The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28 .


Other exploratory outcomes are included such as severity of symptoms , suicide intention and ideation , depression , hopelessness , self-esteem , impulsivity , anger , and duration of respective treatments .


Clinical Trial.gov : NCT01512602 .


The aim of our study was to evaluate the differences between sclerotherapy with and without ethanol concentration monitoring for the treatment of simple renal cysts .


Sixty-seven patients with 70 simple renal cysts were randomly assigned to two groups in a 12-month prospective controlled trial .


One group ( group A ) was treated with computed tomography ( CT ) - guided sclerotherapy without ethanol concentration monitoring ( 33 patients with 35 cysts ) , whereas the other group ( group B ) had ethanol concentration monitoring ( 34 patients with 35 cysts ) during the procedure .


Treatment outcomes between the two groups were compared 12 months later with follow-up ultrasound examination .


After the 12-month follow-up period , the overall success rate was 74.3 % in group A and 94.3 % in group B ( p = 0.022 ) .


The mean cyst size before and after treatment was 8.6 2.0 cm and 2.3 2.9 cm , respectively , in group A , and 8.4 1.7 cm and 0.8 1.9 cm , respectively , in group B.


The final size of the cysts in group B was significantly smaller than that in group A ( p = 0.015 ) .


The likelihood of treatment with ethanol concentration monitoring being successful was approximately 16 times higher than without ethanol concentration monitoring ( p = 0.026 ; odds ratio = 15.7 ; 95 % confidence interval : 1.38-179 .49 ) .


There were no major complications in either group .


Monitoring of Hounsfield units ( HU ) of ethanol by CT is an effective method in the treatment of simple renal cysts with ethanol sclerotherapy .


The ethanol sclerotherapy procedure can be terminated at the point of clear fluid aspiration because the HU ( -190 ) of CT scan corresponds to it .


To correlate aqueous vasoactive protein changes with macular edema after dexamethasone implant in retinal vein occlusion ( RVO ) .


Prospective , interventional case series .


Twenty-three central RVO ( CRVO ) and 17 branch RVO ( BRVO ) subjects with edema despite prior anti-vascular endothelial growth factor ( VEGF ) treatment had aqueous taps at baseline and 4 and 16 weeks after dexamethasone implant .


Best-corrected visual acuity ( BCVA ) and center subfield thickness were measured every 4 weeks .


Aqueous vasoactive protein levels were measured by protein array or enzyme-linked immunosorbent assay .


Thirty-two vasoactive proteins were detected in aqueous in untreated eyes with macular edema due to RVO .


Reduction in excess foveal thickness after dexamethasone implant correlated with reduction in persephin and pentraxin 3 ( Pearson correlation coefficients = 0.682 and 0.638 , P = .014 and P = .003 ) .


Other protein changes differed among RVO patients as edema decreased , but 50 % of patients showed reductions in hepatocyte growth factor , endocrine gland VEGF , insulin-like growth factor binding proteins , or endostatin by 30 % .


Enzyme-linked immunosorbent assay in 18 eyes ( 12 CRVO , 6 BRVO ) showed baseline levels of hepatocyte growth factor and VEGF of 168.2 20.1 pg/mL and 78.7 10.0 pg/mL , and each was reduced in 12 eyes after dexamethasone implant .


Dexamethasone implants reduce several pro-permeability proteins providing a multitargeted approach in RVO .


No single protein in addition to VEGF can be implicated as a contributor in all patients .


Candidates for contribution to chronic edema in subgroups of patients that deserve further study include persephin , hepatocyte growth factor , and endocrine gland VEGF .


To compare the efficiency of dexamethasone implants to bevacizumab injections in macular oedema secondary to central retinal vein occlusion .


Randomized clinical trial at Cairo University Hospitals .


Sixty eyes of 60 newly diagnosed patients with macular oedema secondary to central retinal vein occlusion with best corrected visual acuity 0.3 logMAR ( 6/12 ) to counting fingers , no evidence of retinal ischaemia and/or neovascularization on fluorescein angiography and central subfield thickness 300m on ocular coherence tomography .


Patients were randomly assigned ( 30 eyes each group ) to either intravitreal dexamethasone implant or bevacizumab injections repeated whenever needed .


Best corrected visual acuity and ocular coherence tomography were done at baseline and monthly for 6 months .


Comparing best corrected visual acuity and central foveal subfield thickness between both groups during the 6-month period .


There was no significant difference in best corrected visual acuity between the two groups during the 6 months ( P-values > 0.05 ) .


The bevacizumab group had a statistically significant thinner central subfield thickness at 1 month ( P-value 0.006 ) and no statistically significant difference for the rest of the 6 months ( P-values > 0.05 ) .


There was a statistically significant higher intraocular pressure for dexamethasone implant group ( compared with bevacizumab ) at 3-6 months ( P-values < 0.05 ) , respectively .


Both drugs provided effective best corrected visual acuity improvements and central subfield thickness reductions that showed no statistically significant difference between the two groups .


To evaluate the effects of vildagliptin compared to glimepiride on glycemic control , insulin resistance and post-prandial lipemia .


167 type 2 diabetic patients , not adequately controlled by metformin , were randomized to vildagliptin 50 mg twice a day or glimepiride 2 mg three times a day for 6 months , in a double blind , randomized clinical trial .


We evaluated : body mass index ( BMI ) , glycemic control , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , fasting plasma proinsulin ( FPPr ) , glucagon , lipid profile , resistin , retinol binding protein-4 ( RBP-4 ) , visfatin and vaspin .


Furthermore , at the randomization and at the end of the study all patients underwent an euglycemic hyperinsulinemic clamp to evaluate M value and an oral fat load .


Despite a similar decrease of glycated hemoglobin , there were an increase of body weight with glimepiride + metformin and a decrease with vildagliptin + metformin .


Fasting plasma insulin increased with glimepiride + metformin , while it did not change with vildagliptin + metformin .


Vildagliptin + metformin improved lipid profile .


Regarding insulin sensitivity , vildagliptin + metformin increased M value .


Resistin , RBP-4 , vaspin and visfatin were decreased by vildagliptin + metformin , but in group to group comparison , only vaspin reduction resulted statistically significant .


Vildagliptin + metformin reduced post-prandial lipemia and insulinemia compared to glimepiride + metformin .


Vildagliptin , in addition to metformin , was more effective than glimepiride + metformin in reducing insulin resistance and post-prandial lipemia .


Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation ( NMES ) in the subacute phase after stroke have beneficial effects on basic arm body functions and activities ?


Multicentre randomised trial with concealed allocation , assessor blinding , and intention-to-treat analysis .


Forty-six people in the subacute phase after stroke with severe arm motor deficits ( initial Fugl-Meyer Assessment arm score 18 ) .


In addition to conventional stroke rehabilitation , participants in the experimental group received arm stretch positioning combined with motor amplitude NMES for two 45-minute sessions a day , five days a week , for eight weeks .


Control participants received sham arm positioning ( ie , no stretch ) and sham NMES ( ie , transcutaneous electrical nerve stimulation with no motor effect ) to the forearm only , at a similar frequency and duration .


The primary outcome measures were passive range of arm motion and the presence of pain in the hemiplegic shoulder .


Secondary outcome measures were severity of shoulder pain , restrictions in performance of activities of daily living , hypertonia , spasticity , motor control and shoulder subluxation .


Outcomes were assessed at baseline , mid-treatment , at the end of the treatment period ( 8 weeks ) and at follow-up ( 20 weeks ) .


Multilevel regression analysis showed no significant group effects nor significant time group interactions on any of the passive range of arm motions .


The relative risk of shoulder pain in the experimental group was non-significant at 1.44 ( 95 % CI 0.80 to 2.62 ) .


In people with poor arm motor control in the subacute phase after stroke , static stretch positioning combined with simultaneous NMES has no statistically significant effects on range of motion , shoulder pain , basic arm function , or activities of daily living .


NTR1748 .


To evaluate the efficacy and safety of omega-3 fatty acid supplementation in children with nonalcoholic fatty liver disease ( NAFLD ) .


Overweight/obese children with NAFLD ( n = 76 ; median age , 13 years ; IQR , 11.1-15 .2 years ) were eligible to participate in the study .


The diagnosis of NAFLD was based on elevated alanine aminotransferase ( ALT ) to 30 % of the upper limit of normal ( ULN ) and liver hyperechogenicity on ultrasound .


Patients were randomized to receive omega-3 fatty acids ( docosahexaenoic acid and eicosapentaenoic acid , 450-1300 mg/day ) or placebo ( omega-6 sunflower oil ) .


The primary outcome was the number of patients who demonstrated decreased ALT activity by 0.3 times the ULN .


Secondary outcomes included alterations in liver function tests , liver hyperechogenicity , insulin resistance , and other metabolic markers after 6 months of intervention .


Out of 76 enrolled patients , 64 completed the trial and were analyzed .


After 6 months , we found no significant differences between the omega-3 and placebo groups in the number of patients with decreased ALT by 0.3 times the ULN ( 24 vs 23 ) or in median ( IQR ) ALT activity ( 48.5 [ 31-62 ] U/L vs 39 [ 27-55 ] U/L ) , liver hyperechogenicity , insulin resistance , or serum lipid levels .


However , patients in the omega-3 group had lower levels of aspartate aminotransferase ( 28 [ 25-36 ] U/L vs 39 [ 27-55 ] U/L ; P = .04 ) and gamma-glutamyl transpeptidase ( 26 [ 17.5-36 .5 ] U/L vs 35 [ 22-52 ] U/L ; P = .04 ) , and significantly higher levels of adiponectin .


Omega-3 fatty acid supplementation did not increase the number of patients with decreased ALT levels and it did not affect liver steatosis on ultrasound , but it improved aspartate aminotransferase and gamma-glutamyl transpeptidase levels in children with NAFLD compared with placebo .


Registered with ClinicalTrials.gov : NCT01547910 .


Rivastigmine displays dose-dependent efficacy on cognition in patients with Alzheimer 's disease ( AD ) , as measured by the Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) .


Subanalysis of the OPTIMA ( OPtimising Transdermal Exelon In Mild-to-moderate Alzheimer 's disease ) study aimed to define ADAS-cog domains by factor analysis of individual items .


Efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch on individual items and newly derived domains was assessed .


OPTIMA was a 48-week , double-blind ( DB ) study in patients with mild-to-moderate AD .


