Data were analysed using descriptive statistics and Spearman rank-order correlations .


The two interventions had similar demographic and physical activity characteristics except that home-based participants were younger ( p < 0.01 ) , more likely to be employed full time ( p 0.001 ) and reported less moderate-to-vigorous physical activity in the physical activity diaries compared to group exercise participants ( HB 29 21 min d ( -1 ) vs. G 57 35 min d ( -1 ) , p 0.001 ) .


Home-based participants had fair-to-good agreement between the physical activity diaries and AAS or ActiGraph data ( r = 0.39-0 .68 , p < 0.05 ) .


Group exercise physical activity diary data did not correlate significantly with either the AAS or ActiGraph data .


In contrast , group exercise AAS data had good correlations with ActiGraph data ( r = 0.49-0 .64 , p 0.001 ) .


Physical activity diaries should be interpreted cautiously unless intervention participants have an adequate understanding of physical activity intensity .


The AAS is the preferred self-report measure in middle-aged adults independent of intervention .


Human infections with avian influenza A/H7N9 have resulted in high morbidity and mortality in China .


To compare safety and immunogenicity of different doses of influenza A/Shanghai/2 / 13 ( H7N9 ) vaccine mixed with or without the MF59 adjuvant .


Multicenter , randomized , double-blind , phase 2 trial at 4 US sites enrolled 700 adults aged 19 to 64 years beginning in September 2013 ; 6-month follow-up was completed in May 2014 .


The H7N9 inactivated virus vaccine was administered intramuscularly on days 0 and 21 at nominal doses of 3.75 , 7.5 , 15 , or 45 g of hemagglutinin ( actual doses approximately 50 % higher ) with or without the MF59 adjuvant .


A total 99 , 100 , or 101 participants were randomized to each group ( 7 groups ; N = 700 ) .


Proportions achieving day 42 antibody titer of 40 or greater or seroconversion ( a minimum 4-fold increase to titer 40 ) with the hemagglutination inhibition assay ; vaccine-related serious adverse events through month 13 ; and solicited postvaccination symptoms through day 7 .


Hemagglutination inhibition antibodies were minimal after participants received an unadjuvanted vaccine .


After receiving 2 doses of H7N9 vaccine at a dosage of 3.75 g plus the MF59 adjuvant , day 42 seroconversion occurred in 58 participants ( 59 % ; 95 % CI , 48 % -68 % ) .


The peak seroconversion occurred at day 29 in 62 participants ( 62 % ; 95 % CI , 52 % -72 % ) .


The day 42 geometric mean titer was 33.0 ( 95 % CI , 24.7-44 .1 ) .


Higher antigen doses were not associated with increased response .


For the neutralizing antibody assays , after receiving 3.75 g of H7N9 vaccine plus the MF59 adjuvant , day 42 seroconversion occurred in 81 participants ( 82 % ; 95 % CI , 73 % -89 % ) .


The day 42 geometric mean titer was 81.4 ( 95 % CI , 66.6-99 .5 ) .


There was no statistically significant difference in day 42 hemagglutination inhibition seroconversion after mixing adjuvant with either the first or both 15 g doses ( n = 34 [ 35 % ; 95 % CI , 25 % -45 % ] vs n = 47 [ 47 % ; 95 % CI , 37 % -58 % ] , respectively ; P = .10 ) .


Recent receipt of seasonal influenza vaccination and older age were associated with attenuated response .


No vaccine-related serious adverse events occurred .


Solicited postvaccination symptoms were generally mild with more local symptoms seen in participants who received the adjuvant .


Point-of-use mixing and administration of 2 doses of H7N9 vaccine at the lowest tested antigen dose with MF59 adjuvant produced seroconversion in 59 % of participants .


Although these findings indicate potential value in this approach , the study is limited by the absence of antibody data beyond 42 days and the absence of clinical outcomes .


clinicaltrials.gov Identifier : NCT01938742 .


Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation .


The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial ( RCT ) .


Sixty-one smokers ( 65.6 % female , mean age = 47.3 years , smoked a mean of 19.7 cigarettes/day ) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control .


Participants in both conditions received an 8-week telephone-delivered , standard smoking cessation protocol ( with the transdermal nicotine patch ) .


Follow-ups were conducted at the end of treatment ( EOT ) , 6 - and 12-month timepoints .


There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended ( 9.32.8 vs. 9.33.0 , respectively ) .


While not statistically significant , participants in the exercise condition demonstrated higher verified abstinence rates ( EOT : 40 % vs. 22.6 % , odds ratio [ OR ] = 2.28 ; 6 - and 12-month follow-ups : 26.7 % vs. 12.9 % , OR = 2.46 ) .


Irrespective of treatment condition , higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention .


The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation .


Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation , the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit .


Statins are commonly used for the management of dyslipidemia in type 2 diabetes mellitus patients .


We hypothesized that atorvastatin could modulate the beta-cell function by altering the levels of proapoptotic and antiapoptotic lipoproteins and could also have an effect on insulin resistance .


The aim of the present pilot study was to assess the effect of atorvastatin 10 mg on pancreatic beta-cell function and insulin resistance in patients with hyperlipidemia and type 2 diabetes by using the homeostasis model assessment-2 ( HOMA2 ) index .


Fifty-one type 2 diabetes patients receiving oral antidiabetes drugs , not taking statins , with baseline low-density lipoprotein cholesterol between 2.6 mmol/L and 4.1 mmol/L were included .


Forty-three patients ( 21 in placebo group and 22 in atorvastatin group ) completed the study and were taken up for final analysis .


Fasting blood samples were obtained at baseline and at 12 weeks to determine levels of blood glucose , lipid profile , insulin , C-peptide and glycosylated hemoglobin ( A1C ) .


Atorvastatin nonsignificantly increased fasting serum insulin ( +14.29 % , p = 0.18 ) , accompanied by marginal nonsignificant increases in fasting plasma glucose and A1C .


There was a decrease in HOMA2 percent beta-cell function ( -2.9 % , p = 0.72 ) and increase in HOMA2 insulin resistance ( +14 % , p = 0.16 ) in the atorvastatin group as compared with baseline , but the difference was not statistically significant .


Atorvastatin in the dose used failed to produce significant change in pancreatic beta-cell function and insulin resistance in type 2 diabetes patients as assessed by the HOMA2 index .


The possible explanations include absence of lipotoxicity at prevailing levels of dyslipidemia at baseline or inadequacy of statin dose used in the study .


( Clinical Trials Registry-India : CTRI/2008/091 / 000099 ) .


Critically ill patients typically receive 60 % of estimated calorie requirements .


We aimed to determine whether the substitution of a 1.5-kcal / mL enteral nutrition solution for a 1.0-kcal / mL solution resulted in greater calorie delivery to critically ill patients and establish the feasibility of conducting a multicenter , double-blind , randomized trial to evaluate the effect of an increased calorie delivery on clinical outcomes .


A prospective , randomized , double-blind , parallel-group , multicenter study was conducted in 5 Australian intensive care units .


One hundred twelve mechanically ventilated patients expected to receive enteral nutrition for 2 d were randomly assigned to receive 1.5 ( n = 57 ) or 1.0 ( n = 55 ) kcal/mL enteral nutrition solution at a rate of 1 mL/kg ideal body weight per hour for 10 d. Protein and fiber contents in the 2 solutions were equivalent .


The 2 groups had similar baseline characteristics ( 1.5 compared with 1.0 kcal/mL ) .


The mean ( SD ) age was 56.4 16.8 compared with 56.5 16.1 y , 74 % compared with 75 % were men , and the Acute Physiology and Chronic Health Evaluation II score was 23 9.1 compared with 22 8.9 .


The groups received similar volumes of enteral nutrition solution [ 1221 mL/d ( 95 % CI : 1120 , 1322 mL/d ) compared with 1259 mL/d ( 95 % CI : 1143 , 1374 mL/d ) ; P = 0.628 ] , which led to a 46 % increase in daily calories in the group given the 1.5-kcal / mL solution [ 1832 kcal/d ( 95 % CI : 1681 , 1984 kcal/d ) compared with 1259 kcal/d ( 95 % CI : 1143 , 1374 kcal/d ) ; P < 0.001 ] .


The 1.5-kcal / mL solution was not associated with larger gastric residual volumes or diarrhea .


In this feasibility study , there was a trend to a reduced 90-d mortality in patients given 1.5 kcal/mL [ 11 patients ( 20 % ) compared with 20 patients ( 37 % ) ; P = 0.057 ] .


The substitution of a 1.0 - with a 1.5-kcal / mL enteral nutrition solution administered at the same rate resulted in a 46 % greater calorie delivery without adverse effects .


The results support the conduct of a large-scale trial to evaluate the effect of increased calorie delivery on clinically important outcomes in the critically ill .


Ilaprazole , a proton pump inhibitor ( PPI ) currently in clinical use , may provide improved acid suppression vs. other PPIs .


To compare the pharmacodynamic and pharmacokinetic profiles of ilaprazole and esomeprazole .


A phase 1 , randomised , open-label , single-centre , 4-period crossover study was conducted in 40 healthy volunteers .


Ilaprazole 10 , 20 or 40mg or esomeprazole 40mg was administered once daily for 5days with 5-day washout intervals .


Pharmacokinetic blood samples and intragastric pH measurements were collected at scheduled timepoints for 24h after dosing on Days 1 and 5 .


Esomeprazole 40mg provided significantly better pH control during the initial hours ( 0-4h ) after a single dose , but ilaprazole ( particularly 20 and 40mg ) provided significantly better pH control for the entire 24-h period and during evening and overnight hours after single and multiple doses .


Increasing ilaprazole doses resulted in dose-proportional increases in peak plasma concentration and area under the plasma concentration vs. time curve following single and multiple doses .


Ilaprazole was safe and generally well tolerated ; an unexpectedly high incidence of allergic eye and skin reactions were observed but were not specific to any dosing regimen .


Plasma gastrin concentrations did not increase proportionately with increasing ilaprazole dose .


Ilaprazole provided significantly better pH control over 24h and during evening and overnight hours compared with esomeprazole in healthy volunteers , which may translate to greater relief of night-time heartburn in the clinical setting for patients with gastric acid-related disorders .


The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke .


This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records .


Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization .


Remotely installed , electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome .


Outcome data from electronic health records were analyzed using marginal models .


There were 106 Clinical Practice Research Datalink family practices allocated ( intervention , 53 ; control , 53 ) , with 11 391 ( control , 5516 ; intervention , 5875 ) participants with acute stroke ever diagnosed .


Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices .


