP pancreatitis .


Malaria due to Plasmodium knowlesi is reported throughout South-East Asia , and is the commonest cause of it in Malaysia .


P. knowlesi replicates every 24h and can cause severe disease and death .


Current 2010 WHO Malaria Treatment Guidelines have no recommendations for the optimal treatment of non-severe knowlesi malaria .


Artemisinin-combination therapies ( ACT ) and chloroquine have each been successfully used to treat knowlesi malaria ; however , the rapidity of parasite clearance has not been prospectively compared .


Malaysia 's national policy for malaria pre-elimination involves mandatory hospital admission for confirmed malaria cases with discharge only after two negative blood films ; use of a more rapidly acting antimalarial agent would have health cost benefits .


P. knowlesi is commonly microscopically misreported as P. malariae , P. falciparum or P. vivax , with a high proportion of the latter two species being chloroquine-resistant in Malaysia .


A unified ACT-treatment protocol would provide effective blood stage malaria treatment for all Plasmodium species .


ACT KNOW , the first randomised controlled trial ever performed in knowlesi malaria , is a two-arm open-label trial with enrolments over a 2-year period at three district sites in Sabah , powered to show a difference in proportion of patients negative for malaria by microscopy at 24h between treatment arms ( clinicaltrials.gov #NCT 01708876 ) .


Enrolments started in December 2012 , with completion expected by September 2014 .


A total sample size of 228 is required to give 90 % power ( 0.05 ) to determine the primary end point using intention-to-treat analysis .