Patients meeting pre-defined decline criteria during open-label treatment with 9.5 mg/24 h patch were randomized in the DB phase to 13.3 mg/24 h ( n = 280 ) or 9.5 mg/24 h ( n = 287 ) patch .


ADAS-cog change from baseline was a co-primary outcome measure .


Factor analysis categorized ADAS-cog items into newly derived domains .


Change from DB-baseline was calculated for domains and individual items .


Numerically , less decline was displayed with 13.3 mg/24 h versus 9.5 mg/24 h patch in the total ADAS-cog score at all time points ( significant at Week 24 , p = 0.027 ) .


Factor analysis identified two domains : memory and language .


Significantly , less decline was observed on the memory domain with 13.3 mg/24 h versus 9.5 mg/24 h patch at Weeks 12 , 24 , and 48 ( p < 0.05 ; observed cases ) .


Three items ( following commands , orientation , and word recognition ) displayed numerically less decline with 13.3 mg/24 h versus 9.5 mg/24 h patch at all time points .


No significant between-group differences were observed on the language domain .


Results suggest that the greater cognitive efficacy of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch is driven primarily by effects on memory , particularly in the areas of following commands , orientation , and word recognition .


Automated bolus delivery has recently been shown to reduce local anesthetic consumption and improve analgesia , compared with continuous infusion , in continuous sciatic and epidural block .


However , there are few data on the influence of local anesthetic delivery method on local anesthetic consumption following interscalene blockade .


This randomized , double-blind trial was designed to determine whether hourly automated perineural boluses ( 4 mL ) of local anesthesia delivered with patient-controlled pro re nata ( PRN , on demand ) boluses would result in a reduction in total local anesthesia consumption during continuous interscalene blockade after shoulder surgery compared with continuous perineural infusion ( 4 mL/h ) plus patient-controlled PRN boluses .


One hundred one patients undergoing major shoulder surgery under general anesthesia with ultrasound-guided continuous interscalene block were randomly assigned to receive 0.2 % ropivacaine via interscalene end-hole catheter either by continuous infusion 4 mL/h ( n = 50 ) or as automated bolus 4 mL/h ( n = 51 ) .


Both delivery methods were combined with 5 mL PRN boluses of 0.2 % ropivacaine with a lockout time of 30 minutes .


Postoperative number of PRN boluses , 24 - and 48-hour local anesthetic consumption , pain scores , rescue analgesia ( morphine ) , and adverse events were recorded .


There were no significant differences in either the number of PRN ropivacaine boluses or total 48 hour local anesthetic consumption between the groups ( 18.5 [ 11-25 .2 ] PRN boluses in the continuous infusion group vs 17 [ 8.5-29 ] PRN boluses in the automated bolus group ) .


Postoperative pain was similar in both groups ; on day 2 , the median average pain score was 4 ( 2-6 ) in the continuous infusion group versus 3 ( 2-5 ) in the automated bolus group ( P = 0.54 ) .


Nor were any statistically significant intergroup differences observed with respect to morphine rescue , incidence of adverse events , or patient satisfaction .


In continuous interscalene blockade under ultrasound guidance after shoulder surgery , automated boluses of local anesthetic combined with PRN boluses did not provide any reduction in local anesthetic consumption or rescue analgesia , compared with continuous infusion combined with PRN boluses .


The current study aimed to investigate the impact of brief mindfulness training on the performance of a sample of patients with TBI in an over-selectivity task .


Twenty-four patients who had suffered TBI and reported problems with focused or sustained attention .


The study was a between-subjects design ( mindfulness intervention vs control ) with difference between number of most and least chosen stimulus selections on an over-selectivity task as the dependent measure .


The results of this study indicated that stimulus over-selectivity was present in a group of patients with TBI .


However , the level of emergent over-selectivity was significantly reduced by a mindfulness induction when compared to a no - intervention control group .


The findings are discussed in terms of the efficacy of mindfulness training in reducing TBI-related cognitive deficits .


Type 2 diabetes mellitus ( T2DM ) management requires continuous treatment intensification due to progressive decline in - cell function in insulin resistant individuals .


Initial combination therapy of a dipeptidyl peptidase ( DPP ) -4 inhibitor with a thiazolidinedione ( TZD ) may be rational .


We assessed the effects of the DPP4 inhibitor alogliptin ( ALO ) combined with the TZD pioglitazone ( PIO ) , vs ALO monotherapy or placebo ( PBO ) , on - cell function and glycemic control in T2DM .


A 16-week , two-center , randomized , double-blind , PBO-controlled , parallel-arm intervention study in 71 patients with well-controlled T2DM ( age 59.16.3 years ; A1C 6.70.1 % ) treated with metformin , sulfonylurea , or glinide monotherapy was conducted .


Patients were treated with combined ALO 25mg and PIO 30mg daily or ALO 25mg daily monotherapy or PBO .


Main outcome measures included change in A1C and fasting plasma glucose ( FPG ) from baseline to week 16 .


In addition , change in - cell function parameters obtained from standardized meal tests at baseline and at week 16 was measured .


ALO/PIO and ALO decreased A1C from baseline by 0.90.1 and 0.40.2 % respectively ( both P < 0.001 vs PBO ) .


FPG was decreased to a greater extent by ALO/PIO compared with ALO monotherapy ( P < 0.01 ) .


ALO/PIO treatment improved - cell glucose sensitivity ( vs PBO ; P < 0.001 ) and fasting secretory tone ( vs PBO ; P = 0.001 ) , while ALO monotherapy did not change - cell function parameters .


All treatments were well tolerated .


Short-term treatment with ALO/PIO or ALO improved glycemic control in well-controlled T2DM patients , but only combined ALO/PIO improved - cell function .


These data support that initial combination therapy with a DPP4 inhibitor and TZD to address multiple core defects in T2DM may be a sensible approach .


The aim of this study was to evaluate the efficacy of a group Cognitive Behavioural Therapy ( CBT ) treatment for depression and anxiety in Parkinson 's disease ( PD ) .


A waitlist-controlled trial design was used .


Eighteen adults with PD and a comorbid DSM-IV-TR diagnosis of depression and/or anxiety were randomised to either Intervention ( 8-week group CBT treatment ) or Waitlist ( 8-week clinical monitoring preceding treatment ) .


The Depression , Anxiety , Stress Scale-21 ( DASS-21 ) was the primary outcome .


Assessments were completed at Time 1 ( pretreatment ) , Time 2 ( posttreatment/post-waitlist ) and 1-month and 6-month follow-ups .


At Time 2 , participants who received CBT reported greater reductions in depression ( M ( change ) = -2.45 ) than Waitlist participants ( M ( change ) = .29 ) and this effect was large , d = 1.12 , p = .011 .


Large secondary effects on anxiety were also observed for CBT participants , d = .89 , p = .025 .


All treatment gains were maintained and continued to improve during the follow-up period .


At 6-month follow-up , significant and large effects were observed for both depression ( d = 2.07 ) and anxiety ( d = 2.26 ) .


Group CBT appears to be an efficacious treatment approach for depression and anxiety in PD however further controlled trials with larger numbers of participants are required .


Australian New Zealand Clinical Trials Registry ( Trial ID : ACTRN12610000455066 ) .


Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation , with people walking more in summer compared to winter .


Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls .


Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial , to quantify the extent of such bias .


Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date .


The aim of the present study was to assess seasonal differences in a ) objective walking behaviour and b ) Theory of Planned Behaviour ( TPB ) variables during a randomised controlled trial of an intervention to promote walking .


315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care .


A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures , assessed immediately post-intervention and six months later .


Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures .


There were no significant differences in time spent walking in spring/summer compared to autumn/winter .


There was no significant seasonal variation in most TPB variables , although the belief that there will be good weather was significantly higher in spring/summer ( F = 19.46 , p < .001 ) .


Season did not significantly predict intention or objective walking behaviour , or moderate the effects of TPB variables on intention or behaviour .


Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial .


Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured .


Previous studies may have overestimated the extent of seasonality effects by selecting the most extreme summer and winter months to assess PA. .


In addition , participants recruited to behaviour change interventions might have higher levels of motivation to change and are less affected by seasonal barriers .


Current Controlled Trials ISRCTN95932902 .


To evaluate the efficacy of high-intensity focused ultrasound ( HIFU ) and cortical hormone in the treatment of non-neoplastic epithelial disorders of vulva .


A total of 268 cases with pathologically diagnosed non-neoplastic epithelial disorders of vulva were randomly allocated into two groups of high-intensity focused ultrasound ( HIFU ) ( n = 119 ) and cortical hormone ( n = 124 ) .


And 25 cases became lost to follow-ups .


Their signs , symptoms and quality-of-life were assessed before treatment , 1 month post-treatment and 3 months post-treatment .


And the relationship was analyzed between pathologic type , age , course and efficacies .


Their signs , symptoms and quality-of-life improved in both groups after 1 and 3 month .


Compared with drug therapy , HIFU showed superior results in lesion amelioration at 1 month with significantly statistical difference and so did lesion amelioration and therapeutic effect at 3 month .


And the efficacy of HIFU was better in those with > 10-year disease course and pathologically diagnosed lichen sclerosus in 3 months .


HIFU is both safe and effective in the treatment of non-neoplastic epithelial disorders of vulva .


The aim of this study was to investigate the acute effects of whole-body vibration on the motor function of patients with stroke .


The present investigation was a randomized clinical trial studying 43 individuals with hemiparesis after stroke , with 33 subjects allocated to the intervention group and 10 subjects allocated to the control group .


The intervention group was subjected to one session of vibration therapy ( frequency of 50 Hz and amplitude of 2 mm ) comprising four 1-min series with 1-min rest intervals between series in three body positions : bipedal stances with the knees flexed to 30 degrees and 90 degrees and a unipedal stance on the paretic limb .


The analytical tests were as follows : simultaneous electromyography of the affected and unaffected tibialis anterior and rectus femoris muscles bilaterally in voluntary isometric contraction ; the Six-Minute Walk Test ; the Stair-Climb Test ; and the Timed Get-Up-and-Go Test .


The data were analyzed by independent and paired t tests and by analysis of covariance .


There was no evidence of effects on the group and time interaction relative to variables affected side rectus femoris , unaffected side rectus femoris , affected side tibialis anterior , unaffected side tibialis anterior , and the Stair-Climb Test ( P > 0.05 ) .