During the intervention period , blood pressure values were recorded in the electronic health records for 90 % and cholesterol values for 84 % of participants .


After intervention , the latest mean systolic blood pressure was 131.7 ( SD , 16.8 ) mm Hg in the control trial arm and 131.4 ( 16.7 ) mm Hg in the intervention trial arm , and adjusted mean difference was -0.56 mm Hg ( 95 % confidence interval , -1.38 to 0.26 ; P = 0.183 ) .


The financial cost of the trial was approximately US $ 22 per participant , or US $ 2400 per family practice allocated .


Large pragmatic intervention studies may be implemented at low cost by using electronic health records .


The intervention used in this trial was not found to be effective , and further research is needed to develop more effective intervention strategies .


http://www.controlled-trials.com .


Current Controlled Trials identifier : ISRCTN35701810 .


Introducing colonoscopy as part of colorectal cancer screening on a national level , we aimed at evaluating the efficacy of the two most common bowel cleansing agents , Moviprep ( ) and Phosphoral ( ) .


Secondly , we evaluated the benefit for the patient and society in terms of sick leave and discomfort .


In a single-blinded randomized equivalence trial , Phosphoral ( ) ( NaP ) was compared with Moviprep ( ) ( 2 l polyethylene glycol + ascorbic acid ) in patients undergoing colonoscopy due to suspicion of cancer .


Patients filled out questionnaires concerning stool consistency , discomfort and number of sick days due to bowel cleansing .


Blinded colonoscopists estimated the efficiency of the cleansing using the validated Harefield Cleansing Scale .


Two hundred and sixty-six patients were included 250 of whom underwent full colonoscopy .


There was no difference in the percentage of acceptable bowel cleansings in the two groups ; however , a significantly higher number of A scores were observed in the Moviprep ( ) group ( p = 0.028 ) .


We found no correlation between stool consistency and outcome of the cleansing and no difference in subjective discomfort during cleansing .


Vomiting during cleansing occurred more often in the Phosphoral ( ) group ( p = 0.002 ) .


There was a trend toward a smaller number of sick days in patients who used Moviprep ( ) compared with Phosphoral ( ) .


Moviprep ( ) and Phosphoral ( ) provided equally efficient bowel cleansing in 90 % of patients , but Moviprep ( ) provided a higher quality of cleansings graded as successful .


The two agents were equally tolerated , and no difference was found in the related number of sick days .


Improving health-related quality of life ( HRQoL ) is an important treatment goal in the management of patients with atrial fibrillation ( AF ) .


Uncertainty exists as to whether patients ' HRQoL differ when treated with medical rhythm control or rate control .


We compared HRQoL between patients treated with rhythm control or rate control in a large observational registry of patients with recent-onset AF .


In the Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation ( RECORD-AF ) , 2439 patients with recent onset ( < 1 year ) AF completed an AF-specific HRQoL questionnaire , the University of Toronto Atrial Fibrillation Severity Scale .


HRQoL was assessed by the AF symptom severity score ( 0-35 , with higher scores reflecting more severe AF-related symptoms ) at baseline and 1 year .


The minimal clinically important difference was defined as a change of 3 points .


The primary analysis was based on a propensity score-adjusted longitudinal regression analysis which compared the change in AF symptom severity scores between the 2 groups .


Over an average follow-up of 1 year , the AF symptom severity scores improved in both groups ( rhythm control : -2.82 point [ 95 % confidence interval , -3.22 to -2.41 ] ; rate control : -2.11 point [ 95 % confidence interval , -2.54 to -1.67 ] ; P < 0.01 for both groups ) .


The magnitude of improvement was higher in the rhythm control group than the rate control group ( unadjusted difference : -0.75 point ; 95 % confidence interval , -1.31 to -0.19 ; P = 0.01 ; propensity score-adjusted difference : -0.71 point ; 95 % confidence interval , -1.31 to -0.11 ; P = 0.02 ) .


In this observational cohort of recent-onset AF patients , treatment with medical rhythm - or rate control over 1 year was associated with an improvement in HRQoL .


The magnitude of HRQoL improvement was minimally higher in patients treated with rhythm control than rate control .


However , the overall degree of improvement was not large , and its clinical significance was uncertain .


To compare outcomes after 6-month maintenance treatment of adults diagnosed with obsessive-compulsive disorder ( OCD ) based on DSM-IV criteria who responded to acute treatment with serotonin reuptake inhibitors ( SRIs ) augmented by exposure and response prevention ( EX/RP ) or risperidone .


A randomized trial was conducted at 2 academic sites from January 2007 through December 2012 .


In the acute phase , 100 patients on therapeutic SRI dose with at least moderate OCD severity were randomized to 8 weeks of EX/RP , risperidone , or pill placebo .


Responders entered the 6-month maintenance phase , continuing the augmentation strategy they received acutely ( n = 30 EX/RP , n = 8 risperidone ) .


Independent evaluations were conducted every month .


The main outcome was the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) .


Intent-to-treat analyses indicated that , after 6-month maintenance treatment , EX/RP yielded OCD outcomes that were superior to risperidone ( Y-BOCS = 10.95 vs 18.70 ; t40 = 2.76 , P = .009 ) ; more patients randomized to EX/RP met response criteria ( Y-BOCS decrease 25 % : 70 % vs 20 % ; P < .001 ) and achieved minimal symptoms ( Y-BOCS 12 : 50 % vs 5 % ; P < .001 ) .


During maintenance , OCD severity decreased slightly in both conditions ( Y-BOCS decrease = 2.2 points , P = .020 ) .


Lower Y-BOCS at entry to maintenance was associated with more improvement in both conditions ( r38 = 0.57 , P < .001 ) .


OCD patients taking SRIs who responded to acute EX/RP or risperidone maintained their gains over 6-month maintenance .


Because EX/RP patients improved more during acute treatment than risperidone-treated patients , and both maintained their gains during maintenance , EX/RP yielded superior outcomes 6 months later .


The findings that 50 % of patients randomized to EX/RP had minimal symptoms at 6-month maintenance , a rate double that of prior studies , suggests that EX/RP maintenance helps maximize long-term outcome .


ClinicalTrials.gov identifier : NCT00389493 .


Examine women 's perceptions of what is ` normal ' and ` desirable ' in female genital appearance .


Experiment with random allocation across three conditions .


Community .


A total of 97 women aged 18-30years .


Women were randomly assigned to view a series of images of ( 1 ) surgically modified vulvas or ( 2 ) nonmodified vulvas , or ( 3 ) no images .


They then viewed and rated ten target images of surgically modified vulvas and ten of unmodified vulvas .


Women used a four-point Likert scale ( ` strongly agree ' to ` strongly disagree ' ) , to rate each target image for ` looks normal ' and ` represents society 's ideal ' .


For each woman , we created two summary scores that represented the extent to which she rated the unmodified vulvas as more ` normal ' and more ` society 's ideal ' than the modified vulvas .


For ratings of ` normality , ' there was a significant effect for condition ( F2 ,94 = 2.75 P = 0.007 , radj2 = 0.082 ) : women who had first viewed the modified images rated the modified target vulvas as more normal than the nonmodified vulvas , significantly different from the control group , who rated them as less normal .


For ratings of ` society 's ideal ' , there was again a significant effect for condition ( F2 ,92 = 7.72 , P < 0.001 , radj2 = 0.125 ) ; all three groups rated modified target vulvas as more like society 's ideal than the nonmodified target vulvas , with the effect significantly strongest for the women who had viewed the modified images .


Exposure to images of modified vulvas may change women 's perceptions of what is normal and desirable .


This may explain why some healthy women seek labiaplasty .


Chronic musculoskeletal pain is among the most prevalent , costly , and disabling medical disorders .


However , few clinical trials have examined interventions to improve chronic pain in primary care .


To determine the effectiveness of a telecare intervention for chronic pain .


The Stepped Care to Optimize Pain Care Effectiveness ( SCOPE ) study was a randomized trial comparing a telephone-delivered collaborative care management intervention vs usual care in 250 patients with chronic ( 3 months ) musculoskeletal pain of at least moderate intensity ( Brief Pain Inventory [ BPI ] score 5 ) .


Patients were enrolled from 5 primary care clinics in a single Veterans Affairs medical center from June 2010 through May 2012 , with 12-month follow-up completed by June 2013 .


Patients were randomized either to an intervention group ( n = 124 ) or to a usual care group whose members received all pain care as usual from their primary care physicians ( n = 126 ) .


The intervention group received 12 months of telecare management that coupled automated symptom monitoring with an algorithm-guided stepped care approach to optimizing analgesics .


Primary outcome was the BPI total score , which ranges from 0 ( `` no pain '' ) to 10 ( `` pain as bad as you can imagine '' ) and for which a 1-point change is considered clinically important .


Secondary pain outcomes included BPI interference and severity , global pain improvement , treatment satisfaction , and use of opioids and other analgesics .


Overall , mean ( SD ) baseline BPI scores in the intervention and control groups were 5.31 ( 1.81 ) and 5.12 ( 1.80 ) , respectively .


Compared with usual care , the intervention group had a 1.02-point lower ( 95 % CI , -1.58 to -0.47 ) BPI score at 12 months ( 3.57 vs 4.59 ) .


Patients in the intervention group were nearly twice as likely to report at least a 30 % improvement in their pain score by 12 months ( 51.7 % vs 27.1 % ; relative risk , 1.9 [ 95 % CI , 1.4 to 2.7 ] ) , with a number needed to treat of 4.1 ( 95 % CI , 3.0 to 6.4 ) for a 30 % improvement .


Secondary pain outcomes also improved .


Few patients in either group required opioid initiation or dose escalation .


Telecare collaborative management increased the proportion of primary care patients with improved chronic musculoskeletal pain .


This was accomplished by optimizing nonopioid analgesic medications using a stepped care algorithm and monitoring .


clinicaltrials.gov Identifier : NCT00926588 .


Regional anesthesia is a commonly used technique in orthopedic procedures .


Sedation should reduce the patient 's anxiety and fear while increasing regional anesthesia quality .


This study evaluated the hemodynamic changes , level of sedation , both patients ' and surgeons ' levels of satisfaction and potential side effects in patient-controlled sedation using propofol .


This randomized clinical trial studied sixty ASA physical class I-III patients scheduled for total knee replacement surgery under combined spinal-epidural anesthesia .


Patients in Group P ( n = 30 ) received propofol via a patient-controlled analgesia device with the following settings : intravenous propofol bolus dose 400 g.kg ( -1 ) , 5-minute lockout interval and no basal infusion .


In Group S , we infused saline 150 using the same settings .


To determine the level of sedation , we used BIS and Observer 's Assessment of Alertness / Sedation Scale .


For all patients , we recorded the number of requests .


As the fi nal evaluation , we scored surgeons ' and patients ' satisfaction on 4-point scales .


Both BIS values and OAA/S scores were lower in Group P than in Group S. Patients ' satisfaction was higher in Group P , although there was no significant difference with respect to surgeons ' satisfaction between the groups .


The number of requests for sedation was significantly higher in Group S. However , most requests were considered unsuccessful .


This study suggests that patient-controlled sedation with propofol can be used efficiently in orthopedic procedures .


The high number of adult males engaging in low levels of physical activity and poor dietary practices , and the health risks posed by these behaviors , necessitate broad-reaching intervention strategies .


Information technology ( IT ) - based ( Web and mobile phone ) interventions can be accessed by large numbers of people , yet there are few reported IT-based interventions targeting males ' physical activity and dietary practices .


This study examines the effectiveness of a 9-month IT-based intervention ( ManUp ) to improve the physical activity , dietary behaviors , and health literacy in middle-aged males compared to a print-based intervention .


Participants , recruited offline ( eg , newspaper ads ) , were randomized into either an IT-based or print-based intervention arm on a 2:1 basis in favor of the fully automated IT-based arm .


Participants were adult males aged 35-54 years living in 2 regional cities in Queensland , Australia , who could access the Internet , owned a mobile phone , and were able to increase their activity level .


The intervention , ManUp , was based on social cognitive and self-regulation theories and specifically designed to target males .


Educational materials were provided and self-monitoring of physical activity and nutrition behaviors was promoted .


Intervention content was the same in both intervention arms ; only the delivery mode differed .


Content could be accessed throughout the 9-month study period .


Participants ' physical activity , dietary behaviors , and health literacy were measured using online surveys at baseline , 3 months , and 9 months .


A total of 301 participants completed baseline assessments , 205 in the IT-based arm and 96 in the print-based arm .


A total of 124 participants completed all 3 assessments .


There were no significant between-group differences in physical activity and dietary behaviors ( P. 05 ) .


Participants reported an increased number of minutes and sessions of physical activity at 3 months ( exp ( ) = 1.45 , 95 % CI 1.09-1 .95 ; exp ( ) = 1.61 , 95 % CI 1.17-2 .22 ) and 9 months ( exp ( ) = 1.55 , 95 % CI 1.14-2 .10 ; exp ( ) = 1.51 , 95 % CI 1.15-2 .00 ) .


Overall dietary behaviors improved at 3 months ( exp ( ) = 1.07 , 95 % CI 1.03-1 .11 ) and 9 months ( exp ( ) = 1.10 , 95 % CI 1.05-1 .13 ) .


The proportion of participants in both groups eating higher-fiber bread and low-fat milk increased at 3 months ( exp ( ) = 2.25 , 95 % CI 1.29-3 .92 ; exp ( ) = 1.65 , 95 % CI 1.07-2 .55 ) .


Participants in the IT-based arm were less likely to report that 30 minutes of physical activity per day improves health ( exp ( ) = 0.48 , 95 % CI 0.26-0 .90 ) and more likely to report that vigorous intensity physical activity 3 times per week is essential ( exp ( ) = 1.70 , 95 % CI 1.02-2 .82 ) .


The average number of log-ins to the IT platform at 3 and 9 months was 6.99 ( SE 0.86 ) and 9.22 ( SE 1.47 ) , respectively .


The average number of self-monitoring entries at 3 and 9 months was 16.69 ( SE 2.38 ) and 22.51 ( SE 3.79 ) , respectively .


The ManUp intervention was effective in improving physical activity and dietary behaviors in middle-aged males with no significant differences between IT - and print-based delivery modes .


Australian New Zealand Clinical Trials Registry : ACTRN12611000081910 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000081910 ( Archived by WebCite at http://www.webcitation.org/6QHIWad63 ) .


To determine if there was a difference between patients participating in research and those who did not regarding their satisfaction with the medical encounter and their physician .


We prospectively randomized 128 patients to either complete 20 minutes of questionnaires ( participate in research ) or not .


After the visit , all patients rated their satisfaction with their visit and satisfaction with the doctor on an 11-point ordinal satisfaction scales , with 0 being not at all satisfied and 10 being completely satisfied .


Average satisfaction scores were analyzed in relation to demographics , questionnaires , and involvement in research .


There were no significant differences between patients that did and did not participate in research for satisfaction with the medical encounter or satisfaction with the treating physician .


Satisfaction was not associated with marital status , work status , or diagnosis .


There was a significant correlation between greater satisfaction and both less education and lower self-efficacy .


There was no significant correlation between patient satisfaction and magnitude of disability , pain intensity , or health anxiety .


This study demonstrated that patients ' participation in research can coexist with patient satisfaction .


Prognostic I.


A dietary regimen consisting of a clear liquid diet ( CLD ) for at least 24 hours is recommended for colonoscopy preparation .


However , this requirement results in problems in patient compliance with bowel preparation .


The aim of this study was to evaluate the efficacy of a CLD compared with a regular diet ( RD ) for colonoscopy preparation using a polyethylene glycol ( PEG ) solution .


This was a multicenter , randomized , investigator-blind prospective study .


A total of 801 healthy outpatients undergoing afternoon colonoscopy were randomized to either a CLD or RD in addition to a 4 L PEG regimen .


The quality of bowel cleansing was not different between the CLD and RD groups in terms of the proportion with excellent or good preparation .


In addition , no significant differences were observed between the two groups for polyp and adenoma detection rates and overall adverse events .


Good compliance with bowel preparation was higher in the RD group than in the CLD group .


A CLD for a full day prior to colonoscopy should not be mandatory for PEG-based bowel preparation .


Dietary education concerning the avoidance of high-fiber foods for 3 days before colonoscopy is sufficient , at least for healthy outpatients .


Impairments of memory are commonly reported by people with traumatic brain injuries ( TBI ) .


Such deficits are persistent , debilitating , and can severely impact quality of life .


Currently , many do not routinely receive follow-up appointments for residual memory problems following discharge .


This is a multi-centre , randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme .


Three hundred and twelve people with a traumatic brain injury will be randomised from four centres .


Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment , have memory problems , are 18 to 69 years of age , are able to travel to one of our centres and attend group sessions , and are able to give informed consent .


Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care .


Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme , which has been developed in previous pilot studies .


The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems .


All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation .


The primary outcome is the Everyday Memory Questionnaire at 6 months .


Secondary outcomes include the Rivermead Behavioural Memory Test-3 , General Health Questionnaire-30 , health related quality of life , cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire , individual goal attainment , European Brain Injury Questionnaire ( patient and relative versions ) , and the Everyday Memory Questionnaire-relative version .


The primary analysis will be based on intention to treat .


A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme .


The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI .


We discuss our decision-making regarding choice of outcome measures and control group , and the unique challenges to recruiting people with memory problems to trials .


ISRCTN65792154 ; Date : 18 October 2012 .


Cardiovascular disease is the major cause of death in hemodialysis patients .


Regular aerobic or intradialytic exercise may play a role in reducing cardiovascular mortality in these patients .


The aim of this study was to evaluate the relationship between intradialytic exercise and echocardiographic findings .


Forty patients were enrolled in the study from Shahrekord Hemodialysis Center .


They were randomly assigned into the exercise and control groups .


In the exercise group , the patients had a 30-minute exercise program per dialysis session , 3 times a week , for 3 months .


Electrocardiography and echocardiography were done at the beginning of the study and 3 months later .


The mean age and body mass index of the patients were 43.2 + / - 10.5 years and 21.7 + / - 5.4 kg/m2 , respectively .


Left ventricular ejection fraction increased and systolic pulmonary artery pressure and right ventricular size decreased significantly after the study in the exercise group patients .


Our results showed the improvement of cardiac systolic and diastolic function in patients who had physical exercise during dialysis sessions .


Regular intradialysis exercise can be suggested for hemodialysis patients without cardiac disease .


Vaccination is an effective strategy to prevent influenza .


This observer-blind , randomized study in children 10-17 years of age assessed whether the hemagglutination inhibition ( HI ) antibody responses elicited by H1N1/2009 vaccines adjuvanted with AS03 ( an adjuvant system containing - tocopherol and squalene in an oil-in-water emulsion ) or without adjuvant , met the European regulatory immunogenicity criteria at Days 21 and 182 .


Three hundred and ten healthy children were randomized ( 3:3:3:5 ) to receive one dose of 3.75 g hemagglutinin ( HA ) AS03A-adjuvanted vaccine , one or two doses of 1.9 g HA AS03B-adjuvanted vaccine , or one dose of 15 g HA pandemic vaccine .


All children received a booster dose of the allocated vaccine at Day 182 .


Serum samples were tested for HI antibody response at Days 21 , 42 , 182 and 189 .


All vaccination regimens elicited HI antibody responses that met the European regulatory criteria at Days 21 and 42 .


HI antibody responses fulfilling European regulatory criteria were still observed six months after the first vaccine dose in all study vaccines groups .


Two doses of 1.9 g HA AS03B-adjuvanted vaccine elicited the strongest HI antibody response throughout the study .


The non-adjuvanted 15 g HA vaccine elicited a lower HI antibody response than the AS03-adjuvanted vaccines .


At Day 189 , the European regulatory criteria were met for all vaccines with baseline HI antibody titers as reference .


An anamnestic response for all vaccines was suggested at Day 189 , based on the rapid increase in HI antibody geometric mean titers ( 1.5-2 .5 - fold increase ) .


Injection site reactogenicity was higher following the AS03-adjuvanted vaccines compared with the non-adjuvanted vaccine .


No safety concerns were identified for any study vaccine .


All study vaccines elicited HI antibody responses that persisted at purported protective levels through six months after vaccination and fulfilled the European regulatory criteria .


The importance of measuring blood pressure before morning micturition and in the afternoon , while working , is yet to be established in relation to the accuracy of home blood pressure monitoring ( HBPM ) .


To compare two HBPM protocols , considering 24-hour ambulatory blood pressure monitoring ( wakefulness ABPM ) as gold-standard and measurements taken before morning micturition ( BM ) and in the afternoon ( AM ) , for the best diagnosis of systemic arterial hypertension ( SAH ) , and their association with prognostic markers .


After undergoing 24-hour wakefulness ABPM , 158 participants ( 84 women ) were randomized for 3 - or 5-day HBPM .


Two variations of the 3-day protocol were considered : with measurements taken before morning micturition and in the afternoon ( BM+AM ) ; and with post-morning-micturition and evening measurements ( PM+EM ) .