There was evidence of effects on the group interaction relative to variables Six-Minute Walk Test and Timed Get-Up-and-Go Test ( P < 0.05 ) .


Whole-body vibration contributed little to improve the functional levels of stroke patients .


Retrospective studies have shown that statins decrease the rate and severity of exacerbations , the rate of hospitalization , and mortality in chronic obstructive pulmonary disease ( COPD ) .


We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large , multicenter , randomized trial .


We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations ( STATCOPE ) as a randomized , controlled trial of simvastatin ( at a daily dose of 40 mg ) versus placebo , with annual exacerbation rates as the primary outcome .


Patients were eligible if they were 40 to 80 years of age , had COPD ( defined by a forced expiratory volume in 1 second [ FEV1 ] of less than 80 % and a ratio of FEV1 to forced vital capacity of less than 70 % ) , and had a smoking history of 10 or more pack-years , were receiving supplemental oxygen or treatment with glucocorticoids or antibiotic agents , or had had an emergency department visit or hospitalization for COPD within the past year .


Patients with diabetes or cardiovascular disease and those who were taking statins or who required statins on the basis of Adult Treatment Panel III criteria were excluded .


Participants were treated from 12 to 36 months at 45 centers .


A total of 885 participants with COPD were enrolled for approximately 641 days ; 44 % of the patients were women .


The patients had a mean ( SD ) age of 62.28.4 years , an FEV1 that was 41.617.7 % of the predicted value , and a smoking history of 50.627.4 pack-years .


At the time of study closeout , the low-density lipoprotein cholesterol levels were lower in the simvastatin-treated patients than in those who received placebo .


The mean number of exacerbations per person-year was similar in the simvastatin and placebo groups : 1.361.61 exacerbations and 1.391.73 exacerbations , respectively ( P = 0.54 ) .


The median number of days to the first exacerbation was also similar : 223 days ( 95 % confidence interval [ CI ] , 195 to 275 ) and 231 days ( 95 % CI , 193 to 303 ) , respectively ( P = 0.34 ) .


The number of nonfatal serious adverse events per person-year was similar , as well : 0.63 events with simvastatin and 0.62 events with placebo .


There were 30 deaths in the placebo group and 28 in the simvastatin group ( P = 0.89 ) .


Simvastatin at a daily dose of 40 mg did not affect exacerbation rates or the time to a first exacerbation in patients with COPD who were at high risk for exacerbations .


( Funded by the National Heart , Lung , and Blood Institute and the Canadian Institutes of Health Research ; STATCOPE ClinicalTrials.gov number , NCT01061671 . )


The Japan Atherosclerosis Society 's 2007 Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases ( JAS2007GL ) advocate reducing LDL cholesterol ( LDL-C ) to target levels in patients with dyslipidemia , but achievement rates are frequently unsatisfactory even in the presence of lipid-lowering therapy .


This multicenter , open-label , randomized , parallel-group study compared the efficacy of rosuvastatin and atorvastatin on JAS2007GL LDL-C goals in Japanese patients not achieving their target goal with atorvastatin treatment .


The study involved 20 clinical institutes in Japan ( Kishiwada Atherosclerosis Prevention Study [ KAPS ] Group ) .


Patients with category II or III risk of coronary artery disease ( CAD ) , or those with a history of CAD ( secondary prevention ) , who had not achieved their JAS2007GL LDL-C goals during treatment with atorvastatin for at least 4 weeks were switched either to rosuvastatin 5 mg/day ( from atorvastatin 10 mg/day ) or rosuvastatin 10 mg/day ( from atorvastatin 20 mg/day ) ( n = 75 ) or continued to receive atorvastatin ( n = 77 ) .


The primary endpoint was achievement of LDL-C goals at 3 months .


The main secondary endpoint was achievement of LDL-C goal + high-sensitivity C-reactive protein level < 1.0 mg/L at 3 months .


Achievement rates for the primary endpoint were 49.3 % in the rosuvastatin group and 31.7 % in the atorvastatin group ( P = 0.022 ) .


Achievement rates for the main secondary endpoint were 40.0 % in the rosuvastatin group and 20.8 % in the atorvastatin group ( P = 0.010 ) .


Rosuvastatin and atorvastatin were both well tolerated in this study .


Rosuvastatin is a useful treatment option for Japanese patients who are not achieving their JAS2007GL LDL-C goal with atorvastatin .


Many cancer patients have problems performing activities of daily living ( ADL ) .


A randomised controlled trial was designed to examine the effects of an ADL intervention in addition to standard treatment and care in a hospital setting .


The objective of this article was to present the study and to analyse the feasibility of the recruitment process and the intervention .


Adult disabled cancer patients at Nstved Hospital in Denmark were enrolled between 1 March 2010 and 30 June 2011 and randomised into an ADL intervention or to a control group .


The intervention was performed by occupational therapists .


The feasibility of the recruitment was analysed with regard to success in achieving the estimated number of participants and identification of barriers , and feasibility of the intervention was based on calculations of patient attendance and patient acceptability .


The primary outcome of the randomised controlled trial was patients ' health-related quality of life 2 and 8weeks after baseline .


A total of 118 disabled cancer patients were enrolled in the study over a time span of 16months .


Very few meetings between occupational therapist and patient were cancelled .


Time spent on the intervention varied considerably , but for the majority of patients , time consumption was between 1-3 hours .


Despite difficulties with recruitment , participation was considered feasible and the intervention was accepted among patients .


Missing data in the follow-up period were mostly due to death among participants .


Very few participants declined to complete questionnaires during follow-up .


Glucocorticoids ( GCS ) remain one of the mainstay treatments in the management of ulcerative colitis ( UC ) but up to a third of patients will ultimately fail to respond and progress to a more severe and difficult to manage disease state .


Previous clinical studies suggest that the Toll-Like Receptor 9 ( TLR9 ) agonist DIMS0150 not only induces production of key anti-inflammatory cytokines as IL-10 but interestingly also enhances steroid sensitivity in steroid refractory UC patients .


We investigated , in the context of a clinical study , whether a pre-selection of steroid response genes could identify steroid refractory UC subjects most likely to respond to DIMS0150 treatment .


In a non-interventional pilot study , blood from steroid refractory UC patients and healthy volunteers was taken and thirty-four previously described steroid response genes were analysed by real time PCR analysis .


To establish clinical utility of the identified biomarkers , a placebo controlled , randomized , double blinded study in active steroid dependent and steroid resistant UC patients on concomitant steroid therapies was used ( EudraCT number : 2006-001846-15 ) .


We identified three potential biomarkers CD163 , TSP-1 and IL-1RII whose response to steroids was significantly enhanced when DIMS0150 was applied .


Thirty-four subjects were randomized to receive a single rectal administration of placebo or 30mg of DIMS0150 .


Blood derived PBMCs were obtained prior to dosing and assayed for evidence of a steroid enhancing effect following steroid incubation in the presence of DIMS0150 .


Comparison to established steroid sensitivity marker IL-6 confirmed that clinical responders are steroid refractory UC patients .


Upon study completion and un-blinding , the biomarker assay correctly predicted a clinical response in over 90 % of the patients .


Using specific steroid response biomarkers , GCS refractory UC patients most likely to benefit from DIMS0150 treatment could be identified and illustrates the usefulness of a personalized treatment approach .


The elderly ( 75years ) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly ( < 75years ) .


Whether the effects of everolimus-eluting stent ( EES ) in ST-segment elevation myocardial infarction ( STEMI ) are independent of age has not been reported .


We investigated the outcomes following primary PCI ( PPCI ) with bare-metal stent ( BMS ) or EES in elderly vs. non-elderly STEMI patients .


The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES .


The primary patient-oriented endpoint ( POCE ) was the combined of all-cause death , any-recurrent myocardial infarction ( MI ) and any-revascularization at 1-year .


The secondary endpoint included the device-oriented combined ( DOCE ) of cardiac death , target-vessel MI and target-lesion revascularization .


These endpoints and their components were compared between elderly and non-elderly .


Among patients enrolled in the trial , 245 ( 16.3 % ) were elderly , allocated to BMS ( n = 132 ) or EES ( n = 113 ) , while the remaining 1253 ( 83.7 % ) were non-elderly , allocated to BMS ( n = 615 ) or EES ( n = 638 ) .


At 1-year , both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group ( 24.5 % vs. 10.5 % , p < 0.001 and 15.9 % vs. 5.1 % , p < 0.001 ) .


Whereas in non-elderly , both POCE and DOCE were lower in EES vs. BMS ( 12.4 % vs. 8.8 % , p = 0.03 and 6.7 % vs. 3.6 % , p = 0.01 ) , no differences were found in elderly , with a tendency for interaction between age and stent type for POCE ( p = 0.05 ) .


On multivariate analysis age 75 years was an independent predictor of POCE ( HR 2.19 [ 95 % CI 1.59-3 .01 ] , p < 0.0001 ) and DOCE ( HR 2.42 [ 95 % CI 1.60-3 .7 ] , p < 0.001 ) at 1-year .


In STEMI patients undergoing PPCI , advanced age ( 75 years ) is associated with worse outcomes .


The beneficial effects of EES over BMS tended to be age-dependent .


This study investigated the efficacy and safety of cryotherapy , in the form of frozen gel gloves , in relation to docetaxel-induced hand and fingernail toxicities .


After piloting with 21 patients , a consecutive series sample of patients ( n = 53 ) prescribed docetaxel every 3 weeks , for a minimum of three cycles , was enrolled in this randomised control trial .


Participants acted as their own control , with the frozen gel glove worn on one randomised hand for 15 min prior to infusion , for the duration of the infusion , and for 15 min of after completion of treatment .


Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria .


To assess the potential for cross-infection of multi-use gloves , microbial culture and sensitivity swabs were taken of each glove at every tenth use .


Of the 53 participants enrolled in the main study , 21 provided evaluable data .


There was a 60 % withdrawal rate due to patient discomfort with the intervention .


The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma grade 1 ( 5/5 % ) , nail discolouration grade 1 ( 81/67 % ) , nail loss grade 1 ( 19/19 % ) and nail ridging grade 1 ( 57/57 % ) .


No significant differences were determined between hand conditions in terms of time to event , nor in terms of toxicity in gloved and non-gloved hands .