All patients underwent echocardiography ( for left ventricular hypertrophy - LVH ) and urinary albumin measurement ( for microalbuminuria - MAU ) .


Kappa statistic for the diagnosis of SAH between wakefulness-ABPM and standard 3-day HBPM , 3-day HBPM ( BM+AM ) and ( PM+EM ) , and 5-day HBPM were 0.660 , 0.638 , 0.348 and 0.387 , respectively .


The values of sensitivity of ( BM+AM ) versus ( PM+EM ) were 82.6 % 71 % , respectively , and of specificity , 84.8 % 74 % , respectively .


The positive and negative predictive values were 69.1 % 40 % and 92.2 % 91.2 % , respectively .


The comparisons of intraclass correlations for the diagnosis of LVH and MAU between ( BM+AM ) and ( PM+EM ) were 0.782 0.474 and 0.511 0.276 , respectively .


The 3 day-HBPM protocol including measurements taken before morning micturition and during work in the afternoon showed the best agreement with SAH diagnosis and the best association with prognostic markers .


Glenohumeral subluxation is the most frequent complication in post stroke hemiplegia and its reduction has been considered an important goal .


Though it has been demonstrated that cyclical electrical stimulation of posterior deltoid and supraspinatus muscles can reduce subluxation , the role of biceps has not been given due consideration .


The purpose of this study was to determine whether electrical stimulation to the long head of biceps could more effectively reduce gleno humeral subluxation .


24 patients were selected and consecutively assigned to group 1 ( electrical stimulation to supraspinatus & posterior deltoid ) and group II ( electrical stimulation to supraspinatus , posterior deltoid & long head of the biceps ) along with routine physiotherapy and occupational therapy for a period of 5 weeks .


All patients were assessed for shoulder subluxation , pain and shoulder active abduction range of motion at the time of recruitment to study and after 5 weeks of therapy .


Both the groups showed significant improvement in parameters measured .


Tukey 's post hoc analysis showed the results were more significant in Group II .


Electrical stimulation to biceps along with the supraspinatus and posterior deltoid can more effectively reduce shoulder subluxation .


To evaluate the efficacy and safety of tamsulosin dose increase to 0.4 mg daily in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg treatment .


We carried out a 12-week , single-center , randomized , placebo-controlled trial in 220 patients .


Patients treated with 0.2 mg tamsulosin daily without other lower urinary tract symptoms secondary to benign prostatic hyperplasia medication for more than 3months and refractory to this treatment were enrolled .


We defined `` refractory '' as an International Prostate Symptom Score of 13 or greater and a maximum flow rate of 15 or under despite medication .


Patients with a surgical history related to lower urinary tract symptoms secondary to benign prostatic hyperplasia or a postvoid residual of 150mL or greater were excluded .


Eligible patients were randomly assigned to the 0.4 mg group ( two tablets of 0.2 mg tamsulosin once daily ) or the 0.2 mg group ( one tablet of 0.2 mg tamsulosin and one tablet of placebo once daily ) .


International Prostate Symptom Score , maximum flow rate , blood pressure , heart rate , and adverse events were compared between the two groups at 4weeks and 12weeks .


A total of 220 patients were enrolled and analyzed .


There were no differences in baseline characteristics between the two groups .


After 12weeks of medication , the International Prostate Symptom Score was not different between the two groups .


However , the improvement in maximum flow rate was greater in the 0.4 mg group than the 0.2 mg group ( 3.00.48 mL/s vs -0.250.30 mL/s , P < 0.01 ) .


The proportion of patients who showed an increase in maximum flow rate of more than 5mL/s was 10.9 % in the 0.2 mg group versus 16.3 % in the 0.4 mg group ( P = 0.209 ) .


There were no significant differences in bother score or postvoid residual between the two groups .


Systolic and diastolic blood pressure , and heart rate were also not different between the two groups .


The incidence of adverse events was 10.9 % in the 0.2 mg group ( dizziness 5.5 % ; abnormal ejaculation 1.8 % ; palpitation 1.8 % ; and headache 1.8 % ) and 9.09 % in the 0.4 mg group ( dizziness 3.6 % ; abnormal ejaculation 1.8 % ; palpitations 1.8 % ; and headache 1.8 % ) .


Tamsulosin 0.4 mg appears to be a safe treatment regimen for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia in Asian patients who do not respond to 0.2 mg treatment .


Increasing the dose of tamsulosin results in a significant improvement in maximum flow rate without any increase in cardiovascular complications .


Mechanisms for cancer related fatigue suggest that exercise but `` not too much and not too little '' could be effective .


This study aimed to investigate feasibility and estimate the potential effects of a walking exercise program in people with advanced cancer and fatigue .


A pilot randomized trial .


McGill University Health Centre ( MUHC ) , Montreal , Canada .


People with advanced cancer undergoing interdisciplinary assessment and rehabilitation with a fatigue level of 4 to 10 on a visual analogue scale .


An 8-week fatigue-adapted , walking intervention , facilitated using a pedometer ( STEPS ) , and offered at the same time as or after rehabilitation .


Measures of fatigue , physical function and well-being were administered at entry , and 8 , 16 and 24 weeks .


Generalized estimating equations ( GEE ) estimated the odds of response for people receiving the STEPS program in comparison to the odds of response in the controls ( odds ratio , OR ) .


Twenty-six persons were randomized to three groups : during rehabilitation , after rehabilitation , and usual care .


For the fatigue measures the OR for STEPS offered at any time using an intention-to-treat approach was 3.68 ( 95 % CI : 1.05-12 .88 ) ; for the physical function measures , the OR was 1.40 ( 95 % CI : 0.41 - 4.79 ) and 2.36 ( 95 % CI : 0.66-8 .51 ) for the well-being measures .


Fifty percent of eligible people were able to participate .


This small trial suggests that a personalized exercise program reduces fatigue and that 100 people are needed in a full strength trial .


Tuberculosis ( TB ) remains a global health problem , with vaccination likely to be a necessary part of a successful control strategy .


Results of the first Phase 2b efficacy trial of a candidate vaccine , MVA85A , evaluated in BCG-vaccinated infants were published last year .


Although no improvement in efficacy above BCG alone was seen , cryopreserved samples from this trial provide an opportunity to study the immune response to vaccination in this population .


We investigated blood samples taken before vaccination ( baseline ) and one and 28 days post-vaccination with MVA85A or placebo ( Candin ) .


The IFN - ELISpot assay was performed at baseline and on day 28 to quantify the adaptive response to Ag85A peptides .


Gene expression analysis was performed at all three timepoints to identify early gene signatures predictive of the magnitude of the subsequent adaptive T cell response using the significance analysis of microarrays ( SAM ) statistical package and gene set enrichment analysis .


One day post-MVA85A , there is an induction of inflammatory pathways compared to placebo samples .


Modules associated with myeloid cells and inflammation pre - and one day post-MVA85A correlate with a higher IFN - ELISpot response post-vaccination .


By contrast , previous work done in UK adults shows early inflammation in this population is not associated with a strong T cell response but that induction of regulatory pathways inversely correlates with the magnitude of the T cell response .


This may be indicative of important mechanistic differences in how T cell responses develop in these two populations following vaccination with MVA85A .


The results suggest the capacity of MVA85A to induce a strong innate response is key to the initiation of an adaptive immune response in South African infants but induction of regulatory pathways may be more important in UK adults .


Understanding differences in immune response to vaccination between populations is likely to be an important aspect of developing successful vaccines and vaccination strategies .


ClinicalTrials.gov number NCT00953927 .


To evaluate and analyze the mechanism of Pizhen for the treatment of patients with scapular muscle fasciitis .


One hundred and sixteen patients were divided into two groups according to random number table method , 58 cases in the treatment group and 58 cases in the control group .


After treatment , 109 patients were followed up , and 7 patients lost follow-up ( 2 cases in the treatment group and 5 patients in the control group ) .


In the treatment group , there were 15 males and 41 females , with a mean age of ( 28.02 + / - 4.85 ) years ; the course of disease ranged from 0.25 to 3 years ; and the patients were treated by Pizhen once a week , and 2 weeks were one treatment course .


In the control group , there were 19 males and 34 females , with a mean age of ( 27.23 + / - 4.54 ) years old ; the course of disease ranged from 0.25 to 1 year ; and the patients were treated by acupuncture massage instrument , 20 minutes at a time , once a day for 2 weeks .


Soft tissue displacement and banana area were tested by a soft tissue tension tester , pressure value was measured by pressure measuring instrument , and VAS was recorded by pain visual analog scale record .


There were significant differences in tissue displacement , banana area , pressure value and VAS between two groups before and after treatment .


The tissue displacement and pressure value in the treatment group were higher than those in the control group , while banana area and VAS were lower than those in the control group .


In the treatment group , 30 patients healed , 13 patients got marked improvement , 12 good and 1 poor ; while 16 patients healed , 19 patients got marked improvement ,11 good and 7 poor in the control group .


The therapeutic effects in the treatment group was better than that in the control group .


Pizhen is an effective method to treat pain in patients with scapular muscle fasciitis by relaxing tendon of soft tissue around pain point of scapular and relaxing compress and stimulation of nerves .


Peer support involves people in recovery from mental illness supporting their peers .


This mixed-methods pilot randomized control trial with qualitative interviews aimed to ( a ) compare peer support worker ( PSW ) and mental health worker ( MHW ) client outcomes and ( b ) provide estimates to inform the design of a larger study .


Fifteen adults living with a mental illness and receiving services at a community health team were randomly assigned to a PSW or a MHW group .


The Quality of Life Interview-Brief Version was administered at baseline and after 6 months of intervention .


Participants completed a semi-structured exit interview .


While both groups improved from baseline to 6 months , the PSW group did not improve more than the MHW group .


Interviews highlighted therapeutic alliance and boundaries .


This research adds to existing literature that PSWs produce outcomes similar to nonpeer staff and struggle with boundaries related to their unique role .


Adaptive support ventilation can speed weaning after coronary artery surgery compared with protocolized weaning using other modes .


There are no data to support this mode of weaning after cardiac valvular surgery .


Furthermore , control group weaning times have been long , suggesting that the results may reflect control group protocols that delay weaning rather than a real advantage of adaptive support ventilation .


Randomized ( computer-generated sequence and sealed opaque envelopes ) , parallel-arm , unblinded trial of adaptive support ventilation versus physician-directed weaning after adult fast-track cardiac valvular surgery .


The primary outcome was duration of mechanical ventilation .


Patients aged 18 to 80 yr without significant renal , liver , or lung disease or severe impairment of left ventricular function undergoing uncomplicated elective valve surgery were eligible .