While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe , its limited efficacy , patient discomfort and some logistical issues preclude its use in our clinical setting .


Elevated resting pulse rate ( RPR ) is a well-recognized risk factor for adverse outcomes .


Epidemiological evidence supports the beneficial effects of regular exercise for lowering RPR , but studies are mainly confined to persons younger than 65 years .


We set out to evaluate the utility of a physical activity ( PA ) intervention for slowing RPR among older adults .


A total of 424 seniors ( ages 70-89 years ) were randomized to a moderate intensity PA intervention or an education-based `` successful aging '' health program .


Resting pulse rate was assessed at baseline , 6 months , and 12 months .


Longitudinal differences in RPR were evaluated between treatment groups using generalized estimating equation models , reporting unstandardized coefficients with robust SEs .


Increased frequency and duration of aerobic training were observed for the PA group at 6 and 12 months as compared with the successful aging group ( P < .001 ) .


In both groups , RPR remained unchanged over the course of the 12-month study period ( P = .67 ) .


No significant improvement was observed ( [ SE ] = 0.58 [ 0.88 ] ; P = .51 ) for RPR when treatment groups were compared using the generalized estimating equation method .


Comparable results were found after omitting participants with a pacemaker , cardiac arrhythmia , or who were receiving - blockers .


Twelve months of moderate intensity aerobic training did not improve RPR among older adults .


Additional studies are needed to determine whether PA of longer duration and/or greater intensity can slow RPR in older persons .


Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus ( PDA ) but with many contraindications and potential side-effects .


In the past two years , oral paracetamol administration to several preterm infants with PDA has been reported .


Here , a randomized , non-blinded , parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants .


One hundred and sixty infants ( gestational age 34 weeks ) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol ( n = 80 ) or ibuprofen ( n = 80 ) .


After the initial treatment course in both groups , the need for a second course was determined by echocardiographic evaluation .


The main outcome was rate of ductal closure , and secondary outcomes were adverse effects and complications .


The ductus was closed in 65 ( 81.2 % ) infants of the paracetamol group compared with 63 ( 78.8 % ) of the ibuprofen group .


The 95 % confidence interval of the difference between these groups was [ -0.080,0.128 ] , demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen .


In fact , the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group .


No significant differences in other clinical side effects or complications were noted .


This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding .


Therefore , paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants .


ChiCTR.org ChiCTR-TRC-12002177 .


Hyperkalemia is a common medical emergency that may result in serious cardiac arrhythmias .


Standard therapy with insulin plus glucose reliably lowers the serum potassium concentration ( [ K ( + ) ] ) but carries the risk of hypoglycemia .


This study examined whether an intravenous glucose-only bolus lowers serum [ K ( + ) ] in stable , nondiabetic , hyperkalemic patients and compared this intervention with insulin-plus-glucose therapy .


A randomized , crossover study was conducted in 10 chronic hemodialysis patients who were prone to hyperkalemia .


Administration of 10 units of insulin with 100 ml of 50 % glucose ( 50 g ) was compared with the administration of 100 ml of 50 % glucose only .


Serum [ K ( + ) ] was measured up to 60 min .


Patients were monitored for hypoglycemia and EKG changes .


Baseline serum [ K ( + ) ] was 6.01 0.87 and 6.23 1.20 mmol/l in the insulin and glucose-only groups , respectively ( p = 0.45 ) .


At 60 min , the glucose-only group had a fall in [ K ( + ) ] of 0.50 0.31 mmol/l ( p < 0.001 ) .


In the insulin group , there was a fall of 0.83 0.53 mmol/l at 60 min ( p < 0.001 ) and a lower serum [ K ( + ) ] at that time compared to the glucose-only group ( 5.18 0.76 vs. 5.73 1.12 mmol/l , respectively ; p = 0.01 ) .


In the glucose-only group , the glucose area under the curve ( AUC ) was greater and the insulin AUC was smaller .


Two patients in the insulin group developed hypoglycemia .


Infusion of a glucose-only bolus caused a clinically significant decrease in serum [ K ( + ) ] without any episodes of hypoglycemia .


Variable airway function is a central feature of the asthmatic condition .


Thus , habitually active asthmatics are certain to exercise under conditions of variable airway ( dys ) function .


The purpose of this study was to determine the effects of variable preexercise airway function on ventilation during whole-body exercise in asthmatic adults .


Eight mild asthmatic ( age = 26 yr ; VO2peak = 49 mLkgmin ) and nine nonasthmatic ( age = 30 yr ; VO2peak = 46 mLkgmin ) adults performed constant workrate cycling exercise to exhaustion after four separate interventions : 1 ) a control trial ( CON ) ; 2 ) inhalation of fast-acting 2-agonist ( BD ) ; 3 ) eucapnic voluntary hyperpnea challenge ( BC ) ; and 4 ) sham to the hyperpnea ( SHAM ) .


Pulmonary function was assessed at baseline and after each intervention .


Exercise ventilation and operating lung volumes were compared among the four exercise trials in both control and asthmatic subjects .


Baseline pulmonary function was significantly lower in asthmatic subjects compared with control subjects .


In asthmatic subjects , postintervention ( i.e. , preexercise ) forced expiratory volume 1.0 s was significantly different among the four exercise trials ( CON = 3.5 0.4 , BD = 4.1 0.4 , SHAM = 3.6 0.3 , BC = 2.8 0.3 L , P < 0.05 ) , whereas it was not different in control subjects .


There were no differences in exercise ventilation or operating lung volumes during exercise among the four trials either within asthmatic subjects or between control and asthmatic subjects .


These findings suggest that the state of airway function-whether bronchodilated or bronchoconstricted-before exercise in the mild asthmatic does not affect the exercise ventilatory response .


Thus , ventilatory system function in the asthmatic appears to be responsive to the acute requirement for increased airflow during whole-body exercise .


To comparatively analyze the efficacy , acceptability , and tolerability of various augmentation agents in adult patients with treatment-resistant depression .


An electronic literature search of PubMed , EMBASE , the Cochrane Library , Web of Science , EBSCO , PsycINFO , EAGLE , and NTIS for trials published up to December 2013 was conducted .


Several clinical trial registry agencies and US Food and Drug Administration reports were also reviewed .


No language , publication date , or publication status restrictions were imposed .


Randomized controlled trials comparing 11 augmentation agents ( aripiprazole , bupropion , buspirone , lamotrigine , lithium , methylphenidate , olanzapine , pindolol , quetiapine , risperidone , and thyroid hormone ) with each other and with placebo for adult treatment-resistant depression were included .


The proportion of patients who responded to treatment was defined as primary efficacy , and the proportion of all-cause discontinuation and side-effects discontinuation were respectively defined as acceptability and tolerability , which were assessed with odds ratios ( ORs ) and a Bayesian random-effects model with 95 % credible intervals ( CrIs ) .


A total of 48 trials consisting of 6,654 participants were eligible .


In terms of the primary efficacy , quetiapine ( OR = 1.92 ; 95 % CrI , 1.39-3 .13 ) , aripiprazole ( OR = 1.85 ; 95 % CrI , 1.27-2 .27 ) , thyroid hormone ( OR = 1.84 ; 95 % CrI , 1.06-3 .56 ) , and lithium ( OR = 1.56 ; 95 % CrI , 1.05-2 .55 ) were significantly more effective than placebo .


Sensitivity analyses indicated that efficacy estimates for aripiprazole and quetiapine were more robust than those for thyroid hormone and lithium .


In terms of acceptability , no significant difference was found between active agents and placebo .


In terms of tolerability , compared to placebo , quetiapine ( OR = 3.85 ; 95 % CrI , 1.92-8 .33 ) , olanzapine ( OR = 3.36 ; 95 % CrI , 1.60-8 .61 ) , aripiprazole ( OR = 2.51 ; 95 % CrI , 1.11-7 .69 ) , and lithium ( OR = 2.30 ; 95 % CrI , 1.04-6 .03 ) were significantly less well tolerated .


Quetiapine and aripiprazole appear to be the most robust evidence-based options for augmentation therapy in patients with treatment-resistant depression , but clinicians should interpret these findings cautiously in light of the evidence of potential treatment-related side effects .


As cancer survivorship increases , health care systems will be challenged to meet patient needs .


With the limited availability of clinician time and resources , novel methods of using patient-reported outcomes may improve the quality and efficiency of follow-up care in patients with breast cancer .


The authors conducted a randomized trial in patients with TNM stage I to III breast cancer comparing standard care with SIS.NET ( System for Individualized Survivorship Care , based on patient self-reported data , with review by Nurse practitioners , targeted Education , and Triage ) , a follow-up protocol including integration of online health questionnaires at 3-month intervals and the evaluation of self-reported symptoms monitored and addressed remotely by a nurse practitioner ( NP ) .


The primary endpoint was to quantify the time between symptom reporting and remote evaluation of symptoms .


The secondary endpoint was to compare use of health care resources ( breast cancer-related visits , total medical appointments , and laboratory and imaging studies ) over an 18-month period .


A total of 102 participants were enrolled ; 2 patients were excluded due to cancer recurrence .


In the SIS.NET arm , 74 % of new or changed self-reported symptoms were reviewed by a NP in < 3 days .


SIS.NET patients reported more new or changed symptoms compared with standard care patients ( 7.36 vs 3.2 ; P = .0045 ) .


During the 18-month trial , there were no statistically significant differences noted between the SIS.NET and standard care arms with regard to oncology-related appointments ( mean , 4.2 vs 4.1 appointments ) , number of physician visits ( mean , 10.8 vs 9.6 visits ) , or medical tests ( mean , 5.5 vs 5 tests ) .


Integration of online health questionnaires with remote review by a NP facilitated symptom reporting and may provide a means of convenient symptom assessment , but it did not appear to reduce health care resource use .


To compare the cumulative analgesic effect of electroacupuncture ( EA ) stimulation of Sanyinjiao ( SP 6 ) , Xuanzhong ( GB 39 ) and non-acupoint for primary dysmenorrhea patients .


A total of 200 patients with primary dysmenorrhea were randomly assigned to Sanyinjiao ( SP 6 , a dysmenorrheal-relieving related acupoint ) group , Xuanzhong ( GB 39 , an unrelated acupoint ) group , non-acupoint group and control group , with 50 cases in each group .