Care was standardized , except postoperative ventilation .


In the adaptive support ventilation group , target minute ventilation and inspired oxygen concentration were adjusted according to blood gases .


A spontaneous breathing trial was carried out when the total inspiratory pressure of 15 cm H2O or less with positive end-expiratory pressure of 5 cm H2O .


In the control group , the duty physician made all ventilatory decisions .


Median duration of ventilation was statistically significantly shorter ( P = 0.013 ) in the adaptive support ventilation group ( 205 [ 141 to 295 ] min , n = 30 ) than that in controls ( 342 [ 214 to 491 ] min , n = 31 ) .


Manual ventilator changes and alarms were less common in the adaptive support ventilation group , and arterial blood gas estimations were more common .


Adaptive support ventilation reduces ventilation time by more than 2 h in patients who have undergone fast-track cardiac valvular surgery while reducing the number of manual ventilator changes and alarms .


Benign anorectal conditions are fairly common .


Physicians of various specialties usually see patients with these conditions before being referred to colorectal specialists , frequently with an incorrect diagnosis.We sought to evaluate the effect of attending an outpatient colorectal clinic by medical students on the diagnostic accuracy of these conditions .


Over a 1-year period , medical students were randomized into a group that attended the clinic , and one that did not .


Both groups were shown images of six common benign anorectal conditions .


The overall diagnostic accuracy as well as the diagnostic accuracy for each one of these conditions was prospectively evaluated for both groups .


Nineteen students attended clinic and 17 did not .


Overall diagnostic accuracy was 80.6 % for students attending clinic and 43.1 % for non-attending students .


( p < 0.05 ) In the attending group , diagnostic accuracy was significantly greater for prolapsed internal hemorrhoids ( 73.6 % versus 35.2 % , p < 0.05 ) , thrombosed external hemorrhoid , ( 73.6 % versus 17.6 % , p < 0.05 ) fissure ( 100 % versus 47 % , p < 0.05 ) , and anal tags ( 68.4 % versus 11.7 % , p < 0.05 % ) .


Exposure to these conditions during surgical clerkships in medical school may help future specialists provide better care for patients with benign anorectal disorders .


The AMANDYSK trial was designed to assess long-term efficacy of chronic treatment with amantadine in patients with Parkinson disease ( PD ) and levodopa-induced dyskinesia ( LID ) .


This was a 3-month , multicenter , randomized , double-blind , placebo-controlled , parallel-group , wash-out study conducted in 57 amantadine-treated ( 200 mg/d for 6 months ) dyskinetic patients with PD .


The primary outcome measure was the change from baseline in a Unified Parkinson 's Disease Rating Scale ( UPDRS ) dyskinesia subscore ( items 32 [ duration ] + 33 [ severity ] ) .


Secondary outcomes included other LID measurements ( `` responders '' analysis , premature dropout for LID , Abnormal Involuntary Movement Scale ) .


Exploratory outcomes included time with troublesome dyskinesia as measured by diaries , UPDRS Motor Examination ( part III ) for motor symptoms of PD , and fatigue and apathy scores for nonmotor symptoms .


UPDRS items 32 + 33 deteriorated more in patients switched to placebo ( `` discontinuing '' group ) ( +1.7 2.0 units ; 95 % confidence interval 0.9 , 2.4 ) as compared with those maintained on amantadine ( `` continuing '' group ) ( +0.2 1.5 units ; 95 % confidence interval -0.4 , 0.8 ; p = 0.003 ) .


Secondary outcomes confirmed this difference because there were significantly more responders , more dropouts for LID , greater increase in `` ON '' time with troublesome dyskinesia , and greater worsening of Abnormal Involuntary Movement Scale score in the discontinuing group .


There were no between-group differences in the UPDRS Motor Examination , whereas apathy ( as measured by caregivers ) and fatigue scores tended to worsen more in patients randomized to placebo .


Wash-out of amantadine in dyskinetic patients with PD significantly worsened LID .


No significant effect was observed on motor parkinsonian symptoms , while exploratory outcomes suggested that amantadine might improve apathy and fatigue in such patients .


This article provides Class II evidence that in patients with PD , withdrawing amantadine significantly aggravates LID in a median time of 7 days .


The U.S. Food and Drug Administration has requested post-market surveillance data , including data on metal ion levels , regarding metal-on-metal total hip arthroplasty .


We performed a prospective , randomized study of metal ion levels in erythrocytes , serum , and whole blood at five years after 28 and 36-mm metal-on-metal and 28-mm metal-on-polyethylene total hip arthroplasty .


One hundred and five enrolled patients were randomized equally to the three bearing surface options and were blinded with regard to their treatment group .


Metal ion measurements and clinical evaluations were performed at regular intervals .


Cobalt and chromium ion levels in all blood sample types at the five-year time point were significantly lower in the metal-on-polyethylene group than in each of the two metal-on-metal groups ( p < 0.001 ) with the exception of chromium in erythrocytes ( p = 0.194 ) .


Cobalt in serum ( p = 0.029 ) and erythrocytes ( p = 0.002 ) showed significant increases from two to five years in the 36-mm metal-on-metal group ; similar increases were not seen in the 28-mm metal-on-metal group .


At five years , five patients in the 36-mm metal-on-metal group and none in the 28-mm metal-on-metal group had cobalt or chromium levels of > 7 ppb .


Correlations among levels in serum , erythrocyte , and whole blood were stronger for cobalt than for chromium .


One patient in the 36-mm metal-on-metal group underwent revision because of an adverse local tissue reaction .


The 36-mm metal-on-metal bearing underperformed the 28-mm metal-on-metal bearing with respect to metal ion levels .


The authors are closely following all patients treated with metal-on-metal total hip arthroplasty .


The aim of this study was to assess the safety and tolerability , pharmacokinetics and pharmacodynamics of LY3000328 when administered as single escalating doses to healthy volunteers .


This was a phase 1 , placebo-controlled , dose escalation study with LY3000328 in 21 healthy male volunteers .


Subjects were administered escalating LY3000328 doses up to 300mg with food in this single dose study .


Blood samples were collected at set times post-dose for the assessment of LY3000328 pharmacokinetics and the measurement of cathepsin S ( CatS ) activity , CatS mass and calculated CatS specific activity .


All doses of LY3000328 were well tolerated , with linear pharmacokinetics up to the 300mg dose .


The pharmacodynamic activity of LY3000328 was measured ex vivo showing a biphasic response to LY3000328 , where CatS activity declines , then returns to baseline , and then increases to a level above baseline .


CatS mass was also assessed post-dose which increased in a dose-dependent manner , and continued to increase after LY3000328 had been cleared from the body .


CatS specific activity was additionally calculated to normalize CatS activity for changes in CatS mass .


This demonstrated the increase in CatS activity was attributable to the increase in CatS mass detected in plasma .


A specific inhibitor of CatS which is cleared quickly from plasma may produce a transient decrease in plasma CatS activity which is followed by a more prolonged increase in plasma CatS mass which may have implications for the future clinical development of inhibitors of CatS .


The clinical value of ischemic preconditioning ( IP ) on patients undergoing hepatectomy under portal triad clamping ( PTC ) is uncertain , especially for patients with liver cirrhosis .


Hence , we conducted a prospective randomized controlled trial to test whether IP could protect liver against ischemic reperfusion ( IR ) injury after hepatectomy under PTC .


One hundred patients , including 67 with cirrhosis , undergoing hepatectomy with PTC were randomly divided into IP and control groups .


Liver function tests at postoperative days 1 , 3 , and 7 as well as postoperative morbidity , mortality , and duration of hospitalization were compared between the two groups .


The general clinical characteristics between both groups were comparable .


The duration of the operation , the amount of intraoperative blood loss , and the need and amount of perioperative blood transfusion were similar in both groups .


The postoperative levels of serum alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , total bilirubin , and albumin were not statistically different between the two groups .


In addition , the morbidity and mortality rates and the duration of hospitalization were similar in both groups .


IP did not improve liver tolerance to IR injury after hepatectomy under PTC .


Therefore , the clinical use of IP can not be recommended as a standard procedure before PTC .


To assess the effects of renal impairment ( RI ) on the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus ( T2DM ) .


A cohort of Japanese patients with T2DM and mild to moderate RI and poor glycaemic control , despite diet/exercise therapy alone or diet/exercise therapy in combination with an oral hypoglycaemic agent ( an - glucosidase inhibitor , a sulfonylurea , or pioglitazone ) , were randomized in a double-blind manner to 50mg ipragliflozin or placebo once daily for 24weeks .


The patients continued open-label ipragliflozin for a 28-week extension period ( total treatment duration : 52weeks ) .


Ipragliflozin significantly decreased glycated haemoglobin ( HbA1c ) and fasting plasma glucose ( FPG ) levels and body weight from baseline to week 24 ( last observation carried forward ) compared with placebo in all patients with RI .


The decreases in HbA1c and FPG levels were statistically significant in patients with mild RI , but not in patients with moderate RI .


Ipragliflozin significantly reduced body weight in both RI groups .


The improvements in glycaemic control were maintained in the 28-week extension period .


Ipragliflozin was associated with no clinically significant safety concerns , and its safety profiles were not influenced by the severity of RI .


Ipragliflozin significantly improved glycaemic control and body weight in patients with T2DM with mild RI , but did not improve glycaemic control in patients with moderate RI .


Ipragliflozin is a valid treatment option for patients with mild RI but not those with moderate RI .


Use of granulocyte colony-stimulating factor ( G-CSF ) to treat damaged myocardium is a relatively new concept .


Clinical beneficial and safety outcomes are still controversial .


The aim of this study was to evaluate recruitment of hematopoietic stem cells and therapeutic efficacy of G-CSF in the treatment of myxomatous mitral valve disease ( MMVD ) of dogs .


Thirty client-owned MMVD dogs with clinical signs of heart failure were enrolled in a prospective double-blind , randomized , placebo-controlled study to compare the short-term effect of G-CSF ( n = 17 ) with control group ( n = 13 ) for identical periods .


Clinical , hematological , and cardiovascular assessments were performed on days 0 , 1 , 3 , and 7 .


Follow-up examination was conducted four weeks after the study .


Dogs treated with G-CSF had a significantly elevated white blood cell ( WBC ) ( 10 ( 3 ) / L ) count at day 3 compared with baseline ( from 10.23 4.42 to 42.84 11.84 ; P = .000 ) .


The WBC population was also changed ( elevated neutrophils and decreased lymphocytes ) and the numbers of CD34 + cells in the peripheral blood were also increased at day 3 .