The participants were administered with EA ( 2 Hz/100 Hz , 0.5-1 .6 mA ) at SP 6 , GB 39 and non-acupoint for 30 min , once daily for 3 consecutive days .


The intensity of the pain was ranked from 0 ( no pain ) to 100 ( intolerable ) using visual analogue scale ( VAS ) and RSS ( Cox retrospective symptom scale ) severity rating scores ( RSS-COX 2 ) before and after three interventions .


In comparison with the control group , VAS and RSS-COX 2 scores were significantly lower in the SP 36 , GB 39 and non-acupoint groups ( P < 0.001 , P < 0.05 ) , suggesting an alleviation of the pain severity after EA treatment .


No significant differences were found among the three treatment groups in both VAS and RSS-COX 2 scores ( P > 0.05 ) .


EA stimulation of SP 6 , GB 39 and non-acupoint has a good cumulative analgesic effect in patients with primary dysmenorrhea .


The purpose of this study was to examine the effectiveness of a patient-provider educational intervention in reducing at-risk drinking among older adults .


This was a cluster-randomized controlled trial of 31 primary care providers and their patients ages 60 years and older at a community-based practice with seven clinics .


Recruitment occurred from July 2005 to August 2007 .


Eligibility was determined by telephone and a baseline mailed survey .


A total of 1,186 at-risk drinkers were identified by the Comorbidity Alcohol Risk Evaluation Tool .


Follow-up patient surveys were administered at 3 , 6 , and 12 months after baseline .


Study physicians and their patients were randomly assigned to usual care ( n = 640 patients ) versus the Project SHARE ( Senior Health and Alcohol Risk Education ) intervention ( n = 546 patients ) , which included personalized reports , educational materials , drinking diaries , physician advice during office visits , and telephone counseling delivered by a health educator .


Main outcomes were alcohol consumption , at-risk drinking ( overall and by type ) , alcohol discussions with physicians , health care utilization , and screening and intervention costs .


At 12 months , the intervention was significantly associated with an increase in alcohol-related discussions with physicians ( 23 % vs. 13 % ; p .01 ) and reductions in at-risk drinking ( 56 % vs. 67 % ; p .01 ) , alcohol consumption ( -2.19 drinks per week ; p .01 ) , physician visits ( -1.14 visits ; p = .03 ) , emergency department visits ( 16 % vs. 25 % ; p .01 ) , and nonprofessional caregiving visits ( 12 % vs. 17 % ; p .01 ) .


Average variable costs per patient were $ 31 for screening and $ 79 for intervention .


The intervention reduced alcohol consumption and at-risk drinking among older adults .


Effects were sustained over a year and may have been associated with lower health care utilization , offsetting screening and intervention costs .


Uric acid is an antioxidant with neuroprotective effects in experimental models of stroke .


We assessed whether uric acid therapy would improve functional outcomes at 90 days in patients with acute ischaemic stroke .


URICO-ICTUS was a randomised , double-blind , placebo-controlled , phase 2b/3 trial that recruited patients with acute ischaemic stroke admitted to ten Spanish stroke centres .


Patients were included if they were aged 18 years or older , had received alteplase within 45 h of symptom onset , and had an eligible National Institutes of Health Stroke Scale ( NIHSS ) score ( > 6 and 25 ) and premorbid ( assessed by anamnesis ) modified Rankin Scale ( mRS ) score ( 2 ) .


Patients were randomly allocated ( 1:1 ) to receive uric acid 1000 mg or placebo ( both infused intravenously in 90 min during the infusion of alteplase ) , stratified by centre and baseline stroke severity .


The primary outcome was the proportion of patients with excellent outcome ( ie , an mRS score of 0-1 , or 2 if premorbid score was 2 ) at 90 days , analysed in the target population ( all randomly assigned patients who had been correctly diagnosed with ischaemic stroke and had begun study medication ) .


The study is registered with ClinicalTrials.gov , number NCT00860366 .


Between July 1 , 2011 , and April 30 , 2013 , we randomly assigned 421 patients , of whom 411 ( 98 % ) were included in the target population ( 211 received uric acid and 200 received placebo ) .


83 ( 39 % ) patients who received uric acid and 66 ( 33 % ) patients who received placebo had an excellent outcome ( adjusted risk ratio 123 [ 95 % CI 096-156 ] ; p = 0099 ) .


No clinically relevant or statistically significant differences were reported between groups with respect to death ( 28 [ 13 % ] patients who received uric acid vs 31 [ 16 % ] who received placebo ) , symptomatic intracerebral haemorrhage ( nine [ 4 % ] vs six [ 3 % ] ) , and gouty arthritis ( one [ < 1 % ] vs four [ 2 % ] ) .


516 adverse events occurred in the uric acid group and 532 in the placebo group , of which 61 ( 12 % ) and 67 ( 13 % ) , respectively , were serious adverse events ( p = 0703 ) .


The addition of uric acid to thrombolytic therapy did not increase the proportion of patients who achieved excellent outcome after stroke compared with placebo , but it did not lead to any safety concerns .


Institute of Health Carlos III of the Spanish Ministry of Health and Fundacin Doctor Melchor Colet .


Bimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects .


The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis .


In two multicenter , double-masked , randomized , parallel-group studies ( study 1 : n = 173 [ idiopathic ] ; study 2 : n = 36 [ chemotherapy-induced ] ) , subjects received bimatoprost 0.03 % or vehicle applied once daily to the upper eyelid margins .


The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment ( GEA ) scores .


Additional measures were eyelash length , thickness , and darkness , assessed by digital image analysis , and patient satisfaction ( Eyelash Satisfaction Questionnaire-9 ) .


Safety assessments included adverse-event monitoring and ophthalmic examinations .


Significantly more bimatoprost-treated subjects had at least a one-grade improvement in GEA score from baseline to month 4 compared with vehicle in study 1 ( 77.3 vs 17.6 % ; P < 0.001 ) and study 2 ( 88.9 vs 27.8 % ; P < 0.001 ) .


Bimatoprost-treated subjects had significantly greater increases in eyelash length , thickness , and darkness at the primary time point ( month 4 in both studies ; all P < 0.001 , study 1 ; P0 .04 , study 2 ) .


The bimatoprost group showed greater subject satisfaction in both studies .


The incidence of adverse events was similar in the two groups .


Ophthalmic examination showed slightly greater mean reductions in intraocular pressure ( IOP ) with bimatoprost than with vehicle , and the reductions were within the normal range for daily IOP fluctuations .


Bimatoprost 0.03 % was shown to be effective and safe in these studies of Japanese subjects with eyelash hypotrichosis .


This journal requires that authors assign a level of evidence to each article .


For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .


To determine the efficacy of delivering short-message service ( SMS ) to provide diabetes-related information in reducing the risk of developing diabetes in Chinese professional drivers with pre-diabetes .


A pilot single-blinded randomized controlled trial was conducted in Hong Kong between 05/2009 and 04/2012 .


Professional drivers with impaired glucose tolerance ( IGT ) were randomly allocated to either a SMS group receiving messages comprising knowledge and lifestyle modification on diabetes or to a control group with usual care .


Primary outcomes were the incidence rate of diabetes mellitus over 12 and 24 months period .


Fifty-four , out of 104 professional drivers recruited , were randomly allocated to intervention group .


Fewer subjects developed diabetes at 12 months in intervention group ( 5.56 % ) compared to control group ( 16.00 % ) .


Relative risk ( RR ) of diabetes onset was 0.35 ( 95 % CI : 0.101.24 ) and the number needed to treat ( NNT ) for preventing one diabetes was 9.57 .


At 24 months , RR increased to 0.62 ( 95 % CI : 0.241.61 ) with a NNT of 10.58 .


Logistic regression showed a significant odds ratio of 0.04 ( P = 0.021 ) for intervention group compared to control group at 12-month follow-up for completers and a non-significant odds ratio of 0.34 ( P = 0.303 ) at 24-month follow-up .


The SMS program proved to have potential to reduce the risk of developing diabetes at 12 months but additional measures should be integrated to prevent or delay disease progression .


To observe treatment efficacy of acupuncture at different distal acupoints for acute lumbar sprain after massage .


One hundred and fifty patients with acute lumbar sprain were randomly divided into a Yaotongdian ( Extra ) group , a Houxi ( SI 3 ) group , a Weizhong ( BL 40 ) group , a Chengshan ( BL 57 ) group and a Shuigou ( GV 26 ) group , total 5 groups , 30 cases in each one .


After the same massage treatment and based on groups divided , different distal acupoints above-mentioned were selected to be acupunctured .


Visual analogue scale ( VAS ) scores , lumbar activity and treatment efficacy of patients in 5 groups were evaluated .


With acupuncture at distal acupoints after massage , VAS scores of patients in 5 groups were decreased compared with those after massage treatment ( all P < 0.05 ) ; lumbar activity was all obviously improved ( all P < 0.01 ) ; and cured and markedly effective rates were all increased in comparison with those after massage ( all P < 0.01 ) .


But among 5 groups the differences of VAS scores , lumbar activity and cured and markedly effective rates were not statistically significant ( all P > 0.05 ) .


Based on massage treatment , acupuncture at distal acupoints could further improve the treatment efficacy for acute lumbar sprain , but there is no obvious effective difference among every distal acupoint .


As long as choosing acupoints with lower pain threshold and stimulating enough , good efficacy could be acquired for acute lumbar sprain .


To compare closed and open orchidectomy in dogs and the associated complications .


A randomised controlled blinded prospective clinical study of 73 cases was undertaken involving the recording of all complications during and in the 10days following orchidectomy of dogs fulfilling the standardised inclusion criteria .


The active variable was the surgical technique of either open or closed orchidectomy .


Dogs undergoing open orchidectomy experienced significantly more complication events than the dogs undergoing closed orchidectomy [ 24 of 34 ( 70 % ) versus 18 of 39 ( 46 % ) , P = 004 ] .


Dogs undergoing open orchidectomy were statistically more likely to develop scrotal complications ( 21 of 34 , 61 % ) compared with dogs undergoing closed orchidectomy ( 13 of 39 , 33 % ; P = 002 ) .


Open orchidectomy is associated with a higher overall complication rate in the first 10days after surgery than closed orchidectomy .


Open orchidectomy is also associated with increased scrotal complications including swelling , bruising and pain compared with closed orchidectomy .