However , the results of clinical , laboratory , and echocardiographic assessments did not differ significantly between the G-CSF treatment and control groups after four weeks .


G-CSF administration elevated the peripheral WBC count , especially neutrophils , and recruited hematopoietic stem cells .


However , positive effects of G-CSF on cardiac function were not detected during short-term monitoring .


Metabolic syndrome ( MetS ) is a clustering of metabolic risk factors for cardiovascular diseases and type 2 diabetes .


The study aimed to estimate the prevalence of MetS , its components , and their associations among rural middle-aged population in Vietnam .


A cross-sectional study with a representative sample ( n = 2443 ) was conducted to collect data on demographic , socioeconomic , anthropometric , lifestyles , plasma glucose , and lipid profile .


The age - and sex-adjusted prevalences of MetS and its components were calculated using the direct standardization .


Associations of risk factors with MetS were evaluated using logistic regression , taken into account the confounding factors .


The total age - and sex-adjusted prevalence ( 95 % CI ) of MetS was 16.3 % ( 14.0-18 .6 ) .


The most frequent component of MetS was high triglycerides ( 43.2 % ) , followed by low HDL-C ( 42.0 % ) , elevated blood pressure ( 29.2 % ) , high plasma glucose ( 14.3 % ) , and central obesity ( 12.3 % ) .


Of the total population , only 17.6 % did not have any component of MetS and more than 40 % had at least two MetS components .


The association of MetS with residence , age , body mass index , marital status , and siesta time per day was statistically significant in univariate analysis and replicated in multivariate analysis .


The MetS prevalence and its components are common and major public health burden in the middle-aged adults in Vietnam .


Habitants living in urban , being never-married , having an increase in age , BMI , and siesta time per day are significantly associated with MetS , and they should be paid much more attention for screening and implementing preventive activities .


Among infants born prematurely , competence at oral feeding is necessary for growth and hospital discharge .


Extremely preterm ( EP ) infants ( 28 weeks of gestational age [ GA ] ) are at risk for a variety of medical complications , which can limit the infant 's capacity to develop oral feeding competence .


This study examined feeding progression by assessing timing of acquisition of five early feeding milestones among EP infants and the impact of immaturity and medical complications .


A chart review was conducted for 94 EP infants who participated in a larger longitudinal randomized study .


Feeding progression was defined as infants ' postmenstrual age ( PMA ) at five milestones : first enteral feeding , full enteral feeding , first oral feeding , half oral feeding , and full oral feeding .


GA at birth and five medical complications ( neurological risk , bronchopulmonary dysplasia , necrotizing enterocolitis , patent ductus arteriosus , and gastroesophageal reflux disease ) were used as potential factors influencing the feeding progression .


Linear mixed models were used to examine feeding progression across the milestones and contributions of GA at birth and five medical complications on the progression , after controlling for milk type as a covariate .


EP infants gradually achieved feeding milestones ; however , the attainment of the feeding milestones slowed significantly for infants with younger GA at birth and the presence of medical complications , including neurological risk , bronchopulmonary dysplasia , necrotizing enterocolitis , and patent ductus arteriosus but not gastroesophageal reflux disease .


Milk type was a significant covariate for all analyses , suggesting that infants fed with breast milk achieved each of five milestones earlier than formula-fed infants .


Improved understanding of the timing of essential feeding milestones among EP infants and the contribution of specific medical conditions to the acquisition of these milestones may allow for more targeted care to support feeding skill development .


Gastrointestinal bleeding ( GIB ) is a common and often serious complication after stroke .


Although several risk factors for post-stroke GIB have been identified , no reliable or validated scoring system is currently available to predict GIB after acute stroke in routine clinical practice or clinical trials .


In the present study , we aimed to develop and validate a risk model ( acute ischemic stroke associated gastrointestinal bleeding score , the AIS-GIB score ) to predict in-hospital GIB after acute ischemic stroke .


The AIS-GIB score was developed from data in the China National Stroke Registry ( CNSR ) .


Eligible patients in the CNSR were randomly divided into derivation ( 60 % ) and internal validation ( 40 % ) cohorts .


External validation was performed using data from the prospective Chinese Intracranial Atherosclerosis Study ( CICAS ) .


Independent predictors of in-hospital GIB were obtained using multivariable logistic regression in the derivation cohort , and - coefficients were used to generate point scoring system for the AIS-GIB .


The area under the receiver operating characteristic curve ( AUROC ) and the Hosmer-Lemeshow goodness-of-fit test were used to assess model discrimination and calibration , respectively .


A total of 8,820 , 5,882 , and 2,938 patients were enrolled in the derivation , internal validation and external validation cohorts .


The overall in-hospital GIB after AIS was 2.6 % , 2.3 % , and 1.5 % in the derivation , internal , and external validation cohort , respectively .


An 18-point AIS-GIB score was developed from the set of independent predictors of GIB including age , gender , history of hypertension , hepatic cirrhosis , peptic ulcer or previous GIB , pre-stroke dependence , admission National Institutes of Health stroke scale score , Glasgow Coma Scale score and stroke subtype ( Oxfordshire ) .


The AIS-GIB score showed good discrimination in the derivation ( 0.79 ; 95 % CI , 0.764-0 .825 ) , internal ( 0.78 ; 95 % CI , 0.74-0 .82 ) and external ( 0.76 ; 95 % CI , 0.71-0 .82 ) validation cohorts .


The AIS-GIB score was well calibrated in the derivation ( P = 0.42 ) , internal ( P = 0.45 ) and external ( P = 0.86 ) validation cohorts .


The AIS-GIB score is a valid clinical grading scale to predict in-hospital GIB after AIS .


Further studies on the effect of the AIS-GIB score on reducing GIB and improving outcome after AIS are warranted .


To assess the immediate effect of a suboccipital muscle inhibition ( SMI ) technique on : ( a ) neck pain , ( b ) elbow extension range of motion during the upper limb neurodynamic test of the median nerve ( ULNT-1 ) , and ( c ) grip strength in subjects with cervical whiplash ; and determine the relationships between key variables .


Randomised , single-blind , controlled clinical trial .


Faculty of Nursing , Physiotherapy and Podiatry , University of Seville , Spain .


Forty subjects { mean age 34 years [ standard deviation ( SD ) 3.6 ] } with Grade I or II cervical whiplash and a positive response to the ULNT-1 were recruited and distributed into two study groups : intervention group ( IG ) ( n = 20 ) and control group ( CG ) ( n = 20 ) .


The IG underwent the SMI technique for 4minutes and the CG received a sham ( placebo ) intervention .


Measures were collected immediately after the intervention .


The primary outcome was elbow range of motion during the ULNT-1 , measured with a goniometer .


The secondary outcomes were self-perceived neck pain ( visual analogue scale ) and free-pain grip strength , measured with a digital dynamometer .


The mean baseline elbow range of motion was 116.0 ( SD 10.2 ) for the CG and 130.1 ( SD 7.8 ) for the IG .


The within-group comparison found a significant difference in elbow range of motion for the IG [ mean difference -15.4 , 95 % confidence interval ( CI ) -20.1 to -10.6 ; P = 0.01 ] , but not for the CG ( mean difference -4.9 , 95 % CI -11.8 to 2.0 ; P = 0.15 ) .


In the between-group comparison , the difference in elbow range of motion was significant ( mean difference -10.5 , 95 % CI -18.6 to -2.3 ; P = 0.013 ) , but the differences in grip strength ( P = 0.06 ) and neck pain ( P = 0.38 ) were not significant .


The SMI technique has an immediate positive effect on elbow extension in the ULNT-1 .


No immediate effects on self-perceived cervical pain or grip strength were observed .


A growing number of elderly patients with end-stage renal disease start dialysis .


We examined elderly ( 65 years ) patients ' views about their decision-making experience after starting dialysis in comparison with patients aged 50-64 years , and patients 49 years .


Ninety-nine patients from 15 outpatient dialysis centers in North Carolina , USA completed a semi-structured interview asking them about the context of decision-making and their decision-making experience , and a 10-item investigator-developed Informed Decision-Making ( IDM ) questionnaire with binary response options ( yes/no ) .


While IDM scores were low for all three groups ( < 5 out of 10 ) , they were significantly lower for the older group compared to the other two younger groups ( p = 0.02 ) .


A significantly lower percentage of the older group said that the doctor explained underlying conditions that led to kidney failure ( p = 0.04 ) , the impact of dialysis on daily life ( p = 0.04 ) , and the life-long need for dialysis ( p < 0.01 ) , and that the doctor tried to make sure the patient understood the information ( p = 0.01 ) .


Also a significantly higher percentage of elderly patients felt the decision was made by the doctor rather than on their own or with their family , or collaboratively with the doctor ( p = 0.04 ) .


Informed decision-making is significantly poorer in patients aged 65 years or older than in younger patients .


Clinicians should communicate clearly about the benefits and burdens of dialysis to older adults and provide an opportunity for them to understand the significant trade-offs that dialysis may require .


The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer ( NSCLC ) regardless of histologic subtype .


NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous ( NS ) NSCLC by assessing the feasibility of this doublet ( ratio 1:2 ) in an investigational approach .


A reference arm with pemetrexed plus cisplatin was included .


Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC .


Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m ( 2 ) and cisplatin 75 mg/m ( 2 ) on day 1 ( arm A ) or oral vinorelbine 80 mg/m ( 2 ) on days 1 and 8 ( first cycle 60 mg/m ( 2 ) ) and cisplatin 80 mg/m ( 2 ) on day 1 ( arm B ) .


After 4 cycles , patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine .


Overall , 153 patients were randomized ( arm A/arm B : 51/102 ) .


Disease control rate ( % ) for arm A was 76.5 ( 95 % confidence interval [ CI ] , 62.5-87 .2 ) and for arm B it was 75.0 ( 95 % CI , 65.3-83 .1 ) , Response rates for arm A were 31.4 % ( 95 % CI , 19.1-45 .9 ) and for arm B were 24.0 % ( 95 % CI , 16.0-33 .6 ) .


Median progression-free survival for arm A was 4.3 months ( 95 % CI , 3.8-5 .6 ) and for arm B it was 4.2 months ( 95 % CI , 3.6-4 .7 ) .


Median survival for arm A was 10.8 months ( 95 % CI , 7.0-16 .4 ) and for arm B it was 10.2 months ( 95 % CI , 7.8-11 .9 ) .


Main grade 3/4 hematologic toxicities were neutropenia 18.3 % ( arm A ) and 44.0 % ( arm B ) , whereas febrile neutropenia was reported in 2 % of patients in each arm .


Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin , coupled with an acceptable safety profile .