There is much description in the literature of how patients with chronic obstructive pulmonary disease ( COPD ) manage their breathlessness and engage in self-care activities ; however , little of this is from the perspective of those with less severe disease , who are primarily managed in primary care .


This study aimed to understand the self-care experiences of patients with COPD who are primarily managed in primary care , and to examine the challenges of engaging in such behaviors .


Semistructured interviews were carried out with 15 patients with COPD as part of a larger project evaluating a self-management intervention .


Thematic analysis was supported by NVivo software ( version 8 , QSR International , Melbourne , Australia ) .


Three main themes are described , ie , experiencing and understanding symptoms of COPD , current self-care activities , and the importance of family perceptions in managing COPD .


Self-care activities evolved spontaneously as participants experienced symptoms of COPD .


However , there was a lack of awareness about whether these strategies would impact upon symptoms .


Perceptions of COPD by family members posed a challenge to self-care for some participants .


Health care professionals should elicit patients ' prior disease experiences and utilize spontaneous attempts at disease management in future self-management .


These findings have implications for promoting self-management and enhancing quality of life .


Dexamethasone has analgesic properties when given intravenously before surgery , but the optimal dose has not been determined .


We hypothesised that a dose of 40 mg dexamethasone would improve analgesia after outpatient shoulder surgery compared with 8 mg .


A randomised , double-blind , placebo-controlled clinical trial was conducted at Horsens Regional Hospital , Denmark .


Patients scheduled for arthroscopic subacromial decompression and/or acromioclavicular joint resection as an outpatient procedure ( n = 101 ) were randomised to receive intravenous dexamethasone 40 mg ( D40 ) , 8 mg ( D8 ) or placebo ( D0 ) before surgery .


The primary outcome was pain intensity 8 h after surgery rated on a numeric rating scale of 0 to 10 .


Secondary outcomes were pain intensity , analgesic consumption and side effects during the first 3 days after surgery .


Data from 73 patients were available for analysis : ( D40 : 25 , D8 : 26 , D0 : 22 patients ) .


Eight hours after surgery , pain intensity were : [ median ( interquartile range ) ] group D40 : 2 ( 1-4 ) , group D8 : 2.5 ( 1-5 ) , group D0 : 4 ( 2-7 ) .


There was no significant difference in pain intensity between group D40 and D8 after 8 h ( P = 0.46 ) or at any other time .


When comparing all three groups , a statistically significant dose-response relationship was seen for present , average and worst pain intensity after 8 h and on the following morning .


No differences were found in analgesic consumption .


No serious side effects were observed .


Although our data supported a dose-response relationship , increasing the dexamethasone dose from 8 to 40 mg did not improve analgesia significantly after outpatient shoulder surgery .


Major depressive disorder ( MDD ) is a long-lasting disorder with frequent relapses that have significant effects on the patient 's family .


Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder .


A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD .


Although MDD can easily become a chronic illness , there has been no intervention study on the families of patients with chronic depression .


In the present study , we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year .


Participants are patients with MDD lasting more than one year and their relatives .


Individually randomized , parallel-group trial design will be employed .


Participants will be allocated to one of two treatment conditions : relatives will receive ( a ) family psychoeducation ( four , two-hour biweekly multifamily psychoeducation sessions ) plus treatment-as-usual for the patient ( consultation by physicians ) , or ( b ) counseling for the family ( one counseling session from a nurse ) plus treatment-as-usual for the patient .


The primary outcome measure will be relatives ' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder .


Additionally , the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II ( BDI-II ) scale will be assessed .


Data from the intention-to-treat sample will be analyzed 16weeks after randomization .


This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year .


If this type of intervention is effective , it could be a new method of rehabilitation for patients with MDD lasting more than one year .


Clinical Trials.gov NCT01734291 ( registration date : 18 October 2012 ) .


Metabolomics is an emerging field with the potential to advance nutritional epidemiology ; however , it has not yet been applied to large cohort studies .


Our first aim was to identify metabolites that are biomarkers of usual dietary intake .


Second , among serum metabolites correlated with diet , we evaluated metabolite reproducibility and required sample sizes to determine the potential for metabolomics in epidemiologic studies .


Baseline serum from 502 participants in the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial was analyzed by using ultra-high-performance liquid-phase chromatography with tandem mass spectrometry and gas chromatography-mass spectrometry .


Usual intakes of 36 dietary groups were estimated by using a food-frequency questionnaire .


Dietary biomarkers were identified by using partial Pearson 's correlations with Bonferroni correction for multiple comparisons .


Intraclass correlation coefficients ( ICCs ) between samples collected 1 y apart in a subset of 30 individuals were calculated to evaluate intraindividual metabolite variability .


We detected 412 known metabolites .


Citrus , green vegetables , red meat , shellfish , fish , peanuts , rice , butter , coffee , beer , liquor , total alcohol , and multivitamins were each correlated with at least one metabolite ( P < 1.093 10 ( -6 ) ; r = -0.312 to 0.398 ) ; in total , 39 dietary biomarkers were identified .


Some correlations ( citrus intake with stachydrine ) replicated previous studies ; others , such as peanuts and tryptophan betaine , were novel findings .


Other strong associations included coffee ( with trigonelline-N-methylnicotinate and quinate ) and alcohol ( with ethyl glucuronide ) .


Intraindividual variability in metabolite levels ( 1-y ICCs ) ranged from 0.27 to 0.89 .


Large , but attainable , sample sizes are required to detect associations between metabolites and disease in epidemiologic studies , further emphasizing the usefulness of metabolomics in nutritional epidemiology .


We identified dietary biomarkers by using metabolomics in an epidemiologic data set .


Given the strength of the associations observed , we expect that some of these metabolites will be validated in future studies and later used as biomarkers in large cohorts to study diet-disease associations .


The PLCO trial was registered at clinicaltrials.gov as NCT00002540 .


To assess the efficacy and safety of tocilizumab ( TCZ ) plus methotrexate/placebo ( MTX/PBO ) over 2years and the course of disease activity in patients who discontinued TCZ due to sustained remission .


ACT-RAY was a double-blind 3-year trial .


Patients with active rheumatoid arthritis despite MTX were randomised to add TCZ to ongoing MTX ( add-on strategy ) or switch to TCZ plus PBO ( switch strategy ) .


Using a treat-to-target approach , open-label conventional synthetic disease-modifying antirheumatic drugs ( csDMARDs ) , other than MTX , were added from week 24 if Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ( DAS28-ESR ) > 3.2 .


Between weeks 52 and 104 , patients in sustained clinical remission ( DAS28-ESR < 2.6 at two consecutive visits 12weeks apart ) discontinued TCZ and were assessed every 4weeks for 1year .


If sustained remission was maintained , added csDMARDs , then MTX/PBO , were discontinued .


Of the 556 randomised patients , 76 % completed year 2 .


Of patients entering year 2 , 50.4 % discontinued TCZ after achieving sustained remission and 5.9 % achieved drug-free remission .


Most patients who discontinued TCZ ( 84.0 % ) had a subsequent flare , but responded well to TCZ reintroduction .


Despite many patients temporarily stopping TCZ , radiographic progression was minimal , with differences favouring add-on treatment .


Rates of serious adverse events and serious infections per 100 patient-years were 12.2 and 4.4 in add-on and 15.0 and 3.7 in switch patients .


In patients with normal baseline values , alanine aminotransferase elevations > 3upper limit of normal were more frequent in add-on ( 14.3 % ) versus switch patients ( 5.4 % ) .


Treat-to-target strategies could be successfully implemented with TCZ to achieve sustained remission , after which TCZ was stopped .


Biologic-free remission was maintained for about 3months , but most patients eventually flared .


TCZ restart led to rapid improvement .


NCT00810199 .


The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation ( AF ) with radiofrequency catheter ablation ( RFA ) compared with antiarrhythmic drugs ( AADs ) as first-line treatment .


A decision-analytic Markov model , based on MANTRA-PAF ( Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation ) study data , was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment .


Positive clinical effects were found in the overall population , a gain of an average 0.06 quality-adjusted life years ( QALYs ) to an incremental cost of 3033 , resulting in an incremental cost-effectiveness ratio of 50 570/QALY .


However , the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients .


This implied an incremental cost-effectiveness ratio of 3434/QALY in 50-year-old patients respectively 108 937/QALY in > 50-year-old patients .


Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF .


However , the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain , and in most of these AADs should be attempted before RFA ( MANTRA-PAF ClinicalTrials.gov number ; NCT00133211 ) .


With the increasing rate of cesarean delivery ( CD ) worldwide , there is a need for a revision of practices to prevent post-partum hemorrhage ( PPH ) after CD .


In search of a safe , cheap and effective alternative to oxytocin for prevention of PPH during the postoperative period of CD , the present study aimed to compare rectally administrated misoprostol with i.v. oxytocin infusion .


A randomized , placebo-controlled , double-blind prospective trial was undertaken on 192 women who did not have risk factors for PPH and who had an uneventful emergency CD under spinal anesthesia .


They were randomly allocated to receive either 800mg of rectal misoprostol or an i.v. infusion of oxytocin at the end of operation .


Primary outcome measures were the amount of postoperative ( 24h ) blood loss and incidence of PPH during the postoperative period .


The secondary outcome measures were the postoperative drop in hemoglobin concentration after 24h , need for additional uterotonic and blood transfusion , and side-effects/complications during the 24-h observation period .


There was a significant reduction of blood loss in the misoprostol group compared with the oxytocin group ( 144.5100.1 vs 191.7117.1 , P < 0.0001 ) .


The two groups were similar in terms of the secondary outcome parameters .


Rectally administrated 800-mg misoprostol may be an effective alternative to oxytocin infusion to prevent PPH after CD .


To compare the difference of the clinical efficacy on common peroneal palsy between the comprehensive therapy of electroacupuncture , moxibustion and moving cupping method and western medication .


Ninety cases of common peroneal nerve palsy were randomized into a comprehensive therapy group and a western medication group , 45 cases in each one .


In the comprehensive therapy group , electroacupuncture was applied to Yanglingquan ( GB 34 ) , Zusanli ( ST 36 ) , Xuanzhong ( GB 39 ) , Jiexi ( ST 41 ) , Taichong ( LR 3 ) , Zulinqi ( GB 41 ) and the others , combined with warm moxibustion and moving cupping on the lateral side of the affected leg .


The comprehensive therapy was used once a day .


In the western medication group , vitamin B1 , 10 mg each time , 3 times a day ; and mecobalamine , 0.5 mg each time , three times a day were prescribed for oral administration .


In the two groups , 15 days made one session , and the efficacy was observed after 2 sessions treatment .


The total effective rate of the improvement of sensory function and motor nerve function was 97.8 % ( 44/45 ) in the comprehensive therapy group and was 82.2 % ( 37 / 45 ) in the western medication .


The efficacy in the comprehensive therapy group was better than that of the western medication ( P < 0.01 ) .


The electrophysiological examination showed that the amplitude of motor conduction of deep peroneal nerve and that of sensory conduction of surficial peroneal nerve after treatment were improved remarkably as compared with those before treatment in the comprehensive therapy group ( both P < 0.05 ) .


The amplitude of motor conduction of deep peroneal nerve was improved significantly in the comprehensive therapy group as compared with that in the western medication group ( P < 0.05 ) .


The comprehensive therapy of electroacupuncture , moxibustion and moving cupping method achieves the significant efficacy on common peroneal nerve palsy as compared with western medication .


Patients with stroke present an asymmetric posture , severe balance dysfunction with delayed and disrupted equilibrium reactions , exaggerated postural sway and abnormal gait with an increased risk of falling .


The aim of this study is to evaluate the efficacy of hydrokinesytherapy on stance , balance and gait in individuals after stroke .


In this single-blinded randomized controlled trial , patients with stroke were divided into two groups : an experimental one ( G1 ) , performing hydrokinesytherapy ( 3 times/week ) in addition to a conventional physical therapy ( 3 times/week ) and a control one ( G2 ) , performing only a conventional physical therapy ( 6 times/week ) .


All of the participants underwent a proper clinical and baropodometric evaluation before and after 8 weeks of treatment .


The two groups presented similar clinical and instrumental features at enrolment ( mean modified Rankin Scale of 3 , and a disease duration of 6.3 1.4 months ) .


After treatment , the patients undergoing hydrokinesytherapy showed a significantly greater improvement than those undergoing traditional training .


Hydrokinesytherapy may be considered a promising treatment in improving gait and balance in individuals following stroke .


To evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer ( SCLC ) .


The Cancer and Leukemia Group B 30504 trial was a randomized , placebo-controlled , phase II study that enrolled patients before chemotherapy ( cisplatin 80 mg/m ( 2 ) or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m ( 2 ) per day on days 1 to 3 every 21 days for four to six cycles ) .


Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression .


Cross-over after progression was allowed .


The primary end point was progression-free survival ( PFS ) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with = .15 ; 80 randomly assigned patients provided 89 % power to detect a hazard ratio ( HR ) of 1.67 .


One hundred forty-four patients were enrolled ; 138 patients received chemotherapy .


Ninety-five patients were randomly assigned ; 10 patients did not receive maintenance therapy ( five on each arm ) .


Eighty-five patients received maintenance therapy ( placebo , n = 41 ; sunitinib , n = 44 ) .


Grade 3 adverse events with more than 5 % incidence were fatigue ( 19 % ) , decreased neutrophils ( 14 % ) , decreased leukocytes ( 7 % ) , and decreased platelets ( 7 % ) for sunitinib and fatigue ( 10 % ) for placebo ; grade 4 adverse events were GI hemorrhage ( n = 1 ) and pancreatitis , hypocalcemia , and elevated lipase ( n = 1 ; all in same patient ) for sunitinib and thrombocytopenia ( n = 1 ) and hypernatremia ( n = 1 ) for placebo .


Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib ( HR , 1.62 ; 70 % CI , 1.27 to 2.08 ; 95 % CI , 1.02 to 2.60 ; one-sided P = .02 ) .


Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib ( HR , 1.28 ; 95 % CI , 0.79 to 2.10 ; one-sided P = .16 ) .


Three sunitinib and no placebo patients achieved complete response during maintenance .


Ten ( 77 % ) of 13 patients evaluable after cross-over had stable disease on sunitinib ( 6 to 27 weeks ) .


Maintenance sunitinib was safe and improved PFS in extensive-stage SCLC .


Few data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis .


Posttrial observational study .


Frequent Hemodialysis Network ( FHN ) Nocturnal Trial participants who consented to extended follow-up .


The FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year .


Patients were enrolled starting in March 2006 and follow-up was completed by May 2010 .


After the 1-year trial concluded , FHN Nocturnal participants were free to modify their hemodialysis prescription .


We obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers .


We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment .


Median follow-up for the trial and posttrial observational period was 3.7 years .


In the nocturnal arm , there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up .


In the conventional arm , the numbers of deaths were 1 and 4 , respectively .


In the nocturnal dialysis group , the overall mortality HR was 3.88 ( 95 % CI , 1.27-11 .79 ; P = 0.01 ) .


Using as-treated analysis with a 12-month running treatment average , the HR for mortality was 3.06 ( 95 % CI , 1.11-8 .43 ; P = 0.03 ) .


Six-month running treatment data analysis showed an HR of 1.12 ( 95 % CI , 0.44-3 .22 ; P = 0.7 ) .


These results should be interpreted cautiously due to a surprisingly low ( 0.03 deaths/patient-year ) mortality rate for individuals randomly assigned to conventional home hemodialysis , low statistical power for the mortality comparison due to the small sample size , and the high rate of hemodialysis prescription changes .


Patients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis .


The implications of this result require further investigation .


Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population .


This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) .


At present , there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients .


Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population .


Therefore , a randomized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients .


The intervention is based on problem-solving therapy .


An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score 12 ) .


Sample size calculations yield 126 glioma patients to be included , who are randomly assigned to either the intervention group or a waiting list control group .


In addition , we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group .


Assessments take place at baseline , after 6 and 12 weeks , and after 6 and 12 months .


Primary outcome measure is the change in depressive symptoms .


Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction .


In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessments .


Their mood , health-related quality of life and fatigue is evaluated as well .


This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients .


If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .


Netherlands Trial Register NTR3223 .


The purpose of this study was to examine the relationship in change scores between regional lumbar motion and patient-rated pain of the previous week and back-related function in chronic low back pain patients enrolled in a randomized clinical trial and treated with either exercise therapy or spinal manipulation using 6 different motion parameters .


Regional lumbar motions were sampled using a 6 degrees of freedom instrumented spatial linkage system in 199 participants at baseline and 12-week follow-up .


The regional lumbar motion data were analyzed as a total cohort as well as relative to subgroup stratifications ; back pain only vs back and leg pain , and treatment modality .


For identifying clinically meaningful improvements in the measurements of back pain and back-related function , we used a 30 % threshold .


The relationship between change scores in patient-rated outcomes and objective measures of regional lumbar motion was found to be weak .


In contrast , distribution of pain and treatment received affected associations between motion parameters and patient-rated outcomes .


Thus , stronger correlation coefficients and significant differences between clinically relevant improved vs no clinical relevant change were found in some motion parameters in the subgroup with back pain only and the treatment group receiving spinal manipulation .


Overall , changes in regional lumbar motion were poorly associated with patient-rated outcomes measured by back-related function and back pain intensity scores .


However , associations between regional lumbar motion vs patient-rated pain and back-related function were different in relative subgroups ( back pain only vs back and leg pain and treatment ) .


We investigated the hypothesis that rimonabant , a cannabinoid antagonist/inverse agonist , would increase anxiety in healthy subjects during a simulation of the public speaking test .


Participants were randomly allocated to receive oral placebo or 90mg rimonabant in a double-blind design .


Subjective effects were measured by Visual Analogue Mood Scale .


Physiological parameters , namely arterial blood pressure and heart rate , also were monitored .


Twelve participants received oral placebo and 12 received 90mg rimonabant .


Rimonabant increased self-reported anxiety levels during the anticipatory speech and performance phase compared with placebo .


Interestingly , rimonabant did not modulate anxiety prestress and was not associated with sedation , cognitive impairment , discomfort , or blood pressure changes .


Cannabinoid-1 antagonism magnifies the responses to an anxiogenic stimulus without interfering with the prestress phase .


These data suggest that the endocannabinoid system may work on-demand to counteract the consequences of anxiogenic stimuli in healthy humans .


Hypovitaminosis D , especially during cold seasons , is quite prevalent among primary school children in Tehran .


The present study aimed to compare the efficacy of calcium-vitamin D-fortified-milk , - orange juice and supplement in primary school children .


Children aged 9-12years from both sexes were randomly assigned to one of six groups to receive plain milk , fortified milk , plain orange juice , fortified orange juice , supplement or placebo .


Both fortified-milk and - juice contained 100IU of vitamin D and 500mg of calcium per 200mL package , whereas supplement contained 200IU of vitamin D and 500mg of calcium .


The duration of intervention was 12weeks , from November 2008 to March 2009 .


A total of 410 children completed the study .


Regression analysis with adjustment for both sex and initial values of 25 ( OH ) D revealed that consumption of either supplement , fortified orange juice or fortified milk resulted in a 20.8 nm [ confidence interval ( CI ) = 17.4-23 .9 ] , 9.9 nm ( CI = 7.4-12 .3 ) or 6.9 nm ( CI = 3.3-10 .5 ) increase in circulating 25 ( OH ) D compared to the related control groups .


However , changes in serum osteocalcin and intact parathyroid hormone in the supplement group did not differ from those of fortified milk or plain milk .


The increment of osteocalcin in both plain milk and fortified milk was more than in fortified orange juice , although the difference was statistically insignificant .


Despite having double amount of vitamin D and being more effective in raising serum 25 ( OH ) D , supplementation did not confer additional benefit in terms of osteocalcin and intact parathyroid hormone compared to either fortified or plain milk .


Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy .


However , the process requires considerable time of expert staff .


The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular ( AV ) and interventricular ( VV ) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources .


BRAVO is a multi-centre , randomized , cross-over , non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device .


Patients are randomly allocated to six months in each arm .


In the echocardiographic arm , AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI .


In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography .


At the end of each six month arm , patients undergo the primary outcome measure of objective exercise capacity , quantified as peak oxygen uptake ( VO2 ) on a cardiopulmonary exercise test .


Secondary outcome measures are echocardiographic measurement of left ventricular remodelling , quality of life score and N-terminal pro B-type Natriuretic Peptide ( NT-pro BNP ) .


The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014 .


If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization , it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented .


Clinicaltrials.gov NCT01258829 .