To compare radiation exposure of nurses when performing nursing tasks associated with interventional procedures depending on whether or not the nurses called out to the operator before approaching the patient .


In a prospective study , 93 interventional radiology procedures were randomly divided into a call group and a no-call group ; there were 50 procedures in the call group and 43 procedures in the no-call group .


Two monitoring badges were used to calculate effective dose of nurses .


In the call group , the nurse first told the operator she was going to approach the patient each time she was about to do so .


In the no-call group , the nurse did not say anything to the operator when she was about to approach the patient .


In all the nursing tasks , the equivalent dose at the umbilical level inside the lead apron was below the detectable limit .


The equivalent dose at the sternal level outside the lead apron was 0.16 Sv 0.41 per procedure in the call group and 0.51 Sv 1.17 per procedure in the no-call group .


The effective dose was 0.018 Sv 0.04 per procedure in the call group and 0.056 Sv 0.129 per procedure in the no-call group .


The call group had a significantly lower radiation dose ( P = .034 ) .


Radiation doses of nurses were lower in the group in which the nurse called to the operator before she approached the patient .


To characterize preinjection intraocular pressure ( IOP ) in eyes receiving monthly ranibizumab versus sham or verteporfin photodynamic therapy ( PDT ) for age-related macular degeneration ( AMD ) .


Post hoc analysis of IOP data from 2 phase 3 clinical trials , the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD ( MARINA ) and the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD ( ANCHOR ) trial .


All safety-evaluable patients who received 1 or more injections of sham or PDT or of ranibizumab and had 1 or more postbaseline IOP measurements recorded for the study eye .


Preinjection IOP measurements for study eyes ( n = 1125 ) and fellow eyes in MARINA and ANCHOR at baseline and at each monthly visit through month 24 were analyzed .


End points evaluated were maximum preinjection IOP during the 24-month treatment period ; any occurrence of absolute preinjection IOP of 21 mmHg or more , 25 mmHg or more , or 30 mmHg or more ; any occurrence of IOP increase of 6 mmHg or more , 8 mmHg or more , or 10 mmHg or more from baseline ; any combination of IOP increase of 6 mmHg or more or 8 mmHg or more from baseline with concurrent absolute preinjection IOP of 21 mmHg or more or 25 mmHg or more ; glaucoma-related adverse events ; new glaucoma medications used for 45 days or more ; and glaucoma filtration or laser surgeries .


Across treatment groups , 60.1 % to 70.9 % of study eyes had a maximum preinjection IOP of less than 21 mmHg .


Comparing ranibizumab 0.5 mg versus sham or PTD treatment , respectively : 39.9 % versus 29.1 % and 10.9 % versus 5.1 % had maximum preinjection IOPs of 21 mmHg or more or 25 mmHg or more , respectively ; 44.1 % versus 29.9 % and 24.2 % versus 13.6 % had IOP increases from baseline of 6 mmHg or more or 8 mmHg or more , respectively ; 26.1 % versus 13.6 % and 16.8 % versus 9.0 % had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , respectively , with a concurrent IOP of 21 mmHg or more ; 9.6 % versus 3.7 % and 7.5 % versus 2.4 % had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , respectively , with a concurrent IOP of 25 mmHg or more .


No differences were observed in fellow eyes .


Most ranibizumab-treated eyes did not experience sustained preinjection IOP of 21 mmHg or more ( > 2 consecutive visits ) over 24 months .


When evaluating the combined IOP end point , more ranibizumab-treated eyes had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more , with concurrent highest IOPs of 21 mmHg or more and 25 mmHg or more versus sham or PDT .


Intraocular pressure should be monitored in eyes receiving ranibizumab .


Depressive and anxiety disorders are highly prevalent , but only a small percentage ( approximately 50 % ) of patients receive appropriate treatment .


Relevant barriers include communication and coordination gaps between different providers that result from the lack of integration between different care-giving systems .


Aftercare following inpatient treatment represents one of these gaps because systematic follow-up care does not exist .


Case management-based aftercare coordination by phone might be a promising approach to overcoming this gap and improving long-term treatment outcomes .


Case management is a patient-centered and situation-based approach comprising systematic tracking and support of patients by a case manager .


The aim of this study is to evaluate the effectiveness of aftercare coordination by phone for patients with depressive and anxiety disorders .


The effectiveness of aftercare coordination will be investigated in a prospective randomized controlled trial in four psychotherapeutic inpatient routine care units ( St. Franziska-Stift Bad Kreuznach , MediClin Seepark Klinik Bad Bodenteich , Segeberger Kliniken Gruppe Bad Segeberg and Luisenklinik Bad Drrheim ) .


The patients receiving aftercare coordination ( intervention group ; IG ) will be compared with those who receive treatment as usual ( TAU control group ; CG ) .


Eligible patients will be required to have a diagnosis of an anxiety and/or depressive disorder and a recommendation for follow-up outpatient psychotherapy .


The aftercare coordination consists of six phone contacts at intervals of two weeks that are performed by therapists in the inpatient units .


The patients will complete questionnaires at discharge ( t1 ) , 3months after discharge ( i.e. , at the end of the intervention ( t2 ) ) and 9months after discharge ( t3 ) .


The primary outcome will be change in symptom severity from t1 to t3 , the secondary outcomes will be health-related quality of life and the proportion of patients who manage to begin outpatient psychotherapy by t3 .


This study will determine whether case management-based aftercare coordination by phone is an adequate approach for overcoming treatment barriers in the clinical pathways of patients with depressive and anxiety disorders .


If proven effective , an accessible supplementary treatment approach that will help to maintain and even improve long-term treatment outcomes will be made available for patients following inpatient treatment .


ClinicalTrials.gov : ( NCT02044913 ) .


To investigate whether repetitive sessions of formative self-testing ( RFST ) result in an equal cardiopulmonary resuscitation ( CPR ) skill level compared to repetitive sessions of formative self-testing with additional practice ( RFSTAP ) .


In a non-inferiority trial , 196 third-year medical students were randomised to an RFST or RFSTAP group .


Testing and practising took place in a self-learning station equipped with a manikin connected to a computer .


Each cycle of RFST consisted of a 2-min CPR test followed by feedback and feedforward .


In the RFSTAP group , additional practice consisted of CPR exercises with a computer voice feedback .


To be successful , a combined score consisting of 70 % compressions with a depth of 50 mm and 70 % compressions with complete release ( < 5 mm ) and a compression rate of 100-120 min ( -1 ) and 70 % ventilations with a volume of 400-1000 ml had to be achieved within 6 weeks .


Skill retention was measured after 6 months .


The non-inferiority margin was predefined as a 10 % difference in success rate .


After six weeks the success rate in both groups was 96 % : 99/103 ( RFST ) and 89/93 ( RFSTAP ) .


After 6 months , the success rate in the competent students was 26/96 ( 27 % ) for RFST and 32/86 ( 37 % ) for RFSTAP ( three students dropped out in each group ) .


The difference in the success rate between RFSTAP and RFST was 10 % and 90 % ( CI -2 to 23 % ) , respectively .


As the upper bound exceeded 10 % , non-inferiority was inconclusive .


For each CPR skill separately , RFST was non-inferior for ventilation and complete release , superior for compression depth and inferior for compression rate .


RFST and RFSTAP were equally effective to refresh skills within 6 weeks .


After 6 months , non-inferiority was inconclusive for the combined score .


Our results indicate the potential of RFST to refresh CPR skills .


Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory .


In the absence of long-term data on hard outcomes , we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis , and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years .


In a pragmatic , cluster-randomized , parallel-group trial in Denmark , the Netherlands and the UK , 3057 people with screen-detected Type 2 diabetes were randomized by general practice to receive ( 1 ) routine care of diabetes according to national guidelines ( 1379 patients ) or ( 2 ) intensive multifactorial target-driven management ( 1678 patients ) .


Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospective Diabetes Study Risk Engine ( version 3 ) .


Among 2101 individuals with complete data at follow up ( 73.4 % ) , 10-year modelled cardiovascular disease risk was 27.3 % ( sd 13.9 ) at baseline and 21.3 % ( sd 13.8 ) at 5-year follow-up ( intensive treatment group difference -6.9 , sd 9.0 ; routine care group difference -5.0 , sd 12.2 ) .


Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years , after adjustment for baseline cardiovascular disease risk and clustering ( -2.0 ; 95 % CI -3.1 to -0.9 ) .


Despite increasing age and diabetes duration , there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis .


Compared with routine care , 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years .


Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory , where the rate of cardiovascular disease risk progression may be slowed .


To explore the difference in the efficacy and effect mechanism of subcortical ischemic vascular disease ( SIVD ) complicated with depression between acupuncture and medication .


Sixty patients were randomized-into an acupuncture group and a medication group , 30 cases in each one .


In the acupuncture group , acupuncture was applied to Baihui ( GV 20 ) , Shuigou ( GV 26 ) , Fengfu ( GV 16 ) , Fengchi ( GB 20 ) and the others , once a day , 6 times a week .


The treatment of 4 weeks made one session and totally 2 sessions were required .


In the medication group , nimodipine 30 mg , three times a day and fluoxetine 20 mg , once a day were prescribed for oral administration , for 8 weeks totally .


Before treatment , at the end of the 4th week and at the end of the 8th week of treatment , cerebral blood flow velocity ( CBFV ) and solubility CD40 ligand ( sCD40L ) were determined respectively .


The scores in Montreal cognitive assessment ( MoCA ) and Hamilton ' s depression scale ( HAMD ) were evaluated in the two groups .


The efficacies on cognitive function and depression symptoms were compared in the patients between the two groups .


Results Compared with the outcome before treatment , mean blood flow velocity ( Vm ) of middle cerebral artery ( MCA ) , anterior cerebral artery ( ACA ) and posterior cerebral artery ( PCA ) was increased significantly at the end of the 4th week of treatment in the two groups ( all P < 0.05 ) .


At the end of the 8th week , Vm was increased much significantly ( all P < 0.01 ) .


The differences were not significant in comparison between the two groups ( all P > 0.05 ) .


Compared with the expression before treatment , sCD40L was reduced significantly after treatment in the patients of the two groups ( all P < 0.01 ) , but the differ - ence was not significant between the two groups ( all P > 0.05 ) .


Compared with that before treatment , MoCA score was increased significantly after treatment in the two groups ( all P < 0.01 ) , HAMD score was reduced sig - nificantly ( all P < 0.01 ) , the differences were not significant in comparison between the two groups ( all P > 0.05 ) .