To evaluate the effects of clopidogrel on clinical and clinicopathologic variables in healthy horses with experimentally induced endotoxemia .


12 adult mares .


Procedures-Horses were assigned with a randomization procedure to receive clopidogrel ( 4 mg/kg , once , then 2 mg/kg , q 24 h ; n = 6 ) or a placebo ( 6 ) through a nasogastric tube .


After 72 hours of treatment , horses received lipopolysaccharide ( LPS ; 30 ng/kg , IV ) .


Heart rate , respiratory rate , rectal temperature , CBC variables , plasma fibrinogen concentration , serum tumor necrosis factor - concentration , plasma von Willebrand factor concentration , and measures of platelet activation ( including ADP - and collagen-induced platelet aggregation and closure times , thrombelastography variables , and results of flow cytometric detection of platelet membrane P-selectin , phosphatidylserine , and microparticles ) were determined at various times before and after LPS administration by investigators unaware of the treatment groups .


Statistical analyses were performed with repeated-measures ANOVA .


4 of 6 clopidogrel-treated horses had significant decreases in ADP-induced platelet aggregation before and after LPS administration .


Heart rate increased significantly after LPS administration only for the placebo group .


No significant differences were detected between groups for CBC variables , closure time , and plasma concentration of fibrinogen or serum concentration of tumor necrosis factor - , and no clinically relevant differences were detected for other hemostatic variables .


In this study , administration of LPS did not induce platelet hyperreactivity in horses on the basis of measures of platelet adhesion , aggregation , degranulation , and procoagulant activity .


Administration of clopidogrel was associated with variable platelet antiaggregatory activity and attenuated some clinical signs of endotoxemia .


Exercise has been reported to decrease cancer-related fatigue and to increase quality of life ( QoL ) in various breast cancer ( BC ) populations .


However , studies investigating exercise during radiotherapy or resistance training are scarce .


We conducted a randomized , controlled trial ( BEST study ) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention .


One hundred sixty patients with BC stage 0-III were randomly assigned to a 12-week progressive resistance training ( 2 times/week ) or a 12-week relaxation control ( RC , 2 times/week ) .


Both interventions were group-based .


The primary end point fatigue was assessed with a 20-item multidimensional questionnaire , QoL with EORTC questionnaires .


Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13 .


Adherence to the intervention program as well as the completion rate ( 97 % ) for the primary outcome variable fatigue was high .


In intention-to-treat analyses for the N = 155 patients , significant between-group mean differences ( MD ) favoring the exercise group ( EX ) were observed for general fatigue ( P = 0.044 ) , especially for the subscale physical fatigue [ MD = -0.8 ; 95 % confidence interval -1.5 to -0.2 , P = 0.013 ] , but not for affective ( P = 0.91 ) or cognitive fatigue ( P = 0.65 ) .


For QoL , significantly larger improvements regarding the role function ( P = 0.035 ) and pain ( P = 0.040 ) were noted among exercisers compared with RCs .


Future perspective improved significantly stronger in the RC group compared with the EX group ( P = 0.047 ) .


The 12-week resistance training program was a safe , feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy .


As exercise was compared with another group-based intervention , results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits , and that the clinically relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher .


ClinicalTrials.gov NCT01468766 .


Chronic kidney disease ( CKD ) is associated with an increased risk of cardiovascular events following acute coronary syndrome ( ACS ) .


The underlying pathobiology and optimal treatments for this population continue to be evaluated .


Patients with CKD will receive fewer evidence-based therapies and experience high rates of adverse cardiovascular events in both the short - and long term .


The MERLIN-TIMI 36 ( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis in Myocardial Infarction 36 ) trial randomized non-ST-elevation ACS patients to ranolazine or placebo , with no exclusion for renal dysfunction ( except dialysis ) .


We conducted a prespecified analysis among 6543 patients based on the degree of CKD .


Patients with worse renal function were older with more comorbidities ( P < 0.0001 for each ) .


They were less likely to receive evidence-based cardiovascular medicines ( P < 0.04 for each ) .


Rates of an early invasive management strategy varied based on renal function ; however , among patients with the highest TIMI risk scores , the rates of an early invasive management strategy were similar regardless of glomerular filtration rate ( GFR ) ( Pinteraction = 0.005 ) .


Lower GFR was associated with increased rates of cardiovascular disease or myocardial infarction in the short and long term , even after adjustment ( GFR < 30 vs 90 mL/min/1 .73 m ( 2 ) ; hazard ratio [ HR ] : 3.24 [ 95 % confidence interval { CI } : 1.26-8 .38 ] through 7 days and HR : 2.12 [ 95 % CI : 1.33-3 .39 ] through 1 year ) .


The effect of ranolazine vs placebo on clinical outcomes was similar among those with and without CKD ( Pinteraction = not significant ) .


Following ACS , patients with renal dysfunction had more cardiovascular risk factors but were less likely to receive evidence-based medical therapies .


A strong graded , independent relationship between the degree of CKD and poor clinical outcomes was observed over time .


Continued efforts to optimize ACS treatment strategies in patients with CKD are warranted .


Empiric circumferential pulmonary vein isolation ( CPVI ) has become the therapy of choice for drug-refractory atrial fibrillation ( AF ) .


Although results are suboptimal , it is unknown whether mechanistically-based strategies targeting AF drivers are superior .


This study sought to determine the efficacy and safety of localized high-frequency source ablation ( HFSA ) compared with CPVI in patients with drug-refractory AF .


This prospective , multicenter , single-blinded study of 232 patients ( age 53 10 years , 186 males ) randomized those with paroxysmal AF ( n = 115 ) to CPVI or HFSA-only ( noninferiority design ) and those with persistent AF ( n = 117 ) to CPVI or a combined ablation approach ( CPVI + HFSA , superiority design ) .


The primary endpoint was freedom from AF at 6 months post-first ablation procedure .


Secondary endpoints included freedom from atrial tachyarrhythmias ( AT ) at 6 and 12 months , periprocedural complications , overall adverse events , and quality of life .


In paroxysmal AF , HFSA failed to achieve noninferiority at 6 months after a single procedure but , after redo procedures , was noninferior to CPVI at 12 months for freedom from AF and AF/AT .


Serious adverse events were significantly reduced in the HFSA group versus CPVI patients ( p = 0.02 ) .


In persistent AF , there were no significant differences between treatment groups for primary and secondary endpoints , but CPVI + HFSA trended toward more serious adverse events .


In paroxysmal AF , HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events .


In persistent AF , CPVI + HFSA offered no incremental value .


( Radiofrequency Ablation of Drivers of Atrial Fibrillation [ RADAR-AF ] ; NCT00674401 ) .


This study evaluated the non-inferiority of renoprotection afforded by benidipine versus hydrochlorothiazide in hypertensive patients with chronic kidney disease ( CKD ) .


In this prospective , multicenter , open-labeled , randomized trial , the antialbuminuric effects of benidipine and hydrochlorothiazide were examined in renin-angiotensin system ( RAS ) inhibitor-treated patients with blood pressure ( BP ) readings of 130/80 mmHg and 180/110 mmHg , a urinary albumin to creatinine ratio ( UACR ) of 300 mg/g , and an estimated glomerular filtration rate ( eGFR ) of 30 ml/min/1 .73 m ( 2 ) .


Patients received benidipine ( n = 176 , final dose : 4.8 mg/day ) or hydrochlorothiazide ( n = 170 , 8.2 mg/day ) for 12 months .


Benidipine and hydrochlorothiazide exerted similar BP - and eGFR-decreasing actions .


The UACR values for benidipine and hydrochlorothiazide were 930.8 ( 95 % confidence interval : 826.1 , 1048.7 ) and 883.1 ( 781.7 , 997.7 ) mg/g at baseline , respectively .


These values were reduced to 790.0 ( 668.1 , 934.2 ) and 448.5 ( 372.9 , 539.4 ) mg/g at last observation carried forward ( LOCF ) visits .


The non-inferiority of benidipine versus hydrochlorothiazide was not demonstrated ( benidipine/hydrochlorothiazide ratio of LOCF value adjusted for baseline : 1.67 ( 1.40 , 1.99 ) ) .


The present study failed to demonstrate the non-inferiority of the antialbuminuric effect of benidipine relative to that of hydrochlorothiazide in RAS inhibitor-treated hypertensive patients with macroalbuminuria .


A unilateral paravertebral ( PVB ) block with catheter can provide extendable analgesia without physiological changes .


The objective of this study was to assess the efficacy of PVB bupivacaine for providing perioperative pain relief in adults undergoing percutaneous nephrolithotomy ( PCNL ) under general anesthesia .


Fifty American Society of Anesthesiologists Grade I , II patients , aged 18 to 65 years , were included in this prospective , randomized , controlled , observer blinded trial .


PVB group patients received preinduction 20mL of 0.5 % bupivacaine in the T9-10 paravertebral space and a catheter in addition to general anesthesia .


Control group patients received only general anesthesia .


All patients received intravenous fentanyl ( 2g/kg on induction , 0.5 g/kg on 20 % increase in heart rate or mean blood pressure ) and paracetamol every 6 hours .


Postoperative pain was assessed using the visual analog scale ( VAS ) ( 0-10cm ) at rest and movement by a blinded observer at 0 , 1 , 2 , 4 , 6 , 12 , and 24 hours postoperatively .


Data of 48 patients were analyzed .


Intraoperative fentanyl requirement was higher in the control group ( 2.740.75 g/kg [ 95 % confidence interval ( CI ) 2.42 , 3.05 ] ) than the PVB group ( 2.070.26 g/kg [ 95 % CI 1.96 , 2.18 ] ) , ( P = 0.0001 ) .


Time to first postoperative analgesic requirement was longer in the PVB group ( 120min [ 30-570 ] ) than the control group ( 30min [ 0-180 ] ) , ( P = 0.0000 ) .


The VAS on rest ( 0 , 1 , 2 , and 12h ) and movement ( all time points ) were significantly lower in the PVB group .


Postoperative fentanyl consumption was lower in this group ( 175g [ 25-475 ] ) compared with the control group ( 525g [ ( 150-1275 ] ) , ( P = 0.0000 ) .


Unilateral PVB block with catheter provided effective perioperative analgesia for PCNL .


Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy , yet their relationship to aphakia vs primary intraocular lens ( IOL ) implantation remains unsettled .