The total effective rate of cognitive improvement was 86.7 % ( 26/30 ) in the acupuncture group and was 80.0 % ( 24/30 ) in the medication group , the differences were not significant in comparison of the two groups ( P > 0.05 ) .


The total effective rate of the improvement in depression was 93.3 % ( 21/30 ) in the acupuncture group and was 86.7 % ( 26/30 ) in the medication group , the differences were not significant in comparison of the two groups ( P > 0.05 ) .


Acupuncture could significantly increases CBFV and reduces serum sCD40L expressions in the patients of SIVD complicated with depression , and significantly improves cognitive function and relieves depression symptoms .


The efficacy of it is similar to that of western medication .


The increase of serum sCD40L expression is possibly involved in the occurrence and development of SIVD .


Reducing sCD40L expression contributes to the alleviation of damage induced by cerebral ischemia and reperfusion .


Randomized trial evidence on the risk/benefit ratio of thrombolysis for mild stroke is limited .


We sought to determine the efficacy of intravenous recombinant tissue-type plasminogen activator ( IV r-tPA ) in a subset of patients with mild deficit in the third International Stroke Trial ( IST-3 ) .


IST-3 compared IV r-tPA with control within 6 hours of onset in patients for whom IV r-tPA was considered promising but unproven .


Analysis was restricted to subjects randomized within 3 hours of onset with a baseline National Institutes of Health Stroke Scale 5 , pretreatment blood pressure < 185/110 , and no other r-tPA exclusion criteria .


We compared r-tPA and control arms for primary ( Oxfordshire Handicap Score [ OHS ] 0-2 ) and secondary ( ordinal OHS and OHS 0-1 ) outcomes at 6 months .


Among 3035 IST-3 subjects , 612 ( 20.2 % ) had an National Institutes of Health Stroke Scale 5 ; of these 106 ( 17.6 % ) met the restricted criteria .


Allocation to r-tPA was associated with an increase in OHS 0 to 2 ( 84 % r-tPA versus 65 % control ; adjusted odds ratio , 3.31 ; 95 % confidence interval , 1.24-8 .79 ) and a favorable shift in OHS distribution ( adjusted odds ratio , 2.38 ; 95 % confidence interval , 1.17-4 .85 ) .


There was no significant effect of r-tPA on OHS 0 to 1 ( 60 % versus 51 % ; adjusted odds ratio , 1.92 ; 95 % confidence interval , 0.83-4 .43 ) .


This post hoc analysis in a highly selected sample of IST-3 supports the rationale of A Study of the Efficacy and Safety of Activase ( Alteplase ) in Patients With Mild Stroke ( PRISMS ) trial-a randomized , phase IIIb study to evaluate IV r-tPA in mild ischemic stroke .


The ACS1 ( Azilsartan Circadian and Sleep Pressure - the first study ) is a multicenter , randomized , open-label , two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg .


The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group ( n = 350 ) or an amlodipine group ( n = 350 ) .


The primary endpoint is a change in nocturnal systolic blood pressure ( BP ) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period .


In addition , we will carry out the same analysis after dividing four different nocturnal BP dipping statuses ( extreme-dippers , dippers , nondipper , and risers ) .


The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm .


Intrathecal morphine-induced pruritus is a very common side-effect that is difficult to prevent or treat .


Central and peripheral mechanisms are believed to be involved .


The aim of this study was to determine if a peripherally acting , - opioid antagonist would reduce morphine-induced pruritus .


We conducted a multicentre , randomized , blinded , placebo-controlled trial of women having elective Caesarean section under spinal anaesthesia with intrathecal morphine 100 g.


After delivery , participants received either subcutaneous methylnatrexone bromide 12 mg ( MNTX group , n = 69 ) or saline ( placebo group , n = 68 ) .


Pruritus , nausea , pain , analgesic use , and side-effects were assessed at 2 , 4 , 8 , and 24 h.


The primary outcome was the severity of pruritus ( 0-10 score ) .


One hundred and thirty-seven women completed the study , with five major protocol violations .


There was no statistically significant difference between the MNTX and placebo groups for the median ( IQR ) pruritus AUC scores [ 24 ( 9-47 ) vs 36 ( 11-68 ) , median difference 8.5 , 95 % confidence interval ( CI ) 0-20 , P = 0.09 ] or the worst pruritus score [ 3 ( 2-7 ) vs 5 ( 2-6 ) , median difference 1 , 95 % CI 0-2 , P = 0.24 ] .


The incidence of pruritus was 84 % in the MNTX group and 88 % in the placebo group ( P = 0.48 ) .


Analgesic and gastrointestinal outcomes did not significantly differ between the groups .


A single dose of subcutaneous methylnaltrexone bromide 12 mg did not reduce the overall severity or incidence of pruritus .


In this study , treatment with a peripherally acting - opioid antagonist was generally ineffective against intrathecal morphine-induced pruritus , but a small clinical effect can not be excluded .


Australian New Zealand Clinical Trials Registry ( ACTRN12611000345987 ) .


To compare the efficacy of different treatment strategies for distal ureteral stones smaller than 10 mm .


A total 127 patient were included in the study .


Based on the treatment modality , patients were divided into three groups.Patients in group 1 only received conventional treatment including daily hydration of 2500 mL , ciprofloxacin , diclofenac sodium and a spasmolytic agent ; group 2 patients received conventional treatment ( daily hydration of 2500 mL , ciprofloxacin , diclofenac sodium and a spasmolytic agent ) and tamsulosin 0.4 mg orally daily for 4 weeks ; and group 3 patients underwent ureteroscopy .


Patients were further subdivided into 2 categories based on maximum stone diameter : category A ( less than 5 mm ) and category B ( 5.0-9 .9 mm ) .


Following treatment , all groups were compared in terms of stone-free rate and time to expulsion .


Following treatment , the stone-free rates for groups 1 , 2 and 3 were 48.7 % , 59.5 % and 95.6 % , respectively ( P < .0001 ) .


The mean expulsion times for groups 1 , 2 and 3 were 15.3 5.33 , 15.1 5.5 and 1.95 2.2 days , respectively ( P < .001 ) .


Compared to the other treatments , the stone-free rate and mean expulsion time in the ureteroscopy group were significantly increased and decreased , respectively .


There are several treatment options for distal ureteral stones .


Based on our data , we conclude that ureterorenoscopy should be the standard of care for distal ureteral stones smaller than 10 mm .


To evaluate if a supervised exercise training program improves the quality of life ( QoL ) of differentiated thyroid carcinoma ( DTC ) patients on TSH-suppressive therapy with levothyroxine ( L-T4 ) .


Initially , a cross-sectional study was performed to compare the QoL and the health-related quality of life ( HRQoL ) between subclinical hyperthyroidism ( SCH ) patients ( n = 33 ) and euthyroid subjects ( EU ; n = 49 ) .


In the prospective phase of the study , SCH patients were randomized in a non-blinded fashion to either participate ( SCH-Tr = trained patients ; n = 16 ) or not ( SCH-Sed = untrained patients ; n = 17 ) in a supervised exercise training program .


The exercise program consisted of 60 minutes of aerobic and stretching exercises , twice a week , during twelve weeks .


The QoL was assessed by the application of the WHOQOL-Bref , and the SF-36 was used to assess the HRQoL .


SCH patients had statistically lower scores than EU on the `` physical '' domain of WHOQOL-Bref , besides `` physical function '' , `` role-physical '' , `` bodily pain '' , `` general health '' , `` vitality '' , `` role-emotional '' , and `` mental-health '' domains of SF-36 .


After three months , SCH-Tr patients showed improvement in the `` physical '' and `` psychological '' domains of WHOQOL-Bref ( p < 0.05 ) , and in the `` physical function '' , `` role-physical '' , `` bodily pain '' , `` vitality '' and `` mental health '' domains of SF-36 .


Patients on TSH-suppressive therapy with L-T4 for DTC had impaired QoL and HRQoL compared to EU , but it was improved after 3-months of an exercise training program .


Exercise seems to play an important role in the follow-up of DTC patients , since it seems to minimize the adverse effects of the treatment on QoL and HRQoL .


The long-term efficacy of - blockers in patients with and without myocardial infarction ( MI ) is controversial .


This is post hoc analysis from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization , Management , and Avoidance ( CHARISMA ) trial of 4772 patients with prior MI , 7804 patients with known atherothrombosis , and 2101 patients with risk factors alone but without heart failure .


Primary outcome was a composite of nonfatal MI , stroke , or cardiovascular mortality .


The cohorts were divided into 2 groups based on baseline - blocker use .


In the propensity score-matched prior MI cohort , after 28 months of follow-up , - blocker use was associated with a 31 % lower risk of the primary outcome ( 70 [ 7.1 % ] versus 100 [ 10.2 % ] ; hazards ratio , 0.69 ; 95 % confidence interval , 0.50-0 .94 ; P = 0.021 ) , driven by a lower risk of recurrent MI ( 33 [ 3.4 % ] versus 48 [ 4.9 % ] ; hazards ratio , 0.62 ; 95 % confidence interval , 0.39-1 .00 ; P = 0.049 ) with no difference in mortality ( 52 [ 5.3 % ] versus 66 [ 6.7 % ] ; P = 0.20 ) .


In the known atherothrombotic disease and the risk factors alone cohorts , - blocker use was not associated with lower ischemic outcomes , whereas a trend toward a higher risk of stroke ( 3.5 % versus 1.5 % ; hazards ratio , 2.13 ; 95 % confidence interval , 0.92-4 .92 ; P = 0.079 ) was observed in the risk factors alone cohort .


This higher stroke risk was significant in the regression model adjusted to the propensity score ( hazards ratio , 2.69 ; 95 % confidence interval , 1.33-5 .44 ; P = 0.006 ) and in the multivariable models .


- blocker use in patients with prior MI but no heart failure was associated with a lower composite cardiovascular outcome driven by lower risk of recurrent MI with no difference in mortality .


However , - blocker use was not associated with lower cardiovascular events in those without MI , with a suggestion of inferior outcome with regard to stroke risk .


http://www.clinicaltrials.gov .


Unique identifier : NCT00050817 .


In Denmark 8,000 to 10,000 people will attempt suicide each year .


The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior , and a recent survey has shown that 30 % of the patients are suffering from borderline personality disorder .


The majority of patients ( 70 % to 75 % ) with borderline personality disorder have a history of deliberate self-harm and 10 % have a lifetime risk to die by suicide .


The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy , for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder .


Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual .


The trial is designed as a single-center , two-armed , parallel-group observer-blinded randomized clinical superiority trial .


We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention , Capital Region of Denmark .


Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence .


The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy , where the duration treatment will vary in accordance with established methods up to 16 weeks .